+

WO1997043969A1 - Appareil de remodelage esthetique d'une structure corporelle - Google Patents

Appareil de remodelage esthetique d'une structure corporelle Download PDF

Info

Publication number
WO1997043969A1
WO1997043969A1 PCT/US1996/013401 US9613401W WO9743969A1 WO 1997043969 A1 WO1997043969 A1 WO 1997043969A1 US 9613401 W US9613401 W US 9613401W WO 9743969 A1 WO9743969 A1 WO 9743969A1
Authority
WO
WIPO (PCT)
Prior art keywords
tongue
interior
electrode
catheter
oral cavity
Prior art date
Application number
PCT/US1996/013401
Other languages
English (en)
Inventor
Stuart D. Edwards
Original Assignee
Somnus Medical Technologies, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US08/651,378 external-priority patent/US5738114A/en
Priority claimed from US08/651,800 external-priority patent/US5836906A/en
Application filed by Somnus Medical Technologies, Inc. filed Critical Somnus Medical Technologies, Inc.
Priority to AU68506/96A priority Critical patent/AU6850696A/en
Publication of WO1997043969A1 publication Critical patent/WO1997043969A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/24—Surgical instruments, devices or methods for use in the oral cavity, larynx, bronchial passages or nose; Tongue scrapers
    • 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
    • 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
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • 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
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • 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
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/1815—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 microwaves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/06—Electrodes for high-frequency therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/40—Applying electric fields by inductive or capacitive coupling ; Applying radio-frequency signals
    • A61N1/403—Applying electric fields by inductive or capacitive coupling ; Applying radio-frequency signals for thermotherapy, e.g. hyperthermia
    • 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
    • A61B18/1402—Probes for open surgery
    • 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
    • A61B18/18—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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00022—Sensing or detecting at the treatment site
    • A61B2017/00026—Conductivity or impedance, e.g. of tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00022—Sensing or detecting at the treatment site
    • A61B2017/00084—Temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00814—Surgery of the tongue, e.g. glossoplasty
    • 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
    • A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
    • A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
    • 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
    • A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
    • A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
    • A61B2018/00023—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids closed, i.e. without wound contact by the fluid
    • 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
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00059—Material properties
    • A61B2018/00089—Thermal conductivity
    • A61B2018/00101—Thermal conductivity low, i.e. thermally insulating
    • 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
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00184—Moving parts
    • A61B2018/00196—Moving parts reciprocating lengthwise
    • 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
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
    • A61B2018/0022—Balloons
    • A61B2018/0025—Multiple balloons
    • A61B2018/00261—Multiple balloons arranged in a line
    • 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
    • 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
    • A61B2018/00666—Sensing and controlling the application of energy using a threshold value
    • 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
    • A61B2018/00666—Sensing and controlling the application of energy using a threshold value
    • A61B2018/00678—Sensing and controlling the application of energy using a threshold value upper
    • 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
    • A61B2018/00696—Controlled or regulated parameters
    • A61B2018/00702—Power or energy
    • A61B2018/00708—Power or energy switching the power on or off
    • 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
    • A61B2018/00696—Controlled or regulated parameters
    • A61B2018/00744—Fluid flow
    • 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
    • A61B2018/00773—Sensed parameters
    • 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
    • A61B2018/00773—Sensed parameters
    • A61B2018/00791—Temperature
    • 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
    • A61B2018/00773—Sensed parameters
    • A61B2018/00875—Resistance or impedance
    • 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
    • A61B2018/00982—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
    • 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
    • A61B2018/1405—Electrodes having a specific shape
    • A61B2018/1425—Needle
    • 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
    • A61B90/37—Surgical systems with images on a monitor during operation
    • A61B2090/378—Surgical systems with images on a monitor during operation using ultrasound
    • A61B2090/3782—Surgical systems with images on a monitor during operation using ultrasound transmitter or receiver in catheter or minimal invasive instrument
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0082—Catheter tip comprising a tool
    • A61M2025/0096—Catheter tip comprising a tool being laterally outward extensions or tools, e.g. hooks or fibres
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/02—Radiation therapy using microwaves
    • A61N5/04—Radiators for near-field treatment

