Stoma implant assembly

Abstract

The present invention relates to a stoma implant assembly comprising a base having an opening configured to engage an outlet. The base is configured to engage a subject's body and the outlet comprises a hole therethrough. The outlet comprises a distal end having a connection configured to releasably secure a second connection. The present stoma plant assembly mitigates some of the disadvantages associated with currently available stoma plant assemblies.

Description

Technical Field

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

Background Art

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

[0003] Abdominal infections, colon or rectal injuries, or partial or complete blockage of the intestine can cause serious complications in humans. In this regard, colostomy may be required as either a temporary or permanent solution.

[0004] Colostomy is a surgical procedure that moves one end of the large intestine 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 a term used to describe an opening through which a vessel (such as a stoma bag) can be used to collect body fluids such as feces and urine.

[0005] Typically, a stoma bag is attached to the patient's skin by an adhesive tape. However, attachment in this manner is prone to leakage, severe dermatitis, and infections, which can lead to discomfort and a decrease in the quality of life. [[ID=​​​​​​​​​​​​​​​In a first embodiment, although it does not have to be the only or most extensive embodiment, the present invention relates to a stoma implant assembly, It comprises a base having an opening configured to engage with an outlet, and the base is configured to engage with the body of the subject, The outlet belongs to a stoma implant assembly, having a distal end with a connector configured to securely fix a second connector therefor, and the outlet has a hole through which it passes.

[0008] In certain embodiments, the base comprises one or more engagement holes. In some embodiments, the one or more engagement holes are located concentrically around the opening.

[0009] In a preferred embodiment, the base is an annular base.

[0010] In one embodiment, the outlet and the base form an interference fit configuration. In one embodiment, the outlet and the base form a substantially fluid-sealing seal. In one embodiment, the outlet and the base form a fluid-sealing seal.

[0011] In one embodiment, the stoma implant assembly further comprises a cap and / or stoma bag having a second connector. The second connector is mutual or complementary to the connector. A seal is preferably formed between the second connector and the first connector, and between any members between them.

[0012] In certain embodiments, the hole extends towards the center along the longitudinal axis of the outlet. In preferred embodiments, the hole is perpendicular to the base during use. In one embodiment, the outlet hole has a diameter of approximately 5 mm to 50 mm, 10 mm to 40 mm, 11 mm to 39 mm, 10 mm to 15 mm, 16 mm to 35 mm, 30 mm to 40 mm, 11 mm, or 39 mm.

[0013] Preferably, the outlet has a space between the base, the portion forming the interference fit, and the connecting portion. Preferably, the space is at least about 3 mm, at least about 5 mm, about 3 mm to about 10 mm, or about 5 mm in length.

[0014] In one embodiment, the connector is located at or adjacent to the distal end of the outlet. In one embodiment, the connector is located adjacent to the distal end of the outlet. In a certain embodiment, the connector is located at the distal end of the outlet. In a particular embodiment, the connector comprises a flange or extension around the outlet. The extension or flange extends away from the outlet.

[0015] In certain embodiments, the connector comprises a pair of spaced projections. In one embodiment, the pair of spaced projections form a curved groove between them. In some embodiments, the spaced projections are configured to receive a clip.

[0016] In one embodiment, the stoma implant assembly further comprises a clip. In one embodiment, the clip is an adjustable clip. In one embodiment, the clip is a deflection clip. In one embodiment, the clip is operable between an open configuration and a closed configuration. In one embodiment, the clip is deflected toward the closed configuration.

[0017] In one embodiment, the clip comprises an elongated member having a first end and a second end. In one embodiment, the elongated member forms a loop. In a further embodiment, the second end extends beyond the first end and abuts the loop at an acute angle.

[0018] In one embodiment, the connector is provided with a male thread. In one embodiment, the male thread is located at or adjacent to the distal end of the outlet.

[0019] In one embodiment, the stoma implant assembly further comprises a cover. In one embodiment, the cover comprises a second connector. In one embodiment, the second connector comprises a female thread, which is reciprocal to a male thread.

[0020] In one embodiment, the cover includes a sealing member configured to form a seal between the cover and the outlet. In one embodiment, the sealing member takes the form of an O-ring.

