An enteral tube waterproof cover device

Abstract

An enteral tube waterproof cover device comprises: a waterproof cover 14; an annular gel material flange 21; and an adhesive layer. The adhesive layer is adapted suitable for adhering the annular gel

Description

Field of the Invention

[0001] The present invention relates to an enteral tube waterproof cover device, in particular a device for covering enteral tubes. To prevent the entrance of bacteria and water; more particularly but not exclusively for swimming or bathing. Background of the Invention

[0002] In many societies across the world there are increasing numbers of people having operations.

[0003] A stoma is an opening on the surface of a patient's abdomen which has been surgically created for a feeding tube. Enteral feeding tubes allow liquid food and medication to enter the stomach or intestine through a tube.

[0004] For gastrostomy feeding, an opening is made through the abdominal wall. This opening is called a stoma. A feeding tube is then passed through the opening into the stomach.

[0005] Currently, there is no safe or convenient way for people with feeding tubes to enjoy swimming and bathing for long periods of time without risking being exposed to potentially harmful bacteria through their stoma site.

[0006] Prior Art

[0007] US 2020 0 323 554 (CASH) discloses a method of using a protective device comprising the steps of: covering a site with a bubble, said bubble comprising a cover, said cover extending over an upper most surface of the site external to the user and above a perimeter of the site device when connected, and a foot having a predeterm ined inner perimeter connected to the cover and an initially planar base, said base forming at least a water-resistant connection against the skin of the user under the cover, said cover extending a distance beyond the inner perimeter of the foot when compressed; and securing the bubble to a body part with an adhesive at the base about the site, said site having a medical device connected to the user with the bubble providing a water resistant covering over the medical device.

[0008] CN 206 026 768 (FANG) discloses a dialysis protection bag characterized by comprising a bag body with an opening and a protection sleeve connected with the edge of the opening, wherein the protection sleeve comprises a protection film and a breathable adhesive tape, the edge of the protection film is connected with the breathable adhesive tape, the protection film is made of hydrocolloid, and the protection film is provided with a hole communicated with the opening.

[0009] LJS 8 377 020 (BERVEN) discloses apparatus for covering an ostomy bag of a patient, the ostomy bag having an ostomy-bag flange, wherein the ostomy-bag flange adheres to the patient's skin surrounding a stoma, the apparatus comprising: an ostomy-bag cover, wherein the ostomy-bag cover covers the ostomy bag and its ostomy-bag flange in order to prevent water from reaching the ostomy bag and its ostomy-bag flange, the ostomy-bag cover having: a body formed from a liquid-impermeable membrane, the cover-flange portion having a pressure-sensitive adhesive that releasably attaches to the patient's skin; and a sealable exhaust vent to remove excess air within the ostomy-bag cover, wherein a cover-flange portion includes at least a first flap extension to cover the navel of the patient so as to account for adhesion on uneven skin. Summary of the Invention

[0010] According to the present invention there is provided an enteral tube waterproof cover comprising a waterproof cover, an annular gel material flange, and an adhesive layer, wherein the adhesive layer is adapted to adhere the flange to a user's flange around the stoma, the waterproof cover covers the gel material flange, and the waterproof cover comprises a one-way valve to allow exit of air from the device.

[0011] In this way the device of the present invention provides a reliable means of having a stoma in water, such as swimming and bathing, with ability to release air, and if necessary, water from the device.

[0012] In some embodiments of the device the adhesive layer comprises self-adhesive material on a first face of the flange.

[0013] In some embodiments of the device the adhesive layer comprises a displaceable backing.

[0014] In some embodiments of the device the gel material flange comprises microbiocidal and antibacterial material, which may comprise medical grade Manuka honey.

[0015] In some embodiments of the device, the device comprises a resiliently deformable waterproof cover, which may be a transparent or translucent waterproof material so as to allow visibility to see the tube and to see if water is within the cover.

[0016] In some embodiments of the device the cover takes a form of an inverted tear-drop, with an upper part covering the flange, and a tail depending below, with a valve proximate its lowest point, allowing water to accumulate at the valve, and be clearly visible in an empty space against the skin.

[0017] In some embodiments of the device the device comprises an attachment wrap arranged to allow attachment over the waterproof cover, to provide a device according to a second aspect of the present invention.

[0018] In some embodiments of the device the attachment strap is adapted to extend around the user's waist. And may comprise an adjustable securement means for the attachment strap. The wrap may hide or provide a decorative feature over the cover and provide extra waterproofing and / or security.

[0019] In some embodiments of the device the wrap comprises an enlarged section to cover over the waterproof cover.

