WO1990007915A1 - Protheses auriculaires pour l'oreille moyenne d'etres vivants, notamment d'etres humains - Google Patents

Protheses auriculaires pour l'oreille moyenne d'etres vivants, notamment d'etres humains Download PDF

Info

Publication number
WO1990007915A1
WO1990007915A1 PCT/EP1990/000124 EP9000124W WO9007915A1 WO 1990007915 A1 WO1990007915 A1 WO 1990007915A1 EP 9000124 W EP9000124 W EP 9000124W WO 9007915 A1 WO9007915 A1 WO 9007915A1
Authority
WO
WIPO (PCT)
Prior art keywords
section
hearing prosthesis
wire
prosthesis according
middle ear
Prior art date
Application number
PCT/EP1990/000124
Other languages
German (de)
English (en)
Inventor
Klaus Schumann
Original Assignee
Klaus Schumann
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 Klaus Schumann filed Critical Klaus Schumann
Publication of WO1990007915A1 publication Critical patent/WO1990007915A1/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
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/18—Internal ear or nose parts, e.g. ear-drums
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/0047—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L24/0073—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material with a macromolecular matrix
    • A61L24/0089—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material with a macromolecular matrix containing inorganic fillers not covered by groups A61L24/0078 or A61L24/0084
    • 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
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/18—Internal ear or nose parts, e.g. ear-drums
    • A61F2002/183—Ear parts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/14—Materials or treatment for tissue regeneration for ear reconstruction or ear implants, e.g. implantable hearing aids

