Inversion Delivery Device And Method For A Prosthesis

• US 20130197629A1
• Filed: 10/22/2012
• Published: 08/01/2013
• Est. Priority Date: 05/16/2011
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: HLT, Inc. (Bracco SPA)
• Inventors: Wilson, Robert F., Czyscon, Joseph S., Thunstrom, Kyle, Gainor, John P., Nelson, Dale K.
• Granted Patent: US 9,522,064 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2002/9534 for repositioning of stents

Abstract

A delivery device usable to deliver an inverting implant is provided that includes a positioning mechanism that automatically initiates the inversion process once a predetermined length of the implant has exited a delivery catheter. The positioning mechanism allows the implant to be safely and accurately deployed with reduced operator experience and in a greater variety of target locations.

Claims

1. A delivery system for an invertible device comprising:

a delivery catheter;

a pusher catheter slidably disposed within said delivery catheter;

a positioning mechanism releasably connecting an invertible device to said delivery system;

wherein during advancement of said invertible device out of said delivery catheter, said positioning mechanism initiates inversion of said implant by preventing further advancement of a distal portion of said invertible device.

2. The delivery system of claim 1, wherein said positioning mechanism further comprises at least one tether.

3. The delivery system of claim 2, wherein said are at least one tether is connected to said pusher catheter.

4. The delivery system of claim 2, wherein said are at least one tether is connected to a delivery sheath of said delivery catheter.

5. The delivery system of claim 2, wherein said are at least one tether is connected to a middle region of said invertible device.

6. The delivery system of claim 2, wherein said at least one tether is connected to a distal region of said invertible device.

7. The delivery system of claim 2, wherein said at least one tether has a first end that is selectively releasable from said positioning mechanism.

8. The delivery system of claim 7, further comprising a tether release mechanism that selectively engages and releases said first end of said at least one tether.

9. A delivery system for an invertible device comprising:

a delivery catheter;

a pusher catheter slidably disposed within said delivery catheter;

a positioning mechanism releasably connecting an invertible device to said delivery system;

said positioning mechanism limiting distal movement of said invertible device during an implant inversion procedure.

10. The delivery device of claim 9, wherein said positioning mechanism comprises at least one tether that is connected near a distal end of said invertible device and to said delivery catheter.

11. The delivery device of claim 9, wherein said positioning mechanism comprises at least one tether that is connected to said invertible device and to said delivery catheter.

12. The delivery device of claim 9, further comprising a plurality of attachment cables that are releasably connected to a proximal end of said invertible device.

13. The delivery device of claim 9, wherein positioning mechanism further comprises:

an outer sheath having a first slot; and

,

a sliding member located within said outer sheath and having a depression.

14. The delivery device of claim 13, wherein said positioning mechanism comprises at least one tether having an end sized to fit within said depression of said sliding member.

15. A method for inverting an invertible device comprising:

advancing a first predetermined length of an invertible device distally from a delivery catheter;

limiting distal movement of said predetermined length of said invertible device; and

,

distally advancing a second predetermined length of said invertible device from said catheter so as to invert said second predetermined length into said first predetermined length.

16. The method of claim 15, wherein said limiting distal movement of said predetermined length of said invertible device is performed with a at least one tether.

17. The method of claim 16, further comprising releasing said positioning mechanism from said invertible device.

18. The method of claim 15, wherein said limiting distal movement of said predetermined length of said invertible device further comprises tensioning at least one tether connected to said invertible device.

19. The method of claim 18, further comprising releasing a first set of ends of said at least one tether.

20. The method of claim 19, further comprising releasing a plurality of attachment cables from said invertible device.

21. A method of delivering a support structure to a target site comprising:

positioning a distal end of a delivery catheter at said target site;

retracting proximally said distal end of said delivery catheter to expose a predetermined length of a support structure;

advancing a proximal end of said support structure distally while preventing distal advancement of a distal end of said support structure, thereby causing a proximal portion of said support structure to invert into said predetermined length;

releasing said support structure.

22. A device for delivering a support structure to a target site comprising:

a delivery catheter adapted to house a support structure;

an advancement mechanism capable of axially advancing said support structure through said delivery catheter;

a stop mechanism capable of preventing advancement of a distal portion of said support structure past a predetermined distance distal of a distal end of said delivery catheter;

a release mechanism for releasing said support structure.

23. A delivery system for an invertible device comprising:

a delivery catheter;

a pusher catheter slidably disposed within said delivery catheter;

a positioning mechanism releasably connecting an invertible device to said delivery system;

wherein during advancement of said invertible device out of said delivery catheter, said positioning mechanism enables inversion of said implant by preventing further advancement of a distal portion of said invertible device.

24. The delivery system of claim 23, wherein said positioning mechanism further comprises at least one tether.

25. The delivery system of claim 24, wherein said at least one tether is connected to said pusher catheter.

26. The delivery system of claim 24, wherein said at least one tether is connected to a delivery sheath of said delivery catheter.

27. The delivery system of claim 24, wherein said at least one tether is connected to a middle region of said invertible device.

28. The delivery system of claim 24, wherein said at least one tether is connected to a distal region of said invertible device.

29. The delivery system of claim 24, wherein said at least one tether has a first end that is selectively releasable from said positioning mechanism.

30. The delivery system of claim 29, further comprising a tether release mechanism that selectively engages and releases said first end of said at least one tether.

31. A method of delivering a support structure to a target site comprising:

positioning a distal end of a delivery catheter at said target site;

advancing a support structure relative to said delivery catheter to expose a predetermined length of said support structure;

advancing a proximal end of said support structure distally while preventing advancement of said predetermined length of said support structure, thereby causing a proximal portion of said support structure to invert into said predetermined length;

releasing said support structure.

32. A method for inverting an invertible valve assembly comprising:

advancing a first predetermined length of an invertible valve assembly distally from a delivery catheter;

limiting distal movement of said predetermined length of said invertible valve assembly; and

,

distally advancing a second predetermined length of said invertible valve assembly from said catheter so as to invert said second predetermined length into said first predetermined length;

observing a valve of said valve assembly control blood flow prior to releasing said invertible valve assembly.

33. The method of claim 32, wherein said limiting distal movement of said predetermined length of said invertible valve assembly is performed with at least one tether.

34. The method of claim 33, further comprising releasing said positioning mechanism from said invertible valve assembly.

35. The method of claim 32, wherein said limiting distal movement of said predetermined length of said invertible valve assembly further comprises tensioning at least one tether connected to said invertible valve assembly.

36. The method of claim 35, further comprising releasing a first end of said at least one tether.

37. The method of claim 36, further comprising releasing a plurality of attachment cables from said invertible valve assembly.

38. A method of delivering a valve assembly to a target site comprising:

positioning a distal end of a delivery catheter at said target site;

retracting proximally said distal end of said delivery catheter to expose a predetermined length of a valve assembly;

advancing a proximal end of said valve assembly distally while preventing distal advancement of a distal end of said valve assembly, thereby causing a proximal portion of said valve assembly to invert into said predetermined length;

observing said valve assembly operate in a blood stream to control blood flow;

releasing said valve assembly.

39. A method of delivering a valve assembly to a target site comprising:

positioning a distal end of a delivery catheter at said target site;

advancing a valve assembly relative to said delivery catheter to expose a predetermined length of said valve assembly;

advancing a proximal end of said support structure distally while preventing advancement of said predetermined length of said support structure, thereby causing a proximal portion of said support structure to invert into said predetermined length;

observing said valve assembly operate in a blood stream to control blood flow;

releasing said support structure.