Heatset annuloplasty suture guide
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.
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:
a) providing an elongate biocompatible ribbon comprising a braided, heat settable material;
b) 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, whereby the elongate cavity has at least a non-linear lengthwise segment;
c) placing the elongate biocompatible ribbon in the cavity; and
d) eating 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 lengthwise configuration is an annular D-shape.
4. The method of claim 1 wherein no internal frame is provided in the braided polyethertetraphylate tubular material.
5. The method of claim 1 step d) is performed without substantially degrading the braided, heat setable material.
6. 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;
sealing the inner and outer walls of the tube together at the two cut ends form a seal line;
rolling the tube to place the seal line substantially centrally in the inner wall of the tube;
forming the tube to define a V cross-section providing an eight walled member;
heat setting the eight walled member to retain the V cross-section.
7. The method of claim 6 further comprising:
joining the apecies of the V to form an essentially oval cross-section.
8. The method of claim 7 further comprising following joining of the apices, attaching opposing ends of the tubes to form an annular member.