Delivery systems and methods of implantation for prosthetic heart valves

• US 9,629,719 B2
• Filed: 04/21/2011
• Issued: 04/25/2017
• Est. Priority Date: 04/23/2010
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Rothstein, Paul
• Primary Examiner(s): HOLWERDA, KATHLEEN SONNETT
• Application Number:
  US13/091,672
• Publication Number:
  US 20110264191A1
• Time in Patent Office: 2,196 Days
• Field of Search: 606108, 606205-209, 623 111, 623 112, 623 211
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• 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 2002/9665 with additional retaining means

Abstract

A delivery system for delivery of an implantable stented device to a body lumen that includes an elongated member having a distal tip and a proximal end portion, a wire connection member positioned between the distal tip and proximal end portion of the elongated member, and a plurality of capturing wires extending from a distal end of the wire connection member. Each of the capturing wires includes a distal end having a lower portion that is moveable relative to an upper portion between an open position and a closed position, and a slot defined by the upper and lower portions when they are in the closed position.

Claims

1. A delivery system for delivery of an implantable stented device to a body lumen, the delivery system including a distal end and a proximal end and comprising:

a handle adjacent the proximal end of the delivery system;

a wire connection member positioned between the distal end of the delivery system and the handle;

a plurality of capturing wires fixedly attached to the wire connection member and extending from a distal end of the wire connection member, each of the capturing wires having a distal end having a lower portion that is moveable relative to an upper portion between an open position and a closed position, and a slot defined by the upper portion and the lower portion in the closed position, the lower portion and the upper portion being integrally formed and extending from a proximal juncture of the distal end of the capturing wire;

a plurality of sleeves, wherein each of the plurality of sleeves surrounds one of the capturing wires; and

a sleeve connection member positioned between the wire connection member and the distal end of the delivery system, wherein each of the sleeves is fixedly attached to the sleeve connection member and extends from a distal end of the sleeve connection member, and wherein the sleeve connection member is axially translatable to move the sleeves axially relative to their respective capturing wires.

2. The delivery system of claim 1, wherein each of the sleeves is slideable along at least a portion of a length of its respective capturing wire.

3. The delivery system of claim 2, wherein each of the sleeves is tubular and comprises an internal opening that is positionable to surround the distal end of its respective capturing wire when the upper and lower portions are in their closed position.

4. The delivery system of claim 1, further comprising a sheath that is slideable relative to the wire connection member, wherein the sheath comprises an internal area for surrounding the plurality of capturing wires and the wire connection member.

5. The delivery system of claim 1, wherein each of the capturing wires comprises a shape-memory material.

6. The delivery system of claim 1, wherein the plurality of capturing wires are spaced from each other in a radial pattern relative to the distal end of the wire connection member.

7. The delivery system of claim 1, wherein each of the capturing wires comprises a formed shape so that it flares outwardly relative to a longitudinal axis of the delivery system when in an uncompressed condition.

8. The delivery system of claim 7, further comprising a slideable sheath having an internal area for compressing the wires toward the longitudinal axis of the delivery system and at least partially surrounding the plurality of capturing wires.

9. The delivery system of claim 1, wherein the upper portion, lower portion, and slot of each of the capturing wires are formed using laser cutting techniques.

10. The delivery system of claim 1, wherein the lower portion and the upper portion of each of the capturing wires are biased away from each other when not subjected to externally applied forces.

11. The delivery system of claim 1, in combination with a self-expandable stented device that is transitionable from a collapsed state to an expanded state with the removal of an externally applied force.

12. The delivery system of claim 11, wherein the stented device includes a plurality of wire crowns, wherein each of the crowns is engageable with the distal end of one of the capturing wires.

13. A delivery system for delivery of an implantable stented device to a body lumen, the delivery system including a distal end and a proximal end and comprising:

a handle adjacent the proximal end of the delivery system;

a wire connection member positioned between the distal end of the delivery system and the handle;

a plurality of capturing wires fixedly attached to the wire connection member and extending from a distal end of the wire connection member, each of the capturing wires having a distal end having a lower portion that is moveable relative to an upper portion between an open position and a closed position, and a slot defined by the upper portion and the lower portion in the closed position, the lower portion and the upper portion being integrally formed and extending from a proximal juncture of the distal end of the capturing wire; and

a plurality of sleeves, wherein each of the plurality of sleeves surrounds one of the capturing wires;

wherein a proximal end portion of the delivery system comprises;

a sheath actuator for controlling slideable movement of a sheath relative to the wire connection member; and

a sleeve actuator for controlling slideable movement of the plurality of sleeves.

14. The delivery system of claim 13, wherein the sleeve actuator comprises a threaded rod and a knob that is rotatable along the threaded rod to simultaneously axially move each of the plurality of sleeves relative to the distal end of its respective capturing wire.

15. The delivery system of claim 13, wherein the sheath actuator comprises a locking mechanism that is releasable to allow axial movement of the sheath actuator relative to the wire connection member.