US20080045986A1 — Atherectomy devices and methods

Claim 1

Independent Claim 151 words

1 . A device for removing material from body lumens, the device comprising: a catheter having a proximal end and a distal end and a catheter lumen extending therethrough; a cutter assembly rotatably coupled to the distal end of the catheter, the cutter assembly including a cutter having at least one fluted cutting edge, the cutter located within a cylindrical housing and exposed at a distal opening in the cylindrical housing, where an edge of the distal opening forms a forward cutting surface, where the cylindrical housing and cutter rotate to remove tissue; and a rotatable torque shaft extending through the catheter lumen and having a first end coupled to the cutter assembly and a second end adapted to couple to a rotating mechanism, an exterior surface of the torque shaft comprising a raised surface helically located thereon such that upon rotation, the raised surface conveys materials in a proximal direction.

Claim 2

Dependent Claim 151 words

1 . A device for removing material from body lumens, the device comprising: a catheter having a proximal end and a distal end and a catheter lumen extending therethrough; a cutter assembly rotatably coupled to the distal end of the catheter, the cutter assembly including a cutter having at least one fluted cutting edge, the cutter located within a cylindrical housing and exposed at a distal opening in the cylindrical housing, where an edge of the distal opening forms a forward cutting surface, where the cylindrical housing and cutter rotate to remove tissue; and a rotatable torque shaft extending through the catheter lumen and having a first end coupled to the cutter assembly and a second end adapted to couple to a rotating mechanism, an exterior surface of the torque shaft comprising a raised surface helically located thereon such that upon rotation, the raised surface conveys materials in a proximal direction.

Claim 3

Dependent Claim 19 words

2 . The device of claim 1 , where the cutter and cylindrical housing rotate in a first direction.

Claim 4

Dependent Claim 25 words

3 . The device of claim 1 , where the cutter rotates in a first direction and the cylindrical housing rotates in a second direction.

Claim 5

Dependent Claim 25 words

4 . The device of claim 1 , where the cutter rotates at a first rate and the cylindrical housing rotates at a second rate.

Claim 6

Dependent Claim 16 words

5 . The device of claim 4 , where the first and second rates are different.

Claim 7

Dependent Claim 20 words

6 . The device of claim 1 , where the catheter does not rotate upon rotation of the torque shaft.

Claim 8

Dependent Claim 20 words

7 . The device of claim 1 , where the cutter partially extends beyond the distal opening of the housing.

Claim 9

Dependent Claim 15 words

8 . The device of claim 1 , where the cutter comprises a dome-shaped profile.

Claim 10

Dependent Claim 19 words

9 . The device of claim 1 , where the cutter comprises a blunt nose at a distal end.

Claim 11

Dependent Claim 23 words

10 . The device of claim 1 , further comprising a tube member linking the housing to a distal end of the catheter

Claim 12

Dependent Claim 21 words

11 . The device of claim 1 , where the cutter comprises a steel material and is coated with titanium nitride.

Claim 13

Dependent Claim 16 words

12 . The device of claim 1 , where the cutter comprises a tungsten carbide material.

Claim 14

Dependent Claim 30 words

13 . The device of claim 1 , where the cylindrical housing comprises a steel material and where at least the forward cutting surface is coated with a titanium nitride.

Claim 15

Dependent Claim 17 words

14 . The device of claim 1 , where forward cutting surface is made of tungsten carbide

Claim 16

Dependent Claim 29 words

15 . The device of claim 1 , where the fluted cutting edge on the cutter is tangent to a helical path about the rotational axis of the cutter.

Claim 17

Dependent Claim 22 words

16 . The device of claim 1 , further comprising a guidewire lumen extending through the torque shaft and through the cutter

Claim 18

Dependent Claim 22 words

17 . The device of claim 16 , further comprising a guidewire extending through the guidewire lumen and distal to the cutter.

Claim 19

Dependent Claim 19 words

18 . The device of claim 17 , where a distal portion of the guidewire includes an anchoring mechanism.

