US20080004644A1 — Atherectomy devices and methods

Claim 1

Independent Claim 134 words

1 . A vascular device for removing material from body lumens, the device comprising: a catheter body having a proximal end and a distal end; a cutter assembly located at the distal end of the catheter body, the cutter assembly comprising a housing having at least one opening and a cutter having at least one cutting surface configured to rotate relative to the housing, where movement between the housing opening and the cutting surface removes material located therebetween; a rotating shaft extending through the catheter body and coupled to the cutter, the shaft having a proximal end adapted to couple to a first rotating mechanism; and a deflecting member extending along the catheter body, such that movement of the deflecting member causes deflection of the cutter assembly relative to an axis of the catheter.

Claim 2

Dependent Claim 134 words

1 . A vascular device for removing material from body lumens, the device comprising: a catheter body having a proximal end and a distal end; a cutter assembly located at the distal end of the catheter body, the cutter assembly comprising a housing having at least one opening and a cutter having at least one cutting surface configured to rotate relative to the housing, where movement between the housing opening and the cutting surface removes material located therebetween; a rotating shaft extending through the catheter body and coupled to the cutter, the shaft having a proximal end adapted to couple to a first rotating mechanism; and a deflecting member extending along the catheter body, such that movement of the deflecting member causes deflection of the cutter assembly relative to an axis of the catheter.

Claim 3

Dependent Claim 18 words

2 . The device of claim 1 , where the catheter body is coupled to a fluid source.

Claim 4

Dependent Claim 18 words

3 . The device of claim 1 , where the catheter body is coupled to a vacuum source.

Claim 5

Dependent Claim 18 words

4 . The device of claim 1 , where the rotating shaft is coupled to a rotating mechanism.

Claim 6

Dependent Claim 21 words

5 . The device of claim 1 , where the deflecting member comprises a steerable sheath adapted to deflect in shape.

Claim 7

Dependent Claim 34 words

6 . The device of claim 5 , where the steerable sheath comprises a deflecting wire extending through a portion of the sheath, such that axial movement of the deflecting wire deflects the sheath.

Claim 8

Dependent Claim 18 words

7 . The device of claim 6 , where the deflecting wire is affixed to the cutter assembly.

Claim 9

Dependent Claim 28 words

8 . The device of claim 6 , where the deflecting wire is affixed to a portion of the catheter body that extends out of the deflecting sheath.

Claim 10

Dependent Claim 17 words

9 . The device of claim 5 , where the sheath is rotatable about the catheter body.

Claim 11

Dependent Claim 19 words

10 . The device of claim 5 , where the sheath is rotatable about an axis of the catheter.

Claim 12

Dependent Claim 41 words

11 . The device of claim 1 , where the deflecting member comprises a pre-shaped mandrel slidably located in the catheter body, where at least the distal end the catheter body assumes the shape of the pre-shaped mandrel when advanced therein.

Claim 13

Dependent Claim 41 words

12 . The device of claim 1 , where the deflecting member comprises a pre-shaped tube slidably located in the catheter body, where at least the distal end the catheter body assumes the shape of the pre-shaped mandrel when advanced therein.

Claim 14

Dependent Claim 44 words

13 . The device of claim 1 , where the deflecting member comprises a slidable sheath having a fixed curved shape, such that advancement of the slidable sheath over the catheter body causes the catheter body to assume the curved shape of the sheath.

Claim 15

Dependent Claim 17 words

14 . The device of claim 13 , where the sheath is rotatable about the catheter body.

Claim 16

Dependent Claim 17 words

15 . The device of claim 13 , where the catheter body is rotatable within the sheath.

Claim 17

Dependent Claim 21 words

16 . The device of claim 1 , where the deflecting member comprises a steerable guidewire extending through the catheter body.

Claim 18

Dependent Claim 52 words

17 . The device of claim 1 , where the deflecting member comprises a mandrel slidably located in the catheter body and extendable out of a distal surface of the catheter body, where upon extending out of the distal surface pushes against tissue to deflect the distal end of the catheter body.

Claim 19

Dependent Claim 52 words

18 . The device of claim 1 , where a portion of the housing comprises a curved surface and the opening forms a plane across the curved surface such that as the cutting surface rotates across the opening, a portion of the cutting surface extends out of the housing through the opening.

