Devices for interstitial delivery of thermal energy into tissue and methods of use thereof

• US 20020193781A1
• Filed: 06/14/2001
• Published: 12/19/2002
• Est. Priority Date: 06/14/2001
• Status: Abandoned Application

• Current Assignee: Trimedyne Incorporated (InnovaQuartz, LLC)
• Original Assignee: Trimedyne Incorporated (InnovaQuartz, LLC)
• Inventors: Loeb, Marvin P.
• Application Number:
  US09/881,190
• Publication Number:
  US 20020193781A1
• Time in Patent Office: Days
• US Class Current: 606/15
• CPC Class Codes: A61B 18/1402 Probes for open surgery
• CPC Class Codes: A61B 18/1477 Needle-like probes
• 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 18/22 the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
• CPC Class Codes: A61B 2017/00274 Prostate operation, e.g. prostatectomy, turp, bhp treatment
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2018/00547 Prostate
• 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 2018/1425 Needle
• CPC Class Codes: A61B 2018/2005 with beam delivery through an interstitially insertable device, e.g. needle
• CPC Class Codes: A61B 2090/3937 Visible markers
• CPC Class Codes: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

A device is provided for interstitial delivery of thermal energy and/or a biologically compatible bulking material into tissues in a confined space. The device include means for delivering laser, radio-frequency, electrical, microwave, ultrasound or other thermal energy, as well as a port and channel for concomitant or subsequent injection of a bulking agent. The method of use of the device in the treatment of female stress incontinence (FSI), gastro-esophageal reflex disease (GERD), benign prostate hyperplasia (BPH) and other conditions is described.

Claims

1. A catheter device adapted for delivering thermal energy to a body tissue, having a proximal end for connection to an energy source, a tubular body portion, and a distal end adapted for penetration into body tissue, which catheter device comprises:

(a) a permanently curved flexible metal cannula made of a superelastic shape memory alloy, and having a beveled distal end capable of penetrating body tissue; and

(b) a flexible energy conduit within the flexible metal cannula and adapted for delivering energy to a predetermined tissue site;

said metal cannula being sufficiently flexible to be straightened when confined within a relatively more rigid passageway without exceeding the elastic limit thereof.

2. The catheter device of claim 1, wherein the flexible energy conduit is a fiber optic, having a proximal end adapted for connection to a radiant energy source.

3. The catheter device of claim 2, wherein the fiber optic comprises at least one optical fiber having a core diameter in the range of about 100 microns to about 600 microns.

4. The catheter device of claim 1, wherein the energy conduit comprises at least one wire capable of transmitting radiofrequency energy from a source of radiofrequency energy to at least one electrode capable of delivering radiofrequency energy to a body tissue.

5. The catheter device of claim 1, wherein the energy conduit comprises a pair of leads having proximal ends adapted for connection to an electrical power source and distal ends operably connected to an ultrasonic generator.

6. The catheter device of claim 5, wherein the ultrasonic generator is a piezoelectric generator.

7. The catheter device of claim 5, wherein the ultrasonic generator is a magnetostrictive generator.

8. The catheter device of claim 1, wherein the energy conduit comprises a pair of leads having proximal ends adapted for connection to an electrical power source and a distal end portion operably connected to a resistive heating loop.

9. The catheter device of claim 1, wherein the energy conduit comprises a pair of leads having proximal ends adapted for connection to an electrical power source and distal ends operably connected to a microwave energy source.

10. The catheter device of claim 1, wherein the flexible metal cannula comprises a superelastic shape memory alloy of nickel and titanium, having a nickel:

titanium atomic ratio in the range of about 49;

51 to about 51 to 49.

11. The catheter device of claim 10, wherein the nickel-titanium alloy further comprises about 0.1% to about 5% by weight of a metal selected from the group consisting of iron, chromium and copper.

12. The catheter device of claim 1, wherein the metal cannula further comprises a hollow, substantially cylindrical handpiece coaxially disposed over the proximal end portion of the metal cannula and affixed thereto.

13. The catheter device of claim 12, wherein the handpiece further comprises a marker which is positioned in a fixed relationship to the direction of the curvature of the distal end portion of the metal cannula.

14. The catheter device of claim 12, wherein the handpiece further defines a tubular port having an exterior end adapted for connection to a source of fluid, and said tubular port being in fluid flow communication with the metal cannula providing a channel from the exterior of the handpiece to the interior of the flexible metal cannula, such that a fluid may be passed through said port.

15. The catheter device of claim 14, wherein said handpiece is adapted for connection of the port to a vacuum source.

16. The catheter device of claim 1, wherein the flexible metal cannula has a polymeric sleeve on its exterior surface.

17. The catheter device of claim 16, wherein the polymeric sleeve is made of a fluorocarbon polymer.

18. The catheter device of claim 1, wherein the flexible metal cannula has a polymeric coating on its exterior surface.

19. The catheter device of claim 18, wherein the polymeric coating is a fluorocarbon polymer coating.

20. A catheter device adapted for delivering energy to heat a body tissue, having a proximal end for connection to an energy source, a tubular body portion, and a distal end adapted for penetration into body tissues, which catheter device comprises;

(a) an introducer sheath which is a hollow tube open at both ends;

(b) a permanently curved flexible metal cannula, receivable within the introducer sheath, having a beveled distal end capable of penetrating body tissues when the distal end of the metal cannula extends beyond the distal end of the introducer sheath; and

(c) a flexible energy conduit within the flexible metal cannula adapted for delivering energy to a predetermined tissue site.

21. The catheter device of claim 20, wherein the flexible metal cannula is made of a superelastic shape memory alloy and at the distal end portion thereof having a radius of curvature of less than 2 cm, said flexible metal cannula being temporarily straightenable when confined within a relatively more rigid introducer sheath.

22. The catheter device of claim 20, wherein the flexible energy conduit is a fiber optic, capable of delivering light energy to a body tissue, and having a proximal end adapted for connection to a light source.

23. The catheter device of claim 22, wherein the fiber optic comprises at least one optical fiber having a core diameter in the range of about 100 microns to about 600 microns.

24. The catheter device of claim 20, wherein the energy conduit comprises at least one wire whose proximal end is adapted for connection to a source of radiofrequency energy and whose distal end comprises at least one electrode capable of delivering radiofrequency energy to a body tissue.

25. The catheter device of claim 20, wherein the energy conduit comprises a pair of leads having proximal ends adapted for connection to an electrical power source and distal ends operably connected to an ultrasonic energy generator.

26. The catheter device of claim 25, wherein the ultrasonic generator is a piezoelectric generator or a magnetostrictive generator.

27. The catheter device of claim 20, wherein the energy conduit comprises a pair of leads having proximal ends adapted for connection to an electrical power source and a distal end portion operably connected to a resistive wire heating loop.

28. The catheter device of claim 20, wherein the energy conduct comprises a pair of leads having proximal ends adapted for connection to a source of electrical energy and distal ends operably connected to a microwave energy generator.

29. The catheter device of claim 20, wherein the metal cannula further comprises a hollow, substantially cylindrical handpiece coaxially disposed over the proximal end portion of the metal cannula and affixed thereto.

30. The catheter device of claim 29, wherein the handpiece further defines a tubular port in fluid communication with the cannula and adapted for connection to a pump, such that a fluid may be passed through said port.