DESC:1
FORM 2
THE PATENTS ACT 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
[See section 10 and rule 13]
1. TITLE OF THE INVENTION : A MEDICAL APPARATUS AND METHOD
FOR SIMULTANEOUS DELIVERY OF NUTRITION AND NIV THERAPY TO
PATIENTS
2. APPLICANT(S)
(a) NAME - Mednovate Private Limited
(b) NATIONALITY - Indian
(c) ADDRESS - 102, Y4 Tower, Yamuna Apartments, Sector D6 Vasant Kunj, New
Delhi , India , 110070
3. PREAMBLE TO THE DESCRIPTION
COMPLETE
The following specification particularly describes the invention and the manner in which it is
to be performed.2
A MEDICAL APPARATUS AND METHOD FOR SIMULTANEOUS
DELIVERY OF NUTRITION AND NIV THERAPY TO PATIENTS
FIELD OF THE DISCLOSURE
5 [0001] This invention generally relates to a field of medical apparatuses and
instruments, and more specifically relates to a medical apparatus for simultaneous
delivery of enteral-feeding and Non-Invasive Ventilation (NIV) therapy to patients.
BACKGROUND
10 [0002] The subject matter discussed in the background section should not be assumed
to be prior art merely as a result of its mention in the background section. Similarly, a
problem mentioned in the background section or associated with the subject matter of
the background section should not be assumed to have been previously recognized in
the prior art. The subject matter in the background section merely represents different
15 approaches, which in and of themselves may also correspond to implementations of the
claimed technology.
[0003] Nasogastric (NG) Tubes or Orogastric Tubes are used to deliver certain
medications or nutrition directly into stomach of patients with same stipulations as
feeding. The NG tubes may also be used for removal of gastric contents. The NG tubes
20 are configured to be placed in nose or mouth of the patients and slid into stomach of the
patients. A formulation is put into an NG tube and flows to the stomach of the patients.
The NG tube can deliver special nutrition, as well as medication, directly to the stomach
of the patient. In some instances, the patient may require tube feeding if the patient is
not getting adequate nutrition from oral feeding. This may be a case if the patient has a
25 condition that affects their appetite, or makes it difficult for the patient to chew or
swallow. In many instances, hospital patients just need additional nutrition to support
their healing. While considering common applications of NG tubes, especially in
medical therapies provided to the patients, one may also consider use of the NG tube in3
a Non-Invasive Ventilation (NIV) therapy. The NIV therapy is the therapy used in
hospitals and home care for treating patients of respiratory disorders. The NIV therapy
is administered using an NIV Mask. For patients on continuous NIV, administering
nutrition becomes a challenging as current NIV masks do not have a mechanism to
5 allow passage of the NG tube. The NIV Mask is often placed on top of NG tube or ryles
tube which causes leakage to the NIV therapy or pressure sores at a point of intersection
of NIV Mask cushion and the NG tube. As a result, either the patients are starved and
kept undernourished deliberately or the NIV therapy is compromised.
[0004] There have been many solutions developed in past for facilitating easy insertion
10 of NG tube with the NIV Mask. One of the solutions involve using of bends or grooves
in the NIV Mask cushion which reduces leakage in NIV therapy. However, a challenge
associated with using the bends or grooves is that the NG tube still comes in contact
with the face of the patient and causes pressure sores. Another solution involves using
external NG tube adapters which is not a universal solution and the external NG tube
15 adapters needs to be sourced and stocked for only specific use cases. An additional
challenge associated with the use of the NG tube adapters is that there are certain
limitations related with size of the NG tube adapters, as well as limitations related with
the type of the NG tube based on compatibility with an NG tube adapter.
[0005] Over recent years, there have been many other solutions developed for NG tube
20 insertion with the NIV Mask. One of the recently developed solution existing in the
market involves placing NIV mask over an inserted feeding tube and tightening of
straps of the NIV Mask to reduce a gap between a feeding tube and the NIV Mask, or
using an adhesive pad to close any gaps between the feeding tube, the NIV Mask
cushion, and the face of the patient. However, a major drawback associated with the
25 tightening of the straps of the NIV Mask is that an extra pressure is exerted on the
feeding tube as well as on the face of the patient, due to which a deformation of the
feeding tube occurs, thereby leading to blockages. Further, the pressure on the face of
the patient causes skin related problems and irritation and discomfort. Additionally, use
of the adhesive pad requires use of an extra element, which creates additional work for4
a clinician while fitting the feeding tube. Moreover, the adhesive pad needs to be placed
and stuck properly, especially in cases when the feeding tube is of larger size, as
improper placement will lead to ineffective sealing of the gaps. Thus, use of the
adhesive pad is quite tedious and needs to be extremely accurate to be effective.