Claim 20

Dependent Claim 42 words

19 . The device of claim 18 , where the anchoring mechanism comprises a structure selected from the group consisting of a self-expanding helical coil, a porous basket, a wire basket, a plurality of wires, and a pre-shaped section of the guidewire.

Claim 21

Dependent Claim 24 words

20 . The device of claim 1 , where a distal portion of the catheter is more flexible than a remainder of the catheter.

Claim 22

Dependent Claim 71 words

21 . The device of claim 20 , further comprising a sweep sheath located within the catheter lumen and exterior to the rotatable torque shaft, the sweep sheath being rotatable and axially moveable within the catheter, the sweep sheath also having a pre-set curved segment at a distal end thereof such that when the pre-set curve curved segment is in the flexible distal portion of the catheter, the cutter assembly deflects.

Claim 23

Dependent Claim 39 words

22 . The device of claim 21 , where the sweep sheath is rotatable relative to the catheter such that upon rotation, the cutter assembly sweeps in an arc having a radius greater than a radius of the catheter.

Claim 24

Dependent Claim 53 words

23 . The device of claim 21 , where a portion of the catheter lumen exterior to the sweep sheath permits delivery of fluid in a proximal to distal direction while the raised surface on the rotatable torque shaft permits simultaneous distal to proximal movement of material upon rotation of the torque shaft.

Claim 25

Dependent Claim 26 words

24 . The device of claim 21 , where the sweep sheath is lockable relative to the catheter to fix the deflection of the cutter assembly.

Claim 26

Dependent Claim 26 words

25 . The device of claim 21 , where the sweep sheath has sufficient friction against the catheter to fix the deflection of the cutter assembly.

Claim 27

Dependent Claim 39 words

26 . The device of claim 1 , where the catheter comprises at least one opening near the cutter assembly, where the opening is fluidly coupled to the shaft lumen and configured to allow flush fluid to be emitted.

Claim 28

Dependent Claim 24 words

27 . The device of claim 1 , where a port near the proximal end of the catheter is coupled to a fluid source.

Claim 29

Dependent Claim 21 words

28 . The device of claim 1 , where the proximal end of the catheter is coupled to a vacuum source.

Claim 30

Dependent Claim 19 words

29 . The device of claim 1 , further including a ferrule linking the cutter assembly to the catheter.

Claim 31

Dependent Claim 31 words

30 . The device of claim 1 , where the raised surface on the rotatable torque shaft is wound in the same rotational sense as the helical flutes on the cutter.

Claim 32

Dependent Claim 178 words

31 . A device for removing material from body lumens, the device comprising: a catheter having a proximal end and a distal end and a catheter lumen extending therethrough; a cutter located at the distal end of the catheter body, the cutter comprising a housing having at least one opening and a cutter configured to rotate within the housing, the cutter includes least one fluted cutting edge that cuts in a first direction that is tangential to the rotational direction of the cutter, and where the cutter further includes at least one forward cutting surface that cuts in a second cutting direction when the catheter is moved in a distal or proximal direction and that is parallel to axis of the vessel, a torque shaft extending through the catheter lumen and having a first end coupled to the cutter assembly and a second end adapted to couple to a rotating mechanism, an exterior surface of the torque shaft comprising a raised surface helically located thereon such that upon rotation, the raised surface conveys materials in a proximal direction.

Claim 33

Dependent Claim 178 words

31 . A device for removing material from body lumens, the device comprising: a catheter having a proximal end and a distal end and a catheter lumen extending therethrough; a cutter located at the distal end of the catheter body, the cutter comprising a housing having at least one opening and a cutter configured to rotate within the housing, the cutter includes least one fluted cutting edge that cuts in a first direction that is tangential to the rotational direction of the cutter, and where the cutter further includes at least one forward cutting surface that cuts in a second cutting direction when the catheter is moved in a distal or proximal direction and that is parallel to axis of the vessel, a torque shaft extending through the catheter lumen and having a first end coupled to the cutter assembly and a second end adapted to couple to a rotating mechanism, an exterior surface of the torque shaft comprising a raised surface helically located thereon such that upon rotation, the raised surface conveys materials in a proximal direction.

