Percutaneous abdominal implant

• US 8,821,462 B2
• Filed: 08/19/2008
• Issued: 09/02/2014
• Est. Priority Date: 08/21/2007
• Status: Active Grant

• Current Assignee: Ostomycure AS
• Original Assignee: Ostomycure AS
• Inventors: Axelsson, Robert, Johansson, Martin, Edwin, Bjrn, Fosse, Erik
• Primary Examiner(s): Su, Susan
• Assistant Examiner(s): Townsend, Guy K
• Application Number:
  US12/674,666
• Publication Number:
  US 20110178540A1
• Time in Patent Office: 2,205 Days
• Field of Search: 604/332
• US Class Current: 604/332
• CPC Class Codes: A61F 2005/4455 Implantable
• CPC Class Codes: A61F 5/445 Colostomy, ileostomy or urethrostomy devices A61F5/441, A61F5/442, A61F5/443 take precedence
• CPC Class Codes: A61M 2039/0261 Means for anchoring port to the body, or ports having a special shape or being made of a specific material to allow easy implantation/integration in the body
• CPC Class Codes: A61M 39/0247 Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053

Abstract

An implant for percutaneous implantation through the abdominal wall for encircling and engaging an externalized length of a body duct of a human or animal patient. The implant has an exterior tubular section defined by an circumferential exterior wall at least a part of which is adapted to protrude outwardly from the abdominal wall with a free end for mounting of a detachable device, an interior section defined by an circumferential interior wall adapted to extend through the abdominal wall and inside the patient for internal fixation of the implant, wherein the exterior tubular section and the interior section have a common axis A. The circumferential exterior wall of the exterior tubular section and the circumferential interior wall of the interior section are arranged axially spaced apart at a distance D from each other to provide an axial gap between opposing free ends of the exterior tubular section and the interior section, with the exterior tubular section and interior section being connected inside the sections.

Claims

1. A percutaneous implant for encircling and engaging an externalised length of a body duct of a human or animal patient, comprising:

an exterior tubular section defined by an circumferential exterior wall at least a part of which is adapted to protrude outwardly from the abdominal wall with a free end which serves for mounting of a detachable device;

an interior section adapted for internal fixation of the implant, with the interior section comprising a tubular member having a free end adjacent the free end of the exterior tubular section, and a radially extending anchoring flange for anchoring the implant inside the body,

wherein the exterior tubular section and the interior section have a common axis A, with the exterior tubular section and the interior section arranged axially spaced apart from each other to provide an axial open gap that is parallel to the common axis A and that is delimited by the free end of the exterior tubular section and the free end of the tubular member,

wherein the exterior tubular section and interior section are connected to each other by an ingrowth structure comprising a rigid ingrowth mesh or a plurality of rigid members, which mesh or plurality maintains the exterior tubular section and interior section spaced by the open gap and provides passageways, channels or openings that substantially or completely prevent formation of a biofilm between the exterior tubular and interior sections.

2. The percutaneous implant according to claim 1, wherein the rigid ingrowth mesh is shaped as a tubular body having a length L of at least the distance of the open gap between the exterior tubular section and the interior section.

3. The percutaneous implant according to claim 1, wherein the interior section includes a rigid ingrowth mesh for ingrowth of at least the exterior surface of the body duct wall along at least a part of the interior section.

4. The percutaneous implant according to claim 1, wherein the implant has a circumferential radial gap between the rigid ingrowth mesh or plurality of rigid members and the interior faces of either the exterior tubular section or the interior section or both.

5. The percutaneous implant according to claim 1, wherein the anchoring flange comprises a plurality of through-openings of the same or different sizes or combination of sizes.

6. The percutaneous implant according to claim 1, wherein the passageways, channels or openings of the rigid ingrowth mesh are of a polygonal cross-section.

7. The percutaneous implant according to claim 1, wherein the passageways, channels or openings of the rigid ingrowth mesh are of a hexagonal cross-section.

8. The percutaneous implant according to claim 1, wherein the plurality of passageways, channels or openings of the rigid ingrowth mesh have edges that are substantially 90°

to the surface of the mesh.

