Devices, systems, and methods for reshaping a heart valve annulus

• US 10,219,905 B2
• Filed: 10/21/2016
• Issued: 03/05/2019
• Est. Priority Date: 10/01/2003
• Status: Active Grant

• Current Assignee: MVRx, Inc.
• Original Assignee: MVRx, Inc.
• Inventors: Chang, Robert T., Macoviak, John A., Rahdert, David A., Machold, Timothy R.
• Primary Examiner(s): Stewart, Jason-Dennis
• Application Number:
  US15/299,908
• Publication Number:
  US 20170156864A1
• Time in Patent Office: 865 Days
• 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 17/0487 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 2017/00575 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 for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/00876 magnetic
• CPC Class Codes: A61B 2017/0417 T-fasteners
• 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 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• 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 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• 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 2230/0093 : Umbrella-shaped, e.g. mushroom-shaped
• 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 retrievability. 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 a bridge stop to secure the implant, and the methods of implantation employ various tools.

Claims

1. A bridge stop for securing an implant within a heart of a patient for reshaping a mitral valve annulus, the bridge stop comprising:

an elongate body that is sized and dimensioned for delivery and deployment within a Great Cardiac Vein of the heart, the elongate body being shaped to engage tissue along at least one side of the Great Cardiac Vein;

a reinforcement portion extending longitudinally along at least a portion of the elongate body, the substantially rigid reinforcing portion being disposed on or within the elongate body, wherein the reinforcement portion comprises a reinforcing tube and the elongate body comprises a flexible tube portion along one or both ends, wherein the reinforcing tube is stiffer than the flexible tube portion and the bridge member is attached along the reinforcing tube; and

a bridging element coupled to the elongate body along the reinforcing portion and configured to be tensioned while the bridge stop is disposed within the Great Cardiac Vein so as to reshape the mitral valve annulus.

2. The bridge stop of claim 1, wherein the elongate body is longitudinally curved so as to conform to the Great Cardiac Vein.

3. The bridge stop of claim 1, wherein the elongate body has a pre-determined length within a range of three to eight centimeters.

4. The bridge stop of claim 1, wherein the elongate body is hollow to allow passage of a guidewire therethrough to facilitate delivery to the Great Cardiac Vein.

5. The bridge stop of claim 1, wherein the elongate body comprises a stent that is balloon expandable or self-expanding.

6. The bridge stop of claim 5, wherein the reinforcement portion comprises a reinforcement strut extending along the stent.

7. The bridge stop of claim 5, wherein the stent is C-shaped so as to engage tissue along one side of the Great Cardiac Vein.

8. The bridge stop of claim 1, wherein the elongate body is configured to transition from a delivery configuration to a deployed configuration.

9. The bridge stop of claim 8, wherein the delivery configuration is a radially compressed configuration to facilitate intravascular delivery into the Great Cardiac Vein and the deployed configuration is an expanded configuration in which the elongate body circumferentially engages tissue along at least one half of the Great Cardiac Vein.

10. The bridge stop of claim 1, wherein the reinforcement portion comprises a center reinforcing tube and the elongate body comprises a flexible tube portion along both ends, wherein the reinforcing tube is stiffer than the flexible tube portion and the bridge member is attached along the reinforcing tube.

11. A bridge stop for securing an implant within a heart of a patient for reshaping a mitral valve annulus, the bridge stop comprising:

an elongate body that is sized and dimensioned for delivery and deployment within a Great Cardiac Vein of the heart, the elongate body being shaped to engage tissue along at least one side of the Great Cardiac Vein;

a reinforcement portion extending longitudinally along at least a portion of the elongate body, the substantially rigid reinforcing portion being disposed on or within the elongate body; and

a bridging element coupled to the elongate body along the reinforcing portion and configured to be tensioned while the bridge stop is disposed within the Great Cardiac Vein so as to reshape the mitral valve annulus, wherein attachment of the bridging member is held within, on or around the elongate body, wherein the bridging member is wound around a portion of the elongate body.

12. A bridge stop for securing an implant within a heart of a patient for reshaping a mitral valve annulus, the bridge stop comprising:

an elongate body that is sized and dimensioned for delivery and deployment within a Great Cardiac Vein of the heart, the elongate body being shaped to engage tissue along at least one side of the Great Cardiac Vein;

a reinforcement portion extending longitudinally along at least a portion of the elongate body, the substantially rigid reinforcing portion being disposed on or within the elongate body; and

a bridging element coupled to the elongate body along the reinforcing portion and configured to be tensioned while the bridge stop is disposed within the Great Cardiac Vein so as to reshape the mitral valve annulus, wherein attachment of the bridging member is held within, on or around the elongate body, wherein the bridging member is attached to a plate secured to the elongate body.

13. A bridge stop for securing an implant within a heart of a patient for reshaping a mitral valve annulus, the bridge stop comprising:

an elongate body that is sized and dimensioned for delivery and deployment within a Great Cardiac Vein of the heart, the elongate body being shaped to engage tissue along at least one side of the Great Cardiac Vein;

a reinforcement portion extending longitudinally along at least a portion of the elongate body, the substantially rigid reinforcing portion being disposed on or within the elongate body; and

a bridging element coupled to the elongate body along the reinforcing portion and configured to be tensioned while the bridge stop is disposed within the Great Cardiac Vein so as to reshape the mitral valve annulus, wherein attachment of the bridging member is held within, on or around the elongate body, wherein the elongate body is attached to the bridging element by a joint configured to allow movement of the bridging element relative the elongate body.

14. An implant system for treating a mitral heart valve of a heart having a cardiac cycle, the system comprising:

an anterior bridge stop configured to be positioned at a desired location within the heart of a patient;

a posterior bridge stop comprising an elongate body that is sized and dimensioned for delivery and deployment in a Great Cardiac Vein of the patient, the elongate body being shaped to engage tissue along one half of the Great Cardiac Vein and including a reinforcing portion that is substantially rigid and extends longitudinally along at least a portion of the elongate body and;

a bridging element adapted to span a left atrium of the heart between the anterior bridge stop and the posterior bridge stop and maintain sufficient tension therebetween during at least a portion of the cardiac cycle so as to provide a desired spacing between the anterior bridge stop and posterior bridge stop thereby reshaping the left atrium so as to improve function of the mitral heart valve, wherein the bridging element is attached to the posterior bridge stop along a reinforcement portion at a joint that allows for relative movement between the bridging element and the elongate body.

15. The system of claim 14, wherein the elongate body of the posterior bridge stop comprises a stent and the reinforcement portion comprises a reinforcement strut that extends along the stent and that is attached to the bridging element.