WO1999013811A1 - Device for ventilating the middle ear - Google Patents
Device for ventilating the middle ear Download PDFInfo
- Publication number
- WO1999013811A1 WO1999013811A1 PCT/SE1997/001447 SE9701447W WO9913811A1 WO 1999013811 A1 WO1999013811 A1 WO 1999013811A1 SE 9701447 W SE9701447 W SE 9701447W WO 9913811 A1 WO9913811 A1 WO 9913811A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- tube
- middle ear
- tissue
- ventilation
- outer tube
- Prior art date
Links
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
- A61F11/20—Ear surgery
- A61F11/202—Surgical middle-ear ventilation or drainage, e.g. permanent; Implants therefor
Definitions
- the present invention relates to a device for ventilating the middle ear by means of a ventilation tube which is made of a tissue-compatible material, preferably titanium, and which has a through-channel for air communication between the cavity of the middle ear and the outside air.
- a ventilation tube which is made of a tissue-compatible material, preferably titanium, and which has a through-channel for air communication between the cavity of the middle ear and the outside air.
- the function of the middle ear is to transmit sound energy from the environment to the inner ear, where the sound signals undergo complex processes of interpretation.
- This transmission of sound energy from the environment to the inner ear requires an impedance conversion of the sound signal, since the sound energy is being conveyed from one medium (air) to another medium (liquid) which is located in the inner ear and which has a considerably higher impedance than air.
- an impedance conversion takes place in the middle ear.
- a basic condition if normal hearing is to be maintained is that the normal impedance in the middle ear is retained and that the movement in the transmission chain is not damped, which necessitates a normally ventilated middle ear.
- a standard procedure here is the restoration of the middle ear, which involves removing excess connective tissue and enlarging the middle ear by excising bone, primarily in the mastoid area. This surgery increases the chances of the patient acquiring better hearing, but it has to be combined with an air channel for successful results.
- the surgical intervention is relatively extensive and cannot be repeated simply to make a diagnosis of the condition of the middle ear. It would therefore be desirable to have access to a channel which is large enough to accommodate a fibre optic instrument for examining the condition of the middle ear.
- Fixtures of various types which are anchored in the bone are used to secure various types of prostheses, for example dental prostheses in the jawbone of the oral cavity, and hearing aids anchored in the bone of the skull.
- the titanium surface adapts extremely well both to the bone tissue and also, respectively, to the mucous membrane of the oral cavity or the skin.
- the metal titanium with its excellent biocompatibility properties, has also been shown to have relatively high affinity for binding blood products and forming tissue even on surfaces which are not primarily in contact with tissue. Among other things, this has led to ventilation tubes, placed in the tympanic membrane, becoming blocked more easily if they are made of titanium rather than of polymer material. In addition, a tube fitted in the tympanic membrane is in practice impossible to clean since the tympanic membrane is sensitive to contact.
- Swedish Patent Application 8703694-3 describes a ventilation tube for temporary healing into the tympanic membrane, which consists of a plastic tube whose outer side has been provided with a continuous coating of titanium oxide.
- the ventilation tube can consist of a titanium tube whose inner air channel has been treated with a layer which annuls titanium' s normal affinity for body secretions and body tissues, with the aim of preventing blockage of the ventilation channel.
- the described ventilation tube has advantages over conventional ventilation tubes made of titanium, this type of ventilation tube does not represent a solution in those cases where a permanent anchoring is sought. In this case too, a certain amount of blockage of the ventilation channel takes place sooner or later, and this makes cleaning necessary. Especially in the case of adults with chronic inflammation of the middle ear, there is at the present time no satisfactory method for obtaining the desired ventilation of the middle ear.
- the aim of the present invention is to remedy the difficulties described hereinabove and to create a permanent ventilation channel for the middle ear.
- the ventilation tube is designed such that it can be anchored in the bone tissue, for example in the mastoid bone.
- the ventilation tube therefore comprises, on the one hand, a front portion which is arranged to be introduced into the bone tissue and is designed so that a permanent anchoring of the ventilation tube is obtained, and, on the other hand, a rear portion which forms a passage through the skin.
- the ventilation channel is preferably designed in such a way that blocking is minimized through both the design of the outer tube and the choice of material for the inner channel of the ventilation tube.
- the ventilation channel is also designed in such a way that it is possible to monitor the course of the disease in the middle ear using fibre optics and in this way to improve the result of treatment.
- the ventilation tube comprises an outer tube which is made of tissue-compatible material with the ability to grow firmly into the bone tissue and to function in the external and the internal epithelial passage.
- the ventilation tube further comprises an inner tube which is introduced into the outer tube and which has the necessary properties for minimizing blockage.
- This inner tube is additionally releasable in order to permit cleaning or replacement without causing damage to the supporting tissue.
- a channel is obtained through the ventilation tube which is large enough to allow the middle ear to be examined by fibre optics.
