Devices and methods for heart valve repair

• US 20040193191A1
• Filed: 12/19/2003
• Published: 09/30/2004
• Est. Priority Date: 02/06/2003
• Status: Active Grant

• Current Assignee: Ancora Heart, Inc.
• Original Assignee: Guided Delivery Systems, Inc.
• Inventors: Starksen, Niel F., To, John
• Granted Patent: US 8,287,555 B2
• Time in Patent Office: Days
• US Class Current: 606/153
• 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 17/0682 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: 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
• CPC Class Codes: A61F 2/2466 Delivery devices therefor

Abstract

Devices and methods provide enhanced treatment of a cardiac valve annulus. Methods generally involve contacting an anchor delivery device with the valve annulus and releasing a plurality of coupled anchors from the anchor delivery device to secure the anchors to the annulus. Anchors, which in some embodiments are super-elastic or shape memory self-securing anchors, are then drawn together to tighten the annulus. Devices generally include an elongate catheter having a housing at or near the distal end for releasably housing a plurality of coupled anchors. The housing may be flexible, may conform to a valve annulus, and in some embodiments may be coupled with an expandable member to enhance contact of the housing with annular tissue. In one embodiment, self-securing anchors lie approximately flat within the delivery device housing, allowing anchors with relatively large deployed shapes to be housed in and deployed from a relatively narrow delivery device.

Claims

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

contacting an 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.

2. A method as in claim 1, wherein contacting, delivering and drawing are performed on a mitral valve annulus of the heart.

3. A method as in claim 2, wherein the anchor delivery device is contacted with the length of the mitral valve annulus from within a left ventricle of the heart.

4. A method as in claim 3, wherein the anchor delivery device is contacted with the length of the mitral valve annulus on an inferior side of an intersection of a left ventricular wall and at least one mitral valve leaflet of the heart.

5. A method as in claim 2, wherein the anchor delivery device is contacted with the mitral valve annulus from within a left atrium of the heart.

6. A method as in claim 1, wherein contacting, delivering and drawing are performed on a tricuspid valve annulus of the heart.

7. A method as in claim 1, wherein contacting, delivering and drawing are performed via intravascular access to the heart.

8. A method as in claim 7, wherein the valve annulus is a mitral valve annulus, the method further comprising advancing the anchor delivery device through an aorta and into a left ventricle of the heart to contact a length of the mitral valve annulus on an inferior side of an intersection of a left ventricular wall and at least one mitral valve leaflet of the heart.

9. A method as in claim 7, wherein the valve annulus is a mitral valve annulus, the method further comprising advancing the anchor delivery device through a central vein and into a right atrium of the heart, across an interatrial septum, and into a left ventricle of the heart to contact a length of the mitral valve annulus on an inferior side of an intersection of a left ventricular wall and at least one mitral valve leaflet of the heart.

10. A method as in claim 7, wherein the valve annulus is a mitral valve annulus, the method further comprising advancing the anchor delivery device into a coronary sinus of the heart to contact a length of the mitral valve annulus through the coronary sinus.

11. A method as in claim 1, wherein contacting, delivering and drawing are performed as part of an open heart surgical procedure.

12. A method as in claim 1, wherein contacting, delivering and drawing are performed without stopping the heart.

13. A method as in claim 1, wherein contacting, delivering and drawing are performed through one or more minimally invasive incisions.

14. A method as in claim 1, further comprising deforming a flexible distal portion of the anchor delivery device to conform the distal portion to the length of valve annulus prior to contacting the anchor delivery device with the annulus.

15. A method as in claim 14, further comprising advancing the flexible distal portion within a space between a left ventricular wall, at least one mitral valve leaflet and at least one chordae tendineae of the heart.

16. A method as in claim 15, further comprising expanding an expandable member coupled with the flexible distal portion to urge the flexible distal portion against an intersection of the left ventricular wall and the at least one mitral valve leaflet.

