Delivery devices and methods for heart valve repair

• US 9,226,825 B2
• Filed: 07/27/2004
• Issued: 01/05/2016
• Est. Priority Date: 06/13/2002
• Status: Active Grant

• Current Assignee: Ancora Heart, Inc.
• Original Assignee: Guided Delivery Systems, Inc.
• Inventors: Starksen, Niel F., To, John, Fabro, Mariel, Wei, Michael F., Morales, Rodolfo A.
• Primary Examiner(s): YABUT, DIANE D
• Application Number:
  US10/901,554
• Publication Number:
  US 20050107812A1
• Time in Patent Office: 4,179 Days
• Field of Search: 606/143, 128/898
• US Class Current: 1/1
• 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
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening
• 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. A method for advancing an operational device into a left ventricle of a heart to contact ventricular wall tissue comprising:

advancing an operational device into a left ventricle and circumferentially along at least a portion of the ventricular wall tissue at or adjacent to a mitral valve having leaflets, the operational device comprising a plurality of side wall openings facing the tissue below the leaflets;

acting on the ventricular wall tissue by securing a series of anchors at or adjacent to the mitral valve, wherein the series of anchors are delivered through the plurality of side wall openings such that each anchor engages the tissue on a ventricular side of the heart without penetrating into tissue of a left atrium and wherein the series of anchors are directly coupled to a tether, the tether arranged to travel through the plurality of side wall openings to deliver the series of anchors, wherein the series of anchors comprise a proximal anchor coupled to the tether and a distal anchor secured to the tether and wherein the acting on step comprises pulling on the tether to reduce the distance between the proximal and distal anchors; and

removing the operational device from the left ventricle.

2. The method according to claim 1 wherein a radius of curvature of the operational device in an expanded state is about 25%-50% larger than a radius of curvature of the mitral valve.

3. The method according to claim 1 wherein the advancing step comprises passing the operational device through the aorta.

4. The method according to claim 1 further comprising urging the operational device radially outwardly to seat the operational device against the ventricular wall tissue at or adjacent to a mitral valve, wherein the distal portion of the operational device is entirely within the ventricle, the urging step being carried out at least in part by virtue of the operational device having a radius of curvature when in an expanded state larger than the radius of curvature of the mitral valve.

5. The method according to claim 4 wherein the urging step further comprises radially outwardly expanding an expansible element associated with the operational device, and wherein the radially outwardly expanding step is carried out with an expansible element having a radius larger than the radius of the operational device.

6. The method according to claim 4 wherein the urging step further comprises radially outwardly expanding a balloon associated with the operational device.

7. The method according to claim 4 wherein the urging step is carried out:

with an operational device having a length; and

to seat the entire length of the operational device against the ventricular wall at or adjacent to the mitral valve.

8. The method according to claim 1 wherein the operational device advancing step is carried out using a steerable operational device.

9. The method according to claim 1 wherein the operational device advancing step comprises:

advancing a guide catheter into a left ventricle and along at least a portion of the ventricular wall at or adjacent to the mitral valve;

passing a flexible guide sheath over the guide catheter and along at least a portion of the ventricular wall at or adjacent to the mitral valve; and

advancing the operational device through the guide sheath.

10. The method according to claim 9 further comprising withdrawing the guide catheter from the guide sheath before advancing the operational device through the guide sheath.

11. The method according to claim 9 further comprising removing the guide sheath from the ventricular wall at or adjacent to the mitral valve before the acting on step.

12. The method according to claim 9 wherein the guide catheter advancing step is carried out using a steerable guide catheter.

13. The method according to claim 1 wherein the acting on step is carried out using self-forming anchors.

14. The method according to claim 1 wherein the advancing step comprises advancing the operational device through a guide sheath.

15. The method according to claim 14 wherein the acting on step comprises delivering the anchors from a housing of the operational device, through a distal portion of the guide sheath and into the ventricular wall tissue at or adjacent to the mitral valve thereby attaching the distal portion of the guide sheath to the ventricular wall.

16. A method for advancing an operational device into a left ventricle of a heart to contact ventricular wall tissue comprising:

advancing an operational device into a left ventricle and circumferentially along at least a portion of the ventricular wall tissue at or adjacent to a mitral valve having leaflets, the operational device comprising a plurality of side wall openings facing the tissue below the leaflets;

acting on the ventricular wall tissue by securing a series of anchors at or adjacent to the mitral valve, wherein the series of anchors are delivered through the plurality of side wall openings such that each anchor engages the tissue on a ventricular side of the heart without penetrating into tissue of a left atrium and wherein the series of anchors are directly coupled to a tether, the tether arranged to travel through the plurality of side wall openings to deliver the series of anchors, wherein the series of anchors comprise a proximal anchor coupled to the tether and a distal anchor secured to the tether and wherein the acting on step comprises pulling on the tether to reduce the distance between the proximal and distal anchors; and

removing the operational device from the left ventricle; and

wherein;

the advancing step is carried out using an operational device comprising;

an elongate housing having a longitudinal axis and an open interior;

wherein the series of anchors comprise tissue-engageable anchors, the anchors located within the open interior of the housing;

each anchor having a first part and a second part, the second part having a tissue piercing tip,

wherein the side wall openings are located in the housing and are sized for passage of the anchor tip-first through the openings;

each anchor placeable in a relatively straight, undeployed state generally parallel to the longitudinal axis within the housing; and

the acting on step further comprises driving the anchors tip-first through the side wall openings with the anchors naturally assuming a curved, tissue-engaging deployed state after passing through the openings in the housing.

