Catheter for Treating Tissue with Non-Thermal Ablation

• US 20100049192A1
• Filed: 08/19/2009
• Published: 02/25/2010
• Est. Priority Date: 08/20/2008
• Status: Active Application

• Current Assignee: prostaCare Pty Ltd.
• Original Assignee: Ionix Medical, Inc.
• Inventors: Sundquist, Stephen K., Fruland, Benjamin R., Holtz, Michael C., Nelson, Tom A., Kroll, Kai
• Granted Patent: US 10,842,555 B2
• Time in Patent Office: Days
• US Class Current: 606/41
• CPC Class Codes: A61B 18/1206 Generators therefor
• 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 18/16 Indifferent or passive electrodes for grounding
• CPC Class Codes: A61B 18/1815 using microwaves
• CPC Class Codes: A61B 2018/00083 low, i.e. electrically insulating
• CPC Class Codes: A61B 2018/00148 with metal
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00285 Balloons
• CPC Class Codes: A61B 2018/00547 Prostate
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00755 Resistance or impedance
• CPC Class Codes: A61B 2018/00767 Voltage
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/00982 combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
• CPC Class Codes: A61B 2018/00988 Means for storing information, e.g. calibration constants, or for preventing excessive use, e.g. usage, service life counter
• CPC Class Codes: A61B 2018/1266 with DC current output
• CPC Class Codes: A61B 2018/143 multiple needles
• CPC Class Codes: A61B 2018/1467 using more than two electrodes on a single probe
• CPC Class Codes: A61B 2018/1475 : Electrodes retractable in or deployable from a housing
• CPC Class Codes: A61B 2018/1861 : with an instrument inserted into a body lumen or cavity, e.g. a catheter
• CPC Class Codes: A61B 2090/378 : using ultrasound
• CPC Class Codes: A61B 2218/002 : Irrigation
• CPC Class Codes: A61B 34/25 : User interfaces for surgical systems
• CPC Class Codes: A61B 5/055 : involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
• CPC Class Codes: A61B 8/08 : Detecting organic movements or changes, e.g. tumours, cysts, swellings A61B8/02 - A61B8/06 take precedence
• CPC Class Codes: A61N 1/36071 : Pain

Abstract

Systems and methods for non-thermal ablation of tissue are provided. A non-implantable minimally invasive system for treatment of tissue in a body via direct current ablation is provided. A catheter for use in such system is further provided. The catheter includes a tubular body having a proximal end, a distal end, and a tip positioned at the distal end. The tubular body is semi-flexible, bi-directionally torqueable, and chemically resistant. The tubular body includes a plurality of routing holes provided between the proximal end and the distal end for facilitating deployment of electrodes from the tubular body. The tubular body further comprises an inner sheath generally at an interior portion and an outer sheath generally at an exterior portion and being chemically resistant.

Claims

1. A catheter for use in a system for treating tissue in a body using direct current ablation comprising:

a tubular body having a proximal end and a distal end and being semi-flexible, bi-directionally torqueable, and chemically resistant, the tubular body comprising;

a tip positioned at the distal end;

a plurality of routing holes provided between the proximal end and the distal end for facilitating deployment of electrodes from the tubular body;

an inner sheath generally at an interior portion; and

a chemically resistant outer sheath generally at an exterior portion.

D. wherein the tubular body has a flex modulus of between about 0.5 and 3 GPa.

2. The catheter of claim 1, wherein the tubular body of capable of torque of approximately 1 inch-pound.

3. The catheter of claim 1, wherein the tubular body is configured to withstand an approximately 40-80 Newton axial force with less than approximately 1% of strain over 300 mm length.

4. The catheter of claim 1, wherein the inner sheath comprises a PEEK tube and the outer sheath comprises a braided outer tube.

5. The catheter of claim 1, wherein the inner sheath comprises an inner layer, a reinforcing layer, and an outer layer.

6. The catheter of claim 5, wherein the inner layer is PTFE, the reinforcing layer is a stainless steel wire braid, and the outer layer comprises a Pebax coating.

7. The catheter of claim 5, wherein the inner layer is Pebax, the reinforcing layer is a stainless steel wire braid, and the outer layer comprises a Pebax coating.

