Apparatus, system, and method for treating a regurgitant heart valve

• US 10,213,304 B2
• Filed: 10/15/2015
• Issued: 02/26/2019
• Est. Priority Date: 07/27/2011
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Kapadia, Samir
• Primary Examiner(s): Eastwood, David C
• Application Number:
  US14/883,819
• Publication Number:
  US 20160030166A1
• Time in Patent Office: 1,230 Days
• Field of Search: 600 16, 600 37, 606191-200, 623 21, 623 211, 623 22, 623 236, 623 238
• 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. 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 the anchoring member is securely positioned within heart tissue associated with 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;

wherein after the anchoring member is secured in the heart chamber, blood is permitted to flow through at least a portion of the occluding member.

2. The method of claim 1, 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.

3. The method of claim 1, wherein the diseased heart valve is a mitral valve.

4. The method of claim 1, wherein the diseased heart valve is a tricuspid valve.

5. The method of claim 1, wherein said step of operating the adjustment member so that the anchoring member is securely positioned within heart tissue associated with 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.

6. The method of claim 1, 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.

7. The method of claim 1, 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.

8. The method of claim 7, wherein the adjustment member is adjusted without opening the pocket.