Claims
- 1. Apparatus for disrupting clot over a luminal length of a blood vessel, the apparatus comprising:
a catheter body having a proximal end, a distal end, at least one lumen extending between said ends, a distal opening, and at least one side opening proximal to the distal-end opening; a first radially expandable occlusion body on the catheter body between the distal-end opening and the at least one side opening; and an agitator removable insertable into the catheter body lumen.
- 2. Apparatus as in claim 1, wherein the distal-end opening is configured to inhibit flow therethrough to preferential cause flow from the lumen to pass through the at least one side opening.
- 3. Apparatus as in claim 2, further comprising a flow resistor between the distal-end opening and the at least one side opening for inhibiting fluid flow through the at least one lumen.
- 4. Apparatus as in claim 3, wherein the flow resistor inhibits flow such that between about 0.1% and about 20% of fluid flows through the distal-end opening and between about 80% and about 99.9% of fluid flows through the at least one side opening.
- 5. Apparatus as in claim 3, wherein the flow resistor comprises a cylindrical material having at least one channel.
- 6. Apparatus as in claim 5, wherein the cylindrical material comprises an elastomeric material.
- 7. Apparatus as in claim 5, wherein the outer diameter of the cylindrical material is equal to the inner diameter of the at least one lumen.
- 8. Apparatus as in claim 5, wherein the at least one channel comprises a cylindrical hole having an inner diameter sufficient to allow passage of the guidewire.
- 9. Apparatus as in claim 5, wherein the at least one channel comprises one or more flexible slits.
- 10. Apparatus as in claim 5, wherein the at least one channel comprises a valve for allowing passage of the guidewire and one or more holes for allowing passage of fluid.
- 11. Apparatus as in claim 3, wherein the flow resistor comprises a membrane with at least one aperture.
- 12. Apparatus as in claim 11, wherein the membrane is crowned with a concave surface facing toward the proximal end of the catheter body.
- 13. Apparatus as in claim 12, wherein the aperture has a cross-sectional area up to 1 mm.
- 14. Apparatus as in claim 13, wherein the aperture has an oval periphery.
- 15. Apparatus as in claim 3, wherein the flow resistor comprises a ball valve for partially blocking flow of fluid through the at least one lumen, the ball valve having at least one channel, a ball, and a widened area within the channel into which the ball may be displaced to allow passage of a guidewire through the channel.
- 16. Apparatus as in claim 3, wherein the flow resistor comprises a compliant membrane coupled to the at least one lumen, the compliant membrane communicating with an inflation lumen, the inflation lumen communicating with an inflation port, wherein inflation via the inflation port and inflation lumen moves the compliant membrane to partially or wholly block fluid flow through the at least one lumen of the catheter body.
- 17. Apparatus as in claim 1, wherein a cross-sectional area of the distal-end opening is between about 0.1% and about 20% of a cross-sectional area of the at least one side opening.
- 18. Apparatus as in claim 1, wherein the at least one side opening consists of a single opening in a side wall of the catheter body.
- 19. Apparatus as in claim 18, wherein the single opening has a minimum width which is equal to at least 50% of the outer diameter of the catheter body at the location of the single opening.
- 20. Apparatus as in claim 19, further comprising a reinforcement sleeve over the catheter body at the location of the single opening.
- 21. Apparatus as in claim 2, wherein the at least one side opening comprises a plurality of spaced-apart openings in a side wall of the catheter body.
- 22. Apparatus as in claim 1, further comprising an agitator near the distal end of the catheter body for agitating clot over the length of the blood vessel.
- 23. Apparatus as in claim 22, wherein the agitator comprises a mechanical agitator.
- 24. Apparatus as in claim 23, further comprising a driver which moves the agitator at a frequency of 1-20,000 Hertz.
- 25. Apparatus as in claim 23, wherein the driver rotates the agitator within the catheter body.
- 26. Apparatus as in claim 23, wherein the driver axially translates the agitator within the catheter body.
- 27. Apparatus as in claim 23, wherein the agitator assumes a non-linear geometry when inserted into the lumen of the catheter body.
- 28. Apparatus as in claim 27, further comprising a driver which rotates the agitator at a frequency from 1 Hz to 50 Hz.
- 29. Apparatus as in claim 28, wherein the driver allows manual axial translation of the driver within the catheter body.
