Percutaneous implant and ostomy method

• US 9,226,848 B2
• Filed: 04/28/2010
• Issued: 01/05/2016
• Est. Priority Date: 04/28/2009
• Status: Active Grant

• Current Assignee: Ostomycure AS
• Original Assignee: Ostomycure AS
• Inventors: Thomsen, Peter, Johansson, Martin, Edwin, Bjrn, Hulten, Leif
• Primary Examiner(s): HAND, MELANIE JO
• Application Number:
  US13/266,876
• Publication Number:
  US 20120123361A1
• Time in Patent Office: 2,078 Days
• US Class Current: 1/1
• CPC Class Codes: A61F 5/445 Colostomy, ileostomy or urethrostomy devices A61F5/441, A61F5/442, A61F5/443 take precedence
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

A percutaneous ostomy implant for implantation into the abdominal wall of a patient. The implant has a cylindrical part for mounting an external detachable device thereto, an ingrowth mesh and a circular flange for anchoring the implant. The cylindrical part and circular flange are attached to opposite ends of the ingrowth mesh. The ingrowth mesh is arranged such that when the implant is implanted in the abdominal wall of a patient, the epidermis meets the ingrowth mesh and is able to attach therethrough directly to serosal tissue of a bowel segment inside the implant.

Claims

1. A percutaneous ostomy implant for implantation into the abdominal wall of a patient, the implant comprising:

a cylindrical part for mounting an external detachable device thereto;

an ingrowth mesh; and

a circular flange for anchoring the implant;

wherein the cylindrical part and circular flange are attached to opposite ends of the ingrowth mesh;

wherein the ingrowth mesh has an exterior surface that is exposed and completely unobstructed to allow direct and unbroken contact with the abdominal wall in the region adjacent to the circular flange as well as adjacent to the epidermis, thereby permitting tissue ingrowth through the mesh from its attachment to the flange to the skin surface, and

wherein the cylindrical part is spaced sufficiently from the flange axially such that when the implant is implanted in the abdominal wall of a patient, the ingrowth mesh is arranged to meet and contact the epidermis of the patient so that the epidermis can infiltrate the ingrowth mesh and attach therethrough directly to serosal tissue of a bowel segment located inside the implant.

2. The implant according to claim 1, wherein the circular flange is penetrated by multiple small holes to allow ingrowth of connective tissue.

3. The implant according to claim 1, wherein the ingrowth mesh is a laser-cut titanium ingrowth structure.

4. The implant according to claim 1, wherein the ingrowth mesh is attached to the cylindrical part and circular flange by laser-welding.

5. The implant according to claim 1, formed of commercially pure or grade 2 titanium.

6. The implant according to claim 1, having a roughened surface formed by aluminum oxide-blasting.

7. The implant according to claim 1, wherein the circular flange comprises inner and outer concentric rings, the inner ring being attached to one end of the ingrowth mesh and the outer ring being connected to the inner ring by a plurality of S-shaped connecting members.

8. The implant according to claim 1, wherein the exterior surface of the ingrowth mesh is exposed to allow direct and unbroken contact with the abdominal wall in the region adjacent to the circular flange.

9. The implant according to claim 1, wherein the ingrowth mesh is cylindrical.

10. The implant according to claim 9, wherein an annular gap is provided between the inner face of the cylindrical part and the ingrowth mesh.

11. The implant according to claim 1 in combination with an external detachable device mounted to the cylindrical part of the implant.

12. A method of implanting an ostomy implant into the abdominal wall of a patient, which method comprises:

providing an implant-according to claim 1; and

implanting the implant into the abdominal wall of a patient such that the epidermis meets the ingrowth mesh and is able to attach therethrough directly to serosal tissue of a bowel segment inside the implant.

13. The method according to claim 12, which further comprises drawing a bowel segment through the implant such that the serosal tissue of the bowel contacts the epidermis through the ingrowth mesh.

14. The method according to claim 12, which further comprises mounting a healing device to the cylindrical part of the implant during the healing phase in order to protect the implant and prevent it from being retracted below skin level.

15. The method according to claim 12, which further comprises mounting a lid to the cylindrical part of the implant.

21. The implant according to claim 1, wherein the cylindrical part further comprises a healing device that prevents the implant from being distracted below the abdominal wall of the subject, the healing device also serving for sealingly closing the end of the implant.

22. The implant according to claim 21, wherein the healing device further includes cap means that surrounds and sealingly closes the end of the implant, the cap means comprising mating means for removable attachment to the mating means of the implant.

23. The implant according to claim 22, wherein cap means of the healing device further includes an O-ring serving for sealing against the exterior circumferential wall of the implant, and the implant includes a healing plate resting on the skin surface of the subject, wherein the healing plate has an external screw thread for coupling with a complementary internal screw thread on the cap means.

16. In a percutaneous ostomy implant, the improvement comprising an ingrowth mesh structure configured in use to surround a vessel having serosal tissue, a cylindrical part at one end of the mesh structure and a circular flange at the opposite end of the mesh structure for anchoring the implant, wherein the ingrowth mesh has an exterior surface that is exposed and completely unobstructed to allow direct and unbroken contact with the abdominal wall in the region adjacent to the circular flange as well as adjacent to the epidermis, thereby permitting tissue ingrowth through the mesh from its attachment to the flange to the skin surface, and wherein the ingrowth mesh is arranged to be spaced sufficiently axially away from the flange in order to meet and contact the epidermis of the patient and to allow the epidermis of the abdominal wall to infiltrate the ingrowth mesh and attach directly to the serosal tissue in the implant through the ingrowth mesh.

17. The implant according to claim 16, arranged such that the attachment of serosal tissue to the ingrowth mesh may extend above or outwardly of the epidermis-serosa junction.

18. A method of performing an ostomy comprising providing a percutaneous ostomy implant according to claim 16, surrounding a vessel having serosal tissue with the mesh structure and allowing epidermis to attach directly to the serosal tissue through the ingrowth mesh.

19. The method according to claim 18, wherein the mesh structure is arranged such that attachment of serosal tissue to the ingrowth mesh extends above the epidermis-serosa junction, so as to form a stable structure.

20. A method of manufacturing a percutaneous ostomy implant according to claim 16 for a given patient or class of patients which comprises:

providing a cylindrical part for mounting an external detachable device thereto;

a cylindrical ingrowth mesh; and

a circular flange for anchoring the implant;

attaching the cylindrical part and circular flange to opposite ends of the ingrowth mesh;

wherein the ingrowth mesh is dimensioned such that if the implant is implanted immediately above the muscle layer in the abdominal wall of the patient or a member of the class of patients respectively, the epidermis would meet the ingrowth mesh and be able to attach therethrough directly to serosal tissue of a bowel segment inside the implant.

24. The implant according to claim 16, further comprising a healing device engaged with the implant to prevent the implant from being distracted below the abdominal wall of the subject, the healing device also serving for sealingly closing the protruding part and free end of the implant body.

25. The implant according to claim 24, wherein the healing device further includes cap means that surrounds and sealingly closes the end of the implant, the cap means comprising mating means for removable attachment to the mating means of the implant.

26. The implant according to claim 25, wherein cap means of the healing device further includes an O-ring serving for sealing against the exterior circumferential wall of the implant, and the implant includes a healing plate resting on the skin surface of the subject, wherein the healing plate has an external screw thread for coupling with a complementary internal screw thread on the cap means.

27. The method according to claim 18, which further comprises providing a healing device to the implant during a healing phase in order to protect the implant and prevent it from being retracted below skin level.

28. The method according to claim 27, which further comprises mounting a lid upon the healing device of the implant.