WO2005068014A1 - Outil neurologique - Google Patents

Outil neurologique Download PDF

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Publication number
WO2005068014A1
WO2005068014A1 PCT/EP2005/000275 EP2005000275W WO2005068014A1 WO 2005068014 A1 WO2005068014 A1 WO 2005068014A1 EP 2005000275 W EP2005000275 W EP 2005000275W WO 2005068014 A1 WO2005068014 A1 WO 2005068014A1
Authority
WO
WIPO (PCT)
Prior art keywords
cannula
aid
contact
micro
sliding mechanism
Prior art date
Application number
PCT/EP2005/000275
Other languages
German (de)
English (en)
Inventor
Heinrich Gerding
Thomas Diessner
Dietmar LÜTKE NOTARP
Hans Christian LÜDTKE-HANDJERY
Ralf Hornig
Stefan Hosdorf
Valerij Ortmann
Original Assignee
Iip-Technologies 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 Iip-Technologies Gmbh filed Critical Iip-Technologies Gmbh
Publication of WO2005068014A1 publication Critical patent/WO2005068014A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0526—Head electrodes
    • A61N1/0543—Retinal electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B3/00—Apparatus for testing the eyes; Instruments for examining the eyes
    • 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
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves 
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36046—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of the eye

Definitions

  • the present invention relates to a minimally invasive neurological tool for diagnosis and therapy. More specifically, the present invention relates to an electrical diagnostic and therapeutic tool for the human or animal retina, optic nerve and visual cortex.
  • the light-sensitive tissue that covers the back of the eye and that contains the light-sensitive photoreceptor cells is called the retina.
  • the retina consists of two types of photoreceptors, the rod and the cone, as well as several layers of other non-light-sensitive nerve cells.
  • the rods and cones convert light into electrical impulses that are processed by other nerve cells.
  • the ganglion cells generate the output signal of the retina.
  • the optic nerve transmits the visual information to the brain, where it is converted into a sensory "seeing".
  • Various diseases such as macular degeneration or retinitis pigmentosa cause degeneration of the photoreceptor cells. Degeneration often affects other cells of the retina, but it is known that even after years of blindness, the ganglion cells are essentially intact.
  • One method involves the implantation of a photosensitive device to stimulate the neurons or ganglion cells.
  • a visual prosthesis was proposed which has a tightly packed array of small solar cells, which in turn are coupled to a large number of electrodes which are intended to stimulate neurons on the surface of the retina in a pattern corresponding to the illumination.
  • Another approach is shown in US Pat. No. 5,935,155, in which the received electromagnetic energy of a small induction coil is converted into electrical stimulation pulses.
  • a compact array of electrodes which is in contact with the ganglion cells, induces the visual sensation through a stimulation pattern. Both approaches are still in the development stage and require a number of human and animal tests to evaluate each technology.
  • the evaluation comprises a series of implantations of the electrode arrangements in a human or animal eye.
  • the electrodes are brought into direct contact with the retina and transmit electrical pulses to the ganglion cells.
  • Humayun describes two different electrodes in Vision Research 39 (1999) 2569-2576 and in Aren. Ophalmol. / Vol. 114, Jan. 1996, pp.40-46. Both electrode arrays are brought close to the retina without any mechanical contact to manufacture the ganglion cells. The mechanical rigidity and the sharp edges pose a high risk of mechanical damage to the retina. The several millimeter wide opening required for the implantation of such electrodes increases the risk of infection when carrying out the test.
  • Eckmiller describes in Invest. Ophthalmol. Vis. Be. 2002 43: E-Abstract 2848 the implantation of a thin micro contact tape and the epiretinal stimulation with the help of this tape.
  • the special elasticity of this film-like micro contact tape allows a safe implantation of the electrode structure and direct contact with the retina.
  • a safe and effective evaluation method is still in development. The same method will be used later to diagnose the retinal degeneration process before a stimulation device is permanently implanted.
  • 1 a device according to the invention when used in the eye of a mammal
  • 2 a schematic representation of the device in a perspective representation
  • FIG. 4 shows a cross section through the cannula of the device with the aid located therein.
  • FIG. 1 shows a device according to the invention during the implantation of an electrically conductive contact film 10 into the eye of a mammal.
  • An inner cannula 1 penetrates the sclera of the eye and is brought close to the retina.
  • the contact film 10 can then be pushed out of the inner cannula 1 and thus come into electrical contact with the retina.
  • the contact film 10 can be drawn back into the inner cannula 1 and the implantation device can then be removed from the eye again. The entire process can be visually observed by the user through the lens of the affected eye.
  • FIG 2 shows the details of the device used in Figure 1 in a perspective exploded view.
  • the device has a base body 6. Which essentially represents the handpiece of the device.
  • a slide consisting of lower slide part 2 and upper slide part 3 is slidably mounted in the longitudinal direction.
  • the space in which the slide is arranged is closed by a cover 4.
  • the lower part 2 of the slide carries an outer cannula 7 on its front side, which in the assembled state overlaps an inner cannula 1.
  • the inner cannula 1 is arranged on a closure piece 13 which closes the base body 6 on the end face.
  • a micro contact foil 10 is fixed in the slide.
  • the micro-contact foil 10 is guided from the slide through the outer cannula 7 and the inner cannula 1.
  • a seal 5 closes the outer space connected to the outer cannula 7 from the inner space of the slide and in particular from a connecting device 8 which is provided for external contacting of the micro-contact foil 10.