5 [0006] Another recent solution or approach existing in the market is the insertion of the
feeding tube through an orifice provided in the NIV Mask. The insertion of the feeding
tube through the orifice in the NIV Mask is a better method of ensuring that there are
no leakages and the gap between the NIV Mask and the feeding tube is sealed. However,
when the NIV Mask needs to be removed, the feeding tube also needs to be removed.
10 The removal and reinsertion or replacement of the NG feeding tube may be
uncomfortable and irritable to the patient. Further, since the orifice is of a fixed
diameter, there is a limitation of the size of NG tube which can be inserted.
[0007] Hence, in view of the above, it is desired to address above mentioned
disadvantages or other shortcomings by providing a thoroughly designed,
15 multioperation, and adaptable apparatus and method configured to facilitate
simultaneous delivery of enteral feeding and Non-Invasive Ventilation (NIV) therapy
to patients, without any requirement of purchasing external accessories or adhesive
tapes, ensuring compatibility in terms of use with all kinds of NG tubes as well as
achieve a leakproof mechanism, facilitating ease in attaching and removing the NIV
20 Mask without hampering the NG tube, thereby confirming the use of the NIV Mask as
a regular NIV Mask when tube feeding is not necessary, or at least provide a useful
alternative.
OBJECTIVES OF THE INVENTION
25 [0008] It is an objective of the invention to provide an apparatus configured to facilitate
simultaneous delivery of enteral-feeding and Non-Invasive (NIV) therapy to patients.5
[0009] It is an objective of the invention to provide the apparatus having a tube
inclusion port assembly configured to be both integrated as well as detachable from
NIV Mask mould.
[0010] It is an objective of the invention to provide the apparatus having a seal at one
5 end of a detachable split port, so that when a NG tube is not inserted in a patient, an
NIV Mask is used as an ordinary NIV Mask without having any source of leakage.
[0011] It is an objective of the invention to provide the apparatus having the NG tube
configured to be inserted at any point throughout a length of the split port, upon
detachment of the split port.
10 [0012] It is an objective of the invention to provide the apparatus having the NIV Mask
which is configured to be taken off and removed any number of times, thereby easing
process of the delivery of nutrition and the NIV therapy in any way.
[0013] It is an objective of the invention to provide the apparatus having a detachable
split port opening configured to allow the entire NG tube including its attached feeding
15 port to pass through the opening created after detaching the split port.
[0014] It is an objective of the invention to provide the apparatus having a leakproof
mechanism.
[0015] It is an objective of the invention to provide the apparatus which is configured
to allow insertion of different NG tubes of varying diameters.
20 [0016] It is an objective of the invention to provide the apparatus which is a low-cost
solution and does not bring any radical change in cost of the NIV Mask.
[0017] It is an objective of the invention to provide the apparatus having the NIV Mask
which is configured to be easily removable and re-insertable without interfering with
the NG tube.6
[0018] It is an objective of the invention to provide a method for facilitating
simultaneous delivery of the enteral-feeding and the Non-Invasive (NIV) therapy to the
patients.
[0019] It is an objective of the invention to provide the apparatus which is very smooth
5 in terms of operation to ensure effective safety of the patients.
[0020] It is an objective of the invention to provide the apparatus which is costeffective.
SUMMARY
10 [0021] According to a main aspect, the present embodiments disclose an apparatus
which is configured to facilitate effective operation of simultaneous delivery of enteralfeeding and Non-Invasive Ventilation (NIV) therapy to patients. The apparatus mainly
comprises of an NIV Mask having a Mask Frame with a Tube Inclusion Port Assembly.