- 30. Apparatus as in claim 27, wherein the a non-linear geometry is selected from the group consisting of helical, spiral, serpentine, zig-zag, alternating helical, and random.
- 31. Apparatus as in claim 1, wherein the first radially expandable occlusion body comprises a balloon.
- 32. Apparatus as in claim 1, further comprising a second radially expandable occlusion body proximal to the at least one side opening.
- 33. Apparatus as in claim 32, wherein the first and second radially expandable bodies are axially spaced-apart by a distance in the range from 5 cm to 50 cm.
- 34. Apparatus as in claim 33, wherein the catheter body has first and second inflation lumens connected to the first and second radially expandable bodies, respectively.
- 35. A method for disrupting clot over a luminal length of a blood vessel, said method comprising:
positioning a catheter body within the luminal length of the blood vessel; infusing a thrombolytic agent through a lumen of the catheter body into the luminal length of the blood vessel; and eccentrically rotating at least a portion of the catheter body within the luminal length of the blood vessel to agitate the thrombolytic agent within the clot.
- 36. A method as in claim 35, wherein positioning the catheter body includes passing the catheter body over a guidewire.
- 37. A method as in claim 35, wherein infusing the thrombolytic agent is performed with the catheter body remaining positioned over the guidewire.
- 38. A method as in claim 35, wherein the catheter is rotated at a frequency of 1-20,000 Hertz.
- 39. A method as in claim 35, wherein rotating the catheter body comprises a radially expandable agitator within the catheter body to sweep the catheter body against the clot.
- 40. A method as in claim 39, wherein the radially expandable agitator is resilient and radially self-expanding so that it is constrained by the blood vessel as it is rotated.
- 41. A method as in claim 40, wherein the agitator has a non-linear geometry when expanded against the clot.
- 42. A method as in claim 35, wherein the luminal length is at least 3 cm.
- 43. A method as in claim 35, wherein the blood vessel is a vein.
- 44. A method as in claim 43, wherein the vein is selected from the group consisting of vena cava, iliac vein, femoral vein, popliteal vein, common iliac vein, external iliac vein, brachial vein, and subclavian vein.
- 45. A method as in claim 35, wherein the blood vessel is an artery.
- 46. A method as in claim 45, wherein the artery is selected from the group consisting of the internal iliac artery, external iliac artery, popliteal artery, coronary arteries, superficial femoral artery, and the brachial artery.
- 47. A method as in claim 35, wherein the blood vessel comprises one or more grafts.
- 48. A method as in claim 35, further comprising isolating at least one end of the luminal length of the blood vessel.
- 49. A method as in claim 48, further comprising isolating both a proximal end and a distal end of the luminal length.
- 50. A method as in claim 48, wherein isolating comprises inflating at least one occlusion balloon.
- 51. A method as in claim 48, wherein isolating at least a distal end is performed prior to infusing the agent.
- 52. A method as in claim 51, wherein isolating at least one distal end is maintained until after agitating has stopped.
- 53. A method as in claim 35, further comprising aspirating disrupted clot material from along the luminal length of the blood vessel.
- 54. A method as in claim 53, wherein aspirating disrupted clot and infusing the agent are performed through a common lumen in the catheter body.
- 55. A kit comprising:
a catheter having an agitator and a thrombolytic agent delivery means; and instructions for use according to the method of claim 35.
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] The present application is a continuation-in-part of U.S. patent application Ser. No. 10/142,005 (Attorney Docket No. 19744P-000720), filed May 8, 2002, which is a continuation-in-part of PCT/US01/02406 (Attorney Docket No. 19744P-000710PC), filed on Jan. 24, 2001, which was a continuation-in-part of U.S. patent application Ser. No. 09/491,401 (Attorney Docket No. 19744P-000700), filed on Jan. 25, 2000, the full disclosures of which are incorporated herein by reference.
Continuation in Parts (3)
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Number |
Date |
Country |
Parent |
10142005 |
May 2002 |
US |
Child |
10278735 |
Oct 2002 |
US |
Parent |
PCT/US01/02406 |
Jan 2001 |
US |
Child |
10142005 |
May 2002 |
US |
Parent |
09491401 |
Jan 2000 |
US |
Child |
PCT/US01/02406 |
Jan 2001 |
US |