Apparatus and method for treating a regurgitant valve

• US 20070198082A1
• Filed: 12/14/2006
• Published: 08/23/2007
• Est. Priority Date: 12/15/2005
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Yadav, Jay, Kapadia, Samir
• Granted Patent: US 7,901,454 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00588 Rigid or stiff implements, e.g. made of several rigid parts linked by hinges
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00597 Implements comprising a membrane
• 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 2017/00615 Implements with an occluder on one side of the opening and holding means therefor on the other
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0443 the shaft being resilient and having a coiled or helical shape in the released state
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2496 Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers

Abstract

An apparatus for treating regurgitation of blood through a diseased heart valve having at least two leaflets includes an occluding member configured to be positioned within the diseased heart valve so that at least a portion of the occluding member is positioned adjacent to one of the at least two leaflets. The at least one portion of the occluding member contacts at least one surface of the at least one leaflet. The occluding member is dimensioned so that the at least one leaflet abuts the at least one surface of the occluding member. The apparatus further includes a suspending wire operatively attached to the occluding member and configured to facilitate positioning of the occluding member within the heart valve. The suspending wire includes an anchoring portion having a coiled shape. The anchoring portion is configured to secure the suspending wire to at least one of a blood vessel and a heart wall surrounding a heart chamber.

Claims

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

an occluding member configured to be positioned within the diseased heart valve so that at least a portion of said occluding member is positioned adjacent to one of the at least two leaflets of the heart valve, said portion contacting at least one surface of said at least one leaflet;

said occluding member being dimensioned so that, during at least a portion of the cardiac cycle, said at least one leaflet abuts said at least one surface of said occluding member to mitigate regurgitation of blood through the heart valve; and

a suspending wire operatively attached to said occluding member and configured to facilitate positioning of said occluding member within the heart valve;

said suspending wire comprising an anchoring portion, said anchoring portion being configured to secure said suspending wire to at least one of a blood vessel and a heart wall surrounding a heart chamber containing the heart valve.

2. The apparatus of claim 1, wherein said occluding member includes a mechanical heart valve.

3. The apparatus of claim 1, wherein said occluding member includes a bioprosthetic heart valve.

4. The apparatus of claim 1, wherein at least a portion of said occluding member is configured to be positioned between the valve leaflets.

5. The apparatus of claim 1, wherein at least a portion of said occluding member is configured to be positioned below the free ends of the valve leaflets.

6. The apparatus of claim 1, wherein at least a portion of said occluding member is configured to be positioned approximately at a level of the annulus of the valve.

7. The apparatus of claim 1, wherein said anchoring portion has a coiled configuration.

8. The apparatus of claim 1, wherein said apparatus further comprises a coaxial safety wire operatively connected between said occluding member and said anchoring portion.

9. The apparatus of claim 1, wherein said apparatus further comprises first and second control wires extending into said occluding member.

10. The apparatus of claim 9 further comprising first and second tensioning mechanisms connected to said first and second control wires, respectively, said first and second tensioning mechanisms being capable of respectively adjusting the vertical and lateral length of said occluding member.

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

providing an apparatus comprising an occluding member operatively attached to a suspending wire having an anchoring portion;

positioning a balloon in the diseased heart valve to determine the size and shape of the diseased heart valve;

selecting an occluding member having a size and shape that corresponds to the size and shape of the diseased heart valve so that at least one leaflet of the heart valve coapts with the occluding member;

introducing the apparatus into a patient'"'"'s body; and

positioning the apparatus in one chamber of the patient'"'"'s heart.

12. The method of claim 11, wherein the balloon comprises a first layer and second layer.

13. The method of claim 12, wherein the second layer encapsulates at least one portion of the first layer.

14. The method of claim 13, wherein the at least one portion of the second layer has a non-uniform thickness.

15. The method of claim 11, wherein said step of positioning the balloon in the diseased heart valve further comprises the steps of:

positioning the balloon in a deflated configuration in a regurgitant orifice of the diseased heart valve;

inflating the balloon so that blood flow through the regurgitant orifice is substantially hindered or prevented; and

measuring the geometry of the balloon in at least one of a plurality of dimensions.

16. The method of claim 11, wherein said step of positioning the apparatus in one chamber of the patient'"'"'s heart further comprises the steps of:

extending the apparatus into at least one chamber of the patient'"'"'s heart; and

securing the apparatus in the patient'"'"'s heart valve so that at least one leaflet of the patient'"'"'s heart valve coapts with the occluding member to inhibit regurgitant bloodflow through the heart valve.

17. The method of claim 11, wherein said step of positioning the apparatus in one chamber of the patient'"'"'s heart further comprises the step of fine-tuning the position of the occluding member by adjusting the tension of the occluding member.

18. The method of claim 11, wherein said step of introducing the apparatus into a patient'"'"'s body further comprises the step of introducing the apparatus into a patient'"'"'s vasculature.

19. The method of claim 11, wherein said step of introducing the apparatus into a patient'"'"'s body further comprises the step of creating an incision in the patient'"'"'s chest, and wherein said step of positioning the apparatus in one chamber of the patient'"'"'s heart further comprises the step of inserting the apparatus into the heart through an apical puncture.