Apparatus and methods for clot dissolution

• US 7,763,010 B2
• Filed: 05/08/2002
• Issued: 07/27/2010
• Est. Priority Date: 01/25/2000
• Status: Expired due to Fees

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Bacchus Vascular Incorporated (Medtronic Plc)
• Inventors: Khairkhahan, Alexander, Strang, Tyler Jon, Demarais, Denise, Evans, Michael A., Ning, Kelvin, De Cicco, Dino
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): Stigell; Theodore J
• Application Number:
  US10/142,005
• Publication Number:
  US 20020188276A1
• Time in Patent Office: 3,002 Days
• Field of Search: 604/264, 604/19, 604/35, 604/36, 604/48, 604/22, 604/500, 604/28, 604/101.05, 604506-510, 604/101.01, 604/101.03, 604/101.04, 604/164.13, 604266-268, 604/523, 604/528, 606192-194, 606/167, 606/170, 606/180, 606/200, 606/159, 606/171, 600/585, 600/435, 600/137
• US Class Current: 604/508
• 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 the ability to infuse a thrombolytic agent, aspirate clot and fluid, and allow passage of a guidewire. Optionally, the catheter may also include a mechanical agitator for further disrupt clot in the presence of the thrombolytic agent. A flow resistor in the catheter provides for infusion and/or aspiration to be concentrated primarily at a clot treatment area in a blood vessel while also providing optional infusion and/or aspiration distal to the treatment area. In some embodiments, infusion, aspiration and guidewire passage occur through a common lumen. 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. A method for disrupting clot over a luminal length of a blood vessel, said method comprising:

positioning a catheter body at a location within the luminal length of the blood vessel, the catheter body having at least one lumen having a distal-end opening and at least one side opening; and

infusing a thrombolytic agent through the distal-end opening and the at least one side opening, wherein the catheter body comprises (i) a flow resistor disposed within the catheter body such that the infusing occurs predominantly through the at least one side opening;

or (ii) at least one single side opening having a larger cross-sectional area compared to a cross-sectional area of the distal-end opening such that the infusing occurs predominantly through the at least one side opening;

or a combination of (i) and (ii).

2. A method as in claim 1, wherein positioning the catheter body includes passing the catheter body over a guidewire.

3. A method as in claim 1, wherein infusing the agent is performed with the catheter body remaining positioned over the guidewire.

4. A method as in claim 1, further comprising agitating the clot over the luminal length.

5. A method as in claim 4, wherein agitating the clot comprises mechanically agitating the clot.

6. A method as in claim 4, wherein agitating the clot comprises rotating and/or axially translating a radially expansible agitator within the blood vessel and against the clot.

7. A method as in claim 6, wherein the radially expansible agitator is resilient and radially constrained by the blood vessel so that the agitator presses against the clot as it is rotated and/or axially translated.

8. A method as in claim 1, wherein the luminal length is at least 3 cm.

9. A method as in claim 1, wherein the blood vessel is a vein.

10. A method as in claim 9, 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.

11. A method as in claim 1, wherein the blood vessel is an artery.

12. A method as in claim 11, 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.

13. A method as in claim 1, wherein the blood vessel comprises one or more grafts.

14. A method as in claim 1, wherein infusing predominantly through the at least one side opening comprises partially blocking flow of the agent through the at least one lumen distal to the at least one side opening.

15. A method as in claim 1, further comprising isolating at least one end of the luminal length of the blood vessel.

16. A method as in claim 15, further comprising isolating both a proximal end and a distal end of the luminal length.

17. A method as in claim 15, wherein isolating comprises inflating at least one occlusion balloon.

18. A method as in claim 15, wherein isolating is performed prior to infusing the agent.

19. A method as in claim 18, wherein isolating is maintained until after infusing the agent has stopped.

20. A method as in claim 1, further comprising aspirating disrupted clot material from along the luminal length of the blood vessel.

21. A method as in claim 20, wherein aspirating disrupted clot and infusing the agent are performed through a common lumen.

22. A method as in claim 20, wherein the at least one lumen comprises two lumens, aspirating clot being performed through one lumen and infusing the agent being performed through the other lumen.

23. A method as in claim 20, wherein the clot material is agitated by an agitator supported by the catheter body, and wherein the disrupted clot material is aspirated through an aspiration lumen within the catheter body.

24. A method as in claim 23, wherein the disrupted clot material is aspirated using a pump disposed within the aspiration lumen.

25. A method as in claim 20, wherein the clot material is agitated by an agitator supported by the catheter body, and wherein the disrupted clot material is aspirated through an aspiration lumen of an aspiration catheter.

26. A method as in claim 20, further comprising providing reduced aspiration of fluid through the distal-end opening of the at least one lumen.

27. A method as in claim 26, wherein providing reduced aspiration comprises resisting fluid flow through the at least one lumen proximal to the distal-end opening.