Devices and methods for heart valve repair

• US 6,986,775 B2
• Filed: 06/13/2003
• Issued: 01/17/2006
• Est. Priority Date: 06/13/2002
• Status: Expired due to Term

• Current Assignee: Ancora Heart, Inc.
• Original Assignee: Guided Delivery Systems, Inc.
• Inventors: Starksen, Niel F., Morales, Rodolfo A.
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US10/461,043
• Publication Number:
  US 20030233142A1
• Time in Patent Office: 949 Days
• Field of Search: 606/139, 606/143, 606/151, 606/219, 128/898
• US Class Current: 606/139
• CPC Class Codes: A61B 1/00082 Balloons
• CPC Class Codes: A61B 1/00096 Optical elements
• CPC Class Codes: A61B 1/04 combined with photographic or television appliances
• 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 17/0487 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 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/0684 having a forming anvil staying above the tissue during stapling
• CPC Class Codes: A61B 17/083 Clips, e.g. resilient
• CPC Class Codes: A61B 17/10 for applying or removing wound clamps, e.g. containing only one clamp or staple A61B17/076 takes precedence; containing multiple wound clamps A61B17/068; Wound clamp magazines containers, packaging elements or packages specially adapted for particular articles or with special means for dispensing contents B65D83/00, B65D85/00
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3423 Access ports, e.g. toroid shape introducers for instruments or hands access sites for liquids A61M39/0247
• CPC Class Codes: A61B 2017/00243 cardiac
• 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 2017/06023 Multiple eyelets
• CPC Class Codes: A61B 2017/3425 for internal organs, e.g. heart ports
• CPC Class Codes: A61B 2017/3484 Anchoring means, e.g. spreading-out umbrella-like structure
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 8/12 : in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61F 2/2445 : Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2451 : Inserts in the coronary sinus for correcting the valve shape

Abstract

Methods and devices provide constriction of a heart valve annulus to treat cardiac valve regurgitation and other conditions. Embodiments typically include a device for attaching a cinching or tightening apparatus to a heart valve annulus to reduce the circumference of the annulus, thus reducing valve regurgitation. Tightening devices may include multiple tethered clips, multiple untethered crimping clips, stabilizing devices, visualization devices, and the like. In one embodiment, a plurality of tethered clips is secured circumferentially to a valve annulus, and the tether coupling the clips is cinched to reduce the circumference of at least a portion of the annulus. Methods and devices may be used in open heart surgical procedures, minimally invasive procedures, catheter-based procedures, and/or procedures on beating hearts or stopped hearts.

Claims

1. A method constricting a heart valve annulus, the method comprising:

introducing a tethered clip assembly to the annulus, the tethered clip assembly comprising a plurality of clips coupled with a tether, the plurality of clips comprising a first clip, an intermediate clip, and a terminal clip, wherein the first clip and a lead end of the tether are constructed to prevent the first clip from moving distally past the lead end of the tether, and wherein one or more of the remaining clips are slidably coupled to the tether,

the introducing step comprising passing the tethered clip assembly through an elongate shaft and a curved distal end portion of the elongate shaft;

securing individual clips at circumferentially spaced-apart locations about at least a portion of the annulus including the first clip, a series of intermediate clips, and a terminal clip;

cinching the tether through the clips to circumferentially tighten the annulus; and

preventing the terminal clip from moving proximally past a chosen location along the tether after the cinching step.

2. A method as in claim 1, wherein the tether is coupled to at least the intermediate and terminal clips through an eyelet in the clips and wherein deforming at least the terminal clip comprises applying force to the eyelet on the clip(s) to reduce the inner diameter of the eyelet and secure the tether within the eyelet.

3. A method as in claim 1, wherein introducing the plurality of clips comprises advancing a tethered clip applicator through an incision in a wall or septum of the heart.

4. A method as in claim 3, wherein advancing comprises advancing through an incision in a left atrial wall of the heart.

5. A method as in claim 3, further comprising placing an instrument introduction device through the incision in the wall of the heart, wherein advancing the clip applicator comprises advancing the applicator through the instrument introduction device.

6. A method as in claim 1, wherein the individual clips are secured successively.

7. A method as in claim 1, wherein the individual clips are simultaneously secured to the circumferentially spaced-apart locations.

8. A method as in claim 1, wherein cinching comprises applying tensile force to the tether.

9. A method as in claim 8, wherein applying tensile force comprises pulling the tether proximally through an applicator which has introduced the terminal clip.

10. A method as in claim 1, wherein the preventing step comprises deforming the terminal clip so that the terminal clip becomes fixed to the tether.

11. A method as in claim 1, further comprising securing at least one tether anchor to the annulus adjacent to the terminal clip after cinching.

12. A method as in claim 11, wherein securing the tether anchor comprises securing a rivet to the annulus.

13. A method as in claim 1, further comprising visualizing the annulus.

14. A method as in claim 13, wherein visualizing is performed using visualization device comprising at least one of an ultrasound device, and angioscopic device, a transesophageal echocardiogram device and a fluoroscopic device.

15. A method as in claim 13, wherein visualization is performed using an ultrasound device comprising a gel-containing cone for enhancing ultrasound visualization.

16. A method as in claim 13, wherein visualizing comprises using a real-time Doppler ultrasound device to visualize a regurgitant flow across the heart valve during at least the cinching step.

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

visualization a reduction in the regurgitant flow during the cinching step; and

selecting an amount of cinching based on the reduction in the regurgitant flow.

