DE102016222602A1 - Implant and kits for treating a bone defect - Google Patents

Abstract

The invention relates to an implant, in particular for treating a bone defect, comprising osteoconductive support bodies comprising a support body material or consisting of a support body material, and an in vivo degradable / in vivo resorbable bone cement, wherein the support body material is not degradable / in vivo resorbable and / or slower in vivo degradable / slower in vivo resorbable than the bone cement. The invention further relates to kits, in particular for producing the implant and / or for treating a bone defect.

Description

AREA OF APPLICATION AND PRIOR ART

The invention relates to an implant and kits for treating a bone defect.

Large bone defects on the acetabulum are a major problem in hip replacement surgery. Hip revision surgery focuses on the following three objectives.

First, the original joint center is to be restored.

Furthermore, a stable fixation of an implant used to treat a bone defect is sought. In the fixation of the implant is generally distinguished between a so-called primary stability and a so-called secondary stability.

Primary stability is understood to mean the fixation of the implant based on friction or fasteners, such as bone screws, in the first weeks after surgery. Secondary stability is understood to mean fixation of the implant based on bony adhesions. Secondary stability usually begins about one month after surgery and can last up to several years.

Finally, a so-called biological reconstruction of bony defects is sought. A biological reconstruction is understood to mean the ingrowth of bone into the implant as well as the conversion of the implant into vital, own bones.

In order to fix implants used to treat bone defects, in practice the two options described below have prevailed.

One option provides for the use of metallic augmentates, for example in the form of porous structures. For example, a metallic augmentate for treating bone defects is sold commercially by the Applicant under the name Structan.

The use of metallic augmentates has the advantage that the original joint center can usually be restored well. On top of that, a good fixation of the implant can be achieved. The disadvantage, however, is that metallic augmentation remain unchanged in the body, so that a biological reconstruction of bony defects does not take place.

In addition, in the case of a (re) revision, the entire augmentation must be replaced, which as a rule results in an enlargement of the defect. This is especially true in the case of the appearance of bony adhesions with the metallic augmentation. Another disadvantage is that metallic augments are not malleable. This, in turn, may result in the defect having to be adapted to the augmentation, which usually also increases the defect. In addition, it is disadvantageous that metallic augmentates can not be processed, so that in the case of a (re) revision, a build-up on the augmentation is not possible.

The second option for fixation of implants used to treat bone defects involves the use of bone chips or shavings. Bone chips or chips have the advantage that they allow a reconstruction of bony defects. Also, the restoration of the center of rotation usually poses no problems. However, a disadvantage is the surgical handling of bone chips or shavings. So the bone material usually needs to be provided during the operation. For this purpose, an allogenic femoral head is thawed and crushed. Handling is complicated by the irregular shapes of the bone particles. It therefore requires some experience on the part of the surgeon to use these bone filling materials properly. In addition, since the bone banks must meet strict requirements, the provision of bone chips or shavings is very complex and expensive overall. Another disadvantage is the potential risk of infection. In addition, it is disadvantageous that bone chips or chips are generally characterized by only a limited mechanical load capacity (low primary stability). Finally, there is a risk of absorption without bone growth having occurred or occurred. In other words, there is a certain risk that secondary stability can not be achieved.

From the US 8,562,613 B2 is a kit for the treatment of bone defects with a mixture of an osteoconductive material and an osteoinductive material and a porous container known.

Subject of the EP 0 764 008 B1 is a device for use in stabilizing a spinal motion segment with a flexible pouch, which pouch may contain a biological filling material to promote bone or fiber fusion.

The EP 1 408 888 B1 discloses a system for correcting vertebral compression fractures comprising a porous bag and a filling tool, wherein the filling tool is adapted to inject a bone filling material under pressure into the porous bag.

From the WO 2012/061024 A1 For example, an implantable container is known which at least partially contains demineralized and osteoinductive bone particles.

The publication "Bone Regeneration by the Combined Use of Tetrapod-Shaped Calcium Phosphate Granules with Basic Fibroblast Growth Factor-Binding Ion Complex Gel in Canine Segmental Radial Defects (J. Vet. Med. Sci. 76 (7): 955-961, 2014)" by Honnami et al. deals with a combination of tetrapod-shaped granules of alpha-tricalcium phosphate and an osteoinductive gel.

TASK AND SOLUTION

The object of the invention is to provide an implant which is suitable for treating a bone defect, preferably periprosthetic bone defect, and at least largely avoids the disadvantages mentioned in the introduction, in particular in the context of a hip revision operation. In particular, the implant should enable a sufficient mechanical stability such as primary and / or secondary stability and, if appropriate, a biological reconstruction of a bony defect as well as the simplest possible handling.

This object is achieved by an implant having the features according to independent claim 1 and by a kit according to claim 23. Preferred embodiments are defined in the dependent claims. The wording of all claims is hereby incorporated by express reference into the content of the present specification. In the description further subject matters are disclosed.

According to a first aspect, the invention relates to an implant, preferably for treatment and / or biological reconstruction, in particular lining and / or sealing and / or underfeeding and / or at least partial filling, of a bone defect. The implant is preferably a surgical implant.

• - osteokonduktive Stützkörper und
• - einen in vivo abbaubaren/in vivo resorbierbaren Knochenzement.

The implant has or consists of the following:

• - osteoconductive supportive bodies and
• an in vivo degradable / in vivo resorbable bone cement.

The in vivo degradable / in vivo resorbable bone cement is preferably an in vivo degradable / in vivo resorbable mineral bone cement.

The osteoconductive support bodies comprise a support body material or consist of a support body material.

The implant is characterized in particular by the fact that the support body material is not degradable in vivo / not resorbable in vivo and / or degradable more slowly in vivo / is more slowly resorbable in vivo than the bone cement.

The term "bone defect" in the sense of the present invention means a bone area affected by loss of bone tissue, in particular articular bone tissue, preferably hip joint or knee bone tissue or vertebral body tissue, in particular articular bone area, preferably hip joint or knee joint area or vertebral area. Bone loss may be the result of bone fracture, bone trauma, bone disease such as tumor disease, or surgical intervention / reintervention, especially revision after total hip or knee arthroplasty. For the purposes of the present invention, the term "bone defect" preferably means a periprosthetic bone defect or bone tissue loss, in particular due to mechanical overload, abrasion-induced osteolysis and / or implant migration.

The bone defect is preferably a joint bone defect, in particular knee joint bone defect or hip bone defect, preferably an acetabulum defect.

Furthermore, the term "bone defect" in the sense of the present invention may mean a human bone defect or an animal bone defect.

For the purposes of the present invention, the term "animal bone defect" is understood to mean the bone defect of a non-human mammal, such as horse, cow, goat, sheep, pig or a rodent, such as, for example, hare, rat or mouse.

The term "supporting body" in the sense of the present invention means bodies, in particular regularly and / or irregularly shaped bodies, which are designed to be deformable or destructive in a bone defect to be treated, but at least without substantial deformation or Destruction, to resist and thus to take load-bearing functions. The osteoconductive support body can therefore be referred to as load-bearing support body in the context of the present invention.

In the context of the present invention, the term "osteoconductive" as used in connection with the support bodies means the ability of the support bodies to form a three-dimensional structure, in particular a guide structure, or a three-dimensional matrix, in particular guide matrix, which promotes ingrowth of bone tissue, in particular new bone tissue.

The term "biodegradable / in vivo resorbable" in the sense of the present invention means degradable in vivo or resorbable in vivo. Accordingly, for example, the term "in vivo degradable / in vivo resorbable bone cement" in the sense of the present invention means a bone cement which is either degradable in vivo or resorbable in vivo.

The term "non-in vivo degradable / not resorbable in vivo" in the sense of the present invention does not mean degradable in vivo or not absorbable in vivo. Accordingly, for example, in the context of the support body material, this term means that the support body material is either not degradable in vivo or is not resorbable in vivo.

The term "slower degradable in vivo / slower in vivo resorbable" in the sense of the present invention means slower degradable in vivo or more slowly resorbable in vivo. Accordingly, in the context of the support body material, for example, this expression means that the support body material is degradable either more slowly in vivo or more slowly resorbable in vivo than the bone cement.

The term "degradable in vivo" in the context of the present invention refers to a material that can be metabolized in a human or animal body, in particular under the action of enzymes. Degradation of the material may be complete until mineralization, i. Release of chemical elements and their incorporation into inorganic compounds, such as carbon dioxide, oxygen and / or ammonia, run or remain at the level of waste-stable intermediate or transformation products.

