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WO2004069119A1 - Dispositif de liaison avec l'oreille interne - Google Patents

Dispositif de liaison avec l'oreille interne Download PDF

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Publication number
WO2004069119A1
WO2004069119A1 PCT/EP2004/001234 EP2004001234W WO2004069119A1 WO 2004069119 A1 WO2004069119 A1 WO 2004069119A1 EP 2004001234 W EP2004001234 W EP 2004001234W WO 2004069119 A1 WO2004069119 A1 WO 2004069119A1
Authority
WO
WIPO (PCT)
Prior art keywords
cartridge
inner ear
shape memory
catheter
human inner
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/EP2004/001234
Other languages
English (en)
Inventor
Olaf Michel
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Cell Center Cologne GmbH
Original Assignee
Cell Center Cologne GmbH
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 Cell Center Cologne GmbH filed Critical Cell Center Cologne GmbH
Publication of WO2004069119A1 publication Critical patent/WO2004069119A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/41—Detecting, measuring or recording for evaluating the immune or lymphatic systems
    • A61B5/411—Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
    • A61B5/283—Invasive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6852—Catheters

Definitions

  • the invention relates to a cartridge, which substantially consists of a flexible shape memory material, and which, taking advantage of the memory effect, upon temperature change or other influences suitable for evoking the memory effect, optimally adapts to anatomically pre-formed windows or artificially created bone niches in the human inner ear or the equilibrium organ. Furthermore, the invention relates to catheter and sensor systems, coupled to suitable pumps, if necessary, micro dosage systems, signal amplifiers and/or recording devices containing said cartridge as well as its use for drug application and/or the injection of electrical stimuli or for drawing off chemical, electrical or pressure stimuli, and/or the drainage of secretions.
  • Drug application or injection of electrical stimuli into the human inner ear can become necessary in order to fight damages of the hearing or equilibrium organ, while drawing off stimuli from the inner ear serves for diagnosing said damages.
  • the inner ear is not easily accessible, so that drug application is often performed systemically, like e.g. in the cases of acute hearing loss, Meniere's disease (dizziness) or tinnitus (annoying noises within the ear, in absence of noise impact from outside). These are often treated with vasoactive infusions, hyperbaric oxygen therapy and steroids.
  • the systemically administered drugs affect the entire body, which, even with low dosage, often evokes side effects, impeding an effective therapy. Targeted local administration of drugs or injection of electrical stimuli directly into the inner ear is therefore useful, but not yet technically solved in a satisfactory way.
  • An already known method uses an attic cannula for placing drugs in the middle ear, from where they have to diffuse to the inner ear.
  • Locally administered drugs are e.g. urea, mannitol, sorbitol and glycerol, lidocain or xylocain, antibiotics or immunoglobulines as well as different therapeutical peptides and polysaccharides.
  • Another possibility of bringing the drug closer to the inner ear is the use of a drug carrier made of cellulose or a material of similar expansive capacity (WOOO/033775). A conical carrier is induced into the niche of the round window and is sprinkled with the drug.
  • the catheters "Round Window CathTM” and particularlyRound Window E CathTM” sold by IntraEAR®, Inc. use an inflatable cuff for the fixation of catheter tubes or sensors to the round window membrane. Though this allows the performance of infusions with exact dosage, the catheters consist of latex and the inflatable rubber cuff therefore slips easily out of the round window.
  • the present invention relates to a cartridge, which substantially consists of a flexible shape memory material, and which, taking advantage of the memory effect, upon temperature change or other influences suitable for evoking the memory effect, optimally adapts to anatomically pre-formed windows or artificially created bone niches in the human inner ear or the equilibrium organ.
  • the cartridge of the invention is a device for e.g. application of drugs, which is introduced into the bone niches of the inner ear, e.g. into the round window.
  • Shape memory materials beside their visible (temporary) form, also have another
  • shape memory metals for the construction of hearing aid casings are described (JP 08275298 A). Furthermore, a catheter is known for the application of non-diffusive drugs directly into the fluid cavities of the inner ear, the fixation hooks of which can consist of a shape memory metal (DE 19853299 Al). However, the use of shape memory materials for the production of a cartridge of the invention for the application of particularly diffusive drugs or as anchorage for catheters and electrodes has not yet been taken into consideration.
