Driveable catheter system

• US 6,398,755 B1
• Filed: 05/24/1999
• Issued: 06/04/2002
• Est. Priority Date: 10/06/1998
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Jones, Jeffrey M., Elbert, Arcadi, Roe, Steven N., Belef, W. Martin, Moore, Thomas C., Beyhan, Niyazi, Ream, John H.
• Primary Examiner(s): Dawson, Glenn K.
• Application Number:
  US09/317,778
• Time in Patent Office: 1,107 Days
• Field of Search: 606/108, 606/169, 606/171, 604/95, 604/171, 604/264, 604/164, 604/95.01, 604/164.01, 604/523, 604/528
• US Class Current: 604/95.01
• CPC Class Codes: A61B 1/0016 using motor drive units
• CPC Class Codes: A61B 46/10 specially adapted for instruments, e.g. microscopes
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/4209 by using holders, e.g. positioning frames
• CPC Class Codes: A61B 8/4461 Features of the scanning mechanism, e.g. for moving the transducer within the housing of the probe
• CPC Class Codes: A61M 2025/0008 having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
• CPC Class Codes: A61M 25/0113 Mechanical advancing means, e.g. catheter dispensers

Abstract

The system (2) includes a catheter drive unit (22) and a catheter (24) extending therefrom movably mounted to a catheter drive sled (26). The catheter drive unit rotates and translates the catheter core (34) within the catheter sheath (36). The sled has a serrated, conical drive unit interface (82), with a bag-piercing tip (86) mateable with a translator drive output (92) so that a sterile drape (112) enclosing the catheter drive unit is automatically pierced when the catheter drive unit is mounted to the sled. A control unit (6) is spaced apart from the catheter drive unit and provides power and commands to the catheter drive unit and receives information and data from the catheter drive unit. The rotator and translator drive motors (54, 90) are operated from both the control unit and the catheter drive unit. Both the control unit and catheter drive unit have translation displacement displays (10, 30).

Claims

1. A catheter drive sled, for use with a catheter drive unit, the sled comprising:

a sled base comprising a drive track;

a drive unit adapter movably mounted to the sled base for movement along the drive track, the drive unit adapter configured for removably mounting a catheter drive unit to the sled base;

a sled drive train comprising a drive unit interface operably coupleable to the catheter drive unit and a drive track interface operably coupled to the drive track; and

the drive unit interface comprising a generally conical drive surface.

2. The catheter drive sled according to claim 1 wherein the sled base comprises a raised nose portion.

3. The catheter drive sled according to claim 2 wherein the nose portion comprises a catheter sheath engagement member.

4. The catheter drive sled according to claim 1 wherein the drive track comprises a rack having a plurality of teeth.

5. The catheter drive sled according to claim 1 wherein the sled base comprises a drive track guide and the drive unit adapter comprises a guide element which engages with, is guided by and moves along the drive track guide.

6. The catheter drive sled according to claim 5 wherein the guide element comprises guide rollers.

7. The catheter drive sled according to claim 1 wherein the generally conical drive surface extends outwardly away form the sled base and inwardly to a drape-piercing tip, whereby the drive unit interface is adapted to effectively pierce a sterile drape enclosing the catheter drive unit when the catheter drive unit is mounted to the drive unit adapter.

8. The catheter drive sled according to claim 1 wherein the catheter drive sled is a single use, disposable sled.

9. The catheter drive sled according to claim 8 wherein the catheter drive sled is free from any electrical device.

10. A catheter drive unit, removably mountable to a catheter drive module, comprising:

a housing;

a catheter core rotator within the housing;

a drive unit translator within the housing, the drive unit translator comprising;

a translator drive motor;

a translator drive output; and

a translator drive train operably coupling the translator drive motor and the translator drive output, the translator drive train comprising a user-operable clutch for selectively decoupling the translator motor from the translator drive output; and

a translation displacement sensor located along the translator drive train between the clutch and the translator drive output.

11. The catheter drive unit according to claim 10 further comprising a translation drive ON/OFF button operably coupled to the drive unit translator, wherein the translator drive ON/OFF button is mounted to the housing.

