Mitral valve spacer device

• US 10,646,342 B1
• Filed: 01/03/2020
• Issued: 05/12/2020
• Est. Priority Date: 05/10/2017
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Marr, Devin H., Delgado, Sergio, Dixon, Eric Robert, Taylor, David M., Metchik, Asher L., Winston, Matthew T.
• Primary Examiner(s): Woo, Julian W
• Application Number:
  US16/733,659
• Publication Number:
  US 20200138567A1
• Time in Patent Office: 130 Days
• CPC Class Codes: A61B 17/1227 Spring clips
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2463 Implants forming part of the valve leaflets
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Abstract

A delivery system includes an elongate shaft, a handle, a first clasp control member, a second clasp control member, and an actuator. The handle is connected to a proximal portion of the elongate shaft. The first and second clasp control members each extend into a distal portion of the elongate shaft, through at least a portion of the elongate shaft, out of the proximal portion of the elongate shaft, and through the handle. The actuator is coupled to the handle and has a first side portion connected to the first clasp control and a second side portion connected to the second clasp control. The first side portion and the second side portion are releasably couplable such that when the first side portion and the second side portion are coupled, proximal movement of the actuator proximally pulls both the first clasp control member and the second clasp control member, and such that when the first side portion and the second side portion are uncoupled, individual proximal movements of the first side portion and the second side portion independently pull the first clasp control member and the second clasp control member, respectively.

Claims

1. A delivery system comprising:

an elongate shaft having a proximal portion and a distal portion;

a handle connected to the proximal portion of the elongate shaft;

a first clasp control member that extends into the distal portion of the elongate shaft, through at least a portion of the elongate shaft, out of the proximal portion of the elongate shaft, and through the handle;

a second clasp control member that extends into the distal portion of the elongate shaft, through the elongate shaft, out of the proximal portion of the elongate shaft, and through the handle;

an actuator coupled to the handle, the actuator comprising

a first side portion connected to the first clasp control member; and

a second side portion connected to the second clasp control member;

wherein the first side portion and the second side portion are releasably couplable such that when the first side portion and the second side portion are coupled, proximal movement of the actuator proximally pulls both the first clasp control member and the second clasp control member, and such that when the first side portion and the second side portion are uncoupled, individual proximal movements of the first side portion and the second side portion independently pull the first clasp control member and the second clasp control member, respectively.

2. The delivery system of claim 1 wherein the first clasp control member comprises a suture.

3. The delivery system of claim 1 wherein the first side portion and the second side portion are releasably connected by a pin.

4. The delivery system of claim 1 wherein the first side portion and the second side portion are constrained to proximal and distal movement relative to one another when the first side portion and the second side portion are released.

5. The delivery system of claim 1 wherein the first clasp control member extends through a first control member lumen in the handle, and the second clasp control member extends through a second control member lumen in the handle.

6. The delivery system of claim 5 wherein at least a portion of the first control member lumen extends proximally at an angle toward the second control member lumen.

7. The delivery system of claim 1 wherein the elongate shaft is flexible.

8. The delivery system of claim 1 further comprising an anchor actuation shaft in a lumen of the elongate shaft, wherein the anchor actuation shaft extends out of the proximal portion of the elongate shaft, and wherein the anchor actuation shaft extends out of the distal portion of the elongate shaft.

9. A delivery assembly comprising:

a first clasp that is moveable between an open position and a closed position, wherein the first clasp is configured to be securable to a first native valve leaflet by moving the first clasp from the open position to the closed position of the first clasp;

a first clasp control member coupled to the first clasp, wherein applying tension to the first clasp control member moves the first clasp to the open position;

a second clasp that is moveable between an open position and a closed position, wherein the second clasp is configured to secure a second native valve leaflet by moving the second clasp from the open position to the closed position of the second clasp;

a second clasp control member coupled to the second clasp, wherein applying tension to the second clasp control member moves the second clasp to the open position;

an elongate shaft having a proximal portion and a distal portion;

a handle connected to the proximal portion of the elongate shaft;

wherein the first clasp control member extends from the first clasp, into the distal portion of the elongate shaft, through the elongate shaft, out of the proximal portion of the elongate shaft, and through the handle;

