Catheter for the Transvascular Implantation of Prosthetic Heart Valves

• US 20090234443A1
• Filed: 01/12/2006
• Published: 09/17/2009
• Est. Priority Date: 01/20/2005
• Status: Active Grant

• Current Assignee: JenaValve Technology, Inc.
• Original Assignee: JenaValve Technology GmbH (JenaValve Technology, Inc.)
• Inventors: Damm, Christoph, Moszner, Robert, Figulla, Hans-Reiner, Ferrari, Markus, Ottma, Rüdiger
• Granted Patent: US 8,679,174 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• 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 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2240/008 Means for testing implantable prostheses

Abstract

The invention relates to a catheter for the transvascular implantation of prosthetic heart valves, in particular comprising self-expanding anchorage supports (10), which allow a minimally invasive implantation of prosthetic heart valves. The aim of the invention is to reduce the risk to the patient during the implantation. To achieve this, according to the invention a prosthetic heart valve comprising anchorage supports is temporarily housed in a folded form in a cartridge-type unit (4) during the implantation. The cartridge-type unit can be fixed on the proximal end of a guide system (1), which comprises a flexible region (9) that can be guided through the aorta. Actuating elements (2, 3) run through the interior of the hollow guide system, said elements permitting sections of the cartridge-type unit to be displaced radially about their longitudinal axis and/or laterally in a proximal direction, thus allowing individual sections of the anchorage support and the associated prosthetic heart valve to be sequentially released.

Claims

1. Catheter for the transvascular implantation of heart valve prosthesis with a support element, comprising:

a cartridge unit configured to hold the support element in a collapsed state; and

operating elements disposed within a hollow guide system and extending to the cartridge unit, the operating elements configured to affect movement of the cartridge unit rotatably about its longitudinal axis to affect movement of the support element rotatably and axially along its longitudinal axis in at least one of the proximal and distal directions to affect a sequential release of a hoop element of the support element for introduction into a pocket of a heart valve followed by a release of a remainder of the support element to clamp at least a portion of the heart valve between the hoop element and the remainder of the support element.

2. Catheter as claimed in claim 1, further including a bendable region.

3. Catheter as claimed in claim 2, wherein the bendable region includes a plurality of joints and is configured to affect a bend in the catheter of 180 degrees.

6. Catheter as claimed in claim 1, wherein a liquid coolant is circulated through the interior of the guide system as far as the cartridge unit.

7. Catheter as claimed in claim 6, wherein the guide system is configured to be liquid-proof.

8. Catheter as claimed in claim 1, wherein the cartridge unit is provided with first and second cartridge elements telescopically disposed with respect to one another, and wherein the support element and heart valve prosthesis are held in the collapsed state by the first and second cartridge elements.

9. Catheter as claimed in claim 1, wherein the cartridge unit includes at least one cartridge element configured to selectively engage the support element via a plurality of anchoring elements mounted on the cartridge element.

17. Catheter as claimed in claim 8, wherein the first cartridge element is movable in the distal direction to permit the hoop element to self-expand while the second cartridge element maintains the remainder of the support element in the collapsed state.

18. Catheter as claimed in claim 17, wherein the second cartridge element is movable in the proximal direction to permit the remainder of the support element to at least partially expand.

19. Catheter as claimed in claim 9, wherein the plurality of anchoring elements are configured to permit rotation of the support element about a longitudinal axis of the catheter when the cartridge element is rotated.

4-5. -5. (canceled)

10-16. -16. (canceled)

20. A catheter for implanting a heart valve prosthesis connected to a support element including at least one support hoop, comprising:

a first manipulating element;

a second manipulating element configured to at least partially surround the first manipulating element; and

a third manipulating element configured to at least partially surround the second manipulating element;

wherein relative axial movement between the first, second, and third manipulating elements is configured to permit sequential expansion of the support element from a collapsed form to an expanded form.

21. The catheter of claim 20, wherein axial movement of the third manipulating element in a distal direction relative to the first manipulating element is configured to permit the at least one support hoop to expand from a collapsed form to an expanded form.