[0021] In one embodiment, the cover includes a check valve. In another embodiment, the cover is configured to connect to or formed together with a stoma bag. In yet another embodiment, the check valve is a ball check valve or a diaphragm check valve.

[0022] In one embodiment, the base, outlet, and / or cover are formed of a biocompatible material. In one embodiment, the material is preferably a polymer. In one embodiment, the material is a semicrystalline thermoplastic. In one embodiment, the material is a polyether ether ketone. In a preferred embodiment, the material is PEEK polyether ether ketone.

[0023] In one embodiment, a stoma implant assembly for use in colostomy. In a further embodiment, a stoma implant assembly when used in colostomy.

[0024] In a second aspect, the present invention relates to a method for fitting a stoma implant assembly into a person, A step of aligning the base opening beneath the skin with an incision in the abdomen of the subject, wherein the opening is configured to engage with an outlet, A step of fixing a discharge port to a base through an incision, the discharge port having a distal end with a connection portion configured to releasably fix a second connection portion, the discharge port having a hole therethrough, the step of fixing; including; whereby fitting the stoma implant assembly onto a subject, belonging to a method.

[0025] The stoma implant assembly and its components may substantially be as described above in this specification for the first aspect.

[0026] In one embodiment, the method further includes the step of positioning a subject's stoma through the hole.

[0027] In one embodiment, the method further includes the step of positioning a stoma bag or cap having a second connection portion over the connection portion. In a further embodiment, the method further includes the step of engaging a clip over the second connection portion and the connection portion.

[0028] In an embodiment, the method further includes the step of releasing a clip over the second connection portion. In this regard, there may be a further step of placing another stoma bag or cap over the connection portion and positioning a clip thereover.

[0029] In one embodiment, the method further includes the step of positioning a cover having a second connection portion over the connection portion of the discharge port.

[0030] In an embodiment, the method further includes the step of connecting a stoma bag to the stoma bag connection portion of the cover.

[0031] The various features and embodiments of the present invention referred to in the individual chapters of the above and subsequent descriptions may be applied to other chapters with modifications where appropriate. Consequently, features described in one chapter may be combined with features described in other chapters where appropriate.

[0032] Further features and advantages of the present invention will become apparent from the following detailed description.

[0033] To aid in understanding the present invention and to enable those skilled in the art to put it into practice, embodiments of the present invention are described simply by reference to the accompanying drawings. [Brief explanation of the drawing]

[0034] [Figure 1] This figure shows an embodiment of the stoma implant assembly of the present invention. [Figure 2] Figure 1 is an exploded view of the stoma implant assembly. [Figure 3] This is a top view of the base. [Figure 4] This figure shows an embodiment of the base that is fixed to the outlet. [Figure 5] This is a schematic side view of the base and outlet. [Figure 6] This is a diagram showing an embodiment of the clip. [Figure 7] This is a diagram showing a seal for a stoma bag. [Figure 8] This figure shows another embodiment of the base. [Figure 9] This is a diagram showing a stoma implant assembly connected to the ureter. [Figure 10] This is a diagram showing a stoma implant assembly connected to the large intestine. [Figure 11] This figure shows another embodiment of a stoma implant assembly. [Figure 12] Figure 11 shows a cross-section of the stoma implant assembly. [Figure 13] This figure shows yet another embodiment of the stoma implant assembly. [Figure 14] This is a diagram showing an embodiment of the cover. [Modes for carrying out the invention]

[0035] Embodiments of the present invention primarily relate to stoma implant assemblies. Accordingly, the assembly and method steps are illustrated in a concise schematic form in the drawings, showing only the specific details necessary to understand the embodiments of the present invention, so as not to obscure the disclosure with excessive detail that would be readily apparent to those skilled in the art who are interested in this description.

[0036] In this specification, adjectives such as first and second, left and right may be used solely to distinguish one element or action from another, without necessarily requiring or suggesting any actual relationship or order.

[0037] The words “to include” or “to have” are intended to define non-exclusive inclusion, such that a process, method, article, or apparatus having a list of elements may include not only those elements but also other elements not explicitly enumerated, including elements specific to such process, method, article, or apparatus.

[0038] As used herein, the term "about" means that the quantity is nominally the number following the term "about," but the actual quantity may vary from this exact number to an insignificant degree.

