Synthetic chord for cardiac valve repair applications
Synthetic chord devices and methods for using the same for connecting tissues are provided. Aspects of the synthetic chord devices include a first flexible connector having first and second ends. Located at the first end is an attachment element that includes a tissue piercing member coupled to a securing member. The securing member includes an elongated shape memory coil that is present in a removable sheath configured to maintain elongation of the shape memory coil. A reinforcing element is located at the second end. The devices and methods of the invention find use in a variety of applications, such as cardiac valve, e.g., mitral valve, repair.
1. A synthetic chord comprising:
(a) a flexible connector comprising a first end and a second end and an axis along a length between the first end and the second end;
(b) an attachment element comprising a tissue piercing member and a securing member stably associated with the first end of the flexible connector, wherein the securing member comprises an elongated shape memory coil that is present in a removable sheath having a proximal and distal end and configured to maintain elongation of the shape memory coil, and wherein a portion of the elongated shape memory coil is configured to assume a stacked multi-loop configuration with at least two stacked loops looped around the axis when said portion of the elongated shape memory coil is present in a relaxed state outside of the removable sheath;
(c) wherein said at least two stacked loops have a spiraling form, spiraling in opposite directions;
(d) wherein said stacked multi-loop configuration includes a free end opposite an attached end, said attached end attached to said first end of said flexible connector;
(e) wherein said free end of said stacked multi-loop configuration extends radially before extending circumferentially toward said attached end; and
(f) a reinforcing element located at the second end of the flexible connector.
2. The synthetic chord according to claim 1 , wherein the stacked multi-loop configuration comprises two stacked loops.
3. The synthetic chord according to claim 1 , wherein the elongated shape memory coil comprises a shape memory material.
4. The synthetic chord according to claim 3 , wherein the shape memory material is a metal alloy.
5. The synthetic chord according to claim 1 , wherein the elongated shape memory coil comprises a central shape memory wire present in a casing.
6. The synthetic chord according to claim 5 , wherein the casing is fabricated from a material that promotes tissue ingrowth.
7. The synthetic chord according to claim 1 , wherein the tissue piercing member comprises a needle.
8. The synthetic chord according to claim 1 , wherein the securing member and tissue piercing member of the attachment element are separated from each other by a second flexible connector.
9. The synthetic chord according to claim 8 , wherein the distal end of the removable sheath is stably associated with the second flexible connector.
10. The synthetic chord according to claim 1 , wherein prior to deployment in a patient, the securing member has a proximal elongated end present in the removable sheath and a coiled proximal end outside of the proximal end of the removable sheath.
11. The synthetic chord according to claim 1 , wherein the securing member further comprises a stabilizer for maintaining the elongated shape memory coil about tissue upon deployment.
12. The synthetic chord according to claim 11 , wherein the stabilizer comprises a barb.
13. The synthetic chord according to claim 1 , wherein the reinforcing element is a pledget.
14. The synthetic chord of claim 1 , wherein said opposite directions of said at least two stacked loops include a clockwise orientation and a counterclockwise orientation.
15. The synthetic chord of claim 1 , wherein said at least two stacked loops each include a majority of at least one full turn.
16. The synthetic chord of claim 15 , wherein at least one of said at least two stacked loops includes a full turn.
17. The synthetic chord of claim 1 , wherein said at least two stacked loops include an S-curve segment therebetween.
18. A method for connecting a first tissue to a second tissue in a patient, the method comprising:
(a) passing the tissue piercing member of the synthetic chord according to claim 1 through the first tissue so that the reinforcing element contacts the first tissue;
(b) passing the tissue piercing member through the second tissue so that the securing member spans the second tissue;
(c) removing the removable sheath so that the portion of the elongated shape memory coil assumes the stacked multi-loop configuration with at least two stacked loops looped around the axis of the flexible connector with the at least two stacked loops having the spiraling form, spiraling in opposite directions to deploy about the second tissue in a manner sufficient for the synthetic chord to connect the first tissue to the second tissue;
(d) wherein said removing step includes the stacked multi-loop configuration having the free end opposite the attached end, the attached end attached to the first end of the flexible connector, and
(e) wherein said removing step includes the free end of the stacked multi-loop configuration extending radially before extending circumferentially toward the attached end.
19. The method of claim 18 , wherein the opposite directions of the at least two stacked loops include a clockwise orientation and a counterclockwise orientation.
20. A kit comprising: a set of two or more synthetic chords according to claim 1 .