DE102014001387A1 - Distraction implant with asymmetric membrane - Google Patents

Abstract

The present invention relates to an implant, preferably a dental implant, comprising an implant body and a distraction membrane, the use of the implant for callus distraction and method of implantation, wherein the implant has a displaceable connecting element between the implant body and distraction 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 method of implantation, wherein the implant has a displaceable connecting element between the implant body and distraction membrane.

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 width, the bone needed for jawbone augmentation can be gained during surgery. It can also be used bone substitute material or the addition amount can be stretched by mixing bone and substitute material. This augmentation area is often protected with a flexible membrane, so that an undisturbed healing of the bone can take place. Other procedures include bone spreading, bone cleavage, bone block grafting, sinus lift, cavity techniques, sometimes using bone substitute materials 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. Distraction 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. When there is sufficient vascular potency, progressive distraction results in metaplasia of the organized hematoma, also called blood coagulum, in a zone of longitudinally-arranged, fibrous tissue that can transform directly into cortical bone under optimal external and internal conditions. To make matters worse, however, that the bone tissue undergoes highly complex control during its regeneration.

The WO 03/051220 A2 describes a method of distracting a jawbone using bone segments. The DE 10 2010 055 431 A1 , the WO 01/91663 A1 and the US 5,980,252 describe devices and methods for callus distraction by means of artificial interfaces, for example membranes. The US 6,537,070 B1 discloses a multi-part implant intended to produce a distraction osteogenesis by unscrewing the items. 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 that allow to perform 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 a displacement of the distraction membrane along a longitudinal axis portion of the implant body, in particular of the first portion of the longitudinal axis, is made possible by the movable arrangement of the connecting element, characterized in that the distraction membrane has a hole through which the implant body extends through and that the hole not positioned at the center of the membrane.

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 particularly well covered by the distraction membrane, since a jaw comb 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. For example, the dentist may stock different distraction membranes and, depending on the shape of the alveolar ridge, select the appropriate distraction membrane. It is of course also possible to individually adapt a distraction membrane to a ridge.

In a preferred embodiment, the membrane has a four-sided base.

In a preferred embodiment, the third side surface opposes the fourth side surface, wherein the distance of the hole of the distraction membrane 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 dental implant, comprises an implant body having a longitudinal axis between a first end and a second end and a distraction membrane, wherein the second end of the implant body has a bone screw thread, wherein the distraction membrane is connected to the implant body via a connecting element, wherein the connecting element is arranged to be movable over a first subregion starting at the first end along the longitudinal axis of the implant body and wherein the movable arrangement of the connecting element enables a displacement of the distraction membrane along a longitudinal axis section of the implant body, characterized in that the implant has a reversibly attachable cap to Covering the region of the implant body lying between the first end of the implant body and the connecting element.

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 formed in the region of its opening so that it can be pushed by stretching on the first portion or on the connecting element and after being pushed by the expansion pressure firmly against the first portion or on the connecting element and is pressed. So she can not slip off by itself, but be withdrawn with the appropriate train again. 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. Otherwise, if the implant were used, they would either come into direct contact with the tissue lying above the bone defect, so that bacteria could easily accumulate there, which could lead to infections or they protrude into the oral cavity and cause an unpleasant sensation when touched, for example, by 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 via a connecting element to the implant body, wherein the connecting element is arranged to be movable over a first portion of the longitudinal axis of the implant body and wherein the movable arrangement of the connecting element, a displacement of the Distraction membrane along a longitudinal axis portion of the implant body is made possible, characterized in that the first portion is formed as a rack and the connecting element has a rotatable on the rack formed as the first portion internally threaded nut which is rotatably mounted in a sleeve, wherein the sleeve connected to the membrane is.

An implant according to the invention is preferred, wherein the implant body has a second partial region, which is designed as a thread cutter cutting forward and backward. An implant according to the invention is preferred, the distraction membrane having a hole through which the implant body passes. Preferred is an implant according to the invention, wherein the hole is not positioned at the center of the distraction membrane. Preferred is an implant according to the invention, 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 of the implant body is movably arranged and wherein the implant has a reversibly attachable cap for covering the region of the implant body, which lies 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. Preferably, the sleeve and the sleeve counterpart are connected to each other, for example glued, welded, bolted, jammed or connected via a click connection.