17. A method as in claim 14, wherein deforming the flexible distal portion comprises expanding a shaped expandable member to deform the distal portion.

18. A method as in claim 14, wherein deforming the flexible distal portion comprises articulating the distal portion in at least two directions.

19. A method as in claim 14, wherein deforming the flexible distal portion comprises applying tension to at least a first tensioning cord to cause a first bend in the distal portion.

20. A method as in claim 19, wherein deforming the flexible distal portion further comprises applying tension to at least a second tensioning cord to cause a second bend in the distal portion.

21. A method as in claim 20, wherein the first bend comprises approximately a C-shaped bend to conform the distal portion to the annulus, and the second bend comprises an upwardly directed bend.

22. A method as in claim 14, wherein deforming the flexible distal portion comprises introducing a fluid into a shape-memory distal portion.

23. A method as in claim 14, further comprising locking the shape of the flexible distal portion.

24. A method as in claim 1, wherein delivering the plurality of anchors comprises releasing the anchors to allow them to change from an undeployed shape to a deployed shape to secure to the annulus.

25. A method as in claim 24, wherein the anchors are constrained in their undeployed shape and elastically spring to their deployed shape when released from constraint.

26. A method as in claim 25, wherein the deployed shape of each of the plurality of anchors has a radius of at least about 3 mm, and wherein the delivery device has a cross-sectional diameter of about 1.67 mm or less.

27. A method as in claim 25, wherein releasing the plurality of coupled anchors from constraint comprises applying force to each of the anchors with an anchor contacting member, wherein the applied force causes each anchor to exit the anchor delivery device through at least one opening therein.

28. A method as in claim 27, wherein the force is applied sequentially to the anchors by the anchor contacting member to cause the anchors to exit the delivery device sequentially.

29. A method as in claim 27, wherein applying force to each of the anchors comprises retracting the anchor contacting member proximally relative to the anchor delivery device.

30. A method as in claim 27, wherein each anchor comprises two arms with sharpened tips, and wherein the arms curve in opposite directions when each anchor is released from the delivery device to change from its undeployed to its deployed shape.

31. A method as in claim 25, wherein the anchors are released from the delivery device simultaneously.

32. A method as in claim 25, wherein releasing the plurality of coupled anchors from constraint comprises retracting at least one anchor retaining mandrel of the anchor delivery device.

33. A method as in claim 32, wherein retracting the at least one mandrel comprises retracting two mandrels, each mandrel positioned to retain an arm of each anchor.

34. A method as in claim 33, wherein each anchor has an opened arcuate undeployed shape and assumes a closed shape with overlapping ends after release from constraint.

35. A method as in claim 34, wherein the undeployed shape is approximately a C-shape or semicircle having two sharpened ends, and the deployed shape is a closed circle in which the two ends overlap, wherein upon release from the delivery device the anchors secure to the annulus by penetrating the annulus with the ends and subsequently assuming the closed circle shape.

36. A method as in claim 1, wherein delivering the plurality of anchors comprises crimping the anchors to secure them to the valve annulus.

37. A method as in claim 1, wherein delivering the plurality of anchors comprises driving the anchors out of the delivery device using at least one expandable member disposed within the delivery device.

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

contacting a stabilizing member with the valve annulus on a side of the valve opposite the anchor delivery device; and

applying force to the stabilizing member to immobilize the annulus between the stabilizing member and the anchor delivery device to facilitate delivery of the anchors.

39. A method as in claim 1, wherein drawing the anchors together to comprises cinching a tether slidably coupled with the anchors.

40. A method as in claim 39, wherein cinching the tether comprises applying tensile force to a tether disposed between each of the plurality of anchors and the annulus.

41. A method as in claim 39, wherein cinching the tether comprises applying tensile force to a tether extending through at least one eyelet on each of the plurality of anchors.

42. A method as in claim 39, further comprising:

securing the tether to at least a terminal anchor of the plurality of anchors; and

cutting the tether to leave the cinched anchors secured to the valve annulus.

