Delivery devices and methods for heart valve repair

• US 20060025784A1
• Filed: 07/27/2004
• Published: 02/02/2006
• Est. Priority Date: 09/04/2003
• Status: Active Grant

• Current Assignee: Ancora Heart, Inc.
• Original Assignee: Guided Delivery Systems, Inc.
• Inventors: Starksen, Niel F., To, John, Morales, Rodolfo A., Fabro, Mariel, Wei, Michael F.
• Granted Patent: US 7,753,924 B2
• Time in Patent Office: Days
• US Class Current: 606/151
• 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 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 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/0682 for applying U-shaped staples or clamps, e.g. without a forming anvil
• 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 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/0443 the shaft being resilient and having a coiled or helical shape in the released state
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/2905 flexible
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• 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
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/2466 : Delivery devices therefor

Abstract

Devices, systems and methods facilitate positioning of a cardiac valve annulus treatment device, thus enhancing treatment of the annulus. Methods generally involve advancing an anchor delivery device through vasculature of the patient to a location in the heart for treating the valve annulus, contacting the anchor delivery device with a length of the valve annulus, delivering a plurality of coupled anchors from the anchor delivery device to secure the anchors to the annulus, and drawing the anchors together to circumferentially tighten the valve annulus. Devices generally include an elongate catheter having at least one tensioning member and at least one tensioning actuator for deforming a distal portion of the catheter to help it conform to a valve annulus. The catheter device may be used to navigate a subannular space below a mitral valve to facilitate positioning of an anchor delivery device.

Claims

1. An anchor device for use within a patient comprising:

an elongate carrier constructed to be passable through a blood vessel and into a heart;

a series of tissue-engageable anchors releasably carried by the elongate carrier, the anchors comprising a distal anchor, a first intermediate anchor and a proximal anchor;

a tether serially coupling the anchors to one another, the tether having a distal end secured to the distal anchor or engageable with the distal anchor when the tether is pulled in a proximal direction;

at least the proximal anchor being slidably coupled to the tether; and

a separator positioned along the tether between adjacent ones of the anchors to restrict how close the adjacent ones of the anchors can come to one another when the tether is placed in tension.

2. The device according to claim 1 wherein the elongate carrier comprises a catheter-type housing having an open interior.

3. The device according to claim 2 wherein the anchors are releasably housed within the open interior of the housing.

4. The device according to claim 1 wherein said adjacent ones of said anchors are the distal and first intermediate anchors.

5. The device according to claim 1 wherein the anchors are self-forming and self-securing anchors.

6. The device according to claim 1 wherein the separator comprises a generally tubular member.

7. The device according to claim 6 wherein the tether passes through the generally tubular member.

8. The device according to claim 1 wherein the separator has a textured outer surface.

9. The device according to claim 1 wherein the separator is a nonporous separator.

10. The device according to claim 1 wherein the separator is a porous separator.

11. The device according to claim 10 wherein the porous separator comprises pores, said pores provided by cutouts formed in the separator.

12. The device according to claim 1 wherein the separator comprises a woven or braided separator.

13. The device according to claim 12 wherein the separator is rigid.

14. The device according to claim 1 wherein the separator is effectively axially incompressible.

15. The device according to claim 1 wherein the separator is axially compressible from a first length to a second, compressed length.

16. The device according to claim 15 wherein the axially compressible separators are joined to one another.

17. The device according to claim 1 wherein the separator comprises first and second portions engaging the tether and a third portion connecting the first and second portions.

18. The device according to claim 17 wherein the third portion extends to one side of and generally parallel to the tether.

19. The device according to claim 1 wherein:

the elongate carrier has a longitudinal axis;

the anchors are self-forming tissue-engageable anchors;

the anchors each have a first part and a second part, the second part having a tissue-piercing tip;

the elongate carrier having openings sized for passage of the anchors therethrough;

the anchors placeable in a relatively straight, undeployed state generally parallel to the longitudinal axis within the elongate carrier; and

the anchors naturally assuming a curved, tissue-engaging deployed state after passing through the opening in the elongate carrier.