18. A method as in claim 13, wherein the visualization step is carried out using at least one visualization device coupled with an applicator device for introducing the tethered clip assembly and securing the clips at circumferentially spaced-apart locations.

19. A method as in claim 18, wherein the at least one visualization device comprises an angioscope having a viewing end within or adjacent to a lens, bubble or inflatable balloon which displaces blood to permit viewing in the beating heart.

20. A method as in claim 1, wherein the introducing, securing and cinching steps are performed as part of an open heart surgical procedure.

21. A method as in claim 1, wherein the introducing, securing and cinching steps are performed without stopping the heart.

22. A method as in claim 1, wherein the introducing, securing and cinching steps are performed through one or more minimally invasive incisions.

23. A method as in claim 1, wherein the introducing, securing and cinching steps are performed intravascularly.

24. A method as in claim 1, wherein the introducing, securing and cinching steps are performed on a mitral valve annulus.

25. A method as in claim 1, wherein the introducing, securing and cinching steps are performed on a tricuspid valve annulus.

26. A method as in claim 1, further comprising stabilizing the annulus relative to the heart prior to introducing the clips.

27. A method as in claim 26, wherein stabilizing comprises introducing at least a first stabilizing ring beneath the valve leaflets, wherein the ring engages the intersection between the leaflet and the interior ventricular wall.

28. A method as in claim 1, wherein the introducing step is carried out with the first clip fixed to the lead end of the tether.

29. A method for constricting a heart valve annulus, the method comprising:

introducing a tethered clip assembly to the annulus, the tethered clip assembly comprising a plurality of clips coupled with a tether, the tether comprising parallel segments, the plurality of clips comprising a first clip, an intermediate clip, and a terminal clip, wherein the first clip and a lead end of the tether are constructed to prevent the first clip from moving distally past the lead end of the tether, and wherein one or more of the remaining clips are slidably coupled to the tether;

securing individual clips of the tethered clip assembly at circumferentially spaced-apart locations about at least a portion of the annulus, the parallel segments of the tether being coupled to at least the intermediate and terminal clips through first and second eyelets in the clips;

cinching a tether through the clips to circumferentially tighten the annulus; and

preventing the terminal clip from moving proximally past a chosen location along the tether after the cinching step by applying force to the first and second eyelets on the terminal clip to reduce the inner diameter of the first and second eyelets and secure the tether to the terminal clip.

30. A method for constricting a heart valve annulus, the method comprising:

placing an instrument introduction device through an incision in the left atrial wall of the heart;

introducing a tethered clip assembly to the annulus by advancing a tethered clip applicator through the instrument introduction device, the tethered clip assembly comprising a plurality of clips coupled with a tether, the plurality of clips comprising a first clip, an intermediate clip, and a terminal clip, wherein the first clip and a lead end of the tether are constructed to prevent the first clip from moving distally past the lead end of the tether, and wherein one or more of the remaining clips are slidably coupled to the tether;

securing the introduction device to an epicardial surface of the heart wall before the advancing step;

securing individual clips of the tethered clip assembly at circumferentially spaced-apart locations about at least a portion of the annulus;

cinching the tether through the clips to circumferentially tighten the annulus; and

preventing the terminal clip from moving proximally past a chosen location along the tether after the cinching step.

31. A method as in claim 30, wherein the instrument introduction device comprises at least one of a valve, a diaphragm and a haemostatic barrier for allowing passage of at least the clip applicator while preventing outflow of blood from the heart.

32. A method for constricting a heart valve annulus, the method comprising:

introducing a tethered clip assembly to the annulus, the tethered clip assembly comprising a plurality of clips coupled with a tether, the plurality of clips comprising a first clip, an intermediate clip, and a terminal clip, wherein the first clip and a lead end of the tether are constructed to prevent the first clip from moving distally past the lead end of the tether, and wherein one or more of the remaining clips are slidably coupled to the tether;

securing individual clips of the tethered clip assembly at circumferentially spaced-apart locations about at least a portion of the annulus;

stabilizing the annulus prior to introducing the clips;

wherein stabilizing comprises;

introducing a first stabilizing ring beneath the valve leaflets, wherein the ring engages the intersection between the leaflets and the interior ventricular wall; and

introducing a second stabilizing ring over the annulus, wherein the first and second stabilizing rings clamp and immobilize the annulus prior to the securing step;

cinching the tether through the clips to circumferentially tighten the annulus; and

preventing the terminal clip from moving proximally pst a chosen location along the tether after the cinching step.

33. A method as in claim 32, wherein the securing step comprises delivering the clips from one of said rings.

34. A method for constricting a heart valve annulus in a beating heart, said method comprising;

stabilizing the annulus;

securing individual clips at circumferentially spaced-apart locations about at least a portion of the annulus while said remains stabilized;

the stabilizing step comprising;

introducing a first stabilizing ring beneath the valve leaflets, wherein the ring engages the intersection between the leaflets and the interior ventricular wall; and

introducing a second stabilizing over the valve leaflets, wherein the first and second stabilizing rings clamp and immobilize the annulus prior to securing the clips; and

cinching a tether through the clips to circumferentially tighten the annulus.

35. A method as in claim 34, wherein securing said clips comprises delivering the clips from one of said rings.

36. A method as in claim 34, wherein securing said clips comprises deploying clips successively from an applicator which is advanced around a path defined by the stabilizing ring while said annulus remains stabilized.