Claim 20

Dependent Claim 25 words

19 . The device of claim 1 , where the torque shaft and cutter each have a lumen allowing for advancement of a guidewire therethrough.

Claim 21

Dependent Claim 31 words

20 . The device of claim 1 , further comprising a guidewire track having a lumen, where at least a portion of the guidewire track is exterior to the catheter body.

Claim 22

Dependent Claim 24 words

21 . The device of claim 1 , cutter comprises a plurality of flutes and the cutting surface is an edge of the flute.

Claim 23

Dependent Claim 17 words

22 . The device of claim 21 , where the cutting surface of the flute is helical.

Claim 24

Dependent Claim 39 words

23 . The device of claim 21 , where each flute is arranged relative to the openings in the housing such that during operation, a total length of the cutting surface exposed through the housing openings remains the same.

Claim 25

Dependent Claim 24 words

24 . The device of claim 1 , further including a ferrule linking the housing to the said outer tube on the catheter body.

Claim 26

Dependent Claim 38 words

25 . The device of claim 1 , where the shaft has at least one helical conveyor member wound about an exterior such that rotation of the torque shaft conveys material along the length of the torque shaft.

Claim 27

Dependent Claim 27 words

26 . The device of claim 1 , where the helical conveyor member is wound in the same rotational sense as the helical flutes on the cutter

Claim 28

Dependent Claim 18 words

27 . The device of claim 1 , where a guide-wire portion is fixedly attached to the cutter.

Claim 29

Dependent Claim 23 words

28 . The device of claim 1 , where the deflecting member comprises a wire extending along a length of the flexible catheter.

Claim 30

Dependent Claim 17 words

29 . The device of claim 28 , where the wire is affixed to the cutter assembly.

Claim 31

Dependent Claim 21 words

30 . The device of claim 1 , further comprising a burr rotatably located on a tip of the cutter assembly.

Claim 32

Dependent Claim 21 words

31 . The device of claim 1 , where the deflecting member is lockable to fix the deflection of the catheter.

Claim 33

Dependent Claim 24 words

32 . The device of claim 1 , where the deflecting member has sufficient friction to lock the catheter relative to the deflecting member.

Claim 34

Dependent Claim 146 words

33 . A vascular device for removing material from body lumens, the device comprising: a straightening tube, having a straight distal portion; a catheter body having a proximal end and a distal end, the catheter body having a flexible section located towards the distal end, such that when located in the straight distal portion of the straightening tube the flexible section is less curved a cutter assembly located at the distal end of the catheter body, the cutter assembly comprising a housing having at least one opening and a cutter having at least one cutting surface configured to rotate relative to the housing, where movement between the housing opening and the cutting surface removes material located therebetween; and a rotating shaft extending through the catheter body and coupled to the cutter, the torque shaft having a proximal end adapted to couple to a first rotating mechanism.

Claim 35

Dependent Claim 146 words

33 . A vascular device for removing material from body lumens, the device comprising: a straightening tube, having a straight distal portion; a catheter body having a proximal end and a distal end, the catheter body having a flexible section located towards the distal end, such that when located in the straight distal portion of the straightening tube the flexible section is less curved a cutter assembly located at the distal end of the catheter body, the cutter assembly comprising a housing having at least one opening and a cutter having at least one cutting surface configured to rotate relative to the housing, where movement between the housing opening and the cutting surface removes material located therebetween; and a rotating shaft extending through the catheter body and coupled to the cutter, the torque shaft having a proximal end adapted to couple to a first rotating mechanism.

Claim 36

Dependent Claim 51 words

34 . The vascular device of claim 33 , where the flexible section of the catheter body comprises a curved shape and the straight distal portion of the straightening tube comprises a substantially straight shape such that when located in the straight distal portion the flexible section of the catheter straightens.

Claim 37

Dependent Claim 47 words

35 . The vascular device of claim 34 , where the catheter body is coupled to a second rotating mechanism, such that when the curved section is advanced out of the straightening tube, rotation of the catheter body causes the cutter assembly to move in an arc.

Claim 38

Dependent Claim 34 words

36 . The vascular device of claim 35 , further comprising a locking hub configured to lock the catheter body relative to the straightening tube such that the arc may have a constant radius.

