EP3849363A1

EP3849363A1 - Nicu garments and methods of making and use thereof

Info

Publication number: EP3849363A1
Application number: EP19860914.1A
Authority: EP
Inventors: Chaitenya RAZDAN; Courtney RUSSOMANNO; Rachel Sax RAMOS
Original assignee: CareandWear II Inc
Current assignee: CareandWear II Inc
Priority date: 2018-09-13
Filing date: 2019-09-13
Publication date: 2021-07-21
Also published as: EP3849363A4; US20220047000A1; WO2020056280A1

Abstract

A garment comprising a front body portion, a back body portion, a first sleeve portion, a second sleeve portion, a first leg portion, a second leg portion, and a neck opening, wherein the front body portion comprises a body access portion, the body access portion being provided on the front body portion in a non-bisecting arrangement, and wherein the first sleeve portion comprises an arm access portion, the arm access portion comprising an arm access opening provided in a permanently or selectively disconnected configuration.

Description

NICU GARMENTS AND METHODS OF MAKING AND USE THEREOF

CROSS REFERENCE TO RELATED APPLICATIONS

[001] The current application claims priority to United States Provisional Patent Application No. 62/730899, entitled “NICU GARMENTS AND METHODS OF MAKING AND USE THEREOF,” filed on September 13, 2018, the contents of which is incorporated by reference in the entirety.

TECHNICAL FIELD

[002] Aspects of the present disclosure are directed to garments useful in a medical setting, particularly in a Neonatal Intensive Care Unit (NICU) setting, and methods of making and use thereof.

BACKGROUND OF THE DISCLOSURE

[003] Garments for use in medical settings have various unique requirements, such as the ability to provide sufficient access to a wearer’s body (e.g., by a medical practitioner) and/or compatibility with medical devices, such as intravenous (IV) therapy lines, gastrostomy tubes (G-tubes), and/or respirators. Garments worn by patients in the NICU are especially unique due to the physical capabilities of such patients. For example, NICU garments must provide easy access to a wearer without aid from the wearer and/or with minimal disruption to the wearer. There remains an unmet need in the art for garments that meet these requirements.

BRIEF DESCRIPTION OF THE DISCLOSURE

[004] Aspects of the present disclosure are directed to a garment wearable by a baby, particularly a baby in a NICU or other medical setting. An example garment according to aspects of the present disclosure may be configured to provide acceptable access to the wearer while requiring minimal disruption to the wearer and minimal aid from the wearer. According to some aspects, the garment may comprise a front body portion, a back body portion, two sleeve portions, two leg portions, and a neck opening. At least one of the sleeve portions may comprise an arm access portion. Alternatively or additionally, the front and/or back body portion may comprise a body access portion. [005] Further aspects of the disclosure relate to a method of making a garment wearable by a baby, the method includes connecting a front body portion to a back body portion and a first and second sleeve to the front body portion and the back body portion. The method may further include connecting a first leg portion and a second leg portion to the front body portion and the back body portion. The method further may include providing a neck opening at the intersection of the front body portion and the back body portion. At least one of the sleeve portions may comprise an arm access portion. Alternatively or additionally, the front and/or back body portion may comprise a body access portion

[006] [Additional advantages and novel features of these aspects will be set forth in part in the description that follows, and in part will become more apparent to those skilled in the art upon examination of the following or upon learning by practice of the disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

[007] FIG. 1 A shows an example front view of a garment according to aspects of the present disclosure.

[008] FIG. 1 B shows an example front view of a garment according to aspects of the present disclosure.

[009] FIG. 1 C shows an example front view of a garment according to aspects of the present disclosure.

[0010] FIG. 2 shows an example front view of a garment according to aspects of the present disclosure.

[001 1] FIG. 3 shows an example back view of a garment according to aspects of the present disclosure.

DETAILED DESCRIPTION OF THE DISCLOSURE

[0012] Aspects of the present disclosure are directed to a garment wearable by a baby, particularly a baby in a NICU or other medical setting. An example garment according to aspects of the present disclosure may be configured to provide acceptable access to the wearer while requiring minimal disruption to the wearer and minimal aid from the wearer. According to some aspects, the garment may comprise a front body portion, a back body portion, two sleeve portions, two leg portions, and a neck opening. At least one of the sleeve portions may comprise an arm access portion. Alternatively or additionally, the front and/or back body portion may comprise a body access portion.

