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WO1991007930A1 - Prothese d'orbite - Google Patents

Prothese d'orbite Download PDF

Info

Publication number
WO1991007930A1
WO1991007930A1 PCT/DE1990/000914 DE9000914W WO9107930A1 WO 1991007930 A1 WO1991007930 A1 WO 1991007930A1 DE 9000914 W DE9000914 W DE 9000914W WO 9107930 A1 WO9107930 A1 WO 9107930A1
Authority
WO
WIPO (PCT)
Prior art keywords
orbital
prosthesis
orbital prosthesis
glass ceramic
machinable
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/DE1990/000914
Other languages
German (de)
English (en)
Inventor
Matthias JÜTTE
Siegfried Klein
René WOYTINAS
Gunter Carl
Wolfgang Götz
Karin Naumann
Werner Vogel
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.)
Friedrich Schiller Universtaet Jena FSU
Original Assignee
Friedrich Schiller Universtaet Jena FSU
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 Friedrich Schiller Universtaet Jena FSU filed Critical Friedrich Schiller Universtaet Jena FSU
Publication of WO1991007930A1 publication Critical patent/WO1991007930A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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
    • A61F2/14—Eye parts, e.g. lenses or corneal implants; Artificial eyes
    • A61F2/141—Artificial eyes
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/02—Inorganic materials
    • A61L27/12—Phosphorus-containing materials, e.g. apatite
    • 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00179—Ceramics or ceramic-like structures
    • A61F2310/00293—Ceramics or ceramic-like structures containing a phosphorus-containing compound, e.g. apatite