  • the cartridge of the invention which substantially consists of a flexible shape memory material, and which, taking advantage of the memory effect, upon temperature change or other influences suitable for evoking the memory effect, optimally adapts to anatomically pre-formed windows or artificially created bone niches in the human inner ear or the equilibrium organ, facilitates a stable coupling of catheters, electrodes and sensors.
  • the term "cartridge” not only comprises a tubular, oblong, solid sheath, into which something can be inserted or which firmly encloses something, but also shrouding rings, tube sections or cuffs.
  • the classical shape of the cartridge is preferred, however, and can advantageously be developed in the form of a coupling device, onto which a catheter system can be hoisted.
  • a stable long-term infusion can be performed.
  • the tube system can easily be replaced without damaging the coupling device in the inner ear.
  • the therapy can e.g. be continued without problems, if due to a defect only the tube system of the catheter is to be replaced.
  • the possibility of firmly anchoring the infusion tube in the coupling device guarantees for sufficient stability of the system.
  • the very part of the cartridge which is located in the corresponding bone window of the inner ear, consists of a shape memory material to guarantee for optimal fit and therefore for stable anchoring in the inner ear.
  • Parts of the cartridge that serve for e.g. the coupling of catheters, electrodes and sensors can also consist of other biocompatible materials that are common in the medical field.
  • the cartridge is prepared in such a way that the original form corresponds to the bone niche the cartridge is to be inserted into, while the temporary form is more compact and facilitates uncomplicated insertion and, if necessary, removal. Both forms are "preset" to the shape memory material, preferably metal, beforehand during the course of manufacturing.
  • the material can be
  • the coupling device at body temperature has a form, which adapts to the bones of a natural window.
  • a particularly preferred embodiment adapts to the round window of the human inner ear.
  • the cartridges of the invention can also have the shape of the oval window or of an artificially drilled bone niche.
  • ear forceps can be used, which are brought to a temperature, e.g. by cooling, that will, upon contact with the cartridge, induce said cartridge to recover its temporary form, e.g. by cooling the cartridge upon contact.
  • the cartridge will be changed to recover the second preset form and e.g. contracts.
  • the cartridge can then be removed without any risk of injuries.
  • the flexible shape memory material is a shape memory metal or shape memory plastic.
  • shape memory metals are Ni-Ti alloys.
  • Ni-Ti alloys are very common in the medical field and is used e.g. in the manufacturing of artery stents. Their advantage is based on the fact that certain Ni-Ti alloys change into their preset permanent form upon heating to body temperature. These alloys are sold e.g. under the name of Nitinol and are used by Shape Memory Applications, Inc. , The Nitinol CompanyTM for the manufacturing of stents.
  • Many shape memory materials, like Nitinol contain nickel.
  • Nickel-free compounds of shape memory metals are described e.g. in EP 0 707 085 Al.
  • plastics with memory effect which can also have, according to their exact composition, very different properties.
  • plastics with memory effect can also have, according to their exact composition, very different properties.
  • biocompatibility and biological degradability can also be controlled by chemical composition. MnemoScience GmbH, Aachen Germany produces such polymers.
  • a cartridge of the invention made of such a shape memory polymer is also a preferred embodiment.
  • an entirely biologically degradable polymer can be selected, so that the cartridge can remain in the patient's ear.
  • the present invention particularly relates to the use of shape memory metals, shape memory plastics or other flexible materials with memory effect for the manufacturing of said cartridge or of catheter and sensor systems, respectively.
  • the end pointing towards the human inner ear or the equilibrium organ should be of threaded form or of conical form with grooves.
  • said embodiments are connected very firmly to their anchorage, they do neither injure the bone, nor the membranes covering the inner ear and therefore protecting the fluid cavities of the inner ear. Thus, infections are prevented.
  • the fact that the cartridge of the invention has no hooks renders the removal unproblematic and prevents injuries.
  • the end pointing away from the human inner ear or equilibrium organ is connectable with a catheter.