[0013] As used herein, the term“baby” should be understood as a young child.

A baby is not particularly limited to a certain age, although those skilled in the art will understand that a baby generally refers to a human aged from 0 months to 4 years, optionally from 0 months to 3 years, optionally from 0 months to 2 years, and optionally from 0 months to 1 year. In one example implementation, the wearer of a garment according to aspects of the present disclosure may be a patient in a NICU, such as a baby born prematurely (e.g., before about 37 weeks of pregnancy), a baby having a low birth weight (e.g., less than about 5.5 pounds), and/or a baby having a medical condition that requires special medical care. It should be understood, however, that the garments according to aspects of the present disclosure may be worn by patients in a setting other than a NICU, including but not limited to other hospital units, doctor offices, at home, etc. In addition, the inventive aspects of the current disclosure are also applicable to garments for adults and/or older children as well. Such garments may comprise any material suitable for such use, including but not limited to, polyester, nylon, cotton, silk, a moisture wicking material, or any combination thereof.

[0014] According to some aspects, the garment may comprise a front body portion, a back body portion, two sleeve portions, two leg portions, and a neck opening. It should be understood that some or all of the garment portions may be comprised by a single, discrete piece of material, such as a single, discrete piece of fabric. Alternatively, one or more of the garment portions may be attached to another portion or other portions of the garment at one or more seams, such as by stitching, gluing, taping, and/or any other suitable attachment means known in the art.

[0015] FIG. 1 A shows a front view of an example garment according to aspects of the present disclosure. It should be understood that the“front” of a garment as used herein is the side of the garment that primarily contacts the anterior (e.g., chest and front) side of a wearer. As shown in FIG. 1 A, the garment 1 1 may comprise a front body portion 12, two sleeve portions 13a and 13b, two leg portions 14a and 14b, and a neck opening 15. As shown in FIG. 1A, each of the two sleeve portions 13a and 13b may be attached to the front body portion 12 at a shoulder portion 16a and 16b, respectively, of the garment, the shoulder portions 16a and 16b being proximal the neck opening 15.

[0016] As shown in FIG. 1A, according to some aspects, garment 11 may comprise a body access portion 17. According to some aspects, body access portion 17 may comprise a body access opening configurable to at least an open positon and a closed position. According to some aspects, body access portion 17 may be in a closed position when selectively connectable body connection points 18 are in connected positions. As used herein, the term “selectively connectable connection point” refers to a point at which two portions of the garment 1 1 may be connected in a selectively connectable and/or disconnectable manner. For example, the selectively connectable connection point may be a connection provided by a selectably connectable and/or disconnectable fastener. Examples of such fasteners include any fastener known in the art that is configured to reversibly connect two portions of a garment and is suitable for use in a medical setting, particularly a NICU setting. For example, the fastener may be selected from the group consisting of a tie, snap, button, fabric hook and loop fastener, zipper, buckle, hook and eye, cord, toggle, brooch, eyelet, and/or combinations of any of the foregoing. The fastener may comprise any material known in the art suitable for use in a medical setting, examples of which include, but are not limited to, plastics (such as polyamides or nylons, polycarbonates, polyesters, polyethylenes, high- density polyethylenes, low-density polyethylenes, polyethylene terephthalates, polypropylenes, polystyrenes, high impact polystyrenes, polyurethanes, polyvinyl chlorides, polyvinylidene chlorides, acrylonitrile butadiene styrenes, and combinations thereof), metals including magnetic materials (such as iron and/or ores or alloys thereof), fibers including natural fibers and human-made fibers, such as cotton, and combinations thereof. It should be understood that body access portion 17 may be in an open position when selectively connectable body connection points 18 are disconnected. It should also be understood that body access portion 17 may be in a partially open position when a portion of more than one selectively connectable body connection points 18 are disconnected and a portion of more than one selectively connectable body connection points 18 are connected, allowing variable access to the body of a wearer. In the example shown in FIG. 1 A, body access portion 17 is in the closed position. [0017] As further shown in FIG. 1A, body access portion 17 may be provided on the front body portion 12 of garment 1 1 in a non-bisecting arrangement. As used herein, the term“non-bisecting” refers to an arrangement that does not bisect, that is, does not divide into two equal or approximately parts. For example, as shown in FIG. 1 A, body access portion 17 may have a first end 19 that terminates at the neck opening 15 and a second end 110 that terminates at the edge of leg portion 14b of the garment. In this way, body access portion 17 is in a non-bisecting arrangement in relation to front body portion 12 of garment 1 1 , since point 110 terminates at one leg 14b, rather than between the two legs 14a, 14b. It should be understood that while the second end 110 is provided on leg portion 14b in the example garment shown in FIG. 1A, the second end 110 may alternatively be provided on leg portion 14a, essentially providing about a mirror-image of body access portion 17A shown in FIG. 1A. As shown in FIG. 1A, each of, or at least one of, the first end 19 and the second end 110 may comprise a selectively connectable body connection point as described herein.

