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WO1993010729A1 - Tuyau de ventilation de l'oreille moyenne - Google Patents

Tuyau de ventilation de l'oreille moyenne Download PDF

Info

Publication number
WO1993010729A1
WO1993010729A1 PCT/SE1992/000805 SE9200805W WO9310729A1 WO 1993010729 A1 WO1993010729 A1 WO 1993010729A1 SE 9200805 W SE9200805 W SE 9200805W WO 9310729 A1 WO9310729 A1 WO 9310729A1
Authority
WO
WIPO (PCT)
Prior art keywords
implant
cortical bone
middle ear
base part
implant according
Prior art date
Application number
PCT/SE1992/000805
Other languages
English (en)
Inventor
Ove Densert
Stig Hansson
Original Assignee
Hb Proxima
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
Application filed by Hb Proxima filed Critical Hb Proxima
Publication of WO1993010729A1 publication Critical patent/WO1993010729A1/fr

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 in accordance with the preamble of the attached main claim.
  • a negative pressure in the middle ear i. e. a pressure lower than that of the ambient atmosphere
  • SOM otosalpingitis
  • chronical middle ear diseases involving a retraction of the entire tympanic membrane or parts thereof, with following atelectasis/collapse of the middle ear air cavity, in which the middle ear structures, including parts of the ossicular chain, may undergo progressive destruction.
  • SOM otosalpingitis
  • cholesteatoma which is a cyst-like formation (growth) of sguamous cells.
  • cholesteatoma When the growth expands, this may cause eroding of the nearby structures and damage to the middle ear, the facial nerve, the periphery balance system and as well as infections involving the central nervous system. Thus, although not being histologically malignant, cholesteatoma have very serious complications and require advanced surgical interventions. A negative pressure in the middle may however be a direct cause for cholesteatoma.
  • the Eustachian tubes which connect the middle ear to the nasopharynx, are believed to be closed normally and to open upon swallowing and thus inter alia to serve to equalize the air pressure in the middle ear. It has been found that the air in the middle ear is continuously absorbed into the surrounding tissue. In cases where the Eustachian tubes are blocked or do not function correctly, a more or less chronic negative pressure may be created in the middle ear. Another reason for a negative pressure in the middle ear is when the Eustachian tubes do not close properly. The patient experiences this as unpleasant and tries to alleviate the feeling of discomfort by "sniffing", which leads to a negative pressure in the middle ear. This negative pressure may result in that the Eustachian tubes are closed and remain closed by the higher pressure of the ambient atmosphere.
  • the mutual factor which is responsible for the above middle ear conditions is the negative air pressure created in the middle ear cavity.
  • cholesteatoma When cholesteatoma are removed surgically, this is mostly done by obtaining access to the middle ear by removing the cortical bone behind the external ear canal and the underlying mastoid cell system. Since the basic mechanisms of cholesteatoma still remain after the surgical procedures, the negative pressure in the middle ear still creates problems which makes it technically difficult to reconstruct the sound transmission via surgery and may also lead to a recurrence of the cholesteatoma.
  • the above mode of ventilating the middle ear allows a conservation of the entire middle ear system in ear surgery of the kind described above since the device used does not encroach on or affect the middle ear structures.
  • Fig 1 illustrates a tubular base part intended to inserted into a hole drilled through the cortical bone.
  • Fig 2 illustrates a tubular intermediate part intended to penetrate the layer of skin on the cortical bone behind the ear
  • Figs 3 and 4 illustrate a healing cap with attachment screw for protecting the area around the intermediate part during healing.
  • Figs 5 and 6 illustrate a filter unit with protective cap for connection to the intermediate part.
  • Fig 1 shows a longitudinal section through a base part 1 for implanting in bone according to a preferred embodiment of the invention.
  • the base part is provided with a longitudinal bore 5 extending through the entire length of the base part.
  • the bore 5 has a conically flaring portion 6 at the distal end, distal and proximal in this context corresponding to the distal respectively proximal end of the base part when this is implanted into the bone.
  • the base part 1 has the general configuration of a self- tapping screw being provided with threads 2 at its proximal end in conjunction with cut-outs 3 which are provided in order to form a cutting edge 4 for cutting threads in the bone when the base part is screwed into a bored hole extending through the cortical bone behind the ear.
  • the base part has a length which is sufficient to allow the base part to extend into the mastoid cell system. Since the cells in the mastoid cell system are interconnected and the proximal cells are connected to the middle ear, a communication allowing air to pass will be established from the exterior of the patient through the cortical bone and the cell system to the middle ear when the tubular base part has been screwed into the bore in the cortical bone mentioned above.
  • the base part is made of or covered with a layer of titanium or a titanium alloy in order to ensure good compatibility with the surrounding bone tissue and to avoid the development of granular tissue which possibly might block the bore in the base part and of course also to ensure a firm healing or integration of the base part into the surrounding bone tissue.
