Systems and methods for clot disruption and retrieval

• US 20040082962A1
• Filed: 10/06/2003
• Published: 04/29/2004
• Est. Priority Date: 12/06/1999
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Bacchus Vascular Incorporated (Medtronic Plc)
• Inventors: Demarais, Denise, Leeflang, Stephen A., Evans, Michael A., Eversull, Christian S.
• Granted Patent: US 6,945,977 B2
• Time in Patent Office: Days
• US Class Current: 606/128
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 2017/00685 Archimedes screw
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61B 2017/320775 Morcellators, impeller or propeller like means
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0076 ellipsoidal or ovoid
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61M 25/0023 by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

Thrombectomy and other treatments are achieved using a catheter having a positioning cage and a macerator within the positioning cage. The catheter is introduced to a target body lumen, typically a blood vessel, and a positioning cage deployed at a treatment site. The macerator is then operated to disrupt thrombus, clot, or other occlusive materials at the treatment site, and the catheter is used to collect and remove the disruptive materials from the body lumen. In particular examples, the macerator may be radially expansible and optionally rotated and/or axially translated within the positioning cage to effect disruption of the occlusive material.

Claims

1. A catheter for removing occlusive material from a body lumen, said catheter comprising:

a catheter body having a proximal end, a distal end, and a lumen therethrough;

a radially expansible positioning cage near the distal end of the catheter body, wherein the catheter body has a lumen and at least one infusion port disposed t deliver an agent from the lumen to within the interior of the cage; and

a radially expansible macerator configured to break up occlusive material within the cage and draw the material into the catheter body lumen.

2. A catheter as in claim 1, further comprising means for selectively adjusting the diameter of the radially expansible positioning cage.

3. A catheter as in claim 1, wherein the radially expansible cage is self-expanding and has a predetermined unconstrained diameter.

4. A catheter as in claim 1, further comprising means for selectively adjusting the diameter of the macerator.

5. A catheter as in claim 1, wherein the macerator is self-expanding and has a predetermined unconstrained diameter.

6. A catheter as in claim 1, wherein the cage is expansible from an initial width in the range from 1 mm to 4 mm to an expanded width in the range from 2 mm to 40 mm and the macerator has an initial width in the range from 1 mm to 4 mm and an expanded width in the range from 2 mm to 35 mm.

7. A catheter as in claim 1, wherein adjustment of the radial dimension of the macerator is not coupled to expansion of the positioning cage.

8. A catheter as in claim 1, wherein the macerator is rotatable.

9. A catheter as in claim 8, further comprising a drive unit at the proximal end of the catheter body, wherein the drive unit is mechanically coupled to the macerator.

10. A catheter as in claim 1, wherein the macerator is positioned over said at least one infusion port.

11. A catheter as in claim 1, wherein the catheter body has a plurality of axially spaced-apart infusion ports.

12. A method for thrombus in a blood vessel, said method comprising:

positioning a catheter within a region of thrombus in the blood vessel;

centering the catheter along an axis of the blood vessel within a positioning cage;

releasing a thrombolytic agent through the catheter to said region; and

rotating a macerator to disrupt the clot.

13. A method as in claim 12, wherein releasing comprises infusing the thrombolytic agent from a port within the centering cage.

14. A method as in claim 13, wherein releasing comprises infusing the thrombolytic agent from a plurality of axially spaced-apart ports within the centering cage.

15. A catheter for removing occlusive material from a body lumen, said catheter comprising:

a catheter body having a proximal end, a distal end, and a lumen therethrough;

a radially expansible positioning cage near the distal end of the catheter body;

a radially expansible macerator configured to break up occlusive material within the cage and draw the material into the catheter body lumen; and

means for within the catheter body for aspirating material disrupted by the macerator from within the cage.

16. A catheter as in claim 15, further comprising means for selectively adjusting the diameter of the radially expansible positioning cage.

17. A catheter as in claim 15, wherein the radially expansible cage is self-expanding and has a predetermined unconstrained diameter.

18. A catheter as in claim 15, further comprising means for selectively adjusting the diameter of the macerator.

19. A catheter as in claim 15, wherein the macerator is self-expanding and has a predetermined unconstrained diameter.

20. A catheter as in claim 15, wherein the cage is expansible from an initial width in the range from 1 mm to 4 mm to an expanded width in the range from 2 mm to 40 mm and the macerator has an initial width in the range from 1 mm to 4 mm and an expanded width in the range from 2 mm to 35 mm.

21. A catheter as in claim 15, wherein adjustment of the radial dimension of the macerator is not coupled to expansion of the positioning cage.

22. A catheter as in claim 15, wherein the macerator is rotatable.

23. A catheter as in claim 22, further comprising a drive unit at the proximal end of the catheter body, wherein the drive unit is mechanically coupled to the macerator.

24. A catheter as in claim 15, wherein the aspirating means comprises a lumen within the catheter body and a connection at the proximal end of the catheter body adapted to be connected to an aspiration source.

25. A catheter as in claim 24, wherein the aspirating means further comprises a helical rotor disposed within the lumen.

26. A catheter for removing occlusive material from a body lumen, said catheter comprising:

a catheter body having a proximal end, a distal end, and a lumen therethrough;

a radially expansible positioning cage near the distal end of the catheter body;

a radially expansible macerator configured to break up occlusive material within the cage and draw the material into the catheter body lumen; and

means for selectively adjusting the diameter of the radially expansible positioning cage and the radially expansible macerator.

27. A catheter as in claim 26, wherein the means for selectively adjusting the diameters comprises an axially positionable shaft coupled to the cage and macerator, said shaft adapted to selectively axially elongate the cage and macerator to cause radial contraction.

28. A catheter as in claim 26, wherein the cage is expansible from an initial width in the range from 1 mm to 4 mm to an expanded width in the range from 2 mm to 40 mm and the macerator has an initial width in the range from 1 mm to 4 mm and an expanded width in the range from 2 mm to 35 mm.

29. A catheter as in claim 26, wherein adjustment of the radial dimension of the macerator is not coupled to expansion of the positioning cage.

30. A catheter as in claim 26, wherein the macerator is rotatable.

31. A catheter as in claim 30, further comprising a drive unit at the proximal end of the catheter body, wherein the drive unit is mechanically coupled to the macerator.

32. A method for disrupting and removing occlusive material from a blood vessel, said method comprising:

introducing a first catheter into the blood vessel from one side of the occlusive material;

introducing a second catheter into the blood vessel from another side of the clot;

releasing a thrombolytic agent and mechanically disrupting the clot with the first catheter; and

aspirating the disrupted clot with the second catheter.

33. A method as in claim 32, wherein aspirating comprises filtering the blood to separate the clot and allow blood to pass second catheter.