Definitions

  • the invention relates to an orbital prosthesis as a spherical part, in a size corresponding to 2/3 of the enucleated eye, for filling the empty eye socket after enucleation and with intersecting channels for taking up the straight eye muscles.
  • Orbital prostheses are available as placeholders after enucleation in a large number of geometric variants. They consist of a wide variety of materials. Known orbital prostheses have in the past led to a non-negligible percentage of rejection reactions in the area of the orbit, although the materials used are well tolerated in many areas of the human body.
  • An orbital prosthesis made of Supramid according to WALSER from Leonhard Klein has four channels that meet in the middle of the orbital prosthesis. The muscles coming from the orbital cavity are guided into the channels via a relatively sharp edge. The muscles are sutured in the middle of the orbital prosthesis and then grow together. The shape of the channels creates the risk of pressure necrosis of the four straight eye muscles running through the channels.
  • the relatively narrow bars on the front (the side facing the conjunctiva) of the orbital prosthesis lead to pressure necrosis when the glass prosthesis is inserted.
  • the Leonhard Klein orbital prosthesis according to CIBIS is coated with lyophilized sclera or dura before implantation. Here too there are rejection reactions and absorption of the tissue that is not supplied with blood.
  • the preparation of such an orbital prosthesis in the operating room is very complex and extends the operating time by around 30 Minutes, with an actual operation time of about 30 minutes. A growth of the muscles with the non-perfused tissue also results in a non-healing rate of 10% to 30%.
  • the known orbital prostheses and the materials used represent an inadequate compromise between economic producibility, sterilizability, surgical procedures, tolerance and the durability of the cosmetic result.
  • the invention is intended to improve the prosthetic care of patients after enucleation.
  • the surgical procedure should be simplified and the burden on the patient should be reduced.
  • the prosthesis should be able to be produced with little effort.
  • an optimal, lifelike and permanent restoration of the aesthetic facial expression is sought.
  • the invention is based on the object of creating an orbital prosthesis which drastically minimizes the postoperative complications, in particular rejection reactions and pressure necrosis, through the use of material and appropriate material and functional design.
  • a surface facing the conjunctiva is essentially smooth, flattened up to 2 mm and the orbital prosthesis is made of machinable bio-glass ceramic. It is advantageous to arrange a pin-like elevation on the surface facing the conjunctiva for locking the glass prosthesis.
  • the manufacture of the orbital prosthesis from the machinable bioactive glass ceramic of the composition has been surprisingly advantageous
  • This material is used advantageously in adult patients.
  • the orbital prosthesis is made from the machinable biocompatible or bioactive glass ceramic with grain sizes from 1 ⁇ m to 2 ⁇ m as a first component of the composite material with an organic substance, preferably PMMA or epoxidized hydrocarbons as a second component.
  • the proportions between the organic material and the machinable biocompatible glass ceramic or the machinable bioactive glass ceramic are in the ratio of 10 to 20% by volume to 90 to 80% by volume.
  • An orbital prosthesis made from this material composition has the advantage that each prosthesis is shaped by shaping the operation can be adapted to the anatomical conditions of the patient's orbit.
  • the invention brings about a reduction in the duration of the operation compared to known orbital prostheses.
  • the orbital prosthesis can be manufactured to size with comparatively little effort using conventional tools. Sterilization of the orbital prosthesis is easily carried out in the autoclave with little effort.
  • the long-term stability of the cosmetic result of the operation while avoiding the postucleation syndrome is essential.
  • FIG. 1 Orbital prosthesis with a smooth surface facing the conjunctiva.
  • FIG. 2 Orbital prosthesis with pin-like elevation.
  • the orbital prosthesis is described using the example of the prosthesis with a smooth side facing the conjunctiva.
  • the orbital prosthesis is manufactured as a spherical part 1.
  • the shape and size are chosen according to the enucleated eye (about 2/3 of the eye diameter).
  • a surface 2 facing the conjunctiva is flattened by 1.5 mm with an eye diameter of 24 mm. This surface is ground, polished, or shaped in the case of the composite material.
  • a first channel for straight eye muscles 3 and a second channel for straight eye muscles 4 are incorporated at right angles to one another in the region of the axes of symmetry.
  • the first channel for straight eye muscles 3 and the second channel for straight eye muscles 4 are worked in such a way that they flatten out towards the back (seen from the surface 2 facing the conjunctiva).
  • One channel is used to record an opposite straight eye muscle. It is advantageous that the muscle channels pass into the spherical shape through curves 5, that is to say no sharp edges occur on the prosthesis.
  • One straight eye muscle is pulled through one muscle channel and sewn to the opposite eye muscle. Healing into the muscles is very inexpensive thanks to the biologically compatible material, the shape of the muscle channels and the sewing of the eye muscles.
  • the surface of the orbital prosthesis is kept smooth. This eliminates pressure necrosis by evenly distributing the pressure force of the glass prosthesis on the orbital prosthesis.
  • the orbital prosthesis is made from the biologically compatible material, which consists of the machine-workable bioactive glass ceramic of the composition
  • the commercially available bioactive material BI0VERI ⁇ ( R) I is preferably used in enucleated adults because the orbital prosthesis heals permanently.
  • the orbital prosthesis is made from a biologically compatible material, which is made from the machine-workable, biocompatible glass ceramic of the composition
  • the commercially available biocompatible material BIOVERI ⁇ (R) II is preferably used for enucleated children. 1 In the course of skull growth, a larger one
  • Bioverit ( R ) II biocompatible is in cylindrical shape or
  • a ball is turned from the ceramic starting material according to the 4 desired seal sizes (14/16/18 mm).
  • the size of the channels should be 4.5 mm x 3 mm.
  • the orbital prosthesis consists of one
  • the Ceramic material has grain sizes between 1 ⁇ m to 20 ⁇ m, preferably a grain size of 5 ⁇ m.
  • the glass ceramic is treated with 50% phosphoric acid at 110 ° C and the excess liquid is separated off by filtration and drying.
  • Polymethyl methacrylate or the epoxidized polymeric hydrocarbon with an average molecular weight Mn of 3700 and an epoxy equivalent weight E ⁇ G of 15 is mixed intensively with the pretreated glass ceramic.
  • the proportions between the organic material and the machinable biocompatible or bioactive glass ceramic are in the ratio of 10 to 20 vol% to 90 to 80 vol%.
  • the components are placed in a shape selected according to the shape of the eye socket and harden in 15 minutes.
  • the density of the orbital prosthesis is adjusted so that the natural conditions are met. Another advantage is the possibility of modeling the orbital prosthesis for direct adaptation of the orbital prosthesis to the anatomical conditions by grinding and polishing in the course of the operation.
  • the surgical technique for implanting the orbital prosthesis includes the following steps: - usual disinfection of the surgical area - laying a limbus holding thread - cutting off the conjunctiva at the limbus - locating the four straight eye muscles and connecting with catgut atraumatically 5 x 0 - separating the straight eye muscles at the base - severing the oblique eye muscles - enucleation of the globe with enucleation scissors or better with an enucleation loop
  • the surface of the orbital prosthesis is kept essentially smooth, a pin-like elevation 6 being worked out from the biologically compatible material.
  • the pin-like elevation 6 is cylindrical.
  • the transitions of the shapes are rounded at the end of the pen and at the base of the pen.
  • the pen has a length of about 3 mm, with a diameter of 1.5 mm.
  • the associated glass prosthesis has a recess on the back corresponding to the pin-like elevation 6.
  • the orbital prosthesis can be manufactured to size with comparatively little effort using conventional tools.
  • the orbital prosthesis can be sterilized with little effort in an autoclave at 121 degrees Celsius. An optimal blood supply of the sewn eye muscles is given. the long-term stability of the cosmetic result of the operation, avoiding the postucleation syndrome, is essential.

