WO1996041594A1 - Cover diaphragm - Google Patents

Cover diaphragm Download PDF

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Publication number
WO1996041594A1
WO1996041594A1 PCT/DE1996/000630 DE9600630W WO9641594A1 WO 1996041594 A1 WO1996041594 A1 WO 1996041594A1 DE 9600630 W DE9600630 W DE 9600630W WO 9641594 A1 WO9641594 A1 WO 9641594A1
Authority
WO
WIPO (PCT)
Prior art keywords
covering
bone
soft tissue
tissue
cover membrane
Prior art date
Application number
PCT/DE1996/000630
Other languages
German (de)
French (fr)
Inventor
Axel Kirsch
Original Assignee
Axel Kirsch
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 Axel Kirsch filed Critical Axel Kirsch
Priority to JP9502465A priority Critical patent/JPH11507281A/en
Priority to BR9609157A priority patent/BR9609157A/en
Priority to AU52695/96A priority patent/AU700349B2/en
Priority to EP96909032A priority patent/EP0830115A1/en
Publication of WO1996041594A1 publication Critical patent/WO1996041594A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/28Bones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • AHUMAN NECESSITIES
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    • A61F2/00Filters 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
    • A61F2/0077Special surfaces of prostheses, e.g. for improving ingrowth
    • AHUMAN NECESSITIES
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    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
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    • A61F2/2846Support means for bone substitute or for bone graft implants, e.g. membranes or plates for covering bone defects
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    • A61LMETHODS 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
    • A61L31/00Materials 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
    • A61L31/005Ingredients of undetermined constitution or reaction products thereof
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    • A61L31/00Materials 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
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    • A61L31/00Materials 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
    • A61L31/04Macromolecular materials
    • A61L31/043Proteins; Polypeptides; Degradation products thereof
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    • A61L31/00Materials 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
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
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    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006Properties of materials and coating materials
    • A61F2002/30062(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
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    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006Properties of materials and coating materials
    • A61F2002/30062(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
    • A61F2002/30064Coating or prosthesis-covering structure made of biodegradable material
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30317The prosthesis having different structural features at different locations within the same prosthesis
    • A61F2002/30322The prosthesis having different structural features at different locations within the same prosthesis differing in surface structures
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30667Features concerning an interaction with the environment or a particular use of the prosthesis
    • A61F2002/30677Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
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    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30878Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
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    • A61F2002/30929Special external or bone-contacting surface, e.g. coating for improving bone ingrowth having at least two superposed coatings
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    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/3094Designing or manufacturing processes
    • A61F2002/30971Laminates, i.e. layered products
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    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0004Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
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    • A61F2250/0026Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in surface structures
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    • A61L2430/00Materials or treatment for tissue regeneration
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Definitions