[0020] A preferred embodiment of the invention will now be described by way of example only and with reference to the Figures in which: Brief Description of the Drawings Figure 1 shows an isometric view of a device according to the second aspect of the present invention, comprising a wrap and a device; Figure 2 shows a reverse isometric view of the embodiment of the device as shown in Figure 1; Figure 3 shows an exploded isometric view of the embodiment of the device shown in Figure 1; Figure 4 shows a reverse exploded isometric view of the embodiment of the device shown in Figure 1; Figure 5 shows an isometric view of the embodiment of the device shown in Figure 1, without the wrap; Figure 6 shows a reverse isometric view of the embodiment of the device shown in Figure 1; Figure 7a shows an exploded isometric view of the embodiment of the device shown in Figure 6, and Figure 7b shows a reverse isometric view of the embodiment of the device as shown in Figure 7a; and Figure 8a shows an isometric view of the embodiment of the wrapped wrap from the embodiment of the device shown in Figure 1, and Figure 8b shows a reverse isometric view of the embodiment of the wrap as shown in Figure 8a. Detailed Description of the Embodiments

[0021] With reference to the figures there is shown an embodiment of an enteral tube waterproof cover device 99 generally comprising a waterproof cover 14 having two perimetrically seamed layers, namely an inner layer and an outer layer wherein the inner layer has a hole 15 and is bonded around that hole to an annular gel material flange 21 \; and an adhesive layer, on the outer face of the flange. The embodiment of the device 99 is shown in Figure 1 with a wrap 100 so as to form a device 199 according to the second aspect of the present invention.

[0022] The adhesive layer is adapted to adhere the flange to a user’s skin around the ostomy, the waterproof cover covers and extends from the gel material flange, and the waterproof cover comprises a one-way valve 11 to allow exit of air from the device.

[0023] In particular reference to the pictured embodiment, the embodiment comprises an annular circular flange 21 which has a shallow depth of gel material adapted to surround a central hole 22 through which hole in use is passed the clip and tube of a user's stoma.

[0024] This flange is covered by a cover 14 which takes a form of an inverted tear-drop, with an upper part 12 covering the flange, and a tail 13 depending below, with a valve 11 proximate its lowest point. The embodiment measures 175 mm from top of the arcuate curvature at the top end 12, in use, reflecting the curvature of the flange, to bottom of the tail, and has a width of 145 mm.

[0025] The flange 21 is provided with a self-adhesive layer, which layer is covered by a backing 31 that is removable before use. The backing comprises a side tab 33 to aid in its removal.

[0026] The backing comprises a centre point circle 32 of a smallest diameter and using a separate sizing guide (not shown), which comprises a plurality of circular lines of increasing diameter, in use the user will:

[0027] Measure their fixator and cut the backing, and where necessary flange and where necessary inner of the cover to the appropriate size / shape, whereby the backing, flange and cover include increasingly large holes 32, 22, 15;

[0028] Remove the protective backing 31 from the flange 21, exposing the adhesive layer;

[0029] Fold the device in half, line up the bottom edge of the hole to the bottom edge of the stoma and press lower half in place;

[0030] Fold the top over the stoma and press adhesive to the skin and ideally use hands to warm the device to your skin for initial adhesion.

[0031] The adhesive layer thereby adheres the flange to the user around the stoma site, so as to create a waterproof seal around the stoma site and feeding tube, allowing the user to enjoy water-based activities such as swimming and bathing that would otherwise be dangerous due to bacteria in the water.

[0032] The flange is formed with medical grade Manuka honey. The Manuka honey ensures it is comfortable to wear for extended periods of time, whilst also providing antibacterial, and antimicrobial properties, being more comfortable for the skin surrounding the stoma.

[0033] The cover comprises a clear PET (polyethylene terephthalate) pouch which is sturdy and waterproof, extending the time the user can spend in the water. A PVC (polyvinylchloride) inflation / deflation valve is bonded to the front face of the cover, and allows the user to expel air upon fitting, and quickly remove water should there be a leak.

[0034] When in place the tube clip and connectors stay in place on the tube, in the hole of the flange, without damaging the cover.

[0035] Once all the tube has been fed into the device, and the seal created around the flange, the valve is used to get rid of any air still trapped inside added, holding the cover in place wherein the clear material of the cover means it is easy to spot if there is any water in the cover.

[0036] Additionally or alternatively the inverted tear-drop tail of the cover below the flange provides a clear and easy to understand zone where air and / or water is visible and water liable to collect.

[0037] The valve is used to express air so that the cover does not float in water and also allows for quick drainage of water should it leak in from around the flange.

[0038] As shown in Figure 8 the wrap 100 may be worn tightly over the device, helping to hold them in place for high intensity activities.

[0039] The wrap comprises waterproof material to add another level of protection, such as neoprene.