Definitions

  • This invention relates to a method for maintaining upper airway patency in human patients, and more particularly to a method which utilizes electromagnetic energy to debulk selected sections of the tongue and/or lingual tonsil without damaging the hypoglossal nerve.
  • Sleep-apnea syndrome is a medical condition characterized by daytime hypersomnomulence, morning arm aches, intellectual deterioration, cardiac arrhythmias, snoring and thrashing during sleep. It is caused by frequent episodes of apnea during the patient's sleep.
  • central sleep apnea syndrome is characterized by repeated loss of respiratory effort
  • obstructive sleep apnea syndrome is characterized by repeated apneic episodes during sleep resulting from obstruction of the patient's upper airway or that portion of the patient's respiratory tract which is cephalad to, and does not include, the larynx Treatment thus far includes various medical, surgical and physical measures.
  • Medical measures include the use of medications such as protriptyline, medroxyprogesterone, acetazolamide, theophylline, nicotine and other medications in addition to avoidance of central nervous system depressants such as sedatives or alcohol
  • medications such as protriptyline, medroxyprogesterone, acetazolamide, theophylline, nicotine and other medications in addition to avoidance of central nervous system depressants such as sedatives or alcohol
  • the medical measures above are sometimes helpful but are rarely completely effective. Further, the medications frequently have undesirable side effects.
  • Surgical interventions have included uvulopalatopharyngoplasty, tonsillectomy, surgery to correct severe retrognathia and tracheostomy.
  • the jaw is dislodged and pulled forward, in order to gain access to the base of the tongue.
  • Weight loss may be effective but is rarely achieved by these patients
  • Phrenic nerve or diaphragmatic pacing includes the use of electrical stimulation to regulate and control the patient's diaphragm which is innervated bilaterally by the phrenic nerves to assist or support ventilation
  • This pacing is disclosed in Direct Diaphragm Stimulation by J Mugica et al PACE vol lO Jan-Feb 1987, Part II, Preliminary Test of a Muscular Diaphragm Pacing System on Human Patients by J Mugica et al from Neurostimulation An Overview 1985 pp 263-279 and Electrical Activation of Respiration by Chanomovitez IEEE Eng. in Medicine and Biology, June, 1993
  • Laryngeal Pacemaker by F Kaneko et al from Trans Am Soc Artif Intern Organs 1985 senses volume displaced by the lungs and stimulates the appropriate nerve to open the patient's glottis to treat dyspnea
  • This apparatus is not effective for treatment of sleep apnea
  • the apparatus produces a signal proportional in the displaced air volume of the lungs and thereby the signal produced is too late to be used as an indicator for the treatment of sleep apnea
  • an object of the invention is to provide a method and apparatus to cosmetically remodel body structures
  • Another object of the invention is to provide a method and apparatus to cosmetically remodel the tongue
  • Still another object of the invention is to provide a method and apparatus to cosmetically remodel the tongue in an environment that has been selectively disinfected to reduce or eliminate infection
  • Yet another object of the invention is to provide a method for cosmetically remodeling an interior of a body structure in the oral cavity outside of an oral cavity gag response zone
  • an ablation apparatus which ablates at least a portion of an interior of a body structure that is configured to reduce a chance of body structure infection
  • a catheter is provided with a catheter tissue interface surface and a port formed in the catheter tissue interface surface
  • An electrode is at least partially positioned in the interior of the catheter and is configured to be advanced and retracted in and out of the port
  • the electrode includes an electrode electromagnetic energy delivery surface
  • a disinfectant member coupled to a source of a disinfectant medium and includes a distal end that is configured to extend into an oral cavity
  • An electrode advancement and retraction device is at least partially positioned in the interior of the catheter
  • a cable is coupled to the electrode
  • a method for cosmetically remodeling a body structure while reducing the chances of body structure infection.
  • An ablation apparatus includes a catheter with a catheter tissue interface surface, and an electrode at least partially positioned in an interior of the catheter and advanceable and retractable to and from the catheter into an interior of the body member.
  • a disinfectant member that is configured to introduce a disinfectant medium into at least a portion of an oral cavity is also provided.
  • the disinfectant member and the ablation apparatus are introduced into the oral cavity At least a portion of the oral cavity is disinfected sufficiently to reduce an infection of the body member
  • the electrode is introduced from the interior of the catheter through a body structure external surface into the interior of the body structure Sufficient energy is delivered from the electrode into the interior of the body structure to ablate and cosmetically remodel a portion of the interior of the body structure The electrode is retracted from the interior of the body structure
  • a method for cosmetically remodeling a tongue in an oral cavity An ablation apparatus is provided The ablation apparatus includes a source of electromagnetic energy and one or more electromagnetic energy delivery electrodes coupled to the electromagnetic energy source A distal end of the ablation apparatus is introduced into the oral cavity The distal end of the ablation apparatus is positioned outside of an oral cavity gag response zone At least one electrode is introduced into an interior of the tongue when the distal end of the ablation apparatus is positioned outside of the oral cavity gag response zone A sufficient amount of electromagnetic energy is delivered from the electrode into the interior of the tongue to debulk and cosmetically remodel a section of the tongue without damaging the hypoglossal nerve The electrode is then removed from the interior of the tongue BRIEF DESCRIPTION OF THE FIGURES
  • Figure 1 is a cross-sectional view of an ablation apparatus used with the methods of the present invention.
  • Figure 2 is cross-sectional view illustrating the catheter and connector of the ablation apparatus shown in Figure 1.
  • Figure 3 is a perspective view of the connector illustrated in Figure 1
  • Figure 4 is a perspective view of a needle electrode associated with the ablation apparatus illustrated in Figure 1.
  • Figure 5 is a perspective view of a flexible needle electrode utilized with the methods of the present invention.
  • FIG. 6 illustrates the creation of ablation zones with the ablation apparatus shown in Figure 1
  • Figure 7 is a cross-sectional view of the tongue with the mouth closed
  • Figure 8 is a cross-sectional view of the tongue with the mouth open
  • Figure 9 is a perspective view of the tongue.
  • Figure 10 is a perspective view of the dorsum of the tongue
  • Figure 11 is a cross-sectional view of the tongue.
  • Figure 12 is a cross-sectional view of the tongue illustrating the location of the hypoglossal nerves and the creation of an ablation zone.
  • Figure 13 is a cross-sectional view of the tongue illustrating a plurality of ablation zones
  • Figure 14 is a perspective view of the ventral surface of the tongue
  • Figure 15 is a cross-sectional view of the tongue.
  • Figure 16 is a block diagram illustrating an analog amplifier, analog multiplexer and microprocessor used with the feedback control system.
  • Figure 17 is a block diagram of a temperature/impedance feedback system that can be used to control cooling medium flow rate through the catheter of Figure 1
  • Figure 18 is a block diagram of a temperature/impedance feedback system that can be used to control cooling medium flow rate through the catheter of Figure 1
  • Figure 19 is a three dimensional graph illustrating the percent shrinkage of the tongue following RF ablation
  • Figure 20 is a graph illustrating two-dimensional shrinkage of bovine tongue tissue with RF ablation
  • Figure 21 is a graph illustrating three-dimensional shrinkage of bovine tongue tissue due to RF ablation.