This Tube Inclusion Port Assembly is attached within the NIV Mask, and has a
15 plurality of components. The plurality of components comprises a base structure, a
detachable tapered structure, embedded leakproof seal, and an outer closing cap. This
tube inclusion port assembly is used to allow inclusion of NG tube. The NG tube has
two ends in which a first end is wide and has a feeding port, and a second end is a
narrow end. The first end which is the wide end is configured to remain outside nose of
20 a patient, and has a feeding port for administering nutrition, fluids, and other stuff via a
syringe, to be given to the patient. Each of the plurality of components of the Tube
Inclusion Port Assembly are configured to be fitted with each other in position, to
facilitate the Tube Inclusion Port Assembly to get easily connected with the NIV Mask
Frame. The Tube Inclusion Port Assembly is configured to be fitted within the NIV
25 Mask. The detachable tapered structure along with the embedded leakproof seal is
configured to allow sliding of NG tube between a first groove and a second groove. The
first groove and the second groove are positioned within the detachable tapered7
structure and the embedded leakproof seal. The base structure is configured to be
attached within the NIV Mask Frame. The base structure is further configured to be
tapered from inside. The detachable tapered structure is configured to be inserted
through an inner portion of the base structure. The detachable tapered structure is
5 further configured to fit tightly with the base structure. The detachable tapered structure
is further configured to be tapered from inside. The embedded leakproof seal is
configured to be fit tightly within the detachable tapered structure, to prevent air
leakage. The embedded leakproof seal and the detachable tapered structure have a split
gap. The split gap on both the embedded leakproof seal and the detachable tapered
10 structure are perfectly aligned for seamless integration. The split gap provided in both
that is embedded leakproof seal and detachable tapered structure is closed using an
opposing lock mechanism. The opposing lock mechanism is configured to be positioned
within an inner periphery of the base structure. The outer closing cap is configured to
be in an open position, when the NG tube is passing through the tube inclusion port
15 assembly. The rubber cap is further configured to be in a closed position, when there is
no need for passing the NG tube through the tube inclusion port assembly. The NIV
Mask, the Mask Frame, and the tube inclusion port assembly having the plurality of
components are integrated as a single unit to form the apparatus. The base structure,
detachable tapered structure, embedded leakproof seal, and outer closing cap are
20 integrated as a single unit to form the tube inclusion port assembly.
[0022] According to one aspect, the length of the base structure is equal to a length of
the detachable tapered structure, which facilitates easy sliding of the detachable tapered
structure through the base structure. The embedded leakproof seal may facilitates easy
sliding of the embedded leakproof seal through the detachable tapered structure.
25 [0023] According to yet another aspect, the present embodiments disclose a method
which is configured to facilitate the effective operation of the simultaneous delivery of
enteral-feeding and Non-Invasive Ventilation (NIV) therapy to the patients. The
method comprises firstly inserting a detachable tapered structure into a base structure.
The method further comprises secondly wrapping an embedded leakproof seal on a8
nasogastric tube. The method further comprises thirdly passing the nasogastric tube
through a gap of the detachable tapered structure, in a way that the wide end of the
nasogastric tube is outside, and the narrow end of the nasogastric tube slides inside the
base structure. The method further comprises fourthly sealing the base structure gap by
5 pressing the detachable tapered structure to avoid air leakage. The method further
comprises fifthly, inserting a plurality of locking holes of an outer closing cap on one
end to couple a plurality of protrusion on the detachable tapered structure in an open
position, and inserting a plurality of locking holes of an outer closing cap on another
end to couple a plurality of protrusion on the detachable tapered structure in a close
10 position.
[0024] It is to be understood that both the foregoing general description and the
following detailed description are exemplary and explanatory only and are not
restrictive of the invention, as claimed.
15 BRIEF DESCRIPTION OF THE DRAWINGS
[0025] The accompanying drawings illustrate various embodiments of systems,
methods, and embodiments of various other aspects of the disclosure. Any person with
ordinary skills in the art will appreciate that the illustrated element boundaries (e.g.
boxes, groups of boxes, or other shapes) in the figures represent one example of the
20 boundaries. It may be that in some examples one element may be designed as multiple
elements or that multiple elements may be designed as one element. In some examples,
an element shown as an internal component of one element may be implemented as an
external component in another, and vice versa. Furthermore, elements may not be
drawn to scale. Non-limiting and non-exhaustive descriptions are described with
25 reference to the following drawings. The components in the figures are not necessarily
to scale, emphasis instead being placed upon illustrating principles.9
[0026] FIG. 1 illustrates an isometric view of an apparatus used for facilitating effective
operation of simultaneous delivery of enteral-feeding and Non-Invasive Ventilation
(NIV) therapy to patients, according to an embodiment of the present invention;
[0027] FIG. 2 illustrates an exploded view of a tube inclusion port assembly of an
5 apparatus, according to another embodiment of the present invention; and
[0028] FIG. 3 illustrates different sectional views of an apparatus used for facilitating
the effective operation of the simultaneous delivery of the enteral-feeding and the NonInvasive Ventilation (NIV) therapy to the patients, according to yet another
embodiment of the present invention.
