Device and Method for the Ablation of Fibrin Sheath Formation on a Venous Catheter

• US 20090318849A1
• Filed: 06/19/2009
• Published: 12/24/2009
• Est. Priority Date: 06/20/2008
• Status: Active Grant

• Current Assignee: AngioDynamics, Inc.
• Original Assignee: AngioDynamics, Inc.
• Inventors: Hobbs, Eamonn P., Hamilton, William C. JR.
• Granted Patent: US 9,173,704 B2
• Time in Patent Office: Days
• US Class Current: 604/20
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2018/00357 Endocardium
• CPC Class Codes: A61B 2018/00386 Coronary vessels
• CPC Class Codes: A61B 2018/00613 Irreversible electroporation reversible electroporation A61N1/327
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/0097 Cleaning probe surfaces
• CPC Class Codes: A61M 2025/0019 Cleaning catheters or the like, e.g. for reuse of the device, for avoiding replacement
• CPC Class Codes: A61M 2205/054 with electrotherapy
• CPC Class Codes: A61M 25/0043 characterised by structural features
• CPC Class Codes: A61N 1/327 for enhancing the absorption properties of tissue, e.g. by electroporation

Abstract

An indwelling venous catheter and method capable of destroying undesirable cellular growth is provided. The catheter includes a shaft having at least one lumen and adapted to be placed inside a vein for long term use. A plurality of electrodes are positioned near a distal section of the shaft and are adapted to receive from a voltage generator a plurality of electrical pulses in an amount sufficient to cause destruction of cells in the undesirable cellular growth that have grown around the shaft. In one aspect of the invention, a probe is configured to be removably insertable into the at least one lumen and the electrodes are positioned near the distal section of the probe.

Claims

1. An indwelling venous catheter capable of destroying undesirable cellular growth comprising:

a shaft having at least one lumen and adapted to be placed inside a vein for long term use;

a plurality of electrodes positioned near the shaft and adapted to receive from a voltage generator a plurality of electrical pulses in an amount sufficient to cause destruction of cells in the undesirable cellular growth around the shaft.

2. The catheter of claim 1, wherein:

the shaft has two lumens; and

the electrodes are attached at a distal section of the shaft.

3. The catheter of claim 1, wherein:

the catheter is a dialysis catheter; and

the shaft has an arterial lumen and a venous lumen.

4. The catheter of claim 1, further comprising a probe adapted to be removably inserted into the shaft lumen, wherein the probe includes at least one of the electrodes.

5. The catheter of claim 1, further comprising:

a probe having a lumen and adapted to be removably inserted into the shaft lumen;

at least two electrically conducting elements positioned within the probe lumen and adapted to be movable from a retracted position to a deployed position, wherein a distal section of the electrically conducting elements extend past the distal end of the shaft to define the plurality of electrodes.

6. The catheter of claim 5, wherein the distal section of the electrically conducting elements has a pre-curved profile that, in the deployed position, curves radially outwardly and then extends proximally along the shaft.

7. The catheter of claim 1, wherein at least one of the electrodes is ring-shaped and is coaxially arranged with the lumen.

8. The catheter of claim 1, further comprising:

a plurality of electrically conducting wires connected to the electrodes and running along the shaft.

9. The catheter of claim 1, wherein the electrically conducting wires are positioned within a wall of the shaft so as to electrically insulate the electrically conducting wires.

10. The catheter of claim 1, further comprising the voltage generator wherein the voltage generator is adapted to generate a set of between two and twenty-five electrical pulses with each pulse having a duration of from 50 to 200 microseconds and a voltage in a range of from 2,000 V/cm to 6,000 V/cm.

11. The catheter of claim 1, further comprising the voltage generator adapted to generate the electrical pulses in an amount sufficient to cause destruction of fibrin sheath that have grown around the shaft.

12. The catheter of claim 1, further comprising the voltage generator adapted to generate the electrical pulses in an amount sufficient to cause destruction of infectious cells that have grown around the shaft.

