Rotational atherectomy device with exchangeable drive shaft and meshing gears

Patent metadata

Field	Value
Publication number	US-9924964-B2
Application number	US-201414477558-A
Country	US
Kind code	B2
Filing date	Sep 4, 2014
Priority date	Jul 25, 2013
Publication date	Mar 27, 2018
Grant date	Mar 27, 2018

Abstract

An atherectomy device with an exchangeable drive shaft is disclosed, having a drive shaft gear at a distal end of the exchangeable drive shaft for meshing engagement with a prime mover gear on the output shaft of the prime mover. The exchangeable drive shaft is inserted into an opening at the distal end of the handle housing and moved axially in a proximal direction. Surface features on at least the prime mover housing and the engageable drive shaft help to align the drive shaft gear with the prime mover gear for meshing engagement.

First claim

What is claimed is:

1. A system, comprising:
a handle, comprising:
a distal section having a distal end and a channel extending proximally from an opening in the distal end of the handle;
a prime mover disposed therewithin; and
a prime mover gear fixedly attached to a shaft of the prime mover;

an exchangeable drive shaft cartridge, comprising:
a drive shaft comprising an abrading element disposed proximate a distal end thereof;
a gear engagement assembly comprising a drive shaft gear fixedly attached to the drive shaft proximate a proximal end thereof; and
a first data module comprising one or more characteristics of the drive shaft cartridge;

a processor operatively coupled with the prime mover;
a second data module operatively coupled with the processor;
wherein the opening in the distal end of the handle and the channel extending proximally therefrom are configured for passage therethrough of at least a portion of the exchangeable drive shaft cartridge, whereby the drive shaft gear is moved toward the prime mover gear during loading and away from the prime mover gear during unloading;
one or more alignment elements for aligning the prime mover gear and the drive shaft gear with one another; and
one or more connectors for removably connecting the handle and the drive shaft cartridge with one another;
wherein, removably connecting the handle and the drive shaft cartridge:
meshes the prime mover gear and the drive shaft gear to operatively couple the prime mover and the drive shaft; and
operatively couples the processor and the first data module.

2. The system of claim 1 , wherein the processor and the prime mover are operatively coupled by near field communications, one or more radio frequency identification tags, wired communications, or wireless communications.

3. The system of claim 1 , wherein the processor and the first data module are operatively coupled by near field communications, one or more radio frequency identification tags, wired communications, or wireless communications.

4. The system of claim 1 , wherein the processor and the second data module are operatively coupled by near field communications, one or more radio frequency identification tags, wired communications, or wireless communications.

5. The system of claim 1 , wherein the second data module is operatively coupled to one or more servers by near field communications, one or more radio frequency identification tags, wired communications, or wireless communications.

6. The system of claim 1 , wherein:
the one or more characteristics of the drive shaft cartridge includes at least an identity thereof; and
the processor accesses one or more operational parameters for the drive shaft cartridge from the second data module.

7. The system of claim 6 , wherein the one or more operational parameters comprise:
an allowable time for which the abrading element can be used; and
one or more permitted speeds for the prime mover, the one or more permitted speeds selected from the group consisting of continuously variable speeds and a plurality of discrete speeds.

8. The system of claim 7 , comprising a user interface operatively coupled with the processor for:
displaying the one or more operational parameters to an operator; and
enabling the operator to select an operating speed from the one or more permitted speeds for the prime mover.

9. The system of claim 8 , wherein the processor and the user interface are operatively coupled by near field communications, one or more radio frequency identification tags, wired communications, or wireless communications.

10. The system of claim 8 , comprising one or more speed sensors for monitoring an actual speed of the prime mover, wherein the processor:
modulates a speed of the prime mover so as to maintain the actual speed proximate the operating speed selected by the operator;
tracks a total time for each operating speed whereat the abrading element is used;
tracks a cumulative time for which the abrading element is used; and
inhibits the drive shaft cartridge from being used when the cumulative time is equal to or greater than the allowable time.

11. The system of claim 10 , wherein the processor updates the second data module with usage statistics comprising one or more of the cumulative time and the total time for each operating speed.

12. The system of claim 10 , wherein the one or more operational parameters comprises monitoring and operating the system including one or more of the prime mover, the drive shaft, the drive shaft cartridge, and the handle.

13. The system of claim 12 , comprising:
a liquid reservoir; and
a pump operatively coupled with the processor and in fluid communication with both the liquid reservoir and the handle;
wherein, the processor operates the pump to supply liquid from the liquid reservoir to the handle.

14. The system of claim 13 , wherein the one or more operational parameters comprises changing a flow rate of the liquid in response to a change in the operating speed selected by the operator.

15. The system of claim 1 , comprising an enunciator operatively coupled with the processor, wherein the processor monitors the system and enunciates anomalies.

16. The system of claim 1 , wherein the processor updates at least one of the first data module and the second data module to inhibit the drive shaft cartridge from being used more than once.

17. The system of claim 1 , wherein the processor inhibits the handle from being used if the drive shaft cartridge is not compatible for use with the handle.

18. The system of claim 1 , wherein the second data module comprises one or more operational parameters for each of one or more drive shaft cartridges compatible for use with the handle.

19. The system of claim 1 , comprising an inventory of drive shaft cartridges, wherein the processor updates the inventory.

20. The system of claim 1 , wherein the processor accesses one or more operational parameters for the drive shaft cartridge from the first data module, the one or more operational parameters comprising:
an allowable time for which the abrading element can be used; and
one or more permitted speeds for the prime mover, the one or more permitted speeds selected from the group consisting of continuously variable speeds and a plurality of discrete speeds.

21. The system of claim 20 , comprising a user interface operatively coupled with the processor for:
displaying the one or more operational parameters to an operator; and
enabling the operator to select an operating speed from the one or more permitted speeds for the prime mover.

22. The system of claim 21 , comprising one or more speed sensors for monitoring an actual speed of the prime mover, wherein the processor:
modulates a speed of the prime mover so as to maintain the actual speed proximate the operating speed selected by the operator;
tracks a total time for each operating speed whereat the abrading element is used;
tracks a cumulative time for which the abrading element is used; and
inhibits the drive shaft cartridge from being used when the cumulative time is equal to or greater than the allowable time.

23. The system of claim 22 , wherein the processor updates the second data module with usage statistics comprising one or more of the cumulative time and the total time for each operating speed.

24. The system of claim 22 , comprising:
a liquid reservoir; and
a pump operatively coupled wit

Assignees

• Cardivascular Systems

Inventors

• Karasti Kraig A
• Rydberg Nicholas W
• Narveson Christopher M
• Smith Gregory H

Classifications

• A61B2017/00991

  Telescopic means · CPC title

• A61B2017/00477

  Coupling (A61B2017/0046 takes precedence) · CPC title

• A61B90/98

  using electromagnetic means, e.g. transponders · CPC title

• A61B2017/00022

  Sensing or detecting at the treatment site · CPC title

• A61B2017/0046

  with a releasable handle; with handle and operating part separable · CPC title