High capacity debulking catheter with distal driven cutting wheel

• US 8,052,704 B2
• Filed: 11/02/2007
• Issued: 11/08/2011
• Est. Priority Date: 12/20/2000
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Foxhollow Technologies Incorporated (Medtronic Plc)
• Inventors: Olson, William John
• Primary Examiner(s): NGUYEN, TUAN VAN
• Application Number:
  US11/934,680
• Publication Number:
  US 20080065125A1
• Time in Patent Office: 1,467 Days
• Field of Search: 606/155, 606/159, 606/170, 606/167, 606/171, 606/180, 606/198, 606/186, 600/459, 600/564, 600/164.01, 600/508
• US Class Current: 606/159
• CPC Class Codes: A61B 17/2202 the ultrasound transducer being inside patient's body at the distal end of the catheter
• 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 17/320783 through side-hole, e.g. sliding or rotating cutter inside catheter
• CPC Class Codes: A61B 2017/00685 Archimedes screw
• 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 2017/320775 Morcellators, impeller or propeller like means
• CPC Class Codes: A61B 2017/320791 with cutter extending outside the cutting window
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00

Abstract

An atherectomy catheter includes a rotary cutting knife that is driven from the distal (nose) or side (circumference) direction. The catheter collects plaque shavings in a hollow collection chamber mounted in between the rotary cutting knife and the main catheter tubing. In contrast to prior art designs, which utilized nose mounted plaque collection chambers, the present design is able to store a substantially larger volume of removed plaque, thus increasing the length of time and amount of plaque removal that can be accomplished before the catheter must be removed from the body and cleaned. This decreases medical procedure time, allows for more complete and careful plaque removal, and reduces the burden on the patient and physician.

Claims

1. A catheter comprising:

a flexible tube comprising a proximal end and a distal end;

said flexible tube having dimensions and flexibility compatible with migration through at least some arteries or veins or other body lumens of a living mammal;

a catheter head with dimensions also compatible with migration through at least some arteries or veins or other body lumens of a living mammal;

said catheter head comprising a substantially rigid housing coupled to the distal end of said flexible tube;

said rigid housing comprising at least a window to the space outside said housing that also opens into a hollow inner portion of said housing;

a tissue debulking assembly disposed at least partially within said rigid housing;

wherein said tissue debulking assembly comprises a substantially circular rotatable cutter with an axis of rotation, said rotatable cutter being positioned distal of said inner portion of said housing, a source of rotational power and a drive assembly connecting said rotatable cutter to said source of rotational power, said drive assembly comprising a drive shaft extending distally from said rotatable cutter;

and wherein said hollow inner portion of said housing comprises a collection chamber for tissue removed by said tissue debulking assembly and said hollow inner portion of said housing does not contain said drive assembly, whereby said hollow inner portion is substantially open for collection of tissue.

2. The catheter of claim 1, in which said source of rotational power is selected from the group consisting of an electric motor, a pressure powered turbine, or a chemical powered turbine.

3. The catheter of claim 1, wherein said drive assembly further comprises a gearing mechanism.

4. The catheter of claim 1, wherein said catheter additionally contains a deflectable nose region mounted on the distal end of said rigid housing, and a mechanism to allow said operator to deflect said nose region against a body lumen, thereby pushing said window and said rotatable cutter against an opposite wall of said body lumen, allowing said rotatable cutter to cut material from said body lumen.

5. The catheter of claim 1, wherein said catheter contains openings for receiving a guidewire.

6. The catheter of claim 1, wherein the tissue debulking assembly further comprises a RF electrode, a laser, or an ultrasound emitter.

7. The catheter of claim 1, wherein said tissue debulking assembly can be moved, under operator control, along a long axis of the rigid housing by a shuttle mechanism, thereby closing said window and pinching off any portion of tissue that is dangling through said window into said rigid housing;

resulting in said pinched off portion of tissue being stored in said collection chamber.

8. The catheter of claim 1, wherein said catheter head has an imaging device oriented to survey material that is positioned near a cutting zone of said cutter.

9. The catheter of claim 8, in which said imaging device is selected from the group consisting of ultrasound transducer arrays, optical fibers, and coherence tomography devices.

10. The catheter of claim 1, wherein the source of rotational power is positioned distal to the rotatable cutter.

11. The catheter of claim 1, further comprising a source of ultrasonic vibration operatively coupled to the rotatable cutter, the source of ultrasonic vibration being configured to ultrasonically vibrate the rotatable cutter.

