APPARATUS, SYSTEMS, AND METHODS FOR
CONSTRAINING AND/OR SUPPORTING TISSUE
STRUCTURES ALONG AN AIRWAY
Related Applications
This application claims the benefit of U.S.
Provisional Patent Application Serial No. 61/201,256
filed 9 December 2008, and entitled "Apparatus, Systems,
and Methods for Constraining and/or Supporting Tissue
Structures Along An Airway," which is incorporated herein
by reference. This application also claims the benefit of
U.S. Provisional Patent Application Serial No. 61/276,222
filed 9 September 2009, and entitled "Apparatus, Systems,
and Methods for Constraining and/or Supporting Tissue
Structures Along An Airway," which is also incorporated
herein by reference.
Background of the Invention
The Greek word "apnea" literally means "without
breath." People with untreated sleep apnea stop breathing
repeatedly during their sleep, sometimes hundreds of
times during the night and often for a minute or longer.
Obstructive sleep apnea (OSA) is the most common
category of sleep-disordered breathing. The muscle tone
of the body ordinarily relaxes during sleep. At the level
of the throat, the human airway is composed of
collapsible walls of soft tissue which can obstruct
breathing during sleep. Mild, occasional sleep apnea,
such as many people experience during an upper
respiratory infection may not be important, but chronic,
severe obstructive sleep apnea requires treatment to
prevent sleep deprivation and other complications.
Individuals with low muscle tone and soft tissue
around the airway (e.g., due to obesity), and structural
features that give rise to a narrowed airway are at high
risk for obstructive sleep apnea. The elderly are more
likely to have OSA than young people. Men are more
typical sleep apnea sufferers than women and children,
although it is not uncommon in the latter two.
Common symptoms include loud snoring, restless
sleep, and sleepiness during the daytime. Diagnostic
tests include home oximetry or polysomnography in a sleep
clinic.
Sleep apnea is very common, as common as adult
diabetes, and affects more than twelve million Americans,
according to the National Institutes of Health.
Untreated, sleep apnea can cause high blood pressure and
other cardiovascular disease, memory problems, weight
gain, impotency, and headaches. Moreover, untreated sleep
apnea may be responsible for job impairment and motor
vehicle crashes.
Some treatments involve lifestyle changes, such as
avoiding alcohol or muscle relaxants, losing weight, and
quitting smoking. Many people benefit from sleeping at a
30 degree elevation of the upper body or higher, as if in
a recliner. Doing so helps prevent the gravitational
collapse of the airway. Lateral positions (sleeping on a
side) , as opposed to supine positions (sleeping on the
back) , are also recommended as a treatment for sleep
apnea, largely because the gravitational component is
smaller in the lateral position. Some people benefit from
various kinds of oral appliances to keep the airway open
during sleep. There are also surgical procedures to
remove and tighten tissue and widen the airway, but these
tend to be very intrusive. "Breathing machines" like
continuous positive airway pressure (CPAP) may help.
The CPAP machine delivers a stream of compressed air
via a hose to a nasal pillow, nose mask or full-face
mask, splinting the airway (keeping it open under air
pressure) so that unobstructed breathing becomes
possible, reducing and/or preventing apneas and
hypopneas. This has the additional benefit of reducing or
eliminating the extremely loud snoring that sometimes
accompanies sleep apnea. Prospective CPAP candidates are
often reluctant to use this therapy, since the nose mask
and hose to the machine look uncomfortable and clumsy,
and the airflow required for some patients can be
vigorous. Some patients will develop nasal congestion
while others may experience rhinitis or a runny nose.
Other conditions that can accompany the use of CPAP
include flatulence caused by swallowing too much air;
irritation of the skin due to wearing a CPAP mask; upper
airway infection; red eye and tear flow; anxiety and
feelings of suffocation and/or claustrophobia; and the
need to cart around CPAP equipment during travel.
Compliance requires self-discipline and resolve. Some
patients adjust to the treatment within a few weeks,
others struggle for longer periods, and many discontinue
treatment entirely.
Summary of the Invention
The invention provides apparatus, systems, and
methods for constraining and/or supporting tissue
structures along an airway.
One aspect of the invention provides apparatus,
systems, and methods that mechanically support a mandible
and/or head in a desired orientation. The apparatus,
systems, and methods constrain movement of the head to
affirmatively resist collapse, of the tongue and tissue
structures in, on, or near the floor of the mouth into
the airway, thereby moderating or preventing the
incidence of sleep apnea.
Another aspect of the invention provides apparatus,
systems, and methods that externally brace tissue
structures in, on, or near the neck, along the walls of
the pharyngeal airway itself. The apparatus, systems, and
methods mechanically support these tissue structures in,
on, or near the neck in a desired orientation, biased
away from the pharyngeal airway. The mechanical support
that the apparatus, systems, and methods provide
affirmatively resists collapse of the tissue structures
in, on, or near the neck toward and into the pharyngeal
airway, thereby moderating or preventing the incidence of
sleep apnea.
Another aspect of the invention provides apparatus,
systems, and methods that locate at least one scaffold
in, on, or near tissue structures in the floor of the
mouth, between the anterior part of the mandible and the
hyoid bone. The scaffold mechanically supports the tissue
structures in a desired orientation in the floor of the
mouth, to affirmatively resist movement of the tissue
structures out of the desired orientation and into the
airway, thereby moderating or preventing the incidence of
sleep apnea.
In every aspect of the invention, the apparatus,
systems, and methods achieve beneficial therapeutic
results, moderating or preventing the incidence of sleep
apnea, without use of external positive pressure
ventilation techniques, like CPAP. The apparatus,
systems, and methods thereby avoid the discomfort of the
CPAP mask, as well as the conditions that CPAP can cause,
such as dryness in the nose and mouth.
Still, if desired, the apparatus, systems, and
methods can be used in combination with external positive
pressure ventilation techniques, like CPAP. Also, if
desired, the apparatus, systems, and methods can be
incorporated into overall therapeutic systems, which
correct the orientation of tissue structures during sleep
according to sensed sleep positions or sleep sound
architectures.
Brief Description of the Drawings
Fig. 1A is an anatomic side section view of an oral
cavity, pharynx, and larynx of an adult human, with the
mouth closed.
Fig. 1B is an anatomic side section view of an oral
cavity, pharynx, and larynx of an adult human, with the
mouth opened.
Figs. 1C and 1D are diagrammatic views of an oral
cavity and an airway, showing how a change in the frame
size of the oral cavity affects airway patency.
Fig. 2A is an anatomic side elevation view of a
human skull, with the jaws closed.
Fig. 2B is an anatomic side elevation view of a
human skull, with the jaws opened.
Fig. 3 is an anatomic lateral view of the oral
cavity shown in Fig. 1B, with superficial and deep facial
structures and left half of the mandible removed to show
muscles of the tongue and pharynx, some of which have
been cut for the purpose of illustration.
Fig. 4 is an anatomic side elevation view of the
genioglossus and intrinsic muscles of the tongue.
Fig. 5 is an anatomic anterior view of the major
muscles of the neck, also showing the hyoid bone and the
muscles connected to it.
Fig. 6 is an anatomic side elevation view of the
extrinsic muscles of the tongue, external larynx, and
pharynx.
Fig. 7 is an anatomic anterior view of the mandible
and suprahyoid muscles and floor of the mouth, viewed
from below.
Fig. 8 is an anatomic superior view of the floor of
the mouth and the mylohyoid and geniohyoid muscles.
Fig. 9 is an anatomic side section view of an oral
cavity, pharynx, and larynx of an adult human, standing
with the mouth closed, annotated to show the passage of
air through a normal, unobstructed airway when the person
is upright and active.
Fig. 10 is an anatomic side section view of an oral
cavity, pharynx, and larynx of an adult human, in a
supine sleep position with the mouth closed, annotated to
show the passage of air through the airway when the
person is asleep, and also showing the effects of gravity
on tissue structures along airway that can narrow the
airway during sleep.
Fig. 11 is an anatomic side section view of an oral
cavity, pharynx, and larynx of an adult human, in a
supine sleep position with the mouth opened, showing the
effects of gravity and an opened mouth on tissue
structures along airway, being annotated to show the
collapse of certain tissue structures into the airway and
the resultant obstruction of airflow.
Fig. 12A is a side elevation view of the head of an
individual in a supine sleep position, showing in basic
terms an apparatus worn by the individual that
mechanically supports the mandible and/or head in a
desired orientation, to affirmatively resists movement of
the mandible and/or head out of the desired orientation.
Fig. 12B is an anatomic side section view of the
oral, cavity of the individual shown in Fig. 11A,
annotated to show the apparatus functioning to
affirmatively resist movement of the mandible and/or head
out of the desired orientation and thereby maintain an
unobstructed airway.
Figs. 13A, 13B, 13C, and 13D are perspective views
of an individual wearing an apparatus like that shown in
Fig. 12A, showing different types of constraining forces
that the apparatus can provide to a mandible and/or head.
Figs. 14A, 14B, and 14C are perspective views of a
representative embodiment of an apparatus like that shown
in Fig. 12A, sized and configured as a structure that is
preformed to an anatomic shape that can be comfortably
inserted onto the front of the neck (in the region of the
larynx) just under the chin and likewise removed from the
neck when use is not required.
Figs. 15A, 15B, and 15C are perspective views of a
representative embodiment of an apparatus like that shown
in Fig. 12A, sized and configured as a full collar
structure that is worn about the entire neck at the level
of the larynx and including releasable fasteners so that
an individual can adjust the fit and form of the collar
around their neck.
Figs. 16A and 16B are side elevation views of a
representative embodiment of an apparatus like that shown
in Fig. 12A, including a pressure-sensitive medical grade
adhesive gel or material applied to the inside of the
apparatus to maintain intimate contact between skin and
the apparatus during periods of use.
Figs. 17A and 17B are perspective views of a
representative embodiment of an apparatus like that shown
in Fig. 12A, in which the magnitude and/or direction of
the constraining force can be varied, altered, or
titrated by use of insertable stays.
Figs. 18A and 18B are perspective views of a
representative embodiment of an apparatus like that shown
in Fig. 12A, in which the magnitude and/or direction of
the constraining force can be varied,: altered, or
titrated by use of a pressurized fluid or gas.
Fig. 19A is a side elevation view of a
representative embodiment of an apparatus like that shown
in Fig. 12A, including an actuator making it possible to
adjust the constraining forces on an individual's
mandible and head.
Fig. 19B is a side elevation view of the apparatus
shown in Fig. 19A, integrated into an overall therapeutic
system, which controls the actuator in response to a
sensed sleep condition.
Fig. 20A and 20B are, respectively, a side elevation
view and top view of a representative embodiment of an
apparatus like that shown in Fig. 12A, including an
actuator making it possible to adjust the constraining
forces on an individual's mandible and head, and
integrated into an overall therapeutic system, which
controls the actuator in response to a sensed sleep
condition.
Figs. 21A, 21B, and 21C are perspective views of a
representative embodiment of an apparatus like that shown
in Fig. 12A, comprising a load bearing structure that is
sized and configured to be supported between rigid bony
anchoring points between the shoulder and mandible.
Figs. 22A, 22B, and 22C are perspective views of a
representative embodiment of an apparatus like that shown
in Figs. 21A, 21B, and 21C, in which the load bearing
structure can be mechanically adjusted in an axial
direction.
Figs. 23A, 23B, and 23C are perspective views of a
representative embodiment of an apparatus like that shown
in Figs. 22A, 22B, and 22C, in which the load bearing
structure can be pneumatically adjusted in an axial
direction.
Figs. 24A, 24B, and 24C are perspective views of a
representative embodiment of an apparatus like that shown
in Fig. 12A, comprising a load bearing structure that is
sized and configured to be supported between rigid bony
anchoring points between the shoulder and mandible, and
which constrains the head in a rotationally turned
position.
Figs. 25A, 25B, and 25C are side elevation views of
a representative embodiment of an apparatus like that
shown in Fig. 12A, comprising a load bearing structure
that is sized and configured to be supported between
rigid bony anchoring points between the shoulder and
mandible, and which can adjustably constrain the jaw in
an anterior position.
Figs. 26A, 26B, and 26C are side elevation views of
a representative embodiment of an apparatus like that
shown in Figs. 25A, 25B, and 25C, which includes a chin
support surface to which an adhesive material can be
applied to adhere to tissue.
Figs. 27A, 27B, and 27C are perspective views of a
representative embodiment of an apparatus like that shown
in Fig. 12A, comprising a helical load bearing structure
that is sized and configured to be supported between
rigid bony anchoring points between the shoulder and
mandible, and which constrains the head in a rotationally
turned position.
Figs. 28A, 28B, and 28C are views of a
representative embodiment of an apparatus comprising a
neck piece to which an adhesive material is applied to
externally brace tissue structures in, on, or near the
neck, and/or along the walls of the pharyngeal airway,
and/or the floor of the mouth.
Figs. 29A and 29B are views of a representative
embodiment of an apparatus comprising a neck piece to
which negative pressure is applied to externally brace
tissue structures in, on, or near the neck, and/or along
the walls of the pharyngeal airway, and/or the floor of
the mouth.
Figs. 29C and 29D are views of a representative
embodiment of an apparatus comprising a neck mask or cup
to which negative pressure is applied to externally brace
tissue structures in, on, or near the neck, and/or the
floor of the mouth.
Fig. 30A Fig. 11 is an anatomic side section view of
an oral cavity, pharynx, and larynx of an adult human, in
a supine sleep position with the mouth opened, showing
the effects of gravity and an opened mouth on tissue
structures along airway, being annotated to show the
collapse of certain tissue structures into the airway and
the resultant obstruction of airflow.
Fig. 30B is a side elevation view of the head of an
individual in a supine sleep position, showing the an
apparatus like that shown in Figs. 2 8 A/B/C or Figs. 2 9
A/B serving to externally brace tissue structures in, on,
or near the neck, and/or along the walls of the
pharyngeal airway, and/or the floor of the mouth, to
resist collapse of tissue structures into the airway and
thereby maintain airflow.
Figs. 31A and 31 B are perspective views of a
representative embodiment of an apparatus comprising a
neck piece and chin support to which an adhesive material
is applied to externally brace tissue structures in, on,
or near the neck, and/or along the walls of the
pharyngeal airway, and/or the floor of the mouth.
Figs. 32A and 32B are perspective views of a
representative embodiment of an apparatus like that shown
in Fig. 28A, in which its ability to brace tissue
structures in, on, or near the neck, pharyngeal airway,
and/or floor of the mouth can be incremental adjusted by
use of insertable stays.
Fig. 32C is a perspective view of a representative
embodiment of an apparatus like that shown in Fig. 28A,
in which its ability to brace tissue structures in, on,
or near the neck, pharyngeal airway, and/or floor of the
mouth can be incremental adjusted by use of actuator.
Figs. 33A and 33B are perspective views of a
representative embodiment of an apparatus like that shown
in Fig. 28A, in which its ability to brace tissue
structures in, on, or near the neck, pharyngeal airway,
and/or floor of the mouth can be incremental adjusted by
use of fluid or gas pressure, and which can be integrated
into an overall therapeutic system, which controls tissue
bracing in response to a sensed sleep condition.
Figs. 34A, 34B, and 34C are anatomic views of an
oral cavity, pharynx, and larynx of an adult human, with
the mouth closed, showing the presence of a scaffold
implanted in, on, or near tissue structures in the floor
of the mouth, which mechanically supports the tissue
structures in a desired orientation to stablize. the
tissue structures and affirmatively resist their movement
into an airway.
Fig. 34D is a side section, more diagrammatic view
of a scaffold implanted in, on, or near tissue structures
in the floor of the mouth, like that shown in. Figs. 34A,
34B, and 34C, showing fixation of the scaffold to the
rigid bone structures of the mandible and/or hyoid bone.
Fig. 35A is an anatomic side section view of an oral
cavity, pharynx, and larynx of an adult human, in a
supine sleep position with the mouth opened, showing the
effects of gravity and an opened mouth on tissue
structures along airway, being annotated to show the
collapse of certain tissue structures into the airway and
the resultant obstruction of airflow.
Fig. 35B is an anatomic side section view of the
oral cavity of the individual shown in Fig. 35A,
annotated to show the scaffold shown in Figs. 34A/B/C
functioning to mechanically support tissue structures in,
on, or near the floor of the mouth and affirmatively
resist their movement into an airway.
Fig. 35C is a diagrammatic side view of an oral
cavity and an airway, like that shown in Figs. 1C and 1D,
showing how the presence of a scaffold as shown in Fig.
35B affects airway patency.
Figs. 36 and 37 are anatomic views of an oral
cavity, pharynx, and larynx of an adult human, with the
mouth closed, showing the presence of a scaffold
implanted in, on, or near tissue structures in the floor
of the mouth, which mechanically supports the tissue
• structures in a desired orientation to stablize the
tissue structures and affirmatively resist their movement
into an airway.
Figs. 38A/B/C/D are plane views of scaffolds like
that shown in Figs. 34A/B/C and 36/37 implanted in arrays
in, on, or near tissue structures in the floor of the
mouth.
Figs. 39A/B/C/D/E and 40 are views of a
representative embodiment of a scaffold sized and
configured for implantation in, on, or near tissue
structures in the floor of the mouth having a
preferential bending feature that mechanically supports
the tissue structures in a desired orientation and
affirmatively resist their movement into an airway.
Figs. 41A and 41B are anatomic side section views of
the oral cavity of an adult human in a supine sleep
position, the mouth being closed in Fig. 41A and being
opened in Fig. 41B annotated to show the scaffold shown
in Figs. 39A/B/C/D/E functioning to mechanically support
tissue structures in, on, or near the floor of the mouth
and affirmatively resist their movement into an airway,
Fig. 41B also showing the preferential bending feature of
the scaffold.
Figs. 42 and 43 are perspective views of a
representative embodiment of a scaffold like that shown
in Figs. 39A/B/C/D/E and. 40, and further including
features that help stabilize the scaffold in tissue.
Figs. 44A/B/C/D/E and 45 are views of a
representative embodiment of a scaffold sized and
configured for implantation in, on, or near tissue
structures in the floor of the mouth having a
preferential bending feature that mechanically supports
the tissue structures in a desired orientation and
affirmatively resist their movement into an airway.
Figs. 46A/B/C/D/E and 47 are views of a
representative embodiment of a scaffold sized and
configured for implantation in, on, or near tissue
structures in the floor of the mouth having a
preferential bending feature that mechanically supports
the tissue structures in a desired orientation and
affirmatively resist their movement into an airway.
Figs. 48A/B/C/D/E/F and 49 are views of a
representative embodiment of a scaffold sized and
configured for implantation in, on, or near tissue
structures in the floor of the mouth having a
preferential bending feature that mechanically supports
the tissue structures in a desired orientation and
affirmatively resist their movement into an airway.
Fig. 50A is an anatomic anterior view of an
individual, showing the non-invasive implantation of a
scaffold like that shown in Figs. 34A/B/C and 36/37
through a percutaneous delivery assembly.
Figs. 50B, 50C, 50D, and 50E are a sequence of views
showing the manipulation of the delivery assembly shown
in Fig. 50A to deliver a scaffold into tissue in the
floor of the mouth.
Fig. 51 is an anatomic anterior view of an
individual, showing an array of scaffolds affixed by
adhesive material to the external skin along the neck
and/or overlying the floor of the mouth.
Figs. 52A and 52B are views showing a formed unitary
flexible bracing structure affixed by adhesive material
to the external skin along the neck and/or overlying the
floor of the mouth.
Figs. 53A and 53B are perspective views and Fig. 53C
is an anatomic side section view of a representative
embodiment of an apparatus comprising a neck piece and
chin support that magnetically interacts with magnets
implanted in, on, or near tissue structures in the neck
or the floor of the mouth to externally brace tissue
structures in, on, or near the neck, and/or along the
walls of the pharyngeal airway, and/or the floor of the
mouth.
