Helical coil mitral valve annuloplasty systems and methods
Systems and methods for modifying a heart valve annulus in a minimally invasive surgical procedure. A helical anchor is provided, having a memory set to a coiled shape or state. The helical anchor is further configured to self-revert from a substantially straight state to the coiled state. The helical anchor is loaded within a needle that constrains the helical anchor to the substantially straight state. The needle is delivered to the valve annulus and inserted into tissue of the annulus. The helical anchor is then deployed from the needle (e.g., the needle is retracted from over the helical anchor). Once deployed, the helical anchor self-transitions toward the coiled shape, cinching engaged tissue of the valve annulus.
1. A method for modifying a heart valve annulus, the method comprising:
inserting a distal tip of a needle within tissue of a valve annulus, wherein a helical anchor is disposed within a lumen of the needle such that the helical anchor is constrained to a substantially straight state, and wherein the helical anchor is configured to self-transition from the substantially straight state to a natural, coiled state; and
deploying the helical anchor from the needle and into the tissue of the valve annulus,
wherein upon deployment from the needle, the helical anchor self-transitions from the substantially straight state to the coiled state to cinch the tissue engaged by the helical anchor.
2. The method of claim 1 , further comprising:
applying RF energy to the helical anchor following the step of deploying the helical anchor.
3. The method of claim 2 , wherein the RF energy heats the helical anchor to thereby cause collagen in the tissue to undergo shape change and modify a shape of the valve annulus.
4. The method of claim 1 , wherein prior to the step of inserting the distal tip of the needle within tissue of the valve annulus, the method further comprising:
positioning a distal end of a catheter having the needle loaded within a first lumen thereof adjacent to the valve annulus;
deploying a clip that is slidably disposed within a second lumen of the catheter into the tissue of the valve annulus to secure the distal end of the catheter relative to the valve annulus; and
deploying the needle from the distal end of the catheter.
5. The method of claim 1 , wherein the step of inserting the distal tip of the needle within tissue of the valve annulus includes capturing a layer of the tissue within a channel defined between a tracking arm of the needle and an outer surface of a distal portion of the needle.
6. The method of claim 1 further comprising:
percutaneously delivering and inserting a first guide wire into the valve annulus at a first location corresponding with a first commissure of the valve annulus to mark the first location;
percutaneously delivering and inserting a second guide wire into the valve annulus at a second location corresponding with a mid-point of a posterior aspect of the valve annulus to mark the second location;
percutaneously delivering and inserting a third guide wire into the valve annulus at a third location corresponding with a second commissure of the valve annulus to mark the third location; and
thereafter performing the step of inserting the distal tip of the needle within the tissue of the valve annulus to deploy the helical anchor into the tissue of the valve annulus based upon the marked first, second and third locations.
7. The method of claim 1 , wherein a push rod is slidably disposed within the lumen of the needle and wherein the step of deploying the helical anchor from the needle and into the tissue of the valve annulus includes withdrawing the needle from around the helical anchor while holding the push rod stationary.
8. The method of claim 1 , wherein the helical anchor is formed of a shape-memory material.
9. The method of claim 1 , wherein the helical anchor is entirely disposed within a thickness of the valve annulus after deployment.
10. The method of claim 1 , wherein the needle is inserted into the tissue to be substantially parallel with a surface of the tissue.