Stoma implant assembly

Abstract

The present invention relates to a stoma implant assembly. The present stoma plant assembly alleviates some of the disadvantages associated with presently available stoma plant assemblies.

Description

TITLEStoma implant assemblyFIELD OF THE INVENTION

[0001] The present invention relates to the field of medical devices. More particularly, the invention relates to a stoma implant assembly and method of using the stoma implant assembly.BACKGROUND TO THE INVENTION

[0002] Any reference to background art herein is not to be construed as an admission that such art constitutes common general knowledge in Australia or elsewhere.

[0003] Infection of the abdomen, injury of the colon or rectum, or partial or complete blockages of the bowel can cause significant health complications to a person. In this regard, a colostomy may be required as either a temporary or permanent solution.

[0004] Colostomy is a surgical procedure that conveys one end of the large intestines through the abdominal wall. In this regard, the colon is diverted through an incision in the abdominal wall to create a stoma. A ‘stoma’ is the term used to describe an opening where a vessel (such as a stoma bag) can be utilized for collecting bodily fluids, such as faeces and urine.

[0005] Typically, a stoma bag is attached to the skin of a patient by adhesive tape. However, attachment in this manner is prone to leakage, severe skin irritations and infections that can lead to discomfort and reduced quality of life.

[0006] It would be advantageous to address one or more of the issues mentioned hereinabove, or to provide a commercial alternative to the consumer.SUMMARY OF THE INVENTION

[0007] In a first aspect, although it need not be the only or indeed the broadest aspect, the invention resides in a stoma implant assembly comprising: a base adapted to engage the body of a subject, wherein the base comprises a bore therethrough, wherein the base is integrally formed; and a cover and / or a coupler adapted to releasably secure to the base, wherein the cover and / or the valve coupler are releasably securable to the base.

[0008] In one embodiment, the base comprises a planar portion and a raised portion.

[0009] In some embodiments, the cover and / or coupler is / are integrally formed.

[0010] In embodiments, the planar portion comprises one or more engagement apertures adapted to engage the body of the subject.

[0011] In one embodiment, the raised portion comprises an aperture therethrough. In an embodiment, the planar portion comprises an aperture that aligns with the aperture of the raised portion to form the bore.

[0012] In embodiments, the raised portion comprises a first connection portion. In some embodiments, the cover and / or the coupler comprises a second connection portion that is reciprocal to the first connection portion.

[0013] In certain embodiments, the first connection portion is a male threaded portion. In a particular embodiment, the second connection portion is a female threaded portion.

[0014] In an embodiment, the base, cover and / or valve is formed of a biocompatible material. In a preferred embodiment, the biocompatible material is VESTAKEEP Implant i2G.

[0015] In embodiments, the coupler is a valve coupler and / or a bag coupler assembly.

[0016] In one embodiment, the valve coupler comprises a valve. In one embodiment, the valve is a check valve.

[0017] In certain embodiments, the bag coupler assembly comprises a body and a clip adapted to sealingly and releasably engage a bag therewith.

[0018] In an embodiment, the coupler is adapted to releasably securable to a stoma bag. In some embodiments, the coupler is adapted to provide one-way flow.

[0019] In one embodiment, the stoma implant assembly for use in colostomy and / or urostomy. In another embodiment, the stoma implant assembly when used in colostomy and / or urostomy.

[0020] In a second aspect, the invention resides in a method for fitting a stoma implant assembly in a subject, the method including: placing a planar portion of a base under the skin of the subject with a raised portion thereof through incision in the abdomen of the subject, wherein the base is integrally formed; and coupling a valve coupler, cover and / or bag coupler assembly with a distal end of the raised portion, wherein the distal end of the raised portion comprises a first connecting portion adapted to releasably secure a second connecting portion, and wherein the coupler and / or cover comprises a bore therethrough, to thereby fit the stoma implant assembly in a subject.

[0021] The stoma implant assembly and components thereof may be as substantially described herein for the first aspect.

