Patent Application
20230329853
The present invention relates generally to medical tools, and specifically to transcatheter aortic valve implantation accessories.
The current standard of care for aortic valve stenosis in high-risk patients is transcatheter aortic valve implantation (TAVI), which includes the implantation of a self-expandable or balloon-expandable valve prosthesis. During TAVI procedures the valve prosthesis can interfere with the tissue surrounding the aortic valve apparatus. The manipulation and interaction of the valve prosthesis frame with conduction tissue below the aortic valve cusps in the left ventricular outflow tract (LVOT) during valve deployment can provoke heart block, including atrioventricular (AV) block (which has an incidence of up to 18% after TAVI procedures). The impingement, damage, lesion, abrasion, and/or trauma caused by the metal frame of the valve prosthesis on the conductive tissue, including the AV node, the bundle of His, and the bundle branches, can cause bradycardia that requires temporary or permanent pacemaker implantation. During TAVI procedures the height of valve implantation is a determinant of risk of paravalvular leakage (PVL). Precise implantation depth generally reduces the occurrence of PVL.
Some embodiments of the present invention provide a valve-delivery-assist tool for use during a transcatheter aortic valve implantation (TAVI) procedure on a native aortic valve. The valve-delivery-assist tool comprises a delivery catheter, an aortic-valve cusp guide, and a conduction-tissue protector comprising a sheet. The aortic-valve cusp guide is releasably disposed in the delivery catheter, and the valve-delivery-assist tool is configured such that the aortic-valve cusp guide deflects laterally upon being released from the delivery catheter. The conduction-tissue protector is releasably disposed compressed in the delivery catheter, and is configured to expand upon being released from a distal end of the delivery catheter.
The valve-delivery-assist tool is typically configured such that after lateral deflection of the aortic-valve cusp guide and expansion of the conduction-tissue protector, the released conduction-tissue protector and the released aortic-valve cusp guide are axially stationary with respect to each other such that a distal-most point of the released conduction-tissue protector is disposed distal to a distal-most point of the released aortic-valve cusp guide.
The valve-delivery-assist tool is typically configured such that disposition of the released aortic-valve cusp guide into a non-coronary cusp of the native aortic valve and rotational centering of the aortic-valve cusp guide within the non-coronary cusp, axially and rotationally align the released conduction-tissue protector to face a septal wall of a left ventricular outflow tract (LVOT). The conduction-tissue protector temporarily protects, by mechanically shielding, conduction tissue of the AV node from mechanical compression of the LVOT by a prosthetic aortic valve during the TAVI procedure, and/or from impingement, damage, lesion, abrasion, and/or trauma caused by the metal frame of the prosthetic aortic valve on the conductive tissue.
For some applications, the valve-delivery-assist tool further comprises a landing-support stabilizer, which is releasably disposed compressed in the delivery catheter and configured to expand (e.g., deflect laterally) after being released from the distal end of the delivery catheter. Typically, the valve-delivery-assist tool is configured such that disposition of the released aortic-valve cusp guide within a non-coronary cusp (NCC) of the native aortic valve and rotationally centering the aortic-valve cusp guide within the NCC, axially disposes the released landing-support stabilizer at a predetermined height below the native aortic valve. The predetermined height serves to define the depth of the subsequent TAVI implantation of the prosthetic aortic valve. This depth limiting may reduce the risk of paravalvular leakage (PVL) that may be caused by inappropriate depth of implantation.
For some applications, the valve-delivery-assist tool further comprises a safety tip for assisting with crossing the native valve and providing ventricular access.
There is therefore provided, in accordance with an Inventive Concept 1 of the present invention, a valve-delivery-assist tool for use during a transcatheter aortic valve implantation (TAVI) procedure on a native aortic valve, the valve-delivery-assist tool including:
Inventive Concept 2. The valve-delivery-assist tool according to Inventive Concept 1, wherein the valve-delivery-assist tool is configured such that disposition of the released aortic-valve cusp guide into a non-coronary cusp of the native aortic valve and rotational centering of the aortic-valve cusp guide within the non-coronary cusp, axially and rotationally align the released conduction-tissue protector to face a septal wall of a left ventricular outflow tract (LVOT).
Inventive Concept 3. The valve-delivery-assist tool according to Inventive Concept 1, wherein the valve-delivery-assist tool is configured such that after lateral deflection of the aortic-valve cusp guide and expansion of the conduction-tissue protector, the released conduction-tissue protector and the released aortic-valve cusp guide are axially stationary with respect to each other such that the distal-most point of the released conduction-tissue protector is disposed between 2 and 30 mm distal to the distal-most point of the released aortic-valve cusp guide.
Inventive Concept 4. The valve-delivery-assist tool according to Inventive Concept 1, wherein the valve-delivery-assist tool is configured such that after lateral deflection of the aortic-valve cusp guide and expansion of the conduction-tissue protector, the released conduction-tissue protector and the released aortic-valve cusp guide are axially stationary with respect to each other such that a proximal-most point of the released conduction-tissue protector is disposed distal to, or no more than 5 mm proximal to, the distal-most point of the released aortic-valve cusp guide.
Inventive Concept 5. The valve-delivery-assist tool according to Inventive Concept 1, wherein the valve-delivery-assist tool is configured such that after lateral deflection of the aortic-valve cusp guide and expansion of the conduction-tissue protector, the released conduction-tissue protector and the released aortic-valve cusp guide are rotationally stationary with respect to each other.
Inventive Concept 6. The valve-delivery-assist tool according to Inventive Concept 1, wherein the conduction-tissue protector further includes a frame supporting the sheet.
Inventive Concept 7. The valve-delivery-assist tool according to Inventive Concept 6, wherein the frame surrounds the sheet of the released conduction-tissue protector.
Inventive Concept 8. The valve-delivery-assist tool according to Inventive Concept 6, wherein the frame includes one or more wires.
Inventive Concept 9. The valve-delivery-assist tool according to Inventive Concept 1, wherein the released conduction-tissue protector is configured such that the sheet is generally planar.
Inventive Concept 10. The valve-delivery-assist tool according to Inventive Concept 1, wherein the sheet includes a mesh.
