Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F11/00—Methods or devices for treatment of the ears or hearing sense; Non-electric hearing aids; Methods or devices for enabling ear patients to achieve auditory perception through physiological senses other than hearing sense; Protective devices for the ears, carried on the body or in the hand

Definitions

• the present invention relates to a method for treatment of Meniere's disease by producing variations in positive air pressure, which are transmitted to one of the ears of a patient, and to an apparatus for carrying out the method.
• Meniere's disease can be treated by affecting the pressure in the internal ear, in particular the endolymphatic system.
• WO 83/02556 teaches the treatment of Meniere's disease by a particular kind of air pressure pulses and an apparatus for their generation.
• Pulse trains of a low frequency that is, short time periods of raised pressure interrupted by similarly short time periods of 'normal' (ambient) pressure, are administered to the external ear of a patient that has been put in communication with the middle ear by means of a transmyringeal passage.
• the pulse trains resemble to a square wave and are separated by periods of ambient pressure.
• Modulation pulses of a higher frequency are superimposed on the low frequency pulses. Via the middle ear the pressure pulses are transmitted to the internal ear where they reduce the excessive volume of liquid in the endolymphatic space.
• WO 93/08775 discloses an air pressure generator for the treatment of Meniere's disease by pressure pulses of the following parameters: a minimum pressure which is 33 % of the maximum pressure; a maximum pressure of from 10 to 30 cm H 2 0; intervals between pulses of 5 seconds; a number of pulses per treatment from 1 to 18; a modulation frequency of from 1 to 10 Hz; a pulse length of from 0.1 to 2 seconds.
• the present invention seeks to overcome these drawbacks and problems, and to provide an improved method of treating Meniere's disease and a corresponding apparatus.
• a pulse train comprising increasing air (gas) pressure from ambient pressure (p 0 ) to a first level (pi) above ambient pressure and from the first level (pi) repeatedly increasing the pressure to a second level (p 2 ) and decreasing it to the first level (pi) and, upon said repeated increase and decrease, decreasing the pressure from the first level (pi) to ambient pressure (p 0 )
• pi is from 4 to 16 cm H 2
• the pressure increase rate is from 0 to 4 mm H 2 0 per millisecond
• the pressure decrease rate is from 0 to 2 mm H 2 0 per millisecond
• the modulation frequency is from 3 to 9 Hz, preferably from 5 to
• the pressure pulses are formed in an apparatus comprising an air (gas) pressure chamber being in sealing communication with said outwardly sealed external ear volume. It is preferred to vary the pressure by applying an electromagnetic force to a diaphragm forming a wall of the pressure chamber.
• the electromagnetic force is controlled by a control circuit comprising a microprocessor, power control means, and pressure monitoring means.
• the power supply means prefferably to provide the coil with pulse modulated DC.
• the pressure equalising means comprises valve means. It is preferred for the valve means to be in an open (equalising) position except during the generation of pulse trains.
• the diaphragm actuating means comprises an elongate actuating member having an axis and being fixed to the diaphragm at its one end and to an electromagnet, an electric coil for displacement of the magnet along said axis in the direction of the chamber; means for providing the coil with electric power controlled by the control means; means for displacement of the diaphragm in a direction away from the chamber.
• the means for displacement of the diaphragm in a direction away from the chamber to comprise resilient means not controlled by the control means; it is even more preferred for these displacement means to essentially consist of compressed air contained in the chamber, the conduit, and the sealed external ear volume
• the apparatus of the invention is therefore preferred to provide a mechanical safety valve for protection of the patient against negative pressure opening at a pressure of about - 1 cm H 2 0; the acceptance of a slightly negative pressure is due to design requirements for such a mechanical safety valve. It is also preferred to provide the apparatus of the invention with a safety valve for protection of the patient against positive pressure opening at a pressure of about + 35 cm H 2 0.
• the safety valves are purely mechanical and not controlled by the control means.
• the pressure equalising means preferentially comprise on/off electromagnetic silent valve means working below a hearing level of 20 DB, in particular valve means provided with sealing faces comprising a resilient polymer.
• the combined volume of the chamber and the conduit can be varied within a broad range but considerations of design and conditions of use suggest the combined volume to be preferably from about 20 ccm 2 to about 50 ccm 2 .
• an E ⁇ PROM electrically erasable and programmable read-only memory
• the information for control of the apparatus in form of parameter sets, each set comprising all parameters necessary to carry out a treatment, that is, the variation of pressure in the chamber with time during treatment.
• input means to allow a parameter set to be replaced by another set.
