WO2015114040A1

WO2015114040A1 - Distraction implant having an asymmetric membrane

Info

Publication number: WO2015114040A1
Application number: PCT/EP2015/051781
Authority: WO
Inventors: Domonkos Horvath
Original assignee: Celgen Ag
Priority date: 2014-01-29
Filing date: 2015-01-29
Publication date: 2015-08-06
Also published as: EP3099267A1; DE102014001387A1

Abstract

The present invention relates to an implant, preferably a dental implant, comprising an implant body and a distraction membrane, to the use of the implant for callus distraction and to a method for implanting, the implant comprising a movable connection element between the implant body and the distraction membrane.

Description

Distraction implant with asymmetric membrane description

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 methods of implantation, wherein the implant has a displaceable connecting element between implant body and distraction onsembrane.

In order to be able to permanently and firmly fix implants in a jaw, 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.

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. For bone extraction different methods are used.

With little bone deficiency in the width, the bone necessary for the construction of the jaw bone can be obtained during the operation. 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 undisturbed healing of the bone can take place. Further procedures These include bone spread, bone cleavage, bone-block transplantation, sinus lift, cavity techniques, sometimes using bone replacement matehales and protective membranes, and socket preservation. From a biological point of view, the best substitute for a bone is an autologous cancellous graft. However, such grafts are available only limited and show a high absorption rate after transplantation.

The materials and techniques used in the prior art often provide insufficient bone quality, so that implants are not firmly anchored in their implant bearings.

Callus distraction has been known for over a hundred years. The most important biological stimulus for bone formation is the mechanical stress. This releases piezoelectric forces that activate osteoblasts and osteoclasts. Dissection osteogenesis induces new bone formation by inducing biological growth stimuli through slow separation of bone segments. By this method, the direct formation of braid bones is achieved by distraction. The defined tension in the bone generation is essential. If such a defined tensile stress is applied to bone fragments, the mesenchymal tissue in the gap and at the adjacent fragment ends exhibits an osteogenic potential. In the presence of sufficient vascular potency, progressive distraction results in metaplasia of the organized hematoma, also called blood coagulum, in a zone of longitudinally arranged fibrous tissue that is under optimal external and internal conditions directly into mesh bones. To make matters worse, however, that the bone tissue undergoes highly complex control during its regeneration.

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.

In addition, in an as yet unpublished prior art, the present applicant proposes 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 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 technical problem on which it is based in particular by providing an implant, in particular a dental implant, comprising 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 extends over a first subregion of the longitudinal axis of the implant body is movably arranged and wherein by the movable arrangement of the connecting element, a displacement of the distraction membrane along a longitudinal axis portion of the implant body, in particular the first portion of the longitudinal axis, is enabled, characterized in that the distraction membrane has a hole through which the implant body or the connecting element extends and that the hole is not positioned at the center of the membrane.

In a preferred embodiment, the distraction membrane has a hole through which the implant body passes.

In an alternative embodiment, 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. Thus, the longitudinal axis portion of the Implant body, along which the distraction membrane can be moved, distal to the implant body.

In a preferred embodiment, the distraction membrane is curved. In a preferred embodiment, 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 hole of the distraction membrane to the first side surface is less than the distance of the second Holes to the second side surface.

This asymmetric positioning of the distraction membrane on the implant body axis of the implant according to the invention has the advantage that such a ridge can be covered particularly well by the distraction membrane, since a ridge usually has no symmetrical cross section. Depending on the curvature of the alveolar ridge, it is thus possible to select a suitable distraction membrane whose hole is either only slightly removed from the center of the distraction membrane or whose hole strength is removed from the center of the distraction membrane. The dentist may, for example, keep different distraction mem- bers in stock and select the appropriate distraction membrane depending on the alveolar ridge shape. It is of course also possible to individually adapt a distraction membrane to a ridge.

In a preferred embodiment, the membrane has a four-sided base. In a preferred embodiment, the third side surface is opposite the fourth side surface, wherein the distance of the hole of the distraction tower to the third side surface is approximately equal to the distance of the hole to the fourth side surface. In a preferred embodiment, the implant, in particular a dental implant, comprises an implant body having a longitudinal axis between a first end and a second end and a distraction mesh, the second end of the implant body having a bone screw thread, wherein the distraction membrane is connected to the implant body via a connecting element is, wherein the connecting element is movably arranged over a first portion starting at the first end along the longitudinal axis of the implant body and wherein via the movable arrangement of the connecting element, a displacement of the dis- traction membrane along a longitudinal axis portion of the implant body is made possible, characterized in that the implant reversibly attachable cap for covering the portion of the implant body that lies between the first end of the implant body and the connecting element comprises. In a preferred embodiment, 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 shaped in the region of its opening so that it can be stretched over the first section or can be pushed onto the connecting element and after pushing 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. Thus, rough and edged elements of the implant body are covered, for example, the rack. These would otherwise come in use of the implant either in direct contact with the lying over the bone defect tissue so that could easily accumulate bacteria there, which could lead to infections or they protrude into the oral cavity and lead to an unpleasant sensation to touch Example through the tongue, especially if the implant body is made of metal. Also covered by 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. Preferably, 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. In a preferred embodiment, 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 preferably not a crown, in particular an artificial tooth crown.

In a preferred embodiment, the 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 by the movable arrangement of the connecting element Moving the Distraktionsmembran 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 is rotatably mounted in a sleeve, wherein the sleeve with the Membrane is connected.

An implant according to the invention is preferred, wherein the implant body has a second partial area, which is designed as a thread cutter cutting forward and backward. Before- zugt is an inventive implant, wherein the distraction membrane has a hole through which reaches the implant body. Preferred is an implant according to the invention, wherein the hole is not positioned at the center of the distraction membrane. An implant according to the invention is preferred, comprising the implant body with a longitudinal axis between a first end and a second end and the distraction membrane, wherein the second end of the implant body has a bone screw thread, wherein the connecting element over the first portion starting at the first end along the longitudinal axis the implant body is movably arranged and wherein the implant has a reversibly attachable cap for covering the region of the implant body, which is located between the first end of the implant body and the connecting element. An implant according to the invention is preferred, wherein the implant is a dental implant, in particular a provisional dental implant. Preferred is an implant according to the invention for use in bone distraction.

