SYSTEMS AND METHODS FOR AUTOMATICALLY REMOVING FLUID FROM MULTIPLE
REGIONS OF A RESPIRATORY TRACT
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This patent application claims priority to India Provisional Application No. 3988/CHE/20 14
filed on August 14, 20 14, entitled "DEVICE AND METHOD FOR REMOVAL OF SECRETIONS TO
PREVENT VENTILATORASSOCIATED PNEUMONIA", the disclosure of which is incorporated by
reference.
INCORPORATION BY REFERENCE
[0002] All publications and patent applications mentioned in this specification are herein
incorporated by reference in their entirety to the same extent as if each individual publication or
application was specifically and individually indicated to be incorporated by reference.
FIELD
[0003] The present disclosure relates generally to fluid management apparatuses including or for use
with tracheal tubes and related devices. More particularly, the disclosure relates to fluid management
systems that are able remove secretions and monitor blockages from crucial points along an endotracheal
tube either continuously or at predefined intervals. When a blockage is detected, the system is able to
then clear the blockage. Fluids and mucous can then be collected for analysis. Devices are respiration
insertion devices that monitor and remove fluid at different regions along a tracheal tube.
BACKGROUND
[0004] Tracheal tubes are inserted into the airway of patients in medical situations where the patient
is unable to breathe on his own due to obstructions or lack of awareness/consciousness on the patient's
part. Tracheal tubes aid in mechanically ventilating patients until the patients are able to breathe on their
own. Most tracheal tubes currently in use include an inflatable cuff or balloon between the tracheal tube
and the walls of the patient's trachea. The balloon or cuff blocks off the airway passage and establishes a
closed system where gas pressure to the patient's lungs can be more easily regulated and the cuff or
balloon helps to prevent passage of fluids and debris into the patient's trachea. FIGS. 1A-B show typical
respiratory tract locations where fluid might build in an intubated patient. While FIG. 1A shows that
primary fluid accumulation typically occurs above an inflatable cuff of a tracheal tube, FIG. IB shows
that other regions along the trachea of an intubated patient may also be susceptible to fluid accumulation.
[0005] A major complication associated with intubation and the use of tracheal tubes is ventilatorassociated
pneumonia (VAP). VAP is a type of lung infection that occurs in patients who are placed on
ventilators. VAP typically affects those who are already weak, such as patients in an intensive care unit
(ICU) and/or with compromised immune systems. Developing VAP can increase the length of time a
patient is in the ICU and the hospital. VAP also increases the likelihood of death by 20-30%.
[0006] VAP generally occurs because the tracheal tube allows passage of bacteria into the lower
portions of the lung in an intubated patient. These patients may already have underlying issues that
decrease their resistance to bacteria. Bacteria may thrive in the fluid accumulated around the tracheal
tube, especially where there are bends in the tracheal tube which allow fluid to accumulate. Thus the
initial bend in the tracheal tube between the back of the oral cavity and just past the pharynx, as well as
the area above the inflatable cuff or balloon, may be especially prone to fluid and mucous accumulation.
When patients remain on a ventilator for extended periods, the risk of bacterial infection increases.
Further, bacteria also may be drawn down towards the lung when breathing. In addition, the bacteria that
cause VAP can be differentiated from bacteria that cause the more common community-acquired
pneumonia (CAP). Several bacteria associated with VAP are resistant to commonly-used antibiotics.
Thus it would be desirable to minimize the amount of fluid collecting along the tracheal tube that can
provide a hospitable media for bacteria to grow.
[0007] Existing mechanism for addressing the fluid build-up around a tracheal tube are not adequate.
In the majority of currently available and described systems, the apparatus is only designed to draw fluid
away from the tracheal tube at one location or if there is potential for more than one location of suction
along the tracheal tube, the additional area is limited to the region immediately above the inflated cuff or
balloon. In some variations ports are disposed along a tracheal tube at two locations, but these locations
are not associated with specific anatomical locations on a patient. For example, U.S. Patent 8,434,488
('488) describes a tracheal tube with multiple ports that are integrated with the main tracheal tube
opening. The tracheal tube in '488 includes only one suction lumen where the suctioning occurs in
slightly distal to the cuff. The '488 tracheal tube also includes a line for inflating the cuff and maintaining
a certain pressure within the cuff. FIG. 1C and D shows traditional fluid management systems where
suction only occurs at the region directly above the inflatable cuff. In addition, traditional fluid
management systems require the caregiver to manually suction out any fluid present throughout the
course of time that a patient is intubated, which requires more staff time of an already short-staffed health
system.
[0008] Thus, there exists a need for fluid management apparatuses for use with ventilation that can
monitor for fluid accumulation along different regions of a respiratory (e.g., tracheal) insert and
automatically and periodically remove fluid.
SUMMARY OF THE DISCLOSURE
[0009] The present invention relates to apparatus (including systems and devices) and methods for
periodically (and automatically) removing fluid accumulation at three or more regions along a respiratory
insertion device (e.g., tube) that are most likely to collect fluid, so that any accumulated fluid may be
removed. These apparatuses may also be configured to flush the fluid lines and/or provide a lavage to the
patient.
[00010] Certain regions (corresponding to the patient's anatomy) along a respiratory insertion device
(such as an endotracheal tube, tracheostomy tubes etc., which may be referred to herein for convenience
as a "tracheal tube") are more prone to fluid collection when inserted into a patient in a 30 degree reclined
/horizontal position. Three identified regions include the subglottic region directly above the inflatable
balloon or cuff, an oropharynx cavity located past the oral cavity, and in the oral cavity. Being able to
remove fluid build-up in these three regions will significantly reduce the likelihood of VAP in an
intubated patient.
[00011] The fluid management apparatuses described herein can automatically remove fluid from
multiple regions of the respiratory tract of a patient. In some variations, the fluid management apparatus
(e.g., system) can be manually set to remove fluid from different regions along a tracheal tube. Also
discussed herein are respiratory insertion devices that may attach to the fluid management system,
although the fluid management apparatuses described herein may also be configured to operate with
existing commercially available respiratory insertion devices (e.g., endotracheal tubes and tracheostomy
tubes).
[00012] A fluid management system may include an input (e.g., button, touchscreen, dial, switch, etc.)
that is able to receive user selected control information such as lavage delivery frequency, lavage
duration, lavage pressure, suction application frequency, and suction pressure. In some variations, the user
can set the pressure threshold for determining whether there is a blockage within a fluid line connected to
a respiratory insertion device. The thresholds may also be pre-set. For example, pre-set values may be
set by the manufacturer. The threshold values for pressure may be the same for each of the separate lines,
but different pressure values for different lines may be selected in some variations.
[00013] The fluid management apparatuses described herein may also have other control and sensing
components. This may include suction valves that are in fluid communication with sensors and
suctioning mechanism. Valves may control the flow of fluid within the fluid lines. These apparatuses
may also include flow and pressure sensors that detect either or both the presence of fluid in a particular
line, and/or blockage within the fluid lines as well as monitor when all the fluid has been removed from a
particular region. The system may also include filters before and/or after the valves and sensors
connected or connectable to one or more fluid lines. The filters may minimize contamination reaching
the valves and sensors.
[00014] The apparatuses described herein may automatically remove fluid from multiple regions
along a respiratory tract. The system may also be configured to lavage an oral cavity portion of the
respiratory tract. In some variations, the system includes controller circuitry, a display, and one or more
valves configured to couple to a source of air pressure. The system may also include a first, a second, and
a third fluid line, wherein the first, second and third fluid lines couple with the one or more valves of the
controller and wherein the controller is configured to independently apply positive or negative pressure
through each of the first, second or third fluid lines. The first fluid line can couple to a first flow sensor
and a first pressure sensor, the second fluid line can couple to a second flow sensor and a second pressure
sensor, and third fluid line can couple to a third flow sensor and a third pressure sensor. The flow sensors
can be outside of their respective fluid lines. In some variations there are 4 fluid lines, with an additional
fluid line as well as the three (oral, oropharynx and subglottic) lines mentioned above. The additional
fluid line may remove secretions from inside the respiratory insertion device (e.g., endotracheal tube)
either by using a closed suction catheter or using a modified respiratory insertion device with an
additional lumen at the distal end facing inwards to remove secretions from inside the respiratory
insertion device (e.g., endotracheal tube).
[00015] The fluid management system's controller circuitry may be configured to periodically,
automatically, and independently apply negative pressure to each of the first, second and third fluid lines
(and in some variations additional fluid lines, such as a fourth, or tracheal, fluid line), and to stop applying
negative pressure in the first, second or third fluid lines when fluid flow in the first, second or third fluid
line is below a first flow threshold and when pressure in that fluid line is above a first pressure threshold.
The controller circuitry may also apply positive pressure to the first, second or third fluid lines when the
fluid flow is below the first flow threshold when applying negative pressure and the pressure is below a
second pressure threshold in the first second or third fluid lines. Finally, the controller circuitry may be
configured to display for one or more of the first, second and third fluid lines data comprising one or more
of flow rate of a secretion within the fluid line, thickness of secretion within the fluid line, volume of
secretion within the fluid line, or color of the secretion within the fluid line.
[00016] The fluid management system may also include a lavage system (or sub-system). The lavage
system (sub-system) may apply positive pressure to deliver a lavage fluid through one of the fluid lines
(e.g., the line connected to the region of the respiratory insertion device within the oral cavity) and to
apply negative pressure to one or more other of the fluid lines to remove the lavage fluid. The pump may
be in communication with the controller and the source of lavage fluid and can be signaled to provide
positive pressure to the fluid lines. The system may include a plurality of fluid lines that directly connect
(or they may be connected via separate one or more lavage delivery fluid lines) to the source of lavage
liquid. The controller may signal the lavage pump to apply positive pressure to the one or more lavage
delivery fluid lines to deliver lavage fluid. Any of these apparatuses may also include one or more
receptacles for holding returned lavage fluid.
[00017] Thus, any of these systems may also include a source of lavage fluid (e.g., antibacterial
mouthwash, etc.), where the controller is configured to automatically apply positive pressure to deliver
lavage liquid at a lavage delivery frequency; and a first collection container coupled to the first fluid lines
to collect fluid from the first fluid line, a second collection container coupled to the second fluid line to
collect fluid from the second fluid line, and a third collection container coupled to the third fluid line to
collect fluid from the third fluid line.
[00018] As mentioned above, these apparatuses may also include an input configured to receive userselected
control information, which may include (or be limited to) control information regarding suction
and/or lavage, including: lavage delivery frequency, lavage duration, lavage pressure, suction application
frequency, suction duration, and suction pressure.
[00019] In general, any of these apparatuses may also include one or more filters, wherein one or
more valves is in communication with fluid lines through the one or more filters. The valves may be
suction valves, where a first suction valve is between the first fluid line and the source of air pressure, a
second suction valve is between the second fluid line and the source of air pressure and a third suction
valve is between the third fluid line and the source of air pressure.
[00020] As mentioned, the apparatus may also include one or more lavage delivery fluid lines that are
connected to the source of lavage liquid and wherein the controller is configured to apply positive
pressure to the one or more lavage delivery fluid lines to deliver lavage fluid. The apparatus may also
include a pump configured to apply positive pressure, wherein the pump is in communication with the
controller and the source of lavage fluid. Thus, the controller may be configured to apply positive
pressure to deliver the lavage fluid through the first fluid line and to apply negative pressure to the first,
second and third fluid lines to remove the lavage fluid. Finally the apparatus may include a vessel for
collecting the used lavage fluid.