  • the invention relates to a covering membrane made of body-compatible, possibly at least partially resorbable membrane material for temporarily covering a recess in the body's own bone tissue filled with bone building material, in particular hydroxyapatite granules.
  • bone building material which is usually made from a mis ⁇ chung from bone substitute material, such as hydroxyapatite granules, and the body's own bone particles, or also from bone substitute material or body's own bone particles alone.
  • bone building material which is usually made from a mis ⁇ chung from bone substitute material, such as hydroxyapatite granules, and the body's own bone particles, or also from bone substitute material or body's own bone particles alone.
  • EP 0 475 477 discloses a covering membrane of the type described above, in which the covering membrane is essentially completely resorbable, but there is the possibility that the covering membrane is resorbed so quickly that the bony growth of the bone-building material and so that the healing of the bone defect and the lost periodontal tissue or the dental cement can, under unfavorable circumstances, be disturbed by the inflammatory process accompanying any resorption of foreign tissue.
  • the US 48 16 339 shows a cover membrane made of several layers, these layers not consisting of resorbable membrane material, but of polytetrafluoroethylene-containing materials.
  • the multilayer structure serves to optimize the waxing properties, but the lack of resorption of the membrane material can lead to long-term problems.
  • a cover membrane of the gate Described in accordance with the invention, in which the fact that the membrane material can be more quickly absorbed from the side facing away from the body's own bone than from the side facing towards the body's own bone largely ensures that the bony growth of the bone building material and thus the healing of the bone defect essentially undisturbed by the inflammation process accompanying any resorption of foreign tissue.
  • the generic cover membrane has proven itself. However, it has turned out to be desirable to give the soft or connective tissue surrounding the bone defect site the possibility of rapidly growing on the covering membrane, so that a good connection between the soft tissue and the bone that is later restored is ensured. This is particularly, but not exclusively, of particular importance if the covering membrane is to remain in the body.
  • the invention is based on the object of developing the generic covering membrane in such a way that a flawless stabilizing and relative movement-avoiding connection of the soft tissue surrounding the bone defect site or of the collagen structures that result from the predeterminated granulation tissue, which after bleeding into the bone defect parts this fills, and the cover membrane is guaranteed.
  • this object is achieved in that the side of the covering membrane facing the soft tissue and / or the bone tissue (each) has a retention support device for improving the retention of the soft tissue or the (respective) collagen structure (s) on the covering membrane /exhibit.
  • the invention also provides for the retention support device (s) to have at least one mechanical retention aid.
  • the invention further provides that the mechanically active retention aid (s) is / are at least partially designed for positive engagement by soft tissue and / or collagen structure (s).
  • the mechanical retention aid (s) is / are at least partially formed by projections and / or depressions in the covering membrane of the covering device.
  • the invention also provides that the mechanical retention aid (s) is / are at least partially formed by uneven surfaces of the covering membrane of the covering device.
  • the invention provides that the mechanical retention aids are at least partially formed by a tissue and / or knitted structure of the surface of the covering membrane of the covering device facing the soft tissue or the bone tissue.
  • the invention also provides that the retention support devices are / are formed at least partially by appropriate selection of the chemical composition and / or the morphological structure of the material of the covering membrane in the area of the covering membrane facing the soft tissue or the bone tissue.
  • the invention is characterized by at least two layers of different structure and / or composition, the layer facing the soft tissue being the Retention support device (s) has / have.
  • the invention is also characterized by open micropores provided in the soft tissue and / or the layer facing the bone tissue.
  • the invention is characterized by chemically and / or physically acting molecular docking aids for the soft tissue or the collagen structure (s) provided in the area facing the soft tissue and / or the area facing the bone tissue.
  • the invention is based on the surprising finding that it is possible to effectively promote the adhesion of the connective or soft tissue or the collagen structures which sprout into the bone defect site by virtue of the fact that the soft or connective tissue or the bone defect parts facing surface of the covering membrane is formed in such a way that retention support devices are provided for improving the growth of the respective tissue or the respective collagen structures, whereby a reliable stabilizing connection with the covering membrane is ensured.
  • retention support devices can be, for example, mechanically acting devices for preferably interlocking gripping through soft or connective tissue or collagen structures.
  • chemical, ie molecularly acting, docking aids can also be provided, which may be formed by a corresponding special “special layer” of the cover membrane, which, for. B. facing the connective tissue.
  • a corresponding special “special layer” of the cover membrane which, for. B. facing the connective tissue.
  • the base layer can be designed in such a way that there is a particularly good cell-occlusive and / or mechanically supportive effect.
  • FIG. 1 shows a first embodiment of a cover membrane according to the invention in section perpendicular to the membrane plane;
  • FIG. 2 in a representation corresponding to FIG. 1, a further exemplary embodiment of a cover membrane according to the invention.
  • Fig. 3 shows another embodiment of a
  • the surface facing the connective or soft tissue lying at the top of the drawing has a covering membrane 18, projections 36 and depressions 38, which are each designed so that they form through collagen structures of the connective tissue that grows from above ⁇ can be encompassed, whereby the retention of Connective tissue on the cover membrane 18 is improved.
  • the covering membrane 18 is constructed from a base layer 40, which faces the bone, and a cover layer 42, the latter having open micropores 44, which are also suitable for the ingrowth of collagen structures.
  • the covering membrane 18 has a backing layer 46 on the side of the base layer 40 facing away from the covering layer 42, ie facing the bone defect site, which is also provided with open micropores 44, which are used to ingrow collagen structures from the bone defect site are suitable.
  • the layers 42 and 46 preferably have such a resorption genetics that there is a resorption time of about 6 to 12 weeks in periodontal surgery and a resorption time of about 6 to 9 months in bone surgery.

Abstract

A cover diaphragm (18) of physically compatible or at least partially resorbable material for the temporary covering of a recess in the body's bone tissue filled with bone-forming material, especially granulated hydroxyl apatite, in which the side of the cover diaphragm (18) facing the soft tissue and/or the bone tissue has a retention reinforcing device (36, 38, 42, 44, 46) to improve the retention of the soft tissue or the collagen structure on the cover diaphragm (18).

