Device and method for directional rotational atherectomy

• US 5,312,427 A
• Filed: 10/16/1992
• Issued: 05/17/1994
• Est. Priority Date: 10/16/1992
• Status: Expired due to Fees

• Current Assignee: Shturman Cardiology Systems, Inc.
• Original Assignee: Shturman Cardiology Systems, Inc.
• Inventors: Shturman, Leonid
• Primary Examiner(s): Pellegrino, Stephen C.
• Assistant Examiner(s): LEWIS, WILLIAM W
• Application Number:
  US07/962,634
• Time in Patent Office: 578 Days
• Field of Search: 606/159, 606/170, 606/171, 606/180, 604/22, 604/96, 128/750-755
• US Class Current: 606/159
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• 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 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

Device and method for performing an atherectomy. The device utilizes a dual lumen catheter, with a guide wire being receivable in one of these lumens, and a flexible, elongated drive shaft carrying an abrasive burr at its distal end being disposed in the other lumen. The drive shaft and abrasive burr each include a central lumen so that they can be advanced over a positioning wire. The positioning wire has a generally straight proximal portion, and a distal end that is slidably secured to the guide wire so that the positioning wire can be moved proximally and distally with respect to the guide wire. The positioning wire also includes a distal end portion with a burr positioning segment. The burr positioning segment has a predetermined curved shape so that when the abrasive burr is advanced over the positioning wire to a position along the curved burr positioning segment, the burr positioning segment positions the burr laterally away from the guide wire, thus giving control over the lateral position of the burr within an artery. The device therefore allows selective removal of tissue from one side of an artery, permitting selective treatment of eccentric stenotic lesions without damaging the artery wall, and permitting treatment of lesions generally without blocking blood flow through the artery during use of the device.

Claims

1. A directional rotational atherectomy device, comprising:

an elongated catheter having at least first and second lumens, and a distal end;

a guide wire receivable in the first lumen of the catheter and extending distally therefrom;

a flexible, elongated drive shaft having proximal and distal ends and a central lumen, the drive shaft being receivable in the second lumen of the catheter and being longitudinally movable therein;

means operatively connected to the proximal end of the drive shaft for rotating the drive shaft;

an abrasive burr carried by the drive shaft, the burr including a central lumen generally coaxial with the drive shaft lumen; and

a positioning wire receivable in the drive shaft lumen, the positioning wire having a distal end and means for slidably securing the distal end of the positioning wire about the guide wire distally of the distal end of the catheter so that the positioning wire can be moved proximal and distally with respect to the guide wire, the positioning wire further including a distal burr-positioning segment having a predetermined shape, the drive shaft and burr being movable longitudinally with respect to the positioning wire and the catheter to selectively locate the burr along the predetermined shape of such distal burr-positioning segment;

at least the proximal portion of the burr-positioning segment of the positioning wire being retractable into and advanceable out of the catheter, the predetermined shape of the distal burr-positioning segment of the positioning wire being curved so that when the burr is positioned along such curve and such proximal portion of the burr-positioning segment is retracted into the catheter, the burr will be drawn to a position close to the guide wire, and when the proximal portion of the curved burr-positioning segment of the positioning wire is advanced out of the catheter the predetermined curved shape of the distal burr-positioning segment spaces the burr laterally further away from the guide wire,

2. The directional rotational atherectomy device of claim 1 wherein the means for slidably securing the distal end of the positioning wire to the guide wire comprises a generally cylindrical sleeve received closely about the guide wire.

3. The directional rotational atherectomy device of claim 2 wherein the sleeve comprises a generally cylindrical bushing attached to the distal end of the positioning wire.

4. The directional rotational atherectomy device of claim 2 wherein the sleeve comprises a helical winding of the distal end portion of the positioning wire.

5. The directional rotational atherectomy device of claim 1 wherein the positioning wire is made of a shape-memory alloy.

6. The directional rotational atherectomy device of claim 5 wherein the alloy is nitinol.

7. The directional rotational atherectomy device of claim 1 further comprising a stop positioned on the guide wire distally of the distal end of the positioning wire and against which the distal end of the positioning wire can engage so that further advancement of the positioning wire will cause the burr-positioning segment to flex laterally away from the guide wire, thereby changing the lateral position of the burr when it is located over the distal burr-positioning segment.

8. The directional rotational atherectomy device of claim 1 wherein the positioning wire is movable longitudinally to selectively advance and retract the burr-positioning segment of the positioning wire between a first position, where it is substantially confined in the second lumen of the catheter to a generally straight configuration, and a second position where it is advanced distally out of the catheter'"'"'s second lumen.

9. The directional rotational atherectomy device of claim 1 further comprising intravascular ultrasound imaging catheter means advancable over the guide wire to a position adjacent the abrasive burr for providing a cross-sectional image of tissue of interest and of the position of the abrasive burr with respect to such tissue.

