PERCUTANEOUS IMPLANT AND OSTOMY METHOD

• US 20120123361A1
• Filed: 04/28/2010
• Published: 05/17/2012
• Est. Priority Date: 04/28/2009
• Status: Active Grant

• Current Assignee: Ostomycure AS
• Original Assignee: Ostomycure AS
• Inventors: Johansson, Martin, Thomsen, Peter, Edwin, Björn, Hulten, Leif
• Granted Patent: US 9,226,848 B2
• Time in Patent Office: Days
• US Class Current: 604/337
• 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

1-29. -29. (canceled)

30. 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 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.

31. The implant according to claim 30, wherein the circular flange is penetrated by multiple small holes to allow ingrowth of connective tissue.

32. The implant according to claim 30, wherein the ingrowth mesh is a laser-cut titanium ingrowth structure.

33. The implant according to claim 30, wherein the ingrowth mesh is attached to the cylindrical part and circular flange by laser-welding.

34. The implant according to claim 30, formed of commercially pure or grade 2 titanium.

35. The implant according to claim 30, having a roughened surface formed by aluminum oxide-blasting.

36. The implant according to claim 30, 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.

37. The implant according to claim 30, 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.

38. The implant according to claim 30, wherein the ingrowth mesh is cylindrical.

39. The implant according to claim 38, wherein an annular gap is provided between the inner face of the cylindrical part and the ingrowth mesh.

40. The implant according to claim 30 in combination with an external detachable device mounted to the cylindrical part of the implant.

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

providing an implant having;

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 the circular flange being attached to opposite ends of the ingrowth mesh; 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.

42. The method according to claim 41, 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.

43. The method according to claim 41, 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.

44. The method according to claim 41, which further comprises mounting a lid to the cylindrical part of the implant.

45. A method for providing a percutaneous port for continent ostomy in a subject in need of the same, which comprises:

implanting an ostomy implant in the abdominal wall of the subject for encircling and engaging an externalised length of a body duct, the implant having

a body that includes an exterior ring section at least a part of which protrudes outwardly from the abdominal wall with a free end, and

an interior section extending through the abdominal wall and inside the patient for internal fixation of the implant, with the exterior ring section and interior section having a common axis; and

providing a healing device to prevent the implant from being distracted below the abdominal wall of the subject.

46. The method according to claim 45, wherein the healing device also serves for sealingly closing the protruding part and free end of the implant body.

47. The method according to claim 45, which further comprises:

creating a pocket between external fascia and subcutis of the subject;

creating a channel through the rectus muscle and the peritoneum of the subject;

if necessary, securing and stabilising the implant to the overlaying fascia and the underlying muscle;

closing the pocket;

pulling the terminal ileum of the reservoir through the abdominal wall and the implant; and

attaching the healing device to the implant.

48. The method according to claim 45, wherein the implant has any one of the structures disclosed in WO2007/099500A1, WO2009/024568A1 or European patent application no. 04077475.4 with the further addition of mating means for the healing device and wherein the healing device further includes cap means that surrounds and sealingly closes the protruding part of the implant, the cap means comprising mating means for removable attachment to the mating means of the implant.

49. The method according to claim 48, wherein cap means of the healing device further includes an O-ring 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.

50. An ostomy implant for providing a percutaneous port for continent ostomy in a subject, with the implant positionable in the abdominal wall of the subject for encircling and engaging an externalised length of a body duct, the implant comprising:

a body section comprising an exterior ring section, at least a part of which protrudes outwardly from the abdominal wall with a free end, and an interior section extending through the abdominal wall and inside the patient for internal fixation of the implant, with the exterior ring section and interior section having a common axis; and

a healing device engaged with the implant body 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.

51. The implant according to claim 50, wherein the body has any one of the structures disclosed in WO2007/099500A1, WO2009/024568A1 or European patent application no. 04077475.4 and mating means for removable attachment to the healing device;

and the healing device further includes cap means that surrounds and sealingly closes the protruding part of the implant, the cap means comprising mating means for removable attachment to the mating means of the implant body.

52. The implant according to claim 51, 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 body 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.

53. A percutaneous ostomy implant comprising an ingrowth mesh structure configured in use to surround a vessel having serosal tissue and allow the epidermis of the abdominal wall to attach directly to the serosal tissue through the ingrowth mesh.

54. The implant according to claim 53, arranged such that the attachment of serosal tissue to the ingrowth mesh may extend above or outwardly of the epidermis-serosa junction.

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

56. The method according to claim 55, 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.

57. A method of manufacturing a percutaneous ostomy implant for a given patient or class of patients which comprises:

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

a preferably 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.