Steerable delivery system and components

Patent metadata

Field	Value
Publication number	US-2019008639-A1
Application number	US-201816027974-A
Country	US
Kind code	A1
Filing date	Jul 5, 2018
Priority date	Jul 6, 2017
Publication date	Jan 10, 2019
Grant date	—

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. Disclosed are a number of features that can improve steerability or release of the prosthesis into the body location.

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; 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; and wherein the delivery system is configured to be bent at least at one location to facilitate delivery of the expandable implant to the body location.

2 . The delivery system of claim 1 , wherein the inner shaft comprises an outer retention ring slideable along the inner shaft and at least one tab, wherein the at least one tab is moveable between a radially flared position and a radially compressed position, wherein when the at least one tab is in the radially compressed position, the outer retention ring can slide over the at least one tab, and wherein when the at least one tab is in the radially flared position, the outer retention ring is prevented from moving proximally over the at least one tab.

3 . The delivery system of any one of claim 1 , wherein the delivery system further comprises a steerable sheath surrounding the outer sheath assembly, wherein the steerable sheath comprises a plurality of circumferential slots, a proximal pull wire attached at a proximal bend location, and a distal pull wire attached at a distal bend location, wherein a proximal force on the proximal pull wire forms a first bend at the proximal bend location and a proximal force on the distal pull wire forms a second bend at the distal bend location, and wherein when a proximal force is applied to the distal pull wire, the delivery system is only bent at the second bend location.

4 . The delivery system of claim 3 , wherein the steerable sheath comprises a pair of pull wires, wherein the pair of pull wires are circumferentially spaced apart at a proximal end portion of the steerable sheath and are circumferentially adjacent at a distal end portion of the steerable sheath.

5 . The delivery system of claim 4 , further comprising a third pull wire located circumferentially between the pair of pull wires at the proximal end portion, wherein the third pull wire meets the pair of pull wires in the distal end portion.

6 . The delivery system of claim 3 , wherein the steerable sheath comprises a pair of pull wires, wherein the pull wires are circumferentially adjacent at a proximal end portion of the steerable sheath and are circumferentially spaced apart at a distal end portion of the steerable sheath.

7 . The delivery system of claim 1 , wherein the outer sheath assembly comprises an axial runner containing a pull wire having an untensioned configuration and a tensioned configuration, wherein the outer sheath assembly can bend when the pull wire is in the untensioned configuration and wherein the outer sheath assembly cannot bend when the pull wire is in the tensioned configuration.

8 . The delivery system of claim 1 , wherein the outer sheath assembly comprises a helical backbone having a plurality of circumferentially extending slots along a length of the outer sheath assembly, wherein the helical backbone is longitudinally thicker at a first circumferential portion than at a second circumferential portion, and wherein the first circumferential portion is approximately a first circumferential half and the second circumferential portion is approximately a second circumferential half.

9 . The delivery system of claim 1 , wherein the outer sheath assembly comprises a pull wire, wherein the pull wire extends longitudinally straight at a proximal portion of the outer sheath assembly, and wherein the pull wire extends distally and circumferentially at a distal portion of the outer sheath assembly.

10 . The delivery system of claim 1 , wherein the outer sheath assembly comprises a longitudinally extending slot on at least a portion of an inner surface of the outer sheath assembly, and wherein the inner retention member comprises a tab configured to mate with and follow along the longitudinally extending slot.

11 . The delivery system claim 1 , wherein the inner retention member comprises a plurality of longitudinally extending slots, and wherein the inner retention member comprises a plurality of rotatable flaps each configured to rotatably cover one of the plurality of longitudinally extending slots.

12 . The delivery system of claim 1 , wherein the outer sheath assembly further comprises an outer retention ring configured to cover the inner retention member, wherein the outer retention ring is attached to the outer sheath assembly with at least one suture, wherein an initial retraction of the outer sheath assembly uncovers the inner retention member from the outer sheath assembly while the outer retention ring remains over the inner retention member, and wherein further proximal retraction of the outer sheath assembly provides tension on the at least one suture to uncover the inner retention member from the outer retention ring.

13 . The delivery system of claim 1 , wherein the outer sheath assembly comprises a distal section having a plurality of longitudinally spaced apart circumferential rings.

14 . The delivery system of claim 1 , wherein a distal end of the outer sheath assembly comprises a capsule forming the implant retention area, the capsule having an outer polymer layer, a high melting temperature polymer layer radially inwards of the outer polymer layer, a metal layer radially inwards of the high melting temperature polymer layer, and a liner radially inwards of the metal layer, wherein the high temperature polymer layer comprises a polymer layer having a melting temperature of at least 150° C.

15 . 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; 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 rail assembly located within the inner lumen, the rail assembly comprising a rail shaft having a 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 configured to provide an axial force on the rail shaft to steer the rail assembly; and a nose cone assembly located within the rail lumen, the nose cone assembly comprising a nose cone shaft having a guide wire lumen and a proximal and distal end.

16 . The delivery system of claim 15 , wherein the outer shaft comprises a series of slots that rotate around a circumference of the outer shaft from a proximal end to a distal end.

17 . The delivery system of claim 15 , further comprising 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

Assignees

• Edwards Lifesciences Corp

Inventors

• Landon David Robert
• Cooper Alexander H
• Sanchez Julio Cesar
• Rabito Glen T
• Wu Victoria Cheng-Tan
• Golemo Kevin M
• Ratz J Brent
• Gutierrez Tarannum Ishaq
• Aguilar Jr Ramon
• Scheinblum Taylor Jacob
• Stewart Kevin M
• Johnson Garrett Dallas
• Edwards Jesse Robert
• Luong Hieu Minh
• Lam Lindsay

Classifications

• A61F2/9517

  handle assemblies therefor · CPC title

• A61M25/005

  with embedded materials for reinforcement, e.g. wires, coils, braids · CPC title

• A61M25/0054

  with regions for increasing flexibility · CPC title

• A61F2/2418

  Scaffolds therefor, e.g. support stents · CPC title

• A61F2/2439 Primary

  Expansion controlled by filaments · CPC title