Description

Abdeckmembran Covering membrane
Beschreibungdescription
Die Erfindung betrifft eine Abdeckmembran aus körperkom¬ patiblem, ggf. aus zumindest teilweise resorbierbarem Membranmaterial zum vorübergehenden Abdecken einer mit Knochenauf aumaterial, insbesondere Hydroxylapatit- granulat, gefüllten Ausnehmung in körpereigenem Knochen¬ gewebe.The invention relates to a covering membrane made of body-compatible, possibly at least partially resorbable membrane material for temporarily covering a recess in the body's own bone tissue filled with bone building material, in particular hydroxyapatite granules.
In der Knochen- und ParodontalChirurgie, beispielsweise bei der Rekonstruktion von Knochen in der plastischen Chirugie oder bei kieferchirurgischen Operationen, ist es üblich, Knochendefektstellen in Form von Ausnehmungen oder Höhlungen im körpereigenen Knochengewebe mit Knochenauf¬ baumaterial zu füllen, welches in der Regel aus einer Mis¬ chung aus Knochenersatzmaterial, wie Hydroxylapatit- granulat, und körpereigenen Knochenpartikeln, oder auch aus Knochenersatzmaterial oder körpereigenen Knochenpar¬ tikeln allein, besteht. Um zu gewährleisten, daß das Knochenaufbaumaterial im wesentlichen ausschließlich von der Knochenseite her knöchern durchwachsen wird, bis es durch Remodelling-Vorgänge knöchern substituiert ist, nicht aber in in unerwünschter Weise von unter der Schleimhaut liegendem Bindegewebe, wird die Ausnehmung bis jetzt mit Nicht-Knochengewebe erfolgt. Nur dann nämlich, wenn ein gänzlich knöchernes Durchwachsen des Knochenauf¬ baumaterials gewährleistet ist, läßt sich die Knochende- fektstelle im wesentlichen vollständig beseitigen und das Knochenaufbaumaterial nach knöchernem Durchwachsen in den körpereigenen Knochen reintegrieren. Nur hierdurch läßt sich in der Parodontalchirurgie gleichzeitig erreichen, daß einerseits der Knochen beim Vorhandensein eines ein- oder mehrwandigen Knochendefektes am Zahn regeneriert und andererseits das Parodontalgewebe durch Neubildung von Zement auf der Wurzeloberfläche und von parodontalem Weichgewebe aus dem unterhalb des Defektes liegenden gesunden Parodontalgewebe entsteht.In bone and periodontal surgery, for example in the reconstruction of bones in plastic surgery or in jaw surgery, it is customary to fill bone defect sites in the form of recesses or cavities in the body's own bone tissue with bone building material, which is usually made from a mis ¬ chung from bone substitute material, such as hydroxyapatite granules, and the body's own bone particles, or also from bone substitute material or body's own bone particles alone. In order to ensure that the bone-building material grows through the bone essentially exclusively from the bone side until it is replaced by remodeling processes, but not in an undesirable manner from connective tissue lying under the mucous membrane, the recess has so far been made with non-bone tissue he follows. The bone end can only be removed if complete bone growth is guaranteed. Essentially completely remove the flawed area and reintegrate the bone augmentation material into the body's own bones after bone growth. Only in this way can periodontal surgery at the same time ensure that on the one hand the bone regenerates in the presence of a single or multi-walled bone defect on the tooth and on the other hand the periodontal tissue arises from the formation of healthy periodontal tissue underneath the defect through the formation of cement on the root surface and periodontal soft tissue.
Aus der EP 0 475 477 ist eine Abdeckmembran der vorstehend beschriebenen Art bekannt, bei der die Abdeckmembran zwar im wesentlichen vollständig resorbierbar ist, wobei aber die Möglichkeit besteht, daß die Resorption der Abdeckmem¬ bran so rasch erfolgt, daß das knöcherne Durchwachsen des Knochenaufbaumaterials und damit das Ausheilen des Knochendefektes und des verlorengegangenen Parodontalge- webes bzw. des Zahnzementes unter ungünstigen Umständen von dem jedwede Resorption von körperfremdem Gewebe be¬ gleitenden Entzündungsprozeß gestört werden kann.EP 0 475 477 discloses a covering membrane of the type described above, in which the covering membrane is essentially completely resorbable, but there is the possibility that the covering membrane is resorbed so quickly that the bony growth of the bone-building material and so that the healing of the bone defect and the lost periodontal tissue or the dental cement can, under unfavorable circumstances, be disturbed by the inflammatory process accompanying any resorption of foreign tissue.
Ähnliche Abdeckmembranen mit ähnlichen, unter ungünstigen Umständen beobachtbaren Problemen sind aus der EP 0 082 621 und der WO 90/01955 bekannt.Similar covering membranes with similar problems which can be observed under unfavorable circumstances are known from EP 0 082 621 and WO 90/01955.
