US20090018565A1 — Atherectomy devices, systems, and methods

Claim 1

Independent Claim 70 words

1 . A method comprising: introducing into a blood vessel a catheter having a tissue removal assembly at or near a distal portion of the catheter, the tissue removal assembly having a diameter, manipulating the tissue removal assembly to debulk tissue in the blood vessel, creating a cleared tissue diameter within the vessel of at least two times the diameter of the tissue removal assembly, and removing the cleared tissue.

Claim 2

Dependent Claim 70 words

1 . A method comprising: introducing into a blood vessel a catheter having a tissue removal assembly at or near a distal portion of the catheter, the tissue removal assembly having a diameter, manipulating the tissue removal assembly to debulk tissue in the blood vessel, creating a cleared tissue diameter within the vessel of at least two times the diameter of the tissue removal assembly, and removing the cleared tissue.

Claim 3

Dependent Claim 21 words

2 . A method according to claim 1 : further including removing the cleared tissue through a lumen in the catheter.

Claim 4

Dependent Claim 53 words

3 . A method according to claim 1 : wherein manipulating the tissue removal assembly further comprises, moving a deflection member in a first direction to radially deflect the distal portion of the catheter including the tissue removal assembly, and advancing the catheter in the vessel and clearing the blood vessel of tissue.

Claim 5

Dependent Claim 67 words

4 . A method according to claim 1 : wherein manipulating the tissue removal assembly further comprises, moving a deflection member in a first direction to radially deflect the distal portion of the catheter including the tissue removal assembly, and moving the deflection member in a second direction causing the deflected tissue removal assembly to rotate in an arcuate path and clearing the blood vessel of tissue.

Claim 6

Dependent Claim 74 words

5 . A method according to claim 1 : wherein manipulating the tissue removal assembly further comprises, moving a deflection member in a first direction to radially deflect the distal portion of the catheter including the tissue removal assembly, and moving the deflection member in a second direction causing the deflected tissue removal assembly to rotate in an arcuate path, and advancing the catheter in the vessel and clearing the blood vessel of tissue.

Claim 7

Dependent Claim 27 words

6 . A method according to claim 1 : wherein creating a cleared tissue diameter includes no more than one introducing the catheter into the blood vessel.

Claim 8

Dependent Claim 22 words

7 . A method according to claim 1 : wherein the tissue removal assembly is sized and configured for thrombectomy and/or atherectomy.

Claim 9

Dependent Claim 31 words

8 . A method according to claim 1 : further including creating a cleared tissue diameter within the vessel of at least three times the diameter of the tissue removal assembly.

Claim 10

Dependent Claim 31 words

9 . A method according to claim 1 : further including creating a cleared tissue diameter within the vessel of at least four times the diameter of the tissue removal assembly.

Claim 11

Dependent Claim 24 words

10 . A method according to claim 1 : further including introducing the catheter into the blood vessel using an 8Fr or smaller introducer.

Claim 12

Dependent Claim 26 words

11 . A method according to claim 10 : wherein the catheter is sized to allow contrast injection while residing in the 8Fr or smaller introducer.

Claim 13

Dependent Claim 97 words

12 . A method comprising: introducing into a blood vessel a catheter having a deflection segment at or near a distal portion of the catheter, the deflection segment having a length L, a straight axis S, and a deflected axis D, and manipulating a deflection member coupled to the catheter thereby deflecting the length L of the deflection segment from the straight axis S to the deflected axis D to create an angle A between the straight axis S and the deflected axis D, the angle having a range between about zero degrees and about ninety degrees.

Claim 14

Dependent Claim 97 words

12 . A method comprising: introducing into a blood vessel a catheter having a deflection segment at or near a distal portion of the catheter, the deflection segment having a length L, a straight axis S, and a deflected axis D, and manipulating a deflection member coupled to the catheter thereby deflecting the length L of the deflection segment from the straight axis S to the deflected axis D to create an angle A between the straight axis S and the deflected axis D, the angle having a range between about zero degrees and about ninety degrees.

Claim 15

Dependent Claim 21 words

13 . A method according to claim 12 : wherein the deflection member is positioned within a lumen of the catheter.

Claim 16

Dependent Claim 28 words

14 . A method according to claim 12 : wherein the length L of the deflection segment comprises a range between about zero mm and about fifteen mm.

Claim 17

Dependent Claim 24 words

15 . A method according to claim 12 : further including introducing the catheter into the blood vessel using an 8Fr or smaller introducer.

Claim 18

Dependent Claim 26 words

16 . A method according to claim 15 : wherein the catheter is sized to allow contrast injection while residing in the 8Fr or smaller introducer.

Claim 19

Dependent Claim 23 words

17 . A method according to claim 12 : wherein introducing includes no more than one introducing the catheter into the blood vessel.

Claim 20

Dependent Claim 22 words

18 . A method according to claim 12 : wherein the tissue removal assembly is sized and configured for thrombectomy and/or atherectomy.

