Expandable tip atherectomy method and apparatus

• US RE36,764 E
• Filed: 06/07/1995
• Issued: 07/04/2000
• Est. Priority Date: 07/15/1991
• Status: Expired due to Term

• Current Assignee: Nadim M. Zacca
• Original Assignee: Nadim M. Zacca
• Inventors: Zacca, Nadim M., Jasso, Martin R.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): LEWIS, WILLIAM W
• Application Number:
  US08/488,361
• Time in Patent Office: 1,854 Days
• Field of Search: 606/159, 606/170, 606/171, 606/181, 604/22
• US Class Current: 606/159
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 2017/00553 using a turbine
• CPC Class Codes: A61B 2017/22062 to be filled with liquid
• CPC Class Codes: A61B 2017/22082 after introduction of a substance
• CPC Class Codes: A61B 2017/22092 Lubricant
• CPC Class Codes: A61B 2017/320004 abrasive

Abstract

A device for removing obstructions from vessels or small openings in the body, comprising a rotatable ablator tip which is guided to the obstruction in a reduced diameter configuration, expanded and rotated to remove the obstruction, and contracted to remove the device from the body. The variably expandable abrasive tip coil in one embodiment of the invention is actuated by a piston means disposed within the coil. A pair of collars is attached to the ends of the coil, and the piston effects relative longitudinal axial movement of the collars and, hence, the respective ends of the coil tip. When the ends of the coil tip are so moved with respect to one another, expansion and contraction of the diameter of the coil tip results. In another embodiment of the invention, the expansion tip coil is actuated by an expandable and contractible bellows means disposed within the coil, instead of the piston means. In another embodiment of the invention, the expansion and contraction of the coil tip are effected by longitudinal axial movement of an internal coil attached to one end of the coil tip, within an outer coil attached to the other end of the coil tip. In another embodiment of the invention, expansion and contraction of the coil tip are effected by an inflatable balloon disposed within the coil tip. The balloon expansion means enlarges preferably at the central portion of the coil to make a bulge.

The questions raised in reexamination request No. 90/003,360, filed Mar. 15, 1994, and 90/003,723 filed Feb. 14, 1995, have been considered and the results thereof are reflected in this reissue patent which constitutes the reexamination certificate required by 35 U.S.C. 307 as provided in 37 CFR 1.570(e).

Claims

1. An apparatus for removing an obstruction from a vessel, comprising:

a coil;

said coil being capable of elongation thereby reducing the circumference as said coil is elongated;

.[.means for selectively elongating.]. .Iadd.an elongator engageable with said coil and movable between first and second positions wherein .Iaddend.said coil .Iadd.is elongated in one of said positions.Iaddend.;

.[.means for introducing said coil.]. .Iadd.an introducer extendable .Iaddend.inside .[.a.]. .Iadd.the .Iaddend.vessel proximate to .[.an.]. .Iadd.the .Iaddend.obstruction.Iadd., wherein said introducer supports said coil.Iaddend.;

said coil having .[.an abrasive surface covering.]. at least part of its outer surface .Iadd.treated to form a roughened surface.Iaddend.; and

.[.means for.]. .Iadd.a drive shaft attached to said coil and capable of .Iaddend.selectively rotating said coil.

2. An apparatus for removing an obstruction from a vessel according to claim 1, wherein said coil is of substantially ovaloid configuration prior to elongation .Iadd.and at least part of its outer surface has an abrasive coating.Iaddend..

3. An apparatus for removing an obstruction from a vessel according to claim 1, wherein approximately all of the outer surface of said coil is .[.an abrasive surface.]. .Iadd.treated to form projections.Iaddend..

56. removal member..Iaddend..Iadd.81. The method of claim 75 further including holding the guidewire in position..Iaddend..Iadd.82. The method of claim 75 further including locking the guidewire in position..Iaddend..Iadd.83. The apparatus of claim 1 wherein said coil forms ridges..Iaddend..Iadd.84. The apparatus of claim 1 wherein said coil has an elongated position with a reduced circumference and a contracted position with an enlarged circumference, said coil returning to said contracted position after said elongation..Iaddend..Iadd.85. The apparatus of claim 84 wherein said coil is preformed to return to said contracted position..Iaddend..Iadd.86. The apparatus of claim 1 wherein said at least part of its outer surface has a coating of an abrasive..Iaddend..Iadd.87. The apparatus of claim 1 wherein said coil includes a tip having a tapered cutting surface..Iaddend..Iadd.88. The apparatus of claim 1 wherein collars are disposed at each end of said coil..Iaddend..Iadd.89. The apparatus of claim 1 wherein a portion of said coil is radioscopically