[0022] The various features and embodiments of the present invention referred to in the individual sections above and in the description which follows apply, as appropriate, to other sections, mutatis mutandis. Consequently, features specified in one section may be combined with features specified in other sections as appropriate.

[0023] Further features and advantages of the present invention will become apparent from the following detailed description.BRIEF DESCRIPTION OF THE DRAWINGS

[0024] To assist in understanding the invention and to enable a person skilled in the art to put the invention into practical effect, embodiments of the invention will be described by way of example only with reference to the accompanying drawings, in which:FIG 1 shows an embodiment of a base of a stoma implant assembly;FIG 2 shows an underside of the base of FIG 1;FIG 3 shows a valve coupler;FIG 4 shows a cross-sectional view of a valve coupler coupled with the base;FIG 5 shows an embodiment of a cover;FIG 6 shows a cross-sectional view of a cover coupled with the base;FIG 7 shows another embodiment of a base;FIG 8 shows an embodiment of a bag coupler assembly;FIG 9 shows an embodiment of the bag coupler assembly coupled with the base;FIG 10 shows the engagement of a second connection portion to a first connection portion; andFIG 11 shows a plurality of embodiments of the present stoma implant assembly.DETAILED DESCRIPTION OF THE INVENTION

[0025] Embodiments of the present invention reside primarily in a stoma implant assembly. Accordingly, the assembly, device, apparatus or method steps have been illustrated in the drawings, showing only those specific details that are necessary for understanding the embodiments of the present invention, but so as not to obscure the disclosure with excessive detail that will be readilyapparent to those of ordinary skill in the art having the benefit of the present description.

[0026] In this specification, adjectives such as first and second, upper and lower, and the like may be used solely to distinguish one element or action from another element or action without necessarily requiring or implying any actual such relationship or order.

[0027] Words such as “comprises” or “includes” are intended to define a nonexclusive inclusion, such that an assembly, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed, including elements that are inherent to such an assembly, method, article, or apparatus.

[0028] As used herein, the term ‘about’ means the amount is nominally the number following the term ‘about’ but the actual amount may vary from this precise number to an unimportant degree.

[0029] The present invention is predicated on the finding that an improved stoma implant assembly can be utilized to collect waste and / or other fluids from the body. The present invention allows a stoma bag to collect fluids from the body of a subject whilst alleviating the issues with skin irritations, infections, discomfort and / or leakage. Furthermore, the present stoma bag assembly is postulated to provide a superior securement and / or bond to the body of a subject which alleviates the above issues.

[0030] The present stoma implant assembly 100 comprises a base 200 adapted to engage the body of a subject and a cover 300 and / or coupler 400. Shown in FIG 1 is an embodiment of the base 200. The base 200 comprises a bore 210 therethrough. The base 200 comprises a planar portion 220 and a raised portion 230. The planar portion 220 is adapted to be retained under the skin of a subject. The raised portion 230 is adapted to pass through an incision in the subject.

[0031] In one embodiment, the bore extends centrally along a longitudinal axis of the base. In a certain embodiment, the bore is perpendicular to the planar portion. In one embodiment, the bore of the base has a diameter of betweenabout 5mm and about 50mm, between about 5mm and about 20mm, between about 10mm and about 20mm, between about 10mm and about 15mm, between about 12mm and about 15mm, between about 25mm and about 50mm, between about 30mm and about 40mm, between about 33mm and about 37mm, about 13mm, or about 35 mm.

[0032] The planar portion 220 comprises a centrally located aperture 221 therethrough. The planar portion 220 suitably comprises one or more engagement apertures 222 (only which one is labelled). In some embodiments, the one or more engagement apertures are located concentrically around the aperture. It is believed that the one or more engagement apertures 222 allow for a more secure attachment to the body of the subject and alleviates the problem of leakage. It is postulated that the flesh or skin of the subject heals into these apertures and forms a seal therewith. Furthermore, it will be appreciated that the engagement apertures can be shaped and sized as required. The base 200 is adapted to be placed under the skin of the subject. The base being under the skin allows the base to form a barrier to leakage.