12. The catheter of claim 11, wherein the source of ultrasonic vibration is a piezoelectric ultrasonic vibrator.

13. A catheter comprising:

a flexible body comprising a proximal end and a distal end;

said flexible body having dimensions and flexibility compatible with migration through at least some arteries or veins or other body lumens of a living mammal;

a catheter head with dimensions also compatible with migration through at least some arteries or veins or other body lumens of a living mammal;

said catheter head having a substantially rigid housing coupled to the distal end of said flexible body;

said rigid housing comprising at least a window to the space outside said housing that also opens into a hollow inner portion of said housing;

a tissue debulking assembly disposed at least partially within said rigid housing;

wherein said tissue debulking assembly comprises a substantially circular rotatable cutter positioned distal of said hollow inner portion of said housing, a source of rotational power and a drive assembly connecting said rotatable cutter to said source of rotational power, the source of rotational power being positioned distal of the rotatable cutter; and

wherein said catheter additionally contains a deflectable nose region mounted on the distal end of said rigid housing, and a mechanism to allow said operator to deflect said nose region against a body lumen, thereby pushing said window and said rotatable cutter against an opposite wall of said body lumen, allowing said rotatable cutter to cut material from said body lumen; and

wherein said hollow inner portion comprises a collection chamber for tissue removed by said tissue debulking assembly and wherein said hollow inner portion of said housing does not contain said drive assembly, such that said hollow inner portion is substantially open for collection of tissue.

14. The catheter of claim 13, in which said source of rotational power is selected from the group consisting of an electric motor, a pressure powered turbine, or a chemical powered turbine.

15. The catheter of claim 13, wherein said catheter contains openings for receiving a guidewire.

16. The catheter of claim 13, wherein the tissue debulking assembly further comprises a RF electrode, a laser, or an ultrasound emitter.

17. The catheter of claim 13, wherein said tissue debulking assembly can be moved, under operator control, along a long axis of the rigid housing by a shuttle mechanism, thereby closing said window and pinching off any portion of tissue that is dangling through said window into said rigid housing;

resulting in said pinched off portion of tissue being stored in said collection chamber.

18. The catheter of claim 13, wherein said catheter head has an imaging device oriented to survey material that is positioned near a cutting zone of said cutter.

19. The catheter of claim 18, in which said imaging device is selected from the group consisting of ultrasound transducer arrays, optical fibers, and coherence tomography devices.

20. The catheter of claim 13, further comprising a source of ultrasonic vibration operatively coupled to the rotatable cutter, the source of ultrasonic vibration being configured to ultrasonically vibrate the rotatable cutter.

21. The catheter of claim 20, wherein the source of ultrasonic vibration is a piezoelectric ultrasonic vibrator.

22. A catheter comprising:

a flexible body comprising a proximal end and a distal end;

said flexible body having dimensions and flexibility compatible with migration through at least some arteries or veins or other body lumens of a living mammal;

a catheter head with dimensions also compatible with migration through at least some arteries or veins or other body lumens of a living mammal;

said catheter head having a substantially rigid housing coupled to the distal end of said flexible body;

said rigid housing comprising at least a window to the space outside said housing that also opens into a hollow inner portion of said housing;

a tissue debulking assembly disposed at least partially within said rigid housing;

wherein said tissue debulking assembly comprises a substantially circular rotatable cutter positioned distal of said hollow inner portion of said housing, a source of rotational power and a drive assembly connecting said rotatable cutter to said source of rotational power, said rotatable cutter being coupled to said a rotational power source within the rigid housing at a position distal to the rotatable cutter;

and wherein said rotational power source is positioned at a location selected from distal to said cutter and said window or proximal to said cutter and said window;

wherein said catheter additionally contains a deflectable nose region mounted on the distal end of said rigid housing, and a mechanism to allow said operator to deflect said nose region against a body lumen, thereby pushing said window and said rotatable cutter against an opposite wall of said body lumen, allowing said rotatable cutter to cut material from said body lumen; and

wherein said hollow inner portion comprises a collection chamber for tissue removed by said tissue debulking assembly and wherein said hollow inner portion of said housing does not contain said drive assembly, such that said hollow inner portion is substantially open for collection of tissue; and

wherein said catheter head has an imaging device oriented to survey material that is positioned near the cutting zone of said cutter.

23. The catheter of claim 22, in which said rotational power source is selected from the group consisting of an electric motor, a pressure powered turbine, or a chemical powered turbine.

24. The catheter of claim 22, wherein said catheter contains openings for receiving a guidewire.

25. The catheter of claim 22, wherein the tissue debulking assembly further comprises a RF electrode, a laser, or an ultrasound emitter.

26. The catheter of claim 22, wherein said tissue debulking assembly can be moved, under operator control, along a long axis of the rigid housing by a shuttle mechanism, thereby closing said window and pinching off any portion of tissue that is dangling through said window into said rigid housing;

resulting in said pinched off portion of tissue being stored in said collection chamber.

27. The catheter of claim 22, in which said imaging device is selected from the group consisting of ultrasound transducer arrays, optical fibers, and coherence tomography devices.

28. The catheter of claim 22, further comprising a source of ultrasonic vibration operatively coupled to the rotatable cutter, the source of ultrasonic vibration being configured to ultrasonically vibrate the rotatable cutter.

29. The catheter of claim 28, wherein the source of ultrasonic vibration is a piezoelectric ultrasonic vibrator.