22. The catheter of claim 21, wherein axial movement of the second manipulating element in the proximal direction relative to the first manipulating element is configured to permit a remainder of the support element to expand from a collapsed form to a partially expanded form.

23. The catheter of claim 22, wherein axial movement of the third manipulating element in the proximal direction relative to the first manipulating element is configured to collapse the partially expanded remainder of the support element and collapse the expanded support hoop.

24. The catheter of claim 22, wherein further axial movement of the third manipulating element in the distal direction relative to the first manipulating element is configured to permit the remainder of the support element to expand from the partially expanded form to a fully expanded form.

25. The catheter of claim 22, wherein relative axial movement of the first manipulating element in the proximal direction relative to the third manipulating element is configured to permit the remainder of the support element to expand from the partially expanded form to a fully expanded form.

26. The catheter of claim 20, wherein:

the first manipulating element includes anchoring elements configured to selectively engage the support element; and

the first manipulating element and the support element are configured to rotate about a longitudinal axis.

27. A catheter for implanting a support element having at least one support hoop, comprising:

a cartridge unit disposed between proximal and distal ends of the catheter configured to;

affect expansion of the at least one support hoop via movement of a first element in the distal direction, the expanded at least one support hoop configured to be introduced into a pocket of a native heart valve;

affect expansion of a first portion of the remainder of the support element via movement of a second element in the proximal direction and maintain a second portion of the remainder of the support element in a collapsed form via the first element; and

affect contraction of the expanded at least one support hoop and the expanded first portion of the remainder of the support element via movement of the first element in the proximal direction.

28. The catheter of claim 27, wherein the cartridge unit further includes a third element configured to affect rotation of the support element about a longitudinal axis of the cartridge unit.

29. The catheter of claim 27, wherein the first element is further configured to affect expansion of the second portion of the remainder of the support element via movement of the first element in the distal direction.

30. The catheter of claim 27, wherein the cartridge unit further includes a third element configured to affect expansion of the second portion of the remainder of the support element via movement of the third element in the proximal direction.

31. The catheter of claim 27, wherein:

the cartridge unit is further configured to affect expansion of the second portion of the remainder of the support element; and

the expanded at least one hoop element and the fully expanded remainder of the support element are configured to clamp at least a portion of the heart valve.

32. The catheter of claim 27, wherein the at least one support hoop includes a plurality of support hoops.

33. A catheter for implanting a heart valve prosthesis attached to a support structure having a body portion and at least one hoop element, the catheter comprising:

a first element configured to selectively maintain the at least one hoop element in a collapsed form by at least partially surrounding the hoop element;

a second element configured to selectively maintain the body portion in a collapsed form by at least partially surrounding the body portion; and

a third element configured to selectively engage the body portion;

wherein axial movement of the first element in a distal direction relative to the second element permits the at least one hoop element to self-expand, and axial movement of the second element in a proximal direction relative to the first element permits at least a portion of the body portion to self-expand.

34. The catheter of claim 33, wherein the expanded at least one hoop element is configured to be positioned in a pocket of a native heart valve.

35. The catheter of claim 33, wherein:

either axial movement of the first element in a distal direction relative to the second element or axial movement of a third element in a proximal direction relative to the first element permits the body portion to fully expand; and

the expanded at least one hoop element and the fully expanded body portion are configured to clamp a native heart valve therebetween.

36. A catheter for implanting a support element supporting a valve prosthesis, comprising:

a first element configured to selectively maintain a first portion of the support element in a collapsed form by at least partially surrounding the support element; and

a second element configured to selectively maintain a second portion of the support element in a collapsed form by at least partially surrounding the support element;

wherein the first element is configured to selectively release the first portion to self-expand by movement of the first element in a first direction relative to the second element, and the second element is configured to selectively release the second portion to self-expand by movement of the second element in a second direction relative to the first element, substantially opposite the first direction.

37. A method of implanting a support element having a valve prosthesis connected thereto and including at least one support hoop, comprising:

positioning the support element in a collapsed form relative to a native heart valve;

expanding the at least one support hoop from a collapsed form to an expanded form while maintaining the remainder of the support element in the collapsed form;

positioning the at least one expanded support hoop into a pocket of the native heart valve;

partially expanding the remainder of the support element to at least partially expand the valve prosthesis; and

collapsing the partially expanded remainder of the support element into the collapsed form.