Figs. 54 to 57 are anatomic side section views of
the oral cavity of an adult human showing a tongue
suspension structure coupled to an anchor in the floor of
the mouth to resist posterior slippage of the tongue into
the airway, the anchor comprising a flexible scaffold
anchoring structure in Figs. 55, 56, and 57.
Fig. . 58A is a perspective view of a representative
embodiment of a flexible scaffold anchoring structure
like that shown in Figs. 55, 56, and 57, but further
including an array of magnets or ferrous materials.
Fig. 58B is an anatomic side section view of the
oral cavity of an adult human in a supine sleep position,
the mouth being opened, annotated to show the flexible
scaffold anchoring shown in Fig. 58A magnetically
interacting with an apparatus comprising a neck piece and
chin support that preferentially bends the flexible
scaffold anchoring structure.
Figs. 59A and 59B are anatomic side section views of
an oral cavity in an adult human showing a magnetically
interactive shaped structure placed in the floor of the
mouth and tethered to a structure in, on, or near the
tongue, being activated by an external magnetic source
(see Fig. 59B) to resist posterior slippage of the tongue
into the airway.
Figs. 60A to 60C are views of a representative
embodiment of a scaffold having a preferential bending
function for implantation in the floor of the mouth, and
also with attachment to the back of the tongue.
Figs. 60D and E are anatomic side section views of
an oral cavity in an adult human showing the scaffold
illustrated in Figs. 60A to 60C implanted in the floor of
the mouth with attachment to the back of the tongue, with
Fig. 60D showing the mouth closed and Fig. 60E showing
the mouth opened to compress the scaffold and cause
preferential bending.
Description of the Preferred Embodiments
Although the disclosure hereof is detailed and exact
to enable those skilled in the art to practice the
invention, the physical embodiments herein disclosed
merely exemplify the invention, which may be embodied in
other specific structure. While the preferred embodiment
has been described, the details may be changed without
departing from the invention, which is defined by the.
claims.
Contents
The description that follows is divided into the
following main sections and sub-sections:
I. Pertinent Anatomy
A. Oral Cavity or Mouth
1. The Palate (Roof of the Mouth)
2. The Floor of the Mouth
3 . The Tongue
4. The Pharynx (Pharyngeal Airway)
B. The Mandible
C. The Neck
1. The Hyoid Bone
2. Extrinsic Muscles of the Tongue Attached
to Hyoid
3. Other Muscles in the Neck Attached to
Hyoid
4. Swallowing
II. Collapse of the Airway
III. Apparatus and Methods for Constraining The Mandible
and/or Head
A. Overview
1. First Constraint Condition (Maintain
Closure of the Mouth)
2. Second Constraint Condition (Limit
Inferior Rotation of the Head)
3. Third Constraint Condition (Provide an
Anterior Position to the Jaw)
4 . Fourth Constraint Condition
(Twist/Elevate the Head)
B. Representative Embodiments
1. Mandible/Head Support
(i) Chin Support with Neck Piece
(ii) Pressure-Sensitive Adhesive
(iii) Variable Constrain of Mandible
and/or Head
(iv) Dynamic Constrain of Mandible
and/or Head
(v) Anchored Load bearing Structures
(vi) Helical Load Bearing Structure
IV. Apparatus and Methods for Bracing Tissue Structures
In, On, or Near the Neck
A. Overview
1. Variable Neck Bracing/Reshaping
2. Dynamic Neck Bracing/Reshaping
V. Scaffolds In, On, or Near the Floor of the Mouth
A. Overview
B. Representative Placement
1. Mylohyoid-Geniohyoid
2. Geniohyoid-Genioglossus
3. Digastric-Mylohyoid
C. Representative Scaffold Configurations
1. General Physical Characteristics
2. Preferential Bending Characteristic
3. Representative Implantation Methods
4. External Scaffolds and Combinations
VI. Enhanced Anchorage of the Tongue to Muscles in the
Floor of the Mouth
VII. Preferential Bending in Floor of the Mouth with
Interaction with Tongue
I. Pertinent Anatomy
A. The Oral Cavity or Mouth.
Fig. 1A is an anatomic view (in section) of an oral
cavity in the head of an adult human. In human anatomy,
the oral cavity - which will also be called the mouth -
constitutes the orifice through which food and air enter
the body.
As further delineated in Figs. 2A and 2B, a pair of
bones, called the jaws, form the skeletal framework of
the mouth. The jaws contain teeth and include a movable
lower jaw (the mandible) and a fixed upper jaw. The jaws
function by moving in opposition to each other (as Figs.
1A/B and 2A/B show) and are used for biting, chewing, and
the handling of food.
Referring back to Figs. 1A and 1B, the interior non-
skeletal boundaries of the oral cavity are defined by the
lips, the cheeks (no shown), the hard and soft palates,
and the throat or pharynx. The oral cavity or mouth opens
to the outside at the lips (which will also be called the
front or anterior region of the oral cavity). Lowering of
the mandible relative to the maxilla opens the mouth, as
Fig. 1B shows. The oral cavity empties into the pharynx
(which will also be called the back or posterior region
of the oral cavity).
Fig. 1A illustrated the nomenclature that will be
used to depict direction. Anterior and posterior mean
front and back, respectively, as just described. Superior
or cranial and inferior or caudal mean up and down,
respectively.
As Figs. 1A and 1B show, the pharynx is a cone-
shaped passageway leading from the oral cavity (and nasal
cavity) to the esophagus and larynx. The esophagus leads
to the stomach. It is the path through which food
entering the oral cavity is carried into the stomach for
digestion in the digestive system. The larynx is a
hollow, tubular structure connected to the top of the
windpipe (trachea). Air entering the oral cavity passes
through the larynx on its way to the lungs. The larynx
also produces vocal sounds, and for this reason is also
called the voice box. The larynx also prevents the
passage of food and other foreign particles into the
lower respiratory tracts.
The chief structures of the mouth are the teeth,
palate, and tongue. The teeth, carried by the
articulating jaws, tear and grind ingested food into
small pieces that are suitable for digestion. The palate
separates the mouth from the nasal cavity, allowing
separate passages for air and for food. The tongue is a
large muscle firmly anchored to the floor of the mouth.
The tongue positions and mixes food and also carries
sensory receptors for taste. In addition to its primary
role in the intake and initial digestion of food and the
intake of air during breathing, the mouth and its
structures are essential in humans to the formation of
speech.
1. The Palate (The Roof of the Mouth)
The palate (see Figs. 1A and 1B) constitutes the
roof of the mouth. It separates the oral and nasal
cavities. The palate consists of an anterior hard palate
of bone and, in humans, a posterior soft palate that has
no skeletal support and terminates in a fleshy, elongated
projection called the uvula.
The hard palate composes two-thirds of the total
palate area. The hard palate is a plate of bone covered
by a moist, durable layer of mucous-membrane tissue,
which secretes small amounts of mucus. This layer forms
several ridges that help grip food while the tongue
agitates it during chewing. The hard palate provides
space for the tongue to move freely and supplies a rigid
floor to the nasal cavity so that pressures within the
mouth do not close off the nasal passage.
The soft palate is composed of muscle and connective
tissue, which give it both mobility and support. This
palate is very flexible. When elevated for swallowing and
sucking, it completely blocks and separates the nasal
cavity and nasal portion of the pharynx from the mouth
and the oral part of the pharynx. While elevated, the
soft palate creates a vacuum in the oral cavity, which
keeps food out of the respiratory tract.
2. The Floor of the Mouth
The floor of the mouth (see Fig. 3) is a tissue
region that is bounded anteriorly by the mandible and
posteriorly by the hyoid. The floor of the mouth is
immediately surrounded by other tissue structures, such
as muscles attached to the hyoid and/or mandible (as will
be described later), which are mutually interconnected
and mutually affected by the condition and orientation of
tissue in the floor of the mouth. The floor of the mouth
can be seen only when the tongue is raised. In the
midline is a prominent fold (called the frenulum
linguae), to which the tongue is anchored.
3. The Tongue
The tongue (shown enlarged in Fig. 4, and which is
also shown in Figs 1A and 1B and 3) is a muscular organ
located on the floor of the mouth. The tongue is a mobile
muscular organ that can assume a variety of shapes and
positions. The tongue rests partly in the oral cavity and
partly in the pharynx (Figs. 1A and 2B show).
The tongue is an extremely mobile structure in
humans and an important accessory organ in such motor
functions as speech, chewing, and swallowing. In
conjunction with the cheeks, it is able to guide and
maintain food between the upper and lower teeth until
mastication is completed.
At rest, the tongue occupies essentially all of the
oral cavity proper. The tongue is involved with
mastication, taste, deglutition, and oral cleansing. Its
two major functions are forming words during speaking and
squeezing food into the pharynx when swallowing.
4. The Pharynx (Pharyngeal Airway)
Referring back to Figs. 1A and 1B, the pharynx
serves both respiratory and digestive functions. For the
respiratory function, the pharynx serves as the essential
airway for the body. Blockage of the airway of the
pharynx can lead to a cessation of breathing and
resultant disruption or interruption of the normal body
functions.
As Fig. 6 shows, thick fibers of constrictor muscles
and connective tissue attach the pharynx to the base of
the skull and surrounding structures. Both circular and
longitudinal constructor muscles occur in the walls of
the pharynx. The circular muscles form constrictions that
help push food to the esophagus and prevent air from
being swallowed. The longitudinal muscles lift the walls
of the pharynx during swallowing.
B. The Mandible
Please ref to Figs. 2A and 2B. The mandible is the
lower jaw. It is a U-shaped bone having alveolar
processes that house the mandibular teeth.
The ascending parts of the mandible at the side are
called rami (branches). The joints by means of which the
lower jaw is able to make all its varied movements are
between a rounded knob, or condyle, at the upper back
corner of each ramus and a depression, called a glenoid
fossa, in each temporal bone. The hinge-type joint that
is formed between these articular surfaces is called the
temporomandibular joint (TMJ). Another, rather sharp
projection at the top of each ramus and in front, called
a coronoid process, does not form part of a joint.
Attached to it is the temporalis muscle, which serves
with other muscles in, shutting the jaws.
Several muscle groups (not shown) act on the TMJ to
(i) elevate the mandible, closing the jaws; (ii) protrude
the jaw; (iii) depress the chin; (iv) produce side-to-
side movement of the jaw; (v) elevate the mandible,
closing the jaws; and (vi) produce a grinding motion for
cutting food.
C. The Neck
The neck (see Fig. 5) is the portion of the body
joining the head to the shoulders and chest. The neck is
a major conduit between the head, trunk, and limbs. Many
important anatomic structures are crowded together in the
neck, such as muscles, veins (e.g., the jugular veins),
arteries (e.g., the carotid arteries), vertebrae (e.g.,
the seven cervical vertebrae and enclosed spinal cord),
the pharynx, and part of the esophagus. A broad, thin
plane of muscular fibers, called the platysma myoides or
platisma, extends immediately beneath the superficial
fascia of each side of the neck. Food and air entering
the oral cavity must pass through the neck.
Also present in the neck is the hyoid bone, as Fig.
6 prominently shows. The hyoid bone lies in the anterior
part of the neck at the level of the C3 vertebra in the
angle between the mandible and the thyroid cartilage,
which is the largest cartilage of the larynx.
1. The Hyoid Bone
A primary function of the hyoid bone is to serve as
an anchoring structure for the tongue. As Fig. 6 shows,
the hyoid bone is situated at the root of the tongue in
the front of the neck and between the mandible and the
thyroid cartridge. The hyoid bone has no articulation
with other bones. It serves a purely anchoring function.
The hyoid bone is suspended from the styloid processes of
the temporal bones by the stylohyoid ligaments (as Figs.
5 and 6 show, as as also shown in Fig. 3). The hyoid bone
is firmly bound to the thyroid cartilage (as Fig. 5 shows
in an anterior view). It serves as an anchoring point for
muscles of the tongue and, thus, as a prop to the keep
the tongue from blocking the airway, as will be described
in greater detail later. As best shown in Figs. 7 and
8, the hyoid consists of a body, a pair of larger horns
(the greater cornua), and a pair of smaller horns (the
lesser cornua). The hyoid bone is more or less in the
shape of a U, with the body forming the central part, or
base, of the letter. In the act of swallowing, the hyoid
bone, tongue, and larynx all move upward rapidly.
The greater cornua are the limbs of the U. Their
outer ends generally are overlapped by the large
sternocleido-mastoid muscles (see Fig. 5), which run from
the sternum and clavicle to the mastoid region at the
base of the skull on each side of the head just below and
behind the ear in humans. The lesser cornua are small
projections from the places called the junctions of the
body and the greater cornua.
2. Extrinsic Muscles of the Tongue Attached to
the Hyoid
Certain extrinsic muscles of the tongue originate
outside the tongue and attach to it. Extrinsic tongue
muscles mainly alter the position of the tongue. The
tongue also has intrinsic muscles, which serve to alter
the shape of the tongue". However, the muscles of the
tongue do not act in isolation. Some muscles perform
multiple actions. Thus, extrinsic muscles can alter the
shape of the tongue, as well.
Among the extrinsic muscles of the tongue that are
attached to the hyoid bone are the genioglossus muscles
(see Figs. 3, 4, and 6). Fan-shaped muscles, they
contribute to most of the bulk of the tongue. They arise
by a short tendon from the superior part of the mental
spine of the mandible, the region of the mandible that
forms the prominence of the chin. They fan out as they
enter the tongue inferiorly and their fibers attach to
the outer dorsum of the tongue (i.e., the posterosuperior
surface of the tongue). The most inferior fibers insert
into the body of the hyoid bone and pull the root of the
tongue anteriorly, for protruding or "sticking out" the
tongue. The "root of the tongue" is defined as the
inferior, relatively fixed part of the tongue that is
attached to the hyoid bone and mandible. Acting
bilaterally, the genioglossus muscles depress the central
part of the tongue, creating a central groove or furrow.
Acting unilaterially, the genioglossus will deviate (or
"wag") the tongue toward the contralateral side.
Also among the extrinsic muscles of the tongue that
are attached to the hyoid bone are the hyoglossus muscles
(shown in Figs. 3 and 6). They originate on each side
from the whole length of the greater cornua, as well as
from the body of the hyoid. They are inserted into the
posterior half or more of the sides of the tongue. The
hyoid bone anchors the muscles when they contract, to
depress the tongue and to widen the oral cavity.
3. Other Muscles in the Neck That Are Attached to
the Hyoid
In the anterolateral part of the neck, the hyoid
bone provides for attachments for other muscles that are
not intrinsic or extrinsic muscles of the tongue. Among
these are certain suprahyoid muscles superior (above or
cranial) to the hyoid bone.
Suprahyoid muscles attached to the hyoid bone
include the mylohyoid muscles (shown in Figs. 3 and 4).
The mylohyoid muscles originate from the mylohyoid line
of the mandible (which lies along a lateral side of the
mandible between the angle of the mandible and the front
of the mandible, also called mental protuberance). The
mylohyoid muscles form the mobile but stable floor of the
mouth and a muscular sling interior to the tongue that
serves as a diaphragm. These muscles support the tongue
and elevate it and the hyoid bone when swallowing or
protruding the tongue.
Suprahyoid muscles attached to the hyoid also
include the two geniohyoid muscles (also shown in Figs. 3
and 4). The two geniohyoid muscles originate close to the
point at which the two halves of the mandible meet. The
geniohyoid muscles are superior to the mylohyoid muscles,
where they reinforce the floor of the mouth. The fibres
of the muscles extend downward and backward, close to the
central line, to be inserted into the body of the hyoid
bone. Contraction of the muscles pulls the hyoid bone
upward and forward, to shorten the floor of the mouth and
widen the pharynx.
Suprahyoid muscles attached to the hyoid also
include the two digastric muscles ((see Figs. 5 and 7),
which also originate from the diagastric fossa of the
mandible and the mastoid notch of temporal bone. The
diagrastric muscles descend toward the hyoid bone and are
joined by an intermediate tendon. A fibrous sling derived
from the deep cervical fascia allows each muscle to slide
anteriorly and posteriorly as it connects this tendon to
the body and greater cornua of the hyoid bone. The
digastric muscles depress the mandible; while also
raising and steadying the hyoid bone during swallowing
and speaking.
Inserting into the middle part of the lower border
of the hyoid bone are the sternohyoids (shown in Figs. 5
and 7), which are long muscles arising from the
breastbone and collarbone and running upward and toward
each other in the neck. Other muscles attached to the
hyoid bone are the thyrohyoid (shown in Fig. 5), arising
from the thyroid cartilage of the larynx (which depresses
the hyoid bone and elevates the larynx); the omohyoid
(not shown), which originates from the upper margin of
the shoulder blade and the suprascapular ligament (which
depresses, retracts, and steadies the hyoid bone); and
the stylohyoid (shown in Figs. 4, 5, and 7), arising from
the styloid process of temporal bone(which elevate and
retracts the hyoid bone, thereby elongating the floor of
the mouth).
4. Swallowing
The position of the hyoid bone with relation to the
muscles attached to it has been likened to that of a ship
steadied as it rides when anchored "fore and aft."
Through the muscle attachments, the hyoid plays an
important role in mastication, in swallowing, and in
voice production.
For example, at the beginning of a swallowing
motion, the geniohyoid and mylohyoid muscles elevate the
hyoid bone and the floor of the mouth simultaneously.
These muscles are assisted by the stylohyoid and
digastric muscles. The tongue is pressed upward against
the palate and the food is forced backwards.
II. Collapse of the Airway
As shown in Fig. 9, the airway is the path that air
follows to get into and out of the lungs. The mouth and
nose are the normal entry and exit ports. Entering air
passes through the mouth, between the tongue and palate,
to the back of the throat (pharynx) , and continues
through the voice box (larynx) , down the trachea, and
finally out the branching tubes in the lungs, known as
bronchi (not shown). A normal breath of air passes
through the oral or nasal passages, behind the palate,
uvula, and root of the tongue, then into and through the
pharyngeal airway, and between the vocal cords of the
larynx into the lungs.
As shown in Fig. 9, under normal breathing
conditions, in a healthy person who is awake, active, and
upright, the force of gravity naturally draws the tongue,
tissue structures in the floor of the mouth, and tissue
in the neck in a caudal direction, i.e., toward the feet.
The force of gravity provides, when a person is upright,
a natural bias to the tongue, tissue structures in the
floor of the mouth, and tissue in the neck toward the
feet mostly out of the path that air follows in the oral
cavity. The caudal gravitational bias provided when a
person is upright maintains a desired tongue orientation
out of the airway in the oral cavity, thereby providing
beneficial spacing between tongue and the palate, as well
as maintains a desired orientation of neck tissue out of
the airway.
Further, when a healthy person is awake and active,
the coordinated activity of muscles of the tongue, floor
of the mouth, neck, upper part of the pharyngeal airway
or throat, and/or mandible serves also to keep the airway
open to allow air to flow through the nasal passages,
behind the palate, uvula, and tongue base, through the
airway, and between the vocal cords and into the lungs.
However, during sleep (see Fig. 10) , the tongue,
tissue structures in the floor of the mouth, and/or
tissue in the neck can shift or collapse: as they lose
tension and as the sleeping body position alters the
influence of gravity, into the airway. The undesired
shifting or collapse of the tongue, tissue structures in
the floor of the mouth, and/or tissue in the neck into
the airway during sleep can be attributed to one or a
combination of causes.
One cause is gravity. During sleep, a person is no
longer upright, but is instead lying down in a prone,
supine, or side position. The pull of gravity on tissue
of a person lying down is not toward the feet. Instead,
the force of gravity on a person lying down serves to
shift the orientation of the tongue, and/or tissue
structures in the floor of the mouth, and/or tissue in
the neck inward and/or toward the airway.