Claim 39

Dependent Claim 49 words

37 . The vascular device of claim 33 , where the flexible section of the catheter body comprises a substantially straight shape and the distal portion comprises a curved shape such that when located in the stiff distal section the flexible section of the catheter assumes the curved shape.

Claim 40

Dependent Claim 45 words

38 . The vascular device of claim 37 , where the outer sheath is coupled to a second rotating mechanism, such that when advanced over the in the stiff distal section, rotation of the catheter body causes the cutter assembly to move in an arc.

Claim 41

Dependent Claim 40 words

39 . The vascular device of claim 38 , further comprising a locking hub configured to lock the catheter body relative to the steering member body relative to the steering member such that the arc may have a constant radius.

Claim 42

Dependent Claim 52 words

40 . The device of claim 33 , where a portion of the housing comprises a curved surface and the opening forms a plane across the curved surface such that as the cutting surface rotates across the opening, a portion of the cutting surface extends out of the housing through the opening.

Claim 43

Dependent Claim 26 words

41 . The device of claim 33 , where the torque shaft and cutter assembly each have a lumen allowing for advancement of a guidewire therethrough.

Claim 44

Dependent Claim 24 words

42 . The device of claim 33 , cutter comprises a plurality of flutes where the cutting surface is an edge of the flute.

Claim 45

Dependent Claim 17 words

43 . The device of claim 42 , where the cutting surface of the flute is helical.

Claim 46

Dependent Claim 38 words

44 . The device of claim 42 , where each flute is arranged relative to the openings in the housing such that during a total length of the cutting surface exposed in the housing opening remains the same.

Claim 47

Dependent Claim 24 words

45 . The device of claim 33 , further including a ferrule linking the housing to the said outer tube on the catheter body.

Claim 48

Dependent Claim 38 words

46 . The device of claim 33 , where the shaft has at least one helical conveyor member wound about an exterior such that rotation of the torque shaft conveys material across a length of the torque shaft.

Claim 49

Dependent Claim 27 words

47 . The device of claim 33 , where the helical conveyor member is wound in the same rotational sense as the helical flutes on the cutter

Claim 50

Dependent Claim 18 words

48 . The device of claim 33 , where a guide-wire portion is fixedly attached to the cutter.

Claim 51

Dependent Claim 23 words

49 . The device of claim 33 , where the deflecting member comprises a wire extending along a length of the flexible catheter.

Claim 52

Dependent Claim 198 words

50 . A vascular device for removing material from body lumens, the device comprising: a steering member; a catheter body having a stiffer proximal portion and a more flexible distal portion; a steering member located along the catheter body, the steering member having a curved section located towards the distal end, where the curved section is more flexible than the stiffer proximal portion of the catheter body such that when located along the flexible portion the flexible distal portion of the catheter body takes the shape of the curved section a cutter assembly located at the distal end of the catheter body, the cutter assembly comprising a housing having at least one opening and a cutter having at least one cutting surface configured to rotate relative to the housing, where movement between the housing opening and the cutting surface removes material located therebetween; a rotating shaft extending through the catheter body and coupled to the cutter, the torque shaft having a proximal end adapted to couple to a first rotating mechanism; and where on advancement of the curved section of the steering member out of the distal portion of the sheath, the curved section reshapes the catheter body.

Claim 53

Dependent Claim 198 words

50 . A vascular device for removing material from body lumens, the device comprising: a steering member; a catheter body having a stiffer proximal portion and a more flexible distal portion; a steering member located along the catheter body, the steering member having a curved section located towards the distal end, where the curved section is more flexible than the stiffer proximal portion of the catheter body such that when located along the flexible portion the flexible distal portion of the catheter body takes the shape of the curved section a cutter assembly located at the distal end of the catheter body, the cutter assembly comprising a housing having at least one opening and a cutter having at least one cutting surface configured to rotate relative to the housing, where movement between the housing opening and the cutting surface removes material located therebetween; a rotating shaft extending through the catheter body and coupled to the cutter, the torque shaft having a proximal end adapted to couple to a first rotating mechanism; and where on advancement of the curved section of the steering member out of the distal portion of the sheath, the curved section reshapes the catheter body.

