Thrombus removal device

• US 20020058904A1
• Filed: 11/08/2001
• Published: 05/16/2002
• Est. Priority Date: 11/08/2000
• Status: Abandoned Application

• Current Assignee: Kevin Gilmartin, Robert Book
• Original Assignee: Kevin Gilmartin, Robert Book
• Inventors: Boock, Robert, Gilmartin, Kevin
• Application Number:
  US10/007,740
• Publication Number:
  US 20020058904A1
• Time in Patent Office: Days
• US Class Current: 604/35
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• 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 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/22082 after introduction of a substance

Abstract

A method and device for clot maceration and removal, including inserting a shaft having two lumens into an occluded blood vessel, the shaft having: a guidewire/drug delivery lumen defined partially by a first wall and a thrombus removal lumen defined partially by a second wall. The thrombus removal lumen further defines a skived section where a thrombus may be trapped for removal. A portion of the first wall is coextensive with a portion of the second wall, and the coextensive portion defines at least one hole whereby a drug delivered through the guidewire/drug delivery lumen may pass to the thrombus removal lumen. A maceration device is also disclosed which may be used independently or may be inserted within the guidewire/drug delivery lumen. The maceration device includes: a base wire; a capping plug attached to a distal end of the base wire; a pressure translator slidably attached to the base wire; and a means for maceration coupled between the pressure translator and the capping plug. Variations of the above are also disclosed.

Claims

1. A catheter for drug delivery and thrombus removal, comprising:

a shaft having two lumens, including;

a guidewire/drug delivery lumen defined partially by a first wall; and

a thrombus removal lumen defined partially by a second wall, the thrombus removal lumen further defining a skived section whereby a thrombus may be trapped for removal,

such that a portion of the first wall is coextensive with a portion of the second wall, and the coextensive portion defines at least one hole whereby a drug delivered through the guidewire/drug delivery lumen may pass to the thrombus removal lumen.

2. The catheter of claim 1, wherein the catheter further includes a basket disposed downstream of the skived section for containing the thrombus, and wherein the hole in the skived section is capable of delivering a drug to a volume substantially adjacent the basket.

3. The catheter of claim 1, further comprising a source of vacuum, wherein the source of vacuum is in pressure communication with the thrombus removal lumen via a valve.

4. The catheter of claim 3, wherein the source of vacuum provides a vacuum at a level of between about zero and the minimum blood pressure measured at a distal end of the thrombus removal lumen.

5. The catheter of claim 2, wherein the basket is made of polyurethane or a material of low durometer.

6. The catheter of claim 1, wherein the catheter has an overall outer diameter of between about 0.0786 in and 0.0196 in.

7. The catheter of claim 1, wherein the guidewire/drug delivery lumen has an overall diameter of between about 0.0343 in and 0.0085 in.

8. A method of removing a clot from a blood vessel, comprising:

delivering a catheter to a blood vessel, the catheter including;

a shaft having two lumens, including;

a guidewire/drug delivery lumen defined partially by a first wall; and

a thrombus removal lumen defined partially by a second wall, the thrombus removal lumen further defining a skived section whereby a thrombus may be trapped for removal,

such that a portion of the first wall is coextensive with a portion of the second wall, and the coextensive portion defines at least one hole whereby a drug delivered through the guidewire/drug delivery lumen may pass to the thrombus removal lumen; and

delivering a drug to the clot through the guidewire/drug delivery lumen.

9. A method of removing a clot from a blood vessel, comprising:

delivering a catheter to a blood vessel, the catheter including;

a shaft having two lumens, including;

a guidewire/drug delivery lumen defined partially by a first wall; and

a thrombus removal lumen defined partially by a second wall, the thrombus removal lumen further defining a skived section whereby a thrombus may be trapped for removal,

such that a portion of the first wall is coextensive with a portion of the second wall, and the coextensive portion defines at least one hole whereby a drug delivered through the guidewire/drug delivery lumen may pass to the thrombus removal lumen; and

mechanically trapping the clot in the skived section.