[00021] The fluid management systems described herein may also include an output, such as a display
(e.g., screen, monitor, etc.), where data regarding the first, second, and in some variations, a third, fourth,
or additional fluid lines are shown. Data can include flow rate of a secretion within the fluid line,
thickness of secretion within the fluid line, volume of secretion within the fluid line, or color of the
secretion within the fluid line.
[00022] Any of these apparatuses may include collection containers. One or more, e.g., a first, second
and third (and in some variations a fourth) collection container, may be coupled to a first, second, and
third fluid line, where each is connected to a valve of the one or more valves and the source of air
pressure.
[00023] The respiratory insertion device extends distally along its major axis. The respiratory
insertion device includes a first and a second lumen where the first and second lumen includes a first and
a second opening in fluid connection with the first and the second lumen, respectively. The first and
second opening are located spatially from each other along the tracheal tube such that two regions along
the tracheal tube prone to fluid accumulation correspond to the location of the first and second opening.
In some cases, the first and the second opening are at least 0.4 inch from each other. In other examples, a
third lumen having a corresponding third opening is also disposed along the tracheal tube in a region
away from and not in the regions corresponding to the location of the first and the second openings of the
first and second lumen.
[00024] The first, the second, and potentially a third lumen all include a means for fluidly connecting
to corresponding fluid lines at an opposite terminus from their respective openings. The fluid lines are
coupled to a suctioning apparatus, such as a pump, that is able to draw fluid away from the regions
associated with the first, second, and third openings. There may be separate fluid lines that connect to the
first, the second, and the third lumen or there may be one fluid line that serves to remove fluid from all
the lumen present using appropriate connectors.
[00025] The fluid management system also includes a controller that is in electrical communication
with the sensors, the pump or pumps, valves and other components. The controller periodically will test
for fluid or mucous blockage within the different lumen that correspond to the different regions of the
tracheal tube. If blockage is detected the controller will communicate to the pump(s) to apply positive
and then negative pressure to clear away the fluid and mucous.
[00026] In general, a tracheal tube is a catheter that is inserted into the trachea for the primary purpose
of establishing and maintaining a patent airway and to ensure the adequate exchange of oxygen and
carbon dioxide. Many different types of tracheal tubes are available, suited for different specific
applications, including endotracheal tubes and tracheostomy tubes. For example, an endotracheal tube
(ET) is typically a specific type of tracheal tube that is nearly always inserted through the mouth
(orotracheal) or nose (nasotracheal). A tracheostomy tube is another type of tracheal tube, which may be,
e.g., a 2-3-inch-long curved metal or plastic tube that may be inserted into a tracheostomy stoma
(following a tracheotomy) to maintain a patent lumen. The respiratory (or in some variations,
endorespiratory) insertion devices described herein may be tracheal tubes or they may be adapted for use
with a tracheal tube, as described in greater detail below.
[00027] The system can couple to a respiratory insertion device (which may also be referred to as a
respiratory insertion body), where the respiratory insertion device extending distally in an elongate axis,
the respiratory insertion device may include a plurality of lumen extending in the elongate axis, and a
plurality of openings, wherein each lumen is in fluid connection with an opening, and where the openings
for different lumen are separated along the elongate axis by at least 0.4 inches. In general, each of the
lumen in the plurality of lumen are configured to fluidly connect with one of the first, second or third
fluid lines. As described in detail below, in some variations the systems described herein may include
additional fluid lines, and in particular a fourth fluid line that is configured to attach to a lumen in a
tracheal device that may be connected to remove fluid from within the central and/or main lumen of the
tracheal tube. This may be referred to as a tracheal line.
[00028] As mentioned, the respiratory insertion devices described herein may be tracheal tubes or
they may connect to an existing tracheal tube. In the former case where the tracheal tube incorporates the
fluid management features, the respiratory insertion device may have three or more (e.g., 4) integrated
lumens along with the main tracheal tube passageway, e.g., the three lumens for the locations already
mentioned and a fourth lumen to remove secretions from inside the main tracheal tube. As previously
mentioned, suction of pre-determined regions along the tracheal tube path is through openings along the
respiratory insertion device. In the latter case, where the respiratory insertion device attaches to an
existing endotracheal tube, several examples are described herein. In one example, the respiratory
insertion device can clip onto an existing endotracheal tube and be slid down along the length of the
tracheal tube. The respiratory insertion device clip includes separate lumen having corresponding
openings that contact pre-determined regions along the tracheal tube. In some variations of the
respiratory insertion device clip may have a hinge for easier placement of the respiratory insertion device.
[00029] The respiratory insertion body can independently remove fluid from multiple regions of a
respiratory tract. The respiratory insertion body may have an elongate axis extending proximally to
distally with a first lumen disposed along the elongated body having a first lumen proximal end and a first
lumen distal end, a second lumen disposed along the elongated body having a second lumen proximal end
and a second lumen distal end, and a third lumen disposed along the elongated body having a third lumen
proximal end and a third lumen distal end. In some variations, the apparatus may include a first, second,
and third opening disposed respectively on the first, second, and third lumen distal end. The first, second
and third openings may be positioned along the elongate body so that the first, second and third openings
are separated from each other by at least 0.4 inches along the elongate axis. The first opening in
respiratory insertion body may be configured to be positioned in the oral cavity of a user, the second
opening is configured to be positioned at a oropharynx region of the user, and a third opening through the
endotracheal insertion body is configured to be positioned at a subglottic region of the user when the
endotracheal insertion body is inserted into the user's throat. In some examples, the elongate body
comprises a tubular body having a central tracheal tube lumen opening at a proximal end and a distal end
of the endotracheal insertion body. In other examples, the elongate body comprises a sheath configured to
connect over an endotracheal tube. The elongated body may also be a spiral sheath configured to connect
over an endotracheal tube. In some cases, a series of clips/attachments that can fit over an endotracheal
tube. In general, the first lumen proximal end, the second lumen proximal end, and the third lumen
proximal end each comprise a fluid line coupler configured to attach to a fluid line. Finally, first opening
is between about 3 cm and 1 cm from the third opening, and further wherein the second opening is
between about 2 cm and 10 cm from the third opening.
[00030] Some of the respiratory insertion devices described herein are for coupling to tracheostomy
tubes or may incorporate a tracheostomy tube. In one case, the insertion device has a bifurcated elongate
body having a first arm and a second arm, the body having an elongate axis extending proximally to
distally. The first arm is configured to extend through a lumen of the tracheal tube and comprises a bent
distal end region configured to extend out of a distal end of the tracheostomy tube, wrap around the distal
end of the tracheal tube and extend proximally up the tracheal tube. The second arm is configured to
extend distally along the outside of the tracheal tube. A first and second opening disposed within the first
arm of the elongated body. The first opening is disposed proximal to the bent distal end region of the first
arm and configured to reside within the lumen of the tracheal tube. The second opening may be disposed
distally to the bent distal end region and configured to reside outside of a distal end region of the tracheal
tube. A third opening may be disposed on a third lumen within the second arm, the third opening disposed
near a distal end of the second arm. The proximal end of the first lumen may comprise a first fluid line
coupler configured to attach to a first fluid line, a proximal end of the second lumen comprises a second
fluid line coupler configured to attach to a second fluid line and a proximal end of the third lumen
comprises a third fluid line coupler configured to attach to a third fluid line.
[00031] In another example, a respiratory insertion device includes an integrated tracheostomy tube.
Here the insertion device may have an elongate body, the body having an elongate axis extending
proximally to distally, an inflation cuff near a distal end of the elongate body, a central lumen within the
elongate body, a first lumen extending proximally to distally along the elongated body having a first
opening facing inwards towards the central lumen/passageway (between the first lumen and a central
lumen that serves as a tracheal tube), a second lumen extending proximally to distally along the
elongated body having a second opening into the second lumen on an outside of the elongated body distal
to the inflation cuff, and a third lumen extending proximally to distally along the elongated body having a
third opening into the third lumen on an outside of the elongated body proximal to the inflation cuff.
Similar to previous examples, a proximal end of the first lumen may comprise a first fluid line coupler
configured to attach to a first fluid line, a proximal end of the second lumen may comprise a second fluid
line coupler configured to attach to a second fluid line and a proximal end of the third lumen may
comprise a third fluid line coupler configured to attach to a third fluid line.
BRIEF DESCRIPTION OF THE DRAWINGS
[00032] FIG. 1A illustrates a traditional endotracheal tube (tracheal tube) that has been inserted
into a patient where the arrow shows a pocket of fluid build-up.
[00033] FIG. B illustrates a trachea and a bronchi region, showing different regions where fluid
can collect.
[00034] FIG. 1C illustrates a traditional fluid removal set-up that only suctions a subglottic region
of the patient.
[00035] FIG. 1D illustrates a traditional tracheal tube system that requires manual suction and
subglottic secretion drainage
[00036] FIG. 2 illustrates one example of a fluid management system, along with a respiratory
insertion device, that automatically and periodically monitors and removes fluid from multiple regions
along a tracheal tube.
[00037] FIG. 3 illustrates an example of a respiratory insertion device of an automatic fluid
removal system inserted through a subject's mouth (shown in cross-section) and the opening created
within a patient's trachea.
[00038] FIG. 4 illustrates a generic fluid management system as described herein.
[00039] FIG. 5 illustrates one embodiment of a fluid management system that can be used in
combination with various embodiments of a respiratory insertion device (three are shown on the right).
[00040] FIG. 6 illustrates two aspects of a fluid management system, including sensing and
control components.
[00041] FIG. 7 is a block diagram of one embodiment of the fluid management system showing a
controller in connection various components (including the tracheal tube, a flow sensor, a pressure sensor,
a pressure control mechanism, control valve, vacuum, lavage, a display and a power source).
[00042] FIG. 8 is a block diagram of an alternative embodiment of the tracheal tube fluid
management system for three regions of the trachea having an external suction.
[00043] FIG. 9 is a block diagram of an alternative embodiment of the tracheal tube fluid
management system for three regions of the trachea having a built-in suction.
[00044] FIG. 0 is a circuit diagram of one variation of a fluid management system.
[00045] FIG. is a block diagram of an embodiment of a fluid management system having the
secretion collection vessels sensing units and a pressure sensor, and having six independent lines
including three lines for suctioning and three lavage lines.
[00046] FIG. 12 is a block diagram of another variation of a fluid management system having
non-return valves along each independent suctioning line.
[00047] FIG. 13 illustrates an alternate embodiment of a fluid management system having the
secretion collection jars behind the suctioning values and controls.
[00048] FIG. 14 illustrates an alternative embodiment of a fluid management system having one
collection jar behind the suctioning lines, valves and lavage valves, using 3-way valves.
[00049] FIG. 15 illustrates an alternative embodiment of a fluid management system having four
independent lines with corresponding sensors.
[00050] FIG. 16A is a pictorial of the closed controller, fluid lines, and secretion collection
reservoir.
[00051] FIG. 16B is a close-up pictorial of the controller showing microcontroller, valves, pumps
and circuitry.
[00052] FIG. 16C is yet another close-up pictorial showing controls, controller having suction
valves, pressure controller, vacuum, and fluid lines.
[00053] FIG. 17 illustrates another representative block diagram of the fluid management system
having three independent suctioning lines.
[00054] FIG. 18 illustrates various combinations of traditional tracheal tube and systems with the
disclosed fluid management system and an insertion body.
