IMPLANTABLE STOMA RING

Abstract

The present invention relates to a ring (1) for implantation in patients receiving stoma having (i) an inner ring (2) suitable for fitting an abdominal wall on its outer circumference having an opening (3) suitable for an abdominal organ to pass through the ring to the exterior side (5) and (ii) a lip seal (4) extending over the interior side (5) of the inner ring (2) to seal the stoma opening for use in abdominal surgery. In addition, the present invention is directed to a method of treatment, comprising the surgical introduction of a ring (1) of the invention into the abdominal wall of a mammal in need of abdominal, preferably stoma surgery.

Claims

1-17 (canceled)

18. A method of performing stoma surgery, comprising the steps of: incising an abdominal wall of a patient to form an abdominal aperture; selecting a stoma ring (1) having an inner ring (2) and a lip seal (4), the stoma ring (1) being selected to match a diameter of an outer circumference of the inner ring (2) to a diameter of the abdominal aperture, the stoma ring (1) being further selected such that a width (6) of the inner ring (2) is less than a width of the abdominal wall, wherein the inner ring has an interior side (5) adapted to face inwardly in the patient and an exterior side adapted to face outwardly with respect to the patient, the lip seal (4) extending from the interior side (5) of the inner ring (2) to seal a stoma opening inwardly in the patient; fixating the ring (1) in the abdominal aperture; guiding an end of an abdominal organ through an opening (3) formed through the inner ring (2); and fixating the abdominal organ to form an external orifice.

19. The method of performing stoma surgery according to claim 18, wherein the step of selecting the stoma ring (1) further comprises selecting the stoma ring (1) such that the width (6) of the inner ring (2) is less than a peritoneal width of the patient and is further less than a width of an abdominal muscle layer of the patient.

20. The method of performing stoma surgery according to claim 18, wherein the width (6) of the inner ring (2) is between 3 mm and 20 mm.

21. The method of performing stoma surgery according to claim 18, wherein a diameter of the opening (3) of the inner ring (2) is between 2 cm and 6 cm, the width (6) of the inner ring (2) is between 3 mm and 20 mm, a thickness (7) of the inner ring (2) is between 1 mm and 15 mm, and the lip seal (4) is ring-shaped and extends between 0.2 mm and 20 mm over the interior side (5) of the inner ring (2).

22. The method of performing stoma surgery according to claim 18, wherein the inner ring (2) has an outward curved cross-sectional contour.

23. The method of performing stoma surgery according to claim 18, wherein the inner ring (2) has an outward convex cross-sectional contour.

24. The method of performing stoma surgery according to claim 18, wherein the inner ring (2) has an oval cross-sectional contour.

25. The method of performing stoma surgery according to claim 18, wherein the stoma ring (1) is flexible and not dilatable.

26. The method of performing stoma surgery according to claim 18, wherein the stoma ring (1) is rigid.

27. The method of performing stoma surgery according to claim 18, wherein the stoma ring (1) is pliable and not dilatable.

28. The method of performing stoma surgery according to claim 18, wherein at least a portion of the stoma ring (1) is braided for suturing.

29. The method of performing stoma surgery according to claim 18, wherein at least a portion of the ring comprises biocompatible material.

30. The method of performing stoma surgery according to claim 18, wherein at least a portion of the stoma ring (1) comprises biocompatible polyethylene glycol terephthalate.

31. The method of performing stoma surgery according to claim 18, wherein at least a portion of the stoma ring (1) comprises biocompatible polytetrafluoroethylene.

32. The method of performing stoma surgery according to claim 18, wherein at least one of the outer circumference of the inner ring (2) and the opening (3) is antiseptic.

33. The method of performing stoma surgery according to claim 18, wherein at least one of the outer circumference of the inner ring (2) and the opening (3) is coated with an adhesive.

34. The method of performing stoma surgery according to claim 18, wherein the stoma ring (1) is elastic, dilatable and constrictable to adapt a diameter of the opening (3 ).

