Device and method for directional rotational atherectomy

Claim 2

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,

Claim 3

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.

Claim 4

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.

Claim 5

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

Claim 6

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

Claim 7

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

Claim 8

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.

Claim 9

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.

Claim 10

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.

Claim 11

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.

Claim 12

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.

Claim 13

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

Claim 14

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

Claim 15

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

Claim 16

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.

Claim 17

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

Claim 18

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

Claim 19

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.

Claim 20

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.

Claim 21

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.

Claim 22

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.

Claim 23

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.

Claim 24

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

Claim 25

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.

Claim 26

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.

Claim 29

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.

Claim 30

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.

Claim 31

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.

Claim 32

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.

Claim 33

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.

Claim 34

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.

Claim 35

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.

Claim 36

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.

Claim 37

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.

Claim 38

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.