Annuloplasty procedures, related devices and methods

• US 10,433,962 B2
• Filed: 10/27/2017
• Issued: 10/08/2019
• Est. Priority Date: 05/06/2016
• Status: Active Grant

• Current Assignee: US Department of Health and Human Services (Government of the United States of America), Transmural Systems LLC
• Original Assignee: Transmural Systems LLC
• Inventors: Rafiee, Nasser, MacDonald, Stuart, Rafiee, Koosha, Busold, Rany, Lederman, Robert J., Rogers, Toby
• Primary Examiner(s): Prone, Christopher D.
• Application Number:
  US15/796,344
• Publication Number:
  US 20180098850A1
• Time in Patent Office: 711 Days
• CPC Class Codes: A61B 17/0467 Instruments for cutting sutures surgical cutting instruments A61B17/32
• 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 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 17/3201 Scissors for biopsy A61B10/02
• CPC Class Codes: A61B 2017/00358 Snares for grasping
• 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 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2230/0045 Omega-shaped
• CPC Class Codes: A61F 2250/0065 telescopic
• CPC Class Codes: A61M 2025/0175 having telescopic features, interengaging nestable members movable in relations to one another
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence

Abstract

Devices and methods are disclosed for the treatment or repair of regurgitant cardiac valves, such as a mitral valve. An illustrative annuloplasty device can be placed in the coronary sinus to reshape the mitral valve and reduce mitral valve regurgitation. An improved protective device can be placed between the annuloplasty device and an underlying coronary artery to inhibit compression of the underlying coronary artery by the annuloplasty device in the coronary sinus. In addition, the protective device can inhibit compression of the coronary artery from inside the heart, such as from a prosthetic mitral valve that exerts radially outward pressure toward the coronary artery. The annuloplasty device can also create an artificial inner ridge or retaining feature projecting into the native mitral valve region to help secure a prosthetic mitral valve.

Claims

1. An implant, comprising:

a) a bridge having a proximal end, a distal end, and an arched portion defined between the proximal end and the distal end of the bridge;

b) an elongate inner tether coupled to the bridge;

c) an outer sheath material having a first end and a second end circumferentially surrounding the bridge and elongate inner tether; and

d) an implant lock, wherein the first and second ends of the outer sheath material are directed through the implant lock.

2. The implant of claim 1, wherein at least one of the elongate inner tether and the outer sheath includes radiopaque material disposed along its length.

3. The implant of claim 2, wherein the elongate inner tether includes a radiopaque wire disposed therein, the radiopaque wire being disposed within a length of heat shrunk polymeric tube that resides within a hollow core of the elongate inner tether.

4. The implant of claim 1, further comprising an outer polymeric tube within the outer sheath material that is shrunk around the bridge and the inner elongate tether, the polymeric tube extending axially beyond the proximal end and the distal end of the bridge.

5. The implant of claim 4, wherein the elongate inner tether passes over a top face of the arched portion of the bridge within the outer polymeric tube and outer sheath material.

6. The implant of claim 4, wherein the outer sheath material is a hollow woven tubular material that extends proximally and distally beyond the outer polymeric tube, and further wherein portions of the outer polymeric tube extending beyond the proximal end and the distal end of the bridge form a strain relief to provide a transition in stiffness of the implant from the bridge to the outer sheath material.

7. The implant of claim 4, wherein the bridge is formed from shape memory material and is configured to change in shape from a first height to a second, lower height to facilitate introduction of the bridge into a percutaneous delivery system.

8. The implant of claim 7, wherein the shape memory material is in the shape of a flattened wire.

9. The implant of claim 1, wherein the implant lock is configured to maintain the length of the outer sheath material when installed in a heart.

10. The implant of claim 9, wherein the implant lock defines at least one distal opening therein, said at least one distal opening being connected to two distally extending tubular limbs for guiding the outer sheath material therethrough.

11. The implant of claim 10, wherein a first of the tubular limbs is configured to traverse the tricuspid valve and includes an atraumatic distal tip formed thereon for distributing axially applied stress across a surface of a native septum after traversing the tricuspid valve, the first tubular limb being configured to permit the outer sheath material to pass therethrough, and further wherein a second of the tubular limbs is configured to traverse the coronary sinus and is configured to permit the outer sheath material to pass therethrough.

12. The implant of claim 11, wherein the first and second tubular limbs are each polymeric tubes preformed with a curvature of about 90 degrees along their lengths to approximate the vascular anatomy that they traverse to reduce applied thereto.

13. The implant of claim 10, wherein at least one of the limbs is an adjustable limb having an adjustable length, wherein the length of said at least one adjustable limb can be adjusted while it is being urged against native anatomy.

14. The implant of claim 10, wherein at least one of said tubular limbs includes at least one radiopaque marker disposed thereon.

15. The implant of claim 14, wherein said at least one radiopaque marker includes a plurality of markers formed along the length of said at least one tubular limb.

16. The implant of claim 1, wherein the outer sheath material has a varying transverse dimension along its length.

17. The implant of claim 16, wherein the outer sheath material has an enlarged width in a region where the bridge is present.