Claim 54

Dependent Claim 53 words

51 . The device of claim 50 , where the deflecting member comprises a mandrel slidably located in the catheter body and extendable out of a distal opening of the catheter body, where upon extending out of the distal opening to push against tissue to deflect the distal end of the catheter body.

Claim 55

Dependent Claim 52 words

52 . The device of claim 50 , where a portion of the housing comprises a curved surface and the opening forms a plane across the curved surface such that as the cutting surface rotates across the opening, a portion of the cutting surface extends out of the housing through the opening.

Claim 56

Dependent Claim 25 words

53 . The device of claim 50 , where the torque shaft and cutter each have a lumen allowing for advancement of a guidewire therethrough.

Claim 57

Dependent Claim 24 words

54 . The device of claim 50 , cutter comprises a plurality of flutes and the cutting surface is an edge of the flute.

Claim 58

Dependent Claim 16 words

55 . The device of claim 54 , where the edge of the flute is helical.

Claim 59

Dependent Claim 38 words

56 . The device of claim 54 , where each flute is arranged relative to the openings in the housing such that during a total length of the cutting surface exposed in the housing opening remains the same.

Claim 60

Dependent Claim 24 words

57 . The device of claim 50 , further including a ferrule linking the housing to the said outer tube on the catheter body.

Claim 61

Dependent Claim 38 words

58 . The device of claim 50 , where the shaft has at least one helical conveyor member wound about an exterior such that rotation of the torque shaft conveys material across a length of the torque shaft.

Claim 62

Dependent Claim 27 words

59 . The device of claim 50 , where the helical conveyor member is wound in the same rotational sense as the helical flutes on the cutter

Claim 63

Dependent Claim 18 words

60 . The device of claim 50 , where a guide-wire portion is fixedly attached to the cutter.

Claim 64

Dependent Claim 23 words

61 . The device of claim 50 , where the deflecting member comprises a wire extending along a length of the flexible catheter.

Claim 65

Dependent Claim 21 words

62 . The device of claim 50 , further comprising a burr rotatably located on a tip of the cutter assembly.

Claim 66

Dependent Claim 87 words

63 . A method for debulking material within a totally or partially occluded blood vessel, the method comprising: inserting a catheter body having a cutter assembly within the blood vessel; rotating the cutter assembly to remove the material and form a first opening in the body lumen; deflecting the first cutter assembly relative to an axis of the catheter body; rotating the catheter body while rotating the cutter assembly to form a second opening in the body lumen where the second is larger than the first opening.

Claim 67

Dependent Claim 87 words

63 . A method for debulking material within a totally or partially occluded blood vessel, the method comprising: inserting a catheter body having a cutter assembly within the blood vessel; rotating the cutter assembly to remove the material and form a first opening in the body lumen; deflecting the first cutter assembly relative to an axis of the catheter body; rotating the catheter body while rotating the cutter assembly to form a second opening in the body lumen where the second is larger than the first opening.

Claim 68

Dependent Claim 35 words

64 . The method of claim 63 , further comprising providing a burr surface on a distal end of the catheter body, and grinding a hardened material in the blood vessel with the burr surface.

Claim 69

Dependent Claim 40 words

65 . The method of claim 63 , where the cutter assembly comprises at least one cutter edge, where the cutter edge protrudes beyond an outer surface of a housing surrounding the cutter assembly to cut tissue outside the housing

Claim 70

Dependent Claim 30 words

66 . The method of claim 63 , where, the cutter is rotated such that only a partial number of cutter edges are aligned with the openings in the housing.

Claim 71

Dependent Claim 34 words

67 . The method of claim 63 , where the catheter body includes a guidewire lumen and where inserting the catheter body within the blood vessel comprises advancing the catheter body over a guidewire.

Claim 72

Dependent Claim 23 words

68 . The method of claim 63 , where the catheter head is deflected by a deflecting sheath coupled to the catheter body.

Claim 73

Dependent Claim 23 words

69 . The method of claim 68 , where the deflecting sheath is rotated to orient the deflected tip in the desired direction.

Claim 74

Dependent Claim 43 words

70 . The method of claim 63 , where the catheter head is deflected by a pre-shaped mandrel slidably located in the catheter body, where at least the distal end the catheter body assumes the shape of the pre-shaped mandrel when advanced therein.

