Knotless suture anchoring devices and tools for implants

• US 9,078,645 B2
• Filed: 12/18/2012
• Issued: 07/14/2015
• Est. Priority Date: 12/19/2011
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Conklin, Brian S., Campbell, Louis A., Marquez, Salvador
• Primary Examiner(s): EASTWOOD, DAVID C
• Application Number:
  US13/719,009
• Publication Number:
  US 20130158600A1
• Time in Patent Office: 938 Days
• Field of Search: 606142-144, 606/151, 606/157, 606/232
• US Class Current: 1/1
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0483 Hand-held instruments for holding sutures A61B17/0469 takes precedence; other holders for needles or sutures A61B17/06061; surgical forceps A61B17/28; surgical pincettes A61B17/30
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 2017/0488 Instruments for applying suture clamps, clips or locks for applying suture anchors A61B2017/0409; for applying wound clamps A61B17/10; for applying ligaturing clamps or clips A61B17/128
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2466 Delivery devices therefor

Abstract

Devices for securing prostheses such as heart valves or annuloplasty rings with sutures and without using knots are disclosed. The devices are particularly well suited for traditional surgery or minimally invasive surgery, and improve the ease of implantation by eliminating surgical knots a clinician would normally tie in the limited space in and around the implant site. The devices have opposed the clamp halves surrounded by a coil spring. Sutures pass between the clamp halves and the coil spring has an inner coil diameter sufficient to compress the sutures between the clamp. A retention member positioned between the clamp halves maintains a minimum space and therebetween to enable the locking device to be slid along the sutures into position, and to adjust the tension of the sutures therethrough. A delivery tool may be used to deliver and deploy the locking devices.

Claims

1. A system for locking a device on one or more sutures, comprising:

one or more sutures each having a thickness;

a bifurcated locking clamp including a pair of substantially similar clamp halves each having an exterior surface and an inner surface facing the inner surface of the other clamp half to form a variable sized slot therebetween, the clamp halves being connected for movement toward or away from one another while being fixed axially with respect to one another, wherein the suture(s) extend through the slot between the inner surfaces of the clamp halves;

a biasing member positioned on the outside of the locking clamp having a relaxed size that, in the absence of an object in the slot, urges the inner surfaces of the clamp halves together such that the slot has a width smaller than the suture thickness;

a retention member positioned between the clamp halves against the force of the biasing member and having a thickness that maintains the slot width large enough to permit passage of the suture therethrough, wherein removal of the retention member permits the biasing member to urge the inner surfaces of the clamp halves together and clamp the suture(s) therebetween; and

wherein the clamp halves are hinged together on a first circumferential side such that the variable sized slot defines a variable sized opening on the side opposite the first circumferential side, and wherein the biasing member comprises a plurality of C-clips arranged around the locking clamp with their free ends located on either side of the variable sized slot opposite the first circumferential side.

2. The system of claim 1, wherein the clamp halves are separate elements.

3. The system of claim 1, wherein the clamp halves are hinged together.

4. The system of claim 1, wherein the retention member comprises a retention pin having a head and a shaft.

5. The system of claim 1, wherein the retention member comprises a bifurcated retention clip.

6. The system of claim 1, wherein the clamp halves further include outward flanges on opposite axial ends that retain the biasing member in position around the locking clamp.

7. The system of claim 1, wherein the inner surfaces of the clamp halves possess features to create one-way friction between the clamp halves and the suture(s).

8. The system of claim 1, wherein a maximum radial dimension of the bifurcated locking clamp is about 2 mm or less.

9. The system of claim 1, wherein the clamp halves are molded from a single piece of material with a living hinge on the first circumferential side.

10. The system of claim 1, wherein one end of a suture is fixed with respect to the locking clamp while the other end extends through the slot.

11. A system for locking a device onto at least one suture having a thickness, comprising:

an elongated delivery tool having a proximal end, a distal end, and a delivery tube therebetween having a lumen, the tool further including an elongated tension member that extends along the delivery tube;

a suture locking device positioned on the distal end of the delivery tool having a bifurcated locking clamp including a pair of substantially similar clamp halves each having an exterior surface and an inner surface facing the inner surface of the other clamp half, the clamp halves are fixed axially with respect to one another while being connected for movement toward or away from one another to form a variable sized slot therebetween, wherein the device further includes a biasing member that, in the absence of an object in the slot, urges the inner surfaces of the clamp halves together such that the slot has a width smaller than the suture thickness, wherein the device has a retention member positioned between the clamp halves against the force of the biasing member with a thickness that maintains the slot width large enough to permit passage of a suture therethrough, and wherein removal of the retention member permits the biasing member to urge the inner surfaces of the clamp halves together and clamp the suture(s) therebetween, a distal end of the elongated tension member engaging the retention member to enable tension in the tension member to apply a proximal force to the retention member;

an actuator on the proximal end of the delivery tool that causes relative axial displacement between the retention member and the suture locking device so as to remove the retention member from within the variable sized slot and permit the clamp halves to clamp the suture therebetween; and

wherein the clamp halves are hinged together on a first circumferential side such that the variable sized slot defines a variable sized opening on the side opposite the first circumferential side, and wherein the biasing member comprises a plurality of C-clips arranged around the locking clamp with their free ends located on either side of the variable sized slot opposite the first circumferential side.

12. The system of claim 11, wherein the elongated tension member and retention member are a single element defining a retention cable extending through multiple suture locking devices arranged in series within the delivery tube.

13. The system of claim 12, wherein the actuator on the proximal end of the delivery tool causes proximal displacement of the retention cable relative to the series of suture locking devices.

14. The system of claim 13, further including a pusher tube located within the delivery tube and in contact with a proximal suture locking device in the series of suture locking devices, and further wherein the actuator alternately causes distal displacement of both the pusher tube and the retention cable, and then proximal displacement of the retention cable relative to the series of suture locking devices and to the pusher tube.

15. The system of claim 11, wherein the delivery tube has a longitudinal channel commencing at a distal tip and extending a distance axially along the tube, the series of suture locking devices being oriented so that their variable sized slots are all aligned with the longitudinal channel to permit side entry of a suture into one or more of the slots.

16. The system of claim 11, wherein the delivery tube is formed of a manually malleable material to enable bending by a surgeon, and the tension member is flexible to avoid impeding bending of the delivery tube.

17. The system of claim 11, further including a suture snare that passes from the proximal end to the distal end of the delivery tool and having a capture loop on a distal end, the capture loop extending from the lumen of the delivery tube through the variable sized slot of the suture locking device and being compressible to enable it to be pulled proximally through the slot.

18. The system of claim 11, further including a tensioning assembly affixed to the proximal end of the delivery tool having an anchor for temporarily securing a suture that extends through the delivery tool and through the suture locking device and enables adjustment of the tension in the suture when secured to an implant location beyond the distal end of the delivery tool and suture locking device.