Treatment of urinary incontinence and other disorders by application of energy and drugs

• US 6,692,490 B1
• Filed: 09/28/1999
• Issued: 02/17/2004
• Est. Priority Date: 05/18/1999
• Status: Expired due to Term

• Current Assignee: Verathon Incorporated (Roper Technologies, Inc.)
• Original Assignee: Novasys Medical, Inc. (Roper Technologies, Inc.)
• Inventors: Edwards, Stuart D.
• Primary Examiner(s): ROLLINS, ROSILAND STACIE
• Application Number:
  US09/407,658
• Time in Patent Office: 1,603 Days
• Field of Search: 606/32, 606/41, 606/42, 606/45, 606/47, 606/48-50, 607/41, 607/100, 607/101, 607/102, 607/104, 607/105, 604/22
• US Class Current: 606/41
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• 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 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/22062 to be filled with liquid
• CPC Class Codes: A61B 2018/00029 open
• CPC Class Codes: A61B 2018/00065 porous
• 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 2018/00232 having an irregular shape
• CPC Class Codes: A61B 2018/00238 porous
• CPC Class Codes: A61B 2018/00261 arranged in a line
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00482 Digestive system
• CPC Class Codes: A61B 2018/00494 Stomach, intestines or bowel
• CPC Class Codes: A61B 2018/00505 Urinary tract
• CPC Class Codes: A61B 2018/00517 Urinary bladder or urethra
• CPC Class Codes: A61B 2018/00523 : Treatment of incontinence
• CPC Class Codes: A61B 2018/00654 : with individual control of each of a plurality of energy emitting elements
• CPC Class Codes: A61B 2018/00791 : Temperature
• CPC Class Codes: A61B 2018/00797 : measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/00898 : Alarms or notifications created in response to an abnormal condition
• CPC Class Codes: A61B 2018/1467 : using more than two electrodes on a single probe
• CPC Class Codes: A61B 2018/1472 : for use with liquid electrolyte, e.g. virtual electrodes
• CPC Class Codes: A61B 2090/0436 : Shielding
• CPC Class Codes: A61B 2090/3614 : using optical fibre
• CPC Class Codes: A61B 2218/002 : Irrigation
• CPC Class Codes: A61B 2218/007 : Aspiration
• CPC Class Codes: A61F 5/0026 : Anti-eating devices using electrical stimulation
• CPC Class Codes: A61M 2025/105 : having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2210/1053 : Stomach
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters
• CPC Class Codes: A61N 1/06 : for high-frequency therapy
• CPC Class Codes: A61N 1/36007 : of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36017 : with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 2005/061 : Bladder and/or urethra
• CPC Class Codes: A61N 5/0601 : Apparatus for use inside the body
• CPC Class Codes: A61N 5/062 : Photodynamic therapy, i.e. excitation of an agent
• CPC Class Codes: A61N 7/02 : Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

The invention provides a method and system for treating disorders of the genito-urinary tract and other disorders in other parts of the body. A particular treatment can include one or more of, or some combination of ablation, nerve modulation, three-dimensional tissue shaping, drug delivery, mapping, stimulating, shrinking (by creation of a pattern of thermal lesions) and reducing strain on structures by altering the geometry thereof and providing bulk to particularly defined regions. The particular body structures or tissues can include one or more of, or some combination of regions, including the bladder, esophagus, vagina, penis, larynx, pharynx, aortic arch, abdominal aorta, thoracic aorta, large intestine, small intestine, sinus, auditory canal, uterus, vas deferens, trachea and all associated sphincters. In one aspect of the invention, a catheter is deployed in the body. It may enter the body via a natural orifice, a stoma, or a surgically created opening that is made for the purpose of inserting the catheter. Insertion may be facilitated with the use of a guide wire or a generic support structure or visualization apparatus. In second aspect of the invention, the treatment can include application of energy and substances to effect changes in the target tissue. Types of energy that can be applied include radiofrequency, laser, microwave, infrared waves, ultrasound or some combination thereof. Types of substances that can be applied include pharmaceutical agents such as analgesics, antibiotics and anti-inflammatory drugs, bulking agents such as biologically nonreactive particles, cooling fluids or dessicants such as liquid nitrogen for use in cryo-based treatments.

