US20090234378A1 — Atherectomy devices and methods

Claim 1

Independent Claim 174 words

1 . A rotary tissue removal device for removing material from body lumens, the device comprising: a catheter body having a proximal end and a distal end and a catheter lumen extending therethrough where the elongate body has sufficient flexibility to navigate through tortuous anatomy; a housing located at the distal end of the catheter, the housing having at least one opening; a cutter rotatably located within the housing and having a plurality of fluted cutting edges located on both a near fluted cutting portion and a far fluted cutting portion, where the near fluted cutting portion and the far fluted cutting portion are spaced along an axis of the cutter and the far fluted cutting portion has fewer fluted cutting edges than the near fluted cutting portion, where on rotation of the cutter the fluted cutting edges remove material from the body lumen; and a rotatable torque shaft extending through the catheter lumen and having a first end coupled to the cutter and a second end adapted to couple to a rotating mechanism.

Claim 2

Dependent Claim 174 words

1 . A rotary tissue removal device for removing material from body lumens, the device comprising: a catheter body having a proximal end and a distal end and a catheter lumen extending therethrough where the elongate body has sufficient flexibility to navigate through tortuous anatomy; a housing located at the distal end of the catheter, the housing having at least one opening; a cutter rotatably located within the housing and having a plurality of fluted cutting edges located on both a near fluted cutting portion and a far fluted cutting portion, where the near fluted cutting portion and the far fluted cutting portion are spaced along an axis of the cutter and the far fluted cutting portion has fewer fluted cutting edges than the near fluted cutting portion, where on rotation of the cutter the fluted cutting edges remove material from the body lumen; and a rotatable torque shaft extending through the catheter lumen and having a first end coupled to the cutter and a second end adapted to couple to a rotating mechanism.

Claim 3

Dependent Claim 36 words

2 . The device of claim 1 , where the torque shaft includes an exterior surface having a raised portion helically located thereon such that upon rotation, the raised portion conveys materials in a proximal direction.

Claim 4

Dependent Claim 41 words

3 . The device of claim 1 , where the far cutting portion comprises two far fluted cutting edges symmetrically located about the axis, and where the near cutting portion comprises four near fluted cutting edges symmetrically located about the axis.

Claim 5

Dependent Claim 46 words

4 . The device of claim 1 , where the at least one opening comprises a plurality of openings, where the cutter is located within the housing such that upon rotation of the cutter the fluted cutting edges cut material through the openings in the housing.

Claim 6

Dependent Claim 33 words

5 . The device of claim 4 , where the openings are sufficiently large to expose a portion of the fluted cutting edges located on both the near and far fluted cutting portions.

Claim 7

Dependent Claim 44 words

6 . The device of claim 1 , where the housing comprising a cylindrical housing having an open front face, where an edge of a sidewall of the cylindrical housing comprises a front cutting surface, and where the cutter rotates within the cylindrical housing.

Claim 8

Dependent Claim 15 words

7 . The device of claim 6 , where the front cutting surface is beveled.

Claim 9

Dependent Claim 18 words

8 . The device of claim 6 , where the cylindrical housing is fixed relative to the cutter.

Claim 10

Dependent Claim 16 words

9 . The device of claim 6 , where the cylindrical housing rotates with the cutter.

Claim 11

Dependent Claim 70 words

10 . The device of claim 1 , 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 deflects.

Claim 12

Dependent Claim 38 words

11 . The device of claim 10 , where the sweep sheath is rotatable relative to the catheter such that upon rotation, the cutter sweeps in an arc having a radius greater than a radius of the cutter.

Claim 13

Dependent Claim 168 words

12 . A rotary tissue removal device for removing material from body lumens, the device comprising: a catheter body having a proximal end and a distal end and a catheter lumen extending therethrough where the elongate body has sufficient flexibility to navigate through tortuous anatomy; a housing located at the distal end of the catheter body, the housing having at least one opening; a cutter having being rotatably located within the housing and rotatable about an axis, and having a first plurality of cutting edges extending helically along the entire cutter, and a second plurality of cutting edges extending helically only along a portion of the cutter, where on rotation of the cutter the fluted cutting edges remove material from the body lumen through the opening in the housing and drive the cut material in a proximal direction; and a rotatable torque shaft extending through the catheter lumen and having a first end coupled to the cutter and a second end adapted to couple to a rotating mechanism.

