System and methods for clot dissolution

• US 6,663,613 B1
• Filed: 01/25/2000
• Issued: 12/16/2003
• Est. Priority Date: 01/25/2000
• Status: Expired due to Term

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Bacchus Vascular Incorporated (Medtronic Plc)
• Inventors: Leeflang, Stephen A., Evans, Michael A., Eversull, Christian S., Demarais, Denise M.
• Primary Examiner(s): Casler, Brian L.
• Assistant Examiner(s): RODRIGUEZ, CRIS LOIREN
• Application Number:
  US09/491,401
• Time in Patent Office: 1,421 Days
• Field of Search: 604/264, 604/19, 604/35, 604/36, 604/48, 604/22, 604/95-1-, 604/96.01, 604/97.01, 604/97.02, 604/101.01, 604/101.03, 604/101.04, 604/101.05, 604/164.13, 604/266-268, 604/523, 604/528, 606/192, 606/194, 606/167, 606/170, 606/180, 606/200, 606/159, 606/171, 600/570, 600/571, 600/585, 600/115, 600/116, 600/137, 600/139, 600/143
• US Class Current: 604/523
• 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 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61M 25/0021 characterised by the form of the tubing A61M25/0054 takes precedence
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0105 Steering means as part of the catheter or advancing means; Markers for positioning systems for detection of markers A61B

Abstract

Clot disruption and dissolution are achieved using a catheter having both an agitator and the ability to deliver a thrombolytic agent. The catheter is introduced to a target region with a blood vessel and the agitator manipulated to engage and disrupt a region of clot therein. The thrombolytic agent, such as tPA, streptokinase, or urokinase, is directly released into the clot at the point where the agitator is engaging the clot. In this way, the thrombolytic activity of the agent is enhanced and the dissolution of the clot is improved.

Claims

1. Apparatus for disrupting clot over a predetermined luminal length of a blood vessel, said apparatus comprising:

a catheter body having a proximal end and a distal end;

means near the distal end of the catheter body for agitating clot over the predetermined length in the blood vessel, the agitating means extending along a length of the catheter body;

means near the distal end of the catheter body for distributing an agent over the predetermined length in the blood vessel, wherein the agent distributing means is disposed along the length of the catheter body; and

means for aspirating disrupted clot from a region around the mechanical agitation means.

2. Apparatus as in claim 1, wherein the agitating means comprises a rotatable and/or axially translatable agitator.

3. Apparatus as in claim 2, wherein the agitator comprises a resilient element which may be radially constrained to have a low profile or may be freed from radial constraint to have an enlarged profile having a non-linear geometry.

4. Apparatus as in claim 2, wherein the agitator comprises a resilient element which may be axially shortened to assume an enlarged profile having a non-linear geometry.

5. Apparatus as in claim 3 or 4, wherein the resilient element has a non-linear geometry selected from the group consisting of helical, spiral, serpentine, zig-zag, alternating helical, and random.

6. Apparatus as in claim 1, wherein the agitating means comprises mechanical agitating means.

7. Apparatus as in claim 6, wherein the mechanical agitating means agitates at a frequency of about 10-20,000 Hz.

8. Apparatus as in claim 1, wherein the agent is a member selected from the group consisting of a thrombolytic agent, a fibrinolytic agent, a calcium dissolving agent, a gene therapy agent, an anti-reproliferative agent, and a group GP IIb/IIIa Inhibitor.

9. Apparatus for disrupting clot over a predetermined luminal length of a blood vessel, said apparatus comprising:

a catheter body having a proximal end and a distal end;

means near the distal end of the catheter body for mechanically agitating clot over the predetermined length in the blood vessel, the mechanical agitating means comprising a rotatable and/or axially translatable agitator comprising a resilient element which may be radially constrained to have a low profile or may be freed from radial constraint to have an enlarged profile having a non-linear geometry selected from the group consisting of helical, spiral, serpentine, zig-zag, alternating helical, and random; and

means near the distal end of the catheter body for distributing a thrombolytic agent over the predetermined length in the blood vessel, the thrombolytic distributing means comprising a porous sheath disposed over the resilient element.

10. Apparatus as in claim 9, wherein the porous sheath is flexible and wherein the resilient element presses the sheath into the clot.

11. Apparatus as in claim 9, wherein the thrombolytic distributing means comprises a distribution element in the resilient element, wherein the resilient element includes means for infusing the thrombolytic agent disposed over its length.

12. Apparatus as in claim 11, wherein the infusing means comprises a plurality of spaced-apart ports.

13. Apparatus for disrupting clot over a predetermined luminal length of a blood vessel, said apparatus comprising:

a catheter body having a proximal end and a distal end;

means near the distal end of the catheter body for mechanically agitating clot over the predetermined length in the blood vessel, the mechanical agitating means comprising a rotatable and/or axially translatable agitator comprising a resilient element which may be radially constrained to have a low profile or may be freed from radial constraint to have an enlarged profile having a non-linear geometry selected from the group consisting of helical, spiral, serpentine, zig-zag, alternating helical, and random; and

means near the distal end of the catheter body for distributing a thrombolytic agent over the predetermined-length in the blood vessel, the thrombolytic distributing means comprising a distribution element in the resilient element, the resilient element including means for infusing the thrombolytic agent disposed over its length, the infusing means comprising porous region(s) over the length of the resilient element.

