Tissue removing catheter and RF cutting method

• US 5,876,369 A
• Filed: 07/19/1997
• Issued: 03/02/1999
• Est. Priority Date: 01/23/1995
• Status: Expired due to Fees

• Current Assignee: CardioVascular Technologies, Inc.
• Original Assignee: Advanced Catheter Engineering, Inc.
• Inventors: Houser, Russell U.
• Primary Examiner(s): Yasko, John D.
• Assistant Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US08/899,490
• Time in Patent Office: 591 Days
• Field of Search: 604/22, 606/167, 606/169, 606/170, 606/171, 606/174, 606/175, 606/176, 606/177, 606/178, 606/179, 606/180, 606/183, 606/185
• US Class Current: 604/22
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2018/00601 Cutting
• CPC Class Codes: A61B 2018/1861 with an instrument inserted into a body lumen or cavity, e.g. a catheter
• CPC Class Codes: A61B 2218/007 Aspiration

Abstract

An atherectomy device includes a catheter with a window at its distal tip for admitting tissue into a catheter compartment. A cylindrical cartridge in the compartment has a cutting edge that supports an electrically conductive cutting element, e.g. a band or wire. The cutting element and adjacent tissue can be heated to a selected temperature by generating an electrical current through the cutting element. The catheter is maneuverable to position its distal end near a lesion in an artery. The catheter incorporates a dilatation balloon or other feature to urge the catheter against the lesion, so that at least part of the lesion enters the compartment through the window. Then, the cartridge is manipulated from the catheter'"'"'s proximal end to move the cutting edge across the window, severing the acquired tissue. According to alternative embodiments, the cartridge is either rotated or moved axially relative to the catheter, in either event closing the catheter window when the cut is complete. Further alternatives involve either placing an indifferent electrode on the patient and providing an RF signal via a single conductor to the cutting element for ohmic heating, or providing an RF (or a DC) current through the cutting element and two separate conductors for direct resistive heating of the cutting element.

Claims

1. A device for removing unwanted tissue, including:

an elongate catheter having a proximal end and a distal end, a catheter wall defining a compartment within the catheter, and a window through the catheter wall to allow entry into the compartment;

a cartridge within the compartment, said cartridge having a cartridge wall, a cartridge opening for receiving tissue, and a cutting edge along the cartridge opening;

a control means coupled to the cartridge and operable to selectively position and move the cartridge, for providing a controlled movement of the cutting edge along an adjacent window; and

a tissue heating means comprising a cutting element disposed along the cutting edge and an energy source operatively coupled to the cutting element to heat the cutting element and thereby heat tissue adjacent the cutting edge at least to a selected temperature above normal body temperature, and to maintain said tissue adjacent the cutting edge at least at the selected temperature during said controlled movement.

2. The device of claim 1 wherein:

the catheter is maneuverable to locate the distal end of the catheter within a body lumen and to place the window against a tissue wall segment to acquire tissue within the compartment, and the cutting edge, when undergoing the controlled movement, severs the acquired tissue; and

said control means is operable to move the cartridge between an open position for permitting entry into the compartment via the window, and a closed position in which the cartridge wall closes the window.

3. The device of claim 1 wherein:

the cutting edge is part of the cartridge wall and leads the cartridge wall when undergoing the controlled movement.

4. The device of claim 3 wherein:

the cutting edge is a distal edge of the cartridge, and the controlled movement of the cutting edge is in the distal direction.

5. The device of claim 3 wherein:

the cartridge is cylindrical and substantially coaxial with the catheter, the catheter wall extends axially and is open along a portion of its circumference to form the catheter opening, the cutting edge comprises an axial edge of the catheter wall along the opening, and the cartridge is rotatable whereby the controlled movement of the cutting edge is arcuate.

6. The device of claim 1 including:

a drive member connected to the cartridge and contained within a lumen of the catheter, and movable near the proximal end of the catheter to impart like movement to the cartridge.

7. The device of claim 1 wherein:

said tissue cutting element is electrically conductive, and the energy source comprises a means for generating an electrical current in the cutting element to heat the cutting element and said adjacent tissue at least to said selected temperature.