In a preferred embodiment, the connecting element has a sleeve counterpart, via which the sleeve is connected to the membrane. In a preferred embodiment, the sleeve counterpart is firmly connected to the distraction membrane. Preferably, the sleeve counterpart and the membrane is in one piece, so the sleeve counterpart part of the membrane. In particular, the sleeve counterpart is preferably designed as a shaping of the membrane counterface.

In a preferred embodiment, the internally threaded nut rests on the sleeve counterpart and is rotatably mounted there. Before- given to the sleeve and the sleeve counterpart are connected to each other, for example, glued, welded, bolted, verklennnnt 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 infestation, as a groove or the like is avoided at the transition from membrane mating surface to sleeve counterpart in an advantageous manner.

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.

In a preferred embodiment, 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. In a preferred embodiment, 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. In a preferred embodiment, the first portion is formed as a rack. The rack is preferably a round rack.

In an alternative embodiment, the membrane has a hole, wherein the hole also serves for attaching the connecting element. In an alternative embodiment, 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. In an alternative embodiment, the hole has a thread. The thread may in particular be formed by the hole wall present in the second layer. It is thus preferable for the membrane to have 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.

In an alternative embodiment, the hole has no thread, for example, if in the hole, a connecting element is inserted, glued or clicked or if preferably the membrane and the sleeve counterpart are integrally formed. In a preferred embodiment, the connecting element is located on the mating surface of the membrane or extends into the membrane as viewed from the mating surface.

An implant according to the invention is preferred, comprising an implant body and a distraction membrane, wherein the distraction membrane is connected to the implant body via a connecting element, the connecting element being movably arranged over a first partial area of the longitudinal axis of the implant body and being accessible via the movable arrangement of the connector. 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 portion which is formed as a forward and backward cutting tap. In a preferred embodiment, the implant is a temporary implant. In a preferred embodiment, the implant is a tap. In a preferred embodiment, 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.

In the context of the present invention, a "dental implant" is understood to be an alloplastic fabrication part inserted into the jawbone, whose basic body is preferably pen-shaped or helical.

In a preferred embodiment, the implant is a provisional dental implant. The present invention solves the underlying technical problem in particular by providing a dental implant according to the invention, comprising an implant body and a distraction membrane, wherein the distraction membrane is connected via the connection element with the implant body, wherein the connecting element via a first, coronal portion of the longitudinal axis the implant body is arranged to be movable and wherein the movable arrangement of the connecting element makes it possible to displace the distraction membrane along a longitudinal axis section of the implant body, in particular along the longitudinal axis of the implant body over the first partial area of the longitudinal axis, and wherein the implant body has a second, apical partial area , which is preferably designed as a forward and backward cutting tap. The preferred implant is characterized in particular by the fact that it has an end, in particular a tip for screwing into a bone, wherein the end, in particular the tip is designed as a forward and backward cutting tap. An implant with this preferred construction advantageously makes it possible that no additional, in particular complicated, surgical steps are required for bone formation by distraction osteogenesis than for the actual placement of the implant itself. The procedural steps in setting a conventional dental implant necessarily include the two operative ones Steps a) Create a threaded hole using a tap or temporary implant and following b) inserting and growing the final implant.

Before that, the optional steps of "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. When using an implant according to the invention in step a), 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. Moreover, the placement of the implant body of an implant can advantageously take place in a conventional manner so that the dentist does not have to learn a new technique. After setting the implant body can then be used without much effort, the membrane and connected by the connecting element with the implant body. As a result of the continuous or, in particular, stepwise movement of the connecting element along the implant body away from the bone with a typical distraction speed, the membrane is slowly pulled away from the jawbone so that a distraction osteogenesis occurs between the actual steps a) and b) over a desired period of time. In this case, 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. After the bone structure has been completed to the desired extent, the connecting element can be removed by the dentist. ne surgical effort to be removed from the implant body. If the membrane of the implant is resorbable, then no further operative step for removing the membrane is necessary because it can remain between mucous membrane and bone and is degraded there. When using a nonabsorbable membrane, only a small surgical step is needed to remove the membrane. Afterwards, step b) can then be carried out in the usual way, ie the implant body can be removed and the final implant set. Alternatively, the implant according to the invention can also be a permanent implant and the implant body remain in the bone and, for example, provided with a permanent crown in a dental implant.

Thus, the present invention also provides an implant which allows the conventional steps a) and b) to be carried out in the usual way, but in between to carry out a bone distraction to build up the bone without a major surgical outlay, whereby the individual distraction steps are not necessarily performed by a dentist 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.

It is particularly advantageous if the implant body has a second portion, which is designed as a forward and backward cutting tap. It is possible with this inventive embodiment that the implant according to the invention in step a) when screwing into the bone in the forward direction in a known manner a thread in the wellbore cuts through which the implant is held in the bone. Thereafter, the bone is formed by the distraction of the membrane. After completion of the bone structure implant according to the invention must be removed again so that the final implant in step b) can be set. The implant is removed by unscrewing. The implant is also unscrewed through the newly formed bone. Due to the additionally backward-cutting function of the tap, 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.

When using the implant according to the invention as a final implant, the forward and backward cutting tap is also advantageous since, after setting and healing of the implant, even smaller corrections in the positioning of the implant are possible by minimally turning back the implant.

One skilled in the art will recognize suitable embodiments of forward and reverse cutting taps. In particular, such 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 deberg be formed, for example, by at least one corresponding cutting groove between the thread flanks, ie a notch, which connects at least two thread valleys together, so that at least one threaded mountain has an edge to the notch.

Preferably, the implant is self-tapping. In the context of the present invention, "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 Preferably, the implant has a cutting edge in the apical region for forward cutting Cutting edge formed by the apical end of the threaded mountain.