Die US 48 16 339 zeigt eine Abdeckmembran aus mehreren Schichten, wobei diese Schichten nicht aus resorbierbarem Membranmaterial bestehen, sondern aus polytetrafluor- ethylenhaltigen Materialien. Der mehrschichtige Aufbau dient dabei dazu, die Einwachseigenschaften zu optimieren, wobei aber die fehlende Resorption des Membranmaterials zu Langzeitproblemen führen kann.The US 48 16 339 shows a cover membrane made of several layers, these layers not consisting of resorbable membrane material, but of polytetrafluoroethylene-containing materials. The multilayer structure serves to optimize the waxing properties, but the lack of resorption of the membrane material can lead to long-term problems.
In der DE-OS 43 02 708 ist eine Abdeckmembran der gat- tungsgemäßen Art beschrieben, bei der dadurch, daß das Membranmaterial von der dem körpereigenen Knochen abge¬ wandten Seite schneller resorbierbar ist als von der dem körpereigenen Knochen zugewandten Seite, weitgehend ge¬ währleistet ist, daß das knöcherne Durchwachsen des Knochenaufbaumaterials und damit das Ausheilen des Knochendefektes im wesentlichen ungestört von dem jedwede Resorption von körperfremdem Gewebe begleitenden Entzün¬ dungsprozeß folgen kann.In DE-OS 43 02 708 a cover membrane of the gate Described in accordance with the invention, in which the fact that the membrane material can be more quickly absorbed from the side facing away from the body's own bone than from the side facing towards the body's own bone largely ensures that the bony growth of the bone building material and thus the healing of the bone defect essentially undisturbed by the inflammation process accompanying any resorption of foreign tissue.
Die gattungsgemäße Abdeckmembran hat sich durchaus bewährt. Allerdings hat es sich als wünschenswert herausgestellt, dem die Knochendefektstelle umgebenden Weich- bzw. Bindegewebe die Möglichkeit zu geben, an der Abdeckmembran rasch anzu¬ wachsen, damit eine gute Verbindung zwischen dem Weichgewebe und dem später wieder hergestellten Knochen gewährleistet ist. Dies ist insbesondere, jedoch nicht ausschließlich, dann von besonderer Bedeutung, wenn die Abdeckmembran im Körper verbleiben soll.The generic cover membrane has proven itself. However, it has turned out to be desirable to give the soft or connective tissue surrounding the bone defect site the possibility of rapidly growing on the covering membrane, so that a good connection between the soft tissue and the bone that is later restored is ensured. This is particularly, but not exclusively, of particular importance if the covering membrane is to remain in the body.
Der Erfindung liegt die Aufgabe zugrunde, die gattungsgemäße Abdeckmembran dahingehend weiterzubilden, daß eine einwand¬ freie stabilisierende und Relativbewegungen vermeidende Ver¬ bindung des die Knochendefektstelle umgebenden Weichgewebes bzw. der Kollagenstrukturen, die aus dem knöchern prädeter¬ minierten Granulationsgewebe, welches nach Einblutung in die Knochendefektsteile diese ausfüllt, und der Abdeckmembran gewährleistet ist.The invention is based on the object of developing the generic covering membrane in such a way that a flawless stabilizing and relative movement-avoiding connection of the soft tissue surrounding the bone defect site or of the collagen structures that result from the predeterminated granulation tissue, which after bleeding into the bone defect parts this fills, and the cover membrane is guaranteed.
Erfindungsgemäß wird diese Aufgabe dadurch gelöst, daß die dem Weichgewebe und/oder die dem Knochengewebe zugewandte Seite der Abdeckmembran (je) eine Retentionsunterstützungs- einrichtung zur Verbesserung der Retention des Weichgewebes bzw. der (jeweiligen) Kollagenstruktur(en) an der Abdeckmem¬ bran aufweist/aufweisen. Auch sieht die Erfindung vor, daß die Retentionsunterstüt- zungseinrichtung(en) (jeweils) mindestens eine mechanische Retentionshilfe aufweist/aufweisen.According to the invention, this object is achieved in that the side of the covering membrane facing the soft tissue and / or the bone tissue (each) has a retention support device for improving the retention of the soft tissue or the (respective) collagen structure (s) on the covering membrane /exhibit. The invention also provides for the retention support device (s) to have at least one mechanical retention aid.
Ferner sieht die Erfindung vor, daß die mechanisch wirken¬ de(n) Retentionshilfe(n) zumindest teilweise zum formschlüs¬ sigen Umgreifen durch Weichgewebe und/oder Kollagenstruk¬ tur(en) ausgebildet ist/sind.The invention further provides that the mechanically active retention aid (s) is / are at least partially designed for positive engagement by soft tissue and / or collagen structure (s).
Ferner ist erfindungsgemäß vorgesehen, daß die mecha¬ nische(n) Retentionshilfe(n) zumindest teilweise durch Vorsprünge und/oder Vertiefungen der Abdeckmembran der Ab¬ deckeinrichtung gebildet ist/sind.It is further provided according to the invention that the mechanical retention aid (s) is / are at least partially formed by projections and / or depressions in the covering membrane of the covering device.
