Steerable rail delivery system

Patent metadata

Field	Value
Publication number	US-10813757-B2
Application number	US-201816028172-A
Country	US
Kind code	B2
Filing date	Jul 5, 2018
Priority date	Jul 6, 2017
Publication date	Oct 27, 2020
Grant date	Oct 27, 2020

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. The steerable delivery system can contain a steerable rail configured for multi-plane bending to direct a distal end of the delivery system.

First claim

What is claimed is:

1. A delivery system for delivering an expandable implant to a body location, the delivery system comprising:
an outer sheath assembly comprising an outer shaft having an outer lumen and a proximal end and a distal end, wherein the outer sheath assembly comprises an implant retention area configured to retain the expandable implant in a compressed configuration;
a rail assembly located within the outer lumen, the rail assembly comprising a rail shaft having a rail lumen and a proximal end and a distal end, wherein the rail assembly comprises one or more pull wires attached on an inner surface of the rail shaft configured to provide an axial force on the rail shaft to steer the rail assembly; and
an inner assembly located within the outer lumen, the inner assembly comprising an inner shaft having an inner lumen and a proximal end and a distal end, wherein the inner assembly comprises an inner retention member configured to be releasably attached to the expandable implant;
wherein the outer sheath assembly and the inner assembly are configured to move together distally relative to the rail assembly while the expandable implant remains in the compressed configuration; and
wherein the outer sheath assembly is configured to retract proximally relative to the inner assembly in order to at least partially expand the expandable implant from the compressed configuration.

2. The delivery system of claim 1 , wherein the inner assembly is located within the rail lumen.

3. The delivery system of claim 1 , wherein the one or more pull wires comprise a proximal pull wire and a distal pull wire, wherein the proximal pull wire attaches to the rail shaft at a location proximal to an attachment point of the distal pull wire, and wherein the rail shaft is configured to form a proximal bend and a distal bend.

4. The delivery system of claim 1 , further comprising the expandable implant, wherein a distal end of the expandable implant is restrained by the outer sheath assembly and a proximal end of the expandable implant is restrained the inner retention member of the inner assembly.

5. The delivery system of claim 4 , wherein the expandable implant comprises a replacement mitral valve comprising a plurality of anchors configured to positioned on a ventricular side of a native mitral valve annulus.

6. The delivery system of claim 1 , wherein the rail assembly is configured to steer the rail assembly toward a native mitral valve location in a transseptal approach.

7. The delivery system of claim 1 , wherein the rail assembly comprises at least one pull wire lumen attached to an inner surface of the rail lumen, wherein the at least one pull wire passes through the at least one pull wire lumen.

8. The delivery system of claim 1 , further comprising:
a mid shaft assembly within the outer lumen, the mid shaft assembly comprising a mid shaft having a middle lumen and a proximal end and a distal end, wherein the mid shaft assembly comprises an outer retention member configured to radially restrain at least a portion of the expandable implant; and
a nose cone assembly located within the inner lumen, the nose cone assembly comprising a nose cone shaft having a guide wire lumen, a proximal and distal end, and a nose cone on the distal end;
wherein the mid shaft assembly and the nose cone assembly are configured to move together distally with the outer sheath assembly and the inner assembly relative to the rail assembly while the expandable implant remains in the compressed configuration; and
wherein the mid shaft assembly is configured to retract proximally relative to the inner assembly in order to at least partially expand the expandable implant from the compressed position.

9. The delivery system of claim 8 , wherein the outer retention member comprises an inner liner that wraps around a distal end of the outer retention member and is in contact with a radially outer surface of the outer retention member.

10. The delivery system of claim 4 , wherein the expandable implant comprises a replacement tricuspid valve.

11. The delivery system of claim 1 , wherein the rail assembly is a steerable rail assembly.

12. The delivery system of claim 1 , wherein the outer sheath assembly comprises a capsule at the distal end, the capsule comprising:
an outer polymer layer;
a metal middle layer located on a radially inner surface of the outer polymer layer; and
an inner liner located on a radially inner surface of the middle layer.

13. The delivery system of claim 12 , wherein the inner liner comprises extruded PTFE.

14. The delivery system of claim 12 , wherein the metal middle layer is at least partially a metal coil.

15. The delivery system of claim 12 , wherein the inner liner comprises pre-axially compressed PTFE.

16. A delivery system for delivering an expandable implant to a body location, the delivery system comprising:
an outer sheath assembly comprising an outer shaft having an outer lumen and a proximal end and a distal end, wherein the outer sheath assembly comprises an implant retention area configured to retain the expandable implant in a compressed configuration;
a rail assembly located within the outer lumen, the rail assembly comprising a rail shaft having a rail lumen and a proximal end and a distal end, wherein the rail assembly comprises one or more pull wires attached on an inner surface of the rail shaft configured to provide an axial force on the rail shaft to steer the rail assembly;
an inner assembly located within the outer lumen, the inner assembly comprising an inner shaft having an inner lumen and a proximal end and a distal end, wherein the inner assembly comprises an inner retention member configured to be releasably attached to the expandable implant;
a mid shaft assembly within the outer lumen, the mid shaft assembly comprising a mid shaft having a middle lumen and a proximal end and a distal end, wherein the mid shaft assembly comprises an outer retention member configured to radially restrain at least a portion of the expandable implant;
a nose cone assembly located within the inner lumen, the nose cone assembly comprising a nose cone shaft having a guide wire lumen, a proximal and distal end, and a nose cone on the distal end; and
a handle comprising:
a first actuator configured to move together distally the outer sheath assembly, the inner assembly, and the mid shaft assembly relative to the rail assembly;
a second actuator configured to retract proximally the outer sheath assembly relative to the inner assembly;
a third actuator configured to retract proximally the mid shaft assembly relative to the inner assembly; and
a locking button for preventing axial motion of the nose cone assembly;

wherein the mid shaft assembly and the nose cone assembly are configured to move together distally with the outer sheath assembly and the inner assembly relative to the rail assembly while the expandable implant remains in the compressed configuration;
wherein the mid shaft assembly is configured to retract proximally relative to the inner assembly in order to at least partially expand the expandable implant from the compressed position;
wherein the outer sheath assembly and the inner assembly are configured to move together distally relative to the rail assembly while the expandable implant remains in the compressed configuration; and
wherein the outer sheath assembly is configured to retract proximally relative to the inner assembly in order to at least partially expand the expandable implant from the compressed configuration.

17. The delivery system o

Assignees

• Edwards Lifesciences Corp

Inventors

• Cooper Alexander H
• Landon David Robert
• Stewart Kevin M
• Johnson Garrett Dallas
• Rabito Glen T
• Gutierrez Tarannum Ishaq
• Okabe Hiroshi
• Aguilar Jr Ramon
• Edwards Jesse Robert
• Scheinblum Taylor Jacob
• Chow Patrick
• Sanchez Julio Cesar
• Luong Hieu Minh

Classifications

• A61F2/2466

  Delivery devices therefor · CPC title

• A61F2/2436 Primary

  Deployment by retracting a sheath · CPC title

• A61F2/2427 Primary

  Devices for manipulating or deploying heart valves during implantation · CPC title

• A61F2/2439 Primary

  Expansion controlled by filaments · CPC title

• A61M25/0147

  with movable mechanical means, e.g. pull wires · CPC title