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WO1998052489A1 - Membrane barriere biocompatible - Google Patents

Membrane barriere biocompatible Download PDF

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Publication number
WO1998052489A1
WO1998052489A1 PCT/EP1998/002955 EP9802955W WO9852489A1 WO 1998052489 A1 WO1998052489 A1 WO 1998052489A1 EP 9802955 W EP9802955 W EP 9802955W WO 9852489 A1 WO9852489 A1 WO 9852489A1
Authority
WO
WIPO (PCT)
Prior art keywords
membrane
perforations
biocompatible
barrier membrane
biocompatible barrier
Prior art date
Application number
PCT/EP1998/002955
Other languages
German (de)
English (en)
Inventor
Dusan Ristic
Original Assignee
Dusan Ristic
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 Dusan Ristic filed Critical Dusan Ristic
Publication of WO1998052489A1 publication Critical patent/WO1998052489A1/fr

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Classifications

    • 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
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/02—Inorganic materials
    • A61L31/022—Metals or alloys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C8/00—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools
    • A61C8/0003—Not used, see subgroups
    • A61C8/0004—Consolidating natural teeth
    • A61C8/0006—Periodontal tissue or bone regeneration

Definitions

  • the invention relates to a biocompatible barrier membrane for maintaining, improving, restoring and recreating the hard and / or soft tissue of parts of the human or animal body, in particular the mouth area.
  • non-absorbable, universal barrier membranes have developed into an important tool in periodontology and implantology. They are used in human medicine and oral surgery both for controlled tissue regeneration and for controlled bone regeneration, thereby - also for later implantation - usable bone profile in height and width is obtained.
  • Generic membranes have so far been made from PTFE (polytetrafluoroethylene). This material is microporous and can be removed from the human body after use.
  • a disadvantage of the known PTFE material is that the spontaneous opening of the sewn-on mucosal flap or the like. More bacteria can settle on the material, and that this triggers increased plaque formation.
  • the material is also relatively soft and not sufficiently rigid for some areas of application, so that attempts have already been made to reinforce it by inserting titanium strips.
  • the PTFE material is also difficult to distinguish optically from natural tissue. Membranes made of biocompatible metals or metal alloys, on the other hand, can be easily recognized and separated from human or animal tissue.
  • Films made of titanium are also known for controlled tissue regeneration, in particular for the treatment of the mouth area, for example from FR 2 713 090 and EP 0 622 052 and from DE-OS 196 05 485.
  • the bone-inductive properties of the Titans used through which a relatively rapid bone formation is achieved. With such titanium membranes, the defect area is shielded from the surrounding area.
  • a hard, tough, elastic, stretchable and polishable, rollable and forgeable metal or such a metal alloy such as titanium, tantalum, platinum, cobalt and / or their alloys, depending on the selection of the film thickness and / or corresponding stiffness or metal alloy, the desired rigidity can always be achieved.
  • the base metals mentioned also coat with a protective oxide layer and are extremely resistant to biological and chemical attacks. there is therefore no risk of increased or increased bacterial colonization with subsequent plaque formation.
  • the disadvantage with them so far is that they provide complete shielding and do not allow substances that are absolutely desirable for healing, such as bodily fluids and / or blood cells, to pass through.
  • the object of the invention is therefore to provide a solution in which an increased bacterial colonization with subsequent plaque formation is avoided, and in which at the same time a sufficient, higher rigidity of the membrane is achieved.
  • the body's own juices, especially blood cells should be able to pass through the membrane.
  • the membrane made of titanium, tantalum, platinum, cobalt and / or a titanium, tantalum, platinum or cobalt alloy is microperforated.
  • micro-perforated metal membrane is that unwanted bacteria or cells are kept away from the area to be covered, while for example body juices or blood cells can pass through the membrane.
  • microperforated metal foils according to the invention can be used indefinitely or are durable, since they can in particular also be resterilized and are not subject to natural decay.
  • the membrane preferably consists of the particularly suitable biocompatible metal alloy Syntacoben®, from which, among other things, hip joint prostheses and the like. getting produced. It is a ductile cobalt alloy (approx. 45% Co, 18% Ca, 3.8 Mo, 3.8 W, 5% Fe, 1% Ti, rest of nickel), which is shaped hot and cold and with different Strength levels can be produced. This material is standardized as a ductile colbalt-nickel-chrome-molybdenum-tungsten-iron alloy in Switzerland under SNV 056510- 1975 and in America under ASTM F 563/78 as a surgical implant material. An international standard (ISO) is also in preparation.
  • Syntacoben® is a ductile cobalt alloy (approx. 45% Co, 18% Ca, 3.8 Mo, 3.8 W, 5% Fe, 1% Ti, rest of nickel), which is shaped hot and cold and with different Strength levels can be produced.
  • This material is standardized as a ductile colbal
  • the material is characterized by high toughness, strength, ductility and corrosion resistance and is particularly suitable for the manufacture of small-sized implants that have to absorb high forces.
