EP2648647A1 - Membrane de distraction améliorée - Google Patents

Membrane de distraction améliorée

Info

Publication number
EP2648647A1
EP2648647A1 EP11794049.4A EP11794049A EP2648647A1 EP 2648647 A1 EP2648647 A1 EP 2648647A1 EP 11794049 A EP11794049 A EP 11794049A EP 2648647 A1 EP2648647 A1 EP 2648647A1
Authority
EP
European Patent Office
Prior art keywords
membrane
bone
distraction
contact surface
edges
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.)
Withdrawn
Application number
EP11794049.4A
Other languages
German (de)
English (en)
Inventor
Domonkos Horvath
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Celgen AG
Original Assignee
Celgen AG
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 Celgen AG filed Critical Celgen AG
Publication of EP2648647A1 publication Critical patent/EP2648647A1/fr
Withdrawn legal-status Critical Current

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
    • 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
    • A61B17/60—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 for external osteosynthesis, e.g. distractors, contractors
    • A61B17/66—Alignment, compression or distraction mechanisms
    • A61B17/663—Alignment, compression or distraction mechanisms for jaw bones, e.g. subcutaneous distractors with external access
    • A61B17/666—Alignment, compression or distraction mechanisms for jaw bones, e.g. subcutaneous distractors with external access for alveolar distraction
    • 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
    • A61B17/8061—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates specially adapted for particular bones
    • A61B17/8071—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates specially adapted for particular bones for the jaw
    • 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
    • A—HUMAN NECESSITIES
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    • 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
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    • 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
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    • 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
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    • 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
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    • 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
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    • 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
    • A61F2002/30108—Shapes
    • A61F2002/3011—Cross-sections or two-dimensional shapes
    • A61F2002/30112—Rounded shapes, e.g. with rounded corners
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    • 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
    • A61F2002/30108—Shapes
    • A61F2002/30199—Three-dimensional shapes
    • A61F2002/30224—Three-dimensional shapes cylindrical
    • A61F2002/30235—Three-dimensional shapes cylindrical tubular, e.g. sleeves
    • A61F2002/30237—Three-dimensional shapes cylindrical tubular, e.g. sleeves partial tubes
    • 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
    • A61F2002/30108—Shapes
    • A61F2002/30199—Three-dimensional shapes
    • A61F2002/30242—Three-dimensional shapes spherical
    • 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
    • A61F2002/30108—Shapes
    • A61F2002/30199—Three-dimensional shapes
    • A61F2002/30242—Three-dimensional shapes spherical
    • A61F2002/30245—Partial spheres
    • 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
    • A61F2002/30316—The 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
    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30476—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements locked by an additional locking mechanism
    • A61F2002/30507—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements locked by an additional locking mechanism using a threaded locking member, e.g. a locking screw or a set screw
    • 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
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    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30518—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements with possibility of relative movement between the prosthetic parts
    • A61F2002/30523—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements with possibility of relative movement between the prosthetic parts by means of meshing gear teeth
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    • 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
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    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30593—Special structural features of bone or joint prostheses not otherwise provided for hollow
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    • 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
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    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00011—Metals or alloys
    • A61F2310/00023—Titanium or titanium-based alloys, e.g. Ti-Ni alloys

Definitions

  • the present invention relates to a membrane for the regeneration of a bone, in particular a distraction membrane, suitable for callus distraction, in particular in the jaw region, the use of the membrane for callus distraction and method for callus distraction.
  • Bone losses are today usually filled with bone substitute materials or with auto- or allogenic bone. From a biological point of view, the best substitute for a bone is an autologous cancellous graft. However, such grafts are available only limited and show a high absorption rate after transplantation.
  • a bone substitute missing bone substance can also be partially filled by bone regeneration. Segmental interruptions of bony continuity on long bones can thus be treated by distraction osteogenesis.
  • Callus distraction has been known for over a hundred years.
  • the most important biological stimulus for bone formation is the mechanical stress. This releases piezoelectric forces that activate osteoblasts and osteoclasts.
  • Distraction osteogenesis induces new bone formation by inducing biological growth stimuli through slow separation of bone segments.
  • the defined tension in the bone generation is essential. If such a defined tensile stress is applied to bone fragments, the mesenchymal tissue in the gap and at the adjacent fragment ends exhibits an osteogenic potential.
