System and method for loading a leadless pacemaker onto a catheter-based delivery system

Patent metadata

Field	Value
Publication number	US-10926093-B2
Application number	US-201715497675-A
Country	US
Kind code	B2
Filing date	Apr 26, 2017
Priority date	May 5, 2016
Publication date	Feb 23, 2021
Grant date	Feb 23, 2021

Abstract

A device for loading a leadless pacemaker onto a catheter-based delivery system includes a distal portion and a proximal portion. The distal portion includes a retention feature configured to receive the leadless pacemaker. The proximal portion is proximal the distal portion and includes a funneling structure opening toward the retention feature. The distal and proximal portions of the device are configured such that, when a distal end of the catheter-based delivery system is brought towards the proximal portion of the loading device and the leadless pacemaker is retained by the retention feature, the funneling structure guides features of the distal end of the catheter-based delivery system through an opening in an attachment feature located at a proximal end of the leadless pacemaker.

First claim

What is claimed is:

1. A device for loading a leadless pacemaker onto a catheter-based delivery system, the device comprising:
a first part having a first cavity;
a second part having a second cavity, wherein the first cavity and the second cavity combine in a closed condition to form
a distal portion having a volume including a neck subvolume between a distal subvolume and a proximal subvolume, wherein a diameter of the neck subvolume is less than a diameter of the proximal subvolume and a diameter of the distal subvolume, and
a proximal portion proximal to the distal portion and having a funnel tapering distally to narrow from a proximal opening to a distal opening between the funnel and the proximal subvolume; and

a hinge directly coupling the first part to the second part distal to the funnel such that the first part and the second part pivot to transition the device between the closed condition and an open condition, wherein the funnel separates at the proximal opening when the device is in the open condition.

2. The device of claim 1 , wherein the distal opening has a distal opening diameter smaller than the diameter of the proximal subvolume.

3. The device of claim 2 , wherein the funnel is configured to guide one or more tethers of the catheter-based delivery system through the distal opening into the volume.

4. The device of claim 2 , wherein the distal subvolume is configured to receive a housing of the leadless pacemaker and the proximal subvolume is configured to receive an attachment feature of the leadless pacemaker.

5. The device of claim 4 , wherein the neck subvolume opens into the distal subvolume and the proximal subvolume.

6. The device of claim 2 , wherein the volume is configured to receive the leadless pacemaker, and wherein the device includes a stop surface to prevent the leadless pacemaker from displacing relative to the volume once received in the volume.

7. The device of claim 2 , wherein the volume is configured to receive the leadless pacemaker, and wherein the device includes stop features that interface with the leadless pacemaker to prevent the leadless pacemaker from displacing relative to the volume once received in the volume.

8. The device of claim 2 , wherein the first part and the second part separate in the open condition to receive the leadless pacemaker in the volume, and wherein the first part and the second part join together in an opposed fashion in the closed condition.

9. The device of claim 8 , wherein the funnel includes at least one of a ramp feature or asymmetrical geometry configured to cause the first part and the second part to separate when acted against by a distal docking end of the catheter-based delivery system.

10. The device of claim 2 , wherein the device includes a retainer configured to receive a distal docking end of the catheter-based delivery system, the retainer being distally-proximally displaceable relative to the funnel.

11. The device of claim 10 , wherein the volume is configured to receive the leadless pacemaker, and wherein the funnel is configured to guide distal end features of the catheter-based delivery system through an opening in an attachment feature of the leadless pacemaker when the retainer is displaced towards the funnel when the distal docking end occupies the retainer and the leadless pacemaker occupies the volume.

12. The device of claim 10 , wherein the retainer includes a first retainer portion opposed to a second retainer portion, the first and second retainer portions capable of being separated to receive the distal docking end of the catheter-based delivery system in the retainer, the first and second retainer portions combining to form the retainer when the first and second retainer portions are joined together in an opposed fashion.

13. The device of claim 2 , wherein the funnel has an asymmetric geometry opening into the volume.

14. The device of claim 2 , wherein the funnel has a distally tapering conical geometry, a distally tapering pyramid geometry, or a pair of distally converging opposed surfaces.

15. The device of claim 1 further comprising the catheter-based delivery system, and wherein:
the funnel comprises an interface ring having a ring diameter,
a distal docking end of the catheter-based delivery system has a docking end diameter, and
the ring diameter is substantially the same as the docking end diameter.

16. The device of claim 15 , wherein:
the distal docking end of the catheter-based delivery system is configured to seat in the interface ring,
the interface ring comprising opposed ramps, and
the opposed ramps of the interface ring are configured to force apart the first part and the second part when the distal docking end of the catheter-based delivery system is forced against the opposed ramps.

17. The device of claim 1 , further comprising the catheter-based delivery system including:
a first tether and a second tether configured to extend between the catheter-based delivery system and the leadless pacemaker via the device to cause a tension force,
wherein the funnel comprises sloped ramps,
the first part and the second part are first and second opposed parts, and
the sloped ramps are configured to convert the tension force to a lateral force, thereby separating the first and second opposed parts.

18. The device of claim 1 further comprising a latch to secure the first part to the second part.

19. The device of claim 18 , wherein the latch includes a first latch portion of the first part and a second latch portion of the second part.

20. The device of claim 19 , wherein the first latch portion and the second latch portion interface in a mechanical latching arrangement.

21. The device of claim 19 , wherein the first latch portion and the second latch portion interface in a non-mechanical arrangement.

22. The device of claim 1 , wherein the hinge includes a male pin received in a female hole.

23. The device of claim 1 further comprising the leadless pacemaker in the volume.

Assignees

• Pacesetter Inc

Inventors

• Ho Friedrich
• Eby Thomas B
• Paspa Paul

Classifications

• A61N1/3756 Primary

  Casings with electrodes thereon, e.g. leadless stimulators · CPC title

• A61N1/37518

  Anchoring of the implants, e.g. fixation · CPC title

• A61N1/37205

  Microstimulators, e.g. implantable through a cannula · CPC title

• A61N1/362 Primary

  Heart stimulators (heart defibrillators A61N1/39) · CPC title

• A61B17/3468

  for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069) · CPC title