Another cause is that, during sleep, many of the
muscles in or affecting the tongue, neck, upper part of
the pharyngeal airway, and/or mandible can undergo phasic
changes in their electrical activity synchronous with
respiration, leading to relaxation of these muscles.
During one particular stage of sleep, the stage of rapid
eye movement (REM), the muscles may completely relax. The
muscles also completely relax during exhalation, prior to
the beginning of inhalation.
Also, during sleep, muscles affecting the mandible
can relax. The mandible drops (as Fig. 11 shows), and the
mouth opens. During sleep, the head may also rotate
interiorly in flexion, or translation may occur within
the TMJ to cause a posterior sliding of the mandible. The
shift in mandible and/or head orientation during sleep
leads to a shortening of the native anterior-to-posterior
distance between the mandible and hyoid within the floor
of the mouth.
The native anterior-to-posterior distance between
the mandible and hyoid is shown as D1 in Fig. 9. A
shortened anterior-to-posterior distance between the
mandible and the hyoid, caused by a shift in the mandible
and/or head orientation during sleep is shown as D2 in
Fig. 11. As a comparison between D1 (Fig. 9) and D2 (Fi.
11 shows, D2 is less than D1.
As the anterior-to-posterior distance is reduced by
mandible and head orientation, the tongue and tissue
structures in the floor of the mouth, which occupy this
space, are shifted inward and toward the airway.
Also, during sleep, as a result of the diminution or
absence of native muscle activity, the position of the
root of the tongue can shift in a posterior direction,
toward and into the airway. Further, during sleep, the
diminution or absence of native muscle activity in the
neck can lead to the collapse of tissue in the neck
toward and into the airway.
AS Fig. 10 shows, for many individuals, the airway
remains open enough, despite the sleep-related effects of
gravity on tissue, and/or changes in mandible and head
orientation, and/or relaxation of one or more of muscles
affecting the tongue, floor of the mouth, or neck, to
permit the flow of air during sleep.
As shown in Fig. 11, other individuals, however,
are, for various reasons, more prone to experiencing more
chronic or sever breathing restrictions as the airway
narrows. For such individuals, narrowing of the airway
during sleep can be accompanied by a sleep disordered
breathing condition, such as habitual snoring or
obstructive sleep apnea (OSA). Such individuals may even
experience a cessation of breathing, which leads to a
marked fall in blood oxygen levels, terminating in
arousal, making it impossible to achieve deep,
restorative sleep.
For example, in some individuals, due to hereditary,
disease, or obesity, tissue structures within the mouth,
such as the soft palate, uvula, and/or tongue may be
enlarged or have lost compliance, or the walls of the
pharyngeal airway itself may have narrowed due to tissue
enlargement or lack of tissue compliance in regions of
the neck. For such individuals, relaxation of muscles of
the mandible, tongue, neck, and/or upper part of the
pharyngeal airway, can lead to tissue in the floor of the
mouth, and/or at the root of the tongue, and/or along the
neck falling into the oral, nasal, or pharyngeal regions
of the airway, thereby obstructing or completely closing
the airway for breathing. In some individuals, this
result is exacerbated if the person is resting in a
supine position, flat on their back. Loud snoring and
labored breathing can occur. When complete blockage of
the airway occurs (as Fig. 11 shows) , air cannot reach
the lungs. Breathing stops, until the shortage of oxygen
in the blood stream awakes the person, or causes the
level of sleep to become more shallow. If these episodes
repeatedly occur during sleep, the condition is called
obstructive sleep apnea. Partial blockage of the airway,
can also lead to a drop in the blood oxygen level (called
oxygen desaturation) and a condition called hypopnea.
Hypopnea can also lead to obstructive sleep apnea.
III. Apparatus and Methods for Constraining the Mandible
and/or Head
Fig. 12A shows in basic terms an apparatus 10 for
constraining a mandible and/or head. In use, the
apparatus 10 helps an individual with a sleep disordered
breathing condition, such as habitual snoring or
obstructive sleep apnea (OSA), to achieve deep,
restorative sleep.
As will be described, the apparatus 10 functions
without use of external positive pressure ventilation
techniques, like CPAP and its attendant problem,
previously described. However, if desired, the apparatus
10 can be used in combination with external positive
pressure ventilation techniques, like CPAP. The apparatus
10 can also be used in combination with intraoral oral
appliances used to position the tongue and/or jaw during
sleep, or with the Pillar® Procedure (Restore Medical
Inc.), or tissue removal or other surgical intervention
techniques, such as maxillomandibular advancement (MA) or
uvulopalatopharyngeoplasty (UPPP). The additive effects
of the apparatus 10 can serve to moderate the required
nature and extent of these often highly invasive surgical
procedures, thereby reducing the often long recover time
and increasing patient appeal. When used in combination
with CPAP, oral appliances, and surgical procedures, the
presence of the apparatus 10 can increase the success
rates of conventional treatments.
A. Overview
In basic term, as Fig. 12A shows, the apparatus 10
mechanically supports the mandible and/or head in a
desired orientation, particularly when the individual is
in a sleep position. The mechanical support that the
apparatus 10 provides affirmatively resists movement of
the mandible and/or head out of the desired orientation.
A therapeutic result of the mechanical support that
the apparatus 10. provides can include maintaining a
desired anterior-to-posterior distance between the
mandible and hyoid. In this arrangement, the desired
anterior-to-posterior distance between the mandible and
hyoid is selected to bias the tongue and tissue
structures in the floor of the mouth toward an
orientation that lies out of the airway, as Fig. 12B
shows. The apparatus 10 thereby resists movement of the
tongue and tissue structures in the floor of the mouth
into orientations (as shown in Fig. 11) that lie toward
and in the airway.
However, the mechanical support that the apparatus
10 provides to tissue need not include the maintenance of
an anterior-to posterior distance between the manidible
and hyoid.
For example, another therapeutic result of the
mechanical support that the apparatus 10 provides can
include the application of tension to the muscles along
the pharyngeal airway. The tension applied by the
apparatus 10 creates a more rigid airway. The tension
applied by the apparatus 10 conditions muscle structures
in the neck to resist collapse of tissue in the neck
toward and into the pharyngeal airway, as Fig. 12B shows.
The apparatus 10 can impose one or more different
conditions to constrain the mandible and/or head. The
different conditions complement one another in resisting
movement of the tongue and tissue structures in the floor
of the mouth into orientations that lie toward and in the
airway. Compare the orientation of tissue shown in
Fig.11, in which the tongue and tissue structures have
collapsed into the airway, with the orientation of tissue
Fig. 12B, in which the presence of the apparatus 10
serves to resist movement of the tongue and tissue
structures in the floor of the mouth into orientations
that lie toward and in the airway. In a representative
embodiment, the imposition of four conditions, singly or
in combination, are disclosed.
1. First Constraint Condition (Maintain
Closure of the Mouth)
As shown in Fig. 13A, the apparatus 10 may impose a
first constraint condition 12, to affirmatively resist an
articulation of the mandible that leads to opening the
mouth. The first constraint condition 12 keeps the jaw
(and thus the mouth) closed. This constraint condition 12
can establish and maintain a desired anterior-to-
posterior distance between the mandible and hyoid.
2. Second Constraint Condition (Limit
Inferior Rotation of the Head)
As Fig. 13B shows, the apparatus 10 may impose a
second constraint condition 14, to affirmatively limit
inferior rotation (nodding) of the head. The second
constraint condition 14 lifts the chin and, therefore,
the head. This constraint condition 14 can also establish
and maintain a desired anterior-to-posterior distance
between the mandible and hyoid. A lifting force on the
chin and mandible can also serve to stretch and maintain
an opened airway.
3. Third Constraint Condition (Provide an
Anterior Position to the Jaw)
As Fig. 13C shows, the apparatus 10 may also impose
a third constraint condition 16, to affirmatively resist
inferior translational movement of the mandible within
the TMJ. The third constraint condition 16 may move the
mandible slightly forward into a protruding, under-bite
position, which may not be the native, position of the
person's jaw. This constraint condition 16 can increase
the anterior-to-posterior distance between the mandible
and hyoid. Alternatively, the third constraint condition
16 may at least maintain a desired anterior-to-posterior
position, without moving the mandible forward.
4. Fourth Constraint Condition (Twist /
Elevate the Head)
As Fig. 13D shows, the apparatus may impose a fourth
constraint condition 18, to maintain a desired twist as
well as elevation to the head. The fourth constraint
condition 18 applies a side force or torque to the
mandible to cause a slight twisting of the head to one
side. This constraint condition 18 applies tension to
muscles structures along the pharyngeal airway to create
a more rigid airway.
B. Representative Embodiments
As will be described in greater detail later, the
size, configuration, and mechanical properties of the
apparatus 10 are selected to impose one or more of the
above-described constraint conditions 12, 14, 16, 18 to
the mandible and/or head particularly during sleep, in
the absence of or diminution of native muscle activity
and/or during sleep postures that can cause airway
obstruction. The size, configuration, and mechanical
properties of the apparatus 10 to achieve these
objectives during sleep are counterbalanced with
sufficient compliance and flexibility to reasonably
accommodate normal activities willed by volitional muscle
activity, to allow the jaw to be intentionally opened or
the head to be intentionally turned. As will be described
later, the particular size, configuration, and mechanical
properties of the apparatus 10 can be tailored or
customized to the individual patient.
1. Mandible/Head Support
(i) Chin Support With Neck Piece
Fig. 14A, 14B, and 14C show a representative basic
embodiment of an apparatus 10 for constraining a mandible
and/or head. The apparatus 10 comprises a neck piece 20
or holdfast and a chin support 22 carried by the neck
piece 20. The chin support 22 preferably includes a
concave pocket region 430 under the chin, which provides
clearance between the chin support 22 and tissue in, on,
or near the floor of the mouth. The clearance provided by
the pocket region 430 assures that the chin support 22
does not, in use, inadvertently compress muscles or
tissue in, on, or near the floor of the mouth.
Compression of muscles or tissue in, on, or near the
floor of the mouth by a chin support structure can
interfere with the native anchoring function that the
floor of the mouth provides to the mandible, hyoid bone,
and tongue, which serves as a trampoline to stabilize the
mandible, hyoid bone, and tongue while accommodating
relative movement among them.
The neck piece 20 can be variously configured. In
the embodiment shown in Figs. 13A, 13B, and 13C, the neck
piece 20 comprises a structure that is preformed to an
anatomic shape sized and configured to be comfortably
inserted onto the front of the neck (in the region of the
larynx) just under the chin. The structure can be
likewise removed from the neck when use is not required.
In this arrangement, the chin support' 22 can
comprise an integrally formed component, forming a
unitary, pre-formed device. The device can be molded or
formed from, e.g., from an elastic or semi-elastic
polymer material. The pre-formed device can be shaped,
sized, and contoured based upon the particular anatomy of
the individual who will wear the device. However, the
device can also be shaped, sized, and contoured based
more upon a range of generic models of a human chin and
neck.
The chin support 22 can comprise a structure made of
a fabric material and be treated as a single or limited
use, disposable item. The chin support 22 can be affixed
to the front of the neck with a releasable adhesive, like
a band-aid.
A somewhat different embodiment is shown in Figs.
15A, 15B, and 15C. In this embodiment, the neck piece 20
comprises a full collar structure that is sized and
configured to be worn about the entire neck at the level
of the larynx. In this arrangement, the collar desirably
includes releasable fasteners 24, e.g., such as snaps,
magnets, buckles, straps, VELCRO® fabric, and the like,
so that an individual can adjust the fit and form of the
collar around their neck. In this arrangement, the collar
can be made of a padded fabric.
In either embodiment, the chin support 22 desirably
extends from the neck piece 20 in an anterior and
slightly superior orientation. When the neck piece 20 is
worn on the neck, the chin support 22 is sized and
configured to fit comfortable beneath the chin when the
mouth is closed. As before stated, the chin support 22
preferably includes a concave pocket region 430 under the
chin, which provides clearance between the chin support
22 and tissue in, on, or near the floor of the mouth to
avoid interference with the native anchoring function
that the floor of the mouth provides to the mandible,
hyoid bone, and tongue.
In either embodiment, the neck piece 20 and chin
support 22 are sized and configured to be easily fitted
on the neck when the features of the apparatus are
desired (i.e., at night, during sleep). The fit and form
of the neck piece 20 and chin support 22 permit easy
removal of the neck piece 20 and chin support 22 from the
body when the features of the apparatus 10 are not
desired (i.e., during daytime hours when the individual
is awake and active).
The mechanical properties of the materials for the
neck piece 20 and chin support 22, as well as the
attachment and orientation of the chin support 22 to the
neck piece 20, are selected to provide enough mechanical
resistances to prevent an unintended articulation due to
a tilting of the head, or a dropping open of the mandible
away from the upper jaw, particularly when there is an
absence or diminution of native muscle activity to keep
the head from tilting or kee4p the mouth close, as could
occur during sleep.
Still, the mechanical properties of the materials
for the chin support 22 and neck piece 20 are
counterbalanced with sufficient flexibility and yield to
accommodate a purposeful opening of the mouth as a result
of volitional muscle activity. Desirably, the materials
comprise soft, supple, breathable fabric for comfort.
As shown in Figs. 14C and 15C, the apparatus 10
forms a yieldable buttress for the mandible in the closed
position. The apparatus 10 can thereby serve to maintain
a desired anterior-posterior distance between the
mandible and hyoid by imposing the first constraint
condition 12, which is keeping the mouth closed. The
apparatus 10 also imposes the second constraint condition
14, which affirmatively limits inferior rotation of the
head.
The size and configuration of the chin support 22
and neck piece 20 are selected and contoured to limit
direct pressure on soft tissue under the chin and in the
floor of the mouth. Limiting direct pressure on these
tissue regions, prevents an unintended inward movement of
these tissue regions toward the airway and a resultant
narrowing of the airway.
(ii) Pressure-Sensitive Adhesive
As shown in Figs. 16A and 16B, the apparatus 10 can
include a pressure-sensitive medical grade adhesive gel
or material 26. The adhesive material 26 is applied to
the inside of the neck piece 20 and/or chin support 22.
The adhesive material 26 maintains intimate contact
between skin and the neck piece 20 and/or chin support 22
during periods of use. As before stated the apparatus 10
can comprise a fabric material and be treated as a single
or limited use, disposable item. The adhesive material 26
can comprise conventional pressure-sensitive compositions
used for adhesion to the skin, particularly in the field
of colostomy care. Examples of such adhesive materials 26
include Hollister Colostomy Adhesive (Hollister Inc,
Libertyville, IL), Nu-HopeTM Adhesive (Bruce Medical), or
Permatype™ Surgical Adhesive (edipMed.com).
Representative pressure sensitive adhesive materials
26 comprise a self- adhesive elastomeric matrix, in which
water-absorbing, swelling particles, called
hydrocolloids, are dispersed.
The adherence of the adhesive material 26 to tissue
stabilizes the orientation of the mandible as dictated by
the chin support 22. The inclusion of adhesive material
26 with the assembly can enhance the achievement of at
least one additional desirable constraint condition, and
thereby enhance the overall function of the apparatus.
For example, the application of an adhesive material
26 to the chin support 22 makes it possible to impose the
third constraint condition 16, which is to provide and
maintain an anterior position to the jaw (see Fig. 16B) .
The adhesive material 26 on the chin support 22 grabs
chin tissue. A desired anterior orientation of the
mandible can be established and then maintained by
adhesive force by the chin support 22. The adhesive force
can maintain the mandible in a desired slightly anterior
(protruding) orientation and thereby affirmatively resist
posterior translational movement of the mandible within
the TMJ. However, it should be appreciated that the third
constraint condition 16 can be achieved with the form and
fit of the apparatus, without the use of an adhesive
material 26. As before stated, the chin support 22
preferably includes a concave pocket region 430 under the
chin, which normally provides clearance between the chin
support 22 and tissue in, on, or near the floor of the
mouth. Tissue in, on, or near the floor of the mouth can
be drawn into this pocket region 430 without compressing
the tissue, to thereby avoid, during use, interference
with the native anchoring function that the floor of the
mouth provides to the mandible, hyoid bone, and tongue.
(iii) Variable Constraint of the Mandible
and/or Head
Figs. 17A and 17B show a representative, more
advanced embodiment of an apparatus 10 for constraining a
mandible and/or head. In this embodiment, the magnitude
and/or direction of the constraining force can be varied,
altered, or titrated.
As shown in Figs. 17A and 17B, the neck piece 20
and/or the chin support 22 includes pockets 28. The
pockets 28 are sized and configured to receive
reinforcing elements or stays 30. As shown, the stays 30
can comprise strips of plastic material, but other cross-
sectional configurations, linear or curvilinear, and
material choices are possible. Each stay 30 possesses one
or more quantifiable physical properties, which can be
expressed in terms, e.g., length, thickness, elasticity,
tensile strength, flexure (Standard Gurley Units),
compressibility, spring constant, torque, shape, etc. By
the purposeful selection and insertion of stays 30,
individually or in groups of two or more, the physical
properties of the neck piece 20 and/or chin support 22,
which affect its ability to constrain the mandible
and/head in a desired way, can be incremental adjusted.
Over time, the physical properties of the neck piece 20
and/or chin support 22 can be titrated against the
individual's sleep performance, to optimize for that
individual the physical properties of the neck piece 20
and/or chin support 22 most conducive to deep,
restorative sleep.
Alternatively, as shown in Figs. 18A and 18B, the
pockets 28 can comprise inflatable chambers, to receive
gas or fluid pressure from an external source 32, or to
otherwise be enlarged or expanded. By the purposeful
expansion of the inflatable chambers 28, e.g., by
introduction of gas or fluid pressure, individually or in
groups of two or more inflatable chambers, the physical
properties of the neck piece 20 and/or chin support 22,
which affect its ability to constrain the mandible
and/head in a desired way, can be incremental adjusted.
Over time, the physical properties of the neck piece 20
and/or chin support 22 can be titrated against the ,
individual's sleep performance, to optimize for that
individual the physical properties of the neck piece 20
and/or chin support 22 most conducive to deep,
restorative sleep.
In the preceding embodiments, and as before stated,
it is desirable that the chin support 22 accommodate
displacement of tissue in, on, or near the floor of the
mouth without compressing the tissue, to thereby avoid,
during use, interference with the native anchoring
function that the floor of the mouth provides to the
mandible, hyoid bone, and tongue.
(iv) Dynamic Constraint of the Mandible
and/or Head
The magnitude and/or direction of the constraining
force can be also varied in a dynamic manner. As shown in
Fig. 19A, an apparatus 10 for constraining a mandible
and/or head can include an actuator 34 coupled to the
chin support 22, making it possible to articulate the
chin support 22 by operation of the actuator 34.
Operating the actuator 34, the chin support 22 can be
incrementally articulated toward the chin, to exert a
progressive lifting force and/or rotation force on an
individual's mandible and head. Conversely, the actuator
34 can articulate the chin support 22 away from the chin,
to moderate the lifting force. As previously mentioned, a
lifting force and/or rotational force on the chin and
mandible can also serve to stretch and maintain an opened
airway.
The actuator 34 for articulating the chin support 22
can vary and can be controlled in various ways. For
example, electromechanical lifters or shape activated
materials may be incorporated into the chin support 22.
In an illustrated embodiment, the chin support 22
comprises inflatable chambers 36 that are expanded in
response to the application of fluid (e.g., gas or air)
pressure from a source 38 through a solenoid control
valve 40. The solenoid control valve 40 includes an open
condition, allowing conveyance of fluid pressure from the
source to the chin support chambers 36; a closed
condition, preventing conveyance of fluid pressure from
the source to the chin support chamber 36; and a vent
condition, venting fluid pressure from the chin support
chamber 36.