  • vascular potency When there is sufficient vascular potency, progressive distraction results in metaplasia of the organized hematoma, also called blood coagulum, in a zone of longitudinally-arranged, fibrous tissue that can transform directly into cortical bone under optimal external and internal conditions. To make matters worse, however, that the bone tissue undergoes highly complex control during its regeneration.
  • WO 01/91663 A1 and US 5,980,252 describe devices and methods for callus distraction by means of artificial interfaces, for example membranes.
  • the membranes used there are flat plates or plates, which usually consist of a metal, such as titanium. As these plates or platelets move to distract the bone, they rub against the adjacent tissue with their edges and the side surfaces which form the height of the membrane. This results in irritation and further injury to the adjacent tissue, which can worsen healing.
  • these flat plates only smaller areas of a non-planar, ie flat bone portion, such as a jaw can be distracted, otherwise the membrane is not evenly applied to the bone.
  • the technical problem underlying the present invention is to provide a membrane which makes it possible to carry out bone regeneration methods which overcome the disadvantages of the prior art.
  • the technical problem underlying the present invention is also the provision of membranes, uses thereof, and methods which enable bone to be regenerated, in particular by distraction, whereby the tissue applied to the membrane is less or not irritated or injured than by membranes from the prior art.
  • the technical problem underlying the present invention is also the provision of membranes, uses thereof and methods which make it possible to regenerate nonplanar bone sections, for example a ridge of alveoli.
  • the present invention solves the underlying technical problem in particular by providing membranes, in particular distraction membranes, methods and uses according to the claims.
  • the present invention solves the technical problem on which it is based in particular by providing a membrane, also called a distraction membrane, which is suitable for callus distraction, in particular in the area of the jaw, wherein the membrane forms a contact surface and having a counter surface and wherein at least a portion of the contact surface and the counter surface is curved.
  • the membrane is thus arched over at least a portion of the length or the width of the membrane.
  • the present invention also solves the technical problem underlying it by providing a membrane, also called a distraction membrane, which is suitable for callus distraction, in particular in the jaw region, the membrane having a contact surface, a mating surface and at least one side surface, and wherein the Edges between the contact surface and the at least one side surface and / or the counter surface and the at least one side surfaces are rounded.
  • a membrane also called a distraction membrane, which is suitable for callus distraction, in particular in the jaw region
  • the membrane having a contact surface, a mating surface and at least one side surface, and wherein the Edges between the contact surface and the at least one side surface and / or the counter surface and the at least one side surfaces are rounded.
  • the present invention also solves the underlying technical problem by providing a distraction membrane suitable for bone distraction in the jaw region, the distraction membrane having a contact surface for attaching or adhering osteoblasts in the region of a bone defect, a counter surface opposite the contact surface and at least one side surface and wherein at least a portion of the contact surface and the counter surface is curved, wherein all edges between the contact surface and the at least one side surface and the counter surface and the at least one side surface are rounded.
  • the present invention also solves the technical problem underlying it by providing a distraction membrane suitable for bone distraction in the jaw region, the distraction membrane having a contact surface for attaching or adhering osteoblasts in the region of a bone defect the contact surface opposite mating surface and at least one side surface and wherein at least a portion of the contact surface and the mating surface is curved, wherein the distraction onsmembran has rounded edges, all edges between see the contact surface and the at least one side surface and the mating surface and the at least one side surface are rounded.
  • a preferred embodiment is a membrane, also called Dis Dimensioni- onsmembran, which is suitable for callus distraction, especially in the jaw region, wherein the membrane is curved according to the invention and wherein the membrane has a contact surface, a counter surface and at least one side surface and wherein the edges between the Contact surface and the at least one side surface and / or the counter surface and the at least one side surfaces are rounded.
  • the present invention also solves the technical problem underlying it by providing a membrane, also called a distraction membrane, which is suitable for callus distraction, in particular in the jaw region, the membrane having a contact surface, a mating surface and at least one side surface, and wherein the at least one side surface is bent over, in particular is bent over to the contact surface.
  • a membrane also called a distraction membrane, which is suitable for callus distraction, in particular in the jaw region, the membrane having a contact surface, a mating surface and at least one side surface, and wherein the at least one side surface is bent over, in particular is bent over to the contact surface.