- the inner tube is provided with a membrane so that the ventilation of gas (for example air, water vapour) can be permitted while, by contrast, liquid and particles/bacteria are prevented from entering. In this case too, the inner tube (the insert) is easy to replace .
- the outer tube is designed such that its inner end is free in the excavated bone, for example the mastoid bone, and that it is surface-modified in order to make the ingrowth of tissue more difficult across the inner end of the tube.
- Such surface-coating can be obtained by known surface- coating methods, for example by sputtering, and with known materials, for example polyurethane or silicon.
- the outside of the outer tube is designed in such a way that mechanical stability against the bone tissue is obtained during the healing phase, which is a precondition for osteointegration.
- the ventilation tube consists of an outer tube
- the outer tube comprises a front portion 2 with an external thread 3 arranged to be introduced into a hole made in the bone of the middle ear, so that the ventilation tube obtains a good mechanical stability against the surrounding bone tissue during a healing phase. This is a precondition for osteointegration and permanent anchoring of the ventilation tube.
- the threaded portion is designed at the very front with cutting edges 4 in order to permit a certain degree of self-tapping/scraping of bone material from the surrounding bone tissue when the tube is introduced into the pre-drilled hole in the bone, and cavities 4a for accommodating bone shavings which have been removed.
- the insertion end 5 of the front portion is unthreaded and has a slightly rounded edge towards the inner bore 14 in order to prevent material from being scraped loose from the inner tube 8 and ending up in the middle ear when the inner tube is disengaged.
- this unthreaded part extends a short distance into the middle ear and this free end is therefore surface-coated with, for example, a polymer material for preventing overgrowth of tissue, for example polyurethane or silicon.
- the ventilation tube further comprises a rear portion 6 whose outer surface has a suitable shape for passing through the skin, and which portion is of such a length that after anchoring of the ventilation tube in the bone tissue, it is arranged to extend from the bone/skin interface, through the skin and out into the open air. Extending though the ventilation tube there is a continuous bore or channel 7 in which an inner tube 8 made of polymer material, for example polyurethane or Teflon, is to be applied.
- an inner tube 8 made of polymer material, for example polyurethane or Teflon
- the opposite end 9 of the outer tube 1 is designed with an attachment thread 10 for attachment of an assembly instrument for screwing the ventilation tube into the bone.
- This attachment thread can additionally be used for other purposes, such as the attachment of various inserts, for example filters, membranes or capillaries 11 of types known per se. It can additionally be used for attachment of an air pump
- the attachment thread 10 is to form an attachment for a plug, the insert 11 being made solid.
- the bore 7 through the outer tube has such a diameter that a fibre optic instrument can be introduced for examining the middle ear .
- the inner tube 8 has a length which is adapted to the length of the outer tube so that a certain free end is exposed in the middle ear when the inner tube has been pushed fully into the outer tube.
- the inner tube is further provided with a flange 13 whose greatest diameter exceeds the diameter of the bore 7, so that the inner tube is prevented from coming too far into the middle ear.
- the inner tube can be easily replaced or taken out for cleaning.
- the diameter and length are chosen so that liquid cannot readily pass through the inner channel 14 when showering and washing.
- membranes or capillaries 11 these can, for example a membrane, be incorporated in the inner tube. Such a membrane prevents water and bacteria from entering and seals off from the outer tube.
Landscapes
- 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)
- Surgery (AREA)
- Physics & Mathematics (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
Description
Claims
Priority Applications (10)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
SE9603175A SE510152C2 (en) | 1996-09-02 | 1996-09-02 | Device for ventilating the middle ear |
PCT/SE1997/001447 WO1999013811A1 (en) | 1996-09-02 | 1997-09-12 | Device for ventilating the middle ear |
US09/485,992 US6599297B1 (en) | 1996-09-02 | 1997-09-12 | Device for ventilating the middle ear |
JP2000511442A JP3992434B2 (en) | 1997-09-12 | 1997-09-12 | Device for ventilating the middle ear |
AU47966/97A AU739770B2 (en) | 1997-09-12 | 1997-09-12 | Device for ventilating the middle ear |
CA002301129A CA2301129C (en) | 1997-09-12 | 1997-09-12 | Device for ventilating the middle ear |