Auch sieht die Erfindung vor, daß die mechanische(n) Reten¬ tionshilfe(n) zumindest teilweise durch Oberflächenuneben¬ heiten der Abdeckmembran der Abdeckeinrichtung gebildet ist/sind.The invention also provides that the mechanical retention aid (s) is / are at least partially formed by uneven surfaces of the covering membrane of the covering device.
Ferner sieht die Erfindung vor, daß die mechanischen Reten- tionshilfen zumindest teilweise durch eine gewebe- und/oder gewirkartige Struktur der dem Weichgewebe bzw. dem Knochen¬ gewebe zugewandten Oberfläche der Abdeckmembran der Abdeck¬ einrichtung gebildet sind.Furthermore, the invention provides that the mechanical retention aids are at least partially formed by a tissue and / or knitted structure of the surface of the covering membrane of the covering device facing the soft tissue or the bone tissue.
Auch sieht die Erfindung vor, daß die Retentionsunterstüt- zungseinrichtungen zumindest teilweise durch entsprechende Auswahl der chemischen Zusammensetzung und/oder der mor¬ phologischen Struktur des Materials der Abdeckmembran in dem dem Weichgewebe bzw. dem Knochengewebe zugewandten Bereich der Abdeckmembran gebildet ist/sind.The invention also provides that the retention support devices are / are formed at least partially by appropriate selection of the chemical composition and / or the morphological structure of the material of the covering membrane in the area of the covering membrane facing the soft tissue or the bone tissue.
Ferner ist die Erfindung gekennzeichnet durch mindestens zwei Schichten unterschiedlicher Struktur und/oder Zusammen¬ setzung, wobei die dem Weichgewebe zugewandte Schicht die Retentionsunterstützungseinrichtung(en) aufweist/aufweisen.Furthermore, the invention is characterized by at least two layers of different structure and / or composition, the layer facing the soft tissue being the Retention support device (s) has / have.
Auch ist die Erfindung gekennzeichnet durch in der dem Weichgewebe und/oder der dem Knochengewebe zugewandten Schicht vorgesehene offene Mikroporen.The invention is also characterized by open micropores provided in the soft tissue and / or the layer facing the bone tissue.
Schließlich ist die Erfindung gekennzeichnet durch in dem dem Weichgewebe und/oder dem dem Knochengewebe zugewandten Bereich vorgesehene chemisch und/oder physikalisch wirkende molekulare Andockhilfen für das Weichgewebe bzw. die Kol¬ lagenstruktur(en) .Finally, the invention is characterized by chemically and / or physically acting molecular docking aids for the soft tissue or the collagen structure (s) provided in the area facing the soft tissue and / or the area facing the bone tissue.
Der Erfindung liegt die überraschende Erkenntnis zugrunde, daß es gelingt, die Anhaftung des Binde- bzw. Weichgewebes bzw. der Kollagenstrukturen, welche in die Knochendefekt- stelle einsprießen, dadurch wirkungsvoll zu fördern, daß die dem Weich- bzw. Bindegewebe bzw. der Knochendefektsteile zugewandte Oberfläche der Abdeckmembran so ausgebildet wird, daß Retentionsunterstützungseinrichtungen für eine Verbes¬ serung des Anwachsens des jeweiligen Gewebes bzw. der jeweiligen Kollagenstrukturen vorgesehen sind, wodurch eine zuverlässige stabilisierende Verbindung mit der Abdeckmem¬ bran gewährleistet ist. Es kann sich hier beispielsweise um mechanisch wirkende Einrichtungen zum vorzugsweise form¬ schlüssigen Umgreifen durch Weich- bzw. Bindegewebe bzw. Kollagenstrukturen handeln.The invention is based on the surprising finding that it is possible to effectively promote the adhesion of the connective or soft tissue or the collagen structures which sprout into the bone defect site by virtue of the fact that the soft or connective tissue or the bone defect parts facing surface of the covering membrane is formed in such a way that retention support devices are provided for improving the growth of the respective tissue or the respective collagen structures, whereby a reliable stabilizing connection with the covering membrane is ensured. These can be, for example, mechanically acting devices for preferably interlocking gripping through soft or connective tissue or collagen structures.
Zusätzlich, oder auch stattdessen, können auch chemische, d. h. molekular wirkende, Andockhilfen vorgesehen sein, die ggf. durch eine entsprechende spezielle "Sonderschicht" der Abdeckmembran gebildet sind, die z. B. dem Bindegewebe zuge¬ wandt ist. Durch eine derartige mehrschichtige Ausbildung der Abdeckmembran ist es möglich, die dem Bindegewebe bzw. der Knochendefektstelle zugewandte Schicht dahingehend zu optimieren, daß ein besonders gutes Verbinden mit dem an- wachsenden Gewebe bzw. der entsprechenden Kollagenstrukturen gewährleistet ist. Die Basisschicht kann so ausgebildet wer¬ den, daß sich eine besonders gute zellokklusive und/oder mechanisch stützende Wirkung ergibt.In addition, or instead, chemical, ie molecularly acting, docking aids can also be provided, which may be formed by a corresponding special “special layer” of the cover membrane, which, for. B. facing the connective tissue. Such a multilayered design of the covering membrane makes it possible to optimize the layer facing the connective tissue or the bone defect site so that a particularly good connection with the other growing tissue or the corresponding collagen structures is guaranteed. The base layer can be designed in such a way that there is a particularly good cell-occlusive and / or mechanically supportive effect.
