WO2022097078A1

WO2022097078A1 - Apparatus for positioning respiratory device

Info

Publication number: WO2022097078A1
Application number: PCT/IB2021/060261
Authority: WO
Inventors: Amol Kalyanrao Joshi; Trupti Amol Joshi
Original assignee: Amol Kalyanrao Joshi; Trupti Amol Joshi
Priority date: 2020-11-06
Filing date: 2021-11-05
Publication date: 2022-05-12

Abstract

The present disclosure relates to an apparatus (100) for positioning respiratory device, including at least one vertical strap (110) that includes a first fastener, at least two horizontal straps (112) including a second fastener, each of the at least two horizontal straps are coupled to the at least one vertical strap by a joint (122). A rim element (108) coupled to each of the first fastener and the second fastener such that the first fastener of at least one vertical strap adapted to support upper portion of a frame of the respiratory device, and the second fastener of at least two horizontal straps adapted to support side portions of the frame, to stabilize the frame on face of the user, and to enable supply of gas from the respiratory device to the airways of the user at a positive pressure.

Description

APPARATUS FOR POSITIONING RESPIRATORY DEVICE

TECHNICAL FIELD

[0001] The present disclosure relates, in general, to gear assembly, and more specifically, relates to an apparatus for positioning a respiratory device on a face of a patient.

BACKGROUND

[0002] Respirator masks are typically held in position on head of a patient/user by headgear assembly. The headgear assembly typically includes one or more pair of side portions and a rear portion, the side portions are adapted to engage with the patient's mask and the rear portion can be adapted to engage the back of the patient's head.

[0003] Headgear assemblies are structured to position and stabilize a patient interface, such as a nasal mask, on a patient's face so that a good seal can be maintained. In addition, the headgear assembly should be comfortable so that a patient can wear the mask assembly at night while they sleep. Completely rigid headgear assemblies are known in the art, however, they typically suffer from being uncomfortable to wear for long periods. In addition, because of their rigidity, they typically do not fit a broad range of patients.

[0004] The headgear assemblies known in the art are uncomfortable to wear and they are complicated, costly and may require delicate conventional harness attachments and buckles. Although multiple headgear assemblies exist today, these mechanisms suffer from significant drawbacks such as the headgear assemblies are costly, and may require at least two or more people necessary for donning the mask, the mask cannot be reused with damaged attachments, and pressure is applied on the bridge of nose and chin, which may result in pressure ulcers.

[0005] Therefore, there is a need in the art to provide a means that can adjust the mask as per the comfort of the user to provide ventilation with a minimal acceptable leak by solving the aforementioned problems. OBJECTS OF THE PRESENT DISCLOSURE

[0006] Anobject of the present disclosure relates, in general, to gear assembly, and more specifically, relates to an apparatus for positioning a respiratory device on a face of a patient.

[0007] Another object of the present disclosure is to provide an apparatus with suitable configuration that can maintain the frame and cushion of the conventional respiratory device in a desired adjusted position on the face of the patient effectively.

[0008] Another object of the present disclosure is to provide an apparatus that can provide positive pressure ventilation with minimal acceptable leak.

[0009] Another object of the present disclosure is to provide an apparatus that can be formed of a flexible material to maintain patient comfort.

[0010] Another object of the present disclosure is to provide an apparatus that can be user-friendly.

[0011] Another object of the present disclosure is to provide an apparatus that can be made with extensively available materialand can be cost-effective.

[0012] Another object of the present disclosure is to provide an apparatus that can be adjusted by the patient as per the requirement/comfort of the patient and can prevent pressure ulcers.

[0013] Another object of the present disclosure is to provide an apparatus that can be used with the conventional mask having damaged harness attachments.

[0014] Another object of the present disclosure is to provide an apparatus that can be used with all types of oro-nasal non-invasive ventilation (NIV) masks of different makes, models, sizes including different head sizes circumference.