[00055] FIG. 9A shows one variation of a respiratory insertion device.
[00056] FIG. 19B illustrates a spiral embodiment of a respiratory insertion device.
[00057] FIG. 19C illustrates a spiral-shaped respiratory insertion device for use with a tracheal
tube.
[00058] FIG. 19D shows a close-up view of regions of the respiratory insertion device of FIG.
A.
[00059] FIG. 20 illustrates a hinged embodiment of the respiratory insertion device.
[00060] FIG. 21 illustrates a stent-like embodiment of the respiratory insertion device.
[00061] FIG. 22A illustrates a ring-type embodiment of a respiratory insertion device with
suctioning lumen.
[00062] FIG. 22B is an alternative perspective view of the ring-type embodiment of the
respiratory insertion device with suctioning lumen of FIG. 22A.
[00063] FIG. 22C is an enlarged drawing of a portion of the ring-type embodiment respiratory
insertion device with suctioning lumen.
[00064] FIG. 23A illustrates a front view of an alternative embodiment of a clip respiratory
insertion device.
[00065] FIG. 23B illustrates a side view of the alternative embodiment of the clip respiratory
insertion device of FIG. 23A.
[00066] FIG. 24A is an offset view of yet another embodiment to the clip respiratory insertion
device comprising two materials.
[00067] FIG. 24B is a side view of another embodiment to the clip respiratory insertion device
comprising C-shaped supports.
[00068] FIG. 25A is a front perspective view of an embodiment of a respiratory insertion device
having five channels for lavage and secretion removal.
[00069] FIG. 25B is a side view of an embodiment of the respiratory insertion device having five
channels for lavage and secretion removal.
[00070] FIG. 25C is a perspective view of an embodiment of the respiratory insertion device
having five channels for lavage and secretion removal.
[00071] FIG. 26A is a front and perspective view of an embodiment of a clip respiratory insertion
device having stacked lumen.
[00072] FIG. 26B is a side view of the free clip respiratory insertion device of FIG. 26A having
stacked lumen.
[00073] FIG. 26C is a side view of a clip respiratory insertion device having stacked lumen
engaged with a tracheal tube.
[00074] FIG. 27A is a side view of an oropharyngeal airway insertion body. FIG. 27D shows a
section view through the proximal end of the insertion body of FIG. 27A.
[00075] FIG. 27B is another view of the oropharyngeal airway insertion body.
[00076] FIG. 27C is a third view of the oropharyngeal airway insertion body showing suctioning
ports.
[00077] FIG. 28A is a side view of an integrated respiratory insertion device showing a first
suctioning region.
[00078] FIG. 28B is a side view of the integrated respiratory insertion device of FIG. 28A
showing a second suctioning region.
[00079] FIG. 28C is a side view of the integrated respiratory insertion device of FIG. 28A
showing a third suctioning region.
[00080] FIG. 28D is a depiction of a section through the proximal end of the integrated
respiratory insertion device of FIG. 28A.
[00081] FIG. 28E shows a distal end of the integrated respiratory insertion device of FIG. 28A.
[00082] FIG. 28F shows another view of the respiratory insertion body having three ports along
its main body.
[00083] FIG. 28G shows a cross-section of the respiratory insertion body of FIGS. 28A-F, where
an internal port for suctioning the inside of the endotracheal tube is shown.
[00084] FIG. 29A is a drawing of a first embodiment of a respiratory insertion device for use with
a tracheostomy tube.
[00085] FIG. 29B shows the respiratory insertion device of FIG. 29A engaged with a
tracheostomy tube.
[00086] FIG. 30 is an example of an integrated respiratory insertion device with the tracheostomy
tube.
DETAILED DESCRIPTION
[00087] Described herein are systems and devices for managing unwanted fluid collection along a
tracheal tube. In general, the fluid management system may include a controller, a plurality of fluid lines,
a plurality of flow sensors, a plurality of pressure sensors, a lavage subsystem, and at least one secretion
collection jar. In some embodiments, the fluid management system may also contain a display for
showing pressure values or keeping a user informed of where within the cycle the system is during
operation. The system may also be adapted to display an analysis of secretions. Respiratory insertion
devices may couple to any of the fluid management systems described. The respiratory insertion devices
that will be described below may generally function to remove fluid build-up along certain regions of a
tracheal tube. The respiratory insertion devices may be used in conjunction with an existing tracheal tube
or may perform the function of the tracheal tube including tracheostomy tube in addition to working to
manage fluid collection along the respiratory tract. In general, the system may include a controller, power
source, pumps, valves, suctioning devices, sensors, fluid lines, display, and switches.
[00088] The system described herein can automatically remove fluid from multiple regions along a
respiratory tract. The term automatically may refer to any act or function that is capable of operating
independently (e.g., without ongoing input from a user). In some variations, the term automatically may
indicate that some action is performed without manual intervention. This does not mean that no manual
intervention is ever required, because in the present case, human intervention may be used to trigger or set
the process that in all other respects can be automatic. In particular, a user can set the system to run at
defined intervals or when certain conditions are met.
[00089] Fluid may refer to a substance that is capable of flowing and continually deforms under
applied shear stress. Fluids can include liquids, gases, plasma, and some solids. As applicable here, the
term fluid may be used synonymous with liquid, a substance that has a definite volume but no fixed
shape. Thus, fluids may refer to biological liquids secreted from a person's oral and respiratory system,
mainly saliva, mucous, gastric contents and lavage fluid.
[00090] Next, the system may include fluid lines that connect the respiratory insertion device with the
fluid management system. Fluid lines may be any hollow body that can convey fluids, liquids, or gases
from one location to another (e.g., tubing, channels, etc.). Fluid lines can be formed from metals, glass,
rubber, and other synthetic or naturally-occurring material. Fluid lines may be flexible and formed of
fluid impermeable, hollow, cylindrical bodies that couple the respiration insertion body to the fluid
management system.
[00091] The respiratory tract may refer to regions associated with respiration on a mammal,
specifically, a human. In general, "respiratory tract" can refer to the upper respiratory tract and/or the
lower respiratory tract. The upper respiratory tract can refer to parts of the respiratory system above the
glottis (vocal cords) while the lower respiratory tract consists of the trachea, bronchi, bronchioles, and
lungs. The respiratory tract may refer to the oral cavity, the glottis, the trachea, and the region directly
above the bronchi.
[00092] As discussed above, a tracheal tube may refer to a hollow tube that can be inserted into a
trachea of a patient, primarily to establish and maintain the patient's airway and to ensure adequate
respiration. In general, tracheal tubes may include endotracheal tubes and tracheostomy tubes.
[00093] A controller may generally refer to a device that can interface with peripheral components
and manage how the peripheral components interact and work in connection with each other. The
controller may include circuitry (e.g., chip, chipsets, cards, and the like) for sending commands to the
components present with the fluid management device. The controller may contain logic gates,
routine/subroutines, and data storage components for running the monitoring and suctioning programs.
The controller may also include external user interfaces such as displays, buttons, and switches.
[00094] Sensors generally refer to a component that can detect a certain characteristic of the
environment it is in. In particular, described herein are flow and pressure sensors. Flow sensors may be
configured to detect the presence or absence of fluid. Flow sensors can be differential pressure
flowmeter, velocity flowmeters, positive displacement flowmeters, mass flowmeter, or open channel
flowmeter, IR based sensors, capacitive sensors, and UV sensors. Pressure sensors may detect pressure
and may include, but not limited to absolute pressure sensors, gauge pressure sensors, vacuum pressure
sensors, differential pressure sensors, and sealed pressure sensors. Some pressure sensors are force type
sensors that collect a force value to measure strain when pressure is applied to the area and include piezo
resistive strain gauge, capacitive, electromagnetic, piezoelectric, optical, and potentiometric. Other nonforce
collecting pressure sensors may include resonant, thermal, and ionization-type pressure sensors. As
with any type of sensor, calibration will help in accurately determining the value associated with the
condition detected. Finally the flow and pressure sensors may be either internal or external to the fluid
management system. One possible position is where the flow and pressure sensors are placed on fluid
lines of the system in relative close proximity to where the system couples to the respiration insertion
device. Other potential locations for the flow and pressure sensors may be within the controller unit body.
[00095] Lavage may refer to rinsing out a body cavity with water or a medicated solution either to
clear away unwanted materials or for diagnostic purposes. As described herein, lavage may occur at
various pre-determined regions along the respiration insertion device. For example, the apparatuses
described herein may apply lavage to the oral cavity and the oropharynx region on a patient.
Fluid Management Systems
[00096] In general, a fluid management system may include fluid lines, sensors, a controller and
circuitry for the controller, and lavage components. The controller is typically the portion of the fluid
management system that oversees operation of the fluid management system components. The controller
may contain circuitry and micro-controls for regulating fluid removal, in the case of suctioning fluids
away from a region along the tracheal tube, or fluid delivery in the case of lavage of a certain region of
the oral cavity or respiratory tract where the tracheal tube has been inserted. The controller may contain
valves that connect and maintain fluid lines that link the respiratory insertion device to sensing,
suctioning, and pumping components of the fluid management system. In use, the controller may also
include micro-controls that contain circuitry for coordinating the sensing, suctioning, and pumping cycles.
The controller periodically, automatically, and independently apply pressure, suctioning, or sensing to
each fluid line
[00097] The fluid management system also contains fluid lines that connect the respiratory insertion
device with the sensing, pumping, and suctioning components of the fluid management system. The fluid
lines can be arranged in multiple configurations. In some examples, separate fluid lines connect to each
of the ports contained on the respiratory insertion device. In other examples, more than one port on the
respiratory insertion device can be connected to one fluid line via a multi-port component. The fluid
lines should be flexible such as surgical tubing, pressure tubing, or the like. While no preference for fluid
line materials are noted here, it would be useful for the fluid lines to be able to withstand suctioning
without the walls of the tubing collapsing or withstanding pressure without having the line break from the
applied pressure.
[00098] The fluid management system typically also contains sensors that allow the system to
determine the presence (e.g., by flow) of secretions in the fluid line (presumably removed from the pre¬
determined regions along the tracheal tube), and/or to regulate the amount of pressure or suction being
applied. Flow and suctioning sensors may be present to sense the presence/absence of secretions flowing
past the sensors. The sensors may be configured to provide analogue/digital signals to the controller
The fluid management system may then compare the signals sensed with pre-programed values entered
by a user or manufacturer to keep the system running till it senses the presence of secretions.
[00099] The controller may incorporate a power supply that drives the fluid management system
components. In the case where the power supply is integrated into the body of the controller, buttons and
switches can be found on the body of the fluid management system that allows the user to control the
fluid management system. In other examples, the power supply is externally maintained and is connected
to the fluid management system when in use. The fluid management system may also contain internally
or externally-maintained pumping and suctioning mechanisms.
[000100] Next, the fluid management system may include a lavage mechanism for rinsing out a void
region associated with the tracheal tube. Lavage of an area that is in contact with a tracheal tube and
where fluid or moisture may help decrease the amount of harmful microbes that might accumulate. While
lavage of a patient's oral cavity is most common, lavage of other regions along a tracheal tube such as the
oropharynx region or the subglottic region is also possible. The fluid management system includes fluid
lines that connect to the respiratory insertion device to deliver and subsequently suction the lavage fluid
from the void region. The fluid for lavage can be sterile water, saline, chlorhexidine or other suitable
solution.