[0033] In one embodiment, the planar portion and / or the base comprises a rough outer surface. In this regard, it is postulated that the rough outer surface provide further ability for the patients skin or flesh to bond thereto and this allows for a stronger seal to be formed between the present stoma implant and the body of the subject.

[0034] In one embodiment, the base is formed of a material that is biobompatible with the human body. In one embodiment, the base is formed of polymer. In an embodiment, the material is a semi-crystalline thermoplastic. In embodiments, the material is a polyetheretherketone. In a preferred embodiment, the material is PEEK polyetheretherketone. In one embodiment, the material is a PEEK biomaterial. In embodiments, the material is VESTAKEEP manufactured by Evonik. Preferably, the material is VESTAKEEP Implant i2G manufactured by Evonik.

[0035] The raised portion 230 comprises an aperture therethrough. In an embodiment, the aperture is centrally located on the raised portion 230. The aperture of the raised portion and the centrally located aperture 221 aligntogether to form the bore through the base. This allows for bodily fluid to be conveyed therethrough. In an embodiment, the base is integrally formed. As used herein, the term ‘integrally formed’ generally refers to a component that is formed of a unitary material.

[0036] The raised portion 230 suitably comprises a distal end and a proximal end. The distal end of the raised portion 230 suitably comprises a first connection portion. In an embodiment, the first connection portion is a male threaded portion 231. The first connection portion is adapted to releasably sealingly engage a second connection portion (mentioned in more detail hereinafter). The second connection portion is suitably a female threaded portion that is complementary to the present male threaded portion 231.

[0037] The raised portion 230 suitably comprises a flared distal end or a flared area adjacent the distal end. The flared distal end forms a channel 232 with the planar portion 220 so that skin and flesh can secure therebetween, and thus form a superior seal.

[0038] The channel 232 is a distance between the flared distal end or a flared area adjacent the distal end and the planar portion. In one embodiment, the distance is between about 10mm, and about 50mm, between about 20mm and about 50mm, between about 30mm and about 50mm, between about 40mm and about 50mm, between about 45mm and about 50mm, or about 49mm. It is postulated that this distance is sufficient for a seal to be formed with the body of the subject.

[0039] The channel 232 may be adjusted in order to more readily accommodate the anatomy or stature of the subject. In this regard, some subjects may require a greater distance in the channel 232 to form an appropriate seal. Shown in FIG 11 are multiple embodiments of the present base with a plurality of channels having an increasing distance (from left to right). It will be appreciate that this allows for many different body types and / or locations to be accommodated.

[0040] Shown in FIG 3 is an embodiment of the coupler, and FIG 4 shows a cross sectional schematic view of the coupler with the base 200. In oneembodiment, the coupler is a valve coupler 400. The valve coupler 400 is suitably integrally formed. The valve coupler 400 comprises a body 410. The body 410 comprises the second connection portion. The second connection portion is suitably a female threaded portion 431 that is complementary to the present male threaded portion 231. The body 410 further comprises an outlet 420 adapted to be in fluid in communication with the bore of the body 200. The outlet 420 is adapted to convey bodily fluids therethrough.

[0041] The valve coupler 400 is suitably a one-way flow valve coupler. In one embodiment, the valve coupler comprises a valve. In embodiments, the valve comprises or is a ball valve, ball check valve, diaphragm check valve. Shown in FIG 4 is an embodiment where the valve is a ball valve. The ball valve facilitates and ensure one-way flow of bodily fluids away from the body. The valve, as shown, is preferably located in the outlet 420.

[0042] The valve coupler 400 is suitably adapted to removably sealingly engage to a bag or bag assembly.

[0043] As shown in FIG 4, the valve coupler 400 comprises a stepped profile. In one embodiment, the second connection portion comprises the stepped profile. The stepped profile provides multiple seals formed with the base. In one embodiment, the second connection portion is figured or adapted to form multiple sealing points with the base (mentioned in more detail hereinafter).

