Atraumatic interface in an implant delivery device

• US 10,398,550 B2
• Filed: 09/10/2014
• Issued: 09/03/2019
• Est. Priority Date: 09/12/2013
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Inventors: Chalekian, Aaron J., Thomas, Ralph J., Geiger, Gary W.
• Primary Examiner(s): Stransky, Katrina M
• Assistant Examiner(s): Bachman, Lindsey
• Application Number:
  US15/021,170
• Publication Number:
  US 20160220369A1
• Time in Patent Office: 1,819 Days
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod

Abstract

A delivery device (10) for a collapsible prosthetic heart valve may include an operating handle (20, 220, 320) having a housing (30, 230, 330) and a carriage selectively (40) fixed or movable relative to the housing, and a catheter assembly (16, 116, 216, 416). The catheter assembly may have an inner shaft (26, 126, 226, 326, 426) around which a compartment (23) is defined, an outer shaft (22) surrounding at least a portion of the inner shaft, a distal sheath (24) fixedly connected to the outer shaft, and a mechanism configured to apply a distal force to the outer shaft while the carriage (40) is fixed relative to the housing (30, 230, 330) to stretch the outer shaft from a compressed length to an extended length. The extended length may be greater than the compressed length along an axis of elongation of the outer shaft (22).

Claims

1. A delivery device for a collapsible prosthetic heart valve, the delivery device comprising:

an operating handle having a housing and a carriage selectively fixed or movable relative to the housing; and

a catheter assembly, including;

an inner shaft around which a compartment is defined, the inner shaft being operatively connected to the housing, the compartment being adapted to receive the valve in an assembled condition;

an outer shaft surrounding at least a portion of the inner shaft, the outer shaft being fixedly connected to the carriage and movable relative to the inner shaft and the housing, the outer shaft having a compressed length and an extended length greater than the compressed length along an axis of elongation of the outer shaft;

a distal sheath fixedly connected to the outer shaft, the distal sheath being movable between a closed condition covering the compartment and an open condition uncovering the compartment for deployment of the valve; and

a mechanism configured to apply a distal force to the outer shaft while the carriage is fixed relative to the housing to stretch the outer shaft from the compressed length to the extended length.

2. The delivery device of claim 1, wherein the mechanism includes a pressurized fluid source in communication with a lumen of the outer shaft and a fluid dam having a proximal-facing surface extending circumferentially around the inner shaft adjacent the compartment, the fluid dam being fixedly connected to the outer shaft and having an opening through which the inner shaft extends.

3. The delivery device of claim 2, wherein the fluid dam is a portion of a transition piece that fixedly connects the outer shaft to the distal sheath.

4. The delivery device of claim 2, wherein the fluid dam is a first fluid dam and the opening is a first opening, and the mechanism includes a second fluid dam having a proximal-facing surface located proximally of the first fluid dam and having a second opening through which the inner shaft extends, the second opening having a greater width than the first opening.

5. The delivery device of claim 2, wherein the inner shaft includes a recess configured to provide a region of extra fluid volume within the outer shaft at a location close to the fluid dam.

6. The delivery device of claim 1, wherein the mechanism includes a threaded portion of the inner shaft receivable inside an intermediate portion of a transition piece that fixedly connects the outer shaft to the distal sheath, the threaded portion and the intermediate portion each having threads that are configured to mate with one another.

7. The delivery device of claim 6, wherein the inner shaft is longitudinally fixed relative to the housing, and the operating handle includes an actuator configured to rotate the inner shaft relative to the housing.

8. The delivery device of claim 6, wherein the catheter assembly includes a retainer coupled to the inner shaft within the compartment, the retainer including an inner piece and an outer piece mounted on the inner piece so as to be rotatable about the inner piece and constrained from movement relative to the inner piece along an axis of elongation of the inner shaft, the outer piece having a recess configured to receive a retention member of the valve.

9. The delivery device of claim 1, wherein the mechanism includes a pull wire having a first end fixedly coupled to the outer shaft and a second free end, and the inner shaft includes a fulcrum over which the pull wire extends, the fulcrum being located distally of the first end of the pull wire, the pull wire being configured such that when the second free end is pulled proximally, the distal force is applied to the outer shaft.

10. The delivery device of claim 9, wherein the inner shaft includes first and second lumens therein, and the pull wire extends within the first lumen between the operating handle and an opening adjacent the fulcrum.

11. The delivery device of claim 9, wherein the operating handle further includes a spooling assembly configured to automatically receive excess length of the pull wire as the distal sheath is moved distally.

12. A method of fully enclosing a compartment of delivery device for implanting a medical device in a patient, the method comprising:

providing the delivery device having a catheter assembly and an operating handle, the operating handle having a housing and a carriage selectively longitudinally fixed or movable relative to the housing, the catheter assembly including an inner shaft around which a medical device compartment is defined, an outer shaft surrounding at least a portion of the inner shaft, and a distal sheath fixedly connected to the outer shaft, the distal sheath being movable between a fully closed condition covering the compartment and an open condition uncovering the compartment; and

applying a distal force to the outer shaft while the carriage and the inner shaft are longitudinally fixed relative to the housing, thereby stretching the outer shaft from a compressed length to an extended length greater than the compressed length and moving the distal sheath to the fully closed condition, such that a distal end of the distal sheath contacts a proximally-facing abutment surface of the delivery device.

13. The method of claim 12, further comprising, before the applying step, loading the medical device into the compartment of the catheter assembly and moving the distal sheath from the open condition to a partially closed condition covering a major portion of the compartment, such that the outer shaft is compressed from the extended length to the compressed length.

14. The method of claim 12, further comprising, before the applying step, partially deploying the medical device by sliding the distal sheath to partially uncover the compartment and re-collapsing the medical device by sliding the distal sheath to a partially closed condition covering a major portion of the compartment, such that the outer shaft is compressed from the extended length to the compressed length.

15. The method of claim 14, further comprising, before the partially deploying step, inserting the catheter assembly into the patient so that the medical device is positioned at a target location within the patient.

16. The method of claim 12, wherein the applying step includes flowing a pressurized fluid within the outer shaft and against a proximal-facing surface of a fluid dam fixedly connected to the outer shaft.

17. The method of claim 12, wherein the applying step includes decoupling the inner shaft from the housing and rotating the inner shaft relative to the outer shaft, thereby applying the distal force to a threaded transition piece fixedly connected to the outer shaft.

18. The method of claim 17, wherein the catheter assembly includes a retainer coupled to the inner shaft and having a rotatable portion, the medical device has a retention member engaged within a recess of the retainer, and the medical device remains rotationally fixed relative to the distal sheath and relative to the rotatable portion of the retainer during the rotation of the inner shaft.

19. The method of claim 12, wherein the catheter assembly further includes a pull wire having a first end fixedly coupled to the outer shaft and a second free end, and the inner shaft includes a fulcrum over which the pull wire extends, and the applying step includes pulling the pull wire in a proximal direction, thereby applying the distal force to the outer shaft.

20. The method of claim 19, wherein the pull wire is pulled in the proximal direction by rotating a portion of a spooling assembly coupled to the housing.