[000101] The fluid management system may also contain analysis components that can test the fluid
withdrawn from the different regions along the tracheal tube of a patient. The fluid management system
may contain pre-programmed subroutines that may periodically test the withdrawn fluid for certain types
of harmful microbes. If detected, the fluid management system may include a way of notifying the doctor
or caregiver of the potential for infection based on the positive test for the harmful microbe(s) or
analyzing the viscosity, volume and/or color of the fluid extracted.
[000102] Fluid management systems may also include one or more secretion collection containers
(e.g., jars, chambers, cups, etc.). Secretion collection jars may be placed in different locations with respect
to the other components of the fluid management system as will be discussed in more detail below.
Further, there may be a single secretion collection jar that collects all the fluid from the different regions
along the respiratory insertion device or there may be separate individual fluid collection jars that
correspond to fluid collection from the different regions. There may also be a separate fluid collection jar
for receiving lavage fluid. The fluid obtained may be discarded or sampled to test for presence of
microbes. In some examples, collection jars may also include a fluid level sensor for detecting when the
liquid has reached a certain level and provide alerts to the user to empty the collection jar or jars.
[000103] In use, the system starts with sample suctioning at a predefined time period (which is
adjustable and can be set by the physician based on the clinical judgement and condition of the patient).
During the sample suctioning the control unit switches ON the suction valves and the suction begins for a
minimum set amount of time (pre-set by the physician or manufacturer). During this sample suctioning
stage, secretion fluids (saliva, mucous, gastric reflux or any other bodily fluid) are sucked out up till the
sensing unit which is near to the head of the patient. The sensing unit senses the flow/presence of fluid
and keeps the suction ON until it senses that the flow/presence of fluid/secretions has decreased to a preset
value. This fluid gets collected in the collection Jar.
[000104] When there are no more fluids/secretions in the patient's oral cavity/oropharynx/subglottic
(above the cuff) and/or inside the tracheal tube main lumen, the sensor unit may sense the absence of
secretions in the tubing and checks for port blockage by the use of pressure sensor. On detection of port
blockage a lavage liquid from the liquid container is injected in the blocked line by use of the pump and
opening the valves. This fluid injected in the opposite direction to the direction of suctioning, unblocks
the port. The injected fluid is immediately sucked out by use of the suction from the other two lines or by
the same line.
[000105] In the case where none of the ports are blocked, the pressure sensor does not sense port
blockage and the system concludes that there are no more secretions. It then turns off until the next cycle
of sample suctioning.
[000106] The sheath/sleeve will have additional ports, or by using the ports in the oral cavity, lavage
liquid is passed through the oral cavity at regular intervals pre-set by the physician (or in some
embodiments, the manufacturer) to perform oral rinsing to maintain oral hygiene. The lavage liquid is
suctioned out immediately by the same port /other ports. The device effectively reduces nurses/care
givers contact with the patients trachea and thus reduces the chances of cross infection
[000107] The device has built in software to calculate and analyze the volume, flow rate and viscosity
of secretions and plot a graph of the patient's secretion pattern and detect and predict the onset of
infection or detect early signs of infection. It is also possible to detect pathogens where the device has an
additional feature of detecting the particular strain of bacteria/ pathogen causing the infection by using
micro fluidics based technology.
[000108] The device can share data through USB, internet, WiFi, Bluetooth, Ethernet, memory stick,
or any other data transfer technologies and has a small printer attachment to print out hard copies of the
infection graph of the patient
[000109] Turning to FIGS. 2 and 4, a general embodiment of the fluid management system 200 and a
respiratory insertion device 270 is shown. In this particular example, there are three fluid lines 220 that
couple to respiratory insertion device 270. Further discussion of the various embodiments of the
respiratory insertion device and how it connects to the fluid management system as well to existing
tracheal tubes will be discussed in greater detail below. The fluid management system shown in this
example has an integrated controller 201 that includes flow sensors 230 and pressure sensors 240 (not
shown). Also included but not shown here are pressure controls 242 and suctioning/vacuuming controls
232 for detecting and removing fluid pooling in the pre-set regions along the tracheal tube. Also shown is
a single secretion collection jar 260. As previously mentioned, while the fluid management system is
capable of separately collecting fluid withdrawn from the pre-set regions along the tracheal tube, a user
may easily combine the fluid through separate fluid lines 220 into one fluid collection jar 260. FIG. 3
provides a better view a respiratory insertion device 370 in an intubated patient with an existing tracheal
tube. The pictorial shows a cross-section of a patient's oral, oropharyngeal, and subglottic regions having
and regions along the tracheal tube and the patient's respiratory tract that corresponds to fluid
accumulation and where respiration insertion body can monitor and remove fluid.
[000110] FIG. 4 shows a general schematic of a fluid management system 400 and its major
components. The location and connections between the components shown are illustrative and meant to
point out to the reader general locations of these components. The components may be arranged and
coupled in a variety of ways that are suitable for managing fluid accumulation in an intubated patient and
will be discussed in greater detail below.
[0001 11] Finally, any of the fluid management system may incorporate lavage as a complement to
removing fluid secretions around the tracheal tube. Lavage can be applied to the oral cavity, the
oropharynx, or subglottic region of the patient to moisten areas where saliva would normally bathe but
cannot in the case of an unconscious, intubated patient. Lavage can be used to periodically wash the
above mentioned regions to clear out debris and microbes that may cause infection. The fluid and
suctioning lines for lavage can be in addition to what is already present for sensing and removing fluid
from the oral, oropharynx, and subglottic regions and have separate pumping and suctioning components
within or external to the controller. In some instances, the lavage lines can tap into and share existing
fluid lines.
[000112] FIGS. 5 and 6 show the fluid management system unit as it has been currently conceived and
reduced to practice. In FIG. 5, a representative number of respiratory insertion devices are shown to
indicate that the fluid management system can be used with any of the respiratory insertion devices that
will be described below. The overall goal of the fluid management system is to sense and control the
amount of fluid secretions from an intubated patient that collects along the tracheal tube.
[0001 13] The sensing aspect of the fluid management system may contain two types of sensors. The
flow sensors may be used to determine the flow at a particular instant in the tube, whereas the pressure
sensors may be used to determine port blockage after the flow sensors have detected absence of
secretions. Simultaneously, the pressure sensors can register pressure values associated with any of the
fluid lines connecting to the respiratory insertion device and report the value(s) back to the controller. A
routine within the controller can be initiated to compare the detected pressure with preset values such that
if the detected pressure is lesser than the pre-set value, blockage or fluid collection is indicated at a
particular region along the respiratory insertion device. Sensors can be placed in any appropriate region,
including at the port openings of the respiratory insertion device or along the fluid lines to sense whether
there is fluid present at these locations. As mentioned, sensors may be non-contact, e.g., configured
outside of the fluid line, so that they do not contact fluid within the fluid line(s). If fluid flow (and
therefore fluid) is detected and reported back to the controller, the controller can initiate a set of
instructions for clearing the fluid. In this configuration, the pressure sensor may detect blockage only in
the case when the flow sensors first detect that there is no secretions.
[000114] The control aspect of the fluid management system regulates the mechanical and pressure
flow within the system. As FIG. 6 shows, solenoid valves in connection with at least one pump are used
to control the flow of fluid within the fluid management system and the respiratory insertion device. Also
maintained within the fluid management system module are electronics for collecting and retaining
information associated with frequency of monitoring for blockage. There may also be internal tests that
detect presence of potentially harmful microbes within any of the fluid lines. Information on the status of
the fluid management system can be displayed on an integrated monitor or can be shown on a separate
monitor.
[000115] A first embodiment of the fluid management system is shown in FIG. 7. A controller 701
links all of the other components present. A respiratory insertion device 770 can be an integrated tracheal
tube, a sheath, or one of the other arrangements that will be discussed below. The respiratory insertion
device may be arranged as the primary tracheal tube or an attachment to an existing tracheal tube within a
patient. Respiratory insertion device 770 may include at least two lumen for suctioning two different
regions along a tracheal tube. Respiratory insertion device 770 is fluidiy connected to the remaining fluid
management system 700 components via fluid lines 720. Adjacent to respiratory insertion device 770 are
flow sensors 730. Flow sensors detect the flow/presence of secretions at an instant at the particular
location and aid in switching off the device, if they sense absence of secretions. The cycle starts at a
predetermined time interval and keeps running till there is no more flow. Flow sensors 730 are associated
with each line present within respiratory insertion device 770. Flow sensors 730 can detect whether there
is still fluid present within the corresponding line within respiratory insertion device 770. Flow sensors
730 can automatically and continuously (within the given cycle) detect flow within their corresponding
lines as part of a step-wise routine. Alternatively, a user can manually determine flow in any or all of the
lines through selecting certain options provided within controller 701 . In this present embodiment, the
flow sensors 730 are shown to be in line with other components of fluid management system 700, but in
other examples, the flow sensors may be associated with separate lumen within the respiratory insertion
device. The flow sensors can be any suitable sensor that can detect and report back on flow and/or
presence of secretions within a line. Examples of such sensors may include IR sensors, UV sensors,
resistive sensors, capacitive sensors, ultrasound sensors, and Hall Effect sensors.
[000116] Staying with the embodiment shown in FIG. 7, fluid management system 700 also includes
pressure sensors 740 and pressure controls 742. Pressure sensors 740 are able to detect the pressure
within a corresponding fluid line that connects to a particular lumen of the respiratory insertion device
770. Controller 70 1 may include routines that test the pressure within the fluid lines automatically and
periodically or manually at the request of the user. Pressure controls 742 may either create negative
pressure within a line to assess the amount of blockage within a particular line or create positive pressure
to aid in unblocking a particular line. There may also be a pressure relief/release 747 within fluid
management system in situations where the sensed pressure within a line is above a set threshold value.
Having pressure relief/release 747 may prevent excessive pressure being exerted on the patient's
respiratory tract or within the fluid connections of either the respiratory insertion device or the fluid
management system.
[000117] The embodiment shown in FIG. 7 also includes a collection jar 760. While the box diagram
does not indicate the possible number of collection jars, there can be one central collection where all of
the extracted fluid can be retained or more than one collection jar. In the case where there is only one
collection jar, corresponding multi-port valves will be used to connect the fluid lines to the collection jar.
A multiple collection jar set-up may be more useful for revealing where the source of an infection and
provide caregivers with a clearer idea of what region along the patient's respiratory tract to target
treatment in case of infection. It may also be useful to include a volume sensor within all of the collection
jars present such that when fluid with the jars reaches a certain level, a fluid level sensor can signal the
controller to sound an alarm to notify the user that one or all of the collection jars require emptying.
