Methods of delivering a flexible annuloplasty ring

• US 10,182,912 B2
• Filed: 04/29/2016
• Issued: 01/22/2019
• Est. Priority Date: 08/24/2010
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Migliazza, John F., Crockett, Bob, Abram, Tim
• Primary Examiner(s): Sharma, Yashita
• Application Number:
  US15/143,332
• Publication Number:
  US 20160317303A1
• Time in Patent Office: 998 Days
• Field of Search: 623 236- 241, 600 37, 606139, 606151-158
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility

Abstract

An annuloplasty repair segment for heart valve annulus repair. In one embodiment a multi-stranded cable replaces solid core wire for both the triscuspid and mitral valves. Cable allows for greater deployment flexibility for minimally-invasive surgical (MIS) implant, while still maintaining the required strength and similar tensile properties of solid-core wire. In addition, selective placement of point-welds or other such control points locally control other parameters such as the amount and direction of displacement as the ring undergoes external loading. Cable with well-placed control points result in a MIS annuloplasty ring with sufficient flexibility in the x-y plane to allow a surgeon to squeeze the ring into a small incision, such as for example 1 cm×1 cm, while maintaining structural rigidity under forces exerted on the implanted ring by the cardiac cycle and allowing for asymmetrical deflection to be designed into the product.

Claims

1. A method of delivering a flexible annuloplasty ring to a native annulus of a native heart valve of a heart, comprising:

obtaining a flexible annuloplasty ring having an elastic inner core member defined by a braided cable formed of multiple metallic wire strands, the inner core member having a pre-existing closed or open unstressed ring shape, and the inner core member having a majority of its length with a first elastic modulus that enables the core member to be compressed from the unstressed ring shape into a stressed narrow shape and to reshape the native annulus and maintain the native annulus in an altered shape;

converting the annuloplasty ring from the unstressed ring shape into the stressed narrow shape;

passing the annuloplasty ring in the stressed narrow shape through an access tube positioned with a distal tip adjacent the native annulus;

expelling the annuloplasty ring from the distal tip of the access tube so that it self-converts back towards the unstressed ring shape;

guiding the annuloplasty ring during the step of expelling to deploy the annuloplasty ring around the native annulus; and

securing the annuloplasty ring to the native annulus.

2. The method of claim 1, wherein the flexible annuloplasty ring further includes an outer covering of suture-permeable material closely encasing the elastic inner core member, and the step of securing includes securing the outer covering to the native annulus.

3. The method of claim 2, wherein the step of securing the outer covering to the native annulus includes sewing the outer covering to the native annulus.

4. The method of claim 1, wherein the step of guiding includes applying a force to a distal tip of the annuloplasty ring in its stressed narrow shape with a guide wire as it is expelled from the access tube so as to guide the distal tip in a particular direction.

5. The method of claim 4, further including detaching the guide wire from the distal tip of the annuloplasty ring after the step of securing and removing the guide wire in conjunction with the access tube.

6. The method of claim 4, wherein the guide wire passes through a midportion of the annuloplasty ring so as to deflect just a distal section of the annuloplasty ring.

7. The method of claim 1, wherein the annuloplasty ring has an open shape with two free ends and the stressed narrow shape consists of the annuloplasty ring being elongated within the access tube so that the two free ends are oppositely oriented within the tube, and wherein the elongated guide element is a corkscrew-shaped guide wire, and the step of guiding includes pushing the corkscrew-shaped guide wire out of the access tube and then pushing and rotating the annuloplasty ring from the access tube so that it coils around the guide wire and assumes an implant shape.

8. The method of claim 1, wherein the annuloplasty ring has a closed shape, and wherein the access tube has a distal portion and a proximal portion, and wherein the proximal portion is flexible to enable bending during delivery to the implantation site while the distal portion is more rigid than the proximal portion and the annuloplasty ring is positioned in its stressed narrow shape in the distal portion.

9. The method of claim 1, wherein the step of expelling includes peeling away one side of the access tube to form an axial opening such that the annuloplasty ring expands through the axial opening and self-converts back towards its unstressed ring shape.

10. The method of claim 9, wherein the step of peeling away one side of the access tube comprises pulling proximally a thin filament embedded in the side of the access tube to form the axial opening.

11. The method of claim 1, further including at least one control point positioned around the periphery of the annuloplasty ring that defines a segment around the periphery of the annuloplasty ring that is less flexible than locations without the control point.

12. The method of claim 1, wherein the braided cable is a multi-stranded braided cable formed of multiple metallic wire strands wound into multi-strand braids with the multi-strand braids being braided into the multi-stranded braided cable.

13. The method of claim 1, wherein the multi-stranded braided cable has at least seven multi-strand braids in cross-section.

14. The method of claim 13, wherein the multi-stranded braided cable has a 7×

7 cross-sectional braid pattern.

15. The method of claim 13, wherein the multi-stranded braided cable has a 7×

19 cross-sectional braid pattern.

16. The method of claim 13, wherein the multi-stranded braided cable has a 19×

7 cross-sectional braid pattern.

17. The method of claim 13, wherein the multi-stranded braided cable has a 7×

7×

7 cross-sectional braid pattern.

18. The method of claim 1, wherein the multi-stranded braided cable comprises strands of at least two different metals braided together.

19. The method of claim 1, wherein the elastic inner core member makes up a majority of the cross-sectional area of the flexible annuloplasty ring.

20. The method of claim 1, wherein the inner core member in the unstressed ring shape is sufficiently rigid to reshape the native annulus.