10. A method of removing a clot from a blood vessel, comprising:

delivering a catheter to a blood vessel, the catheter including;

a shaft having two lumens, including;

a guidewire/drug delivery lumen defined partially by a first wall; and

a thrombus removal lumen defined partially by a second wall, the thrombus removal lumen further defining a skived section whereby a thrombus may be trapped for removal,

such that a portion of the first wall is coextensive with a portion of the second wall, and the coextensive portion defines at least one hole whereby a drug delivered through the guidewire/drug delivery lumen may pass to the thrombus removal lumen; and

providing a source of vacuum coupled in fluid communication to the thrombus removal lumen;

providing a pressure differential to the thrombus removal lumen using the vacuum source.

11. A method of removing a clot from a blood vessel, comprising:

delivering a catheter to a blood vessel, the catheter including;

a shaft having two lumens, including;

a guidewire/drug delivery lumen defined partially by a first wall; and

a thrombus removal lumen defined partially by a second wall, the thrombus removal lumen further defining a skived section whereby a thrombus may be trapped for removal,

such that a portion of the first wall is coextensive with a portion of the second wall, and the coextensive portion defines at least one hole whereby a drug delivered through the guidewire/drug delivery lumen may pass to the thrombus removal lumen, and

wherein the catheter further includes a basket disposed downstream of the skived section for containing the thrombus;

mechanically trapping the clot in the basket.

13. The catheter of claim 12, further comprising at least two scoops in the thrombus removal section, and wherein the scoops are separated by a flexible joint.

14. The catheter of claim 13, wherein the flexible joint is selected from the group consisting of coils, polymers, and combinations thereof.

15. The catheter of claim 12, wherein the shaft, thrombus removal section, and tip are configured and arranged to be of a size sufficiently small to pass through a standard neurological catheter.

16. The catheter of claim 12, wherein the catheter is of a size and flexibility substantially the same as a standard neurological guidewire.

17. The catheter of claim 12, wherein the scoop is substantially made of a soft polymer.

20. The device of claim 19, wherein the maceration means is a spring.

21. The device of claim 19, further comprising a means for providing a varying pressure on a proximal end of the pressure translator.

22. The device of claim 19, wherein the spring has a diameter of between about 0.009 in and 0.038 in and a pitch of between about 0 and 45°

in an unstressed state.

23. The device of claim 19, wherein the pressure translator is made of a polymer having moderate stiffness.

24. The device of claim 19, wherein the maceration means is selected from the group consisting of:

mechanical vibrators, spring like oscillators, springs, shaped wires, microcatheters, and longitudinal filaments caused to tense and compress and expand.

27. The catheter of claim 26, wherein a portion of the guidewire/drug delivery tube adjacent the collection region defines at least one hole.

28. The catheter of claim 26, further comprising a source of vacuum, wherein a source of vacuum is in pressure communication with the thrombus removal lumen via a valve.

29. The catheter of claim 28, wherein the source of vacuum provides a vacuum at a level of between about zero and the minimum blood pressure at a distal end of the thrombus removal lumen.

30. The catheter of claim 26, wherein the struts are made of a material selected from the group consisting of:

polymers, stainless steel, or nitinol.

31. The catheter of claim 26, wherein the catheter has an overall outer diameter of between about 0.0786 in and 0.0196 in.

32. The catheter of claim 26, wherein the guidewire/drug delivery lumen has an overall diameter of between about 0.035 in and 0.085 in.

33. The catheter of claim 26, wherein the guidewire/drug delivery tube and the thrombus removal tube are coaxial.

35. The method of claim 34, further comprising varying the pressure provided by the source of suction in a cyclical manner.

12. A catheter for thrombus removal, comprising:

a shaft;

a thrombus removal section distal of the shaft; and

an atraumatic tip distal of the thrombus removal section,

such that the thrombus removal section includes at least one scoop for removing a thrombus from a thrombosed vessel.

18. A method of removing a clot, comprising:

inserting a catheter into an occluded blood vessel, the catheter including;

a shaft;

a thrombus removal section distal of the shaft; and

an atraumatic tip distal of the thrombus removal section,

such that the thrombus removal section includes at least one scoop for removing a thrombus from a thrombosed vessel; and

trapping a portion of a clot in the at least one scoop.

19. A device to macerate or remove a clot, comprising:

a base wire;

a capping plug attached to a distal end of said base wire;

a pressure translator slidably attached to the base wire; and

a means for maceration coupled between the pressure translator and the capping plug.

