CA2384866A1 - Treatment of tissue by application of energy and drugs - Google Patents

Treatment of tissue by application of energy and drugs Download PDF

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Publication number
CA2384866A1
CA2384866A1 CA002384866A CA2384866A CA2384866A1 CA 2384866 A1 CA2384866 A1 CA 2384866A1 CA 002384866 A CA002384866 A CA 002384866A CA 2384866 A CA2384866 A CA 2384866A CA 2384866 A1 CA2384866 A1 CA 2384866A1
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Canada
Prior art keywords
electromagnetic energy
tissue
selected location
energy
sensor
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Granted
Application number
CA002384866A
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French (fr)
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CA2384866C (en
Inventor
Stuart D. Edwards
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NOVASYS MEDICAL
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Stuart D. Edwards
Novasys Medical
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Priority claimed from US09/407,658 external-priority patent/US6692490B1/en
Application filed by Stuart D. Edwards, Novasys Medical filed Critical Stuart D. Edwards
Publication of CA2384866A1 publication Critical patent/CA2384866A1/en
Application granted granted Critical
Publication of CA2384866C publication Critical patent/CA2384866C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/32—Devices for opening or enlarging the visual field, e.g. of a tube of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1477—Needle-like probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
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    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
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    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
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    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • A61B18/24—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor with a catheter
    • A—HUMAN NECESSITIES
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    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B2017/00022—Sensing or detecting at the treatment site
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    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22062—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation to be filled with liquid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
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    • A61B2018/0022—Balloons
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    • A61B2018/00267—Expandable means emitting energy, e.g. by elements carried thereon having a basket shaped structure
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    • A61B2018/00482—Digestive system
    • A61B2018/00494—Stomach, intestines or bowel
    • A—HUMAN NECESSITIES
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00505—Urinary tract
    • A61B2018/00517—Urinary bladder or urethra
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00505—Urinary tract
    • A61B2018/00523—Treatment of incontinence
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00642—Sensing and controlling the application of energy with feedback, i.e. closed loop control
    • A61B2018/00654—Sensing and controlling the application of energy with feedback, i.e. closed loop control with individual control of each of a plurality of energy emitting elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00791—Temperature
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00791—Temperature
    • A61B2018/00797—Temperature measured by multiple temperature sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00898—Alarms or notifications created in response to an abnormal condition
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1467—Probes or electrodes therefor using more than two electrodes on a single probe
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1472—Probes or electrodes therefor for use with liquid electrolyte, e.g. virtual electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/04—Protection of tissue around surgical sites against effects of non-mechanical surgery, e.g. laser surgery
    • A61B2090/0409—Specification of type of protection measures
    • A61B2090/0436—Shielding
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/361—Image-producing devices, e.g. surgical cameras
    • A61B2090/3614—Image-producing devices, e.g. surgical cameras using optical fibre
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2218/00—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2218/001—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body having means for irrigation and/or aspiration of substances to and/or from the surgical site
    • A61B2218/002—Irrigation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B2218/001—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body having means for irrigation and/or aspiration of substances to and/or from the surgical site
    • A61B2218/007—Aspiration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/0601—Apparatus for use inside the body
    • A—HUMAN NECESSITIES
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    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
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    • A61N5/0613—Apparatus adapted for a specific treatment
    • A61N5/062—Photodynamic therapy, i.e. excitation of an agent
    • A—HUMAN NECESSITIES
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    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A61N7/02—Localised ultrasound hyperthermia

Abstract

The invention provides a method and system for treating disorders parts of t he 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 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 o f, or some combination of reions, including the bladder, esophagus, vagina, penis, laryns, pharynx, aortic arch, abdominal aorta, thoracic aorta, large intestine, small intestine, sinus, auditory canal, uterus, vas deferens, trachea and all associated sphincters. 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 treatment s.