[0018] As shown in FIG. 1A, body access portion 17 may abut a leg access portion 11 1 , which may span from the second end 110 of body access portion 17 to an opposite leg access portion end 1 12 that terminates at an edge of leg portion 14a. It should be understood, however, that if the second end 1 10 of body access portion 17 is provided at the edge of leg portion 14a, the leg access portion end 112 would be provided at the edge of leg portion 14b. According to some aspects, leg access portion 11 1 may allow access to a wearer’s body below his or her trunk. According to some aspects, the leg access portion end 1 12 may comprise a selectively connectable leg connection point, as shown in FIG. 1A. Similar to body access portion 17, leg access portion 1 11 may comprise one or more selectively connectable leg connection points along its length, such that leg access portion 11 1 may be selectively placed in an open, closed, or partially open position, as described herein.

[0019] According to some aspects, body access portion 17 and/or leg access portion 11 1 may be configured to provide acceptable access to a wearer. According to some aspects, acceptable access may comprise complete or about complete access to the trunk and/or legs of a wearer. Alternatively or additionally, acceptable access may comprise partial access to the trunk and/or legs of a wearer suitable to perform a desired procedure with minimal aid from and disruption to the wearer.

[0020] FIG. 1 B shows a view of garment 11 of FIG. 1A wherein body access portion 17 is in an open position, and leg access portion 11 1 is in a partially open position. In this position, among other advantages, the chest of a wearer may be accessed with minimal changing and/or disruption to the wearer. For example, at least in part due to the non-bisecting arrangement of body access portion 17, the chest of a wearer may be accessed with little to no disruption to, for example, the navel of the wearer and/or a G-tube if such is inserted into the abdomen of a wearer.

[0021] FIG. 1 C shows garment 11 of FIG. 1A wherein body access portion 17 is in a partially open position, and leg access portion 1 11 is in a closed position.

[0022] According to some aspects, the garment may comprise one or more arm access portions. For example, FIG. 2 shows another example garment 11 according to aspects of the present disclosure having optional arm access portion 22a and 22b on each sleeve portion 23a and 23b, respectively.

[0023] According to some aspects, arm access portions 22a and 22b may comprise one or more arm connection points. For example, as shown in FIG. 2, arm access portion 22a may comprise a first arm connection point 24 at or near the corresponding shoulder portion 25 of the garment 1 1 , such as may be proximal to neck opening 211. Alternatively or additionally, arm access portion 22a may comprise a second arm connection point 26 located at or near an edge of the corresponding sleeve portion 23a. It should be understood that the first arm connection point 24 and the second arm connection point 26 may independently comprise a selectively connectable arm connection point as described herein and/or a permanent arm connection point. As used herein, the term“permanent connection point” refers to a point at, or segment along which, two portions of the garment are connected in a manner that is not easily disconnected. For example, the permanent connection point may be a connection provided by a permanent fastener. Examples of permanent fasteners include any fastener known in the art that are configured to non- disconnectably connect two portions of a garment and are suitable for use in a medical setting, such as a NICU setting. For example, such non-disconnectable fasteners may comprise a seam sewn into the garment, glue, or combinations thereof. [0024] As shown in FIG. 2, arm access portions 22a and 22b may each comprise an arm access opening. For example, arm access portion 22a may comprise an arm access opening 27 that may span at least a portion of the distance between the first arm connection point 24 and the second arm connection point 26.