8. The catheter of claim 5, wherein a section of the stainless steel wire braid is replaced with a non-braided section and wherein the routing holes are provided in the non-braided section.

9. The catheter of claim 1, wherein the inner sheath and the outer sheath are bonded to one another.

10. The catheter of claim 1, wherein the chemically resistant outer sheath resists strong acid and strong base.

11. The catheter of claim 1, wherein the routing holes are provided along a distal portion of the tubular body proximate the distal end.

12. The catheter of claim 1, wherein the routing holes further operate as vacuum ports.

13. The catheter of claim 12, further comprising a vacuum connecter proximate the proximal end of the catheter.

14. The catheter of claim 1, comprising 3 bands of routing holes in 4 rows.

15. The catheter of claim 14, wherein the bands are spaced 2 cm apart.

16. The catheter of claim 1, wherein the tip has a Coude shape.

17. The catheter of claim 1, wherein the tip comprises silicon rubber.

18. The catheter of claim 1, wherein the tip is flexible and angled at approximately 30 degrees to facilitate tracking of the catheter in the body.

19. The catheter of claim 1, further comprising a spool provided within the tubular body.

20. The catheter of claim 19, wherein electrodes may be wrapped around the inner sheath for deployment through the routing holes.

21. The catheter of claim 1, wherein the inner sheath rotates relative the outer sheath for deploying the electrodes.

22. The catheter of claim 1, further comprising a radiopaque marking along the tubular body.

23. The catheter of claim 1, further comprising an outer tube for placement over the outer sheath and deployed electrodes for removal of the catheter.

24. The catheter of claim 1, wherein the tubular body is preformed to match a shape of the area of the body to be treated.

25. The catheter of claim 24, wherein the tubular body is preformed to match the veromontanum area.

26. The catheter of claim 25, wherein the tubular body comprises alternating rigid sections and flexible sections.

27. The catheter of claim 1, further including an inflatable balloon for deploying electrodes such that inflation of the balloon deploys electrodes from the catheter.

28. The catheter of claim 1, further comprising a vibrating mechanism associated with the tubular body for vibrating the tubular body.

29. The catheter of claim 28, wherein the vibrating mechanism is provided proximate the proximal end of the tubular body.

30. A catheter for use in a system for treating tissue in a body using direct current ablation comprising:

a tubular body having a proximal end and a distal end and being semi-flexible, bi-directionally torqueable, and chemically resistant, the tubular body comprising;

a tip positioned at the distal end;

a plurality of routing holes provided between the proximal end and the distal end for facilitating deployment of electrodes from the tubular body;

an inner sheath generally at an interior portion; and

an outer sheath generally at an exterior portion and being chemically resistant;

a first fixation element operably coupled to the tubular body.

31. The catheter of claim 30, wherein the first fixation element is provided at the distal end of the tubular body.

32. The catheter of claim 31, wherein the first fixation element comprises a balloon having a shape similar to a shape of the tip.

33. The catheter of claim 30, wherein the first fixation element is provided at a location proximal of the distal end of the tubular body.

34. The catheter of claim 33, wherein the first fixation element has a length of approximately 5 cm.

35. The catheter of claim 30, wherein the first fixation element is an elastomeric balloon.

36. The catheter of claim 35, wherein the balloon comprises silicon rubber.

37. The catheter of claim 35, wherein the first fixation element is configured for inflation by air.

38. The catheter of claim 35, wherein the first fixation element is configured for inflation by saline.

39. The catheter of claim 30, wherein the first fixation element comprises a balloon and is configured and positioned to substantially block the flow of chemicals created by electrolysis to other structures of the body.

40. The catheter of claim 39, further comprising a second fixation element comprising a balloon configured and positioned such that the first fixation element and the second fixation element may together form a contained area.

41. The catheter of claim 30, further comprising a second fixation element comprising electrodes.

42. The catheter of claim 30, wherein the first fixation element is provided on the tubular body between the proximal end and the distal end and wherein the first fixation element is configured to permit fluid flow there across.

43. The catheter of claim 42, wherein the first fixation element comprises a polymeric element including channels for fluid flow.