CA2114462C - Covering device with covering membrane - Google Patents
Covering device with covering membraneInfo
- Publication number
- CA2114462C CA2114462C CA002114462A CA2114462A CA2114462C CA 2114462 C CA2114462 C CA 2114462C CA 002114462 A CA002114462 A CA 002114462A CA 2114462 A CA2114462 A CA 2114462A CA 2114462 C CA2114462 C CA 2114462C
- Authority
- CA
- Canada
- Prior art keywords
- covering device
- covering
- membrane
- stiffening layer
- endogenic
- 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.)
- Expired - Fee Related
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
-
- 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
- A61F2/28—Bones
- A61F2/2846—Support means for bone substitute or for bone graft implants, e.g. membranes or plates for covering bone defects
-
- 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
- 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
- A61L31/08—Materials for coatings
- A61L31/10—Macromolecular materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
- A61B17/8085—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates with pliable or malleable elements or having a mesh-like structure, e.g. small strips
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive
-
- 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
- A61F2/0077—Special surfaces of prostheses, e.g. for improving ingrowth
-
- 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
- A61F2/28—Bones
- A61F2002/2835—Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
-
- 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
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
- A61F2002/30004—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
- A61F2002/30032—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in absorbability or resorbability, i.e. in absorption or resorption time
-
- 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
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
- A61F2002/3006—Properties of materials and coating materials
- A61F2002/30062—(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
-
- 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
- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2002/30929—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth having at least two superposed coatings
-
- 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
- A61F2/30—Joints
- A61F2/3094—Designing or manufacturing processes
- A61F2002/30971—Laminates, i.e. layered products
-
- 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
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F2013/00089—Wound bandages
- A61F2013/00357—Wound bandages implanted wound fillings or covers
-
- 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
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
-
- 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
- A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2240/001—Designing or manufacturing processes
-
- 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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0014—Special 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
- A61F2250/003—Special 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 adsorbability or resorbability, i.e. in adsorption or resorption time
-
- 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
-
- 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
- A61F2310/00389—The prosthesis being coated or covered with a particular material
- A61F2310/00395—Coating or prosthesis-covering structure made of metals or of alloys
- A61F2310/00407—Coating made of titanium or of Ti-based alloys
Abstract
The invention relates to a covering device for the temporary covering of a recess in endogenic bone tissue filled with an osteogenic material. The covering device comprises a covering membrane disposed adjacent the recess and the endogenic bone tissue and a stiffening layer connected to the covering membrane. The covering membrane consists of resorbable membrane material which is more rapidly resorbable from the side remote from the endogenic bone tissue than from the side facing the endogenic bone tissue.
Description
COVERING DEVICE WITH COVERING MEMBRANE
This invention relates to a covering device for the temporary covering with a covering membrane of a recess in endogenic bone tissue 5 filled with osteogenic material, such as hydroxyapatite granules.
In bone surgery, e.g. in the reconstruction of bones in plastic surgery or in the case of operations on the jaw, it is standard practice to fillbone defects or deficiency points in the form of recesses or cavities in the endogenic bone tissue with an osteogenic material, which generally consists 10 of a mixture of bone replacement material, such as hydroxyapatite granules, and endogenic bone particles. To ensure that the osteogenic material substantially exclusively grows through in osseous manner from the bone side, but not in an undesired manner by the mucous tissue, the recess is closed with a covering membrane of the aforementioned type, which is intended to ensure that there is no growth through the osteogenic material with non-bone tissue. Thus, only in the case of ensuring a complete osseous growth through of the osteogenic material, is it possible to substantially completely elimin~te the bone defect point and to reintegrate into the endogenic bone the osteogenic material after osseous growth has taken place.
Hitherto, polytetrafluoroethylene films, for example, have been used as covering membranes, but they suffer from the disadvantage of remaining in the body when the bone defect point heals and can therefore give rise to future complications.