  • Figure 22 is a graph illustrating percent volume change in a tongue following RF ablation.
  • a method for cosmetically remodeling and debulking the tongue, uvula, soft palate, lingual tonsil and/or adenoids provides an ablation apparatus including a source of electromagnetic energy and one or more electromagnetic energy delivery electrodes coupled to the electromagnetic energy source. At least one electrode is advanced into an interior of the tongue. Sufficient electromagnetic energy is delivered from the electrode to debulk a section of the tongue without damaging the hypoglossal nerve The electrode is then removed from the interior of the tongue.
  • a method for treating airway obstructions is achieved by debulking the tongue without damaging the hypoglossal nerve
  • the electrode can be introduced into the tongue from the tongue's tip, ventral surface, dorsum, underneath the tongue, along the tongue's midline, or in certain instances through the chin area
  • the tongue is ablated (debulked) without damaging the hypoglossal nerves, resulting in a remodeling of the tongue and a cosmetic change. This is achieved by positioning the electrodes far enough away from the hypoglossal nerves so that during the delivery of electromagnetic energy to the tongue, the hypoglossal nerves are not damaged
  • Another method for treating airway obstructions is achieved by debulking the lingual tonsil without damaging the hypoglossal nerve These methods are used to treat sleep apnea.
  • Ablation apparatus 10 for cosmetically remodeling and debulking the tongue, lingual tonsils, uvula, soft palate and/or adenoids is illustrated.
  • Ablation apparatus 10 can be positioned so that one or more energy delivery devices or electrodes 12 are introduced into an interior of the tongue through the tongue.
  • Ablation apparatus 10 may include atraumatic intubation with or without visualization, provide for the delivery of oxygen or anesthetics, and can be capable of suctioning blood or other secretions.
  • ablation apparatus 10 is used to treat a variety of different obstructions in the body where passage of gas is restricted
  • One embodiment is the treatment of sleep apnea using electrodes 12 to ablate (cell necrosis) selected portions of the tongue, lingual tonsils and/or adenoids by the use of resistive heating, RF, microwave, ultrasound and liquid thermal jet
  • the preferred energy source is an RF source.
  • ablation apparatus 10 can be used to ablate targeted masses including but not limited to the tongue, tonsils, turbinates, soft palate tissues, hard tissue and mucosal tissue.
  • ablation apparatus 10 is used to debulk the tongue in order to increase the cross-sectional area of the air passageway
  • a disinfectant medium introduction member introduces a disinfectant medium in the oral cavity in order to reduce infection of the ablated body member.
  • a presurgical evaluation may be performed including a physical examination, fiberoptic pharyngoscopy, cephalometric analysis and polygraphic monitoring
  • the physical examination emphasizes the evaluation of the head and neck. It also includes a close examination of the nasal cavity to identify obstructing deformities of the septum and turbinate, oropharyngeal obstruction from a long, redundant soft palate or hypertrophic tonsils, and hypopharyngeal obstruction from a prominent base of the tongue
  • Debulking apparatus 10 includes a catheter 14, an optional handle 16 and one or more electrodes 12 extending from different ports 18 formed along a longitudinal surface of catheter 14, or from a distal end of electrode 12. Catheter 14 can be a handpiece.
  • Advancement device 20 can include guide tracks or tubes 23 positioned in the interior of catheter 14 Electrodes 12 may be positioned in guide tracks 23 and advanced from guide tracks into the interior of the tongue.
  • Ablation or debulking apparatus 10 includes a catheter 14, an optional handle 16 and one or more ablation source delivery device 12 extending from different ports 18 formed along a longitudinal surface of catheter 14, or from a distal portion of ablation source delivery device 12 Catheter 14 can be a handpiece.
  • Ablation source delivery device advancement device 20, also known as advancement device 20 may be provided.
  • Ablation source delivery device advancement device 20 can include guide tracks or tubes 23 positioned in the interior of catheter 14
  • Ablation source delivery device 12 may be positioned in guide tracks 23 and advanced from the guide tracks into the interior of the tongue Cabling is coupled to ablation source delivery device 12
  • Ablation source delivery device 12 may be least partially positioned in an interior of catheter 14
  • ablation source delivery device 12 is advanced and retracted through a port 18 formed in an exterior surface of catheter 14
  • Ablation source delivery device advancement and retraction device 20 advances ablation source delivery device 12 out of catheter 14, into an interior of a body structure and can also provide a retraction of ablation source delivery device 12 from the interior of the body structure
  • the body structure can be any number of different structures, the body structure will hereafter be referred to as the tongue
  • Ablation source delivery device 12 pierce an exterior surface of the tongue and are directed to an interior region of the tongue
  • Sufficient ablation energy is delivered by ablation source 12 to the interior of the tongue to cause the tongue to become sufficiently ablated and debulked
  • Ablation source delivery device 12 can be a hollow structure that is, (i) adapted to deliver different chemicals to a selected tongue interior ablation site (for chemical ablation) (ii) deliver alcohol or other liquids or semi-liquids to achieve ablation as well as a
  • an insulation sleeve that is in a surrounding relationship to an exterior of an electrode.
  • Other devices can include a structure located on ablation source delivery device 12 which limits their advancement, or a structure coupled to a catheter which limits the advancement of ablation source delivery devices 12, such as a stop and the like.
  • One suitable fluid is an electrolytic solution.
  • a cooled electrolytic solution can be used to deliver the thermal energy to the tissue.
  • the electrolytic solution may be cooled in the range of about 30 to 55 degrees C.
  • Catheter 14 includes a catheter tissue interface surface 22, a cooling medium inlet conduit 24 and a cooling medium exit conduit 26 extending through an interior of catheter 14.
  • Ports 18 are formed in the exterior of catheter 14, and are preferably formed on catheter tissue interface surface 22. Ports 18 are isolated from a cooling medium flowing in inlet and outlet conduits 24 and 26. Cooling medium inlet and exit conduits 24 and 26 are configured to provide a cooled section of catheter tissue interface surface 22 of at least 1 to 2 cm 2 . More preferably, the cooled section of catheter tissue interface surface 22 is at least equal to the cross-sectional diameter of the underlying zone of ablation.
  • the cooled section of catheter tissue interface surface 22 is at least equal to the cross-sectional diameter of the underlying zone of ablation. In another embodiment, the cooled section of catheter tissue interface surface 22 only provides cooling to an area associated with each deployed ablation source delivery device.
  • the size of the cooled section of catheter tissue interface surface 22 varies for each patient.
  • the size is sufficient enough to minimize swelling of the tongue following the delivery of electromagnetic energy.
  • the reduction of swelling can be 50% or greater, 75% or greater , and 90% and greater.
  • the amount of cooling provided is sufficient to enable the patient to return home shortly after the debulking procedure is performed, and not run the risk of choking on the tongue. It has been found that by providing a sufficient level of cooling over a relatively large area, the amount of ablation in an interior region of the tongue is enhanced. By providing a sufficiently large enough cooled section of catheter tissue interface surface 22, an adenomas response is minimized.
