IMPLANT IMPLANTATION UNIT AND PROCEDURE FOR IMPLANTING THE UNIT

• US 20090062908A1
• Filed: 06/13/2008
• Published: 03/05/2009
• Est. Priority Date: 08/03/2001
• Status: Active Grant

• Current Assignee: JenaValve Technology, Inc., Medtronic Vascular Galway Limited (Medtronic Plc)
• Original Assignee: JenaValve Technology, Inc.
• Inventors: Bonhoeffer, Philipp, Boudjemline, Younes
• Granted Patent: US 8,216,301 B2
• Time in Patent Office: Days
• US Class Current: 623/1.240
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• 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 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/001 for adjusting a diameter

Abstract

The implant implantation unit, at a determined position in the tubular element with a wall comprising a cavity, is pushed there by a catheter and the unit comprises deformable feelers to, under the control of remote activation elements, change from a stowed form to a deployed functional form, to detect the cavity and position itself there with reference to the position of the cavity.

Claims

1. (canceled)

2. (canceled)

3. (canceled)

4. (canceled)

5. (canceled)

6. (canceled)

7. (canceled)

8. (canceled)

9. (canceled)

10. (canceled)

11. A device for implantation of a replacement heart valve, comprising:

a carrier element having a first end and a second end, the carrier element being deployable from a stowed position to a deployed position; and

at least one feeler element being deployable from a stowed position to a deployed position, at least a portion of the at least one feeler element being disposed laterally about the carrier element between the first end and the second end of the carrier element,

wherein the at least one feeler element is deployable independently of the carrier element so as to protrude radially outwardly relative to the carrier element.

12. The device of claim 11, wherein in the stowed position of the at least one feeler element, at least a portion of the at least one feeler element is substantially parallel to a lateral surface portion of the carrier element.

13. The device of claim 11, wherein in the stowed position of the at least one feeler element, the at least one feeler element folds alongside a lateral surface portion of the carrier element.

14. The device of claim 11, wherein in the deployed position of the carrier element and the deployed position of the at least one feeler element, the at least one feeler element folds alongside a lateral surface portion of the carrier element.

15. The device of claim 11, wherein the at least one feeler element has a configuration sufficient for the at least one feeler element to be received by a pocket defined between a valve leaflet and a wall of a blood vessel and has a length sufficient to extend substantially from a base of the pocket where the valve leaflet meets the wall of the blood vessel to at least a free end of the valve leaflet.

16. The device of claim 11, further comprising a valve prosthesis carried by the carrier element.

17. The device of claim 11, wherein the at least one feeler element has a rounded free end.

18. The device of claim 11, wherein the at least one feeler element comprises a plurality of feeler elements.

19. The device of claim 18, wherein the plurality of feeler elements are connected to each other to form a ring that is disposed around the carrier element.

20. The device of claim 18, wherein the carrier element has a tubular configuration and the plurality of feeler elements are angularly spaced from each other about the carrier element.

21. The device of claim 11, wherein the carrier element comprises a tubular mesh.

22. The device of claim 11, further comprising a casing covering the carrier element.

23. The device of claim 11, wherein the carrier element and the at least one feeler element are self-expandable.

24. The device of claim 11, wherein at least one of the carrier element and the at least one feeler element comprises nitinol.

25. The device of claim 11, wherein the at least one feeler element is deployable independently of the carrier element so as to protrude radially outwardly relative to the carrier element and extend at an acute angle relative to a longitudinal axis of the carrier element.

26. The device of claim 11, wherein the at least one feeler element is deployable independently of the carrier element so as to protrude radially outwardly relative to the carrier element such that, in a lateral cross-sectional plane through the carrier element and the at least one feeler element, a surface of the at least one feeler element substantially facing the carrier element is disposed at an acute angle relative to an outer lateral surface of the carrier element.

27. The device of claim 11, wherein, in the stowed position of the carrier element, the carrier element is configured to be received in a first sleeve, and in the stowed position of the at least one feeler element, the at least one feeler element is configured to be received within a second sleeve concentrically disposed about the first sleeve.

28. The device of claim 27, wherein the carrier element and the at least one feeler element are configured to be respectively placed in the deployed position by respectively removing the at least one feeler element from the second sleeve and the carrier element from the first sleeve.

29. The device of claim 27, wherein the at least one feeler element and the carrier element are sequentially deployable by sequentially removing the at least one feeler element from the second sleeve and the carrier element from the first sleeve.

30. The device of claim 11, wherein the carrier element is deployable from the stowed position to the deployed position via an inflatable balloon.

31. A device for implantation of a replacement heart valve, comprising:

a carrier element having a first end and a second end, the carrier element being deployable from a stowed position to a deployed position; and

at least one feeler element being deployable from a stowed position to a deployed position,

wherein the at least one feeler element is deployable independently of the carrier element so as to protrude radially outwardly relative to the carrier element such that, in a lateral cross-sectional plane through the carrier element and the at least one feeler element, a surface of the at least one feeler element substantially facing the carrier element is disposed at an acute angle relative to an outer lateral surface of the carrier element.

