Device, system, and method for treating cardiac valve regurgitation

• US 20070250160A1
• Filed: 04/21/2006
• Published: 10/25/2007
• Est. Priority Date: 04/21/2006
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Rafiee, Nasser
• Granted Patent: US 7,442,207 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• 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 2017/00243 cardiac
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses

Abstract

A device, a system and a method for treating heart valve regurgitation. The annulus reshaping device comprises a base and a plurality of legs radially arranged there upon. The device can transform from a delivery configuration wherein it is deliverable by catheter to a treatment site, into a deployment configuration, and then a treatment configuration for treating valvular regurgitation. The device is implanted into the annulus of a heart valve, and the legs of the device can be telescopically withdrawn to apply an inward force to the annulus. The system comprises a device slidably received within a catheter. The method of treatment comprises delivering a device to a treatment area, via catheter, releasing the device from the catheter, positioning the legs of the device on a valve annulus, and applying an inward force to the annulus to reduce the regurgitation.

Claims

1. A device for altering the shape of a heart valve annulus, comprising:

a base having an exterior perimeter;

a plurality of legs radially arranged about the exterior perimeter and extending from to the base;

each leg having a proximal end fixed to the base and a distal end;

each leg including a tip engageable with a valve annulus;

each leg further having a first length and a second length and each being capable of transformation between the first length and the second length; and

means for causing the legs to transform between the first length and the second length.

2. The device of claim 1 further comprising an adjustment cord and wherein the legs each further comprises an inner section and an outer section;

the inner section being fixed to the base at a proximal end of the section;

the outer section having the tip located on a distal end thereof;

the inner section and the outer section being slidably connected such that the outer section can telescopically slide along a portion of the inner section; and

the adjustment cord being attached to the outer section.

3. The device of claim 2 wherein the means for causing the legs to transform between the first length and the second length is an adjustment member that is rotatably connected to the base and the adjustment cord is attached to the adjustment member such that when the adjustment member is rotated, the adjustment cord is wrapped around the adjustment member and the tip of the outer section of the legs is drawn toward the base.

4. The device of claim 3 wherein the adjustment member has a ratchet and pawl configuration so that it can only rotate in one direction.

5. The device of claim 1 wherein at least the legs comprise a material selected from a group consisting of a nickel-titanium alloy, a nickel-cobalt alloy, a cobalt alloy, a thermoset plastic, stainless steel, a stainless steel alloy, a biocompatible shape-memory material, a biocompatible material having superelastic properties, a biocompatible material having thermoelastic properties, and a combination thereof.

6. The device of claim 1 wherein the device has a delivery configuration for delivery to location adjacent to a heart valve via a catheter, a deployment configuration, and a treatment configuration.

7. The device of claim 1 wherein the legs are made from a material having shape memory properties and the means for causing the legs to transform from the first deployment length to the second deployment length is a change in temperature.

8. The device of claim 1 wherein the first length of the legs is longer than the second length.

9. The device of claim 1 wherein the plurality of legs is at least four legs.

10. The device of claim 1 wherein at least a portion of the device includes a therapeutic agent selected from a group consisting of an antithrombotic, an anticoagulant, an antibiotic, an anti-inflammatory, and a combination thereof.

11. The device of claim 1 wherein at least a portion of the device is radiopaque.

12. A system for altering the shape of a heart valve annulus, comprising:

a contracting device having a base with an exterior perimeter and a plurality of legs fixed to the base in such a manner that they are radially arranged about the exterior perimeter, each leg having a proximal end fixed to the body and a distal end, each leg including a tip engageable with a valve annulus, the device having a delivery configuration and a deployment configuration, each leg further having a first length and a second length and each being capable of transformation between the first length and the second length, and an adjustment member for causing the legs to transform between the first length and the second length; and

a delivery catheter, wherein the contracting device is slidably received within a lumen of the delivery catheter.

13. The system of claim 12 wherein the delivery catheter comprises a compression device.

14. The system of claim 12 wherein the delivery catheter comprises a guiding sheath, a holding tube slidably received within a lumen of the guiding sheath, and a push tube slidably received within a lumen of the holding tube.

15. The system of claim 12 wherein the legs are in a delivery configuration while the contracting device is within a lumen of the delivery catheter and wherein the legs self-expand to a deployment configuration when the contracting device is released from the delivery catheter.

16. The device of claim 12 wherein at least the legs comprise a material selected from a group consisting of a nickel-titanium alloy, a nickel-cobalt alloy, a cobalt alloy, a thermoset plastic, stainless steel, a stainless steel alloy, a biocompatible shape-memory material, a biocompatible material having superelastic properties, a biocompatible material having thermoelastic properties, and a combination thereof.

17. The device of claim 12 wherein the plurality of legs is at least four legs.

18. The device of claim 12 wherein at least a portion of the device is radiopaque.

19. A method of altering the shape of a heart valve annulus, comprising the steps of:

delivering a device, having legs with a changeable length for altering the shape of the valve annulus, in a lumen of a catheter to a location proximate a treatment area;

releasing the device from the catheter;

transforming the device into a deployment state;

positioning legs of the device on the valve annulus;

engaging the device with the annulus of a valve; and

reducing the length of the legs of the device.

20. The method of claim 19 further comprising the steps of;

providing means for observing the device during the other steps of the method; and

observing the device during the other steps of the method.