57. visible..Iaddend..Iadd.90. The apparatus of claim 1 wherein said coil includes a hollow interior for receiving a guidewire therethrough which extends through said coil..Iaddend..Iadd.91. An intravascular device for removing vascular occlusion material within a vascular lumen in a patient, the intravascular device comprising:

an expandable removal element having a proximal and distal end;

an inner drive shaft comprising a helix extending into the removal element and operatively connected to the distal end of the removal element to energize the removal element intravascularly; and

an outer drive shaft comprising a helix operatively coupled to the proximal end of the removal element to energize the removal element intravascularly wherein the inner drive shaft extends coaxially through the outer drive shaft and wherein the inner drive shaft and outer drive shaft are shiftable with respect to one another..Iaddend..Iadd.92. An intravascular device as defined in claim 91 further comprising;

rotating means operatively connected to the removal element through the inner and the outer drive shafts for rotating the removal element intravascularly..Iaddend..Iadd.93. A intravascular device as defined in claim 91 further comprising a distal tip located at the distal end of said removal element wherein an abrasive is deposited on the distal tip to create a cutting surface distally of the removal element to remove

4. An apparatus for removing an obstruction from a vessel, comprising:

a coil;

the circumference of said coil being capable of enlargement by unwinding and compressing the coil;

.[.means for selectively unwinding and compressing.]. .Iadd.an elongator connected to said coil and movable between a first position and a second position wherein .Iaddend.said coil .[.for effecting such enlargement of.]. .Iadd.is unwound and compressed in one of said positions to enlarge .Iaddend.the circumference of said coil;

.[.means for introducing said coil in.]. .Iadd.an introducer extendable inside .Iaddend.the vessel proximate to the obstruction.Iadd., wherein said introducer supports said coil.Iaddend.;

said coil having .[.an abrasive surface.]. .Iadd.projections .Iaddend.covering at least part of its outer surface .Iadd.for frictionally engaging the obstruction for removal.Iaddend.; and

.[.means for.]. .Iadd.a drive shaft attached to said coil and capable of .Iaddend.selectively rotating said coil.

5. An apparatus for removing an obstruction from a vessel according to claim 4, wherein approximately all of the outer surface of said coil is .[.an abrasive surface.]. .Iadd.covered with said projections.Iaddend..

6. An apparatus for removing an obstruction from a vessel, comprising:

a length of coil preformed in an ovaloid shape;

.[.means for.]. .Iadd.a drive shaft connected to said length of coil and capable of .Iaddend.rotating said length of coil;

said length of coil having an abrasive surface covering at least a part of its outer surface;

a tubular catheter with a central lumen .Iadd.disposed within said rotating member.Iaddend.;

said catheter terminating in a tip with an opening in said tip communicating with the central lumen of said catheter;

said length of coil surrounding the terminal end of said catheter with the terminal end of said length of coil fixed to the terminal end of said tip of said catheter;

.[.means for elongating.]. .Iadd.an elongator attached to said length of coil and movable between a first position and a second position wherein .Iaddend.said length of coil .Iadd.is elongated in one of said positions .Iaddend.thereby reducing the circumference of said length of coil; and

said .[.elongation means.]. .Iadd.elongator .Iaddend.being disposed between said catheter and said length of coil.

7. An apparatus for removing an obstruction from a vessel according to claim 6, wherein said .[.means for rotating said length of coil.]. .Iadd.drive shaft .Iaddend.comprises a drive shaft coil powered to rotate said ovaloid length of coil at selected speeds from 0 rpm up to about 300,000 rpm.

8. An apparatus for removing an obstruction from a vessel according to claim 6, wherein said length of coil is comprised of multifilar coil wire.

9. An apparatus for removing an obstruction from a vessel according to claim 6, wherein said length of coil is comprised of a wire with a flat outer surface.

10. An apparatus for removing an obstruction from a vessel according to claim 6, wherein said length of coil is comprised of a .Iadd.plurality of strands of .Iaddend.wire .[.with a rounded outer surface.]. .Iadd.having an abrasive coating.Iaddend..