Inventive Concept 11. The valve-delivery-assist tool according to Inventive Concept 10, wherein the mesh includes braided wires.
Inventive Concept 12. The valve-delivery-assist tool according to any one of Inventive Concepts 1-11, wherein the aortic-valve cusp guide includes an elongate slender rod.
Inventive Concept 13. The valve-delivery-assist tool according to Inventive Concept 12, wherein the elongate slender rod of the released aortic-valve cusp guide is configured to be shaped as a pigtail.
Inventive Concept 14. The valve-delivery-assist tool according to any one of Inventive Concepts 1-11, wherein the valve-delivery-assist tool is configured such that a best-fit plane defined by the released aortic-valve cusp guide forms an angle of between 15 and 60 degrees with a best-fit plane defined by the released conduction-tissue protector.
Inventive Concept 15. The valve-delivery-assist tool according to Inventive Concept 14, wherein the valve-delivery-assist tool is configured such that the angle is between 25 and 35 degrees.
Inventive Concept 16. The valve-delivery-assist tool according to any one of Inventive Concepts 1-11, further including an elongate valve-delivery-assist support, which links together the conduction-tissue protector and the aortic-valve cusp guide.
Inventive Concept 17. The valve-delivery-assist tool according to Inventive Concept 16, wherein the released aortic-valve cusp guide extends laterally from the elongate valve-10 delivery-assist support.
Inventive Concept 18. The valve-delivery-assist tool according to Inventive Concept 16, wherein the valve-delivery-assist tool is configured such that the released conduction-tissue protector extends from the elongate valve-delivery-assist support in two generally opposite directions.
Inventive Concept 19. The valve-delivery-assist tool according to Inventive Concept 16, wherein the valve-delivery-assist tool is configured such that an entirety of the released conduction-tissue protector is rotationally fixed with respect to the elongate valve-delivery-assist support.
Inventive Concept 20. The valve-delivery-assist tool according to Inventive Concept 16, wherein the elongate valve-delivery-assist support includes:
Inventive Concept 21. The valve-delivery-assist tool according to any one of Inventive Concepts 1-11, further including a landing-support stabilizer, which is releasably disposed compressed in the delivery catheter and configured to expand after being released from the distal end of the delivery catheter,
Inventive Concept 22. The valve-delivery-assist tool according to Inventive Concept 21, wherein the landing-support stabilizer is configured to automatically expand upon being released from the distal end of the delivery catheter.
Inventive Concept 23. The valve-delivery-assist tool according to Inventive Concept 21, wherein the landing-support stabilizer is configured to be manually expanded after being released from the distal end of the delivery catheter.
Inventive Concept 24. The valve-delivery-assist tool according to Inventive Concept 21, wherein the valve-delivery-assist tool is configured such that after lateral deflection of the aortic-valve cusp guide and expansion of the conduction-tissue protector and the landing-support stabilizer, the released landing-support stabilizer, the released conduction-tissue protector, and the released aortic-valve cusp guide are axially stationary with respect to one another such that the proximal-most point of the released landing-support stabilizer is disposed between 1 and 10 mm distal to the distal-most point of the released aortic-valve cusp guide.
Inventive Concept 25. The valve-delivery-assist tool according to Inventive Concept 24, wherein the valve-delivery-assist tool is configured such that after lateral deflection of the aortic-valve cusp guide and expansion of the conduction-tissue protector and the landing-support stabilizer, the released landing-support stabilizer, the released conduction-tissue protector, and the released aortic-valve cusp guide are axially stationary with respect to one another such that the proximal-most point of the released landing-support stabilizer is disposed between 1.5 and 4 mm distal to the distal-most point of the released aortic-valve cusp guide.
Inventive Concept 26. The valve-delivery-assist tool according to Inventive Concept 21, wherein the valve-delivery-assist tool is configured such that disposition of the released aortic-valve cusp guide within a non-coronary cusp of the native aortic valve and rotationally centering the aortic-valve cusp guide within the non-coronary cusp, axially disposes the released landing-support stabilizer at a predetermined height below the native aortic valve.
Inventive Concept 27. The valve-delivery-assist tool according to Inventive Concept 26, wherein the predetermined height is between 2 and 10 mm.
Inventive Concept 28. The valve-delivery-assist tool according to Inventive Concept 21, wherein the valve-delivery-assist tool is configured such that after lateral deflection of the aortic-valve cusp guide and expansion of the conduction-tissue protector and the landing-support stabilizer:
Inventive Concept 29. The valve-delivery-assist tool according to Inventive Concept 28, wherein the valve-delivery-assist tool is configured such that after lateral deflection of the aortic-valve cusp guide and expansion of the conduction-tissue protector and the landing-support stabilizer:
Inventive Concept 30. The valve-delivery-assist tool according to Inventive Concept 21, wherein the valve-delivery-assist tool is configured such that after lateral deflection of the aortic-valve cusp guide and expansion of the conduction-tissue protector and the landing-support stabilizer:
Inventive Concept 31. The valve-delivery-assist tool according to Inventive Concept 21, wherein the valve-delivery-assist tool is configured such that the released landing-support stabilizer and the released aortic-valve cusp guide are disposed on opposite sides of the released conduction-tissue protector.
Inventive Concept 32. The valve-delivery-assist tool according to Inventive Concept 21, wherein the landing-support stabilizer includes an elongate slender rod.
Inventive Concept 33. The valve-delivery-assist tool according to Inventive Concept 32, wherein the elongate slender rod of the released landing-support stabilizer is shaped as a partial loop or a complete loop having one or more turns.
Inventive Concept 34. The valve-delivery-assist tool according to Inventive Concept 33, wherein the valve-delivery-assist tool further includes (a) an elongate landing-support-stabilizer shaft, which is fixed to and supports the landing-support stabilizer, and (b) an elongate support shaft, and
Inventive Concept 35. The valve-delivery-assist tool according to Inventive Concept 33, wherein the valve-delivery-assist tool further includes (a) an elongate landing-support-stabilizer shaft, which is fixed to and supports the landing-support stabilizer, and (b) an elongate support shaft, which is shaped so as to define a channel having a distal opening through which the elongate slender rod is slidable, and
Inventive Concept 36. The valve-delivery-assist tool according to Inventive Concept 21, further including an elongate valve-delivery-assist support, which links together the landing-support stabilizer, the conduction-tissue protector, and the aortic-valve cusp guide.