43. A method as in claim 42, wherein securing the tether comprises attaching a nitinol knot on the tether to at least the terminal anchor.

44. A method as in claim 42, wherein the cinching, securing and cutting steps are performed using a termination catheter advanced over the tether to a location adjacent the coupled anchors.

45. A method as in claim 39, wherein the anchors are further drawn together by a self-deforming coupling member coupled with the anchors.

46. A method as in claim 45, wherein the coupling member is coupled with the tether.

47. A method as in claim 1, wherein drawing the anchors together comprises allowing a self-deforming coupling member coupled with the anchors to deform to constrict the annulus.

48. A method as in claim 1, wherein the contacting, delivering and drawing steps cause a first length of the valve annulus to be tightened, the method further comprising:

contacting the anchor delivery device with a second length of the valve annulus;

delivering a plurality of coupled anchors from the anchor delivery device to secure the anchors to the second length of the annulus; and

drawing the anchors together to circumferentially tighten the second length of the annulus.

49. A method as in claim 48, wherein the first length of the valve annulus comprises an anterior length and the second length of the valve annulus comprises a posterior length.

50. A method as in claim 1, further comprising stabilizing the annulus with the anchor delivery device prior to delivering the anchors.

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

52. A method as in claim 51, wherein visualizing is performed using a visualization device selected from the group consisting of an ultrasound device, an angioscopic device, a transesophageal echocardiogram device and a fluoroscopic device.

53. A method as in claim 52, wherein the ultrasound device comprises a gel-containing cone for enhancing ultrasound visualization.

54. A method as in claim 53, 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.

55. A method as in claim 51, wherein drawing the anchors together comprises cinching a tether slidably coupled with the anchors, the method further comprising:

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

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

56. A method as in claim 51, wherein the at least one visualization device is coupled with the anchor delivery device.

57. A method as in claim 56, 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.

58. A method as in claim 1, wherein delivering the plurality of tethered anchors from the anchor delivery device acts to secure at least one heart valve prosthesis to the valve annulus.

59. A method of constricting a valve annulus in a heart, the method comprising:

contacting an anchor delivery device having a cross-sectional diameter of about 1.67 mm or less 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, each anchor having a deployed shape with a radius of at least about 3 mm; and

drawing the anchors together to circumferentially tighten the valve annulus.

60. A method as in claim 59, wherein delivering the plurality of coupled anchors comprises delivering at least 10 anchors.

61. A device for applying coupled anchors to an annulus of a heart valve, the device comprising:

an elongate shaft having a proximal end and a distal end;

a housing adjacent the distal end;

a plurality of coupled anchors disposed within the housing;

at least one anchor contacting member for causing the anchors to be delivered from the housing; and

at least one actuator at or near the proximal end of the shaft for affecting the anchor contacting member to cause delivery of the anchors to the valve annulus.

62. A device as in claim 61, wherein the elongate shaft comprises a flexible catheter which may be advanced intravascularly to the heart to contact the annulus.

63. A device as in claim 62, wherein the flexible catheter may be advanced through an aorta and into a left ventricle of the heart to contact the valve annulus.

64. A device as in claim 62, wherein the housing has a cross-sectional diameter of about 1.67 mm or less and a radius of each anchor, when deployed from the housing, is at least about 3 mm.

65. A device as in claim 62, wherein the housing holds at least 10 anchors.

66. A device as in claim 61, wherein the housing is sufficiently flexible to be conformable to the annulus.

67. A device as in claim 66, wherein the housing conforms to the annulus at an intersection of a left ventricular wall and one or more mitral valve leaflets of the heart.

68. A device as in claim 67, further comprising at least one expandable member coupled with the housing for expanding to urge the housing toward the intersection to enhance contact of the housing with the valve annulus.

69. A device as in claim 67, wherein the housing has an oval or elliptical shape for helping to orient an anchor delivery surface of the housing to contact the valve annulus.

70. A device as in claim 66, wherein the housing is coupled with an actuator for deforming the housing to conform it to the annulus.

