Apparatus and methods for clot dissolution

• US 8,241,241 B2
• Filed: 06/15/2010
• Issued: 08/14/2012
• Est. Priority Date: 01/25/2000
• Status: Expired due to Fees

• Current Assignee: Tyco Healthcare Group LP (Medtronic Plc)
• Original Assignee: Tyco Healthcare Group LP (Medtronic Plc)
• Inventors: Evans, Michael A., Demarias, Denise, De Cicco, Dino, Ning, Kelvin, Khairkhahan, Alexander, Strang, Tyler Jon
• Primary Examiner(s): STIGELL, THEODORE J
• Application Number:
  US12/816,347
• Publication Number:
  US 20110046542A1
• Time in Patent Office: 791 Days
• Field of Search: 604/22, 604/101.01, 604/96.01, 604/101.05, 606/128
• US Class Current: 604/22
• 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. An apparatus for disrupting a clot over a luminal length of a blood vessel, the apparatus comprising:

a catheter body comprising a proximal end and 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; and

an agitator that is rotatable and/or axially translatable for mechanical disruption of a clot in a 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 and the catheter body assumes the non-linear shape of the non-linear region of the agitator along a length of the non-linear region.

2. The apparatus of claim 1, wherein the non-linear region comprises a helical, spiral, serpentine, zig-zag, alternating, or random geometry.

3. The apparatus of claim 1, wherein the non-linear region comprises a first helical section and a second helical section forming an alternating helical geometry.

4. The apparatus of claim 1, the distal portion of the catheter body having a plurality of ports formed along a length of the body.

5. The apparatus of claim 4, wherein the non-linear region of the agitator is disposed in the catheter body lumen such that at least some ports of the plurality are positioned along a length of the non-linear region.

6. The apparatus of claim 4, wherein the non-linear region of the agitator is disposed in the lumen such that one or more ports of the plurality are distal to the non-linear region.

7. The apparatus of claim 4, two or more ports of the plurality having different cross-sectional areas.

8. The apparatus of claim 4, at least one of the ports of the plurality having a cross-sectional area that is larger compared to a proximally located port.

9. The apparatus of claim 1, further comprising one or more balloons expandable so as to reduce blood flow through a region in a blood vessel in which the catheter body is disposed.

10. The apparatus of claim 9, further comprising a pair of balloons axially spaced-apart along the catheter body.

11. An apparatus for disrupting a clot in a blood vessel, the apparatus comprising:

a catheter body comprising a proximal end and a distal portion having at least one lumen, the distal portion of the catheter body having at least one port fowled therein so as to permit fluid flow from the lumen; and

an agitator that is rotatable for mechanical disruption of a clot in a 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;

wherein the agitator is axially translatable with respect to the catheter body so that the non-linear region can be moved in a proximal or distal direction along the catheter body; and

wherein the non-linear region defines a non-linear region of the catheter body.

12. The apparatus of claim 11, wherein the non-linear region comprises a helical, spiral, serpentine, zig-zag, alternating, or random geometry.

13. The apparatus of claim 11, wherein the non-linear region comprises a first helical section and a second helical section forming an alternating helical geometry.

14. The apparatus of claim 11, the distal portion of the catheter body having a plurality of ports formed along a length of the body.

15. The apparatus of claim 14, wherein the non-linear region of the agitator is disposed in the catheter body lumen such that at least some ports of the plurality are positioned along a length of the non-linear region.

16. The apparatus of claim 14, wherein the non-linear region of the agitator is disposed in the lumen such that one or more ports of the plurality are distal to the non-linear region.

17. The apparatus of claim 14, two or more ports of the plurality having different cross-sectional areas.

18. The apparatus of claim 14, at least one of the ports of the plurality having a cross-sectional area that is larger compared to a proximally located port.

19. The apparatus of claim 11, further comprising one or more balloons expandable so as to reduce blood flow through a region in a blood vessel in which the catheter body is disposed.

20. The apparatus of claim 19, further comprising a pair of balloons axially spaced-apart along the catheter body.