  • This embodiment is referred to as “Inner Ear Coupling Device” (IECD) or, due to the use of shape memory materials, “memo-IECD”.
  • IECD Inner Ear Coupling Device
  • Such coupling devices can be based on typical couplings, such as Luer lock sytems and screw connections.
  • Infusion with drugs, which then directly reach the membranes of the inner ear, can be performed through the catheter.
  • Beside antibiotics, vasoactive or ototoxic drugs, synapse blockers or neurotransmitters, analgesics and local anesthetics, interferons, COX- or MAO- inhibitors, respectively, and compounds influencing the NO signal pathway, also growth factors and gene therapy vectors can be applied by means of the cartridge of the invention.
  • the use of pumps and micro dosage systems together with said catheter system also allows stable long-term infusions with exact dosage, without need for painful interventions into the ear in regular intervals.
  • the stability of the connection between cartridge and bone niche even allows the patient a normal mobility, which naturally cannot be offered with the use of simple catheters, which are not or only poorly anchored in the inner ear or with the administration of larger amounts of drugs, which should remain there as long as possible without leaking, via an attic cannula. This can often only be achieved by lying on the side, which can turn out to be a problem in particular with children.
  • the use of a cartridge that may be kept in the ear for a longer time also allows an uncomplicated exchange of the catheter.
  • Electrostimulation is a possible form of tinnitus therapy. Therefore, the present invention particularly also relates to catheter systems for drug application and/or injection of electrical stimuli, wherein a cartridge of the invention is used and which are coupled to suitable pumps and/or micro dosage systems, if necessary.
  • pressure sensors and/or sensors for electrical and chemical stimuli can be coupled to the end pointing away from the human inner ear or the equilibrium organ in addition or alternatively.
  • this embodiment can be supplemented by suitable signal amplifiers and recording devices and be used in e.g. electrocochleography. Drawing off said stimuli is interesting e.g. in diagnostic uses and can contribute to the clarification of causes for certain diseases of the inner ear. For example, it is important to clarify, whether a tinnitus occurred as a simultaneous phenomenon together with acute hearing loss.
  • This embodiment can also serve for process controlling purposes during treatment.
  • the cartridge of the invention can also serve for the introduction of cochlea implants, endoscopes or nanorobots.
  • the present invention also relates to above-described sensor systems for drawing off chemical, electrical or pressure stimuli as well as to the use of a cartridge, a catheter system or a sensor system for drug application, drainage of secretions, injection of electrical stimuli and/or for drawing off signals.
  • Catheters, pressure sensors, pumps, micro dosage systems and devices for injection and measurement of electrical stimuli which can be used and adapted accordingly in the embodiments of the invention, are described e.g. in prior art documents WO00/04854, WO00/33775, WO02/102278, WO98/56434 and references cited therein.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Public Health (AREA)
  • Biophysics (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Otolaryngology (AREA)
  • Psychology (AREA)
  • Acoustics & Sound (AREA)
  • Surgery (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Materials For Medical Uses (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne une cartouche qui consiste principalement en un matériau de mémoire de forme flexible, et qui, profitant de l'effet de mémoire, lors d'un changement de température ou d'autres influences permettant d'évoquer l'effet de mémoire, s'adapte de manière optimale aux fenêtres préalablement formées de manière anatomique ou aux cavités osseuses de l'oreille interne humaine ou de l'organe d'équilibre. De plus, des systèmes de cathéter permettant l'administration de médicaments et/ou l'injection de stimuli électriques, contiennent ladite cartouche et, le cas échéant, sont reliés aux pompes appropriées et/ou aux systèmes de micro-dosage, et des systèmes de détection permettant d'évacuer des stimuli chimiques, électriques ou de pression, sont facultativement reliés aux amplificateurs de signaux convenables et/ou aux dispositifs d'enregistrement et contiennent la cartouche de l'invention. De plus, l'invention concerne l'utilisation de ce cathéter, des systèmes de détection et la fabrication des cartouches à partir d'un matériau flexible avec effet de mémoire.
PCT/EP2004/001234 2003-02-10 2004-02-10 Dispositif de liaison avec l'oreille interne Ceased WO2004069119A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE10305349A DE10305349A1 (de) 2003-02-10 2003-02-10 Innenohr-Steckverbindung
DE10305349.2 2003-02-10