Claim 34

Dependent Claim 23 words

32 . The device of claim 31 , further comprising a tube member linking the housing to a distal end of the catheter.

Claim 35

Dependent Claim 32 words

33 . The device of claim 31 , where the cutter is cylindrically shaped, and a proximal portion of the housing is cylindrical and a distal portion of the housing is tapered.

Claim 36

Dependent Claim 26 words

34 . The device of claim 31 , where forward cutting surface of the cutter is aligned approximately perpendicular to the rotational axis of the cutter.

Claim 37

Dependent Claim 43 words

35 . The device of claim 31 , where the cutter further includes a rearward cutting surface that cuts in a third cutting direction when the catheter moves in a proximal direction and that is parallel to the rotational axis of the cutter.

Claim 38

Dependent Claim 26 words

36 . The device of claim 35 , where rearward cutting surface of the cutter is aligned approximately perpendicular to the rotational axis of the cutter.

Claim 39

Dependent Claim 20 words

37 . The device of claim 31 , where the cutter comprises a steel material coated with a titanium nitride.

Claim 40

Dependent Claim 16 words

38 . The device of claim 31 , where the cutter comprises a tungsten carbide material.

Claim 41

Dependent Claim 26 words

39 . The device of claim 31 , where the fluted cutting edge is tangent to a helical path about the rotational axis of the cutter.

Claim 42

Dependent Claim 22 words

40 . The device of claim 31 , further comprising a guidewire lumen extending through the torque shaft and through the cutter.

Claim 43

Dependent Claim 22 words

41 . The device of claim 40 , further comprising a guidewire extending through the guidewire lumen and distal to the cutter.

Claim 44

Dependent Claim 19 words

42 . The device of claim 41 , where a distal portion of the guidewire includes an anchoring mechanism.

Claim 45

Dependent Claim 42 words

43 . The device of claim 42 , where the anchoring mechanism comprises a structure selected from the group consisting of a self-expanding helical coil, a porous basket, a wire basket, a plurality of wires, and a pre-shaped section of the guidewire.

Claim 46

Dependent Claim 24 words

44 . The device of claim 31 , where a distal portion of the catheter is more flexible than a remainder of the catheter.

Claim 47

Dependent Claim 70 words

45 . The device of claim 44 , further comprising a sweep sheath located within the catheter lumen and exterior to the torque shaft, the sweep sheath being rotatable and axially moveable within the catheter, the sweep sheath also having a pre-set curved segment at a distal end thereof such that when the pre-set curve curved segment is in the flexible distal portion of the catheter, the cutter assembly deflects.

Claim 48

Dependent Claim 40 words

46 . The device of claim 44 , where the sweep sheath is rotatable relative to the catheter such that upon rotation, the cutter assembly sweeps in an arc having a diameter greater than the diameter of the cutter assembly.

Claim 49

Dependent Claim 53 words

47 . The device of claim 44 , where a portion of the catheter lumen exterior to the sweep sheath permits delivery of fluid in a proximal to distal direction while the raised surface on the rotatable torque shaft permits simultaneous distal to proximal movement of material upon rotation of the torque shaft.

Claim 50

Dependent Claim 26 words

48 . The device of claim 44 , where the sweep sheath is lockable relative to the catheter to fix the deflection of the cutter assembly.

Claim 51

Dependent Claim 24 words

49 . The device of claim 44 , where the has sufficient friction against the catheter to fix the deflection of the cutter assembly.

Claim 52

Dependent Claim 39 words

50 . The device of claim 31 , where the catheter comprises at least one opening near the cutter assembly, where the opening is fluidly coupled to the shaft lumen and configured to allow flush fluid to be emitted.

Claim 53

Dependent Claim 23 words

51 . The device of claim 31 , where the port near the proximal end of catheter is coupled to a fluid source.

Claim 54

Dependent Claim 21 words

52 . The device of claim 31 , where the proximal end of the catheter is coupled to a vacuum source.