wherein the second clasp control member extends from the second clasp, into the distal portion of the elongate shaft, through the elongate shaft, out of the proximal portion of the elongate shaft, and through the handle;

an actuator coupled to the handle, the actuator comprising

a first side portion connected to the first clasp control member; and

a second side portion connected to the second clasp control member;

wherein the first side portion and the second side portion are releasably couplable such that when the first side portion and the second side portion are coupled, proximal movement of the actuator proximally tensions both the first clasp control member and the second clasp control member to move both the first and second clasps to the open position, and such that when the first side portion and the second side portions are uncoupled, individual proximal movements of the first side portion and the second side portion individually tension the first clasp control member and the second clasp control member to independently open the first and second clasps, respectively.

10. The delivery assembly of claim 9 wherein the first clasp control member comprises a suture.

11. The delivery assembly of claim 9 wherein the first side portion and the second side portion are releasably connected by a pin.

12. The delivery assembly of claim 9 wherein the first side portion and the second side portion are constrained to proximal and distal movement relative to one another when the first side portion and the second side portion are released.

13. The delivery assembly of claim 9 wherein the first clasp control member extends through a first control member lumen in the handle, and the second clasp control member extends through a second control member lumen in the handle.

14. The delivery assembly of claim 13 wherein at least a portion of the first control member lumen extends proximally at an angle toward the second control member lumen.

15. The delivery assembly of claim 9 wherein the elongate shaft is flexible.

16. The delivery assembly of claim 9 wherein the first clasp and the second clasp are coupled to a spacer.

17. The delivery assembly of claim 9 further comprising an anchor actuation shaft in a lumen of the elongate shaft, wherein the anchor actuation shaft extends out of the proximal portion of the elongate shaft, and wherein the anchor actuation shaft extends out of the distal portion of the elongate shaft.

18. A delivery assembly comprising:

a pair of anchors that are moveable between an open position and a closed position;

an anchor actuation shaft operably coupled to the pair of anchors;

a first clasp that is moveable between an open position and a closed position;

a first clasp control member coupled to the first clasp configured such that applying tension to the first clasp control member moves the first clasp to the open position;

a second clasp that is moveable between an open position and a closed position,

a second clasp control member coupled to the second clasp configured such that applying tension to the second clasp control member moves the second clasp to the open position;

an elongate shaft having a proximal portion and a distal portion;

a handle connected to the proximal portion of the elongate shaft;

wherein the anchor actuation shaft extends into the distal portion of the elongate shaft, through the elongate shaft, out of the proximal portion of the elongate shaft, and into the handle;

wherein axial movement of the anchor actuation shaft relative to the elongate shaft moves the pair of anchors between the open position and the closed position;

wherein the first clasp control member extends from the first clasp, into the distal portion of the elongate shaft, through the elongate shaft, out of the proximal portion of the elongate shaft, and through the handle;

wherein the second clasp control member extends from the second clasp, into the distal portion of the elongate shaft, through the elongate shaft, out of the proximal portion of the elongate shaft, and through the handle;

an actuator coupled to the handle, the actuator comprising;

a first side portion connected to the first clasp control member; and

a second side portion connected to the second clasp control member;

wherein the first side portion and the second side portion are releasably couplable such that when the first side portion and the second side portion are coupled, proximal movement of the actuator proximally tensions both the first clasp control member and the second clasp control member to move both the first and second clasps to the open position, and such that when the first side portion and the second side portions are uncoupled, individual proximal movements of the first side portion and the second side portion individually tension the first clasp control member and the second clasp control member to independently open the first and second clasps, respectively.

19. The delivery assembly of claim 18 wherein the first clasp control member extends through a first control member lumen in the handle, the second clasp control member extends through a second control member lumen in the handle, and at least a portion of the first control member lumen extends proximally at an angle toward the second control member lumen.

20. The delivery assembly of claim 18 wherein the first clasp control member extends through a first control member lumen in the handle;

wherein the second clasp control member extends through a second control member lumen in the handle;

wherein the anchor actuation shaft extends through an anchor actuation shaft lumen in the handle;

wherein a first portion of the first control member lumen is parallel to the anchor actuation shaft lumen; and

wherein a second portion of the first control member lumen extends at an angle relative to the anchor actuation shaft lumen.