EP3099268A1 - Implant distracteur à filet tranchant vers l'avant et vers l'arrière - Google Patents

Implant distracteur à filet tranchant vers l'avant et vers l'arrière

Info

Publication number
EP3099268A1
EP3099268A1 EP15703533.8A EP15703533A EP3099268A1 EP 3099268 A1 EP3099268 A1 EP 3099268A1 EP 15703533 A EP15703533 A EP 15703533A EP 3099268 A1 EP3099268 A1 EP 3099268A1
Authority
EP
European Patent Office
Prior art keywords
implant
membrane
distraction
bone
connecting element
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Withdrawn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
EP15703533.8A
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 EP3099268A1 publication Critical patent/EP3099268A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • 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
    • 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

Definitions

  • the present invention relates to an implant, preferably a dental implant, comprising an implant body and a distraction membrane, the use of the implant for callus distraction and method of implantation, wherein the implant body has a portion which is designed as a forward and backward cutting tap.
  • the jawbone at the appropriate place must be both thick enough and strong enough. So there must be bone in sufficient quantity as well as quality.
  • jawbone structure If not enough bone is available for the secure anchoring of a sufficiently large or long implant, a so-called jawbone structure must be made. In particular, the recovery of bone height is considered problematic.
  • different methods are used. With little bone deficiency in width, the bone needed for jawbone augmentation can be gained during surgery. It can also be used bone substitute material or the addition amount can be stretched by mixing bone and substitute material. This augmentation area is often protected with a flexible membrane so that a Disrupted healing of the bone can be done.
  • Other procedures include bone spread, bone splitting, bone block transplantation, sinus lift, cavity techniques, sometimes using bone replacement matehales and protective membranes, and socket preservation.
  • WO 03/051220 A2 describes a method for distraction of a jaw bone by means of bone segments.
  • DE 10 2010 055 431 A1, WO 01/91663 A1 and US 5,980,252 describe devices and methods for callus distraction by means of artificial interfaces, for example membranes.
  • US Pat. No. 6,537,070 B1 discloses a multipart implant which is intended to produce a distraction osteogenesis by unscrewing the individual parts. However, this is limited at most to the direct area of the implant thread.
  • an implant comprising an implant body and a distraction membrane, wherein the distraction membrane can be displaced along a portion of the longitudinal axis of the implant body.
  • the technical problem underlying the present invention is to provide improved means and methods for dental implantation and bone dissection which enable implantation procedures and jaw bone regeneration procedures to be accomplished which overcome the disadvantages of the prior art.
  • the technical problem underlying the present invention is the provision of means and methods which allow to carry out a simplified dental implantation when the jawbone has to be built up.
  • the technical problem underlying the present invention is also the provision of distraction devices which have a simple and safe construction.
  • the technical problem underlying the present invention can also be seen to provide devices and methods in which a required by a dental implant bone structure by distraction osteogenesis can be done so that the distraction can be removed again and replaced by a durable dental implant.
  • the present invention solves the underlying technical problem in particular by the provision of implants, methods and uses according to the claims.
  • the present invention solves the underlying technical problem in particular by providing an implant, comprising an implant body and a distraction membrane, wherein the distraction membrane is connected via a connecting element to the implant body, wherein the connecting element is arranged to be movable over a first portion of the longitudinal axis of the implant body and wherein via the movable arrangement of the connecting element, a displacement of the distraction membrane along the longitudinal axis of the implant body along a longitudinal axis portion of the implant body, in particular over the first portion of the longitudinal axis is enabled, and wherein the implant body has a second portion which is formed as a forward and backward cutting tap is.
  • the implant is a temporary implant.
  • the im- implants a tap.
  • the implant is a dental implant. All embodiments of the implant according to the invention described here therefore relate in particular also to a dental implant according to the invention.
  • the present invention solves the underlying technical problem in particular by providing a dental implant comprising an implant body and a Dis Thermalionsmemb-, wherein the distraction membrane is connected via a connecting element with the implant body, wherein the connecting element via a first, coronal portion of the longitudinal axis of the Implant body is movably arranged and wherein on the movable arrangement of the connecting element, a displacement of the distraction membrane along the longitudinal axis of the implant body over the first portion of the longitudinal axis is made possible and wherein the implant body has a second, apical portion which is designed as a forward and backward cutting tap.
  • the implant according to the invention is therefore characterized in particular by having an end, in particular a tip for screwing into a bone, wherein the end, in particular the tip, is designed as a thread cutter cutting forward and backward.
  • the dental implant is a temporary implant.
  • the dental implant is a tap.
  • a "dental implant” is understood as meaning an alloplastic fabrication part inserted into the jawbone whose base body is preferably a pencil or helical shape no additional, particularly complex, surgical steps are necessary than for the actual setting of the implant itself.
  • the procedural steps in setting a conventional dental implant implicitly include the two operative steps a) creating a borehole that has a thread, using a tap or a provisional Implantation and subsequent b) Insertion and waxing of the final implant, before which the optional steps of "Inserting a pilot hole into the bone” and "Augmenting the pilot hole” can be performed final implant, a crown is usually placed on the final implant. But this can also be the case with temporary implants.
  • no further, in particular costly, operational steps are necessary, although with the implant according to the invention between the steps a) and b) a bone distraction can take place for the construction of the bone surrounding the implant.
  • the placement of the implant body of an implant according to the invention can advantageously take place in a conventional manner so that the dentist does not have to learn any new technique.
  • the implant body can then be used without much effort and the membrane be connected by the connecting element with the implant body.
  • the membrane is slowly pulled away from the jawbone, so that a distraction osteogenesis occurs between the actual steps a) and b) for a desired period of time.
  • the stepwise displacement of the connecting element by the patient or a non-trained helper can take place, as is also customary, for example, when adjusting a brace, since the connecting element is outside the mucous membrane and thus easy to reach.
  • the connector can be removed by the dentist without any operational effort from the implant body. If the membrane of the implant according to the invention is resorbable, then no further operative step for removing the membrane is necessary since it can remain between the mucous membrane and bone and is degraded there. When using a nonabsorbable membrane, only a small surgical step is needed to remove the membrane.
  • step b) can then be carried out in the usual way, ie the implant body can be removed and the final implant set.
  • the implant according to the invention may also be a permanent implant and the implant body remain in the bone and provided with a permanent crown, for example, in a dental implant.
  • the present invention provides an implant which allows the conventional steps a) and b) to be carried out in the usual way, but in between, without any major surgical effort, to carry out a bone distraction to build up the bone, in which case the individual distraction steps need not necessarily be performed by a dentist in a dental practice.
  • the present teaching therefore covers, in particular, dental implants and methods for bone regeneration, wherein bones in the jaw area and / or in the periodontal area are to be regenerated.
  • the implant body has a second portion, which is designed as a forward and backward cutting tap. It is possible with this embodiment according to the invention that the implant according to the invention cuts a thread into the drill hole in a known manner in step a) when screwing it into the bone in the forward direction, by which the implant is held in the bone. Thereafter, the bone is formed by the distraction of the membrane. After completion of the bone construction, the implant according to the invention must be removed again so that the final implant can be placed in step b). The removal of the implant according to the invention is carried out by unscrewing. In this case, the implant according to the invention is also unscrewed by the newly formed bone.
  • a thread is advantageously also cut in the newly formed bone, in particular in a largely atraumatic and compression-free manner. This prevents unnecessary damage to the newly formed bone and allows the final implant to be screwed in without a thread having to be introduced into the newly formed bone in a further intermediate step or without the final implant also having to have a tap.
  • the forward and backward cutting tap is advantageous since, after setting and healing of the implant, even smaller corrections in the positioning of the implant are possible by minimizing the turning back of the implant.
  • Suitable embodiments of forward and reverse cutting taps are designed as external threads, which has at least one corresponding cutting element.
  • Suitable cutting elements are in particular cutting edges or cutting grooves. These can in particular be formed on the threaded mount, for example by at least one corresponding cutting groove between the thread flanks, ie a notch connecting at least two thread valleys, so that at least one threaded mountain has an edge to the notch.
  • the implant is self-tapping.
  • self-tapping is understood to mean that the implant can be inserted immediately after a predrilling of the threaded hole and without pre-cutting of the thread
  • the implant has a cutting edge in the apical region for forward cutting Cutting edge formed by the apical end of the threaded mountain.
  • the second portion is an external thread having an apically directed end and a cervical end.
  • the cutting edge is formed by a recess in the threaded mountain formed by the thread flanks in the region of the cervical end of the thread.
  • the cutting edge is in the thread closest to the cervical end.
  • the external thread of the second portion at the apical end has a cutting edge for forward cutting and a cutting edge for backward cutting at the cervical end.
  • the external thread of the tap can be catchy or multi-threaded.
  • each thread on the cervical end preferably has a cutting edge for cutting backwards. It is preferably provided that the thread has no recesses or cutting grooves extending along more than two thread valleys and serve, for example, for receiving bone chips when screwing a tap.