  • a supply unit 9 an electrical contact of the micro-contact foil is made via the connection device 8 to external devices, without this significantly restricting the handling of the hand-held device.
  • the lid 4 is secured on the base body 6 with a locking ring 11 c.
  • the lower slide part 2 and the upper slide part 3 are fixed to each other by a further locking ring 11 a.
  • the closure piece 13, which carries the inner cannula 1, is secured to the handheld device with a locking ring 11b.
  • FIG. 3 shows the handheld device in a cross section from the side.
  • the connection device 8 is connected to the connection area of the microcontact film 10 by means of a connecting piece 14.
  • the micro-contact foil is firmly and immovably in the lower part 2 of the slide.
  • the seal 5 is pressed against the bottom part 2 of the slide by a screw 15 and presses the micro-contact foil against the bottom part 2, so that the micro-contact foil is fixed here and at the same time sealed off in a liquid-tight manner. From there, the micro-contact film enters the outer cannula 7 to the left, which is larger in its outer dimensions than the inner cannula 1 and which surrounds it from the outside in an overlap area.
  • the micro-contact foil 10 merges from the outer cannula 7 into the inner cannula 1 and, in the illustration in FIG. 3, lies essentially completely in the inner cannula 1.
  • the base body 6 is closed by the cover 4 above the slide arrangement, so that overall there is an approximately pin-shaped, manually manageable hand-held device.
  • FIG. 4 shows the inner cannula 1 in a cross section. It is illustrated that the inner cannula 1 has an approximately rectangular cross section with such a free inner lumen.
  • the microcontact film 10 is located in this lumen.
  • the inner cannula 1 is provided on the inside with a coating 12 which protects the microcontact film 10 from adhesion to the inner cannula 1, so that it is easier to move it into the position shown in FIG.
  • the coating 12 is preferably a silicate coating which does not lose its insulating and friction-reducing properties even under the influence of body fluids.
  • the device described so far has been designed for the diagnostic and therapeutic electrical stimulation of the retina of mammals and humans.
  • the tool can also be used for other types of minimally invasive neurological diagnostic and therapeutic aids.
  • the advantage of the proposed construction lies in the ability to implant a thin and very flexible micro-contact foil 10 as an aid through different tissue layers and to bring it precisely to the desired location at the tip with the affected tissue. This effect is achieved in that the aid is stored in the correspondingly shaped inner cannula 1 and is protected during the implantation process.
  • the inner cannula provides mechanical protection for the device during implantation.
  • the base body 6 serves as a support base for the other components of the device described so far.
  • the base body 6 can be made of a polymer or another suitable, preferably electrically non-conductive material with sufficient rigidity. The material should be sterilizable and biocompatible for short-term contact with blood vessels and tissue.
  • the outer cannula 7, which surrounds the micro-contact foil 10, serves as a kind of mechanical protective element between the slide and the inner cannula 1, in order to prevent the micro-contact foil 10 from bulging under pressure.
  • the arrangement of the inner and outer cannula can also be reversed, so that the inner cannula 1 in the present case is connected to the slide and thus displaceable and the outer cannula 7 in the present case is firmly connected to the closure piece 13 and cannot be displaced.
  • the seal 5 fixes the aid, in the present case the micro-contact film 10, on the lower slide part 2.
  • the micro-contact film 10 can also be glued to the lower slide part 2.
  • the supply device 9 ensures the connection of the microcontact film 10 to an external signal generator and, if appropriate, a corresponding detector.
  • the auxiliary means in the form of the micro-contact film 10 as well as the connection device 8, the lower slide part 2, the upper slide part and the outer cannula 7 represent a slide mechanism which can be moved within the hand-held device by, for example, 15 mm in the longitudinal direction of the base body 6.
  • the locking ring 11 a serves to secure the slide mechanism itself.
  • the free end of the micro-contact film 10 with a micro-contact array after the implantation of the inner capacitor cannula in the eye is expelled by moving the slide mechanism 2, 3, 7 towards the inner cannula 1 from the inner cannula 1 and can be connected to the nerve tissue to be examined or stimulated.
  • the micro-contact foil 10 in order to make a decision based on this test can determine whether and in what form a visual prosthesis based on electrical stimulation of the nerve cells is suitable for the patient concerned.
  • This device will therefore always be usable when a thin, flexible and mechanically sensitive aid has to be connected to an equally sensitive tissue.
  • the special design ensures that the aid is not damaged during the implantation and that the cannula 1, which is necessarily relatively rigid for the implantation, does not have to come into contact with the tissue to be treated or examined.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Surgery (AREA)
  • Cardiology (AREA)
  • Radiology & Medical Imaging (AREA)
  • Vascular Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Biophysics (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgical Instruments (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un dispositif servant à l'implantation effractive minimale de moyens diagnostiques ou thérapeutiques et comprenant un boîtier servant à la fixation et à la connexion sur d'autres unités auxiliaires. Selon l'invention, le moyen sous forme de film se trouve dans une canule et le dispositif comprend un dispositif coulissant qui sert à faire sortir le moyen par segments de la canule et à le réintroduire dans la canule.
PCT/EP2005/000275 2004-01-15 2005-01-13 Outil neurologique WO2005068014A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102004002379.4 2004-01-15
DE102004002379A DE102004002379A1 (de) 2004-01-15 2004-01-15 Neurologisches Werkzeug

