Ablation of rectal and other internal body structures

• US 6,077,257 A
• Filed: 09/20/1996
• Issued: 06/20/2000
• Est. Priority Date: 05/06/1996
• Status: Expired due to Fees

• Current Assignee: Vidacare Incorporated
• Original Assignee: Vidacare Incorporated
• Inventors: Marcus, Steven, Edwards, Stuart D.
• Primary Examiner(s): McDermott, Corrine
• Application Number:
  US08/717,612
• Time in Patent Office: 1,369 Days
• Field of Search: 604/19-22, 604/48, 604/49, 604/51-54, 604/101, 604/500, 604/506, 607/96, 607/98-102, 607/138, 606/39, 606/45, 606/47
• US Class Current: 604/506
• CPC Class Codes: A61B 17/24 for use in the oral cavity, larynx, bronchial passages or nose for medical inspection of cavities or tubes in the body A61B1/00; Tongue scrapers
• CPC Class Codes: A61B 18/12 by passing a current through the tissue to be heated, e.g. high-frequency current
• CPC Class Codes: A61B 18/1402 Probes for open surgery
• CPC Class Codes: A61B 18/1442 Probes having pivoting end effectors, e.g. forceps
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/1485 having a short rigid shaft for accessing the inner body through natural openings
• 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 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/1815 using microwaves
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00296 mounted on an endoscope
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/22077 with a part piercing the tissue A61B2017/22044 takes precedence
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/00101 low, i.e. thermally insulating
• CPC Class Codes: A61B 2018/00196 reciprocating lengthwise
• CPC Class Codes: A61B 2018/00214 : Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/0022 : Balloons
• CPC Class Codes: A61B 2018/00261 : arranged in a line
• CPC Class Codes: A61B 2018/00285 : Balloons
• CPC Class Codes: A61B 2018/00327 : Ear, nose or throat
• CPC Class Codes: A61B 2018/0041 : Removal of thrombosis
• CPC Class Codes: A61B 2018/00416 : Treatment of aneurisms
• CPC Class Codes: A61B 2018/00636 : Sensing and controlling the application of energy
• CPC Class Codes: A61B 2018/00666 : using a threshold value
• CPC Class Codes: A61B 2018/00678 : upper
• CPC Class Codes: A61B 2018/00708 : switching the power on or off
• CPC Class Codes: A61B 2018/00744 : Fluid flow
• CPC Class Codes: A61B 2018/00761 : Duration
• CPC Class Codes: A61B 2018/00773 : Sensed parameters
• CPC Class Codes: A61B 2018/00791 : Temperature
• CPC Class Codes: A61B 2018/00797 : measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/00875 : Resistance or impedance
• CPC Class Codes: A61B 2018/00886 : Duration
• 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 2090/3614 : using optical fibre
• CPC Class Codes: A61B 2218/003 : using a spray or a foam
• CPC Class Codes: A61B 90/361 : Image-producing devices, e.g. surgical cameras
• CPC Class Codes: A61F 2/82 : Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61M 2025/0096 : being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61N 1/06 : for high-frequency therapy
• CPC Class Codes: A61N 1/403 : for thermotherapy, e.g. hyperthermia
• CPC Class Codes: A61N 5/045 : specially adapted for treatment inside the body

Abstract

The invention provides an apparatus and system for ablation of body structures or tissue in the region of the rectum. A catheter is inserted into the rectum, and an electrode is disposed thereon for emitting energy. The environment for an ablation region is isolated or otherwise controlled by blocking gas or fluid using a pair of inflatable balloons at upstream and downstream locations. Inflatable balloons also serve to anchor the catheter in place. A plurality of electrodes are disposed on the catheter and at least one such electrode is selected and advanced out of the catheter to penetrate and ablate selected tissue inside the body in the region of the rectum. The electrodes are coupled to sensors to determine control parameters of the body structure or tissue, and which are used by feedback technique to control delivery of energy for ablation or fluids for cooling or hydration. The catheter includes an optical path disposed for coupling to an external view piece, so as to allow medical personnel to view or control positioning of the catheter and operation of the electrodes. The catheter is disposed to deliver flowable substances for aiding in ablation, or for aiding in repair of tissue, such as collagen or another substance for covering lesions or for filling fissures. The flowable substances are delivered using at least one lumen in the catheter, either from at least one hole in the catheter, from an area of the catheter covered by a microporous membrane, or from microporous balloons.

Claims

1. A method for ablating a structure within a body, said method including the steps of:

inserting a catheter into region of said body;

isolating said region from gas or fluid from outside said region using at least one balloon having a microporous membrane;

advancing an electrode linearly into said structure through the movement of a rotatable element which translates rotational movement from a control element into a linear movement of said electrode; and

emitting, from said electrode into said region, an effective amount of energy to ablate said structure.

2. A method as in claim 1, wherein said region is in or near the sphincter, rectum, colon, or prostate.

3. A method as in claim 1, wherein said structure includes a cyst, hemorrhoid, polyp, tumor, or lesion.

4. A method as in claim 1, wherein said energy includes RF energy having a frequency between about 435 kilohertz and about 485 kilohertz.

5. A method as in claim 1, wherein said step of emitting is conducted for less than about 10 minutes.

6. A method as in claim 1, including the step of advancing said electrode from within said catheter to a point inside a selected mass of tissue within said region.