  • forward cutting or “forward cutting” is understood to mean that an internal thread is cut into the bone when the implant is screwed into the bone.
  • backward cutting or “backward cutting” is understood to mean that an internal thread is cut into the bone when the implant is being turned out of the bone.
  • suitable implant body forms are known.
  • the second portion of the implant body having the tap may be based on a threaded portion of a prior art implant, other than the feature of cutting forward and backward.
  • the length of the tap can be removed from the prior art.
  • the implant according to the invention also has the advantage that the implant body does not have to be rotated for disctraction but remains rigidly in the bone, so that ingrowth in the bone is improved and irritation of the mucous membrane is avoided by rotating the implant body.
  • the connecting element is thus arranged such that it itself and thus also the membrane connected to the connecting element can be moved along at least a partial region of the longitudinal axis of the implant body.
  • the distraction membrane is positioned distally of the implant body.
  • the distraction membrane is thus located at the distal end of the implant body and can then be moved away from the implant body by the connecting element.
  • the longitudinal axis section of the implant body, along which the distraction membrane can be displaced lies distally of the implant body.
  • the distraction membrane has a hole through which the implant body passes. In a preferred embodiment, the hole is not positioned at the midpoint of the distraction membrane.
  • the first portion is formed as a rack.
  • the rack is preferably a round rack.
  • the first portion is formed as a rack and the connecting element has a rotatable on the rack formed as the first portion inner threaded nut which is rotatably mounted in a sleeve, wherein the sleeve is connected to the distraction membrane.
  • the implant body along its longitudinal axis on a first portion and a second portion with a thread, wherein the first portion is formed as a rack.
  • the implant in particular a dental implant, comprises an implant body and a distraction membrane, wherein the distraction membrane is connected to the implant body via a connecting element, wherein the connecting element is movably arranged over a first portion of the longitudinal axis of the implant body and wherein the movable arrangement of the Connecting element a displacement of the distraction membrane along a longitudinal axis portion of the implant body is made possible, characterized in that the first portion is formed as a rack and the connecting element has a rotatably on the rack formed as a first portion internally threaded nut which in a sleeve is rotatably mounted, wherein the sleeve is connected to the membrane.
  • the connecting element has a sleeve counterpart, via which the sleeve is connected to the membrane.
  • the sleeve counterpart is firmly connected to the distraction membrane.
  • the sleeve counterpart and the membrane is in one piece, so the sleeve counterpart part of the membrane.
  • the sleeve counterpart is preferably designed as a shaping of the membrane counter-surface.
  • the internally threaded nut rests on the sleeve counterpart and is rotatably mounted there.
  • the sleeve and the sleeve counterpart are connected to each other, for example glued, welded, bolted, jammed or connected via a click connection.
  • the inventively preferred construction of the connecting element with sleeve, sleeve counterpart and internally threaded nut rotatably mounted in the sleeve has the additional technical advantage that so above the membrane by the connector a smooth shape is formed, at which bacteria can only be poorly set.
  • the preferred one-piece design of the membrane and the sleeve counterpart further enhances this protection against bacterial attack, as this advantageously avoids a groove or the like at the transition from membrane counter surface to sleeve counterpart.
  • the implant according to the invention also has the advantage that the implant body does not have to be rotated for distraction but remains rigid in the bone, so that the ingrowth in the bone is improved and irritation of the mucous membrane is avoided by rotating the implant body.
  • the connecting element is thus arranged such that it itself and thus also the membrane connected to the connecting element can be moved along at least a partial region of the longitudinal axis of the implant body.
  • the implant in particular a dental implant, comprises an implant body and a distraction membrane, wherein the distraction membrane is connected to the implant body via a connecting element, wherein the connecting element is movably arranged over a first subregion of the longitudinal axis of the implant body, and wherein the movable Arrangement of the connecting element is made possible a displacement of the distraction membrane along a longitudinal axis portion of the implant body, characterized in that the distraction membrane has a hole through which the implant body extends and that the hole is not positioned at the center of the membrane.
  • the distraction membrane is curved.
  • the distraction membrane has a first side surface, a second side surface, a third side surface, and a fourth side surface, the first side surface facing the second side surface, and wherein the distance of the distraction membrane hole from the first side surface is less than that Distance of the hole to the second side surface.
  • the membrane has a four-sided base.
  • the implant in particular dental implant, comprises an implant body having a longitudinal axis between a first end and a second end and a distraction membrane, wherein the second end of the implant body has a bone screw thread, wherein the distraction membrane is connected to the implant body via a connecting element wherein the connecting element is arranged to be movable over a first partial region beginning at the first end along the longitudinal axis of the implant body and wherein the movable
  • the arrangement of the connecting element makes it possible to displace the distraction membrane along a longitudinal axis section of the implant body, characterized in that the implant has a reversibly attachable cap for covering the area of the implant body lying between the first end of the implant body and the connecting element ,
  • the cap is reversibly attachable to the connecting element or first subregion of the implant body. In a preferred embodiment, the cap is reversibly fastened to the connecting element. In a preferred embodiment, the cap is reversibly attachable to the first portion of the implant body.
  • the cap may have a shape and length such that it may be slipped over the exposed area of the implant body. It can be formed in the region of its opening so that it can be pushed by stretching on the first portion or on the connecting element and after being pushed by the expansion pressure firmly against the first portion or on the connecting element and is pressed. This way, she can not slip off by herself, but can be pulled off again with the appropriate train.
  • the cap preferably has a length that is at most only slightly longer than the portion of the first portion of the implant body, which extends from the first end of the implant body to the connecting element. As a result, it can be ensured that the cap does not extend unnecessarily far into the oral cavity when the implant is worn.
  • the cap can be removed if necessary, for example, when the membrane is to be moved for distraction or when the implant is to be removed.
  • the cap according to the invention covers the implant body.
  • rough and edged elements of the implant body are covered, for example, the rack.
  • the cap edges that could cause injury.
  • the caps thus advantageously prevent infections and injuries and at the same time increase the wearing comfort of the implant. In addition, they are easy to set up and remove by both the dentist and the patient themselves.
  • the cap is made of a flexible or elastic material, such as plastic or rubber, so that it can be reversibly but firmly closing pushed onto the implant body.
  • the cap is made of a flexible or elastic plastic.
  • the person skilled in suitable materials for such a protective cap are known.
  • the cap is not a crown, in particular no artificial tooth crown.
  • the implant is a temporary implant.
  • the implant is a dental implant.
  • the implant is a provisional dental implant.
  • the connecting element comprises a gear, in particular a self-locking gear, for moving the distraction membrane along the longitudinal axis of the implant body.
  • the connecting element has a spacer sleeve.
  • the connecting element has a housing with a passage and a threaded body, wherein the rack is inserted in the longitudinal extent through the passage substantially free of play through the housing, and wherein the threaded body is rotatably mounted in the housing such that the Threaded body and the rack are in operative engagement.
  • the implant comprises a crown.
  • the implant is for use in bone distraction.
  • An implant according to the invention thus comprises the three components implant body, connecting element and membrane.
  • a “membrane” is understood to mean a medical membrane which is used in medical procedures for the regeneration of a bone or in the introduction of bone substitute materials in a bone defect, whereby the term “bone regeneration” encompasses both new bone formation, for example by natural o - the artificial distraction as well as the introduction and ingrowth let us understand bone replacement materials in a bone defect.
  • 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 counter surface of the membrane in the non-curved state are rectangular or round.
  • the size of these two surfaces of a rectangular membrane results from 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 of the height and the length of a rectangular membrane, the size of the other two side surfaces resulting from the height and the width of the membrane 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 used according to the invention preferably serves for bone regeneration in the oral and maxillofacial region, ie in particular for bone regeneration in a jaw.
  • the jaw can be an upper jaw or a lower jaw.
  • the membrane is a distraction membrane.
  • a “distraction membrane” is understood to mean a medical membrane which can serve or serve as an artificial boundary surface in bone distraction.
  • a membrane is preferably rigid and resistant to fracture, in particular dimensionally stable It can be attached to a distraction device and controlled by the distraction device at a desired rate, either continuously or individually, from the bone, for example, pulled away or pushed away from the bone
  • a “bone distraction” or a “callus distraction” is understood to mean a medical procedure for bone regeneration in which an element is slowly removed from a bone defect, so that cells located in a callus formed between the bone defect and the element , in particular osteoblasts, an artificial biomechanical pulse, in particular Anlagenimpuls is exercised.
  • the element may be, for example, a bone, a bone fragment or an artificial body.
  • the element may be a distraction membrane.
  • a “biomechanical pulse” is understood to mean a mechanical force transmission, in particular the transmission of a tensile force, to a cell, in particular osteoblasts, and the biological processes in the cell triggered thereby.
  • the membrane is made of a metal or a metal alloy.