10
15
2010
DETAILED DESCRIPTION
5 [0029] Some embodiments of the disclosure, illustrating all its features, will now be
discussed in detail. The words “comprising,” “having,” “containing,” and “including,”
and other forms thereof, are intended to be equivalent in meaning and be open ended in
that an item or items following any one of these words is not meant to be an exhaustive
listing of such item or items, or meant to be limited to only the listed item or items. It
10 must also be noted that as used herein and in the appended claims, the singular forms
“a,” “an,” and “the” include plural references unless the context clearly dictates
otherwise. Although any systems and methods similar or equivalent to those described
herein can be used in the practice or testing of embodiments of the present disclosure,
the preferred, systems and methods are now described. Embodiments of the present
15 disclosure will be described more fully hereinafter with reference to the accompanying
drawings in which like numerals represent like elements throughout the several figures,
and in which example embodiments are shown. Embodiments of the claims may,
however, be embodied in many different forms and should not be construed as limited
to the embodiments set forth herein. The examples set forth herein are non-limiting
20 examples and are merely examples among other possible examples.
[0030] While the present invention is described herein by way of example using
embodiments, those skilled in the art will recognize that the invention is not limited to
the embodiments described, and are not intended to represent the scale of the various
components. It should be understood that the detailed description thereto is not intended
25 to limit the invention to the particular form disclosed, but on the contrary, the invention
is to cover all modifications, equivalents, and alternatives falling within the scope of
the present invention as defined by the appended claim. As used throughout this11
description, the word "may" is used in a permissive sense (i.e. meaning having the
potential to), rather than the mandatory sense, (i.e. meaning must). Further, the words
"a" or "an" mean "at least one” and the word “plurality” means “one or more” unless
otherwise mentioned. Furthermore, the terminology and phraseology used herein is
5 solely used for descriptive purposes and should not be construed as limiting in scope.
Language such as "including," "comprising," "having," "containing," or "involving,"
and variations thereof, is intended to be broad and encompass the subject matter listed
thereafter, equivalents, and additional subject matter not recited, and is not intended to
exclude other additives, components, integers or steps. Likewise, the term "comprising"
10 is considered synonymous with the terms "including" or "containing" for applicable
legal purposes. Any discussion of documents, acts, materials, devices, articles and the
like is included in the specification solely for the purpose of providing a context for the
present invention. It is not suggested or represented that any or all of these matters form
part of the prior art base or were common general knowledge in the field relevant to the
15 present invention.
[0031] The present invention is described hereinafter by various embodiments. This
invention may, however, be embodied in many different forms and should not be
construed as limited to the embodiment set forth herein. Rather, the embodiment is
provided so that this disclosure will be thorough and complete and will fully convey the
20 scope of the invention to those skilled in the art. In the following detailed description,
numeric values and ranges are provided for various aspects of the implementations
described. These values and ranges are to be treated as examples only, and are not
intended to limit the scope of the claims. In addition, a number of materials are
identified as suitable for various facets of the implementations. These materials are to
25 be treated as exemplary, and are not intended to limit the scope of the invention.
[0032] The present invention discloses an apparatus configured to facilitate
simultaneous delivery of enteral-feeding and Non-Invasive Ventilation (NIV) therapy
to patients. The disclosed apparatus comprises a Tube Inclusion Port Assembly
configured to be both integrated as well as detachable from an NIV Mask mould. The12
apparatus comprises a seal at one end of a detachable split port, so that when a NG tube
is not inserted in a patient, an NIV Mask is used as an ordinary NIV Mask without
having any source of leakage. The apparatus comprises the NG tube configured to be
inserted at any point throughout a length of the split port, upon detachment of the split
5 port. The apparatus comprises the NIV Mask configured to be taken off and removed
any number of times, thereby easing process of the delivery of the nutrition and the NIV
therapy in any way.
[0033] Referring now to drawings from FIG. 1 to FIG. 3, explained herein are inventive
concepts of certain embodiments. FIG. 1 illustrates an isometric view of an apparatus
10 (100) used for facilitating effective operation of simultaneous delivery of the enteralfeeding and the Non-Invasive Ventilation (NIV) therapy to patients, according to an
embodiment of the present invention. The apparatus (100) comprises of an NIV Mask
(104) having a NIV Mask Frame (106), a base structure (108), an elbow (116), an outer
closing cap (120), and a NIV Mask Cushion (122). The NIV Mask (104) is further
15 configured to be placed on face of the patient covering nose and mouth of the patient,
during performing of the NIV therapy on the patient. The NIV Mask Frame (106) is an
outer and topmost portion of the NIV Mask (104) which is configured to provide
strength to the NIV Mask (104), at a top portion of the NIV Mask (104). The NIV Mask
Frame (106) is further configured to be positioned adjacently with respect to elbow
20 (116).