The actuator 34 normally maintains the control valve
40 in the closed condition. The actuator 34 operates to
open the valve 40, to expand the chin support chambers 36
under the individual's jaw. Progressive expansion of the
chin support chambers 36 incrementally lifts the
individual's jaw and/or and/or provides a rotational
force and/or provides progressive resistance to mandible
and/or head movement rotation.
The actuator 34 can be operated manually by the
individual or by a healthcare assistant. The actuator 34
can include a manual control unit 42 with lift magnitude
readings or settings. Using the manual control unit 42,
the individual or healthcare assistant can select a
desired magnitude of lift. Over time, the magnitude of
lift can be titrated against the individual sleep
performance, to optimize for that individual the
magnitude of lift most conducive to deep, restorative
sleep.
A dynamically controlled apparatus 10 for
constraining a mandible and/or head can be integrated
into an overall therapeutic system, which controls the
actuator 34 in response to a sensed sleep condition,
e.g., a physical sleep position and/or sleep posture of
the individual, either with respect to the position of
the torso of the individual, or the position of the head
of the individual, or both; sleep sound or vibration
architecture; blood pressure; the level of oxygen in the
blood; heart rate; respiration rate; periodic cessation
of breathing, and/or muscle strain, or other sensed
physiologic or physical conditions, to adjust the
magnitude of lift in real time in a manner most conducive
to deep, restorative sleep.
For example, in Fig. 19B, the neck piece 20 carries
a sensor 46 for sensing a physical or physiological
condition attending the individual's sleep. For example,
in the illustrated embodiment, a sound sensitive element
(e.g., one or more microphones) can be integrated into
neck piece 20. The microphone 46 detects the sleep sound
architecture of the individual. The sleep sound
architecture is monitored and processed according to
preprogrammed rules by a monitor element 48, which
generates an alarm output 50 if the monitored sleep sound
architecture does not conform to a "best" or desired
benchmark.
The alarm output 50 is conveyed to the actuator 42.
According to preprogrammed rules, the actuator 42
controls the control valve 40 to incrementally expand the
chambers 36 and lift to exert a progressive lifting force
and/or rotational force on the individual's jaw.
Progressive lifting the individual's jaw and /or
incrementally turning the individual's head stretches the
airway. This, in turn, leads to an opening of the airway
and a change in the sleep sound architecture toward a
benchmark condition. When the benchmark condition
returns, the actuator 42 vents fluid pressure from the
chin support chamber and returns the valve 134 to the
closed condition.
Figs. 20A and 20B show another representative
embodiment of a dynamically controlled apparatus 10 for
constraining a mandible and/or head in response to sensed
sleep conditions, as identified above.
In this embodiment, the apparatus 10 comprises a
structure 52 sized and configured to support the neck of
an individual while the individual rests in a side
sleeping position on a sleeping surface 54 (as Fig. 20A
shows). The structure 52 includes a neck support surface
56, on which the individual rests a side of their neck
while their head rests on a pillow.
As Fig. 20B best shows, a posterior region 58 of the
neck support surface 126 is contoured upward away from
the sleep surface 54 to form a rest for the back of the
neck, while the individual rests on a side of their neck
in the remainder of the neck support surface 56. An
anterior region 60 of the neck support surface 56 (the
direction the individual's head faces) is also contoured
upward, although not as much the posterior region, to
form a forward rest for individual's chin. In this
arrangement, the support surface takes the shape of a
non-symmetric "U."
The structure includes a mandible positioning
surface 62 located between the anterior and posterior
regions of the neck support surface. The mandible
positioning surface 62 is sized and configured to
underlay the contour of the individual's jaw.
In this arrangement, a sensor 64 for sensing a
physical or physiological condition attending the
individual's sleep can be coupled to the apparatus. For
example, in the illustrated embodiment, a sound sensitive
element 64 (e.g., one or more microphones) can be
integrated into the anterior region of the neck support
surface 60 (as Figs. 20A and 20B show). The microphone 64
detects the sleep sound architecture of the individual
resting on their side in the neck support structure 56.
The sleep sound architecture is monitored and processed
according to preprogrammed rules, and an alarm output is
generated if the monitored sleep sound architecture does
not conform to the "best" or desired benchmark.
A corrective action element 66 controls the
elevation of the mandible positioning surface 62 with
respect to the neck support surface 56. Under the control
of the corrective action element 66, the mandible
positioning surface 62 can be incrementally lifted above
the neck support surface to exert a progressive lifting
force and/or rotational force on the individual's jaw.
The lifting and/or rotation of the mandible
positioning surface 62 can be controlled in various ways.
For example, electromechanical lifters or stiffeners may
be used. In the illustrated embodiment, the mandible
positioning surface 62 is lifted in . response to the
application of fluid pressure from a source 68 through a
solenoid control valve 70. The solenoid control valve 70
includes an open condition, allowing conveyance of fluid
pressure from the source 68 into the mandible positioning
surface 62; a closed condition, preventing conveyance of
fluid pressure from the source 68 into the mandible
positioning surface 62; and a vent condition, venting
fluid pressure from the mandible positioning surface to
placed it in a collapsed condition.
The corrective action element 66 normally maintains
the control valve 134 in the closed condition. In
response to a sensed undesirable sleep condition (i.e.,
the alarm condition), the corrective action element 66
progressively opens the valve 70, to progressive lift the
mandible positioning surface under the individual's jaw.
Progressive lifting the mandible positioning surface
incrementally lifts the individual's jaw, incrementally
turns the individual's head, and stretches the airway.
This, in turn, leads to an opening of the airway and a
change in the sleep sound architecture toward a benchmark
condition. Alternatively, the benchmark condition can
comprise another sensed sleep condition, e.g., a physical
sleep position and/or sleep posture of the individual,
either with respect to the position of the torso of the
individual, or the position of the head of the
individual, or both; sleep sound or vibration
architecture; blood pressure; the level of oxygen in the
blood; heart rate; respiration rate; periodic cessation
of breathing, and/or muscle strain, or other sensed
physiologic or physical conditions. When the benchmark
condition returns, the corrective action element 66 vents
fluid pressure from mandible positioning surface 62 and
returns the valve 70 to the closed condition.
As before stated, the lifting of the jaw and chin in
the preceding embodiments preferable avoids compressing
tissue in, on, or near the floor of the mouth to avoid,
during use, interference with the native anchoring
function that the floor of the mouth provides to the
mandible, hyoid bone, and tongue.
(v) Anchored Load Bearing Structure
In the embodiment shown in Figs. 21A, 21B, and 21C,
the apparatus 10 includes a load bearing structure 72
that is sized and configured to be supported between
rigid bony anchoring points between the shoulder and
mandible (shown in Fig. 23C).
The load bearing structure 72 includes a caudal
region 74. The caudal region 74 is sized and configured
to engage the chest and back in contact, at least in
part, with the left and right clavicle. The clavicle,
also called the collar bone, is a long bone that makes up
part of the shoulder girdle (pectoral girdle). The
clavicle is also shown in Fig. 5 with respect to the
tissue structures of the neck.
The load bearing structure 72 also includes a
cranial region 76. The cranial region 76 is sized and
configured to engage, at least in part, the bony
perimeter of the mandible. For this purpose, the cranial
region 76 can be contoured to include a channel 92 in
which, during use, the bony periphery of the mandible
rests. In this embodiment, the cranial region 76 is
otherwise substantially free of contact with soft tissue
under the chin.
The right and left clavicle and the bony perimeter
of the mandible comprise, respectively, rigid caudal and
cranial anchoring points for the load bearing structure
72. In the illustrated embodiment, the intermediate
region of structure comprises load bearing trusses or
spacers 78 coupled to the caudal and cranial regions 74
and 76. A hinge joint 80 allows the structure 72 to be
opened (as Fig. 21A shows) and closed (as Fig. 21 B
shows) for insertion into position for use and removal
after use. A releasable latch 82 locks the structure 72
in a closed position for use (as Fig. 21C shows) . The
releaseable latch 82 can comprise, e.g., releasable
fasteners, e.g., such as' snaps, magnets, buckles, straps,
VELCRO® fabric, and the like, so that an individual can
adjust the fit and form of the structure 72.
Inserted between bony, rigid anchor points of the
clavicle and mandible when the mouth is closed, the load
bearing structure 72 constrains the mandible and/or head
in the manner previously described.
Axial Adjustment
In one embodiment (see Figs. 22AA, 22B, and 22C, the
load bearing trusses 78 in the intermediate region of the
structure 72 include a mechanism 84 to permit adjustment
of the axial distance between the caudal and cranial end
regions 74 and 76. In the illustrated embodiment, load
bearing trusses 78 comprise telescoping extension legs
78a and 78b. In this arrangement, the adjustment
mechanism 84 comprises one or more screw clamps 86 at the
telescopic junction of the legs 78a and 78b. Loosening
the screw clamps 86 frees the legs for extension or
retraction in an axial direction (as the arrows in Fig.
22B show), thereby increasing or reducing, respectively,
the axial distance between the caudal and cranial regions
74 and 76. Tightening screw clamps 86 locks the legs 78a
and 78b against extension or retraction, to holdfast a
desired length as Fig. 22C shows.
The adjustment mechanism 84 makes it possible to
adjust the axial length of the structure 72 according to
an individual's anatomy and treatment objectives. In this
way, the first and second constraint conditions 12 and
14, described above, that keep the mouth closed and that
limit inferior rotation of the head can be optimized
and/or titrated for a given individual.
The adjustment mechanism 84 also makes it possible
to exert an enhanced lifting force on an individual's
mandible and head to stretch and further open the airway.
Alternatively, as shown in Figs. 23A, 23B, and 23C,
the adjustment, mechanism 84 can comprise telescoping,
pneumatic chambers or cylinders 88 that enlarge in an
axial direction in response to the introduction of gas or
fluid pressure from an external source 90.
Rotational Bias
In another embodiment (see Figs. 24A, 24B, and 24C),
the load bearing structure 72 is sized and configured to
provide a rotational offset to the cranial region 76
relative to the caudal region 74 about the axial axis. In
the illustrated embodiment, the load bearing structure 72
is manufactured with a fixed, preset offset.
The rotational offset makes it possible to impose
the fourth constraint condition 18, described above. The
rotational offset establishes and maintains a desired
twist or torque to the chin. Along with an axial length
adjustment mechanism 84, the rotational offset also
establishes and maintains a desired elevation of the
chin. The rotational offset applies a side force or
torque to the mandible to cause a twisting of the chin to
one side. This constraint condition 14 applies tension to
muscles structures along the pharyngeal airway to create
a more rigid airway.
Mandible Adjustment
In the embodiment shown in Figs. 25A, 25B, and 25C,
the contoured channel 92 of the cranial region '76 slides
on a track 90 for translating the channel 92 in an
anterior direction. A locking screw 94 holdfasts the
channel 92 in a desired translated position. The
adjustable mandible resting channel 92 makes it possible
to impose the third constraint condition 16, which is to
provide and maintain an anterior position to the jaw.
Resting the chin in the channel 92, and then translating
the channel 92 forward moves the mandible forward,
establishing a desired anterior orientation of the
mandible. Upon being locked, the channel 92 maintains the
mandible in a desired, slightly anterior (protruding)
orientation, to thereby affirmatively resist inferior
translational movement of the mandible within the TMJ.
Alternatively, in any of the above-described
embodiments, the cranial region 76 of the structure 72
can include, instead of a formed, chin-fitting channel
92, a larger tissue support surface 96, as shown in Fig.
26A. In this embodiment, the tissue support region 96 is
desirably formed of a flexible and soft material for user
comfort, comprising, e.g., a soft, supple, breathable
fabric, e.g., a webbing material.
Further, as shown in Fig. 26B, an adhesive material
26 can be applied to the tissue support region 96. The
adhesive material 26 adheres to surface tissue under the
chin. The adherence of surface tissue to the tissue
support region 96 can exert a stabilizing force on tissue
structures in, on, or near the chin and the floor of the
mouth. The stabilizing force draws the surface tissue in
a caudial direction, away from the airway.
As will be described in greater detail later,
because of the native, interconnected morphology of
tissue structures in this region, the application of a
stabilization force on surface tissue serves to also
indirectly stabilize interior tissue structures in this
region, e.g., intrinsic and extrinsic muscles of the
tongue. The adherence of surface tissue to the tissue
support region 96 braces tissue structures in, on, or
near the chin and the floor of the mouth, to hold them in
a desired orientation biased away from collapse into the
airway. The mechanical stabilization and support can also
serve to dampen vibration of these tissue structures,
thereby moderating loud breathing or snoring during
sleep.
The adherence of surface tissue to the tissue
support region 96 can also enhance the anterior
stabilization of the mandible, to resist inferior
translational movement of the mandible within the TMJ
and/or to impose the third constraint condition 16, which
provides and maintain an anterior position to the jaw.
(vi) Helical Load Nearing Structure
Figs. 27A and 27B show an alternative embodiment of
a load bearing structure 72 that is sized and configured
to be supported between rigid bony anchoring points
between the shoulder and mandible.
The load bearing structure 72 includes a caudal
region 74. The caudal region 74 is sized and configured
to engage the chest and back in contact, at least in
part, with the left and right clavicle, as Fig. 27C
shows.
The load bearing structure 72 also includes a
cranial region 76. The cranial region 76 is sized and
configured to engage, at least in part, the bony
perimeter of the mandible.
In the embodiment shown in Figs. 27A, 27B, and 27C,
the intermediate region of structure comprises a helical
load bearing member 98, which spirals between the caudal
and cranial regions 74 and 76.
As Fig. 27B shows, inserted between bony, rigid
anchor points of the clavicle and mandible when the mouth
is closed, the helically shaped load bearing member 98
applies a lifting force to the mandible, thereby
constraining the mandible and/or head to keep the mouth
closed and the chin lifted. The helically shaped load
bear member 98 also applies a preferential torque to the
mandible in the direction of the helical twist of the
load bearing member 98. The helical load bearing member
98 thereby imposes an additional constraint condition,
preferentially twisting the head to apply tension to
muscles structures along the pharyngeal airway, thereby
creating a more rigid airway.
The helical load bearing member 98 can comprise a
preformed elastic or semi-elastic material. Alternately,
the helical load bearing member 98 can comprise a
structure that enlarges and expands in situ (e.g., in
response to pneumatic fluid pressure) (see Fig. 27C) to
fit and anchor itself in the space between the clavicle
and mandible. In this arrangement, adjustment of the
fluid pressure serves to adjust the lift and/or
preferential torque that the helical structure 72
provides. As before described, the individual or
healthcare assistant can select a desired magnitude of
fluid pressure to achieve the therapeutic objectives of
lift and/or preferential torque that are sought. Over
time, the magnitude of fluid pressure can be titrated
against the individual sleep performance, to optimize for
that individual the magnitude of lift and/or preferential
torque most conducive to deep, restorative sleep.
The expandable helical load bearing member 98 can be
integrated into an overall therapeutic system, which
controls the magnitude of the fluid pressure in response
to a sensed sleep condition, e.g., a physical sleep
position and/or sleep posture of the individual, either
with respect to the position of the torso of the
individual, or the position of the head of the
individual, or both; sleep sound or vibration
architecture; blood pressure; the level of oxygen in the
blood; heart rate; respiration rate; periodic cessation
of breathing, and/or muscle strain, or other sensed
physiologic or physical conditions to adjust the
magnitude of lift and torque in real time, most conducive
to deep, restorative sleep.
As before stated, the load bearing structures as
described above preferable avoid compressing tissue in,
on, or near the floor of the mouth to avoid, during use,
interference with the native anchoring function that the
floor of the mouth provides to the mandible, hyoid bone,
and tongue.
IV. Apparatus and Methods for Bracing Tissue Structures
In, On, or Near the Neck
Apparatus and methods have been described for
constraining the mandible and/or head. The apparatus and
methods have included, as a structural component, a neck
piece 20. In these embodiments, the neck piece 20 serves
as a carrier for a chin support 22, which was described
as the structural component providing, in that
embodiment, the primary therapeutic benefit of achieving
a desired orientation of the mandible and/or head.
Figs. 28A, 28B, and 28C shows an apparatus
comprising a neck piece 100 that serves a different
primary therapeutic benefit. This therapeutic benefit is
to externally brace tissue structures in, on, or near the
neck, and/or along the walls of the pharyngeal airway
itself, and/or the floor of the mouth.
Diverse tissue structures occupy the neck, the
pharyngeal airway, and floor of the mouth. These
structures comprise layers of dermis, fat, and muscle,
which are mutually interconnected from the epidermis
inward to the tongue and base of the tongue. Due to their
native, interconnected morphology, the application of a
force to brace, move, or constrain one of these tissue
structures in effect braces, moves, or constrains them
all to various degrees. The neck piece 100 is sized and
configured to mechanically stabilize and support these
interconnected tissue-structures in, on, near, or around
(i.e., to fully circumferentially surround) the neck,
pharyngeal airway, and floor of the mouth in a desired
orientation biased away from collapse into the airway.
The mechanical stabilization and support that the neck
piece 100 provides affirmatively resists movement or
collapse of the tissue structures in, on, or near the
neck, pharyngeal airway, and floor of the mouth toward
and into the airway. The mechanical stabilization and
support that the neck piece 100 provides can also serve
to dampen vibration of these tissue structures, thereby
moderating loud breathing or snoring during sleep.
As will be described, the neck piece 100 can
function without use of external positive pressure
ventilation techniques, like CPAP. However, the neck
piece 100 can also be used in combination with CPAP,
and/or intraoral oral appliances used to position the
tongue and/or jaw during sleep, and/or with the Pillar®
Procedure (Restore Medical Inc.), and/or tissue removal
or other surgical intervention techniques, such as
maxillomandibular advancement (MA) or
uvulopalatopharyngeoplasty (UPPP). The additive effects
of the neck piece 100 can serve to moderate the required
nature and extent of these often highly invasive surgical
procedures, thereby reducing the often long recover time
and increasing patient appeal. When used in combination
with CPAP, oral appliances, and surgical procedures, the
presence of the neck piece 100 can increase the success
rates of conventional treatments.
Desirably, structures that externally brace tissue
structures in, on, or near the neck, and/or along the
walls of the pharyngeal airway itself, and/or the floor
of the mouth are sized and configured to avoid
compressing tissue in, on, or near the floor of the mouth
to avoid, during use, interference with the native
anchoring function that the floor of the mouth provides
to the mandible, hyoid bone, and tongue.
A. Overview
In Figs. 28A, 28B, and 28C, the neck piece 100 takes
the form of a collar 102 that is sized and configured to
encircle the neck between the mandible and the clavicle
(collar bone). The clavicle and mandible provide rigid,
bony anchoring points for the collar 102. The collar 102
is flexible and soft for user comfort (desirably
comprising a soft, supple, breathable fabric), but
nevertheless possesses the requisite size and mechanical
properties to perform in the manner described. The neck
piece 100 can comprise a fabric material and be treated
as a single or limited use, disposable item.
In the illustrated embodiment, the collar 102 is
size and configuration to. have an inside circumference
that exceeds the native outer circumference of the neck
by a small difference (e.g., less than 5 cm, and more
desirably between about 0.5 cm to about 2 cm), which is
determined by a healthcare provider based upon the
anatomy and morphology of the individual wearing the
collar 102. The slightly oversized collar 102 makes it
possible to conform tissue structures in, on, or near the
neck, the pharyngeal airway, and the floor of the mouth
to an orientation away from the airway.