In a preferred embodiment, the second portion is an external thread having an apically directed end and a cervical end. Preferably, the external thread of the second portion on the cervical end has a cutting edge for cutting backwards. Preferably, the cutting edge is formed by a recess in the thread mountain formed by the threaded thread in the region of the cervical end of the thread. Preferably, the cutting edge is in the thread closest to the cervical end.

Preferably, the external thread of the second portion at the apical end has a cutting edge for forward cutting and at the cervical end a cutting edge for cutting backwards. The external thread of the tap can be catchy or multi-threaded. In the case of a multi-start thread, 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.

In the context of the present invention, "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. In the context of the present invention, "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.

A person skilled in suitable implant body forms are known. In particular, the second portion of the implant body having the tap may be based on a threaded portion of a prior art implant except for the feature that it is cutting forward and backward.

The length of the tap can be removed from the prior art.

In a preferred embodiment, the 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 having a bone screw thread, wherein the distraction membrane is connected via a connecting element with the implant body, wherein the connecting element is arranged to move over a first portion starting at the first end along the longitudinal axis of the implant body 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 has a revertible cap for covering the area of the implant body, which lies between the first end of the implant body and the connecting element, wherein the cap reversible on Fastener is fastened.

In a preferred embodiment, the connecting element has a spacer sleeve.

In a preferred embodiment, the connecting element has a sleeve as a housing with a passage and an internally threaded nut as 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 supported in the housing, that the threaded body and the rack are in operative engagement.

In a preferred embodiment, the implant does not comprise a crown. But it can also be provided a crown. In a preferred embodiment, 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, in particular distraction membrane.

In the context of the present invention, 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 - understood the artificial distraction as well as the introduction and ingrowth of bone substitute materials in a bone defect.

In the context of the present invention, 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. Preferably, the contact surface and the counter surface of the membrane in the non-curved state are rectangular or round. In the non-curved state, 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. In the non-curved state, 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 results from the height and the width of the membrane. The membrane according to the invention is as thin as possible, that is, the size of the side surfaces is many times smaller than the size of the contact surface and in a quadrangular membrane, the height of the membrane is many times smaller than the length and the width of the membrane.

A membrane 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. In a preferred embodiment, the membrane is a distraction membrane.

In the context of the present invention, a "distraction membrane" is understood to mean a medical membrane which can serve or serve as an artificial boundary surface in bone distraction.Such a membrane is preferably rigid and resistant to fracture, in particular dimensionally stable It may be attached to a distraction device and controlled distally at a desired rate, either continuously or individually, away from the bone, for example, pulled away or pushed away from the bone A distraction membrane is thus a specific subset of medical membranes can readily be distinguished by a person skilled in the art from other medical membranes which serve, for example, for easy covering of a bone defect. In the context of the present invention, 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 Zugimpuls is exercised. The element may be, for example, a bone, a bone fragment or an artificial body. In particular, the element may be a distraction membrane.

In connection with the present invention, 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.

In a preferred embodiment, the edges of the membrane are rounded.

In a preferred embodiment, the membrane is made of a metal or a metal alloy. In a preferred embodiment, the membrane, in particular distraction membrane, consists of titanium.

In a preferred embodiment, the membrane, in particular distraction membrane of titanium, wherein the contact surface is coated, wherein the layer is preferably made of a mineral material or predominantly a mineral material contains. The contact surface may, for example, be coated with hydroxyapatite.

In a preferred embodiment, the membrane is made of a resorbable material. As a result, it is advantageously possible to dispense with removing the membrane after the bone has been built up. Rather, the membrane can remain between mucous membrane and bone, where it degrades into harmless substances and decomposed.

In a preferred embodiment, the membrane according to the invention is resorbable, in particular bioresorbable. In a preferred embodiment, the membrane is a bioresorbable distraction membrane.

The person skilled in the art is aware of various materials for resorbable, that is to say biodegradable, membranes and different resorbable membranes known from the prior art. Suitable resorbable materials are, for example, polylactite or polycaprolactone.

Absorbable distraction membranes from the prior art can also be used for the implant according to the invention. However, 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 is 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.

In one embodiment, the membrane may be bilayered. The contact surface is then formed by the second layer. In a preferred embodiment, the membrane is at least three layers. In a preferred embodiment, the membrane is three-layered. In a preferred embodiment, the membrane is three-layered, wherein the contact surface is formed by a third layer.

In a preferred embodiment, 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 contains predominantly a mineral material. In a preferred embodiment, 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 a predominantly a mineral material. The membrane can therefore be two-layered or three-layered. Also, the membrane can still have further layers, such as a fourth layer, a fifth layer or other layers.

The layer which forms the contact surface, that is to say in particular the second layer or the third layer, is preferably designed such that the contact surface permits a particularly good attachment 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. It has surprisingly been found that by a multilayer structure of a membrane, in particular a distraction membrane, it can be constructed in such a way that both the contact surface and the mating surface can interact particularly well with the respective tissues resting against the surfaces. The membrane according to the invention thus represents a surprisingly good substitute for autologous or allogenic bone blocks. In this case, 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, the entire membrane according to the invention is advantageously in spite of adequate stability. absorbability 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. In addition, 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. In a preferred embodiment, 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.

The use of a bioresorbable plastic as a scaffold layer has the additional advantage that this scaffold layer may have a specific shape, for example, may be curved and / or may have a predetermined porosity, which 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.

Due to the materials chosen, the artificial bone fragment according to the invention can advantageously be designed as a membrane despite the multi-layered nature, that is to say be very thin. This has the advantage, compared to known from the prior art natural or artificial bone fragment blocks, which must have a certain thickness, that through the thin first layer and the thin second layer and also by an optional thin third layer improved blood circulation and vascularization can take place.

Without wishing to be bound by theory, the state of the art assumes that an important factor in bone neoplasm is a shielding of the bone defect from ingrowing connective tissue. Therefore, in the treatment of bone defects shielding membranes are often used which shield the bone defect against the connective tissue and prevent ingrowth of the connective tissue into the callus forming in the bone defect. 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 appears to be far more important than the shielding of the bone defect from ingrowth of the surrounding connective tissue. Therefore, the membrane of the invention may preferably be perforated. It can thus have pores which extend from the mating surface through the membrane to the contact surface. Through these pores, 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 compared to bone blocks, the pores are correspondingly short, so that a particularly good connection can be made between the tissue lying against the opposite 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. For a long time, the osteoblasts in the callus experience sufficient biomechanical impulses to stimulate bone formation.