[0034] In an embodiment, the NIV Mask Frame (106) is made of a material selected
from a group of materials such as Polycarbonate, Polyvinyl chloride, silicone or any
other medical grade material.
[0035] The base structure (108) is configured to be positioned adjacent to the elbow
25 (116). The base structure (108) is formed via extrusion in the NIV Mask (104). The
base structure (108) is further configured to be tapered from an outer end to an inside
end.13
[0036] In one embodiment, the base structure (108) is made of a material similar to the
NIV Mask Frame (106), which is selected from at least one of a polycarbonate,
polyvinyl chloride, silicone or any other medical grade material.
[0037] The elbow (116) is configured to be positioned on the central axis of the NIV
5 Mask (104) . The elbow (116) is further configured to be tightly fitted within the NIV
Mask Frame (106), at an outer portion of the NIV Mask Frame (106). The elbow (116)
is further configured to be centrally aligned with the NIV Mask Frame (106), or aligned
towards a lower side of the NIV Mask (104).
[0038] In one embodiment, the elbow (116) is made of a material selected from a group
10 of materials such as Polycarbonate, Polyvinyl chloride, silicone or any other medical
grade material.
[0039] The nasogastric tube (118) is basically an NG feeding tube which is used to
provide passage for the food or the fluid for intake by the patient. The nasogastric tube
(118) comprises of a first end and a second end. The first end is wide and has a feeding
15 port, and the second end is a narrow end. The wide end is not able to pass through the
nose of the patient and remains outside from the nose of the patient. Thus, the
detachable tapered structure (110) is removable to provide passage for an adaptor of the
nasogastric tube (118). The first end which is the wide end is configured with a feeding
port for administering nutrition, fluids, and other stuff via a syringe, to be given to the
20 patient The slim end is configured to slide through the Tube Inclusion Port Assembly
(102).
[0040] In one embodiment, the nasogastric tube (118) is made of a material selected
from a group of materials of Reinforced Plastic Material, Rubber Material, Silicon
Material, or any other soft material.
25 [0041] The outer closing cap (120) is configured to be in an open position or in the
closed position. The outer closing cap (120) further comprise one end with a cavity to14
provide a passage for the nasogastric tube (118). The outer closing cap (120) further
comprise an another end with a protrusion to couple the embedded leakproof seal (112),
for sealing the entrance of the base structure (108)The outer closing cap (120) is
configured to be in an open position, when the nasogastric tube (118) passes through a
5 gap present at one end of a tapered sliding mechanism and at one end of the outer
closing cap (120). The outer closing cap (120) is further configured to be in a closed
position, when there is no need for passing the nasogastric tube (118) through the gap.
The outer closing cap (120) comprise a plurality of locking holes on both the ends to
couple a plurality of protrusion on the detachable tapered structure (110).
10 [0042] In one embodiment, the outer closing cap (120) is made of a material selected
from a group of materials of Reinforced Plastic Material, Rubber Material, Silicon
Material, or any other soft material.
[0043] The cushion (122) is configured to be positioned adjacent to the NIV Mask
Frame (106). The cushion (122) is further configured to provide a leakproof means of
15 covering the nose and mouth of the patient while minimizing pressure on the patients
face
[0044] In one embodiment, the cushion (122) is made of a material selected from a
group of materials of Reinforced Plastic Material, Rubber Material, Silicon Material,
or any other soft material.
20 [0045] FIG. 2 illustrates an exploded view of a Tube inclusion port assembly (102) of
an apparatus (100), according to another embodiment of the present invention. The
apparatus (100) comprises of the tube inclusion port assembly (102) having a plurality
of components, the NIV Mask Frame (106), and the base structure (108) housed within
the NIV Mask Frame (106). The plurality of components is a detachable tapered
25 structure (110), embedded leakproof seal (112), and the outer closing cap (120). The
detachable tapered structure (110) is configured to be inserted through an inner portion
of the base structure (108). The detachable tapered structure (110) is further configured15
to fit tightly with the base structure (108). The detachable tapered structure (110) is
further configured to be tapered an outer end to an inner end. The detachable tapered
structure (110) is tapered to match the tapered surface of the base structure (108). The
embedded leakproof seal (112) is configured to be fit tightly within the detachable
5 tapered structure (110), to prevent air leakage.