The neck piece 100 includes a pressure-sensitive
medical grade adhesive gel or material 104 applied to the
inside of the collar 102 (see Figs. 28A and 28C). As
previously described, the adhesive material 104 can
comprise conventional pressure-sensitive compositions
used for adhesion to the skin, particularly in the field
of colostomy care. Representative pressure sensitive
adhesive compositions comprise a self- adhesive
elastomeric matrix, in which water-absorbing, swelling
particles, called hydrocolloids, are dispersed.
Due to the presence of the adhesive material 104,
the inside of the collar 102 adheres, to surface tissue
along the neck. As shown in Fig. 28C, because the inside
circumference of the collar 102 is purposely slightly
larger than the native circumference of the neck, the
adhesive material 104 on the collar 102 draws tissue
outward away from the tissue structures of the neck,
pharyngeal airway, and floor of the mouth. The adhesive
material 104 holds tissue in this position to exert a
stabilizing force on tissue structures in, on, near, or
around (i.e., to fully circumferentially surround) the
neck, the pharyngeal airway, and the floor of the mouth.
Depending upon the anatomy and morphology of the
individual wearing the collar 102, the inside
circumference of the collar 102 may not need to
significantly exceed the native outside circumference of
the wearer's neck. The adhesion force created by the
collar 102 and adhesive material 104 can mechanically
brace and stabilize tissue structures in, on, or near the
neck, pharyngeal airway, and floor of the mouth and
thereby resist movement or collapse of these tissue
structures into the airway. The collar 102 need not
otherwise enlarge the circumference of the neck.
Still, if desired, the inside circumference of the
collar 102 can be sized relative to the neck to also
exert a pulling force on tissue structures in, on, or
near the neck, the pharyngeal airway, and the floor of
the mouth. The outward adhesive force reshapes these
tissue structures toward the slightly larger
circumference of the collar 102.
The collar 102 thereby serves to stabilize and/or
reshape tissue structures in, on, or near the neck,
pharyngeal airway, and floor of the mouth, holding and/or
biasing them in a circumference and orientation, which is
away from the collapse into the airway. The adhesion
force between tissue along the neck and the adhesive
material 104 on the oversized collar 102 braces tissue
structures in, on, and near the neck, pharyngeal airway,
and floor of the mouth against collapse into the airway.
The adhesion force mechanically resists movement or
collapse of the tissue inwardly toward the airway. In
this respect, the collar 102 is unique in that it avoids
inward pressure on soft tissue structure in, on, near the
tongue and floor of the mouth. As before described, it is
desirable to avoid compressing tissue in, on, or near the
floor of the mouth to thereby avoid, during use,
interference with the native anchoring function that the
floor of the mouth provides to the mandible, hyoid bone,
and tongue.
The force that the adhesive material 104 on the
collar 102 applies to the tissue structures can be
augmented or enhanced, or replaced in its entirety, by
the presence of negative pressure in the region between
the inside of the collar 102 and the soft tissue of the
upper neck and under the chin. As Fig. 29A shows,
placement of a suitable sealing interface 106 between the
mandible and clavicle anchor points can form a sealed
chamber 108 along the interior of the collar 102.
Applying negative pressure to the sealed chamber from an
external source 110 draws tissue away from the airway.
The external source 110 can comprise, e.g., an air pump
can be carried by the collar, or it can be located remote
from the collar 102, e.g., bedside, and coupled by tubing
to the air chamber 16, as Fig. 29A shows. The air pump
110 can comprise, e.g., a diaphragm pimping mechanism, or
a reciprocating piston mechanism, or a centrifugal
(turbine) air-moving mechanism. The air pump 110 may be
manually operated, or a power source 114 may drive the
air pump 110. The power source 114 can be, e.g., an
electric motor that can be plugged into a conventional
electrical receptacle, or be battery-powered, or both (in
which case the battery can be rechargeable) . When driven,
the air pump 110 draws air from the chamber 108, to
establish within the chamber 108 a pressure condition
that is less than atmospheric.
A regulator 112 may be coupled to govern operation
of the air pump 110 to establish and maintain a desired
sub-atmospheric pressure condition within the chamber
108. The desired pressure condition is selected to be
less than atmospheric pressure and is desirably less the
minimum pressure condition expected experienced in the
pharyngeal conduit, which is typically encountered during
the inhalation phase of the respiration cycle. The
pressure selected desirably nullifies the vector sum of
the extralumenal forces, which are created by the
interaction of atmospheric pressure, gravity, the
contractive forces within the tissue due to upper airway
muscle activity, and the inward forces generated by
subatmospheric luminal pressure generated during
inhalation. It is believed that the pressure condition
established within the chamber 16 should be at least -1
cm H2O and desirable at least -10 cm H2O. The pressure
created desirably also takes into account different
anatomical structural differences of individual airways.
Negative pressure can also be generated by use of a
one way valve that allows air to escape (but not re-
enter) when skin and the inside of the collar 102 are
pressed together.
The presence of negative pressure complements the
pulling force applied to tissue by the adhesive material
104 on the collar 102, to hold tissue structures in, on,
or near the neck away from the airway.
Alternatively, negative pressure alone, without the
use of adhesive material 104, can serve to hold tissue
structures in, on, or near the neck away from the airway.
In another alternative arrangement (see Fig. 29B),
the collar 102 can include an array of negative pressure
ports 116 coupled to the external source 110. The ports
116 convey negative pressure and draw localized regions
of tissue into contact with the interior of the collar
102, in the same fashion that an adhesive material 104
would and with the same beneficial affect of holding
tissue structures in, on, or near the neck away from the
airway.
In another alternative embodiment (see Figs. 29C and
29D), a smaller, neck mask or cup 300 can be affixed by
means of a flexible strap 302 in the region of the throat
and/or floor of the mouth. The neck mask or cup 3 00
includes a sealing interface 304 about its periphery to
form an interior air chamber 306 (see Fig. 29C). An air
pump 308 can be coupled to the neck mask by tubing 310,
to apply negative pressure to the air chamber 306, as
Fig. 29C shows. When worn, as Fig. 29D shows, the .
presence of negative pressure within the air chamber 306
holds tissue structures in, on, or near the neck and/or
floor of the mouth away from the airway.
B. Tissue Bracing
During sleep (see Fig. 30A) , when a person is lying
down in a prone, supine, or side position, and when
muscles in or affecting neck, and/or the pharyngeal
airway, and/or the floor of the mouth can relax, The
mandible can drops (as Fig. 30A shows), and the mouth
opens. During sleep, the head may also rotate inferiorly
in flexion, or translation may occur within the TMJ to
cause a posterior sliding of the mandible. The shift in
mandible and/or head orientation during sleep leads to a
shortening of the native anterior-to-posterior distance
between the mandible and hyoid within the floor of the
mouth. As the anterior-to-posterior distance is reduced
by mandible and head orientation, the tongue and tissue
structures in the floor of the mouth, which occupy this
space, are shifted inward and toward the airway. Even in
the absence of a reduction of the anterior-to-posterior
distance between the mandible and hyoid bone, the
diminution or absence of native muscle activity, and the
force of gravity during sleep can shift the position of
the root of the tongue in a posterior direction, toward
and into the airway. Further, during sleep, the
diminution or absence of native muscle activity in the
neck can lead to the collapse of tissue in the neck
toward and into the airway. As a result, the airway can
be diminished or even blocked.
As shown in Fig. 30B, the presence of the collar 102
and the adhesive material 104 it carries conditions the
tissue structures in, on, or near the neck, and/or the
pharyngeal airway, and/or the floor of the mouth to
resist collapse toward and into the airway. The presence
of the collar 102 and the adhesive material 104 it
carries braces these tissue structures outward, away from
collapse into the airway. The collar 102 preferably
includes a concave pocket region 430, which is sized and
configured to receive tissue underlying the floor of the
mouth, so that the collar 102, in use, does not compress
the floor of the mouth to block the desirable lowering of
the tongue and its beneficial effects upon the airway, as
will be described in greater detail later.
The bracing effect of the apparatus is particularly
advantageous for individuals having tissue structures
that are enlarged or that otherwise lack normal tone or
compliance. For such individuals, it may be warranted to
tighten the skin of the neck prior to use of the collar
102. The skin of the neck can be tightened, e.g.,
surgically or by use of collagen tightening technologies,
such injection of agents or by heat, or by liposuction,
or by neck lifting techniques. The skin of the neck also
may be locally tightened by wrapping with pressure
sensitive tape prior to use of the apparatus.
As Fig. 29A shows, the collar 102 desirably includes
releasable fasteners 118 , e.g., such as snaps, magnets,
buckles, straps, VELCRO® fabric, and the like, so that an
individual can secure the collar 102 around their neck
prior to use and remove the collar 102 from the neck
after use. The adhesive material 104 releases upon remove
of the collar 102. The fasteners 118 make it possible for
the individual to loosen or tighten the collar 102 to
adjusting the pulling force exerted on the tissue
structures.
The collar 102 can be used by itself (as Fig. 29B
shows), to achieve a beneficial bracing effect upon
tissue structure in. on, or near the neck, the pharyngeal
airway, and/or floor of the mouth. As Figs. 31A and 31B
show, the collar 102 can also include a chin support 120,
like that previously described, to create a multi-
function assembly 100 that combines neck bracing with
mandible and/or head constraints.
The neck piece or collar 102 can be formed from
elastic webbing material. Alternatively, the neck piece
or collar 102 can comprise a pre-formed device made,
e.g., from an elastic or semi-elastic polymer material.
In either arrangement, the neck piece or collar 102 can
be shaped, sized, and. contoured based upon the particular
anatomy of the individual who will wear the device.
However, the neck piece or -collar 102 can also be shaped,
sized, and contoured based more upon a range of generic
models of human anatomy.
The inside circumference of the collar 102, and the
difference between it and the native outer circumference
of the neck, can be assessed by medical professionals
using textbooks of human skeletal anatomy, assisted by
analysis of the morphology of the tissue structures in,
on, or near the individual's neck, using, for example,
plain films, MRI, or CRT scanning.
The inside circumference of the collar 102 can be
titrated against the individual sleep performance, to
optimize for that individual the inside circumference
most conducive to deep, restorative sleep. The selection
and application of adhesive material 104 used can also be
titrated to optimize the desired results.
As discussed before, the size and configuration of
the neck piece or collar 102, and the apparatus 100 in
general, are also selected and contoured to limit direct
pressure on soft tissue under the chin and in the floor
of the mouth, to prevent an unintended inward movement of
these tissue regions toward the airway and a resultant
narrowing of the airway.
1. Variable Neck Bracing / Reshaping
The physical properties of the neck piece or collar
102 can be made variable. As shown in Figs. 32A and 32B,
the neck piece or collar 102 can include about its outer
circumference pockets 122 that are sized and configured
to receive reinforcing elements or stays 124. As
previously discussed, the stays 124 can comprise strips
of plastic material, but other cross-sectional
configurations, linear or curvilinear, and material
choices are possible. The physical properties of given
stay 124 can be characterized in terms of, e.g., length,
thickness, elasticity, tensile strength, flexure
(Standard Gurley Units), compressibility, spring
constant, torque, shape, etc. By the purposeful selection
and insertion of stays 124, individually or in groups of
two or more, the physical properties of the neck piece or
collar 102, which affect its ability to brace tissue
structures in, on, or near the neck, pharyngeal airway,
and/or floor of the mouth can be incremental adjusted.
Over time, the physical properties of the neck piece or
collar 102 can be titrated against the individual sleep
performance, to optimize for that individual the physical
properties of the neck piece most conducive to deep,
restorative sleep.
In one variation, the mechanical properties of the
neck piece or collar 102 can be varied by control of an
actuator 126. Operating the actuator 126, the mechanical
properties of the neck piece in terms of its flexibility
or stiffness and/or circumference can be incrementally
varied. The mechanism for varying the mechanical
properties of the neck piece can vary. For example, the
stays 124 may comprise shape activated materials that
stiffen, e.g., in result to the conduction of electrical
current.
2. Dynamic Neck Bracing / Reshaping
In an illustrated embodiment (see Figs. 33A and
33B), the neck piece or collar 102 includes chambers 128
that receive fluid pressure from a source 13 0 through a
solenoid control valve 130. The fluid pressure expands or
contacts the circumference of the neck piece or collar
102, and also makes the neck piece or collar 102 more or
less flexible. The actuator operates to valve, to
progressive introduce more or less fluid pressure into
the chambers of the neck piece. Progressive fluid
pressure alterations can stiffen or soften the neck piece
and also constrict or expand its circumference.
The actuator 126 can be operated manually by the
individual or by a healthcare assistant. The actuator 126
can include a manual control and pressure magnitude
readings or settings. Using the actuator 126, the
individual or healthcare assistant can select a desired
magnitude of pressure. Over time, the magnitude of
pressure can be titrated against the individual sleep
performance, to optimize for that individual the
magnitude of lift most conducive to deep, restorative
sleep.
As Figs. 33A and 33B show, a dynamically controlled
apparatus 100 for shaping the neck can be integrated into
an overall therapeutic system 134, which controls the
actuator 126 in response to a sensed sleep condition,
e.g., a physical sleep position and/or sleep posture of
the individual, either with respect to the position of
the torso of the individual, or the position of the head
of the individual, or both; sleep sound or vibration
architecture; blood pressure; the level of oxygen in the
blood; heart rate; respiration rate; periodic cessation
of breathing, and/or muscle strain, or other sensed
physiologic or physical conditions, to provide deep,
restorative sleep.
Moving the head or mandible may be one of the
simplest and most effective means to correct an apnea
event. Thus, the dynamically controlled apparatus 100 can
also affect the magnitude and/or direction of
constraining forces on the mandible and head in the
manner previously described and disclosed in Fig. 19A. In
this manner, an actuator 34 coupled to the chin support
22 makes it possible to articulate the chin support 22 by
operation of the actuator 34, to exert a progressive
lifting force and/or rotation force on an individual's
mandible and head, in response to sensed conditions. As
previously mentioned, a lifting force and/or rotational
force on the chin and mandible can also serve to stretch
and maintain an opened airway. Moving the head or
mandible may be one of the simplest and most effective
means to correct an apnea event.
This dynamically controlled apparatus 100 can also
be integrated with positive air pressure systems, such
that the magnitude of positive air pressure being applied
becomes one of the sensed conditions that affects the
orientation of collar. Positive pressure is applied to a
nose mask, full face mask, or nasal pillow worn by the
individual. A machine coupled to the mask delivers a
stream of compressed air to the delivery device at a
prescribed pressure, which is also called the titrated
pressure. The intent of CPAP is to splint the airway
(keeping it open under air pressure) so that unobstructed
breathing becomes possible, reducing and/or preventing
snoring, apneas, and hypopneas.
For example, when high titrated pressures are
required, the mask must be tightened. This causes the
mandible to drop and the tongue to fall back, thereby
causing even higher pressures. Sensing this condition,
and, in response, adjusting the collar 102 to exert a
lifting force and/or rotation force on an individual's
mandible and head, will reduce the pressure requirement
or allow higher pressure to be applied without overly
tightening the mask.
Therefore, the collar 102 can be integrated with
positive airway pressure masks (pillows and the like) to
effect head position and tissue stabilization while
administering positive airway pressure therapy.
V. Scaffolds In, On, or Near the Floor of the Mouth
A. Overview
As Figs. 1A and 1B show, the oral cavity is framed
by relatively stable structures -- i.e., the rigid
structures comprising the hard palate and cervical spine
-- and the floor of the mouth. The floor of the mouth
comprises superficial muscles such as the mylohyoid and
geniohyoid. The floor of the mouth is bounded by the
rigid, movable structures of the mandible (anterior) and
the hyoid bone (posterior). The muscles of the floor of
the mouth extend between these rigid, movable structures.
Along with the mandible and the hyoid bone, the muscles
in the floor of the mouth also serve as an anchoring
structure for the tongue. The region behaves like a
trampoline, stabilizing these structures, while
accommodating relative movement among them.
While awake, the frame size is maintained by active
tension in the floor of the mouth muscles (i.e., keeping
the trampoline taunt). The active tension in the frame in
turn maintains the anterior position of the mandible,
creating more volume in the oral cavity and thus an
airway of sufficient diameter. This is also shown
diagrammatically in Fig. 1C.
However, absence of muscle activity during sleep,
gravity, and the negative pressure cascade during the
breathing cycle all create conditions for the tongue to
slide in a posterior direction and close the airway. This
is shown diagrammatically in Fig. 1D. During sleep, the
floor of the mouth muscles lose active tension, and the
trampoline becomes slack. The mandible drops and falls
back (in a posterior direction) due to lack of tension in
other muscles. The slack muscles in the floor of the
mouth buckle or bend inward, because the tongue pulls the
muscles in the floor of the mouth inward. The mandible
repositions toward the airway, shortening the distance
between the mandible and the hyoid. The frame size of the
oral cavity decreases. The tongue slides to the posterior
and closes the airway.
Figs. 34A, 34B, and 34C show a system 136 comprising
at least one scaffold 138 placed in, on, or near selected
tissue regions in the floor of the mouth. In use, the
scaffold 13 8 helps an individual with a sleep disordered
breathing condition, such as habitual snoring or
obstructive sleep apnea (OSA), achieve deep, restorative
sleep. As Figs. 34A, 34B, and 34C show, at least one of
the scaffolds 138 is placed in, on, or near the selected
tissue regions in the floor of the mouth between the
anterior part of the mandible and the hyoid bone.
The diverse tissue structures occupying the floor of
the mouth comprise layers of dermis, fat, and muscle,
which are mutually interconnected from the epidermis
inward to the genioglossis muscle, tongue and base of the
tongue. Due to their native, interconnected morphology,
the application of a force to brace, move, or constrain
one of these tissue structures in effect braces, moves,
or constrains them all to various degrees. By analogy,
this structure has previously compared to a trampoline,
which provides for both motion and stabilization of the
tongue. The scaffold 138, in effect, stiffens and shapes
the trampoline.
The scaffold 138 comprises a shaped, elongated body
made from a biocompatible metallic or polymer material,
or a metallic or polymer material that is suitably
coated, impregnated, or otherwise treated with a material
to impart biocompatibility, or a combination of such
materials.
The physical characteristics of the scaffold 138
body are selected in term of length, thickness,
elasticity, tensile strength, flexure (Standard Gurley
Units), compressibility, spring constant, torque, shape,
etc., so that, when placed in tissue, the scaffold 138
mechanically supports the selected tissue region in a
desired orientation in the floor of the mouth, even in
the absence or diminution of native muscle activity in
that region. To achieve this function, the scaffold 138
can comprise a rigid material, or a semi-rigid, or an
elastic material with a selected spring constant (e.g., a
spring constant similar to tongue tissue), or an
electrically actuated shaped material, or a thermally-
activated shaped material, or combinations thereof. The
scaffold 138 can also comprise a fluid or material that
is injected into the floor of the mouth and that stiffens
or cures in situ by itself (e.g., by cross-liking) or in.
response to applied external energy such as light,
ultrasound, heat, or radio frequency energy. The scaffold
138 can also comprise a region of tissue in the floor of
the mouth that has been ablated, e.g., by the application
of radio frequency energy, heat, laser, or cold, to form
lesions and stiffen. The mechanical support that the
scaffold 138 provides stabilizes the tissue region,
thereby providing affirmatively resistance to movement of
the selected tissue region out of the desired
orientation, which would otherwise occur due to the
absence or diminution of native muscle activity in that
region. The mechanical support that the scaffold 138
provides can also serve to dampen vibration of the tissue
region, thereby moderating loud breathing or snoring
during sleep.
As shown in Figs. 35A and 35B, the desired
orientation provided by the scaffold's mechanical support
can, e.g., serve to resist undesired posterior movement
of a tongue during sleep. As previously described with
respect to Fig. 1D (and as also shown anatomically in
Fig. 35A), a lack of native muscle activity in the floor
of the mouth during sleep can cause the root of the
tongue to fall posteriorly, to narrow or obstruct the
airway. As previously described, the mandible drops and
falls back (in a posterior direction); the muscles in the
floor of the mouth buckle or bend inward; and the
mandible repositions toward the airway, shortening the
distance between the mandible and the hyoid. This change
in distance and tension between the mandible and hyoid
leads to a decrease in the frame size of the oral cavity.