Wesentlich ist dabei in jedem Fall, daß durch entsprechende Ausbildung, z. B. auch Strukturierung, der dem Weich- bzw. Knochengewebe zugewandten Oberfläche das Einwachsen von Kol¬ lagenstrukturen aus dem Bindegewebe ermöglicht wird.It is essential in any case that through appropriate training, for. B. also structuring, the surface facing the soft or bone tissue is made possible by the ingrowth of collagen structures from the connective tissue.
Weitere Merkmale und Vorteile der Erfindung ergeben sich aus der nachstehenden Beschreibung, in der Ausführungsbeispiele anhand der schematischen Zeichnung im einzelnen erläutert sind.Further features and advantages of the invention result from the description below, in which exemplary embodiments are explained in detail with reference to the schematic drawing.
Dabei zeigt:It shows:
Fig. 1 ein erstes Ausführungsbeispiel einer Ab¬ deckmembran nach der Erfindung im Schnitt senkrecht zur Membranebene;1 shows a first embodiment of a cover membrane according to the invention in section perpendicular to the membrane plane;
Fig. 2 in Fig. 1 entsprechender Darstellung ein weiteres Ausführungsbeispiel einer Abdeck¬ membran nach der Erfindung; undFIG. 2, in a representation corresponding to FIG. 1, a further exemplary embodiment of a cover membrane according to the invention; and
Fig. 3 ein weiteres Ausführungsbeispiel einerFig. 3 shows another embodiment of a
Abdeckmembran nach der Erfindung in Fig. 2 entsprechender Darstellung.Cover membrane according to the invention in Fig. 2 corresponding representation.
Wie Fig. 1 erkennen läßt, weist die dem in der Zeichnung oben liegenden Binde- bzw. Weichgewebe zugewandte Oberfläche eine Abdeckmembran 18 Vorsprünge 36 und Vertiefungen 38 auf, die jeweils so ausgebildet sind, daß sie durch Kollagen¬ strukturen des von oben einwachsenden Bindegewebes form¬ schlüssig umgriffen werden können, wodurch die Retention des Bindegewebes an der Abdeckmembran 18 verbessert wird.As can be seen in FIG. 1, the surface facing the connective or soft tissue lying at the top of the drawing has a covering membrane 18, projections 36 and depressions 38, which are each designed so that they form through collagen structures of the connective tissue that grows from above ¬ can be encompassed, whereby the retention of Connective tissue on the cover membrane 18 is improved.
Bei dem abgewandelten Ausführungsbeispiel in Fig. 2 ist die Abdeckmembran 18 aus einer Basisschicht 40, die dem Knochen zugewandt ist, und einer Deckschicht 42 aufgebaut, wobei letztere offene Mikroporen 44 aufweist, die ebenfalls zum Einwachsen von Kollagenstrukturen geeignet sind.In the modified exemplary embodiment in FIG. 2, the covering membrane 18 is constructed from a base layer 40, which faces the bone, and a cover layer 42, the latter having open micropores 44, which are also suitable for the ingrowth of collagen structures.
Beim Ausführungsbeispiel von Fig. 3 weist die Abdeckmembran 18 auf der der Deckschicht 42 abgewandten Seite der Basis¬ schicht 40, also der Knochendefektstelle zugewandt, eine Rückschicht 46 auf, die ebenfalls mit offenen Mikroporen 44 versehen ist, welche zum Einwachsen von Kollagenstrukturen aus der Knochendefektstelle heraus geeignet sind. Die Schichten 42 und 46 weisen dabei vorzugsweise eine derartige Resorptionsgenetik auf, daß sich in der Parodontalchirurgie eine Resorptionszeit von ca. 6 bis 12 Wochen und in der Knochenchirurgie eine Resorptionszeit von etwa 6 bis 9 Monaten ergibt.In the embodiment of FIG. 3, the covering membrane 18 has a backing layer 46 on the side of the base layer 40 facing away from the covering layer 42, ie facing the bone defect site, which is also provided with open micropores 44, which are used to ingrow collagen structures from the bone defect site are suitable. The layers 42 and 46 preferably have such a resorption genetics that there is a resorption time of about 6 to 12 weeks in periodontal surgery and a resorption time of about 6 to 9 months in bone surgery.
Die in der vorstehenden Beschreibung, in den Zeichnungen so¬ wie in den Ansprüchen offenbarten Merkmale der Erfindung können sowohl einzeln als auch in beliebigen Kombinationen für die Verwirklichung der Erfindung in ihren verschiedenen Ausführungsformen wesentlich sein. The features of the invention disclosed in the above description, in the drawings and in the claims can be essential both individually and in any combination for the implementation of the invention in its various embodiments.

