Delivery system for vascular implant

• US 8,911,455 B2
• Filed: 12/21/2012
• Issued: 12/16/2014
• Est. Priority Date: 10/01/2008
• Status: Active Grant

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Original Assignee: Cardiaq Valve Technologies Incorporated
• Inventors: Quadri, Arshad, Ratz, J. Brent
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): SCHILLINGER, ANN M
• Application Number:
  US13/725,896
• Publication Number:
  US 20130110227A1
• Time in Patent Office: 725 Days
• Field of Search: 623 111- 154
• US Class Current: 606/139
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• 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 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• 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 2230/0067 conical

Abstract

A medical treatment system and method of treatment is described having an implant that can be positioned and deployed, then undeployed to allow repositioning of the implant. The system includes a self-expanding medical implant that longitudinally foreshortens upon radially expanding from a radially compacted state, a distal interface configured to attach the implant to a distal mount of a delivery device, and a proximal interface configured to attach the implant to a proximal mount of the delivery device. Moving the distal mount longitudinally away from the proximal mount applies a longitudinal tension to the implant causing the implant to expand longitudinally and contract radially, and moving the distal mount toward the proximal mount reduces a longitudinal tension in the implant allowing the implant to expand radially toward a fully expanded state.

Claims

1. A method of delivering a self-expanding vascular implant to a native valve, comprising:

delivering a self-expanding vascular implant on a delivery system to the native valve, the delivery system retaining the vascular implant in a radially compacted configuration, wherein the delivery system comprises a ring mounted on an elongate support member, the ring comprising at least one slot, and wherein a suture received in the at least one slot extends from the ring and connects to the implant;

allowing the self-expanding vascular implant to expand, wherein tension on the suture controls expansion of the implant; and

moving at least one of proximal and distal anchors extending from the self-expanding vascular implant into engagement with an annulus of the native valve while the self-expanding vascular implant remains connected to the delivery system, wherein the self-expansion of the vascular implant causes the proximal and distal anchors to extend radially outwardly and to move closer to each other to grasp at least one side of the annulus of the native valve between the distal anchors and proximal anchors.

2. The method of delivering a self-expanding vascular implant of claim 1, further comprising compacting the self-expanding vascular implant after allowing the self-expanding vascular implant to expand.

3. The method of delivering a self-expanding vascular implant of claim 2, further comprising repositioning the implant and allowing for re-expansion of the implant.

4. The method of delivering a self-expanding vascular implant of claim 1, wherein the delivery system retains the vascular implant in a radially compacted configuration by applying tension to the implant.

5. The method of delivering a self-expanding vascular implant of claim 1, wherein the delivery system retains the vascular implant in a radially compacted configuration by restraining the implant within a sheath.

6. The method of delivering a self-expanding vascular implant of claim 1, wherein allowing the self-expanding vascular implant to expand comprises allowing the self-expanding vascular implant to partially expand.

7. The method of delivering a self-expanding vascular implant of claim 6, further comprising allowing the self-expanding vascular implant to further expand after engaging the annulus of the native valve.

8. The method of delivering a self-expanding vascular implant of claim 1, wherein a proximal end of the implant remains connected to the delivery system during expansion of the implant by engaging a portion of the delivery system with a plurality of proximal interfaces on the implant.

9. The method of delivering a self-expanding vascular implant of claim 1, wherein the implant remains connected to the delivery system during expansion of the implant by engaging a portion of the delivery system with a distal end of the implant.

10. A method of delivering a self-expanding vascular implant to a native valve, comprising:

delivering a self-expanding vascular implant on a delivery system to the native valve, the delivery system retaining the vascular implant in a radially compacted configuration, wherein the delivery system comprises a first elongate member having a ring mounted thereon, the ring comprising at least one slot, and a second elongate member extending through the first elongate member having a nose cone at a distal end thereof, wherein a proximal portion of the implant is connected to the at least one slot in the ring and the implant is positioned at least partially between the ring and the nose cone;

allowing the self-expanding vascular implant to expand; and

moving at least one of proximal and distal anchors extending from the self-expanding vascular implant into engagement with an annulus of the native valve such that the proximal anchors are located on a first side of the native valve annulus and the distal anchors are located on a second side of the native valve annulus opposite the first side.

11. The method of delivering a self-expanding vascular implant of claim 10, wherein the ring connected to the proximal portion of the implant during delivery comprises a plurality of longitudinally-extending, circumferentially-spaced slots.

12. The method of delivering a self-expanding vascular implant of claim 10, wherein the delivery system comprises a gap proximal to the plurality of longitudinally-extending, circumferentially-spaced slots.

13. The method of delivering a self-expanding vascular implant of claim 10, wherein the proximal portion of the implant that connects to the at least one slot in the ring during delivery comprises a plurality of spaced apart interfaces.

14. The method of delivering a self-expanding vascular implant of claim 13, wherein the plurality of spaced apart interfaces have a geometry selected from the group consisting of an eyelet, a hook, a radiused or sharp angled triangle element, a block, a sphere and a t-shaped leg.

15. The method of delivering a self-expanding vascular implant of claim 13, wherein the plurality of spaced apart interfaces that connect to the at least one slot in the ring during delivery are provided at a proximal end of the implant.

16. The method of delivering a self-expanding vascular implant of claim 13, wherein the plurality of spaced apart interfaces that connect to the at least one slot in the ring during delivery are provided at an intermediate location on the implant.

17. The method of delivering a self-expanding vascular implant of claim 10, wherein during delivery, the proximal portion of the implant is connected to the at least one slot in the ring with a suture.

18. The method of delivering a self-expanding vascular implant of claim 10, wherein the delivery system further comprises a sheath provided over the implant to radially compact the implant, and wherein allowing the self-expanding vascular implant to expand comprises at least partially removing the sheath from the implant.

19. The method of delivering a self-expanding vascular implant of claim 10, wherein during delivery, the delivery system is connected to a distal portion of the implant.

20. The method of delivering a self-expanding vascular implant of claim 19, wherein during delivery, the delivery system comprises a distal ring comprising a plurality of slots connected to the distal portion of the implant.