Inventive Concept 37. The valve-delivery-assist tool according to Inventive Concept 36, wherein the released landing-support stabilizer extends laterally from the elongate valve-delivery-assist support.
Inventive Concept 38. The valve-delivery-assist tool according to Inventive Concept 37, wherein a best-fit plane defined by the released landing-support stabilizer forms an angle of between 45 and 90 degrees with a central longitudinal axis of the elongate valve-delivery-assist support that is straight and passes through the distal end of the elongate valve-delivery-assist support.
Inventive Concept 39. The valve-delivery-assist tool according to Inventive Concept 36, wherein the elongate valve-delivery-assist support includes:
Inventive Concept 40. The valve-delivery-assist tool according to Inventive Concept 21, wherein the valve-delivery-assist tool is configured such that a best-fit plane defined by the released landing-support stabilizer forms an angle of between 45 and 90 degrees with a best-fit plane defined by the released conduction-tissue protector.
Inventive Concept 41. The valve-delivery-assist tool according to Inventive Concept 40, wherein the valve-delivery-assist tool is configured such that a best-fit plane defined by the released aortic-valve cusp guide forms an angle of between 45 and 90 degrees with the best-fit plane defined by the released landing-support stabilizer.
Inventive Concept 42. The valve-delivery-assist tool according to Inventive Concept 21,
Inventive Concept 43. The valve-delivery-assist tool according to Inventive Concept 42, wherein the safety tip is configured to expand upon released from the distal end of the delivery catheter.
Inventive Concept 44. The valve-delivery-assist tool according to Inventive Concept 42, wherein the safety tip includes an elongate slender rod.
Inventive Concept 45. The valve-delivery-assist tool according to Inventive Concept 44, wherein the elongate slender rod of the released safety tip is configured to be shaped as a pigtail.
Inventive Concept 46. The valve-delivery-assist tool according to Inventive Concept 42, wherein the safety tip and the conduction-tissue protector are integral to each other.
Inventive Concept 47. The valve-delivery-assist tool according to any one of Inventive Concepts 1-11, for use with a guidewire,
Inventive Concept 48. The valve-delivery-assist tool according to Inventive Concept 47, wherein the curved shape is a pigtail shape.
Inventive Concept 49. The valve-delivery-assist tool according to any one of Inventive Concepts 1-11,
Inventive Concept 50. The valve-delivery-assist tool according to Inventive Concept 49, wherein the safety tip is configured to expand upon released from the distal end of the delivery catheter.
Inventive Concept 51. The valve-delivery-assist tool according to Inventive Concept 49, wherein the safety tip includes an elongate slender rod.
Inventive Concept 52. The valve-delivery-assist tool according to Inventive Concept 51, wherein the elongate slender rod of the released safety tip is configured to be shaped as a pigtail.
Inventive Concept 53. The valve-delivery-assist tool according to Inventive Concept 49, wherein the safety tip and the conduction-tissue protector are integral to each other.
Inventive Concept 54. The valve-delivery-assist tool according to any one of Inventive Concepts 1-11, further including a reshaping element, which is coupled to the conduction-15 tissue protector, which is configured to change a shape of the released conduction-tissue protector.
Inventive Concept 55. The valve-delivery-assist tool according to Inventive Concept 54,
Inventive Concept 56. The valve-delivery-assist tool according to Inventive Concept 54, wherein the reshaping element includes an elongate reshaping shaft.
Inventive Concept 57. The valve-delivery-assist tool according to any one of Inventive Concepts 1-11, wherein the valve-delivery-assist tool is shaped so to define a contrast channel, which is shaped so as to define one or more lateral or distal openings for injection of contrast media.
Inventive Concept 58. The valve-delivery-assist tool according to Inventive Concept 57, wherein the delivery catheter is shaped so as to define the contrast channel.
Inventive Concept 59. The valve-delivery-assist tool according to Inventive Concept 57, wherein the valve-delivery-assist tool includes an elongate shaft that is shaped so as to define the contrast channel.
Inventive Concept 60. The valve-delivery-assist tool according to any one of Inventive Concepts 1-11, wherein the delivery catheter includes an embolic protector structure, which includes a filter or mesh, and which can be elongated and opened proximally to a distal end of the embolic protector structure.
There is further provided, in accordance with an Inventive Concept 61 of the present invention, a valve-delivery-assist tool for use during a transcatheter aortic valve implantation (TAVI) procedure on a native aortic valve, the valve-delivery-assist tool including:
Inventive Concept 62. The valve-delivery-assist tool according to Inventive Concept 61, wherein the landing-support stabilizer is configured to automatically expand upon being released from the distal end of the delivery catheter.
Inventive Concept 63. The valve-delivery-assist tool according to Inventive Concept 61, wherein the landing-support stabilizer is configured to be manually expanded after being released from the distal end of the delivery catheter.
Inventive Concept 64. The valve-delivery-assist tool according to Inventive Concept 61, wherein the valve-delivery-assist tool is configured such that after lateral deflection of the aortic-valve cusp guide and expansion of the landing-support stabilizer, the released landing-support stabilizer and the released aortic-valve cusp guide are axially stationary with respect to one another such that a proximal-most point of the released landing-support stabilizer is disposed distal to the distal-most point of the released aortic-valve cusp guide.
Inventive Concept 65. The valve-delivery-assist tool according to Inventive Concept 64, wherein the valve-delivery-assist tool is configured such that after lateral deflection of the aortic-valve cusp guide and expansion of the landing-support stabilizer, the released landing-support stabilizer and the released aortic-valve cusp guide are axially stationary with respect to one another such that the proximal-most point of the released landing-support stabilizer is disposed between 1 and 10 mm distal to the distal-most point of the released aortic-valve cusp guide.
Inventive Concept 66. The valve-delivery-assist tool according to Inventive Concept 65, wherein the valve-delivery-assist tool is configured such that after lateral deflection of the aortic-valve cusp guide and expansion of the landing-support stabilizer, the released landing-support stabilizer and the released aortic-valve cusp guide are axially stationary with respect to one another such that the proximal-most point of the released landing-support stabilizer is disposed between 1.5 and 4 mm distal to the distal-most point of the released aortic-valve cusp guide.