[0025] According to some aspects, opening 27 may comprise at least a portion that is free of fasteners such that opening 27 is in a permanently disconnected configuration. Due to its permanently disconnected configuration, at least a portion of opening 27 may be provided in an open position, as shown, for example, in FIG. 2, or may be provided in a faux-closed position. As used herein, the term“faux-closed” position refers to a position wherein the opening appears closed and functions as a barrier between a wearer and an external environment (including external pathogens and/or undesirable temperatures), without being held closed by a fastener. For example, according to some aspects, in the faux-closed position, a first edge 27a of opening 27 may overlap at least a portion of a second edge 27b of opening 27, or vice versa, thereby providing a barrier between a respective arm of a wearer without the use of fasteners. In this way, arm access portions 22a may provide the barrier function while also providing easy access to the arm of a wearer with minimal disruption to the wearer. In addition, arm access portion 22a may provide, for example, undisrupted medical device access (e.g., IV line access) to the arm of a wearer, while maintaining a barrier between the wearer and an external environment.

[0026] As also shown in FIG. 2, garment 11 may comprise one or more foldable portions provided, for example, on one or more sleeve portions 23a and 23b and/or one or more leg portions 28a and 28b. As used herein, the term “foldable portion” may refer to any portion of the garment that is readily foldable, which may, for example, ease access to the user’s arm, such as when device access is initiated and/or when access is required for medical procedures such as IV line placement and/or removal, etc. As shown in FIG. 2, the one or more foldable portions may further be provided at and/or proximal to the ends of one or more sleeve portions 23a and 23b and/or one or more leg portions 28a and 28b such that, when in a folded position, the ends of one or more sleeve portions 23a and 23b and/or one or more leg portions 28a and 28b are provided with cuffs, for example cuffs 29a, 29b, and 29c provided on sleeve portions 23a and 23b and leg portion 28b, respectively. According to some aspects, cuffs 29a and 29b, and 29c may provide acceptable access to hands and a foot, respectively, of a wearer (e.g., for neonatal monitoring). One or more of the foldable portions may alternatively be provided in an unfolded position (for example, the position of foldable portion 201 of leg portion 28a) to provide the feet and/or hands of a wearer with additional protection from the external environment (e.g., for warmth) and/or to prevent a baby or other wearer from scratching or other self-injury, for example. In some variations, such cuffs may also be omitted or modified, depending on the wearer and/or need.

[0027] FIG. 3 shows an example back view of the garment 1 1 of FIG. 1. It should be understood that the“back” is the side of a garment that may at least partially contact the posterior side of a wearer. According to some aspects, the back body portion 32 of the garment may optionally comprise a body access portion in addition to or instead of the body access portion provided on the front body portion (not shown in FIG. 3), having similar features and functions of body access portion 17 for front of garment 11 as shown in FIGs. 1A-1 C.

[0028] Aspects of the present disclosure are also directed to methods of making the garment as described herein, and methods of using the garment as described herein, for example, in a medical setting.

[0029] While the aspects described herein have been described in conjunction with the example aspects outlined above, various alternatives, modifications, variations, improvements, and/or substantial equivalents, whether known or that are or may be presently unforeseen, may become apparent to those having at least ordinary skill in the art. Accordingly, the example aspects, as set forth above, are intended to be illustrative, not limiting. Various changes may be made without departing from the spirit and scope of the disclosure. Therefore, the disclosure is intended to embrace all known or later-developed alternatives, modifications, variations, improvements, and/or substantial equivalents.

[0030] Thus, the claims are not intended to be limited to the aspects shown herein, but are to be accorded the full scope consistent with the language of the claims, wherein reference to an element in the singular is not intended to mean“one and only one” unless specifically so stated, but rather“one or more.” All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims. No claim element is to be construed as a means plus function unless the element is expressly recited using the phrase“means for.”