[0015] Another object of the present disclosure is to provide an apparatus that can be utilized effectively in resource-limited settings.

[0016] Yet another object of the present disclosureis to provide an apparatus that do not require any conventional mask attachments and buckles.

SUMMARY

[0017] The present disclosure relates, in general, to gear assembly, and more specifically, relates to an apparatus for positioning a respiratory device on a face of a patient.

[0018] In an aspect, the present disclosure provides an apparatusfor positioning respiratory device, including at least one vertical strap comprising a first fastener, at least two horizontal straps comprising a second fastener, each of the at least two horizontal straps are coupled to the at least one vertical strap by a joint, a rim element coupled to each of the first fastener and the second fastener such that the first fastener of at least one vertical strap adapted to support upper portion of a frame of the respiratory device, and the second fastener of at least two horizontal straps adapted to support side portions of the frame, the frame adapted to be worn on a face of user, the respiratory device adapted to supply gas to airways of the user, wherein the positioning of the rim element on the frame adapted to stabilize the frame to be in close contact with the face of the user, to enable supply of gas from the respiratory device to the airways of the user at a positive pressure.

[0019] In an embodiment, the first fastener may include any or a combination of vertical limb hooks patch and vertical limb loops patch.

[0020] In another embodiment, the vertical limb loops patch can be configured to facilitate connection with the vertical limb hooks patch.

[0021] In another embodiment, second fastener may include any or a combination of horizontal limb hooks patch and horizontal limb loop patch.

[0022] In another embodiment, the horizontal limb loops patch can be configured to facilitate connection with the horizontal limb hooks patch.

[0023] In another embodiment, the shape of rim element can be any or a combination of spherical, semi- spherical, circular, ring and bangle.

[0024] In another embodiment, the rim element can be of variable thickness.

[0025] In another embodiment, the rim element can be made of stiff material selected from a group including metal, plastic and a combination thereof.

[0026] In another embodiment, the at least one vertical strap and at least two horizontal straps can be made of flexible composite material.

[0027] In another embodiment, the flexible composite material selected from a group comprising spun polyester fabric, cotton blend, preshrunk fabric, mercerized, double layered fabric, and a combination thereof.

[0028] Various objects, features, aspects, and advantages of the inventive subject matter will become more apparent from the following detailed description of preferred embodiments, along with the accompanying drawing figures in which like numerals represent like components.

BRIEF DESCRIPTION OF THE DRAWINGS

[0029] The following drawings form part of the present specification and are included to further illustrate aspects of the present disclosure. The disclosure may be better understood by reference to the drawings in combination with the detailed description of the specific embodiments presented herein.

[0030] FIGs. 1A-1C illustrate exemplary representation of an apparatus for positioning respiratory device, in accordance with an embodiment of the present disclosure.

[0031] FIGs 2A-2F illustrate exemplary view of an apparatus worn on the face of the user, in accordance with an embodiment of the present disclosure.

[0032] FIG 3A and 3B illustrate exemplary view of an apparatus with respiratory device, in accordance with an embodiment of the present disclosure.

DETAILED DESCRIPTION

[0033] The following is a detailed description of embodiments of the disclosure depicted in the accompanying drawings. The embodiments are in such detail as to clearly communicate the disclosure. If the specification states a component or feature “may”, “can”, “could”, or “might” be included or have a characteristic, that particular component or feature is not required to be included or have the characteristic.

[0034] As used in the description herein and throughout the claims that follow, the meaning of “a,” “an,” and “the” includes plural reference unless the context clearly dictates otherwise. Also, as used in the description herein, the meaning of “in” includes “in” and “on” unless the context clearly dictates otherwise.

[0035] The present disclosure relates, in general, to gear assembly, and more specifically, relates to an apparatus for positioning a respiratory device on a face of a patient. The apparatus can offer more comfort to the patient and can provide the required functionality of the non-invasive ventilation (NIV) mask. The present disclosure can be described in enabling detail in the following examples, which may represent more than one embodiment of the present disclosure.