The inventively preferred construction of the connecting element with sleeve, sleeve counterpart and internally threaded nut rotatably mounted in the sleeve has the additional technical advantage that so above the membrane by the connector a smooth shape is formed, at which bacteria can only be poorly set. The preferred one-piece design of the membrane and the sleeve counterpart further enhances this protection against bacterial 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, 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 is movably arranged over a first portion of the longitudinal axis of the implant body and wherein 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 designed 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 main 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 connecting element with the implant body, wherein the connecting element via a first, coronal portion of the longitudinal axis of the implant body is movably arranged and wherein on the movable arrangement of the connecting element, a displacement of the distraction membrane along a longitudinal axis portion of the implant body, in particular along the longitudinal axis of the implant body over the first portion of the longitudinal axis is enabled, and wherein the implant body has a second, apical portion, preferably as forward and backward cutting tap is formed.

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 makes it possible advantageously for bone formation by distraction osteogenesis not to require additional, in particular costly, surgical steps than for the actual placement of the implant itself. The procedural steps in setting a conventional dental implant necessarily include the two operative steps a ) Creating a borehole that has a thread, using a tap or a provisional implant and subsequently b) insertion and waxing of 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 connector can be removed by the dentist without any operational effort 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 may also be a permanent implant and the implant body remain in the bone and provided with a permanent crown, for example, in a dental implant.

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 embodiment of the invention that the implant according to the invention in step a) when screwing into the bone in the forward direction in a known manner cuts a thread in the borehole, 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 of 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 additional 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.

Even when using the implant according to the invention as a final implant of the forward and backward cutting tap is advantageous because even after setting and healing of the implant even smaller corrections in the positioning of the implant by a minimal turning back of the implant are possible.

One skilled in the art will recognize suitable embodiments of forward and reverse cutting taps. In particular, such a thread cutter are designed as an external thread having at least one corresponding cutting element. Suitable cutting elements are in particular cutting edges or cutting grooves. These can in particular be formed on the thread mount, for example by at least one corresponding cutting groove between the thread flanks, that is, a notch, the at least two Threaded valleys interconnects, 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 pre-drilling of the threaded hole and without pre-cutting the thread. The implant preferably has a cutting edge in the apical region for forward cutting. For example, a cutting edge may be formed through the apical end of the threaded mount.

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 threaded mountain formed by the thread flanks 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 as the implant is being 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 has a bone screw thread, wherein the distraction membrane is connected via a connecting element with the implant body, wherein the connecting element via a first portion is movably disposed 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 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 is a reversibly attachable cap for covering the region of the implant body that lies between the first end of the implant body and the connecting element, wherein the cap is reversibly attachable to the connecting element t.

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 be a medical membrane used in medical A method for regenerating a bone or in the introduction of bone substitute materials is used in a bone defect. The term "bone regeneration" is understood to mean both the formation of new bone, for example by natural or artificial distraction, and the introduction and incorporation of bone replacement 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 resulting 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 or will serve as an artificial interface in bone distraction. Such a membrane is preferably rigid and resistant to fracture, in particular dimensionally stable. A distraction membrane is preferably designed such that it can be attached to a distraction device and controlled by the distraction device at a desired speed continuously or in single steps from the bone can be removed, for example, pulled away from the bone or pushed away. A distraction membrane is thus a specific subset of medical membranes that can be readily distinguished by one of ordinary skill in the art from other medical membranes that, for example, serve to readily cover 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 the context of 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 Distraktionsmembran made of titanium, wherein the contact surface is coated, wherein the layer preferably consists of a mineral material or predominantly contains a mineral material. The contact surface may, for example, be coated with hydroxyapatite.

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, polylactitol or polycaprolactone.

Resorbable distraction membranes of 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 counter surface, 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 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 predominantly contains 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 predominantly a mineral material. The membrane can therefore be two-layered or three-layered. The membrane may also have further layers, for example a fourth layer, a fifth layer or further layers.

The layer which forms the contact surface, 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 particularly advantageous in the case of a distraction membrane, since this ensures that adhering cells of the callus are distracted particularly well by the movement of the membrane, ie, they experience biomechanical impulses.

It has surprisingly been found that, by means of 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. The collagen of the first layer of a membrane according to the invention acts on the connective tissue present on the opposite surface. At the same time, this collagen layer can serve as protection of the rigid second layer. The second layer, which preferably consists of a bioresorbable plastic or contains predominantly a bioresorbable plastic, serves as a scaffold structure, so that the membrane can be rigid and non-bendable and thus suitable for use as a distraction membrane. Due to the preferred use of resorbable plastics sufficient stability of the membrane is achieved, so that can be dispensed with the use of metals, such as titanium. Thus, in spite of sufficient stability, the entire membrane according to the invention is advantageously resorbable in the body, so that the membrane or membrane parts do not have to remain in the body or have to be surgically removed again. In addition, the bioresorbable plastic is well suited as a contact surface for cells, especially osteoblasts of a callus or can be well coated with a third layer. In a preferred embodiment, this contact surface can therefore be formed in particular also 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, the blood circulation and promotes 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 over the prior art natural or artificial bone fragment blocks, which must have a certain thickness, that improved perfusion and vascularization are provided by the thin first layer and the thin second layer, and also by an optional thin third layer can take place.

