Devices, systems, and methods for reshaping a heart valve annulus, including the use of an adjustable bridge implant system

• US 20060106278A1
• Filed: 10/21/2005
• Published: 05/18/2006
• Est. Priority Date: 05/14/2004
• Status: Abandoned Application

• Current Assignee: MVRx, Inc.
• Original Assignee: Ample Medical, Inc. (MVRx, Inc.)
• Inventors: Machold, Timothy R., Rahdert, David A., Scott, David J., Chang, Robert T., Macoviak, John A., Tholfsen, David Rainone
• Application Number:
  US11/255,529
• Publication Number:
  US 20060106278A1
• Time in Patent Office: Days
• US Class Current: 600/37
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/0485 Devices or means, e.g. loops, for capturing the suture thread and threading it through an opening of a suturing instrument or needle eyelet
• 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 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/00876 magnetic
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/0445 cannulated, e.g. with a longitudinal through-hole for passage of an instrument
• CPC Class Codes: A61B 2017/0451 Cams or wedges holding the suture by friction
• CPC Class Codes: A61B 2017/0453 threaded elements, e.g. set screws
• CPC Class Codes: A61B 2017/0454 the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/0458 : Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0461 : with features cooperating with special features on the suture, e.g. protrusions on the suture
• CPC Class Codes: A61B 2017/0462 : One way system, i.e. also tensioning the suture
• CPC Class Codes: A61B 2017/0464 : for soft tissue
• CPC Class Codes: A61B 2017/0496 : for tensioning sutures
• CPC Class Codes: A61B 2017/06176 : with protrusions, e.g. barbs
• CPC Class Codes: A61F 2/2445 : Annuloplasty rings in direct contact with the valve annulus
• 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 2/2487 : Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2210/009 : magnetic
• CPC Class Codes: A61F 2250/0012 : for adjusting elasticity, flexibility, spring rate or mechanical tension

Abstract

Implants or systems of implants and methods apply a selected force vector or a selected combination of force vectors within or across the left atrium, which allow mitral valve leaflets to better coapt. The implants or systems of implants and methods make possible rapid deployment, facile endovascular delivery, and full intra-atrial adjustability and retrievability years after implant. The implants or systems of implants and methods also make use of strong fluoroscopic landmarks. The implants or systems of implants and methods make use of an adjustable implant and a fixed length implant. The implants or systems of implants and methods may also utilize an adjustable bridge stop to secure the implant, and the methods of implantation employ various tools.

Claims

1. An implant system comprising

a bridging element sized and configured to span a left atrium between a great cardiac vein and an interatrial septum,

a posterior bridge stop coupled to the bridging element and that abuts venous tissue within the great cardiac vein,

an anterior bridge stop coupled to the bridging element and that abuts interatrial septum tissue in the right atrium, and

a bridging element adjustment mechanism to shorten and/or lengthen the bridging element.

2. An implant system according to claim 1

wherein the bridging element is twisted in a first direction to shorten the bridging element and/or the bridging element is twisted in a second direction to lengthen the bridging element.

3. An implant system according to claim 2

wherein the bridging element comprises a ductile material.

4. An implant system according to claim 1

wherein the bridging element further comprises a loop of bridging element, the loop of bridging element doubling the length of the bridging element and provides an adjustment ratio of one half unit to one unit.

5. An implant system according to claim 1

wherein the bridging element comprises braided Nitinol wires and includes an integral bridge stop, the braided Nitinol wires having a first end and a second end, the first end including a preshaped portion to form the integral bridge stop when the bridging element is implanted.

6. An implant system according to claim 5

wherein the preshaped portion comprises a range of about one centimeter to about three centimeters.

7. An implant system according to claim 1

wherein at least one of the posterior bridge stop and the anterior bridge stop includes the bridging element adjustment mechanism.

8. An implant system according to claim 1

wherein the bridging element includes discrete stop beads to allow the bridging element to be adjusted in discrete lengths.

9. A bridge stop according to claim 1

wherein the bridging element comprises a toothed ribbon portion or a perforated ribbon portion or a threaded shaft portion extending through at least a portion of one of the anterior bridge stop and the posterior bridge stop.

10. A bridge stop according to claim 1

wherein the bridging element includes a toothed ribbon portion or a perforated ribbon portion or a threaded shaft portion coupled to the bridging element, the toothed ribbon portion or the perforated ribbon portion or the threaded shaft portion extending through at least a portion of one of the anterior bridge stop and the posterior bridge stop.

11. A bridge stop according to claim 1

the bridging element further including a first edge and a second edge.

12. A bridge stop according to claim 11

wherein at least one of the first edge and second edge includes a toothed pattern.

13. A bridge stop according to claim 11

wherein the first edge includes a toothed pattern and the second edge includes a toothed pattern offset from the toothed pattern on the first edge.

14. A bridge stop according to claim 1

wherein the bridging element includes at least one radio-opaque marker.

15. A bridge stop according to claim 1

wherein the bridging element includes a relocation loop.

16. A bridge stop according to claim 15

wherein the relocation loop includes at least one radio-opaque marker.

17. A bridge stop according to claim 1

wherein the bridging element comprises a metallic material or polymer material or a metallic wire form structure or a polymer wire form structure or suture material or equine pericardium or porcine pericardium or bovine pericardium or preserved mammalian tissue.

18. A system for adjusting the tension of an implant comprising

an implant system as defined in claim 1, and

a catheter having a proximal end and a distal end, the catheter having an adjustment mechanism on its proximal end.

19. A system according to claim 18

further including a relocation loop coupled to the implant system.

20. A system according to claim 18

wherein the catheter adjustment mechanism comprises a hooked tip.

21. A system according to claim 19

wherein the relocation loop includes at least one radio-opaque marker.

22. A method of placing an implant as defined in claim 1 within a left atrium of a heart.

23. A method of adjusting an implant system comprising

providing an implant system as described in claim 1, and

operating the adjustment mechanism to lengthen or to shorten the bridging element.

24. A method according to claim 23 further including

repeating the operating the adjustment mechanism to lengthen or shorten the bridging element until a desired length of the bridging element is achieved.

25. A method according to claim 24 further including

allowing the implant system to settle for a predetermined time before repeating the operating the adjustment mechanism step.

26. A method according to claim 23 further including

coupling a catheter to the bridging element adjustment mechanism, the catheter being used to operate the bridging element adjustment mechanism.

27. A method according to claim 23 further including

coupling a catheter to the bridging element, the catheter being used to lengthen or shorten the bridging element.

28. A method according to claim 23 further including

providing a catheter, the catheter including a proximal end and a distal end, the catheter having a first adjustment mechanism on its proximal end and a second adjustment mechanism on its proximal end,

coupling the first adjustment mechanism to one of the posterior bridge stop and the anterior bridge stop,

coupling the second adjustment mechanism to the bridging element,

operating the first adjustment mechanism to allow adjustment of the bridging element,

operating the second adjustment mechanism to lengthen or shorten the bridging element, and

operating the first adjustment mechanism again to re-secure the bridging element.