[0036] FIGs. 1A-1C illustrate exemplary representation of an apparatus for positioning respiratory device, in accordance with an embodiment of the present disclosure. [0037] Referring to FIG. 1A, apparatus 100 (also referred to as gear assembly 100, herein) can be configured to position any conventional respiratory device (also interchangeably referred to as respiratory mask) on a face of the user/patient, the apparatus 100 can be configured to support the frame 102 of any conventional respiratory device, the conventional respiratory device may include cushion 104 that may be permanently or removably connected to the frame 102, the conventional respiratory device may further include an L-connector 106. The apparatus 100 can be structured in such a manner to maintain the frame 102, cushion 104and L-connector 106 in a desired adjusted position on the face of the user. The apparatus 100 is in this example can be implemented in a nasal mask structured to deliver breathable gas to a nose of the user, however, the present disclosure is not limited to this configuration but may be applied to other configurations such as mouth mask, face mask and the like.

[0038] In an embodiment, the apparatus 100 as illustrated in FIG. IB may include atleast one vertical strap 110 and atleast two horizontal straps 112, the atleast one vertical strap 110 and atleast two horizontal straps 112 can be configured to maintain a predetermined shape, for example, T- shaped strap, the T- shaped strap of the gear assembly 100 can be constructed from a soft, flexible composite material selected from a group comprising spun polyester fabric, cotton blend, preshrunk, mercerized, double-layered fabric, and the like.

[0039] Referring to FIG. 1C, the atleast two horizontal straps 112 can be connected to the atleast one vertical strap 110 by a sewn joint 122, the atleast one vertical strap 110 may include first fastener at the ends of the atleast one vertical strap 110, the first fastener may include vertical limb loops patch 114, and the vertical limb hooks patch 116, the vertical limb loops patch 114 can be sewn with 0.5 mm depth tiny plastic loops or any suitable depth tiny plastic loops, and vertical limb hooks patch 116 can be sewn with 0.5 mm depth tiny plastic hooks or any suitable depth tiny flexible plastic hooks, the vertical limb loops patchl l4 can be configured to facilitate connection with the vertical limb hooks patchl l6 provided on the atleast one vertical strap 110.

[0040] In another embodiment, each of the atleast two horizontal straps 112 may include second fastener, the second fastener may include horizontal limb loops patch 118 and horizontal limb hooks patch 120, the horizontal limb loops patch 118 can be sewn with 0.5 mm depth tiny plastic loops or any suitable depth and horizontal limb hooks patch 120 can be sewn with 0.5 mm depth tiny plastic hooks or any suitable depth tiny flexible plastic hooks, each of the horizontal limb loops patch 118 can be configured to facilitate connection with the horizontal limb hook patch 120. [0041] In another embodiment, the T- shaped strap can be available or sewn at suitable length and width, the atleast one vertical strap 110 can be connected to an upper portion of the frame 102 and the atleast two horizontal straps 112 can be connected to the each of side portions of the frame 102. Each of the loopspatches of the straps can engage with the hookspatches and are adapted to position the frame 102, on the face of the user, by connecting the gear assembly 100 to a rim element 108 with help of hooksand loopspatches of the straps (110, 112), such that the frame 102 of the conventional respiratory device are not engaged or connected directly to any of the parts of gear assembly 100.

[0042] In another embodiment, the apparatus 100 may include rim element 108 as illustrated in FIG. 1A that can be positioned and fixed between the vertical limb hooks patch 116 and the vertical limb loops patch 114 and between each of the horizontal limb loops patch 118 and horizontal limb hooks patch 120. The L- connector 106 of the respiratory device can be inserted in the rim element 108, the cushion 104 of the respiratory device can rest on the bridge of the nose reaching up-to chin, to cover the nostril and the mouth of the user completely. The rim element 108 can maintain the gear assembly 100 in a desired adjusted position on the face of the patient.