  • Handle 16 is preferably made of an insulating material. Electrodes 12 are made of a conductive material such as stainless steel Additionally, electrodes 12 can be made of a shaped memory metal, such as nickel titanium, commercially available from Raychem Corporation, Menlo Park, California. In one embodiment, only a distal end of electrode 12 is made of the shaped memory metal in order to effect a desired deflection. When introduced into the oral cavity, catheter 14 can be advanced until a patient's gag response is initiated.
  • Catheter 14 is then retracted back to prevent patient's gagging.
  • the distal end of electrode 12 can be semi-curved.
  • the distal end can have a geometry to conform to an exterior of the tongue.
  • catheter 14 is a handpiece. In this embodiment, a separate handle 16 is not necessary.
  • Debulking apparatus 10 is used to treat an interior region of the tongue.
  • Catheter 14 has a distal end that is sized to be positioned within an oral cavity.
  • Ablation source delivery device 12 is at least partially positioned within an interior of catheter 14.
  • Ablation source delivery device 12 includes ablation delivery surface 30.
  • Ablation source delivery device 20 is coupled to ablation source delivery device 12 and calibrated to advance ablation source delivery device 12 from catheter 14, including but not limited to a distal position of catheter 14, into the interior of the tongue when catheter 14 is positioned adjacent to a surface of the tongue.
  • Ablation source delivery device 12 is advanced an advancement distance 33 from catheter 14 of sufficient length to treat the interior region of the tongue with ablation energy and/or an ablation effect without damaging the hypoglossal nerve or the surface of the tongue.
  • Catheter 14 can be malleable in order to conform to the surface of the tongue when a selected ablation target site is selected.
  • An encapsulated soft metal such as copper, or an annealed metal/plastic material can be used to form malleable catheter 14 All or a portion of catheter 14 may be malleable or made of a shaped memory metal
  • a distal end 14' of catheter 14 can be deflectable This can be achieved mechanically or with the use of memory metals
  • a steering wire, or other mechanical structure can be attached to either the exterior or interior of distal end 14'
  • a deflection knob located on handle 16 is activated by the physician causing a steering wire to tighten This imparts a retraction of distal end 14', resulting in its deflection
  • other mechanical devices can be used in place of the steering wire The deflection may be desirable for tissue sites with difficult access
  • Controlled volumetric reduction of the tongue, under feedback control is used to achieve an effective opening in the airway passage
  • a variety of different pain killing medicaments including but not limited to Xylocaine, may be used
  • a digital ultrasonic measurement system can be used The ultrasound measurement quantifies biological shape changes, provides ultrasonic transmission and reception, uses piezoelectric transducers (crystals) and provides time of flight data
  • a disinfectant medium introduction member 21 may also be introduced into the oral cavity
  • the disinfectant medium can be introduced prior to ablation, during ablation and/or after the ablation It can be delivered continuously
  • the level of disinfection of the oral cavity is selectable as the volume of the oral cavity that is disinfected
  • Disinfectant medium introduction member 21 can be introduced before, after or during the introduction of ablation apparatus 10 into the oral cavity Additionally, disinfectant medium introduction member 21 can be removed at the same time or at a different time that ablation apparatus 10 is removed from the oral cavity
  • Disinfectant medium introduction member 21 can be included in ablation apparatus 10, in an interior of catheter 14 or at an exterior of catheter 14, and may be an introducer with a lumen configured to introduce a disinfectant agent from a disinfectant agent source 23 into all or a selected portion of the oral cavity
  • Disinfectant medium introduction member 21 can be capable of movement within the oral cavity in order to provide for disinfection of all or only a portion of the oral cavity.
  • the oral cavity is that body internal environment where infectious germs may be introduced into the ablated tongue, soft tissue structure, and the like
  • Disinfectant medium introduction member 21 may be slideably positioned in catheter 14 or at its exterior
  • disinfectant medium introduction member 21 can be an optical fiber coupled to a light energy source, including but not limited to a UV source 25
  • the optical fiber can also be slideably be positioned in the oral cavity
  • the optical fiber is configured to provide for the selective disinfection of all or only a portion of the oral cavity and can have a variety of different distal ends to achieve this purpose
  • Suitable disinfectant agents include but are not limited to Peridex, an oral rinse containing 0 12% chlorhexidine glucinate (1 , l '-hexanethylenebisf5-(p- chlorophenyl) biganide ⁇ di-D-gluconate in a base containing water, 11 6% alcohol, glycerin, PEG 40 sorbitan a ⁇ soterate, flavor, dosium saccharin,
  • Electrodes 12 are at least partially positioned in an interior of catheter 14 Each electrode 12 is advanced and retracted through a port 18 formed in an exterior surface of catheter 14 Advancement and retraction device advances electrodes 12 out of catheter 14, into an interior of a body structure and retracted back into catheter 14 Electrodes 12 pierce an exterior surface of the tongue and are directed to an interior region of the tongue Sufficient electromagnetic energy is delivered by electrodes 12 to the interior of the tongue to cause the tongue to become sufficiently ablated and debulked Electrodes 12 can be hollow to receive a variety of different infusion mediums, including but not limited to saline.
  • Electrodes 12 may be limited in the distance that they can be advanced into the tongue This is achieved with an insulation sleeve, a structure located on electrodes 12 which limits their advancement, or a structure coupled to catheter which limits the advancement of electrodes 12, such as a stop and the like
  • the disinfectant medium can be introduced prior to ablation, during ablation and/or after the ablation It can be delivered continuously
  • the level of disinfection of the oral cavity is selectable as is the volume of the oral cavity that is disinfected
  • the degree of disinfection varies Disinfection is provided to reduce infection of the ablated body structure
  • An ablation delivery surface such as an electromagnetic energy delivery surface 30 of electrode 12 can be adjusted by inclusion of an adjustable or non- adjustable insulation sleeve 32 ( Figures 3, 4, and 5) Insulation sleeve 32 can be advanced and retracted along the exterior surface of electrode 12 in order to increase or decrease the length of the electromagnetic energy delivery surface
  • Insulation sleeve 32 can be made of a variety of materials including but not limited to nylon, polyimides, other thermoplastics and the like
  • the size of electromagnetic energy delivery surface 30 can be varied by other methods including but not limited to creating a segmented electrode with a plurality of electrodes that are capable of being multiplexed and individually activated, and the like
  • ablation source delivery device 12 has an advancement length 33 that extends from an exterior surface of catheter 14 and is directed into the interior of the tongue Advancement length 33 is sufficient to position ablation delivery surface 30 at a selected tissue site in the interior of the tongue Ablation delivery surface 30 is of sufficient length so that the ablation effect is delivered to the selected tissue site, create a desired level of ablation at the selected tissue site without causing damage to the hypoglossal nerve.
  • Ablation delivery surface 30 is not always at the distal end of ablation source delivery device 12 Insulation 32 can also be positioned at the distal end of ablation source delivery device 12 In this embodiment, ablation delivery surface 30 does not extend to the distal end of ablation source delivery device 12.
  • ablation delivery surface 30 still delivers a sufficient ablation effect to create a desired level of cell necrosis in the interior of the tongue at the selected tissue site without damaging the hypoglossal nerve and/or damage to the surface of the tongue.