Claims

Patentansprüche claims
1. Abdeckmembran aus körperkompatiblem, ggf. aus zumindest teilweise resorbierbarem Membranmaterial zum vorübergehenden Abdecken einer mit Knochenaufbaumaterial, insbesondere Hydroxylapatitgranulat, gefüllten Ausnehmung in körpereigen¬ em Knochengewebe, dadurch gekennzeichnet, daß die dem Weich¬ gewebe und/oder die dem Knochengewebe zugewandte Seite der Abdeckmembran (18) (je) eine Retentionsunterstützungsein- richtung (36, 38, 42, 44, 46) zur Verbesserung der Retention des Weichgewebes bzw. der (jeweiligen) Kollagenstruktur(en) an der Abdeckmembran (18) aufweist/aufweisen.1. Cover membrane made of body-compatible, possibly at least partially resorbable membrane material for temporarily covering a recess in the body's own bone tissue filled with bone-building material, in particular hydroxyapatite granules, characterized in that the side of the cover membrane facing the soft tissue and / or the bone tissue (18) (each) has a retention support device (36, 38, 42, 44, 46) to improve the retention of the soft tissue or the (respective) collagen structure (s) on the covering membrane (18).
2. Abdeckmembran nach Anspruch 1, dadurch gekennzeichnet, daß die Retentionsunterstützungseinrichtung(en) (jeweils) mindestens eine mechanische Retentionshilfe (36, 38) auf¬ weist/aufweisen.2. Cover membrane according to claim 1, characterized in that the retention support device (s) (each) has / have at least one mechanical retention aid (36, 38).
3. Abdeckmembran nach Anspruch 2, dadurch gekennzeichnet, daß die mechanisch wirkende(n) Retentionshilfe(n) (36, 38) zumindest teilweise zum formschlüssigen Umgreifen durch Weichgewebe und/oder Kollagenstruktur(en) ausgebildet ist/sind.3. Cover membrane according to claim 2, characterized in that the mechanically acting (s) retention aid (s) (36, 38) is / are at least partially designed for positive engagement by soft tissue and / or collagen structure (s).
4. Abdeckmembran nach Anspruch 2 oder 3, dadurch gekenn¬ zeichnet, daß die mechanische(n) Retentionshilfe(n) zu¬ mindest teilweise durch Vorsprünge (36) und/oder Vertiefun¬ gen (38) der Abdeckmembran (18) der Abdeckeinrichtung gebil¬ det ist/sind.4. Cover membrane according to claim 2 or 3, characterized gekenn¬ characterized in that the mechanical (n) retention aid (s) at least partially by projections (36) and / or recesses (38) of the covering membrane (18) of the covering device ¬ det is / are.
5. Abdeckmembran nach einem der Ansprüche 2 bis 4, dadurch gekennzeichnet, daß die mechanische(n) Retentionshilfe(n) zumindest teilweise durch Oberflächenunebenheiten der Ab- deckmembran (18) der Abdeckeinrichtung gebildet ist/sind.5. Cover membrane according to one of claims 2 to 4, characterized in that the mechanical (s) retention aid (s) at least partially due to surface irregularities of the Ab- cover membrane (18) of the covering device is / are formed.
6. Abdeckmembran nach einem der Ansprüche 2 bis 5, dadurch gekennzeichnet, daß die mechanischen Retentionshilfen zu¬ mindest teilweise durch eine gewebe- und/oder gewirkartige Struktur der dem Weichgewebe bzw. dem Knochengewebe zuge¬ wandten Oberfläche der Abdeckmembran (18) der Abdeckeinrich¬ tung gebildet sind.6. Covering membrane according to one of claims 2 to 5, characterized in that the mechanical retention aids at least at least partially by a fabric and / or knitted structure of the soft tissue or bone tissue facing surface of the covering membrane (18) of the covering device tion are formed.
7. Abdeckmembran nach einem der vorangehenden Ansprüche, dadurch gekennzeichnet, daß die Retentionsunterstützungsein- richtungen zumindest teilweise durch entsprechende Auswahl der chemischen Zusammensetzung und/oder der morphologischen Struktur des Materials der Abdeckmembran (18) in dem dem Weichgewebe bzw. dem Knochengewebe zugewandten Bereich (42) der Abdeckmembran (18) gebildet ist/sind.7. Cover membrane according to one of the preceding claims, characterized in that the retention support devices at least partially by appropriate selection of the chemical composition and / or the morphological structure of the material of the cover membrane (18) in the area facing the soft tissue or the bone tissue (42 ) the cover membrane (18) is / are formed.
8. Abdeckmembran nach einem der vorangehenden Ansprüche, gekennzeichnet durch mindestens zwei Schichten (40, 42, 46) unterschiedlicher Struktur und/oder Zusammensetzung, wobei die dem Weichgewebe zugewandte Schicht (42) und/oder die dem Knochengewebe zugewandte Schicht (46) die Retention- sunterstützungseinrichtung(en) (44) aufweist/aufweisen.8. Cover membrane according to one of the preceding claims, characterized by at least two layers (40, 42, 46) of different structure and / or composition, the layer facing the soft tissue (42) and / or the layer facing the bone tissue (46) retaining - has / have support device (s) (44).
9. Abdeckmembran nach Anspruch 8, gekennzeichnet durch in der dem Weichgewebe und/oder der dem Knochengewebe zuge¬ wandten Schicht (42, 46) vorgesehene offene Mikroporen (44) .9. Cover membrane according to claim 8, characterized in that in the soft tissue and / or the bone tissue facing layer (42, 46) provided open micropores (44).
10. Abdeckmembran nach einem der vorangehenden Ansprüche, gekennzeichnet durch in dem dem Weichgewebe und/oder dem dem Knochengewebe zugewandten Bereich vorgesehene chemisch und/oder physikalisch wirkende molekulare Andockhilfen für das Weichgewebe bzw. die Kollagenstruktur(en) . 10. Covering membrane according to one of the preceding claims, characterized by chemically and / or physically acting molecular docking aids for the soft tissue or the collagen structure (s) provided in the soft tissue and / or in the region facing the bone tissue.
PCT/DE1996/000630 1995-06-08 1996-04-03 Cover diaphragm WO1996041594A1 (en)