• Input means not requiring an electrical connection such as infrared (IR) input means, are preferred.
• the various parameter sets then are stored in PC or similar and transferred therefrom to the apparatus of the invention. It is also preferred to store several parameter sets in the E 2 PROM, and to provide the apparatus with means for their individual selection.
• the apparatus of the invention thus comprises a fixed basic program stored in the PROM memory of the microprocessor and an exchangeable supplementary program stored in the E 2 PROM. It is, of course, possible to chose functionally equivalent storage media for the fixed and/or the exchangeable software for controlling the apparatus of the invention.
• Fig. 1 is a schematic function diagram of an apparatus according to the invention
• Fig. 2 is a schematic pulse diagram with a non-linear time axis.
• the preferred embodiment of the apparatus according to the present invention illustrated schematically in Fig. 1 comprises an about cylindrical chamber 1 for generating pressure pulses by displacement of a flexible circular rubber diaphragm 4 forming one base of the chamber 1 wall, a piston 2 centrally fixed to the diaphragm 4 at its one end and at a ferromagnetic alloy core 22 at its other end, the core 22 being partially inserted into an field coil 3.
• the chamber 1 has a terminal section 5 provided with a ⁇ silent' (hearing level ⁇ 20 DB) on/off electromagnetic equalising valve 12 which puts it in communication with the atmosphere when in an open position.
• the chamber 1 Via a flexible plastic tube 10 (of polystyrene, polypropene or a similar material) the chamber 1 is put into communication with an air volume in the external ear bordering to the tympanic membrane of a patient sealed off by an ear plug 11.
• the tympanic membrane is penetrated by a microtube which has been applied by surgery; thereby the external and middle ear of the patient is put into communication.
• the pressure in the chamber 1 is monitored by a pressure sensor 8, the signal 20 of which is processed in a control unit comprising a microprocessor 16 and software 14.
• a control unit comprising a microprocessor 16 and software 14.
• One output signal 18 from the microprocessor 16 controls the power supplied to the field coil 3 while another output signal 13 controls the equalising valve 12 by switching it between an open and a closed position. If, for some reason the chamber 1 pressure cannot be maintained within the physiologically acceptable interval the equalising valve is opened. If the chamber pressure exceeds the maximum treatment pressure by 25 cm H 2 0 a hardware controlled safety function breaks the power both to the equalising valve 12 and the field coil 3. As a further safety precaution mechanical safety valves 7,9 against negative pressure (opening pressure - 1 cm H 2 0) excess positive pressure, respectively, are provided in addition.
• the treatment data are stored in the microprocessor in form of one or several parameter sets.
• a parameter set contains all information in regard of pulse amplitude, frequency, pressure increase and decrease rate, etc.
• each parameter set comprises data for the software controlled safety functions.
• Fig. 2 a typical treatment sequence is shown, except for the number of pulse trains being reduced to two for the sake of simplicity.
• phase A the pressure sensor 8 is brought to a working temperature, the equilibrating valve 12 is in an open position, and the chamber 1 is at ambient pressure. Then follows a leak test in phase B during which the valve 12 is kept closed while the pressure is gradually increased to a test pressure p of about 1 cm H 2 0, and then again decreased to zero.
• test phase C an openness test is carried during which the chamber 1 volume V c is varied in the same way as in phase B but with valve 12 in an open position. If the test pressure p t deviates from the expected values the program will stop the apparatus from proceeding to the treatment sequence proper.
• the chamber pressure p is gradually raised to an intermediate pressure i and from there to the maximum pressure p, followed by a decrease to the intermediate pressure pi; the pi — > p 2 — > pi cycle is repeated trice, followed by lowering the pressure to ambient pressure po.
• a second pulse train (phase F) similar to the one in phase D is generated.
• phase G second interval at po
• 10 to 30 further pulse trains (not shown) with corresponding intervals.
• This first treatment section of equally spaced 12 - 32 pulse trains is followed by a rest period of about 40 seconds, and second and third treatment sections also spaced by a corresponding rest period. For optimal effect the treatment should be repeated several times a day.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Acoustics & Sound (AREA)
• Biophysics (AREA)
• Otolaryngology (AREA)
• Psychology (AREA)
• Veterinary Medicine (AREA)
• Physics & Mathematics (AREA)
• Heart & Thoracic Surgery (AREA)
• Vascular Medicine (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
• Percussion Or Vibration Massage (AREA)

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• 1998
  • 1998-07-06 SE SE9802422A patent/SE9802422D0/xx unknown
• 1999
  • 1999-06-29 WO PCT/SE1999/001167 patent/WO2000001331A2/en not_active Application Discontinuation
  • 1999-06-29 EP EP99933405A patent/EP1094769A2/de not_active Withdrawn
  • 1999-06-29 AU AU49466/99A patent/AU4946699A/en not_active Abandoned

Non-Patent Citations (1)

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