HEATSET ANNULOPLASTY SUTURE GUIDE

Abstract

An implantable annuloplasty suture guide is intended to lie against at least a portion of an annulus surrounding a human heart. The implantable annuloplasty suture guide is made of an elongated ribbon of braided, heat setable material. The braided, heat-setable material is heat-set in a curved lengthwise configuration corresponding to at least a portion of the annulus of the human heart valve. A method of making an implantable annuloplasty suture guide configured to lie against at least a portion of an annulus defined by tissue surrounding a human heart. The method includes the steps of providing an elongate biocompatible ribbon comprising a braided, heat setable material. A fixture is provided, with the fixture comprising a heat conducting material defining an elongate cavity having a curved length-wise configuration corresponding to at least a portion of the annulus defined by the tissue surrounding the human heart. The elongate biocompatible ribbon is placed in the cavity and the fixture is heated to provide a select temperature for a select time in the cavity, the select temperature and the select time being sufficient to heat-set the elongate biocompatible ribbon in the curved length-wise configuration.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a plan view of a heatset annuloplasty suture guide in accordance with the present invention;

FIGS. 2A-2E are elevation views depicting progressive steps in the formation of an invaginated braided tube used in forming a heatset annuloplasty suture guide;

FIGS. 3A-3E are perspective views depicting progressive steps in the formation of an invaginated braided tube used in forming a heatset annuloplasty suture guide;

FIG. 4 is an exploded perspective view of a jig for heat setting the invaginated tube into a V configuration;

FIG. 5 is a perspective view of the heatset V-shaped invaginated tube before having the apices of the V attached to define an eight layer tube;

FIG. 6 is a cross-sectional view of an eight layer tube used in making a heatset annuloplasty suture guide;

FIG. 7 is a cross-sectional view of a heatset annuloplasty suture guide taken along line 7-7 of FIG. 1;

FIG. 8 is a perspective exploded view of the elements of a heatset fixture;

FIG. 9 is a plan cross-sectional view of the assembled heatset fixture;

FIG. 10 is an elevational cross-sectional view of the assembled heatset fixture taken along line 10-10 of FIG. 9;

FIG. 11 is a plan view of a non-heatset braided tubular annuloplasty suture guide formed into a ring;

FIG. 12 is a plan view of the non-heatset braided annuloplasty ring of FIG. 11 placed on a circumferencial edge of a fixture platform;

FIG. 13 is a plan view of a heatset D-shaped annuloplasty suture guide;

FIG. 14 is a non-heatset elongate annuloplasty suture guide;

FIG. 15 is the non-heatset elongate annuloplasty suture guide of FIG. 14 with its end attached by a cord placed a circumferential edge of a fixture platform;

FIG. 16 is a heatset annuloplasty suture guide of FIG. 15 following removal of the cord;

FIG. 17 is a perspective view of an annuloplasty suture guide holder with an annuloplasty suture guide having a D-shaped configuration attached thereto;

FIG. 18 is an isometric view of an annuloplasty suture guide for mitral valve repair sewn into the mitral annulus of a heart; and

FIG. 19 is a plan view of an annuloplasty suture guide for tricuspid valve repair sewn into an enlarged tricuspid annulus.

Claims

1. A method of making an implantable annuloplasty suture guide, the annuloplasty suture guide being configured to lie against at least a portion of an annulus defined by tissue surrounding a human heart valve, the method comprising: providing an elongate biocompatible ribbon comprising a braided, heat setable material;providing a fixture, the fixture comprising a heat conducting material defining an elongate cavity having a curved length-wise configuration corresponding to the at least a portion of the annulus defined by tissue surrounding a human heart valve;placing the elongate biocompatible ribbon in the cavity; andheating the fixture to provide a select temperature for a select time in the cavity, the select temperature and the select time being sufficient to heatset the elongate biocompatible ribbon in the curved length-wise configuration.

2. The method of claim 1 wherein the braided, heat setable material is a braided polyethertetraphylate tubular material.

3. The method of claim 1 wherein the curved length-wise configuration is an annular D-shape.

4. The method of claim 1 wherein the curved length-wise configuration is substantially circular.

5. The method of claim 1 further comprising in step a) the elongate biocompatible ribbon is linear having opposing first and second ends and prior to step b) the opposing first and second ends are tied together with a cord extending therebetween so that the biocompatible ribbon has a C-shaped configuration.

6. The method of claim 5 further comprising, following step d), removing the cord.

7. The method of claim 1 wherein no internal frame is provided in the braided polyethertetraphylate tubular material.

8. The method of claim 1 step d) is performed without substantially degrading the braided, heat setable material.

9. The method of claim 1 further comprising prior to step a), forming the braided, heat setable material into an non-heat set annular configuration by a process comprising: providing a single length of tubular braid material;invaginating the single length of tubular braid to form a double walled tube having first and second ends and inner and outer walls, with a roll over fold formed at one end and two cut ends formed at the other end;

10. The method of claim 9 further comprising: joining the apecies of the V to form an essentially oval cross-section.

11. The method of claim 10 further comprising following joining of the apices, attaching opposing ends of the tubes to form an annular member.

12. An implantable annuloplasty suture guide configured to lie against at least a portion of an annulus surrounding a human heart valve, the implantable annuloplasty suture guide comprising: an elongate ribbon comprising a braided, heat-setable material, the braided, heat-setable material being heatset in a curved length-wise configuration corresponding to at least a portion of the annulus surrounding a human heart valve.

13. The implantable annuloplasty suture guide of claim 12 wherein the braided, heat setable material is a braided polyethertetraphylate tubular material.

14. The implantable annuloplasty suture guide of claim 12 wherein the curved length-wise configuration is an annular D-shape.

15. The implantable annuloplasty suture guide of claim 12 wherein the curved length-wise configuration is substantially circular.

16. The implantable annuloplasty suture guide of claim 12 wherein the curved length-wise configuration is a substantially C-shape.

17. The implantable annuloplasty suture guide of claim 13 wherein no internal frame is provided in the braided polyethertetraphylate tubular material.

18. The implantable annuloplasty suture guide of 12 wherein the braided, heat setable material a single length of tubular braid material invaginated to form a double walled tube having first and second ends and inner and outer walls, with a roll over fold formed at one end and two cut ends formed at the other end, the inner and outer walls of the tube being sealed together at the two cut ends form a seal line, the seal line being rolled to reside substantially centrally in the inner wall of the tube and the tube being formed to define a V cross-section providing an eight walled member and the eight walled member being heat set to retain the V cross-section.

19. The implantable annuloplasty suture guide of claim 18 further comprising the apices of the V being joined to form and essentially oval cross-section.

20. The implantable annuloplasty suture guide of claim 19 further comprising the opposing ends of the tubes being joined to form an annular member.