[000118] A lavage system 750 is also present in the embodiment shown in FIG. 7. Lavage system 750
includes a lavage pump 75 1 and a lavage pressure control valve 752. Although not specifically shown
here, lavage system 750 may deliver a rinsing fluid to at least one region along respiratory insertion
device 770. Controller 701 regulates lavage pump 751 and lavage pressure control valve 752 to deliver
the rinse fluid at a desirable flow rate and pressure to the region or regions of interest. When the rinse
portion of the lavage cycle is complete, lavage pump 751 can exert negative pressure to suction away the
rinse fluid. While not specifically shown, an additional fluid line in connection with a collection jar can
receive the post-rinse fluid. Alternatively, the additional fluid line can connect to any of the fluid
collection jars already present within the fluid management system. FIGS. 8 and 9 show two possible
arrangements of the suctioning features in the fluid management system embodiment discussed earlier. In
FIG. 8, a suctioning feature is not included in fluid management system 800. In this arrangement, the
suctioning or vacuuming feature is provided for externally. FIG. 9 shows the case where the
suctioning/vacuuming is included within the fluid management system. While there are both advantages
and disadvantages to both arrangements, neither greatly affect the overall functionality of the fluid
management system. Finally, in both of the variations shown, the collection jars are situated after the
suctioning and pressure valves. The advantage of having the suctioning and pressure valves in closer
proximity to the respiratory insertion device is more precise control of the suctioning and pressure within
the respiratory insertion device. The disadvantage of having the pressure and suctioning valves situated
between the respiratory insertion device and the collection jar is that during suctioning, these valves may
become more easily contaminated by the fluid passing through. Having the collection jar between the
respiratory insertion device and the pressure and suctioning valves would minimize contaminating the
valves but also provide less precise control of the pressure and suctioning that occurs at the distal end of
the respiratory insertion device.
[000119] FIG. 0 shows a more detailed diagram of an embodiment of the fluid management system.
While the system in FIG. 10 is similar to what is shown in FIGS. 7-9, the diagram in FIG. 10 indicates
more than a general concept of the fluid management system and discloses in great detail the components
used to reduce the fluid management system to practice.
[000120] FIGS. 1-15 show further variation in the arrangement of the collection jars and the various
valves present within the fluid management system. In fluid management system 1 00 shown in FIG. 11,
the collection jars are placed before the suctioning and pressure valves. In system 1100, three separate
lines emanate from respiratory insertion device 1170. Collection jar 1160 are associated with each line
1120. Collection jar 1160 can be a single jar or multiple jars, for example, a collection jar corresponding
to each line. As previously mentioned, one of the main advantages of having the collection jars in front
of at least some of the valves is that less contaminants reach those valves during suctioning, and requiring
less frequent cleaning or replacement of these valves. There are also sensing units 1130, 1140 which
sense pressure and flow and are associated with each fluid line. In many of the embodiments, filters are
placed before the various modules to minimize contamination of these modules. System 1100 also
includes lavage 1150 having three separate lavage lines 1153 that connect to the respiratory insertion
device (not shown). The three lavage lines 153 are controlled by a central lavage control valve 1152 and
a lavage pump 1151. Also included is a lavage jars 1158 that contain lavage liquid where the lavage
liquid can be pumped through to each of the lavage lines 1153 for rinsing out the different regions along
the respiratory insertion device. It should be mentioned that the lavage control valve may only allow
lavage liquid to pass to one or two of the lavage lines 1 53 for rinsing. Control of which lavage lines
receive rinsing fluid may be controlled by the operator or may be based on a detected value or condition
set by the controller that then automatically signals the lavage system to activate. While not shown,
lavage system 1150 may include a separate line for removing lavage liquid once lavage is completed or
may utilize fluid lines 1120 for collecting used lavage liquid, here the lavage liquid is returned to
collection jar 160.
[000121] FIG. 12 shows an alternative embodiment of the fluid management system setup. Similar to
system 1100 setup, system 1200 has collection jars 1260 are situated before suctioning valves 1245. One
notable difference in system 1200 is the lavage lines 1253 feed into fluid lines 1220 and not directly into
the respiratory insertion device. As shown each lavage line 1253 taps into a corresponding fluid line 1220.
In order to prevent lavage fluid 1259 from traveling toward suctioning valves 1245 instead of towards the
respiratory insertion device during lavage, system 1200 includes a series of non-return valves 1248.
When on, non-return valves 248 forces lavage fluid toward the respiratory insertion device. For
example, a non-return valve may have an on/off feature and may be operated to close the suction line only
after there is pressure due to the lavage liquid; at other times the suction lines remain open.
[000122] FIG. 3 shows yet another embodiment of the fluid management system setup. Similar to
system 1200, system 1300's lavage 1350 is routed to corresponding fluid lines 1320 prior to reaching the
trachea tube on the patient. In system 1300, a collection jar 1360 is placed behind suctioning valves 1345
and pressure valves 1344 are situated between collection jar 1360 and the respiratory insertion device. As
previously mentioned, one disadvantage of having fluid lines 1320 contact suctioning valves 1345 and
pressure valves 1344 is the greater chance for contamination. In order to minimize this effect, valves will
be constructed having non-clogging components that will allow fluids of different density and viscosity to
pass. In some examples, the interior of the valves can be coated with non-adhering material making it
more difficult for microbes to attach. The valves can also be non-contact valves (e.g., pinch valves) and
thus solve the problem of contamination as the valve body will never come in contact with the fluids and
the valves will only pinch the fluid lines 720 to shut them.
[000123] FIG. 14 shows a final fluid management system configuration having three fluid lines. In
System 1400, jar 1460 is situated near the suction source and far away from suctioning valves 1445 and
the respiratory insertion device. Suction valves 1445 are three way valves which allow different functions
of the fluid management system to share some of the same lines which may decrease the space required
within the fluid management system. System 1400 includes lavage lines (not shown in FIG. 14) that
connect to rest of the fluid management components fluid lines 1420 between suction valves 1445 and jar
1460. System 1400 also include sensor units 1430 and 1440 for monitoring pressure and flow. System
1400 also includes additional suction control valves 1457 that may control the removal and flow rate of
the used lavage liquid 1459 from the respiratory insertion device of the patient.
[000124] FIG. 15 shows a fluid management system embodiment having four independent fluid lines.
The remainder of the fluid management system remain the same. In this embodiment, the extra fluid line
can be used to remove fluid from a fourth location along the tracheal tube. Also, the additional fluid line
may be used to remove fluid from within the actual tracheal tube as well.
[000125] FIGS. 16A-C shows pictorials of a fluid management system setup reduced to practice. FIG.
16A shows the controller in connection with various fluid lines. FIG. 16B and C shows close-ups of the
controller which includes valves, pump, motor, and micro-controls.
Respiratory insertion devices
[000126] As mentioned, the fluid management systems described above may be coupled to a
respiratory insertion device. FIGS. 17-30 describe the respiratory insertion device connected to the fluid
management system as well as different embodiments of the respiratory insertion device envisioned.
[000127] In some variations, a respiratory insertion device will snap over any endotracheal tube and
can be slid down into the appropriate position. For example, the sheath/sleeve may be placed in the oral
cavity of an intubated patient with the dorsal end reaching till the vocal chords. The sheath/sleeve may
have two or more (e.g., three) parallel independent channels running with multiple openings/ ports at
different locations corresponding to the subglottic region, oropharyngeal region and the oral cavity. In
some variations the sheath includes only two lumen (channels) as the tracheal tube onto which it is
connected already has a lumen that may be used to remove fluid from a region around (and/or within) the
tracheal tube. The ends of these channels having connectors for coupling with suction line tubing.
[000128] The respiratory insertion device can be constructed of any suitable materials. Such materials
include but are not limited to: polyurethane, polyvinyl chloride (PVC), polyethylene terephthalate
(PETP), low-density polyethylene (LDPE), polypropylene, silicone, neoprene, polytetrafluoroethylene
(PTFE), or poly-isoprene or any other relevant elastomer, plastic, or rubber or any other bio-compatible
material.
[000129] The respiratory insertion device may be connected to connecting tubing, and the sensing
unit(s) may be placed for optimum sensing. The sensing unit contains fluid detection sensors and sends
its values to a control and processing unit which has a microcontroller, and a set of valves namely,
suction shut on/off valve, lavage shut on/off valve, suction pressure control valve, lavage pressure control
valve. It also houses the variable output pump, collection jar and display. The collection jar has a
provision to attach a sample collection system which includes but not limited to the small jar, for
collection of small amount of secretions to be sent to the microbiology/ pathology lab.
[000130] The control and processing unit is driven by an external or internal power supply. It takes the
suction from an external negative pressure source such as any suction creating apparatus (wall mounted
suction line, portable suction system, independent suction system) and is connected to the control unit.
[000131] FIG. 1 shows the global tracheal management system which includes a fluid management
system 1700 and a respiratory insertion device 1770. In general respiratory insertion device 1770 includes
a sheath 1773 having a proximal end 1771 and a distal end 1772. Proximal end 1771 is situated adjacent
to fluid management system 1700. Distal end 1772 corresponds to the subglottic region of an intubated
patient. Respiratory insertion device 1770 generally includes at least two lumen and typically comprises a
third. In FIG. 1 , three lumen 1774, 1776, and 1775 are shown. The proximal and distal end of each of
lumen 1774, 1776, and 1775 extend longitudinally along the length of sheath 1773. Each of the proximal
end of lumen 1774, 1776, and 1775 can couple to corresponding fluid lines (not shown) of fluid
management system 1600. Distal ends of lumen 1774, 1776, and 1775 corresponds to different regions
along a tracheal tube. In particular, the oral cavity, the oropharynx, and the subglottic regions on an
intubated patient are of interest. Distal end of lumen 1774, 1776, and 1775 each include oral suctioning
ports 1777, 1778, and 1779 for detection and withdrawal of fluid from these regions in direct contact with
the ports. Further shown in FIG. 17 are flow sensors 1730 and liquids/pressure sensors 1740. Flow
sensors 1730 can detect the flow rate of fluid with the fluid lines and aid in the regulation of flow within
the fluid lines. Pressure sensors 1740 can detect the amount of resistance when negative pressure is
applied through the fluid lines and relay to the controller if the amount of resistance is greater than a
threshold value, indicating that there is blockage in the line. While pressure sensors 1740 shown in FIG.
17 are located on lumen 1774, 1776, and 1775, the pressure sensors can be placed on the fluid line and
external to the respiratory insertion device.
[000132] Different combinations of the respiration insertion device can be coupled to the various
configurations of the fluid management system discussed above. FIG. 18 shows a subset of possible
combinations of respiratory insertion device with the fluid management system. First of all, the fluid
management system can be used with a traditional tracheal tube, more specifically an endotracheal tube or
a tracheostomy tube. This may not be ideal because traditional tracheal tube do not possess the necessary
lumen and corresponding ports that would allow monitoring and evacuation of fluid. FIG. 18 also shows
that the fluid management system can be used with a modified tracheal tube having lumen that attach to
an existing tracheal tube. FIG. 18 also shows a continuous aspiration of subglottic secretion (CASS) tube
which allow for suctioning along the subglottic regions as well as use with innovative integrated tracheal
tube configurations that will also be more thoroughly discussed in the following paragraphs. And finally,
the diagram indicates that the fluid management system can also work with an integrated endotracheal
tube where the lumen are integrated into the device body.
[000133] FIGS. 19A-D show a first embodiment of a respiratory insertion device 1970. Respiratory
insertion device 1970 has a proximal end 1971 that is near the mouth of the intubated patient and a distal
end 1972 that corresponds to the end of the patient's trachea and the top of the bronchi region.
