Stent Valve, Delivery Apparatus and Method Therefor

• US 20130274870A1
• Filed: 09/26/2011
• Published: 10/17/2013
• Est. Priority Date: 09/24/2010
• Status: Active Grant

• Current Assignee: Boston Scientific Medical Device Limited (Boston Scientific Corporation)
• Original Assignee: Symetis SA (Boston Scientific Corporation)
• Inventors: Essinger, Jacques, Delaloye, Stephane, Hefti, Jean-Luc, Mantanus, Luc, Biadillah, Youssef, Lombardi, Fabien
• Granted Patent: US 9,414,915 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61M 2039/0666 Flap-valve

Abstract

A delivery catheter (12) for a stent valve (10), the delivery catheter having a distal portion (14) insertable into an anatomy, the distal portion comprising an accommodation region (18) for accommodating a stent-valve for delivery into the anatomy, the delivery catheter further comprising at least one sheath (20; 22) that is translatable between a closed position for at least partly closing the accommodation region and an open position for at least partly opening the accommodation region.

Claims

1-72. -72. (canceled)

73. A transcatheter aortic valve implantation system, comprising:

an aortic stent-valve comprising a stent component and valve leaflets supported by the stent component, the stent component having an inflow end and an outflow end and being self-expandable from a compressed condition for delivery towards an expanded functional condition, the stent component comprising outflow structure at the outflow end, a crown intermediate the inflow and outflow ends, the crown having a free extremity intermediate the inflow and outflow ends and directed towards the outflow end, and the stent-component further comprising a fixation section between the crown and the inflow end;

a delivery catheter having a distal portion insertable into the anatomy, the distal portion comprising a stent-valve accommodation region for accommodating the stent-valve in the compressed condition for delivery, a first sheath for covering at least a portion of the fixation section at the accommodation region to constrain the fixation section compressed, and a second sheath for covering at least a portion of the outflow structure and at least a portion of the crown at the accommodation region to constrain the outflow structure and the crown compressed, the second sheath be translatable in a proximal direction to uncover the crown and the outflow structure for deployment, and the first sheath being translatable in a distal direction to uncover the fixation section for deployment.

74. The system of claim 73, wherein the outflow structure comprises a plurality of arches having apexes at the outflow end of the stent component.

75. The system of claim 73, wherein translation of the second sheath deploys the crown followed by the stabilization arches to permit axial seating of the crown against native leaflets and generation of axial alignment forces by the arches contacting the ascending aorta, and translation of the first sheath deploys the fixation section to anchor the stent-valve.

76. The system of claim 73, wherein the stent-valve is configured such that, when the first sheath covers at least a portion of the fixation section, and the second sheath is translated proximally to uncover the crown and the outflow structure, the stent component defines a partly deployed substantially flared shape from the portion of the fixation section constrained by the first sheath, towards the free extremity of the crown, the flared shape permitting universal seating of the crown against native leaflets.

77. The system of claim 76, wherein the partly deployed substantially flared shape corresponds to the crown being partly deployed in a form smaller than its fully deployed shape.

78. The system of claim 73, wherein in a condition in which the stent-valve is loaded at the accommodation region and the system is ready for introduction into the anatomy, the first and second sheaths are spaced apart from each other.

79. The system of claim 78, wherein the stent-valve further comprises an inner skirt covering a portion of an inner surface of the stent component, and an outer skirt covering a portion of an exterior surface of the stent component, the inner skirts including a region of partial overlap, and wherein the space between the first and second spaced apart sheaths is in register with at least a portion of the region of partial overlap of the inner and outer skirts.

80. The system of claim 73, configured for transvascular delivery of the stent-valve to the heart.

81. The system of claim 73, wherein the first sheath is shorter than the second sheath.

82. The system of claim 73, wherein the first sheath and the second sheath are non-overlapping and/or have a same diameter as each other.

83. The system of claim 73, wherein the delivery catheter further comprises an interface member at the accommodation region, the interface member being deployable upon translation of at least one of the sheaths, the interface member providing a guide surface for aiding withdrawal of the delivery catheter from the anatomy after the stent valve is deployed.

84. The system of claim 73, wherein the delivery catheter comprises a flexible stem portion extending between the distal portion and a control handle at a proximal portion of the delivery catheter, the stem portion comprising a plurality of flexible slidable tubes nested one within another for controlling translation of the sheaths in response to operation of the control handle, wherein the control handle comprises an actuator for applying pre-tension to at least one of the tubes for biasing the first sheath in a proximal direction.

85. A delivery catheter for a stent-valve, comprising a distal portion insertable into the anatomy, the distal portion comprising an accommodation region for accommodating a stent-valve for delivery into the anatomy, the delivery catheter further comprising at least one sheath that is translatable between a closed position for at least partly closing the accommodating region and an open position for at least partly opening the accommodation region, and an interface member that is substantially non-deployed in an initial state of the delivery catheter and deployable to provide a guide surface for aiding withdrawal of the delivery catheter from the anatomy.

86. The delivery catheter of claim 85, wherein the delivery catheter further comprises a stent-holder at the accommodation region and having a profile for mating engagement with a stent-valve when the stent-valve is accommodated within the accommodation region, and wherein the guide surface of the interface member, when deployed, provides a more streamlined profile than the stent-holder alone, to facilitate withdrawal of the delivery catheter with the at least one sheath in the open position.

87. The delivery catheter of claim 86, wherein the delivery catheter is withdrawable through an 18 French arterial introducer, with the at least one sheath in the open position.

88. The delivery catheter of claim 85, further comprising a second sheath, and wherein the interface member is deployable to perform at least one of the following:

provide an interface at or between the generally facing open ends of the sheaths, align the open ends of the sheaths to be substantially in register with each other and/or centred with respect to the catheter axis, and define a bridge and/or a smooth profile between the facing open ends of the sheaths.

89. The delivery catheter of claim 85, wherein the interface member is captive on the delivery catheter.

90. The delivery catheter of claim 85, wherein in the non-deployed condition, the interface member is received within the or a sheath.

91. The delivery catheter of claim 85, wherein the interface member is self-expandable from a compressed non-deployed condition to an expanded deployed condition.

92. The delivery catheter of claim 85, wherein the interface member is axially slidable within the accommodation region when in the deployed condition.

93. The delivery catheter of claim 85, wherein the interface member comprises a tapered or rounded end defining the guide surface.

94. A delivery catheter for a transcatheter stent-valve, the delivery catheter comprising:

a distal portion insertable into the anatomy

a stent-valve accommodation region at the distal portion,

a stent-holder arranged within the accommodation region and having a profile for mating engagement with a stent-valve when the stent-valve is received within the accommodation region to restrain the stent-valve against axial movement, and

a sheath that is translatable between a closed position covering the stent holder, and an open position uncovering the stent holder, at least one sleeve or sleeve segment that, in use, provides a liner between an interior surface portion of the sheath and an exterior surface portion of a stent-valve at the stent holder, and/or an exterior surface portion of the stent holder.

95. The delivery system of claim 94, wherein the sleeve or sleeve segment is mounted on the stent holder.

96. The delivery system of claim 94, wherein the sleeve or sleeve segment comprises a plurality of segments.

97. The delivery system of claim 96, wherein the sleeve comprises a sleeve section communicating with a plurality of sleeve segments.

99. The delivery system of claim 94, wherein the sleeve or sleeve segment is positioned for covering at least the profiled portion of the stent holder for mating engagement with the stent-valve.