Inversion delivery device and method for a prosthesis

• US 10,188,517 B2
• Filed: 11/09/2016
• Issued: 01/29/2019
• Est. Priority Date: 05/16/2011
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: HLT, Inc. (Bracco SPA)
• Inventors: Gainor, John P., Wilson, Robert F., Nelson, Dale K., Czyscon, Joseph S., Thunstrom, Kyle
• Primary Examiner(s): Fishback, Ashley
• Application Number:
  US15/347,312
• Publication Number:
  US 20170056173A1
• Time in Patent Office: 811 Days
• 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 method for inverting an invertible device comprising:

advancing a first predetermined length of an invertible device distally from a delivery catheter, thereby establishing a target position;

limiting movement of said first predetermined length of said invertible device, thereby keeping said first predetermined length at said target position; 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.

2. The method of claim 1, wherein said limiting movement of said first predetermined length of said invertible device is performed with at least one tether.

3. The method of claim 2, further comprising releasing said at least one tether from said invertible device.

4. The method of claim 1, wherein said limiting movement of said first predetermined length of said invertible device further comprises tensioning at least one tether connected to said invertible device.

5. The method of claim 4, further comprising releasing a first end of said at least one tether.

6. The method of claim 5, further comprising releasing a plurality of attachment cables from said invertible device.

7. 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, thereby allowing said predetermined length to expand against said target site;

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.

8. 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, thereby allowing said predetermined length to expand against said target site;

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.

9. 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 first 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.

10. The method of claim 9, wherein said limiting distal movement of said first predetermined length of said invertible valve assembly is performed with at least one tether.

11. The method of claim 10, further comprising releasing said at least one tether from said invertible valve assembly.

12. The method of claim 9, wherein said limiting distal movement of said first predetermined length of said invertible valve assembly further comprises tensioning at least one tether connected to said invertible valve assembly.

13. The method of claim 12, further comprising releasing a first end of said at least one tether.

14. The method of claim 13, further comprising releasing a plurality of attachment cables from said invertible valve assembly.

15. 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.

16. 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 valve assembly 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.