As a result of the material used for the covering membranes, such as e.g. plastic films, the membrane is not stiff and can instead change its position as a result, e.g. of radial stressing through the surrounding soft body tissue, e.g. as a result of muscular movements. Such movements of the covering membrane lead to the disadvantage that the transfer of the blood clot in the bone defect point into the bone specifically characterized tissue is30 impaired, because the membrane-near layer of the osteogenic material or the ..",_ blood clot is dedifferentiated in its definition by the covering membrane movement.
An object of the present invention is to provide a covering device of the aforementioned type by means of which it is possible to ensure 5 the undisturbed transfer of the osteogenic material or blood clot in the bone defect point into the granulation tissue of a bone of a specifically characterized type. Preferably by means of appropriate choice of the membrane material for the covering membrane, it is also possible to avoid membrane material left in the body following the healing of the bone defect 10 point giving rise to complications.
Accordingly the invention provides a covering device for the temporary covering of a recess in endogenic bone tissue filled with an osteogenic material, the covering device comprising:
a covering membrane consisting of resorbable membrane 15 material and capable of being disposed adjacent the recess and the endogenic bone tissue, and a stiffening layer connected to the covering membrane, wherein the resorbable membrane material is more rapidly resorbable from the side remote from the endogenic bone tissue than from 20 the side facing the endogenic bone tissue.
The stiffening layer can be integrated into the covering membrane.
In one embodiment, the stiffening layer is constructed as a stiffening element separate *om the covering membrane, and the stiffening 25 layer may be located on the covering membrane side remote from the endogenic bone tissue.
The stiffening layer can be constituted by a perforated metal plate, a metal lattice or gauze. Preferably, the stiffening layer is made from titanium.
. -In another embodiment of the invention, the stiffening layer is made from plastic. The stiffening layer can also comprise a plastic grid.
The plastics material from which the stiffening layer is made may be different from the membrane material forming the covering membrane.
According to the invention the stiffening layer advantageously has a thickness of 0.3 to 1.0 mm, and preferably of approximately 0.5 mm.
According to another embodiment of the invention, the membrane material density can increase from the side remote from the endogenic bone to the side facing the endogenic bone.
The membrane material may comprise several layers of different densities and/or compositions, or may be in the form of several woven or knitted layers of different texture.
The membrane material can at least partly comprise lyophilized dura mater, polylactide/vicryl, collagen, polylactide or oxymethyl cellulose.
The invention is also characterized by such a setting of the resorbability gradient of the membrane material decreasing from the side remote from the endogenic bone to the side facing the endogenic bone, that the membrane material layer engaging on the bone is only resorbed by the endogenic tissue when the recess of the endogenic bone closed by the 20 covering membrane has been substantially completely grown through in osseous manner and has been reintegrated into the bone.
The invention is based on the surprising finding that it is possible to ensure a completely satisfactory transfer of the osteogenic material or the blood clot enclosing it in the bone defect point into the 25 osseous-characterized tissue by preventing movement of a covering membrane by the provision of a stiffening layer. The stiffening layer ensures that the blood clot is transferred in undisturbed manner into the bone tissue.
Embodiments of the invention will now be described in greater detail hereinafter with reference to the attached drawings, in which:
B
Figure 1 shows a cross-sectional view of a bone defect point covered with a covering device according to an embodiment of the invention, at right angles to the plane of the covering device; and Figure 2 is a sectional view of the stiffening layer of the 5 covering device according to Figure 1, at right angles to the covering membrane plane and on a larger scale.
As shown in Figure 1 a bone defect point formed by a recess 12 in an endogenic bone 10 is substantially completely filled with an osteogenic material 14 constituted by hydroxyapatite granules with which are 10 admixed in known manner bone particles comprising endogenic bone tissue.
The recess 12 filled with the osteogenic material 14 is covered by a covering membrane 16, which is surmounted by a stiffening layer 17. The membrane 16 and layer 17 are tightly engaged on the endogenic bone 10 all around the recess 12 by means of fixing pins 18, 20. The function of the covering 15 membrane 16 is to ensure the osseous growing through of the osteogenic material 14 from the endogenic bone 10 in such a way that any growing through of the osteogenic material with anything other than bone tissue and in particular with mucous tissue is prevented.
