Apparatus and method for reducing cardiac valve regurgitation

• US 20070233239A1
• Filed: 10/26/2006
• Published: 10/04/2007
• Est. Priority Date: 07/15/2005
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Kassab, Ghassan, Navia, Jose
• Granted Patent: US 7,927,371 B2
• Time in Patent Office: Days
• US Class Current: 623/2.370
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2210/009 magnetic
• CPC Class Codes: A61F 2250/0001 Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61F 2250/0004 adjustable

Abstract

An apparatus for modifying the annulus of a cardiac valve to reduce regurgitation of blood flow through the cardiac valve includes a first annuloplasty ring having a first diameter and being disposed about a first aspect of the annulus of the cardiac valve. The apparatus also includes an elongate flexible body having proximal and distal end portions and being insertable into the first annuloplasty ring. The elongate flexible body has an adjustable mechanism for selectively adjusting the elongate flexible body from a first relaxed configuration to a second tensioned configuration. The first annuloplasty ring is adaptable to obtain a second smaller diameter and to cause the annulus of the cardiac valve to be modified and reduce regurgitation of blood flow through the cardiac valve when the elongate flexible body obtains the second tensioned configuration.

Claims

1. An apparatus for modifying the annulus of a cardiac valve to reduce regurgitation of blood flow through the cardiac valve, said apparatus comprising:

a first annuloplasty ring having a first diameter and being disposed about a first aspect of the annulus of the cardiac valve; and

an elongate flexible body comprising proximal and distal end portions and being insertable into said first annuloplasty ring, said elongate flexible body including an adjustable mechanism for selectively adjusting said elongate flexible body from a first relaxed configuration to a second tensioned configuration;

said first annuloplasty ring being adaptable to obtain a second smaller diameter and to cause the annulus of the cardiac valve to be modified and reduce regurgitation of blood flow through the cardiac valve when said elongate flexible body obtains said second tensioned configuration.

2. The apparatus of claim 1, wherein said adjustment mechanism is manually manipulated so that said elongate flexible body obtains said second tensioned configuration.

3. The apparatus of claim 1, wherein said adjustment mechanism is electromagnetically manipulated so that said elongate flexible body obtains said second tensioned configuration.

4. The apparatus of claim 1, wherein a second annuloplasty ring is disposed about a second aspect of the annulus of the cardiac valve, said second annuloplasty ring being magnetically coupled to said first annuloplasty ring to secure said first annuloplasty ring about the first aspect of the annulus of the cardiac valve.

5. The apparatus of claim 1, wherein a positioning catheter is used to magnetically guide said first and/or second annuloplasty rings to the first and/or second aspects of the annulus of the cardiac valve, respectively.

6. A method for modifying the annulus of a cardiac valve to reduce regurgitation of blood flow through the cardiac valve, said method comprising the steps of:

providing a first annuloplasty ring having a first diameter and being disposed about a first aspect of the annulus of the cardiac valve and an elongate flexible body having proximal and distal end portions and being insertable into the first annuloplasty ring, the elongate flexible body including an adjustable mechanism for selectively adjusting the elongate flexible body from a first relaxed configuration to a second tensioned configuration;

inserting the elongate flexible body into the first annuloplasty ring in the first relaxed configuration;

manipulating the adjustment mechanism so that the elongate flexible body obtains the second tensioned configuration and causes the first annuloplasty ring to obtain a second smaller diameter, thereby modifying the annulus of the cardiac valve and reducing regurgitation of blood flow through the cardiac valve; and

removing the elongate flexible body from the first annuloplasty ring.

7. The method of claim 6, wherein the adjustment mechanism is manually manipulated so that the elongate flexible body obtains the second tensioned configuration.

8. The method of claim 6, wherein the adjustment mechanism is electromagnetically manipulated so that the elongate flexible body obtains the second tensioned configuration.

9. The method of claim 6 further comprising the step of placing a second annuloplasty ring about a second aspect of the annulus of the cardiac valve so that the first and second annuloplasty rings are magnetically coupled to one another and the first annuloplasty ring is secured to the first aspect of the annulus of the cardiac valve.

10. The method of claim 9 further comprising the step of using a positioning catheter to magnetically guide the first and/or second annuloplasty rings to the first and/or second aspects of the annulus of the cardiac valve, respectively.

11. An apparatus for modifying the annulus of a cardiac valve to reduce regurgitation of blood flow through the cardiac valve, said apparatus comprising:

a first annuloplasty ring having a first diameter and being disposed about a first aspect of the annulus of the cardiac valve; and

a flexible body comprising first and second oppositely disposed strut members having proximal and distal end portions and a cinching mechanism for adjusting said flexible body from a first relaxed configuration to a second tensioned configuration, said cinching mechanism being operatively connected to said distal end portion of said strut members;

said cinching mechanism comprising a resistance member operatively coupled to said distal end portion of said strut members and a harness member operatively coupled to a pull wire extending between said strut members;

said flexible body being disposed in a delivery catheter being insertable into said first annuloplasty ring, said delivery catheter comprising proximal and distal end portions and an opening at said distal portion for extending said harness member therethrough;

said flexible body being adaptable to obtain said second tensioned configuration and to cause said first annuloplasty ring to obtain a second smaller diameter so that the annulus of the cardiac valve is modified and regurgitation of blood flow through the cardiac valve is reduced.