Accordingly, the term "degradable in vivo" in the context of bone cement, for example, means a bone cement which can be metabolized in a human or animal body, in particular under the action of enzymes, whereby the degradation of the bone cement takes place completely to mineralization or at the stage of stable intermediate or transformation products can remain. This may include a degradation of the bone cement by osteoclasts, which dissolve the bone cement by acid production. In the space between osteoclast and bone substance, there is a markedly reduced pH (about 4.5), which is maintained by active proton transport and serves to break down the bone cement.

Accordingly, the term "slower degradable in vivo" used in the context of the support body material means that the support body material in a human or animal body is metabolized more slowly than the bone cement.

For the purposes of the present invention, the term "animal body" is understood to mean the body of a non-human mammal, such as horse, cow, goat, sheep, pig or a rodent, such as, for example, hare, rat or mouse.

The term "in vivo absorbable" in the context of the present invention refers to a material which can be absorbed in a human or animal body by living cells or living tissue, such as kidneys, without degradation or significant degradation of the material takes place.

Accordingly, for example, in the context of bone cement, the term "in vivo absorbable" means a bone cement that can be taken up in a human or animal body by living cells or living tissue, such as kidneys, without degradation or appreciable degradation of the bone cement ,

Accordingly, the term "slower in vivo absorbable" used in the context of the support body material means that the support body material in a human or animal body is absorbed more slowly by living cells or living tissue without degradation or appreciable degradation of the support body material than the bone cement ,

Bone cements, preferably mineral bone cements, in the form of a solid sparingly soluble in water, are generally formed by the reaction of bone cement powder, preferably mineral bone cement powder, and water. After mixing the bone cement powder, preferably mineral bone cement powder, with water, a pasty mass is usually first formed, which cures gradually to a solid. To facilitate the mixing, the bone cement powder, preferably mineral bone cement powder, can also be dispersed in an organic carrier liquid, and thus take the form of an anhydrous pasty preparation which hardens after contact or mixing with water to form a sparingly soluble solid.

The term "bone cement", in particular "mineral bone cement", in the context of the present invention may include all of the variants of a bone cement described in the last paragraph. Accordingly, from the term "bone cement", in particular "mineral bone cement", in the context of the present invention, both a bone cement powder, preferably mineral bone cement powder (which has not yet reacted with water and / or a body fluid), a dispersion, suspension or solution of a bone cement powder , preferably mineral bone cement powder, detected in water and / or an organic carrier liquid as well as a solid formed by reaction of a bone cement powder, preferably mineral bone cement powder, with water, in particular hardened solid.

In contrast, the term "bone cement powder", preferably "mineral bone cement powder" in the sense of the present invention exclusively a not yet reacted with water powder, which is suitable for forming a water-insoluble solid in water after reaction with water.

• - Bei gutem Heilungsverlauf können die osteokonduktiven Stützkörper mit besonderem Vorteil von körpereigenem Knochen integriert oder zellulär umgebaut werden. Dadurch ist eine biologische Rekonstruktion des Knochendefekts gewährleistet. Bei Patienten mit langsamem Knochenwachstum bleiben die osteokonduktiven Stützkörper erhalten, zumindest länger als der Knochenzement. Dadurch ist eine im Vergleich zu gattungsgemäßen Knochenimplantaten verbesserte Sekundärstabilität gegeben. Dies gilt insbesondere im Hinblick auf ältere Patienten, bei welchen ein Knochenwachstum häufig überhaupt nicht mehr stattfindet.
• - Ein weiterer Vorteil besteht darin, dass die osteokonduktiven Stützkörper in einem verdichteten, bevorzugt impaktierten (eingeklemmten oder verkeilten), Zustand als Platzhalter und/oder Leitstruktur ein Einwachsen von Knochengewebe, insbesondere neuem Knochengewebe, in das Implantat und insbesondere in den zu behandelnden Knochendefekt bewirken.
• - Ein weiterer Vorteil besteht darin, dass das Implantat, insbesondere wenn die osteokonduktiven Stützkörper in einem verdichteten, bevorzugt impaktierten, Zustand vorliegen, dauerhaft und vor allem homogen belastet werden kann. Eine homogene Implantatbelastung stellt eine Grundvoraussetzung für Knochenwachstum dar. Beispielsweise kann das Implantat, insbesondere mit verdichtetet, bevorzugt impaktiert, vorliegenden osteokonduktiven Stützkörpern, dauerhaft mit einer Druckbelastung von bis zu 2.8 MPa beaufschlagt werden. Dabei kann eine durch Verdichten, insbesondere Impaktieren, erzeugte und von den osteokonduktiven Stützkörpern aufgebaute Struktur mit besonderem Vorteil eine elastische Verformung, insbesondere von 5 % bis 15 %, und ein geringes E-Modul, insbesondere von 50 MPa bis 300 MPa, aufweisen.
• - Im Gegensatz zu gattungsgemäßen Implantaten, insbesondere metallischen Augmentaten, bei welchen lediglich Zwischenräume an Implantatrandzonen mechanisch belastet werden, können in einem verdichteten Zustand der osteokonduktiven Stützkörper vorhandene Hohl- und/oder Zwischenräume aufgrund des geringen E-Moduls auch innerhalb der gesamten Defektauffüllung, d.h. homogen, mechanisch belastet werden (Mikrobewegungen). Dies wiederum bewirkt eine Stimulierung und/oder Verstärkung von Knochenwachstum, insbesondere von Knochenneubildung. Insgesamt ist dadurch eine homogene Verknöcherung des gesamten Knochendefektbereichs erzielbar.
• - Der Knochenzements bewirkt mit besonderem Vorteil eine (zusätzliche) Stabilisierung des Implantats, insbesondere einer durch Verdichten, vorzugsweise Impaktieren, der osteokonduktiven Stützkörper erhaltenen Struktur oder Matrix, während der ersten Heilungs- und Knocheneinwachsphase. Nach Abbau/Resorption des Knochenzements kann der Knochen dessen Platz einnehmen. Das Implantat kann daher vorzugsweise auch zur Behandlung eines umschlossenen Knochendefekts oder zur Behandlung von Knochendefekten, bei welchen mit Knochenwachstum gerechnet werden kann, verwendet werden.

The present invention is characterized in particular by the following advantages:

• - With good healing process, the osteoconductive support body can be integrated with particular advantage of the body's own bone or rebuilt cell. This ensures a biological reconstruction of the bone defect. In patients with slow bone growth, the osteoconductive support bodies are preserved, at least longer than the bone cement. As a result, an improved compared to generic bone implants secondary stability is given. This is especially true with regard to older patients, in which bone growth often does not occur at all.
• - Another advantage is that the osteoconductive support body in a compacted, preferably impacted (jammed or wedged) state as a placeholder and / or lead structure ingrowth of bone tissue, especially new bone tissue, in the implant and in particular in the bone defect to be treated ,
• - Another advantage is that the implant, in particular when the osteoconductive support body in a compacted, preferably impacted state, can be permanently and above all homogeneously loaded. A homogeneous implant load is a basic prerequisite for bone growth. For example, the implant, especially with compacted, preferably impacted, present osteoconductive support bodies, permanently subjected to a pressure load of up to 2.8 MPa. In this case, a structure produced by compacting, in particular impacting, and constructed by the osteoconductive supporting bodies can with particular advantage have an elastic deformation, in particular of 5% to 15%, and a low modulus of elasticity, in particular of 50 MPa to 300 MPa.
• In contrast to generic implants, in particular metallic Augmentaten, in which only gaps on implant edge zones are mechanically loaded, in a compacted state of the osteoconductive support body existing cavities and / or gaps due to the low modulus of elasticity within the entire defect replenishment, ie homogeneous , mechanically loaded (micro-movements). This, in turn, stimulates and / or enhances bone growth, especially new bone formation. Overall, a homogeneous ossification of the entire bone defect area is thereby achieved.
• The bone cement particularly advantageously effects an (additional) stabilization of the implant, in particular a structure or matrix obtained by compacting, preferably impacting, the osteoconductive support body during the first healing and bone ingrowth phase. After removal / resorption of the bone cement, the bone can take its place. The implant may therefore also be used preferably for the treatment of an occluded bone defect or for the treatment of bone defects in which bone growth can be expected.

In a preferred embodiment, the implant has a mixture comprising the osteoconductive support body and the bone cement or a mixture consisting of the osteoconductive support bodies and the bone cement.