11. An apparatus for removing an obstruction from a vessel according to claim 6, wherein said length of coil is comprised of a coil of deposited metal having ribbon-shaped winds.

12. An apparatus for removing an obstruction from a vessel according to claim 6, wherein said abrasive surface covers the approximate half of said length of coil adjacent to said tip of said catheter.

13. An apparatus for removing an obstruction from a vessel according to claim 6, wherein said abrasive surface covers the approximate half of said length of coil adjacent to said tip of said catheter and the entire exposed surface of said tip of said catheter.

14. An apparatus for removing an obstruction from a vessel according to claim 6, wherein said abrasive surface covers approximately all of the outer surface of said length of coil .Iadd.with sharp projecting members.Iaddend..

15. An apparatus for removing an obstruction from a vessel according to claim 6, wherein said abrasive surface covers approximately all of the outer surface of said length of coil and the exposed outer surface of said tip of said catheter.

16. An apparatus for removing an obstruction from a vessel according to claim 6, wherein said abrasive surface is selected from the group of diamond particles, synthetic diamond particles or a peened surface.

17. An apparatus for removing an obstruction from a vessel according to claim 6, .[.wherein said tubular catheter is comprised of a flexible biocompatible material.]. .Iadd.further including a guidewire passing through said central lumen.Iaddend..

18. An apparatus for removing an obstruction from a vessel according to claim 17, wherein said coil is comprised of a wire with a rounded outer surface.

19. An apparatus for removing an obstruction from a vessel according to claim 17, wherein said coil is comprised of a coil of deposited metal having ribbon-shaped winds.

20. An apparatus for removing an obstruction from a vessel according to claim 17, wherein said abrasive surface covers the approximate half of said coil adjacent to said tip of said catheter.

21. An apparatus for removing an obstruction from a vessel according to claim 17, wherein said abrasive surface covers the approximate half of said coil adjacent to said tip of said catheter and the entire exposed surface of said tip of said catheter.

22. An apparatus for removing an obstruction from a vessel according to claim 17, wherein said abrasive surface covers approximately all of the outer surface of said coil.

23. An apparatus for removing an obstruction from a vessel according to claim 17, wherein said abrasive surface covers approximately all of the outer surface of said coil and the exposed outer surface of said tip of said catheter.

24. An apparatus for removing an obstruction from a vessel according to claim 17, wherein said abrasive surface is selected from the group of diamond particles, synthetic diamond particles or a peened surface.

25. An apparatus for removing an obstruction from a vessel according to claim 17, wherein said expandable means is comprised of a balloon that can be selectively inflated and deflated.

26. An apparatus for removing an obstruction from a vessel of claim 17, wherein at least one end of said coil is fixed to said catheter.

27. An apparatus for removing an obstruction from a vessel according to claim 6, wherein said elongation means is comprised of a remotely actuated piston engageable with said length of coil to retract and extend said length of coil to and from the ovaloid shape.

28. An apparatus for removing an obstruction from a vessel according to claim 6, wherein said elongation means is comprised of a remotely actuated bellows engageable with said length of coil to retract and extend said length of coil to and from the ovaloid shape.

29. An apparatus for removing an obstruction from a vessel according to claim 6, wherein said tubular catheter comprises an inner flexible catheter coil substantially concentrically and coaxially disposed within an outer flexible drive shaft coil, said tip of said tubular catheter being fixed to the terminal end of said inner flexible catheter coil, said terminal end of said length of coil which is attached to said tip of said tubular catheter being the distal end of said length of coil, said means for rotating said length of coil comprising said outer flexible drive shaft coil, said outer flexible drive shaft coil being fixed to the proximal end of said length of coil, said elongation means comprising an inner slide sleeve fixed at its distal end to said tip of said catheter and at its proximal end to said inner flexible catheter coil, an outer slide sleeve rotationally and longitudinally axially slidably disposed around said inner slide sleeve, the proximal end of said outer slide sleeve being disposed within said proximal end of said length of coil, said inner flexible catheter coil being longitudinally axially movable within said outer drive shaft coil.

30. An apparatus for removing an obstruction from a vessel according to claim 6, wherein said tubular catheter is comprised of a flexible biocompatible material.