25. A method of macerating a clot, comprising:

disposing a device through a guide catheter, the device including;

a base wire;

a capping plug attached to a distal end of said base wire;

a pressure translator slidably attached to the base wire; and

a means for maceration coupled between the pressure translator and the capping plug; and

varying a fluid pressure in a cyclical manner on the proximal end of the pressure translator.

26. A catheter for drug delivery and thrombus removal, comprising:

a shaft having two lumens therein, including;

a guidewire/drug delivery lumen defined by a guidewire/drug delivery tube; and

a thrombus removal lumen defined by a suction tube;

a plurality of struts adjacent and distal from the thrombus removal tube, the plurality of struts defining a collection region, the collection region fluidically coupled to the thrombus removal lumen.

34. A method of removing a thrombus from a blood vessel, comprising:

inserting a catheter into a blood vessel, the catheter including;

a shaft having two lumens therein, including;

a guidewire/drug delivery lumen defined by a guidewire/drug delivery tube; and

a thrombus removal lumen defined by a suction tube;

a plurality of struts adjacent and distal from the thrombus removal tube, the plurality of struts defining a collection region, the collection region fluidically coupled to the thrombus removal lumen; and

providing a source of suction fluidically coupled to the proximal end of the thrombus removal lumen.

36. A catheter for clot maceration and removal, comprising:

a shaft having two lumens therein, including;

a guidewire/drug delivery lumen defined by a guidewire/drug delivery tube; and

a thrombus removal lumen defined by a suction tube;

a plurality of struts adjacent and distal from the thrombus removal tube, the plurality of struts defining a collection region, the collection region fluidically coupled to the thrombus removal lumen; and

a maceration device to insert within the guidewire/drug delivery lumen, including;

a base wire;

a capping plug attached to a distal end of said base wire;

a pressure translator slidably attached to the base wire; and

a means for maceration coupled between the pressure translator and the capping plug.

37. A catheter for clot maceration and removal, comprising:

a shaft having two lumens, including;

a guidewire/drug delivery lumen defined partially by a first wall; and

a thrombus removal lumen defined partially by a second wall, the thrombus removal lumen further defining a skived section whereby a thrombus may be trapped for removal,

such that a portion of the first wall is coextensive with a portion of the second wall, and the coextensive portion defines at least one hole whereby a drug delivered through the guidewire/drug delivery lumen may pass to the thrombus removal lumen; and

a maceration device to insert within the guidewire/drug delivery lumen, including;

a base wire;

a capping plug attached to a distal end of said base wire;

a pressure translator slidably attached to the base wire; and

a means for maceration coupled between the pressure translator and the capping plug.

38. A method of employing a catheter for clot maceration and removal, comprising:

inserting a shaft having two lumens therein into an occluded blood vessel, the shaft including;

a guidewire/drug delivery lumen defined by a guidewire/drug delivery tube; and

a thrombus removal lumen defined by a suction tube;

a plurality of struts adjacent and distal from the thrombus removal tube, the plurality of struts defining a collection region, the collection region fluidically coupled to the thrombus removal lumen; and

inserting a maceration device within the guidewire/drug delivery lumen, the maceration device including;

a base wire;

a capping plug attached to a distal end of said base wire;

a pressure translator slidably attached to the base wire; and

a means for maceration coupled between the pressure translator and the capping plug.

39. A method of employing a catheter for clot maceration and removal, comprising:

inserting a shaft having two lumens into an occluded blood vessel, the shaft including;

a guidewire/drug delivery lumen defined partially by a first wall; and

a thrombus removal lumen defined partially by a second wall, the thrombus removal lumen further defining a skived section whereby a thrombus may be trapped for removal,

such that a portion of the first wall is coextensive with a portion of the second wall, and the coextensive portion defines at least one hole whereby a drug delivered through the guidewire/drug delivery lumen may pass to the thrombus removal lumen; and

inserting a maceration device within the guidewire/drug delivery lumen, the maceration device including;

a base wire;

a capping plug attached to a distal end of said base wire;

a pressure translator slidably attached to the base wire; and

a means for maceration coupled between the pressure translator and the capping plug.