Definitions

  • the invention relates to newly developed hearing prostheses for the middle ear of living beings, especially humans. Furthermore, the invention relates to the use of cement, preferably glass ion cement, for fastening such a hearing prosthesis. Furthermore, the invention relates to a further developed, improved cement and the use of such a cement for attaching a newly developed hearing prosthesis and the use of such a cement for other purposes.
  • Hearing disorders can be caused by inner ear disorders.
  • Older, more than one year old, inner ear damage is characterized primarily by hearing loss above 3 kHz. These include presbyacus damage after chronic noise pollution, damage after bang, damage after hearing loss and damage in Meniere's disease. According to estimates, a total of 11 million people in the Federal Republic of Germany have been affected by such diseases and damage. So far, all older inner ear deafness has been provided externally with hearing aids. Since these facilities are only accepted by the population, an external hearing prosthesis that is not secure is desirable. As older inner ear damage mainly affects frequencies above 3 kHz, the primary concern is to optimize the vibration behavior of the organ in the high frequency range. l
  • DD-PS 126 349 From DD-PS 126 349 a prefabricated wire prosthesis for replacing the auditory bone chain is known, which fixes itself due to its own spring tension between the lateral legs. With this wire prosthesis, hammer, anvil and stirrup or hammer and anvil can be replaced.
  • the object of the invention is to propose a hearing prosthesis for the center of living beings, in particular humans, which ensures good frequency response optimization in a simple, reliable and acceptable manner for the patient.
  • Wire has a first, a second and a third section.
  • the first section is essentially straight; he the connection to the stirrup of the middle ear.
  • the first section is followed by a second, curved section for connection to the third section.
  • the third section i is also curved, the curvature being opposite to that of the second section; the third section serves as an end-to-end contact with the middle ear hammer.
  • the solution according to the invention optimizes the frequency response.
  • the narrowband frequency response optimum of the healthy auditory bones at 3 kHz should be shifted from 3 kHz to the frequency optimum between and 10 kHz. This can compensate for hearing loss in the high frequency range from the inner ear. Loss of hearing in the high frequency range most often occurs as a result of chronic noise pollution and in old age.
  • the prostheses according to the invention can best be accomplished with wire made of V2A steel. It is a loan to destroy intact structures of the middle ear in order to replace them with structures that are more suitable and that are intended to shift the narrowband frequency optimum (3 kHz) to higher frequencies over a broadband range.
  • the prostheses according to the invention thus function as a hearing aid. Steel prostheses are best suited for this; these must be installed safely, for which glass ionomer cement is best suited. The hitherto practiced clamping has not proven itself since loosening occurs secondarily.
  • the wire can be biased.
  • the end of the third section may have a tip, which is preferably made by a diamond drill.
  • the first section can be cemented, vo preferably glass ionomer cement, be verbi bar with the stirrup of the ear.
  • the wire can be made of metal, preferably noble metal, stainless steel or V2A steel.
  • the wire preferably has a round or circular cross section, the cross section diameter being less than 1 mm.
  • the wire has a first and a second section, the first section being configured in exactly the same way as the first Solution.
  • the second section adjoins the first section and is designed as an eyelet for connection to the hammer of the middle ear.
  • a third solution to the problem, for which protection is also claimed independently, consists in the features of the secondary claim 16.
  • This solution consists of a pin and a wire with two lever arms.
  • the pin can be connected to the facial of the middle ear; the peg is therefore anchored in the facial area with cement, preferably glass ionomer cement.
  • the wire with the two lever arms is rotatably mounted.
  • One lever arm is curved to rest against the stirrups of the middle ear.
  • the other lever arm is oppositely curved to abut the hammer of the middle ear.
  • the invention further relates to the use of cement for fastening the hearing prostheses described above to the middle ear, that is to say in particular to the stirrup and / or the hammer.
  • the zem is preferably glass ionomer cement, that is to say a xenogenic material which is known in dentistry.
  • vital tissue pulp
  • its outstanding property is an active hold on tooth material, such as enamel and dentin, or bones, including auditory bones (stirrups, anvils, etc.).
  • Glass ionomer cement is a gel made of glass (calcium aluminum fluorosilicate) and polymeric carboxylic acids. Tartaric acid is added to shorten the curing time. The polymeric carboxylic acids adhere to enamel and dentin. Commercially available material is supplied in two components - glass powder and polycarboxylic acid.
  • the invention further relates to a glass ionomer cement, which is characterized in that polyacrylic acid is added to the glass ionomer cement.
  • the polyacrylic acid is preferably vacuum dried. The addition of water releases the polyacrylic acid, which then reacts with the metal ions of the glass particles present in the glass ionomer zeolite.
  • the resulting cement has a number of advantages: the hardening time is very short, but the processing time is still long enough. The load capacity that can be achieved is very high.
  • the invention further relates to the use of a glass ionomer cement mixed with polyacrylic acid for fastening one of the above-described hearing prostheses to the middle ear, that is to say in particular to the stirrup and / or the hammer.
  • a glass ionomer cement mixed with polyacrylic acid for fastening one of the above-described hearing prostheses to the middle ear, that is to say in particular to the stirrup and / or the hammer.
  • acrylic acid the glass ionomer zemen has flow properties, which is an advantage in middle ear surgery.
  • the glass ionomer cement hardens more quickly and is not as sensitive to liquids, e.g. Flushing fluid and blood.
  • the mixture is preferably made individually.
  • the invention relates to the use of glass ionoma cement with an admixture of polyacrylic acid in the reconstruction of midface and skull base fractures.
  • Gla ionomer cement mixed with acrylic acid, bone defects can be bridged permanently without having to work with wire or screw (revision of ethmoid fractures, lower jaw fractures, midface fractures).
  • the hearing aids known up to now are "BTE devices” (behind-the-ear devices) and “ITE devices” (in-the-ear devices).
  • the device presented here could be called an “IdP device” (In der Pauke device).
  • Fig. 4 shows a second embodiment of the invention
  • Fig. 5 shows a third embodiment of the invention.
  • the eardrum 2 connects to the ear canal 1.
  • the ossicular chain consists of the ham 3, the anvil 4 and the stirrup 5.
  • the facial nerve is designated VII.
  • At the lower end of the stirrup 5 is the snail (cochlea) 6 with inner ear fluid.
  • the auditory ossicle chain 3, 4, 5 is located in the timpani (cavity) 7.
  • the pivot point between the hammer 3 and anvil 4, that is to say the common pivot point between the hammer 3 and anvil 4, is designated by 8.
  • the Hearing prosthesis consists of the wire 11, which sits a first section 12, a second section 13 and a third section 14 b.
  • the first section 12 is essentially straight. He di for connection to the stirrup 5.
  • the second section 13 connects to the first section 12. It is curved and is used for connection to the third section 14.
  • the third section 14 is also curved, the curvature being opposite to that of the second section 13.
  • the third section 14 is used for end-to-end contact with the ham 3.
  • the first section 12 is connected by glass ionomer cement 15 to d stirrup 5.
  • the scale is shown in mm at the bottom right.
  • the hearing prosthesis 11 is used as follows: First, the patient's part of the hammer shown on the left in FIG. 1 and the entire anvil 4 are removed, for example by punching or similar instruments. The first section 12 of the hearing prosthesis 11 is then attached to the stirrup 5 by glass ionomer cement. The free tip 16 of the third section 14 is under tension on the underside 17 of the remaining hammer 3. The tip 16 is thus clamped under tension on the underside 17 of the hammer 3.
  • the frequency response is optimized by reducing the ossicular masses (removing the left part of the hammer 3 and the entire anvil 4). In particular, the sensitivity of high frequencies is increased. This frequency response optimization was determined empirically. Furthermore, the damping in the so-called small and large joints (small joint: between stirrup and anvil; large joint: between anvil and hammer) is no longer present. By eliminating these attenuations, the sound transmission is also optimized.
  • the tip 16 at the end of the third section 14 is made by a diamond drill in the usual way.
  • the wire is made of V2A steel. It has a circular cross-section, the cross-sectional diameter being less than 1 mm.
  • the wire pre-tension is 3 to 4 mm.
  • the cross-section of the wire 11 preferably has a diameter of 0.2 mm. He is sharpened at Spit 16.
  • the dashed lines a and b in the area of the third section 14 document other prostheses 11 of different lengths.
  • middle ear prosthesis 11 is clamped between the hammer res and stirrup 5, the tip 16 boring into the underside 17 of the hammer 3 and being fixed with glass ionomer cement.
  • the dashed lines a and b in the area of the third section 14 in turn document other, differently long middle ear prostheses 11.
  • the hearing prosthesis consists of a wire 11 with a first, essentially straight section 12 for connection to the riser 5 of the middle ear.
  • the second section 23 adjoining the first section 12 is designed as a right-angled eyelet.
  • the first section 12 is fixed to the stirrup 5 with glass ionomer cement.
  • the eardrum center is pressed in by about 0.6 mm until there is contact with the 23.
  • the eyelet 23 is then fixed with glass ionomer cement on the underside 17 of the hammer 3.
  • the wire 11 is therefore prestressed.
  • the pretensioning takes place without the action of the screwing device, there is a distance between the 23 and the underside 17 of the hammer 3.
  • the screwing device 10 can be loosened and removed again.
  • the wire 11 is then pretensioned on both sides with G ionomer cement.
  • the wire is made of 0.2 mm thick V2A wire.
  • the pin 31 is connected to the facial VII of the middle ear.
  • the pin 31 is glued to the facial VII with glass ionomer cement 32.
  • the wire 41 has a first lever arm 42 bearing on the stirrup 5 of the middle ear and a second lifting arm 43 for bearing on the hammer 3 of the middle ear.
  • the first, shorter lever arm 42 is curved toward the stirrup; he wi placed on the stirrup 5 and fixed there with glass ionomer cement 1.
  • the second, longer lever arm 43 is curved opposite to the first lever arm 42. Its end 46 is clamped under the hammer 3 and fixed there with glass ionomer cement.
  • the invention is based on the idea or the concept of removing mass from the ossicular chain and replacing it with the prosthesis, that is to say a wire or a similar component.