[0039] As used herein, the term “stoma bag” refers to a waterproof pouch used to collect fluid from the body through a stoma. A “stoma bag” is also known as a colostomy bag or ostomy bag.

[0040] As used herein, the term “stoma” refers to an opening in the abdomen from which a vessel may be used to collect fluid from the body.

[0041] Please understand that the dimensions provided in the diagrams are for illustrative purposes only.

[0042] This invention is based on the finding that improved stoma implant assemblies can be used to collect bodily waste and / or other fluids. This invention enables stoma bags to collect fluids from a person's body while reducing problems of dermatitis, infection, discomfort, and / or leakage.

[0043] Figure 1 shows an embodiment of the stoma implant assembly of the present invention. Figure 2 shows a disassembled and assembled version of the stoma implant assembly of Figure 1. The stoma implant assembly 100 comprises a base 110 having an opening (not shown) and an outlet 120. The base 110 is configured to engage with the outlet 120. Furthermore, the base 110 is configured to engage with the subject's body subcutaneously such that the base 110 is under the skin and the outlet 120 passes through an incision in the subject's abdomen.

[0044] In the embodiment shown in Figure 1, the stoma implant assembly 100 may further comprise a clip 130. In one embodiment, the clip 130 is an adjustable clip. The stoma implant assembly 100 may further comprise a cap or seal for a stoma bag. In the embodiment shown in Figure 1, the stoma implant assembly 100 is shown together with a seal 140 for a stoma bag (not shown for illustrative purposes).

[0045] Figure 3 shows an embodiment of the base 110. The base 110 includes an opening 111. In one embodiment, the opening 111 is centrally located within the base 110. In the embodiment shown, the base 110 takes an annular shape. The base 110 is configured to be placed under the skin. The opening 111 of the base 110 is aligned with an incision, and the outlet 120 may be fixed to the base 110 through the incision. In one embodiment, the base 110 is dimensioned such that the outlet 120 forms an interference fit (or friction fit) configuration with the base 110. The interference fit advantageously allows the outlet to be easily attached to the base. However, it should be understood that other attachment configurations known to those skilled in the art may be used to attach the outlet 120 to the base 110. The stoma may be passed through the outlet 120 so that bodily fluids can be collected from the body to the outside.

[0046] The base 110 being located beneath the skin allows it to form a barrier against leakage. In one embodiment, the base 110 includes one or more engagement openings 112. In one embodiment, the one or more engagement openings are located concentrically around the opening. The one or more engagement openings 112 are thought to allow for a more secure attachment to the subject and mitigate leakage problems.

[0047] In one embodiment, the base 110 is formed of a material that is biocompatible with the human body. In one embodiment, the base 110 is formed of titanium. In one embodiment, the material is preferably a polymer. In one embodiment, the material is a semicrystalline thermoplastic. In an embodiment, the material is a polyether ether ketone. In a preferred embodiment, the material is PEEK polyether ether ketone. One source of PEEK polyether ether ketone is provided under the trade name SustaPEEK MG (Medical Grade) PEEK, manufactured by Rochling.

[0048] Figure 4 shows an embodiment of the outlet 120 and the base 110 that forms an interference fit. Figure 5 shows a side view of the embodiment shown in Figure 4. The outlet 120 has a proximal end and a distal end (which are in an interference engagement state with the base 110). The proximal end is sized to form an interference configuration with the base 110. The distal end of the outlet 120 has a connecting portion 125. The connecting portion 125 is configured to engage with a cap, stoma seal, or cover (as described in more detail later herein).

[0049] The outlet 120 is provided with a hole 129 through which it passes. The hole 129 extends along the longitudinal axis of the outlet 120. The hole 129 is centrally located within the outlet 120. Preferably, during use, the hole 129 is substantially perpendicular to the surface of the base 110. The stoma is preferably passed through the hole 129 within the outlet 120.

[0050] In the embodiment shown, the connector 125 comprises a pair of spaced projections 126a and 126b extending radially outward. The spaced projections 126a and 126b form a groove 127 extending around the distal end of the outlet 120. The groove 127 may be in the form of a concave groove, as shown in Figure 4. This is considered advantageous as it provides a smooth surface for forming a watertight seal.