Respiratory insertion device 1970 has a spiral configuration where a device body 1973 winds around an
existing tracheal tube 1990. Device 1970 is prevented from pushing past a safe region of the patient's
respiratory tract once the distal end of device 1970 abuts a cuff 99 1 of the tracheal tube and proper
positioning of device 1970 along the existing tracheal tube is achieved when the distal end of device 1970
sits against cuff 1991 and the proximal end of device 1970 adjoins the proximal end of the existing
tracheal tube. Device 1970 includes at least one device fluid line 1980 for suctioning. Device fluid line
1980 may include a coupler 1981 for attaching to the fluid lines of the fluid management system. The
small circles along the tracheal tube show where fluid is most likely to accumulate. As prior references
have indicated, one area of fluid accumulation corresponds to the subglottic region of the patient
especially around the cuff. Other two regions not specifically mentioned and targeted by earlier tracheal
tube fluid management devices are the oral cavity and the oropharyngeal regions adjacent to the tracheal
tube. An unconscious intubated patient cannot tell that saliva is pooling in their mouth and has no
automatic reflex to rid his or her mouth of the fluid especially with the presence of the tracheal tube. The
oropharyngeal region is also susceptible to fluid accumulation due to the arcuate bend in the tracheal tube
as it passes the oral cavity into the trachea in combination with the typical horizontal position of an
intubated patient. FIG. 19A shows a respiratory insertion device similar to that in FIG. 17; FIGS. 19B,
19C, and 19D show enlarged views of portions of this device. Suctioning ports are disposed at various
regions on the device body 1973. A blow-up view that corresponds to the oropharyngeal region along the
tracheal tube shows a plurality of ports 1978. The circles and arrows show the fluid and other debris
moving toward ports 1978 to be suctioned away. While not specifically shown, ports are also disposed on
the respiratory insertion device body that corresponds to the oral cavity and the subglottic region of the
intubated patient. Also, the spacing of the ports corresponding to different regions of the tracheal tube
should be at least 0.4 inches from each other (e.g., the ports at the distal ends of the lumen). At the
proximal ends of the lumen, which may connect to fluid lines, ports into the lumen may be immediately
adjacent to each other or may extend as tubes from the device. This requirement does not apply to ports
associated with the same region, which is shown in the enlarged views in FIGS. 19B, 19C, and 19D.
[000134] FIG. 20 illustrates aspects of a respiratory insertion device 2070 for removing fluid from two
or more regions along a tracheal tube in accordance with some embodiments. Device 2070 includes a
sheath 2073. Sheath 2073 having a hinge 2084 and an opening 2085. Disposed along the perimeter of
sheath 2073 are a plurality of lumen. In FIG. 20, two lumen 2074 and 2075 are shown. Lumen 2074 and
2075, when connected to fluid lines of the fluid management system, are able to suction two different
locations of an existing tracheal tube through ports (not shown) disposed adjacent to the distal end 2072
of device 2070. In use, hinge 2084 of sheath 2073 can open and increase the circumference of opening
2085. A user can then more easily slide device 2070 over an existing tracheal tube either prior to placing
the tracheal tube in a patient or after placement of the tracheal tube. Couplers 2081 are also present for
connecting to the fluid management system. In variations of this embodiment, more than two lumen are
disposed along the perimeter of the device sheath.
[000135] FIG. 2 1 illustrates aspects of a respiratory insertion device 2170 for removing fluid from two
or more regions along a tracheal tube in accordance with some embodiments. Device 2170 includes one
or more sleeve 2173. Sleeve 2173 function much like a stent wherein sleeve 2173 expands laterally when
a force is longitudinally applied and thus device 2170 can be segmentally inserted over an existing
tracheal tube. Device 2170 may include lumens along the perimeter of the top sleeve that extend along
the longitudinal axis of the top sleeve. The top sleeve may include a lumen that terminates at a top sleeve
port opening for suctioning a first region along the existing tracheal tube. The first region may
correspond to the oral cavity of the intubated patient. Lumen 2174, 2175, and 2176 are shown entering
the sleeve 2173 at a ring 2182. The top sleeve can align and couple to lower sleeves having
corresponding lumen that terminate at port openings along the length of the lower sleeve. A first port
opening 2 177 may correspond to the oral cavity of a patient. Other port openings 2178 and 2179 may
correspond to a second and a third region along the existing tracheal tube such as the oropharyngeal and
subglottic regions. While the lumen in FIG. 1 are all shown to insert at largely one point onto the sleeve,
it is also possible for the different lumen to insert at different points on the ring and having corresponding
channels in the lower sleeves. Also, each lumen include couplers 2181 for attaching to the fluid
management system or the like. It should be note that in positioning this device embodiment, ventilation
may have to be disrupted for a short period to enable fitting of the sleeve over the existing tracheal tube.
[000136] FIG. 22A-C illustrate aspects of a respiratory insertion device 2270 for removing fluid from
two or more regions along a tracheal tube in accordance with some embodiments. Device 2270 is
designed to fit over an existing tracheal tube and includes a series of stacked rings 2282 held together by a
series of support structures 2273. Stacked rings 2282 may include at least one set of longitudinallyaligned
ring apertures. Device 2270 further include an integrated lumen 228 1 that is able to reach various
points along the length of the existing tracheal tube. The distal end of the integrated lumen 2281 includes
a series of tentacle-like lumen that thread through at least one of the longitudinally-aligned ring apertures
2288. The tentacle-like lumen at the distal end that are able to reach farther along the existing tracheal
tube may thread through two or more of the longitudinally-aligned ring apertures 2288. The tentacle-like
lumen 2274, 2275, and 2276 terminate with corresponding suctioning ports 2277, 2278, and 2279 that are
able to remove fluid from the corresponding regions along the existing tracheal tube. Finally, the lumen
come together at the proximal end of the integrated lumen 2281 and couple to a connector 2281 that links
the lumen to the fluid management system.
[000137] FIG. 23A-B illustrate aspects of a respiratory insertion device 2370 for removing fluid from
two or more regions along a tracheal tube in accordance with some embodiments. Device 2370 is able to
attach to an existing tracheal tube. Device 2370 includes a device body 2373 along one side and a series
of clips 2383 that enables device 2370 to attach to the existing tracheal tube. Series of clips 2383 each
include an opening 2385 that allows a user to slightly increase the diameter of the series of clips 2383 for
fitting device 2370 over the existing tracheal tube. Device 2370 includes a cavity 2386 that runs
essentially the entire length of device 2370. While not shown, catheter or tubing can be inserted through
cavity 2386 to terminate at various points along device 2370 for suctioning at different regions along the
tracheal tube.
[000138] An alternative embodiment to device 2370 is a device 2470 as shown in FIGS. 24A-B. One
difference between device 2470 and 2370 is that device 2470 is composed of two different materials. The
majority of device 2470 is composed of a softer elastomer that is flexible along the longitudinal axis of
the device. Device 2470 includes regions having "C" shaped-supports 2487 comprising stiffer material.
The C-shaped supports 2487 are situated along the longitudinal axis of device 2470 provides overall
rigidity in the transverse plane of device 2470. Device 2470 includes a channel 2486 that runs along and
follows the curve of the device body. Channel 2486 may retain at least one catheter or tubing body for
suctioning at least one area along the existing tracheal tube. Where there are greater than one catheter or
tubing body held within channel 2486, the distal ends of the catheter or tubing body terminates at
different points along the existing tracheal tube.
[000139] Next, FIG. 25A-C illustrate aspects of a respiratory insertion device 2570 for removing fluid
from two or more regions along a tracheal tube in accordance with some embodiments. Device 2570 is a
variation on the clip format. Device 2570 has a proximal end 2571, a distal end 2572, and a device body
2573. Proximal end 2571 is situated near a patient's mouth, while distal end 2572 is located between the
lower trachea and bronchi of a patient. FIG. 25A shows a close-up of proximal end 2571 which includes
a series of channels 2586 that follow the length of device body 2573 and terminate at various points along
an existing tracheal tube. In some examples, channels 2586 correspond to the oral, oropharyngeal, and
subglottic regions on a patient. FIGS. 25B and C show that some of the channels 2586 terminate at three
ports 2574, 2575, and 2576 for suctioning different regions along the existing tracheal tube. Depending
on how fluid lines are attached, some of the channels can be used for lavage of various regions of the
patient's oral, oropharyngeal, and subglottic cavities. Finally, device 2570 includes an opening 2585 that
allows for easier placement of device 2570 over a tracheal tube.
[000140] FIGS. 26A-C shows a variation of the device shown in FIGS. 25A-C. Similarly, device
2670 has a clip-on format that allows it to attach to an existing tracheal tube. Device 2670 includes a
device body 2673, a proximal end 2671 , and a distal end 2672. Device 2670 also has a C-shaped cross
section having an opening 2685, where the distance of the opening is greater than that for device 2570.
At proximal end 2671 of device 2670 includes two couplers 2681 that allows device 2670 to connect to a
suctioning system such as the fluid management system described earlier. Couplers 268 attach to
channels 2674 and 2675 that run along the length of device 2670 and terminates at different zones along
device 2670. At the terminus of channels 2674 and 2675 are ports 2674 and 2675 for suctioning different
regions along an existing tracheal tube.
[000141] FIG. 27A-27D illustrate aspects of a respiratory insertion device 2770 for removing fluid
from two or more regions along a tracheal tube in accordance with some embodiments. Device 2770 is
another version of a clip-on fluid suctioning device that can be mated with an existing tracheal tube.
Device 2770 has a device body 2773, a proximal end 2771 that is close to a patient's oral cavity when in
use, and a distal end 2772 that is between the patient's lower trachea and bronchi when in use. Device
2770 includes a series of clips 2783 for coupling to a tracheal tube. Device 2770 also includes stacked
lumen 2774, 2775, and 2776 that run the length of device body 2773 and terminate at different regions
along device body 2773. At the terminus of lumen 2774, 2775, and 2776 are corresponding ports 2777,
2778, and 2779 for working with the fluid management systems described above or other like systems to
detect and suction fluid from different regions along the tracheal tube. While not shown, proximal end of
lumen 2774, 2775, and 2776 can be coupled to fluid lines of the fluid management system or other like
systems.
[000142] FIG. 28A-G illustrate aspects of a respiratory insertion device 2870 for removing fluid from
two or more regions along a tracheal tube in accordance with some embodiments. Device 2870 is an
integrated tracheal tube having sensing and suctioning capabilities as well as an airway passage for
connecting to an external breathing mechanism. Device 2870 includes a device body 2873, a proximal
end 2871, and a distal end 2872. A cuff 2891 is located towards distal end 2872 of device 2870. Device
2870 further includes a tracheal tube portion 2890, a cuff inflation line 2892, and a first, second, and third
lumen 2874, 2875, 2876 for suctioning different regions along the respiratory tract of a patient. The distal
ends of lumen 2874, 2875, and 2876 all terminate with corresponding ports 2877, 2878, and 2879 that aid
in sensing and removing fluid from different points along device body 2873. FIG. 28G shows a crosssection
of this particular embodiment of respiration insertion device 2870 where respiration insertion
device 2870 further includes an internal port 2893 for suctioning in internal region of the tracheal tube
portion of respiration insertion device 2870. Also visible are the channels associated with ports 2877 and
2878 which correspond to the oral cavity and the oropharyngeal cavity regions.