Publications (1)

Publication Number Publication Date
WO2005068014A1 true WO2005068014A1 (fr) 2005-07-28

Family

ID=34778071

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2005/000275 WO2005068014A1 (fr) 2004-01-15 2005-01-13 Outil neurologique

Country Status (2)

Country Link
DE (1) DE102004002379A1 (fr)
WO (1) WO2005068014A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2268340A1 (fr) * 2008-04-07 2011-01-05 S.K. Pharmaceutical, Inc. Implants de nerf optique

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6389317B1 (en) * 2000-03-31 2002-05-14 Optobionics Corporation Multi-phasic microphotodetector retinal implant with variable voltage and current capability
US6393327B1 (en) * 2000-08-09 2002-05-21 The United States Of America As Represented By The Secretary Of The Navy Microelectronic stimulator array
US6582441B1 (en) * 2000-02-24 2003-06-24 Advanced Bionics Corporation Surgical insertion tool
WO2003105668A2 (fr) * 2002-06-01 2003-12-24 Alfred E. Mann Institute For Biomedical Engineering At The University Of Southern California Dispositifs d'injection et procedes d'essais d'implants et d'essais d'emplacements cibles non entraves

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5024223A (en) * 1989-08-08 1991-06-18 Chow Alan Y Artificial retina device
DE19741487C2 (de) * 1997-09-19 2000-08-31 Univ Eberhard Karls Vorrichtung für einen Zugang in den Subretinalraum eines Auges
DE10164420A1 (de) * 2001-10-12 2003-07-17 Humanoptics Ag Vorrichtung zum Falten einer Intraokularlinse sowie Aufbewahrungssystem für eine Intraokularlinse

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6582441B1 (en) * 2000-02-24 2003-06-24 Advanced Bionics Corporation Surgical insertion tool
US6389317B1 (en) * 2000-03-31 2002-05-14 Optobionics Corporation Multi-phasic microphotodetector retinal implant with variable voltage and current capability
US6393327B1 (en) * 2000-08-09 2002-05-21 The United States Of America As Represented By The Secretary Of The Navy Microelectronic stimulator array
WO2003105668A2 (fr) * 2002-06-01 2003-12-24 Alfred E. Mann Institute For Biomedical Engineering At The University Of Southern California Dispositifs d'injection et procedes d'essais d'implants et d'essais d'emplacements cibles non entraves

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9138345B2 (en) 2003-02-18 2015-09-22 S. K. Pharmaceuticals, Inc. Optic nerve implants
EP2268340A1 (fr) * 2008-04-07 2011-01-05 S.K. Pharmaceutical, Inc. Implants de nerf optique
EP2268340A4 (fr) * 2008-04-07 2013-04-17 S K Pharmaceutical Inc Implants de nerf optique

Also Published As

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