Claim 14

Dependent Claim 168 words

12 . A rotary tissue removal device for removing material from body lumens, the device comprising: a catheter body having a proximal end and a distal end and a catheter lumen extending therethrough where the elongate body has sufficient flexibility to navigate through tortuous anatomy; a housing located at the distal end of the catheter body, the housing having at least one opening; a cutter having being rotatably located within the housing and rotatable about an axis, and having a first plurality of cutting edges extending helically along the entire cutter, and a second plurality of cutting edges extending helically only along a portion of the cutter, where on rotation of the cutter the fluted cutting edges remove material from the body lumen through the opening in the housing and drive the cut material in a proximal direction; and a rotatable torque shaft extending through the catheter lumen and having a first end coupled to the cutter and a second end adapted to couple to a rotating mechanism.

Claim 15

Dependent Claim 36 words

13 . The device of claim 12 , where the torque shaft includes an exterior surface having a raised portion helically located thereon such that upon rotation, the raised portion conveys materials in a proximal direction.

Claim 16

Dependent Claim 30 words

14 . The device of claim 12 , where the first plurality of cutting edges comprises two cutting edges, and where second plurality of cutting edges comprises four cutting edges.

Claim 17

Dependent Claim 41 words

15 . The device of claim 14 , where the first plurality of cutting edges are symmetrically located about the axis of the cutter, and where second plurality of cutting edges are symmetrically located about the axis of the cutting assembly.

Claim 18

Dependent Claim 59 words

16 . The device of claim 12 , where the at least one opening in the housing comprises a plurality of openings in a sidewall of the housing, where the cutter is located within the housing such that upon rotation of the cutter at least the first plurality of cutting edges cuts material through the openings in the housing.

Claim 19

Dependent Claim 29 words

17 . The device of claim 16 , where the openings are sufficiently large to expose a portion of both the first and second plurality of fluted cutting edges.

Claim 20

Dependent Claim 43 words

18 . The device of claim 12 , where the housing comprising a cylindrical housing having an open front face, where an edge of a sidewall of the housing comprises a front cutting surface, and where the cutter rotates within the cylindrical housing.

Claim 21

Dependent Claim 15 words

19 . The device of claim 18 , where the front cutting surface is beveled.

Claim 22

Dependent Claim 18 words

20 . The device of claim 18 , where the cylindrical housing is fixed relative to the cutter.

Claim 23

Dependent Claim 16 words

21 . The device of claim 18 , where the cylindrical housing rotates with the cutter.

Claim 24

Dependent Claim 71 words

22 . The device of claim 12 , 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 body, 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 deflects.

Claim 25

Dependent Claim 38 words

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

Claim 26

Dependent Claim 163 words

24 . A rotary tissue removal device for removing material from body lumens, the device comprising: a catheter body having a proximal end and a distal end and a catheter lumen extending therethrough where the elongate body has sufficient flexibility to navigate through tortuous anatomy; a housing located at the distal end of the catheter, the housing having at least one opening on a sidewall of the housing; a cutter having being rotatably located within the housing and rotatable about an axis, and having a first plurality of cutting edges extending helically along the entire cutter, and a second plurality of cutting edges extending helically only along a portion of the cutter, where on rotation of the cutter the cutting edges remove material from the body lumen through the opening in the housing; and a rotatable torque shaft extending through the catheter lumen and having a first end coupled to the cutter and a second end adapted to couple to a rotating mechanism.

Claim 27

Dependent Claim 163 words

24 . A rotary tissue removal device for removing material from body lumens, the device comprising: a catheter body having a proximal end and a distal end and a catheter lumen extending therethrough where the elongate body has sufficient flexibility to navigate through tortuous anatomy; a housing located at the distal end of the catheter, the housing having at least one opening on a sidewall of the housing; a cutter having being rotatably located within the housing and rotatable about an axis, and having a first plurality of cutting edges extending helically along the entire cutter, and a second plurality of cutting edges extending helically only along a portion of the cutter, where on rotation of the cutter the cutting edges remove material from the body lumen through the opening in the housing; and a rotatable torque shaft extending through the catheter lumen and having a first end coupled to the cutter and a second end adapted to couple to a rotating mechanism.

