Helical coil mitral valve annuloplasty systems and methods

• US 10,028,832 B2
• Filed: 07/10/2014
• Issued: 07/24/2018
• Est. Priority Date: 07/10/2013
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Quill, Jason, Clague, Cynthia, Green, Michael, Hill, Alexander J., Menk, Ana, Rothstein, Paul, Bortlein, Georg
• Primary Examiner(s): David, Shaun L
• Application Number:
  US14/328,050
• Publication Number:
  US 20150018940A1
• Time in Patent Office: 1,475 Days
• Field of Search: None
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00331 with preformed bends
• CPC Class Codes: A61B 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2002/249 Device completely embedded in the heart wall
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section

Abstract

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.

Claims

1. An apparatus for delivering a helical anchor to tissue of a valve annulus comprising:

a catheter having a first lumen and a second lumen, wherein a distal tip of the catheter has an angled surface, and a distal end of the first lumen is disposed distal of a distal end of the second lumen on the angled surface of the distal tip;

a needle slidably disposed within the first lumen and extendable from the distal end of the first lumen, wherein the needle has a lumen that is configured to retain the helical anchor in a straightened state; and

a clip disposed within the second lumen and having a distally-extended position in which the clip is distally extended from the distal end of the second lumen, wherein in the distally-extended position the clip is disposed radially adjacent to the distal end of the first lumen for anchoring the distal tip of the catheter to the valve annulus, whereby when the helical anchor is configured to be deployed from a distal end of the needle into tissue of the valve annulus, the helical anchor is configured to be disposed distal of the clip in the distally-extended position.

2. The apparatus of claim 1, further comprising:

an actuator for distally extending the clip relative to the catheter.

3. The apparatus of claim 2, further comprising:

an actuator for translating the needle relative to the catheter.

4. The apparatus of claim 1, wherein a distal portion of the needle has a preformed bend.

5. The apparatus of claim 1, wherein the clip is a pair of clips having opposing curved ends when in the distally-extended position.

6. The apparatus of claim 1, wherein the needle includes a tracking arm disposed to extend opposite of an outer surface of a distal portion of the needle such that a channel is defined between the outer surface of the needle and an inner surface of the tracking arm for receiving tissue of the valve annulus when the distal portion of the needle is inserted within the valve annulus.

7. The apparatus of claim 1, wherein the needle includes a push rod disposed within the lumen thereof.

8. A system for modifying a valve annulus comprising:

a helical anchor configured to modify the valve annulus, the helical anchor being configured to transition from a straightened, delivery state to a coiled state; and

an apparatus configured to deliver the helical anchor to the valve annulus, the apparatus including,

a catheter having a first lumen and a second lumen, wherein a distal tip of the catheter has an angled surface, and a distal end of the first lumen is disposed distal of a distal end of the second lumen on the angled surface of the distal tip;

a needle slidably disposed within the first lumen and extendable from the distal end of the first lumen, wherein the needle is configured to retain the helical anchor in the straightened, delivery state within a lumen thereof; and

a clip disposed within the second lumen and having a distally-extended position in which the clip is distally extended from the distal end of the second lumen, wherein in the distally-extended position the clip is disposed radially adjacent to the distal end of the first lumen, the clip configured to anchor the distal tip of the catheter to the valve annulus, whereby when the helical anchor is deployed from a distal end of the needle into tissue of the valve annulus, the helical anchor is disposed distal of the clip in the distally-extended position.

9. The system of claim 8, wherein the apparatus further includes an actuator for distally extending the clip relative to the catheter.

10. The system of claim 8, wherein the apparatus further includes an actuator for translating the needle relative to the catheter.

11. The system of claim 8, wherein the helical anchor includes a sharpened tip for penetrating tissue.

12. The system of claim 8, wherein the needle includes a push rod disposed within the lumen thereof to aid in deploying the helical anchor therefrom.

13. The system of claim 8, wherein the clip is a pair of clips having opposing curved ends when in the distally-extended position.