  • a preferred embodiment is a membrane, also called Dis Dimensioni- onsmembran, which is suitable for callus distraction, especially in the jaw region, wherein the membrane is curved according to the invention and wherein the membrane has a contact surface, a counter surface and at least one side surface and wherein the at least one side surface is bent over, in particular is bent over to the contact surface.
  • a membrane is understood to be a medical membrane which is suitable for distracting a bone, preferably a jawbone, in particular in the tooth region.
  • a membrane is also called a distraction membrane.
  • the present teaching covers membranes, distraction devices and methods for bone regeneration, wherein preferably bones in the jaw area and / or in the periodontal area are to be regenerated.
  • the present invention understands the term "bone regeneration” as the regeneration of bone defects, for example, after cystectomy, tumor surgery or trauma surgery, etc., regardless of the topography, and / or in particular also the regeneration of minor bone defects that arise, for example, by periodontitis.
  • a membrane is understood to mean a plate-shaped, ie planar or planar, body in the non-arched state.
  • the membrane has a contact surface, which serves for attachment or adhesion of osteoblasts in the region of a bone defect, and a counter surface opposite the contact surface.
  • These two surfaces may have any shape, for example, round, oval, square or polygonal.
  • the contact surface and the opposite surface of the membrane in the non-curved state are rectangular. In the non-curved state, the size of these two surfaces results in a rectangular Membrane of the length and the width of the membrane.
  • the membrane also has at least one side surface, in particular four side surfaces, if it is a rectangular membrane.
  • the size of two of the side surfaces is the height and the length of a rectangular membrane, the size of the other two side surfaces of the height and the width of the membrane.
  • the membrane according to the invention is as thin as possible, that is, the size of the side surfaces is many times smaller than the size of the contact surface and in a quadrangular membrane, the height of the membrane is many times smaller than the length and the width of the membrane.
  • a membrane is preferably a disctraction membrane.
  • a distraction membrane suitable for bone distraction in the jaw region is preferred, the membrane having a contact surface and a mating surface and at least a partial region of the contact surface and the mating surface being arched, and the membrane having rounded edges.
  • a membrane having a contact surface, a counter surface and at least one side surface, wherein at least a portion of the contact surface and the counter surface is curved and wherein the edges between the contact surface and the at least one side surface and / or the counter surface and the at least a side surfaces are rounded.
  • the entire contact surface and the entire mating surface of the membrane are curved.
  • a curvature is understood to mean a curvature of surfaces, here the contact surface and the counter surface.
  • the membrane is simply arched; in the case of a rectangular membrane, two opposing side surfaces are then curved and the other two side surfaces are not curved.
  • the membrane is configured as a shell, that is, a membrane that is curved or arched single or double.
  • the membrane is curved so that it has the shape of a portion of a spherical shell, for example, a hemispherical shell.
  • the membrane is arched in such a way that it has the shape of a cylindrical shell.
  • the curvature has a radius which corresponds to the radius of a bone to be treated, for example a long bone or a skull bone.
  • the curvature has a radius which corresponds to the radius of a comb of a pigtail bone to be treated.
  • the curvature has a radius of at least 5 mm. In a preferred embodiment, the curvature has a radius of at most 15 mm. In a preferred embodiment, the curvature has a radius of at least 5 mm and at most 15 mm. In an alternative embodiment of the invention can be provided that the edges formed by two side surfaces are rounded.
  • the membrane has rounded edges.
  • a membrane having a rectangular contact surface, a counter surface and four rectangular side surfaces, wherein the contact surface and the counter surface are curved and wherein all edges of the membrane are rounded.
  • the membrane is shaped and dimensioned such that it covers at least a part of the surface of a jawbone facing the denture. It can therefore be provided a flat or curved membrane, which is bent in the plan, ie flat state in approximately horseshoe-shaped, and which has a length so that the membrane can cover at least a portion of a ridge. In particular, it can be provided that the membrane can cover a large part, for example up to 80% of a ridge or an entire alveolar crest.
  • a person skilled in the art for example a dental technician, can easily determine the size and shape of a membrane that is necessary to cover a desired region of the alveolar ridge. With membranes formed in this way, it is advantageously possible to treat broader bone defects, for example bone defects extending over several missing teeth, and even the entire alveolar ridge.