Claim 28

Dependent Claim 26 words

25 . The device of claim 24 , where the second plurality of cutting edges does not extend to a distal end of the cutting assembly.

Claim 29

Dependent Claim 21 words

26 . The device of claim 24 , where the first and second plurality of cutting edges are fluted cutting edges.

Claim 30

Dependent Claim 24 words

27 . The device of claim 24 , where the first plurality of cutting edges are symmetrically located about the axis of the cutter.

Claim 31

Dependent Claim 24 words

28 . The device of claim 24 , where the second plurality of cutting edges are symmetrically located about the axis of the cutter.

Claim 32

Dependent Claim 36 words

29 . The device of claim 24 , where the torque shaft includes an exterior surface having a raised portion helically located thereon such that upon rotation, the raised portion conveys materials in a proximal direction.

Claim 33

Dependent Claim 41 words

30 . The device of claim 24 , where the far cutting portion comprises two far fluted cutting edges symmetrically located about the axis, and where the near cutting portion comprises four near fluted cutting edges symmetrically located about the axis.

Claim 34

Dependent Claim 47 words

31 . The device of claim 24 , where the at least one opening on the sidewall of the housing comprises a plurality of openings such that upon rotation of the cutter the first and second fluted cutting edges cut material through the openings in the housing.

Claim 35

Dependent Claim 33 words

32 . The device of claim 24 , where the openings are sufficiently large to expose a portion of the fluted cutting edges located on both the near and far fluted cutting portions.

Claim 36

Dependent Claim 70 words

33 . The device of claim 24 , 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 deflects.

Claim 37

Dependent Claim 39 words

34 . The device of claim 33 , where the sweep sheath is rotatable relative to the catheter body such that upon rotation, the cutter sweeps in an arc having a radius greater than a radius of the cutter.

Claim 38

Dependent Claim 23 words

35 . The device of claim 24 , further comprising a guidewire lumen extending through the torque shaft and extending through the cutter.

Claim 39

Dependent Claim 76 words

36 . The device of claim 24 , further comprising a tapered member located on a front surface of the housing, the tapered member having a passage in fluid communication with the guidewire lumen and terminating at a guidewire opening at a distal end of the tapered member, such that as the tapered member advances through material in the body lumen, the tapered member dilates material away into the opening in the sidewall of the housing.

Claim 40

Dependent Claim 206 words

37 . A vascular device for separating and removing material from vessels and for use with a guidewire, the device comprising: a catheter body; a rotatable cutter having at least one cutting surface and a guidewire lumen extending therethrough; a housing containing the rotatable cutter having at least one cutting surface and having a plurality of openings located about a sidewall of the housing, where the cutter is configured to rotate within the housing about an axis of the cutter, where movement between the housing opening and the cutting surface removes material located therebetween; a dilator member having a passage extending therethrough and in fluid communication with the guidewire lumen, the conical dilator extending distally from a front of the housing, where the dilator member comprises a tapered shape having a smaller diameter surface at a distal tip and a larger diameter surface adjacent to the front of the housing, such that as the dilator member advances through material in the vessel, dilator member dilates material away from the guidewire and into the plurality of openings in the housing; and a 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.

Claim 41

Dependent Claim 206 words

37 . A vascular device for separating and removing material from vessels and for use with a guidewire, the device comprising: a catheter body; a rotatable cutter having at least one cutting surface and a guidewire lumen extending therethrough; a housing containing the rotatable cutter having at least one cutting surface and having a plurality of openings located about a sidewall of the housing, where the cutter is configured to rotate within the housing about an axis of the cutter, where movement between the housing opening and the cutting surface removes material located therebetween; a dilator member having a passage extending therethrough and in fluid communication with the guidewire lumen, the conical dilator extending distally from a front of the housing, where the dilator member comprises a tapered shape having a smaller diameter surface at a distal tip and a larger diameter surface adjacent to the front of the housing, such that as the dilator member advances through material in the vessel, dilator member dilates material away from the guidewire and into the plurality of openings in the housing; and a 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.

Claim 42

Dependent Claim 36 words

38 . The device of claim 37 , where the conical surface comprises a smooth surface to minimize interference of the conical surface against material when the housing is rotated or moved in an angular motion.

