INTERVENTIONAL CATHETER ASSEMBLIES AND CONTROL SYSTEMS

• US 20110112562A1
• Filed: 04/28/2010
• Published: 05/12/2011
• Est. Priority Date: 03/10/2003
• Status: Active Grant

• Current Assignee: Boston Scientific Medical Device Limited (Boston Scientific Corporation)
• Original Assignee: Pathway Medical Technologies, Inc. (Bayer AG)
• Inventors: TORRANCE, Casey
• Granted Patent: US 8,323,240 B2
• Time in Patent Office: Days
• US Class Current: 606/159
• 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 coupled to a drive shaft and a drive assembly for rotation; and

c. a torque selection feature providing operator selection of preselected torque levels delivered by the drive assembly to the drive shaft.

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 assembly is inactivated when a preselected torque level is exceeded.

3. An interventional catheter assembly of claim 1, wherein a first torque setting 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 motor 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, wherein the drive motor comprises a variable speed drive motor that delivers a constant voltage for any specified rotational output.

7. An interventional catheter assembly of claim 6, wherein the current delivered to the drive motor is adjusted, under load conditions, if the voltage for any specified rotational output is insufficient to produce the specified rotational output under load conditions.

8. An interventional catheter assembly of claim 1, additionally comprising an operating head drive motor coupled to the drive shaft, wherein the drive motor employs a cascaded variable regulator voltage source.

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

10. 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.

11. An interventional catheter assembly of claim 10, 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 drive system.

12. An interventional catheter assembly comprising:

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

an operating head positioned at or near a distal end of the catheter system and coupled to a drive shaft and a drive assembly for rotation;

a guidewire brake operable to clamp a guidewire in a stationary position when engaged and to allow translation and/or rotation of the guidewire through the brake when released;

a guidewire brake control system interrupt that prevents the drive system from being actuated when the guidewire brake is in a release position, and a selectable guidewire brake interrupt override control that, when actuated, permits an operator to translate and/or rotate the drive shaft and operating head while the guidewire is simultaneously moved.

13. An interventional catheter assembly of claim 12 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.

14. An interventional catheter assembly of claim 12, 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 drive system.

15. An interventional catheter assembly of claim 12, wherein the operating head has advanceable, rotatable cutter surfaces at or near a distal end.

16. A method for operating an interventional catheter having an advanceable operating head positioned at or near a distal end of a catheter system sized for insertion into and navigation through a body lumen or cavity, comprising:

inserting a flexible guidewire into and navigating the guidewire through a body lumen or cavity to a target site;

inserting and navigating the advanceable operating head and a portion of the catheter system over the guidewire to the target site;

actuating the operating head remotely and advancing it to separate and break down undesired occlusive material at the target site; and

withdrawing the operating head from the target site by simultaneously moving the guidewire and the operating head.

17. A method of claim 16, additionally comprising clamping the guidewire in a position in which it is prevented from moving axially or rotatably after the guidewire is positioned at the target site.

18. A method of claim 16, additionally comprising withdrawing the operating head from the target site while rotating the operating head at a low speed.

19. A method of claim 16, additionally comprising sensing whether the guidewire is in a clamped or a release position.

20. A method of claim 19, additionally comprising providing a control system feature that permits rotation and advancement of the operating head when the guidewire is in a clamped condition and that prevents actuation of the operating head when the guidewire brake is in a release position.