8. The device of claim 7 wherein:

the means for generating an electrical current in the cutting element include a power supply, and first and second electrical conductors coupled to the power supply and further coupled to opposite ends of the cutting element.

9. A process for removing body tissue, including:

inserting a catheter into a body, and guiding the catheter to position a window of the catheter proximate selected tissue within the body;

with the window so positioned, applying a force against the catheter in a direction to urge the window and wall portion of the catheter adjacent the window toward and against the selected tissue, to cause the selected tissue to enter the catheter through the window; and

while the selected tissue is within the catheter, simultaneously using a cutting edge to cut tissue in a direction along the window and generating heat near the cutting edge to heat the selected tissue near the cutting edge during cutting, to sever the selected tissue for retention within the catheter.

10. The process of claim 9 further including:

after severing the selected tissue, closing the window to prevent egress of the selected tissue.

11. The process of claim 9 wherein:

said generating heat near the cutting edge to heat the selected tissue during said cutting tends to cauterize the tissue in the region of the cut.

12. The process of claim 9 wherein:

the cutting movement is substantially linear and axial with respect to the catheter.

13. The process of claim 9 wherein:

the cutting movement is arcuate, about an axis running longitudinally of the catheter.

14. A process for removing selected tissue from a body, including:

inserting an elongate catheter into a body, and guiding the catheter to selectively locate a tissue cutting element, carried by the catheter, adjacent selected tissue; and

with said cutting element so selectively located, and while heating the cutting element to maintain the cutting element at least at a selected temperature above normal body temperature, manipulating the catheter to cause the cutting element to traverse a cutting path through the selected tissue whereby the heated cutting element simultaneously heats and cuts the selected tissue along the cutting path, to severe the selected tissue.

15. The process of claim 14 further including:

during said manipulating of the catheter, applying a force against the catheter in a direction to urge the cutting element toward and against tissue along the cutting path.

16. The process of claim 15 wherein:

the catheter includes a window near the cutting element for admitting tissue into the catheter, and said severing of the selected tissue is performed with the selected tissue extending into the catheter through the window.

17. The process of claim 14 wherein:

said causing of the cutting element to traverse the cutting path tends to cauterize tissue adjacent the cutting path.

18. The process of claim 14 wherein:

said cutting path is substantially linear and axial with respect to the catheter.

19. The process of claim 14 wherein:

said cutting path is arcuate, about an axis running longitudinally of the catheter.

20. A device for removing selected tissue from a body, including:

an elongate catheter having a proximal end and a distal end;

a cutting element supported by the catheter in the region of the distal end;

a position controller operatively coupled to the cutting element for providing a controlled movement of the cutting element;

an energy source operatively coupled to the cutting element and adapted to heat the cutting element at least to a selected temperature of above normal body temperature, and for maintaining the cutting element at least at said selected temperature during said controlled movement; and

wherein the catheter is flexible and maneuverable to locate the distal end of the catheter to position the cutting element adjacent a tissue wall segment whereby the cutting element, when undergoing the controlled movement, severs the adjacent tissue and heats the adjacent tissue while severing.

21. The device of claim 20 further including:

a structure adapted to urge the cutting element laterally against the selected tissue.

22. The device of claim 21 wherein:

the structure adapted to urge the cutting element includes a dilatation balloon mounted along the distal region, axially aligned with and on the opposite side of the catheter from the cutting element, and means for inflating the balloon.

23. The device of claim 21 wherein:

the structure adapted to urge the cutting element includes a flexible band axially aligned with and on the opposite side of the catheter from the cutting element.

24. The device of claim 20 wherein:

said cutting element is electrically conductive, and the energy source includes a electrical powder source for generating an electrical current in the cutting element.

25. The device of claim 24 further including

first and second electrical conductors coupled to the power supply and respectively to opposite ends of the cutting element.

26. The device of claim 24 further including

an indifferent electrode, a first conductor connected to the power source and to the cutting element, and a second conductor connected to the power source and to the indifferent electrode, to maintain the adjacent tissue at least at the select temperature primarily by ohmic heating, wherein the power source is an RF power source.