Claims (49)

1. Apparatus comprising a catheter disposed for insertion into a body at a selected location;
and at least one electrode coupled proximately to said treatment element, said electrode being capable of delivering electromagnetic energy.
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 said at least one electrode includes a sequence of electrodes disposed for coupling to circuits for independent control of at least a first and a second said electrode.
4. Apparatus as in claim 1, wherein said at least one electrode includes a sequence of electrodes disposed in a plurality of arrays.
5. Apparatus as in claim 1, wherein said at least one electrode includes a sequence of electrodes disposed in an array.
6. Apparatus as in claim 1, wherein at least one electrode is coupled to a heat resistant inflatable balloon.
7. Apparatus in claim 1, wherein a pullwire can be disposed to alter the shape of said heat resistant inflatable balloon.
8. Apparatus as in claim 1, wherein at least one electrode is mounted to at least one umbrella-like strut.
9. Apparatus as in claim 7, wherein said pullwire can be disposed to extend said umbrella-like struts.
10. Apparatus as in claim 1, wherein said catheter is disposed for either laparoscopic or manual insertion (including use of a guide wire or an introducer sheath) into said selected location.
11. Apparatus as in claim 1, wherein said electromagnetic energy includes RF energy at about 300 to about 500 kilohertz, photodynamic therapy, electromagnetic energy such as microwave energy in about the 915 megahertz to 2.45 gigahertz range, sonic energy such as ultra sound, infrared energy such as from an infrared laser or diode laser, chemical energies such as enzymes, acid-base reactions, radioactive tracers, chemical desiccants such as liquid nitrogen or other bioactive substances.
12. Apparatus as in claim 1, including an optional shielding element coupled to said catheter.
13. Apparatus as in claim 12, wherein said optional shielding element includes an inflatable balloon, a sponge, or polymer shield; said shielding element being disposed to present a liquid-tight seal in a region proximate to said selected location.
14. Apparatus as in claim 1, including a sensor disposed for delivering electromagnetic energy from said selected location to a location outside said body.
15. Apparatus as in claim 14, wherein said sensor includes at least one of: an electromagnetic impedance sensor, an optical sensor, conductivity sensor, a temperature sensor, pressure sensor, sensor for identifying nervous activity, pH
sensor or a radiopaque marker.
16. Apparatus as in claim 1, including a temperature regulator coupled to said catheter.
17. Apparatus as in claim 16, wherein said temperature regulator includes a chilled liquid disposed proximate to said one surface.
18. 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.
19. Apparatus as in claim 18, wherein said flowable substance has a selected response to said electromagnetic energy, said selected response including receiving said electromagnetic energy for ablation, coating, expansion, plumping, shaping, bulking, modulating nervous pathways, reducing compliance and shrinking tissue.
20. 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.
21. Apparatus as in claim 20, wherein said controlled application includes uniform distribution of said electromagnetic energy in said interior region.
22. 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.
23 Apparatus as in claim 22, 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.
24. Apparatus as in claim l, 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.
25. Apparatus as in claim 24, wherein said sphincter or tissue is proximate to a bladder, esophagus, uterus, fallopian tube or vas deferens, sinus cavity, aorta, larynx, or pharynx.
26. Apparatus as in claim 24, wherein the sphincter of tissue includes the trigone area of a bladder, the detruser muscles of a bladder, the bladderneck or the urethra or any nerves that inform these areas.
27. A method comprising the steps of inserting a catheter into a body at a selected location;
positioning an electrode and irrigation and aspiration port in said body so that one or more electrodes are proximate to the tissue to be treated;
allowing passage of a flowable substance through said one surface; and delivering electromagnetic energy from at least one electrode proximate to said one surface.
28. A method as in claim 27, including the step of independently controlling at least a first and a second said one electrode in a sequence of electrodes included in said at least one electrode.
29. A method as in claim 27, including the step of inserting said catheter either laparoscopically or manually into said selected location, using a guidewire, introducer sheath if necessary.