Inventive Concept 67. The valve-delivery-assist tool according to Inventive Concept 61, wherein the valve-delivery-assist tool is configured such that disposition of the released aortic-valve cusp guide within a non-coronary cusp of the native aortic valve and rotationally centering the aortic-valve cusp guide within the non-coronary cusp, axially disposes the released landing-support stabilizer at a predetermined height below the native aortic valve.
Inventive Concept 68. The valve-delivery-assist tool according to Inventive Concept 67, wherein the predetermined height is between 2 and 10 mm.
Inventive Concept 69. The valve-delivery-assist tool according to Inventive Concept 61, wherein the valve-delivery-assist tool is configured such that after lateral deflection of the aortic-valve cusp guide and expansion of the landing-support stabilizer, the released landing-support stabilizer and the released aortic-valve cusp guide are rotationally stationary with respect to one another.
Inventive Concept 70. The valve-delivery-assist tool according to Inventive Concept 61, wherein the landing-support stabilizer includes an elongate slender rod.
Inventive Concept 71. The valve-delivery-assist tool according to Inventive Concept 70, wherein the elongate slender rod of the released landing-support stabilizer is shaped as a partial loop or a complete loop having one or more turns.
Inventive Concept 72. The valve-delivery-assist tool according to Inventive Concept 71,
Inventive Concept 73. The valve-delivery-assist tool according to Inventive Concept 71,
Inventive Concept 74. The valve-delivery-assist tool according to Inventive Concept 61, further including an elongate valve-delivery-assist support, which links together the landing-support stabilizer and the aortic-valve cusp guide.
Inventive Concept 75. The valve-delivery-assist tool according to Inventive Concept 74, wherein the released landing-support stabilizer extends laterally from the elongate valve-delivery-assist support.
Inventive Concept 76. The valve-delivery-assist tool according to Inventive Concept 75, wherein a best-fit plane defined by the released landing-support stabilizer forms an angle of between 45 and 90 degrees with a central longitudinal axis of the elongate valve-delivery assist support that is straight and passes through the distal end of the elongate valve-delivery-assist support.
Inventive Concept 77. The valve-delivery-assist tool according to Inventive Concept 74, wherein the elongate valve-delivery-assist support includes:
Inventive Concept 78. The valve-delivery-assist tool according to any one of Inventive Concepts 61-77, for use with a guidewire,
Inventive Concept 79. The valve-delivery-assist tool according to Inventive Concept 78, wherein the curved shape is a pigtail shape.
Inventive Concept 80. The valve-delivery-assist tool according to any one of Inventive Concepts 61-77, further including a safety tip, which is releasably disposed compressed in the delivery catheter, configured to be released from the distal end of the delivery catheter, and shaped so as to define a guidewire channel through the safety tip.
Inventive Concept 81. The valve-delivery-assist tool according to Inventive Concept 80, wherein the safety tip is configured to expand upon released from the distal end of the delivery catheter.
Inventive Concept 82. The valve-delivery-assist tool according to Inventive Concept 80, wherein the safety tip includes an elongate slender rod.
Inventive Concept 83. The valve-delivery-assist tool according to Inventive Concept 82, wherein the elongate slender rod of the released safety tip is configured to be shaped as a pigtail.
There is still further provided, in accordance with an Inventive Concept 84 of the present invention, a method for performing a transcatheter aortic valve implantation (TAVI) procedure on a native aortic valve, the method including:
Inventive Concept 85. The method according to Inventive Concept 84, wherein advancing the delivery catheter partially into the left ventricle includes seating the delivery catheter in a commissure between two of the aortic valve cusps.
Inventive Concept 86. The method according to Inventive Concept 84, wherein the one of the aortic valve cusps is a non-coronary cusp.
Inventive Concept 87. The method according to Inventive Concept 84, wherein the valve-delivery-assist tool is configured such that after lateral deflection of the aortic-valve cusp guide and expansion of the conduction-tissue protector, the released conduction-tissue protector and the released aortic-valve cusp guide are rotationally stationary with respect to each other.
Inventive Concept 88. The method according to Inventive Concept 84, wherein the conduction-tissue protector further includes a frame supporting the sheet.
Inventive Concept 89. The method according to Inventive Concept 88, wherein the frame surrounds the sheet of the released conduction-tissue protector.
Inventive Concept 90. The method according to Inventive Concept 84, wherein releasing the conduction-tissue protector includes releasing the conduction-tissue protector includes such that the sheet is generally planar.
Inventive Concept 91. The method according to Inventive Concept 84, wherein the sheet includes a mesh.
Inventive Concept 92. The method according to Inventive Concept 91, wherein the mesh includes braided wires.
Inventive Concept 93. The method according to Inventive Concept 84, wherein the aortic-valve cusp guide includes an elongate slender rod.
Inventive Concept 94. The method according to Inventive Concept 93, wherein the elongate slender rod of the released aortic-valve cusp guide is configured to be shaped as a pigtail.
Inventive Concept 95. The method according to Inventive Concept 84, wherein releasing the aortic-valve cusp guide includes releasing the aortic-valve cusp guide such that a best-fit plane defined by the released aortic-valve cusp guide forms an angle of between 15 and 60 degrees with a best-fit plane defined by the released conduction-tissue protector.
Inventive Concept 96. The method according to Inventive Concept 95, wherein the angle is between 25 and 35 degrees.
Inventive Concept 97. The method according to Inventive Concept 84, wherein the valve-delivery-assist tool further includes an elongate valve-delivery-assist support, which links together the conduction-tissue protector and the aortic-valve cusp guide.
Inventive Concept 98. The method according to Inventive Concept 97, wherein the released aortic-valve cusp guide extends laterally from the elongate valve-delivery-assist support.
Inventive Concept 99. The method according to Inventive Concept 97, wherein releasing the released conduction-tissue protector includes releasing the released conduction-tissue protector such that the released conduction-tissue protector extends from the elongate valve-delivery-assist support in two generally opposite directions.