In another embodiment, the bone cement is an in vivo degradable bone cement.

In another embodiment, the bone cement is an in vivo resorbable bone cement.

In another embodiment, the support body material is a non-in vivo degradable support body material.

In another embodiment, the support body material is a non-in vivo resorbable support body material.

In another embodiment, the support body material is degradable more slowly in vivo than the bone cement.

In another embodiment, the support body material is more slowly resorbable in vivo than the bone cement.

In another embodiment, the support body material is a combination, particularly mixture, of support body materials comprising or consisting of a support body material that is not degradable in vivo, and a support body material that is more slowly degradable in vivo than the bone cement.

In a further embodiment, the support body material is a combination, particularly mixture, of support body materials comprising or consisting of a support body material which is not resorbable in vivo and a support body material which is more slowly degradable in vivo than the bone cement.

In another embodiment, the support body material is a combination, particularly mixture, of support body materials comprising or consisting of a support body material that is not degradable in vivo, and a support body material that is more slowly resorbable in vivo than the bone cement.

In a further embodiment, the support body material is a combination, particularly mixture, of support body materials comprising or consisting of a support body material which is not resorbable in vivo and a support body material which is more slowly resorbable in vivo than the bone cement.

In a further embodiment, the support body material has an in vivo degradation time (degradation time) of 6 months to 30 years, in particular 1 year to 20 years, preferably 4 years to 10 years.

In a further embodiment, the support body material has an in vivo absorption time of 6 months to 30 years, in particular 1 year to 20 years, preferably 4 years to 10 years.

In a further embodiment, the bone cement has an in vivo degradation time (degradation time) of 3 months to 5 years, in particular 6 months to 4 years, preferably 8 months to 3 years.

In a further embodiment, the bone cement has an in vivo absorption time of 3 months to 5 years, in particular 6 months to 4 years, preferably 8 months to 3 years.

In another embodiment, the support body material is apatite. In other words, according to another embodiment, the osteoconductive support bodies comprise apatite or consist of apatite.

The present invention is based in particular on the surprising finding that the advantages described in connection with the osteoconductive support body are particularly pronounced when the support body material is apatite.

The apatite is in a further embodiment in crystalline form. By a high crystallinity high strength can be achieved. By a low crystallinity a good and / or fast degradability can be achieved.

In another embodiment, the apatite is a microcrystalline apatite, i. an apatite with crystallites which have at least one dimension or dimension in the micrometer range, in particular in a range of> 0.5 μm, in particular 0.6 μm to 500 μm, preferably 0.6 μm to 100 μm. The at least one dimension or dimension may in particular be the length and / or width (thickness or height) and / or the diameter, in particular the mean diameter, of the crystallites.

In principle, however, the apatite can also be a macrocrystalline apatite.

In a further embodiment, the apatite is a nanocrystalline apatite, ie an apatite with crystallites, which have at least one dimension or dimension in the nanometer range, in particular in a range of 0.1 nm to 500 nm, preferably 0.1 nm to 100 nm , In the at least one dimension or Dimension may be, in particular, the length and / or width (thickness or height) and / or the diameter, in particular average diameter, of the crystallites.

In another embodiment, the apatite is in amorphous form. As a result, a particularly good and / or rapid absorption can be achieved.

In a further embodiment, the apatite is a phase-pure apatite. The term "phase-pure" should be understood to mean in particular phase-pure in the sense of a relevant regulation, preferably according to ASTM F1185.

In a further embodiment, the apatite has a porosity of 0.1% to 50%, in particular 5% to 20%, preferably 10% to 15%. By a low porosity, a high mechanical stability can be achieved.

In another embodiment, the apatite is not porous.

In particular, the osteoconductive support bodies may have a combination of porous apatites and / or apatites with different porosity and / or nonporous apatites, in particular if the support bodies are manufactured according to an additive manufacturing process.

In another embodiment, the apatite is naturally occurring apatite or an apatite derived from natural apatite.

In another embodiment, the apatite is a synthetic, i. artificially made, apatite.

In another embodiment, the apatite is selected from the group consisting of hydroxyapatite, fluorapatite, chloroapatite, carbonate-fluoroapatite and mixtures of at least two of said apatites.

Most preferably, the apatite is hydroxyapatite. For example, the hydroxyapatite may be a fully synthetic, nanocrystalline, and phase pure hydroxyapatite. Such a hydroxyapatite is commercially available, for example, under the name Ostim.

In another embodiment, the apatite is a sintered apatite.

Furthermore, it may be preferred if the apatite is sintered at a pressure of 10 MPa to 300 MPa, in particular 50 MPa to 250 MPa, preferably 100 MPa to 200 MPa.

Preferably, the sintered apatite is selected from the group consisting of sintered hydroxyapatite, sintered fluoroapatite, sintered chloroapatite, sintered carbonate-fluoroapatite, and mixtures of at least two of said sintered apatites.

In another embodiment, the support body material is tricalcium phosphate (also referred to as tribasic or tertiary calcium phosphate). In other words, according to another embodiment, the osteoconductive support bodies comprise tricalcium phosphate or consist of tricalcium phosphate.

In particular, the present invention is based on the surprising finding that the advantages described in connection with the osteoconductive support body are particularly pronounced when the support body material is tricalcium phosphate.

The tricalcium phosphate is in a further embodiment in crystalline form. By a high crystallinity high strength can be achieved. By a low crystallinity a good and / or fast degradability can be achieved.

The tricalcium phosphate preferably has a crystallinity of 50% to 99%, in particular 75% to 95%.

In a further embodiment, the tricalcium phosphate is microcrystalline tricalcium phosphate, i. tricalcium phosphate with crystallites which have at least one dimension or dimension in the micrometer range, in particular in a range of> 0.5 μm, in particular 0.6 μm to 500 μm, preferably 0.6 μm to 100 μm. The at least one dimension or dimension may in particular be the length and / or width (thickness or height) and / or the diameter, in particular the mean diameter, of the crystallites.

In principle, however, the tricalcium phosphate can also be a macrocrystalline tricalcium phosphate.

In a further embodiment, the tricalcium phosphate is nanocrystalline tricalcium phosphate, ie tricalcium phosphate with crystallites, which have at least one dimension or dimension in the nanometer range, in particular in a range of 0.1 nm to 500 nm, preferably 0.1 nm to 100 nm. The at least one dimension or dimension may in particular be the length and / or width (thickness or height) and / or the diameter, in particular the mean diameter, of the crystallites.

In another embodiment, the tricalcium phosphate is in an amorphous form. As a result, a particularly good and / or rapid absorption can be achieved.

In another embodiment, the tricalcium phosphate is phase-pure tricalcium phosphate. The term "phase-pure" should be understood to mean in particular phase-pure in the sense of a relevant regulation, preferably according to ASTM F1088.

In a further embodiment, the tricalcium phosphate has a porosity of 0.1% to 50%, in particular 5% to 20%, preferably 10% to 15%.

In a further embodiment, the tricalcium phosphate is not porous.

In another embodiment, the tricalcium phosphate is naturally occurring tricalcium phosphate or a tricalcium phosphate derived from natural tricalcium phosphate.

In a further embodiment, the tricalcium phosphate is a synthetic, i. artificially produced tricalcium phosphate.

The tricalcium phosphate in a particularly preferred embodiment is selected from the group consisting of alpha tricalcium phosphate (a-TCP), beta tricalcium phosphate (β-TCP) and a mixture of alpha tricalcium phosphate and beta tricalcium phosphate.

In another embodiment, the tricalcium phosphate is sintered tricalcium phosphate.

Furthermore, it may be preferred if the tricalcium phosphate is sintered at a pressure of 10 MPa to 300 MPa, in particular 50 MPa to 250 MPa, preferably 100 MPa to 200 MPa.

The sintered tricalcium phosphate is preferably selected from the group consisting of sintered alpha-tricalcium phosphate, sintered beta-tricalcium phosphate, and a mixture of sintered alpha-tricalcium phosphate and sintered beta-tricalcium phosphate.

In a further embodiment, the support body material is a combination, in particular mixture, comprising or consisting of apatite, in particular sintered apatite, and tricalcium phosphate, in particular sintered tricalcium phosphate. In other words, the osteoconductive support body according to another embodiment, a combination, in particular mixture, comprising or consisting of apatite, in particular sintered apatite, and tricalcium phosphate, in particular sintered tricalcium phosphate, on. The support body material is preferably a combination, in particular a mixture, comprising or consisting of hydroxyapatite, in particular sintered hydroxyapatite and beta-tricalcium phosphate, in particular sintered beta-tricalcium phosphate. For further features and advantages of the apatite and tricalcium phosphate, reference is made to the preceding statements.