  • the membranes can be made up in shape and size or individually adapted to the bone defect to be treated.
  • the membrane has at least one further curvature, in particular a plurality of further curvatures with a smaller radius.
  • the membrane has bent edges. In a preferred embodiment, the membrane has at least two bent side surfaces.
  • the membrane has at least one perforation.
  • the membrane contains titanium. In a preferred embodiment, the membrane is made of titanium. In another embodiment, the membrane may also consist of or contain a biodegradable material.
  • the membrane is sandblasted. In a preferred embodiment, the contact surface of the membrane is sandblasted.
  • the contact surface of the membrane is coated.
  • the edges of the membrane are covered with a nonwoven fabric or a film.
  • the edges of the membrane are covered in addition to the rounding with a nonwoven fabric or a film.
  • the edges of the membrane are all edges between the contact surface and the at least a side surface and the mating surface and the at least one side surface rounded and additionally covered with a nonwoven fabric or a film.
  • edges of the membrane are all edges between the contact surface and the at least one side surface and the counter surface and the at least one side surface rounded and not covered with a nonwoven fabric or a film.
  • edges of the membrane are all edges between the contact surface and the at least one side surface and the counter surface and the at least one side surface rounded and not covered with beads or edge joints.
  • the membrane of the invention may be intended for repeated or single use.
  • the membrane is intended for single use, as this is common practice in medical membranes and the adhesiveness of the surface of the membrane decreases due to contact with body fluid.
  • the membrane according to the invention may be intended for single use only if it has been manufactured individually for a particular bone defect and / or if it has biodegradable constituents which decompose on use of the membrane.
  • the membrane according to the invention has at least one fastening element.
  • the fastening element is located on the mating surface of the membrane.
  • the at least one fixing element serves to attach the membrane to at least one actuator element.
  • a fastener may be, for example, a perforation, an eyelet or a point of attachment.
  • the at least one fastening element is a perforation, in particular a perforation for inserting a screw.
  • When serving as a fastener perforation may be a round hole, a slot or an angled hole.
  • the membrane may also have several differently shaped perforations.
  • the fastening element serves to fasten a rack.
  • the fastening element may be, for example, a perforation or an attachment point, for example a welding or soldering point.
  • the present invention also relates to a membrane according to the invention, wherein the membrane is attached to at least one actuator element.
  • the actuator element is a screw, a cord or a rack.
  • the actuator element is a screw or a rack.
  • the actuator element is a rack.
  • the membrane is attached to a plurality of actuator elements, in particular screws.
  • the membrane according to the invention is a membrane for bone regeneration.
  • the membrane according to the invention is a membrane for periodontal regeneration.
  • Parodontal regeneration is understood to mean a regeneration of the periodontium, ie not only of the bone but also of the periodontal ligament, the periodontal skin, the gingiva and the papillae, for example by guided tissue regeneration (GTR).
  • GTR guided tissue regeneration
  • the membrane for periodontal regeneration is so small dimensioned that it can also be used in interdental spaces.
  • the membrane for periodontal regeneration is very thin.
  • the periodontal regeneration membrane is shaped to have at least one lobe or segment that can be inserted into a tooth space.
  • the membrane for periodontal regeneration is a one-part, two-part or multi-part membrane.
  • the periodontal regeneration membrane has at least one fastening element for fastening a bone screw, for example at least one perforation.
  • the present invention also relates to a membrane according to the invention for use in callus distraction, in particular for the development of a jawbone by distraction.
  • the present invention also relates to a membrane of the invention for use in periodontal regeneration by distraction.
  • the present invention also relates to the use of a diaphragm according to the invention for callus distraction, in particular for the construction of a jaw bone by distraction.
  • the present invention also relates to the use of a membrane according to the invention for periodontal regeneration by distraction.
  • the present invention also relates to a distraction device comprising a membrane according to the invention, a fixing device and an actuator element connecting the fixing device to the membrane.
  • the present invention also relates to a kit containing at least two of the membranes according to the invention.
  • the present invention also relates to a kit comprising a membrane according to the invention, a fixing device and an actuator element for connecting the fixing device to the membrane.
  • the kit contains an instruction manual.
  • the present invention also relates to a kit comprising at least two of the inventive disctraction membranes, in particular for producing a device according to the invention.