12. The apparatus of claim 11, wherein a second annuloplasty ring is disposed about a second aspect of the annulus of the cardiac valve, said second annuloplasty ring being magnetically coupled to said first annuloplasty ring so that said first annuloplasty ring is secured to the first aspect of the annulus of the cardiac valve.

13. The apparatus of claim 11, wherein a positioning catheter is used to magnetically guide said first and/or second annuloplasty rings to the first and/or second aspects of the annulus of the cardiac valve, respectively.

14. A method for modifying the annulus of a cardiac valve to reduce regurgitation of blood flow through the cardiac valve, said method comprising the steps of:

providing a first annuloplasty ring having a first diameter and being disposed about a first aspect of the annulus of the cardiac valve, and a flexible body comprising first and second oppositely disposed strut members having proximal and distal end portions and a cinching mechanism for adjusting the flexible body from a first relaxed configuration to a second tensioned configuration, the cinching mechanism comprising a resistance member operatively coupled to the distal end portion of the strut members and a harness member operatively coupled to a pull wire extending between the strut members, the flexible body being disposed in a delivery catheter comprising proximal and distal end portions and an opening at the distal portion for extending the harness member therethrough;

inserting the flexible body into the first annuloplasty ring in the first relaxed configuration;

manipulating the cinching mechanism so that the first annuloplasty ring obtains a second smaller diameter and modifies the annulus of the cardiac valve to reduce regurgitation of blood flow through the cardiac valve; and

removing the flexible body from the first annuloplasty ring.

15. The method of claim 14, wherein said step of manipulating the cinching mechanism further comprises the steps of:

applying a radial force to the pull wire so that the harness member extends through the opening of the delivery catheter and contacts a portion of the first annuloplasty ring;

withdrawing the pull wire so that the harness member ensnares the portion of the first annuloplasty ring; and

manipulating the flexible body so that the first annuloplasty ring obtains a second smaller diameter and modifies the annulus of the cardiac valve to reduce regurgitation of blood flow through the cardiac valve.

16. The method of claim 14 further comprising the step of placing a second annuloplasty ring about a second aspect of the annulus of the cardiac valve so that the first and second annuloplasty rings are magnetically coupled to one another and the first annuloplasty ring is secured to the annulus of the cardiac valve.

17. The method of claim 16 further comprising the step of using a positioning catheter to magnetically guide the first and/or second annuloplasty rings to the first and/or second aspects of the annulus of the cardiac valve, respectively.

18. An apparatus for modifying the annulus of a cardiac valve to reduce regurgitation of blood flow through the cardiac valve, said apparatus comprising:

a first annuloplasty ring having a first diameter and being disposed about a first aspect of the annulus of the cardiac valve; and

an electromagnetic wire having proximal and distal end portions, said electromagnetic wire including a plurality of magnetic members operably connected to said electromagnetic wire and an adjustable mechanism for selectively adjusting said electromagnetic wire from a first relaxed configuration to a second tensioned configuration, said electromagnetic wire being insertable into said first annuloplasty ring;

said adjustable mechanism being selectively adjustable so that said first annuloplasty ring is adaptable to obtain a second smaller diameter and modify the annulus of the cardiac valve to reduce regurgitation of blood flow through the cardiac valve.

19. The apparatus of claim 18, wherein a second annuloplasty ring is disposed about a second aspect of the annuloplasty ring, said second annuloplasty ring being magnetically coupled to said first annuloplasty ring so that said first annuloplasty ring is secured to the first aspect of the annulus of the cardiac valve.

20. The apparatus of claim 19, wherein a positioning catheter is used to magnetically guide said first and/or second annuloplasty rings to the first and/or second aspects of the annulus of the cardiac valve, respectively.

21. A method for modifying the annulus of a cardiac valve to reduce regurgitation of blood flow through the cardiac valve, said method comprising the steps of:

providing a first annuloplasty ring having a first diameter and being disposed about a first aspect of the annulus of the cardiac valve and an electromagnetic wire having proximal and distal end portions, the electromagnetic wire including a plurality of magnetic members operably connected to the electromagnetic wire and an adjustable mechanism for selectively adjusting the electromagnetic wire from a first relaxed configuration to a second tensioned configuration;

inserting the electromagnetic wire into the first annuloplasty ring in the first relaxed configuration;

manipulating the adjustable mechanism so that the electromagnetic wire obtains the second tensioned configuration and the first annuloplasty ring obtains a second smaller diameter to modify the annulus of the cardiac valve and reduce regurgitation of blood flow through the cardiac valve; and

removing the electromagnetic wire from the first annuloplasty ring.

22. The method of claim 21, wherein said step of manipulating the adjustable mechanism further comprises the step of applying electromagnetic energy to the electromagnetic wire so that the electromagnetic wire obtains the second tensioned configuration.

23. The method of claim 21 further comprising the step of placing a second annuloplasty ring about a second aspect of the annulus of the cardiac valve so that the first and second annuloplasty rings are magnetically coupled to one another and the first annuloplasty ring is secured to the first aspect of the annulus of the cardiac valve.

24. The method of claim 23 further comprising the step of using a positioning catheter to magnetically guide the first and/or second annuloplasty rings to the first and/or second aspects of the annulus of the cardiac valve, respectively.