Claim 43

Dependent Claim 47 words

39 . The device of claim 37 , where the at least one cutting surface of the cutter includes a first plurality of cutting edges extending helically along the entire cutter, and a second plurality of cutting edges extending helically only along a portion of the cutter.

Claim 44

Dependent Claim 25 words

40 . The device of claim 39 , where the second plurality of cutting edges does not extend to a distal end of the cutter.

Claim 45

Dependent Claim 23 words

41 . The device of claim 39 , where each of the first plurality of cutting edges is symmetrically located about the axis.

Claim 46

Dependent Claim 23 words

42 . The device of claim 39 , where each of the second plurality of cutting edges is symmetrically located about the axis.

Claim 47

Dependent Claim 21 words

43 . The device of claim 39 , where the first and second plurality of cutting edges are fluted cutting edges.

Claim 48

Dependent Claim 46 words

44 . The device of claim 39 , where the at least one opening on the sidewall of the housing comprises a plurality of openings such that upon rotation of the cutter at least the first cutting edges cut material through the openings in the housing.

Claim 49

Dependent Claim 27 words

45 . The device of claim 44 , where the openings are sufficiently large to expose a portion of the first and second plurality of cutting edges.

Claim 50

Dependent Claim 36 words

46 . The device of claim 37 , where the torque shaft includes an exterior surface having a raised portion helically located thereon such that upon rotation, the raised portion conveys materials in a proximal direction.

Claim 51

Dependent Claim 70 words

47 . The device of claim 46 , 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 deflects.

Claim 52

Dependent Claim 39 words

48 . The device of claim 48 , where the sweep sheath is rotatable relative to the catheter body such that upon rotation, the cutter sweeps in an arc having a radius greater than a radius of the cutter.

Claim 53

Dependent Claim 25 words

49 . The device of claim 37 , further comprising a guidewire lumen extending through the torque shaft and extending through the cutter and housing.

Claim 54

Dependent Claim 147 words

50 . A method for debulking occlusive material within a totally or partially occluded blood vessel, the method comprising: positioning a guidewire adjacent to the occlusive material in the blood vessel; feeding a debulking device on the guidewire to the occlusive material, the debulking device having a cutter, where the cutter includes a housing having a plurality of openings located about the housing and containing a rotatable cutter configured to cut the occlusive material through the openings, where the debulking device further includes a conical dilator tip located at a front of the housing; rotating the rotatable cutter; dilating the occlusive material away from the guidewire and towards an opening in the housing by inserting the conical tip into the occlusive material; and debulking the occlusive material after dilating the occlusive material by cutting the occlusive material with the rotatable cutter through the opening in the housing.

Claim 55

Dependent Claim 147 words

50 . A method for debulking occlusive material within a totally or partially occluded blood vessel, the method comprising: positioning a guidewire adjacent to the occlusive material in the blood vessel; feeding a debulking device on the guidewire to the occlusive material, the debulking device having a cutter, where the cutter includes a housing having a plurality of openings located about the housing and containing a rotatable cutter configured to cut the occlusive material through the openings, where the debulking device further includes a conical dilator tip located at a front of the housing; rotating the rotatable cutter; dilating the occlusive material away from the guidewire and towards an opening in the housing by inserting the conical tip into the occlusive material; and debulking the occlusive material after dilating the occlusive material by cutting the occlusive material with the rotatable cutter through the opening in the housing.

Claim 56

Dependent Claim 49 words

51 . The method of claim 50 , further comprising deflecting the debulking device relative to an axis of the vessel and rotating the debulking device while rotating the rotatable cutter to form a second opening in the body lumen where the second is larger than the first opening.

Claim 57

Dependent Claim 31 words

52 . The method of claim 50 , where deflecting the debulking device relative to an axis of the vessel comprises advancing a pre-curved sweep sheath distally within the debulking device.

Claim 58

Dependent Claim 36 words

53 . The method of claim 50 , where a distal portion of the debulking device includes at least one fluid port coupled to a fluid source, and further comprising delivering fluid through the fluid port.

Claim 59

Dependent Claim 19 words

54 . The method of claim 53 , where delivering fluid comprises delivering a drug through the fluid port.

Claim 60

Dependent Claim 33 words

55 . The method of claim 50 , further comprising providing a helical conveyor member within the debulking device and transporting the debris material out of the body via the helical conveyor member.

Atherectomy devices and methods

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