Inventive Concept 100. The method according to Inventive Concept 97, wherein the valve-delivery-assist tool is configured such that an entirety of the released conduction-10 tissue protector is rotationally fixed with respect to the elongate valve-delivery-assist support.
Inventive Concept 101. The method according to Inventive Concept 97, wherein the elongate valve-delivery-assist support includes:
Inventive Concept 102. The method according to Inventive Concept 84,
Inventive Concept 103. The method according to Inventive Concept 102, wherein the predetermined height is between 2 and 10 mm.
Inventive Concept 104. The method according to Inventive Concept 102, wherein the landing-support stabilizer is configured to automatically expand upon being released from the distal end of the delivery catheter.
Inventive Concept 105. The method according to Inventive Concept 102, wherein releasing the landing-support stabilizer from the distal end of the delivery catheter in the left ventricle includes manually expanding the landing-support stabilizer.
Inventive Concept 106. The method according to Inventive Concept 102, wherein the valve-delivery-assist tool is configured such that after lateral deflection of the aortic-valve cusp guide and expansion of the conduction-tissue protector and the landing-support stabilizer:
Inventive Concept 107. The method according to Inventive Concept 106, wherein the valve-delivery-assist tool is configured such that after lateral deflection of the aortic-valve cusp guide and expansion of the conduction-tissue protector and the landing-support stabilizer:
Inventive Concept 108. The method according to Inventive Concept 102, wherein the valve-delivery-assist tool is configured such that after lateral deflection of the aortic-valve cusp guide and expansion of the conduction-tissue protector and the landing-support stabilizer:
Inventive Concept 109. The method according to Inventive Concept 102, wherein the valve-delivery-assist tool is configured such that the released landing-support stabilizer and the released aortic-valve cusp guide are disposed on opposite sides of the released conduction-tissue protector.
Inventive Concept 110. The method according to Inventive Concept 102, wherein the landing-support stabilizer includes an elongate slender rod.
Inventive Concept 111. The method according to Inventive Concept 110, wherein the elongate slender rod of the released landing-support stabilizer is shaped as a partial loop or a complete loop having one or more turns.
Inventive Concept 112. The method according to Inventive Concept 111,
Inventive Concept 113. The method according to Inventive Concept 111,
Inventive Concept 114. The method according to Inventive Concept 102, wherein the valve-delivery-assist tool further includes an elongate valve-delivery-assist support, which links together the landing-support stabilizer, the conduction-tissue protector, and the aortic-valve cusp guide.
Inventive Concept 115. The method according to Inventive Concept 114, wherein the released landing-support stabilizer extends laterally from the elongate valve-delivery-assist support.
Inventive Concept 116. The method according to Inventive Concept 115, wherein releasing the landing-support stabilizer includes releasing the landing-support stabilizer such that a best-fit plane defined by the released landing-support stabilizer forms an angle of between 45 and 90 degrees with a central longitudinal axis of the elongate valve-delivery-assist support that is straight and passes through the distal end of the elongate valve-delivery-assist support.
Inventive Concept 117. The method according to Inventive Concept 114, wherein the elongate valve-delivery-assist support includes:
Inventive Concept 118. The method according to Inventive Concept 102, wherein releasing the landing-support stabilizer includes releasing the landing-support stabilizer such that a best-fit plane defined by the released landing-support stabilizer forms an angle of between 45 and 90 degrees with a best-fit plane defined by the released conduction-tissue protector.
Inventive Concept 119. The method according to Inventive Concept 118, wherein releasing the aortic-valve cusp guide includes releasing the aortic-valve cusp guide such that a best-fit plane defined by the released aortic-valve cusp guide forms an angle of between 45 and 90 degrees with the best-fit plane defined by the released landing-support stabilizer.
Inventive Concept 120. The method according to Inventive Concept 84,
Inventive Concept 121. The method according to Inventive Concept 120, wherein releasing the safety tip includes releasing the safety tip such that it expands.
Inventive Concept 122. The method according to Inventive Concept 120, wherein the safety tip includes an elongate slender rod.
Inventive Concept 123. The method according to Inventive Concept 122, wherein the elongate slender rod of the released safety tip is configured to be shaped as a pigtail.
Inventive Concept 124. The method according to Inventive Concept 120, wherein the safety tip and the conduction-tissue protector are integral to each other.
Inventive Concept 125. The method according to Inventive Concept 84, wherein advancing the delivery catheter includes advancing a guidewire between the aortic valve cusps into the left ventricle, and advancing the delivery catheter over the guidewire.
Inventive Concept 126. The method according to Inventive Concept 84, wherein advancing the delivery catheter partially into the left ventricle includes passing a nose cone between two of the aortic valve cusps into the left ventricle while the nose cone is removably coupled to the delivery catheter.
Inventive Concept 127. The method according to Inventive Concept 126,
Inventive Concept 128. The method according to Inventive Concept 127, wherein the curved shape is a pigtail shape.
Inventive Concept 129. The method according to Inventive Concept 84, wherein the valve-delivery-assist tool further includes a reshaping element, which is coupled to the conduction-tissue protector, which is configured to change a shape of the released conduction-tissue protector.
Inventive Concept 130. The method according to Inventive Concept 129,
Inventive Concept 131. The method according to Inventive Concept 129, wherein the reshaping element includes an elongate reshaping shaft.
Inventive Concept 132. The method according to Inventive Concept 84, wherein the valve-delivery-assist tool is shaped so to define a contrast channel, which is shaped so as to define one or more lateral or distal openings, and wherein the method further includes injecting contrast media via the one or more lateral or distal openings.
Inventive Concept 133. The method according to Inventive Concept 132, wherein the delivery catheter is shaped so as to define the contrast channel.
Inventive Concept 134. The method according to Inventive Concept 132, wherein the valve-delivery-assist tool includes an elongate shaft that is shaped so as to define the contrast channel.
Inventive Concept 135. The method according to Inventive Concept 84, wherein the delivery catheter includes an embolic protector structure, which includes a filter or mesh, and wherein the method further includes elongating and opening the embolic protector structure proximally to a distal end of the embolic protector structure.