71. A device as in claim 66, wherein the housing is coupled with a shaped expandable member which expands to deform the housing to conform it to the annulus.

72. A device as in claim 66, wherein the housing comprises a shape-changing portion.

73. A device as in claim 72, further comprising at least a first tensioning cord coupled with the shape-changing portion for applying tension to the shape-changing portion to cause it to bend in at least a first direction.

74. A device as in claim 73, further comprising at least a second tensioning cord coupled with the shape-changing portion for applying tension to the shape-changing portion to cause it to bend in at least a second direction.

75. A device as in claim 74, wherein the first direction comprises approximately a C-shape for conforming to the annulus and the second direction comprises an upward or proximal direction for applying force to the annulus.

76. A device as in claim 73, wherein the shape-changing portion includes multiple notches along at least one side to control bending into a curve which conforms to the shape of the annulus.

77. A device as in claim 73, wherein the shape-changing portion comprises multiple stacked segments coupled with at least the first tensioning member to control bending into the shape of the annulus.

78. A device as in claim 73, wherein the shape-changing portion comprises a shape-memory material configured to conform to the shape of the annulus.

79. A device as in claim 78, wherein the shape-changing portion further comprises at least one lumen for introducing a fluid to cause the shape-memory material to conform to the shape of the annulus.

80. A device as in claim 61, wherein the housing has a cross-sectional shape selected from the group consisting of a semicircle, a circle, an oval and a partial oval.

81. A device as in claim 80, wherein the housing comprises a plurality of openings, each opening sized to allow one of the plurality of anchors to be released.

82. A device as in claim 61, wherein each anchor has an undeployed shape when constrained in the housing by the at least one retaining member and elastically springs to a deployed shape when released from the housing.

83. A device as in claim 82, wherein the undeployed shape of each anchor is relatively straight, with each anchor having two sharpened tips, and wherein each anchor curves upon deployment, with the two tips curving in opposite directions.

84. A device as in claim 83, wherein the deployed shape of each anchor comprises two intersecting shapes, with an eyelet for passage of a slidable tether disposed at the intersection of the shapes.

85. A device as in claim 84, wherein the intersecting shapes are selected from the group consisting of circles, semicircles, helices, overlapping helices and ovals.

86. A device as in claim 82, wherein each anchor has an opened arcuate undeployed shape and assumes a closed shape with overlapping ends after release from constraint.

87. A device as in claim 86, wherein the undeployed shape is approximately a C-shape or semicircle having two sharpened ends, and the deployed shape is a closed circle in which the two ends overlap, wherein upon release from the delivery device the anchors secure to the annulus by penetrating the annulus with the ends and subsequently assuming the closed circle shape.

88. A device as in claim 86, wherein the anchors lie flush with the annulus of the valve when secured to the annulus.

89. A device as in claim 86, wherein the anchors comprise at least one super-elastic or shape-memory material.

90. A device as in claim 61, wherein the anchors are slidably coupled with a tether.

91. A device as in claim 90, wherein each of the plurality of anchors includes at least one eyelet, and the tether passes through the at least one eyelet of each anchor.

92. A device as in claim 90, wherein the tether is disposed along the anchors so as to be positioned between the anchors and the valve annulus when the anchors are deployed.

93. A device as in claim 90, wherein the anchors are further coupled with a self-deforming coupling member fixedly coupled with each anchor, the self-deforming member changing from an undeployed shape to a deployed shape upon release from the housing to cinch the anchors to tighten the annulus.

94. A device as in claim 90, further comprising a termination device slidably advanced over the tether, the termination device comprising:

at least one attachment member for attaching the tether to at least a terminal anchor of the plurality of anchors; and

at least one cutting member for cutting the tether to leave the cinched, tethered anchors secured to the valve annulus.

95. A device as in claim 94, wherein the termination device comprises at least one relatively stiff portion near its distal end for applying opposing force against the terminal anchor while tether is cinched.

