Medical device for treating a heart valve insufficiency or stenosis

• US 20080255661A1
• Filed: 06/14/2007
• Published: 10/16/2008
• Est. Priority Date: 04/13/2007
• Status: Active Grant

• Current Assignee: JenaValve Technology, Inc.
• Original Assignee: JenaValve Technology, Inc.
• Inventors: Jung, Johannes, Straubinger, Helmut
• Granted Patent: US 9,138,315 B2
• Time in Patent Office: Days
• US Class Current: 623/2.36
• 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

Abstract

A medical device for treating a heart valve insufficiency, with an endoprosthesis which can be introduced into a patient'"'"'s body and expanded to secure a heart valve prosthesis in the patient'"'"'s aorta with a catheter. In an embodiment, the endoprosthesis has a plurality of positioning arches configured to be positioned with respect to a patient'"'"'s aorta and a plurality of retaining arches to support a heart valve prosthesis. The endoprosthesis includes a collapsed mode during the process of introducing it into the patient'"'"'s body and an expanded mode when it is implanted. The endoprosthesis may be introduced into a patient'"'"'s body and expanded via a catheter. In an embodiment, the catheter has first and second slide mechanisms configured to independently manipulate first and second sleeve elements to sequentially expand the endoprosthesis from the collapsed mode to the expanded mode.

Claims

1. A self-expandable endoprosthesis for treating a heart valve insufficiency, comprising a plurality of positioning arches configured to be respectively positioned within a plurality of pockets of a native heart valve, a plurality of retaining arches configured to anchor the endoprosthesis within a patient, and at least one imperforate retaining head for releasably connecting the endoprosthesis to a catheter.

2. The self-expandable endoprosthesis as claimed in claim 1 wherein the at least one imperforate retaining head is adapted to co-operate with a fixing mechanism of a catheter tip.

3. The self-expandable endoprosthesis as claimed in claim 1 wherein the endoprosthesis is configured in a first pre-definable mode when being introduced into the patient'"'"'s body and a second pre-definable mode when implanted, wherein the endoprosthesis is in a collapsed state when in the first mode and an expanded state when the device is in the second mode.

4. The self-expandable endoprosthesis as claimed in claim 1 further including an anchoring segment configured to support a heart valve prosthesis.

5. The self-expandable endoprosthesis as claimed in claim 1 wherein the at least one retaining head is configured to releasably engage a pocket formed in a crown element of a catheter tip.

6. The self-expandable endoprosthesis as claimed in claim 5 wherein the at least one retaining head has a shape substantially complementary to the shape of the at least one pocket.

7. The self-expandable endoprosthesis as claimed in claim 1, further configured to be selectively expanded from a collapsed mode to an expanded mode and wherein the positioning arches and retaining arches are configured to hold the flaps of the native heart valve therebetween when in the expanded mode.

24. The self-expandable endoprosthesis as claimed in claim 1, wherein the endoprosthesis is made from a shape memory metal.

37. The self-expandable endoprosthesis as claimed in claim 4, wherein the heart valve prosthesis is a bio-heart valve prosthesis.

38. The self-expandable endoprosthesis as claimed in claim 4, wherein the heart valve prosthesis is made from porcine or equine tissue.

56. The self-expandable endoprosthesis as claimed in claim 1, wherein the retaining head is disposed between two adjacent positioning arches.

8-23. -23. (canceled)

25-36. -36. (canceled)

39. (canceled)

40. A catheter tip configured to sequentially release an endoprosthesis having a plurality of positioning arches, a plurality of retaining arches, and a plurality of retaining heads, the catheter tip comprising a retaining mechanism having a plurality of retaining pockets each configured to receive a respective one of the plurality of retaining heads, each Docket being substantially complementary in shape to a respective one of the retaining heads.

43. The catheter tip as claimed in claim 40, wherein each of the plurality of pockets has a shape configured to provide a snap-fit connection with a respective one of the plurality of retaining heads.

44. The catheter tip as claimed in claim 40, wherein the retaining mechanism is substantially cylindrical.

47. The catheter tip as claimed in claim 43, wherein each of the plurality of Dockets includes a flange arranged on an edge of the pocket.

48. The catheter tip as claimed in claim 40, wherein the retaining mechanism further comprises a plurality of grooves formed therein, each groove associated with a respective one of the plurality of pockets, extending substantially in the longitudinal direction of the retaining mechanism from said pocket to one end of the retaining mechanism, and having a shape configured to accommodate a connecting web of the endoprosthesis.

49. A catheter tip as claimed in claim 48, wherein the connecting web of the endoprosthesis is configured to connect one of the plurality of retaining heads with a respective one of the plurality of positioning arches.