There is additionally provided, in accordance with an Inventive Concept 136 of the present invention, a method for performing a transcatheter aortic valve implantation (TAVI) procedure on a native aortic valve, the method including:
Inventive Concept 137. The method according to Inventive Concept 136, wherein the landing-support stabilizer is configured to automatically expand upon being released from the distal end of the delivery catheter.
Inventive Concept 138. The method according to Inventive Concept 136, wherein releasing the landing-support stabilizer from the distal end of the delivery catheter in the left ventricle includes manually expanding the landing-support stabilizer.
Inventive Concept 139. The method according to Inventive Concept 136, wherein advancing the delivery catheter partially into the left ventricle includes passing a nose cone between two of the aortic valve cusps into the left ventricle while the nose cone is removably coupled to the delivery catheter.
Inventive Concept 140. The method according to Inventive Concept 136, wherein advancing the delivery catheter partially into the left ventricle includes seating the delivery catheter in a commissure between two of the aortic valve cusps.
Inventive Concept 141. The method according to Inventive Concept 136, wherein the one of the aortic valve cusps is a non-coronary cusp.
Inventive Concept 142. The method according to Inventive Concept 136, wherein releasing the landing-support stabilizer and the aortic-valve cusp guide includes releasing the landing-support stabilizer and the aortic-valve cusp guide such that the released landing-support stabilizer and the released aortic-valve cusp guide are axially stationary with respect to one another such that a proximal-most point of the released landing-support stabilizer is disposed distal to the distal-most point of the released aortic-valve cusp guide.
Inventive Concept 143. The method according to Inventive Concept 136, wherein the predetermined height is between 2 and 10 mm.
Inventive Concept 144. The method according to Inventive Concept 136, wherein the valve-delivery-assist tool is configured such that after lateral deflection of the aortic-valve cusp guide and expansion of the landing-support stabilizer, the released landing-support stabilizer and the released aortic-valve cusp guide are rotationally stationary with respect to one another.
Inventive Concept 145. The method according to Inventive Concept 136, wherein the landing-support stabilizer includes an elongate slender rod.
Inventive Concept 146. The method according to Inventive Concept 145, wherein the elongate slender rod of the released landing-support stabilizer is shaped as a partial loop or a complete loop having one or more turns.
Inventive Concept 147. The method according to Inventive Concept 146,
Inventive Concept 148. The method according to Inventive Concept 146,
Inventive Concept 149. The method according to Inventive Concept 136, wherein the valve-delivery-assist tool further includes an elongate valve-delivery-assist support, which links together the landing-support stabilizer and the aortic-valve cusp guide.
Inventive Concept 150. The method according to Inventive Concept 149, wherein the released landing-support stabilizer extends laterally from the elongate valve-delivery-assist support.
Inventive Concept 151. The method according to Inventive Concept 150, wherein releasing the landing-support stabilizer includes releasing the landing-support stabilizer such that a best-fit plane defined by the released landing-support stabilizer forms an angle of between 45 and 90 degrees with a central longitudinal axis of the elongate valve-delivery-assist support that is straight and passes through the distal end of the elongate valve-delivery-assist support.
Inventive Concept 152. The method according to Inventive Concept 149, wherein the elongate valve-delivery-assist support includes:
Inventive Concept 153. The method according to Inventive Concept 136, wherein advancing the delivery catheter includes advancing a guidewire between the aortic valve cusps into the left ventricle, and advancing the delivery catheter over the guidewire.
Inventive Concept 154. The method according to Inventive Concept 136, wherein advancing the delivery catheter partially into the left ventricle includes passing a nose cone between two of the aortic valve cusps into the left ventricle while the nose cone is removably coupled to the delivery catheter.
Inventive Concept 155. The method according to Inventive Concept 154,
Inventive Concept 156. The method according to Inventive Concept 155, wherein the curved shape is a pigtail shape.
Inventive Concept 157. The method according to Inventive Concept 136,
Inventive Concept 158. The method according to Inventive Concept 157, wherein releasing the safety tip includes releasing the safety tip such that it expands.
Inventive Concept 159. The method according to Inventive Concept 157, wherein the safety tip includes an elongate slender rod.
Inventive Concept 160. The method according to Inventive Concept 159, wherein the elongate slender rod of the released safety tip is configured to be shaped as a pigtail.
The present invention will be more fully understood from the following detailed description of embodiments thereof, taken together with the drawings, in which:
For some applications, valve-delivery-assist tool 20 comprises:
Typically, valve-delivery-assist tool 20 is configured such that aortic-valve cusp guide 24 deflects laterally upon being released from delivery catheter 22, such as described hereinbelow with reference to
For example, aortic-valve cusp guide 24 may comprise a polymer or a shape-memory alloy, such as Nitinol.
Typically, conduction-tissue protector 26 is not shaped so as to define a receptacle (i.e., an internal open space).
Typically, valve-delivery-assist tool 20 is configured such that after lateral deflection of aortic-valve cusp guide 24 and expansion of conduction-tissue protector 26, released conduction-tissue protector 26 and released aortic-valve cusp guide 24 are axially stationary with respect to each other, optionally such that:
For some applications, such as labeled in
For some applications, valve-delivery-assist tool 20 is configured such that after lateral deflection of aortic-valve cusp guide 24 and expansion of conduction-tissue protector 26, released conduction-tissue protector 26 and released aortic-valve cusp guide 24 are rotationally stationary with respect to each other. Alternatively, valve-delivery-assist tool 20 is configured such that after lateral deflection of aortic-valve cusp guide 24 and expansion of conduction-tissue protector 26, released conduction-tissue protector 26 is rotatable with respect to released aortic-valve cusp guide 24. This rotatability allows manual adjustment of conduction-tissue protector 26 with respect to the ventricular wall. This adjustability may be useful in patients whose anatomy differs substantially from more common anatomy for which the standard angle a (alpha) between aortic-valve cusp guide 24 and conduction-tissue protector 26 (described hereinabove with reference to
Conduction-tissue protector 26 is configured to distribute mechanical force applied by a prosthetic aortic valve, such as described hereinbelow with reference to
For some applications, released conduction-tissue protector 26 is configured such that sheet 28 is generally planar, while for other applications, released conduction-tissue protector 26 is configured such that sheet 28 is not generally planar.