  • the crystallographic structure of Syntacoben® corresponds to that of stainless steel, but the corrosion resistance, fatigue strength, hardness and tensile strength of this cobalt alloy exceed the corresponding properties of even the best quality stainless steel of type V4A or AISI 316 L, whereby excellent ductility is guaranteed.
  • the membrane is microperforated with at least 100 perforations per mm, preferably with 12,000 perforations and more per mm 2 .
  • a barrier membrane is used between the bone and mucous membranes, it is possible for the membrane to grow well with soft tissue at about 100 perforations per mm 2 , so that entire skin lobes can then be pulled up adhering to the membrane and sewn by the surgeon. The rag and membrane can be lifted together. With 12,000 microperforations per mm 2 , on the other hand, it is impossible to grow through, a defect area covered with such material can be completely protected against undesired bacteria and cells.
  • the invention provides in a further embodiment that the membrane has perforations of ⁇ 50 micrometers, preferably ⁇ 5 micrometers. With this, the results described above can be achieved even better.
  • two treatment strategies can be seen: fewer and larger perforations per unit area enable the tissue to grow through the membrane according to the invention, so that this membrane can be used as a kind of reinforcement of soft tissue, that, for example, this tissue can be kept away from the surface of a tooth until there is enough slow has always formed growing bone.
  • This "soft tissue reinforcement" by the membrane according to the invention prevents this soft tissue from tearing and thereby supports the desired effect of the regrowth of, for example, bone substance.
  • the second effect can be seen in the fact that a large number of microperforations with a small diameter prevent the growth of tissue cells as well as the passage of bacteria, but nevertheless enable the passage of, for example, proteins. With perforations of ⁇ 1 micrometer, only the body's own juices and blood cells can pass through the membrane.
  • the invention also provides that the membrane can only be passed through by proteins, but not by bacteria or tissue cells. This enables the construction of the desired material, in particular the tissue or bone substance to be regenerated. Bacteria and soft tissue cells have to be kept away, for example, so that bone material develops. The formation of bone material, on the other hand, requires the addition of proteins.
  • the invention also proposes a method for producing a biocompatible barrier membrane.
  • the perforations are made mechanically and / or by bundled light energy, in particular lasers and / or by chemical processes, in particular etching or the like. , and / or produced by bombardment with protons or other particles. This enables particularly fine perforations of ⁇ 5 micrometers to be achieved. It has been found, for example, that with a perforation by laser light the size of the individual perforations on the processing side facing the laser is initially relatively large, but the laser can be adjusted so precisely that on the side facing away from the laser that is to be processed Membrane only a tiny opening remains, so that the desired values of ⁇ 5 micrometers per per perforation can be achieved in this way.
  • FIG. 1 shows a membrane according to the invention made of titanium, tantalum, platinum, cobalt or a corresponding metal alloy
  • FIG. 2 shows a biocompatible barrier membrane according to the invention in the application position.
  • a - greatly enlarged - generally designated 1 membrane of titanium, tantalum, platinum, cobalt or a corresponding metal alloy has a blank 2 with microperforations 3.
  • these microperforations 3 are generated mechanically and / or by bundled light energy, in particular lasers, and / or by chemical methods, in particular etching or the like. , and / or produced by bombardment with protons or other particles. It is possible, for example, to form at least 100, but preferably 12,000 perforations and more per mm 2 , so that the individual perforations are ⁇ 50 micrometers, but preferably ⁇ 5 micrometers.
  • Such micro perforations 3 have the advantage that they can only be passed by proteins 4, but not by bacteria 5 or tissue cells 6.
  • a defect region 7 covered with a corresponding membrane 2 is protected, and soft tissue 9 to be lifted is reinforced in order to prevent tearing, so that new, slower-growing bone material 8 can form underneath.
  • the membrane 2 thus forms, for example, a barrier between the gingival soft tissue 9 and the defect area (cavity) 7 above the root surface 10.
  • the gingival tissue 9 and the epithelium 11 no longer proliferate apically, which leads to the formation of new desmodonts, dental cement and bone tissue (inside the alveoli - cortical). In this way, a new attachment can be achieved. Is after a short time to recognize new cement or new bone. Experience has shown that it only takes a period of 2 to 6 months for the bone structure to improve significantly. After a period of 10 to 12 months, the necessary bone build-up is usually complete.
  • the membrane according to the invention can be used to achieve sufficient durability for newly inserted implants after the corresponding bone material has been built up.
  • the membrane 2 according to the invention has the function, if necessary, of growing the new, soft tissue in order to raise it with the surrounding flaps in order to make more space for the desired bone tissue.
  • the invention is not limited to the exemplary embodiments shown. Further configurations are possible without leaving the basic idea.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Vascular Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Inorganic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Developmental Biology & Embryology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Dentistry (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

