Interventional catheter assemblies and control systems

• US 8,323,240 B2
• Filed: 04/28/2010
• Issued: 12/04/2012
• Est. Priority Date: 03/10/2003
• Status: Active Grant

• Current Assignee: Boston Scientific Medical Device Limited (Boston Scientific Corporation)
• Original Assignee: Medrad Incorporated (Bayer AG)
• Inventors: Wulfman, Edward I., Torrance, Casey
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): Berdichevsky, Aarti B
• Application Number:
  US12/769,587
• Publication Number:
  US 20110112562A1
• Time in Patent Office: 951 Days
• Field of Search: 604/93.01, 604/95.01, 604/95.05, 604/156, 606/159, 606/167
• US Class Current: 604/95.01
• CPC Class Codes: A61B 17/32002 with continuously rotating, oscillating or reciprocating cutting instruments
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 17/3462 with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals expandable cannulas A61B17/3417
• CPC Class Codes: A61B 2017/00017 Electrical control of surgical instruments
• CPC Class Codes: A61B 2017/00199 with a console, e.g. a control panel with a display
• CPC Class Codes: A61B 2017/00973 pedal-operated
• CPC Class Codes: A61B 2017/22049 Means for locking the guide wire in the catheter
• CPC Class Codes: A61B 2017/2927 the angular position of the head being adjustable with respect to the shaft
• CPC Class Codes: A61B 2017/320032 Details of the rotating or oscillating shaft, e.g. using a flexible shaft
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 5/061 Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body A61B1/00158 takes precedence
• CPC Class Codes: A61B 5/415 the glands, e.g. tonsils, adenoids or thymus
• CPC Class Codes: A61B 5/418 lymph vessels, ducts or nodes
• 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: A61M 2039/062 used with a catheter
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 39/06 Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
• CPC Class Codes: A61M 39/0606 without means for adjusting the seal opening or pressure A61M39/0693 takes precedence

Abstract

An interventional catheter assembly has an operating head and catheter system that are inserted and navigated within a patient'"'"'s body while an operator controls the system externally of the operating head. Fluidic communication is provided between the operating head and the external system controls, and rotation is provided to the operating head by means of an external drive system. Numerous system controls are provided, along with various operating systems, sealing assemblies, actuators, torque transfer systems, and the like are provided. Some systems and controls are provided in a control pod and some controls, as well as displays, are provided in a console unit. Control pod, catheter system and operating head may be provided as a sterile, single use interventional catheter system, while the console unit may be provided as a multiple use device that communicates with the sterile, single use interventional catheter system during operation.

Claims

1. An interventional catheter assembly comprising:

a. a catheter system forming, at least one passageway and sized and configured for introduction to and navigation through a body lumen or cavity;

b. an operating head positioned at or near a distal end of the catheter system and operably and non-detachably coupled to a drive shaft and a drive system for rotation; and

c. an operator torque selection feature providing operator selection of a torque level from a plurality of predetermined torque levels delivered by the drive system to the drive shaft, whereby the operator can adjust the torque level delivered to the operating head.

2. An interventional catheter assembly of claim 1, wherein the torque selection feature incorporates an override setting for each selectable torque level, whereby the drive system is inactivated when a selected predetermined torque level is exceeded.

3. An interventional catheter assembly of claim 1, wherein a first torque level provides a preselected current level of less than 1 amp to the drive system and another torque setting provides a preselected current level of greater than 1.1 amp to the drive system.

4. An interventional catheter assembly of claim 1, additionally comprising a torque gauge that shows the torque delivered to the operating head as current drawn by the drive system.

5. An interventional catheter assembly of claim 1, additionally comprising control circuitry for inactivating power to the operating head when the current level required to maintain a desired rotational speed at the operating. head exceeds a predetermined value.

6. An interventional catheter assembly of claim 1, additionally comprising an operating head drive motor coupled to the drive shaft.

7. An interventional catheter assembly of claim 1, wherein the operating head has advanceable, rotatable cutter surfaces at or near a distal end.

8. An interventional catheter assembly of claim 1, wherein the operator torque selection feature is provided at a control pod.

9. An interventional catheter assembly of claim 1, additionally comprising an operating head drive motor coupled to the drive shaft, wherein the drive motor comprises a variable speed drive motor that delivers a constant voltage for any specified rotational output.

10. An interventional catheter assembly of claim 9, wherein the current delivered to the drive system is adjusted, under load conditions, if the voltage for any specified rotational output is insufficient to produce the specified rotational output under load conditions.

11. An interventional catheter assembly of claim 1 additionally comprising an aspiration system, wherein the catheter system has an aspiration lumen communicating with a vacuum source that, when activated, provides aspiration of materials from a target site.

12. An interventional catheter assembly of claim 11, additionally comprising control circuitry providing a delay between the time the drive system and aspiration systems are inactivated, such that the drive system may be inactivated immediately upon actuation of a switch, while the aspiration system may be inactivated after a delay period following actuation of the switch.