Claim 21

Dependent Claim 72 words

19 . A system comprising: a catheter having a tissue removal assembly at or near a distal portion of the catheter, the tissue removal assembly having a diameter, a deflection member adapted to manipulate the tissue removal assembly to debulk tissue in the blood vessel, and the tissue removal assembly adapted to create a cleared tissue diameter within the vessel of at least two times the diameter of the tissue removal assembly.

Claim 22

Dependent Claim 72 words

19 . A system comprising: a catheter having a tissue removal assembly at or near a distal portion of the catheter, the tissue removal assembly having a diameter, a deflection member adapted to manipulate the tissue removal assembly to debulk tissue in the blood vessel, and the tissue removal assembly adapted to create a cleared tissue diameter within the vessel of at least two times the diameter of the tissue removal assembly.

Claim 23

Dependent Claim 32 words

20 . A system according to claim 19 : wherein the tissue removal assembly is sized and configured for removing tissue including acute thrombus, organized thrombus, atheroma, fibrous plaque, and calcified plaque.

Claim 24

Dependent Claim 83 words

21 . A system according to claim 19 : wherein the vessel is chosen from the group consisting of the brachial arteries, the common iliac arteries, the external iliac arteries, the internal iliac arteries, the femoral arteries, the profunda femoris arteries, the deep femoral arteries, the proximal superficial femoral arteries, arteries in the hunter's canal, the popliteal arteries, the posterior tibial arteries, the anterior tibial arteries, the peroneal arteries, the dorsalis pedis arteries, the medial and lateral plantar arteries, and the digital arteries.

Claim 25

Dependent Claim 101 words

22 . A system comprising: a catheter having a deflection segment at or near a distal portion of the catheter, the deflection segment having a length L, a straight axis S, and a deflected axis D, and a deflection member coupled to the catheter and adapted to manipulate the deflection segment of the catheter so as to deflect the length L of the deflection segment from the straight axis S to the deflected axis D to create an angle A between the straight axis S and the deflected axis D, the angle having a range between zero degrees and ninety degrees.

Claim 26

Dependent Claim 101 words

22 . A system comprising: a catheter having a deflection segment at or near a distal portion of the catheter, the deflection segment having a length L, a straight axis S, and a deflected axis D, and a deflection member coupled to the catheter and adapted to manipulate the deflection segment of the catheter so as to deflect the length L of the deflection segment from the straight axis S to the deflected axis D to create an angle A between the straight axis S and the deflected axis D, the angle having a range between zero degrees and ninety degrees.

Claim 27

Dependent Claim 28 words

23 . A system according to claim 22 : wherein the catheter is sized and configured for introduction into the blood vessel using an 8Fr or smaller introducer.

Claim 28

Dependent Claim 28 words

24 . A method according to claim 23 : wherein the catheter is sized and configured to allow contrast injection while residing in the 8Fr or smaller introducer.

Claim 29

Dependent Claim 19 words

25 . A system according to claim 22 : wherein the catheter is sized and configured for tissue debulking.

Claim 30

Dependent Claim 22 words

26 . A system according to claim 22 : wherein the tissue removal assembly is sized and configured for thrombectomy and/or atherectomy.

Claim 31

Dependent Claim 32 words

27 . A system according to claim 22 : wherein the tissue removal assembly is sized and configured for removing tissue including acute thrombus, organized thrombus, atheroma, fibrous plaque, and calcified plaque.

Claim 32

Dependent Claim 129 words

28 . A system comprising: a catheter assembly sized and configured to be introduced into a blood vessel, the catheter assembly including a tissue cutting assembly at or near a distal end of the catheter assembly, the tissue cutting assembly including a rotatable cutter for debulking the tissue from the blood vessel, and instructions for use describing the use of the catheter, the instructions comprising the operations of introducing the catheter assembly into the blood vessel and positioning the tissue cutting assembly at or near a site in need of tissue debulking, manipulating the tissue removal assembly to debulk tissue in the blood vessel, creating a cleared tissue diameter within the vessel of at least two times the diameter of the tissue removal assembly, and removing the cleared tissue.

Claim 33

Dependent Claim 129 words

28 . A system comprising: a catheter assembly sized and configured to be introduced into a blood vessel, the catheter assembly including a tissue cutting assembly at or near a distal end of the catheter assembly, the tissue cutting assembly including a rotatable cutter for debulking the tissue from the blood vessel, and instructions for use describing the use of the catheter, the instructions comprising the operations of introducing the catheter assembly into the blood vessel and positioning the tissue cutting assembly at or near a site in need of tissue debulking, manipulating the tissue removal assembly to debulk tissue in the blood vessel, creating a cleared tissue diameter within the vessel of at least two times the diameter of the tissue removal assembly, and removing the cleared tissue.

Atherectomy devices, systems, and methods

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