20. The device according to claim 19 wherein at least a portion of the elongate carrier is flexible.

21. The device according to claim 20 wherein the elongate carrier is steerable.

22. The device according to claim 19 wherein at least one of the anchors comprises said first part, and wherein at least two of said second parts extend from the first part.

23. The device according to claim 22 wherein the second parts extend in directions generally opposite one another when in the deployed state.

24. The device according to claim 23 wherein the second parts have generally circular or semicircular shapes when in the deployed state.

25. The device according to claim 19 wherein the anchors are oriented generally perpendicular to the longitudinal axis when in the deployed state.

26. The device according to claim 19 wherein each anchor has a generally circular or semicircular shape when in the deployed state.

27. The device according to claim 19 wherein the elongate carrier has a diametrical dimension d and the anchors in the deployed state have a diametrical dimension D, and wherein the ratio of D to d is at least 3.5.

28. The device according to claim 19 wherein the elongate carrier has the diametrical dimension d and the anchors in the deployed state have a diametrical dimension D, and wherein the ratio of D to d is at least 4.4.

29. The device according to claim 19 wherein the elongate carrier has the diametrical dimension d and the anchors in the deployed state have a diametrical dimension D, and wherein the ratio of D to d is at least 7.

30. The device according to claim 19 wherein the elongate carrier has the diametrical dimension d and the anchors in the deployed state have a diametrical dimension D, and wherein the ratio of D to d is at least 8.8.

31. The device according to claim 1 wherein the elongate carrier comprises proximal and distal portions, the anchors being carried by the distal portion, the distal portion being releasable from the proximal portions, the distal portion being pierceable by the anchors.

32. An anchor device for use within a patient comprising:

an elongate carrier, having a longitudinal axis, constructed to be passable through a blood vessel and into a heart, at least a portion of the elongate carrier being flexible;

a series of self-forming, tissue-engageable anchors releasably carried by the elongate carrier, the anchors comprising a distal anchor, a first intermediate anchor and a proximal anchor;

the anchors each having a first part and at least two second parts extending from the first part, each second part having a tissue-piercing tip;

the elongate carrier having openings sized for passage of the anchors therethrough;

the anchors placeable in a relatively straight, undeployed state generally parallel to the longitudinal axis within the elongate carrier;

the anchors naturally assuming a curved, tissue-engaging deployed state after passing through the opening in the elongate carrier;

the second parts having generally circular or semicircular shapes when in the deployed state;

the anchors being oriented generally perpendicular to the longitudinal axis when in the deployed state;

the elongate carrier having a diametrical dimension d and the anchors in the deployed state having a diametrical dimension D, the ratio of D to d being at least 3.5;

a tether serially coupling the anchors to one another, the tether having a distal end secured to the distal anchor or engageable with the distal anchor when the tether is pulled in a proximal direction;

at least the proximal anchor being slidably coupled to the tether; and

a separator positioned along the tether between adjacent ones of the anchors to restrict how close the adjacent ones of the anchors can come to one another when the tether is placed in tension.

33. An anchor device for use within a patient comprising:

an elongate carrier constructed to be passable through a blood vessel and into a heart;

an anchor assembly, releasably carried by the elongate carrier, comprising;

an axially shrinkable connector placeable in a second, reduced-length state from a first, extended-length state; and

tissue-engageable anchors positioned along the shrinkable connector, the anchors comprising a distal anchor, a first intermediate anchor and a proximal anchor; and

a separator positioned along the shrinkable connector between adjacent ones of the anchors to restrict how close the adjacent ones of the anchors can come to one another when the shrinkable connector is placed in the second, reduced-length state.

34. The anchor device according to claim 33 wherein the anchors are positioned along the carrier.