Delivery Catheter With Distal Moving Capsule for Transapical Prosthetic Heart Valve Delivery

• US 20140031922A1
• Filed: 07/25/2012
• Published: 01/30/2014
• Est. Priority Date: 07/25/2012
• Status: Active Grant

• Current Assignee: Medtronic Vascular Galway Limited (Medtronic Plc)
• Original Assignee: Medtronic Vascular Galway Limited (Medtronic Plc)
• Inventors: Duffy, Niall, Rogers, Ronan, Gallagher, John, Kenny, Gavin
• Granted Patent: US 9,271,856 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• 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 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9665 with additional retaining means

Abstract

Heart valve delivery systems and methods of delivering and implanting heart valves using delivery catheters are disclosed. The delivery systems can include a handle assembly with a rotatable control knob and a catheter including an introducer shaft, an intermediate shaft extending from the handle assembly, an inner shaft extending from the handle assembly, and a capsule for containing a prosthesis. The distal end of the capsule can be connected to a distal end of the inner shaft, which can be moved in a distal direction by the rotatable control knob to deploy the prosthesis. By advancing the introducer through the deployed prosthesis and retracting the capsule to mate with the introducer, a smooth profile can be created for retraction of the system through the deployed prosthesis, minimizing hang-ups and snagging.

Claims

1. A prosthesis delivery system comprising:

a handle assembly including a rotatable control knob;

an intermediate shaft extending from the handle assembly and having an interior lumen;

an introducer shaft having an interior lumen and an introducer tip, wherein the introducer shaft is connected to a hub secured to the intermediate shaft and configured to slide in a proximal and distal direction along the intermediate shaft;

an inner shaft extending from the handle assembly and configured to be moved in a proximal and distal direction by the rotatable control knob; and

a capsule including a proximal end, a distal end and a capsule tip, wherein the distal end of the capsule is connected to a distal end of the inner shaft, and wherein the capsule is configured to contain a prosthesis device.

2. The prosthesis delivery system of claim 1, further comprising a prosthesis retaining element connected to a distal end of the intermediate shaft and having an interior lumen.

3. The prosthesis delivery system of claim 2, wherein the prosthesis retaining element comprises a distal cylindrical surface and at least one protrusion or indentation located at a proximal end of the retaining element and configured to correspond to a retaining element on a prosthesis device.

4. The prosthesis delivery system of claim 1, wherein the capsule further comprises a stiffening ring located at the proximal end of the capsule.

5. The prosthesis delivery system of claim 1, further comprising a plurality of spacer beads having an interior surface and an exterior surface, wherein the interior surface of the spacer beads contact an exterior surface of the intermediate shaft, and wherein the exterior surface of the spacer beads contact an interior surface of the introducer shaft.

6. The prosthesis delivery system of claim 1, further comprising an interior shaft including a flared distal tip.

7. The prosthesis delivery system of claim 6, further comprising a locking mechanism configured to prevent movement of the introducer shaft in relation to the second intermediate shaft when in a locked position.

8. The prosthesis delivery system of claim 7, further comprising a release mechanism located on an exterior of the introducer shaft, wherein pressing the release mechanism releases the introducer shaft from the locked position.

9. The prosthesis delivery system of claim 1, wherein the hub further comprises at least one release tab, wherein pressing the release tab allows the hub to slide in the proximal and distal directions along the intermediate shaft.

10. The prosthesis delivery system of claim 1, wherein the handle further comprises a safety latch configured to limit a distance the inner shaft can be retracted in the proximal direction.

11. A method of implanting a prosthesis in a body lumen using a catheter, the catheter comprising:

a handle assembly including a rotatable control knob;

an intermediate shaft extending from the handle assembly and having an interior lumen;

an introducer shaft having an interior lumen and an introducer tip, wherein the introducer shaft is connected to a hub secured to the intermediate shaft and configured to slide in a proximal and distal direction along the intermediate shaft;

an inner shaft extending from the handle assembly and configured to be moved in a proximal and distal direction by the rotatable control knob; and

a capsule including a proximal end, a distal end and a capsule tip, wherein the distal end of the capsule is connected to a distal end of the inner shaft, and wherein the capsule is configured to contain a prosthesis device;

the method comprising;

inserting the catheter into a body lumen;

advancing the catheter to a deployment location;

advancing the capsule distally to deploy the prosthesis device;

advancing the introducer shaft through the deployed prosthesis device until the introducer tip engages the proximal end of the capsule;

retracting the catheter proximally through the deployed prosthesis device; and

removing the catheter from the body lumen.

12. The method of claim 11, further comprising:

retracting the capsule proximally after advancing the introducer shaft through the deployed prosthesis device to mate the proximal end of the capsule with the introducer tip.

13. The method of claim 11, wherein advancing the capsule distally and retracting the capsule proximally comprises rotating the control knob on the handle assembly.

14. The method of claim 11, wherein advancing the introducer shaft through the deployed prosthesis device comprises sliding the hub distally along the intermediate shaft.

15. The method of claim 11, wherein the catheter is inserted through an apex of a heart.

16. The method of claim 15, wherein the catheter is advanced until a stiffening ring located at the proximal end of the capsule is lined up with a basal plane of an aortic valve.

17. The method of claim 11, further comprising proximally retracting the introducer shaft to expose a flared tip of a second intermediate shaft after advancing the introducer shaft through the deployed prosthesis device.

18. The method of claim 17, wherein the introducer shaft engages at least one locking clip located on the second intermediate shaft after being retracted to prevent distal or proximal movement of the introducer shaft.

19. The method of claim 11, wherein the capsule is advanced distally until a stiffening ring located at the proximal end of the capsule engages a prosthesis retaining element connected to a distal end of the intermediate shaft.

20. The method of claim 11, wherein the prosthesis device is a self-expandable heart valve prosthesis.