For some applications, sheet 28 has a teardrop shape, an elliptical shape, or a circular shape.
For some applications, sheet 28 comprises a fabric, PTFE, polypropylene, high density polyethylene (PE), polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), an acellular collagen matrix such as SIS, or another plastic. For other applications, sheet 28 comprises a thin nitinol, stainless steel or titanium sheet. In still other applications, sheet 28 may comprise a combination of materials, such as a high-density PE sheath around a boundary of ePTFE, PET, and/or polypropylene. Sheet 28 may alternatively or additionally comprise polyurethane foam, polycarbonate foam, biologic tissue such as porcine pericardium, bovine pericardium, pleura, peritoneum, and/or silicone. In some applications, sheet 28 may comprise a foam material surrounded by ePTFE. Sheet 28 may be shaped so as not to define any pores, or may be shaped so as to define pores or micropores.
Sheet 28 may or may not be blood-permeable.
For some applications, sheet 28 has:
For some applications, such as shown in
Frame 40 may be attached to or embedded in the surface of a single layer of sheet 28, or may be stitched through sheet 28.
Alternatively, conduction-tissue protector 26 does not comprise frame 40, in which case sheet 28 provides the necessary structure to maintain the shape of conduction-tissue protector 26 upon deployment. For example, sheet 28 may comprise a polymer that is thick enough to define and maintain the shape.
For some applications, aortic-valve cusp guide 24 comprises an elongate slender rod 42. For example, elongate slender rod 42 may comprise a wire or a tube. For some applications, elongate slender rod 42 of released aortic-valve cusp guide 24 is configured to be shaped as a pigtail (as shown). Optionally, for applications in which elongate slender rod 42 comprises a tube, the tube may be used for introducing a liquid, such as contrast media, during the procedure.
For some applications, valve-delivery-assist tool 20 further comprises landing-support stabilizer 50, which is releasably disposed compressed in delivery catheter 22 and configured to expand (e.g., deflect laterally) after being released from distal end 29 of delivery catheter 22. Landing-support stabilizer 50 may be configured to automatically expand upon being released from distal end 29 of delivery catheter 22, or may be otherwise expanded, such as using one of the techniques described hereinbelow with reference to
For some applications, valve-delivery-assist tool 20 is configured such that after lateral deflection of aortic-valve cusp guide 24 and expansion of landing-support stabilizer 50, released landing-support stabilizer 50 and released aortic-valve cusp guide 24 are rotationally stationary with respect to one another.
For some applications, valve-delivery-assist tool 20 is configured such that after lateral deflection of aortic-valve cusp guide 24 and expansion of conduction-tissue protector 26 and landing-support stabilizer 50: released landing-support stabilizer 50, released conduction-tissue protector 26, and released aortic-valve cusp guide 24 are rotationally stationary with respect to one another.
For some applications, valve-delivery-assist tool 20 is configured such that after lateral deflection of aortic-valve cusp guide 24 and expansion of conduction-tissue protector 26, released landing-support stabilizer 50 and released conduction-tissue protector 26 are rotationally stationary with respect to one another.
For some applications, landing-support stabilizer 50 comprises an elongate slender rod 54. For example, elongate slender rod 54 may comprise a wire or a tube. For some applications, elongate slender rod 54 of released landing-support stabilizer 50 is shaped as a partial loop or a complete loop having one or more turns.
For some applications, valve-delivery-assist tool 20 is configured such that released landing-support stabilizer 50 and released aortic-valve cusp guide 24 are disposed on opposite sides of released conduction-tissue protector 26.
For some applications, valve-delivery-assist tool 20 further comprises safety tip 60 for assisting with crossing the native valve and providing ventricular access. Safety tip 60 is releasably disposed compressed in delivery catheter 22, and configured to be released from distal end 29 of delivery catheter 22. Typically, safety tip 60 is configured to expand (e.g., deflect laterally) upon released from distal end 29 of delivery catheter 22. Typically, safety tip 60, conduction-tissue protector 26, and aortic-valve cusp guide 24 are linked to one another such that after expansion of conduction-tissue protector 26, a distal-most point 61 of safety tip 60 is disposed distal to distal-most point 30 of released conduction-tissue protector 26. For some applications, safety tip 60 comprises an elongate slender rod 62 (comprising, for example, a wire or a tube), which optionally is configured to be shaped as a pigtail (as shown). (It is noted that distal-most point 61 of safety tip 60 is not necessarily at a distal end of elongate slender rod 62, such as in configurations in which elongate slender rod 62 curves around in a proximal direction.) Optionally, for applications in which elongate slender rod 62 comprises a tube, the tube may be used for introducing a liquid, such as contrast media, during the procedure. For example, safety tip 60 may comprise a polymer.
Safety tip 60 is shaped so as to define a guidewire channel through safety tip 60, for advancement of valve-delivery-assist tool 20 over a guidewire, such as described hereinbelow with reference to
For some applications, valve-delivery-assist tool 20 further comprises an elongate valve-delivery-assist support 70, which links together conduction-tissue protector 26 and aortic-valve cusp guide 24. Typically, released aortic-valve cusp guide 24 extends laterally from elongate valve-delivery-assist support 70.
For some applications, valve-delivery-assist tool 20 is configured such that released conduction-tissue protector 26 extends from elongate valve-delivery-assist support 70 in two generally opposite directions D1 and D2.
For some applications, valve-delivery-assist tool 20 is configured such that an entirety of released conduction-tissue protector 26 is rotationally fixed with respect to elongate valve-delivery-assist support 70.
For some applications, elongate valve-delivery-assist support 70 comprises:
Typically, elongate conduction-tissue-protector shaft 72 and elongate aortic-valve cusp-guide shaft 74 are fixed together at least partially alongside each other.
For some applications in which valve-delivery-assist tool 20 comprises landing-support stabilizer 50, elongate valve-delivery-assist support 70 links together landing-support stabilizer 50, conduction-tissue protector 26, and aortic-valve cusp guide 24. For some of these applications, released landing-support stabilizer 50 extends laterally from elongate valve-delivery-assist support 70. For some of these applications, released landing-support stabilizer 50 extends laterally 3-20 mm, such as 3-5 mm, from a central longitudinal axis 78 of elongate valve-delivery-assist support 70 that is straight and passes through the distal end of elongate valve-delivery-assist support 70.