[0043] In another embodiment, the apparatus 100 can be configured to position the respiratory device, the apparatus 100 may include at least one vertical strap 110 with the first fastener, and at least two horizontal straps 112 with the second fastener, each of the at least two horizontal straps 112 can be coupled to the at least one vertical strap 110 by the joint 122. The rim element 108 can be coupled to each of the first fastener and the second fastener such that the first fastener of at least one vertical strap 110 adapted to support the upper portion of the frame 102 of the respiratory device, and the second fastener of the at least two horizontal straps 112 adapted to support side portions of the frame 102, the frame 102 adapted to be worn on face of the user, the respiratory device adapted to supply gas to airways of the user, wherein the positioning of the rim element 108 on the frame adapted to stabilize the frame 102 to be in close contact with the face of the user, to enable supply of gas from the respiratory device to the airways of the user at a positive pressure.

[0044] In an example implementation, an inner surface of the vertical limb of the atleast vertical strap 110 can be placed on the head of the user, and the inner surface of each of the horizontal limb of the atleast two horizontal straps 112 can be placed on the side portion of the user. The bangle-shaped rim element 108 can be position on tip of the nose and the mouth and the L- connector 106 of the respiratory device can be inserted in the rim element 108, to cover the nostril and the mouth of the user completely. The horizontal limb of the atleast two horizontal straps 112 can be inserted in the rim element 108 keeping the respiratory device in place. Each of the hook patch folded over the rim element 108 on to the respective loops and adjusted to position the respiratory device on the user and ensure that the atleast vertical strap 110 and the atleast two horizontalstraps 112 are positioned at 120° for uniform pressure and the L- connector 106 can be connected to ventilator tubing for ventilation.

[0045] For example, when the rim element 108 can be attached to the straps (110, 112), the softer material of the straps can be positioned beyond the more rigid/stiff material of the rim element 108, thereby preventing and reducing the opportunity for contact between the patient and the rigid material of the rim element 108that can cause irritation or discomfort to the user. The rim element 108 can add to the rigidity of the gear assembly 100 in certain planes and directions, which assists in stabilizing the respiratory device on the face of the patient during use. The gear assembly 100 can be connected to the rim element 108 with help of hooks and loops patches of the straps (110, 112), such that the frame 102 of the conventional respiratory device are not engaged or connected directly to any of the parts of gear assembly 100.

[0046] The rim element 108 and the strap (110, 112) can be able to maintain their positions with respect to the face of the patient when the straps (110, 112) and rim element 108 are connected to the frame 102. Thus, the likelihood of the displacement of the straps (110, 112) of the patient is reduced. The rim element 108 can be of any suitable configuration to maintain the frame 102 and cushion 104 of the respiratory mask in a desired adjusted position on the face of the patient. The apparatus 100 can provide positive pressure ventilation with a minimal acceptable leak. Thus, the apparatus 100 can replace the conventional harness or headgear provided with different make and sizes and the damaged mask can be reused by using the apparatus 100. The apparatus 100 can be utilized in a pandemic scenario in resource-limited settings, e.g., Covid intensive care unit (ICU) and the like.

[0047] FIGs 2A-2F illustrate exemplary view of an apparatus worn on the face of the user, in accordance with an embodiment of the present disclosure.

[0048] Referring to FIG. 2A, the strap configuration 200 may include many of the same components introduced in FIG.1A and FIG.1C above, FIG 1C illustrates a front view in which the hooks and loops patches are sewn on the assembly 100, andFIG. 2A illustrates an inner view of the assembly 100 without hooks and loops patches, which can come in direct contact with the patient/user. Those components that are unchanged in this embodiment retain their original element number and are not reintroduced. The vertical limb of the at least one vertical strap 110 can be sewn with 600 mmlength, 28 mm width, having 80mmx25mm of vertical limb hooks patch 116, and 300mm x25mm of vertical limb loops patch 114. Similarly, the horizontal limb of the at least two horizontal straps 112 can be sewn with 750 mm length and 28 mm width having 60mmx25mm of horizontal limb hooks patch 120, and 200 mmx25mm of horizontal limb loops patch 118, the range of the strap configuration 200 can be variable based on the requirement.