Without wishing to be bound by theory, the state of the art assumes that an important factor for bone regeneration is a shielding of the bone defect from ingrowing connective tissue. Therefore, in the treatment of bone defects often shielding membranes are used, which shield the bone defect against the connective tissue and prevent ingrowth of the connective tissue in the bone defect forming callus. This shielding is often considered more important than the presence of biomechanical pulses that stimulate osteoblasts to form bone. Surprisingly, however, the provision of biomechanical pulses for bone formation 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 from the tissue lying against the opposing surface to the callus present on the contact surface. The fact that connective tissue can also grow into the bone defect area surprisingly plays a subordinate role as long as the osteoblasts in the callus experience sufficient biomechanical impulses to be stimulated for bone formation.

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 predominantly contains a bioresorbable plastic, wherein the second layer has pores with a diameter of at least 10 microns, 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 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 and 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. Particularly preferably, the layer thickness of the first layer is 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, so they are adjacent to each other. Preferably, the second layer is rigid. The 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 "bioresorbable plastic" is understood as meaning a plastic which is biodegraded and decomposed in the human body, for example a patient. The second layer may 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. Preferably, the second layer 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, "rigid" is understood to mean that the membrane does not break due to tensile and compressive forces of the order of magnitude that occur in a callus distraction, preferably also 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, whereby the blood can then be guided by capillary forces through the membrane to the respective other surface, so that a good circulation of the callus tissue and / or attached to the membrane connective tissue is achieved. In addition, vessels can form in the pores and thus through the membrane, so that a good vascularization of the growing bone can take place. 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 region 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 μm 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. Preferably, the pores 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 at most 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 area, which promotes the blood circulation, and the adhesion area 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 hydroxyapatite 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 μm 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. Preferably, the third layer has a layer thickness of at least 5.0 microns. 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 curved. 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 the comb broadening, since the clinical task of a chamber increase along with comb broadening occurs very often combined.

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 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 as 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). In a preferred embodiment, the membrane for periodontal regeneration is so small that it can also be used in interdental spaces. In a preferred embodiment, the membrane for periodontal regeneration is very thin. In a preferred embodiment, the periodontal regeneration membrane is shaped to have at least one lobe or segment that 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. Preferably, the membrane has a diameter of at least 3 mm, more preferably at least 4 mm, more preferably at least 5 mm, for example about 6 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. Preferably, the third layer forming the contact surface is hydroxyapatite. 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 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 of the invention may be intended for single use only if it has been individually prepared for a particular bone defect and / or if it has biodegradable constituents which decompose upon 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 towards 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 application 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 no Has thread, but this is milled when screwing the connecting element by the 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 Range of jaw passes through the oral mucosa and thus it forms the boundary between the lying under the mucous membrane and lying over the mucous membrane further sub-elements of the connecting element. This can be generated by the membrane and the spacer sleeve, a smooth, not sharp-edged surface, with which the mucous membrane comes into contact, so that the mucosa during distraction not on the implant body, especially on sharp-edged parts of the implant body, such as the threaded portion or the optional Rack part, rubs.

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 or 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. Since the size of the base of the cone is determined in particular by the angle between a generating line and the cone axis, thus, the membrane surface 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 connection, via a plug connection or via a latching connection or via a click connection.

The preferred implant according to the invention with spacer sleeve can moreover advantageously be configured such that neither the implant body nor the spacer sleeve has 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 subelement 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 configured so that the spacer sleeve can be rotated beyond the end 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 membrane 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, in that the internal thread of the housing can be screwed.

The spacer sleeve can be screwed into the membrane self-tapping. Alternatively, the spacer sleeve is screwed with an external thread in a befindliches in the membrane matching internal thread.

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 portion with a thread and a second portion above the lower portion. 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, wherein the executed as a rack part of the implant body is inserted in the longitudinal extent through the passage at least substantially free of play through the housing, and wherein the threaded body rotatably supported in the housing 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. Preferred is also an embodiment in which the connecting element is designed as a spacer sleeve, wherein the membrane is attached 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 worm gear, an implant body with a rack portion and a diaphragm, wherein the rotational movement of the adjusting nut or worm gear in a translational movement of the connecting element and thus the diaphragm is translated to 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 of at least one biogenic material. Preferably, the material is not biodegradable.

In a preferred embodiment, the connecting element and the spacer sleeve of titanium or a titanium alloy, in particular the material TlAl4V, zirconium or a stainless steel or this contained, in particular predominantly contain.

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.

