APPARATUS, SYSTEM, AND METHOD FOR TREATING A REGURGITANT HEART VALVE

• US 20130190798A1
• Filed: 07/27/2012
• Published: 07/25/2013
• Est. Priority Date: 07/27/2011
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Kapadia, Samir
• Granted Patent: US 9,161,837 B2
• Time in Patent Office: Days
• US Class Current: 606/195
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2250/0004 adjustable
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

An apparatus for treating regurgitation of blood through a diseased heart valve having at least two leaflets includes a lollipop-shaped body member having a proximal end portion, a distal end portion, and an intermediate portion extending between the end portions. The intermediate portion includes an expandable occluding member having an adjustable diameter so that, during at least a portion of the cardiac cycle, at least one of the heart leaflet coapts with a portion of the occluding member to mitigate or prevent regurgitation of blood through the diseased heart valve. The proximal end portion is physically connected to the occluding member and includes a connecting mechanism for operably mating with an adjustment member for adjusting the position and diameter of the occluding member within the diseased heart valve. The distal end portion includes an anchoring member for securing the apparatus in a heart chamber containing the diseased heart valve.

Claims

1. An apparatus for treating regurgitation of blood through a diseased heart valve having at least two leaflets, said apparatus comprising:

a lollipop-shaped body member having a proximal end portion, a distal end portion, and an intermediate portion extending between said proximal and distal end portions;

said intermediate portion including an expandable occluding member having an adjustable diameter so that, during at least a portion of the cardiac cycle, at least one of the heart leaflet coapts with a portion of said occluding member to mitigate or prevent regurgitation of blood through the diseased heart valve;

said proximal end portion being physically connected to said occluding member and including a connecting mechanism for operably mating with an adjustment member for adjusting the position and diameter of said occluding member within the diseased heart valve;

said distal end portion including an anchoring member for securing said apparatus in a heart chamber containing the diseased heart valve.

2. The apparatus of claim 1, further including an adjustment mechanism comprising:

a compressible tube member extending axially through said occluding member; and

a threaded wire having first and second ends, said first end being disposed within said tube member and said second end being securely connected to said anchoring member.

3. The apparatus of claim 1, wherein said proximal end portion further comprises an expandable support member for anchoring in a blood vessel surrounding the heart chamber.

4. The apparatus of claim 1, wherein said anchoring member includes a spiral-shaped member having a sharpened tip for embedding into a heart wall surrounding the diseased heart valve.

5. The apparatus of claim 1, wherein said adjustment member comprises:

an elongated body having a proximal control end and a distal connecting end for mating with said connecting mechanism;

said proximal control end including first and second handle members, said first handle member for controlling the position of said occluding member relative to the diseased heart valve, and said second handle member for controlling the diameter of said occluding member.

6. The apparatus of claim 1, further including a biocompatible layer that extends circumferentially about said occluding member.

7. The apparatus of claim 6, wherein said biocompatible layer extends circumferentially between a center portion and a second end of said occluding member.

8. A system for treating regurgitation of blood through a diseased heart valve having at least two leaflets, said system comprising:

a lollipop-shaped body member having a proximal end portion, a distal end portion, and an intermediate portion extending between said proximal and distal end portions; and

an adjustment member including an elongated body having a proximal control end and a distal connecting end for mating with a connecting mechanism of said body member;

said intermediate portion including an expandable occluding member having an adjustable diameter so that, during at least a portion of the cardiac cycle, at least one of the heart leaflet coapts with a portion of said occluding member to mitigate or prevent regurgitation of blood through the diseased heart valve;

said proximal end portion being physically connected to said occluding member and including said connecting mechanism for operably mating with said adjustment member and for adjusting the position and diameter of said occluding member within the diseased heart valve;

said distal end portion including an anchoring member for securing said apparatus in a heart chamber containing the diseased heart valve.

9. The system of claim 8, wherein said adjustment mechanism further comprises:

a compressible tube member extending axially through said occluding member; and

a threaded wire having first and second ends, said first end being disposed within said tube member and said second end being securely connected to said anchoring member.

10. The system of claim 8, wherein said proximal control end of said adjustment member further includes first and second handle members, said first handle member for controlling the position of said occluding member relative to the diseased heart valve, and said second handle member for controlling the diameter of said occluding member.

11. A method for treating regurgitation of blood through a diseased heart valve having at least two leaflets, said method comprising the steps of:

providing a system comprising an apparatus and an adjustment member, the apparatus including a lollipop-shaped body member having a proximal end portion, a distal end portion, and an intermediate portion extending between the distal end portions, the intermediate portion including an expandable occluding member having an adjustable diameter, the proximal end portion being physically connected to the occluding member and including a connecting mechanism that is operably connected to the adjustment member, and the distal end portion including an anchoring member;

securing the anchoring member in a heart chamber containing the heart valve;

operating the adjustment member so that at least a portion of the occluding member is securely positioned within the diseased heart valve; and

operating the adjustment member to increase or decrease the diameter of the occluding member so that at least one of the diseased heart valve leaflets coapts with the occluding member during the cardiac cycle.

12. The method of claim 11, wherein said step of securing the anchoring member in a heart chamber further comprises the step of introducing the apparatus and a portion of the adjustment member into the vasculature of a subject.

13. The method of claim 11, wherein the diseased heart valve is a mitral valve.

14. The method of claim 11, wherein the diseased heart valve is a tricuspid valve.

15. The method of claim 11, wherein said step of operating the adjustment member so that at least a portion of the occluding member is securely positioned within the diseased heart valve further includes the step of turning a first handle portion in a clockwise manner so that the anchoring member is embedded within heart tissue surrounding the heart valve.

16. The method of claim 11, wherein said step of operating the adjustment member to increase or decrease the diameter of the occluding member further includes the step of turning a second handle portion in a clockwise or counterclockwise manner, respectively.

17. The method of claim 11, further comprising the step of securing the adjustment member within the subject by providing a protective sheath around the proximal control end of the adjustment member to form a pocket, and suturing the proximal control end to muscle beneath the outer surface of the subject.

18. The method of claim 17, wherein the adjustment member is adjusted without opening the pocket.