STEERABLE DELIVERY SYSTEM FOR REPLACEMENT MITRAL VALVE AND METHODS OF USE

• US 20170056171A1
• Filed: 08/24/2016
• Published: 03/02/2017
• Est. Priority Date: 08/28/2015
• Status: Active Grant

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Inventors: Stewart, Kevin M., Chow, Patrick, Cooper, Alexander H., Landon, David Robert, Sanchez, Julio Cesar, Rabito, Glen T., Ratz, J. Brent, Quadri, Arshad
• Granted Patent: US 10,350,066 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2220/0041 using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61M 25/0051 made from fenestrated or weakened tubing layer

Abstract

Devices, systems and methods are described herein to provide improved steerability for delivering a prosthesis to a body location, for example, for delivering a replacement mitral valve to a native mitral valve location. A delivery component can have a plurality of slots that provide for desired bending of the delivery component, particularly compound bending of the delivery component that can facilitate steering of the delivery component in three dimensions.

Claims

1. A delivery system for delivering an expandable implant to a body location, the delivery system comprising:

an elongate shaft assembly comprising a proximal end and a distal end, wherein the elongate shaft assembly comprises an implant retention area configured to retain the expandable implant in a compressed configuration, wherein the elongate shaft assembly comprises;

an elongate tubular shaft comprising a proximal end and a distal end and a longitudinal axis extending between the proximal end and the distal end, wherein the elongate tubular shaft comprises a plurality of slots spaced apart longitudinally along a length of the elongate tubular shaft, each of the plurality of slots being oriented substantially perpendicular to the longitudinal axis and comprising a proximal side, a distal side, and two circumferentially spaced apart opposite ends;

wherein each slot forms a gap between the proximal and distal sides of the slot that is configured to close upon application of force to the elongate tubular shaft;

wherein the opposite ends of the slots are separated from each other by a spine portion extending longitudinally along the length of the elongate tubular shaft;

wherein the position and/or shape of the slots varies along the length of the elongate tubular shaft to provide different bending characteristics to different portions of the elongate tubular shaft.

2. The delivery system of claim 1, wherein the plurality of slots comprises a proximal slot section that extends parallel to the longitudinal axis of the elongate tubular shaft, a transition slot section that is angled relative to the longitudinal axis to move the transition slot section from a first circumferential location aligned with the proximal slot section to a second circumferential location, and a distal slot section that extends from the second circumferential location and is parallel to the longitudinal axis of the elongate tubular shaft, the distal slot section being circumferentially offset from the proximal slot section.

3. The delivery system of claim 1, wherein the plurality of slots have varying widths over the length of the elongate tubular shaft, the widths of the slots being defined between the two circumferentially spaced apart opposite ends.

4. The delivery system of claim 3, wherein the plurality of slots comprises a first slot section having a plurality of slots with a first width, a second slot section having a plurality of slots with a second width, and a third slot section having a plurality of slots with a third width, wherein the third width is greater than the second width and the second width is greater than the first width.

5. The delivery system of claim 4, wherein the plurality of slots comprises a first transition section between the first slot section and the second slot section, and a second transition section between the second slot section and the third slot section, wherein the first transition section comprises a plurality of slots having different widths that are between the first width and the second width, and wherein the second transition section comprises a plurality of slots having different widths that are between the second width and the third width.

6. The delivery system of claim 1, wherein each of the plurality of slots comprises a central tooth and triangular gaps positioned on opposite sides of the triangular gaps.

7. The delivery system of claim 1, further comprising one or more pull wires configured to apply a force that causes bending of the elongate tubular shaft along the plurality of slots.

8. The delivery system of claim 1, wherein the elongate shaft assembly further comprises an outer shaft assembly slideable over the elongate tubular shaft, the outer shaft assembly configured to radially restrain at least a portion of the expandable implant.

9. The delivery system of claim 8, further comprising an actuating knob configured to bend the elongate tubular shaft while simultaneously moving the outer shaft assembly distally.

10. The delivery system of claim 1, wherein the plurality of slots are configured to bend the elongate tubular shaft in multiple stages.

11. The delivery system of claim 1, further comprising a sheath around the elongate tubular shaft configured to prevent bending of the proximal end of the elongate tubular shaft.

12. A delivery system for delivering an expandable implant to a body location, the delivery system comprising:

an elongate shaft assembly comprising a proximal end and a distal end and a lumen extending between the proximal end and the distal end, wherein the elongate shaft assembly comprises an implant retention area configured to retain a distal end of the expandable implant in a compressed configuration;

a mid shaft assembly located within the lumen of the elongate shaft assembly and comprising a proximal end and a distal end and a lumen extending between the proximal end and the distal end, wherein the distal end of the mid shaft assembly comprises an outer retention ring configured to retain a proximal end of the expandable implant in the compressed configuration;

an inner assembly located within the lumen of the mid shaft assembly and comprising a proximal end and a distal end and a lumen extending between the proximal end and the distal end, wherein the distal end of the inner assembly is configured to releasably retain the proximal end of the expandable implant; and

a spacer sleeve comprising a proximal end and a distal end and a lumen extending between the proximal end and the distal end, the spacer sleeve located radially between the mid shaft assembly and the inner assembly, wherein the spacer sleeve is located within the lumen of the mid shaft assembly, and the inner assembly is located within the lumen of the spacer sleeve.

13. The delivery system of claim 12, wherein the spacer sleeve is not connected to the inner assembly or the mid shaft.

14. A delivery system for delivering an expandable implant to a body location, the delivery system comprising:

an elongate deflectable delivery component configured to at least partially retain the expandable implant, the elongate deflectable delivery component configured to bend to assist in steering the delivery system to the body location; and

a handle comprising;

a rotatable deflection actuator configured to cause desired bending of the deflectable delivery component;

threading on an outer surface of the handle; and

a rotatable retraction actuator configured to mate with the threading, the rotatable retraction actuator being operably connected to the elongate deflectable delivery component;

wherein rotation of the rotatable retraction actuator causes the rotatable retraction actuator and the rotatable deflection actuator to translate proximally along the threading, thereby translating the elongate deflectable delivery component proximally to at least partially release the expandable implant.

15. The delivery system of claim 14, wherein rotation of the rotatable deflection actuator causes desired bending of the deflectable delivery component while simultaneously applying a distal force to the deflectable delivery component.

16. The delivery system of claim 14, further comprising a pull wire operably connected between the rotatable deflection knob and the deflectable delivery component.

17. The delivery system of claim 14, wherein the deflectable delivery component comprises a mid-shaft and an outer retention ring configured to partially retain the expandable implant.

18. The delivery system of claim 14, further comprising an outer sheath assembly configured to slide over the deflectable delivery component, and wherein the handle comprises an outer sheath actuator configured to move the outer sheath relative to the deflectable delivery component.

19. The delivery system of claim 14, further comprising an inner assembly configured to at least partially engage the expandable implant, wherein rotation of the rotatable retraction actuator causes translation of the elongate deflectable delivery component proximally relative to the inner assembly.

20. The delivery system of claim 14, further comprising a nose cone shaft and a nose cone at a distal end of the nose cone shaft, and wherein the handle comprises a nose cone actuator.