As can be seen from Figure 2, the stiffening layer 17 consists 20 of a perforated titanium sheet, the thickness of which, in the illustrated embodiment is 0.5 mm. The perforated metal sheet of the stiffening layer 17 stiffens the covering membrane 16 in such a manner that, in case of movement of the tissue surrounding the endogenic bone 10, no relative motion of the covering membrane 16 takes place in relation to the osteogenic 25 material 14 and the blood clot filling the recess 12, respectively. As a result, the blood clot can be transformed into bone tissue without the risk of an undesired dedifferentiation.
This invention relates to a covering device for the temporary covering with a covering membrane of a recess in endogenic bone tissue 5 filled with osteogenic material, such as hydroxyapatite granules.
In bone surgery, e.g. in the reconstruction of bones in plastic surgery or in the case of operations on the jaw, it is standard practice to fillbone defects or deficiency points in the form of recesses or cavities in the endogenic bone tissue with an osteogenic material, which generally consists 10 of a mixture of bone replacement material, such as hydroxyapatite granules, and endogenic bone particles. To ensure that the osteogenic material substantially exclusively grows through in osseous manner from the bone side, but not in an undesired manner by the mucous tissue, the recess is closed with a covering membrane of the aforementioned type, which is intended to ensure that there is no growth through the osteogenic material with non-bone tissue. Thus, only in the case of ensuring a complete osseous growth through of the osteogenic material, is it possible to substantially completely elimin~te the bone defect point and to reintegrate into the endogenic bone the osteogenic material after osseous growth has taken place.
Hitherto, polytetrafluoroethylene films, for example, have been used as covering membranes, but they suffer from the disadvantage of remaining in the body when the bone defect point heals and can therefore give rise to future complications.
As a result of the material used for the covering membranes, such as e.g. plastic films, the membrane is not stiff and can instead change its position as a result, e.g. of radial stressing through the surrounding soft body tissue, e.g. as a result of muscular movements. Such movements of the covering membrane lead to the disadvantage that the transfer of the blood clot in the bone defect point into the bone specifically characterized tissue is30 impaired, because the membrane-near layer of the osteogenic material or the ..",_ blood clot is dedifferentiated in its definition by the covering membrane movement.
An object of the present invention is to provide a covering device of the aforementioned type by means of which it is possible to ensure 5 the undisturbed transfer of the osteogenic material or blood clot in the bone defect point into the granulation tissue of a bone of a specifically characterized type. Preferably by means of appropriate choice of the membrane material for the covering membrane, it is also possible to avoid membrane material left in the body following the healing of the bone defect 10 point giving rise to complications.
Accordingly the invention provides a covering device for the temporary covering of a recess in endogenic bone tissue filled with an osteogenic material, the covering device comprising:
a covering membrane consisting of resorbable membrane 15 material and capable of being disposed adjacent the recess and the endogenic bone tissue, and a stiffening layer connected to the covering membrane, wherein the resorbable membrane material is more rapidly resorbable from the side remote from the endogenic bone tissue than from 20 the side facing the endogenic bone tissue.
The stiffening layer can be integrated into the covering membrane.
In one embodiment, the stiffening layer is constructed as a stiffening element separate *om the covering membrane, and the stiffening 25 layer may be located on the covering membrane side remote from the endogenic bone tissue.
The stiffening layer can be constituted by a perforated metal plate, a metal lattice or gauze. Preferably, the stiffening layer is made from titanium.
. -In another embodiment of the invention, the stiffening layer is made from plastic. The stiffening layer can also comprise a plastic grid.
The plastics material from which the stiffening layer is made may be different from the membrane material forming the covering membrane.
According to the invention the stiffening layer advantageously has a thickness of 0.3 to 1.0 mm, and preferably of approximately 0.5 mm.
According to another embodiment of the invention, the membrane material density can increase from the side remote from the endogenic bone to the side facing the endogenic bone.
The membrane material may comprise several layers of different densities and/or compositions, or may be in the form of several woven or knitted layers of different texture.
The membrane material can at least partly comprise lyophilized dura mater, polylactide/vicryl, collagen, polylactide or oxymethyl cellulose.