41-42. -42. (canceled)

45-46. -46. (canceled)

50. (canceled)

51. Catheter system for use in treating a heart valve, the catheter system comprising a catheter tip at a proximal end of the catheter system and including a retaining element having at least one pocket formed therein and configured to releasably connect to and retain an endoprosthesis via the at least one pocket in a first pre-definable mode and sequentially release the endoprosthesis to a second pre-definable mode, wherein the endoprosthesis is in a folded state in its first mode and in an expanded state in its second mode.

52. Catheter system as claimed in claim 51, further comprising a handle at a distal end of the catheter system configured to manipulate the catheter tip and selectively release portions of the endoprosthesis while selectively retaining other portions of the endoprosthesis.

53. Catheter system as claimed in claim 52, wherein the catheter tip further comprises a housing system for accommodating the endoprosthesis, said housing system comprising a first housing portion for accommodating first functional components of the endoprosthesis and a second housing portion for accommodating second functional components of the endoprosthesis, and wherein

the handle has at least one first operating mechanism co-operating with the first housing portion to effect a pre-definable longitudinal displacement thereof relative to the retaining element, and at least one second operating mechanism co-operating with the second housing portion to effect a pre-definable displacement thereof relative to the retaining element.

54. Catheter system as claimed in claim 53, wherein both the first housing portion and the second housing portion are configured as sleeve elements, and the internal diameter of the second housing portion is bigger than the external diameter of the first housing portion so that the second housing portion is designed to accommodate the first housing portion with the first functional components of the endoprosthesis accommodated in it in addition to the second functional components of the endoprosthesis.

55. (canceled)

57-64. -64. (canceled)

65. A catheter for implanting an endoprosthesis having a plurality of positioning arches, a plurality of retaining arches, and a body portion, comprising:

a retaining portion configured to selectively fix the endoprosthesis to the catheter via a plurality of pockets formed in the catheter;

a first housing portion configured to selectively retain the plurality of retaining arches in a collapsed state; and

a second housing portion configured to selectively retain the plurality of positioning arches and the body portion in a collapsed state.

66. The catheter of claim 65, further including:

a first manipulating portion configured to cooperate with and selectively manipulate the first housing portion to move in a distal direction of the catheter with respect to the retaining portion; and

a second manipulating portion configured to cooperate with and selectively manipulate the second housing portion to move in a proximal direction of the catheter with respect to the retaining portion.

67. The catheter of claim 66, wherein the first manipulating portion includes a first slide mechanism movable between first and second stops and a releasable locking element configured to selectively resist movement of the first slide mechanism between the first and second stops.

68. The catheter of claim 67, wherein the second manipulation portion includes a second slide mechanism movable between third and fourth stops and a releasable locking element configured to selectively resist movement of the second slide mechanism between the first and second stops.

69. The catheter of claim 66, wherein the first manipulating portion is configured to move in the distal direction to move the first housing portion in the distal direction.

70. The catheter of claim 66, wherein the second manipulating portion is configured to move in the proximal direction to move the second housing portion in the proximal direction.

71. The catheter of claim 66, wherein proximal movement of the second housing portion is configured to release the plurality of positioning arches from the collapsed state to an expanded state while the plurality of retaining arches and the body portion of the endoprosthesis are maintained in a collapsed mode.

72. The catheter of claim 71, wherein distal movement of the first housing portion is configured to release the plurality of retaining arches from the collapsed state to an expanded state after the plurality of positioning arches are released and while the body portion of the endoprosthesis is maintained in a collapsed mode.

73. The catheter of claim 72, wherein the endoprosthesis includes a heart valve prosthesis and distal movement of the first housing portion to release the plurality of retaining arches from the collapsed state to an expanded state is also configured to expand a heart valve prosthesis.

74. The catheter of claim 72, wherein further proximal movement of the second housing portion is configured to expand the body portion of the endoprosthesis and disconnect the endoprosthesis from the plurality of pockets.

75. The catheter of claim 74, wherein the endoprosthesis automatically disconnects from the plurality of pockets as a function of the body portion of the endoprosthesis expanding from a collapsed state to an expanded state.

76. A catheter comprising:

a tip portion at a proximal end of the catheter configured to sequentially release an endoprosthesis from a collapsed state to an expanded state, the tip portion including;

a first sleeve element configured to selectively surround a first portion of the endoprosthesis, and

a second sleeve element configured to selectively surround a second portion of the endoprosthesis and the first sleeve element; and

a handle portion at a distal end of the catheter configured to affect manipulation of the tip portion to sequentially release the endoprosthesis, the handle portion including;

a first slide mechanism configured to selectively move between first and second stops to selectively manipulate the first sleeve to release the first portion of the endoprosthesis, and

a second slide mechanism configured to selectively move between third and fourth stops to selectively manipulate the second sleeve and release the second portion of the endoprosthesis,

wherein the first and second slide mechanisms are each configured to move between the respective stops independent of one another.