38. The method of claim 37, wherein the step of positioning the at least one expanded support hoop includes rotating the support element via a catheter to position the support hoop in the pocket.

39. A method of implanting a support element having a valve prosthesis connected thereto and including at least one support hoop, comprising:

positioning the support element in a collapsed form relative to a native heart valve;

expanding the at least one support hoop from a collapsed form to an expanded form while maintaining the remainder of the support element in the collapsed form;

positioning the at least one expanded support hoop into a pocket of the native heart valve;

partially expanding the remainder of the support element to at least partially expand the valve prosthesis; and

checking the function of the valve prosthesis after the step of partially expanding the remainder of the support element.

40. The method of claim 39, further including:

determining that the valve prosthesis is functioning improperly; and

collapsing the partially expanded remainder of the support element into the collapsed.

41. The method of claim 39, further including:

determining that the valve prosthesis is functioning properly; and

fully expanding the remainder of the support element.

42. The method of claim 39, wherein the native valve is clamped between the at least one support hoop and the support element when the remainder of the support element is fully expanded.

43. A system for treating a heart valve, comprising:

a support element including a body portion configured to support a heart valve prosthesis and at least one hoop element connected to the body portion; and

a catheter for positioning the support element relative to a native heart valve configured to;

expand the at least one hoop element and position the expanded at least one hoop element into a pocket of the native heart valve,

sequentially expand a first portion of the body portion and maintain a second portion of the body portion in a collapsed form to check the functioning of the heart valve prosthesis, and

sequentially expand a second portion of the body portion to clamp at least a portion of the native heart valve between the at least one hoop element and the body portion.

44. A catheter for transvascular implantation of a heart valve prosthesis with a self-expanding anchoring support, the catheter comprising:

(a) a cartridge unit for carrying the anchoring support and prosthesis and having a flexible tip at its proximal end;

(b) a hollow guide system releasably connected to the cartridge unit at the proximal end of the hollow guide system; and

(c) a manipulating part attached to the distal end of the hollow guide system

wherein operating elements are attached at one end to the manipulating part and at the other end to the cartridge unit, the hollow guide system has a bendable region at its proximal end adjacent to the cartridge unit, the hollow guide system is configured to contain a circulating coolant or pharmaceutical preparation; and

the guide system is substantially liquid proof.

45. Catheter as claimed in claim 44, wherein the bendable region includes a link chain with individual joints.

46. Catheter as claimed in claim 45, wherein the individual joints positively engage respectively in adjacent links.

47. Catheter as claimed claim 44, wherein the operating elements include tension wires.

48. Catheter as claimed in claim 44, wherein the guide system is configured to circulate the liquid coolant through an interior of the guide system to the cartridge unit.

49. Catheter as claimed in claim 44, wherein the cartridge unit is provided with a plurality of sleeve-shaped elements telescopically engaging in one another, between which the anchoring support and heart valve prosthesis are enclosed and clamped in a collapsed state until implantation.

50. Catheter as claimed in claim 44, wherein a guide wire is fed through the interior of the catheter.

51. 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.

52. The replacement valve of claim 51, wherein the at least one attachment element comprises a geometric opening configured for removable attachment to a complimentary element of the delivery device.

53. The replacement valve of claim 51, wherein the at least one attachment element comprises a wire, hook, or strap configured for removable attachment to a complimentary element of the delivery device.

54. The replacement valve of claim 51, wherein the at least one attachment element comprises at least two attachment elements.

55. The replacement valve of claim 51, wherein the at least one attachment element comprises at least three attachment elements.

56. The replacement valve of claim 51, wherein the stent component comprises a lattice structure comprising:

at least one commissural post; and

the at least one attachment element.

57. The replacement valve of claim 56, wherein the lattice structure further comprises at least one supporting element for connecting the at least one commissural post to the at least one attachment element.