The decrease in frame size causes the tongue to collapse
into the airway. The tongue slides in a posterior
direction and closes the airway.
As Fig. 35B shows, the mechanical support of the
scaffold 138 in the floor of the mouth conditions tissue
to support the tongue in a desired anterior orientation,
in effect mimicking native muscle activity that supports
the tongue through interaction with the hyoid bone.
Referring again to the analogy, the scaffold 138 stiffens
and shapes the trampoline. This is shown diagrammatically
in Fig. 35C. The scaffold 138 increases the tension in
the floor of the mouth, preventing inward buckling and
stabilizing the floor of the mouth to increase resistance
to posterior tongue collapse. The scaffold 138 increases
the distance and maintains tension between the mandible
and hyoid, biasing the position of the mandible toward a
mouth closed, chin up, jaw forward orientation. The
mechanical support of the scaffold 138 in the floor of
the mouth stabilizes the tissue region in the absence of
the native muscle activity during sleep, to resist
posterior movement of the tongue into the pharyngeal
airway.
The desired orientation provided by the scaffold's
mechanical support can also, e.g., serve to bias the
displacement of tissue structures in, on, or near the
floor of the mouth away from the airway when the mandible
opens. As previously described, when the mandible opens
(articulates downward), the anterior-to-posterior
distance between the mandible and hyoid shortens, and
tissue structures in, on, or near the floor of the mouth
shift. Typically, due to the gravity position of the
individual when sleeping (no longer upright), and the
relaxation of muscles during sleep, when the mouth opens,
tissue structures in, on, or near the floor of the mouth
tend to shift toward the airway. The scaffold's
mechanical support resists this tendency, by the creation
of a counter force that directs the tissue structures out
of the airway, as shown by the counterforce arrow in Fig.
35B. The scaffold 138 thereby reshapes the floor of the
mouth. The outward force counteracts the inward force due
to gravity. The scaffold 138 thereby increases the frame
size of the oral cavity, increasing the oral cavity
volume, while also stabilizing the frame in this
condition. The presence of the scaffold 138 provides a
subtle shift in the balance of forces in the oral cavity
during sleep, to stabilize the tongue base and maintain
oral cavity volume by increasing and stabilizing the
frame size. Even a small increase in the cross sectional
area of the airway results in an exponential improvement
in airway stability.
The desired orientation provided by the scaffold's
mechanical support can also, e.g., affirmatively serve to
resist posterior translation of the TMJ, without opening
the mouth during sleep. As previously described, a lack
of native muscle activity can cause a posterior
translation of the TMJ, which, in turn, can cause a
narrowing of the pharyngeal airway. The mechanical
support of the scaffold 138 in the floor of the mouth
conditions tissue to resist posterior translation of the
TMJ during sleep, to stabilize the tissue region in the
absence of the native muscle activity during sleep, to
resist narrowing or closure of the pharyngeal airway.
B. Representative Placement in Selected Tissue
Regions In, On, or Near the Floor of the Mouth
The scaffold 138 can be placed anywhere in the floor
of the mouth from the superficial dermis of the skin to
within the genioglossis muscle. This is because of the
interconnected nature of tissue structures in this
region. By stabilizing or bracing one of the tissue
structures within the region, other interconnected tissue
structures to can be stabilized and/or constrained.
Representative embodiments will now be described for
the sake of illustration and not limitation.
1. Between Mylohyoid and Geniohyoid Muscles
Figs. 34 A/B/C, 35 A/B
In one representative embodiment (shown in Figs.
34A/B/C and Fig. 35B), the scaffold 138 is placed between
a mylohyoid muscle and a geniohyoid muscle in, on, or
near the floor of the mouth. Both suprahyoid muscles
originate at the mandible and are inserted in the hyoid
bone.
The mylohyoid serves to elevate the hyoid bone, the
floor of the mouth, and tongue during swallowing and
speaking.
The geniohyoid serves to pull the hyoid bone
anterosuperiorly (forward and up), shorten the floor of
the mouth, and widen the pharynx.
Placement of a scaffold 138 between these two
suprahyoid muscles in, on, or near the floor of the mouth
provides mechanical support within the tissue region that
resists the formation of undesired physiologic conditions
in the floor of the mouth caused by a diminution or
absence of the native activities of these suprahyoid
muscles during sleep.
For example, when placed between the mylohyoid
muscle and a geniohyoid muscle in, on, or near the floor
of the mouth, the scaffold 138 provides mechanical
support to tissue structures in, on, or near the floor of
the mouth that resists collapse of these tissue
structures into the airway when the muscles relax during
sleep, contrary gravity conditions exist, and/or the
mouth opens.
Further, the interaction between the scaffold 138
and muscles can also serve to stabilize a desirable
tissue orientation affected by the mylohyoid muscle,
which is favorable to maintaining an open airway. The
mechanical support of the scaffold 138 thereby resists
formation of a contrary tissue orientation when the
muscles relax during sleep, contrary gravity conditions
exist, and/or the mouth opens, characterized by a lack of
resistance to a posterior dropping of the floor of the
mouth and the tongue, which is not favorable to
maintaining an open pharyngeal airway and which, instead,
leads to a narrowing or obstruction of the pharyngeal
airway. The mechanical support of the scaffold 138
moderates the undesirable physiologic conditions that, in
the absence of the scaffold 138, would otherwise arise
due to a diminution or absence of the native activity or
the mylohyoid during sleep. By resisting this contrary
tissue orientation, the scaffold 138 resists a narrowing
or obstruction of the pharyngeal airway and resulting
apneic episode.
When placed between a mylohyoid muscle and a
geniohyoid muscle in, on, or near the floor of the mouth,
the interaction between the scaffold 138 and muscles can
also provide mechanical support to tissue in the floor of
the mouth that stabilizes a desirable tissue orientation
affected by the geniohyoid muscle, which is' favorable to
maintaining an open pharyngeal airway. The mechanical
support of the scaffold 138 thereby resists formation of
a contrary tissue orientation, when the muscles relax
during sleep, contrary gravity conditions exist, and/or
the mouth opens, characterized by a lack of resistance to
movement of the hyoid bone posteriorly and inferiorly
(backward and down), widening the floor of the mouth, and
narrowing the pharynx, which is not favorable to
maintaining an open pharyngeal airway and ;which, instead,
leads to a narrowing or obstruction of the pharyngeal
airway. The mechanical support of the scaffold 138
moderates the undesirable physiologic conditions that, in
the absence of the scaffold 13 8, could otherwise arise
due to a diminution or absence of the native activity or
the geniohyoid during sleep. By resisting this other
contrary tissue orientation, the scaffold 138 further
resists a narrowing or obstruction of the pharyngeal
airway and resulting apneic episode.
The scaffold 138 may be implanted in muscles tissue
in the floor of the mouth without attachment to the rigid
structures of the mandible and/or hyoid bone.
Alternatively, the scaffold 138 may be attached to one or
both of these rigid bone structures, e.g., by screws,
suture, or clamping. A representative embodiment of a
scaffold 13 8 fixed to both the mandible and hyoid bone is
shown in Fig. 34D. By attaching the ends of a flexible
scaffold 138 to rigid structures, the shape of the
implant can be influenced. As shown in Fig. 34D, the
flexible scaffold 138 can be fixed with an outward bend,
to bias the muscle structures in the floor of the mouth
in an outward orientation for the creation of the counter
force that directs the tissue structures out of the
airway, drawing the hyoid forward. Alternatively, the
flexible scaffold 138 can be activated by an energy
source, e.g., electrical or thermal energy or the like,
to assume the outward bend or to stiffen upon demand. The
connection point between the scaffold 138 and the rigid
bone structure or structures can include a hinge or a
spring-loaded hinge to enhance the tissue shaping
functions of the scaffold 138.
2. Between Geniohyoid and Genioglossus
Muscles
In another representative embodiment (shown in Fig.
36), the scaffold 138 is placed between a geniohyoid
muscle and a genioglossus muscle in, oh, or near the
floor of the mouth.
The geniohyoid muscle is a suprhyoid muscle that
originates at the mandible and is inserted in the hyoid
bone. The geniohyoid muscle serves to pull the hyoid bone
ante rosuperiorly (forward and up), shorten the floor of
the mouth, and widen the pharynx.
The genioglossus muscle is an extrinsic muscle of
the tongue that originates at the superior part of the
mental spine of the mandible and is inserted in the
dorsum of the tongue as well as the body of the hydoid
bone. The genioglossus muscle serves pull the tongue
anteriorly for protrusion.
Placement of a scaffold 138 between an extrinsic
muscle of the tongue (which inserts into the hyoid bone)
and a suprahyoid muscle (which also inserts into the
hyoid bone) provides mechanical support to tissue
structures in, on, or near the floor of the mouth that
resists collapse of these tissue structures into the
airway when the muscles relax during sleep, contrary
gravity conditions exist, and/or the mouth opens.
Further, the interaction between the scaffold 138
and muscles can also serve to resist the formation of
undesired physiologic conditions in the floor of the
mouth caused by a diminution or absence of the native
activities of these muscles during sleep.
For example, when placed between a geniohyoid muscle
and a genioglossus muscle in, on, or near the floor of
the mouth, the scaffold 13 8 can provide mechanical
support to tissue in, on, or near the floor of the mouth
that stabilizes a desirable tissue orientation affected
by the geniohyoid muscle, which is favorable to
maintaining an open pharyngeal airway. The mechanical
support of the scaffold 138 thereby resists formation of
a contrary tissue orientation, when the muscles relax
during sleep, contrary gravity conditions exist, and/or
the mouth opens, characterized by a lack of resistance to
movement of the hyoid bone posteriorly and inferiorly
(backward and down), widening the floor of the mouth, and
narrowing the pharynx, which is not favorable to
maintaining an open pharyngeal airway and which, instead,
leads to a narrowing or obstruction of the pharyngeal
airway. The mechanical support of the scaffold 138
moderates the undesirable physiologic conditions that, in
the absence of the scaffold 138, would otherwise arise
due to a diminution or absence of the native activity or
the geniohyoid during sleep. By resisting this contrary
tissue orientation, the scaffold 138 resists a narrowing
or obstruction of the pharyngeal airway and resulting
apneic episode.
Furthermore, when placed between the geniohyoid
muscle and a genioglossus muscle in, on, or near the
floor of the mouth, the scaffold 138 provides mechanical
support to tissue in the floor of the mouth that
stabilizes a desirable tissue orientation affected by the
genioglossus muscle, which is favorable to maintaining an
open pharyngeal airway. The mechanical support of the
scaffold 138 thereby resists formation of a contrary
tissue orientation, when the muscles relax during sleep,
contrary gravity conditions exist, and/or the mouth
opens, characterized by a lack of resistance to posterior
movement of the tongue, which is not favorable to
maintaining an open pharyngeal airway and which, instead,
leads to a narrowing or obstruction of the pharyngeal
airway. The mechanical support of the scaffold 138
moderates the undesirable physiologic conditions that, in
the absence of the scaffold 138, could otherwise arise
due to a diminution or absence of the native activity or
the genioglossus during sleep. By resisting this contrary
tissue orientation, the scaffold 138 resists a narrowing
or obstruction of the pharyngeal airway and resulting
apneic episode.
As before explained, the scaffold 138, if desired,
may be attached to one or both of the rigid bone
structures of the mandible and hyoid bone, e.g., by
screws, suture, or clamping, as previously shown in Fig.
34D. By attaching the ends of a flexible scaffold 138 to
rigid structures, the shape of the implant can be
influenced. As shown in Fig. 34D, the flexible scaffold
138 can be fixed with an outward bend, to bias the muscle
structures in the floor of the mouth in an outward
orientation for the creation of the counter force that
directs the tissue structures out of the airway, drawing
the hyoid forward. Alternatively, the flexible scaffold
138 can be activated by an energy source, e.g.,
electrical or thermal energy or the like, to assume the
outward bend or to stiffen upon demand. The connection
point between the scaffold 138 and the rigid bone
structure or structures can include a hinge or a spring-
loaded hinge to enhance the tissue shaping functions of
the scaffold 138.
3. Between Digastric and Mylohyoid Muscles
In another representative embodiment (shown in Fig.
37) , the scaffold 138 is placed between a digastric
muscle and a mylohyoid muscle in, on, or near the floor
of the mouth. Both are suprhyoid muscles that originates
at the mandible and is inserted in the hyoid bone.
The digastric muscle serves to depress (close) the
mandible and raise the hyoid bone during swallowing and
speaking.
The mylohyoid serves to elevate the hyoid bone, the
floor of the mouth, and tongue during swallowing and
speaking.
For example, when placed between the suprahyoid
digastric and mylohyoid muscles, the scaffold 138 can
provide mechanical support to tissue structures in, on,
or near the floor of the mouth that resists collapse of
these tissue structures into the airway when the muscles
relax during sleep, contrary gravity conditions exist,
and/or the mouth opens.
Further, the interaction between the scaffold 138
and muscles can also serve to resist the formation of
undesired physiologic conditions in the floor of the
mouth caused by a diminution or absence of the native
activities of these muscles during sleep.
For example, when placed between a digastric muscle
and a mylohyoid muscle in, on, or near the floor of the
mouth, the scaffold 138 provides mechanical support to
tissue in, on, or near the floor of the mouth that
stabilizes a desirable tissue orientation affected by the
digastric muscle, which is favorable to maintaining an
open pharyngeal airway. The mechanical support of the
scaffold 138 thereby resists formation of a contrary
tissue orientation, when the muscles relax during sleep,
contrary gravity conditions exist, and/or the mouth
opens, characterized by a lack of resistance to the
depression (closing) of the mandible, which is not
favorable to maintaining an open pharyngeal airway and
which, instead, leads to a narrowing or obstruction of
the pharyngeal airway. The mechanical support of the
scaffold 138 moderates the undesirable physiologic
conditions that, in the absence of the scaffold 138,
would otherwise arise due to a diminution or absence of
the native activity or the digastric during sleep. 3y
resisting this contrary tissue orientation, the scaffold
138 resists a narrowing or obstruction of the pharyngeal
airway and resulting apneic episode.
Furthermore, when placed between the digastric
muscle and the mylohyoid muscle in, on, or near the floor
of the mouth, the scaffold 138 provides mechanical
support to tissue in the floor of the mouth that
stabilizes a desirable tissue orientation affected by the
mylohyoid muscle, which is favorable to maintaining an
open pharyngeal airway. The mechanical support of the
scaffold 138 thereby resists formation of a contrary
tissue orientation, when the muscles relax during sleep,
contrary gravity conditions exist, and/or the mouth
opens, characterized by a lack of resistance to a
dropping of the floor of the mouth and the tongue, which
is not favorable to maintaining an open pharyngeal airway
and which, instead, leads to a narrowing or obstruction
of the pharyngeal airway. The mechanical support of the
scaffold 138 moderates the undesirable physiologic
conditions that, in the absence of the scaffold 13 8,
would otherwise arise due to a diminution or absence of
the native activity or the mylohyoid during sleep. By
resisting this contrary tissue orientation, the scaffold
138 resists a narrowing or obstruction of the pharyngeal
airway and resulting apneic episode.
As before explained, the scaffold 13 8, if desired,
may be attached to one or both of the rigid bone
structures of the mandible and hyoid bone, e.g., by
screws, suture, or clamping, as previously shown in Fig.
34D. By attaching the ends of a flexible scaffold 138 to
rigid structures, the shape of the implant can be
influenced. As shown in Fig. 34D, the flexible scaffold
13 8 can be fixed with an outward bend, to bias the muscle
structures in the floor of the mouth in an outward
orientation for the creation of the counter force that
directs the tissue structures out of the airway, drawing
the hyoid forward. Alternatively, the flexible scaffold
138 can be activated by an energy source, e.g.,
electrical or thermal energy or the like, to assume the
outward bend or to stiffen upon demand. The connection
point between the scaffold 138 and the. rigid bone
structure or structures can include a hinge or a spring-
loaded hinge to enhance the tissue shaping functions of
the scaffold 138.
C. Representative Scaffold Configurations
1. General Physical Characteristics
Figs. 34 A/B/C show a basic representative
embodiment of a scaffold 138.
As shown, the scaffold 138 desirably includes a side
profile, measured in the inferior to superior direction
when implanted, which is as thin as possible.
Representative side profiles can range, e.g., up to about
10 mm; however, a side profile of between about 1 mm and
4mm is believed to be most desirable. This attributes
lends comfort to the scaffold 138 when implanted.
Desirably, the scaffold 138 is generally rectangular
in shape, having a length greater than its width, to
maintain a desired orientation when implanted. Further,
as shown, the scaffold 138 is sized in length to rest
comfortably in the anterior-to-posterior space between
the hyoid. A representative length ranges between about
30 mm and about 40 mm. In one representative embodiment,
the anterior region and the posterior region of the
scaffold 138 rest about 5 mm from the mandible and hyoid,
respectively. In other representative embodiments, the
scaffold 138 can rest closer to or farther from the
mandible and/or hyoid, e.g., as far as 1 cm from the
mandible and/or hyoid.
The scaffold 138 may be sutured to surrounding
tissue, as desired, for stabilization. However, suturing
is not believed to be necessary in all instances. Local
tissue morphology will dictate whether suturing is
required for stabilization. The most desired location for
suturing is around the hyoid or to the connective tissue
attached to the hyoid.
The scaffold 138 can comprise a rigid or semi-rigid
material. In use, the scaffold 138 is implanted in a
tissue structure in, on, or near the floor of the mouth .
with the longitudinal length of the scaffold 138 oriented
in an anterior-to-posterior direction. Inferior/posterior
rotation or posterior translation of the mandible will
tends to shorten the anterior-to-posterior distance
between the hyoid and the mandible. As before described,
a reduction in the anterior to posterior distance between
the mandible and hyoid, if not resisted, will displace
tissue structures in, on, or near the floor of the mouth
cranially, toward the airway. The presence of the rigid
or semi-rigid scaffold 138 will stiffen tissue structures
in, on, or near the floor of the mouth, thereby resisting
their displacement toward the airway. In this way, the
scaffold 138 serves to bias tissue structures against
collapse in a cranial direction into the airway. The
physical properties of the scaffold 13 8 should be
moderated so that presence of the scaffold 138 does not
cause posterior motion of the hyoid with mandible motion.
An exterior surface of the scaffold 13 8 can be
roughened to prevent migration within tissue. The
roughened surface can comprise, e.g., a microporous
surface to prevent migration and/or promote tissue in-
growth. In this arrangement, a resorbable suture material
can be used to initially stabilize the scaffold 138's
position in tissue, until tissue in-growth occurs.
As Fig. 38A shows, more than a single scaffold 138
may be placed within a targeted tissue region in, near,
or on the floor of the mouth. For example, as shown in
Fig. 38A, three scaffolds 138a, 138b, and 138b, each
having a width of about 3 mm can be placed in along the
anterior-to-posterior distance of the tissue region, for
a composite width of about 10 mm. Thus, a plurality of
scaffolds 138 of lesser width (e.g., 1 mm to 3mm) can be
implanted in tandem to create wider transverse array of
scaffolds. As Fig. 38B shows, the position of scaffolds
13 8 can also be staggered along the anterior-to-posterior
distance, forming an anterior-to-posterior array 140 of
scaffolds 138(1) to 138 (7). The number of scaffolds 138
(n), and thus the composite transverse width and
anterior-to-posterior length of the array vary. The array
140 of scaffolds can increase in width in an anterior-to-
posterior direction (as Fig. 38B shows) , so that the
anterior width of the array (e.g., 10 mm to 20 mm)
increases to a greater posterior width (e.g., 20 mm to 30
mm), providing with multiple scaffolds a trapezoid shaped
array. An array of scaffolds, if desired, can extend in a
transverse orientation (as Fig. 38C shows) , or in an
oblique orientation (as Fig, 38D shows), or in
combinations of anterior-to-posterior, transverse, and/or
oblique orientations.