32. The device of claim 31, further comprising a valve prosthesis carried by the carrier element.

33. The device of claim 31, wherein the at least one feeler element comprises a plurality of feeler elements.

34. The device of claim 33, wherein the plurality of feeler elements are connected to each other to form a ring that is disposed around the carrier element.

35. The device of claim 33, wherein the carrier element has a tubular configuration and the plurality of feeler elements are angularly spaced from each other about the carrier element.

36. The device of claim 31, wherein the carrier element comprises a tubular mesh.

37. The device of claim 31, further comprising a casing covering the carrier element.

38. The device of claim 31, wherein the carrier element and the at least one feeler element are self-expandable.

39. The device of claim 31, wherein at least one of the carrier element and the at least one feeler element comprises nitinol.

40. The device of claim 31, wherein, in the stowed position of the carrier element, the carrier element is configured to be received in a first sleeve, and in the stowed position of the at least one feeler element, the at least one feeler element is configured to be received within a second sleeve concentrically disposed about the first sleeve.

41. The device of claim 40, wherein the carrier element and the at least one feeler element are configured to be respectively placed in the deployed position by respectively removing the at least one feeler element from the second sleeve and the carrier element from the first sleeve.

42. The device of claim 40, wherein the at least one feeler element and the carrier element are sequentially deployable by sequentially removing the at least one feeler element from the second sleeve and the carrier element from the first sleeve.

43. The device of claim 31, wherein the carrier element is deployable from the stowed position to the deployed position via an inflatable balloon.

44. A method of implanting an implantation device relative to a heart valve, the method comprising:

advancing an implantation device comprising a carrier element and at least one feeler element disposed laterally about the carrier element within a lumen of a blood vessel to a position proximate a heart valve having valve leaflets;

inserting the at least one feeler element into a pocket defined by a wall of the blood vessel and a valve leaflet connected to the wall of the blood vessel; and

positioning the carrier element radially inwardly of the valve leaflets.

45. The method of claim 44, further comprising deploying the carrier element such that the valve leaflet of the pocket is clamped between the at least one feeler element and the carrier element.

46. The method of claim 45, wherein deploying the carrier element comprises expanding the carrier element.

47. The method of claim 45, wherein deploying the carrier element comprises removing a sleeve within which the carrier element is received during advancing of the implantation device.

48. The method of claim 44, further comprising deploying the carrier element such that the carrier element exerts a radial pressure on the valve leaflets and the wall of the blood vessel.

49. The method of claim 44, further comprising expanding the carrier element by inflating a balloon.

50. The method of claim 44, further comprising deploying the at least one feeler element radially outwardly relative to the carrier element prior to inserting the at least one feeler element.

51. The method of claim 50, wherein deploying the at least one feeler element comprises deploying the at least one feeler element independently of the carrier element.

52. The method of claim 50, wherein deploying the at least one feeler element comprises removing a sleeve within which the at least one feeler element is received during advancing of the implantation device.

53. The method of claim 44, wherein advancing the implantation device comprises advancing an implantation device comprising a valve prosthesis carried by the carrier element.

54. The method of claim 44, wherein advancing the implantation device comprises advancing an implantation device comprising a carrier element and a plurality of feeler elements disposed laterally about the carrier element at spaced angular positions.

55. The method of claim 54, wherein inserting the plurality of feeler elements comprises inserting each of the plurality of feeler elements into respective pockets defined by the wall of the blood vessel and respective valve leaflets connected to the wall of the blood vessel.

56. The method of claim 44, wherein inserting the at least one feeler element comprises inserting the at least one feeler element such that a free end of the at least one feeler element reaches substantially to a base of the pocket.

57. The method of claim 44, wherein inserting the at least one feeler element comprises inserting the at least one feeler element such that a free end of the at least one feeler element moves along an inclined base of the pocket and causes rotation of the implantation device.

58. The method of claim 44, wherein inserting the at least one feeler element comprises inserting the at least one feeler element such that a free end of the at least one feeler element moves along an inclined base of the pocket and causes automatic positioning of the implantation device.

59. The method of claim 44, wherein inserting the at least one feeler element comprises rotating the implantation device.

60. The method of claim 44, wherein advancing the implantation device comprises advancing the implantation device to a position proximate an aortic valve.

61. The method of claim 44, wherein advancing the implantation device comprises advancing the implantation device to a position proximate a native heart valve.

62. The method of claim 44, wherein advancing the implantation device comprises advancing the implantation device with the at least one feeler element folded alongside a lateral surface of the carrier element.

63. The method of claim 44, further comprising containing the implantation device within concentric sleeves during advancing of the implantation device.

64. The method of claim 63, wherein containing the implantation device within concentric sleeves comprises containing the carrier element within an inner sleeve of the concentric sleeves and containing the at least one feeler element within an outer sleeve of the concentric sleeves.