The present invention is further based, in particular, on the surprising finding that the advantages described in connection with the osteoconductive support body are particularly pronounced if the support body material is a combination, in particular a mixture, comprising or consisting of apatite, in particular hydroxylapatite, and Tricalcium phosphate, especially beta tricalcium phosphate.

In a further embodiment, the support bodies have a roughened surface. As a result, the growth or adhesion of bone tissue, in particular to an osteoconductive guide structure formed by the support body, can be optimized. For the purposes of the present invention, the term "roughening" is to be understood in particular to mean that a roughness of the surface is increased after a shaping of the supporting bodies, in particular in a production step provided for this purpose. The roughening can be done, for example, by etching, in particular by means of phosphoric acid. The support bodies preferably have a roughened surface whose roughness is increased by at least 10% relative to a non-roughened support body surface. The term "roughness" should in particular be understood to mean unevenness of the surface of the support bodies.

In a further embodiment, the support bodies can be produced by means of an additive manufacturing process.

In another embodiment, the support body material is calcium phosphate cement. The calcium phosphate cement may, in particular, be a calcium phosphate cement which precedes a complete calcium phosphate cement Curing a pressure, preferably absolute pressure, of at least 2 bar is subjected. In this way, the porosity can be lowered with particular advantage.

In a further embodiment, the osteoconductive support bodies are connected to one another in a material-locking manner, in particular adhesively bonded together.

In a further embodiment, the osteoconductive support bodies are coated with a binder. The binder is preferably a binder which can be solubilized by heat or a solvent such as N-methyl-pyrrolidone (NMP). Through the use of such a binder, it is possible to connect the osteoconductive support body by heating and then cooling or by adding a solvent together. The binder may, for example, be polylactide and / or poly (lactide-co-glycolide) (PLGA).

In a further embodiment, the osteoconductive support bodies are designed in such a way that they promote compression, preferably impacting, in particular mutual clamping or wedging, of the support body, for example by means of a suitable instrument such as a follower. With regard to correspondingly suitable embodiments of the osteoconductive support body, reference is made to the following explanations.

The osteoconductive support bodies are regularly shaped in a further embodiment, i. According to another embodiment, they are in the form of shaped bodies. For the purposes of the present invention, the term "regularly shaped" is to be understood as meaning in particular the forms described below.

The osteoconductive support body, in particular moldings, may in particular have a polygonal cross-section. For example, the osteoconductive support body, in particular moldings, may have a triangular, square, quadrangular, pentagonal, hexagonal, heptagon-shaped, octagon-shaped, nichel-shaped, ten-shaped or star-shaped cross section.

Furthermore, the osteoconductive support body, in particular moldings, may have different cross sections. With regard to possible cross sections, reference is made to the cross sections mentioned in the previous paragraph.

The osteoconductive support body, in particular moldings, in a further embodiment polyhedron-shaped, in particular cuboid, cube, tetrahedral, prism, pyramid, truncated pyramid and / or spatulate formed.

Furthermore, the osteoconductive support body, in particular molded body, may be formed differently polyhedral. In other words, the osteoconductive support body, in particular moldings, can be present in different polyhedral shapes. For possible polyhedral formations, reference is made to the previous paragraph.

In a further embodiment, the osteoconductive support bodies, in particular shaped bodies, have an oval, i. cornerless, cross-section on. For example, the structural elements may have a circular or elliptical cross section.

In a further embodiment, the osteoconductive support body, in particular moldings, non-polyhedron-shaped, in particular spherical, conical, truncated cone, annular, toroidal, and / or circular cylindrical, are formed.

Furthermore, the osteoconductive support body, in particular molded body, may be formed differently non-polyhedron-shaped. In other words, the osteoconductive support body, in particular moldings, can be present in different non-polyhedral shapes. For possible non-polyhedral designs, reference is made to the previous paragraph.

In a further embodiment, the osteoconductive support bodies, in particular shaped bodies, are in the form of oligopods, i. oligopod-shaped, formed.

The oligopods may have conical and in particular rotationally symmetrical legs. The legs may have a cone angle of 5 ° to 25 °, in particular 7 ° to 15 °.

Furthermore, the oligopods may have legs with a length of 0.5 mm to 5 mm, in particular 1.5 mm to 2.5 mm.

Furthermore, the oligopods may have legs with a diameter of 0.2 mm to 3 mm, in particular 0.3 mm to 0.7 mm.

The oligopods may be selected from the group consisting of tripods, tetrapods, pentapods, hexapods, heptapods, octapods and mixtures of at least two of said oligopods.

According to the invention it is particularly preferred if the osteoconductive support body are formed tetrapod-shaped. A tetrapod-shaped configuration allows a particularly effective mutual engagement of the osteoconductive support body.

In a further embodiment, the osteoconductive supporting bodies, in particular shaped bodies, have elongate structural elements. In particular, the osteoconductive support body, in particular moldings, can be composed of elongated structural elements.

For the purposes of the present invention, the term "elongated structural elements" is understood to mean structural elements having a length-width ratio or length-to-diameter ratio> (spoken: greater) 1.

The osteoconductive support bodies, in particular shaped bodies, preferably have elongate and straight structural elements. The osteoconductive support bodies, in particular shaped bodies, are preferably composed of elongate and straight structural elements.

The elongate structural elements are preferably polyhedron-shaped, in particular cuboidal, cube-shaped, prismatic, pyramidal, truncated pyramidal or spatulate. In other words, it is preferred if the structural elements of each osteoconductive support body, in particular molded body, form a polyhedron-shaped, in particular cuboidal, cube-shaped, prismatic, pyramidal, truncated pyramidal or spatulate arrangement.

The elongated structural elements may have a length of 0.4 mm to 5 mm, in particular 0.8 mm to 4.5 mm, preferably 1 mm to 4 mm.

Furthermore, the elongated structural elements may have a width or a diameter of 0.4 mm to 5 mm, in particular 0.8 mm to 4.5 mm, preferably 1 mm to 4 mm.

Furthermore, the elongate structural elements may be oval, i. cornerless, have cross-section. For example, the structural elements may have a circular or elliptical cross section.

Alternatively, the elongate structural elements may have a polygonal cross-section. By way of example, the structural elements can have a triangular, square, quadrangular, pentagonal, hexagonal, heptagon-shaped, octagonal, triangular, ten-shaped or star-shaped cross section.

Osteoconductive support body, in particular in the form of moldings, with elongate and especially straight structural elements, in particular as described in the preceding embodiments, have the advantage that additional cavity volume can be created by the mutual arrangement of the structural elements per support body, in particular moldings, whereby can additionally improve the osteoconductive properties of the support body, in particular moldings, and consequently of the implant. In particular, the pore size (absolute void volume) and the porosity (ratio of material volume to void volume) of human or animal bone can be optimally modeled hereby.

In another embodiment, the osteoconductive support bodies are irregularly shaped.

The osteoconductive support bodies may in particular be in particulate form, i. in the form of particles.

In a further embodiment, the osteoconductive support body are formed as a broken material.

In a further embodiment, the osteoconductive support body are formed as a non-fractured material. For example, the osteoconductive support bodies may be fabricated as an additive fabricated material, i. be formed as a material which is produced by means of an additive manufacturing process.

Preferably, the osteoconductive support body are formed as bulk material, in particular as granules.

For the purposes of the present invention, the term "bulk material" is intended to mean a particulate material, i. a material in the form of particles, are understood, whose particles have at least one dimension or dimension smaller than 7 mm, preferably in a size range of 0.5 mm to 5 mm. The at least one dimension or dimension may in particular be the height and / or length and / or width (thickness) and / or the diameter, in particular the mean diameter, of the particles. For the purposes of the present invention, the term "granules" is to be understood as meaning a particulate material of irregularly shaped, in particular broken and / or sieved, material.

The osteoconductive support bodies preferably have at least one dimension or dimension in a size range of 0.5 mm to 5 mm, in particular 1 mm to 3 mm, preferably 1 mm to 2 mm. The at least one dimension or dimension may in particular be the length and / or width (thickness or height) and / or the diameter, in particular the mean diameter, of the osteoconductive support body.