[0049] The apparatus 100 may include the rim element 108as illustrated in FIG. 2B, can be positioned and fixed between the vertical limb hooks patch 116 and the vertical limb loops patch 114. The rim element 108 can be of2mm thickness or any suitable thickness with a corresponding outer diameter (OD), for example, 60 mm OD. The rim element 108 can be made of stiff material with varying composition, the stiff material can be selected from a group including metal, plastic and/or any equivalent material. The rim element 108 can be of different shapes such as spherical, round, semi-spherical, circular, ring-shape, bangle-shape and the like. The rim element 108 can be of different sizes for fixing the straps (110, 112) of the respiratory device.

[0050] In another embodiment, the inner surface of the vertical limb of the atleast vertical strap 110 can be placed on the head of the user, and the inner surface of each of the horizontal limb of the atleast two horizontal straps 112 can be placed on the side portion of the user as shown in FIG.2B. The rim element 108 can be position on tip of the nose and the mouth as shown in FIG. 2C and the L- connector 106 of the respiratory device can be inserted in the rim element 108, to cover the nostril and the mouth of the user completely as illustrated in FIG. 2D.

[0051] The horizontal limb of the atleast two horizontal straps 112 can be inserted in the rim element 108 keeping the respiratory device in place as shown in FIG. 2E. Each of the hook patch folded over the rim element 108 on to the respective loops and adjusted to position the respiratory device on the user as shown in FIG. 2Fand ensure that the atleast vertical strap 110 and the atleast horizontal straps 112 are positioned at 120° for uniform pressure and the L- connector 106 can be connected to ventilator tubing for ventilation.

[0052] Masks are necessary to provide continuous or intermittent non invasive positive pressure ventilation (NIPPV) at two levels or single level of positive pressure, without need for intubation in critical patients. The respiratory device can provide breathable gas to the nose and/or mouth of the user, the position of the rim element 108 and the straps (110, 112) can facilitate the delivery of gas to the user/patient at positive pressure. The positioning of the straps (110, 112) may be further improved and the overall shape of the gear assembly may be better adapted to the any aged users, for example, child, adult, male and female.

[0053] In an example implementation, an experiment conducted and tested for the apparatus 100 for following objective advantages. Total 35 different, damaged masks were collected, disinfected, and tried individually by two observers, it was observed to serve the primary purpose of providing pressure during ventilation given by intensive care ventilator, which displays the amount of pressure generated, amount of leak in each breath. In a desperate situation, where, new NIV mask and harness were not available, the apparatus 100 tried on two patients admitted in COVID ICU, and feedback were obtained from the treating doctor and the patient for subjective experience. Similarly, new mask brought and tried for different age group users such asthe strap gear tried with the mask for child age 4 years, 10 years, adult female and male subjects. Based on above experiments, it can be concluded that the apparatus 100 can be used with (damaged or new) NIV mask can replace the existing / known art of harness or headgear effectively.

[0054] Thus, the apparatus 100 with the proposed dimensions can be used with all types of oro-nasal NIV masks of different makes, models, sizes including different head sizes circumference varying from 50 cm to 61 cm. Modified apparatus 100 can be used for smaller head sizes. The apparatus 100 can be adjusted by the patient as per the comfort of the patient and can prevent pressure ulcers at the bridge of the nose, it can also be used with the conventional mask having damaged harness attachments.

[0055] FIG 3A and 3B illustrate exemplary view of an apparatus with the respiratory device, in accordance with an embodiment of the present disclosure. The apparatus 100 as shown in FIG. 3A illustrates the positioning of the respiratory device by the rim element 108, and FIG. 3B illustrates thateach of the at least two horizontal straps 112 can be coupled to the at least one vertical strap 110 by the joint 122, thus the apparatus 100 does not require conventional mask attachments and buckles to place the frame 102 on the face of the user.