17. The method according to claim 16 wherein the advancing step is carried out using an anchor comprising said first part and two of said second part extending from the first part.

18. The method according to claim 17 wherein the second parts extend in directions generally opposite one another when in the deployed state.

19. The method according to claim 17 wherein the second parts have generally circular or semicircular shapes when in the deployed state.

20. The method according to claim 16 wherein each anchor is oriented generally perpendicular to the longitudinal axis when in the deployed state.

21. The method according to claim 16 wherein each anchor has a generally circular or semicircular shape when in the deployed state.

22. A method for advancing an operational device into a left ventricle of a heart to contact ventricular wall tissue comprising:

advancing an operational device into a left ventricle and circumferentially along at least a portion of the ventricular wall tissue at or adjacent to a mitral valve having leaflets, the operational device comprising a plurality of side wall openings facing the tissue below the leaflets;

acting on the ventricular wall tissue by securing a series of anchors at or adjacent to the mitral valve, wherein the series of anchors are delivered through the plurality of side wall openings such that each anchor engages the tissue on a ventricular side of the heart without penetrating into tissue of a left atrium and wherein the series of anchors are directly coupled to a tether, the tether arranged to travel through the plurality of side wall openings to deliver the series of anchors, and wherein the acting on step further comprises delivering the series of coupled anchors from a housing of the operational device into the ventricular wall tissue at or adjacent to the mitral valve and circumferentially tightening the mitral valve by placing the tether in tension; and

removing the operational device from the left ventricle.

23. The method according to claim 22 wherein the anchors delivering step comprises driving at least one of the anchors through a biocompatible material thereby attaching the biocompatible material to the ventricular wall at or adjacent to the mitral valve.

24. The method according to claim 23 wherein the anchor delivering step is carried out using a strip of the biocompatible material and the anchors driving step comprises driving a plurality of the anchors through the strip of biocompatible material.

25. The method according to claim 23 wherein the anchor delivering step is carried out using a plurality of pieces of the biocompatible material and the anchors driving step comprises driving a plurality of the anchors through the pieces of biocompatible material.

26. A method for advancing an operational device into a left ventricle of a heart to contact ventricular wall tissue comprising:

advancing an operational device into a left ventricle and along at least a portion of the ventricular wall tissue at or adjacent to a mitral valve having leaflets, the operational device comprising an expansible element and comprising a plurality of side wall openings facing the tissue below the leaflets;

the operational device advancing step comprising steering the operational device circumferentially around the mitral valve, along the ventricular wall, wherein the distal portion of the operational device is entirely within the ventricle;

radially outwardly expanding the expansible element to urge the operational device radially outwardly to seat the operational device against the ventricular wall at or adjacent to the mitral valve;

acting on the ventricular wall tissue by securing a series of anchors at or adjacent to the mitral valve, wherein the series of anchors are delivered through the plurality of side wall openings such that the each anchor engages the tissue on a ventricular side of the heart without penetrating into tissue of a left atrium and wherein the series of anchors are directly coupled to a tether, the tether arranged to travel through the plurality of side wall openings to deliver the series of anchors, wherein the series of anchors comprise a proximal anchor coupled to the tether and a distal anchor secured to the tether, and the acting on step comprises pulling on the tether to reduce the distance between the proximal and distal anchors; and

removing the operational device from the left ventricle.

27. The method according to claim 26 wherein the advancing step comprises passing the operational device through the aorta.

28. The method according to claim 26 wherein the expansible element has a radius larger than the radius of the operational device.

29. The method according to claim 26 wherein the urging step is carried out with a balloon as the expansible element.

30. The method according to claim 26 wherein the acting on step is carried out using self-forming anchors.

31. The method according to claim 26 wherein the acting on step comprises delivering the anchors from a housing of the operational device into ventricular wall tissue at or adjacent to the mitral valve.

32. The method according to claim 26 wherein the advancing step is carried out using the operational device as the only steerable element.

