Apparatus and methods for clot dissolution

• US 8,535,290 B2
• Filed: 07/13/2012
• Issued: 09/17/2013
• Est. Priority Date: 01/25/2000
• Status: Expired due to Fees

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Evans, Michael A., Demarais, Denise, De Cicco, Dino, Ning, Kelvin, Khairkhahan, Alexander, Strang, Tyler Jon
• Primary Examiner(s): STIGELL, THEODORE J
• Application Number:
  US13/548,338
• Publication Number:
  US 20120283699A1
• Time in Patent Office: 431 Days
• Field of Search: 604/22, 604/96.01, 604/101.01, 604/101.05, 604/508, 604/509, 606/128
• 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 a clot over a luminal length of a blood vessel, the method comprising:

positioning a catheter body in the luminal length of the blood vessel, the catheter body comprising a proximal end, a distal portion having at least one lumen allowing passage of a wire or agitator, the distal portion of the catheter body having at least one port formed therein so as to permit fluid flow from the lumen;

actuating an agitator disposed within the catheter body for mechanical disruption of a clot in the blood vessel, the agitator comprising a non-linear region disposed in the catheter body lumen such that the at least one port is positioned along a distal portion of the non-linear region;

infusing a fluid comprising a thrombolytic agent through the lumen of the catheter body such that the fluid passes through the at least one port of the distal portion positioned along the distal portion of the non-linear region and into the luminal length of the blood vessel.

2. The method of claim 1, wherein positioning the catheter body comprises passing the catheter body over a guidewire or agitator.

3. The method of claim 1, wherein the non-linear region of the agitator is disposed in the lumen such that the fluid is infused both about the non-linear region and distal to the non-linear region.

4. The method of claim 3, wherein the catheter body comprises a plurality of ports formed along a length of the body and one or more ports of the plurality are positioned distal to the non-linear region.

5. The method of claim 4, wherein at least two ports of the plurality have different cross-sectional areas.

6. The method of claim 5, wherein the plurality of ports are formed such that fluid infusion occurs substantially evenly along the length of the body.

7. The method of claim 1, wherein the agitator is resilient and radially expandable so as to be constrained by the blood vessel as it is rotated.

8. The method of claim 1, wherein the blood vessel is a vein.

9. The method of claim 1, wherein the blood vessel is an artery.

10. The method of claim 1, further comprising isolating at least a portion or end of the luminal length of the blood vessel.

11. The method of claim 10, further comprising isolating both a proximal end and a distal end of the luminal length.

12. The method of claim 10, wherein isolating comprises expanding at least one occlusion balloon.

13. The method of claim 1, further comprising aspirating fluid or clot material from the blood vessel.