In a further embodiment, the osteoconductive support body are mutually movable, in particular designed to be displaceable relative to one another.

In another embodiment, the osteoconductive support bodies are impactable, i. mutually clamped or mutually wedged, trained.

In another embodiment, the osteoconductive support bodies are impacted, i. mutually clamped or wedged each other, before.

In a further embodiment, the osteoconductive support bodies, preferably by means of compacting, in particular impacting, can be converted into a structure or matrix having a three-dimensional and, in particular, hollow and / or interstices, or are present in such a structure or matrix.

The hollow or intermediate spaces of the structure or matrix can have a diameter of 0.1 mm to 1.2 mm, in particular 0.2 mm to 1 mm, preferably 0.3 mm to 0.8 mm.

Furthermore, the structure or matrix can with particular advantage have a hollow or interstice volume of 5% to 95%, in particular 10% to 80%, preferably 20% to 70%. Such a hollow or interspace volume optimally reflects the pore volume of a human or animal spongiosa and causes an improvement of the osteoconductivity of the implant and in particular the biological reconstruction of a bony defect.

Furthermore, the cavities or interspaces of the structure or matrix are preferably at least partially interconnected. In this way, the three-dimensional structure or matrix optimally reflects the porosity, in particular the interconnecting porosity, of the human or animal spongiosa. As a result, ingrowth of bone tissue into a defective bone zone and, in particular, a growth of a defective bone zone with vital bone tissue can also be stimulated and / or enhanced with particular advantage. This also contributes to an improvement of the osteoconductive properties of the implant and in particular the biological reconstruction of a bone defect zone.

The hollow or intermediate spaces of the structure or matrix can furthermore be filled at least partially, in particular only partially, or completely, with the bone cement. This form of interpenetration of bone cement and osteoconductive support bodies advantageously contributes to an additional improvement in the support or bearing properties of the implant.

Preferably, the structure or matrix has a modulus of elasticity, hereinafter also referred to as modulus of elasticity, of 10 MPa to 10 GPa, in particular 10 MPa to 1 GPa, preferably 80 MPa to 350 MPa. For the purposes of the present invention, the term "elasticity modulus (modulus of elasticity)" is to be understood as meaning the modulus of elasticity. The amount of elastic modulus is greater, the more resistance a material opposes its elastic deformation. A body made of a material with a high modulus of elasticity is therefore stiffer than a body of the same configuration (same geometric dimension), which consists of a material with a low modulus of elasticity. The elastic modulus values disclosed in this paragraph optimally reflect the corresponding values of cancellous bone having a Young's modulus of 100 MPa to 1000 MPa.

Due to the low moduli of elasticity described in the previous paragraph, the osteoconductive support bodies can be uniformly, i. homogeneous, mechanically loaded. In particular, the cavities or interspaces of the structure or matrix described in the preceding paragraphs can also be mechanically stressed. By a uniform or homogeneous mechanical stress of the osteoconductive support body and thus of the implant is again with particular advantage a bone formation, especially new bone formation, within the entire bony defect area achievable.

In another embodiment, which is advantageous with regard to support or carrying capacity, the osteoconductive support bodies have openings or depressions, in particular through openings. The openings or recesses may for example be selected from the group consisting of holes, pores, cracks, slots, cracks, gaps, notches and combinations of at least two of said openings or depressions.

Such an embodiment of the support body has the advantage that the support body at Compress load (lighter), in particular, deform, let. Corresponding loads leading to a support body compression can occur, for example, when the user is subjected to a force exertion, usually a surgeon. As a result, compression, preferably impacting, of the osteoconductive support body can additionally be improved, which in turn results in improved load bearing properties of the implant. Another advantage is that the bone cement can penetrate into the openings or depressions. As a result, the load or load capacity properties of the implant can be further improved.

The openings or depressions can furthermore be geometrically defined or undefined openings.

In particular, the openings or recesses may have an oval, in particular a circular or elliptical, cross-section.

Alternatively, the openings or recesses may have a polygonal cross section. For example, the openings may have a triangular, square, quadrangular, pentagonal, hexagonal, heptagon-shaped, octagonal, triangular, ten-cornered or star-shaped cross-section.

The openings or depressions may have a diameter of 0.01 mm to 5 mm, in particular 0.1 mm to 4 mm, preferably 0.5 mm to 3 mm. Such diameters may be preferred if the openings are formed as through openings, through which, as will be explained in more detail below, a tension element for the purpose of interconnecting or lashing the osteoconductive support body to be performed.

In an alternative embodiment, the openings or depressions have a diameter, in particular average diameter, of 60 μm to 500 μm, preferably 100 μm to 400 μm. Such diameters are preferred if the openings or recesses are designed as pores.

Preferably, the openings or depressions are pores. In other words, the osteoconductive support body are preferably open-pored. In particular, the osteoconductive support body may have an interconnecting porosity.

In a further embodiment, the osteoconductive support body fibers. The fibers can basically be short and / or long fibers.

For the purposes of the present invention, the term "short fibers" is to be understood as meaning fibers having a length of 0.01 mm to 1 mm, in particular 0.1 mm to 1 mm, preferably 0.5 mm to 1 mm.

For the purposes of the present invention, the expression "long fibers" is to be understood as meaning fibers having a length> (spoken: greater) 1 mm, in particular from 1.1 mm to 30 mm, preferably 1.1 mm to 15 mm, particularly preferably 1.1 mm to 6 mm ,

The short or long fibers may be metal fibers and / or polymer fibers. In principle, the fibers may also be degradable in vivo / resorbable in vivo, partially biodegradable / partially resorbable in vivo, or non-biodegradable / non-resorbable in vivo. With regard to possible metals and / or polymers from which the short or long fibers can be formed, reference is made to the metals or polymers mentioned below in the context of the coating.

In a further embodiment, the osteoconductive support bodies are coated with the bone cement. In this case, the osteoconductive support body can only partially, i. only partial area, or completely, i. full surface, be coated with the bone cement. In particular, openings and / or depressions, preferably pores, of the osteoconductive support body may be coated with the bone cement, in particular only partially, i. only partial area, or completely, i. over its entire surface, coated with the bone cement.

Furthermore, the osteoconductive support body can preferably be distributed homogeneously in the bone cement.

In a further embodiment, the implant further comprises a tension element. The tension element is preferably designed to be guided through through openings of the osteoconductive support body. This makes it possible with particular advantage to connect the osteoconductive support body together or lashed together. The tension element is preferably designed as an elongated tension element.

The tension element is preferably a textile, in particular thread-like, tension element. For example, the tension element may be a thread (pull thread), in particular a monofilament, pseudomonofilament or multifilament thread. In particular, the pulling element may be a surgical suture material.

Furthermore, the tension element can be a textile fabric, in particular in the form of a woven, braided, knitted, laid, nonwoven or nonwoven fabric. Preferably, the tension element is a net, in particular a knitted and / or small-pored net, preferably a hernia net. By integrating the osteoconductive support body in a net-shaped tension element, a regular arrangement of the support body can be achieved in an advantageous manner.

Alternatively, the pulling element may be a wire (pull wire).

Further advantages that can be realized when using a tension element are described below.

The use of a tension element allows attachment or lashing of the osteoconductive support body, whereby an immediate increase in strength of the support body with each other and thus of the implant can be achieved. This can lead to a particular advantage that a smaller amount of bone cement is required to obtain a supportive or sustainable implant. In addition, such an increase in strength of the osteoconductive support body can reduce the risk that a framework structure formed by the support body will break apart after a brittle fracture. Furthermore, by attaching or lashing the osteoconductive support body with particular advantage, an open-pored framework structure can be realized. Furthermore, there is the possibility that a tension element support body unit (or optionally a plurality of tension element support body units) can be fixed to a further implant and / or to a bone and thereby can be fixed in a location-stable manner. The tension member support body unit (or optionally tension member support body units) may be pressed against a refreshed bone. As a result, an optimal connection to the bone is possible. The resulting pressure on the bone advantageously promotes bone growth.

The tension element can furthermore comprise a material, in particular a metal and / or polymer, or consist of a material, in particular metal and / or polymer, as will be described in more detail below in connection with an optionally available sheath.

In a further embodiment, the osteoconductive support body are designed such that they can be connected to one another in a positive, force and / or material fit manner. Preferably, the osteoconductive support body are designed such that they are positively connected to each other. For example, the support body can be configured such that they can be connected to one another via a plug-in system or in the manner of a plug-in system. The plug-in system can be based on a so-called pin-hole principle, preferably with an undercut for better anchoring of the osteoconductive support body. For this purpose, a part of the osteoconductive support body may be provided with pins and another part of the osteoconductive support body with matching tap holes or slots.