31. An apparatus for removing an obstruction from a vessel, comprising:

a coil capable of an enlarged circumference forming a bulge in said coil after partial unwinding and compression of said coil;

said coil having an abrasive surface covering at least part of its outer surface;

means for rotating said coil;

a tubular catheter with a central lumen;

said catheter terminating in a tip with an opening in the tip communicating with the central lumen of the catheter;

said coil surrounding the terminal end of said catheter;

an expandable means disposed between said catheter and said coil and engageable with the inner surface of said coil when activated to expand said coil and allow the free end of said coil to unwind and at the same time to allow for compression of the length of said coil thereby enlarging the circumference and diameter of said coil, and upon deactivation contracting away from said inner surface of said coil allowing said coil to rewind and assume its smaller circumference and diameter; and

means for remotely activating the expandable means to selectively increase and decrease the diameter of said coil.

32. An apparatus for removing an obstruction from a vessel according to claim 31, wherein said means for rotating said coil comprises a drive shaft coil powered to rotate said expandable coil at selected speeds from 0 rpm up to about 300,000 rpm.

33. An apparatus for removing an obstruction from a vessel according to claim 31, wherein said coil is comprised of miltifilar coil wire.

34. An apparatus for removing an obstruction from a vessel according to claim 31, wherein said coil is comprised of a wire with a flat outer surface.

35. An apparatus for removing an obstruction from a vessel, comprising:

a coil;

the diameter of said coil being changeable by winding and unwinding said coil;

means for selectively winding and unwinding said coil for effecting such change in diameter of said coil;

means for introducing said coil in the vessel proximate to the obstruction;

said coil having .[.an abrasive.]. .Iadd.a grainy .Iaddend.surface covering at least part of its outer surface .Iadd.for removing the obstruction by sanding.Iaddend.; and

means for selectively rotating said coil.

36. A method for removing an obstruction from a vessel, comprising .[.the steps of.].:

introducing a variable diameter coil .[.with an abrasive.]. .Iadd.treated to form a .Iaddend.surface .Iadd.with sharp edges .Iaddend.covering at least part of its outer surface into the vessel proximate to the obstruction in a reduced coil diameter state;

unwinding the coil at the site of the obstruction to increase the diameter of the coil;

rotating the increased diameter coil at high speed .Iadd.for the sharp edges .Iaddend.to .[.abrade.]. .Iadd.grind .Iaddend.away the obstruction;

subsequent to such high speed rotation, rewinding the coil to reduce its diameter; and

withdrawing the coil from the vessel.

37. A method for removing an obstruction from a vessel according to claim 36, comprising the additional step, prior to the introducing step, of winding the coil to reduce its diameter.

38. A method for removing an obstruction from a vessel, comprising .[.the steps of.].:

introducing a variable diameter coil with .[.an abrasive.]. .Iadd.a .Iaddend.surface .Iadd.coated with an abrasive .Iaddend.covering at least part of its outer surface into the vessel proximate to the obstruction in a reduced coil diameter state;

axially compressing the coil at the site of the obstruction to increase the diameter of the coil;

rotating the increased diameter coil at high speed .[.to abrade away the obstruction.].;

.Iadd.frictionally engaging the obstruction with the abrasive coating to remove the obstruction by grinding;

.Iaddend.

subsequent to such high speed rotation, axially elongating the coil to reduce its diameter; and

withdrawing the coil from the vessel.

39. A method for removing an obstruction from a vessel according to claim 38, comprising the additional step, prior to the introducing step, of axially elongating the coil to reduce its diameter.

40. A method for removing an obstruction from a vessel, comprising the steps of:

introducing a variable diameter coil with an abrasive surface covering at least part of its outer surface into the vessel proximate to the obstruction in a reduced coil diameter state;

activating an expansion means disposed within said coil into expanding engagement with the interior of said coil to increase its diameter;

rotating the increased diameter coil at high speed to abrade away the obstruction;

subsequent to such high speed rotation, deactivating the expansion means to remove it from expanding engagement with the interior of said coil to reduce its diameter; and

withdrawing the coil from the vessel. .Iadd.