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  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Inorganic Chemistry (AREA)
  • Cardiology (AREA)
  • Surgery (AREA)
  • Composite Materials (AREA)
  • Otolaryngology (AREA)
  • Materials Engineering (AREA)
  • Pulmonology (AREA)
  • Epidemiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Prostheses (AREA)

Abstract

Une prothèse auriculaire pour l'oreille moyenne d'êtres vivants, notamment d'êtres humains, optimise la réponse harmonique de manière simple, fiable et acceptable pour le patient. La prothèse auriculaire comprend un fil métallique (11) ayant une première section (12) essentiellement droite de liaison avec l'étrier (5) de l'oreille moyenne, une deuxième section courbe (13) adjacente à la première section qui assure la liaison avec la troisième section (14) du fil métallique et une troisième section courbe (14) dont l'extrémité s'appuie sur le marteau (3) de l'oreille moyenne. La courbure de la troisième section (14) est opposée à celle de la deuxième section (13).
PCT/EP1990/000124 1989-01-20 1990-01-22 Protheses auriculaires pour l'oreille moyenne d'etres vivants, notamment d'etres humains WO1990007915A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
DEP3901643.9 1989-01-20
DE3901643 1989-01-20
DEP3911878.9 1989-04-11
DE3911878 1989-04-11

Publications (1)

Publication Number Publication Date
WO1990007915A1 true WO1990007915A1 (fr) 1990-07-26

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ID=25876970

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP1990/000124 WO1990007915A1 (fr) 1989-01-20 1990-01-22 Protheses auriculaires pour l'oreille moyenne d'etres vivants, notamment d'etres humains

Country Status (1)

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WO (1) WO1990007915A1 (fr)