Claim 75

Dependent Claim 42 words

71 . The method of claim 63 , where the catheter head is deflected by,a pre-shaped tube slidably located in the catheter body, where at least the distal end the catheter body assumes the shape of the pre-shaped mandrel when advanced therein

Claim 76

Dependent Claim 23 words

72 . The method of claim 63 , where deflecting the catheter body comprises advancing a pre-curved sheath distally along the catheter body.

Claim 77

Dependent Claim 26 words

73 . The method of claim 63 , where the catheter tip is deflected by positioning the offset curve on the wire near the catheter tip.

Claim 78

Dependent Claim 37 words

74 . The method of claim 63 , where deflecting the cutter assembly relative to the axis of the catheter body further includes locking the cutter assembly in position relative to the axis of the catheter body.

Claim 79

Dependent Claim 36 words

75 . The method of claim 63 , 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 80

Dependent Claim 19 words

76 . The method of claim 63 , further comprising withdrawing fluid and the material through the cutter assembly.

Claim 81

Dependent Claim 32 words

77 . The method of claim 76 , 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 82

Dependent Claim 44 words

78 . The method of claim 63 , further comprising providing a guidewire through the cutter assembly, where the guidewire includes a fluid delivery lumen terminating in a guidewire fluid delivery port, the method further comprising delivering fluid through the guidewire fluid delivery port

Claim 83

Dependent Claim 106 words

79 . A vascular device for removing material from body lumens, the device comprising: a catheter body having a proximal portion and a distal portion; a steering tube having varying stiffness along its circumference at the distal portion; a cutter assembly located at the distal end of the catheter body, the cutter assembly comprising a housing having at least one opening and a cutter having at least one cutting surface configured to rotate relative to the housing, where movement between the housing opening and the cutting surface removes material located there between; and the distal portion of the steering tube is attached to the cutter assembly.

Claim 84

Dependent Claim 106 words

79 . A vascular device for removing material from body lumens, the device comprising: a catheter body having a proximal portion and a distal portion; a steering tube having varying stiffness along its circumference at the distal portion; a cutter assembly located at the distal end of the catheter body, the cutter assembly comprising a housing having at least one opening and a cutter having at least one cutting surface configured to rotate relative to the housing, where movement between the housing opening and the cutting surface removes material located there between; and the distal portion of the steering tube is attached to the cutter assembly.

Claim 85

Dependent Claim 21 words

80 . A device of claim 79 , where tension on the steering tube deflects the distal portion of the catheter

Claim 86

Dependent Claim 21 words

81 . A device of claim 79 , where compression of the steering tube deflects the distal portion of the catheter.

Claim 87

Dependent Claim 43 words

82 . A vascular device for circulation of fluid for contrast, the device comprising: a support catheter body having a proximal end and a distal end, the distal end containing at least one port on the surface for injection or aspiration of fluid.

Claim 88

Dependent Claim 43 words

82 . A vascular device for circulation of fluid for contrast, the device comprising: a support catheter body having a proximal end and a distal end, the distal end containing at least one port on the surface for injection or aspiration of fluid.

Claim 89

Dependent Claim 22 words

83 . The device of claim 82 , where the support catheter body contains a mechanism to position itself within the vessel.

Claim 90

Dependent Claim 16 words

84 . The device of claim 83 , where the mechanism is at least one balloon.

Claim 91

Dependent Claim 16 words

85 . The device of claim 83 , where the mechanism is at least one basket.

Claim 92

Dependent Claim 16 words

86 . The device of claim 83 , where the mechanism is at least one coil.

Claim 93

Dependent Claim 16 words

87 . The device of claim 83 , where the mechanism is at least one leg.

Claim 94

Dependent Claim 16 words

88 . The device of claim 83 , where the mechanism is at least one loop.

Claim 95

Dependent Claim 28 words

89 . The device of claim 82 , where the support catheter body comprises a shoulder at the distal end that acts as a stop for a cutter.

Claim 96

Dependent Claim 16 words

90 . The device of claim 82 , where the support catheter comprises an atraumatic tip.

Claim 97

Dependent Claim 36 words

91 . The device of claim 83 , where the expanding member is configured to expand asymmetrically to angle the distal aspect of the support catheter relative to the proximal axis of the proximal vessel lumen.