41. An apparatus for removing an obstruction from a vessel, comprising:

an adjustable diameter tip;

said adjustable diameter tip being capable of elongation thereby reducing its diameter as said tip is elongated;

an elongator engageable with said tip and movable between first and second positions wherein said adjustable diameter tip is elongated in one of said positions;

an introducer extendable inside the vessel proximate to the obstruction, wherein said introducer supports said adjustable diameter tip;

said adjustable diameter tip having at least part of its outer surface treated to form a roughened surface;

a drive shaft connected to said tip and being capable of selectively rotating said adjustable diameter tip; and

said roughened surface being formed by a plurality of projections on said outer surface..Iaddend..Iadd.

42. An apparatus for removing an obstruction from a vessel according to claim 41 wherein said projections have a size of at least 10 microns..Iaddend..Iadd.43. An apparatus for removing an obstruction from a vessel according to claim 41 wherein said projections have sharp edges..Iaddend..Iadd.44. An apparatus for removing an obstruction from a vessel, comprising:

a coil;

said coil being capable of elongation thereby reducing the circumference as said coil is elongated;

an elongator attached to said coil and movable between first and second positions wherein said coil is elongated in one of said positions;

an introducer extendable inside the vessel proximate to the obstruction, wherein said introducer supports said coil;

said coil having at least part of its outer surface treated to form a roughened surface;

a drive shaft attached to said coil and capable of selectively rotating said coil; and

said coil including a wire-like member having a plurality of projections formed thereon and said wire-like member having an axis which is

44. obstruction and grinding the obstruction for removal..Iaddend..Iadd.48. An apparatus for removing an obstruction from a vessel, comprising:

an expandable removal member having a plurality of wire-like members which traverse the longitudinal axis of the vessel;

said expandable removal member being capable of elongation thereby reducing the circumference as said expandable removal member is elongated;

an elongator engageable with said expandable removal member and movable between a first position and a second position wherein said expandable removal member is elongated in one of said positions;

an introducer extendable inside the vessel proximate to the obstruction, wherein said introducer supports said expandable removal member;

said expandable removal member having at least part of its outer surface processed to form a roughened surface;

a drive shaft attached to said expandable removal member and being capable of selectively rotating said expandable removal member; and

said outer surface of said expandable removal member being processed to

43. transverse to the longitudinal axis of the vessel..Iaddend..Iadd.45. An apparatus for removing an obstruction from a vessel according to claim 44 wherein said wire-like member forms a spiral..Iaddend..Iadd.46. An apparatus for removing an obstruction from a vessel, comprising:

a coil;

said coil being capable of elongation thereby reducing the circumference as said coil is elongated;

an elongator engageable with said coil and movable between first and second positions wherein said coil is elongated in one of said positions;

an introducer extendable inside the vessel proximate to the obstruction;

said coil having at least part of its outer surface treated to form a roughened surface;

a drive shaft attached to said coil and supported by said introducer; and

said drive shaft being capable of rotating said coil at least 100,000 revolutions per minute..Iaddend..Iadd.47. An apparatus for removing an obstruction from a vessel, comprising;

a coil;

said coil being capable of elongation thereby reducing the circumference as said coil is elongated;

an elongator engageable with said coil and movable between a first position and a second position wherein said coil is elongated in one of said positions;

said coil having at least part of its outer surface treated to form a roughened surface;

a drive shaft attached to said coil and being capable of selectively rotating said coil; and

said roughened surface being capable of frictionally engaging the

50. capable of positively shifting said inner member..Iaddend..Iadd.66. An apparatus for removing an obstruction from a vessel, comprising:

a motor;

an expandable removal member having a plurality of wire-like members insertable into the vessel;

a hollow drive shaft operatively connecting said motor to said removal member and being capable of rotating said removal member within the vessel;

a hollow inner member insertable through said removal member and said hollow drive shaft;

said inner member being shiftable within said drive shaft and said removal member;

said removal member being responsive to shifting said inner member;

a control member operatively connected to said inner member and being capable of positively shifting said inner member; and

a guidewire extending through said inner member..Iaddend..Iadd.67. The apparatus of claim 65 wherein said removal element includes an abrasive disposed thereon..Iaddend..Iadd.68. An apparatus for removing an obstruction from a vessel, comprising;

a motor;

an expandable removal member insertable into the vessel;

a hollow drive shaft operatively connecting said motor to said removal member and being capable of rotating said removal member within the vessel;

an inner member insertable through said removal member and said hollow drive shaft;

said inner member being shiftable within said drive shaft and said removal member;

said removal member being responsive to shifting said inner member;

a control member operatively connected to said inner member and being capable of positively shifting said inner member; and

said removal element having a proximal end and a distal end, said proximal end being connected to said drive shaft and said distal end being connected to an annular member with an aperture with said inner member

