Surgical delivery device and method of use

• US 10,531,955 B2
• Filed: 12/16/2016
• Issued: 01/14/2020
• 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., Elizondo, David, Weston, Matthew W.
• Primary Examiner(s): Anderson, Gregory A
• Application Number:
  US15/381,146
• Publication Number:
  US 20170095330A1
• Time in Patent Office: 1,124 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 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: B25B 27/10 inserting fittings into hoses

Abstract

A delivery device for a stented heart valve comprises a handle, an elongate shaft extending from a distal end of the handle, and a conical housing having a proximal end coupled to the elongate shaft and an open distal end, the conical housing having a conical lumen therein with a first internal diameter adjacent to the proximal end of the conical housing and a larger second internal diameter adjacent to the open distal end of the conical housing.

Claims

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

an elongate shaft;

a handle coupled to a proximal end of the shaft;

a housing coupled to a distal end of the shaft, the housing having a housing lumen and an open distal end configured for retaining a proximal portion of a stented heart valve in a radially crimped configuration, wherein the shaft includes a shaft lumen configured to provide a pathway between the housing lumen and the handle; and

an engagement mechanism operably coupled to the handle and configured to apply tension to an elongate member, the elongate member configured for retaining a distal portion of the stented heart valve in a radially crimped configuration, the elongate member passing through the housing and shaft lumens and extending from the engagement mechanism to the stented heart valve;

wherein the engagement mechanism has an engaged configuration and a disengaged configuration and the engagement mechanism includes a trigger projecting through and to an outside of the handle for moving the engagement mechanism between the engaged configuration and the disengaged configuration, further wherein the engagement mechanism includes a first elongate gripper and a second elongate gripper, wherein the first and second elongate grippers both selectively clamp the elongate member to transition between the engaged configuration and the disengaged configuration, wherein the first elongate gripper is on the trigger and the second elongate gripper is on the handle.

2. The delivery device of claim 1, wherein the housing lumen has a first internal diameter at a proximal end and a larger second internal diameter at the open distal end, wherein the housing lumen has a constant tapering diameter from the first internal diameter to the second internal diameter;

wherein first internal diameter of the housing lumen is larger than a diameter of the shaft lumen.

3. The delivery device of claim 1, wherein the housing is formed from a transparent material.

4. The delivery device of claim 1, wherein the elongate member is a suture.

5. The delivery device of claim 1, wherein the trigger is pivotally coupled to a pivot pin attached to the handle.

6. The delivery device of claim 1, wherein the second elongate gripper is fixed relative to the handle and the first elongate gripper is movable relative to the second elongate gripper between an engaged configuration and a disengaged configuration.

7. The delivery device of claim 1, further comprising at least one torsion spring operably coupled to the trigger, the torsion spring biasing the engagement mechanism in the engaged configuration.

8. The delivery device of claim 1, further comprising a retention assembly operable to lock the engagement mechanism in the disengaged configuration.

9. The delivery device of claim 8, wherein the retention assembly includes a coil spring and a retention pin structured to be received within a retention pin slot in a trigger of the engagement mechanism.

10. The delivery device of claim 9, wherein the handle includes a mating slot that is structured to receive the retention pin to lock the engagement mechanism in the disengaged configuration.

11. The delivery device of claim 10, further comprising a push button slidably positioned within the mating slot, wherein actuating the push button moves the engagement mechanism from the disengaged configuration back to the engaged configuration.

12. The delivery device of claim 1, wherein terminal ends of the elongate member are tied together to form a continuous loop.

13. The delivery device of claim 1, wherein the distal portion of the stented heart valve is an inflow portion and the proximal portion of the stented heart valve is an outflow portion.

14. The delivery device of claim 1, wherein a distal end of the stented heart valve extends past the housing distal end when a proximal end of the stented heart valve is loaded within the housing lumen.

15. The delivery device of claim 1, wherein the engagement mechanism has an engaged configuration, a partially engaged configuration, and a disengaged configuration.

16. The delivery device of claim 15, wherein the partially engaged configuration releases tension in the elongate member in a controlled manner.

17. The delivery device of claim 1, wherein the engagement mechanism is configured to allow the distal portion of the crimped stented heart valve to re-expand in a controlled manner.

18. The delivery device of claim 1, wherein the elongate member passes between the first and second elongate grippers.

19. A delivery device for a radially expandable stented heart valve comprising:

an elongate shaft;

a handle coupled to a proximal end of the shaft;

a housing coupled to a distal end of the shaft, the housing having a housing lumen and an open distal end configured for retaining a proximal portion of a stented heart valve in a radially crimped configuration, wherein the shaft includes a shaft lumen configured to provide a pathway between the housing lumen and the handle, and

an engagement mechanism operably coupled to the handle and configured to apply tension to an elongate member, the elongate member configured for retaining a distal portion of the stented heart valve in a radially crimped configuration, the elongate member passing through the housing and shaft lumens and extending from the engagement mechanism to the stented heart valve;

wherein the engagement mechanism has an engaged configuration and a disengaged configuration and the engagement mechanism includes a trigger projecting through and to an outside of the handle for moving the engagement mechanism between the engaged configuration and the disengaged configuration, further wherein the engagement mechanism includes a first elongate gripper and a second elongate gripper, wherein the first and second elongate grippers both selectively clamp the elongate member to transition between the engaged configuration and the disengaged configuration,

wherein the first and second elongate grippers are located within the handle.