  • the membrane in particular Dis
  • Dis Dis
  • mennbran made of titanium.
  • the membrane, in particular Dis Dis
  • the contact surface is coated, wherein the layer preferably consists of a mineral material or predominantly contains a mineral material.
  • the contact surface may, for example, be coated with hydroxyapatite.
  • the membrane is made of a resorbable material.
  • the membrane can remain between the mucous membrane and the bone, where it is broken down into harmless substances and decomposed.
  • the membrane according to the invention is resorbable, in particular bioresorbable.
  • the membrane is a bioresorbable distraction membrane.
  • Suitable resorbable materials are, for example, polylactite or polycaprolactone.
  • Resorbable distraction membranes of the prior art can also be used for the implant according to the invention.
  • an at least two-layer resorbable membrane described below is particularly preferably used.
  • a particularly preferred membrane, in particular a distraction membrane, for bone formation, preferably as an artificial bone fragment for bone formation, has at least two layers and a contact surface and a mating surface, wherein the mating surface is formed by the first layer, wherein the first layer consists of collagen or predominantly collagen, and wherein the second layer is rigid.
  • Another particularly preferred membrane is a membrane for bone formation having a contact surface and a counter surface, wherein the membrane has at least two layers, wherein the counter surface is formed by the first layer, wherein the first layer consists of collagen or predominantly contains collagen, and wherein the second layer consists of a bioresorbable plastic or predominantly contains a bioresorbable plastic.
  • the membrane may be bilayered. The contact surface is then formed by the second layer.
  • the membrane is at least three layers.
  • the membrane is three-layered. In a preferred embodiment, the membrane is three-layered, wherein the contact surface is formed by a third layer.
  • the membrane is at least three layers, wherein the contact surface is formed by a third layer, wherein the third layer consists of a mineral material or predominantly contains a mineral material.
  • the membrane is three-layered, wherein the contact surface is formed by a third layer, wherein the third layer consists of a mineral material or contains predominantly a mineral material.
  • the membrane can therefore be two-layered or three-layered.
  • the membrane may also have further layers, for example a fourth layer, a fifth layer or further layers.
  • the layer which forms the contact surface is preferably designed such that the contact surface permits a particularly good adhesion of cells, in particular osteoblasts. This is advantageous, in particular, in the case of a dissecting membrane, since this ensures that adhering cells of the callus are distracted particularly well by the movement of the membrane, that is to say they receive biomechanical impulses.
  • a membrane in particular a distraction membrane
  • it can be constructed in such a way that both the contact surface and the mating surface, particularly well with the respective ones on the Surfaces interacting with adjacent tissues.
  • the membrane according to the invention thus represents a surprisingly good substitute for autologous or allogenic bone blocks.
  • the collagen of the first layer of a membrane according to the invention acts on the connective tissue present on the opposite surface. At the same time, this collagen layer can serve as protection of the rigid second layer.
  • the second layer which preferably consists of a bioresorbable plastic or contains predominantly a bioresorbable plastic, serves as a scaffold structure, so that the membrane can be rigid and non-bendable and thus suitable for use as a distraction membrane. Due to the preferred use of resorbable plastics sufficient stability of the membrane is achieved, so that can be dispensed with the use of metals, such as titanium. Thus, in spite of sufficient stability, the entire membrane according to the invention is advantageously resorbable in the body, so that the membrane or membrane parts do not have to remain in the body or have to be surgically removed again.
  • the bioresorbable plastic is well suited as a contact surface for cells, in particular Osteoblas- th a callus or can be well coated with a third layer.
  • this contact surface can therefore be formed, in particular, by a third layer, which preferably consists of a mineral material or predominantly contains a mineral material. This layer then advantageously corresponds to a natural bone layer of an autogenous or allogenic bone.
  • a bioresorbable plastic as a framework layer has the additional advantage that this framework layer may have a specific shape, for example curved may be and / or may have a predetermined porosity that promotes blood circulation and vascularization.
  • the preferred use of a biodegradable plastic as a framework layer has the additional advantage that this material can be easily cut or otherwise cut, so that the membrane can be cut into the desired shape without much effort.
  • the artificial bone fragment according to the invention can advantageously be designed as a membrane despite the multi-layered nature, ie be very thin. This has the advantage over the prior art natural or artificial bone fragment blocks, which must have a certain thickness, that improved perfusion and vascularization are provided by the thin first layer and the thin second layer, and also by an optional thin third layer can take place.
  • the state of the art assumes that an important factor for bone regeneration is a shielding of the bone defect from ingrowing connective tissue. Therefore, in the treatment of bone defects often shielding membranes are used, which shield the bone defect against the connective tissue and prevent ingrowth of the connective tissue in the bone defect forming callus. This shielding is often considered more important than the presence of biomechanical pulses that stimulate osteoblasts to form bone. Surprisingly, however, the provision of biomechanical pulses for bone formation seems to be far more important as the shielding of the bone defect from the ingrowth of the surrounding connective tissue. Therefore, the membrane of the invention may preferably be perforated. It can therefore have pores which extend from the mating surface through the membrane to the contact surface.
  • both the bone defect and the callus located there as well as the connective tissue separated by the membrane from the bone defect can be well supplied with nutrients and blood and thereby vascularize particularly well. Since the membrane is thin in comparison to bone blocks, the pores are correspondingly short, so that a particularly good connection can be established between tissue lying on the mating surface and the callus present on the contact surface.
  • the fact that connective tissue can also grow into the bone defect area surprisingly plays a subordinate role as long as the osteoblasts in the callus experience sufficient biomechanical impulses to be stimulated for bone formation.
  • a membrane which is preferred according to the invention also leads in particular to a good vascularization of the newly forming bone tissue, in particular if the membrane according to the invention has preferred pores which extend through the membrane from the mating surface to the contact surface in an interconnecting manner.
  • a second layer of the membrane consists of a bioresorbable plastic or predominantly contains a bioresorbable plastic, wherein the second layer has pores with a diameter of at least 10 ⁇ , wherein the pores of the interface between the second Layer and the first layer to the contact surface pass through the second layer interconnectively.
  • the counter surface of the membrane according to the invention is preferably formed by a first layer which consists of collagen or predominantly contains collagen.
  • the first layer contains at least 50% by weight of collagen. More preferably, the first layer contains at least 75% by weight collagen. Particularly preferably, the first layer contains at least 90% by weight, more preferably at least 95% by weight, of collagen.
  • the first layer can also consist entirely of collagen.
  • the collagen may be a native collagen or denatured collagen.
  • the collagen may be a collagen selected from the group consisting of one of collagen types I to XXVIII and mixtures thereof.
  • the collagen is Type I collagen since it is a fibrillar collagen present in many connective tissues.
  • a “first layer” is preferably understood as meaning the layer which forms the counter-surface, which consists of collagen or predominantly contains collagen.
  • the first layer which consists of collagen or predominantly contains collagen, preferably has a layer thickness of at least 0.1 mm and at most 10.0 mm.
  • the layer thickness of the first layer is preferably at least 01, mm.
  • the layer thickness of the first layer is particularly preferably at least 0.2 mm.
  • the layer thickness of the first layer is preferably at least 0.5 mm.
  • the layer thickness of the first layer is preferably at least 1.0 mm.
  • the layer thickness of the first layer is preferably at least 2.0 mm.
  • the layer cover of the first layer is preferably at most 10.0 mm.
  • the layer thickness of the first layer is preferably at most 5 mm.
  • the layer thickness of the first layer is preferably at most 3 mm.
  • the layer thickness of the first layer is preferably at most 2.5 mm.
  • the layer thickness of the first layer is preferably at least 0.5 mm and at most 2.5 mm.
  • the “second layer” is preferably understood as meaning the layer of the membrane according to the invention which forms the backbone of the membrane according to the invention
  • the first layer and the second layer form an interface, ie lie against each other
  • the second layer is rigid may be plate-shaped or scaffold-shaped.
  • the second layer preferably consists of at least one bioresorbable plastic or predominantly contains at least one bioresorbable plastic.
  • the second layer preferably consists of a bioresorbable plastic or predominantly contains a bioresorbable plastic.
  • the second layer contains at least 75% by weight of a bioresorbable plastic. More preferably, the second layer contains at least 95% by weight of a bioabsorbable plastic. In a preferred embodiment, the second layer consists of a bioresorbable plastic.
  • a "resorbable plastic” or a “bioresorbable plastic” is understood as meaning a plastic which is biodegraded and decomposed in the human body, for example a patient.
  • the second layer may be a single bioresorbable plastic contain or also two or more different Bioresorbierbare plastics.
  • the second layer of a membrane according to the invention preferably consists of a single bioresorbable plastic.
  • bioresorbable plastics are, for example, polylactic acids such as polylactide (PLA) and polycaprolactone (PCL).
  • the bioresorbable plastic is a polycaprolactone. In a preferred embodiment, the bioresorbable plastic is a polylactide.