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2688132A1 (fr) * 1992-03-06 1993-09-10 Tem Audio Implant System Prothese passive pour chaine tympano-ossiculaire.
US5531787A (en) * 1993-01-25 1996-07-02 Lesinski; S. George Implantable auditory system with micromachined microsensor and microactuator
US5772575A (en) * 1995-09-22 1998-06-30 S. George Lesinski Implantable hearing aid
US5881158A (en) * 1996-05-24 1999-03-09 United States Surgical Corporation Microphones for an implantable hearing aid
US5951601A (en) * 1996-03-25 1999-09-14 Lesinski; S. George Attaching an implantable hearing aid microactuator
US5977689A (en) * 1996-07-19 1999-11-02 Neukermans; Armand P. Biocompatible, implantable hearing aid microactuator
US6068589A (en) * 1996-02-15 2000-05-30 Neukermans; Armand P. Biocompatible fully implantable hearing aid transducers
US6139488A (en) * 1997-09-25 2000-10-31 Symphonix Devices, Inc. Biasing device for implantable hearing devices
WO2005070327A2 (fr) * 2004-01-23 2005-08-04 Heinz Kurz Gmbh Medizintechnik Prothese pour osselets de l'oreille comportant des moyens d'adaptation de frequence
US8147544B2 (en) 2001-10-30 2012-04-03 Otokinetics Inc. Therapeutic appliance for cochlea

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3473170A (en) * 1967-07-05 1969-10-21 Dow Corning Middle ear prosthesis
US3838468A (en) * 1973-01-15 1974-10-01 Richards Mfg Co Prosthesis and membrane structure to replace the stapes
US4601723A (en) * 1985-01-29 1986-07-22 Mcgrew Robert N Telescoping self-adjusting ossicular prostheses
US4624672A (en) * 1984-03-15 1986-11-25 Edmundas Lenkauskas Coiled wire prosthesis for complete or partial ossicular reconstruction
EP0231162A1 (fr) * 1986-01-27 1987-08-05 Michel Gersdorff Prothèse de l'oreille moyenne

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3473170A (en) * 1967-07-05 1969-10-21 Dow Corning Middle ear prosthesis
US3838468A (en) * 1973-01-15 1974-10-01 Richards Mfg Co Prosthesis and membrane structure to replace the stapes
US4624672A (en) * 1984-03-15 1986-11-25 Edmundas Lenkauskas Coiled wire prosthesis for complete or partial ossicular reconstruction
US4601723A (en) * 1985-01-29 1986-07-22 Mcgrew Robert N Telescoping self-adjusting ossicular prostheses
EP0231162A1 (fr) * 1986-01-27 1987-08-05 Michel Gersdorff Prothèse de l'oreille moyenne

Cited By (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2688132A1 (fr) * 1992-03-06 1993-09-10 Tem Audio Implant System Prothese passive pour chaine tympano-ossiculaire.
US5984859A (en) * 1993-01-25 1999-11-16 Lesinski; S. George Implantable auditory system components and system
US5531787A (en) * 1993-01-25 1996-07-02 Lesinski; S. George Implantable auditory system with micromachined microsensor and microactuator
US5772575A (en) * 1995-09-22 1998-06-30 S. George Lesinski Implantable hearing aid
US6068589A (en) * 1996-02-15 2000-05-30 Neukermans; Armand P. Biocompatible fully implantable hearing aid transducers
US5951601A (en) * 1996-03-25 1999-09-14 Lesinski; S. George Attaching an implantable hearing aid microactuator
US5881158A (en) * 1996-05-24 1999-03-09 United States Surgical Corporation Microphones for an implantable hearing aid
US5977689A (en) * 1996-07-19 1999-11-02 Neukermans; Armand P. Biocompatible, implantable hearing aid microactuator
US6153966A (en) * 1996-07-19 2000-11-28 Neukermans; Armand P. Biocompatible, implantable hearing aid microactuator
US6139488A (en) * 1997-09-25 2000-10-31 Symphonix Devices, Inc. Biasing device for implantable hearing devices
US8147544B2 (en) 2001-10-30 2012-04-03 Otokinetics Inc. Therapeutic appliance for cochlea
US8876689B2 (en) 2001-10-30 2014-11-04 Otokinetics Inc. Hearing aid microactuator
WO2005070327A2 (fr) * 2004-01-23 2005-08-04 Heinz Kurz Gmbh Medizintechnik Prothese pour osselets de l'oreille comportant des moyens d'adaptation de frequence
WO2005070327A3 (fr) * 2004-01-23 2005-10-27 Heinz Kurz Gmbh Medizintechnik Prothese pour osselets de l'oreille comportant des moyens d'adaptation de frequence
US7871439B2 (en) 2004-01-23 2011-01-18 Heinz Kurz Gmbh Medizintechnik Auditory ossicle prosthesis with tuning option

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