Transapical delivery device and method of use

• US 9,504,569 B2
• Filed: 08/27/2010
• Issued: 11/29/2016
• 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: Malewicz, Andrzej M., Weston, Matthew W., Elizondo, David, Weber, Daniel C.
• Primary Examiner(s): Scherbel, Todd J
• Application Number:
  US12/870,614
• Publication Number:
  US 20110106246A1
• Time in Patent Office: 2,286 Days
• Field of Search: 623/2.11
• US Class Current: 1/1
• 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 that includes 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 terminal end of the inner catheter shaft, wherein a distal-most face of the bumper element defines a central passage and a complete, uninterrupted annular surface defined as an area between the central passage and a maximum outer diameter of the distal-most face of the bumper element, wherein the maximum outer diameter is a complete uninterrupted circle and further wherein the distal-most face is configured to abut the stented heart valve;

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;

wherein the retraction mechanism can move the outer catheter shaft into an extended position and a retracted positon;

wherein, when the outer catheter shaft is in the retracted position, no part of the delivery device is more distal than the distal-most face.

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 retraction 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 terminal end of the inner catheter shaft, wherein the bumper element is configured to interface with the stented heart valve, wherein a distal-most face of the bumper element defines a central passage and a complete, uninterrupted annular surface defined as an area between the central passage and a maximum outer diameter of the distal-most face of the bumper element and further wherein the maximum outer diameter is a complete uninterrupted circle,

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 in an extended position and a retracted position;

wherein, when the outer catheter shaft is in the retracted position, no part of the delivery device is more distal than the distal-most face;

wherein the system provides a loaded state in which the stented heart valve is held in a crimped arrangement within the housing and an entirety of the stented heart valve is distal the bumper element.

8. The system of claim 7, wherein 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 abutting the distal-most face of 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 of the housing.

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 of the housing, 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 retraction mechanism further includes a threaded sleeve mounted to the outer catheter shaft and threadably connected to the control knob.

16. The system of claim 7, wherein the system further includes a suture, and further wherein the loaded state includes the suture extending from the stented heart valve, through the inner catheter shaft, and through the handle.