[0040] The wrap is easily adjustable, and is arranged to be secured with hook and loop material 6 / 7 such as Velcro (RTM), as well as being available in a range of sizes, allowing for an adaptable and tight fit for a range of users.

[0041] It also comes in a variety of colours and patterns to suit each individual user.

[0042] A multi-layered construction of the wrap creates an added protection for the water getting in around the flange.

[0043] The wrap comprises an enlarged section 2 to cover the cover device 99, an elongated strap 8 extending laterally therefrom and having an end 3 that includes a large panel 7 and a small end panel 6 of the Velcro (RTM).

[0044] The end is passed through a slot 5 in the distal end 4 of the wrap, proximate the enlarged section 2.

[0045] The invention has been described by way of examples only and it will be appreciated that variation may be made to the above-mentioned embodiments without departing from the scope of protection as defined by the claims.

Claims

1. An enteral tube waterproof cover device comprising a waterproof cover, an annular gel material flange, and an adhesive layer, wherein the adhesive layer is adapted to adhere said annular gel material flange to extend around a stoma site.

2. An enteral tube waterproof cover device according to claim 1, wherein the waterproof cover comprises a one-way valve to allow exit of air from the device.

3. An enteral tube waterproof cover device according to claim 1 wherein the adhesive layer comprises self-adhesive material extending across a first face of the gel material flange.

4. An enteral tube waterproof cover device according to any one of the preceding claims wherein the adhesive layer is provided with a selectably removable backing sheet.

5. An enteral tube waterproof cover device according to claim 4 wherein the selectably removable backing sheet is provided with indicia enabling measurement of said stoma site to be adapted to appropriate dimensions to the stoma site.

6. An enteral tube waterproof cover device according to any one of the preceding claims wherein the gel material flange comprises microbiocidal material.

7. An enteral tube waterproof cover device according to claim 6 wherein the microbiocidal material comprises Manuka honey.

8. An enteral tube waterproof cover device according to any one of the preceding claims wherein the waterproof cover is resiliently deformable.

9. An enteral tube waterproof cover device according to claim 1 wherein the waterproof cover comprises a clear PET (polyethylene terephthalate) pouch.

10. An enteral tube waterproof cover device as claimed in claim 2 wherein the one-way valve comprises a PVC (polyvinylchloride) inflation / deflation valve is bonded to a front face of said waterproof cover device.

11. An enteral tube waterproof cover device according to any one of the preceding claims wherein said waterproof cover device is transparent or translucent.

12. An enteral tube waterproof cover device according to any one of the preceding claims wherein the enteral tube waterproof cover device takes a form of an inverted tear-drop, with an upper part in use covering the flange, and a tail depending below said upper part in use, with the one-way valve proximate its lowest point.

13. An enteral tube waterproof cover device according to any one of the preceding claims wherein the device comprises an attachment belt arranged to allow attachment over the waterproof cover.

14. An enteral tube waterproof cover device according to claim 13 wherein the attachment belt is adapted to extend around the waist of the wearer of the device.

15. An enteral tube waterproof cover device according to claim 13 or 14 comprising an adjustable securing means for the attachment belt.

16. An enteral tube waterproof cover device according to any one of claims 13 to 15 wherein the attachment belt comprises an enlarged section to cover over the waterproof cover.

17. An enteral tube waterproof cover device according to any one of the preceding claims wherein the attachment belt is of multi-layered construction with waterproof material to provide additional waterproofing.

18. An enteral tube waterproof cover device according to any one of the preceding claims wherein the attachment belt comprises hook and loop repositionable fastening material in order to be secured around the wearer.

19. A method of attachment to a stoma site of an enteral tube waterproof cover device, as claimed in any one of the preceding claims;said method comprising the steps of;measuring a fixator and cut said removable backing sheet on the adhesive layer including, said flange to an appropriate size and shaperemoving the removable backing sheet from the adhesive layer followed byfolding the enteral tube waterproof cover in half and aligning a bottom edge of the flange to the bottom edge of the stoma siteremoving a top half of the removable backing sheet on the adhesive layer and press onto the wearers’ skinthe adhesive layer thereby attaches the flange to the user around the stoma site.

20. A method of attachment to a stoma site of the enteral tube waterproof cover device, as claimed in claim 19 wherein the tubes are securely attached to the flange by tube clips and connectors.

21. A method of attachment to a stoma site of the enteral tube waterproof cover device, as claimed in claim 19 wherein enteral tube waterproof cover device is warmed before attachment to the stoma site for enhanced adhesion.

22. An enteral tube waterproof cover device as claimed in claim 9 wherein the one-way valve can also be used for quick drainage of water in the event of leakage around the flange.

23. An enteral tube waterproof cover device as claimed in any one of the preceding claims comprising various colors and patterns to suit the requirements of each individual user.T +44(0)30 0300 2000A

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