Devices for adjusting the curvature of cardiac valve structures

• US 10,363,138 B2
• Filed: 11/09/2016
• Issued: 07/30/2019
• Est. Priority Date: 11/09/2016
• Status: Active Grant

• Current Assignee: Evalve, Inc. (Abbott Laboratories)
• Original Assignee: Evalve, Inc. (Abbott Laboratories)
• Inventors: Prabhu, Santosh V.
• Primary Examiner(s): Lynch, Robert A
• Application Number:
  US15/347,543
• Publication Number:
  US 20180125658A1
• Time in Patent Office: 993 Days
• 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 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0061 swellable
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2250/0004 adjustable
• CPC Class Codes: A61F 2250/001 for adjusting a diameter

Abstract

An interventional curvature device for temporarily adjusting the structure of a heart during a heart valve repair procedure in order to enhance the effectiveness of the heart valve repair procedure. The curvature device is adjustable between a collapsed configuration with a profile suitable for delivery of the device to a coronary sinus and great cardiac vein of a patient, and an expanded configuration for lodging of the device at the coronary sinus and great cardiac vein. The curvature device has a distal section that anchors within the great cardiac vein, and a proximal section that anchors within the coronary sinus. A tether is coupled to the distal end of the device and extends through the device and past the proximal end. An increase in tension in the tether increases the curvature of the device.

Claims

1. An interventional system for temporarily adjusting the structure of a heart, the system comprising:

a curvature device moveable between a collapsed configuration having a profile suitable for delivery of the device to a coronary sinus and great cardiac vein of a patient and an expanded configuration having a profile suitable for lodging of the device at the coronary sinus and great cardiac vein, the curvature device including;

a distal end section, at least a portion of the distal end section being configured to anchor within the great cardiac vein when deployed to the expanded position at the great cardiac vein;

a proximal end section, at least a portion of the proximal end section being configured to anchor within the coronary sinus when deployed to the expanded position at the coronary sinus; and

a tether disposed at the distal end section and extending through and past the proximal end section, the tether being tensionable such that an increase in tension increases the curvature of the device, and a release of tension lessens the curvature of the device,

a delivery catheter having a proximal end and a distal end, the delivery catheter including a sheath at the distal end configured to house the curvature device to maintain the curvature device in the collapsed configuration while housed within the sheath; and

a handle coupled to the proximal end of the delivery catheter, the tether extending to the handle, the handle including a tether control operatively coupled to the tether to enable adjusting of tension in the tether through actuation of the control and including a deployment control operatively coupled to the sheath or curvature device to enable proximal retraction of the sheath or distal pushing of the curvature device.

2. The interventional system of claim 1, wherein the curvature device is at least partially formed from a shape memory material that enables the device to self-expand to the expanded configuration when not constrained to the collapsed configuration.

3. The interventional system of claim 1, wherein the curvature device is at least partially formed as a balloon structure capable of being filled with a fluid to move toward the expanded configuration and withdrawn of fluid to move toward the collapsed configuration.

4. The interventional system of claim 1, wherein the proximal end section includes an anchoring structure having an aperture through which the tether passes.

5. The interventional system of claim 1, wherein the curvature device is formed at least partially from one or more bioresorbable materials.

6. The interventional system of claim 1, wherein the curvature device is formed so as to have one or more lumens when in the expanded configuration so as to allow the passage of blood through the one or more lumens.

7. The interventional system of claim 1, wherein at least a portion of the distal end section and proximal end section include tines for enhancing grip of targeted vasculature when the curvature device is deployed at the targeted vasculature.

8. The interventional system of claim 1, the delivery system further comprising one or more control lines extending from the handle to the distal end of the delivery catheter such that tensioning of the one or more control lines acts to bend the distal end of the delivery catheter to provide steering functionality to the delivery catheter.

9. The interventional system of claim 1, wherein the sheath is proximally retractable relative to the housed curvature device.

10. A method for temporarily adjusting the structure of a heart to enable more effective treatment of the heart, the method comprising:

delivering a curvature device to a coronary sinus and great cardiac vein of the heart with a delivery system, the delivery system comprising;

a delivery catheter having a proximal end and a distal end, the delivery catheter including a sheath at the distal end configured to house the curvature device to maintain the curvature device in the collapsed configuration while housed within the sheath; and

a handle coupled to the proximal end of the delivery catheter, a tether extending to the handle, the handle including a tether control operatively coupled to the tether to enable adjusting of tension in the tether through actuation of the control and including a deployment control operatively coupled to the sheath or curvature device to enable proximal retraction of the sheath or distal pushing of the curvature device;

deploying the curvature device such that a distal end section of the curvature device lodges within the great cardiac vein and such that a proximal end section of the curvature device lodges within the coronary sinus; and

tensioning the tether of the curvature device, the tether being coupled to the distal end section and passing through the proximal end section such that the tensioning causes the distal end section to bend toward the proximal end section to increase the curvature of the curvature device.

11. The method of claim 10, wherein the curvature device is delivered to the great cardiac vein and the coronary sinus by first routing a guidewire to the coronary sinus and the great cardiac vein, and subsequently routing a delivery system housing the curvature device along the guidewire.

12. The method of claim 10, wherein the curvature device is delivered using a transjugular approach or a transfemoral approach.

13. The method of claim 10, wherein the curvature device is at least partially formed from a shape memory material that enables the device to self-expand to the expanded configuration when not constrained to the collapsed configuration.

14. The method of claim 10, further comprising releasing tension in the tether to lessen the curvature of the curvature device, and removing the curvature device from the great coronary vein and the coronary sinus.

15. The method of claim 10, wherein the method enhances the effectiveness of a mitral valve treatment by causing a posterior leaflet of the mitral valve to be moved closer to an anterior leaflet of the mitral valve in an enhanced structural configuration, the method further comprising treating the mitral valve while the curvature device is used to hold the mitral valve in the enhanced structural configuration.

16. The method of claim 15, wherein treating the mitral valve includes deploying an interventional clip to grasp the posterior and anterior leaflets.

17. The method of claim 15, further comprising removing the curvature device from the great cardiac vein and the coronary sinus.

18. An interventional system for temporarily adjusting the structure of a heart, the system comprising:

a curvature device moveable between a collapsed configuration having a profile suitable for delivery of the device to a coronary sinus and great cardiac vein of a patient and an expanded configuration having a profile suitable for lodging of the device at the coronary sinus and great cardiac vein, the curvature device including;

a distal end section, at least a portion of the distal end section being configured to anchor within the great cardiac vein when deployed to the expanded position at the great cardiac vein; and

a proximal end section, at least a portion of the proximal end section being configured to anchor within the coronary sinus when deployed to the expanded position at the coronary sinus,

wherein the curvature device has a curvature such that when deployed to the expanded configuration the curvature device is able to abut against at least a portion of the great cardiac vein and coronary sinus to increase anatomical curvature of the great cardiac vein and coronary sinus,

a delivery catheter having a proximal end and a distal end, the delivery catheter including a sheath at the distal end configured to house the curvature device to maintain the curvature device in the collapsed configuration while housed within the sheath; and

a handle coupled to the proximal end of the delivery catheter, the tether extending to the handle, the handle including a tether control operatively coupled to the tether to enable adjusting of tension in the tether through actuation of the control and including a deployment control operatively coupled to the sheath or curvature device to enable proximal retraction of the sheath or distal pushing of the curvature device.