Devices and methods for directed, interstitial ablation of tissue

• US 20030199860A1
• Filed: 04/22/2002
• Published: 10/23/2003
• Est. Priority Date: 04/22/2002
• Status: Active Grant

• Current Assignee: Catheter Ablation Solutions LLC (Acacia Research Corporation)
• Original Assignee: Trimedyne Incorporated (InnovaQuartz, LLC)
• Inventors: Loeb, Marvin P., Crawford, L. Dean, Graham, Randy P., Pergl, James W.
• Granted Patent: US 6,802,838 B2
• Time in Patent Office: Days
• US Class Current: 606/17
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/2005 with beam delivery through an interstitially insertable device, e.g. needle
• CPC Class Codes: A61B 2018/2277 with refractive surfaces

Abstract

The invention relates to a catheter device including an optical fiber whose distal end is disposed within a hollow tube with a sharp or syringe shaped distal end, which may be inserted into tissue. The distal end of the optical fiber and the hollow tube are configured so as to emit, by refraction (total internal reflection) or reflection from a metal surface, laser energy at an angle of about 80° to about 90° relative to the longitudinal axis of the optical fiber and hollow tube. A first fluid channel within the distal end portion of the tube enables fluid to be infused to cool the distal end of the tube and to cool and clean the emission face of the optical fiber. A second, relatively larger diameter fluid channel in the tube enables the fluid, flowing through said first channel along with hot gasses from the vaporization of tissue, to exit the device through a second port in the tube, away from the tissue being treated. A vacuum can be applied to the second fluid channel to more effectively remove the infused, cooling fluid and hot gasses from the tissue being treated. Alternatively, the tube can incorporate a distal end portion which can be articulated to allow the insertion of the device into tissue perpendicular to the tissue'"'"'s surface, from which laser energy can be emitted forwardly.

Claims

1. A catheter device adapted for delivering laser energy to a body tissue comprising:

a) an elongate hollow tube defining first and second spaced-apart ports;

b) a flexible energy conduit adapted for connection to a laser energy source, extending through said tube and including a distal end adapted to emit laser energy to a predetermined tissue site and the distal end portion thereof defining a channel in said tube in fluid flow communication with said first and second ports respectively; and

c) a fluid conduit for passing a fluid or creating a vacuum through said first and second ports and through said channel for cooling said distal end portion and cleaning said distal end of said energy conduit.

2. The catheter device of claim 1 wherein said first and second ports in said tube define fluid inlet and outlet ports respectively and said conduit for passing a fluid comprises a fitting defining an interior cavity in fluid flow a communication with a fluid source, said tube extending through said fitting;

whereby said inlet port in said tube is located in fluid flow communication with said cavity in said fitting and the fluid flows through said channel and exits through said outlet port.

3. The catheter device of claim 1 wherein said first and second ports in said tube comprise fluid inlet and outlet ports respectively and said fluid conduit for passing a fluid includes a handpiece defining an interior cavity in fluid flow communication with a source of fluid, said tube extending into said handpiece;

whereby said inlet port in said tube is located in fluid flow communication with said interior cavity and fluid flows through said channel and exits through said outlet port.

4. The catheter device of claim 1 wherein said fluid conduit for creating a vacuum comprises a fitting defining an interior cavity in fluid flow communication with a vacuum source, said tube extending into said fitting;

whereby said first port in said tube is located in fluid flow communication with said cavity in said fitting and said fluid flows successively through said second port, said channel and then through said first port in response to the creation of a vacuum in said tube.

5. The catheter device of claim 1 wherein said fluid conduit for creating a vacuum comprises a handpiece defining an interior cavity in fluid flow communication with a vacuum source, said tube extending into said handpiece whereby said first port in said tube is located in fluid flow communication with said cavity in said handpiece and fluid is guided successively through said second port and said channel and then through said first port in response to the vacuum in said tube.

6. The catheter device of claim 1 wherein said first and second ports in said tube define fluid inlet and outlet ports respectively, said fluid conduit for passing a fluid comprising a handpiece defining an interior cavity in fluid flow communication with a fluid source and said tube extends into said handpiece and said fluid inlet port thereof is in fluid flow communication with said cavity in said handpiece, said fluid conduit for creating a vacuum comprising a fitting including an interior cavity in fluid flow communication with a vacuum source, said tube extending into said fitting and said fluid outlet port being in fluid flow communication with said cavity in said fitting whereby fluid is guided successively through said inlet port in said tube and said channel and then through said outlet port in said tube in response to the introduction of fluid through said inlet port and the vacuum through said outlet port.

7. The catheter device of claim 1 wherein said tube includes an interior surface, said flexible energy conduit extending through an elongate insert which extends through said tube, said insert including an outer circumferential surface and a plurality of spaced-apart fins extending between said outer circumferential surface of said tube and said insert surface of said tube to define a first upper passage in said tube and a second lower passage in said tube together defining said channel in said tube.

