Tissue restraining devices and methods of use

• US 9,198,756 B2
• Filed: 05/20/2012
• Issued: 12/01/2015
• Est. Priority Date: 11/18/2010
• Status: Expired due to Fees

• Current Assignee: Pavilion Medical Innovations, LLC
• Original Assignee: Pavilion Medical Innovations, LLC
• Inventors: Aklog, Lishan, deGuzman, Brian
• Primary Examiner(s): DUKERT, BRIAN AINSLEY
• Application Number:
  US13/476,010
• Publication Number:
  US 20120290077A1
• Time in Patent Office: 1,290 Days
• Field of Search: 623/2.36, 623/2.37
• 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 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61F 2/2451 Inserts in the coronary sinus for correcting the valve shape
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2466 Delivery devices therefor

Abstract

Tissue restraining systems and devices as well as methods of using these devices are disclosed herein. According to aspects illustrated herein, there is provided a tissue restraining device that may include an annuloplasty member having one or more contact points along a portion of the annuloplasty member in a spaced relation to one another. The tissue restraining device may also include a second anchor for placement in a substantially opposing, spaced relation to the annuloplasty member. A restraining matrix may extend from the contact points of the annuloplasty member to the second anchor.

Claims

1. A tissue restraining device comprising:

an annuloplasty member for attachment to a valve annulus of a cardiac valve, the annuloplasty member defining an opening;

an anchor having a loop and situated in a spaced relation to the annuloplasty member on an opposite side of the cardiac valve;

a plurality of restraining cords forming a restraining matrix extending from the annuloplasty member into the opening and toward the anchor so that when the tissue restraining device is implanted, the restraining matrix is draped over a leaflet of the cardiac valve, the restraining cords converging at their distal ends to form an apex between the annuloplasty member and the anchor; and

a tensioning strand extending distally from the apex of the restraining matrix, passing through the loop, and extending through the annuloplasty member so the restraining matrix is adjustable as a single unit to change a tension in the restraining matrix.

2. The device of claim 1, wherein each restraining cord of the plurality of restraining cords is removably attached at or proximally to a longitudinal end of the annuloplasty member to change the tension in the restraining matrix.

3. The device of claim 2, wherein the plurality of restraining cords are individually adjustable to change a tension in the restraining matrix.

4. The device of claim 1, wherein the annuloplasty member includes a second tensioning strand to provide a tying point for the tensioning strand.

5. The device of claim 1, wherein the annuloplasty member is configured to be implanted substantially along an annulus of a mitral valve, the anchor is configured to be implanted in a left ventricle, and, when the restraining device is implanted into the mitral valve, the restraining matrix is extended between the annuloplasty member and the anchor to drape over the leaflet.

6. The device of claim 1, wherein the annuloplasty member includes one or more inner lumen and a plurality of openings in communication with the one or more inner lumen to allow the plurality of restraining cords to be passed through the one or more inner lumen of the annuloplasty member and out of the plurality of openings to form the restraining matrix.

7. The device of claim 1, wherein the restraining matrix further comprises cross-restraint members extending between the plurality of the restraining cords.

16. The device of claim 1, wherein each restraining cord of the plurality of the restraining cords extends through an opening of an inner lumen positioned along at least a portion of the annuloplasty member, and extends through the annuloplasty member, so each restraining cord of the plurality of the restraining cords is individually adjustable at or proximally of the annuloplasty member to change the tension in the restraining matrix.

17. The device of claim 1, wherein a second tensioning strand is fixed on the annuloplasty member, the tensioning strand and second tensioning strand are joined to adjustably change the tension in the restraining matrix, at or proximally of the annuloplasty member.

18. The device of claim 1, wherein a chain of loops extends from a distal end of the restraining matrix and the anchor includes at least one hook, such that a loop of the chain of loops is capable of being hooked into the at least one hook, so as to be capable of changing the tension in the restraining matrix from the distal direction of the restraining matrix.

8. A kit for restraining tissue comprising:

a restraining matrix formed by a plurality of restraining cords,

wherein the plurality of restraining cords are spread out at a proximal end of the restraining matrix and are collected together at a distal end of the restraining matrix to form an apex between an annuloplasty member and an anchor so that the proximal end is broader than the distal end;

an attachment member disposed at the proximal end of the restraining matrix and designed to removably attach to an annuloplasty ring,

the anchor having a loop and attached to the distal end of the restraining matrix; and

a tensioning strand extending distally from the apex of the restraining matrix, and to pass through the loop, and extend through the annuloplasty member so the restraining matrix is adjustable as a single unit to change a tension in the restraining matrix.

9. The kit of claim 8 wherein the attachment member includes a plurality of hooks for insertion into the annuloplasty ring to attach the restraining matrix to the annuloplasty ring.

10. The kit of claim 8, wherein the restraining matrix is formed by the plurality of restraining cords, each restraining cord of the plurality of cords is in communication with an opening spaced apart, evenly or unevenly, from one another along a posterior section of the annuloplasty ring.

11. A tissue restraining device comprising:

an annuloplasty member for attachment to a valve annulus of a valve, the annuloplasty member having a bottom side to contact the valve annulus, a top side opposite the bottom side, and an inner sidewall and an outer sidewalls connecting the bottom side and the top side;

an anchor situated in a spaced relation to the annuloplasty member;

a restraining matrix formed by a plurality of restraining cords extending from the inner sidewall of the annuloplasty member toward the anchor, the restraining cords converging at their distal ends to form an apex between the annuloplasty member and the anchor; and

a tensioning strand extending distally from the apex of the restraining matrix through the anchor and proximally of the annuloplasty member so the restraining matrix is adjustable as a single unit for changing a tension in the restraining matrix proximally to or at the annuloplasty member from a distal direction of the restraining matrix.

12. The device of claim 11, wherein the annuloplasty member includes one or more inner lumen and a plurality of openings disposed along the inner sidewall in communication with the one or more inner lumen to allow the plurality of restraining cords to be passed through the one or more inner lumen of the ring and out of the plurality of openings to form the restraining matrix.

13. The device of claim 11, wherein the tensioning strand extends distally from the restraining matrix, passes through a loop of the anchor, and extends through the annuloplasty member to change the tension in the restraining matrix.

14. The device of claim 11, wherein a second tensioning strand is fixed on the annuloplasty member, the tensioning strand and second tensioning strand are joined to adjustably change the tension in the restraining matrix, at or proximally of the annuloplasty member.

15. The device of claim 11, wherein a chain of loops extends from a distal end of the restraining matrix and the anchor includes at least one hook, such that a loop of the chain of loops is capable of being hooked into the at least one hook, so to change the tension in the restraining matrix from the distal direction of the restraining matrix.