Delivery Systems and Methods of Implantation for Prosthetic Heart Valves

• US 20110264191A1
• Filed: 04/21/2011
• Published: 10/27/2011
• Est. Priority Date: 04/23/2010
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Rothstein, Paul
• Granted Patent: US 9,629,719 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• 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 comprising:

an elongated member comprising 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, wherein each of the capturing wires comprises 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.

2. The delivery system of claim 1, further comprising a plurality of sleeves, each of which at least partially surrounds one of the capturing wires.

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

4. The delivery system of claim 3, 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.

5. The delivery system of claim 2, further comprising a sleeve connection member positioned between the wire connection member and the distal tip of the elongated member, wherein each of the sleeves 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.

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

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

8. 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.

9. 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 elongated member when in an uncompressed condition.

10. The delivery system of claim 9, further comprising a slideable sheath having an internal area for compressing the wires toward the longitudinal axis of the elongated member and at least partially surrounding the plurality of capturing wires.

11. The delivery system of claim 2, wherein the proximal end portion of the elongated member comprises:

a sheath actuator for controlling slideable movement of a sheath relative to a distal tip of the elongated member; and

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

12. The delivery system of claim 11, 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 a distal end of its respective capturing wire.

13. The delivery system of claim 11, wherein the sheath actuator comprises a locking mechanism that is releasable to allow axial movement of the sheath actuator relative to the distal tip of the elongated member.

14. 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.

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

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

17. The delivery system of claim 16, 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.

18. A method of deploying an implantable stented device comprising a plurality of stent crowns within a patient using a delivery system that comprises:

an elongated member comprising 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;

a plurality of capturing wires extending from a distal end of the wire connection member; and

a plurality of sleeves at least partially surrounding one of the capturing wires, wherein each of the capturing wires comprises 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, the method comprising the steps of;

positioning one of a plurality of stent crowns of the stented device between the upper and lower portions of each of the capturing wires and adjacent to the slot of the capturing wire;

axially translating each of the plurality of sleeves relative to the distal end of its respective capturing wire to press the upper and lower portions toward each other and capture the respective stent crown within the corresponding slot;

positioning the implantable stented device at an implantation location with the delivery system;

axially translating each of the plurality of sleeves relative to the distal end of its respective capturing wire to allow the upper and lower portions to separate and become disengaged with the stent crown; and

removing the delivery system from the patient.

19. The method of claim 18, wherein the delivery system further comprises a sheath, and wherein the method further comprises the steps of:

axially translating the sheath toward the distal tip prior to positioning the stented device at an implantation location; and

axially translating the sheath away from the distal tip after positioning the stented device at an implantation location.

20. The method of claim 19, wherein the delivery system further comprises a sheath actuator for controlling slideable movement of a sheath relative to the distal tip of the elongated member, and a sleeve actuator for controlling slideable movement of the plurality of sleeves, wherein the step of axially translating each of the plurality of sleeves comprises axially translating the sleeve actuator, and wherein the steps of axially translating the sheath toward and away from the distal tip comprises axially translating the sheath actuator.