  • the present invention also relates to a kit comprising at least one distraction membrane according to the invention, a fixing device and an actuator element for connecting the fixing device to the membrane, in particular for producing a device according to the invention.
  • the kit contains an instruction manual.
  • the present invention also relates to methods for callus distraction, in particular for the construction of a jaw bone by distraction, wherein a membrane according to the invention is applied to a bone segment to be regenerated and a tension is exerted on this membrane via a distraction device.
  • Methods in which the membrane according to the invention can be used are known, for example, from WO 01/91663 A1 or US Pat. No. 5,980,252, the contents of which explain the possible uses of the membranes according to the invention using membranes from the prior art and are incorporated into this application. will conclude. Without being bound by theory, such a distraction process at the beginning of the process, in particular a distance of about 1, 5 mm between the membrane and bone advantageous.
  • FIG. 1 a shows a membrane from the prior art
  • FIG. 1b shows a membrane according to the invention with a rectangular contact surface
  • FIG. 1d shows a membrane according to the invention with a circular contact surface
  • Figure 2b shows a curved membrane with rounded edges
  • Figure 2c shows a membrane with bent edge regions
  • Figure 2d a curved membrane with bent edge portions and rounded edges
  • FIG. 3 shows a curved membrane with perforations
  • FIG. 4a shows a membrane with an eyelet as a fastener
  • FIG. 4b Membrane with a hole as fastening element
  • FIG. 5 shows a horseshoe-shaped membrane for treating large-area jaw defects
  • FIG. 6a shows a membrane with further curvatures for interdental papillae
  • FIG. 6b shows an alternative embodiment of the membrane with further bulges for interdental papillae
  • FIG. 7 shows a membrane whose contact surface is coated
  • FIG. 8 shows a distraction device comprising a membrane, a fixing device and an actuator element connecting the fixing device to the membrane in the form of a toothed rack;
  • FIG. 9b shows a membrane for periodontal regeneration with two
  • FIG. 1a shows a prior art distraction membrane 101.
  • the distraction membrane 101 has a contact surface 1 and a counter-surface 2, which are not visible here. Of the four side surfaces, the surfaces 3a and 4a can be seen, which adjoin one another.
  • Such a membrane can be used as described in WO 01/91663 A1 and US Pat. No. 5,980,252, wherein the contact surface 1 facing a bone and the membrane is removed, for example, via a distraction device at a certain speed, for example 0.5 mm to 2 mm per day, in particular about 1 mm per day from the bone, for example, is pulled away.
  • FIG 1 b shows a membrane according to the invention, which is curved.
  • the membrane 100 has a contact surface 1 and a mating surface 2. Furthermore, the membrane has four side surfaces 3a, 3b, 4a and 4b, of which only the two adjoining side surfaces 3a and 4a can be seen.
  • the membrane is simply curved. According to the invention it is provided that the contact surface 1 is concavely curved and the counter surface 2 is convexly curved. In the case of a simple curvature of the illustrated membrane 100 with rectangular surfaces, two opposite side surfaces 3a and 3b are curved and the other two opposite side surfaces 4a and 4b are not curved.
  • the curved geometry of the membrane leads advantageously to increased stability of the membrane against bending. This allows distraction membranes with a very low height, ie thickness, of the membrane. This is advantageous in the use of such a membrane for callus distraction in the jaw area, since the membrane is placed under the mucosa and membranes with a high altitude thereby lead to tensions of the mucous membrane lobes, which can result in ischemia associated with tissue necrosis. Also, this may result in membrane exposure, which requires the germinated membrane to be removed.
  • the curved geometry of a membrane according to the invention allows Now, the use of stable membranes with a low height so that tensions of the mucous membrane could be avoided.
  • the membrane has a height of at most 1 mm, in particular of at most 0.5 mm.
  • the membrane 100 has a length of at least 5 mm to at most 120 mm and a width of at least 5 mm and at most 120 mm.
  • the membrane may for example have a length of about 20 mm and a width of about 10 mm. Length and width specifications refer to the membrane in the non-arched state.
  • the membrane may have approximately the width of a ridge and length of a portion of the alveolar ridge or the whole alveolar ridge.
  • the membrane is made of a biocompatible material.
  • the membrane is made of a metal, in particular titanium.
  • Membranes made of metals such as titanium have the advantage that they are very stable despite their low height.