[000143] Turning to FIGS.29A-30, devices for use in a tracheostomy scenario will be
described. FIGS. 29A and B show a first embodiment of a tracheostomy device 2970. Device 2970
includes a proximal end with one or more (e.g., three in this example) fluid line connectors 2971, 2971
2971", a distal end 2972, and a device body 2973. Device body 2973 is bifurcated into a first and second
lumen, 2974 and 2976. In use, first lumen 2974 is located outside of the tracheostomy tube while second
lumen 2976 is largely situated within the tracheostomy tube as shown in FIG. 29B. First lumen 2974
includes a first port 2977 at its terminus that is used for detecting and removing fluid from a first external
surface of the tracheostomy tube, primarily above an inflatable cuff 2991 of the tracheostomy
tube. Second lumen 2976 is longer than first lumen 2974 and includes a bend at its terminus. At the
bend, second lumen 2976 exits the tracheostomy tube and terminates below cuff 299 1. At its terminus,
second lumen 2976 includes a second port 2979 for sensing and suctioning a lower region of the
tracheostomy tube just below cuff 299 . Second lumen 2976 also includes a third port 2978 that is
situated within and near the distal end of tracheostomy tube for sensing and removing fluid from the
lower portion of the tracheostomy tube. Finally, device 2970 includes a coupler 2981 for attaching to the
fluid management or like system for sensing and removing fluid from different regions along the
tracheostomy tube.
[000144] A second embodiment of a tracheostomy device 3070 is shown in FIG. 30. Device 3070 is an
integrated tracheostomy tube and a fluid sensing and management device. Device 3070 includes three
independent lumen 3074, 3075, and 3076 that is integrated with a tracheostomy tube 3073. The proximal
ends of lumen 3074, 3075, and 3076 include couplers 3081 for connecting to the fluid management or
other like systems. The terminus of each lumen 3074, 3075, and 3076 are at different locations along
tracheostomy tube 3073. At the terminus of each lumen 3074, 3075, and 3076 are corresponding ports
3077, 3078, and 3079 for sensing and removing fluid from their corresponding regions. In some
instances, fluid, such as a lavage fluid 3050 can be introduced into the interior of tracheostomy tube 3073
and the rinse fluid can be removed via ports 3077, 3078, and 3079.
Method of using the fluid management system with the respiratory insertion devices
[000145] The following paragraphs describe the method of using the fluid management system and
with the respiration insertion device. A user can insert a respiratory insertion device having a plurality of
openings into a subject's respiratory tract so that a first opening is positioned at oral cavity (e.g., near a
base of the subject's tongue), a second opening is positioned at the subject's oropharynx, and a third
opening is positioned at the subject's subglottic region. In one case, the respiratory insertion body
attaches to a pre-existing tracheal tube, while in other cases, the respiratory insertion body incorporating a
tracheal tube, is newly inserted into a patient's trachea.
[000146] Next, the user coupling the respiratory insertion body to a controller by connecting a first
lumen of the respiratory insertion body that is in communication with the first opening to a first fluid line,
connecting a second lumen of the respiratory insertion body that is in communication with the second
opening to a second fluid line, and connecting a third lumen of the respiratory insertion body that is in
communication with the third opening to a third fluid line. The operator then can set the controller to
automatically, at a predetermined time period, apply suction through each of the first, second and third
fluid lines, and automatically turn off suction in one or the first, second or third fluid lines when fluid
flow through one of the fluid lines falls below a flow threshold and when pressure in that fluid line is
above a pressure threshold, and applying positive pressure in that fluid line to clear a blockage when fluid
flow through that fluid line falls below the flow threshold and when pressure is below the pressure
threshold. The operator can also choose to engage a lavage liquid to various regions along the tracheal
tube.
[000147] When a feature or element is herein referred to as being "on" another feature or element,
it can be directly on the other feature or element or intervening features and/or elements may also be
present. In contrast, when a feature or element is referred to as being "directly on" another feature or
element, there are no intervening features or elements present. It will also be understood that, when a
feature or element is referred to as being "connected", "attached" or "coupled" to another feature or
element, it can be directly connected, attached or coupled to the other feature or element or intervening
features or elements may be present. In contrast, when a feature or element is referred to as being
"directly connected", "directly attached" or "directly coupled" to another feature or element, there are no
intervening features or elements present. Although described or shown with respect to one embodiment,
the features and elements so described or shown can apply to other embodiments. It will also be
appreciated by those of skill in the art that references to a structure or feature that is disposed "adjacent"
another feature may have portions that overlap or underlie the adjacent feature.
[000148] Terminology used herein is for the purpose of describing particular embodiments only
and is not intended to be limiting of the invention. For example, as used herein, the singular forms "a",
"an" and "the" are intended to include the plural forms as well, unless the context clearly indicates
otherwise. It will be further understood that the terms "comprises" and/or "comprising," when used in
this specification, specify the presence of stated features, steps, operations, elements, and/or components,
but do not preclude the presence or addition of one or more other features, steps, operations, elements,
components, and/or groups thereof. As used herein, the term "and/or" includes any and all combinations
of one or more of the associated listed items and may be abbreviated as "/".
[000149] Spatially relative terms, such as "under", "below", "lower", "over", "upper" and the like,
may be used herein for ease of description to describe one element or feature's relationship to another
element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms
are intended to encompass different orientations of the device in use or operation in addition to the
orientation depicted in the figures. For example, if a device in the figures is inverted, elements described
as "under" or "beneath" other elements or features would then be oriented "over" the other elements or
features. Thus, the exemplary term "under" can encompass both an orientation of over and under. The
device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative
descriptors used herein interpreted accordingly. Similarly, the terms "upwardly", "downwardly",
"vertical", "horizontal" and the like are used herein for the purpose of explanation only unless specifically
indicated otherwise.
[000150] Although the terms "first" and "second" may be used herein to describe various
features/elements (including steps), these features/elements should not be limited by these terms, unless
the context indicates otherwise. These terms may be used to distinguish one feature/element from another
feature/element. Thus, a first feature/element discussed below could be termed a second feature/element,
and similarly, a second feature/element discussed below could be termed a first feature/element without
departing from the teachings of the present invention.
[000151] Throughout this specification and the claims which follow, unless the context requires
otherwise, the word "comprise", and variations such as "comprises" and "comprising" means various
components can be co-jointly employed in the methods and articles (e.g., compositions and apparatuses
including device and methods). For example, the term "comprising" will be understood to imply the
inclusion of any stated elements or steps but not the exclusion of any other elements or steps.
[000152] Although various illustrative embodiments are described above, any of a number of changes
may be made to various embodiments without departing from the scope of the invention as described by
the claims. For example, the order in which various described method steps are performed may often be
changed in alternative embodiments, and in other alternative embodiments one or more method steps may
be skipped altogether. Optional features of various device and system embodiments may be included in
some embodiments and not in others. Therefore, the foregoing description is provided primarily for
exemplary purposes and should not be interpreted to limit the scope of the invention as it is set forth in
the claims.
[000153] The examples and illustrations included herein show, by way of illustration and not of
limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other
embodiments may be utilized and derived there from, such that structural and logical substitutions and
changes may be made without departing from the scope of this disclosure. Such embodiments of the
inventive subject matter may be referred to herein individually or collectively by the term "invention"
merely for convenience and without intending to voluntarily limit the scope of this application to any
single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific
embodiments have been illustrated and described herein, any arrangement calculated to achieve the same
purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any
and all adaptations or variations of various embodiments. Combinations of the above embodiments, and
other embodiments not specifically described herein, will be apparent to those of skill in the art upon
reviewing the above description.

CLAIMS
What is claimed is:
A system for automatically removing fluid from multiple regions of a respiratory tract and
lavaging an oral cavity portion of the respiratory tract, the system comprising:
a controller comprising controller circuitry and one or more valves configured to couple to a
source of air pressure;
a plurality of fluid lines, wherein the fluid lines couple with the one or more valves of the
controller, and wherein the controller circuitry is configured to control the one or more
valves to apply positive or negative pressure through each fluid line of the plurality of
fluid lines;
a plurality of flow sensors and pressure sensors, wherein the fluid line are each coupled to a
flow sensor and a pressure sensor that are configured to report fluid flow and pressure
within the fluid line to the controller;
a source of lavage liquid, wherein the controller is configured to apply positive pressure to
deliver lavage liquid; and
one or more collection containers coupled to the fluid lines and configured to collect fluid
from the fluid lines;
wherein the controller circuitry is configured to periodically, automatically, and
independently apply negative pressure to each of the fluid lines, and to stop applying
negative pressure in each fluid line of the plurality of fluid lines when the fluid flow in
that fluid line is below a first flow threshold and when pressure in that fluid line is above
a first pressure threshold;
further wherein the controller circuitry is configured to apply positive pressure in that fluid
line when the fluid flow is below the first flow threshold while applying negative
pressure and when the pressure in that fluid line is below a second pressure threshold.
The system of claim 1, further comprising a respiratory insertion body extending distally in an
elongate axis, the respiratory insertion body comprising a plurality of lumen extending in the
elongate axis, and a plurality of openings, wherein each lumen is in fluid connection with an
opening, further wherein the openings for different lumen are separated along the elongate axis
by at least 0.4 inches, further wherein each of the lumen in the plurality of lumen are configured
to fluidly connect with a fluid line from the plurality of fluid lines.
The system of claim 1, further comprising an input configured to receive user-selected control
information comprising one or more of: lavage delivery frequency, lavage duration, lavage
pressure, suction application frequency, and suction pressure.
4. The system of claim 1, wherein the first pressure threshold is the same as the second pressure
threshold.
5. The system of claim 1, wherein the controller further comprises a display, and wherein the
controller circuitry is configured to display for one or more of the first, second and third fluid
lines data comprising one or more of: flow rate of a secretion within the fluid line, thickness of
secretion within the fluid line, volume of secretion within the fluid line, or color of the secretion
within the fluid line.
6. The system of claim 1, wherein the controller is configured to apply positive pressure to deliver
the lavage fluid through one of the fluid lines and to apply negative pressure to one or more other
of the fluid lines to remove the lavage fluid.
7. The system of claim 1, wherein the plurality of fluid lines comprises a first, second and third fluid
lines and wherein the controller circuitry is configured to independently apply negative pressure
through each of the first, second and third fluid lines.
8. The system of claim 1, wherein the plurality of fluid lines comprises a first, second, third and
fourth fluid lines and wherein the controller circuitry is configured to independently apply
negative pressure through each of the first, second, third and fourth fluid lines.
9. The system of claim 1, wherein the plurality of fluid lines comprises one or more lavage delivery
fluid lines that are connected to the source of lavage liquid and wherein the controller is
configured to apply positive pressure to the one or more lavage delivery fluid lines to deliver
lavage fluid.
10. The system of claim 1, further comprising a pump configured to apply positive pressure, wherein
the pump is in communication with the controller and the source of lavage fluid.
11. The system of claim , wherein the source of lavage liquid comprises a receptacle configured to
hold a lavage liquid.
12. The system of claim 1, further comprising one or more filters, wherein one or more valves is in
communication with fluid lines through the one or more filters.
13 . The system of claim 1, wherein the one or more valves comprises a plurality of suction valves,
wherein each of the fluid lines of the plurality of fluid lines is in communication with a suction
valve of the plurality of suction valves.
14. The system of claim , wherein the plurality of flow sensors are outside of the plurality of fluid
lines.
15. The system of claim 1, wherein the controller circuitry is configured to apply positive pressure to
deliver lavage fluid through one or more of the plurality of fluid lines.
16. The system of claim 1, wherein the controller circuitry is configured to periodically apply
positive pressure to deliver lavage fluid through one or more of the plurality of fluid lines at a
lavage delivery frequency.
17. The system of claim , wherein the controller circuitry is configured to transmit to a remote
processor, one or more of: flow rate of a secretion within the fluid line, thickness of secretion
within the fluid line, volume of secretion within the fluid line, or color of the secretion within the
fluid line.
18. The system of claim 1, wherein the collection containers are connected to the fluid lines between
the one or more valves and the source of air pressure.