51. extending into said aperture..Iaddend..Iadd.69. An apparatus for removing an obstruction from a vessel, comprising:

a motor;

an expandable removal member insertable into the vessel;

a hollow drive shaft operatively connecting said motor to said removal member and being capable of rotating said removal member within the vessel;

an inner member insertable through said removal member and said hollow drive shaft;

said inner member being shiftable within said drive shaft and said removal member;

said removal member being responsive to shifting said inner member;

a control member operatively connected to said inner member and being capable of positively shifting said inner member; and

said removal element having a distal end with a tip having an abrasive

52. surface..Iaddend..Iadd.70. An apparatus for removing an obstruction from a vessel, comprising:

a motor;

an expandable removal member insertable into the vessel;

a hollow drive shaft operatively connecting said motor to said removal member and being capable of rotating said removal member within the vessel;

an inner member insertable through said removal member and said hollow drive shaft;

said inner member being shiftable within said drive shaft and said removal member;

said removal member being responsive to shifting said inner member;

a control member operatively connected to said inner member and being capable of positively shifting said inner member; and

said removal element including a plurality of helical wires forming a ridged surface..Iaddend..Iadd.71. An apparatus for removing an obstruction from a vessel, comprising;

a motor;

an expandable removal member insertable into the vessel;

a hollow drive shaft operatively connecting said motor to said removal member and being capable of rotating said removal member within the vessel;

an inner member insertable through said removal member and said hollow drive shaft;

said inner member being shiftable within said drive shaft and said removal member;

said removal member being responsive to shifting said inner member;

a control member operatively connected to said inner member for positively shifting said inner member; and

53. said drive shaft comprising a coil..Iaddend..Iadd.72. The apparatus of claim 71 further comprising a sheath over said coil..Iaddend..Iadd.73. An apparatus for removing an obstruction from a vessel, comprising:

a removal member which is expandable and insertable in the vessel for removing the obstruction;

an expansion control operatively associated with said expandable removal member and being capable of limiting expansion of said expandable removal member; and

said expansion control including a first member connected to one end of said removal member and a second member connected to another end of said removal member, said first and second members engaging to limit the expansion of said removal member..Iaddend..Iadd.74. An apparatus for removing an obstruction from a vessel, comprising;

a removal member which is expandable and insertable in the vessel to remove the obstruction;

an expansion control operatively associated with said expandable removal member to limit expansion of said expandable removal member; and

said expansion control including an expandable member having a first end connected to one end of said removal member and a second end connected to another end of said removal member to limit the expansion of said removal

46. the obstruction..Iaddend..Iadd.53. An apparatus for removing an obstruction from a vessel, comprising:

an abrasive member forming an expandable circumferential outer surface;

said abrasive member being capable of increasing the circumference of said outer surface;

said expandable circumferential outer surface forming a continuous surface without apertures therethrough which would otherwise allow the passage through said outer surface of particles removed from the obstruction;

said expandable continuous circumferential outer surface having an abrasive surface covering at least part of said outer surface;

an actuator attached to said coil and being movable between first and second positions wherein the circumference of said abrasive member is increased in one of said positions;

an introducer extending inside the vessel proximate to the obstruction wherein said introducer supports said abrasive member; and

a drive member attached to said abrasive member and being capable of selectively rotating said abrasive member..Iaddend..Iadd.54. The apparatus of claim 53 wherein said expandable circumferential outer surface is maintained as a continuous outer surface as the circumference of said

47. abrasive member is increased..Iaddend..Iadd.55. The apparatus of claim 53 wherein said abrasive member is a coil having a plurality of spiral wire-like members which are in continuous contact as the circumference of said abrasive member is increased..Iaddend..Iadd.56. The apparatus of claim 55 wherein said spiral wire-like members form a continuous ridged outer surface..Iaddend..Iadd.57. An apparatus for removing an obstruction from a vessel, comprising:

a coil;

said coil being capable of having its circumference reduced;

said coil having an abrasive surface covering at least part of its outer surface;

a closure member disposed within said coil and being capable of preventing the passage into the apparatus of any particles removed from the obstruction;