The use of a preferred membrane according to the invention also leads in particular to a good vascularization of the newly forming bone tissue, in particular when the membrane according to the invention has preferred pores which extend through the membrane from the mating surface to the contact surface interconnecting.

In a preferred embodiment, a second layer of the membrane consists of a bioresorbable plastic or contains predominantly a bioresorbable plastic, wherein the second layer has pores with a diameter of at least 10 μιτι, wherein the pores of the interface between the second layer and the first layer for Contact surface through the second layer pass interconnect through.

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. In a preferred embodiment, 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. In particular, 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. Preferably, 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.

A "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 Preferably, the first layer and the second layer form an interface, ie lie against one another second layer may be plate-shaped or scaffold-shaped. According to the invention, the second layer preferably consists of at least one bioresorbable plastic or predominantly contains at least one bioresorbable plastic. According to the invention, the second layer preferably consists of a bioresorbable plastic or predominantly contains a bioresorbable plastic. In a preferred embodiment, 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.

In the context of the present invention, a "resorbable plastic" or a "bioabsorbable plastic" is understood to mean a plastic which is biodegraded and decomposed in the human body, for example a patient. The second layer may contain a single bioresorbable plastic or two or more different bioresorbable plastics. The second layer of a membrane according to the invention preferably consists of a single bioresorbable plastic. The person skilled in various bioresorbable plastics are known. In this case, the person skilled in the art can readily select suitable bioresorbable plastics from which membrane layers can be produced which are suitable as a stable and in particular rigid framework. Suitable bioresorbable plastics are, for example, polylactic acids such as polylactide (PLA) and polycaprolactone (PCL). In a preferred embodiment, the bioresorbable plastic is a polycaprolactone. In a preferred embodiment, the bioresorbable plastic is a polylactide.

In a preferred embodiment, the second layer is designed as a rigid framework and porous. In a preferred embodiment, the second layer is porous.

In a preferred embodiment, 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 preferably has a layer thickness of at least 1 mm. Preferably, 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. Preferably, 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. Preferably, the second layer has a layer thickness of at most 3 mm. The second layer preferably has a layer thickness of at most 2.5 mm. Preferably, the second layer has a layer thickness of at most 2 mm. Preferably, 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.

In the context of the present invention, 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. In particular, 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.

In a preferred embodiment, the membrane is porous. In a preferred embodiment, the membrane has pores, in particular interconnecting pores.

In a preferred embodiment, the second layer is porous.

In a preferred embodiment, the membrane has at least one perforation. In a preferred embodiment, the membrane is perforated. In a preferred embodiment, 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. Furthermore can form in the pores and thus through the membrane vessels, so it can be done a good vascularization of the growing bone. The inventively preferred pores, in particular interconnecting pores, for example with a diameter of about 1 mm, thus allow the passage of capillaries through the membrane, so that in the area of the newly formed bone a very good blood circulation and immune defense is guaranteed. The perforations allow a good circulation of the membrane covering mucosa and the regenerate between the membrane and the bone. In a preferred embodiment, 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 μιτι to pass through the pores, ie a diameter of very fine blood vessels. In a preferred embodiment, the pores have a size, that is a diameter, of at least 0.005 mm and at most 1.5 mm. In a preferred embodiment, the pores have a size of at least 0.01 mm and at most 1.5 mm. In a preferred embodiment, the pores have a size of at least 0.005 mm. In a preferred embodiment, the pores have a size of at least 0.01 mm. Preferably, the pores have a diameter of at least 0.1 mm. The pores preferably have a diameter of at least 0.3 mm. Preferably, the pores have a diameter of at least 0.5 mm. Preferably, the pores have a diameter of about 1 mm. Preferably, the pores have a diameter of at most 1, 5 mm. Preferably, the pores have a diameter of maximum at least 1, 3 mm. Preferably, the pores have a diameter of at most 1, 2 mm.

Preferably, the pores extend through the membrane. The pores preferably 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. For example, 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. In this case, the contact surface is preferably designed so that it allows adhesion of cells, in particular osteoblasts. Preferably, the contact surface is rough. Preferably, the contact surface is porous. In this case, in addition to the preferred interconnecting pores, 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. Preferably, 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 skilled person variously suitable mineral materials are known. Preferably, the mineral material of the third layer is hydroxylapatite and / or tricalcium phosphate. The third layer is preferably formed from hydroxyapatite or contains hydroxylapatite, in particular contains predominantly hydroxylapatite. In an alternative embodiment, the third layer is formed from tricalcium phosphate or contains tricalcium phosphate, in particular contains predominantly tricalcium phosphate. Alternatively, the mineral material of the third layer may include hydroxyapatite and tricalcium phosphate. Preferably, the third layer is porous. Preferably, the interconnecting pores 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. In a preferred embodiment, the third layer has a layer thickness of at least 1, 0 pm to at most 1 mm. The layer preferably has a layer thickness of at least 1.0 μm. The third layer preferably has a layer thickness of at least 2.0 μm. The third layer preferably has a layer thickness of at least 5.0 μm. The third layer preferably has a layer thickness of at least 10 μm. Preferably, 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. Preferably, the third layer has a layer thickness of at most 0.2 mm.

Preferably, the membrane has a thickness of at least 0.1 mm. The preferred membrane thicknesses result in particular from the addition of the preferred thicknesses of the individual layers. Preferably, the membrane has a thickness of at least 0.2 mm to at most 13 mm. Preferably, the membrane has a thickness of at least 0.2 mm. Preferably, the membrane has a thickness of at least 0.5 mm. Preferably, the membrane has a thickness of at most 13 mm. Preferably, the membrane has a thickness of at most 10 mm. Preferably, the membrane has a thickness of at most 5 mm. Preferably, the membrane has a thickness of at most 3 mm. The membrane may be flat or curved. Especially with membranes with a smaller dimension, the membrane may preferably be flat, ie flat.