  • the implant according to the invention is to be used, some of the cortical bone close to the sinus dura angle is left in order to create a bracket for the base part.
  • the base part will then permit both an inspection of the cavity created by the operation and a ventilation of the middle ear, which will minimize the risks for a new retraction and the development of a new cholesteatoma.
  • the ventilated middle ear is also a prerequisite for sound transmission through the middle ear.
  • Fig 2 illustrates an intermediate part 8 intended to bridge the layer of skin normally covering the cortical bone behind the ear (the muscles close to the incision are normally removed in order to avoid the development of granular tissue) .
  • the intermediate part 8 is provided with external threads 9 on its proximal end corresponding to the internal threads 7 on the base part 1.
  • the exterior of the intermediate part widens conically directly adjacent the threads, at 10, in order to mate with the internal conically flaring portion 6 of the base part 1.
  • a circumferential flange 11 is located on the distal end of the exterior of the intermediate part.
  • the intermediate part is further provided with a longitudinal bore 12 which is provided with internal threads 13 at its distal end. These threads preferably correspond to the internal threads 7 on the base part 1.
  • the intermediate part 8 is screwed tightly into the base part 1 and the skin is allowed to heal around the intermediate part.
  • the intermediate part 8 is also preferably made of titanium or a titanium alloy in order to ensure good tissue compatibility.
  • a part is chosen which has a length which is sufficient to ensure that the flange 11 is located a distance away from the surface of the skin.
  • a healing cap 14 intended to be mounted on the intermediate part 8 is shown in Fig 3.
  • This cap is provided with a through-bore 16 which at its proximal end has a shape which is complementary to the shape of the distal end of the intermediate part.
  • the healing cap thus can be press-fitted onto intermediate part 8 and firmly attached by means of a screw 17, shown in Fig 4, inserted through the bore 16 and engaged with the interior threads 13 of the part 8 by means of the threads 18.
  • a suitable material for the healing cap is for instance high density polyethylene.
  • the filter unit comprises a hollow, open-ended cylindrical main body 19 which at the proximal end is provided with a circumferential, internal flange 20 which can be snapped over the external flange 11 on the intermediate part 8.
  • the distal end of the body 19 is provided with an air- permeable filter 21 and the outside of the body 19 is provided with a circumferential bead 22.
  • the filter unit can be covered by a cap 23 being provided with a circumferential, internal groove 24 which is complementary in shape to the external bead 22 on the filter unit, by which means the cap can be snapped onto the filter unit.
  • the cap 23 further is provided with a comparatively small hole 25.
  • the function of the filter is to allow air to pass but to prevent water, bacteria etc from entering the cell system and the middle ear, thus allowing the patient to lead a normal life including bathing, showering, hair washing etc.
  • the opening of the implant can be mounted on the implant, for instance a cap similar to the filter unit which is airtight.
  • the opening of course can also be sealed by means of a screw similar to the attachment screw 17.
  • the attachment parts of a connection between a tube from an air pressure generator for use in the Meniere treatment mentioned above and the intermediate part can be designed similarly to the design of the filter unit. It may however be more suitable to design the external flange 11 on the intermediate part as parts of a bayonet coupling or, alternatively, to utilize the internal threads in the intermediate part in order to ensure a tight connection between said tube and the intermediate part. Possible modifications of the invention
  • proximal end of the bore in the base part may have a conically flaring design in order to minimize the risk that bone grows into the opening and partly occludes the bore.
  • the tubular implant further has been described as comprising two main parts, one base part to be implanted into the bone and one intermediate part to penetrate the skin. This is for instance advantageous if the implanting operation is to be performed in two stages, a first stage wherein the base part is allowed to integrate into the bone in an undisturbed way under the skin layer and a second stage wherein the intermediate part is inserted through an opening in the skin which then is allowed to heal around the intermediate part.
  • the biocompatible material used is titanium or titanium alloys.
  • any suitable biocompatible material can be used, such as chrome-cobalt alloys (e. g. Vitallium R ) , Zirconium, Hafnium, stainless steel, ceramic materials, materials covered with hydroxy apatite etc.
  • the implant has been described above as being threaded. This feature is very important in the cases where the implant is to be permanent, since it will be very difficult to remove a threaded implant. A smoother implant will also have good integration properties, but may be easier to remove, should the necessity arise.
  • the filter unit has been illustrated as a cap covering the end of the implant.
  • the filter of course also could be made in the form of a plug insertable into the bore in the implant, or made in any other suitable shape.