  • ablation source delivery device 12 only one side or a portion of a side of ablation source delivery device 12 can be insulated. This also provides for an ablation source delivery device 12 which can be positioned throughout the tongue, including adjacent to a hypoglossal nerve. Where ablation source delivery device 12 is adjacent to the hypoglossal nerve, ablation source delivery device 12 is insulated.
  • advancement length 33 is 1.2 to 1.5 cm, and the length of ablation delivery surface 30 is 5 to 10 mm, more preferably about 8 mm.
  • advancement length 33 is insufficient to reach the hypoglossal nerve when introduced through any of the tongue surfaces, particularly the dorsum of the tongue.
  • Advancement device 20 is configured to advance at least a portion of each ablation source delivery device 12 to a placement position in the interior of the tongue. Advancement device 20 can also be configured to retract each ablation source delivery device 12. At the placement position, ablation delivery surface delivers sufficient ablation energy and/or effect to reduce a volume of the selected site without damaging a hypoglossal nerve and/or a surface of the tongue.
  • ablation source delivery device advancement and retraction device 20, with or without guide tracks 23, directs the delivery of ablation source delivery device 12 from catheter 14 into the interior of the tongue at an angle of 60 to 90 degrees relative to a longitudinal axis of catheter 14, and preferably about 70 degrees.
  • ablation source delivery device 12 has a geometric shape, including but not limited to a curved configuration that includes one or more insulated surfaces, either partially insulated on one side, at a proximal end, at a distal end, and the like, that is configured to reduce the volume of the selected tissue site without damaging a hypoglossal nerve
  • ablation source delivery device 12 is introduced through any tongue surface and is configured so that a section of ablation source delivery device 12 which may be positioned close to the hypoglossal nerve is provided with insulation 32 As previously noted, insulation 32 can be positioned at different sites of ablation source delivery device 12
  • Handle 16 can comprise a connector 34 coupled to retraction and advancement device 20.
  • Connector 34 provides a coupling of electrodes 12 to power, feedback control, temperature and/or imaging systems
  • An RF/temperature control block 36 can be included
  • Electrodes 12 can be spring loaded When retraction and advancement device 20 is moved back, springs cause selected electrodes 12 to advance out of catheter 14
  • One or more cables 38 couple electrodes 12 to an electromagnetic energy source 40
  • energy sources 40 can be used with the present invention to transfer electromagnetic energy to the interior of a body structure, including but not limited to RF, microwave, ultrasound, coherent light and thermal transfer
  • energy source 40 is a RF generator When a RF energy source is used, the physician can activate RF energy source 40 by the use of a foot switch (not shown) coupled to RF energy source 40
  • One or more sensors 42 may be positioned on an interior or exterior surface of electrode 12, insulation sleeve 32, or be independently inserted into the interior of the body structure Sensors 42 permit accurate measurement of temperature at a tissue site in order to determine, (i) the extent of ablation, (ii) the amount of ablation, (iii) whether or not further ablation is needed, and (iv) the boundary or periphery of the ablated geometry Further, sensors 42 prevent non-targeted tissue from being destroyed or ablated
  • Sensors 42 are of conventional design, including but not limited to thermistors, thermocouples, resistive wires, and the like Suitable sensors 42 include a T type thermocouple with copper constantene, J type, E type, K type, fiber optics, resistive wires, thermocouple IR detectors, and the like. It will be appreciated that sensors 42 need not be thermal sensors.
  • Sensors 42 measure temperature and/or impedance to permit ablation monitoring. This reduces damage to tissue surrounding the targeted ablation mass. By monitoring the temperature at various points within the interior of the body structure the periphery of ablation can be ascertained and it is possible to determine when the ablation is completed. If at any time sensor 42 determines that a desired ablation temperature is exceeded, then an appropriate feedback signal is received at energy source 40 and the amount of energy delivered is regulated.
  • Ablation or debulking apparatus 10 can include visualization capability including but not limited to a viewing scope, an expanded eyepiece, fiber optics, video imaging, and the like
  • ultrasound imaging can be used to position the electrodes 12 and/or determine the amount of ablation.
  • One or more ultrasound transducers 44 can be positioned in or on electrode 12, catheter 14, or on a separate device.
  • An imaging probe may also be used internally or externally to the selected tissue site.
  • a suitable imaging probe is Model 21362, manufactured and sold by Hewlett Packard Company Each ultrasound transducer 44 is coupled to an ultrasound source (not shown).
  • ablation apparatus 10 can be operated in either bipolar or monopolar modes.
  • electrodes 12 are operated in the bipolar mode, creating sufficient ablation zones
  • ablation apparatus 10 can also be operated in the monopolar mode.
  • a groundpad can be positioned in a convenient place such as under the chin
  • a single electrode 12 is positioned in the tongue to create a first ablation zone 46
  • Electrode 12 can then be retracted from the interior of the tongue, catheter 14 moved, and electrode 12 is then advanced from catheter 14 into another interior section of the tongue
  • a second ablation zone 46 is created This procedure can be completed any number of times to form different ablation regions in the interior of the tongue.
  • Electrodes 12 can be introduced into the tongue and operated in the bipolar mode. Electrodes 12 are then repositioned in the interior of the tongue any number of times to create a plurality of connecting or non-connecting ablation zones 46
  • FIGs 7 through 15 various anatomical views of the tongue and other structures are illustrated
  • the different anatomical structures are as follows' the genioglossus muscle, or body of the tongue is denoted as 48, the geniohyoid muscle is 50, the mylohyoid muscle is 52, the hyoid bone is 54, the tip of the tongue is 56, the ventral surface of the tongue is denoted as 58, the dorsum of the tongue is denoted as 60, the inferior dorsal of the tongue is denoted as 62, the reflex of the vallecula is 64, the lingual follicles are denoted as 66; the uvula is 68, the adenoid area is 70; the lateral border of the tongue
  • Dorsum 60 is divided into an anterior 2/3 and inferior dorsal 62
  • the delineation is determined by circumvallate papilla 74 and foramen cecum 82
  • Inferior dorsal 62 is the dorsal surface inferior to circumvallate papilla 74 and superior reflex of the vallecula 64
  • Reflex of the vallecula 64 is the deepest portion of the surface of the tongue contiguous with the epiglottis Lingual follicles 66 comprise the lingual tonsil
  • Electrodes 12 can be inserted into an interior of the tongue through dorsum surface 60, inferior dorsal surface 62, ventral surface 58, tip 56 or geniohyoid muscle 50 Additionally, electrodes may be introduced into an interior of lingual follicles 66 and into adenoid area 70 Once electrodes 12 are positioned, insulation sleeve 32 may be adjusted to provided a desired electromagnetic energy delivery surface 30 for each electrode 12
  • Ablation zones 46 are created without damaging hypoglossal nerves 84 This creates a larger air way passage and provides a treatment for sleep apnea In all instances, the positioning of electrodes 12, as well as the creation of ablation zones 46 is such that hypoglossal nerves 84 are not ablated or damaged The ability to swallow and speak is not impaired.
  • RF electrode 12 are placed on the dorsum surface of the tongue
  • the first electrode is positioned 0 5 cm proximal to the circumvallate pappilla
  • the other electrodes are spaced 1 6 cm apart and are 1 cm off a central axis of the tongue
  • 465 MHz RF was applied
  • the temperature at the distal end of electrode 12 was about 100 degrees C
  • the temperature at the distal end of the insulation sleeve 32 was about 60 degrees C