12. The catheter drive unit according to claim 11 further comprising a rotator drive ON/OFF button operably coupled to the catheter core rotator, wherein the rotator drive ON/OFF button is mounted to the housing.

13. The catheter drive unit according to claim 10 further comprising a translation displacement display mounted to the housing and operably coupled to the translation displacement sensor.

14. The catheter drive unit according to claim 13 further comprising a position reset button operably coupled to the translation displacement display.

15. The catheter drive unit according to claim 13 further comprising a position-sensitive switch, actuatable when the catheter drive unit is mounted to and dismounted from a catheter drive module, operably coupled to the translator drive motor and the translation displacement display.

16. The catheter drive unit according to claim 15 wherein the position-sensitive switch comprises a magnetic switch.

17. The catheter drive unit according to claim 10 wherein the catheter drive unit is adapted to be housing within a pierceable sterile draped and the translator drive output comprises a generally conical drive surface.

18. The catheter drive unit according to claim 17 wherein the generally conical drive surface defines a generally conical open region.

19. A catheter drive unit comprising:

a housing;

a catheter core rotator carried by the housing;

a drive unit translator carried by the housing;

a translation displacement display mounted to the housing and operably coupled to the drive unit translator.

20. The catheter drive unit according to claim 19 wherein the drive unit translator comprises a drive train, the drive train comprising a translation displacement sensor operably coupled to the translation displacement display.

21. A driveable catheter system comprising:

a driveable catheter assembly comprising a catheter drive unit and a catheter extending from the catheter drive unit;

the catheter comprising a catheter core rotatable and translatable by the catheter drive unit; and

a control unit spaced-apart from but operably coupled to the driveable catheter assembly, said control unit comprising;

a catheter drive unit power supply; and

a catheter drive unit controller comprising a catheter core rotation speed input and a catheter core translation speed input.

22. A catheter system according to claim 21 wherein the driveable catheter assembly comprises a catheter drive sled, the catheter drive unit removably mountable to the catheter drive sled for translational movement therealong.

23. A catheter system according to claim 22 wherein the catheter drive sled is a single use disposable unit free from any electrical device.

24. A catheter system according to claim 22 wherein:

the catheter drive unit comprises;

a catheter core rotator;

a catheter drive unit translator;

a proximity switch, movable between OFF and ON positions, electrically coupling the catheter drive unit translator to the control unit when in the ON position; and

the catheter drive sled comprising a proximity switch actuator which interacts with and actuates the proximity switch to the ON position when the catheter drive unit is mounted to the catheter drive sled.

25. A catheter system according to claim 21 wherein:

the catheter drive unit comprises a catheter core rotator and a catheter drive unit translator;

the catheter drive unit and the control unit are coupled by a two-way electrical communication link;

the control unit comprises a rotator drive on/off input operably coupled to the catheter core rotator and a translator drive on/off input operably coupled to the catheter drive unit translator;

the catheter drive unit comprises a rotator drive on/off input operably coupled to the catheter core rotator and a translator drive on/off input operably coupled to the catheter drive unit translator;

the control unit comprises a control unit translation displacement display; and

the catheter drive unit comprises a drive unit translation displacement display.

26. A driveable catheter assembly comprising:

a catheter drive sled;

a catheter drive unit removably mountable to the sled;

a catheter comprising a rotatable and translatable catheter core operably coupled to and extending from the catheter drive unit;

the catheter drive unit comprising;

a drive unit translator operably coupled to the sled for selective translational movement of the catheter drive unit and catheter core therewith relative to the sled;

a catheter core rotator operably coupled to the catheter core for selective rotation of the catheter core; and

a proximity switch operably coupled to at least one of the drive unit translator and catheter core rotator; and

the sled comprising a proximity switch actuator which interacts with and actuates the proximity switch when the catheter drive unit is mounted to the sled.

27. The catheter assembly according to claim 26 wherein the proximity switch is a magnetic switch and the proximity switch actuator is a magnet.