The invention is also characterized by such a setting of the resorbability gradient of the membrane material decreasing from the side remote from the endogenic bone to the side facing the endogenic bone, that the membrane material layer engaging on the bone is only resorbed by the endogenic tissue when the recess of the endogenic bone closed by the 20 covering membrane has been substantially completely grown through in osseous manner and has been reintegrated into the bone.
The invention is based on the surprising finding that it is possible to ensure a completely satisfactory transfer of the osteogenic material or the blood clot enclosing it in the bone defect point into the 25 osseous-characterized tissue by preventing movement of a covering membrane by the provision of a stiffening layer. The stiffening layer ensures that the blood clot is transferred in undisturbed manner into the bone tissue.
Embodiments of the invention will now be described in greater detail hereinafter with reference to the attached drawings, in which:
B
Figure 1 shows a cross-sectional view of a bone defect point covered with a covering device according to an embodiment of the invention, at right angles to the plane of the covering device; and Figure 2 is a sectional view of the stiffening layer of the 5 covering device according to Figure 1, at right angles to the covering membrane plane and on a larger scale.
As shown in Figure 1 a bone defect point formed by a recess 12 in an endogenic bone 10 is substantially completely filled with an osteogenic material 14 constituted by hydroxyapatite granules with which are 10 admixed in known manner bone particles comprising endogenic bone tissue.
The recess 12 filled with the osteogenic material 14 is covered by a covering membrane 16, which is surmounted by a stiffening layer 17. The membrane 16 and layer 17 are tightly engaged on the endogenic bone 10 all around the recess 12 by means of fixing pins 18, 20. The function of the covering 15 membrane 16 is to ensure the osseous growing through of the osteogenic material 14 from the endogenic bone 10 in such a way that any growing through of the osteogenic material with anything other than bone tissue and in particular with mucous tissue is prevented.
As can be seen from Figure 2, the stiffening layer 17 consists 20 of a perforated titanium sheet, the thickness of which, in the illustrated embodiment is 0.5 mm. The perforated metal sheet of the stiffening layer 17 stiffens the covering membrane 16 in such a manner that, in case of movement of the tissue surrounding the endogenic bone 10, no relative motion of the covering membrane 16 takes place in relation to the osteogenic 25 material 14 and the blood clot filling the recess 12, respectively. As a result, the blood clot can be transformed into bone tissue without the risk of an undesired dedifferentiation.
Claims (22)
1. A covering device for the temporary covering of a recess in endogenic bone tissue filled with an osteogenic material, said covering device comprising:
a covering membrane consisting of resorbable membrane material and capable of being disposed adjacent the recess and the endogenic bone tissue, and a stiffening layer connected to the covering membrane, wherein the resorbable membrane material is more rapidly resorbable from the side remote from the endogenic bone tissue than from the side facing the endogenic bone tissue.
a covering membrane consisting of resorbable membrane material and capable of being disposed adjacent the recess and the endogenic bone tissue, and a stiffening layer connected to the covering membrane, wherein the resorbable membrane material is more rapidly resorbable from the side remote from the endogenic bone tissue than from the side facing the endogenic bone tissue.
2. A covering device according to claim 1, wherein the osteogenic material is hydroxyapatite granules.
3. A covering device according to claim 1 or 2, wherein the stiffening layer is integrated into the covering membrane.
4. A covering device according to claim 1 or 2, wherein the stiffening layer is constructed as a stiffening element separate from the covering membrane.
5. A covering device according to claim 1, 2, 3 or 4, wherein the stiffening layer is disposed on the side of the covering membrane remote from the endogenic bone tissue.
6. A covering device according to any one of claims 1 to 5, wherein the stiffening layer is formed by a perforated metal plate.
7. A covering device according to any one of claims 1 to 5, wherein the stiffening layer is constituted by a metal lattice or gauze.
8. A covering device according to claim 5 or 6, wherein the stiffening layer is made from titanium.
9. A covering device according to any one of claims 1 to 5, wherein the stiffening layer is made from plastic.
10. A covering device according to claim 9, wherein the stiffening layer comprises a plastic grid.
11. A covering device according to claim 9 or 10, wherein the plastic material from which the stiffening layer is formed is different from the membrane material forming the covering membrane.