In a further embodiment, the osteoconductive support body are positively, positively and / or materially connected to each other. Preferably, the support body are positively connected to each other. For example, the osteoconductive support body can be connected to one another via a plug-in system or in the manner of a plug-in system. With regard to the plug-in system, reference is made to the previous paragraph.

In a further embodiment, the support bodies are configured such that they can be positively, positively and / or materially connected to another implant. Preferably, the support body are designed such that they are positively connected to another implant. For example, the support body can be designed such that they can be connected via a plug-in system or in the manner of a plug-in system with another implant. The plug-in system can be based on a so-called pin-hole principle. For this purpose, the osteoconductive support body may be provided with a pin, and the other implant may have complementary pin holes or slots. The inverse ratios may also be possible according to the invention.

In a further embodiment, the osteoconductive support body are connected to each other via elongate connecting elements. For this purpose, the connecting elements preferably protrude into openings and / or depressions of the support body. With respect to possible embodiments of the openings or depressions of the osteoconductive support body, reference is made to the preceding statements. The elongated connecting elements and the osteoconductive support body may have the same material or consist of a same material. However, it is preferred if the elongated connecting elements and the osteoconductive support body have different materials or consist of different materials.

The elongated connecting elements can furthermore comprise a material, in particular a metal and / or polymer, or consist of a material, in particular metal and / or polymer, as described below in connection with one optional existing envelope will be described in more detail.

In a further embodiment, the osteoconductive support body has a proportion of 10 wt .-% to 95 wt .-%, in particular 20 wt .-% to 90 wt .-%, preferably 30 wt .-% to 70 wt .-%, on , based on the total weight of the implant.

The bone cement is in a further embodiment in a curable or settable form. In other words, according to a further embodiment, the bone cement is a hardenable or settable bone cement.

Preferably, the bone cement is characterized by a high mechanical initial strength and high mechanical ultimate strength, a fast setting and in particular by a higher in vivo degradation rate / higher in vivo absorption rate than the osteoconductive support body.

In another embodiment, the bone cement is in a cured or set form. In other words, according to another embodiment, the bone cement is a hardened or hardened bone cement.

In a further embodiment, the bone cement is present together with the osteoconductive support bodies as a mixture, in particular a heterogeneous mixture.

More preferably, the bone cement is arranged between the osteoconductive support bodies.

Particularly preferably, intermediate spaces formed or existing between the osteoconductive support bodies are at least partially, in particular only partially or completely, filled with the bone cement.

In another embodiment, the bone cement is distributed uniformly in a three-dimensional structure or matrix which can be obtained or obtained by compacting, in particular impacting, the osteoconductive support body.

In a further embodiment, the bone cement contains a bone cement powder, preferably a mineral bone cement powder.

In a further embodiment, the bone cement is present in the form of a bone cement powder, preferably in the form of a mineral bone cement powder.

In a further embodiment, the bone cement has a proportion of 5% by weight to 60% by weight, in particular 10% by weight to 50% by weight, preferably 30% by weight to 50% by weight, based on the total weight of the implant, in particular based on the total weight of bone cement and osteoconductive support bodies.

In a further embodiment, the bone cement is in the form of a modelable, in particular pasty, preparation.

In a further embodiment, the preparation contains, in addition to a bone cement powder, an organic carrier liquid and / or water.

The term "organic carrier liquid" in the context of the present invention preferably means an anhydrous or substantially anhydrous carrier liquid.

The organic carrier liquid is preferably a water-insoluble, i. water-insoluble, organic carrier liquid.

In an alternative embodiment, the organic carrier liquid is an organic carrier liquid which is only slightly soluble in water. In this embodiment, the carrier liquid is preferably <25%, in particular <10%, preferably <5%, based on the volume, soluble in water.

The organic carrier liquid may in particular be an oil.

Preferably, the organic carrier liquid is selected from the group consisting of glycerol triacetate, glycerol tributyrate, glycerol trioleate, glycerol dioleate, glycerol monooleate, Caprylcaprat, decyl oleate, isopropyl myristate, isopropyl palmitate, oleic acid, oleyl alcohol, oleyl oleate, short-chain triglycerides, medium-chain triglycerides (e.g., Myritol ^® 318 PH, Miglyol ^® 810 , Miglyol ^® 812, Miglyol ^® 829), short and medium-chain fatty acid ester of propylene glycol (for example, Miglyol ^® 840), ethyl benzoylacetate, ethyl butyrate, ethyl butyrylacetate, ethyl oleate, ethyl caproate, ethyl caprylate, ethyl caprate, ethyl laurate, ethyl levulinate, ethyl myristate, ethyl palmitate, ethyl linoleate, ethyl stearate, Ricinoleic acid, linoleic acid, linoleic acid, arachidic acid, oleic acid, ethyl arachidate, α-tocopherol, β-tocopherol, γ-tocopherol, δ-tocopherol, benzyl alcohol, benzyl benzoate, diethylbutyl malonate, diethylene glycol dibutyl ether, diethyl malonate, diethylphenyl malonate, diethyl phthalate, dieth ylsebacate, diethylsubarate, diethyl succinate, Dibutyl maleate, dibutyl phthalate, lecithin, paraffin oil, petrolatum, liquid paraffins, esters of sebacic acid, in particular sebacic acid dibutyl ester, sebacic acid diethyl ester, diisopropyl sebacate, dioctyl sebacate and mixtures of at least two of said carrier liquids.

In a further embodiment, the bone cement further comprises a curing regulator, in particular a curing accelerator or retarder.

The curing accelerator may be, for example, a surfactant.

The surfactant may be selected according to a further embodiment of consisting of fatty acids and their salts, esters of fatty acids and their salts, carboxylic acid ethers, alkyl sulfates, alkyl ether sulfates, alkyl sulfonates, sulfosuccinates, monoalkylphosphoric, di-alkylphosphoric, acylamino acids and their salts, alkylamine salts, Alkylimidazolines, tetraalkylammonium salts, tetraarylammonium salts, heterocyclic ammonium salts, ethoxylated amines, amphoteric surfactants, lecithins, fatty alcohols, ethoxylated fatty alcohols, ethylene oxide block copolymers, propylene oxide block copolymers, alkylphenol ethoxylates, alkyl polyglucosides, ethoxylated fats and oils, alkanolamides, ethoxylated alkanolamides, polyethylene glycol fatty acid esters, glycol esters, sorbitan esters ( Monoesters and triesters), sugar esters, ester surfactants, ether surfactants and mixtures of at least two of said surfactants.

For example, the surfactant may be selected from the group consisting of sodium lauryl sulfate, glycerol monooleate, polysorbate 20, 21, 40, 60, 61, 65, 80, 81, 85, 120, sorbitan diisostearate, sorbitan dioleate, sorbitan monoisostearate, sorbitan monolaurate, sorbitan monooleate, sorbitan monopalmitate, sorbitan monostearate, Sorbitan trioleate, sorbitan trilaurate, sorbitan tricaprylate, sorbitan tricaprate, isopropyl myristate, lecithin, lysolecithins, oleic acid, oleic acid, polyethylene glycol monocetyl ether, polyethylene glycol monostearyl ether, polyethylene glycol monolauryl ether, polyethylene glycol monooleyl ether, polyethoxylated castor oil, polyoxyl 40 stearate, polyoxyl 50 stearate, ascorbyl palmitate, cetyl phosphate and mixtures of at least two of mentioned surfactants.

In another embodiment, the bone cement further comprises a cure retarder selected from the group consisting of pyrophosphates, citrates, magnesium ions, calcium carbonate, and mixtures of at least two of said cure retarders.

In another embodiment, the preparation is free of water. In other words, it may be preferred according to the invention if the preparation is an anhydrous preparation.

