Delivery devices and methods for heart valve repair

• US 20050107812A1
• Filed: 07/27/2004
• Published: 05/19/2005
• 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, Morales, Rodolfo A., Fabro, Mariel, Wei, Michael F.
• Granted Patent: US 9,226,825 B2
• Time in Patent Office: Days
• US Class Current: 606/143
• 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 the mitral valve annulus comprising:

advancing an operational device into a left ventricle and along at least a portion of a mitral valve annulus of a heart;

urging the operational device radially outwardly to seat the operational device against the mitral valve annulus;

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 annulus; and

acting on the mitral valve annulus by the operational device.

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

3. The method according to claim 1 wherein the advancing step is carried out in a retrograde manner into he left ventricle.

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

5. The method according to claim 1 wherein the urging step further comprises radially outwardly expanding an expansible element associated with the operational device.

6. The method according to claim 5 wherein the radially outwardly expanding step is carried out with an expansible element having a radius larger than the radius of the operational device.

7. The method according to claim 1 wherein the urging step further comprises radially outwardly expanding a balloon associated with the operational device.

8. The method according to claim 1 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 mitral valve annulus.

9. The method according to claim 1 wherein the urging step further comprises magnetically urging the operational device towards the mitral valve annulus.

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

11. 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 a mitral valve annulus of a heart;

passing a flexible guide sheath over the guide catheter and along at least a portion of the mitral valve annulus; and

advancing the operational device through the guide sheath.

12. The method according to claim 11 further comprising withdrawing the guide catheter from the guide sheath before advancing the operational device through the guide sheath.

13. The method according to claim 11 further comprising removing the guide sheath from the mitral valve annulus before the acting on step.

14. The method according to claim 11 wherein the guide catheter advancing step is carried out using a steerable guide catheter.

15. The method according to claim 1 wherein the acting on step comprises:

securing a series of anchors of the operational device to the mitral valve annulus, the series of anchors comprising a proximal anchor coupled to a tether and a distal anchor secured to the tether; and

pulling on the tether to reduce the distance between the proximal and distal anchors.

16. The method according to claim 15 wherein the securing step is carried out using self-forming anchors.

17. The method according to claim 1 wherein:

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

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

self-forming tissue-engageable anchors 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;

the housing having side wall openings 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 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.

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

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

20. The method according to claim 18 wherein the second parts have generally circular or semicircular shapes when in the deployed state.

21. The method according to claim 17 wherein the anchor is oriented generally perpendicular to the longitudinal axis when in the deployed state.

22. The method according to claim 17 wherein the anchor has a generally circular or semicircular shape when in the deployed state.

23. The method according to claim 17 wherein:

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

a series of the anchors, the anchors comprising a distal anchor and a proximal anchor; and

a tether serially coupling the anchors to one another with the proximal anchor coupled to the tether and the distal anchor secured to the tether; and

the acting on step comprises;

securing the series of anchors to the mitral valve annulus; and

pulling on the tether to reduce the distance between the proximal and distal anchors.

24. The method according to claim 17 further comprising selecting an operational device comprising a housing having a diametrical dimension d and an anchor having a diametrical dimension D in the deployed state, and wherein the ratio of D to d is at least 3.5.

25. The method according to claim 17 further comprising selecting an operational device comprising a housing having a diametrical dimension d and an anchor having a diametrical dimension D in the deployed state, and wherein the ratio of D to d is at least 4.4.

26. The method according to claim 17 further comprising selecting an operational device comprising a housing having a diametrical dimension d and an anchor having a diametrical dimension D in the deployed state, and wherein the ratio of D to d is at least 7.

27. The method according to claim 17 further comprising selecting an operational device comprising a housing having a diametrical dimension d and an anchor having a diametrical dimension D in the deployed state, and wherein the ratio of D to d is at least 8.8.

28. The method according to claim 1 wherein the acting on step comprises delivering anchors from a housing of the operational device into tissue at the mitral valve annulus.

29. The method according to claim 28 wherein the anchors delivering step is carried out using a series of tethered anchors, comprising a tether and said anchors, and the acting on step further comprises circumferentially tightening the mitral valve annulus by placing the tether in tension.

30. The method according to claim 28 wherein the anchors delivering step comprises driving at least one of the anchors through a biocompatible material thereby attaching the biocompatible material to the mitral valve annulus.

31. The method according to claim 30 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.

32. The method according to claim 30 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.

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

34. The method according to claim 33 wherein the acting on step comprises delivering anchors from a housing of the operational device, through a distal portion of the guide sheath and into tissue at the mitral valve annulus thereby attaching the distal portion of the guide sheath to the mitral valve annulus.

35. The method according to claim 34 further comprising detaching the distal portion of the guide sheath from a proximal portion of the guide sheath.

36. The method according to claim 1 wherein the acting on step comprises delivering anchors from a housing of the operational device, through a distal portion of the operational device and into tissue at the mitral valve annulus thereby attaching the distal portion of the operational device to the mitral valve annulus, and further comprising detaching the distal portion of the operational device from a proximal portion of the operational device.