96. A device as in claim 61, further comprising at least one crimping member for crimping the coupled anchors to secure them to the annulus.

97. A device as in claim 61, wherein the anchors are coupled with a self-deforming coupling member fixedly coupled with each anchor, the self-deforming member changing from an undeployed shape to a deployed shape upon release from the housing to cinch the anchors to tighten the annulus.

98. A device as in claim 97, wherein the coupling member comprises a super-elastic or shape-memory member having an undeployed shape approximating a straight line and a deployed shape of a line having multiple bends.

99. A device as in claim 61, wherein the at least one anchor contacting member comprises at least one retractable force applying device which, when retracted proximally relative to the housing, sequentially contacts the anchors to apply force to the anchors such that they exit the housing via at least one opening in the housing.

100. A device as in claim 99, wherein the retractable force applying device comprises at least one circular member having a diameter approximating or slightly less than an inner diameter of the housing, and wherein the actuator comprises a tether, cord or wire coupled at its distal end with the circular member.

101. A device as in claim 100, wherein the at least one circular member has a shape selected from the group consisting of a sphere, an oblong or ovoid ball, a plate, a plunger, an anchor, a hook, and a knot.

102. A device as in claim 61, wherein the at least one anchor contacting member comprises at least one retaining member for retaining the anchors within the housing, wherein the at least one actuator moves the retaining member to release the anchors from the housing.

103. A device as in claim 102, wherein the at least one retaining member comprises at least one anchor retaining mandrel, slidably disposed in the housing so that retracting the mandrel releases one or more of the anchors.

104. A device as in claim 103, wherein the at least one mandrel comprises two mandrels, each mandrel positioned to retain an arm of each anchor.

105. A device as in claim 61, wherein the at least one actuator includes means for cinching the coupled anchors to reduce the circumference of the valve annulus.

106. A device as in claim 61, wherein the at least one actuator is selected from the group consisting of a trigger, a handle, a plunger, a squeeze-activated device, a syringe-grip device and a foot-operated device.

107. A device as in claim 61, further comprising at least one expandable member disposed within the housing for pushing the anchors out of the housing.

108. A device as in claim 61, further comprising at least one fastener coupled with the tether for securing the tether to at least one of the anchors after cinching the tether.

109. A device as in claim 108, wherein the at least one fastener comprises a knot made of super-elastic or shape-memory material.

110. A device for applying multiple tethered anchors to an annulus of a heart valve, the device comprising:

a flexible elongate catheter having a distal portion for delivering the tethered anchors, the distal portion having a cross-sectional diameter of about 1.67 mm or less;

a plurality of tethered anchors disposed within the distal portion, each anchor having a radius of at least about 3 mm when deployed from the housing; and

at least one anchor delivery member coupled with the catheter for causing the anchors to be delivered from the catheter.

111. A self-securing anchor for attaching to annular tissue of a heart valve, the self-securing anchor comprising a super-elastic or shape-memory material having a relatively elongate undeployed shape allowing the anchor to be disposed within a delivery catheter having a cross-sectional diameter of 1.67 mm or less, and assuming a deployed shape with a radius of at least 3 mm upon its release from the delivery device.

112. An anchor as in claim 111, wherein two sharpened tips of the anchor curve in opposite directions when the anchor is released from the delivery device.

113. An anchor as in claim 112, wherein the anchor comprises an eyelet disposed between the two sharpened tips.

114. A self-securing anchor for attaching to annular tissue of a heart valve, the self-securing anchor comprising a super-elastic or shape-memory material having an opened arcuate undeployed shape and assuming a closed shape with overlapping ends after release from constraint.

115. A device as in claim 114, wherein the undeployed shape is approximately a C-shape or semicircle having two sharpened ends, and the deployed shape is a closed circle in which the two ends overlap.

116. An anchor as in claim 114, wherein the anchor lies flush with the annular tissue when secured to the tissue.

117. An anchor as in claim 114, wherein the shape-memory material comprises Nitinol.