Ablation of rectal and other internal body structures

• US 6,419,673 B1
• Filed: 04/25/2000
• Issued: 07/16/2002
• Est. Priority Date: 05/06/1996
• Status: Expired due to Fees

• Current Assignee: Stuart Edwards
• Original Assignee: Stuart Edwards
• Inventors: Marcus, Steven V, Edwards, Stuart D.
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US09/557,993
• Time in Patent Office: 812 Days
• Field of Search: 606/41, 606/42, 606/45-50, 607/101-105, 607/133
• US Class Current: 606/41
• 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 18/04 by heating by applying electromagnetic radiation A61B18/18; hyperthermia using electric or magnetic fields, radiation or ultrasound A61N
• CPC Class Codes: A61B 18/1402 Probes for open surgery
• 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 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• 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 2018/00065 porous
• 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 2018/00261 : 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 2018/00547 : Prostate
• CPC Class Codes: A61B 2018/00553 : Sphincter
• CPC Class Codes: A61B 2018/00577 : Ablation
• 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 2018/00702 : Power or energy
• 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 2018/00875 : Resistance or impedance
• CPC Class Codes: A61B 2018/00886 : Duration
• CPC Class Codes: A61B 2018/00898 : Alarms or notifications created in response to an abnormal condition
• 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 2090/3782 : transmitter or receiver in catheter or minimal invasive instrument
• 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: 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

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. 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;

an electrode coupled to said catheter such that rotation of a control element coupled to said catheter is translated to linear movement of said electrode; and

means for aspirating fluid from said region.

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

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

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

5. Apparatus as in claim 1, including means for advancing said electrode from within said catheter to a point inside a selected mass of tissue within said region.

6. Apparatus as in claim 1, wherein said means for isolating includes at least one balloon.

7. Apparatus as in claim 6, wherein said at least one balloon includes a balloon disposed at an upstream location or disposed at a downstream locations from said region.

8. Apparatus as in claim 6, including means for inflating said at least one balloon.

9. Apparatus as in claim 6, wherein said at least one balloon is operative to anchor said catheter in a selected location.

10. Apparatus as in claim 1, including means for anchoring said catheter in a selected location.

11. Apparatus as in claim 10, wherein said means for anchoring includes at least one balloon capable of being disposed against a wall of said region.

12. Apparatus as in claim 1, including

at least one control parameter sensor; and

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

13. Apparatus as in claim 1, including means for delivering a flowable substance to said region.

14. Apparatus as in claim 13, including

at least one control parameter sensor;

and

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

15. Apparatus as in claim 13, wherein said flowable substance includes an effective amount of fluid to cool said region to a selected temperature.

16. Apparatus as in claim 13, wherein said flowable substance includes an effective amount of fluid to rehydrate a selected mass of tissue in said region.

17. Apparatus as in claim 13, wherein said flowable substance includes saline.

18. Apparatus as in claim 13, wherein said flowable substance includes an antibiotic.

19. Apparatus as in claim 13, wherein said flowable substance includes collagen.

20. Apparatus as in claim 13, wherein said flowable substance includes a substance for covering or filling a selected structure within said region.

21. Apparatus as in claim 13, wherein said means for delivering includes at least one hole in said catheter.

22. Apparatus as in claim 13, wherein said means for delivering includes a microporous membrane.

23. Apparatus as in claim 13, wherein said means for delivering includes a balloon having a microporous membrane.

24. Apparatus as in claim 1, including an optical path from said region to a point outside the body, whereby an operator is able to view said region.

25. Apparatus as in claim 24, including means for controlling an orientation or position of said catheter responsive to said view.

26. Apparatus as in claim 24, including a view piece coupled to said optical path.

27. Apparatus as in claim 1, wherein said region is in or near a ligament, bone or cartilage.

28. Apparatus for treatment of a sphincter in a body, comprising:

a catheter;

a source of RF energy coupled to said catheter;

means for disposing said catheter in a region of said body near said sphincter;

an electrode for delivering said RF energy from said catheter to a tissue of said sphincter in an amount effective to treat said tissue, said electrode coupled to said catheter such that rotation of a control element coupled to said catheter is translated to linear movement of said electrode; and

means for aspirating fluid from said region.

29. An apparatus as in claim 28, wherein said sphincter is a lower esophogeal sphincter, a GI sphincter, a rectum, a colon, a blood vessel, an organ, a urethra, a vagina, a prostate.

30. An apparatus as in claim 28, wherein at least a portion of said region is a cavity in said body.

31. An apparatus as in claim 30, wherein said cavity is an element of a gastrointestinal tract, a vascular system, a circulatory tract, a uro-genital tract, a pulmonary system, a lymphatic tract, or an organ.

32. An apparatus as in claim 28, wherein at least a portion of said tissue is an esophogeal varice, a hemorrhoid, a cyst, a polyp, a tumor, or a lesion.

33. An apparatus as in claim 28, wherein said effective amount of RF is effective to heat at least a portion of said tissue, to ablate at least a portion of said tissue, to destroy at least a portion of said tissue, or to contract at least a portion of said tissue.

34. An apparatus as in claim 28, including:

a substance effective for treatment of said tissue;

means for providing said substance from a source coupled to said catheter; and

means for delivering said substance from said catheter to said tissue in an amount effective to treat at least a portion of said tissue.

35. An apparatus as in claim 34, wherein said substance comprises a flowable substance, a medicament, a saline solution, an astringent, a collagenous fluid or other bulking agent, a bio-active substance, a chemo-active substance, a radioactive substance, or a sclerosing agent.

36. An apparatus as in claim 28, wherein said means for delivering said effective amount RF energy comprises an electrode disposed on said catheter.

37. An apparatus as in claim 36, wherein said electrode comprises one or more of the following:

a curvilinear hollow needle disposed for advancing out of said catheter and penetrating a portion of said tissue, a monopolar ring electrode, a pair of bipolar ring electrodes, or a pair of bipolar electrodes disposed for direct contact with a portion of said tissue.

38. An apparatus as in claim 28, including means for delivering near said sphincter a substance effective to treat at least a portion of said tissue.

39. An apparatus as in claim 38, wherein said substance includes one or more of the following:

a flowable substance, a medicament, a saline solution, an astringent, a collagenous fluid or other bulking agent, a bio-active substance, a chemo-active substance.

40. An apparatus as in claim 30, wherein said cavity is an element of a ligament, bone or cartilage.