a mover attached to said coil and being capable of moving said coil between first and second positions wherein the circumference of said coil is reduced in one of said positions;

an introducer extendable inside the vessel proximate to the obstruction wherein said introducer supports said mover; and

a drive shaft attached to said coil and being capable of selectively rotating said coil..Iaddend..Iadd.58. An apparatus for removing an obstruction from a vessel, comprising;

a removal member having an expandable and contractible circumference and first and second ends;

a stationary member connected to said first end wherein said first end is held against rotation;

a rotatable member connected to said second end wherein said second end is capable of being rotated with respect to said first end; and

said circumference being expanded upon rotation of said rotatable member in one direction and contracted upon rotation of said rotatable member in an

54. member..Iaddend..Iadd.75. A method for removing an obstruction from a vessel comprising:

navigating a guidewire to the obstruction;

navigating a removal member having a plurality of wire-like members to the obstruction over the guidewire;

compressing and expanding the wire-like members;

limiting the expansion of the wire-like members;

energizing the removal member to remove the obstruction; and

frictionally engaging the obstruction with an abrasive on the wire-like members to remove the obstruction..Iaddend..Iadd.76. A method for removing an obstruction from a vessel comprising;

navigating a guidewire to the obstruction;

navigating a removal member to the obstruction over the guidewire;

expanding the removal member;

engaging the removal member with another member disposed around the guidewire near the obstruction to limit the expansion of the removal member;

energizing the removal member to remove the obstruction; and

55. variably expanding the removal member..Iaddend..Iadd.77. A method for removing an obstruction from a vessel comprising:

navigating a guidewire to the obstruction;

navigating a removal member having a plurality of wire-like members to the obstruction over the guidewire;

expanding the removal member;

engaging the removal member with another member disposed around the guidewire near the obstruction to limit the expansion of the removal member;

energizing the removal member to remove the obstruction; and

supplying a fluid to the removal member..Iaddend..Iadd.78. A method for removing an obstruction from a vessel comprising;

navigating a guidewire to the obstruction;

navigating a removal member to the obstruction over the guidewire;

expanding the removal member;

limiting the expansion of the removal member;

energizing the removal member to remove the obstruction; and

expanding a dilating member adjacent the obstruction..Iaddend..Iadd.79. The method of claim 75 wherein the limiting element includes abutting members connected to the ends of the removal member..Iaddend..Iadd.80. The method of claim 75 further including activating a motor capable of rotating the

58. vascular occlusion material..Iaddend..Iadd.94. An intravascular device as defined in claim 91 wherein at least a portion of said expandable removal element is made from a radiopaque material..Iaddend..Iadd.95. A vascular occlusion material removal device for removing vascular occlusion material in a vascular lumen, the material removal device comprising:

an expandable material removal element having a first and a second end and including a plurality of wires generally disposed between the first and second ends of the removal element, and the expandable material removal element being movable between an expanded position and a contracted position;

a drive shaft connected to the first end of the expandable material removal element and being capable of rotating the removal element;

an elongator operatively connected to the second end of the removal element and movable between first and second positions wherein said material removal element is operatively variably moved between the expanded position and the contracted position; and

at least one of said wires being treated to form sharp projections on the surface of said wires..Iaddend..Iadd.96. A vascular occlusion material removal device as defined in claim 95 further comprising a removal element expansion control to positively control movement of the removal element between the expanded position and the contracted position, the control

59. being adjacent the removal element..Iaddend..Iadd.97. A vascular occlusion material removal device as defined in claim 95 further comprising a dilatation member connected to the elongating member adjacent the removal element..Iaddend..Iadd.98. A vascular occlusion material removal device as defined in claim 95 further comprising an abrasive disposed on said at least one of the wires..Iaddend..Iadd.99. A vascular occlusion material removal device as defined in claim 98 wherein the abrasive comprises particles deposited on the surface of the wire..Iaddend..Iadd.100. A vascular occlusion material removal device as defined in claim 95 further comprising a cutting surface disposed distally on the removal element and capable of removing vascular occlusion material..Iaddend..Iadd.101. A vascular occlusion material removal device as defined in claim 95 wherein the expandable material removal element has an axial length and a radius;

and wherein the axial length is reducible responsive to shifting of the elongator with respect to the drive shaft, wherein the radius is expanded..Iaddend..Iadd.102. A vascular occlusion material removal device as defined in claim 95 wherein the wires are