But especially when used in the jaw area, the membrane can also be arched alternatively. In a preferred embodiment, the membrane is arched. In an alternative embodiment, 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. Thus, the area is also extended to the side walls of the jaw, where also artificial impulses are given by it. This can then serve for comb broadening, since the clinical task of a chamber elevation combined with comb broadening often occurs in combination. In a preferred embodiment, 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. In a preferred embodiment, the edges between the contact surface and the at least one side surface and / or the counter surface and the at least one side surfaces are rounded.

In an alternative embodiment of the invention it can be provided that the edges formed by two side surfaces are rounded.

In a preferred embodiment, the membrane has rounded edges.

In an alternative embodiment, 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) In a preferred embodiment, the periodontal regeneration membrane is very thin In a preferred embodiment, the periodontal regeneration membrane is shaped to have at least one lobe or segment, which or which can be inserted into a tooth space. Alternatively, however, the membrane may also be non-absorbable, that is, consist of or contain nonabsorbable materials. The person skilled in the art is familiar with various nonabsorbable membranes, in particular distraction membranes from the prior art. These can also be used in an implant according to the invention.

In a preferred embodiment, the membrane is made of a biogenic material.

A preferred embodiment contains a nonabsorbable membrane. In a preferred embodiment, the membrane is made of titanium.

The membrane can also consist of ceramics, polymers, composites or collagen or contain these materials.

In a preferred embodiment, 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.

A person skilled in the art will be able to determine a suitable size of the membrane without further ado. 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 preferably has a diameter of at least 3 mm, more preferably at least 4 mm, particularly preferably at least 5 mm, for example about 6 up to 8 mm, in particular 7.15 mm. The diameter refers to round membranes. In the case of angular membranes, in particular rectangular 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.

Since 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.

In a preferred embodiment, the membrane is multi-layered, in particular three-layered. In an alternative embodiment, 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. Thus, a three-layered membrane with a collagen layer, a titanium layer and a hydroxyapatite layer is preferred.

In one embodiment, the membrane is curved so that it has the shape of a portion of a spherical shell, for example, a hemispherical shell. In a further embodiment, the membrane is arched in such a way that it has the shape of a cylindrical shell. In a preferred embodiment, the curvature has a radius which corresponds to the radius of a bone to be treated. For example, corresponds to a long bone or a skull bone.

In a preferred embodiment, the curvature has a radius which corresponds to the radius of a jawbone crest to be treated.

In a preferred embodiment, 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. Preferably, the membrane is intended for single use, as this is common practice in medical membranes and the adhesiveness of the surface of the membrane decreases due to contact with body fluid. The membrane according to the invention may be intended for single use only if it has been manufactured individually for a particular bone defect and / or if it has biodegradable constituents which decompose on use of the membrane.

The membranes can be made up in shape and size or individually adapted to the bone defect to be treated.

In a preferred embodiment, the distraction membrane has a hole through which the implant body passes. In a preferred embodiment, 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.

In a preferred embodiment, the connecting element is attached to the opposite surface of the membrane or plugged into a hole in the membrane or preferably screwed.

Preferably, 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 in the direction of the head of the implant body.

Various embodiments of a suitable connecting element are readily known to the person skilled in the art, 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.

Preferably, 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. Preferably, the point of attack for the tool on the actuating body of the connecting element. In a preferred embodiment, 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.

In an alternative embodiment it can be provided that 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.

In an alternative embodiment, it may be provided that 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. In a preferred embodiment, 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.

In a preferred embodiment, the connecting element has a spacer sleeve. In a preferred embodiment, the sleeve is a spacer sleeve.

In a preferred embodiment, the connecting element is designed as a spacer sleeve.

Preferably, the spacer sleeve at least partially has a conical shape. In an alternative embodiment, 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.

In the prior art, 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. Preferably, the spacer sleeve forms at least the part of the connecting element which is connected directly to the membrane. In this embodiment, the spacer sleeve can fulfill two tasks in an advantageous manner. On the one hand, 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, on the other hand, 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. Thus, 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.

Preferably, therefore, it is provided that 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.

In a preferred embodiment, the connecting element is designed as a spacer sleeve and, wherein the membrane is attached to a surface of the spacer sleeve. Preferably, the membrane with the mating surface is glued to the surface of the spacer sleeve, for example with a fibrin glue.

In an alternative embodiment, the membrane is formed from a surface of the spacer sleeve. The spacer sleeve is designed such that it has an area 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. In this case, 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. Thus, the surface of the spacer sleeve, to which either the membrane is applied or which is formed like a membrane, formed by the base of the frusto-conical cone. Preferably, the size of this base area corresponds to the size of the membrane surface. As the size of the base area 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. Thus, 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. In an alternative embodiment, 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.

In a preferred embodiment, such a spacer sleeve consists of a bioresorbable material. In a preferred embodiment, 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.

In one possible embodiment, 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. In this case, the membrane is preferably rotatably mounted on the spacer sleeve, so that although the spacer sleeve rotates during the distraction, but not the membrane. In a further alternative embodiment of an implant according to the invention with spacer sleeve, 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 moreover advantageously be designed such that neither the implant body nor the spacer sleeve have to be rotated for disctraction, so that irritation of the mucous membrane by rotating the implant body and / or the spacer sleeve is avoided.

For simple and secure connection of the membrane to the connecting element via a screw connection of a spacer sleeve to the membrane, two alternative embodiments may preferably be provided.

In the first embodiment, 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. To connect the membrane with the connecting element, it is sufficient in this embodiment to rotate the spacer sleeve, so that the first thread of the spacer sleeve rotates into the hole of the membrane and at the same time the second thread of the spacer sleeve with the corresponding thread of the at least one further sub-element of the connecting element combines. Thus, by a single rotation, the spacer sleeve can be connected both to the membrane and to the at least one further part of the connecting element.

