Transapical delivery device and method of use

• US 10,258,470 B2
• Filed: 10/28/2016
• Issued: 04/16/2019
• 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:
  US15/337,372
• Publication Number:
  US 20170079794A1
• Time in Patent Office: 900 Days
• 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 method of delivering a stented heart valve to an implantation site comprising:

receiving a delivery device including an inner catheter shaft having a bumper element at a distal terminal end of the inner catheter shaft, an outer catheter shaft slidably coupled around the inner catheter shaft, the outer catheter shaft having a generally cylindrical housing at a distal end that is configured to receive the bumper element and a crimped stented heart valve therein, wherein the outer catheter shaft is longitudinally moveable relative to the inner catheter shaft between an extended position and a retracted position;

loading the crimped stented heart valve into the housing to provide a loaded state, wherein the loaded state includes an entirety of the stented heart valve distal the bumper element, the outer catheter shaft in the extended position, and a control suture connected to and extending from the stented heart valve that is engaged by the delivery device to apply tension to the control suture and retain the stented heart valve in a crimped configuration in the loaded state;

inserting the delivery device in the loaded state 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

releasing tension from the control suture to allow for expansion of the stented heart valve within the implantation site.

2. The method of claim 1, wherein the longitudinal length of the housing is substantially equivalent to a longitudinal length of the bumper element plus the longitudinal length of the stented heart valve.

3. The method of claim 1, wherein the suture extends from the stented heart valve through the inner catheter shaft.

4. The method of claim 1, wherein the stented heart valve abuts the bumper element when loaded into the housing.

5. The method of claim 1, wherein at least a portion of the inner and outer catheter shafts are bendable.

6. The method of claim 1, wherein the delivery device is inserted transapically into the heart.

7. The method of claim 1, wherein the implantation site is an aortic valve.

8. The method of claim 1, wherein the stented valve is radially expandable and collapsible.

9. The method of claim 1, wherein a terminal face of the bumper element defines a distal-most surface of the inner catheter shaft, and further wherein the loaded state includes the entirety of the stented heart valve distal the terminal face.

10. The method of claim 1, wherein the stented heart valve defines an inflow end opposite an outflow end, and further wherein the step of loading includes arranging the stented heart valve within the housing such that the outflow end is distal the inflow end, and even further wherein the step of retracting the outer catheter shaft includes exposing the outflow end prior to exposing the inflow end.

11. The method of claim 1, wherein the stented heart valve includes a replacement valve secured to support posts of a support stent, and further wherein the step of loading includes the tensioned control suture applying a constraining force onto the support stent at a location apart from the support posts.

12. The method of claim 1, wherein the loaded state includes a first level of tension in the control suture, and further wherein the step of releasing tension from the control suture includes:

reducing tension in the control suture from the first level of tension to a second level of tension;

maintaining the second level of tension; and

further reducing tension in the control suture from the second level of tension to a third level of tension.

13. A method of delivering a stented heart valve to an aortic valve annulus comprising:

receiving a delivery device comprising;

an inner catheter shaft having a bumper element at a distal end;

an outer catheter shaft slidably coupled around the inner catheter shaft, the outer catheter shaft having a generally cylindrical housing at a distal end that is configured to receive the bumper element and a crimped stented heart valve therein; and

wherein the outer catheter shaft is longitudinally moveable relative to the inner catheter shaft between an extended position and a retracted position;

loading the crimped stented heart valve into the housing to provide a loaded state, wherein the loaded states includes an entirety of the stented heart valve distal the bumper element, the outer catheter shaft in the extended position, and a control suture connected to and extending from the stented heart valve that is engaged by the delivery device to apply tension to the control suture and retain the stented heart valve in a crimped configuration in the loaded state;

transapically inserting the delivery device in the loaded state into a heart and positioning the housing within the aortic valve annulus;

retracting the outer catheter shaft relative to the inner catheter shaft to expose the stented heart valve within the aortic valve annulus; and

releasing tension from the control suture to allow for expansion of the stented heart valve within the aortic valve annulus.