Claim 55

Dependent Claim 19 words

53 . The device of claim 31 , further including a ferrule linking the cutter assembly to the catheter.

Claim 56

Dependent Claim 31 words

54 . The device of claim 31 , where the raised surface on the rotatable torque shaft is wound in the same rotational sense as the helical flutes on the cutter.

Claim 57

Dependent Claim 20 words

55 . The device of claim 31 , further comprising a burr rotatably located on a tip of the housing.

Claim 58

Dependent Claim 23 words

56 . The device of claim 31 , where the cutter comprises a plurality of flutes having a plurality of fluted cutting edges.

Claim 59

Dependent Claim 15 words

57 . The device of claim 56 , where the fluted cutting edges are helical.

Claim 60

Dependent Claim 40 words

58 . The device of claim 57 , where each flute is arranged relative to the opening in the housing such that during operation, a total length of the fluted cutting edge exposed through the housing openings remains the same.

Claim 61

Dependent Claim 54 words

59 . The device of claim 56 , where a portion of the housing comprises a curved surface and the opening forms a plane across the curved surface such that as the fluted cutting edge rotates across the opening, a portion of the fluted cutting edge extends out of the housing through the opening.

Claim 62

Dependent Claim 153 words

60 . A method for debulking material within a totally or partially occluded blood vessel, the method comprising: inserting a catheter body having a cutter assembly near a distal end of the catheter body within the blood vessel; rotating a cutter in the cutter assembly to form a first opening, where the cutter includes at least one fluted cutting surface and at least one forward cutting surface, where on rotation of the cutter the fluted cutting surface cuts tangential to a rotational direction of the cutter, and where the forward cutting surface cuts approximately parallel to the axis of the vessel; deflecting a distal portion of the catheter relative to an axis of the catheter body; and moving the cutter in an arc having a radius greater than a radius of the catheter body to form a second opening in the body lumen where the second opening is larger than the first opening.

Claim 63

Dependent Claim 153 words

60 . A method for debulking material within a totally or partially occluded blood vessel, the method comprising: inserting a catheter body having a cutter assembly near a distal end of the catheter body within the blood vessel; rotating a cutter in the cutter assembly to form a first opening, where the cutter includes at least one fluted cutting surface and at least one forward cutting surface, where on rotation of the cutter the fluted cutting surface cuts tangential to a rotational direction of the cutter, and where the forward cutting surface cuts approximately parallel to the axis of the vessel; deflecting a distal portion of the catheter relative to an axis of the catheter body; and moving the cutter in an arc having a radius greater than a radius of the catheter body to form a second opening in the body lumen where the second opening is larger than the first opening.

Claim 64

Dependent Claim 27 words

61 . The method of claim 60 , where moving the cutter in an arc comprises advancing a pre-curved sweep sheathSweep Sheath distally within the catheter body.

Claim 65

Dependent Claim 36 words

62 . The method of claim 60 , where a distal portion of the catheter body includes at least one fluid port coupled to a fluid source, and further comprising delivering fluid through the fluid port.

Claim 66

Dependent Claim 19 words

63 . The method of claim 62 , where delivering fluid comprises delivering a drug through the fluid port.

Claim 67

Dependent Claim 32 words

64 . The method of claim 60 , further comprising providing a helical conveyor member within the catheter body and transporting the debris material out of the body via helical conveyor member.

Claim 68

Dependent Claim 20 words

65 . The method of claim 60 , further comprising advancing a guidewire through the catheter body and cutter assembly.

Claim 69

Dependent Claim 55 words

66 . The method of claim 65 , further comprising deploying an anchoring mechanism from the distal portion of the guidewire, where the anchoring portion comprises a structure selected from the group consisting of a self-expanding helical coil, a porous basket, a wire basket, a plurality of wires, and a pre-shaped section of the guidewire.

Atherectomy devices and methods

Abstract

Inventors

Bibliographic Details

Claims Analysis

References Cited (Backward Citations)

USPTO Annuity & Maintenance Windows

Assigned Categories & Tags

Assign Category Tag