In the second alternative embodiment, the first thread of the spacer sleeve and the second thread of the spacer sleeve are the same. In this case, the threaded connection between the spacer sleeve and the at least one further element of the connecting element is then designed such that the spacer sleeve can be rotated beyond the final position point into the thread or onto the thread of the at least one further subelement of the connecting element. In this embodiment, 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. If now the spacer sleeve is rotated back to the end point with respect to the at least one further subelement of the connecting element, 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.

Of course, the person skilled in the art also knows many other constructive embodiments which allow the connection of the connecting element to the membrane via a spacer sleeve.

In a preferred embodiment, the connecting element has a housing. In a preferred embodiment, the housing is designed as a spacer sleeve.

In an alternative embodiment, the housing of the connecting element is connected to the spacer sleeve. In a preferred embodiment, 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. Alternatively, 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.

In a preferred embodiment, 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. Preferably, the connecting element can be displaced or controlled in a controlled manner along the second subarea above the lower subarea. Preferably, the second portion is formed as a rack. In a preferred embodiment, 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.

In a preferred embodiment, 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. An embodiment in which the connecting element is designed as a spacer sleeve is also preferred, the diaphragm being fastened to a surface of the spacer sleeve. Or the membrane is formed from a surface of the spacer sleeve, as described above.

In an alternative embodiment, the implant is based on the system of a connecting element with a threaded body, in particular an adjusting nut or a worm gear, an implant body with a rack portion and a diaphragm, wherein the rotational movement of one of the adjusting nut or the Worm gear is translated into a translational movement of the connecting element and thus the diaphragm on the rack. Preferably, the threaded body has a thread with a pitch p = 0.1 to 0.5 mm, in particular about 0.3 mm, in particular 0.3 mm and the rack is correspondingly toothed. By a pitch of 0.3 mm of the threaded body results, for example, per complete revolution of the threaded body, a stroke of 0.3 mm.

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.

Although the spacer sleeve rotates in this embodiment, whereby the growing tissue is irritated, but a simpler construction is provided which can consist of only one part in an advantageous manner.

In a preferred embodiment, the connecting element and the spacer sleeve consist of at least one biogenic material. Preferably, the material is not biodegradable.

In a preferred embodiment, 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 contained. In an alternative embodiment, the connecting element and the spacer sleeve can also consist of a biodegradable material, in particular of a biodegradable plastic such as polylactide or polycaprolactone, or contain this, in particular predominantly contain it.

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.

Alternatively, 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.

In a preferred embodiment, the implant comprises a crown. In a preferred embodiment, the dental implant comprises a crown.

The technical problem underlying the present invention can also be seen in the provision of bone dissection and bone disintegration methods which make it possible to perform bone regeneration procedures also outside the jaw area, overcoming the disadvantages of the prior art. 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 advantageously also be used generally for bone formation by distraction, since it can also be used in an application outside the jaw or in the jaw, without the implant also being intended to function as a tooth replacement. Even with such use, the implant is characterized by a simple structure and good handling.

In an alternative embodiment, the implant is not a dental implant.

In an alternative embodiment, the implant body, and particularly preferably the entire implant according to the invention, can be absorbable, ie consist of resorbable materials. This is particularly advantageous when the implant is not a dental implant, but is used only for bone formation by distraction, which use can be done not only in the jaw, but also in other bones. 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.

In an alternative embodiment, the implant body consists of a resorbable material. In a preferred embodiment, the entire implant then consists of resorbable materials.

In a preferred embodiment, the implant of the invention is for use in bone distraction. In a preferred embodiment, 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 jawbone, by dissection.

In a preferred embodiment, 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 calf 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. In a preferred embodiment, the implant is intended for use in a medical procedure, in particular in a surgical procedure.

In a preferred embodiment, the implant is intended for use in bone regeneration by distraction, especially in the jaw area.

In a preferred embodiment, the implant according to the invention is suitable for use for bone distraction, in particular of a jawbone. In a preferred embodiment, 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. More preferably, the distraction rate is 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.

In an alternative embodiment, the implant according to the invention is a dental implant with a membrane for periodontal regeneration. ration. 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). The present invention also relates to a kit comprising the implant base body of an implant according to the invention, at least one connecting element and at least one membrane, in particular a plurality of different membranes Preferably, the kit contains instructions for use The instructions for use preferably contain information such as the kit for the placement of the implant and the performance of a callus distraction can be used.

A preferred embodiment is a kit according to the invention for use in medical procedures, in particular surgical procedures, preferably in bone distraction, especially 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. The speed is preferably 0.2 mm to 2.5 mm per day, in particular 0.5 mm to 2 mm per day. Particularly preferably, the speed is about 1 mm per day. Without being bound by theory, such a distraction process at the beginning of the process, in particular a distance of about 1, 5 mm between the membrane and bone advantageous.

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 callus, in particular for the development of a jaw bone by distraction, comprising the following steps: a) implanting the implant according to the invention in a bone, preferably a jawbone, wherein the implant is a provisional implant and wherein the second Part of the implant body is at least partially screwed 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;

Preferably, a cap is placed on a dental implant in the method according to the invention.

In the case of a distraction in the area of the jaw, 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;

Preferably, a crown is placed on a dental implant in the method according to the invention.

Preferably, in the method according to the invention, a bioabsorbable membrane is used which does not have to be removed. Alternatively, a non-biodegradable membrane, for example Titanium, to be used. This is preferably also removed after removal of the fastener from the implant body.

Preferably, 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.

Alternatively, 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, clamping or gluing the Verbindungselennents, in particular the spacer sleeve of Verbindungselennents, to the hole of the membrane.

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.

Advantageously, step b), in particular the stepwise displacement of the connecting element by the patient or a non-trained helper, for example by means of a tool which can be attached to a point of application for the tool on the connecting element, preferably on the actuating body of the connecting element ,

Preferred embodiments of the invention will become apparent from the dependent claims.

The invention will be explained in more detail below with reference to FIGS. Show it:

Figure 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;

Figure 3 is another view of the preferred embodiment of the implant of Figure 2 and the corresponding Implant body from three different directions of view; the membrane and the connector of the preferred embodiment of the implant of Figure 2; a further embodiment of the implant according to the invention during a bone distraction in the jaw area; a schematic representation of the treatment steps when using an implant according to the invention in comparison to the use of a prior art implant; further embodiments of the implant according to the invention with differently positioned membranes compared to a centrally positioned membrane; an implant according to the invention with a preferred embodiment of a tool for moving the membrane; an inventive implant in combination with different protective caps; an inventive implant with a further embodiment of protective caps.