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 tools and methods which make it possible to perform bone regeneration procedures also outside the jaw area, which overcomes 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 may be absorbable, that is to say 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, this use can be done not only in the jaw area, but also in other bones. An absorbable 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 jaw bone, by distraction.

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 callus distraction in the jaw region. In a preferred embodiment, the dental implant is suitable for bone regeneration in the jaw area. In a preferred embodiment, the dental implant is suitable for periodontal regeneration in the jaw area.

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 region.

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. Periodontal regeneration is understood as 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 containing an implant according to the invention. The present invention also relates to a kit containing 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.

The kit preferably contains an instruction manual. The instructions for use preferably contain information on how the kit can be used for setting the implant and performing a callus distraction.

A preferred embodiment is a kit according to the invention for use in medical procedures, in particular surgical procedures, preferably in bone distraction, 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. Most 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 is advantageous.

The slow removal of the membrane from the bone defect can be continuous or discontinuous, for example daily or half-daily.

• a) Implantieren des erfindungsgemäßen Implantats in einen Knochen, bevorzugt einen Kieferknochen, wobei das Implantat ein provisorisches Implantat ist und wobei der zweite Teilbereich des Implantatkörpers zumindest teilweise in den Knochen oder ein vorgebohrtes Loch im Knochen hineingedreht wird;
• b) Durchführen einer Distraktionsosteogenese mit der Membran des erfindungsgemäßen Implantats; insbesondere wie oben beschrieben;
• c) Entfernen des Befestigungselements vom Implantatkörper;
• d) Herausdrehen des provisorischen Implantatkörpers aus dem Knochen;

The present invention also relates to methods for callus distraction, in particular for the construction 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 portion 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.

• a) Implantieren des erfindungsgemäßen Implantats in einen Knochen, bevorzugt einen Kieferknochen, wobei das Implantat ein dauerhaftes Implantat ist;
• b) Durchführen einer Distraktionsosteogenese mit der Membran des erfindungsgemäßen Implantats; insbesondere wie oben beschrieben;
• c) Entfernen des Befestigungselements vom Implantatkörper;

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, a bioresorbable membrane is used in the method according to the invention, which need not be removed. Alternatively, a non-biodegradable membrane, for example of titanium, may be used. This is preferably also removed after removal of the fastener from the implant body.

• a1) Implantieren des Implantatkörpers in den Knochen;
• a2) Aufstecken der Membran auf den Implantatkörper und Anlegen der Membran an den Knochendefekt;
• a3) Aufstecken des Verbindungselements auf den Implantatkörper; und
• a4) Befestigen des Verbindungselements an die Membran, beispielsweise durch Verschrauben, Feststecken, Festrasten, Festklicken oder Festkleben des Verbindungselements, insbesondere der Distanzhülse des Verbindungselements, an das Loch der Membran.

Preferably, step a) of the processes 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.

• a1) Anlegen der Membran an den Knochendefekt;
• a2) Einführen des Implantatkörpers in das Loch der Membran und implantieren des Implantatkörpers in den Knochen;
• a3) Aufstecken des Verbindungselements auf den Implantatkörper; und
• a4) Befestigen des Verbindungselements an die Membran, beispielsweise durch Verschrauben, Feststecken, Festrasten, Festklicken oder Festkleben des Verbindungselements, insbesondere der Distanzhülse des Verbindungselements, an das Loch der Membran.

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, clipping or gluing the connecting element, in particular the spacer sleeve of the connecting element, to the hole of the membrane.

Prior to step a), the optional steps of "setting a pilot hole in the bone" and "extending the pilot hole" may 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:

1 the cross section of an embodiment of an implant according to the invention;

2 a further preferred embodiment of the implant according to the invention and a detailed view of the second portion with thread cutter;

3 another view of the preferred embodiment of the implant of 2 as well as the corresponding implant body from three different viewing directions;

4 the membrane and the connecting element of the preferred embodiment of the implant of 2 ;

5 a further embodiment of the implant according to the invention during a bone distraction in the jaw area;

6 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;

7 further embodiments of the implant according to the invention with differently positioned membranes compared to a centrally positioned membrane;

8th an implant according to the invention with a preferred embodiment of a tool for moving the membrane;

9 an inventive implant in combination with different protective caps;

10 an inventive implant with a further embodiment of protective caps.

Of course, preferred details in the 1 to 10 shown embodiments are combined with each other.

1 shows the cross section of an embodiment of an implant according to the invention ( 100 ). The implant ( 100 ) comprises an implant body ( 10 ), a distraction membrane ( 20 ) and a connecting element ( 30 ).

The coronal, first subregion ( 11 ) of the implant body ( 10 ) is as a rack ( 13 ) educated. The implant body ( 10 ) has a hole ( 14 ), as a point of attack for a tool for screwing into a bone or unscrewing from a bone of the implant body ( 10 ) serves.