8. The catheter device of claim 1 wherein each said tube and said energy conduit includes opposed side surfaces and said opposed side surfaces of said tube are crimped respectively against said opposed side surfaces of said energy conduit to define a first upper passage and a second lower passage in said tube together defining said channel in said tube.

9. The catheter device of claim 1 wherein said flexible energy conduit extends through a second tube which extends through said tube, said second tube defining a central elongate hollow passage through which said conduit extends and upper and lower elongate arcuate passages together defining said channel in said tube.

10. The catheter device of claim 1 wherein said flexible energy conduit is an elongate fiber optic capable of delivering laser light to a body tissue, having a proximal end adapted for connection to a laser source, said tube including a third port through which the laser light is delivered to the body tissue at an angle of about 80°

to 90°

relative to the longitudinal axis of the device.

11. The catheter device of claim 1 further including a sheath surrounding said tube and defining a port therein, said sheath being rotatable about said tube for aligning said port therein with said second port in said tube.

12. A catheter device adapted for delivering laser energy to a body tissue comprising:

a) a source of laser energy;

b) an elongate hollow tube including a peripheral wall terminating in a distal closed tip and the peripheral wall defining first and second spaced-apart ports;

c) an elongate fiber optic extending through said tube and including a distal end having a tip adapted to emit laser energy in a direction generally normal to the longitudinal axis of the device through a third port formed in said wall of said tube, and a proximal end adapted for connection to the source of laser energy, said fiber optic being spaced from said outer wall and said distal closed tip of said tube to define a fluid channel in said tube which surrounds said fiber optic; and

d) means for introducing a fluid or a vacuum through said first and second ports and through said channel for cooling and cleaning said distal end of said fiber optic.

13. The catheter device of claim 12 wherein said first and second ports in said tube define fluid inlet and outlet ports respectively and said means for introducing a fluid comprises a fitting in fluid flow communication with a source of fluid and adapted for connection to said first port whereby fluid flows through said channel and exits through said second port in said tube.

14. The catheter device of claim 13 wherein said fitting defines an interior cavity and said tube extends through said cavity whereby said first port is in fluid flow communication with said cavity.

15. The catheter device of claim 12 wherein said first and second ports in said tube define fluid inlet and outlet ports respectively and said means for introducing a fluid comprises a handpiece defining an interior cavity in fluid flow communication with a source of fluid, said tube extending into said cavity of said handpiece such that said inlet port in said tube is located in fluid flow communication with said cavity and whereby said fluid flows through said inlet port and said channel and exits through said outlet port in said tube.

16. The catheter device of claim 12 wherein said means for creating a vacuum comprises a fitting in fluid flow communication with a vacuum source and adapted for connection to said first port whereby fluid flows successively through said second port, said channel and then through said first port in response to the creation of a vacuum in said tube.

17. The catheter device of claim 16 wherein said fitting defines an interior cavity and said tube extends through said cavity whereby said first port is in fluid flow communication with said cavity.

18. The catheter device of claim 12 wherein said first and second ports in said tube define fluid inlet and outlet ports respectively, said means for introducing a fluid comprising a handpiece including an interior cavity in fluid flow communication with a source of fluid and said tube extends into said handpiece and said fluid inlet port thereof is in fluid flow communication with said cavity in said handpiece, said means for creating a vacuum comprising a fitting in fluid flow communication with a vacuum source and adapted for connection to said second port whereby fluid flows through said inlet port in said tube and through said channel and exits through said outlet port in said tube in response to the introduction of fluid through said inlet port and the creation of a vacuum through said outlet port.

19. The catheter device of claim 18 wherein said fitting defines an interior cavity and said tube extends through said cavity whereby said first port is in fluid flow communication with said cavity.

20. The catheter device of claim 12 wherein said peripheral wall of said tube includes an interior surface, said flexible energy conduit extending through an elongate insert which extends through said tube, said insert including an outer circumferential surface and a plurality of spaced-apart fins extending between said outer circumferential surface of said insert and said interior surface of said wall of said tube to define a first upper passageway in said tube and a second lower passageway in said tube which together define said channel in said tube.

21. The catheter device of claim 12 wherein each said tube and said energy conduit includes opposed side surfaces and said opposed side surfaces of said tube are crimped respectively against said opposed side surfaces of said energy conduit to define a first upper and a second lower passageway in said tube together defining said channel in said tube.

22. The catheter device of claim 12 wherein said flexible energy conduit extends through a second tube which extends through said tube, said second tube defining a central elongate hollow passageway through which said conduit extends and upper and lower elongate arcuate passageways defining said channel in said tube.