37. A method for advancing an operational device into a left ventricle of a heart to contact the mitral valve annulus comprising:

advancing an operational device into a left ventricle and along at least a portion of a mitral valve annulus of a heart, the operational device comprising an expansible element;

the operational device advancing step comprising steering the operational device;

radially outwardly expanding the expansible element to urge the operational device radially outwardly to seat the operational device against the mitral valve annulus; and

acting on the mitral valve annulus by the operational device.

38. The method according to claim 37 wherein the advancing step is carried out in a retrograde manner into the left ventricle.

39. The method according to claim 38 wherein the advancing step comprises passing the operational device through the aorta.

40. The method according to claim 37 wherein the radially outwardly expanding step is carried out with an expansible element having a radius larger than the radius of the operational device.

41. The method according to claim 37 wherein the urging step is carried out with a balloon as the expansible element.

42. The method according to claim 37 wherein the acting on step comprises:

securing a series of anchors of the operational device to the mitral valve annulus, the series of anchors comprising a proximal anchor coupled to a tether and a distal anchor secured to the tether; and

pulling on the tether to reduce the distance between the proximal and distal anchors.

43. The method according to claim 37 wherein the securing step is carried out using self-forming anchors.

44. The method according to claim 37 wherein the acting on step comprises delivering anchors from a housing of the operational device into tissue at the mitral valve annulus.

45. The method according to claim 44 wherein the anchors delivering step is carried out using a series of tethered anchors, comprising a tether and said anchors, and the acting on step further comprises circumferentially tightening the mitral valve annulus by placing the tether in tension.

46. The method according to claim 37 wherein the acting on step comprises delivering anchors from a housing of the operational device, through a distal portion of the operational device and into tissue at the mitral valve annulus thereby attaching the distal portion of the operational device to the mitral valve annulus, and further comprising detaching the distal portion of the operational device from a proximal portion of the operational device.

47. The method according to claim 37 wherein the advancing step is carried out using the operational device as the only steerable element.

48. A method for advancing an operational device into a left ventricle of a heart to contact the mitral valve annulus comprising:

advancing a guide catheter into a left ventricle and along at least a portion of a mitral valve annulus of a heart, the mitral valve annulus having a mitral valve annulus 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 annulus radius;

passing the guide sheath over the guide catheter and along at least a portion of the mitral valve annulus;

urging the curveable portion of the guide sheath in the curved state towards the mitral valve annulus at least in part by virtue of the guide sheath radius;

advancing an operational device through the guide sheath; and

acting on the mitral valve annulus by the operational device.

49. The method according to claim 48 wherein the guide sheath radius is about 25%-50% larger than the mitral valve annulus radius.

50. The method according to claim 48 wherein the guide catheter advancing step is carried out using a steerable guide catheter.

51. The method according to claim 48 further comprising withdrawing the guide catheter from the guide sheath before the operational device advancing step.

52. The method according to claim 48 further comprising removing the guide sheath from the mitral valve annulus before the acting on step.

53. The method according to claim 48 wherein the acting on step comprises urging the operational device radially outwardly to engage the mitral valve annulus.

54. The method according to claim 48 wherein the acting on step comprises:

securing a series of anchors of the operational device, comprising a proximal anchor coupled to a tether and a distal anchor secured to the tether, to the mitral valve annulus; and

pulling on the tether to reduce the distance between the proximal and distal anchors.

55. The method according to claim 54 wherein the securing step is carried out using self-forming anchors.

56. A method for advancing an operational device into a left ventricle of a heart to contact the mitral valve annulus 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 along at least a portion of a mitral valve annulus of a heart, the mitral valve annulus having a mitral valve annulus radius;

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

passing a curveable portion of the a guide sheath over the guide catheter and along at least a portion of the mitral valve annulus;

urging the curveable portion of the guide sheath towards the mitral valve annulus at least in part by virtue of the guide catheter radius;

advancing an operational device through the guide sheath; and

acting on the mitral valve annulus by the operational device.

57. The method according to claim 56 wherein the guide catheter radius is about 25%-50% larger than the mitral valve annulus radius.

58. The method according to claim 56 wherein the guide catheter advancing step is carried out using a steerable guide catheter.

59. The method according to claim 56 further comprising withdrawing the guide catheter from the guide sheath before the operational device advancing step.

60. The method according to claim 56 further comprising removing the guide sheath from the mitral valve annulus before the acting on step.

61. The method according to claim 56 wherein the acting on step comprises urging the operational device radially outwardly to engage the mitral valve annulus.

62. The method according to claim 56 wherein the acting on step comprises:

securing a series of anchors of the operational device, comprising a proximal anchor coupled to a tether and a distal anchor secured to the tether, to the mitral valve annulus; and

pulling on the tether to reduce the distance between the proximal and distal anchors.

63. The method according to claim 62 wherein the securing step is carried out using self-forming anchors.