  • the second layer is designed as a rigid framework and porous. In a preferred embodiment, the second layer is porous.
  • the second layer has a layer thickness of at least 0.01 mm to at most 4 cm. In a preferred embodiment, the second layer has a layer thickness of at least 0.1 mm to at most 1 cm. In a preferred embodiment, the second layer has a layer thickness of at least 0.1 mm to at most 3.0 mm.
  • the second layer preferably has a layer thickness of at least 0.01 mm. Preferably, the second layer has a layer thickness of at least 0.05 mm.
  • the second layer preferably has a layer thickness of at least 0.1 mm.
  • the second layer preferably has a layer thickness of at least 0.2 mm.
  • the second layer preferably has a layer thickness of at least 0.5 mm.
  • the second layer has a layer thickness of at least 1 mm.
  • the second layer has a layer thickness of at most 4 cm.
  • the second layer preferably has a layer thickness of at most 2.5 cm.
  • the second layer has a layer thickness of at most 1 cm.
  • the second layer preferably has a layer thickness of at most 0.5 cm.
  • the second layer has a layer thickness of at most 3 mm.
  • the second layer has a layer thickness of at most 2.5 mm.
  • the second layer has a layer thickness of at most 2 mm.
  • the second layer is rigid so that it allows the use of the membrane as a distraction membrane or the transmission of biomechanical pulses as a framework.
  • the term “rigid” is understood to mean that the layer or the membrane is so resistant to breakage, preferably also dimensionally stable, that it does not bend in the normally occurring forces, that is to say forces, which occur in a use according to the invention.
  • the term “rigid” is understood to mean that the membrane does not break due to tensile and compressive forces of the same magnitude as in the case of a callus distraction, and preferably does not bend, that is, has sufficient tensile strength.
  • the membrane is porous.
  • the membrane has pores, in particular interconnecting pores.
  • the second layer is porous.
  • the membrane has at least one perforation.
  • the membrane is perforated.
  • the membrane has a multiplicity of holes, in particular pores, which extend through all the layers, that is, interconnecting pores. Such holes advantageously allow the penetration of blood at the contact surface and / or the counter surface of the membrane, wherein the blood can then be guided by capillary forces through the membrane to the other surface, so that a good circulation of the callus tissue and / or Connective tissue adjacent to the membrane is reached.
  • vessels can form in the pores and thus through the membrane, so that a good vascularization of the growing bone can take place.
  • the pores preferred according to the invention in particular interconnecting pores, for example having a diameter of about 1 mm, thus allow the capillaries to grow through the membrane so that a very good blood circulation and immune defense is ensured in the region of the newly formed bone.
  • the perforations allow a good circulation of the membrane covering mucosa and the regenerate between the membrane and the bone.
  • the second layer has pores, in particular interconnecting pores.
  • the interconnecting pores must have a minimum size, ie a minimum diameter, which allows erythrocytes with a typical diameter of about 7.5 ⁇ to pass through the pores, ie a diameter of very fine blood vessels.
  • the pores have a size, that is a diameter, of at least 0.005 mm and highest 1, 5 mm.
  • the pores have a size of at least 0.01 mm and at most 1.5 mm.
  • the pores have a size of at least 0.005 mm.
  • the pores have a size of at least 0.01 mm.
  • the pores have a diameter of at least 0.1 mm.
  • the pores have a diameter of at least 0.3 mm.
  • the pores have a diameter of at least 0.5 mm.
  • the pores have a diameter of about 1 mm.
  • the pores have a diameter of at most 1, 5 mm.
  • the pores have a diameter of at most 1, 3 mm.
  • the pores have a diameter of at most 1, 2 mm.
  • the pores extend through the membrane.
  • the pores extend from the mating surface through the membrane to the contact surface.
  • the pores are therefore preferably interconnecting, that is, they extend from the mating surface to the contact surface.
  • the number of pores preferably depends on the size of the membrane.
  • a membrane having a length of about 20 mm and a width of about 10 mm may have about ten to twenty pores.
  • Such a ratio of the number of pores to the membrane surface gives an optimum between the total pore surface, which promotes the blood circulation, and the adhesion surface for osteoblasts, which adhere to the membrane during the distraction process.
  • the contact surface may be formed in a preferred multilayer by the second layer or another, for example, a third layer.
  • the contact surface is preferably designed such that it prevents adhesion of cells, in particular osteoarthritis. blasts, allows.
  • the contact surface is rough.
  • the contact surface is porous.
  • the contact surface may also have further pores which are not interconnecting and extend only into the membrane, so that cells, in particular osteoblasts, can attach particularly well.
  • a particularly good contact surface can be formed by a further, in particular third, layer, preferably by a third layer of a mineral material.
  • the contact surface of the membrane according to the invention is preferably formed by the second layer or by a third layer.
  • the contact surface of the membrane is formed by a third layer, which consists of a mineral material or contains predominantly a mineral material.
  • the mineral material of the third layer is hydroxylapatite and / or calcium phosphate.
  • the third layer is preferably formed from hydroxyapatite or contains hydroxylapatite, in particular contains predominantly hydroxylapatite.
  • the third layer is formed from calcium phosphate or contains calcium phosphate, in particular contains predominantly calcium phosphate.
  • the mineral material of the third layer may include hydroxyapatite and calcium phosphate.
  • the third layer is porous.
  • the inter-connecting pores preferably extend through the third layer.
  • the membrane according to the invention therefore preferably has a porous mineral third layer which forms the contact surface of the membrane.
  • the third layer has a layer bridge of at least 1, 0 ⁇ to at most 1 mm.
  • the layer preferably has a layer thickness of at least 1.0 ⁇ m.
  • the third layer preferably has a layer thickness of at least 2.0 ⁇ m.
  • the third layer preferably has a layer thickness of at least 5.0 ⁇ m.
  • the third layer preferably has a layer thickness of at least 10 ⁇ m.
  • the third layer has a layer thickness of at most 1 mm.
  • the third layer preferably has a layer thickness of at most 0.5 mm.
  • the third layer has a layer thickness of at most 0.2 mm.
  • the membrane has a thickness of at least 0.1 mm.
  • the membrane has a thickness of at least 0.2 mm to at most 13 mm.
  • the membrane has a thickness of at least 0.2 mm.
  • the membrane has a thickness of at least 0.5 mm.
  • the membrane has a thickness of at most 13 mm.
  • the membrane has a thickness of at most 10 mm.
  • the membrane has a thickness of at most 5 mm.
  • the membrane has a thickness of at most 3 mm.
  • the membrane has a hole for attaching the connecting element.
  • the membrane has a hole, which is particularly preferably present in the central surface area of the membrane, through which a connecting element can be inserted, or into which a connecting element can be screwed, inserted, glued or clicked.
  • the hole has a thread.
  • the thread can in particular by the present in the second layer hole wall be educated.
  • the membrane has a hole, wherein the hole extends through the second layer, in particular through the bioresorbable plastic of the second layer, and the hole has a thread in the region of the second layer. In this thread, the connecting element can be screwed in an advantageous manner.
  • the hole has no thread, for example, if in the hole, a connecting element is inserted, glued or clicked.
  • the connecting element is located on the mating surface of the membrane or extends into the membrane as viewed from the mating surface.
  • the edges of the membrane are rounded.
  • the membrane may be flat or curved.
  • the membrane in particular, in the case of membranes with a smaller expansion, the membrane can preferably be flat, ie flat.
  • the membrane can also be arched alternatively.
  • the membrane is curved.
  • the membrane especially if it is a membrane for use in the jaw region, curved in a U-shape.
  • a U-shaped arched membrane can completely cover a bone defect, especially in the jaw area, ie cover it from above and from both sides. In cross-section like the letter "U” it includes more vestibular and lingual the jawbone.
  • the area is also extended to the side walls of the jaw, where also artificial impulses are given by it. This can then be the Comb broadening, since the clinical task of chamber elevation combined with comb broadening is very often combined.
  • At least a portion of the contact surface and the counter surface is curved.
  • the membrane is therefore preferably curved over at least a portion of the length or the width of the membrane.
  • 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.
  • edges formed by two side surfaces are rounded.
  • the membrane has rounded edges.
  • the membrane according to the invention is a membrane for periodontal regeneration by means of distraction.
  • Periodontal regeneration is understood to mean regeneration of the periodontium, ie not only of the bone but also of the periodontal ligament, the periodontal tissue, the gingiva and the papillae, for example by guided tissue regeneration (GTR)
  • GTR guided tissue regeneration
  • the membrane is very thin for periodontal regeneration
  • the membrane is periodontally regenerated. Regeneration so gefornnt that it has at least one lapping or a segment, or which can be inserted into a tooth space.
  • the membrane may also be non-absorbable, that is, consist of or contain nonabsorbable materials.
  • nonabsorbable membranes in particular distraction membranes from the prior art. These can also be used in an implant according to the invention.