[0051] In another embodiment, the connector may preferably have an external threaded surface. In this regard, the connector may preferably have a male threaded portion configured to be received by a female threaded portion. Connection port

[0052] Preferably, the outlet 120 has a space 121 between the portion that forms an interference fit with the base 110 and the connecting portion 125. Preferably, the space 121 is at least about 3 mm, at least about 5 mm, about 3 mm to about 10 mm, or about 5 mm. This is advantageous as it allows the connecting portion 125 to be separated from the skin around the stoma of the person during use. This is advantageous as it allows the stoma bag attached or fixed to the connecting portion 125 to be separated from the skin. This is advantageous as it reduces the problems of dermatitis, infection, and / or discomfort. Furthermore, this reduces the need to use adhesive to attach the stoma bag to the patient.

[0053] In one embodiment, the outlet 120 is formed of a biocompatible material or composite material. In one embodiment, the outlet 120 is formed of titanium or polyurethane. In one embodiment, the material is preferably a polymer. In one embodiment, the material is a semicrystalline thermoplastic. In an embodiment, the material is a polyether ether ketone. In a preferred embodiment, the material is PEEK polyether ether ketone. One source of PEEK polyether ether ketone is provided under the trade name SustaPEEK MG (Medical Grade) PEEK, manufactured by Rochling.

[0054] Figure 6 shows an embodiment of a clip 130 configured to engage with a connector 125. As previously mentioned, the clip 130 is an adjustable clip. In the embodiment shown in Figure 6, the clip 130 is biased. In this regard, the clip 130 can be used to secure it to the connector 125. The clip 130 and the connector 125 (and any member between them) form a seal between them. Preferably, the seal formed is substantially water-resistant.

[0055] The clip 130 comprises an elongated member 135. The elongated member 135 has a first end 135a and a second end 135b. The elongated member is shaped so that it forms a loop 131. As shown, the loop 131 of the elongated member 135 does not connect to the first end 135a of the elongated member 135; rather, the second end 135b extends beyond the first end 135a (indicated by arrow 132), forming an acute angle and abutting against the portion of the elongated member 135 adjacent to the first end 135a. As shown, the elongated member 125 abuts against the loop 131. Such shaping allows the diameter of the loop 131 to be easily adjusted. In this regard, the acute angle can be reduced by applying pressure to area 133 so that the second end 135b does not engage with the loop 131, thereby allowing the loop 131 to expand in diameter and fit over one of the two projections of the connector 125 and over the groove 127. In one embodiment, the clip is a biased clip. When the pressure is released, area 133 engages with the loop 131 and reduces its diameter. This allows the clip 130 to engage with the connector 125 and form a seal between them. It should be understood that the clip 130 is operable between an open configuration (when pressure is applied to area 133 and the diameter of the substantially circular portion 131 is expanded) and a closed configuration (when no pressure is applied to area 133 and the engagement diameter of the loop 131 is smaller). It should be understood that the closed configuration involves applying pressure to the connector 125 and forming a seal between them.

[0056] Figure 7 shows the seal 140 of the stoma bag. The seal 140 is configured to be used with the stoma bag. The seal may also be used with an opening in the stoma bag. For example, the seal 140 may be used to seal a hole in the stoma bag. The seal 140 can then be used with the clip 130 to secure the seal 140 (and therefore the stoma bag) to the outlet 120.

[0057] The seal 140 comprises a body 141 having an opening 145. In one embodiment, the body portion 141 takes an annular shape. The body 141 comprises a first surface 141a and an opposite second surface 141b (not shown). The first surface 141a and the second opposite surface 141b are connected by an outer surface 141c and an inner surface 141d. The second surface 141b is provided with a cylindrical projection 142. The cylindrical projection 142 comprises an outer wall 142c and an inner wall 142d. The inner wall 142d is continuous with the inner surface 141d. The cylindrical projection 142 is sized so that it engages with a connector 125. In one embodiment, the cylindrical portion is complementary to the connector 125. In one embodiment, the seal 140 is formed of an elastic and plastic material such that the application of the clip 130 onto the cylindrical projection 142 deforms the cylindrical projection and forms a seal with the connector 125. This allows the stoma bag attached to the seal 140 to collect fluid from the body without leakage. Furthermore, the clip 130 can be easily removed, and the stoma bag with the seal can also be removed.

