Catheter-based system for delivery and retrieval of a leadless pacemaker

• US 10,448,973 B2
• Filed: 10/13/2017
• Issued: 10/22/2019
• Est. Priority Date: 10/14/2016
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Inventors: Arnar, Bernhard, Knippel, Bradley, Blue, Jeremiah, Heisel, Jennifer, Stufft, Rebecca, Weber, Adam
• Primary Examiner(s): Nguyen, Vi X
• Application Number:
  US15/783,298
• Publication Number:
  US 20180104449A1
• Time in Patent Office: 739 Days
• CPC Class Codes: A61B 17/32053 Punch like cutting instruments, e.g. using a cylindrical or oval knife A61B17/326 takes precedence; trepans A61B17/1695; for use on the cornea A61F9/007
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/00358 Snares for grasping
• CPC Class Codes: A61B 2017/00407 Ratchet means
• CPC Class Codes: A61M 2025/0024 Expandable catheters or sheaths
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61N 1/362 Heart stimulators heart defibrillators A61N1/39
• CPC Class Codes: A61N 1/37512 Pacemakers
• CPC Class Codes: A61N 1/37518 Anchoring of the implants, e.g. fixation
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

Catheter-based delivery systems for delivery and retrieval of a leadless pacemaker include features to facilitate improved manipulation of the catheter and improved capture and docking functionality of leadless pacemakers. Such functionality includes mechanisms directed to deflecting and locking a deflectable catheter, maintaining tension on a retrieval feature, protection from anti-rotation, and improved docking cap and drive gear assemblies.

Claims

1. A handle for a catheter, the catheter including a deflectable catheter section and a pull wire coupled to the deflectable catheter section, the handle defining a longitudinal axis and comprising:

a housing;

a hub disposed within the housing and coupled to the pull wire;

a deflection lever coupled to the hub and extending from a first side of the housing, the deflection lever movable between a first lever position in which the deflection lever extends away from the longitudinal axis at a first angle and a second lever position in which the deflection lever extends away from the longitudinal axis at a second angle less than the first angle; and

a brake assembly coupled to the hub and rotatable between a first brake position in which the brake assembly applies a first resistance to rotation of the hub and a second brake position in which the brake assembly applies a second resistance to rotation of the hub greater than the first resistance,

wherein movement of the deflection lever from the first lever position to the second lever position rotates the hub, pulling the pull wire to deflect the deflectable catheter section.

2. The handle of claim 1, wherein the lever extends from the housing at least partially in a proximal direction.

3. The handle of claim 1, wherein a moment arm is defined between a center of the hub and an end of the lever, the moment arm having a length from and including 3.00 inches to and including 5.00 inches.

4. The handle of claim 1, wherein the first angle is from and including 50 degrees to and including 60 degrees and the second angle is from and including 0 degrees to and including 25 degrees.

5. The handle of claim 1, wherein the hub comprises a wall extending at least partially around the hub and at least partially guiding the pull wire, the wall being disposed at a radius from and including 0.600 inches to and including 0.900 inches from a center of the hub and having an arc length from and including 0.350 inches to and including 0.550 inches.

6. The handle of claim 1, further comprising a multiplier post about which the pull wire is routed, the multiplier post adapted to remain in a fixed position relative to the housing when the hub is rotated.

7. The handle of claim 1, wherein the brake assembly comprises a brake lever extending from the housing opposite the deflection lever.

8. The handle of claim 7, wherein, when in the first brake position, the brake lever extends at least partially in a proximal direction and rotation of the brake assembly from the first brake position to the second brake position includes rotating the brake assembly in a distal direction.

9. The handle of claim 1, wherein movement of the deflection lever from the first lever position to the second lever position causes rotation of the hub in a first rotation direction and the brake assembly is rotatable between the first brake position and the second brake position by rotating the brake assembly in the first direction.

10. The handle of claim 1, wherein the knob is rotatable from the first brake position to the second brake position by rotating the brake lever in a first direction and movement of the lever between the first lever position and the second lever position causes the hub to rotate in the first direction.

11. A handle for a catheter, the catheter including a deflectable catheter section and a pull wire coupled to the deflectable catheter section, the handle defining a longitudinal axis and comprising:

a housing;

a hub disposed within the housing and coupled to the pull wire;

a deflection lever coupled to the hub and extending from a first side of the housing, the deflection lever movable between a first lever position and a second lever position to deflect the deflectable catheter section; and

a brake assembly comprising;

a knob coupled to the hub and rotatable between a first brake position in which the brake assembly applies a first resistance to rotation of the hub and a second brake position in which the brake assembly applies a second resistance to rotation of the hub that is greater than the first resistance; and

a brake lever coupled to the knob and extending from a second side of the housing opposite the first side.

12. The handle of claim 11, wherein the brake assembly further comprises a hub washer disposed within the housing and rotationally fixed relative to the hub, wherein the first resistance and the second resistance to rotation of the hub results from compression of the hub washer against the housing.

13. The handle of claim 12, wherein the brake assembly further comprises a threaded shaft coupled to the knob and extending through the hub washer, wherein rotation of the knob causes translation of the knob along the shaft and compression of the housing between the knob and the hub washer.

14. The handle of claim 13, wherein the knob is coupled to the threaded shaft by a threaded insert disposed within the knob.

15. The handle of claim 13, wherein the brake assembly further comprises a brake washer disposed between the knob and the housing.

16. The handle of claim 13, wherein the threaded shaft comprises a shaft end that is rotationally fixed within the housing.

17. A system for at least one of delivery or retrieval of an implantable medical device, the system comprising:

a deflectable catheter section;

a pull wire coupled to the deflectable catheter section; and

a handle defining a longitudinal axis, the handle comprising;

a housing;

a hub disposed within the housing and coupled to the pull wire;

a deflection lever coupled to the hub and extending from a first side of the housing, the deflection lever movable between a first lever position and a second lever position to deflect the deflectable catheter section; and

a brake assembly coupled to the hub and rotatable between a first brake position in which the brake assembly applies a first resistance to rotation of the hub and a second brake position in which the brake assembly applies a second resistance to rotation of the hub greater than the first resistance.

18. The system of claim 17, wherein the deflection lever extends from a first side of the housing and the brake assembly comprises a brake lever extending from a second side of the housing opposite the first housing.

19. The system of claim 18, wherein the deflection lever substantially extends in one of a proximal and a distal direction and the brake assembly is movable between the first brake position and the second brake position by applying a force to a brake lever in the distal and proximal direction, respectively.

20. The system of claim 17, wherein the deflectable catheter is biased to passively return to an undeflected state and the brake assembly is rotatable into a third brake position in which sufficient resistance is provided to prevent passive return of the deflectable catheter.