[0056] It will be apparent to those skilled in the art that the gear assembly 100 of the disclosure may be provided using some or all of the mentioned features and components without departing from the scope of the present disclosure. While various embodiments of the present disclosure have been illustrated and described herein, it will be clear that the disclosure is not limited to these embodiments only. Numerous modifications, changes, variations, substitutions, and equivalents will be apparent to those skilled in the art, without departing from the spirit and scope of the disclosure, as described in the claims. ADVANTAGES OF THE PRESENT DISCLOSURE

[0057] The present disclosure provides an apparatus with suitable configuration can maintain the frame and cushion of the conventional respiratory device in a desired adjusted position on the face of the patient effectively.

[0058] The present disclosure provides an apparatus that can be user-friendly.

[0059] The present disclosure provides an apparatus that can be made with extensively available material and can be cost-effective.

[0060] The present disclosure provides an apparatus that can be formed of a flexible material to maintain patient comfort.

[0061] The present disclosure provides an apparatus that can provide positive pressure ventilation with minimal acceptable leak.

[0062] The present disclosure provides an apparatus that can be adjusted by the patient as per the requirement and comfort of the patient and can prevent pressure ulcers.

[0063] The present disclosure provides an apparatus that can be used with the conventional mask having damaged harness attachments.

[0064] The present disclosure provides an apparatus that do not require conventional mask attachments and buckles.

[0065] The present disclosure provides an apparatus that can be used with all types of oro-nasal NIV masks of different makes, models, sizes including different head sizes circumference.

[0066] The present disclosure provides an apparatus that can be utilized effectively in resource-limited settings.

Claims

We Claim:

1. An apparatus (100) for positioning respiratory device, comprising: at least one vertical strap (110) comprising a first fastener; at least two horizontal straps (112) comprising a second fastener, each of the at least two horizontal straps are coupled to the at least one vertical strap by a joint (122); and a rim element (108) coupled to each of the first fastener and the second fastener such that the first fastener of at least one vertical strap (110) adapted to support upper portion of a frame (102) of the respiratory device, and the second fastener of at least two horizontal straps (112) adapted to support side portions of the frame (102), the frame adapted to be worn on a face of user, the respiratory device adapted to supply gas to airways of the user, wherein the positioning of the rim element (108) on the frame adapted to stabilize the frame (102) to be in close contact with the face of the user, to enable supply of gas from the respiratory device to the airways of the user at a positive pressure.

2. The apparatus as claimed in claim 1, wherein the first fastener comprises any or a combination of vertical limb hooks patch (116) and vertical limb loops patch (114).

3. The apparatus as claimed in claim 2, wherein the vertical limb loops patch (114) is configured to facilitate connection with the vertical limb hooks patch (116).

4. The apparatus as claimed in claim 1, wherein second fastener comprises any or a combination of horizontal limb hooks patch (120) and horizontal limb loop patch (118).

5. The apparatus as claimed in claim 4, wherein the horizontal limb loops patch (110) is configured to facilitate connection with the horizontal limb hooks patch (120).

6. The apparatus as claimed in claim 1, wherein the shape of rim element (108) is any or a combination of spherical, semi-spherical, circular, ring and bangle.

7. The apparatus as claimed in claim 1, wherein the rim element (108) is of variable thickness.

8. The apparatus as claimed in claim 1, wherein the rim element (108) is made of stiff material selected from a group comprising metal, plastic and a combination thereof. . The apparatus as claimed in claim 1, wherein the at least one vertical strap (110) and at least two horizontal straps (112) are made of flexible composite material 10. The apparatus as claimed in claim 8, wherein the flexible composite material selected from a group comprising spun polyester fabric, cotton blend, preshrunk fabric, mercerized, double layered fabric and a combination thereof.