[0058] In one embodiment, the elastic and deformable material is preferably a polymer. In one embodiment, the elastic and deformable material is preferably rubber or latex. In one embodiment, the material is a semicrystalline thermoplastic. In an embodiment, the material is a polyetheretherketone. In a preferred embodiment, the material is PEEK polyetheretherketone. One source of PEEK polyetheretherketone is provided under the trade name SustaPEEK MG (Medical Grade) PEEK, manufactured by Rochling.

[0059] In certain situations, individuals with a stoma implant assembly may wish to remove the stoma bag for a short period of time. For example, an individual may wish to participate in activities where the stoma bag would be inconvenient. In these situations, a cap may be used to close the stoma. The cap preferably includes a second connector that is reciprocal to the connector 125. However, the second connector is closed and does not expose the stoma to the external environment during use. Preferably, the cap, together with the outlet, forms a water-resistant seal.

[0060] Embodiments shown in Figures 1 to 7 depict a stoma implant assembly used for connection to the ureter (Figure 9). The use of the stoma implant assembly in this situation requires a smaller opening. In other situations, such as connection to the large intestine (Figure 10), a larger opening may be required. As shown in these figures, the base 110 of the stoma implant assembly 100 is located beneath the patient's skin, and the outlet 120 extends through an abdominal incision.

[0061] Figure 8 shows another embodiment of the base and outlet, where the hole in the outlet and the opening in the base are larger. For ease of explanation, the same numbering as above is used, and these features are substantially the same as those described above, with the exception of some dimensions.

[0062] In one embodiment, the outlet hole may have a diameter of approximately 5 mm to 50 mm, 10 mm to 40 mm, 11 mm to 39 mm, 10 mm to 15 mm, 16 mm to 35 mm, 30 mm to 40 mm, 11 mm, or 39 mm.

[0063] In embodiments where the base and outlet are cylindrical or annular, the diameter of the base is greater than the diameter of the outlet. This allows the base to be firmly fixed to the subject under the skin.

[0064] In certain embodiments, the diameter of the base is preferably 20 mm to about 100 mm, about 40 mm to about 90 mm, about 50 mm to about 70 mm, about 40 mm to about 60 mm, about 60 mm to about 80 mm, about 50 mm, or about 70 mm.

[0065] In certain embodiments, the connecting portion (the widest part of the connecting portion, the separated projection) has a diameter of approximately 15 mm to 60 mm, approximately 19 mm to 47 mm, approximately 15 mm to 25 mm, approximately 45 mm to 55 mm, approximately 19 mm, or approximately 47 mm.

[0066] In one embodiment, the space preferably has a diameter of 10 mm to about 50 mm, 14 mm to about 42 mm, about 10 mm to about 20 mm, about 35 mm to about 45 mm, about 14 mm, or about 42 mm.

[0067] Figure 11 shows another embodiment of a stoma implant assembly. The stoma implant 200 preferably comprises a base 210 having an opening 211 and an outlet 220. The base 210 is configured to engage with the outlet 220. Furthermore, the base 210 is configured to engage with the subject's body subcutaneously so that the case 210 is under the skin and the outlet passes through an incision in the abdomen.

[0068] Figure 12 shows a cross-section of the embodiment shown in Figure 11. As shown, similar to the base 100 described above, the base 210 preferably includes an opening 211. In one embodiment, the opening 211 is centrally located within the base 210. In the embodiment shown, the base 210 takes an annular shape. The base 210 is configured to rest under the skin. The opening 211 of the base 210 is aligned with an incision, and the outlet 220 can be secured to the base 210 through the incision. In one embodiment, the base 210 is dimensionally determined such that the outlet 220 forms an interference fit (or friction fit) configuration with the base 210. The interference fit advantageously allows the outlet to be easily attached to the base. However, it should be understood that other mounting configurations known to those skilled in the art may be utilized to attach the outlet 220 to the base 210. A stoma may have an outlet 220 through which bodily fluids can be collected from the body to the outside. In one embodiment, the outlet 220 and the base 210 are preferably formed integrally. In another embodiment, the outlet 220 and the base are separate components.

[0069] The base 210 being located beneath the skin allows it to form a barrier against leakage. In one embodiment, the base 210 includes one or more engagement holes 212. In one embodiment, the one or more engagement holes are located concentrically around the hole 211. The one or more engagement holes 212 are thought to allow for a more secure attachment to the subject and reduce the problem of leakage.