2. Preferential Bending Characteristic
First Representative Embodiment
Figs. 39 A/B/C/D/E show another representative
embodiment for a scaffold 138. In this embodiment, the
scaffold 138 comprises a rigid or semi-rigid core body
142 formed from a polymer material. The core body 142 is
trapezoidal in shape in plane view (along its anterior-
to-posterior axis, as Fig. 39B best shows) , having an
anterior region 144 that is narrower than its posterior
region 146. A representative width for the anterior
region 144 ranges between about 10 mm to about 20 mm. A
representative width for the posterior region 146 ranges
between about 20 mm to 30 mm. The longitudinal taper in
an anterior to posterior direction serves to resists
migration of the scaffold 138 when implanted.
A surface 148 of the core body 142 is interrupted
with spaced-apart areas of reduced thickness arranged in
intersecting crossing patterns. As best shown in Fig.
3 9B, these patterns form an array of bumps 150 separated
by flexible hinges 152 along this surface 148. The
pattern does not extend to the other surface 156 of the
core body 142, as Fig. 39A best shows.
The hinges 152 form regions of reduced thickness on
the surface 148 of the core body 142. The hinges 152,
being on one side 148 of the core body 142 and not the
other side 156, impart preferential flexibility to the
core body 142 of the scaffold 138 in one direction. Due
to the purposeful pattern of bumps 150 and hinges 152 on
the side 148, when subject to compression, the scaffold
138 will bend easier in a first direction outward in the
direction of the side 148 (as shown in Fig. 39E) than in
the opposite second direction outward in the direction of
the side 156. This is because the hinged bumps 150
contact and interfere to prevent bending in the second
direction, but open and do not interfere when bending in
the first direction occurs (as Fig. 39E shows). A
flexible material 154 encases the entire core body 142,
as Figs. 39D and 39E show, enclosing the bumps 150 and
hinges 152, so that tissue does not enter into and be
pinched within the hinges 152 during flexure.
In use (see Figs. 40 and 41A) , the scaffold 138 is
implanted in a tissue structure in, on, or near the floor
of the mouth. When implanted, the scaffold 138 is
oriented with the narrower anterior region 144 facing the
mandible and the wider posterior region 146 facing the
hyoid bone (see Figs. 4 0 and 41A) . When implanted, the
hinged bumped surface 148 of the scaffold 138 is oriented
toward the feet, i.e., in a caudal direction, as Figs. 40
and 41A also show.
The presence of the scaffold 138 (which is less
flexible than tissue) braces tissue structures in, on, or
near the floor of the mouth. Further, compression of the
scaffold 138 will occur in response to compression of
tissue structures in the floor of the mouth between the
mandible and hyoid. As Fig. 41B shows, the tissue
structures will be compressed, e.g., in response to
opening the mouth, or posterior translation of the
mandible. The tissue structures are compressed when this
occurs, because the anterior-to-posterior distance
between the hyoid and the mandible shortens.
When compressed, the scaffold 138 responds by
preferentially bending in a caudal direction (as Fig. 41B
shows). In this way, the scaffold 138 serves to
dynamically brace or bias the tissue structures against
collapse in a cranial direction into the airway.
A scaffold 13 8 can, if desired, be made from a
flexible material with a spring constant. This scaffold
13 8, when bent, will impart an active spring force in the
desired caudal direction. However, as shown in Figs. 3 9A
to 39E, a rigid or semi-rigid structure, not having a
spring constant per se, can be used, if it is preferably
weakened to provide the preferential bending
characteristics desired (as Fig. 39E shows).
Further, the preferential bending of the scaffold
13 8 can affirmatively restrict mandibular motion.
However, even without affirmatively restricting
mandibular motion, the scaffold 138 can nevertheless
respond to mandibular motion in a beneficial way, to
force compressed tissue in the floor of the mouth to bend
out (away from the floor of the mouth), rather than bend
inward toward the airway (which is its native
inclination, which is further assisted by the force of
gravity when the individual is in a sleeping position).
Representative Embodiments With Tissue Stablization
Figs. 42 and 43 show other representative
configurations for a scaffold 138 having a preferential
bending property. The scaffolds 138 shown in Figs. 42 and
43 comprise generally the same structural features that
impart preferential bending as shown in Figs. 39A to 39D
(the bumps 150 and hinges 152 are covered by flexible
material 154, as shown in cut-away section in Figs. 42
and 43). In Fig. 42, the scaffold 138 further includes
contoured edges 158 and extended "wings" 160 for enhanced
stabilization in tissue. In Fig. 43, the scaffold 138
further includes through-holes 162 for tissue in growth
and enhanced, long term tissue stabilization.
Stablization in tissue resists migration of the scaffold
138 when implanted.
Another Representative Embodiment
Figs. 44A/B/C/D/E/F show another representative
scaffold 138 having preferential bending characteristics.
As shown in Fig. 44A, the scaffold 138 comprises a core -
body 164 formed from a metal or polymer material. The
core body 164 is trapezoidal in shape in plane view
(along its anterior-to-posterior axis, as Fig. 44A best
.shows), having an anterior region 174 that is narrower
than its posterior region 176. The core body 164 includes
opposite facing surfaces 166 (shown in enlarged view in
Fig. 44C) and 168 (shown in enlarged view in Fig. 44D).
The surface. 166 includes a pattern of spaced-^apart cuts
170 that extend uniformly into the core body 164 (see
Figs. 44A and 44C) , along and across the longitudinal
axis of the core body 164. Each cut 170 is thin and does
not extend all the way through the material of the core
body 164 to the other surface 168 (as Fig. 44D shows). A .
thin, continuous uncut layer of material remains along
the surface 168 of the body, as Fig. 44D shows. Thus, the
surface 166 of the core body 164 is slotted and weakened
by the cuts 170, and the other surface 168 is not.
The pattern of cuts 170 preferentially weakens the
core body along the surface 166. The slotted surface
accommodates preferential bending of the core body 164 in
a direction that opens the cuts, the continuous layer 168
flexing at an array of flexible hinge points between the
cuts 170. The core body 164 will flex between anterior to
posterior ends in a direction toward the slotted surface
166, as Fig. 44E shows. The core body 164 will also flex
between side edges in the same direction toward the
slotted surface 166, as Fig. 44F shows. The cuts 170
close and interfere to resist bending of the body in the
opposite direction toward the continuous surface 168.
As Fig. 44A shows, the. core body 164 desirably
includes a pattern of large through holes 172 extending
through the core body 164, which also serves to reduce
the overall stiffness of the core body 164. As Fig. 44B
shows, polymer material 174, e.g., silicone or urethane,
encases the core body 164 and through holes 172 to
protect surrounding tissue during bending.
In use (see Fig. 45), the slotted scaffold 138 is
implanted in a tissue structure in, on, or near the floor
of the mouth with the longitudinal axis oriented along
the anterior-to-posterior direction. The narrower
anterior end 174 faces the mandible, and the wider
posterior end 176 faces the hyoid bone. The continuous
surface 168 is oriented in a cranial direction toward the
roof of the mouth (i.e., the slotted surface 168 faces
the caudal direction), as is also shown in Figs. 44E and
44F. The presence of the scaffold 138 (which is less
flexible than tissue) braces tissue structures in, on, or
near the floor of the mouth. Further, as earlier
explained, compression of the scaffold 138 will occur in
response to compression of the tissue structures in, on,
or near the floor of the mouth. When compressed, the
slotted scaffold 13 8 responds by preferentially bending
caudally (as Figs. 44E and 44F show). In this way, the
slotted scaffold 138 serves to bias tissue structures
against collapse in a cranial direction into the airway.
Another Representative Embodiment
Figs. 46 A/B/C/D/E and 47 show another
representative embodiment of a scaffold 138 having a
preferential bending property. In this embodiment (see
Fig. 46A) , the scaffold 138 includes two or more bar
assemblies 178 (either metal or polymer) encapsulated
within a soft, flexible polymer material 180.
As shown in Figs. 46B and 46C, each bar assembly 178
comprises a flexible seat 182 and a flexible core element
184. The seat 182 includes uplifted seat end regions 186.
The flexible core element 184 releasably nests within the
seat 182, with the ends 188 of each core element 184
frictionally in registry with the uplifted seat end
regions 186 (see Figs. 46B and 46D). The nested
configuration can be sized and configured to offer
yieldable frictional resistance to the separation of the
core element 184 from the seat 182. The soft polymer
material 180 encapsulates the each bar assembly 178 with
the core element 184 nested in the seat 182.
In this arrangement (see Fig. 46D), when a given bar
assembly 178 is bent to a first direction that compresses
the uplifted seat end regions 186 against the ends 188 of
the core element 184, the seat 182 and the core element
184 interfere as a mechanically connected unit to offer
resistance to bending in this direction. When the bar
assembly 178 is bent in an opposite, second direction
(see Fig. 46E), the uplifted seat end regions 186 move
away from the ends 188 of the core element 184. The seat
182 and the core element 184 do not interfere, and
instead bend separately. Because it is easier to bend
thin stacked bars (when the ends are free, as shown in
Fig. 46E) rather than bend one thick bar (as shown in
Fig. 46D), the bar assembly 178 offers less resistance to
bending in the second direction, shown in Fig. 46E.
In the illustrated embodiment (see Fig. 46A), when
the bar assemblies 178 are encapsulated by the soft
polymer material 180, the scaffold 138 is trapezoidal in
shape in plane view (looking toward the feet), having an
anterior region 190 that is narrower than its posterior
region 192, when implanted. The bar assemblies 178 are
confined within the soft polymer material 180, with the
seat 182 of each bar assembly oriented in the same plane,
to provide preferential bending of the scaffold 13 8
according to the bending characteristics just described.
In use (see Fig. 47), the scaffold 138 is implanted
in a tissue structure in, on, or near the floor of the
mouth with anterior region 190 oriented in an anterior
direction, i.e., facing the mandible. The scaffold 138 is
also oriented with the seats 182 of the bar assemblies
178 oriented in a cranial direction, toward the roof of
the mouth (as Fig. 46E indicates). When compression force
tries to bend the scaffold 138, the uplifted seat end
regions 186 of the bar assemblies 178 are compressed
against the ends 188 of the respective core elements 184,
provide rigidity to the bar assembly 178 in this bend
direction, thereby resisting tissue movement into the
oral cavity (i.e., in a cranial direction). The bar
assemblies 178 provide preferential flexibility in the
opposite, caudal direction, away from the oral cavity, as
Fig. 46E shows. The scaffold 138 thereby provide a
preferential bias or bracing to tissue in a caudal-
direction,
The scaffold 13 8 may incorporate on/off activation
of preferential bending or stiffening. In this way, the
scaffold 138 may be "activated" by external means to be
stiffer or shaped at night. For example, by manipulating
tissue under the chin, pressure can be applied to a
preferential bending mechanism incorporated in the
implant, to shape the scaffold 138 in the preferentially
bent condition (i.e., caudal orientation) prior to sleep.
Conversely, manipulation of tissue under the chin can
return the scaffold 138 in a neutral orientation during
the day. Desirably, the preferential bending mechanism
provides an audible indication (e.g., a "click") when the
desired orientation is assumed. Alternatively,
preferential bending can be activated by electrical, RF,
magnetic, or temperature means. The scaffold 138 can
include shape memory material or a shape activated
material.
Desirably, the seat 182 and the core element 184 of
each bar assembly 178 possess essentially the same
stiffness. In this way, the preferential bend
characteristics of bar assemblies within a given scaffold
138 can be can balanced and controlled. In another
arrangement, the core element 184 may comprise a
plurality of thinner and less stiff bending elements,
which can be assembled as desired to achieve targeted
preferential bending characteristics.
Another Representative Embodiment
Figs. 48A/B/C show another representative embodiment
of a scaffold 138 that provides a preferential
orientation to tissue structures in, on, or near the
floor of the mouth.
In this embodiment, the scaffold 138 includes a core
body 194 (see Fig. 48C) comprising a first polymer
material encapsulated in a second polymer material 196.
The core body 194 is preformed with surfaces curved in
both directions (length and width), forming a saddle-
shaped structure (best shown in Fig. 48B). The saddle-
shape structure includes a convex curving surface 196 and
an inverse concave curving surface 198. The first polymer
material of the core body 194 is rigid or semi-rigid and
possesses enough stiffness to maintain the desired
saddle-shape configuration. The second polymer material
196, which encapsulates the core body 194, is less stiff
to provide a non-traumatic interface with surrounding
tissue.
As shown in Fig. 48A, the scaffold 138 can include
contoured edges 200 and/or extended "wings" 202 for
stabilization. The scaffold. 138 can also include through-
holes 204 for tissue in growth and long terra tissue
stabilization. Desirably, the core body 194 is also
trapezoidal in shape in plane view (looking toward the
feet), as Fig. 48A shows, having an anterior region 206
that is more narrow than the posterior region 208, when
implanted.
For use (see Fig. 49), the scaffold 138 is implanted
in a tissue structure in, on, or near the floor of the
mouth with the anterior region 206 oriented in an
anterior direction toward the mandible. The scaffold 138
is also oriented with the convex curve configuration 196
oriented toward the feet. The scaffold 138 therefore
provides a preferential bias or bracing to tissue in a
caudal direction.
Figs. 48D, 48E, and 48F illustrate another
embodiment of a scaffold 138 that includes a core body
194 comprising a first polymer material encapsulated in a
second polymer material 196. In this embodiment, the core
body 194 includes a semi-rigid mesh 194A comprising,
e.g., a nitinol material, as Fig. 48E best shows. As
further shown in Fig. 48F, the core body 194 further
includes an interface 194B (comprising, e.g., silicone
and fabric) that adheres to the mesh material 194A. The
interface 194B provides a durable transition to the outer
layer of the second polymer material 196, which
encapsulates the core body 194 and can comprise, e.g.,
silicone to provide a flexible interface with soft
tissue. The semi-rigid core mesh 194A and overlaying
fabric interface 194B provide resistance to plastic
deformation during use.
As previously described, the core body 194 is
preformed with surfaces curved in both directions (length
and width), forming a saddle-shaped structure (best shown
in Fig. 48D). The saddle-shape structure includes a
convex curving surface 196 and an inverse concave curving
surface 198. The first polymer material of the core body
194 is rigid or semi-rigid and possesses enough stiffness
to maintain the desired saddle-shape configuration. The
second polymer material 196, which encapsulates the core
body 194, is less stiff to provide a non-traumatic
interface with surrounding tissue.
As shown in Fig. 48A, the scaffold 138 can include
contoured edges 200 and/or extended "wings" 202 for
stabilization. The scaffold 138 can also include through-
holes 204 for tissue in growth and long term tissue
stabilization.
3. Representative Implantation Methods
A representative method for implanting a scaffold
138 like that shown in Fig. 34B includes making a
transverse superficial incision under the chin, desirably
along the natural chin fold. The method includes cutting
platysma muscle to provide access to the mylohoid muscle.
Access to the mylohoid muscle can be obtained between the
two digastrics muscles, which do not need to be cut. The
method includes cutting and dissecting the mylohyoid
muscle between the digastric muscles to gain access to
the muscle plane between the mylohyoid and geniohyoid
muscles.
The method includes placing the scaffold 138 in this
plane so that the thin dimension of the scaffold 138 is
in the superior/inferior direction, with the length and
width of the scaffold 13 8 extending in the lateral as
well as anterior/posterior directions.
The method can optionally suturing the implant to
surrounding tissue as desired for stabilization. The most
desired location for suturing is around the hyoid or to
the connective tissue attached to the hyoid: The scaffold
138 body may have an extension into the genioglossus for
additional stabilization of the scaffold 138 body, as
well as provide stabilization for the genioglossus
itself. As before explained, the scaffold 138, if
desired, may be attached to one or both of the rigid bone
structures of the mandible and hyoid bone, e.g., by
screws, suture, or clamping, as previously shown in Fig.
34D.
The method includes suturing the mylohyoid and
platysma muscles closed, and then closing the superficial
skin incision.
The scaffold 138 can, alternatively, be implanted
using a minimally invasive method including trocar,
and/or needle and/or endoscopic delivery of the scaffold
138 through a delivery assembly 210 (see Fig. 50A) that
is percutaneously inserted through a small incision 212.
As Fig. 50B shows, in a representative embodiment, the
delivery assembly 210 includes a cannula 400 and stylet
402 that can be advanced through the cannula 400. As Fig.
50C shows, the scaffold 138 is collapsible and can be
maintained in a collapsed condition within the distal end
of the cannula 400 for percutaneous delivery, as Fig. 50A
also shows. Advancing the stylet 402 in the cannula 400
urges the scaffold 138. from the distal end of the cannula
400, as Fig. 50D shows. The scaffold 138 self-expands, as
Fig. 50E shows, for placement on and fixation in a pocket
formed within a natural tissue plane in the floor of the
mouth, e.g., between geniohyoid and myohyoid muscle
planes. Natural boundaries of muscle fascia, the hyoid
bone, and the mandible provide stability for the
implanted scaffold 138. Alternatively, the hyoid bone and
the mandible can provide fixation sites for the scaffold
138, as previously described.
The procedure is minimally invasive and does not
require high skill or surgical experience. It can be
performed under local or general anesthesia or conscious
sedation, without fluoroscopy or other imaging modality
in a short period of time, e.g., within ten minutes.
Implantation of the scaffold 138 is completely and
quickly "reversible.
In an alternative embodiment, the scaffold 138 can
comprise a hollow body that can be filled with fluid or
otherwise stiffened after placement.
4. External Scaffolds and Combinations
As previously described, diverse tissue structures
occupy the neck, the pharyngeal airway, and floor of the
mouth, comprising layers of dermis, fat, and muscle,
which are mutually interconnected from the epidermis
inward to the tongue and base of the tongue. An adhesive
brace or collar 102 has been described for placement in
association with tissue of the neck to stabilize and
brace these tissue structures against collapse into the
airway. Alternatively, scaffolds 138 have been described
for implantation in, on, or near tissue structures of the
floor of the mouth for the same purpose.
Due to the native, interconnected morphology of
tissue structures in this region, one or more scaffolds
138 can be sized and configured for placement in or on
epidermal tissue or in dermal tissue along the neck
and/or near the floor of the mouth to stabilize and brace
these tissue structures against collapse into the airway.
The chin support structures, affixed by adhesive
materials 104, as previously described, are
representative embodiments of external scaffolds 138. As
Fig. 51 shows, the scaffolds 138 can also include
individual lengths or strips of material affixed by
adhesive materials 104 to the external skin along the
neck or overlying the floor of the mouth. Preferential
bending of these external scaffolds 138 serves to
stabilize or bias tissue structure in, on, or near the
neck, pharyngeal airway, and the floor of the mouth away
from collapse into an airway,' in the same manner as
implanted scaffolds 138.
As shown in Figs. 52A and 52B, the scaffold 138 can
comprise a formed flexible bracing structure 320. The
bracing structure 320 (see Fig. 52A) comprises a pair of
spaced apart trusses 322 and an intermediate cross strut
324, which extends across a proximal part of the trusses
322. The cross-strut includes a depression forming a
pocket 326. The pocket 326 is sized and configured to
receive displaced tissue in, on, or near the floor of the
mouth, to avoid compressing the tissue and thereby avoid,
during use, interference with the native anchoring
function that the floor of the mouth provides to the
mandible, hyoid bone, and tongue.
