Prosthesis delivery device
Techniques of this disclosure relate to delivery devices for use in delivering a prosthesis via percutaneous transcatheter (or transluminal) techniques. Embodiments achieve variable tensile and bending resistance of a transcatheter delivery device, which improves trackability and positioning accuracy of the system while maintaining the tensile characteristics of the transcatheter delivery device required for recapture and deployment of the prosthesis. Other embodiments relate to other components of a transcatheter delivery device that can be torqueable to assist in rotational positioning of the prosthesis. Other embodiments relate to the capsule of the transcatheter delivery device outer sheath member and/or the prosthesis retention member of the transcatheter delivery device that can passively or otherwise rotate about their respective central axis to prevent built-up torque during delivery of a prosthesis. The capsule can include an echogenic marker. The aforementioned features and functionalities can be combined or utilized separately with delivery devices of the disclosure.
1 . A delivery device comprising:
an outer sheath member having a distal end and a proximal end;
a tensile resistance actuator provided proximate the proximal end of the outer sheath member;
an inner shaft member defining a plurality of lumens;
a prosthesis retention member connected to the inner shaft member and configured to retain a prosthesis;
a coupling comprising a distal end disposed within a cavity of the prosthesis retention member and extending proximally from the prosthesis retention member, wherein the prosthesis retention member is configured to freely rotate about the distal end of the coupling, while maintaining the distal end of the coupling within the cavity; and
a plurality of tensile wires, each of the tensile wires slidably positioned within one of the plurality of lumens of the inner shaft member, wherein each of the tensile wires are secured to the coupling and the tensile resistance actuator;
wherein the delivery device has an unlocked configuration in which a length of the tensile wire between the coupling and the tensile resistance actuator is variable;
further wherein the delivery device has a locked configuration in which the length of each tensile wire between the coupling and the tensile resistance actuator is invariable.
2 . The delivery device of claim 1 , further comprising a handle assembly connected to the proximal end of the outer sheath member.
3 . The delivery device of claim 2 , further comprising a torque coil positioned within the outer sheath member and extending over the inner shaft member from the handle assembly to the coupling.
4 . The delivery device of claim 3 , wherein the handle assembly includes a torque coil actuator configured to rotate the torque coil about a longitudinal axis of the torque coil with respect to the inner shaft member.
5 . The delivery device of claim 2 , wherein the tensile resistance actuator is positioned at least partially within the handle assembly and is rotatable with respect to the handle assembly.
6 . The delivery device of claim 2 , wherein the handle assembly includes a tapered surface over which the tensile wires are routed.
7 . The delivery device of claim 2 , wherein the inner shaft member is rotatably coupled about a longitudinal axis of the inner shaft member with respect to the handle assembly.
8 . The delivery device of claim 1 , wherein the tensile resistance actuator is configured to compressively maintain a position of the tensile wires when the delivery device is in the locked configuration.
9 . The delivery device of claim 1 , wherein the prosthesis retention member has a first portion and a second portion, the first portion being rotatable with respect to the second portion.
10 . The delivery device of claim 9 , wherein the first portion of the prosthesis retention member and the second portion of the prosthesis retention member are coupled to one another with a ball and socket joint.
11 . The delivery device of claim 1 , wherein the inner shaft member includes a central lumen.
12 . The delivery device of any claim 1 , wherein the prosthesis retention member is configured to rotate about a longitudinal axis of the prosthesis retention member with respect to the inner shaft member.
13 . The delivery device of claim 12 , wherein the outer sheath member includes a capsule and a body; wherein the capsule is rotatable with respect to the body.
14 . The delivery device of claim 12 , wherein the prosthesis retention member fits over a bearing chassis that is connected to the inner shaft member.
15 . The delivery device of claim 1 , wherein the tensile resistance actuator includes a pivotal lever.
16 . The delivery device of claim 1 , wherein the outer sheath member includes a body and a capsule connected to the body at the distal end of the outer sheath member, wherein the capsule can rotate about a longitudinal axis of the outer sheath member with respect to the body.
17 . The delivery device of claim 16 , wherein the capsule includes an outer surface and an echogenic marker on the outer surface.
18 . The delivery device of claim 1 , wherein at least one biasing element places tension in at least one of the tensile wires in the unlocked configuration.
19 . The delivery device of claim 18 , wherein each tensile wire is tensioned by a respective biasing element in the unlocked configuration.
20 . A delivery device comprising:
an outer sheath member having a distal end and a proximal end;
a tensile resistance actuator provided proximate the proximal end of the outer sheath member;
an inner shaft member defining a plurality of lumens;
a coupling proximate the distal end of the outer sheath member and positioned radially inward relative to the inner shaft member;
a prosthesis retention member connected to the inner shaft member and configured to retain a prosthesis, wherein the prosthesis retention member is configured to freely rotate about a distal end portion of the coupling, while maintaining an axial position along a longitudinal axis of the coupling; and
a plurality of tensile wires, each of the tensile wires slidably positioned within one of the plurality of lumens of the inner shaft member, wherein each of the tensile wires are secured to the coupling and the tensile resistance actuator;
wherein the delivery device has an unlocked configuration in which a length of the tensile wire between the coupling and the tensile resistance actuator is variable;
further wherein the delivery device has a locked configuration in which the length of each tensile wire between the coupling and the tensile resistance actuator is invariable.