Repositionable endoluminal support structure and its applications

• US 10,292,842 B2
• Filed: 05/17/2016
• Issued: 05/21/2019
• Est. Priority Date: 07/21/2008
• Status: Active Grant

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Inventors: White, Jennifer K.
• Primary Examiner(s): Matthews, William H
• Application Number:
  US15/157,337
• Publication Number:
  US 20170020663A1
• Time in Patent Office: 1,099 Days
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2421 with non-pivoting rigid closure members
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2469 with resilient valve members, e.g. conical spiral
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2/94 Stents retaining their form, i.e. not being deformable, after placement in the predetermined place
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0041 using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0004 adjustable
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

An endoluminal support structure includes strut members interconnected by swivel joints to form a series of linked scissor mechanisms. The structure can be remotely actuated to compress or expand its shape by adjusting the scissor joints within a range of motion. In particular, the support structure can be repositioned within the body lumen or retrieved from the lumen. The support structure can be employed to introduce and support a prosthetic valve within a body lumen.

Claims

1. A method of treating a patient, comprising:

controllably expanding a stent in a substantially uniform fashion by applying one or more pairs of first and second axially-opposing forces to struts of the stent, wherein a sum of the one or more pairs of first and second axially-opposing forces is applied asymmetrically around a circumference of the stent; and

applying a rotational force to a rotatable actuator by a rotatable shaft of a catheter, wherein the rotatable actuator is coupled to radially-inwardly facing portions of the struts at a location radially offset from an axially-extending and radially centrally-disposed longitudinal axis of the stent, wherein the rotational force is converted into the one or more pairs of first and second axially-opposing forces by the rotatable actuator.

2. The method of claim 1, further comprising expanding a valve attached to the stent.

3. The method of claim 1, wherein controllably expanding the stent comprises radially expanding the stent and axially foreshortening the stent.

4. The method of claim 3, wherein the one or more pairs of first and second axially-opposing forces are a first pair of axially-opposing forces, wherein a sum of the first pair is applied at a first circumferential location of the stent, wherein the method further comprises controllably compressing the stent in a substantially uniform fashion using a second pair of axially-opposing forces, and wherein a sum of the second pair is applied at a second circumferential location of the stent, the second circumferential location being axially aligned with the first circumferential location along a circumference of the stent, and wherein controllably compressing the stent comprises radially compressing the stent and axially elongating the stent.

5. A method of treating a patient, comprising:

controllably expanding and controllably contracting a stent in a substantially uniform fashion by applying one or more pairs of axial forces to the stent by one or more actuators, each pair of the one or more pairs of axial forces including a proximally-directed force and a distally-directed force, and wherein a sum of the one or more pairs of axial forces is asymmetrically applied around a circumference of the stent by the one or more actuators,

wherein the stent comprises a plurality of pivotably-connected strut members having proximal and distal end portions,

wherein the one or more actuators are coupled to radially-inwardly facing portions of the strut members at locations radially offset from an axially-extending and radially centrally-disposed longitudinal axis of the stent,

wherein controllably expanding the stent includes applying the distally-directed forces to the proximal end portions of the strut members and applying the proximally-directed forces to the distal end portions of the strut members, and

wherein controllably contracting the stent includes applying the proximally-directed forces to the proximal end portions of the strut members and applying the distally-directed forces to the distal end portions of the strut members.

6. The method of claim 5, wherein the strut members are pivotably connected by fasteners.

7. The method of claim 6, wherein the fasteners comprise rivets.

8. The method of claim 5, wherein a first shaft of a delivery apparatus is coupled to a first portion of the one or more actuators, wherein a second shaft of the delivery apparatus is coupled to a second portion of the one or more actuators, and applying the distally-directed forces and the proximally-directed forces comprises causing relative axial movement between the first and second shafts and relative axial movement between the first and second portion of the one or more actuators.

9. The method of claim 5, further comprising:

applying a first rotational force to a rod of the stent by a rotatable shaft of a delivery apparatus to expand the stent; and

applying a second rotational force opposite the first rotational force to the rod of the stent by the rotatable shaft of the delivery apparatus to contract the stent,

wherein the rod applies the proximally-directed forces and the distally-directed forces to the strut members.

10. A method of treating a patient, comprising controllably expanding a stent in a substantially uniform fashion using only one pair of first and second axially-opposing forces applied to struts of the stent by an actuator, the actuator being coupled to the struts, wherein the actuator is disposed radially inwardly relative to the struts and radially offset from an axially-extending and radially centrally-disposed longitudinal axis of the stent, wherein a first axially-opposing force of the one pair of first and second axially-opposing forces is applied to a first axial end portion of the stent at a first circumferential location, and wherein a second axially-opposing force of the one pair of first and second axially-opposing forces is applied to a second axial end portion of the stent at a second circumferential location, the second circumferential location being axially aligned with the first circumferential location along a circumference of the stent.

11. The method of claim 10, wherein the strut members are pivotably connected by fasteners.

12. The method of claim 11, wherein the fasteners comprise rivets.

13. The method of claim 10, wherein the actuator comprises a first shaft and a second shaft, wherein a first end portion the first shaft is coupled to the first axial end portion of a first strut member, wherein a first end portion of the second shaft is coupled to the second axial end portion of a second strut member, wherein second end portions of the first and seconds shafts are movable coupled together, and wherein relative axial movement between the first and second shafts applies the one pair of first and second axially-opposing forces to the struts of the stent.

14. The method of claim 10, wherein the actuator comprises a rotatable rod, and wherein the method further comprises:

applying a first rotational force to the rod by a rotatable shaft of a delivery apparatus to expand the stent; and

applying a second rotational force opposite the first rotational force to the rod of the stent by the rotatable shaft of the delivery apparatus to contract the stent,

wherein the rod applies the proximally-directed forces and the distally-directed forces to the struts of the stent.