The distraction membrane ( 20 ) has a contact surface ( 21 ) and a counter surface ( 22 ) on. The contact area ( 21 ) is preferably formed by a coating, for example of a mineral material.

The distraction membrane ( 20 ) is via the connecting element ( 30 ) with the implant body ( 10 ) such that the membrane ( 20 ) along the implant body ( 10 ) can be moved or moved exactly. The connecting element ( 30 ) has a partially conical spacer sleeve ( 32 ) as a sleeve. In this is the membrane ( 20 ) engaged, screwed or glued. In the spacer sleeve ( 32 ) is an adjusting nut ( 37 ) 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 ) are moved. The adjusting nut ( 37 ) is thus a rotatably mounted threaded body, with the rack ( 13 ) of the coronal section ( 11 ) of the implant body ( 10 ) is in operative engagement.

The distraction membrane ( 20 ) according to the invention has a hole through which the implant body ( 10 ) passes through. The hole in the distraction membrane ( 20 ) not centered, so that the membrane is a longer section ( 20a ) and a shorter section ( 20b ) having.

The apical, second subregion ( 12 ) of the implant body ( 10 ) has an external thread ( 40 ) for screwing or drilling in the implant body ( 10 ) in a bone. The thread ( 40 ) has valleys ( 41 ) and threaded mountains ( 42 ), through which the thread flanks are formed. The thread ( 40 ) has an apical end region ( 44 ) and a cervical end region ( 45 ). The thread ( 40 ) is designed as a forward cutting thread, so that when screwing in 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 a second cutting element ( 43 ) with a cutting edge, which is backward-diverging, so when unscrewing the implant body ( 10 ) can cut an internal thread into the bone from the bone.

2 shows in 2a an overview of a preferred embodiment of the implant according to the invention ( 100 ). The implant ( 100 ) comprises an implant body ( 10 ), a curved distraction membrane ( 20 ) and a connecting element ( 30 ).

The coronal section ( 11 ) of the implant body ( 10 ) is again as a rack ( 13 ) educated.

The apical area ( 12 ) of the implant body ( 10 ) again has an external thread ( 40 ) for screwing or drilling in the implant body ( 10 ) in a bone. The thread ( 40 ) has valleys ( 41 ) and threaded mountains ( 42 ), through which the thread flanks are formed. The thread ( 40 ) has an apical end region ( 44 ) and a cervical end region ( 45 ). The thread ( 40 ) is designed as a forward cutting thread, so that when screwing in 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 ) a second cutting element ( 43 ) with a cutting edge, which is backward-diverging, so when unscrewing the implant body ( 10 ) cuts an internal thread from the bone into the bone.

2 B shows an enlarged section of the apical, second portion ( 12 ) of the implant body ( 10 ) out 2a although the approaches of the coronal, first subarea ( 11 ) with the rack ( 13 ) can be seen in the form of a round rack.

The apical area ( 12 ) of the implant body ( 10 ) again has a forward-cutting external thread ( 40 ) with thread valleys ( 41 ) and thread mountains ( 42 ) as well as an apically directed end region ( 44 ) and a cervical end region ( 45 ) on. The apical end region ( 44 ) of the thread ( 40 ) has a forward cutting cutting element ( 46 ) on. The cervical end region ( 45 ) of the thread ( 40 ) has a cutting element ( 43 ) with a cutting edge ( 43a ), which is back-separating, ie when unscrewing the implant body ( 10 ) cuts an internal thread from the bone into the bone. The cutting edge ( 43a ) by means of a notch ( 43b ) in the uppermost passage of the Gewindeberg ( 42 ) educated.

3 shows in 3a the implant according to the invention ( 100 ) out 2a in a slightly different perspective. The implant ( 100 ) again comprises the implant body ( 10 ), the curved distraction membrane ( 20 ) and a connecting element ( 30 ). The implant body ( 10 ) is again in a first coronal section ( 11 ) with a rack ( 13 ) in the form of a round rack and in a second, apical area ( 12 ) with forward and backward cutting thread ( 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 several pores ( 23 ), which lead to improved circulation of the underlying tissue under the membrane. The connecting element ( 30 ) has holes ( 34 ) as attack points for a tool for rotating an adjusting nut of the connecting element ( 30 ), whereby the membrane ( 20 ) along the first, coronal part ( 11 ) of the implant body ( 10 ) can be moved along, since the adjusting nut as a rotatably mounted threaded body with the rack ( 13 ) of the coronal section ( 11 ) of the implant body ( 10 ) is in operative engagement.