  • the membrane may also consist of a biocompatible plastic.
  • the plastic is preferably a bioabsorbable plastic. These have the advantage that they do not have to be removed after distraction.
  • FIG. 1c shows the arched membrane 100 according to the invention in a side view. It can be seen the curved side surface 3a, with the edge 11 abuts against the concave contact surface 1 and with the curved edge 12 against the convex mating surface 2. With the edges 14a and 14b, the side surface 3a is adjacent to the side surfaces 4a and 4b.
  • the membrane 100 is uniformly curved over the entire contact surface 1. However, it can also be provided that only portions of the contact surface 1 are curved, for example, only the middle third of the edge 11 is curved.
  • the radius R of the curvature can also be different in different areas of the contact surface.
  • the radius R, the curvature of the contact surface 1 of the natural bone shape, such as "jaw shape is adapted.
  • the radius R of curvature of the contact surface is preferably at least 5 mm and at most 15 mm, more preferably at least 5 mm and at most 12 mm, in particular at least
  • the radius R of the curvature of the contact surface 1 is preferably at least 5 mm, particularly preferably at least 6 mm,
  • the radius R of the curvature of the contact surface 1 is at most 15 mm, particularly preferably 12 mm, in particular at most 10
  • the radius R of the curvature of the contact surface 1 is approximately 6 to 7 mm.
  • a domed membrane according to the invention not only has the advantage of increased stability at low altitude, but such a membrane is advantageously shaped so that the arching is consistent with the anatomical and physiological conditions of the bone to be regenerated. As a result, regeneration of the bone over the entire contact surface of the membrane is possible, since in the distraction at each Place at about the same distance from the regenerating bone.
  • the membrane may also have rounded edges.
  • FIG. 1 d shows a curved membrane 100 according to the invention in which the contact surface 1 and the mating surface 2 are not rectangular but circular. Thus, such a membrane has only one side surface 3.
  • the membrane may also have rounded edges.
  • FIG. 2 a shows a planar membrane 100 according to the invention with rounded edges.
  • Preferred is a membrane in which all edges are rounded.
  • the side surfaces 3a, 4a are very narrow due to the small height of the membrane, it can also be provided that the edges between the contact surface 1 of the membrane 100 and the at least one side surface 3a, 4a of the membrane 100 and between the opposing surface 2 of the membrane 100th and the at least one side surface 3a, 4a of the membrane 100 are rounded so that the two roundings merge into one another.
  • the at least one side surface 3a, 4a is round.
  • the edges 14a, 14b between the individual side surfaces 3a, 4a are rounded.
  • the corners of the membrane are rounded.
  • the rounding of the edges of a membrane leads advantageously to the fact that the edges during movement of the membrane during distraction can not injure the surrounding tissue, for example by cutting or crushing of the tissue or fine vessels and capillaries. Due to the rounded edges and / or corners, a membrane according to the invention can advantageously slide past the adjacent tissue without damaging it. The rounded edges advantageously facilitate the adaptation of the mucosa over the membrane.
  • FIG. 2b shows a curved membrane 100 with rounded edges 4a, 4b.
  • inventive curvature and inventive rounding of the edges leads advantageously to a membrane that protects the adjacent tissue particularly well in the distraction, as it does not compress the fine vessels and capillaries of the adjacent tissue at the membrane edges, which for the tissue nutrition of the the membrane covering mucosa are very important. This prevents premature exposure to the membrane.
  • the rounded edges and the curvature of the membrane prevent the distraction of the membrane advantageously also a sudden increase in pressure in the surrounding, especially smaller vessels. The prevention of such a sudden pressure increase is advantageous for wound healing.
  • the edges are additionally covered with a tiling or a film.
  • the tile or film may be bioresorbable or not be bioabsorbable.
  • FIG. 2 c shows a planar membrane 100 with rounded edges 14 a, 14 b, the side surfaces 4 a, 4 b being bent over at the same time as the contact surface 1.
  • the membrane is thus bent in at least two outer regions 23a, 23b of the contact surface 1 and the mating surface 2, in particular bent over to the contact surface 1.
  • a bending of the at least one side surface 4a, 4b of the membrane protects the adjacent tissue when using the membrane, since the tissue rests against the bend, so not on a sharp edge.