[0031] Further, the word“example” is used herein to mean“serving as an example, instance, or illustration.” Any aspect described herein as“example” is not necessarily to be construed as preferred or advantageous over other aspects. Unless specifically stated otherwise, the term“some” refers to one or more. Combinations such as“at least one of A, B, or C,”“at least one of A, B, and C,” and“A, B, C, or any combination thereof” include any combination of A, B, and/or C, and may include multiples of A, multiples of B, or multiples of C. Specifically, combinations such as“at least one of A, B, or C,”“at least one of A, B, and C,” and“A, B, C, or any combination thereof” may be A only, B only, C only, A and B, A and C, B and C, or A and B and C, where any such combinations may contain one or more member or members of A, B, or C. Nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims.

[0032] As used herein, the term“about” and“approximately” are defined to being close to as understood by one of ordinary skill in the art. In one non- limiting embodiment, the term“about” and“approximately” are defined to be within 10%, preferably within 5%, more preferably within 1 %, and most preferably within 0.5%.

Claims

1 . A garment comprising:

a front body portion;

a back body portion connected to the front body portion;

a first sleeve portion and a second sleeve portion connected to the front body portion and the back body portion;

a first leg portion and a second leg portion connected to the front body portion and the back body portion; and

a neck opening at the intersection of the front body portion and the back body portion,

wherein the front body portion comprises a body access portion, the body access portion being provided on the front body portion in a non-bisecting arrangement, and

wherein the first sleeve portion comprises an arm access portion, the arm access portion comprising an arm access opening provided in a permanently disconnected or selectively disconnected configuration.

2. The garment according to claim 1 ,

wherein the arm access portion comprises a first arm connection point proximal the neck opening and a second arm connection point at an edge of the first arm portion, and

wherein the arm access opening spans a length between the first arm connection point and the second arm connection point.

3. The garment according to claim 2, wherein the first arm connection point and the second arm connection point are each selectively connectable.

4. The garment according to claim 3, wherein the first arm connection point and the second arm connection point each comprise a fastener.

5. The garment according to claim 1 , wherein the arm access portion is configured to be in a faux-closed position.

6. The garment according to claim 5, wherein the faux-closed position comprises a first edge of the arm access opening overlapping a second edge of the arm access opening.

7. The garment according to claim 1 , wherein the body access portion comprises a first body connection point proximal the neck opening and a second body connection point at an edge of the second leg portion.

8. The garment according to claim 7, wherein the garment further comprises a leg access portion.

9. The garment according to claim 8,

wherein the leg access portion comprises a leg connection point, and wherein the leg access portion spans a distance between the second body connection point and the leg connection point.

10. The garment according to claim 9, wherein the first body connection point, the second body connection point, and the leg connection point are each selectively connectable.

1 1. The garment according to claim 1 , wherein at least one of the first and second leg portions, or the first and second sleeve portions further comprises cuffs that are moveable from the folded position allow for access to a wearers hands or feet, to an unfolded position to provide a wearers hands and feet with additional protection from an external environment.

12. A method of making a garment, the method comprising:

connecting a front body portion to a back body portion;

connecting a first sleeve portion and a second sleeve portion to the front body portion and the back body portion;

connecting a first leg portion and a second leg portion to the front body portion and the back body portion; and

providing a neck opening at the intersection of the front body portion and the back body portion, wherein the front body portion comprises a body access portion, the body access portion being provided on the front body portion in a non-bisecting arrangement, and

13. The method of making the garment according to claim 12,

14. The method of making a garment according to claim 13, wherein the first arm connection point and the second arm connection point are each selectively connectable.

15. The method of making a garment according to claim 14, wherein the method further comprises providing a fastener at the first arm connection point and the second arm connection point.

16. The method of garment according to claim 15, wherein the arm access portion is configured to be in a faux-closed position.

17. The method of making garment according to claim 16, wherein the faux- closed position comprises a first edge of the arm access opening overlapping a second edge of the arm access opening.

18. The method of making a garment according to claim 17, wherein the body access portion comprises a first body connection point proximal the neck opening and a second body connection point at an edge of the second leg portion.

19. The method of making garment according to claim 18, wherein the garment further comprises a leg access portion.

20. The method of making a garment according to claim 19,

21. The method of making a garment according to claim 20, wherein the first body connection point, the second body connection point, and the leg connection point are each selectively connectable.