Landscapes

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

Abstract

Une prothèse d'orbite est utilisée pour remplir la cavité oculaire vide après une énucléation. La prothèse d'orbite est formée d'une pièce sphérique (1) avec une surface essentiellement lisse (2) en contact avec la conjonctive, en une céramique vitreuse BIOVERITR usinable, a de bonnes propriétés de tolérance biologique dans la cavité oculaire. Cette prothèse permet de réduire la durée de l'intervention et d'obtenir des résultats esthétiques optimaux et durables, tout en réduisant des complications post-opératoires.
PCT/DE1990/000914 1989-12-04 1990-11-29 Prothese d'orbite Ceased WO1991007930A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DD33517889A DD290802A5 (de) 1989-12-04 1989-12-04 Orbitaprothese
DDWPA61F/335178/7 1989-12-04

Publications (1)

Publication Number Publication Date
WO1991007930A1 true WO1991007930A1 (fr) 1991-06-13

Family

ID=5614327

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/DE1990/000914 Ceased WO1991007930A1 (fr) 1989-12-04 1990-11-29 Prothese d'orbite

Country Status (3)

Country Link
AU (1) AU6749690A (fr)
DD (1) DD290802A5 (fr)
WO (1) WO1991007930A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE4140326A1 (de) * 1991-12-06 1993-06-09 Adatomed Pharmazeutische Und Medizintechnische Gesellschaft Mbh, 8000 Muenchen, De Orbita-implantat
WO1998010715A1 (fr) * 1996-09-11 1998-03-19 F.C.I. (France Chirurgie Instrumentation) S.A. Bille intra-orbitaire
FR2826281A1 (fr) * 2001-06-21 2002-12-27 Jean Paul Adenis Bille intraorbitaire a base d'hydroxyapatite et de phosphate tricalcique
WO2007023319A1 (fr) 2005-08-25 2007-03-01 Wayne Austin Dispositif pour un implant orbital

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2649590A (en) * 1946-12-09 1953-08-25 Norman L Cutler Eye implant and prosthesis
US2653327A (en) * 1951-05-21 1953-09-29 Allen Edwin Lee Artificial eye and implant
US3436763A (en) * 1966-03-28 1969-04-08 Albert T Milauskas Orbital implant of fused acrylic plastic and process of implanting
EP0145210A2 (fr) * 1983-10-27 1985-06-19 E.I. Du Pont De Nemours And Company Particules-supports revêtues de précurseurs pour verre biologiquement actif
US4643982A (en) * 1984-12-05 1987-02-17 Hoya Corporation High-strength glass-ceramic containing anorthite crystals and process for producing the same
DE3643416A1 (de) * 1986-01-27 1987-09-24 Jenaer Glaswerk Veb Bioaktive dauerimplantate

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2649590A (en) * 1946-12-09 1953-08-25 Norman L Cutler Eye implant and prosthesis
US2653327A (en) * 1951-05-21 1953-09-29 Allen Edwin Lee Artificial eye and implant
US3436763A (en) * 1966-03-28 1969-04-08 Albert T Milauskas Orbital implant of fused acrylic plastic and process of implanting
EP0145210A2 (fr) * 1983-10-27 1985-06-19 E.I. Du Pont De Nemours And Company Particules-supports revêtues de précurseurs pour verre biologiquement actif
US4643982A (en) * 1984-12-05 1987-02-17 Hoya Corporation High-strength glass-ceramic containing anorthite crystals and process for producing the same
DE3643416A1 (de) * 1986-01-27 1987-09-24 Jenaer Glaswerk Veb Bioaktive dauerimplantate

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE4140326A1 (de) * 1991-12-06 1993-06-09 Adatomed Pharmazeutische Und Medizintechnische Gesellschaft Mbh, 8000 Muenchen, De Orbita-implantat
WO1998010715A1 (fr) * 1996-09-11 1998-03-19 F.C.I. (France Chirurgie Instrumentation) S.A. Bille intra-orbitaire
FR2826281A1 (fr) * 2001-06-21 2002-12-27 Jean Paul Adenis Bille intraorbitaire a base d'hydroxyapatite et de phosphate tricalcique
WO2007023319A1 (fr) 2005-08-25 2007-03-01 Wayne Austin Dispositif pour un implant orbital
US8696747B2 (en) 2005-08-25 2014-04-15 Novamed Ceramisys Limited Device for an orbital implant

Also Published As

Publication number Publication date
AU6749690A (en) 1991-06-26
DD290802A5 (de) 1991-06-13

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