  • the temperature at the distal end of insulation sleeve 32 was 43 degrees C and above RF energy can be applied as short duration pulses with low frequency RF Precise targeting of a desired ablation site is achieved
  • One or more electrodes 12 may be used to create volumetric three-dimensional ablation A variety of ablation geometries are possible, including but not limited to rectilinear, polyhedral, redetermined shapes, symmetrical and non-symmetrical
  • an open or closed loop feedback system couples sensors 42 to energy source 40
  • the temperature of the tissue, or of electrode 12 is monitored, and the output power of energy source 40 adjusted accordingly Additionally, the level of disinfection in the oral cavity can be monitored
  • the physician can, if desired, override the closed or open loop system
  • a microprocessor can be included and incorporated in the closed or open loop system to switch power on and off, as well as modulate the power
  • the closed loop system utilizes a microprocessor 88 to serve as a controller, watch the temperature, adjust the RF power, look at the result, refeed the result, and then modulate the power
  • a tissue adjacent to RF electrodes 12 can be maintained at a desired temperature for a selected period of time without impeding out
  • Each RF electrode 12 is connected to resources which generate an independent output for each RF electrode 12 An output maintains a selected energy at RF electrodes 12 for a selected length of time
  • Signals representative of power and impedance values are received by a controller 98
  • a control signal is generated by controller 98 that is proportional to the difference between an actual measured value, and a desired value
  • the control signal is used by power circuits 100 to adjust the power output in an appropriate amount in order to maintain the desired power delivered at respective RF electrodes 12
  • temperatures detected at sensors 42 provide feedback for maintaining a selected power
  • the actual temperatures are measured at temperature measurement device 102, and the temperatures are displayed at user interface and display 96
  • a control signal is generated by controller 98 that is proportional to the difference between an actual measured temperature, and a desired temperature
  • the control signal is used by power circuits 100 to adjust the power output in an appropriate amount in order to maintain the desired temperature delivered at the respective sensor
  • a multiplexer can be included to measure current, voltage and temperature, at the numerous sensors 42, and energy can be delivered to RF electrodes 12 in monopolar or bipolar fashion.
  • Controller 98 can be a digital or analog controller, or a computer with software When controller 98 is a computer it can include a CPU coupled through a system bus On this system can be a keyboard, a disk drive, or other non-volatile memory systems, a display, and other peripherals, as are known in the art Also coupled to the bus is a program memory and a data memory
  • User interface and display 96 includes operator controls and a display Controller 98 can be coupled to imaging systems, including but not limited to ultrasound, CT scanners, X-ray, MRI, mammographic X-ray and the like
  • the output of current sensor 90 and voltage sensor 92 is used by controller 98 to maintain a selected power level at RF electrodes 12
  • the amount of RF energy delivered controls the amount of power
  • a profile of power delivered can be incorporated in controller 98, and a preset amount of energy to be delivered can also be profiled
  • Other sensors similar to sensors 90 and 92 can be used by controller 98 for other ablation source delivery devices 12 to maintain a controllable amount of an ablation energy and/or ablative agent
  • Circuitry, software and feedback to controller 98 result in process control, and the maintenance of the selected power that is independent of changes in voltage or current, and are used to change, (i) the selected power, (ii) the duty cycle (on-off and wattage), (iii) bipolar or monopolar energy delivery, and (iv) infusion medium delivery, including flow rate and pressure
  • Analog amplifier 104 can be a conventional differential amplifier circuit for use with sensors 42
  • the output of analog amplifier 104 is sequentially connected by an analog multiplexer 106 to the input of A/D converter 108
  • the output of analog amplifier 104 is a voltage which represents the respective sensed temperatures
  • Digitized amplifier output voltages are supplied by A/D converter 108 to microprocessor 88
  • Microprocessor 88 may be a type 68HCII available from Motorola However, it will be appreciated that any suitable microprocessor or general purpose digital or analog computer can be used to calculate impedance or temperature
  • Microprocessor 88 sequentially receives and stores digital representations of impedance and temperature. Each digital value received by microprocessor 88 corresponds to different temperatures and impedances.
  • Calculated power and impedance values can be indicated on user interface and display 96.
  • calculated impedance and power values can be compared by microprocessor 88 with power and impedance limits. When the values exceed predetermined power or impedance values, a warning can be given on user interface and display 96, and additionally, the delivery of RF energy can be reduced, modified or interrupted.
  • a control signal from microprocessor 88 can modify the power level supplied by energy source 40.
  • FIG. 18 illustrates a block diagram of a temperature/impedance feedback system that can be used to control cooling medium flow rate through catheter 14.
  • Electromagnetic energy is delivered to electrode 12 by energy source 44, and applied to tissue.
  • a monitor 1 10 ascertains tissue impedance, based on the energy delivered to tissue, and compares the measured impedance value to a set value. If the measured impedance exceeds the set value a disabling signal 1 12 is transmitted to energy source 40, ceasing further delivery of energy to electrode 12. If measured impedance is within acceptable limits, energy continues to be applied to the tissue.
  • tissue sensor 42 measures the temperature of tissue and/or electrode 12.
  • a comparator 1 14 receives a signal representative of the measured temperature and compares this value to a pre-set signal representative of the desired temperature. Comparator 114 sends a signal to a flow regulator 1 16 representing a need for a higher cooling medium flow rate, if the tissue temperature is too high, or to maintain the flow rate if the temperature has not exceeded the desired temperature.
  • EXAMPLE 1 Ablation apparatus 10 was used to determine two-dimensional shrinkage of a bovine. RF volumetric reduction was achieved using a single needle electrode. Four miniature ultrasonic crystals were positioned to form a square. Measurements were taken at control and post volumetric reduction at 15 watts initially with a 13% volumetric reduction, and 15 watts for 4 hours with an additional 4% volumetric reduction. A total 17% volumetric reduction was achieved. EXAMPLE 2
  • Ablation apparatus 10 was used to determine three-dimensional shrinkage of a bovine tongue. RF volumetric reduction was achieved with a single needle electrode with eight miniature ultrasonic crystals, creating a cube Application of 16 watts initially produced a 17% volumetric reduction of the tongue, 25 watts applied initially produced a 25% volumetric reduction, and 25 watts after hours produced an additional 4% reduction, for a total volumetric reduction of 29%.
  • EXAMPLE 3 A 35% volumetric reduction was achieved in porcine in vivo, with three dimensional gross at 20 watts initial application.
  • Figure 20 illustrates two-dimensional shrinkage of a bovine tongue tissue due to RF ablation with a needle electrode. The before and after ablation results are illustrated.
  • Figure 21 illustrates in graph form ablation at 16 Watts resulted in a 17% volume shrinkage of the tissue in post-ablation verses control. Ablation at 25 watts resulted in a 25% volume shrinkage after ablation. An additional 4% area shrinkage was obtained after in long-term post ablation (4 hours) verses post- ablation.
  • Figure 22 illustrates a percent volume change after RF ablation 16 Watts, ablation at 16 Watts for 20 minutes, 25 Watts, ablation at 25 Watts for 20 minutes, 25 Watts (4 hours), and long tern post ablation (4 hours after 25 Watts ablation)

