Apparatus and method for treating a regurgitant valve

• US 7,901,454 B2
• Filed: 12/14/2006
• Issued: 03/08/2011
• Est. Priority Date: 12/15/2005
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Kapadia, Samir, Yadav, Jay
• Primary Examiner(s): McDermott; Corrine M
• Assistant Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US11/638,864
• Publication Number:
  US 20070198082A1
• Time in Patent Office: 1,545 Days
• Field of Search: 623 234- 237, 623/2.11, 623/2.17
• 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;

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 including a proximal end portion and a distal end portion, the distance between said proximal and distal end portions comprising an intermediate portion; and

said suspending wire comprising an anchoring portion, said anchoring portion comprising a septal occluder located at said intermediate portion of said suspending wire, said anchoring portion being configured to secure said suspending wire to an interatrial septum surrounding a heart chamber containing the heart valve;

a safety wire operatively connected between said occluding member and said anchoring portion, said safety wire being coiled around said suspending wire;

said safety wire being sufficiently flexible so as to not be subjected to the stress and strain of said suspending wire.

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

3. 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.

4. 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.

5. The apparatus of claim 1, wherein said proximal end portion of said suspending wire includes a connecting mechanism for connecting said suspending wire to a positioning wire.

6. The apparatus claim 1, wherein said safety wire extends along said suspending wire and is independently attached thereto at a plurality of points.

7. The apparatus of claim 1, wherein said septal occluder comprises a plurality of oppositely opposed flexible discs, each of said flexible discs being fluidly connected by a connecting waist located intermediate said flexible discs.

8. The apparatus of claim 1, wherein said occluding member is completely covered by a membrane.

9. 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;

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 including a proximal end portion, and a distal end portion, said proximal end portion of said suspending wire including a connecting mechanism for connecting said suspending wire to a positioning wire, the distance between said proximal and distal end portions comprising an intermediate portion; and

said suspending wire comprising an anchoring portion, said anchoring portion comprising a septal occluder located at said intermediate portion of said suspending wire, said anchoring portion being configured to secure said suspending wire to an interatrial septum surrounding a heart chamber containing the heart valve;

a safety wire operatively connected between said occluding member and said anchoring portion, said safety wire being coiled around said suspending wire and being independently attached thereto at a plurality of points, said safety wire being sufficiently flexible so as to not be subjected to the stress and strain of said suspending wire.

10. 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;

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 including a proximal end portion, and a distal end portion, said proximal end portion of said suspending wire including a connecting mechanism for connecting said suspending wire to a positioning wire, the distance between said proximal and distal end portions comprising an intermediate portion; and

said suspending wire comprising an anchoring portion, said anchoring portion comprising a septal occluder located at said intermediate portion of said suspending wire, said anchoring portion being configured to secure said suspending wire to an interatrial septum surrounding a heart chamber containing the heart valve;

a safety wire operative connected between said occluding member and said anchoring portion, said safety wire being coiled around said suspending wire and being independently attached thereto at a plurality of points, said safety wire consisting of at least one thread made of a material selected from the group consisting of nylon, braided nylon, polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), and medical-grade sutures, said safety wire being sufficiently flexible so as to not be subjected to the stress and strain of said suspending wire.