In 3b is the implant body ( 10 ) of the implant 3a without seeing membrane and connecting element in three different perspectives. On the one hand, the design of the coronal first subregion ( 11 ) as a rack ( 13 ) clear. On the other hand, in the second, apical section ( 12 ) the thread cutting in both directions ( 40 ) with the apical end region ( 44 ) and a local cutting element and the cervical end region ( 45 ) with a second cutting element ( 43 ) clear to see. The second cutting element ( 43 ) with a cutting edge ( 43a ), which by means of a notch ( 43b ) is formed in the uppermost passage of the thread, the cutting of a thread in the newly formed by the callus distraction by means of membrane bone when unscrewing the implant body ( 10 ) from the bone.

4 shows in 4a a preferred embodiment of the distraction membrane ( 20 ) and the connecting element ( 30 ).

The distraction membrane ( 20 ) according to the invention has a hole through which the implant body ( 10 ) can pass through. The hole in the distraction membrane ( 20 ) not centered, so that the membrane is a longer section ( 20a ) and a shorter section ( 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 callus tissue. The connecting element ( 30 ) is in three parts. An adjusting nut ( 37 ) comes from a sleeve ( 31a ) and a sleeve counterpart ( 31b ) held. The adjusting nut ( 37 ) lies on the sleeve counterpart ( 31b ) and is in the sleeve ( 31a ) rotatably mounted. Here is the sleeve counterpart ( 31b ) fixed to the distraction membrane ( 20 ) or component of the membrane ( 20 ). The distraction membrane ( 20 ) and the sleeve counterpart ( 31b ) in one piece.

The adjusting nut ( 37 ) has an internal thread ( 38 ) in the rack ( 13 ) of the implant body ( 10 ) out 3b can intervene. Thus, the distraction membrane ( 20 ) by turning the adjusting nut ( 37 ) along the first subregion ( 11 ) of the implant body ( 10 ) are moved.

The rotation of the adjusting nut ( 37 ) is passed through three holes ( 34 ), which serve as points of attack for a turning tool.

4b shows the three items 4a , ie the distraction membrane ( 20 ) with the sleeve counterpart ( 31b ), wherein distraction membrane and sleeve counterpart are integrally formed, the adjusting nut ( 37 ) with internal thread ( 38 ) and holes ( 34 ) and the sleeve ( 31a ). When assembling the device, the sleeve ( 31a ) with the sleeve counterpart ( 31b ) are connected in any suitable manner, for example welded or glued or held by appropriate elements, such as clip elements.

5 shows a further alternative embodiment of the implant according to the invention ( 100 ) during use according to the invention for bone distraction in the jaw region ( 50 ).

Shown again are the implant body ( 10 ) with a second apical area ( 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 ) has an internal thread in its hole ( 25 ) with an external thread ( 35 ) of the spacer sleeve ( 32 ) screwed or screwed.

The connecting element ( 30 ) is designed here so that the housing ( 31 ) a threaded body in the form of a screw ( 33 ) in the housing ( 31 ) is rotatably mounted, that the screw ( 33 ) and the rack ( 13 ) are in operative engagement. The rotational movement of the snail ( 33 ) can thus in a translational movement of the connecting element ( 30 ) and thus the distraction membrane ( 20 ) on the rack ( 13 ) to be translated. The snail ( 33 ) has a point of attack ( 34 ) for a tool, such as an Allen key, so that the worm ( 33 ) can be easily turned.

Furthermore, a jawbone ( 51 ) with two teeth ( 52 to see). 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. there the distraction membrane ( 20 ) via the connecting element ( 30 ) by turning the auger (or daily) 33 ) via a to the point of attack ( 34 ) attaching tool at a rate of 0.2 mm to 2.5 mm per day away from the bone defect.

That's why it comes in at the contact area ( 21 ) adjacent tissue ( 54 ), in particular callus to distraction pulses, which cause bone formation. Above the distraction membrane ( 20 ) is connective tissue ( 53 ).

The distraction membrane ( 20 ) according to the invention longer section ( 20a ) and a shorter section, in which case only the longer section ( 20 ) with the second side surface ( 28 ) you can see. 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 ) is a mass and blood exchange between the at the contact surface ( 21 ) adjacent tissue ( 54 ) and on the opposite surface ( 22 ) adjacent tissue ( 53 ) possible.