14. Apparatus for disrupting clot over a predetermined luminal length of a blood vessel, said apparatus comprising:

a catheter body having a proximal end and a distal end;

means near the distal end of the catheter body for mechanically agitating clot over the predetermined length in the blood vessel; and

means near the distal end of the catheter body for distributing a thrombolytic agent over the predetermined length in the blood vessel, the thrombolytic distributing means comprising a porous sheath disposed over the mechanical agitating means.

15. Apparatus as in claim 14, wherein the porous sheath is flexible and wherein the mechanical agitating means presses the sheath into the clot.

16. Apparatus for disrupting clot over a predetermined luminal length of a blood vessel, said apparatus comprising:

a catheter body having a proximal end and a distal end;

means near the distal end of the catheter body for mechanically agitating clot over the predetermined length in the blood vessel;

means near the distal end of the catheter body for distributing a thrombolytic agent over the predetermined length in the blood vessel; and

means for isolating at least one location on the catheter body to reduce blood flow through a region in a blood vessel being treated.

17. Apparatus as in claim 16, wherein the isolating means isolates both a proximal end and the distal end of the region being treated.

18. Apparatus as in claim 17, wherein the isolating means comprises a pair of axially spaced-apart balloons on the catheter body.

19. Apparatus as in claim 16, 17, or 18, further comprising means for aspirating disrupted clot from a region around the mechanical agitation means.

20. Apparatus for disrupting clot over a predetermined luminal length of a blood vessel, said apparatus comprising:

a catheter body having a proximal end and a distal end;

means near the distal end of the catheter body for mechanically agitating clot over the predetermined length in the blood vessel, the mechanical agitating means comprising a rotatable and/or axially translatable agitator comprising a resilient element which may be axially shortened to assume an enlarged profile having a non-linear geometry selected from the group consisting of helical, spiral, serpentine, zig-zag, alternating helical, and random; and

means near the distal end of the catheter body for distributing a thrombolytic agent over the predetermined length in the blood vessel, the thrombolytic distributing means comprising a porous sheath disposed over the resilient element.

21. Apparatus for disrupting clot over a predetermined luminal length of a blood vessel, said apparatus comprising:

a catheter body having a proximal end and a distal end;

means near the distal end of the catheter body for mechanically agitating clot over the predetermined length in the blood vessel, the mechanical agitating means comprising a rotatable and/or axially translatable agitator comprising a resilient element which may be axially shortened to assume an enlarged profile having a non-linear geometry selected from the group consisting of helical, spiral, serpentine, zig-zag, alternating helical, and random; and

means near the distal end of the catheter body for distributing a thrombolytic agent over the predetermined length in the blood vessel, the thrombolytic distributing means comprising a distribution element in the resilient element, the resilient element including means for infusing the thrombolytic agent disposed over its length, the infusing means comprising porous region(s) over the length of the resilient element.

22. Apparatus for disrupting clot within a blood vessel, said apparatus comprising:

a catheter body having a proximal end and a distal end;

a first radially expandable body near the distal end of the catheter body, for inhibiting flow;

a second radially expandable body proximal to the first radial expandable body, for inhibiting flow, wherein the first and second radially expandable bodies comprise filters;

a mechanical agitator along the catheter body for mechanically agitating clot over a length of the blood vessel, the length of the blood vessel extending from adjacent the first radially expandable body to adjacent the second radially expandable body; and

a thrombolytic distributor between the first and second radially expandable bodies, for distributing a thrombolytic agent over the length of the blood vessel.

23. Apparatus as in claim 22, wherein the thrombolytic distributor comprises a flexible, porous sheath disposed over the mechanical agitator, and the mechanical agitator presses the sheath into the clot.

24. Apparatus for disrupting clot within a blood vessel, said apparatus comprising:

a catheter body having a proximal end and a distal end;

a first radially expandable body near the distal end of the catheter body, for inhibiting flow;

a second radially expandable body proximal to the first radial expandable body, for inhibiting flow;

a mechanical agitator along the catheter body for mechanically agitating clot over a length of the blood vessel, the length of the blood vessel extending from adjacent the first radially expandable body to adjacent the second radially expandable body; and

a thrombolytic distributor between the first and second radially expandable bodies, for distributing a thrombolytic agent over the length of the blood vessel, wherein the thrombolytic distributor comprises a flexible, porous sheath disposed over mechanical agitator, and the mechanical agitator presses the sheath into the clot.

25. Apparatus as in claim 24, wherein the first and second radially expandable bodies comprised balloons.

26. Apparatus as in claim 25, wherein the first and second radially expandable bodies comprise filters.