59. A cardiac stent-valve delivery system comprising:

a first assembly comprising an outer sheath and a guide wire tubing; and

a second assembly comprising a stent holder configured for removable attachment to at least one attachment element of a stent-valve, the stent-valve positioned over the guide wire tubing of the first assembly,

wherein the first assembly and the second assembly are configured for relative movement with respect to one another in order to transition from a closed position to an open position, such that in the closed position the outer sheath encompasses the stent-valve still attached to the stent holder and thus constrains expansion of the stent-valve, and such that in the open position the outer sheath does not constrain expansion of the stent-valve and thus the stent-valve detaches from the stent holder and expands to a fully expanded configuration.

60. The stent-valve delivery system of claim 59, wherein the first assembly and the second assembly are configured to transition from the closed position, to a partially-open position, to the open position, wherein in the partially-open position, the stent-valve expands partially proximally but does not detach from the stent holder because the outer sheath still encompasses the at least one attachment element of the stent-valve and the stent holder.

61. The stent-valve delivery system of claim 60, further comprising a flush mechanism.

62. The stent-valve delivery system of claim 59, further comprising at least one balloon configured to cause at least one of valvuloplasty prior to implantation of the stent-valve and expansion or post-dilation of the stent-valve upon inflation of the at least one balloon.

63. The stent-valve delivery system of claim 62, wherein the at least one balloon is housed either proximally or distally to the stent-valve.

64. The stent-valve delivery system of claim 62, wherein the at least one balloon is housed at least partially within the stent valve.

65. The stent-valve delivery system of claim 59, further comprising a push handle for causing the relative movement of the first assembly and the second assembly.

66. The stent-valve delivery system of claim 59, further comprising a screw mechanism for translating rotational movement of a handle into the relative movement of the first assembly and the second assembly.

67. The stent-valve delivery system of claim 59, further comprising an integrated introducer within which the first assembly and the second assembly are positioned during delivery of the stent-valve to an implantation site.

68. The stent-valve delivery system of claim 59, wherein after expansion of the stent-valve to the fully expanded configuration, the delivery system is configured to return to the closed position by passing the second assembly through the stent-valve towards a distal end of the first assembly.

69. The stent-valve delivery system of claim 59, wherein the at least one attachment element of the stent-valve comprises a geometrical opening configured for removable attachment to a complimentary structure of the stent holder.

70. The stent-valve delivery system of claim 69, wherein the geometrical opening comprises a circular or ovular opening.

71. The stent-valve delivery system of claim 59, wherein the at least one attachment element of the stent-valve comprises a wire, hook, or strap configured for removable attachment to a complimentary structure of the stent holder.

72. The stent-valve delivery system of claim 59, wherein the at least one attachment element of the stent-valve comprises at least two attachment elements configured for removable attachment to corresponding number of complimentary structures of the stent holder.

73. The stent-valve delivery system of claim 59, wherein the at least one attachment element of the stent-valve comprises at least three attachment elements configured for removable attachment to corresponding number of complimentary structures of the stent holder.

74. The stent-valve delivery system of claim 59, wherein the stent-valve comprises a lattice structure comprising:

at least one commissural post; and

the at least one attachment element.

75. The stent-valve delivery system of claim 74, wherein the lattice structure of the stent-valve further comprises at least one supporting element for connecting the at least one commissural post to the at least one attachment element.

76. 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 proximally 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.

77. The method of claim 76, wherein the making a determination comprises determining whether the stent-valve is positioned correctly at the implantation site.

78. The method of claim 77, further comprising returning the stent-valve to the collapsed configuration and repositioning the stent-valve when the stent-valve is not positioned correctly at the implantation site.

79. The method of claim 76, wherein the making a determination comprises determining whether a valve component of the stent-valve is functioning properly.

80. The method of claim 79, wherein determining whether the valve component is functioning properly comprises testing whether the valve component will permit sufficient blood-flow.

81. The method of claim 79, further comprising returning the stent-valve to the collapsed configuration and removing the stent-valve from a patient'"'"'s body when the stent-valve is not functioning properly.

82. The method of claim 76, 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.