Before and after this procedure for bone formation by callus distraction using the distraction membrane ( 20 ) come the advantages of the preferred structure of the implant body ( 10 ) with a forward cutting and backward cutting thread ( 40 ) to carry. When screwing in the implant body ( 10 ) in the bones ( 51 ) comes a forward cutting cutting element ( 46 ) in the apical area ( 44 ) of the thread ( 40 ) used, 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 cervical end region ( 45 ) of the thread ( 40 ), if this is not completely in the bones ( 51 ), but also especially in the area of the first, coronal section ( 11 ) of the implant body ( 10 ). The newly formed bone thus encloses subareas of the implant body ( 10 ), in particular regions of the first implant body part ( 11 ), which has no thread. When the implant ( 100 ) but is a temporary implant, which is preferred according to the invention, the implant body ( 10 ) are unscrewed from the bone again. This is in the area of the original bone ( 51 ) unproblematic, since here already an internal thread through the forward cutting elements of the thread ( 40 ) was generated. However, such an internal thread in the newly formed bone ( 54 ) unavailable. Therefore, the implant according to the invention ( 100 ) in the cervical end region ( 45 ) of the thread ( 40 ) a second cutting element ( 43 ) with a cutting edge, wherein the cutting element ( 43 ) is backward cutting. This can advantageously in unscrewing the implant body ( 10 ) after completion of the distraction an internal thread in the newly formed bone ( 54 ) are cut so that on the one hand the newly formed bone 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 directly into the internal thread not only of the original bone ( 51 ), but also the newly formed bone ( 54 ) can be screwed.

6 schematically shows a comparison of an implantation method using the implant according to the invention with preferred forward and reverse cutting thread to a conventional method. In step ( 1 ) shows a tooth gap with a bone defect into 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. Doing so, as in step ( 2 ), set a pilot hole both in the conventional method and when using the implant according to the invention. In the pilot hole is now in step ( 3 ) In a conventional method, a conventional provisional implant and screwed in the inventive method, 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 period, the provisional implant in step ( 4 ) unscrewed. When using an implant according to the invention take place between step ( 3 ) and step ( 4 ), the intermediate steps ( 3.1 ) to ( 3.5 ), in which in step ( 3.1 ) is placed on the implant body, the distraction membrane with the connecting element, in the steps ( 3.2 ) to ( 3.4 ) a distraction osteogenesis, as in 5 shown and after completion of osteogenesis in step ( 3.5 ) the distraction membrane with the connecting element is removed again from the implant body. Now, even when using the implant according to the invention in step ( 4 ) unscrewing the implant body, wherein an internal thread is cut into the newly formed bone advantageously by the second backward cutting element. Both in the conventional method and in the method with the implant according to the invention can then in step ( 5 ) a permanent implant with a crown be screwed. 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 to However, the implant according to the invention can be used in a simple manner for a dentist, since he does not have to learn fundamentally new techniques when placing the implant.

7 shows various embodiments of the preferred implant of the 2a and 3a , The in the 7a . 7b and 7c shown implants ( 100 ) all have an implant body ( 10 ), a distraction membrane ( 20 ) and a connecting element ( 30 ) with the details, as in 3a shown on. 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 ). In 7a is the curved distraction membrane ( 20 ) not according to the invention arranged centrally. The hole of the distraction membrane ( 20 ), through which the implant body ( 10 ), is therefore located in the middle of the distraction membrane ( 20 ). In contrast, this hole is in the 7b and 7c not according to the invention at the center of the distraction membrane ( 20 ). Thus, the distraction membrane protrudes on one side ( 20a ) further than on the opposite side ( 20b ). This embodiment of the implant according to the invention ( 100 ) has the advantage that such a ridge as in 7d shown particularly well by the distraction membrane ( 20 ), since a ridge ( 51 ) usually has no symmetrical cross-section. Depending on the curvature of the alveolar ridge ( 51 ) can thus be a suitable distraction membrane ( 20 ) whose hole is either as in 7b shown is only slightly removed from the center of the distraction membrane or its hole, as in 7c shown is more distant from the center of the distraction membrane. For example, the dentist may stock different distraction membranes and, depending on the shape of the alveolar ridge, select the appropriate distraction membrane. It is of course also possible to individually adapt a distraction membrane to a ridge.

8th shows the preferred embodiment of the implant from the 2a and 3a ( 100 ) in combination with a tool ( 200 ) for displacing the distraction membrane ( 20 ).

8a shows the implant again ( 100 ) with implant body ( 10 ), Distraction membrane ( 20 ) and connecting element ( 30 ). Like from the 2a and 3a and 4 shows, the connecting element ( 30 ) a present not visible adjusting nut ( 37 ) with three holes ( 34 ). For turning the adjusting nut ( 37 ) and thus for moving the distraction membrane ( 20 ) along the first, coronal area ( 11 ) of the implant body ( 10 ) is suitable in the 8b and c shown tool ( 200 ). This one has a hole ( 210 ), by which the tool on the implant body ( 10 ) can be deferred. Furthermore, the tool ( 200 ) three projections ( 234 ) in the holes ( 34 ) of the adjusting nut ( 37 ) can intervene. Thus, by turning the handle part ( 211 ) about the three connections between the holes ( 34 ) and projections ( 234 ) the adjusting nut ( 37 ) are turned so that they are on the rack ( 13 ) of the implant body ( 10 ) in the direction of the coronal end of the implant body and the distraction membrane ( 20 ) via the connecting element ( 30 ). 8d shows the tool ( 200 ) in on the implant ( 100 ) plugged state.