12. A covering device according to any one of claims 1 to 11, wherein the stiffening layer has a thickness of from 0.3 to 1.0 mm.
13. A covering device according to claim 12, wherein the stiffening layer has a thickness of approximately 0.5 mm.
14. A covering device according to any one of claims 1 to 13, wherein the density of the membrane material increases from the side remote from the endogenic bone to the side facing the endogenic bone.
15. A covering device according to any one of claims 1 to 14, wherein the membrane material comprises several layers having different densities and/or compositions.
16. A covering device according to claim 15, wherein the membrane material has several woven or knitted layers of different texture.
17. A covering device according to any one of claims 1 to 16, wherein the membrane material at least partly comprises lyophilized dura mater.
18. A covering device according to any one of claims 1 to 16, wherein the membrane material at least partly comprises polylactide/vicryl.
19. A covering device according to any one of claims 1 to 16, wherein the membrane material at least partly comprises collagen.
20. A covering device according to any one of claims 1 to 16, wherein the membrane material at least partly comprises polylactide.
21. A covering device according to any one of claims 1 to 16, wherein the membrane material at least partly comprises oxymethyl cellulose.
22. A covering device according to any one of claims 1 to 21, wherein the resorbability gradient of the membrane material decreases from the side remote from the endogenic bone to the side facing the endogenic bone such that the layer of membrane material engaging on the bone is only resorbed by the endogenic tissue when the recess of the endogenic bone closed by the covering membrane has been substantially completely grown through in osseous manner and has been reintegrated into the bone.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DEP4302709.1-35 | 1993-02-01 | ||
DE4302709A DE4302709C1 (en) | 1993-02-01 | 1993-02-01 | Cover device with cover membrane |
Publications (2)
Publication Number | Publication Date |
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CA2114462A1 CA2114462A1 (en) | 1994-08-02 |
CA2114462C true CA2114462C (en) | 1999-03-02 |
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ID=6479340
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Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA002114462A Expired - Fee Related CA2114462C (en) | 1993-02-01 | 1994-01-28 | Covering device with covering membrane |
Country Status (9)
Country | Link |
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US (1) | US5591234A (en) |
EP (1) | EP0609738B1 (en) |
JP (1) | JP2804883B2 (en) |
AT (1) | ATE166562T1 (en) |
BR (1) | BR9400256A (en) |
CA (1) | CA2114462C (en) |
DE (2) | DE4302709C1 (en) |
DK (1) | DK0609738T3 (en) |
ES (1) | ES2117724T3 (en) |
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- 1993-02-01 DE DE4302709A patent/DE4302709C1/en not_active Expired - Fee Related
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1994
- 1994-01-24 AT AT94100944T patent/ATE166562T1/en not_active IP Right Cessation
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- 1994-01-24 ES ES94100944T patent/ES2117724T3/en not_active Expired - Lifetime
- 1994-01-28 CA CA002114462A patent/CA2114462C/en not_active Expired - Fee Related
- 1994-02-01 BR BR9400256A patent/BR9400256A/en not_active IP Right Cessation
- 1994-02-01 JP JP6010317A patent/JP2804883B2/en not_active Expired - Fee Related
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1995
- 1995-09-19 US US08/530,009 patent/US5591234A/en not_active Expired - Fee Related
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DK0609738T3 (en) | 1999-02-15 |
BR9400256A (en) | 1994-08-23 |
DE59406060D1 (en) | 1998-07-02 |
JPH0788172A (en) | 1995-04-04 |
ES2117724T3 (en) | 1998-08-16 |
CA2114462A1 (en) | 1994-08-02 |
EP0609738A1 (en) | 1994-08-10 |
JP2804883B2 (en) | 1998-09-30 |
EP0609738B1 (en) | 1998-05-27 |
ATE166562T1 (en) | 1998-06-15 |
US5591234A (en) | 1997-01-07 |
DE4302709C1 (en) | 1994-07-28 |
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