65. The method of claim 64, further comprising sequentially deploying the at least one feeler element and the carrier element by sequentially removing the at least one feeler element from the outer sleeve and the carrier element from the inner sleeve.

66. The method of claim 44, wherein inserting the at least one feeler element comprises inserting the at least one feeler element until a free end of the at least one feeler element substantially reaches a base of the pocket and provides a sensation permitting detection of a location of the implantation device.

67. A unit for implantation, comprising:

a deployable carrier element configured to be positioned on a first side of a valve leaflet of a heart valve; and

at least one feeler element connected to the carrier element and configured to be positioned on a second side of the valve leaflet, opposite the first side.

68. The unit of claim 67, wherein the at least one feeler element is deployable from a stowed position in which it is folded alongside the carrier element to a deployed position laterally spaced from the carrier element.

69. The unit of claim 67, wherein at least a portion of the at least one feeler element surrounds at least a portion of the carrier element.

70. The unit of claim 67, wherein the carrier element and the at least one feeler element are self-expandable.

71. The unit of claim 67, further comprising a valve prosthesis carried by the carrier element.

72. A method of treating a heart valve, comprising:

positioning at least one feeler element on a first side of a valve leaflet of a heart valve;

positioning a carrier element on a second side of the valve leaflet, wherein the second side is opposite the first side; and

clamping the valve leaflet between the carrier element and the at least one feeler element.

73. The method of claim 72, further comprising exerting a radial force via the carrier element on a wall of a blood vessel to which the valve leaflet is connected.

74. The method of claim 72, further comprising positioning a valve prosthesis carried by the carrier element on the second side of the valve leaflet.

75. The method of claim 72, wherein positioning the carrier element comprises positioning the carrier element radially inside of a plurality of valve leaflets of the heart valve.

76. The method of claim 75, wherein positioning the at least one feeler element comprises respectively positioning a plurality of feeler elements connected to the carrier element radially outside of the plurality of valve leaflets.

77. The method of claim 72, wherein positioning the at least one feeler element comprises positioning the at least one feeler element between the valve leaflet and a wall of a blood vessel to which the valve leaflet is connected.

78. The method of claim 72, wherein the method comprises treating an aortic valve.

79. A device for implanting an implantation device relative to a heart valve, the device comprising:

an inner sleeve configured to receive a deployable tubular element; and

an outer sleeve concentrically disposed relative to the inner sleeve and configured to receive at least one deployable feeler element connected to the tubular deployable element,

wherein the inner sleeve and the outer sleeve are configured to move relative to each other so as to respectively independently deploy the deployable tubular element and the at least one deployable feeler element.

80. The device of claim 79, wherein the device is configured to be advanced within a lumen of a blood vessel associated with the heart valve.

81. The device of claim 79, further comprising an inflatable balloon.

82. The device of claim 81, wherein the inflatable balloon is disposed concentrically within the inner sleeve when the deployable tubular element is received in the inner sleeve.

83. The device of claim 82, wherein the inflatable balloon and the inner sleeve are configured to move relative to each other.

84. The device of claim 81, wherein, upon inflation, the inflatable balloon is configured to radially expand the deployable tubular element.

85. A replacement valve for use within a human body comprising:

a valve component;

a stent component comprising a first section, a second section for housing the valve component, and a third section,

wherein the third section comprises at least one attachment element configured for removable attachment to a delivery device.

86. A replacement valve for use within a human body comprising:

a valve component; and

a stent component comprising;

a first section comprising a fixation element;

a second section configured to house the valve component; and

a third section comprising at least one attachment element.

87. A replacement valve for use within a human body comprising:

a valve component; and

at least two stent components affixed to one another comprising;

a first section comprising a first cone or crown and a second stent structure collectively forming a fixation element; and

a second section configured to house the valve component.

88. A method for replacing a worn or diseased cardiac valve comprising:

implanting a first stent component comprising an annular element, wherein at least a portion of the stent component is housed within the worn or diseased valve; and

positioning a stent-valve comprising a second stent component and a valve component within the first stent component, wherein the second stent component comprises a complimentary annular element for matably attaching to the first stent component.

89. A method for delivering a cardiac stent-valve to an implantation site comprising:

removably attaching the stent-valve to a delivery device;

delivering the stent-valve to the implantation site in a collapsed configuration;

partially expanding the stent-valve while maintaining the stent-valve attached to the delivery device; and

making a determination with respect to the stent-valve when the stent-valve is in the partially-expanded configuration.

90. The method of claim 89, wherein partially expanding the stent-valve comprises partially proximally expanding the stent-valve.

91. The method of claim 89, wherein the making a determination comprises determining whether the stent-valve is positioned correctly at the implantation site.

92. The method of claim 91, further comprising repositioning the stent-valve when the stent-valve is not positioned correctly at the implantation site.

93. The method of claim 89, further comprising causing the stent-valve to fully expand by causing the stent-valve to detach from the delivery device, when the making a determination yields a positive response.