Surgical implant devices and methods for their manufacture and use

• US 10,507,097 B2
• Filed: 03/02/2017
• Issued: 12/17/2019
• Est. Priority Date: 07/31/2006
• Status: Active Grant

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Inventors: Cartledge, Richard George, Cartledge, John P.
• Primary Examiner(s): Yabut, Diane D
• Application Number:
  US15/448,417
• Publication Number:
  US 20170172724A1
• Time in Patent Office: 1,020 Days
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2250/0001 Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61F 2250/0004 adjustable
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

Sealable and repositionable implant devices are provided with one or more improvements that increase the ability of implants such as endovascular grafts to be precisely deployed or re-deployed, with better in situ accommodation to the local anatomy of the targeted recipient anatomic site, and/or with the ability for post-deployment adjustment to accommodate anatomic changes that might compromise the efficacy of the implant. A surgical implant includes an implant body and a selectively adjustable assembly attached to the implant body, having adjustable elements, and operable to cause a configuration change in a portion of the implant body and, thereby, permit implantation of the implant body within an anatomic orifice to effect a seal therein under normal physiological conditions.

Claims

1. An assembly, comprising:

an implant body having a stent member and an adjustment member, wherein the stent member is circumferentially expandable and contractible, the adjustment member is coupled to the stent member, and actuating the adjustment member results in circumferential expansion or contraction of the stent member; and

a delivery apparatus having a rotatable shaft and a locking mechanism coupled to an end portion of the shaft, wherein the shaft is configured to actuate the adjustment member of the implant body upon rotation of the shaft, and the locking mechanism is configured to selectively couple the shaft to the adjustment member of the implant body.

2. The assembly of claim 1, wherein the locking mechanism is movable between a first configuration and a second configuration, wherein the locking mechanism engages the adjustment member such that axial movement of the shaft results in corresponding axial movement of the adjustment member when the locking mechanism is in the first configuration, and wherein the locking member disengages the adjustment member such that the shaft can move axially relative to the adjustment member when the locking mechanism is in the second configuration.

3. The assembly of claim 2, wherein, when the locking mechanism is in the first configuration, the locking mechanism engages the adjustment member such that rotational movement of the shaft results in corresponding rotational movement of the adjustment member relative to the stent member, rotating the shaft in a first direction actuates the adjustment member and radially expands the stent member, and rotating the shaft in a second direction actuates the adjustment member and radially contracts the stent member.

4. The assembly of claim 1, wherein the locking mechanism comprises a catch member that engages the adjustment member when the locking mechanism is in the first configuration and that disengages the adjustment member when the locking mechanism is in the second configuration.

5. The assembly of claim 1, wherein the adjustment member has a first portion with a first shape, and wherein the locking mechanism has a second portion with a second shape configured to matably engage the first shape of the first portion.

6. The assembly of claim 1, wherein the adjustment member comprises a jack screw.

7. The assembly of claim 1, wherein the adjustment member comprises a plurality of jack screws distributed circumferentially around the stent member.

8. The assembly of claim 7, wherein the shaft comprises a plurality of shafts, and the locking mechanism comprises a plurality of locking mechanisms, the locking mechanisms are coupled to respective shafts, and the locking mechanisms are configured for selectively coupling the shafts to respective jack screws.

9. An assembly, comprising:

a stent member, wherein the stent member is circumferentially expandable and contractible;

an adjustment member, wherein the adjustment member is coupled to the stent member and configured for circumferentially expanding and contracting the stent member;

a rotatable shaft; and

a locking mechanism coupled to the shaft and movable between a lock configuration and a release configuration,

wherein the locking mechanism is configured to engage the adjustment member such that axial movement of the shaft results in corresponding axial movement of the adjustment member when locking mechanism is in the lock configuration, and

wherein the locking mechanism is configured to disengage the adjustment member such that the shaft can move axially relative to the adjustment member when the locking mechanism is in the release configuration.

10. The assembly of claim 9, wherein the locking mechanism includes a female portion and a catch member, wherein the female portion is configured for receiving a male portion of the adjustment member, and wherein the catch member engages and retains male portion of the adjustment member within the female portion of the locking mechanism when the locking mechanism is the lock configuration.

11. The assembly of claim 10, wherein the locking mechanism is a first locking mechanism, the assembly further comprises a second locking mechanism coupled to the adjustment member and configured for selectively prohibiting adjustment of the adjustment member.

12. The assembly of claim 9, wherein the stent member includes a plurality of bores with interior threads, and the adjustment member includes a jack screw disposed within the bores and having exterior threads configured for threadably engaging the interior threads of the bores.

13. The assembly of claim 12, wherein the plurality of bores includes a first bore and a second bore, wherein rotating the jack screw in a first direction relative to the first and second bores moves the first and second bores axially toward each other, and rotating the jack screw in a second direction relative to the first and second bores moves the first and second bores axially away from each other.

14. An assembly, comprising:

a radially expandable and contractible stent member;

an adjustment member coupled to the stent member and having a rotatable portion, wherein rotating the rotatable member in a first direction relative to the stent member radially expands the stent member, and rotating the rotatable member in a second direction relative to the stent member radially contracts the stent member;

a rotatable shaft; and

a locking mechanism coupled to the shaft and configured to releasably couple the shaft to the adjustment member of the implant body, wherein the locking mechanism includes a lock configuration and a release configuration, wherein, in the lock configuration, axial movement of the shaft results in corresponding axial movement of the adjustment member, and, in the release configuration, the shaft can move axially relative to the adjustment member.

15. The assembly of claim 14, wherein the stent member has a plurality of axially-spaced, threaded bores, wherein the adjustment member has a jack screw disposed within at least some of the threaded bores and have exterior threads corresponding to interior threads of the threaded bores, wherein rotating the jack screw in a first direction relative to the threaded bores moves the threaded bores axially closer together, and rotating the jack screw in a second direction relative to the threaded bores moves the threaded bores axially apart.

16. The assembly of claim 15, wherein the locking mechanism comprises a catch member that engages the jack screw when the locking mechanism is in the lock configuration and that disengages the jack screw when the locking mechanism is in the release configuration.

17. The assembly of claim 16, wherein the adjustment member comprises a plurality of adjustment members, the shaft comprises a plurality of shafts, and the locking mechanism comprises a plurality of locking mechanisms, wherein each of the locking mechanisms is configured to releasably couple one of the shafts to a respective adjustment member.

18. The assembly of claim 17, wherein the jack screw of each adjustment member is circumferentially-spaced relative to an adjacent jack screw.