7. A method as in claim 1, wherein said step of isolating includes the step of blocking gas or fluid from entering said region using at least one balloon.

8. A method as in claim 7, wherein said at least one balloon includes a balloon disposed at an upstream location or disposed at a downstream locations from said region.

9. A method as in claim 7, wherein said step of isolating includes the step of inflating said at least one balloon.

10. A method as in claim 7, including the step of anchoring said catheter in a selected location using said at least one balloon.

11. A method as in claim 1, including the step of anchoring said catheter in a selected location.

12. A method as in claim 11, wherein said step of anchoring includes the step of disposing at least one balloon against a wall of said region.

13. A method as in claim 1, including the steps of

sensing at least one control parameter of said region;

and

controlling said step of emitting using a feedback technique including said control parameter.

14. A method as in claim 1, including the step of delivering a flowable substance to said region.

15. A method as in claim 14, including the steps of

sensing at least one control parameter of said region;

and

controlling said step of delivering using a feedback technique including said control parameter.

16. A method as in claim 14, wherein said flowable substance includes an effective amount of fluid to cool said region to a selected temperature.

17. A method as in claim 14, wherein said flowable substance includes an effective amount of fluid to rehydrate a selected mass of tissue in said region.

18. A method as in claim 14, wherein said flowable substance includes saline.

19. A method as in claim 14, wherein said flowable substance includes an antibiotic.

20. A method as in claim 14, wherein said flowable substance includes collagen.

21. A method as in claim 14, wherein said flowable substance includes a substance for covering or filling a selected structure within said region.

22. A method as in claim 14, wherein said step of delivering includes exuding said flowable substance from at least one hole in said catheter.

23. A method as in claim 14, wherein said step of delivering includes exuding said flowable substance from a microporous membrane.

24. A method as in claim 14, wherein said step of delivering includes exuding said flowable substance from a balloon having a microporous membrane.

25. A method as in claim 1, including the step of coupling light from said region to a point outside the body, whereby an operator is able to view said region.

26. A method as in claim 1, including the steps of

receiving light from said region representative of a view of said region;

and

controlling an orientation or position of said catheter responsive to said view.

27. Apparatus for ablating a structure in a region within a body, said apparatus including:

a catheter disposed for positioning in said region;

means for isolating said region from gas or fluid from outside said region using at least one balloon having a microprous membrane;

an electrode coupled to said catheter; and

a control element including a rotatable element which translates rotational movement from said control element into a linear movement of said electrode thereby advancing said electrode linearly into said structure.

28. Apparatus as in claim 27, wherein said region is in or near the sphincter, rectum, colon, or prostate.

29. Apparatus as in claim 27, wherein said structure includes a cyst, hemorrhoid, polyp, tumor, or lesion.

30. Apparatus as in claim 27, wherein said energy includes RF energy having a frequency between about 435 kilohertz and about 485 kilohertz.

31. Apparatus as in claim 27, including means for advancing said electrode from within said catheter to a point inside a selected mass of tissue within said region.

32. Apparatus as in claim 27, wherein said means for isolating includes at least one microporous balloon.

33. Apparatus as in claim 32, wherein said at least one balloon includes a balloon disposed at an upstream location or disposed at a downstream locations from said region.

34. Apparatus as in claim 32, including means for inflating said at least one balloon.

35. Apparatus as in claim 32, wherein said at least one balloon is operative to anchor said catheter in a selected location.

36. Apparatus as in claim 27, including means for anchoring said catheter in a selected location.

37. Apparatus as in claim 36, wherein said means for anchoring includes at least one balloon capable of being disposed against a wall of said region.

38. Apparatus as in claim 27, including

at least one control parameter sensor;

and

means, responsive to said control parameter sensor, for controlling said electrode.

39. Apparatus as in claim 27, including at least one flowable substance;

and means for delivering said flowable substance to said region.

40. Apparatus as in claim 39, including

at least one control parameter sensor;

and

means, responsive to said control parameter sensor, for controlling said means for delivering.

41. Apparatus as in claim 39, wherein said flowable substance includes an effective amount of fluid to cool said region to a selected temperature.

42. Apparatus as in claim 39, wherein said flowable substance includes an effective amount of fluid to rehydrate a selected mass of tissue in said region.

43. Apparatus as in claim 39, wherein said flowable substance includes saline.

44. Apparatus as in claim 39, wherein said flowable substance includes an antibiotic.

45. Apparatus as in claim 39, wherein said flowable substance includes collagen.

46. Apparatus as in claim 39, wherein said flowable substance includes a substance for covering or filling a selected structure within said region.

47. Apparatus as in claim 39, wherein said means for delivering includes at least one hole in said catheter.

48. Apparatus as in claim 39, wherein said means for delivering includes a microporous membrane.

49. Apparatus as in claim 39, wherein said means for delivering includes a balloon having a microporous membrane.

50. Apparatus as in claim 27, including an optical path from said region to a point outside the body, whereby an operator is able to view said region.

51. Apparatus as in claim 50, including means for controlling an orientation or position of said catheter responsive to said view.

52. Apparatus as in claim 50, including a view piece coupled to said optical path.