35. The method of performing stoma surgery according to claim 18, wherein the stoma ring (1) is constrictable to adapt a diameter of the opening (3).

36. The method of performing stoma surgery according to claim 18, wherein the patient is a mammal.

37. The method of performing stoma surgery according to claim 36, wherein the mammal is selected from the group consisting of cattle, equine, swine, bovine, canine,

Description

FIGURES

[0036] FIG. 1 depicts specific embodiments of the rings of the present invention.

[0037] FIG. 1A is a front view of a ring (1).

[0038] FIG. 1B is a side view of a ring (1).

[0039] FIG. 1C is a side view of the ring (1) illustrating an inner ring shape.

[0040] FIG. 1D is a side view of the ring (1) illustrating an inner ring shape.

[0041] FIG. 1 E is a side view of the ring (1) illustrating an inner ring shape.

[0042] FIG. 1F is a side view of the ring (1) illustrating an inner ring shape.

FIGURE LEGEND

[0043]

TABLE-US-00001 1 ring 2 inner ring 3 opening of inner ring 4 lip seal (flange) 5 interior side 6 width of (2) 7 thickness of (2) 8 extension of lip seal over (2)

[0044] FIGS. 1A and 1B depict a ring of the invention (1) comprising an inner ring (2) and a lip seal (flange) (4). The inner ring (2) has an opening (aperture) (3) which will receive and fixate the abdominal organ, preferably an intestine or ureter, for the enterostoma. The opening (3) for use in humans is preferably about 20, 30, 40 or 50 mm. The width of the inner ring is preferably 3 to 20 mm, enough to receive and fixate the abdominal wall on the outer circumference of the inner ring (2). Preferably, the opening (3) of the inner ring (2) can be adapted by constricting or expanding the inner ring (2). For example, a thread located in the inside or on the circumference of the inner ring (2) can be shortened and fastened to constrict the ring permanently to the desired exact size of the aperture in the abdominal wall. The ring-shaped lip seal (4) extends preferably about 0.2 to 20 mm (8) over the interior side of the inner ring (2) to seal the stoma opening against leaks from the inside and contamination from the outside.

[0045] The lip seal (4) and the inner ring (2) are preferably flexible to adapt to mechanical stress on the attached abdominal wall. The shape of the lip seal is functional, i.e. sealing and non-injuring. The shape of the inner ring (2) preferably has an outwardly curved cross-section, preferably an outward convex cross-section, more preferably has an oval cross section. Examples of preferred specific shapes of the inner ring are shown in FIGS. 1C to 1E. The inner rings of FIGS. 1C, 1E and 1F have in common that the outside circumference is outwardly curved and that the exterior side(s) of the inner rings are narrower than the middle section. This convex shape allows for increasing the contact area of the outer inner ring with the abdominal wall without changing the width of the inner ring and reduces tensional stress at the contact area of inner ring and lip seal, thus restricting the tensional stress of the abdominal wall to the middle of the inner ring. For easier suturing and/or clamping the ring (1) or at least the seal lip (4) and/or the inner ring (2) can be made from braided materials. Preferably the material is biocompatible and/or antiseptic, e.g. by nature or rendered by coating. For temporary or permanent fixation the part(s) directly in contact with the abdominal wall and/or abdominal organ are preferably adhesive or coated with an adhesive.

[0046] An exemplary procedure for introducing a ring (1) surgically into a patient is as follows: First an incision is made into the skin of the abdominal wall. Secondly a further round incision is made into the external rectus fascia. The muscle is preferably preserved by blunt separation and then the posterior rectus sheath is incised in order to produce a round abdominal aperture. Thirdly, a ring (1) is selected that fits the abdominal aperture. Then the ring is fixated to both abdominal sheaths by a circular suture with a non-absorbable thread. At last, the abdominal organ is pulled through the ring and fixated as usually to form the external orifice.