Treatment of tissue in sphincters, sinuses and orifices

• US 7,022,105 B1
• Filed: 07/16/1999
• Issued: 04/04/2006
• Est. Priority Date: 05/06/1996
• Status: Expired due to Fees

• Current Assignee: Novasys Medical, Inc. (Roper Technologies, Inc.)
• Original Assignee: Novasys Medical, Inc. (Roper Technologies, Inc.)
• Inventors: Edwards, Stuart D.
• Primary Examiner(s): Thanh, LoAn H.
• Application Number:
  US09/356,110
• Time in Patent Office: 2,454 Days
• Field of Search: 604/20, 604/96.01, 60410101-10105, 60410301-10302, 604/103.09, 604104-107, 604/114, 604/915, 606/192, 606/194, 606/27, 606 32- 34, 606/200, 606/41, 607100-105, 607115-116, 607/120, 607/124, 607 1- 3, 607/133, 600/9, 600 11- 12
• US Class Current: 604/103.01
• 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 a method and system for ablation of body structures or tissue in a sphincter, sinus or orifice such as the rectum, colon, esophagus, vagina, penis, larynx or pharynx. In one aspect of the invention, the environment surrounding the targeted ablation region can be isolated or controlled by blocking the flow of gases or liquids using an inflatable balloon positioned immediately adjacent to the tissue that is to be ablated. In a preferred embodiment, the inflatable balloon also serves to anchor the catheter in place and prevent the catheter from being expelled from the body. The inflatable balloon also insures that locally administered drug remain in the area where most needed. In a second aspect of the invention, positive pressure is used to inflate the balloon. Inflation of balloon triggers the extension of at least one curvilinear electrode into the targeted tissue. Negative pressure deflates the air sac and helps retract the curvilinear electrodes so as to allow the catheter to be removed from the body without damaging adjacent body structures. In a third aspect of the invention, the electrodes are coupled to sensors that measure properties of the target region such as temperature and impedance. Measurement of these properties permits the use of feedback technique to control delivery of the RF energy and administration of fluids for cooling and hydrating the affected tissues. In a fourth aspect of the invention, the catheter includes an optical path that can be coupled to external viewing apparatus. In this way, the position of the electrodes in the body can be determined by fluoroscopic or fiber optic techniques.

Claims

1. Apparatus comprising;

a catheter disposed for insertion into a body at a selected location;

an inflatable microporous balloon coupled to said catheter, said inflatable balloon having at least one surface, said balloon having micropores distributed over the entirety of said at least one surface, said balloon being capable of allowing passage of a flowable substance through said at least one surface into an interior region of a body cavity;

a plurality of struts encompassing said balloon;

at least one electrode embedded in each of said struts, said electrodes being capable of delivering electromagnetic energy, said electrodes positionable relative to a target tissue as a result of movement of said struts toward said target tissue caused by inflation of said balloon;

a switch element associated with said electrodes, said electrodes extendable into said tissue through activation of said switch element; and

an anchoring element coupled to said catheter, wherein said anchoring element is positioned to anchor said inflatable balloon at said selected location.

2. Apparatus as in claim 1, wherein one or more of said electrodes are selected for deployment.

3. Apparatus as in claim 1, wherein said catheter is disposed for either laparoscopic or manual insertion into said selected location.

4. Apparatus as in claim 1, wherein said electromagnetic energy includes RF energy at about 400 to about 500 kilohertz, microwaves, ultrasound, light in the infrared range or laser.

5. Apparatus as in claim 1, wherein said anchoring element comprises a second inflatable balloon.

6. Apparatus as in claim 1, including at least one sensor disposed for measuring conditions at said selected location.

7. Apparatus as in claim 6, wherein said sensor includes at least one of:

an electromagnetic impedance sensor;

an optical sensor; and

a temperature sensor.

8. Apparatus as in claim 1, said flowable substance comprising a chilled liquid for regulating temperature at said selected location.

9. Apparatus as in claim 1, said electrodes each including a lumen for delivering a flowable substance to said selected location, said flowable substance being responsive to said electromagnetic energy.

10. Apparatus as in claim 9, wherein said flowable substance has a selected response to said electromagnetic energy, said selected response including receiving said electromagnetic energy for ablation, coating, expansion, bulking, plumping, shaping, or shrinking tissue.

11. Apparatus as in claim 1, wherein said catheter includes at least one lumen capable of delivery of a flowable substance from outside the body to said selected location.

12. Apparatus as in claim 11, wherein said flowable substance includes at least one of:

a drug, a gas, a radioisotope, an analgesic, an antibiotic, an antiinflammatory, an anti-spasmodic, or saline.

13. Apparatus as in claim 1, wherein said selected location is disposed within a human being or other mammal;

and

said electromagnetic energy is delivered proximate to said selected location to a sphincter, to muscle tissue, or to nerve tissue.

14. Apparatus as in claim 13, wherein said sphincter or tissue is proximate to a bladder, esophagus, uterus, fallopian tube or vas deferens, sinus cavity, aorta, larynx, or pharynx.

15. Apparatus as in claim 1, wherein said electrode is disposed for coupling to circuits capable of controlled application of said electromagnetic energy within said interior region of said body cavity.

16. Apparatus as in claim 15, wherein said controlled application includes uniform distribution of said electromagnetic energy in said interior region.