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BR9609157A BR9609157A (en) 1995-06-08 1996-04-03 Roofing membrane
AU52695/96A AU700349B2 (en) 1995-06-08 1996-04-03 Cover diaphragm
EP96909032A EP0830115A1 (en) 1995-06-08 1996-04-03 Cover diaphragm

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DE19520867.6 1995-06-08

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KR (1) KR100250116B1 (en)
AU (1) AU700349B2 (en)
BR (1) BR9609157A (en)
CA (1) CA2217036A1 (en)
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WO1997032616A1 (en) * 1996-03-04 1997-09-12 Axel Kirsch Covering membrane, moulded bodies produced therefrom and process for the production thereof
JP2000510017A (en) * 1996-05-10 2000-08-08 ジェイ. メドフ,ロバート Transplant material restraint
EP2542164A4 (en) * 2010-03-05 2015-02-25 Univ Case Western Reserve Multilayer surgical membrane

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JP2000510017A (en) * 1996-05-10 2000-08-08 ジェイ. メドフ,ロバート Transplant material restraint
EP2542164A4 (en) * 2010-03-05 2015-02-25 Univ Case Western Reserve Multilayer surgical membrane

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AU700349B2 (en) 1999-01-07
KR100250116B1 (en) 2000-06-01
AU5269596A (en) 1997-01-09
CA2217036A1 (en) 1996-12-27
HUP9802830A2 (en) 1999-06-28
JPH11507281A (en) 1999-06-29
KR19990022607A (en) 1999-03-25
DE19520867C2 (en) 1998-05-20
HUP9802830A3 (en) 2000-11-28
DE19520867A1 (en) 1996-12-12
EP0830115A1 (en) 1998-03-25
BR9609157A (en) 1999-05-04

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