  • the membrane is made of a biogenic material.
  • a preferred embodiment contains a nonabsorbable membrane.
  • the membrane is made of titanium.
  • the membrane can also consist of ceramics, polymers, composites or collagen or contain these materials.
  • the membrane is sandblasted. In a preferred embodiment, the contact surface of the membrane is sandblasted. In a preferred embodiment, the contact surface of the membrane is coated.
  • the minimum size of a preferred membrane with hole for passing the implant body results from the diameter of the implant body and the resulting Diameter of the hole.
  • the membrane has a diameter of at least 3 mm, more preferably at least 4 mm, particularly preferably at least 5 mm, for example about 6 to 8 mm, in particular 7.15 mm.
  • the diameter refers to round membranes.
  • the minimum diameter values mentioned refer to the minimum length and minimum width of the membrane.
  • the size of the membrane can be adapted to the size of the bone surface on which bone formation is to take place.
  • the membranes are dimensionally stable, larger membranes in the cm range can also be used, for example membranes with a diameter or length and width of about 1 cm, about 2 cm, about 5 cm or larger.
  • the membrane is multi-layered, in particular three-layered.
  • the first layer of the membrane, which forms the counter surface consists of collagen, for example with a layer thickness of 1 mm to 3 mm, in particular of about 2 mm.
  • the middle layer preferably consists of a metal, in particular titanium.
  • the third layer, which forms the contact surface preferably consists of hydroxylapatite.
  • a three-layered membrane with a collagen layer, a titanium layer and a hydroxyapatite layer is preferred.
  • 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 jawbone crest 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.
  • 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 in particular be intended for single use if it has been manufactured individually for a specific bone defect and / or if it has biodegradable constituents which decompose when the membrane is used.
  • the membranes can be made up in shape and size or individually adapted to the bone defect to be treated.
  • the distraction membrane has a hole through which the implant body passes.
  • the connecting element comprises a gear, in particular a self-locking gear, for moving the membrane along the longitudinal axis of the implant body. The connecting element is used to attach the membrane to the implant body and the controlled displacement of the membrane along the implant body.
  • the connecting element is attached to the opposite surface of the membrane or plugged into a hole in the membrane or preferably screwed.
  • the connecting element connects the membrane and the implant body in such a way that the contact surface of the membrane is directed towards the tip of the implant body and that the connecting element is directed towards the head of the implant body.
  • a suitable connecting element which permit the connection of the membrane with the implant body according to the invention and permit a movement, in particular controlled movement of the membrane along the implant body.
  • the connecting element has a point of application for a tool, so that the connecting element can be moved or moved in a controlled manner along the implant body with the aid of the tool.
  • the point of attack for the tool on the actuating body of the connecting element is preferred.
  • the hole in the distraction membrane has an internal thread and the connecting element has an external thread, wherein the external thread of the connecting element can be screwed into the internal thread of the distraction membrane.
  • the hole of the membrane before screwing the connecting element has no thread, but this is milled when screwing the connecting element through its external thread.
  • the hole of the membrane has no thread and the connecting element is inserted, snapped, glued or clicked into the hole of the membrane, for example.
  • the connecting element is connected to the membrane via a tongue and groove connection or via an adhesive connection, via a plug connection or via a latching connection or via a click connection.
  • the connecting element has a spacer sleeve.
  • the connecting element is designed as a spacer sleeve.
  • the spacer sleeve at least partially has a conical shape.
  • the connecting element has a spacer sleeve and at least one further subelement. The at least one further subelement preferably serves for the displaceable connection of the connecting element to the implant body.
  • a spacer sleeve is a metallic body used in implants.
  • a spacer sleeve is designed to bridge the gap between bone and mucous membrane.
  • the spacer sleeve is usually used during the healing phase of an implant.
  • a spacer sleeve can be present in an advantageous manner in an implant according to the invention as part of the connecting element.
  • the spacer sleeve forms at least the part of the connecting element which is connected directly to the membrane.
  • the spacer sleeve can fulfill two tasks in an advantageous manner.
  • the spacer sleeve as an intermediate element between the membrane and the sub-element of the connecting element, which is mounted on the implant body, allow a secure and simple connection
  • the spacer sleeve is in this embodiment at a position in which they especially in a use in The area of the jaw extends through the oral mucosa and thus forms the boundary between the membrane underlying the mucous membrane and the further sub-elements of the connecting element lying above the mucous membrane.
  • a smooth, not sharp-edged surface can be produced by the membrane and the spacer sleeve, with which the mucous membrane comes into contact, so that the mucous membrane is not attached to the implant body during the distraction. especially on sharp-edged parts of the implant body, such as the threaded part or the optional rack part, rubbing.
  • the membrane has a hole through which the implant body extends, the implant body also extends through the spacer sleeve and the spacer sleeve is inserted into the hole of the membrane or is preferably screwed.
  • the connecting element is designed as a spacer sleeve and, wherein the membrane is attached to a surface of the spacer sleeve.
  • the membrane with the mating surface is glued to the surface of the spacer sleeve, for example with a fibrin glue.
  • the membrane is formed from a surface of the spacer sleeve.
  • the spacer sleeve is designed such that it has a surface which is directed in the direction of the tip of the implant body and on this surface either a membrane is applied o- this surface is membrane-like, in particular coated, for example coated with hydroxyapatite.
  • the spacer sleeve preferably has a conical shape.
  • the cone of the spacer sleeve preferably enlarges in the direction of the tip of the implant body.
  • the size of this base area corresponds to the size of the membrane surface.
  • the cone is determined in particular by the angle between a surface line and the cone axis, thus, the membrane area size can be determined advantageously by a spacer sleeve with a corresponding angle, without changing the height of the spacer sleeve.
  • different spacers which have an equal height, but a different base area, can be used in an implant according to the invention and thus easily different membrane sizes.
  • the cone of the spacer sleeve can shrink in the direction of the tip of the implant body or the spacer sleeve has no cone, for example, if only a small membrane surface is needed.
  • such a spacer sleeve consists of a bioresorbable material.
  • the membrane is connected via a conical interference fit with a spacer sleeve, in which the cone increases in the direction of the tip of the implant body.
  • the spacer sleeve is designed such that it is screwed onto the implant body as a connecting element and can be moved by turning along the implant body.
  • the membrane is preferably rotatably mounted on the spacer sleeve, so that although the spacer sleeve rotates during the distraction, but not the membrane.
  • the spacer sleeve is connected to the membrane via a tongue and groove connection or via an adhesive bond, connected via a plug connection or via a snap connection or via a click connection.
  • the preferred implant according to the invention with spacer sleeve can also be designed in an advantageous manner such that neither the implant body nor the spacer sleeve must be rotated for distraction, so that irritation of the mucous membrane is avoided by rotating the implant body and / or the spacer sleeve.
  • two alternative embodiments may preferably be provided.
  • the first end of the spacer sleeve which is bolted to the membrane, has an external thread.
  • the second end of the spacer sleeve, which is screwed to the at least one further sub-element of the connecting element has a second thread, which is opposite to the first thread.
  • the second thread may be an internal thread or an external thread.
  • the at least one further sub-element of the connecting element, which is screwed to the spacer sleeve has a matching external thread or internal thread.
  • the first thread of the spacer sleeve and the second thread of the spacer sleeve are gleichtinct.
  • the threaded connection between the spacer sleeve and the at least one further element of the connecting element is then configured such that the spacer sleeve can be rotated past the end position point into the thread or onto the thread of the at least one further subelement of the connecting element.
  • the spacer sleeve is then turned onto the thread or into the thread of the at least one further subelement of the connecting element beyond the end point. Then the first thread of the spacer sleeve is brought into contact with the hole of the membrane.
  • the first thread of the spacer sleeve simultaneously rotates into the hole of the membrane, so that upon reaching the end point, the spacer sleeve with both the membrane and the at least one further sub-element of the connecting element is connected.
  • the connecting element has a housing.
  • the housing is designed as a spacer sleeve.
  • the housing of the connecting element is connected to the spacer sleeve.
  • the connecting element has a spacer sleeve and a housing, wherein the housing has an external thread or an internal thread at one end and wherein the spacer sleeve at least partially has a conical shape and wherein the spacer sleeve at the first end with the smaller diameter an external thread to Having screwed into the hole of the diaphragm and wherein the spacer sleeve at the second, the first opposite end has an internal thread into which the external thread of the housing can be screwed, or wherein the spacer sleeve at the second, the first opposite end has an external thread into which Internal thread of the housing can be screwed.
  • the spacer sleeve can be screwed into the membrane self-tapping.
  • the spacer sleeve with an external thread is screwed into a matching internal thread in the membrane.
  • the spacer sleeve may form the lower part of the connecting element or even cover the other parts of the connecting element or partially cover.
  • the implant body has along its longitudinal axis a first lower partial area with a thread and a second partial area above the lower partial riches.