[0070] In one embodiment, the base 210 is formed of a material that is biocompatible with the human body. In one embodiment, the base 210 is formed of titanium. In one embodiment, the material is preferably a polymer. In one embodiment, the material is a semicrystalline thermoplastic. In one embodiment, the material is a polyether ether ketone. In a preferred embodiment, the material is PEEK polyether ether ketone. One source of PEEK polyether ether ketone is provided under the trade name SustaPEEK MG (Medical Grade) PEEK, manufactured by Rochling.

[0071] The outlet 220 has a proximal end (in an interferential engagement state with the base 210) and a distal end. The proximal end is dimensionally determined to form an interferential configuration with the base 210. The distal end of the outlet 220 includes a connector 225. In the embodiments shown in Figures 11 and 12, the connector, together with the cover 230 described hereafter herein, forms part of a fixed assembly. In the embodiments shown in Figures 11 and 12, the cover 230 includes a second connector 235 that forms a fixed assembly with the connector 225. The connector 225 may take the form of a flange or extension with one or more recesses and grooves (not shown) that engage with each projection of the second connector 235. Once engaged, the projections can be twisted, as a result the cover 230 is sealed and held together with the outlet 220. The projections are preferably inserted into recesses and twisted into grooves to be firmly attached therein.

[0072] In one embodiment, the base 110 is formed of a material that is biocompatible with the human body. In one embodiment, the base 110 is formed of titanium. In one embodiment, the material is preferably a polymer. In one embodiment, the material is a semicrystalline thermoplastic. In an embodiment, the material is a polyether ether ketone. In a preferred embodiment, the material is PEEK polyether ether ketone. One source of PEEK polyether ether ketone is provided under the trade name SustaPEEK MG (Medical Grade) PEEK, manufactured by Rochling.

[0073] In one embodiment, the outlet 220 is formed of a material that is biocompatible with the human body. In one embodiment, the outlet 220 is formed of titanium. In one embodiment, the material is preferably a polymer. In one embodiment, the material is a semicrystalline thermoplastic. In one embodiment, the material is a polyether ether ketone. In a preferred embodiment, the material is PEEK polyether ether ketone. One source of PEEK polyether ether ketone is provided under the trade name SustaPEEK MG (Medical Grade) PEEK, manufactured by Rochling.

[0074] Figure 13 shows another embodiment similar to that of the stoma implant assembly 200. For ease of explanation and for brevity, the same numbering is used. The main difference between the embodiment shown in Figure 13 and the embodiments in Figures 11 and 12 is that the outlet connector has a male threaded portion 225a at or adjacent to its distal end. In one embodiment, the outlet has a connector at or adjacent to its distal end. In one embodiment, the male threaded portion 225a may be provided on a flange or extension around the outlet 220. That is, the connector has an extension or flange extending away from the outlet (in a substantially perpendicular direction). This extension or flange has a male thread thereon. The cover 230 preferably has a female threaded portion 235a that is complementary to the male threaded portion 225a. In one embodiment, the female thread is located on the inner surface of the cover. This allows the cover 230 to be easily secured to the outlet by simply screwing it over the outlet.

[0075] The cover 230 may preferably include a sealing member that forms a seal with the outlet 220. A non-limiting example of this seal is a ring. In one embodiment, the seal is an O-ring 236. When the cover 230 is fixed to the outlet 220, the sealing member deforms between the outlet 220 and the cover 230. This allows a seal to be formed between them. It should be understood that a substantially water-resistant seal is formed between the base, the outlet, and the cover. In a preferred embodiment, a fluid-sealing seal is formed between the base, the outlet, and the cover.

[0076] The cover 230 may further comprise a stoma bag connector that allows bodily fluids to be connected. The stoma bag connector 237 is configured to connect to and seal with the stoma bag. In one embodiment, the cover 230 may be formed together with the stoma bag. In one embodiment, the stoma bag connector comprises a one-way valve to allow bodily fluids to flow in only one direction (outside the body and into the stoma bag), or the stoma bag connector is a one-way valve. In one embodiment, the stoma bag connector comprises a check valve. Non-limiting examples of backflow prevention valves include diaphragm check valves, ball check valves, swing check valves, butterfly check valves, and top and inclined disc check valves. However, those skilled in the art will understand that any backflow prevention valve may be utilized.