For some of these applications, such as labeled in
For some applications in which valve-delivery-assist tool 20 comprises landing-support stabilizer 50, elongate valve-delivery-assist support 70 comprises:
In these applications, typically elongate conduction-tissue-protector shaft 72, elongate aortic-valve cusp-guide shaft 74, and elongate landing-support-stabilizer shaft 79 are fixed together at least partially alongside one another.
For some of these applications, released landing-support stabilizer 50 extends laterally from elongate landing-support-stabilizer shaft 79.
For some of these applications, valve-delivery-assist tool 20 is configured such that best-fit plane 76 defined by released landing-support stabilizer 50 forms an angle of between 45 and 90 degrees (e.g., 75 and 90 degrees) with best-fit plane 36 defined by released conduction-tissue protector 26. For some of these applications, valve-delivery-assist tool 20 is configured such that best-fit plane 34 defined by released aortic-valve cusp guide 24 forms an angle of between 45 and 90 degrees (e.g., 75 and 90 degrees) with best-fit plane 76 defined by released landing-support stabilizer 50.
For some applications in which valve-delivery-assist tool 20 comprises safety tip 60, elongate valve-delivery-assist support 70 comprises, in addition to one or more of the shafts described above, an elongate safety-tip shaft 80 (labeled in
For some of these applications, released safety tip 60 extends laterally from elongate safety-tip shaft 80.
For some applications in which valve-delivery-assist tool 20 does not comprise safety tip 60, elongate valve-delivery-assist support 70 nevertheless comprises, in addition to one or more of the shafts described above, elongate support shaft 80, which may provide structural support to valve-delivery-assist tool 20 and/or aid with deployment of landing-support stabilizer 50, such as described hereinbelow with reference to
Reference is now made to
Valve-delivery-assist tool 120 comprises conduction-tissue protector 126, which comprises a sheet 128 comprising a mesh 129, which is typically flat, such as shown. Mesh 129 typically comprises a metal; for example, mesh 129 may be similar to the mesh of metal stents. For example, mesh 129 may comprise braided wires, such as shown.
Axial elongation of mesh 129 causes radial compression of mesh 129 for placement of conduction-tissue protector 126 with delivery catheter 22. Mesh 129 may provide more stiffness and stability to conduction-tissue protector 126. Mesh 129 may comprise a single layer or two or more layers. In some applications, mesh 129 is covered by a valve body covering such as ePTFE, PET, or porcine pericardium. Mesh is collapsible for introduction through delivery catheter 22.
In the configuration shown in
In the configuration shown in
Although valve-delivery-assist tool 120A is shown in
Reference is now made to
Unlike valve-delivery-assist tool 20, valve-delivery-assist tool 220 does not comprise safety tip 60.
Reference is now made to
Unlike valve-delivery-assist tool 20, valve-delivery-assist tool 320 does not comprise landing-support stabilizer 50.
Reference is now made to
Unlike valve-delivery-assist tool 20, valve-delivery-assist tool 420 does not comprise conduction-tissue protector 26.
Reference is now made to
As shown in
As shown in
Delivery catheter 22 typically becomes seated in a commissure between two of the cusps.
As shown in
Curved shape 119 of nose cone 106 may reduce the risk of perforation of the ventricular wall, including if delivery catheter 22 is advanced farther into the ventricle, such as to the apex of the ventricle. In this configuration, valve-delivery-assist tool 20 typically does not comprise safety tip 60.
For other applications, nose cone 106 is a catheter nose cone known in the art, such as a conventional catheter nose cone. For some of these other applications, valve-delivery-assist tool 20 comprises safety tip 60, such as described hereinabove with reference to
As shown in
As shown in
Optionally, aortic-valve cusp guide 24, once seated within the cusp, may also be used to identify the position of native aortic valve 100 and/or the cusp, such as using fluoroscopy.
Alternatively, aortic-valve cusp guide 24 and conduction-tissue protector 26 are deployed from delivery catheter 22 as described hereinbelow with reference to
As shown in
As shown in
As shown in
As shown in
As shown in
Reference is now made to
As shown in
As shown in
Reference is now made to
Reference is now made to
Reference is now made to
Reference is still made to
In an application of the present invention, valve-delivery-assist tool 20 comprises a protector delivery shaft. Conduction-tissue protector 26 is releasably disposed compressed in the protector delivery shaft, and is configured to expand upon being released from the protector delivery shaft. The protector delivery shaft is slidably disposed within delivery catheter 22, such that conduction-tissue protector is releasably disposed compressed in delivery catheter 22 (indirectly, via the protector delivery shaft). Thus, in this configuration, valve-delivery-assist tool 20 is configured such that conduction-tissue protector 26 expands after being released from both distal end 29 of delivery catheter and from the protector delivery shaft, rather than immediately upon release of conduction-tissue protector 26 from distal end 29 of delivery catheter 22.
Reference is now made to
Reshaping element 90 is coupled to conduction-tissue protector 26, such as to frame 40 of conduction-tissue protector 26, e.g., a distal portion of the frame or a distal portion of another element of conduction-tissue protector 26.
Reshaping element 90 is configured to change a shape of released conduction-tissue protector 26. For example, reshaping element 90 may be configured to change a vertical-axis dimension of released conduction-tissue protector 26, such as by axially shortening released conduction-tissue protector 26, as shown in the transition between
For some applications, reshaping element 90 comprises an elongate reshaping shaft 92. Pulling or pushing on elongate reshaping shaft 92 causes the change in shape of released conduction-tissue protector 26.
Reference is now made to
Reference is now made to
In an embodiment, techniques and apparatus described in U.S. Provisional Application 63/070,300, filed Aug. 26, 2020, including, but not limited to the Drawings attached thereto, are combined with techniques and apparatus described herein.
It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.
The present patent application claims priority from U.S. Provisional Application 63/070,300, filed Aug. 26, 2020, which is incorporated herein by reference.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/IB2021/057816 | 8/26/2021 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63070300 | Aug 2020 | US |