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

Implant pour la ventilation de l'oreille moyenne à implanter dans l'os cortical derrière l'oreille. L'implant comprend un corps principal (1, 8) constitué ou recouvert d'une couche de matériau biocompatible, présentant un alésage longitudinal (5, 12) et d'une longueur suffisante pour pénétrer complètement l'os cortical et entrer en contact fonctionnel avec l'espace où se trouve le système de cellules mastoïdienne, sous l'os cortical, lorsqu'il est insérer dans un trou pratiqué à travers l'os cortical.
PCT/SE1992/000805 1991-11-28 1992-11-24 Tuyau de ventilation de l'oreille moyenne WO1993010729A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
SE9103546-9 1991-11-28
SE9103546A SE9103546D0 (sv) 1991-11-28 1991-11-28 Middle ear ventilation tube

Publications (1)

Publication Number Publication Date
WO1993010729A1 true WO1993010729A1 (fr) 1993-06-10

Family

ID=20384471

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/SE1992/000805 WO1993010729A1 (fr) 1991-11-28 1992-11-24 Tuyau de ventilation de l'oreille moyenne

Country Status (3)

Country Link
AU (1) AU3099592A (fr)
SE (1) SE9103546D0 (fr)
WO (1) WO1993010729A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1998030183A1 (fr) * 1997-01-13 1998-07-16 Eberhard Stennert Dispositif d'equilibrage de pression servant de prothese d'une trompe d'eustache
WO1999013811A1 (fr) * 1996-09-02 1999-03-25 Nobel Biocare Ab (Publ) Dispositif de ventilation de l'oreille moyenne
AU739770B2 (en) * 1997-09-12 2001-10-18 Nobel Biocare Ab (Publ) Device for ventilating the middle ear
WO2006059961A1 (fr) * 2004-12-03 2006-06-08 Ahmet Kutluhan Tube de ventilation antral mastoidien

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2338136B1 (de) * 1973-07-19 1975-01-30 Sulzer Ag Koecher zur Aufnahme des Schaftes eines Knochenimplantates
DE3002298A1 (de) * 1980-01-23 1981-07-30 Peter Dr.Med. 2300 Kiel Bumm Kunststoffteil zum einsetzen in eine oeffnung eines knochens
GB2176577A (en) * 1984-04-17 1986-12-31 Richards Medical Co Ventilation tube permitting two-way gaseous communication with one-way liquid valve
US4744792A (en) * 1985-01-22 1988-05-17 Richards Medical Company Middle ear ventilating tube
WO1989010727A1 (fr) * 1988-05-02 1989-11-16 Jan Axel Svenson Passage pour implant

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2338136B1 (de) * 1973-07-19 1975-01-30 Sulzer Ag Koecher zur Aufnahme des Schaftes eines Knochenimplantates
DE3002298A1 (de) * 1980-01-23 1981-07-30 Peter Dr.Med. 2300 Kiel Bumm Kunststoffteil zum einsetzen in eine oeffnung eines knochens
GB2176577A (en) * 1984-04-17 1986-12-31 Richards Medical Co Ventilation tube permitting two-way gaseous communication with one-way liquid valve
US4744792A (en) * 1985-01-22 1988-05-17 Richards Medical Company Middle ear ventilating tube
WO1989010727A1 (fr) * 1988-05-02 1989-11-16 Jan Axel Svenson Passage pour implant

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999013811A1 (fr) * 1996-09-02 1999-03-25 Nobel Biocare Ab (Publ) Dispositif de ventilation de l'oreille moyenne
US6599297B1 (en) * 1996-09-02 2003-07-29 Nobel Biocare Ab Device for ventilating the middle ear
WO1998030183A1 (fr) * 1997-01-13 1998-07-16 Eberhard Stennert Dispositif d'equilibrage de pression servant de prothese d'une trompe d'eustache
AU739770B2 (en) * 1997-09-12 2001-10-18 Nobel Biocare Ab (Publ) Device for ventilating the middle ear
WO2006059961A1 (fr) * 2004-12-03 2006-06-08 Ahmet Kutluhan Tube de ventilation antral mastoidien
JP2008521546A (ja) * 2004-12-03 2008-06-26 アーメット・クトルハン 乳突洞換気チューブ
CN100444816C (zh) * 2004-12-03 2008-12-24 阿米特·库特鲁汉 乳突窦的通风管
KR100978644B1 (ko) * 2004-12-03 2010-08-30 아메트 커트루한 유양돌기동 통기 튜브

Also Published As

Publication number Publication date
AU3099592A (en) 1993-06-28
SE9103546D0 (sv) 1991-11-28

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