Reinforced Suture Sleeve

• US 20110009935A1
• Filed: 07/09/2010
• Published: 01/13/2011
• Est. Priority Date: 07/10/2009
• Status: Active Grant

• Current Assignee: Cirtec Medical Corp.
• Original Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Inventors: Ye, Qingshan, Kane, Larry
• Granted Patent: US 8,958,891 B2
• Time in Patent Office: Days
• US Class Current: 607/116
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 1/059 Anchoring means
• CPC Class Codes: A61N 2001/0582 Suture sleeves

Abstract

A reinforced suture sleeve designed to cover and protect a medical lead from physical damage resulting from an over tightened suture is described. The reinforced suture sleeve comprises a metallic tubular insert with at least one slot that cut through the surface of the insert in a spiraled pattern. A biocompatible and pliable polymeric body is molded over the insert. The spiraled cut slot in the metallic tubular insert provides flexibility without degrading structural integrity. An alternate embodiment comprises a polymeric body provided with an embedded fiber mesh made of polymeric fibers, metallic fibers or combinations thereof. The fiber mesh which an over tightened suture from cutting through the suture sleeve and damaging the medical lead.

Claims

1. A reinforced suture sleeve adapted for protecting an implantable medical lead passing through the sleeve inside a body, wherein the sleeve is suturable to body tissue without a suture being able to cut through the sleeve to damage the medical lead passing therethrough, the suture sleeve comprising:

a) a substantially tubular insert defining a throughbore having a length extending along a longitudinal axis between spaced apart first and second insert ends, wherein the insert has an inner surface defining an inner insert diameter, an outer surface defining an outer insert diameter, and an insert wall thickness there between; and

b) a polymeric body encompassing the outer insert surface.

2. The reinforced suture sleeve of claim 1 wherein the insert has at least one slot extending from the outer insert surface part way into the insert thickness.

3. The reinforced suture sleeve of claim 2 wherein the slot is provided in a spiral pattern extending along the longitudinal axis of the insert from the first insert end to the second insert end.

4. The reinforced suture sleeve of claim 3 wherein the spiral pattern has a pitch from about 10 degrees to about 80 degrees with respect to the longitudinal axis of the insert.

5. The reinforced suture sleeve of claim 1 wherein the insert is of a metallic material.

6. The reinforced suture sleeve of claim 1 wherein the insert is of stainless steel or MP35N.

7. The reinforced suture sleeve of claim 1 wherein at least one of the first and second insert ends have tubes disposed there within, each defining a tube throughbore having a length extending along the longitudinal axis, with at least one tube end that is in communication with the insert.

8. The reinforced suture sleeve of claim 1 wherein both the first and second insert ends have tubes disposed there within, each defining the tube throughbore having a length extending along the longitudinal axis, with at least one tube end that is in communication with the insert.

9. The reinforced suture sleeve of claim 1 wherein the polymeric body is of a biocompatible polymer.

10. The reinforced suture sleeve of claim 1 wherein the polymeric body is of silicone.

11. The reinforced suture sleeve of claim 1 wherein a fiber mesh is embedded within the polymeric body.

12. The reinforced suture sleeve of claim 11 wherein the fiber mesh is selected from the group consisting of polymer fibers, metallic fibers, and combinations thereof.

13. The reinforced suture sleeve of claim 11 wherein the fiber mesh is disposed proximate an outer surface of the polymeric body.

14. The reinforced suture sleeve of claim 11 wherein the fiber mesh is disposed proximate an inner surface of the polymeric body.

15. A method of manufacture a reinforced suture sleeve adapted for protecting an implantable medical lead passing through the sleeve inside a body, wherein the sleeve is suturable to body tissue without a suture being able to cut through the sleeve to damage the medical lead passing therethrough, comprising the following steps:

a) providing a substantially tubular insert defining a throughbore having a length extending along a longitudinal axis between spaced apart first and second insert ends, wherein the insert has an inner surface defining an inner insert diameter, an outer surface defining an outer insert diameter, and an insert wall thickness there between; and

b) molding a polymeric body from a pliable polymeric material encompassing the outer surface of the insert.

16. The method of claim 15 including cutting at least one slot extending from the outer insert surface part way into the insert thickness.

17. The method of claim 16 including cutting the at least one slot in a spiral pattern having a pitch angle of about 10 degrees to about 80 degrees with respect to the longitudinal axis of the insert.

18. The method of claim 15 including providing the polymeric body of silicone.

19. The method of claim 15 including embedding a fiber mesh in the polymeric body.

20. The method of claim 19 including selecting the fabric mesh from the group consisting of polymeric fibers, metallic fibers, and combinations thereof.

21. The method of claim 19 including embedding the fiber mesh more proximate an outer surface of the polymeric body than an inner surface thereof contacting the outer insert surface.