10. The directional rotational atherectomy device of claim 9 including means for securing the intravascular ultrasound imaging catheter with respect to the drive shaft carrying the burr so that the intravascular ultrasound imaging catheter and drive shaft can be advanced and retracted as a unit with respect to the tissue of interest.

11. The directional rotational atherectomy device of claim 1 wherein the guide wire includes intravascular ultrasonic imaging means for providing a cross-sectional image of tissue of interest and of the position of the abrasive burr with respect to such tissue.

12. The directional rotational atherectomy device of claim 1 wherein the guide wire is made of a shape-memory alloy.

13. The directional rotational atherectomy device of claim 12 wherein the alloy is nitinol.

14. The directional rotational atherectomy device of claim 1 wherein the flexible, elongated drive shaft is comprised of a multi-strand helical coil.

15. The directional rotational atherectomy device of claim 1 wherein the drive shaft is comprised of a pair of multi-strand helical coils disposed co-axially of one another.

16. The directional rotational atherectomy device of claim 15 wherein one of the coils is wound clockwise and the other is wound counter-clockwise.

17. The directional rotational atherectomy device of claim 1 wherein the abrasive burr is generally spherical in shape.

18. The directional rotational atherectomy device of claim 1 wherein the abrasive burr comprises a body having an outer surface, and an abrasive material attached to such outer surface.

19. The directional rotational atherectomy device of claim 18 wherein the abrasive material is substantially evenly distributed over the outer surface of the body of the burr.

20. The directional rotational atherectomy device of claim 18 wherein the abrasive material is substantially evenly distributed over a central portion of the outer surface of the body of the burr.

21. The directional rotational atherectomy device of claim 18 wherein the abrasive material is substantially evenly distributed over a distal portion of the outer surface of the body of the burr.

22. The directional rotational atherectomy device of claim 18 wherein the abrasive material is substantially evenly distributed over a proximal portion of the outer surface of the body of the burr.

23. The directional rotational atherectomy device of claim 18 wherein the abrasive material is diamond particles.

24. A directional rotational atherectomy device, comprising:

an elongated catheter having a distal end and at least first and second lumens with longitudinal axes;

a guide wire receivable in the first lumen of the catheter and extending distally therefrom;

a flexible, elongated drive shaft having proximal and distal ends and a central lumen, the drive shaft being receivable in the second lumen of the catheter and being longitudinally movable therein;

means operatively connected to the proximal end of the drive shaft for rotating the drive shaft;

an abrasive burr carried by the drive shaft, the burr including a central lumen having a central axis generally coaxial with the drive shaft lumen; and

a shape-memory alloy positioning wire receivable in the drive shaft lumen, the positioning wire having a distal end and means for slidably securing the distal end of the positioning wire about the guide wire distally of the distal end of the catheter so that the positioning wire can be moved proximally and distally with respect to the guide wire;

the positioning wire further including a distal burr-positioning segment having a predetermined curved shape, the drive shaft and burr being movable longitudinally with respect to the positioning wire and the catheter so that when the burr is positioned along such curved segment and such curved segment is positioned substantially entirely distally of the distal end of the catheter, the longitudinal axis of the burr is spaced laterally from the longitudinal axis of the second catheter lumen;

at least the proximal portion of the curved burr-positioning segment of the positioning wire being retractable into the catheter so that when the burr is positioned along such curve and the proximal portion of the burr-positioning segment is retracted into the catheter, the burr will be drawn to a position close to the guide wire;

the directional rotational atherectomy device further including intravascular ultrasound imaging catheter means advancable over the guide wire to a position adjacent the abrasive burr for providing a cross-sectional image of tissue of interest and of the position of the abrasive burr with respect to such tissue.

25. A method of removing tissue from a body passageway comprising the steps of:

(a) providing a directional rotational atherectomy device comprising;

a catheter having at least two lumens;

a guide wire which is receivable in a first of the catheter lumens;

a flexible, elongated drive shaft disposed in the other catheter lumen, the drive shaft having a central lumen and an abrasive burr carried on the drive shaft, the burr including a central lumen generally coaxial with the drive shaft lumen; and

a positioning wire disposed in the drive shaft lumen and extending distally therefrom, the positioning wire including a distal end and means for slidably securing such distal end to the guide wire, the positioning wire further including a distal burr-positioning segment having a predetermined shape;

(b) advancing the guide wire into the body passageway and positioning the distal end of the guide wire distally of the tissue to be removed;

(c) advancing the positioning wire, the burr with its flexible drive shaft, and the catheter along the guide wire, with at least the proximal portion of the distal burr-positioning segment of the positioning wire being positioned in the catheter, until the burr is positioned adjacent to the tissue to be removed;

(d) withdrawing the catheter with respect to the burr-positioning segment of the positioning wire to allow such segment to at least partially regain its predetermined shape;

(e) moving the drive shaft, if necessary, to position the burr at the desired location along the burr-positioning segment of the positioning wire to selectively position the burr laterally of the guide wire within the body passageway; and

(f) rotating the drive shaft and burr to remove the tissue.