23. The catheter device of claim 12 further including a rotatable sleeve surrounding said tube and defining a port therein adjusted to be rotated into alignment with said second port in said tube.

24. The catheter device of claim 12 wherein said tip of said distal end of said fiber optic is beveled to direct the laser energy generally normally outwardly through said third port in said tube and said distal end of said fiber optic is covered by a capillary tube including a closed distal end.

25. The catheter device of claim 12 wherein said closed distal end of said catheter tube includes an interior beveled surface spaced from and opposite said distal end of said fiber optic for directing laser energy emitted from said fiber optic generally normally through said third port in said tube.

26. A catheter device adapted for delivering laser energy to a body tissue comprising:

a) an elongate hollow tube including a closed distal end and a distal peripheral end portion defining a port;

b) an energy conduit extending longitudinally through said tube including a distal end spaced from and parallel to said port and adapted to emit laser energy; and

c) means for directing the laser energy emitted from said distal end of said energy conduit outwardly through said port in said tube in a direction generally perpendicular to the longitudinal axis of said tube and said energy conduit.

27. The catheter device of claim 26 wherein said distal end of said energy conduit includes a radial end face and said means for directing the laser energy comprises a surface on said radial end face of said energy conduit beveled at about a 39°

angle.

28. The catheter device of claim 26 wherein said closed distal end of said tube includes an interior radial face spaced from said distal end of said energy conduit, said means for directing the laser energy comprising a surface on said radial face beveled at about a 45°

angle.

29. The catheter device of claim 26 wherein said tube includes a peripheral wall defining first and second ports therein defining fluid inlet and outlet ports respectively and said conduit is spaced from said wall to define a fluid channel in said tube, said device further comprising a fitting in fluid flow communication with a source of fluid and adapted for connection to said first port whereby fluid is adapted to flow through said channel and exit through said second port in said tube.

30. The catheter device of claim 26 wherein said tube includes a peripheral wall defining first and second ports therein defining fluid inlet and outlet ports respectively and said conduit is spaced from said wall to define a fluid channel in said tube, said device further comprising a handpiece defining an interior cavity in fluid flow communication with a source of fluid, said tube extending into said cavity of said handpiece such that said inlet port in said tube is located in fluid flow communication with said cavity whereby said fluid is adapted to flow through said inlet port and said channel and exits through said outlet port in said tube.

31. The catheter device of claim 26 wherein said tube includes a peripheral wall defining first and second ports and said conduit is spaced from said wall to define a fluid channel in said tube, said device further comprising a fitting in fluid flow communication with a vacuum source and adapted for connection to said first port;

whereby fluid is adapted to flow successively through said second port, said channel and then through said first port in response to the creation of a vacuum in said tube.

32. The catheter device of claim 26 wherein said tube includes a peripheral wall including an interior surface defining first and second ports formed therein and said conduit is spaced from said interior surface to define a fluid channel, said energy conduit extending through an elongate insert which extends through said tube, said insert including an outer circumferential surface and a plurality of spaced-apart fins extending between said outer circumferential surface of said insert, and said interior surface of said wall of said tube to define a first upper passageway in said rod and a second lower passageway in said tube which together define said channel in said tube.

33. The catheter device of claim 26 wherein each said tube and said energy conduit includes opposed side surfaces and said opposed side surfaces of said tube are crimped respectively against said opposed side surfaces of said energy conduit to define a first upper and a second lower passageway in said tube together defining a channel in said tube in fluid flow communication with respective inlet and outlet ports formed in said tube.

34. The catheter device of claim 26 wherein said distal end of said conduit is covered by a capillary tube including a closed distal end.

35. A catheter device adapted for delivering thermal energy to a body tissue comprising an elongate flexible hollow catheter rod and a flexible energy conduit extending through said catheter rod and adapted to deliver the thermal energy to the body tissue, said catheter rod including a distal end portion adapted to be articulated from a generally longitudinal position to a bent position generally perpendicular to the body tissue.

36. The catheter device of claim 35 further comprising a catheter tube including a distal end portion and an inner surface defining an elongate channel therein having a longitudinal segment and a unitary arcuate segment terminating in an opening defined in the distal end portion of said tube, said rod being slidably articulated through said channel and said distal end portion thereof being composed of a shape memory alloy adapted to maintain said generally longitudinal position when located in said channel and said bent position outside of said channel for delivery of thermal energy in an orientation generally perpendicular to the body tissue.

37. The catheter device of claim 36 further comprising an inflatable balloon surrounding said distal end portion of said catheter tube, said arm further including an inner surface defining an elongate air channel in communication with said balloon for inflating said balloon.