33. A method for advancing an operational device into a left ventricle of a heart to contact ventricular wall tissue comprising:

advancing an operational device into a left ventricle and along at least a portion of the ventricular wall tissue at or adjacent to a mitral valve having leaflets, the operational device comprising an expansible element and comprising a plurality of side wall openings facing the tissue below the leaflets;

the operational device advancing step comprising steering the operational device circumferentially around the mitral valve, along the ventricular wall, wherein the distal portion of the operational device is entirely within the ventricle;

radially outwardly expanding the expansible element to urge the operational device radially outwardly to seat the operational device against the ventricular wall at or adjacent to the mitral valve;

acting on the ventricular wall tissue by securing a series of anchors at or adjacent to the mitral valve, wherein the series of anchors are delivered through the plurality of side wall openings such that the each anchor engages the tissue on a ventricular side of the heart without penetrating into tissue of a left atrium and wherein the series of anchors are directly coupled to a tether, the tether arranged to travel through the plurality of side wall openings to deliver the series of anchors, wherein the acting on step further comprises circumferentially tightening the mitral valve by placing the tether in tension; and

removing the operational device from the left ventricle.

34. A method for advancing an operational device into a left ventricle of a heart to contact ventricular wall tissue comprising:

advancing a guide catheter into a left ventricle and circumferentially along at least a portion of the ventricular wall tissue at or adjacent to a mitral valve, the mitral valve having leaflets and a mitral valve radius;

selecting a flexible guide sheath having a curveable portion, said curveable portion having a guide sheath radius when in an outwardly expanded curved state, the guide sheath radius being larger than the mitral valve radius;

passing the guide sheath over the guide catheter and along at least a portion of the ventricular wall tissue at or adjacent to the mitral valve;

advancing an operational device through the guide sheath, the operational device comprising a plurality of side wall openings facing the tissue below the leaflets, wherein the distal portion of the operational device is entirely within the ventricle;

acting on the ventricular wall tissue by securing a series of anchors at or adjacent to the mitral valve, wherein the series of anchors are delivered through the plurality of side wall openings such that each anchor engages the tissue on a ventricular side of the heart without penetrating into tissue of a left atrium and wherein the series of anchors are directly coupled to a tether, the tether arranged to travel through the plurality of side wall openings to deliver the series of anchors, wherein the series of anchors comprise a proximal anchor coupled to the tether and a distal anchor secured to the tether, and wherein the acting on step further comprises pulling on the tether to reduce the distance between the proximal and distal anchors; and

removing the operational device from the left ventricle.

35. The method according to claim 34 wherein the guide sheath radius is about 25%-50% larger than the mitral valve radius.

36. The method according to claim 34 wherein the guide catheter advancing step is carried out using a steerable guide catheter.

37. The method according to claim 34 further comprising withdrawing the guide catheter from the guide sheath before the operational device advancing step.

38. The method according to claim 34 further comprising removing the guide sheath from the ventricular wall at or adjacent to the mitral valve before the acting on step.

39. The method according to claim 34 wherein the acting on step comprises urging the operational device radially outwardly to engage the ventricular wall tissue at or adjacent to the mitral valve.

40. The method according to claim 34 wherein the acting on step is carried out using self-forming anchors.

41. A method for advancing an operational device into a left ventricle of a heart to contact ventricular wall tissue comprising:

selecting a flexible guide catheter having a curveable portion, said curveable portion having a guide catheter radius when in outwardly expanded curved state;

advancing the guide catheter into a left ventricle and circumferentially along at least a portion of the ventricular wall tissue at or adjacent to a mitral valve, the mitral valve having leaflets and a mitral valve radius;

the selecting step being carried out with the guide catheter radius being larger than the mitral valve radius;

passing a curveable portion of a guide sheath over the guide catheter and along at least a portion of the ventricular wall tissue at or adjacent to the mitral valve;

advancing an operational device through the guide sheath, the operational device comprising a plurality of side wall openings facing the tissue below the leaflets, wherein the distal portion of the operational device is entirely within the ventricle;

acting on the ventricular wall tissue by securing a series of anchors at or adjacent to the mitral valve, wherein the series of anchors are delivered through the plurality of side wall openings such that each anchor engages the tissue on a ventricular side of the heart without penetrating into tissue of a left atrium and wherein the series of anchors are directly coupled to a tether, the tether arranged to travel through the plurality of side wall openings to deliver the series of anchors, wherein the series of anchors comprise a proximal anchor coupled to the tether and a distal anchor secured to the tether, and wherein the acting on step comprises pulling on the tether to reduce the distance between the proximal and distal anchors; and

removing the operational device from the left ventricle.

42. The method according to claim 41 wherein the guide catheter radius is about 25%-50% larger than the mitral valve radius.

43. The method according to claim 41 wherein the guide catheter advancing step is carried out using a steerable guide catheter.

44. The method according to claim 41 further comprising withdrawing the guide catheter from the guide sheath before the operational device advancing step.

45. The method according to claim 41 further comprising removing the guide sheath from the ventricular wall at or adjacent to the mitral valve before the acting on step.

46. The method according to claim 41 wherein the acting on step comprises urging the operational device radially outwardly to engage the ventricular wall at or adjacent to the mitral valve.

47. The method according to claim 41 wherein the acting on step is carried out using self-forming anchors.