[0046] In one embodiment, the detachable tapered structure (110) is made of a material
selected from a group of materials such as polyvinyl chloride, polycarbonate, reinforced
plastic or any other medical grade material.
[0047] In another embodiment, the length of the base structure (108) is equal to a length
10 of the detachable tapered structure (110), which facilitates easy sliding of the detachable
tapered structure (110) through the base structure (108). The embedded leakproof seal
(112) may facilitates easy sliding of the embedded leakproof seal (112), through the
detachable tapered structure (110). The embedded leakproof seal (112) when coupled
with the detachable tapered structure (110), prevent bending by applying by increasing
15 a grip surface area on the nasogastric tube (118) to provide an airtight seal and a
leakproof seal. The embedded leakproof seal (112), made of compressible material to
allow incision of a plurality of diameter nasogastric tube (118). The embedded
leakproof seal (112), made of compressible material such as rubber, polyvinyl chloride,
polycarbonate, reinforced plastic or any other medical grade material
20 [0048] In yet another embodiment, a snap fit lock in the base structure (108) couple to
a slit groove the detachable tapered structure (110). The slit groove present within the
detachable tapered structure (110) and the embedded leakproof seal (112) get tightly
fixed in position, for preventing any source of air leakage, once the apparatus (100)
operates in a closed configuration. Further, the detachable tapered structure (110) and
25 the embedded leakproof seal (112), include a slit groove for incision of the nasogastric
tube (118) at any point throughout a length of the split groove.16
[0049] In yet another embodiment, when the detachable tapered structure (110) is
placed inside the base structure (108), a sound is produced indicating that detachable
tapered structure (110) is placed properly and thus fitted inside the base structure (108).
[0050] In yet another embodiment, the embedded leakproof seal (112) ensures that
5 there are no gaps causing leakage between the detachable tapered structure (110) and
the nasogastric tube (118).
[0051] In yet another embodiment, inner portion of the detachable tapered structure
(110) is tapered, and inner portion of the base structure (108) is also tapered. The split
gap in the inner portion of the detachable tapered structure (110) and the inner portion
10 of the base structure (108) is covered by an opposing locking mechanism which is
housed inside the base structure (108).
[0052] FIG. 3 illustrates different sectional views of an apparatus (100) used for
facilitating the effective operation of the simultaneous delivery of the enteral-feeding
and the Non-Invasive Ventilation (NIV) therapy to the patients, according to yet another
15 embodiment of the present invention. The apparatus (100) comprises of the NIV Mask
Frame (106), the tube inclusion port assembly (102), the outer closing cap (120), the
NIV Mask Cushion (122), an oxygen port (124), an NIV Mask tube entrance (126), and
a clip handle (128). The oxygen port (124) is configured to be positioned adjacent to
the NIV Mask Frame (106) and the elbow (116).
20 [0053] The oxygen port (124) is further configured to be positioned, but not restricted
to, either on the elbow (116), or at any side (left, right, central, top, bottom) of the NIV
Mask Frame (106), or anywhere around the outer periphery of the NIV Mask Frame
(106), to facilitate ease in insertion of the NG tube (118) into the nose of the patient,
and the NIV Mask (104) to get easily fitted on the face of the patient.17
[0054] In one embodiment, the oxygen port (124) is made of a material selected from
polycarbonate, polyvinyl chloride , reinforced plastic material or any other medical
grade material.
[0055] The NIV Mask tube entrance (126) is configured to be positioned adjacent to
5 the oxygen port (124). The NIV Mask tube entrance (126) is further configured to
provide a passage for ventilation flow for the patient.
[0056] In one embodiment, the NIV Mask tube entrance (126) is made of a material
polycarbonate, polyvinyl chloride , reinforced plastic material or any other medical
grade material.
10 [0057] The clip handle (128) is configured to be on positioned each of the two sides,
left and right, of the NIV mask frame (106).
[0058] In one embodiment, the clip handle (128) is made of a material selected from
polycarbonate, polyvinyl chloride , reinforced plastic material or any other medical
grade material.
15 [0059] If the outer closing cap (120) designated by portion “A” as shown in FIG. 3 is
closed, the NIV Mask (104) works as a general NIV Mask used for patients. In an
instance, when the patient requires food, the outer closing cap (120) is removed. This
opens the entrance of the Tube Inclusion Port Assembly (102), allowing for inclusion
of the Nasogastric Tube (118). Hence, in such an event, the apparatus (100) of the
20 present invention is very useful and advantageous as the nasogastric tube (118) of the
apparatus is slidably inserted within the tube inclusion port assembly (102), through the
plurality of components which are housed within the tube inclusion port assembly
(102). This enables simultaneously administering nasogastric feeding along with
providing proper ventilation to the patient.
