Device and methods for endoscopic annuloplasty

• US 20070038293A1
• Filed: 04/25/2006
• Published: 02/15/2007
• Est. Priority Date: 04/09/1999
• Status: Active Grant

• Current Assignee: Evalve, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Evalve, Inc. (Abbott Laboratories Incorporated)
• Inventors: Powell, Ferolyn, Gifford, Hanson, Goldfarb, Eric, Deem, Mark, Dieck, Martin, Fann, James, Dell, Kent, Martin, Brian, St.Goar, Frederick, Fan, Sylvia
• Granted Patent: US 10,327,743 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• 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 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/07207 the staples being applied sequentially
• CPC Class Codes: A61B 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 17/2909 Handles
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/045 snug fit within the anchor
• CPC Class Codes: A61B 2017/0474 Knot pushers
• CPC Class Codes: A61B 2017/0488 Instruments for applying suture clamps, clips or locks for applying suture anchors A61B2017/0409; for applying wound clamps A61B17/10; for applying ligaturing clamps or clips A61B17/128
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/06052 Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle hollow suture needles A61B2017/061
• CPC Class Codes: A61B 2017/06076 helically or spirally coiled for sutures A61B2017/06171
• CPC Class Codes: A61B 2017/06171 : helically or spirally coiled for needles A61B2017/06076
• CPC Class Codes: A61B 2017/0641 : having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/0649 : Coils or spirals
• CPC Class Codes: A61B 2017/088 : Sliding fasteners
• CPC Class Codes: A61B 2017/2905 : flexible
• CPC Class Codes: A61B 2017/2927 : the angular position of the head being adjustable with respect to the shaft
• CPC Class Codes: A61B 2017/2932 : Transmission of forces to jaw members
• CPC Class Codes: A61B 2017/2944 : Translation of jaw members
• CPC Class Codes: A61B 2017/2946 : Locking means
• CPC Class Codes: A61B 2017/306 : holding by means of suction
• CPC Class Codes: A61F 2/2427 : Devices for manipulating or deploying heart valves during implantation
• 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: A61M 25/0147 : with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0152 : with pre-shaped mechanisms, e.g. pre-shaped stylets or pre-shaped outer tubes

Abstract

The methods, devices, and systems are provided for performing endovascular repair of atrioventricular and other cardiac valves in the heart. Regurgitation of an atrioventricular valve, particularly a mitral valve, can be repaired by modifying a tissue structure selected from the valve leaflets, the valve annulus, the valve chordae, and the papillary muscles. These structures may be modified by suturing, stapling, snaring, or shortening, using interventional tools which are introduced to a heart chamber. The tissue structures can be temporarily modified prior to permanent modification. For example, opposed valve leaflets may be temporarily grasped and held into position prior to permanent attachment. In one aspect, a structure is deployed in a gutter region of the valve annulus to modify the shape of the valve.

Claims

1. A method of modifying a heart valve of a patient, comprising:

advancing a catheter through the patient'"'"'s vasculature into the heart from a vascular access point remote from the heart, the catheter having at least one structure releasably coupled thereto;

deploying the structure from the catheter into a gutter on a ventricular side of annulus of the heart valve, the structure adapted to modify the annulus so as to reduce regurgitation in the heart valve; and

in combination with deploying the structure, holding leaflets of the heart valve together so as to reduce regurgitation in the heart valve.

2. A method as in claim 1, wherein advancing the catheter comprises

advancing the catheter into the right atrium;

penetrating the interatrial septum to form an opening in the interatrial septum;

advancing the catheter through the opening in the interatrial septum into the left atrium

advancing catheter downward through the mitral valve.

3. A method as in claim 2, further comprising deflecting a distal region of the catheter upwardly toward the gutter such that the structure approaches the gutter from below the mitral valve.

4. A method as defined in claim 1, wherein holding the leaflets of the valve together comprises permanently attaching opposed points on or along the valve leaflets together.

5. A method as defined in claim 1, wherein holding the leaflets of the valve together comprises suturing, clipping, stapling, riveting, gluing, or fusing opposed points on or along the valve leaflets together.

6. A method as defined in claim 1, wherein holding the leaflets of the valve together is accomplished by linking opposed chordae of the valve leaflets together.

7. A method as defined in claim 8, wherein linking comprises suturing, capturing, fusing, clipping, or gluing the opposed chordae.

8. A method as in claim 1, wherein modifying the annulus comprises circumferentially shortening the annulus.

9. A method as in claim 1, wherein the structure comprises a ring that at least partially surround the annulus within the gutter.

10. A method as in claim 1, wherein the structure comprises a plurality of staples positioned in an annular formation in the gutter about the annulus.

11. A method as in claim 1, wherein the structure includes at least one securing member that secures the structure in the gutter.

12. A method as in claim 1, wherein the heart valve comprises the mitral valve.

13. A method as in claim 1, further comprising:

permitting scar tissue to grow around the structure within the gutter;

re-shaping the structure in order to modify the shape of the annulus, wherein the scar tissue provides a strengthened attachment between the structure and the gutter.

14. A method as in claim 13, wherein the structure is re-shaped after passage of a period of time comprising four to twenty four weeks.

15. A method of modifying a heart valve of a patient, comprising:

advancing a catheter through the patient'"'"'s vasculature into the heart from a vascular access point remote from the heart, the catheter having an annuloplasty device releasably coupled thereto;

performing an intervention on a gutter on a ventricular side of the heart valve to modify an annulus of the heart valve and reduce regurgitation in the heart valve;

in combination with performing an intervention, modifying a spatial relationship between a first valve leaflet and a second valve leaflet of the heart valve so as to reduce regurgitation in the heart valve.

16. A method as in claim 15, wherein performing an intervention comprises applying RF energy to the gutter in order to change the shape of the annulus.

17. A method as in claim 15, wherein performing an intervention comprises deploying a structure from the catheter into the gutter.

18. A method as in claim 15, further comprising:

permitting scar tissue to grow around the structure within the gutter;

re-shaping the structure in order to modify the shape of the annulus, wherein the scar tissue provides a strengthened attachment between the structure and the gutter.

19. A method as in claim 18, wherein the structure is re-shaped after passage of a period of time comprising four to twenty four weeks.