30. A method as in claim 27, wherein said electromagnetic energy includes RF energy at about 400 to about 500 kilohertz. photodynamic therapy, electromagnetic energy such as microwave energy in about the 915 megahertz to 2.45 gigahertz range, sonic energy such as ultra sound, infrared energy such as from an infrared laser or diode laser, chemical energies such as enzymes, acid-base reactions, radioactive tracers, chemical desiccants such as liquid nitrogen or other bioactive substances.
31. A method as in claim 27, including the step of presenting a liquid-tight seal in a region proximate to said selected location.
32. A method as in claim 31, wherein said step of presenting uses said shielding element including an inflatable balloon, a sponge or a polymer shield.
33. A method as in claim 27, including the step of delivering electromagnetic energy from said selected location to a location outside said body.
34. A method as in claim 27, including the step of aspirating said tissue so as to conform it to the at least one electrodes
35. A method as in claim 27, wherein said step of delivering energy includes at least one of: an electromagnetic impedance sensor, an optical sensor, a conductivity sensor, a pH sensor, a pressure sensor, a temperature sensor or a sensor that detect nervous activity.
36. A method as in claim 27, including the step of regulating a temperature proximate to said selected location.
37. A method as in claim 36, wherein said step of regulating uses a chilled liquid disposed proximate to said one surface such as the interior of an organ, or the interior of said balloon.
38. A method as in step 36 wherein said step of regulating relies upon the volume of the said chilled liquid to shape said balloon so as to occupy the interior of said body cavity and bring said at least one electrodes into proximity with said body cavity.
39. A method as in step 38, including the step of manipulating said pullwire to alter the shape of said balloon to bring said at least one electrodes into proximity with said body cavity.
40. A method as in step 27, including the step of manipulating said pullwire to alter the position of said umbrella-like struts to bring said at least one electrodes into proximity with said body cavity.
41. A method as in claim 27, including the step of delivering a flowable substance to said selected location, said flowable substance being responsive to said electromagnetic energy.
42. A method as in claim 41, including eliciting a selected response to said electromagnetic energy, said selected response including receiving said electromagnetic energy for ablation, coating, expansion, plumping, shaping, or shrinking tissue, mapping the position of nerves and stimulating them, shrinking a sphincter by creating a pattern of thermal lesions, reducing compliance or stiffness in a tissue, reducing the strain on a tissue by changing the relative geometry thereof or delivering a drug.
43. A method as in claim 27, including the step of controlling application of said electromagnetic energy within an interior region of a body cavity.
44. A method as in claim 43, wherein said step of controlling application includes the step of distributing said electromagnetic energy uniformly in said interior region.
45. A method as in claim 27, including the step of delivering a flowable substance from outside the body to said selected location.
46. Apparatus as in claim 45, 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, bulking agents such as microbeads suspended in a delivery vehicle, glycerin or saline.
47. A method as in claim 27, 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.
48. A method as in claim 47, wherein said sphincter or tissue is proximate to a bladder, esophagus, uterus, fallopian tube or vas deferens, sinus cavity, aorta, larynx, or pharynx.
49. Apparatus as in claim 47, wherein the sphincter of tissue includes the trigone area of a bladder, the detruser muscles of a bladder, the bladderneck or the urethra or any nerves that inform these areas.
CA2384866A 1999-09-28 2000-09-28 Treatment of tissue by application of energy and drugs Expired - Fee Related CA2384866C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US09/407,658 US6692490B1 (en) 1999-05-18 1999-09-28 Treatment of urinary incontinence and other disorders by application of energy and drugs
US09/407,658 1999-09-28
PCT/US2000/026831 WO2001022897A1 (en) 1999-09-28 2000-09-28 Treatment of tissue by application of energy and drugs

Publications (2)

Publication Number Publication Date
CA2384866A1 true CA2384866A1 (en) 2001-04-05
CA2384866C CA2384866C (en) 2012-07-10

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CA2384866A Expired - Fee Related CA2384866C (en) 1999-09-28 2000-09-28 Treatment of tissue by application of energy and drugs

Country Status (6)

Country Link
US (1) US7326235B2 (en)
EP (1) EP1244392A1 (en)
JP (1) JP2003510126A (en)
AU (1) AU7735200A (en)
CA (1) CA2384866C (en)
WO (1) WO2001022897A1 (en)

Cited By (25)

* Cited by examiner, † Cited by third party
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US7326235B2 (en) 2008-02-05
US20040186468A1 (en) 2004-09-23

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