In a further embodiment, the bone cement, in particular the bone cement powder, comprises at least one calcium compound and / or at least one magnesium compound or consists of at least one calcium compound and / or at least one magnesium compound which is selected from the group consisting of calcium silicates, calcium phosphates, calcium sulfates, calcium carbonates , Calcium, calcium, magnesium, magnesium, magnesium, magnesium, magnesium, magnesium

Preferably, the bone cement, in particular the bone cement powder, comprises at least one calcium compound and / or at least one magnesium compound or consists of at least one calcium compound and / or at least one magnesium compound selected from the group consisting of monocalcium phosphate monohydrate (MCPM), monocalcium phosphate anhydride (MCPA), dicalcium phosphate anhydride (DCPA), dicalcium phosphate dihydrate (DCPD), octacalcium phosphate (OCP), α-tricalcium phosphate (α-TCP), β-tricalcium phosphate (β-TCP), amorphous calcium phosphate (ACP), hydroxyapatite (HA ), Calcium deficient hydroxyapatite (CdHA), substituted hydroxyapatite, non-stoichiometric hydroxyapatite, nanoscale hydroxyapatite, tetracalcium phosphate (TTCP), calcium sulfate (CaSO ₄ ), calcium sulfate hemihydrate (CaSO 4 × 0.5H 2 O), calcium sulfate dihydrate (CaSO 4 × 2H 2 O) , Calcium oxide (CaO), calcium hydroxide (Ca (OH) ₂ ), calcium carbonate (CaCO ₃ ), calcium glycerophosphate, calcium citrate, Ca calcium lactate, calcium acetate, calcium tartrate, calcium chloride (CaCl 2), calcium silicates, magnesium hydrogen phosphate (MgHPO ₄ ) in the form of hydrates or as anhydrous substance, trimagnesium phosphate (Mg 3 (PO ₄ ) ₂ ), magnesium dihydrogen phosphate (Mg (H ₂ PO ₄ ) ₂ ) in the form hydrates or as anhydrous substance, magnesium chloride (MgCl ₂ ) in the form of hydrates or as an anhydrous substance, magnesium glycerophosphate, magnesium hydroxide (Mg (OH) ₂ ), magnesium hydroxide carbonate (for example as 4 MgCO ₃ × Mg (OH) ₂ × 5 H ₂ O ), Magnesium oxide (MgO), magnesium citrates (Mg ₃ (C ₆ H ₅ O ₇ ) ₂ ) or Mg (C ₆ H ₆ O ₇ )), calcium magnesium carbonate (CaMg (CO ₃ ) ₂ , dolomite and mixtures of at least two the said calcium and / or magnesium compounds.

According to a particularly preferred embodiment, the bone cement is a calcium phosphate cement, a magnesium phosphate cement, a magnesium-calcium phosphate cement or a mixture of at least two of said bone cements.

In another embodiment, the bone cement is a magnesium ammonium phosphate cement. With regard to the production of such cement is exemplified in the WO 2009/103273 A1 Reference is made to the disclosure of the content of the present description by express reference.

In a further embodiment, the implant further comprises an enclosure. By means of the cladding, it is particularly advantageous to effect a local binding of the osteoconductive support body and / or the bone cement, preferably the osteoconductive support body and the bone cement. Furthermore, by the enclosure with particular advantage, the intraoperative handling of the implant can be simplified.

For the purposes of the present invention, the term "envelope" is understood to mean a structure or construct which is designed to (at least) preferably at least partially cover the osteoconductive support body and / or the bone cement, preferably the osteoconductive support body and the bone cement completely, to surround or to be able to surround. For this purpose, the sheath preferably has a cavity which (at least) is at least partially, in particular only partially, filled or filled with the osteoconductive support bodies and / or the bone cement, preferably the osteoconductive support body and the bone cement.

In a preferred embodiment, the sheath surrounds or surrounds the osteoconductive support body and / or the bone cement, preferably the osteoconductive support body and the bone cement, at least partially, preferably completely. In other words, in another embodiment, the osteoconductive support bodies and / or the bone cement, preferably the osteoconductive support bodies and the bone cement, are at least partially, preferably completely, contained in the enclosure.

In a further embodiment, the envelope is flexible.

In a further embodiment, the envelope is designed to be closable, in particular by means of a thread, preferably tension or Verzurrfadens. Alternatively, the wrapper may include a hook and loop fastener.

In principle, the wrapping can be container, vessel, bag or container-shaped.

Preferably, the envelope is dimensionally stable or preformed. The sheath may in particular be anatomically, i. have a shape adapted to the bone defect to be treated.

In principle, the envelope may have a symmetrical or asymmetrical shape.

For example, the wrapping may be pillow, bag or bag, wedge, apple carving, sickle, crescent, ring, toroid or cloverleaf.

In a further embodiment, the envelope has openings and / or depressions, in particular selected from the group consisting of holes, pores, cracks, slits, cracks, gaps, notches, and combinations of at least two of said openings or depressions.

According to the invention, it may be particularly preferred if the envelope has pores, in particular has an open-pored design.

The enclosure may be designed to be permeable with particular advantage for body cells, especially bone cells.

The sheath preferably has openings, in particular pores, with a diameter, preferably average diameter, of 10 μm to 5 mm, in particular 100 μm to 3 mm, preferably 500 μm to 2 mm.

In a further embodiment, the sheath comprises or consists of a material which is degradable in vivo or resorbable in vivo.

In particular, the in vivo degradable material may be a biopolymer, i. to be a naturally occurring polymer.

The in vivo degradable or in vivo resorbable material, in particular biopolymer, is preferably a protein, in particular extracellular protein.

The protein is preferably selected from the group consisting of collagen, gelatin, elastin, reticulin, fibronectin, fibrin, laminin, albumin and mixtures of at least two of said proteins.

In a further embodiment, the in vivo degradable or in vivo resorbable material, in particular protein, is collagen, preferably collagen type I, collagen type III or a mixture containing or consisting of collagen type I and collagen type III.

In another embodiment, the in vivo degradable or in vivo resorbable material is free of non-collagenous components, especially free of non-collagenous proteins and / or fats and / or enzymes.

In another embodiment, the in vivo degradable material is in lyophilized, i. freeze-dried form, before.

In a further embodiment, the in vivo degradable or in vivo resorbable material is an extracellular matrix, in particular a biological tissue.

For the purposes of the present invention, the term "biological tissue" is intended in particular to mean a human tissue, an animal tissue, i. a tissue occurring in non-human animals, preferably non-human mammals, or a tissue made by tissue engineering techniques.

The in vivo degradable or in vivo resorbable material is preferably an extracellular matrix of an animal or xenogeneic, in particular bovine, equine or porcine tissue.

In a further embodiment, the material which is degradable in vivo or in vivo is produced from a biological tissue, in particular from an animal or xenogeneic, preferably bovine, equine or porcine tissue.

The tissue may in principle be selected from the group consisting of pericardium, peritoneum, small intestine submucosa, stomach submucosa, urinary bladder submucosa, uterine submucosa, serosa and mixtures of at least two of said tissues.

Preferably, the tissue is selected from the group consisting of pericardium (pericardium), pericardium fibrosum, pericardium serosum, epicardium, squamous epithelium, tunica serosa, muscle such as myocardium and mixtures of at least two of said tissues.

More preferably, the tissue is pericardium, especially bovine pericardium, i. around beef casserole.

In another embodiment, the in vivo degradable material is a collagen material prepared from bovine pericardium and, in particular, non-collagenous components such as noncollagenous proteins, fats and enzymes, purified and lyophilized collagen material. Such a material is already offered commercially by the applicant under the name Lyoplant® for Duraersatz.

In a further embodiment, the in vivo degradable or in vivo resorbable material, in particular biopolymer, is a polysaccharide, in particular mucopolysaccharide.

The polysaccharide is preferably selected from the group consisting of starch, amylose, amylopectin, dextran, dextrin, cellulose, methylcellulose, ethylcellulose, hydroxymethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, carboxymethylcellulose, carboxyethylcellulose, chitin, chitosan, hyaluronic acid, dextran sulfate, heparin, heparan sulfate, chondroitin sulfate, Dermatan sulphate, keratan sulphate and mixtures of at least two of said polysaccharides.

In another embodiment, the in vivo degradable material is a synthetic polymer, i. an artificially (artificially), for example by means of chemical synthesis or by means of biotechnology or genetic engineering methods, produced polymer.

The synthetic polymer may in principle be a segmented polymer or block polymer, a random polymer, an isotactic polymer, a syndiotactic polymer, an atactic polymer or a mixture (blend) of at least two of said polymers.

In a further embodiment, the in vivo degradable or in vivo resorbable material, in particular synthetic polymer, is a polyhydroxyalkanoate.