38. The catheter device of claim 35 further comprising an elongate wire having a distal end secured to the distal end portion of said catheter rod and being made of a shape memory alloy adapted to maintain either a first longitudinal position or a second curved position in response to the movement of said wire for respectively articulating said distal end portion of said catheter rod from said generally longitudinal position to said bent position.

39. The catheter device of claim 38 wherein said catheter rod includes an interior surface defining a passageway through which extends said energy conduit, said wire extending through said interior surface of said catheter rod.

40. The catheter device of claim 35 wherein said catheter rod defines an interior and said catheter device further includes an elongate insert extending through said interior of said catheter rod, said insert defining a central channel through which said energy conduit extends and first and second peripheral interior channels, said catheter rod further defining first and second spaced-apart ports in communication with said first and second channels in said insert, said first and second ports in turn being in fluid flow communication with a source of fluid and a vacuum respectively for delivering a fluid through said first channel and for evacuating the fluid through said second channel.

41. A method for vaporizing an amount of tissue of a lobe of the prostate gland, without damaging the urethra or the tissue immediately underlying the urethra, comprising the steps of:

a) advancing into a lobe of the prostate a hollow tube including a sharp distal end, said tube containing an optical fiber including a proximal end optically coupled to a source of laser energy and including a distal end face beveled at an angle of about between 30°

to 50°

from the axis of said optical fiber and encased in a fluid-tight capillary tube;

b) positioning said tube so that a first port formed therein near its distal end and through which laser energy may be emitted is oriented away from the urethra and into the body of the lobe of the prostate and a second port is located on said tube outside of the lobe of the prostate;

c) transmitting laser energy through said optical fiber of an amount sufficient to vaporize a portion of the lobe of the prostate; and

d) simultaneous with transmission of laser energy, infusing a fluid through a fluid channel of said tube and drawing a vacuum through a second channel of said tube to cool the distal end of said tube and capillary tube and remove hot gasses and fluid from the vaporization zone of the lobe.

42. The method of claim 41 wherein holmuim:

YAG laser energy is transmitted through said optical fiber.

43. The method of claim 41 wherein said distal end of said tube is positioned at least 0.5 cm beneath the surface of the urethra.

45. The method of claim 41 wherein holmuim:

YAG laser energy is transmitted through said optical fiber.

46. The method of claim 41 wherein said distal end of said tube is positioned at least 0.5 cm beneath the surface of the urethra.

44. A method of vaporizing the tissue of a lobe of a prostate gland comprising the steps of:

a) advancing a hollow tube including a sharp distal end into a lobe of the prostate gland, said closed distal end of said tube including an interior radial face beveled at about a 45°

angle and containing an optical fiber including a proximal end coupled to a source of laser energy;

b) positioning said tube so that a first port, formed therein near its distal end and through which laser energy may be emitted, is oriented away from the urethra and into the body of the lobe of the prostate, said tube further including a second port located on said tube outside of the lobe of the prostate;

c) transmitting laser energy through said optical fiber against said radial face of said tube and through said first port to vaporize a portion of the lobe of the prostate; and

d) infusing a fluid through a first channel in said tube and drawing a vacuum through a second channel in said tube to cool said distal end of said tube and remove hot gasses and fluid from the vaporization zone of the lobe.

47. A catheter device adapted for delivering laser energy to a body tissue comprising:

a) a laser energy source;

b) an elongate hollow tube defining first and second spaced-apart ports;

c) a flexible energy conduit extending through said tube and including a proximal end adapted for connection to the laser energy source and a distal end adapted to emit laser energy to a predetermined tissue site, the distal end portion thereof defining a channel in said tube in fluid flow communication with said first and second ports respectively; and

d) a fluid conduit for passing a fluid or creating a vacuum through said first and second ports and through said channel for cooling said distal end portion and cleaning said distal end of said energy conduit.

48. The catheter device of claim 47 wherein said first and second ports in said tube define fluid inlet and outlet ports respectively and said fluid conduit for passing a fluid comprises a fitting defining an interior cavity in fluid flow communication with a fluid source, said tube extending through said fitting;

whereby said inlet port in said tube is located in fluid flow communication with said cavity in said fitting and the fluid flows through said channel and exits through said outlet port.

49. The catheter device of claim 47 wherein said first and second ports in said tube comprise fluid inlet and outlet ports respectively and said fluid conduit for passing a fluid includes a handpiece defining an interior cavity in fluid flow communication with a source of fluid, said tube extending into said handpiece;

whereby said inlet port in said tube is located in fluid flow communication with said interior cavity and fluid flows through said channel and exits through said outlet port.

50. The catheter device of claim 47 wherein the laser energy source is selected from the group consisting of an argon laser, a KTP laser, a Nd:

YAG laser, a diode laser, an Alexandrite laser, and a holmium;

YAG laser.

51. The catheter device of claim 47 wherein the laser energy source is a holmium:

YAG laser.