The 9 and 10 show the implant ( 100 ) from the 2a and 3a with attachable sleeves or caps ( 301 . 302 . 303 . 304 ).

At the beginning of distraction osteogenesis, a longer portion of the first coronal portion ( 11 ) of the implant body ( 10 ), because the distraction membrane and the connecting element have not yet moved in the direction of the coronal end. In an advantageous embodiment, this area is covered by a cap ( 301 . 303 ), which is adapted in length to the length of the exposed area. It can, for example, as in 9a be provided that the cap with the rack ( 13 ) of the implant body ( 10 ) or it may alternatively be provided that the cap, as in 10a with the connecting element ( 30 ) and in particular the sleeve ( 31a ) is jammed.

During the distraction, the length of the exposed area is shortened because the connecting element ( 30 ) and the distraction membrane ( 20 ) in a coronal direction along the implant body ( 10 ) are moved. Thus, during a later phase of the distraction shorter protective caps ( 302 . 304 ), which in turn, like cap ( 302 ) out 9b with the gearing ( 13 ) of the implant body ( 10 ) or like protective cap ( 304 ) out 10b with the sleeve ( 31a ) can be jammed. Of course, further protective caps can be provided, which are in their length between the long protective caps ( 301 . 303 ) and the short protective caps ( 302 . 304 ) lie. Since the protective caps can be produced inexpensively, for example, from an elastic plastic, a multiplicity of different protective caps can be provided and held by the dentist corresponding to the respective length of the exposed area of the implant ( 10 ) correspond. The smooth surface of the caps prevents bacterial colonization and resulting infections. In addition, the protective caps make for a more comfortable wearing, for example when touching the exposed implant area through the tongue and prevents injury.

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• WO 03/051220 A2 [0008]
• DE 102010055431 A1 [0008]
• WO 01/91663 A1 [0008]
• US 5980252 [0008]
• US 6537070 B1 [0008]

Claims (10)

Implant ( 100 ) comprising an implant body ( 10 ) and a distraction membrane ( 20 ), whereby the distraction membrane ( 20 ) via a connecting element ( 30 ) with the implant body ( 10 ), wherein the connecting element ( 30 ) over a first subregion ( 11 ) of the longitudinal axis of the implant body ( 10 ) is movably arranged and whereby 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 ( 109 is possible, characterized in that the distraction membrane ( 20 ) a hole ( 29 ), through which the implant body ( 10 ) and that the hole ( 29 ) not at the midpoint of the distraction membrane ( 20 ) is positioned. Implant according to claim 1, wherein the distraction membrane ( 20 ) is arched. Implant according to one of the preceding claims, wherein the distraction membrane ( 20 ) a first side surface ( 27 ), a second side surface ( 28 ), a third side surface and a fourth side surface, wherein the first side surface ( 27 ) of the second side surface ( 28 ) 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 3, wherein the third side surface is opposite the fourth side surface, and wherein the distance of the hole (3) 29 ) of the distraction membrane ( 20 ) to the third side surface is about the same size as the distance of the hole ( 29 ) to the fourth side surface. Implant according to one of the preceding claims, wherein the first subregion ( 11 ) as a rack ( 13 ) is formed and the connecting element ( 30 ) one on the rack ( 13 ) first subarea ( 11 ) rotatable female thread nut ( 37 ), which in a sleeve ( 32 . 31a ) is rotatably mounted, wherein the sleeve ( 32 . 31a ) with the distraction membrane ( 20 ) connected is. Implant according to claim 5, wherein the connecting element ( 30 ) a sleeve counterpart ( 31b ), over which the sleeve ( 31a ) with the distraction membrane ( 20 ) and wherein the sleeve counterpart ( 31b ) fixed to the distraction membrane ( 20 ) connected is. Implant according to one of the preceding claims, wherein the implant body ( 10 ) a second subregion ( 12 ) used as a forward and backward cutting tap ( 40 ) is trained. 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 ) a bone screw thread ( 40 ), wherein the connecting element ( 30 ) over the first subregion ( 11 ) 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 ), which between the first end of the implant body and the connecting element ( 30 ). Implant according to one of the preceding claims, wherein the implant is a dental implant, in particular a provisional dental implant. An implant according to any one of the preceding claims for use in bone distraction.

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