  • the connecting element can be displaced or controlled in a controlled manner along the second subarea above the lower subarea.
  • the second portion is formed as a rack.
  • the connecting element has a housing with a passage and a threaded body, whereby the part of the implant body designed as a toothed rack is inserted through the passage at least substantially without clearance through the passage, and the threaded body is rotatably mounted in the housing in such a way is that the threaded body and the rack are in operative engagement.
  • the implant is based on the system of a connecting element with an adjusting nut with internal thread, which is rotatably mounted in the housing and is screwed onto the implant body. By turning this adjusting nut moves this and with it the housing and thus the connecting element with membrane along the implant body.
  • the connecting element is designed as a spacer sleeve is also preferred, the diaphragm being fastened to a surface of the spacer sleeve.
  • the membrane is formed from a surface of the spacer sleeve, as described above.
  • the implant is based on the system of a connecting element with a worm gear, an implant body with a rack section and a diaphragm, wherein the rotational movement of a threaded body, in particular a screw in a translational movement of the connecting element and thus the diaphragm on the rack is translated.
  • a threaded body in particular the screw
  • a thread with a pitch p 0.1 to 0.5 mm, in particular about 0.3 mm, in particular 0.3 mm
  • the rack is toothed accordingly.
  • a pitch of 0.3 mm of the thread body results in a stroke of 0.3 mm per complete revolution of the threaded body.
  • Another alternative embodiment is an implant whose implant body in the apical third, in particular as a tap, has a wood screw thread and the remainder is provided with a further thread. At the other thread, the spacer sleeve is moved like a nut.
  • the connecting element and the spacer sleeve of at least one biogenic material are not biodegradable.
  • the connecting element and the spacer sleeve made of titanium or a titanium alloy, in particular the material TIAI4V, zirconium or a stainless steel or contain this, in particular predominantly contain.
  • the connecting element and the spacer sleeve can also be made of a biodegradable material, in particular of a biodegradable plastic such as polylactide or polycaprolactone or contain this, in particular predominantly contained.
  • the implant body preferably consists of a biogenic and non-biodegradable material.
  • the implant body preferably consists of a metal, in particular titanium or of zirconium, in particular if the implant according to the invention is a dental implant.
  • the person skilled in the art is familiar with suitable materials for a dental implant body.
  • the implant body can consist of a biogenic and biodegradable material, for example if the implant according to the invention is not a dental implant.
  • the implant comprises a crown.
  • the dental implant comprises a crown.
  • the technical problem underlying the present invention can also be the provision of distraction devices which have a simple and safe construction.
  • An implant according to the invention can also be used advantageously in general for bone formation by distraction, as it can also be used in an application outside the jaw or in the jaw, without the implant should also act as a denture. Even with such use, the implant is characterized by a simple structure and good handling.
  • the implant is not a dental implant.
  • the implant body and particularly preferably the entire implant according to the invention, can be absorbable, ie consist of resorbable materials.
  • a resorbable implant according to the invention then has the advantage that after the distraction has taken place, the implant no longer has to be surgically removed, but can remain in the body and be degraded there.
  • the implant body consists of a resorbable material.
  • the entire implant then consists of resorbable materials.
  • the implant of the invention is for use in bone distraction.
  • the dental implant according to the invention serves for use in a bone distraction and at the same time as a provisional implant or permanent implant.
  • the implant according to the invention can also be designed as a permanent implant and, in particular, a permanent dental implant. It can then be removed after bone distraction, the connecting element and replaced by a crown.
  • the present invention also relates to an implant according to the invention for use for callus distraction, in particular for the construction of a bone, in particular jaw bone, by distraction.
  • the implant is suitable for callus distraction. In a preferred embodiment, the implant is suitable for bone regeneration. In a preferred embodiment, the dental implant is suitable for callus distraction in the jaw region. In a preferred embodiment, the dental implant is suitable for bone regeneration in the jaw area. In a preferred embodiment, the dental implant is suitable for periodontal regeneration in the jaw area.
  • the implant is intended for use in a medical procedure, in particular in a surgical procedure.
  • the implant is intended for use in bone regeneration by distraction, especially in the jaw area.
  • the implant according to the invention is suitable for use for bone distraction, in particular of a jawbone.
  • the implant according to the invention is used for bone distraction, in particular of a jawbone.
  • Distraction is preferably carried out with the implant according to the invention at a distraction rate of at least 0.2 mm per day to at most 2.5 mm per day, in particular from at least 0.5 mm per day to at most 2 mm per day.
  • the distraction rate is particularly preferably about 1 mm per day.
  • the present invention also relates to an implant according to the invention for use for callus distraction, in particular for the construction of a jaw bone by distraction.
  • the present invention also relates to an implant according to the invention for use in periodontal regeneration by distraction.
  • the implant according to the invention is a dental implant with a membrane for periodontal regeneration.
  • Periodontal 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 present invention also relates to a kit containing an implant according to the invention.
  • the present invention also relates to a kit containing the basic implant body of an inventive Implant, at least one connecting element and at least one membrane, in particular a plurality of different membranes.
  • the kit preferably contains an instruction manual.
  • the instructions for use preferably contain information on how the kit can be used for setting the implant and performing a callus distraction.
  • a preferred embodiment is a kit according to the invention for use in medical procedures, in particular surgical procedures, preferably in bone distraction, in particular in the jaw area.
  • a further preferred embodiment is the use of a kit according to the invention for producing an implant according to the invention.
  • the present invention also relates to the use of an implant according to the invention in a medical procedure, in particular in a surgical procedure.
  • the present invention also relates to the use of an implant according to the invention for callus distraction, in particular in the jaw region, in particular for the construction of a jaw bone by distraction.
  • the present invention also relates to methods for callus distraction, in particular for the construction of a jaw bone by distraction, wherein a membrane of an implant according to the invention is applied to a bone defect to be regenerated and tension is exerted on this membrane via the connecting element. The membrane is thus removed at a certain speed with the rack from the bone defect.
  • Preferred is the speed is 0.2 mm to 2.5 mm per day, in particular 0.5 mm to 2 mm per day. Most preferably, the speed is about 1 mm per day.
  • such a distraction process at the beginning of the procedure in particular a distance of about 1, 5 mm between the membrane and bone is advantageous.
  • the slow removal of the membrane from the bone defect can be continuous or discontinuous, for example daily or half-daily.
  • the present invention also relates to methods for the distraction of the jaw, in particular for the development of a jaw bone by distraction, comprising the following steps: a) implanting the implant according to the invention into a bone, preferably a jawbone, wherein the implant is a provisional implant and wherein the second portion of the implant body is at least partially threaded into the bone or a predrilled hole in the bone; b) carrying out a distraction osteogenesis with the membrane of the implant according to the invention; in particular as described above; c) removing the fastener from the implant body; d) unscrewing the provisional implant body from the bone;
  • a cap is placed on a dental implant in the method according to the invention.
  • step e) is preferably followed by insertion and ingrowth of your permanent implant into the drilled hole of the removed implant according to the invention.
  • the present invention also relates to methods for implanting a permanent dental implant according to the invention, comprising the following steps: a) implanting the implant according to the invention in a bone, preferably a jawbone, wherein the implant is a permanent implant; b) carrying out a distraction osteogenesis with the membrane of the implant according to the invention; in particular as described above; c) removing the fastener from the implant body;
  • a crown is placed on a dental implant in the method according to the invention.
  • a bioabsorbable membrane is used which does not have to be removed.
  • a non-biodegradable membrane for example of titanium, may be used. This is preferably also removed after removal of the fastener from the implant body.
  • step a) of the methods according to the invention comprises the following substeps: a1) implanting the implant body in the bone; a2) attaching the membrane to the implant body and applying the membrane to the bone defect; a3) attaching the connecting element to the implant body; and a4) attaching the connecting element to the membrane, for example by screwing, pinning, locking, clipping or gluing the connecting element, in particular the spacer sleeve of the connecting element, to the hole of the membrane.
  • the following sub-steps may be provided: a1) applying the membrane to the bone defect; a2) inserting the implant body into the hole of the membrane and implanting the implant body in the bone; a3) attaching the connecting element to the implant body; and a4) attaching the connecting element to the membrane, for example by screwing, pinning, locking, clipping or gluing the connecting element, in particular the spacer sleeve of the connecting element, to the hole of the membrane.
  • step a) Before step a), the optional steps "setting a pilot hole in the bone” and “extending the pilot hole” can be performed. After healing the final implant, a crown is usually placed on the final implant. But this can also be the case with temporary implants.