26. The method of claim 25 further comprising the step of withdrawing the positioning wire, the burr with its drive shaft, and the catheter from the body passageway, replacing the positioning wire with a second positioning wire having a distal burr-positioning segment with a predetermined shape which is different from the predetermined shape of the first positioning wire, and reinserting the second positioning wire, the burr with its drive shaft, and the catheter to a position locating the burr adjacent the tissue to be removed.

27. The method of claim 25 including the steps of advancing an intravascular ultrasound imaging catheter over the guide wire to a position adjacent to the tissue to be removed from the body passageway, and utilizing the intravascular ultrasound imaging catheter to image a cross-section of the passageway.

28. The method of claim 25 wherein the imaging step includes positioning the ultrasound imaging catheter adjacent to the abrasive burr and imaging both the tissue to be removed and the relative position of the abrasive burr with respect to such tissue.

29. A directional rotational atherectomy device, comprising:

an elongated catheter having at least first and second lumens and a distal end;

a guide wire receivable in the first lumen of the catheter and extending distally therefrom;

a flexible, elongated drive shaft having proximal end and distal ends and a central lumen, the drive shaft being receivable in the second lumen of the catheter and being longitudinally movable therein;

means operatively connected to the proximal end of the drive shaft for rotating the drive shaft;

an abrasive burr carried by the drive shaft, the burr including a central lumen generally coaxial with the drive shaft lumen; and

a positioning wire receivable in the drive shaft lumen, the positioning wire having a distal end and means for slidably securing the distal end of the positioning wire about the guide with distally of the distal end of the catheter so that the positioning wire can be moved proximally and distally with respect to the guide wire, the positioning wire further including a distal burr-positioning segment having a predetermined shape, the drive shaft and burr being movable longitudinally with respect to the positioning wire and the catheter to selectively locate the burr along the predetermined shape of such distal burr-positioning segment to selectively position the burr laterally of the guide wire;

intravascular ultrasound imaging catheter means advanceable over the guide wire to a position adjacent the abrasive burr for providing a cross-sectional image of tissue of interest and of the position of the abrasive burr with respect to such tissue.

30. A directional rotational atherectomy device, comprising:

an elongated catheter having at least first and second lumens and a distal end;

a guide wire receivable in the first lumen of the catheter and extending distally therefrom;

a flexible, elongated drive shaft having proximal and distal ends and a central lumen, the drive shaft being receivable in the second lumen of the catheter and being longitudinally movable therein;

means operatively connected to the proximal end of the drive shaft for rotating the drive shaft;

an abrasive burr carried by the drive shaft, the burr including a central lumen generally coaxial with the drive shaft lumen; and

a positioning wire receivable in the drive shaft lumen, the positioning wire having a distal end and means for slidably securing the distal end of the positioning wire about the guide wire distally of the distal end of the catheter so that the positioning wire can be moved proximally and distally with respect to the guide wire, the positioning wire further including a distal burr-positioning segment having a predetermined shape, the drive shaft and burr being movable longitudinally with respect to the positioning wire and the catheter to selectively locate the burr along the predetermined shape of such distal burr-positioning segment to selectively position the burr laterally of the guide wire;

the guide wire including intravascular ultrasonic imaging means for providing a cross-sectional image of tissue of interest and of the position of the abrasive burr with respect to such tissue.

31. A directional rotational atherectomy device, comprising:

an elongated catheter having a distal end and at least first and second lumens, such lumens each having a longitudinal axis;

a guide wire receivable in the first lumen of the catheter and extending distally therefrom;

a flexible, elongated drive shaft having proximal and distal ends and a central lumen, the drive shaft being receivable in the second lumen of the catheter and being longitudinally movable therein;

means operatively connected to the proximal end of the drive shaft for rotating the drive shaft;

an abrasive burr carried by the drive shaft, the burr including a central lumen and a longitudinal axis generally coaxial with the drive shaft lumen; and

a positioning wire receivable in the drive shaft lumen, the positioning wire having a distal end and means for slidably securing the distal end of the positioning wire about the guide wire distal end of the catheter so that the positioning wire can be moved proximally and distally with respect to the guide wire, the positioning wire further including a distal burr-positioning segment having a predetermined shape, the drive shaft and burr being movable longitudinally with respect to the positioning wire and the catheter to selectively locate the burr along the predetermined shape of such distal burr-positioning segment, the predetermined shape of the distal burr-positioning segment of the positioning wire being curved so that when the burr is positioned along such curve and such curve is positioned substantially entirely distally of the distal end of the catheter, the longitudinal axis of the burr is spaced laterally from the longitudinal axis of the second catheter lumen.

32. The directional rotational atherectomy device of claim 31 wherein at least the proximal portion of the curved burr-positioning segment of the positioning wire is retractable into the catheter so that when the burr is positioned along such curve and such proximal portion of the burr-positioning segment is retracted into the catheter, the burr will be drawn to a position close to the guide wire.