[0044] Shown in FIG 5 is an embodiment of the cover 300, and FIG 6 shows a cross sectional schematic view of the cover with the base 200. The cover 300 is suitably integrally formed. The cover 300 comprises a body 310. The body 310 suitably comprises a blind hole. In an embodiment, the blind hole in use is aligned with the bore of the base 200. The body 310 comprises the second connection portion. The second connection portion is suitably a female threaded portion 331 that is complementary to the present male threaded portion 231. The cover 300 is suitably complete and prevents fluid communication between the bore of the base 200 and the external environment.

[0045] The cover 300 suitably comprises protrusions 320 on an outer surface thereof. The protrusions 320 assist the subject gripping the cover. It will beappreciated that the valve coupler may also suitably comprise the protrusions on an outer surface thereof.

[0046] Shown in FIG 7 is an embodiment of the base 200. For ease of description, the same numbering convention in FIG 1 has been utilized for FIG 7. The main difference between the embodiment shown in FIG 1 and FIG 7 are the exemplary dimension thereof (which are not limiting). It is postulated that the embodiment of FIG 1 is utilized for urostomy and the embodiment of FIG 7 is utilized for colostomy.

[0047] Shown in FIG 8 is an embodiment of a coupler. The coupler is a bag coupler assembly adapted to releasably sealingly engage a bag for storing or retaining bodily fluids. The coupler 500 comprises an aperture 510. The coupler 500 comprises a body 520 comprising the second connection portion. The second connection portion is suitably a female threaded portion 531 that is complementary to the male threaded portion 231. An upper end of the coupler 500 further comprises a bag engagement portion. In one embodiment, the bag engagement portion comprises a male thread 541 on an outer surface thereof. Male thread 541 is adapted to engage the female thread of a clip 600.

[0048] FIG 9 shows a schematic of the base 200, the bag coupler assembly 500 and clip 600. The clip 600 suitable comprises a female threaded portion adapted to engage the male thread 541 of the bag engagement portion. The male thread of the bag coupler 500 couples with the female threaded portion of the clip 500 and forms a seal therebetween. Furthermore, it will be appreciated that a bag opening can be secured between the male thread and the female thread such that bodily fluids can be received by the bag. The clip is adapted to engage the bag coupler assembly to sealingly and releasably engage the bag therewith. Whilst discussed herein as a male and female thread, the person skilled in the art will appreciate that any mechanism can be utilized to secure a bag to the bag coupler assembly.

[0049] Shown in FIG 10 is an embodiment of the second connection portion and the first connection portion. As shown, the female threaded portion 331 of the second attachment portion is shaped and dimensioned such that it engages the male threaded portion 231 at two points. This allows for a primary seal and asecondary seal to be formed between the base and the cover and / or coupler. It is postulated that this primary and secondary seal provides a further deterrent to leakage. In one embodiment, the first connection portion and the second connection portion together cooperate to form multiple sealing points. In certain embodiments, the first connection portion and the second connection portion together cooperate to form at least two sealing points.

[0050] In one embodiment, the first connection portion and the second connection portion are further adapted to form a third sealing point. In this regard, the second connection portion are adapted to form a third sealing point with the raised portion (as shown in the figures). In a further embodiment, the first connection portion and the second connection portion are further adapted to form a fourth sealing point. In this regard, the second connection portion are adapted to form a fourth sealing point with the raised portion.

[0051] In certain situations, a subject with a stoma implant assembly may wish to remove the stoma bag for a short period of time. For instance, the subject may wish to partake in activities in which a stoma bag may be an inconvenience. In these situations, a cap may be utilized to close off the stoma.

[0052] In use, the stoma implant assembly may be fitted in a subject by placing a planar portion of a base under the skin of the subject with a raised portion thereof through incision in the abdomen of the subject and where the base is integrally formed. The valve coupler, cover and / or bag coupler assembly with a distal end of the raised portion is then coupled to the base. In this regard, the distal end of the raised portion comprises a first connecting portion adapted to releasably secure a second connecting portion, and wherein the coupler and / or cover comprises a bore therethrough.

