Device and method for treatment of atrioventricular regurgitation

• US 7,011,669 B2
• Filed: 03/10/2003
• Issued: 03/14/2006
• Est. Priority Date: 08/11/2000
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Kimblad, Per Ola
• Primary Examiner(s): HO, TAN-UYEN THI
• Application Number:
  US10/383,596
• Publication Number:
  US 20030153946A1
• Time in Patent Office: 1,100 Days
• Field of Search: 606151-153, 606/157, 606/158, 606/142, 606/139, 606/213, 606/216, 606/219, 606/221, 606/228, 623/2.1, 623 124-126, 128/898
• US Class Current: 606/151
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve

Abstract

A device and method for treatment of atrioventricular regurgitation comprises a suturing device. The suturing device is configured to be introducible, via blood vessels leading to the heart, to two leaflets of the atrioventricular valve between the atrium and a corresponding ventricle of the heart. The suturing device is configured for binding together the two leaflets along the free edges of the leaflets. A method of using the device includes inserting the suturing device into a catheter, introducing the catheter to the heart and positioning a distal end of the catheter close to two leaflets of an atrioventricular valve, capturing the free edges of the two leaflets with the suturing device in its open state, binding together the two leaflets by transition of the suturing device into its closed state, and retracting the catheter from the heart. As a result, the closing of the valve is improved.

Claims

1. A method of stabilizing a first heart valve leaflet in a heart, comprising:

providing a delivery catheter;

providing a clip formed from a temperature-activated memory material;

securing the clip in a delivery state to the delivery catheter;

advancing the clip to a desired position adjacent the first heart valve leaflet;

transforming the clip from the delivery state to an open state, wherein the clip is in an open position with a clip opening configured to receive an edge of the first heart valve leaflet;

positioning an edge of the first heart valve leaflet within the clip opening; and

transforming the clip from the open state to a closed state, whereby the edge of the first heart valve leaflet is secured within the clip.

2. The method of claim 1, wherein the memory metal of the clip biases the clip toward the closed state.

3. The method of claim 2, wherein securing the clip in the delivery state to the delivery catheter comprises mechanically biasing the clip toward the open state and mechanically holding the clip in the delivery state.

4. The method of claim 3, wherein transforming the clip to the open state comprises releasing the mechanical holding of the clip in the delivery state.

5. The method of claim 1, further comprising:

prior to transforming the clip to the closed state, positioning an edge of a second heart valve leaflet within the clip opening, whereby when the clip is transformed to the closed state the edge of the second heart valve leaflet is secured within the clip.

6. An apparatus for securing a first heart valve leaflet, the apparatus comprising:

a clip comprising a first end and a second end, the clip having an open state, a delivery state, and a closed state, the clip comprising a memory metal and being biased toward the closed state; and

a delivery catheter, the delivery catheter comprising a first member configured to mechanically bias the clip toward the open state, and a second member configured to mechanically bias the clip toward the delivery state.

7. The apparatus of claim 6, wherein the delivery catheter has a distal end and further comprises a needle at the distal end, the needle configured to puncture an interatrial septum of a patient'"'"'s heart.

8. The apparatus of claim 6, wherein the delivery catheter first member comprises a supportive rod configured to engage the first end of the clip.

9. The apparatus of claim 8, wherein the supportive rod comprises a distal end having a needle thereon, the needle configured to puncture an interatrial septum of a patient'"'"'s heart.

10. The apparatus of claim 9, wherein the delivery catheter comprises a generally tubular outer member, and the supportive rod is slideable within the generally tubular outer member.

11. The apparatus of claim 6, wherein the delivery catheter second member comprises a generally tubular member configured to slideably receive the clip, thereby engaging the second end of the clip and mechanically biasing the clip toward the delivery state.

12. A method of stabilizing a first heart valve leaflet in a heart, comprising:

providing a delivery catheter;

providing a clip formed from a memory material;

securing the clip in a delivery state to the delivery catheter;

advancing the clip to a desired position adjacent the first heart valve leaflet, wherein advancing the clip comprises advancing the clip into the right atrium of the heart, puncturing the interatrial septum of the heart, and advancing the clip through the interatrial septum and into the left atrium of the heart;

transforming the clip from the delivery state to an open state, wherein the clip is in an open position with a clip opening configured to receive an edge of the first heart valve leaflet;

positioning an edge of the first heart valve leaflet within the clip opening; and

transforming the clip from the open state to a closed state, whereby the edge of the first heart valve leaflet is secured within the clip.

13. The method of claim 12, wherein the memory metal of the clip biases the clip toward the closed state.

14. The method of claim 13, wherein securing the clip in the delivery state to the delivery catheter comprises mechanically biasing the clip toward the open state and mechanically holding the clip in the delivery state.

15. The method of claim 14, wherein transforming the clip to the open state comprises releasing the mechanical holding of the clip in the delivery state.

16. The method of claim 12, further comprising:

prior to transforming the clip to the closed state, positioning an edge of a second heart valve leaflet within the clip opening, whereby when the clip is transformed to the closed state the edge of the second heart valve leaflet is secured within the clip.