DELIVERY SYSTEM FOR VASCULAR IMPLANT

• US 20150081009A1
• Filed: 11/24/2014
• Published: 03/19/2015
• Est. Priority Date: 10/01/2008
• Status: Active Grant

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Original Assignee: Cardiaq Valve Technologies Incorporated (Edwards Lifesciences Corporation)
• Inventors: Quadri, Arshad, Ratz, J. Brent
• Granted Patent: US 9,597,183 B2
• Time in Patent Office: Days
• US Class Current: 623/1.12
• 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

1-9. -9. (canceled)

10. A medical treatment system for treating a heart valve, the system comprising:

a delivery device comprising;

a first elongate member having a nose cone at a distal end thereof; and

a second elongate member having a ring mounted thereon, the ring comprising at least one slot, wherein the first elongate member extends through the second elongate member; and

an implant supporting a heart valve body, wherein the implant comprises;

a self-expanding frame;

proximal anchors extending from the frame configured to be positioned on a first side of a native heart valve annulus; and

distal anchors extending from the frame configured to be positioned on a second side of the native heart valve annulus, the second side being opposite the first side;

wherein a proximal portion of the implant is configured to be connected to the at least one slot in the ring;

wherein the implant is configured to positioned at least partially between the ring and the nose cone in a radially compacted configuration during delivery of the implant; and

wherein self-expansion of the frame is configured to cause the proximal anchors and/or the distal anchors to extend radially outward from the frame for engagement with the native heart valve annulus.

11. The system of claim 10, wherein the ring comprises a plurality of longitudinally-extending, circumferentially-spaced slots.

12. The system of claim 11, wherein the delivery device comprises a gap proximal to the plurality of longitudinally-extending, circumferentially-spaced slots.

13. The system of claim 10, wherein the proximal portion of the implant comprises a plurality of spaced apart interfaces configured to connect to the at least one slot in the ring.

14. The system 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 system of claim 13, wherein the plurality of spaced apart interfaces are provided at a proximal end of the implant.

16. The system of claim 13, wherein the plurality of spaced apart interfaces are provided at an intermediate location on the implant.

17. The system of claim 10, wherein the delivery device comprises a suture to connect the proximal portion of the implant with the at least one slot in the ring.

18. The system of claim 10, wherein the delivery device further comprises a sheath configured to be positioned over the implant to radially compact the implant.

19. The system of claim 10, wherein the delivery device is connected to a distal portion of the implant.

20. The system of claim 19, wherein the delivery device comprises a distal ring comprising a plurality of slots configured to connect to the distal portion of the implant.

21. The system of claim 10, wherein self-expansion of the implant is configured to cause 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 proximal anchors and the distal anchors.

22. The system of claim 10, wherein the implant is mounted to the delivery device with the proximal portion of the implant connected to the at least one slot in the ring.

23. The system of claim 10, wherein the implant is covered by a sheath to radially compact the implant.

24. The system of claim 10, wherein the implant is placed under tension when mounted to the delivery device.

25. A medical treatment system for treating a heart valve, the system comprising:

a delivery device comprising;

a first elongate member having a ring mounted thereon, the ring comprising at least one slot; and

a suture received within the at least one slot; and

an implant supporting a heart valve body, wherein the implant comprises;

a self-expanding frame;

proximal anchors extending from the frame configured to be positioned on a first side of a native heart valve annulus; and

distal anchors extending from the frame configured to be positioned on a second side of the native heart valve annulus, the second side being opposite the first side;

wherein the delivery device is configured to retain the implant in a radially compacted configuration;

wherein the implant is configured to be connected to the suture, wherein tension on the suture controls expansion of the implant; and

wherein self-expansion of the frame is configured to cause the proximal anchors and/or the distal anchors to extend radially outward from the frame for engagement with the native heart valve annulus.

26. The system of claim 25, wherein self-expansion of the frame is configured to cause the proximal anchors and the distal anchors 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.

27. The system of claim 25, wherein the delivery device retains the implant in a radially compacted configuration by applying tension to the implant.

28. The system of claim 25, wherein the delivery device further comprises a sheath configured to be positioned over the implant in a radially compacted configuration.

29. The system of claim 25, wherein the delivery device further comprises a second elongate member having a nose cone at a distal end thereof, wherein the second elongate member extends through the first elongate member.

30. The system of claim 29, wherein the implant is configured to be positioned at least partially between the ring and the nose cone in a radially compacted configuration during delivery of the implant.

31. The system of claim 25, wherein the at least one slot is longitudinally extending.

32. The system of claim 25, wherein the suture connects to a proximal portion of the implant.

33. The system of claim 25, wherein the delivery device is configured to retain a distal portion of the implant in a radially compacted shape.

34. The system of claim 33, wherein the delivery device comprises a distal ring comprising a plurality of slots configured to connect to the distal portion of the implant.

35. The system of claim 34, wherein the distal portion of the implant comprises a plurality of spaced apart interfaces configured to connect to the at least one slot in the distal ring.

36. The system of claim 35, 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.

37. The system of claim 34, wherein the implant is mounted to the delivery device with the distal portion of the implant connected to the plurality of slots in the distal ring.

38. The system of claim 37, wherein the implant is covered by a sheath to radially compact the implant.