[0053] The stoma implant assembly and components thereof may be as substantially described hereinabove.

[0054] There may also be a further step of locating the second connecting portion over the first connecting portion.

[0055] There may also be further step of engaging the clip to the body of the bag coupler assembly.

[0056] There may also be another step of disengaging the clip to the body of the bag coupler assembly. In this regard, there may be a further step of placing another stoma bag of cap over the body of the bag coupler assembly and locating the clip thereover to secure thereto.

[0057] The above description of various embodiments of the present invention is provided for purposes of description to one of ordinary skill in the related art. It is not intended to be exhaustive or to limit the invention to a single disclosed embodiment.

[0058] As mentioned above, numerous alternatives and variations to the present invention will be apparent to those skilled in the art of the above teaching. Accordingly, while some alternative embodiments have been discussed specifically, other embodiments will be apparent or relatively easily developed by those of ordinary skill in the art. Accordingly, this invention is intended to embrace all alternatives, modifications and variations of the present invention that have been discussed herein, and other embodiments that fall within the spirit and scope of the above described invention.

Claims

CLAIMS1. A stoma implant assembly comprising: a base adapted to engage the body of a subject, wherein the base comprises a bore therethrough, wherein the base is integrally formed; and a cover and / or a coupler adapted to releasably secure to the base, wherein the cover and / or the valve coupler are releasably securable to the base.

2. The stoma implant assembly of claim 1, wherein the base comprises a planar portion and a raised portion.

3. The stoma implant assembly of claim 1 or claim 2, wherein the cover and / or coupler is / are integrally formed.

4. The stoma implant assembly of claim 2 or claim 3, wherein the planar portion comprises one or more engagement apertures adapted to engage the body of the subject.

5. The stoma implant assembly of any one of claims 2 to 4, wherein the raised portion comprises an aperture therethrough.

6. The stoma implant assembly of claim 5, wherein the planar portion comprises an aperture that aligns with the aperture of the raised portion to form the bore.

7. The stoma implant assembly of any one of claims 2 to 6, wherein the raised portion comprises a first connection portion.

8. The stoma implant assembly of claim 7, wherein the cover and / or the coupler comprises a second connection portion that is reciprocal to the first connection portion.

9. The stoma implant assembly of claim 7 or claim 8, wherein the first connection portion is or comprises a male threaded portion.

10. The stoma implant assembly of claim 8 or claim 9, wherein_the second connection portion is a female threaded portion.

11. The stoma implant assembly of any one of the preceding claims, wherein the base, cover and / or valve is / are formed of a biocompatible material12. The stoma implant assembly of any one of the preceding claims, wherein the coupler is a valve coupler and / or a bag coupler assembly13. The stoma implant assembly of claim 12, wherein the valve coupler comprises a valve.

14. The stoma implant assembly of claim 13, wherein the valve is or comprises a check valve.

15. The stoma implant assembly of claim 12, wherein the bag coupler assembly comprises a body and a clip adapted to sealingly and releasably engage a bag therewith.

16. The stoma implant assembly of claim 12, wherein the bag coupler is adapted to releasably securable to a stoma bag.

17. The stoma implant assembly of any one of the preceding claims for use in colostomy.

18. The stoma implant assembly of any one of the preceding claims when used in colostomy.

19. A method for fitting a stoma implant assembly in a subject, the method including: placing a planar portion of a base under the skin of the subject with a raised portion thereof through incision in the abdomen of the subject, wherein the base is integrally formed; and coupling a valve coupler, cover and / or bag coupler assembly with a distal end of the raised portion, wherein the distal end of the raised portion comprises a first connecting portion adapted to releasably secure a second connecting portion, and wherein the valve and / or cover comprises a bore therethrough, to thereby fit the stoma implant assembly in a subject.

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