25 [0060] In one embodiment, a method is provided to facilitate the effective operation of
the simultaneous delivery of nutrition and Non-Invasive (NIV) therapy to the patients.18
The method comprises passing a nasogastric tube (118) though a base structure (108).
The method further comprises secondly inserting an embedded leakproof seal (112)
inside a detachable tapered structure (110), and align a slit groove of the embedded
leakproof seal (112) and the detachable tapered structure (110). The method further
5 comprises thirdly inserting the nasogastric tube (118) through the slit groove of the
embedded leakproof seal (112) and the detachable tapered structure (110). The method
further comprises fourthly sealing the base structure (108) gap by inserting the
detachable tapered structure (110) with the embedded leakproof seal (112) to avoid air
leakage.
10 [0061] Accordingly, the embodiments represented in FIGS. 1-3 describes in detail, the
structure and operation of use of the apparatus (100). The apparatus (100) mainly
comprises the tube inclusion port assembly (102) and the NIV Mask Frame (106). The
tube inclusion port assembly is characterized by the plurality of components. The
plurality of components is the base structure (108), the detachable tapered structure
15 (110), the embedded leakproof seal (112), and the outer closing cap (120). The base
structure (108) is a mounting structure which is configured to mount the detachable
tapered structure (110), the embedded leakproof seal (112), and the outer closing cap
(120). The base structure (108) is further configured to be detachably coupled with the
NIV Mask Frame (106), at one portion of the NIV Mask Frame (106). The nasogastric
20 tube (118) is provided having a wide end with a feeding port and a narrow end. The
tube inclusion port assembly (102) of the present invention is configured to be fitted
within the NIV Mask (104). The tube inclusion port assembly (102) is further
configured to be easily connected with the NIV Mask Frame (106), through the plurality
of components. The base structure (108), the detachable tapered structure (110), the
25 embedded leakproof seal (112), and the outer closing cap (120) are integrated as the
single unit to form the tube inclusion port assembly (102). The Tube Inclusion Port
Assembly (102) provide a leak proof passage for the nasogastric tube (118) without
removing the NIV Mask (104).19
[0062] The apparatus (100) of the present invention provides an advantage of allowing
insertion of the nasogastric tube (118) or feeding tube of multiple diameters. Further,
the apparatus (100) of the present invention provides an additional advantage of
placement of the NIV Mask (104) after the nasogastric tube (118) is already inserted
5 in the nose of the patient, without passing nasogastric tube (118) through the tube
inclusion port assembly (102). Further, the apparatus (100) of the present invention
provides an additional advantage of preventing PEEP losses or air leakage or any other
leakages during the NIV therapy, due to the proper slidable mechanism of the
nasogastric tube (118). Further, the apparatus (100) of the present invention provides
10 an additional advantage of usage of the NIV Mask (104) as a standard NIV Mask in
case if the feeding to the patient is not required. Further, the apparatus (100) of the
present invention provides an additional advantage if required. Further, the apparatus
(100) of the present invention provides an additional advantage of providing placement
of a split nut opposing lock mechanism for fixing position of the nasogastric tube (118)
15 to improve patient experience, by minimizing accidental movement of the nasogastric
tube (118) during NIV therapy. Further, the apparatus (100) of the present invention
provides an additional advantage of easy release of the split nut from the NIV Mask
Frame (106), in a way that the nasogastric tube (118) does not get accidentally pulled
or pushed during the removal of the NIV Mask (104), or during wearing of the NIV
20 Mask (104). Further, the apparatus (100) of the present invention provides an additional
advantage of simultaneous feeding and administration of the NIV therapy, without
compromising efficacy of both. Further, the apparatus (100) of the present invention
provides an additional advantage of preventing any breaks or stoppages in the NIV
therapy during feeding to the patient. Further, the apparatus (100) of the present
25 invention provides an additional advantage of preventing any contact of the nasogastric
tube (118) with the face of the patient, or the NIV Mask Cushion (122), thereby
resulting in improved patient comfort and reduced pressures sores, while carrying out
the NIV therapy. Further, the apparatus (100) of the present invention provides an
additional advantage of reduction in cost of the NIV therapy as there is no need of20
additional adapters or connectors to administer food or water pipe feeding. Further, the
apparatus (100) of the present invention provides an additional advantage of
accommodating nasogastric tube (118) of multiple diameters through the tube inclusion
port assembly (102).