Claims

1. Apparatus comprising:

a catheter disposed for insertion into a body at a selected location, said catheter including a treatment element coupled at a distal end of said catheter; and

a set of electrodes coupled proximately to said treatment element, said electrodes being adapted to deliver energy and chemical treatment; and

an element for selecting and activating said electrodes by an operator, individually or as sequences of electrodes disposed in arrays.

2. Apparatus as in claim 1, wherein said catheter includes at least one irrigation and aspiration port capable of aspirating tissue and delivering substances.

3. Apparatus as in claim 1, wherein at least one electrode is coupled to a heat resistant inflatable balloon.

4. Apparatus in claim 1, wherein a pullwire can be disposed to alter the shape of said heat resistant inflatable balloon.

5. Apparatus as in claim 1, wherein at least one electrode is mounted to at least one umbrella-like strut.

6. Apparatus as in claim 4, wherein said pullwire can be disposed to extend said umbrella-like struts.

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

8. Apparatus as in claim 1, wherein said applied energy includes one or more of:

RF energy at about 300 to about 500 kilohertz;

photodynamic therapy;

microwave energy in about the 915 megahertz to 2.45 gigahertz range;

sonic energy; and

infrared energy;

and wherein said chemical treatment includes one or more of;

enzymes;

acid-base reactions;

radioactive tracers; and

chemical desiccants.

9. Apparatus as in claim 1, including an optional shielding element coupled to said catheter.

10. Apparatus as in claim 9, wherein said optional shielding element includes any of:

an inflatable balloon;

a sponge; and

apolymner shield;

wherein said shielding element is disposed to prevent to present a liquid-tight seal in a region proximate to said selected location.

11. Apparatus as in claim 1, including a sensor disposed for delivering electromagnetic energy from said selected location to a location outside said body.

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

an electromagnetic impedance sensor;

an optical sensor;

a conductivity sensor;

a temperature sensor;

a pressure sensor;

a sensor for identifying nervous activity;

a pH sensor; and

ardliopaque marker.

13. Aparausas in claim 1, including a temperature ragulator coupled to said catheter.

14. Apparatus as in claim 13, wherein said temperature regulator includes a chilled liquid disposed proximate to said selected location.

15. Apparatus as in claim 1, including at least one lumen for delivering a flowable substance to said selected location, said flowable substance being responsive to said electromagnetic energy.

16. Apparatus as in claim 15, wherein said flowable substance has a selected response to said applied energy, said selected response including receiving said applied energy for one or more of:

ablation;

coating;

expansion;

plumping;

shaping;

bulking;

modulating nervous pathways;

reducing compliance; and

shrinldng tissue.

17. Apparatus as in claim 1, wherein said at least one electrode is disposed for coupling to circuits capable of controlled application of said electromagnetic energy within an interior region of a body cavity.

18. Apparatus as in claim 17, wherein said controlled application includes uniform distribution of said electromagnetic energy in said interior region.

19. 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.

20. Apparatus as in claim 19, wherein said flowable substance includes at least one of:

a drug, a gas, a radioisotope, an analgesic, an antibiotic, an anti-inflammatory, an anti-spasmodic, a bulking agent such as microbeads suspended in a delivery vehicle or a cooling fluid such as a glycerin or saline.

21. Apparatus as in claim 1, wherein said selected location is disposed within one of a human and an animal subject;

and

said electromagnetic energy is delivered proximate to said selected location to one or more of;

a sphincter;

muscle tissue; and

nerve tissue.

22. Apparatus as in claim 21, wherein said sphincter or tissue is proximate to one or more of:

a bladder;

esophagus;

uterus;

fallopian tube;

vas deferens;

sinus cavity;

aorta;

larynx; and

pharynx.

23. Apparatus as in claim 21, wherein the sphincter or tissue includes one or more of:

trigone area of a bladder;

detruser muscles of a bladder;

bladderneck;

urethra; and

nerves that inform any of said trigone area, said detruser muscles, said bladderneck and said urethra.