TRANSAPICAL DELIVERY DEVICE AND METHOD OF USE

• US 20110106246A1
• Filed: 08/27/2010
• Published: 05/05/2011
• Est. Priority Date: 08/28/2009
• Status: Active Grant

• Current Assignee: Medtronic 3F Therapeutics, Inc. (Medtronic Plc)
• Original Assignee: Medtronic 3F Therapeutics, Inc. (Medtronic Plc)
• Inventors: Weber, Daniel C., Malewicz, Andrzej M., Elizondo, David, Weston, Matthew W.
• Granted Patent: US 9,504,569 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• 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 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument

Abstract

A delivery device for a stented heart valve comprises a handle, an inner catheter shaft extending from the handle and having an enlarged bumper element at a distal end, an outer catheter shaft extending from the handle and slidably coupled around the inner catheter shaft, and a retraction mechanism for controlling longitudinal movement of the outer catheter shaft relative to the inner catheter shaft. The outer catheter shaft includes a generally cylindrical housing at a distal end that is structured to receive the bumper element therein.

Claims

1. A delivery device for a stented heart valve comprising:

a handle;

an inner catheter shaft extending from the handle and having an enlarged bumper element at a distal side;

an outer catheter shaft extending from the handle and slidably coupled around the inner catheter shaft, the outer catheter shaft including a generally cylindrical housing at a distal side that is structured to receive the bumper element therein; and

a retraction mechanism for controlling longitudinal movement of the outer catheter shaft relative to the inner catheter shaft.

2. The delivery device of claim 1, wherein the housing defines a housing lumen sized to slidably receive the bumper element.

3. The delivery device of claim 2, wherein an outer diameter of the bumper element is less than a diameter of the housing lumen and greater than a diameter of a lumen defined by the outer catheter shaft proximal the housing.

4. The delivery device of claim 2, wherein the housing lumen is configured to receive a crimped stented heart valve.

5. The delivery device of claim 1, wherein the retraction mechanism includes a control knob rotatably maintained by the handle and connected to the outer catheter shaft, and further wherein the retraction mechanism is configured such that rotation of the control knob causes the outer catheter shaft to move longitudinally relative to the inner catheter shaft.

6. The delivery device of claim 5, wherein the retention mechanism further includes a threaded sleeve mounted to the outer catheter shaft and threadably connected to the control knob.

7. A system for replacing a native heart valve, the system comprising:

a stented heart valve including a stent maintaining a valve structure; and

a delivery device including;

a handle,

an inner catheter shaft extending from the handle and having an enlarged bumper element at a distal side,

an outer catheter shaft extending from the handle and slidably coupled around the inner catheter shaft, the outer catheter shaft including a generally cylindrical housing at a distal side that is structured to receive the bumper element therein,

a retraction mechanism for controlling longitudinal movement of the outer catheter shaft relative to the inner catheter shaft.

8. The system of claim 7, wherein the outer catheter shaft is transitionable relative to the inner catheter shaft between an extended position and a refracted position, a distal end of the housing being distal the bumper element in the extended position, and further wherein the loaded state includes the outer catheter shaft in the extended position.

9. The system of claim 8, wherein the loaded state includes a first end of the stented heart valve contacting the bumper element.

10. The system of claim 9, wherein the loaded state further includes a second, opposite end of the stented heart valve located adjacent the distal end.

11. The system of claim 8, wherein in the extended position a housing lumen is defined by the housing, the housing lumen having a longitudinal length from the bumper element to the distal end, and further wherein the longitudinal length of the housing lumen is substantially equivalent to a longitudinal length of a stented heart valve.

12. The system of claim 7, wherein the housing defines a housing lumen sized to slidably receive the bumper element.

13. The system of claim 12, wherein an outer diameter of the bumper element is less than a diameter of the housing lumen and greater than a diameter of a lumen defined by the outer catheter shaft proximal the housing.

14. The system of claim 7, wherein the retraction mechanism includes a control knob rotatably maintained by the handle and connected to the outer catheter shaft, and further wherein the retraction mechanism is configured such that rotation of the control knob causes the outer catheter shaft to move longitudinally relative to the inner catheter shaft.

15. The system of claim 14, wherein the retention mechanism further includes a threaded sleeve mounted to the outer catheter shaft and threadably connected to the control knob.

16. A method of delivering a stented heart valve to an implantation site comprising:

receiving a delivery device including an inner catheter shaft having a distal bumper element, an outer catheter shaft having a generally cylindrical housing at a distal end, and a retraction mechanism;

loading a crimped stented heart valve into the housing, the stented heart valve having a control suture that is engaged by an engagement mechanism of the delivery device to apply tension to the control suture and retain the stented heart valve in a crimped configuration;

transapically inserting the delivery device into a heart and positioning the housing at an implantation site;

retracting the outer catheter shaft relative to the inner catheter shaft to expose the stented heart valve within the implantation site; and

manipulating the engagement mechanism to release tension from the control suture to allow for expansion within the implantation site.