  • step b) in particular the gradual displacement of the Gebselennentes by the patient or a non-trained helper done, for example by means of a tool that can be attached to a point of application for the tool on the connecting element, preferably on the actuating body of the connecting element ,
  • FIGS. 1 shows the cross section of an embodiment of an implant according to the invention
  • FIG. 2 shows a further preferred embodiment of the implant according to the invention and a detailed view of the second partial area with thread cutter
  • FIG. 3 shows a further view of the preferred embodiment of the implant of FIG. 2 and the corresponding implant body from three different viewing directions;
  • FIG. 4 shows the membrane and the connecting element of the preferred embodiment of the implant of FIG. 2;
  • FIG. 5 shows another embodiment of the invention
  • FIG. 7 shows further embodiments of the invention
  • FIG. 8 shows an implant according to the invention with a preferred embodiment of a tool for moving the membrane
  • FIG. 9 shows an implant according to the invention in combination with different protective caps
  • FIG. 10 shows an implant according to the invention with another implant
  • FIG. 1 shows the cross section of an embodiment of an implant (100) according to the invention.
  • the implant (100) comprises an implant body (10), a distraction membrane (20) and a connecting element (30).
  • the coronal, first portion (1 1) of the implant body (10) is designed as a rack (13).
  • the implant body (10) has a hole (14) which serves as a point of application for a tool for screwing into a bone or unscrewing it from a bone of the implant body (10).
  • the distraction membrane (20) has a contact surface (21) and a counter-surface (22).
  • the contact surface (21) is preferably formed by a coating, for example of a mineral material.
  • the distraction membrane (20) is connected to the implant body (10) via the connecting element (30) such that the membrane (20) can be moved or displaced exactly along the implant body (10).
  • the connecting element (30) has a partially conical spacer sleeve (32). The membrane (20) is snapped, screwed or glued into it.
  • an adjusting nut (37) is rotatably mounted, which has an internal thread.
  • the adjusting nut (37) is thus a rotatably mounted threaded body which is in operative engagement with the rack (13) of the coronal portion (1 1) of the implant body (10).
  • the apical, second portion (12) of the implant body (10) has an external thread (40) for screwing or boring the implant body (10) in a bone.
  • the thread (40) has threaded valleys (41) and threaded peaks (42) through which the thread flanks are formed.
  • the thread (40) has an apical end portion (44) and a cervical end portion (45).
  • the thread (40) is designed as a forward cutting thread, so that when screwing the implant body (10) into a borehole in a bone or bone with a first cutting element (46) cuts an internal thread into the bone.
  • FIG. 2 shows an overview of a preferred embodiment of the implant (100) according to the invention in FIG. 2a.
  • the implant (100) comprises an implant body (10), a curved distraction membrane (20) and a connecting element (30).
  • the coronal section (1 1) of the implant body (10) is again designed as a toothed rack (13).
  • the apical region (12) of the implant body (10) again has an external thread (40) for screwing or boring the implant body (10) into a bone.
  • the thread (40) has threaded valleys (41) and threaded peaks (42) through which the thread flanks are formed.
  • the thread (40) has an apical end portion (44) and a cervical end portion (45).
  • the thread (40) is designed as a forward cutting thread, so that when screwing the implant body (10) into a borehole in a bone or bone with a first cutting element (46) cuts an internal thread into the bone.
  • the cervical end region (45) of the thread (40) has a second cutting element (43) with a cutting edge which is back-separating, ie when the implant body (10) is unscrewed from the bone, an internal thread is cut into the bone.
  • FIG. 2b shows an enlarged section of the apical, second subregion (12) of the implant body (10) from FIG nor the beginnings of the coronal, first portion (1 1) with the rack (13) can be seen in the form of a round rack.
  • the apical region (12) of the implant body (10) again has a forward cutting external thread (40) with thread valleys (41) and thread crests (42) and an apical end portion (44) and a cervical end portion (45).
  • the apical end portion (44) of the thread (40) has a forward cutting cutting element (46).
  • the cervical end region (45) of the thread (40) has a cutting element (43) with a cutting edge (43a) which is backward-divergent, ie when the implant body (10) is unscrewed from the bone, an internal thread is cut into the bone.
  • the cutting edge (43a) is formed by means of a notch (43b) in the uppermost passage of the threaded mountain (42).
  • FIG. 3 shows the implant (100) according to the invention from FIG. 2a in a somewhat different perspective in FIG. 3a.
  • the implant (100) again comprises the implant body (10), the curved distraction membrane (20) and a connecting element (30).
  • the implant body (10) is again subdivided into a first coronal section (11) with a rack (13) in the form of a round rack and into a second, apical area (12) with forward and backward cutting threads (40).
  • the first, coronal end of the implant body (10) has a hole (14), here a hexagonal hole, which serves as a point of application for a tool for screwing or unscrewing the implant body.
  • the membrane (20) has a plurality of pores (23), which lead to improved perfusion of the underlying tissue under the membrane.
  • the connecting element (30) has holes (34) as points of attack for a tool for turning an adjusting nut of the connecting element (30), whereby the membrane (20) along the first, coronal part (1 1) of the implant body (10) can be moved along, since the adjusting nut as a rotatably mounted threaded body with the rack (13) of the coronal portion (1 1) of the implant body (10) is in operative engagement.
  • FIG. 3b the implant body (10) of the implant from FIG. 3a without membrane and connecting element can be seen in three different perspectives.
  • the design of the coronal first portion (11) as a rack (13) becomes clear.
  • the thread (40) which cuts in both directions, with the apical end region (44) and a cutting element there, and the cervically directed end region (45) with a second cutting element (43) are clear to see.
  • the second cutting element (43) with a cutting edge (43a) formed by a notch (43b) in the uppermost flight of the thread allows the cutting of a thread in the newly formed by the callus distraction by means of membrane bone when unscrewing the implant body ( 10) from the bone.
  • FIG. 4 shows in FIG. 4 a a preferred embodiment of the separation membrane (20) and of the connecting element (30).
  • the distraction membrane (20) has pores (23) for improved blood and nutrient delivery to the callus tissue.
  • the connecting element (30) is in three parts.
  • An adjusting nut (37) is held by a sleeve (31 a) and a sleeve counterpart (31 b).
  • the adjusting nut (37) rests on the sleeve counterpart (31 b) and is rotatably mounted in the sleeve (31 a).
  • the sleeve counterpart (31 b) firmly connected to the distraction membrane (20) or part of the membrane (20).
  • the distraction membrane (20) and the sleeve counterpart (31 b) are in one piece.
  • the adjusting nut (37) has an internal thread (38) which can engage in the rack (13) of the implant body (10) from FIG. 3b.
  • the Disistionsmembran (20) by rotation of the adjusting nut (37) along the first portion (1 1) of the implant body (10) are moved.
  • the rotation of the adjusting nut (37) is made possible by three holes (34), which serve as points of attack for a turning tool.
  • FIG. 4b shows the three individual parts from FIG. 4a, that is to say the distraction membrane (20) with the sleeve counterpart (31b), the distraction membrane and the sleeve counterpart being integrally formed, the adjusting nut (37) with internal thread (38) and holes (34) and the sleeve (31a).
  • the sleeve (31 a) with the sleeve counterpart (31 b) can be connected in any suitable manner, for example, welded or glued or held by corresponding elements, such as clip elements.
  • FIG. 5 shows a further alternative embodiment of the implant (100) according to the invention during a use according to the invention for bone distraction in the region of the jaw (50).
  • a spacer sleeve (32) via an internal thread with an external thread (36) of the connecting element (30) screwed or screwed.
  • the Disistionsmennbran (20) is screwed via an internal thread in its hole (25) with an external thread (35) of the spacer sleeve (32) or screwed.
  • the connecting element (30) is designed here so that in the housing (31) a threaded body in the form of a worm (33) is rotatably mounted in the housing (31) such that the worm (33) and the rack (13) in Intervene.
  • the rotational movement of the screw (33) can thus be translated into a translatory movement of the connecting element (30) and thus the distraction membrane (20) on the rack (13).
  • the worm (33) has a point of engagement (34) for a tool, for example an Allen wrench, so that the worm (33) can easily be turned.
  • the jawbone (51) has a bone defect into which the thread (40) of the second, apical part (12) of the implant body (10) is screwed.
  • the distraction membrane (20) is connected via the connecting element (30) by turning the worm (33) on a daily or half-daily basis via an attachment point (34). cutting tool at a rate of 0.2 mm to 2.5 mm per day from the bone defect.
  • Connective tissue (53) is located above the distraction membrane (20).
  • the advantages of the inventive construction of the implant body (10) with a forward-cutting and backward-cutting thread (40) come into play.
  • a forward cutting cutting element (46) is used in the apical region (44) of the thread (40), which cuts a thread in the bone.
  • This is well known from conventional implants and the person skilled in the art is familiar with suitable embodiments.
  • new bone forms in the cervically directed end region (45) of the thread (40), if this is not completely screwed into the bone (51), but also especially in the area of the first, coronal section (11 ) of the implant body (10).
  • the newly formed bone thus encloses portions of the implant body (10), in particular areas of the first implant body part (1 1), which has no thread.