77. The catheter of claim 76, wherein the handle portion further includes a removable stop mechanism associated with the second slide mechanism, and wherein the second slide mechanism is further configured to selectively move between the third stop and a fifth stop when the removable stop mechanism is removed, the fifth stop being located closer to the tip portion than the fourth stop.

78. The catheter of claim 76, wherein the tip portion further includes a retaining element configured to selectively attach the endoprosthesis to the catheter.

79. The catheter of claim 78, wherein the retaining element includes at least one pocket configured to receive a retaining head of the endoprosthesis.

80. The catheter of claim 79, wherein the retaining element includes at least three pockets.

81. A method of implanting an endoprosthesis including a plurality of positioning arches, a plurality of retaining arches, and a plurality of retaining elements, the method comprising:

positioning the endoprosthesis relative to a native heart valve;

manipulating a first slide mechanism of a catheter to affect movement of a first sleeve element to uncover the plurality of positioning arches;

positioning the positioning arches within pockets of the native heart valve;

manipulating a second slide mechanism of the catheter to affect movement of a second sleeve element to uncover the plurality of retaining arches; and

further manipulating the first slide mechanism to affect further movement of the first sleeve to uncover the plurality of retaining elements.

82. The method of claim 81, further including removing a temporary stop mechanism before the step of further manipulating the first slide mechanism.

83. The method of claim 82, further including selectively disengaging a locking element from the temporary stop mechanism before removing the temporary stop mechanism.

84. The method of claim 81, wherein the first slide mechanism is configured to move independently of the second slide mechanism.

85. The method of claim 81, wherein the first slide mechanism is configured to move in the proximal direction of the catheter to affect movement of the first sleeve element in the proximal direction to uncover the plurality of positioning arches.

86. The method of claim 85, wherein the first slide mechanism is configured to further move in the proximal direction of the catheter to affect further movement of the first sleeve element in the proximal direction to uncover the plurality of retaining elements.

87. The method of claim 81, wherein the second slide mechanism is configured to move in the distal direction of the catheter to affect movement of the second sleeve element in the distal direction to uncover the plurality of retaining arches.

88. The method of claim 81, wherein uncovering the plurality of retaining elements automatically disengages the plurality of retaining elements from a plurality of retaining pockets disposed within a retaining element of the catheter.

89. The method of claim 81, further including selectively disengaging a locking element from the first slide mechanism before manipulating the first slide mechanism to affect movement of the first sleeve element to uncover the plurality of positioning arches.

90. The method of claim 81, further including selectively disengaging a locking element from the second slide mechanism before manipulating the second slide mechanism to affect movement of the second sleeve element to uncover the plurality of retaining arches.

91. A method of explanting an endoprosthesis including a plurality of positioning arches, a plurality of retaining arches, and a plurality of retaining elements, the method comprising:

manipulating a first slide mechanism of a catheter to affect movement of a first sleeve to collapse a portion of the endoprosthesis and cover the plurality of retaining elements;

manipulating a second slide mechanism to affect movement of a second sleeve element to collapse the plurality of retaining arches; and

further manipulating the first slide mechanism to affect further movement of the first sleeve element to collapse the plurality of positioning arches.

92. The method of claim 91, wherein the first slide mechanism is configured to move independently of the second slide mechanism.

93. The method of claim 91, wherein the first slide mechanism is configured to further move in a distal direction of the catheter to affect further movement of the first sleeve element in the distal direction to cover the plurality of retaining elements.

94. The method of claim 93, wherein the first slide mechanism is configured to move in the distal direction of the catheter to affect movement of the first sleeve element in the distal direction to collapse the plurality of positioning arches.

95. The method of claim 91, wherein the second slide mechanism is configured to move in a proximal direction of the catheter to affect movement of the second sleeve element in the proximal direction to cover the plurality of retaining arches.

96. The method of claim 91, further including engaging the plurality of retaining elements with a plurality of retaining pockets disposed within a retaining element of the catheter.

97. The method of claim 91, further including selectively engaging a locking element with the first slide mechanism after manipulating the first slide mechanism to affect movement of the first sleeve element to collapse and cover the plurality of positioning arches.

98. The method of claim 91, further including selectively engaging a locking element with the second slide mechanism after manipulating the second slide mechanism to affect movement of the second sleeve element to collapse and cover the plurality of retaining arches.

99. The method of claim 91, wherein the endoprosthesis is fully implanted in a patient to treat a native heart valve and the method includes positioning the catheter relative to the endoprosthesis.

100. The method of claim 91, wherein the endoprosthesis is partially implanted in a patient to treat a native heart valve via the catheter.

101. The method of claim 91, further including removing the plurality of positioning arches from pockets of a native heart valve before the step of further manipulating the first slide mechanism.

102. The method of claim 91, further including partially implanting the endoprosthesis in a patient to treat a native heart valve via the catheter before the step of manipulating a first slide mechanism of a catheter to affect movement of a first sleeve to collapse a portion of the endoprosthesis and cover the plurality of retaining elements.