L'invention concerne une membrane barrière biocompatible destinée à maintenir, à améliorer, à reconstituer et à recréer un tissu dur et/ou mou de parties du corps humain ou animal, en particulier de la zone buccale. A cet effet et conformément à l'invention, la membrane en titane, tantale, platine, cobalt, ou en un alliage de titane, tantale, platine ou cobalt est microperforée.
PCT/EP1998/002955 1997-05-21 1998-05-20 Membrane barriere biocompatible WO1998052489A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE1997121192 DE19721192C2 (de) 1997-05-21 1997-05-21 Biokompatible Barrieremembran
DE19721192.5 1997-05-21

Publications (1)

Publication Number Publication Date
WO1998052489A1 true WO1998052489A1 (fr) 1998-11-26

Family

ID=7830047

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP1998/002955 WO1998052489A1 (fr) 1997-05-21 1998-05-20 Membrane barriere biocompatible

Country Status (2)

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DE (1) DE19721192C2 (fr)
WO (1) WO1998052489A1 (fr)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19713011C2 (de) * 1997-03-27 1999-10-21 Friadent Gmbh Folie für die Medizintechnik
EP2062548B1 (fr) * 2000-05-29 2016-05-04 CelGen AG Membranes médicales destinées à la régénération d'os
DE10347232A1 (de) * 2003-10-10 2005-05-12 Bego Semados Gmbh & Co Kg Anordnung zur Rückbildung eines parodontosebedingten Knochendefektes

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4219015A (en) * 1977-04-22 1980-08-26 Institut Straumann Ag Plates for osteosynthesis
US4842517A (en) * 1986-12-05 1989-06-27 Haruyuki Kawahara Endosseous implant having mesh pore structure
EP0621018A1 (fr) * 1992-04-17 1994-10-26 Kyocera Corporation Prothèse et procédé pour la fabriquer
EP0622052A1 (fr) 1993-04-28 1994-11-02 Ceka N.V. Méthode pour la fabrication d'une membrane destiné à la régénération de l'os contrôlé
FR2713090A1 (fr) 1993-12-03 1995-06-09 Scortecci Gerard Dispositif utilisé pour la régénération tissulaire guidée.
DE19605485A1 (de) 1996-02-14 1997-08-21 Francesco Pedrazzini Knochenaugmentation ohne Augmentationsmaterialien durch Verwendung der geschmeidigen, adaptierfähigen "titan-o-tec" Membrane aus reinem Titan (gr.1cp und gr.2cp) in der gesteuerten Regenerierung von paradontalen und nicht paradontalem Knochengewebe

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19713011C2 (de) * 1997-03-27 1999-10-21 Friadent Gmbh Folie für die Medizintechnik

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4219015A (en) * 1977-04-22 1980-08-26 Institut Straumann Ag Plates for osteosynthesis
US4842517A (en) * 1986-12-05 1989-06-27 Haruyuki Kawahara Endosseous implant having mesh pore structure
EP0621018A1 (fr) * 1992-04-17 1994-10-26 Kyocera Corporation Prothèse et procédé pour la fabriquer
EP0622052A1 (fr) 1993-04-28 1994-11-02 Ceka N.V. Méthode pour la fabrication d'une membrane destiné à la régénération de l'os contrôlé
FR2713090A1 (fr) 1993-12-03 1995-06-09 Scortecci Gerard Dispositif utilisé pour la régénération tissulaire guidée.
DE19605485A1 (de) 1996-02-14 1997-08-21 Francesco Pedrazzini Knochenaugmentation ohne Augmentationsmaterialien durch Verwendung der geschmeidigen, adaptierfähigen "titan-o-tec" Membrane aus reinem Titan (gr.1cp und gr.2cp) in der gesteuerten Regenerierung von paradontalen und nicht paradontalem Knochengewebe

Also Published As

Publication number Publication date
DE19721192A1 (de) 1998-12-03
DE19721192C2 (de) 2000-07-13

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