  • the edges need not necessarily be rounded. Since the membrane 100 is usually moved in the direction of the mating surface 2 during use, the side surfaces 4a, 4b are preferably bent in the direction of the contact surface 1.
  • the side surfaces are very strongly bent, in particular so strongly bent that the edges do not come into contact with the tissue.
  • the side surfaces may be rolled up, in particular be rolled up with a very small radius.
  • the edges may be bent at an angle of up to 90 degrees with respect to the adjacent membrane surface.
  • the bent side surfaces can also be combined with rounded edges.
  • Figure 2d shows a curved membrane 100 with rounded edges 14a, 14b, wherein the side surfaces 4a, 4b are bent simultaneously to the contact surface 1 out.
  • the bends 23a, 23b of the edges 4a, 4b can be seen here as reinforced bulges of the base curvature of the membrane 100.
  • the bends have a smaller radius than the radius R of the base curvature of the membrane.
  • Figure 3 shows an embodiment of a domed membrane 100, wherein the membrane 100 is perforated, so that the contact surface 1 and the mating surface 2 by at least one hole 15, in particular by a plurality of holes, which may be distributed in particular over the entire area with each other are connected.
  • the perforation holes have a diameter of at least about 0.3 mm and at most about 1.3 mm.
  • Perforation holes in particular perforation holes with a diameter of about 1 mm, allow the penetration of capillaries through the membrane, so that in the area of the newly formed bone a very good blood circulation and immune defense is ensured.
  • the perforations allow a good circulation of the membrane covering mucosa and the regenerate between the membrane and the bone.
  • the number of perforation holes preferably depends on the size of the membrane. For example, a membrane having a length of about 20 mm and a width of about 10 mm may have about 10 to 20 perforation holes. Such a ratio of number of perforation holes to the membrane surface provides an optimum between the total hole area, which promotes blood circulation and the adhesion surface for osteoblasts adhering to the membrane during the distraction process.
  • FIG. 4 a shows a curved membrane 100 according to the invention with an eyelet 16 as a fastening element.
  • the eyelet 16 is located on the opposite side 2 of the membrane 100.
  • a distraction device can be attached for example via a cable.
  • the callus distraction membrane 100 can be used in the defect area of a bone by pulling it away from a bone defect at an adapted rate of about 1 mm per day.
  • FIG. 4b shows a curved membrane 100 according to the invention with a hole 17 as a fastening element.
  • a rack of a distraction device can be inserted and attached to the membrane 100, for example by welding, in particular laser welding, soldering or gluing.
  • FIG. 5 shows a preferred horseshoe-shaped embodiment of the membrane 100 for treating large-area jawbone defects.
  • FIG. 6 a shows an alternative embodiment of the membrane 100 according to the invention with the contact surface 1 and the mating surface 2, in which further bulges 18 are provided for the interdental papillae. These further bulges 18 are adapted to the course of the jawbone which forms the interdental papillae.
  • the jawbone is increased in a range of about 2 mm, whereby the periodontium is higher there than in the area of the teeth.
  • the further bulges may be provided.
  • they preferably have a radius of 0.5 mm to 1.5 mm, in particular approximately 1 mm, and are offset by an angle of approximately 90 degrees relative to the first curvature according to the invention.
  • they lie along the long sides of the membrane that run parallel to the alveolar ridge.
  • FIG. 6b shows an alternative embodiment of the membrane 100 according to FIG. 6a.
  • the membrane surfaces 1, 2 between the other bulges 18 further pulled down, so that the alveolar ridge can also be covered on the side of the membrane.
  • FIG. 7 shows an alternative embodiment of the membrane 100, in which the contact surface 1 of the membrane 100 is coated with a coating 19.
  • the contact surface 1 of the membrane 100 is coated with hydroxyapatite.
  • the contact surface 1 of the membrane 100 is coated with a bone substitute material, in particular a natural or artificial bone substitute material.
  • the bone substitute material is preferably a natural bone substitute material, for example from the mineral portion of bone, in particular autogenous, allogenic or xenogeneic bone, for example animal bones, in particular bovine bone.
  • Suitable bone replacement material is, for example, Bio- Oss® from Geistlich.
  • the contact surface of the membrane is coated with a bone substitute material and a biodegradable adhesive, in particular fibrin glue.
  • the bone substitute material is connected via the fibrin glue with the contact surface of the membrane.