Claim 98

Dependent Claim 66 words

92 . A device for supporting a catheter within a lumen of the body comprising: a proximal and a distal end; a central lumen; an expandable member near a distal portion of the device, where the member is configured to expand to position the centerline of the device at its distal end at some angular rotation and position relative to the centerline of the body lumen.

Claim 99

Dependent Claim 66 words

92 . A device for supporting a catheter within a lumen of the body comprising: a proximal and a distal end; a central lumen; an expandable member near a distal portion of the device, where the member is configured to expand to position the centerline of the device at its distal end at some angular rotation and position relative to the centerline of the body lumen.

Claim 100

Dependent Claim 44 words

93 . A device for debulking material in an occluded body lumen, the device comprising: a support catheter with a proximal and a distal end; a coring cutter with a mechanism that enables it to create a lumen through a fibrous or calcific cap.

Claim 101

Dependent Claim 44 words

93 . A device for debulking material in an occluded body lumen, the device comprising: a support catheter with a proximal and a distal end; a coring cutter with a mechanism that enables it to create a lumen through a fibrous or calcific cap.

Claim 102

Dependent Claim 42 words

94 . The device of claim 93 , where the support catheter comprises a support catheter body having a proximal end and a distal end, the distal end containing at least one port on the surface for injection or aspiration of fluid.

Claim 103

Dependent Claim 21 words

95 . The device of claim 93 , where the support catheter contains a mechanism to position itself within the vessel.

Claim 104

Dependent Claim 29 words

96 . The device of claim 93 , where the support catheter body comprises a shoulder at the distal end that acts as a stop for the coring cutter.

Claim 105

Dependent Claim 31 words

97 . The device of claim 93 , where the coring cutter comprises a shoulder at the distal end that allows it to stop against the shoulder of the support catheter.

Claim 106

Dependent Claim 23 words

98 . The device of claim 93 , where the coring cutter comprises a sharp edge at its tip at the distal end.

Claim 107

Dependent Claim 15 words

99 . The device of claim 93 , where the coring cutter comprises helical flutes.

Claim 108

Dependent Claim 15 words

100 . The device of claim 93 , where the coring cutter comprises helical grooves.

Claim 109

Dependent Claim 85 words

101 . A method for circulating fluid for contrast, the method comprising: inserting the support catheter within the blood vessel, where the support catheter comprises a support catheter body having a proximal end and a distal end, the distal end containing at least one port on the surface for injection or aspiration of fluid; injecting the fluid for contrast through a lumen or port in the support catheter body; and aspirating the fluid for contrast into a lumen or port in the support catheter body.

Claim 110

Dependent Claim 85 words

101 . A method for circulating fluid for contrast, the method comprising: inserting the support catheter within the blood vessel, where the support catheter comprises a support catheter body having a proximal end and a distal end, the distal end containing at least one port on the surface for injection or aspiration of fluid; injecting the fluid for contrast through a lumen or port in the support catheter body; and aspirating the fluid for contrast into a lumen or port in the support catheter body.

Claim 111

Dependent Claim 31 words

102 . The method of claim Error! Reference source not found., where the support catheter is centered within the blood vessel using at least one basket or at least one balloon.

Claim 112

Dependent Claim 73 words

103 . The method of claim Error! Reference source not found., further comprising: inserting a catheter body having a coring cutter assembly within the blood vessel; driving the coring cutter assembly through the tough fibrous cap in the vessel to form a first body opening in the vessel; removing the coring cutter assembly from the body; inserting a second cutter assembly with a guidewire, where the guidewire is inserted through the first opening.

Claim 113

Dependent Claim 22 words

104 . The method of claim 103 , where the coring cutter assembly contains a shoulder that rests upon the support catheter.

Claim 114

Dependent Claim 26 words

105 . The method of 103 , where the coring cutter assembly comprises a helical groove or cylinder to drive itself through the tough fibrous cap.

Claim 115

Dependent Claim 26 words

105 . The method of 103 , where the coring cutter assembly comprises a helical groove or cylinder to drive itself through the tough fibrous cap.

Claim 116

Dependent Claim 21 words

106 . The method of claim 103 , where the coring cutter collects the cored-out portion of the tough fibrous cap.

Atherectomy devices and methods

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