Of course, preferred details of the embodiments shown in Figures 1 to 10 can be combined. 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 attack for a tool for screwing into a bone or unscrewing 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) as a sleeve. In this, the membrane (20) is engaged, screwed or glued. In the spacer sleeve (32) an adjusting nut (37) is rotatably mounted, which has an internal thread. By turning the adjusting nut (37), the spacer sleeve (32) and thus also the membrane (20) along the implant body (10) can be moved. 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). According to the invention, the distraction membrane (20) has a hole through which the implant body (10) passes. In this case, the hole in the distraction membrane (20) is not centered, so that the membrane has a longer portion (20a) and a shorter portion (20b).

The apical, second portion (12) of the implant body (10) has an external thread (40) for screwing or boring of the implant body (10) in a bone. The thread (40) has thread 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. In addition, the cervical end region (45) of the thread (40) additionally 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, it can cut 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. In addition, the cervical end region (45) of the thread (40) has a second cutting element (43) with a cutting edge which is rearward-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. 2a, whereby also the projections of the coronal, first subregion (11) with the toothed rod (13) can be seen in the form of a round toothed rod , 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 region (44) of the thread (40) has a forwardly 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 rearward-separating, ie when the implant body (10) is unscrewed from the bone. thread 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 subdivided again 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 attack 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 engagement points for a tool for rotating an adjusting nut of the connecting element (30), whereby the membrane (20) along the first, coronal part (1 1) of the implant body (10) along can be moved because 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.

In FIG. 3b, the implant body (10) of the implant from FIG. 3a without membrane and connecting element can be seen in three different perspectives. On the one hand, the design of the coronal first portion (11) as a rack (13) becomes clear. On the other hand, in the second, apical part (12) in both Direction cutting threads (40) with the apical end portion (44) and a local cutting element and the cervical end portion (45) with a second cutting element (43) clearly visible. The second cutting element (43), having a cutting edge (43a) formed by a notch (43b) in the uppermost flight of the thread, allows the cutting of a thread in the bone newly formed by the callus distraction by means of the membrane during unscrewing of the bone 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) according to the invention has a hole through which the implant body (10) can pass. In this case, the hole in the distraction membrane (20) is not centered, so that the membrane has a longer portion (20a) and a shorter portion (20b) and thus the distance of the hole (29) of the distraction membrane (20) to the first side surface (27 ) is less than the distance of the hole to the second side surface (28). The distance between the two other side surfaces to the hole is the same. 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). In this case, the sleeve counterpart (31 b) is firmly connected to the distraction membrane (20) or Component of the membrane (20). Preferably, the Distraktionsmennbran (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. Thus, the Distraktionsmembran (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). When assembling the device, 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).

Shown again are the implant body (10) with second apical region (12) and first coronal section (11) with rack (13), the distraction membrane (20) with contact surface (21), counter surface (22) and interconnecting perforations or Pores (23) and the connecting element (30). In this embodiment, a spacer sleeve (32) via an internal thread with an external thread (36) of the connecting element (30) screwed or screwed. The distraction membrane (20) is screwed or screwed into an internal thread in its hole (25) with an external thread (35) of the spacer sleeve (32).

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 worm (33) can thus be translated into a translational 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 be turned easily.

Furthermore, a jawbone (51) with two teeth (52) can be seen. 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.

With this structure, an inventive method for bone structure is possible. In this case, the distraction membrane (20) via the connecting element (30) by daily or half-daily turning the screw (33) via a tool to the point (34) attaching tool at a speed of 0.2 mm to 2.5 mm per day removed from the bone defect. As a result, tissue (54) resting on the contact surface (21), in particular callus, becomes distraction pulses which trigger bone formation. Connective tissue (53) is located above the distraction membrane (20). According to the invention, the distraction membrane (20) has a longer part (20a) and a shorter part, whereby only the longer part (20) with the second side (28) can be seen here. This has the advantage that the membrane can cover the asymmetrical structure of a jawbone particularly well. Through the interconnecting perforations or pores (23) of the distraction membrane (20), it is possible to exchange substances and blood between the tissue (54) resting against the contact surface (21) and the tissue (53) resting against the counter surface (22).

Before and after this method of bone augmentation by callus distraction using the distraction membrane (20), the benefits of the preferred implant body (10) construction with a forward cutting and backward cutting thread (40) are borne in mind. When screwing the implant body (10) into the bone (51), 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 those skilled in the art will appreciate suitable embodiments. In the subsequent distraction osteogenesis, 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 above all in the area of the first, coronal section (FIG. 1 1) 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. However, if the implant (100) is a temporary implant, which is preferred according to the invention, then the implant body (10) must be screwed 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. As a result, when the implant body (10) is unscrewed after complete distraction, an internal thread can advantageously be cut into the newly formed bone (54) so that, on the one hand, the newly formed bone is 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 not only of the original bone (51) but also of the newly formed bone (54).

FIG. 6 schematically shows a comparison of an implantation method when using the implant according to the invention with preferred forward and reverse cutting threads in a conventional method. In step (1), a tooth gap with a bone defect is shown in which a permanent implant is to be inserted. For this, the bone defect must be filled up with newly formed bone or bone substitute material. It will as shown in step (2), set a pilot hole both in the conventional method and when using the implant according to the invention. In the pre-drilling, a conventional provisional implant is then screwed in step (3) in a conventional method and in the method according to the invention the implant body of the implant according to the invention. In a conventional method, the bone defect is now filled up, for example, with bone substitute material. After a healing phase, the provisional implant is unscrewed in 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. Now, when using the implant according to the invention in 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. Both in the conventional method and in the method with the implant according to the invention then in step (5) a permanent implant can be screwed with a crown. Thus, 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. In order for the implant according to the invention is in a simple manner for a dental doctor, since he does not have to learn fundamentally new techniques when placing 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. However, 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. In FIG. 7a, the curved distraction membrane (20) is not arranged centrally in accordance with the invention. 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). In contrast, according to the invention, this hole is not located at the center of the distraction membrane (20) in FIGS. 7b and 7c. Thus, the distraction membrane projects farther on one side (20a) than on the opposite side (20b). This embodiment of the implant (100) according to the invention has the advantage that a jaw ridge, as shown in FIG. 7d, can be covered particularly well by the distraction membrane (20), since a jaw ridge (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, more strongly from the center the distraction membrane is removed. 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's natural, too possible to adapt a distraction membrane individually to a ridge.