As Fig, 52B shows, the bracing-structure 320 can be
affixed by adhesive material 328 on epidermal tissue
along the neck and/or near the floor of the mouth. As
shown in Fig. 52B, the bracing structure 320 is sized and
configured, when worn, to fit beneath the chin region,
under the floor of the mouth, and the neck region, and
extend from there to tissue overlying the larynx.
Adhesive material 328 in the pocket 326 holds tissue
outward, stabilizing or biasing tissue structures in, on,
or near the floor .of the mouth away from collapse into an
airway, in essentially the same manner as previously
described scaffolds.
Further, systems and methods comprising combinations
of external and internal (implanted) structures placed in
association with a neck and/or the floor of the mouth can
also be placed and oriented to stabilize or bias tissue
structure in, on, or near the neck, pharyngeal airway,
and the floor of the mouth, away from collapse into an
airway.
For example, an external brace or collar 102 has
been described that is coupled to neck tissue using an
adhesive or by negative pressure, to stabilize tissue
structures against collapse into an airway. By the same
token (see Figs. 53A/B/C), an external brace or collar
102 can also be coupled to neck tissue by magnetic
attraction between one or more external magnets 212 or
ferrous materials carried by the brace or collar 102 and
one or more magnets 210 or ferrous materials implanted
in, on, or near tissue structures of the neck and/or the
floor of the mouth. The magnetic attraction between the
external magnets 212 or ferrous materials on the brace or
collar 102 and the implanted magnets 210 or ferrous
materials can exert a stabilizing force on tissue
structures in, on, or near the neck, the pharyngeal
airway, and the floor of the mouth, with or without the
use of adhesion and/or negative pressure (as Fig. 52C
shows). The magnetic interaction can mechanically brace
and stabilize tissue structures in, on, or near the neck,
pharyngeal airway, and/or floor of the mouth and thereby
resist movement or collapse of these tissue structures
into the airway. The inside circumference of the collar
102 can also be sized relative to the neck to also exert,
as a result of the magnetic interaction, a pulling force
on tissue structures in, on, or near the neck, the
pharyngeal airway, and/or the floor of the mouth. The
magnetically produced, outward pulling force can also
reshape these tissue structures toward the slightly
larger circumference established by the brace or collar
102. The collar 102 preferably includes a concave pocket
region 430 under the chin, which receives tissue
underlying the floor of the mouth, so that the collar 102
does not, in use, compress the floor of the mouth to
block the desirable lowering of the tongue and its
beneficial effects upon the airway, as has been
described.
VI. Enhanced Anchorage of the Tongue to Muscles in the
Floor of the Mouth
Conventional tongue suspension involves placing a
small titanium screw in the jaw. A suture (which is
attached to the screw) is threaded through the tongue and
tightened. The purpose is to hold the tongue in its
proper place when a person is sleeping in order to
prevent obstruction in the airway. Hyoid suspension is
also an adjunctive procedure to treat an obstructive
tongue base, in which, the suture threaded through the
tongue is attached to a screw in the hyoid bone.
Different conventional tongue suspension systems are
exemplified by the Repose® Bone Screw (Influent
Medical/Medtronic); Jackson ¦ et al. US 2006/0207612
(Aspire Medical (which, includes a spool assembly to
tighten and adjust the length and tension of the tether
attached to the jaw); Kuhnel US 2007/0288057 (which
includes an adjustable elastic tether element attached to
the jaw); Hegde et al US 2007/0246052 (Pavad Medical)
(which implants a deformable electrical element in the
tongue that is tethered to the jaw) ; Sanders US
2007/0261701; 2008/0188947 (Linguaflex) (which tethers a
tongue implant to the jaw) ; and Iancea et al US
2009/0044814 (Phillips) (which anchors a barbed suture in
the tongue or extrinsic muscles of the tongue to the
jaw.) In all conventional tongue suspension systems, a
tongue implant is anchored to a rigid structure such as
the mandible or hyoid bone.
It has been discovered that the native,
interconnected morphology of muscles in the floor of the
mouth, the mandible, and hyoid bone serves as a native
anchoring structure for the tongue for tongue suspension.
Figs. 54 to 57 show various tongue suspension
systems 404 comprising a tongue suspension structure 406
sized and configured for placement in or on a tongue. The
tongue suspension structure 406 can, e.g., comprise a
looped suture structure 420 (as Fig. 54 shows) . The
tongue suspension structure 406 can comprise a pronged
tissue implant 422 (as shown in Fig. 55) . The tongue
suspension structure 406 can comprise a shaped generally
flexible body 424 sized and configured to be surgically
implanted in the tongue (as shown in Fig. 56). In Figs.
55 and 56, the body of the tongue suspension structure
406 can comprise a biocompatible metallic or polymer
material, or a metallic or polymer material that is
suitably coated, impregnated, or otherwise treated with a
material to impart bi©compatibility, or a combination of
such materials. As shown in Fig. 57, the tongue
suspension structure 406 comprises a disc-shaped
structure 426 placed on external tissue on the posterior
region of the tongue. In one arrangement, the disc-shaped
tongue suspension structure 426 comprises an expandable
balloon.
The tongue suspension systems 404 shown in Figs. 54
to 57 include an anchoring structure 408 implanted in the
floor of the mouth. The anchoring structure 408 tethers
the tongue suspension structure 406 to muscle tissue in
the floor of the mouth between the mandible and the hyoid
bone to exert an anterior force (FA in Figs. 54 to 56)
upon the tongue suspension structure 406. The anterior
anchoring force FA draws the tongue forward and resists
posterior movement of the tongue into the airway, as can
occur during sleep in the manner previously described.
In Fig. 54, the anchoring structure 408 includes a
tissue anchor 410 with prongs that engage and otherwise
lodge within muscle tissue. Alternatively, or in
combination, the tissue anchor 410 can be sutured or
adhered to adjoining tissue, to further fixate and
stabilize its position in muscle tissue.
In Figs. 55 to 57, the anchoring" structure 408
comprises a flexible scaffold 138 implanted in muscle in
the floor of the mouth, as previously described. In thi
arrangement, the flexible scaffold achoring structure 138
exerts an anterior force FA upon the tongue to resist
posterior movement of the tongue into the airway, as
could occur during sleep in the manner previously
described. The flexible scaffold anchoring structure 138
can be sutured or adhered to adjoining tongue tissue, to
further fixate and stabilize its position in tongue
tissue. Of course, the flexible scaffold anchoring
structure 138 can be used in place of the tissue anchor
410 shown in Fig. 54, if desired.
In Figs. 55 to 57, the flexible anchoring scaffold
structure 13 8 is coupled by a tether structure 418 to the
tongue structure 406. The tether structure 418 can
comprise, e.g., suture or comparable biocompatible
string, fiber, coil, or cable material, or nitinol
material, or polymer wire, or a bioabsorbable column
structure. In Fig. 54, the looped suture structure 42 0
can be coupled directly to a flexible anchoring scaffold
structure 138.
Attaching the tongue suspension structure 406 to a
flexible scaffold anchoring structure 138 as shown in
Figs. 55 to 57 in the floor of mouth reduces potential
for pull out or failure of attachment points.
Importantly, attaching the tongue suspension structure
406 to a flexible scaffold anchoring structure 138 in the
floor of mouth moderates the stress on the soft tissues
(genioglossus) surrounding the tongue suspension
structure 406 and mitigates potential for migration of
the tongue suspension structure 406 and thus reduction of
the tongue tissue suspension effect over time. A tether
structure 418 coupled to a flexible scaffold anchoring
structure in the floor of the mouth will not fail like a
tether structure coupled to a rigid, unyielding
mandible/hyoid bone screw junction. The flexible scaffold
anchoring structure in the floor of the mouth provides a
supple interface due to the trampoline effect of the
floor of the mouth, as previously described. A flexible
scaffold anchoring structure 138 provides stress and
strain relief that a mandible/hyoid bone screw junction
does not. The tongue suspension element 406 will not pull
itself out when coupled to a flexible scaffold anchoring .
structure in the floor of the mouth and is less likely to
create a foreign body sensation or interfere with speech
or swallowing.
It is desirable that the flexible scaffold anchoring
structure 138 in the floor of the mouth comprise a
preferentially shaped, downwardly bowed, saddle-like
structure, in the manner previously described. The
preferential bending of the flexible scaffold anchoring
structure bows muscles in the floor of mouth outward, and
also pulls the tongue outward at the proper vector in
order to increase the volume of the oral cavity without
pulling against rigid bone structures, thereby augmenting
and enhancing the dynamics of the tongue suspension. The
preferentially bent, downwardly bowed, saddle shaped
structure also bends as the mandible falls, further
displacing the floor of the mouth away from the oral
cavity to prevent a resultant closure of the airway,
while also further lowering the tongue for the same
effect. All in all, the flexible scaffold anchoring
structure in the floor of the mouth provides and
maintains a proper direction to the tongue suspension
vector in the dynamic environment of the oral cavity
during sleep.
In one arrangement, the flexible scaffold anchoring
structure 138 in the floor of the mouth can be attached
with sutures or fasteners to the mandible and hyoid, with
a resulting pull out force vector straight out toward the
floor of mouth between mandible and hyoid.
The flexible scaffold anchoring structure 138 can be
in form of a preshaped implant placed through the oral
cavity, or a preshaped implant deployed from under chin,
submental area, or oral cavity. The flexible scaffold
anchoring structure can comprise a fluid or flowable
material that is injected into the floor of the mouth and
that stiffens or cures in situ by itself (e.g., by cross-
liking) or in response to applied external energy such as
light, ultrasound, heat, or radio frequency energy. The
flexible scaffold anchoring structure can comprise an
inflatable structure.
The flexible scaffold anchoring structure 138 can be
made from an elastic material with a selected spring
constant (e.g., a spring constant similar to tongue
tissue), or deformable and activated upon demand to form
the desired preferential bend, as above described, in
response to the application of manual pressure, or
electrical, thermal, or magnetic energy, or other
selectively applied activation means.
For example, as Figs. 58A and 58B show, one or more
magnets 214 or ferrous materials can be incorporated into
a flexible scaffold anchoring structure 138, as
previously described. The magnets 214 or ferrous
materials can be permanently integrated with or affixed
to the flexible scaffold anchoring structure 138
material, or the magnets 214 or ferrous materials can be
releasably attached to the flexible scaffold anchoring
structure 138 material (to allow removal when desired,
e.g., for MRI).
An external array of magnets 212 (e.g., on a chin
carrier structure 102) interact with the magnets 214
carried by the flexible scaffold anchoring structure 13 8
to preferentially bend the flexible scaffold anchoring
structure 138 to preferentially bias or brace muscles in
the floor of the mouth tissue in a caudal direction, as
before described. As before described, the chin carrier
structure 102 preferably includes a concave pocket region
430, which receives tissue underlying the floor of the
mouth as the scaffold 138 displaces the floor of the
mouth away from the oral cavity, so that the chin carrier
structure 102 does not compress the floor of the mouth to
block the desirable lowering of the tongue and its
beneficial effects upon the airway.
Another embodiment is shown in Figs. 59A and 59B. In
this embodiment, a shaped, magnetically interactive
structure 440 made from a magnetic or ferrous material is
located in the floor of the mouth. The magnetically
interactive structure 440 is coupled by a flexible or
semi-flexible tether element 442 to an anchor 444 in the
tongue. Alternatively, the magnetic shaped structure 440
can be tethered by the flexible or semi-flexible tether
element 442 to a structure 426 like that shown in Fig.
57, placed on external tissue on the posterior region of
the tongue. The tether element 442 can be made from a
flexible or semi-flexible material, such as suture or
comparable biocompatible string, fiber, coil, or cable
material, or nitinol material, or polymer wire, or a
bioabsorbable column structure.
A corresponding magnet or magnets 212 in an external
collar (see Fig. 59B) attracts the magnetically
interactive structure 440 to set a magnetic force vector
on the anchor 444 in the tongue. The vector pulls forward
on the tongue, resisting posterior movement of the tongue
toward the airway. The magnet or magnets 212 on the
collar can comprise electromagnets or rare earth magnets.
The position and strength of the magnets 212 on the
collar can be manipulated to change the direction and
magnitude of the force vector.
The magnetically interactive structure 440 can be
variously sized and configured. It can be spherical (ball
shaped), or it may be shaped like a tear drop, or disk,
or as a curved scaffold. The surface of the structure is
desirably smooth and its overall geometry rounded to
allow it to glide or float in tissue. Its position can
thereby adjust to external influences. The magnetically
interactive, shaped structure 440 is not secured to
surrounding muscle and tissue comprising the floor of the
mouth. It is thereby able to move or "glide" in the
adjacent region of tissue and muscle of the floor of the
mouth in response to the externally applied magnetical
forces.
The size and configuration of the magnetically
interactive structure 440 make possible its implantation
in more superficial tissue than the floor of mouth
muscles, including regions of subcutaneous fat. This
makes the magnetically interactive structure 44 0 well
suited for implantation in people who have greater tissue
volumes and subcutaneous fat.
For example, a tear drop shaped structure 440 may be
implanted more superficially than the floor of mouth
muscles, to occupy a subcutaneous fat region or dermis in
the chin, with the apex of the tear drop structure 440
coupled to the tether element 442, which is joined to the
anchor 444 in the tongue. The tear drop shape of implant
reduces stress at the tether attachment juncture. When
subjected to an external force vector by the magnets 212
on the collar, the curved front surface properties of its
tear drop shape enable the tear drop structure 440 to
float or glide in subcutaneous fat or dermis to assume a
position that best aligns with the externally applied
magnetic force vector. Being located superficially to the
floor of mouth in subcutaneous fat or dermis, the tear
drop structure 440 is closer to the external magnetic
source to begin with, so force is amplified by the square
of the reduced distance. Also being able to float or
glide in subcutaneous fat tissue or dermis, the tear drop
shaped structure 440 will further seek the closest
position to the external magnetic force, increasing force
more. By floating and gliding in subcutaneous fat or
dermis, the tear drop shape structure 44 0 can position
itself to maximize the magnitude and direction of the
force vector. In this way, the force/direction/vector/
placed on the tether element 442 and tongue anchor 444
can be titrated and adjusted to achieve improved results
and to accommodate changes that may occur over time. The
tether element 442 may include a mechanism that allows
indexing of tether tension by ratchet, reel, etc., to
allow changing the cinch position on the tether element
442 to change its effective length.
As before described, the chin carrier structure 102
on the collar preferably includes a concave pocket region
430, which receives tissue underlying the floor of the
mouth as the shaped structure 440 moves in response to
magnetic interaction with the external magnets 212, so
that the chin carrier structure 102 does not compress the
floor of the mouth to block the desirable lowering of the
tongue and its beneficial effects upon the airway.
VII. Preferential Bending in Floor of the Mouth with
Interaction with Tongue
Fig. 60A(1) shows another representative embodiment
for a scaffold 138 comprising a rigid or semi-rigid core
body 500 formed from a polymer material. A region 510 of
the surface 502 includes a pattern of spaced-apart cuts
504 that extend uniformly into the core body 500. Each
cut 504 is thin and does not extend all the way through
the material of the core body 500 to the other surface
506 (see also Figs. 60B and 60C). A thin, continuous
uncut layer of material remains along the surface 506 of
the body. Thus, the surface 502 of the core body 500 is
slotted and weakened by the cuts 502, and the other
surface 506 is not.
The pattern of cuts 504 preferentially weakens the
core body along the region 510, forming a hinge. The
core body 500 will pivot about the hinge 510 (see Figs.
60B and 60C) in a direction toward the continuous surface
506. The cuts 504 close and interfere to resist bending
of the body in the opposite direction toward the slotted
surface 502. That is, due to the hinge 510, when subject
to compression, the scaffold 138 will bend easier in a
first direction outward in the direction of the side 506
than in the opposite second direction outward in the
direction of the side 502.
In addition, a pattern of upstanding fingers or
prongs 512 extend from the surface 506 adjacent an edge
of the body 500. A plurality of the fingers or prongs
512 may extend in a single row along the edge (across the
longitudinal axis of the body 500), or a plurality of the
fingers or prongs 512 may extend in a single column from
the edge (along the longitudinal axis of the body 500 (as
Fig. 60A(1) shows), or a plurality of the fingers or
prongs 512 may extend in rows and columns across and
along the longitudinal axis of the body 500 (as Fig.
60A(2) shows. The fingers or prongs 512 are sized and
configured in use to pierce tissue at the posterior of
the tongue (see Fig. 60D). The prongs or fingers 512 are
desirably made from a non-rigid material and may have
rounded, non-traumatic tips. The prongs or fingers 512
may also have variable stiffness, being more rigid
adjacent the body 500 and less rigid adjacent the tip.
In use, the scaffold 138 is implanted in a tissue
structure in, on, or near the floor of the mouth (see
Fig. 60D). When implanted, the scaffold 138 is oriented
with an anterior region 514 (free of the fingers or
prongs 512 facing the mandible and a posterior region 516
(with the fingers or prongs 512 facing the hyoid bone.
When implanted, the slotted hinge 510 of the scaffold 138
is oriented toward the feet, i.e., in a caudal direction.
In this arrangement, the fingers or prongs 514 extend
into and obtain purchase in the posterior (or base) of
the tongue.
The presence of the scaffold 138 (which is less
flexible than tissue) braces tissue structures in, on, or
near the floor of the mouth. Further, compression of the
scaffold 138 will occur in response to compression of
tissue structures in the floor of the mouth between the
mandible and hyoid. The tissue structures will be
compressed, e.g., in response to opening the mouth (see
Fig. 60E), or posterior translation of the mandible. The
tissue structures are compressed when this occurs,
because the anterior-to-posterior distance between the
hyoid and the mandible shortens.
When compressed (as Fig. 60E shows) , the scaffold
13 8 responds by preferentially bending or pivoting in a
caudal direction. In this way, the scaffold 138 serves to
dynamically brace or bias the tissue structures against
collapse in a cranial direction into the airway. Further,
by preferentially pivoting, the scaffold 138 applies an
anterior lifting force to the back of the tongue, lifting
the tongue forward out of the airway.
A scaffold 138 can, if desired, be made from a
flexible material with a spring constant. This scaffold
138, when bent, will impart an active spring force in the
desired caudal direction. However, a rigid or semi-rigid
structure, not having a spring constant per se, can be
used, if it is preferably weakened to provide the
preferential bending characteristics desired.
Alternatively, the scaffold 138 can be activated by
an energy source, e.g., electrical or thermal or magnetic
energy or the like, to pivot and assume the outward bend
or to stiffen upon demand.
The above-described embodiments of this invention
are merely descriptive of its principles and are not to
be limited. The scope of this invention instead shall be
determined from the scope of the following claims,
including their equivalents.
We Claim:
1. An apparatus including means for mechanically
supporting the mandible and/or head in a desired
orientation, particularly when the individual is in a
sleep position, and affirmatively resist movement of the
mandible and/or head out of the desired orientation.
2. An apparatus comprising a neck piece that
externally braces tissue structures in, on, or near the
neck, and/or along the walls of the pharyngeal airway
itself, and/or the floor of the mouth to mechanically
stabilize and support interconnected tissue structures
in, on, or near the neck, pharyngeal airway, and floor of
the mouth in a desired orientation biased away from
collapse into the airway.
3. A system comprising at least one scaffold
placed in, on, or near selected tissue regions in the
floor of the mouth between the anterior part of the
mandible and the hyoid bone.
4 . A system according to claim 3,
wherein the scaffold is placed internally within
tissue.
5. A system according to claim 3
wherein the scaffold is placed externally on skin.
6. A system comprising an implant placed in the
tongue that is coupled to an implant placed in the floor
of the mouth.

Apparatus, systems, and
methods constrain and/or support tissue
structures along an airway.