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Public Health (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Otolaryngology (AREA)
  • Physics & Mathematics (AREA)
  • Electromagnetism (AREA)
  • Plasma & Fusion (AREA)
  • Radiology & Medical Imaging (AREA)
  • Cardiology (AREA)
  • Dentistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Pulmonology (AREA)
  • Surgical Instruments (AREA)

Abstract

On décrit un appareil permettant d'effectuer une ablation d'une portion d'un intérieur d'une structure corporelle, avec une limitation des risques d'infection de cette structure. Cet appareil comprend un cathéter doté d'une surface d'interface tissu/cathéter et d'un orifice de sortie formé dans cette surface. On a placé une électrode au moins partiellement à l'intérieur du cathéter, celle-ci étant conçue pour être introduite dans l'orifice et retirée de celui-ci. L'électrode comprend une surface de dispositif d'apport d'énergie électromagnétique. Un élément d'introduction d'un milieu désinfectant est couplé à une source de milieu désinfectant et comprend une extrémité distale conçue pour s'étendre dans une cavité buccale. On a placé à l'intérieur du cathéter au moins une partie du dispositif faisant avancer et rentrer l'électrode, un câble étant par ailleurs couplé à celle-ci.
PCT/US1996/013401 1996-05-22 1996-08-16 Appareil de remodelage esthetique d'une structure corporelle WO1997043969A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU68506/96A AU6850696A (en) 1996-05-22 1996-08-16 Apparatus for cosmetically remodeling a body structure

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US08/651,378 1996-05-22
US08/651,378 US5738114A (en) 1996-02-23 1996-05-22 Method and apparatus for treatment of air way obstructions
US08/651,800 1996-05-22
US08/651,800 US5836906A (en) 1996-02-23 1996-05-22 Method and apparatus for treatment of air way obstructions

Publications (1)

Publication Number Publication Date
WO1997043969A1 true WO1997043969A1 (fr) 1997-11-27

Family

ID=27096055

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1996/013401 WO1997043969A1 (fr) 1996-05-22 1996-08-16 Appareil de remodelage esthetique d'une structure corporelle

Country Status (2)

Country Link
AU (1) AU6850696A (fr)
WO (1) WO1997043969A1 (fr)