1 . A system for automatically removing fluid from multiple regions of a respiratory tract and
lavaging an oral cavity portion of the respiratory tract, the system comprising:
a controller, the controller comprising controller circuitry, a display, and one or more valves
configured to couple to a source of air pressure;
a first, second and third fluid line, wherein the first, second and third fluid lines couple with
the one or more valves of the controller and wherein the controller is configured to
independently apply positive or negative pressure through each of the first, second or
third fluid lines;
wherein the first fluid line is coupled to a first flow sensor and a first pressure sensor, the
second fluid line is coupled to a second flow sensor and a second pressure sensor, and
third fluid line is coupled to a third flow sensor and a third pressure sensor;
a source of lavage liquid, wherein the controller is configured to automatically apply positive
pressure to deliver lavage liquid at a lavage delivery frequency; and
a first collection container coupled to the first fluid lines to collect fluid from the first fluid
line, a second collection container coupled to the second fluid line to collect fluid from
the second fluid line, and a third collection container coupled to the third fluid line to
collect fluid from the third fluid line;
wherein the controller circuitry is configured to periodically, automatically, and
independently apply negative pressure to each of the first, second and third fluid lines,
and to stop applying negative pressure in the first, second or third fluid lines when fluid
flow in the first, second or third fluid line is below a first flow threshold when pressure in
that fluid line is above a first pressure threshold; wherein the controller circuitry is
configured to apply positive pressure in the first, second or third fluid lines when the fluid
flow is below the first flow threshold while applying negative pressure and the pressure is
below a second pressure threshold in the first second or third fluid lines;
further wherein the controller circuitry is configured to display for one or more of the first,
second and third fluid lines data comprising one or more of: flow rate of a secretion
within the fluid line, thickness of secretion within the fluid line, volume of secretion
within the fluid line, or color of the secretion within the fluid line.
20. The system of claim 19, further comprising a respiratory insertion body extending distally in an
elongate axis, the respiratory insertion body comprising a plurality of lumen extending in the
elongate axis, and a plurality of openings, wherein each lumen is in fluid connection with an
opening, further wherein the openings for different lumen are separated along the elongate axis
by at least 0.4 inches, further wherein each of the lumen in the plurality of lumen are configured
to fluidly connect with one of the first, second or third fluid lines.
2 1. The system of claim 9, further comprising an input configured to receive user-selected control
information comprising one or more of: lavage delivery frequency, lavage duration, lavage
pressure, suction application frequency, suction duration, and suction pressure.
22. The system of claim 19, wherein the controller is configured to apply positive pressure to deliver
the lavage fluid through the first fluid line and to apply negative pressure to the first, second and
third fluid lines to remove the lavage fluid.
23. The system of claim 9, further comprising one or more lavage delivery fluid lines that are
connected to the source of lavage liquid and wherein the controller is configured to apply positive
pressure to the one or more lavage delivery fluid lines to deliver lavage fluid.
24. The system of claim 19, further comprising a pump configured to apply positive pressure,
wherein the pump is in communication with the controller and the source of lavage fluid.
25. The system of claim 19, wherein the source of lavage liquid comprises a receptacle configured to
hold a lavage liquid.
26. The system of claim 19, further comprising one or more filters, wherein one or more valves is in
communication with fluid lines through the one or more filters.
27. The system of claim 1 , wherein the one or more valves comprises a first, second and third
suction valve, wherein the first suction valve is between the first fluid line and the source of air
pressure, the second suction valve is between the second fluid line and the source of air pressure
and the third suction valve is between the third fluid line and the source of air pressure.
28. The system of claim 19, wherein the first flow sensor is outside of the first fluid line, the second
flow sensor is outside of the second fluid line and the third flow sensor is outside of the third fluid
line.
29. The system of claim 9, wherein the controller circuitry is configured to transmit to a remote
processor, one or more of: flow rate of a secretion within the fluid line, thickness of secretion
within the fluid line, volume of secretion within the fluid line, or color of the secretion within the
fluid line.
30. The system of claim 19, wherein the first collection container is connected to the first fluid line
between a first valve of the one or more valves and the source of air pressure, the second
collection container is connected to the second fluid line between a second valve of the one or
more valves and the source of air pressure and the third collection container is connected to the
third fluid line between a third valve of the one or more valves and the source of air pressure.
. A respiratory insertion device configured as an endorespiratory insertion device for independently
removing fluid from multiple regions of a respiratory tract, the device comprising:
an elongate body, the body having an elongate axis extending proximally to distally;
a first lumen disposed along the elongated body having a first lumen proximal end and a first
lumen distal end;
a first opening disposed on the first lumen distal end;
a second lumen disposed along the elongated body having a second lumen proximal end and
a second lumen distal end;
a second opening disposed on the second lumen distal end; and
wherein the first and second and openings are positioned along the elongate body so that the
first and second openings are separated from each other by at least 0.4 inches along the
elongate axis.
32. A respiratory insertion device configured as an endo-respiratory insertion device for
independently removing fluid from multiple regions of a respiratory tract, the device comprising:
an elongate body, the body having an elongate axis extending proximally to distally;
a first lumen disposed along the elongated body having a first lumen proximal end and a first
lumen distal end;
a first opening disposed on the first lumen distal end;
a second lumen disposed along the elongated body having a second lumen proximal end and
a second lumen distal end;
a second opening disposed on the second lumen distal end;
a third lumen disposed along the elongated body having a third lumen proximal end and a
third lumen distal end;
a third opening disposed on the third lumen distal end; and
wherein the first, second and third openings are positioned along the elongate body so that the
first, second and third openings are separated from each other by at least 0.4 inches along
the elongate axis.
33. The device of claim 31, wherein the first opening is configured to be positioned in the oral cavity
of a user, the second opening is configured to be positioned at a oropharynx region of the user,
and a third opening through the respiratory insertion device is configured to be positioned at a
subglottic region of the user when the respiratory insertion device is inserted into the user's
throat.
34. The device of claim 32, wherein the first opening is configured to be positioned in the oral cavity
of a user, the second opening is configured to be positioned at a oropharynx region of the user,
and the third opening through the respiratory insertion device is configured to be positioned at a
subglottic region of the user when the respiratory insertion device is inserted into the user's
throat.
35. The device of any of claims 3 -34, wherein the elongate body comprises a tubular body having a
central tracheal tube lumen opening at a proximal end and a distal ends of the respiratory
insertion device.
36. The device of any of claims 32-34, wherein the elongate body comprises a sheath configured to
connect over an endotracheal tube.
37. The device of any of claim 36, wherein the elongate body comprises a spiral sheath configured to
connect over an endotracheal tube.
38. The device of any of claim 37, further comprising a series of clips/attachments that can fit over an
endotracheal tube.
39. The device of any of claims 31-38, wherein the first lumen proximal end, the second lumen
proximal end, and the third lumen proximal end each comprise a fluid line coupler configured to
attach to a fluid line.
40. The device of any of claims 31-37, wherein the first opening is between about 3 cm and 14 cm
from the third opening, and further wherein the second opening is between about 2 cm and 10 cm
from the third opening.
4 1. A tracheal tube insertion device configured for removing fluid from multiple regions of or around
a tracheal tube within a respiratory tract, the device comprising:
a bifurcated elongate body having a first arm and a second arm, the body having an elongate
axis extending proximally to distally;
wherein the first arm is configured to extend through a lumen of the tracheal tube and
comprises a bent distal end region configured to extend out of a distal end of the tracheal
tube, wrap around the distal end of the tracheal tube and extend proximally up the tracheal
tube;
wherein the second arm is configured to extend distally along the outside of the tracheal tube;
a first and second lumen disposed within the first arm of the elongated body;
a first opening into the first lumen disposed proximal to the bent distal end region of the first
arm and configured to reside within the lumen of the tracheal tube;
a second opening into the second lumen disposed distally to the bent distal end region and
configured to reside outside of a distal end region of the tracheal tube; and
a third opening into a third lumen within the second arm, the third opening disposed near a
distal end of the second arm.
42. A tracheal tube insertion device configured for removing fluid from multiple regions of or around
the tracheal tube insertion device, the device comprising:
an elongate body, the body having an elongate axis extending proximally to distally;
an inflation cuff near a distal end of the elongate body;
a central lumen within the elongate body;
a first lumen extending proximally to distally along the elongated body;
a first opening between the first lumen and the central lumen;
a second lumen extending proximally to distally along the elongated body;
a second opening into the second lumen on an outside of the elongated body distal to the
inflation cuff;
a third lumen extending proximally to distally along the elongated body; and
a third opening into the third lumen on an outside of the elongated body proximal to the
inflation cuff.
43. The device of claim 4 1 or 42, wherein a proximal end of the first lumen comprises a first fluid
line coupler configured to attach to a first fluid line, a proximal end of the second lumen
comprises a second fluid line coupler configured to attach to a second fluid line and a proximal
end of the third lumen comprises a third fluid line coupler configured to attach to a third fluid
line.
44. A method of removing fluid from multiple regions of a respiratory tract and lavaging an oral
cavity portion of the respiratory tract, the method comprising:
inserting a respiratory insertion body having a plurality of openings into a subject's
respiratory tract so that a first opening is positioned in oral cavity, a second opening is
positioned at the subject's oropharynx, and a third opening is positioned at the subject's
subglottic region;
coupling the respiratory insertion body to a controller by connecting a first lumen of the
respiratory insertion body that is in communication with the first opening to a first fluid
line, connecting a second lumen of the respiratory insertion body that is in communication
with the second opening to a second fluid line, and connecting a third lumen of the
respiratory insertion body that is in communication with the third opening to a third fluid
line;
operating the controller to automatically, at a predetermined time period, apply suction
through each of the first, second and third fluid lines, and automatically turn off suction in
one or the first, second or third fluid lines when fluid flow through one of the fluid lines
falls below a flow threshold and when pressure in that fluid line is above a pressure
threshold, and applying positive pressure in that fluid line to clear a blockage when fluid
flow through that fluid line falls below the flow threshold and when pressure is below the
pressure threshold;
operating the controller to automatically and periodically applying a lavage liquid from the
first opening into the oral cavity;
collecting fluid from each of the first, second and third fluid lines into one or more collection
containers; and
displaying properties of fluid in the fluid lines on a display, wherein the one or more
properties comprises: flow rate of a secretion within the fluid line, thickness of secretion
within the fluid line, volume of secretion within the fluid line, or color of the secretion
within the fluid line.
The method of claim 44, further comprising inputting user-selected control information into the
controller, the user-selected control information comprising one or more of: lavage delivery
frequency, lavage duration, lavage pressure, suction application frequency, suction duration, and
suction pressure.
The method of claims 44-45, wherein applying positive pressure in that fluid line to clear a
blockage comprises applying suction from the first second and third openings applying positive
pressure in that fluid line.
The method of claims 44-45, wherein applying positive pressure in that fluid line comprises
delivering lavage fluid through the fluid line.
The method of claims 44-47, wherein inserting a respiratory insertion body having a plurality of
openings into the subject's respiratory tract comprises inserting an endotracheal tube comprising
the respiratory insertion body into subject's respiratory tract.
The method of claim 44-47, wherein inserting a respiratory insertion body having a plurality of
openings into the subject's respiratory tract comprises coupling the respiratory insertion body
onto an endotracheal tube already in the subject's respiratory tract
The method of claims 44-49, further comprising coupling the respiratory insertion body onto an
endotracheal tube.