Atherectomy system having a variably exposed cutter

• US 7,951,161 B2
• Filed: 06/13/2006
• Issued: 05/31/2011
• Est. Priority Date: 05/09/2006
• Status: Active Grant

• Current Assignee: Boston Scientific Medical Device Limited (Boston Scientific Corporation)
• Original Assignee: Medrad Incorporated (Bayer AG)
• Inventors: Morris, David Brian, Weisel, Stephen Earl, Thor, Eric Joel, Bonnette, Michael John
• Primary Examiner(s): Manahan; Todd E
• Assistant Examiner(s): LANG, AMY T
• Application Number:
  US11/451,990
• Publication Number:
  US 20070265647A1
• Time in Patent Office: 1,813 Days
• Field of Search: 604/22, 606/159, 606166-171, 606/180
• US Class Current: 606/159
• CPC Class Codes: A61B 17/32037 for removing obstructions from inner organs or blood vessels, e.g. for atherectomy
• CPC Class Codes: A61B 17/320708 Curettes, e.g. hollow scraping instruments
• CPC Class Codes: A61B 17/32075 Pullback cutting; combined forward and pullback cutting, e.g. with cutters at both sides of the plaque
• CPC Class Codes: A61B 17/320783 through side-hole, e.g. sliding or rotating cutter inside catheter
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/2927 the angular position of the head being adjustable with respect to the shaft
• CPC Class Codes: A61B 2017/320791 with cutter extending outside the cutting window

Abstract

An atherectomy system having a variably exposed cutter wherein a distally located positionable tip closely associated with the cutter and a high pressure fluid jet emanator can be variably and angularly deployed about a hinge mechanism subsequent to entry into the vasculature. The fixed cutter slices or parts atheromatous material and/or thrombotic material from a blood vessel for interaction with high pressure jets to macerate, break up or otherwise reduce the materials for evacuation from the site.

Claims

1. An atherectomy system comprising:

a. a catheter tube, the catheter tube having a proximal end and a distal end, a first lumen and a second lumen, the second lumen smaller in diameter than the first lumen, the catheter tube comprising;

(1) a hinge mechanism in the catheter tube that comprises a notch that interrupts an outer surface of the catheter tube and extends into the first lumen of the catheter tube; and

(2) a positionable tip extending distally from the hinge mechanism, wherein rotation of the hinge mechanism pivots the positionable tip relative to a portion of the catheter tube located proximal the hinge mechanism;

b. a high pressure tube within the first lumen, the high pressure tube having a proximal end and a distal end, the distal end extending past the hinge mechanism and into the positionable tip, the high pressure tube terminating in a distally located fluid jet emanator, the fluid jet emanator having proximally facing jet orifices from which a high pressure fluid is emitted; and

c. a fixed cutter located at a fixed position within the first lumen and secured to the fluid jet emanator, the cutter comprising a cutting surface that is always exposed within the notch of the hinge mechanism;

wherein the atherectomy system does not use a separate suction source.

2. The atherectomy system of claim 1, further comprising

a high pressure fluid source and high pressure pump connected to the proximal end of the high pressure tube.

3. The atherectomy system of claim 1, further comprising a collection chamber and exhaust regulator connected to the first lumen.

4. The atherectomy system of claim 1, further comprising an orifice located in the catheter tube proximal to the notch and extending into the second lumen.

5. The atherectomy system of claim 4, wherein a deployment wire passes from the proximal end of the second lumen through the orifice located proximal the notch and extends externally to fixedly engage the positionable tip.

6. The atherectomy system of claim 5, wherein partially retracting the deployment wire proximally causes the positionable tip to angularly reposition about the hinge mechanism.

7. The atherectomy system of claim 6, wherein the high pressure tube includes a spring portion for accommodating changes in length of the catheter tube attributable to angular movement at the hinge mechanism.

8. The atherectomy system of claim 5, wherein the deployment wire is controllable by attachment to and manipulation of a slide tube.

9. The atherectomy system of claim 8, wherein the cutting surface of the cutter is increasingly and controllably deployed from the notch, with the cutting surface extending beyond the profile of the catheter tube when the deployment wire is pulled proximally.

18. The atherectomy system of claim 1, wherein the cutting surface comprises a proximally facing cutting surface.

19. The atherectomy system of claim 1, wherein the cutting surface comprises a proximally facing cutting surface, and wherein at least a portion of the cutter is located within the positionable tip.

20. The atherectomy system of claim 1, wherein the cutting surface is located proximal from the jet orifices of the fluid jet emanator.

21. The atherectomy system of claim 1, wherein rotation of the hinge mechanism changes an angular position of the cutting surface relative to the portion of the catheter tube located proximal the hinge mechanism.

22. The atherectomy system of claim 1, wherein the cutting surface comprises a distally facing cutting surface.

23. The atherectomy system of claim 1, wherein the cutting surface comprises a distally facing cutting surface, and wherein at least a portion of the cutter is located in the first lumen at a location proximal the notch.

24. The atherectomy system of claim 23, wherein rotation of the hinge mechanism does not change an angular position of the cutting surface relative to the portion of the catheter tube located proximal the hinge mechanism.

