Delivery system for collapsible heart valve

• US 9,700,411 B2
• Filed: 08/17/2011
• Issued: 07/11/2017
• Est. Priority Date: 08/17/2010
• Status: Active Grant

• Current Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories Incorporated)
• Inventors: Klima, Daniel J., Geiger, Gary W., Thomas, Ralph Joseph, Wang, Huisun
• Primary Examiner(s): Scherbel, Todd J
• Application Number:
  US13/211,486
• Publication Number:
  US 20120078351A1
• Time in Patent Office: 2,155 Days
• Field of Search: 623 21, 623 211
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 2017/00314 Separate linked members
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: Y10T 156/1043 Subsequent to assembly

Abstract

A delivery system for delivering a collapsible prosthetic heart valve includes a valve support structure for supporting a collapsible prosthetic heart valve, and a distal sheath movable in a longitudinal direction relative to the valve support structure between a first position in which the distal sheath is adapted to surround a collapsible prosthetic heart valve supported on the valve support structure, and a second position in which the distal sheath is adapted to expose the collapsible prosthetic heart valve for deployment. The distal sheath is at least partially formed of an inner polymer layer, an outer polymer layer, and a tubular supporting member sandwiched between the inner polymer layer and the outer polymer layer.

Claims

1. A delivery system for delivering a collapsible prosthetic heart valve into a patient, comprising:

a valve support structure for supporting a collapsible prosthetic heart valve; and

a distal sheath movable in a longitudinal direction relative to the valve support structure between a first position in which the distal sheath is adapted to surround a collapsible prosthetic heart valve supported on the valve support structure, and a second position in which the distal sheath is adapted to expose the collapsible prosthetic heart valve for deployment, the distal sheath being at least partially formed of an inner polymer layer, an outer polymer layer, and a tubular supporting member sandwiched between the inner polymer layer and the outer polymer layer, the supporting member having a first longitudinal section and a second longitudinal section and including a plurality of struts extending in a circumferential direction of the supporting member, each of the first and second longitudinal sections being sufficiently flexible that the aortic arch is capable of causing the first and second longitudinal sections to flex to facilitate advancement of the distal sheath into the aortic arch, each strut defining a continuous closed loop having a fixed circumference, the loops being coupled to one another by a plurality of connectors so as to define a plurality of open cells, each of the loops in the second longitudinal section having a selected width in the longitudinal direction and each of the loops in the first longitudinal section having a width in the longitudinal direction which is less than the selected width, the connectors in the second longitudinal section being arranged in four rows oriented substantially orthogonally to the loops with each row being diametrically opposed to another row so that the aortic arch is capable of causing the second longitudinal section to bend in four directions and the first longitudinal section having less than four rows of connectors.

2. The delivery system according to claim 1, wherein the supporting member is made at least in part of a shape memory material.

3. The delivery system according to claim 1, wherein the outer polymer layer includes a polymer selected from the group consisting of nylon, polyether block amide, polyurethane and a combination thereof.

4. The delivery system according to claim 1, wherein the inner polymer layer includes polytetrafluoroethylene.

5. The delivery system according to claim 1, wherein the first longitudinal section is more flexible than the second longitudinal section.

6. The delivery system according to claim 1, wherein the distal sheath has a wall thickness between about 0.005 inches and about 0.015 inches.

7. The delivery system according to claim 1, wherein the inner polymer layer has a higher lubricity than the outer polymer layer.

8. The delivery system according to claim 1, wherein each of the plurality of connectors has a substantially triangular shape.

9. The delivery system according to claim 1, wherein each of the plurality of connectors has an hourglass shape.

10. The delivery system according to claim 1, wherein each of the rows of connectors in the first longitudinal section is aligned in the longitudinal direction with one of the rows of connectors in the second longitudinal section.

11. A delivery system for delivering a collapsible prosthetic heart valve into a patient, comprising:

a valve support structure for supporting a collapsible prosthetic heart valve; and

a distal sheath movable in a longitudinal direction relative to the valve support structure between a first position in which the distal sheath is adapted to surround a collapsible prosthetic heart valve supported on the valve support structure, and a second position in which the distal sheath is adapted to expose the collapsible prosthetic heart valve for deployment, the distal sheath being at least partially formed of an inner polymer layer, an outer polymer layer, and a tubular supporting member sandwiched between the inner polymer layer and the outer polymer layer, the supporting member including a plurality of struts extending in a circumferential direction of the supporting member, each strut having a pair of circumferential edges defining a continuous closed loop having a fixed circumference, the loops being coupled to one another by a plurality of connectors so as to define a plurality of open cells between the edge of one strut and the edge of an adjacent strut, the connectors being arranged in rows oriented substantially orthogonally to the loops, the supporting member having a first longitudinal section and a second longitudinal section, each of the first and second longitudinal sections being sufficiently flexible that the aortic arch is capable of causing the first and second longitudinal sections to flex to facilitate advancement of the distal sheath into the aortic arch, the second longitudinal section having a greater number of rows of connectors than the first longitudinal section, the open cells in both the first longitudinal section and the second longitudinal section being collapsible so that the edge of one strut moves closer in the longitudinal direction to the edge of an adjacent strut to enable the support member to bend in multiple directions in both the first longitudinal section and the second longitudinal section.

12. The delivery system according to claim 11, wherein each strut in the second longitudinal section has a selected width in the longitudinal direction, and each strut in the first longitudinal section has a width in the longitudinal direction which is less than the selected width.