AT97910656T ATE245400T1 (en) | 1997-09-12 | 1997-09-12 | DEVICE FOR VENTILATION OF THE MIDDLE EAR |
DE69723740T DE69723740T2 (en) | 1997-09-12 | 1997-09-12 | DEVICE FOR VENTILATING THE MIDDLE EAR |
DK97910656T DK1021147T3 (en) | 1997-09-12 | 1997-09-12 | Device for venting the middle ear |
EP97910656A EP1021147B1 (en) | 1996-09-02 | 1997-09-12 | Device for ventilating the middle ear |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
SE9603175A SE510152C2 (en) | 1996-09-02 | 1996-09-02 | Device for ventilating the middle ear |
PCT/SE1997/001447 WO1999013811A1 (en) | 1996-09-02 | 1997-09-12 | Device for ventilating the middle ear |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1999013811A1 true WO1999013811A1 (en) | 1999-03-25 |
Family
ID=26662738
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/SE1997/001447 WO1999013811A1 (en) | 1996-09-02 | 1997-09-12 | Device for ventilating the middle ear |
Country Status (4)
Country | Link |
---|---|
US (1) | US6599297B1 (en) |
EP (1) | EP1021147B1 (en) |
SE (1) | SE510152C2 (en) |
WO (1) | WO1999013811A1 (en) |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
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JP2004511509A (en) * | 2000-10-18 | 2004-04-15 | アウリス イーエイチエフ | Delivery systems and methods for treatment or prevention of otitis media |
WO2006059961A1 (en) * | 2004-12-03 | 2006-06-08 | Ahmet Kutluhan | Mastoid antral ventilation tube |
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US6632224B2 (en) * | 1996-11-12 | 2003-10-14 | Triage Medical, Inc. | Bone fixation system |
US6648890B2 (en) * | 1996-11-12 | 2003-11-18 | Triage Medical, Inc. | Bone fixation system with radially extendable anchor |
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US6685706B2 (en) * | 2001-11-19 | 2004-02-03 | Triage Medical, Inc. | Proximal anchors for bone fixation system |
US6793678B2 (en) | 2002-06-27 | 2004-09-21 | Depuy Acromed, Inc. | Prosthetic intervertebral motion disc having dampening |
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US6725568B2 (en) * | 2002-10-01 | 2004-04-27 | Edward A. Gronka | Ear canal dryer and method of use thereof |
US7070601B2 (en) * | 2003-01-16 | 2006-07-04 | Triage Medical, Inc. | Locking plate for bone anchors |
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US20060089647A1 (en) * | 2004-08-20 | 2006-04-27 | Culbert Brad S | Method and apparatus for delivering an agent |
US7481006B2 (en) * | 2005-09-08 | 2009-01-27 | Stephen Donovan | Outer and inner ear drying system |
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US11446156B2 (en) | 2018-10-25 | 2022-09-20 | Medos International Sarl | Expandable intervertebral implant, inserter instrument, and related methods |
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Citations (4)
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EP0309431A1 (en) * | 1987-09-25 | 1989-03-29 | DENSERT, Barbara | Ventilation tube and method of ventilating the middle ear by the same means |
US5047053A (en) * | 1990-02-27 | 1991-09-10 | Smith & Nephew Richards Inc. | Permanent middle ear vent tube and method of insertion |
FR2679128A1 (en) * | 1991-07-15 | 1993-01-22 | Bricot Philippe | Trans-tympanic aerator |
WO1993010729A1 (en) * | 1991-11-28 | 1993-06-10 | Hb Proxima | Middle ear ventilation tube |
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-
1996
- 1996-09-02 SE SE9603175A patent/SE510152C2/en not_active IP Right Cessation
-
1997
- 1997-09-12 EP EP97910656A patent/EP1021147B1/en not_active Expired - Lifetime
- 1997-09-12 US US09/485,992 patent/US6599297B1/en not_active Expired - Fee Related
- 1997-09-12 WO PCT/SE1997/001447 patent/WO1999013811A1/en active IP Right Grant
Patent Citations (4)
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EP0309431A1 (en) * | 1987-09-25 | 1989-03-29 | DENSERT, Barbara | Ventilation tube and method of ventilating the middle ear by the same means |
US5047053A (en) * | 1990-02-27 | 1991-09-10 | Smith & Nephew Richards Inc. | Permanent middle ear vent tube and method of insertion |
FR2679128A1 (en) * | 1991-07-15 | 1993-01-22 | Bricot Philippe | Trans-tympanic aerator |
WO1993010729A1 (en) * | 1991-11-28 | 1993-06-10 | Hb Proxima | Middle ear ventilation tube |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2004511509A (en) * | 2000-10-18 | 2004-04-15 | アウリス イーエイチエフ | Delivery systems and methods for treatment or prevention of otitis media |
WO2006059961A1 (en) * | 2004-12-03 | 2006-06-08 | Ahmet Kutluhan | Mastoid antral ventilation tube |
CN100444816C (en) * | 2004-12-03 | 2008-12-24 | 阿米特·库特鲁汉 | Mastoid antral ventilation tube |
KR100978644B1 (en) * | 2004-12-03 | 2010-08-30 | 아메트 커트루한 | Mastoid antral ventilation tube |
Also Published As
Publication number | Publication date |
---|---|
SE510152C2 (en) | 1999-04-26 |
EP1021147B1 (en) | 2003-07-23 |
US6599297B1 (en) | 2003-07-29 |
SE9603175L (en) | 1998-03-03 |
EP1021147A1 (en) | 2000-07-26 |
SE9603175D0 (en) | 1996-09-02 |
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