  • the implant (100) is a temporary implant, which is preferred according to the invention, so the implant body (10) must be unscrewed out of the bone again. This is unproblematic in the area of the original bone (51), since an internal thread has already been produced here by the forward-cutting elements of the thread (40). However, such an internal thread is not present in the newly formed bone (54). Therefore, the implant (100) according to the invention has a second cutting element (43) with a cutting edge in the cervical end region (45) of the thread (40), wherein the cutting element (43) is back-cutting.
  • an internal thread can be cut into the newly formed bone (54), so that on the one hand the newly formed bone can be removed by unscrewing the implant body (10) and its protruding parts, for example the thread (40) is not damaged and so that a subsequent permanent implant can be screwed directly into the internal thread of not only the original bone (51) but also the newly formed bone (54).
  • FIG. 6 schematically shows a comparison of an implantation method when using the implant according to the invention in a conventional method.
  • step (1) a tooth gap with a bone defect is shown in which a permanent implant is to be inserted.
  • the bone defect must be filled up with newly formed bone or bone substitute material.
  • step (2) a pilot hole is set both in the conventional method and when using the implant according to the invention.
  • step (3) a conventional provisional implant and in the inventive method of the implant body of Screwed implant according to the invention.
  • the bone defect is now filled up, for example, with bone substitute material.
  • the provisional implant is unscrewed in step (4).
  • step (3) and step (4) When using an implant according to the invention between step (3) and step (4), however, take the intermediate steps (3.1) to (3.5), in which in step (3.1) on the implant body, the Dis dis traction membrane is placed with the connecting element, in the steps (3.2) to (3.4) a distraction osteogenesis, as shown in Figure 5, performed and after completion of osteogenesis in step (3.5) the distraction membrane is removed with the connecting element again from the implant body.
  • step (4) the unscrewing of the implant body takes place, wherein an internal thread is cut into the newly formed bone advantageously by the second backward-cutting cutting element.
  • a permanent implant can be screwed with a crown.
  • the implant according to the invention can be used in a method that complements a conventional, the dentist known method only a few additional steps.
  • the implant according to the invention can therefore be used in a simple manner for a dentist, since he does not have to learn fundamentally new techniques when setting the implant.
  • FIG. 7 shows various embodiments of the preferred implant from FIGS. 2a and 3a.
  • the implants (100) shown in FIGS. 7a, 7b and 7c all have an implant body (10), a distraction membrane (20) and a connecting element (30) with the details as shown in Fig. 3a.
  • the positioning of the distraction membrane (20) with respect to the longitudinal axis of the implant body (10) and thus also of the connecting element (30) is different in each case.
  • the curved distraction membrane (20) is arranged centrally.
  • the hole of the distraction membrane (20), through which the implant body (10) extends, is thus located in the middle of the distraction membrane (20).
  • this hole is preferably not located at the center of the distraction membrane (20) in FIGS.
  • This preferred embodiment of the implant (100) according to the invention has the advantage that a jaw comb, as shown in FIG. 7d, can be covered particularly well by the distraction membrane (20), since a dimpling comb (51) usually has no symmetrical cross section , Depending on the curvature of the alveolar ridge (51), a suitable distraction membrane (20) can thus be selected, whose hole is either only slightly removed from the center of the distraction membrane, as shown in FIG. 7b, or its hole, as shown in FIG. 7c, stronger is removed from the center of the distraction membrane.
  • the dentist may, for example, keep different distraction membranes in stock and, depending on the shape of the alveolar ridge, select the appropriate distraction membrane. It is of course also possible to individually adapt a distraction membrane to a ridge.
  • FIG. 8 shows the preferred embodiment of the implant according to the invention from FIGS. 2a and 3a (100) in combination with a tool (200) for displacing the distraction membrane (20).
  • FIG. 8a again shows the implant (100) with implant body (10), distraction membrane (20) and connecting element (30).
  • the connecting element (30) comprises an adjusting nut (37) with three holes (34) which is not visible in the present case.
  • the tool (200) shown in FIGS. 8b and c is suitable. This has a hole (210) through which the tool can be pushed onto the implant body (10).
  • the tool (200) has three projections (234) which can engage in the holes (34) of the adjusting nut (37).
  • the adjusting nut (37) can be rotated so that it rests against the toothed rack (13) of the implant body (10) Moves direction of the coronal end of the implant body and the Dis Volumemembran (20) via the connecting element (30) entrains.
  • FIG. 8 d shows the tool (200) in a state attached to the implant (100).
  • FIGS. 9 and 10 show the implant (100) according to the invention from FIGS. 2a and 3a with attachable sleeves or caps (301, 302, 303, 304).
  • a longer portion of the first coronal portion (11) of the implant body (10) is exposed because the distraction membrane and the connector have not yet been moved toward the coronal end.
  • this area is protected by a cap (301, 303) which is in the length of the length of the free adjusted area.
  • the cap is clamped to the toothed rack (13) of the implant body (10) or alternatively it may be provided that the cap, as in FIG. 10 a, is connected to the connecting element (30) and in particular the sleeve (31 a) is jammed.
  • the length of the exposed area is shortened because the connecting element (30) and the distraction membrane (20) are displaced in a coronal direction along the implant body (10).
  • shorter protective caps (302, 304) can be used, which in turn like cap (302) of Figure 9b with the toothing (13) of the implant body (10) or as protective cap (304) of Figure 10b with the Sleeve (31 a) can be jammed.
  • further protective caps can be provided which lie in their length between the long protective caps (301, 303) and the short protective caps (302, 304). Since the protective caps can be inexpensively manufactured, for example, from an elastic plastic, a large number of different protective caps can be provided and held by the dentist, which correspond to the respective length of the exposed region of the implant (10). The smooth surface of the caps prevents bacterial colonization and resulting infections.
  • the protective caps make for a more comfortable feel, for example when the exposed implant area is touched by the tongue and reduces the risk of injury.

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  • Prostheses (AREA)

Abstract

L'invention concerne un implant (100) comprenant un corps (10) d'implant et une membrane de distraction (20), ladite membrane de distraction (20) étant reliée au corps (10) d'implant par l'intermédiaire d'un élément de liaison (30). ledit élément de liaison (30) pouvant être monté mobile par l'intermédiaire d'une première zone partielle (11) de l'axe longitudinal du corps (10) d'implant et l'agencement mobile dudit élément de liaison (30) permettant un déplacement de la membrane de distraction (20) le long d'une partie de l'axe longitudinal du corps (10) d'implant. L'invention se caractérise en ce que le corps (10) d'implant présente une seconde zone partielle (12) conçue sous forme de tête de filetage (40) à effet tranchant vers l'avant et vers l'arrière.
EP15703533.8A 2014-01-29 2015-01-29 Implant distracteur à filet tranchant vers l'avant et vers l'arrière Withdrawn EP3099268A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102014001378.2A DE102014001378B3 (de) 2014-01-29 2014-01-29 Distraktionsimplantat mit vorwärts und rückwärts schneidendem Gewinde
PCT/EP2015/051775 WO2015114037A1 (fr) 2014-01-29 2015-01-29 Implant distracteur à filet tranchant vers l'avant et vers l'arrière

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EP3099268A1 true EP3099268A1 (fr) 2016-12-07

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DE102015009933A1 (de) 2015-07-28 2017-02-02 Celgen Ag Distraktionsmembran zur Kallusdistraktion
DE102015009932A1 (de) * 2015-07-28 2017-02-02 Celgen Ag Implantat mit Distraktionsmembran zur Kallusdistraktion
EP4046589A1 (fr) * 2021-02-23 2022-08-24 Edwin Rostami Ensembles implants dentaires, outils et kit correspondants

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US5961329A (en) * 1997-07-02 1999-10-05 Stucki-Mccormick; Suzanne U. Combination distraction dental implant and method of use
EP1301141B1 (fr) * 2000-05-29 2007-05-02 CelGen AG Dispositifs et membranes medicales pour la regeneration osseuse
DE10033918B4 (de) * 2000-07-12 2007-03-22 Wallerius, Torsten N., Dr. Vorrichtung / Implantat zur geführten Distraktionsosteogenese in atrophierten alveolären Kieferknochen
US7396232B2 (en) * 2001-12-05 2008-07-08 Ophir Fromovich Periosteal distraction
DE10212815A1 (de) * 2002-03-22 2003-10-02 Ernst Fuchs Distraktionsgerät für die Osteogenese
JP5418968B2 (ja) * 2009-07-31 2014-02-19 宏 黒澤 上顎洞底挙上用部材
DE102010015687A1 (de) * 2010-04-21 2011-10-27 Ernst Fuchs Magnetisch bewegter Distraktor für die Osteogenese
DE202010018144U1 (de) * 2010-12-10 2014-05-06 Celgen Ag Universaldistraktor zur Knochenregeneration

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Title
See references of WO2015114037A1 *

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WO2015114037A1 (fr) 2015-08-06

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