5 [0063] Various modifications to these embodiments are apparent to those skilled in the
art from the description. The principles associated with the various embodiments
described herein may be applied to other embodiments. Therefore, the description is
not intended to be limited to the embodiments but is to be providing broadest scope of
consistent with the principles and the novel and inventive features disclosed or
10 suggested herein. Accordingly, the invention is anticipated to hold on to all other such
alternatives, modifications, and variations that fall within the scope of the present
invention and appended claims.
REFERENCE NUMERALS FOR DRAWINGS
15 (100) – Apparatus
(102) – Tube Inclusion Port Assembly
(104) – NIV Mask
(106) – NIV Mask Frame
(108) – Base Structure
20 (110) – Detachable Tapered Structure
(112) – Embedded Leakproof Seal
(116) – Elbow
(118) – Nasogastric Tube
(120) – Outer Closing Cap21
(122) – NIV Mask Cushion
(124) – Oxygen Port
(126) – NIV Tube Entrance
(128) – Clip Handle
522
,CLAIMS:We claim:
1. An apparatus (100) to facilitate effective operation of simultaneous delivery of
enteral-feeding and an non-invasive ventilation (NIV) therapy to patients.
5 an NIV Mask (104) to cover a nose and a mouth for a NIV therapy; and
a Tube Inclusion Port Assembly (102) coupled to the NIV Mask (104), wherein
the Tube Inclusion Port Assembly (102) further comprises:
a base structure (108) formed via extrusion in the NIV mask (104);
a detachable tapered structure (110) couple to the base structure (108) to
10 provide a passage for a nasogastric tube (118);
an embedded leakproof seal (112) installed in a passage of detachable
tapered structure (110); and
an outer closing cap (120) couple to detachable tapered structure (110)
to provide an open position or closed position for nasogastric tube (118) from
15 the base structure (108)
wherein the Tube Inclusion Port Assembly (102) provide a leak proof passage
for the nasogastric tube (118) without removing the NIV Mask (104).
2. The apparatus (100) as claimed in claim 1, wherein the base structure (108) is
20 configured to be positioned adjacent to an elbow (116).
3. The apparatus (100) as claimed in claim 1, wherein the detachable tapered
structure (110) and the embedded leakproof seal (112), include a slit groove for incision
of the nasogastric tube (118) at any point throughout a length of the split groove.
25
4. The apparatus (100) as claimed in claim 1, wherein the embedded leakproof seal
(112), incision of a plurality of diameter nasogastric tube (118).23
5. The apparatus (100) as claimed in claim 1, wherein a snap fit lock in the base
structure (108) couple to the slit groove of the detachable tapered structure (110).
6. The apparatus (100) as claimed in claim 1, wherein the detachable tapered
5 structure (110) is removable to provide passage for an adaptor of the nasogastric tube
(118).
7. The apparatus (100) as claimed in claim 1, wherein the embedded leakproof seal
(112) when coupled with the detachable tapered structure (110), prevent bending by
10 applying by increasing a grip surface area on the nasogastric tube (118) to provide an
airtight seal and a leakproof seal.
8. The apparatus (100) as claimed in claim 1, wherein the outer closing cap (120)
further comprise
15 one end with a cavity to provide a passage for the nasogastric tube (118); and
another end with a protrusion to couple the embedded leakproof seal (112),
for sealing the entrance of the base structure (108).
9. The apparatus (100) as claimed in claim 1, wherein the base structure (108), and
the detachable tapered structure (110) are of equal length.
20
10. A method to facilitate effective operation of simultaneous delivery of enteralfeeding and an non-invasive ventilation (NIV) therapy to patients, via an apparatus
(100), the method comprising:
25 passing a nasogastric tube (118) though a base structure (108);24
inserting an embedded leakproof seal (112) inside a detachable tapered
structure (110), and align a slit groove of the embedded leakproof seal (112) and the
detachable tapered structure (110);
inserting the nasogastric tube (118) through the slit groove of the embedded
5 leakproof seal (112) and the detachable tapered structure (110);
sealing the base structure (108) gap by inserting the detachable tapered
structure (110) with the embedded leakproof seal (112) to avoid air leakage.
10
Dated this 4th of October, 2023
[VIVEK SINGH- IN/PA 2786]
OF SAGACIOUS RESEARCH
AGENT FOR THE APPLICANT25