Publications (1)

Publication Number Publication Date
WO2004069119A1 true WO2004069119A1 (fr) 2004-08-19

Family

ID=32747669

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2004/001234 Ceased WO2004069119A1 (fr) 2003-02-10 2004-02-10 Dispositif de liaison avec l'oreille interne

Country Status (2)

Country Link
DE (1) DE10305349A1 (fr)
WO (1) WO2004069119A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112911479A (zh) * 2021-01-13 2021-06-04 山东第一医科大学附属省立医院(山东省立医院) 一种3d打印助听器及其制造方法

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0707085A1 (fr) 1994-10-14 1996-04-17 Osteonics Corp. Alliage à base de titane bio-compatible de module bas pour dispositifs médicaux
JPH08275298A (ja) 1995-03-31 1996-10-18 Rion Co Ltd 挿耳部材
WO1998056434A1 (fr) 1997-06-13 1998-12-17 Durect Corporation Systeme de diagnostic et de transfert de fluide dans l'oreille interne
WO2000004854A1 (fr) 1998-07-23 2000-02-03 Durect Corporation Systeme de diagnostic et de transfert de fluide permettant de traiter l'oreille interne
EP1004326A2 (fr) * 1998-11-19 2000-05-31 Lenarz, Thomas, Prof. Dr. med. Catheter de transfert de fluide dans l'oreille interne
WO2000033775A1 (fr) 1998-12-04 2000-06-15 Durect Corporation Systeme a liberation controlee pour l'administration d'agents therapeutiques a l'interieur de l'oreille interne
WO2001082848A2 (fr) * 2000-04-28 2001-11-08 Advanced Bionics Corporation Acces avec effraction minimale a la cochlee pour l'insertion d'une electrode et l'administration d'un fluide
WO2002102278A2 (fr) 2001-06-18 2002-12-27 Durect Corporation Dispositif et procede d'administration de microdoses d'agents dans l'oreille

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0707085A1 (fr) 1994-10-14 1996-04-17 Osteonics Corp. Alliage à base de titane bio-compatible de module bas pour dispositifs médicaux
JPH08275298A (ja) 1995-03-31 1996-10-18 Rion Co Ltd 挿耳部材
WO1998056434A1 (fr) 1997-06-13 1998-12-17 Durect Corporation Systeme de diagnostic et de transfert de fluide dans l'oreille interne
WO2000004854A1 (fr) 1998-07-23 2000-02-03 Durect Corporation Systeme de diagnostic et de transfert de fluide permettant de traiter l'oreille interne
EP1004326A2 (fr) * 1998-11-19 2000-05-31 Lenarz, Thomas, Prof. Dr. med. Catheter de transfert de fluide dans l'oreille interne
DE19853299A1 (de) 1998-11-19 2000-06-08 Thomas Lenarz Katheter zur Applikation von Medikamenten in Flüssigkeitsräumen des menschlichen Innenohrs
WO2000033775A1 (fr) 1998-12-04 2000-06-15 Durect Corporation Systeme a liberation controlee pour l'administration d'agents therapeutiques a l'interieur de l'oreille interne
WO2001082848A2 (fr) * 2000-04-28 2001-11-08 Advanced Bionics Corporation Acces avec effraction minimale a la cochlee pour l'insertion d'une electrode et l'administration d'un fluide
WO2002102278A2 (fr) 2001-06-18 2002-12-27 Durect Corporation Dispositif et procede d'administration de microdoses d'agents dans l'oreille

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
DUERIG T; PELTON A; STÖCKEL D: "An overview of nitinol medical applications", MATERIALS SCIENCE AND ENGINEERING A, vol. 273-275, 1999, pages 149 - 160, XP002285560 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112911479A (zh) * 2021-01-13 2021-06-04 山东第一医科大学附属省立医院(山东省立医院) 一种3d打印助听器及其制造方法

Also Published As

Publication number Publication date
DE10305349A1 (de) 2004-08-26

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