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7090672B2 (en) 1995-06-07 2006-08-15 Arthrocare Corporation Method for treating obstructive sleep disorder includes removing tissue from the base of tongue
US7442191B2 (en) 1995-06-07 2008-10-28 Arthrocare Corporation Systems and methods for electrosurgical treatment of turbinates
US7491200B2 (en) 2004-03-26 2009-02-17 Arthrocare Corporation Method for treating obstructive sleep disorder includes removing tissue from base of tongue
US9011428B2 (en) 2011-03-02 2015-04-21 Arthrocare Corporation Electrosurgical device with internal digestor electrode
US9168082B2 (en) 2011-02-09 2015-10-27 Arthrocare Corporation Fine dissection electrosurgical device
US9254166B2 (en) 2013-01-17 2016-02-09 Arthrocare Corporation Systems and methods for turbinate reduction
US9271784B2 (en) 2011-02-09 2016-03-01 Arthrocare Corporation Fine dissection electrosurgical device
US9788882B2 (en) 2011-09-08 2017-10-17 Arthrocare Corporation Plasma bipolar forceps
US10448992B2 (en) 2010-10-22 2019-10-22 Arthrocare Corporation Electrosurgical system with device specific operational parameters

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1994010925A1 (fr) * 1992-11-13 1994-05-26 American Cardiac Ablation Co., Inc. Systeme de cauterisation electrochirurgicale refroidi par liquide
EP0608609A2 (fr) * 1992-12-01 1994-08-03 Cardiac Pathways Corporation Cathéter pour ablation à radio-fréquences avec électrode refroidie et méthode
WO1995018575A1 (fr) * 1994-01-06 1995-07-13 Vidamed, Inc. Sonde medicale presentant des caracteristiques ameliorees de hautes frequences, de chauffage par resistance et d´ablation par micro-ondes

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1994010925A1 (fr) * 1992-11-13 1994-05-26 American Cardiac Ablation Co., Inc. Systeme de cauterisation electrochirurgicale refroidi par liquide
EP0608609A2 (fr) * 1992-12-01 1994-08-03 Cardiac Pathways Corporation Cathéter pour ablation à radio-fréquences avec électrode refroidie et méthode
WO1995018575A1 (fr) * 1994-01-06 1995-07-13 Vidamed, Inc. Sonde medicale presentant des caracteristiques ameliorees de hautes frequences, de chauffage par resistance et d´ablation par micro-ondes

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7090672B2 (en) 1995-06-07 2006-08-15 Arthrocare Corporation Method for treating obstructive sleep disorder includes removing tissue from the base of tongue
US7442191B2 (en) 1995-06-07 2008-10-28 Arthrocare Corporation Systems and methods for electrosurgical treatment of turbinates
US7491200B2 (en) 2004-03-26 2009-02-17 Arthrocare Corporation Method for treating obstructive sleep disorder includes removing tissue from base of tongue
US10448992B2 (en) 2010-10-22 2019-10-22 Arthrocare Corporation Electrosurgical system with device specific operational parameters
US9168082B2 (en) 2011-02-09 2015-10-27 Arthrocare Corporation Fine dissection electrosurgical device
US9271784B2 (en) 2011-02-09 2016-03-01 Arthrocare Corporation Fine dissection electrosurgical device
US9011428B2 (en) 2011-03-02 2015-04-21 Arthrocare Corporation Electrosurgical device with internal digestor electrode
US9788882B2 (en) 2011-09-08 2017-10-17 Arthrocare Corporation Plasma bipolar forceps
US9254166B2 (en) 2013-01-17 2016-02-09 Arthrocare Corporation Systems and methods for turbinate reduction
US9649144B2 (en) 2013-01-17 2017-05-16 Arthrocare Corporation Systems and methods for turbinate reduction

Also Published As

Publication number Publication date
AU6850696A (en) 1997-12-09

Similar Documents

Publication Publication Date Title
US5836906A (en) Method and apparatus for treatment of air way obstructions
US5879349A (en) Apparatus for treatment of air way obstructions
AU718288B2 (en) Apparatus for cosmetically remodeling a body structure
US5820580A (en) Method for ablating interior sections of the tongue
US5730719A (en) Method and apparatus for cosmetically remodeling a body structure
US6126657A (en) Apparatus for treatment of air way obstructions
US5738114A (en) Method and apparatus for treatment of air way obstructions
US5807308A (en) Method and apparatus for treatment of air way obstructions
US5817049A (en) Method for treatment of airway obstructions
US20010051783A1 (en) Method and apparatus for treatment of air way obstructions
AU725853B2 (en) Apparatus for cosmetically remodeling a body structure
WO1997043973A1 (fr) Procede pour l'ablation de sections interieures de la langue
WO1997043969A1 (fr) Appareil de remodelage esthetique d'une structure corporelle
WO1997030645A1 (fr) Procede et appareil traitant par energie electromagnetique une insuffisance des voies aeriennes superieures concernant la sphere bucco-laryngee
AU702374B2 (en) Method and apparatus for treatment of air way obstructions
WO1999003411A1 (fr) Methode et appareil de traitement d'obstruction des voies aeriennes

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A1

Designated state(s): AL AM AT AU AZ BB BG BR BY CA CH CN CU CZ DE DK EE ES FI GB GE HU IL IS JP KE KG KP KR KZ LK LR LS LT LU LV MD MG MK MN MW MX NO NZ PL PT RO RU SD SE SG SI SK TJ TM TR TT UA UG US UZ VN AM AZ BY KG KZ MD RU TJ TM

AL Designated countries for regional patents

Kind code of ref document: A1

Designated state(s): KE LS MW SD SZ UG AT BE CH DE DK ES FI FR GB GR IE IT LU MC NL PT SE BF BJ CF CG CI CM

DFPE Request for preliminary examination filed prior to expiration of 19th month from priority date (pct application filed before 20040101)
121 Ep: the epo has been informed by wipo that ep was designated in this application
NENP Non-entry into the national phase

Ref country code: JP

Ref document number: 97542282

Format of ref document f/p: F

REG Reference to national code

Ref country code: DE

Ref legal event code: 8642

NENP Non-entry into the national phase

Ref country code: CA

122 Ep: pct application non-entry in european phase
点击 这是indexloc提供的php浏览器服务，不要输入任何密码和下载