9. The percutaneous implant according to claim 1, wherein the interior section has a radial thickness r_x, the exterior tubular section has radial thickness r_e and radial thickness r_x is smaller than radial thickness r_e.

10. The percutaneous implant according to claim 1 wherein the interior section is defined by an circumferential interior wall and the rigid ingrowth mesh extends inside the sections.

11. A combination of the percutaneous implant according to claim 1 with a detachable device mounted thereto.

12. The combination of claim 11, wherein the device is an ostomy bag.

13. A method of performing an ostomy procedure which comprises:

providing a percutaneous implant according to claim 1;

making an access opening through the abdominal wall of a patient;

locating the transcutaneous implant in the abdominal opening with the exterior section protruding from the patient and the interior section anchored inside the body; and

encircling and engaging an externalized length of a body duct with the implant.

14. The method of claim 13, which further comprises providing the interior faces of either of the exterior tubular section, the interior section or both with the rigid ingrowth mesh or plurality of rigid members for ingrowth of at least the exterior surface of the body duct therein.

15. The method of claim 13, which further comprises configuring the interior section as a radially extending anchoring flange for anchoring the implant inside the body, and providing the anchoring flange with a plurality of through-openings of the same or different sizes or combination of sizes.

16. The method of claim 15, wherein the openings of the anchoring flange are made by laser cutting.

17. The percutaneous implant according to claim 2, wherein the rigid ingrowth mesh serves at least for keeping the exterior tubular section and the interior section spaced apart in rigid relationship across the axial gap.

18. The percutaneous implant according to claim 1, wherein the anchoring flange extends from the end of the interior section opposite the free end of the tubular member.

19. A percutaneous implant for encircling and engaging an externalised length of a body duct of a human or animal patient, comprising:

an exterior tubular section defined by an circumferential exterior wall at least a part of which is adapted to protrude outwardly from the abdominal wall with a free end which serves for mounting of a detachable device;

an interior section adapted for internal fixation of the implant, with the interior section comprising a radially extending anchoring flange for anchoring the implant inside the body,

an interior section adapted for internal fixation of the implant, with the interior section comprising a tubular member having a free end adjacent the free end of the exterior tubular section, and a radially extending anchoring flange for anchoring the implant inside the body,

wherein the exterior tubular section and the interior section have a common axis A, with the exterior tubular section and the interior section arranged axially spaced apart from each other to provide an axial open gap that is parallel to the common axis A and that is delimited by the free end of the exterior tubular section and the free end of the tubular member,

wherein the exterior tubular section and interior section are connected to each other by a rigid ingrowth structure comprising circumferentially spaced ribs having a suitable length to keep opposing free ends of the exterior tubular section and the interior section spaced apart at a defined and permanent suitable distance corresponding to the open gap with the ribs sufficiently spaced apart to substantially or completely prevent formation of a biofilm between the exterior and interior sections.

20. A percutaneous implant for encircling and engaging an externalised length of a body duct of a human or animal patient, comprising:

an exterior tubular section defined by an circumferential exterior wall at least a part of which is adapted to protrude outwardly from the abdominal wall with a free end which serves for mounting of a detachable device;

an interior section adapted for internal fixation of the implant, with the interior section comprising a tubular member having a free end adjacent the free end of the exterior tubular section, and a radially extending anchoring flange for anchoring the implant inside the body,

wherein the exterior tubular section and the interior section have a common axis A, with the exterior tubular section and the interior section arranged axially spaced apart from each other to provide an axial open gap that is parallel to the common axis A and that is delimited by the free end of the exterior tubular section and the free end of the tubular member,

wherein the exterior tubular section and interior section are connected to each other by a rigid ingrowth structure comprising circumferentially spaced rigid connecting members that maintain the exterior tubular section and interior section spaced by the open gap with the connecting members being spaced apart or having sufficient openings to substantially or completely prevent formation of a biofilm between the exterior and interior sections.

21. The percutaneous implant according to claim 20, wherein the rigid connecting members comprise ribs, crossbars, latticework or netting.