  • FIG. 8 shows a distraction device 200 comprising an arched membrane 100 with perforations 15, a fixing device 120 and an actuator element in the form of a rack 130 connecting the fixing device 120 to the membrane 100.
  • the distraction membrane 100 is fastened to one end of the rack 130.
  • the rack 130 is curved, but may also be straight.
  • the fixing device 120 comprises a gear, in particular a self-locking gear, for moving the rack, wherein the gear is fixed in the area of the bone to be regenerated, in particular in the mouth, can be arranged.
  • the transmission comprises a housing 121 with a passage and a threaded body 122, wherein the rack 130 is inserted in the longitudinal extent through the passage at least substantially clearance through the housing 121, and wherein the threaded body 122 is rotatably supported in the housing 121 such that the Thread body 122 and the rack 130 are in operative engagement.
  • the gear 120 can be arranged in a stationary manner in the region of a bone to be regenerated, in particular in the oral cavity, via further elements of the fixing device 120, for example brackets or bridges.
  • Distraction devices for bone regeneration comprising a distraction membrane and a distraction membrane actuated actuator element, wherein the actuator element is designed as a rack, are disclosed in a patent application of the same inventor having the same filing date as the present invention. The embodiments disclosed therein are also disclosed as disclosed for the inventive membrane.
  • Figures 9a and 9b show preferred embodiments of a domed membrane 100 for periodontal regeneration.
  • the membrane NEN 100 are very thin and have rounded edges 3a, 4a.
  • the membranes have segments with the surfaces 1 b and 2 b, which can be inserted into interdental spaces.
  • the membrane in Figure 9a has such a segment
  • the membrane in Figure 9b has two such segments.
  • the membrane can be used both vestibularly and lingually or simultaneously from both sides.
  • such a membrane is used together with bone screws.
  • the preferred embodiments shown in Figures 1 to 9 can be combined with each other as desired.
  • FIG. 10 shows a distraction device 200 with a curved membrane 100 according to the invention.
  • the membrane is connected to a gear 120 via a rack 130.
  • the transmission 120 is laminated into a bridge 125 which is attached to two teeth 160, 161.
  • Between the teeth 160, 161 is a gap with a bone defect 162 of the arched jaw bone 163.
  • the membrane 100 rests with its contact surface 1 in the bone defect on the jawbone. Since the membrane 100 has approximately the curvature of the jaw bone 163, the contact surface 1 is uniform. Without being bound by theory, in particular a distance of about 1.5 mm between membrane 100 and bone 163 is advantageous.
  • a Koagel 164 has formed, in which there are also osteoblasts.
  • the threaded body 122 in Turned housing 121 of the transmission 120 with a screwdriver or the like, the rack moves 130 and with her the membrane 100 upwards.
  • the threaded body 122 can be rotated so that the membrane 100 moves away from the jawbone 163 at a rate of about 1 mm / day.
  • the threaded body 122 may be rotated once a day by a certain rotation or twice a day by half of that rotation.
  • the clot 164 and the bone callus forming therein are sufficiently perfused by the tissue 165 lying above the membrane 100. Due to the curvature of the membrane 100, the bone defect 162 of the jaw bone 163 is filled up by new bone substance such that the filled-in bone defect has the convexly shaped curvature of the jaw bone 163.

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Abstract

La présente invention concerne une membrane bombée et/ou une membrane présentant des arêtes arrondies, servant à la régénération d'un os, en particulier une membrane de distraction, appropriée pour la distraction du cal, notamment dans la région maxillaire. L'invention concerne également l'utilisation de cette membrane pour la distraction du cal et des procédés pour la distraction du cal.
EP11794049.4A 2010-12-10 2011-12-07 Membrane de distraction améliorée Withdrawn EP2648647A1 (fr)

Applications Claiming Priority (2)

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DE102010055432A DE102010055432A1 (de) 2010-12-10 2010-12-10 Verbesserte Distraktionsmembran
PCT/EP2011/006134 WO2012076161A1 (fr) 2010-12-10 2011-12-07 Membrane de distraction améliorée

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WO (1) WO2012076161A1 (fr)

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DE102010055432A1 (de) 2012-06-14
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US9358043B2 (en) 2016-06-07
JP2014503261A (ja) 2014-02-13

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