25. The atherectomy system of claim 1, wherein the cutter is located on a distal side of the notch and wherein the cutting surface of the cutter comprises a proximally facing cutting surface, and wherein the system further comprises an opposing cutter located on a proximal side of the notch, wherein the opposing cutter comprises a distally facing cutting surface.

26. The atherectomy system of claim 25, wherein the proximally facing cutting surface and the distally facing cutting surface are both located proximal from the jet orifices of the fluid jet emanator.

27. The atherectomy system of claim 25, wherein rotation of the hinge mechanism changes an angular position of the proximally facing cutting surface relative to the distally facing cutting surface.

28. The atherectomy system of claim 1, wherein the first lumen is parallel to the second lumen.

29. The atherectomy system of claim 1, wherein the catheter tube comprises a proximally located plastic coated nitinol section and a distally located uncoated nitinol section, the uncoated nitinol section being free of plastic coating, and the uncoated nitinol section extending distally from the plastic coated nitinol section.

30. The atherectomy system of claim 29, wherein the hinge mechanism is located in the uncoated nitinol section of the catheter tube.

31. The atherectomy system of claim 29, wherein the hinge mechanism and the positionable tip are located in the uncoated nitinol section of the catheter tube.

32. The atherectomy system of claim 1, wherein the fluid jet emanator is closely aligned within the first lumen but free of frictional engagement so as to allow unimpeded flexing of the hinge mechanism.

33. The atherectomy system of claim 1, wherein the system further comprises a saddle mount secured to a distal facing surface of the fluid jet emanator, the saddle mount having a major radius portion and a minor radius portion and a passage therethrough.

34. The atherectomy system of claim 1, the system further comprising:

a hub connected to the catheter tube and a connector fitting connected to the hub;

a slide body connected to the connector fitting;

a slide tube connected to the slide body;

a connector fitting connected to the slide tube; and

a manifold connected to the connector fitting.

10. An atherectomy system comprising:

a. a catheter tube, the catheter tube having a proximal end and a distal end, a first lumen and a second lumen, the second lumen smaller in diameter than the first lumen and located parallel to the first lumen, the catheter tube comprising;

(1) a flexible and bendable section comprising a gap interrupting an outer surface of the catheter tube and extending into the first lumen of the catheter tube;

(2) a positionable tip extending distally from the flexible and bendable section, wherein rotation of the catheter tube at the flexible and bendable section pivots the positionable tip relative to a portion of the catheter tube located proximal the flexible and bendable section;

b. a high pressure tube within the first lumen, and having a proximal end and a distal end, the distal end extending past the hinge mechanism and into the positionable tip, the high pressure tube terminating in a distally located fluid jet emanator having proximally facing jet orifices from which a high pressure fluid is emitted; and

c. a fixed cutter located at a fixed position within the first lumen and secured to the fluid jet emanator, the cutter comprising a cutting surface that is always exposed within the gap interrupting the first lumen of the catheter tube;

wherein the atherectomy system does not use a separate suction source.

11. The atherectomy system of claim 10, further comprising a high pressure fluid source and high pressure pump connected to the proximal end of the high pressure tube.

12. The atherectomy system of claim 10, further comprising a collection chamber and exhaust regulator connected to the first lumen.

13. The atherectomy system of claim 10, further comprising an orifice located in the catheter tube proximal to the gap and extending into the second lumen.

14. The atherectomy system of claim 13, wherein a deployment wire passes from the proximal end of the second lumen through the orifice located proximal the gap and extends externally to fixedly engage the positionable tip.

15. The atherectomy system of claim 14, wherein partially retracting the deployment wire proximally causes the positionable tip to angularly reposition about the flexible and bendable section.

16. The atherectomy system of claim 15, wherein the deployment wire is controllable by attachment to and manipulation of a slide tube.

17. The atherectomy system of claim 16, wherein the cutting surface of the cutter is increasingly and controllably deployed from the gap, with the cutting surface extending beyond the profile of the catheter tube when the deployment wire is pulled proximally.

35. An atherectomy catheter comprising:

a catheter tube comprising a proximal end and a distal end, the catheter tube further comprising;

a first lumen extending through the catheter tube, wherein the first lumen extends to the distal end of the catheter tube;

a notch in an outer surface of the catheter tube that exposes a portion of a first lumen in the catheter tube; and

a positionable tip extending distally from the notch, wherein the first lumen extends into the positionable tip, and wherein the positionable tip is movable between a straight profile position in which the positionable tip is aligned with a portion of the catheter tube located proximal the notch and positions in which the positionable tip is angularly positioned with respect to the portion of the catheter tube located proximal the notch;

a high pressure tube located within the first lumen, the high pressure tube comprising a proximal end and a distal end, the distal end extending through the portion of the first lumen exposed by the notch and into the positionable tip;

a fluid jet emanator operably attached to the distal end of the high pressure tube in the positionable tip, wherein the fluid jet emanator comprises proximally facing jet orifices from which a high pressure fluid is emitted; and

a fixed cutter located within the first lumen and secured to the fluid jet emanator, the fixed cutter comprising a cutting surface that is always exposed within the notch;

wherein the atherectomy system does not use a separate suction source.

36. The atherectomy catheter of claim 35, wherein rotation of the positionable tip about the portion of the catheter tube containing the notch changes an angular position of the cutting surface relative to the portion of the catheter tube located proximal the notch.