45. form a plurality of raised surfaces..Iaddend..Iadd.49. An apparatus for removing an obstruction from a vessel according to claim 48 wherein an abrasive material is added to said outer surface..Iaddend..Iadd.50. An apparatus for removing an obstruction from a vessel according to claim 49 wherein said abrasive material has particles with a diameter in the range of 10 to about 100 microns..Iaddend..Iadd.51. An apparatus for removing an obstruction from a vessel according to claim 48 wherein said outer surface is peened to form raised projections on said outer surface..Iaddend..Iadd.52. An apparatus for removing an obstruction from a vessel, comprising:

a coil of a wire-like member forming a plurality of spirals;

said coil having a first position wherein the circumference of said coil is reduced and a second position wherein the circumference of said coil is increased;

said coil forming a continuous outer surface in said second position wherein the passage of particles are prevented from the obstruction into the interior of said coil;

said coil having an abrasive surface covering at least the outer circumference of said outer surface;

a movable member attached to said coil and capable of moving said coil between said first and second positions;

an introducer member extendable inside the vessel proximate to the obstruction; and

a rotatable member attached to said coil and being capable of selectively rotating said coil and causing said abrasive surface to engage and remove

48. opposite direction..Iaddend..Iadd.59. An apparatus for removing an obstruction from a vessel, comprising:

a removal member having an expandable surface and first and second ends;

an outer member connected to said first end;

an inner member extending through said removal member and connected to said second end;

one of said inner and outer members being rotatable with respect to the other; and

said removal member expanding upon said one of said inner and outer members being rotated with respect to the other..Iaddend..Iadd.60. The apparatus of claim 59 wherein said outer member includes a helically wound member..Iaddend..Iadd.61. The apparatus of claim 59 wherein said inner

49. member includes a helically wound member..Iaddend..Iadd.62. The apparatus of claim 59 wherein said removal member winds upon said rotation..Iaddend..Iadd.63. The apparatus of claim 59 wherein said removal member includes at least one helically wound member processed to form sharp raised surfaces..Iaddend..Iadd.64. The apparatus of claim 59 wherein one of said first and second ends is a distal end of said removal member and includes an abrading surface..Iaddend..Iadd.65. An apparatus for removing an obstruction from a vessel, comprising:

a rotating member;

an expandable removal member insertable into the vessel;

said expandable removal member including a plurality of wire-like members which traverse the longitudinal axis of the vessel and extend to a tip on the distal end of said expandable removal member;

a hollow drive shaft operatively connecting said rotating member to said removal member and being capable of rotating said removal member within the vessel;

a hollow inner member passing through said removal member and said hollow drive shaft and engaging said tip;

said inner member being shiftable within said drive shaft and said removal member;

said wire-like members being responsive to shifting said inner member; and

a control member operatively connected to said inner member and being

60. preformed..Iaddend..Iadd.103. A vascular occlusion removal device as defined in claim 95 further comprising an expansion control to limit expansion of the expandable material removal element..Iaddend..Iadd.104. A vascular occlusion material removal device as defined in claim 95 wherein the elongation member comprises a cylindrical portion having a hollow interior with an aperture in the cylindrical portion to allow fluid to flow through the interior of the cylindrical portion..Iaddend..Iadd.105. A vascular occlusion material removal device as defined in claim 95 further comprising a balloon member connected to the elongating member..Iaddend..Iadd.106. The device of claim 95 wherein the expandable removal element is sufficiently deformable so that the element assumes a configuration corresponding to the configuration defined by the non-occluded diameter upon expansion of the element..Iaddend..Iadd.107. The device of claim 95 wherein said projections are formed by peening the surface of the wires..Iaddend..Iadd.108. The device of class 95 wherein said removal element includes a plurality of groupings of said wires..Iaddend..Iadd.109. An apparatus for removing an obstruction from a vessel, comprising:

a drive shaft disposed within a catheter;

a helical coil mounted on the end of said drive shaft;

said coil having at least part of its outer surface treated to form a roughened surface; and

said drive shaft being capable of selectively rotating said coil to remove

61. the obstruction..Iaddend..Iadd.110. The apparatus of claim 109 wherein said coil includes a helical wire-like member..Iaddend..Iadd.111. The apparatus of claim 109 wherein said coil has an abrasive coating..Iaddend.