13. The catheter of claim 1, further comprising a synchronization device adapted to receive electrocardiogram (ECG) signals and controls generation of the electrical pulses of the voltage generator based on the ECG signals.

14. The catheter of claim 1, further comprising the voltage generator adapted to generate the electrical pulses with each pulse having a duration of less than 1 microsecond.

15. An indwelling venous catheter device capable of destroying undesirable cellular growth comprising:

a shaft having at least one lumen terminating at a distal end opening, the shaft configured to be positioned inside a vein for long-term use;

a probe configured to be removably insertable into the at least one lumen;

a plurality of electrodes positioned near the probe, the electrodes being configured to receive from a voltage generator a plurality of electrical pulses in an amount sufficient to cause destruction of cells in the undesirable cellular growth around the shaft.

16. The catheter device of claim 15, wherein the probe has a tapered distal tip so as to provide a leading edge capable of advancing through the undesirable cellular growth.

17. The catheter device of claim 15, wherein the probe has a lumen, further comprising:

at least two electrically conducting elements positioned within the probe lumen and adapted to be movable from a retracted position to a deployed position, wherein a distal section of the electrically conducting elements extend past the distal end opening of the shaft to define the plurality of electrodes.

18. The catheter device of claim 17, wherein the distal section of the electrically conducting elements has a pre-curved profile that, in the deployed position, curves radially outwardly and then extends proximally along the shaft.

19. The catheter device of claim 15, further comprising the voltage generator wherein the voltage generator is adapted to generate a set of between two and twenty-five electrical pulses with each pulse having a duration of from 50 to 200 microseconds and a voltage in a range of from 2,000 V/cm to 6,000 V/cm.

20. The catheter device of claim 15, further comprising the voltage generator adapted to generate the electrical pulses whose voltage is in a range of from 2,000 V/cm to 6,000 V/cm.

21. The catheter device of claim 15, further comprising the voltage generator adapted to generate the electrical pulses in an amount sufficient to cause destruction of fibrin sheath and infectious cells that have grown around the shaft.

22. The catheter device of claim 15, further comprising a synchronization device adapted to receive electrocardiogram (ECG) signals and controls generation of the electrical pulses of the voltage generator based on the ECG signals.

23. A method of treating undesirable cellular growth on an indwelling venous catheter comprising:

connecting to a voltage generator a plurality of electrodes that are positioned near a shaft of a venous catheter;

applying between the connected electrodes electrical pulses generated by the voltage generator while the shaft of the venous catheter is positioned inside the vein, the electrical pulses being in an amount sufficient to cause destruction of cells in the undesirable cellular growth around the shaft of the venous catheter.

24. The method of claim 23, wherein the step of applying includes applying electrical pulses in an amount sufficient to irreversibly electroporate the cells in the undesirable cellular growth.

25. The method of claim 23, further comprising introducing a therapeutic agent into the cells in the fibrin sheath.

26. The method of claim 23, further comprising deploying the electrodes out of the shaft of the venous catheter prior to applying the electrical pulses.

27. The method of claim 26, wherein the electrodes have a pre-curved profile such that during deployment, the electrodes curve radially outwardly and then extends proximally along the shaft.

28. The method of claim 23, wherein the step of applying includes applying a set of between two and twenty-five electrical pulses with each pulse having a duration of from 50 to 200 microseconds and a voltage in a range of from 2,000 V/cm to 6,000 V/cm.

29. The method of claim 23, wherein the step of applying includes applying the electrical pulses in an amount sufficient to cause destruction of fibrin sheath that have grown around the shaft.

30. The method of claim 23, wherein the step of applying includes applying the electrical pulses in an amount sufficient to cause destruction of infectious cells that have grown around the shaft.

31. The method of claim 23, further comprising:

receiving electrocardiogram (ECG) signals from a synchronization device, wherein generation of the electrical pulses by the voltage generator is controlled by the received ECG signals.