28. A driveable catheter system comprising:

a driveable catheter assembly comprising a catheter drive unit, a catheter extending from the catheter drive unit, and a catheter drive sled, the catheter drive unit removably mountable to the catheter drive sled for translational movement therealong;

the catheter drive unit comprising;

a catheter core rotator drivingly coupled to the catheter;

a catheter drive unit translator drivingly coupled to the catheter drive sled;

a rotator drive on/off input operably coupled to the catheter core rotator;

and a translator drive on/off input operably coupled to the catheter drive unit translator; and

a drive unit translation displacement display operably coupled to the catheter drive unit translator;

the catheter comprising a catheter core rotatable by the catheter core rotator and translatable with the catheter drive unit by the catheter drive unit translator; and

a control unit spaced-apart from but operably coupled to the driveable catheter assembly, said control unit comprising;

a rotator drive on/off input operably coupled to the catheter core rotator and a translator drive on/off input operably coupled to the catheter drive unit translator;

a control unit translation displacement display operably coupled to the catheter drive unit translator;

a catheter drive unit power supply electrically coupled to the catheter core rotator and the catheter drive unit translator; and

a catheter drive unit controller comprising a catheter core rotation speed input and a catheter core translation speed input.

29. A catheter system according to claim 28 wherein the catheter drive unit and the control unit are coupled by a two-way electrical communication link.

30. A catheter system according to claim 28 wherein:

the catheter drive unit comprises a proximity switch, movable between OFF and ON positions, electrically coupling the catheter drive unit translator to the control unit when in the ON position; and

the catheter drive sled comprising a proximity switch actuator which interacts with and actuates the proximity switch to the ON position when the catheter drive unit is mounted to the catheter drive sled.

31. A catheter system according to claim 30 wherein the proximity switch is a magnetic switch and the proximity switch actuator comprises a magnet.

32. A method for setting up a catheter drive system comprising:

selecting a catheter drive unit with a catheter extending therefrom, the catheter comprising a rotatable and translatable catheter core, the catheter drive unit comprising a rotator drive motor selectively rotationally coupled to the catheter core, a translator drive motor, and a catheter core drive train having a translator drive output drivingly coupling the translator drive motor and the tranlator drive output, the catheter drive unit being enclosed within a removable drapeable barrier;

mounting the catheter drive unit to a catheter drive sled, the catheter drive sled comprising a drive unit interface configured for mating engagement with the translator drive output; and

said mounting step comprising effectively piercing the drapeable barrier by the engagement of the translator drive output and the drive unit interface.

33. The method according to claim 32 wherein the selecting step is carried out with the drive unit interface having a generally conical drive surface.

34. The method according to claim 33 wherein said selecting step is carried out with the generally conical drive surface comprising a barrier-piercing tip.

35. A method for controlling the use of a driveable catheter assembly of the type comprising a rotatable and translatable catheter core extending from a catheter drive unit, comprising:

setting rotational and translational speeds for the catheter core from a control unit physically remote from but operably coupled to the catheter drive unit; and

selectively controlling starting and stopping of rotational and translational movement of the catheter core from the catheter drive unit and from the control unit.

36. The method according to claim 35 further comprising viewing translation displacement information from displays at the catheter drive unit and the control unit.

37. The method according to claim 36 further comprising resetting the translation displacement information from the catheter drive unit.

38. A method for setting up a catheter drive system comprising:

selecting a catheter drive unit with a catheter extending therefrom, the catheter comprising a rotatable and translatable catheter core, the catheter drive unit comprising a rotator drive motor selectively rotationally coupled to the catheter core, a translator drive motor, and a catheter core drive train having a translator drive output drivingly coupling the translator drive motor and the tranlator drive output, the catheter drive unit being enclosed within a removable drapeable barrier;

mounting the catheter drive unit to a catheter drive sled, the catheter drive sled comprising a drive unit interface configured for mating engagement with the translator drive output; and

said mounting step comprising effectively piercing the drapeable barrier by the engagement of the translator drive output and the drive unit interface;

setting rotational and translational speeds for the catheter core from a control unit physically remote from but operably coupled to the catheter drive unit; and

selectively controlling starting and stopping of rotational and translational movement of the catheter core from the catheter drive unit and from the control unit.

39. The method according to claim 38 further comprising viewing translation displacement information from displays at the catheter drive unit and the control unit.