[0077] In one embodiment, the cover does not have a stoma bag connection. As previously mentioned, the person may wish to participate in activities where a stoma bag would be inconvenient. In these situations, the cover may be used to close the stoma. This cover preferably includes a second connection portion that is reciprocal to the connection portion 125. However, the second connection portion is closed and does not expose the stoma to the external environment during use. Preferably, the cover may form an outlet and a water-resistant seal.

[0078] In one embodiment, the cover 230 is formed from a material that is biocompatible with the human body. In one embodiment, the cover 230 is formed from titanium. In one embodiment, the material is preferably a polymer. In one embodiment, the material is a semicrystalline thermoplastic. In one embodiment, the material is a polyether ether ketone. In a preferred embodiment, the material is PEEK polyether ether ketone. One source of PEEK polyether ether ketone is provided under the trade name SustaPEEK MG (Medical Grade) PEEK, manufactured by Rochling.

[0079] In one embodiment, the present invention relates to a cover. The cover is configured to be fixed to the outlet. Preferably, the cover is connectable to or formed together with the stoma bag. In this regard, consumers may purchase a cover and / or a stoma bag with a cover once the stoma implant assembly is installed.

[0080] During use, the stoma implant assembly may be fitted into the subject by aligning the opening at the base beneath the skin with an incision in the subject's abdomen. In this regard, the opening is configured to engage with an outlet. The outlet is then secured to the base through the incision in the abdomen. The outlet has a distal end, which has a connector configured to securely fasten a second connector. The stoma is preferably positioned through the opening.

[0081] A further step may be to position the second connection of the stoma bag or cap over the connection.

[0082] There may be a further step of engaging the clip with the second connection point of the stoma bag or cap and over the connection point.

[0083] There may be an additional step of releasing the clip over the stoma bag or cap. In this regard, there may be a further step of placing another stoma bag on the cap over the connector and positioning the clip on it to secure it.

[0084] The above description of various embodiments of the present invention is provided to those skilled in the art for illustrative purposes. It is not intended to be exclusive or to limit the invention to a single disclosed embodiment. As stated above, numerous alternative forms and variations to the invention will be obvious to those skilled in the art of the above teachings. Thus, while some alternative embodiments are specifically discussed, other embodiments will be obvious to those skilled in the art or relatively easily conceived by those skilled in the art. Accordingly, the present invention is intended to encompass all alternative forms, modifications, and variations of the invention discussed herein, as well as other embodiments that fall within the spirit and scope of the invention described above.

Claims

1. A stoma implant assembly, A base having an opening configured to engage with an outlet, the base being configured to engage with the body of a subject, and the outlet having a hole through which the base passes, A cover having a second connecting portion, wherein the cover is provided with a stoma bag connecting portion, and the stoma bag connecting portion is provided with a check valve, and Equipped with, The discharge port has a distal end having a connecting portion configured to be releasably fixed to the second connecting portion. Stoma implant assembly.

2. The stoma implant assembly according to claim 1, wherein the connecting portion is provided with a male thread.

3. The stoma implant assembly according to claim 1 or 2, wherein the second connection portion is provided with a female thread.

4. The stoma implant assembly according to any one of claims 1 to 3, wherein the base comprises one or more engagement openings.

5. The stoma implant assembly according to claim 4, wherein one or more engagement openings are located concentrically around the opening.

6. The stoma implant assembly according to any one of claims 1 to 5, wherein the cover comprises a sealing member configured to form a seal between the cover and the outlet.

7. The stoma implant assembly according to any one of claims 1 to 6, wherein the cover is configured to connect to or be formed together with the stoma bag.

8. The stoma implant assembly according to any one of claims 1 to 7, wherein the check valve is a ball check valve or a diaphragm check valve.

9. The stoma implant assembly according to any one of claims 1 to 8, wherein the base, outlet, and / or cover are formed of a biocompatible material.

10. The stoma implant assembly according to claim 9, wherein the biocompatible material is PEEK.

11. A stoma implant assembly according to any one of claims 1 to 10, for use in colostomy.

12. A stoma implant assembly according to any one of claims 1 to 11, for use in colostomy.

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