Figure 8 shows the preferred embodiment of the implant of Figures 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). As can be seen from FIGS. 2 a and 3 a and 4, the connecting element (30) comprises an adjusting nut (37) with three holes (34) which is not visible in the present case. For turning the adjusting nut (37) and thus for displacing the distraction membrane (20) along the first, coronal area (11) of the implant body (10), 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). Furthermore, the tool (200) has three projections (234) which can engage in the holes (34) of the adjusting nut (37). Thus, by turning the grip part (21 1) over the three connections between the holes (34) and protrusions (234), 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 Distraktionsmembran (20) via the connecting element (30) entrains. FIG. 8 d shows the tool (200) in a state attached to the implant (100). Figures 9 and 10 show the implant (100) of Figures 2a and 3a with attachable sleeves or caps (301, 302,303,304). At the beginning of a distraction osteogenesis, a longer area of the first coronal portion (11) of the implant body (10) is exposed, since the distraction membrane and the connecting element have not yet been moved in the direction of the coronal end. In an advantageous embodiment, this area is protected by a cap (301, 303) which is adapted in the length of the length of the exposed area. It can be provided, for example, as in Figure 9a, that the cap with the rack (13) of the implant body (10) is clamped or it may alternatively be provided that the cap, as in Figure 10a with the connecting element (30) and in particular the Sleeve (31 a) is jammed.

During distraction, 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). Thus, during a later phase of the distraction, shorter protective caps (302, 304) can be used, which in turn, like the cap (302) of FIG. 9b with the toothing (13) of the implant body (10) or protective cap (304) of FIG. 31 a) can be jammed. Of course, 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 plurality of different protective caps can be provided and held by the dentist, which correspond to the respective length of the exposed area of the implant (10). The smooth surface of the caps prevents bacterial colonization and resulting infections. representation In addition, the protective caps make for a more comfortable wearing, for example when the exposed implant area is touched by the tongue and prevents injuries.

Claims

claims

1 . An implant (100) comprising an implant body (10) and a distraction membrane (20), wherein the distraction membrane (20) is connected to the implant body (10) via a connection element (30), the connection element (30) being connected via a first Partial region (1 1) of the longitudinal axis of the implant body (10) is movably arranged and wherein by the movable arrangement of the connecting element (30) a displacement of the distraction membrane (20) along a longitudinal axis portion of the implant body (10) is made possible, characterized in that the distraction membrane (20) has a hole (29) through which the implant body (10) or the connecting element (30) passes and in that the hole (29) is not positioned at the center of the distraction membrane (20).

The implant of claim 1, wherein the distraction membrane (20) is positioned distal to the implant body (10).

3. An implant according to claim 1 or claim 2, wherein the distraction membrane (20) is curved.

4. An implant according to claim 1 or claim 3, wherein the distraction membrane (20) has a hole (29) through which the implant body (10) passes.

5. An implant according to any one of the preceding claims, wherein the distraction membrane (20) has a first side surface (27), a second side surface (28), a third side surface and a fourth side surface, the first side surface (27) of the second side - ten surface (28) is opposite and wherein the distance of the hole

(29) of the distraction membrane (20) to the first side surface (27) is less than the distance of the hole (20) to the second side surface (28).

The implant of claim 5, wherein the third side surface is opposite the fourth side surface, and wherein the distance of the hole (29) of the distraction membrane (20) to the third side surface is approximately equal to the distance of the hole (29) to the fourth side surface.

7. Implant according to one of the preceding claims, wherein the first portion (1 1) is designed as a rack (13) and the connecting element (30) on a toothed rod (13) formed on the first portion (1 1) rotatable internally threaded nut (37) which is rotatably mounted in a sleeve (32, 31 a), wherein the sleeve (32, 31 a) with the distraction membrane (20) is connected.

8. Implant according to claim 7, wherein the connecting element

(30) has a sleeve counterpart (31 b) through which the sleeve (31 a) is connected to the distraction membrane (20) and wherein the sleeve counterpart (31 b) is firmly connected to the distraction membrane (20).

9. Implant according to one of the preceding claims, wherein the implant body (10) has a second portion (12) which is designed as a forward and backward cutting tap (40).

10. Implant according to one of the preceding claims, comprising the implant body (10) with a longitudinal axis between a first end and a second end and the distraction membrane (20), wherein the second end of the implant body (10) has a bone screw thread (40), wherein the connecting element (30) over the first portion (1 1) starting at the first end along the longitudinal axis of the implant body (10) is movably arranged and wherein the implant (100) a reversibly attachable cap (301, 302, 303, 304) for covering the area of the implant body (10) between the first end of the implant body and the Connecting element (30) is located.

1 1. Implant according to one of the preceding claims, wherein the implant is a dental implant, in particular a provisional dental implant.

12. Implant according to one of the preceding claims for use in a bone distraction.

13. A method for callus distraction, in particular for the construction of a jaw bone by distraction, comprising the following steps: a) implanting an implant according to one of claims 1 to 12 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 screwed into the bone or a predrilled hole in the bone; b) performing a distraction osteogenesis with the membrane of the implant; c) removing the fastener from the implant body; d) unscrewing the provisional implant body from the bone;

14. A method for implanting a permanent dental implant according to any one of claims 1 to 12, comprising the following steps: a) implanting the implant in a bone, preferably a jawbone, wherein the implant is a permanent implant; b) performing a distraction osteogenesis with the membrane of the implant; c) removing the fastener from the implant body.