Preferably, the in vivo degradable or in vivo resorbable material, in particular the synthetic polymer, selected from the group consisting of polyglycolide, polylactide, polycaprolactone, polytrimethylene carbonate, poly-para-dioxanone (poly-1,4-dioxan-2-one) , Poly-3-hydroxybutyrate, poly-4-hydroxybutyrate, copolymers of at least two of said polymers and mixtures (blends) of at least two of said polymers.

In a further embodiment, the in vivo degradable or in vivo resorbable material is a synthetic polymer, ie, an artificially (artificially), for example by means of chemical synthesis or by biotechnology or genetic engineering methods, produced polymer which in its chemical and physical properties, in particular in its material and structural properties, (substantially) in accordance with a naturally occurring, in particular synthesized in the cell of a living, polymer. The synthetic polymer may in particular be a protein and / or polysaccharide. With regard to proteins and / or polysaccharides which are generally suitable, reference is made to the proteins and / or polysaccharides mentioned in the previous description.

In another embodiment, the in vivo degradable or in vivo resorbable material is a metal, in particular tantalum.

In a further embodiment, the sheath comprises or consists of a non-in vivo degradable or non-in vivo resorbable material.

The non-in vivo degradable or non-in vivo absorbable material may be selected from the group consisting of polyolefin, polyester, polyamide, polyurethane, elastomer such as thermoplastic elastomer, polyether ketone, organic polysulfide, copolymers of at least two of said polymers and blends. of at least two of said polymers.

The polyolefin may in particular be selected from the group consisting of polyethylene (PE), low density polyethylene, high density polyethylene, high molecular weight polyethylene (HMWPE), ultra high molecular weight polyethylene (UHMWPE), polypropylene (PP), polytetrafluoroethylene (PTFE), polyvinylidene fluoride, polyvinyl chloride, Polytetrafluoropropylene, polyhexafluoropropylene, copolymers of at least two of said polyolefins and mixtures (blends) of at least two of said polyolefins.

The polyester may in particular be selected from the group consisting of polyethylene terephthalate, polypropylene terephthalate, polybutylene terephthalate, copolymers of at least two of said polyesters and mixtures (blends) of at least two of said polyesters.

The polyamide may in particular be selected from the group consisting of polyamide 6 (polymer of ε-caprolactam or ω-aminocaproic acid units), polyamide 66 (polymer of hexamethylenediamine and adipic acid units), polyamide 69 (polymer of hexamethylenediamine and azelaic acid units), Polyamide 612 (polymer of hexamethylenediamine and dodecanedioic acid units), polyamide 11 (polymer of 11-aminoundecanoic acid units), polyamide 12 (polymer of laurolactam or omega-aminododecanoic acid units), polyamide 46 (polymer of tetramethylenediamine and adipic acid units), polyamide 1212 (polymer of Dodecanediamine and dodecanedioic acid units), polyamide 6/12 (polymer of caprolactam and laurolactam units), polyamide 66/610 (polymer of hexamethylenediamine, adipic acid and sebacic acid units), copolymers of at least two of said polyamides and mixtures (blends) of at least two said polyamides.

In particular, the thermoplastic elastomer may be selected from the group consisting of thermoplastic copolyamide, thermoplastic polyester elastomer, thermoplastic copolyester, olefin-based thermoplastic elastomer, styrene block copolymer, urethane-based thermoplastic elastomer, crosslinked olefin-based thermoplastic elastomer, copolymers of at least two of said elastomers and blends (Blends) of at least two of said elastomers.

The polyether ketone may in particular be selected from the group consisting of polyether ketone ketone, polyether ether ether ketone, polyether ether ketone ketone, polyether ketone ether ketone ketone, copolymers of at least two of said polyether ketones and mixtures (blends) of at least two of said polyether ketones.

In a further embodiment, the non-in vivo degradable or non-in vivo absorbable material of the sheath is a metal or an alloy, in particular selected from the group consisting of titanium, steel such as stainless steel, stainless steel or high-alloy steels, in particular with Chromium, nickel, duplex steels, and mixtures thereof.

In another embodiment, the material of the at least one enclosure is any mixture of the materials described in the previous paragraphs.

In a further embodiment, the envelope has a non-textile structure. In particular, the wrapper may be non-textile, i. in the form of a non-textile structure.

In a further embodiment, the casing has a randomized fiber structure, ie a structure with randomly arranged and / or oriented fibers, on or consists of such a structure.

In another embodiment, the wrapper is in lyophilized, i. freeze-dried, form in front.

In another embodiment, the wrapper is latticed, i. in the form of a grid, in particular metal grid, formed. With regard to eligible metals, reference is made to the metals or alloys described so far.

In a further embodiment, the envelope has a textile structure. According to the invention it may be particularly preferred if the envelope is designed in the form of a textile, i. in the form of a textile structure.

The textile structure may comprise threads or be formed from threads which are selected from the group consisting of monofilaments, pseudomonofilaments, multifilaments and combinations of at least two of said threads.

The textile structure, in particular threads thereof, may have an additive, such as an active ingredient and / or an X-ray contrast agent. With regard to suitable additives, reference is made to the additives explained in more detail below.

In principle, the threads of the textile structure can have the same thread thickness (thread diameter).

From a dimensional stability point of view, however, it may be preferred if the sheath, in particular the textile structure, has threads with different thread sizes (thread diameters).

Furthermore, threads of the textile structure, in particular at least partially, dyed, for example, white and / or blue colored, are present. The dyed threads may in particular be orientation threads which facilitate a user, usually a surgeon, the correct placement of the sheath and in particular of the implant.

To avoid unnecessary repetition, reference is made to the materials described above in the context of the optional sheath with respect to possible materials for the threads. The threads may comprise one or more of the polymers mentioned in this connection or consist of one or more of the polymers mentioned in this connection.

Furthermore, the textile structure may be selected from the group consisting of woven, knitted, knitted, braided, nonwoven, nonwoven, mesh, felt and knit fabric.

According to the invention, it may therefore be preferred that the covering has a woven, knitted, knitted, braided, non-woven, nonwoven-shaped, reticulated, felt-shaped or mesh-shaped structure or is constructed from such a structure.

According to a particularly preferred embodiment, the enclosure is reticulate, i. in the form of a network, in particular knitted network trained.

For example, it may be in the network is the product marketed by the applicant under the name Optilene ^® mesh product. This is a knitted net with monofilament polypropylene threads, a basis weight of 60 g / m ² and a pore size of about 1.5 mm. Alternatively, it may be in the network is the product marketed by the applicant under the name Optilene ^® Mesh LP product. This is a knitted net with monofilament polypropylene threads, a basis weight of 36 g / m ² and a pore size of about 1.0 mm. Alternatively, it may be in the network is the product marketed by the applicant under the name Optilene ^® Mesh Elastic product. This is a knitted net with monofilament polypropylene threads, a basis weight of about 48 g / m ² and a pore size of about 3.6 mm × 2.8 mm.

In another embodiment, the wrapper comprises a shrinkable thread, i. a so-called shrinkage thread, on. The shrinkage thread is preferably designed to bring about a change in shape, in particular a shape adaptation, of the wrapping to a bone defect to be treated, and / or a closure of the wrapping by shrinking. The shrinkage behavior of the thread can be brought about, for example, by means of irradiation and fixing. The shrinkage thread may, for example, comprise poly-4-hydroxybutyrate or consist of poly-4-hydroxybutyrate.

In a further embodiment, the envelope is multi-layered, in particular double-layered. In other words, the envelope according to a further embodiment, a plurality of layers, in particular two layers on.

The layers can be the same or different. In particular, the layers may have the same material or consist of a same material. Alternatively, the layers may be made of one or more different materials consist. With regard to suitable materials, reference is made to the previous description.

Furthermore, the layers may each be formed textile-shaped or non-textile.

Furthermore, the sheath may have at least one textile-shaped layer and at least one non-textile layer.

The layers are preferably arranged one above the other and connected to one another, in particular connected to one another at the edge.

The connection of the layers may be based on a seam, in particular on a seam running on the edge of the sheet, or on a fabric closure, in particular a fabric finish formed on the edge of the sheet, such as, for example, an adhesive bonding or welding.

In a further embodiment, the sheath is only partially filled with the osteoconductive support body and the bone cement. The sheath may in particular only be filled to 10% to 90%, in particular 20% to 85%, with the osteoconductive supporting bodies and the bone cement. As a result, a shapable and still stable defect replenishment is ensured with particular advantage.

In a further embodiment, the coating has a proportion of from 0.5% by weight to 50% by weight, in particular from 5% by weight to 40% by weight, preferably from 2% by weight to 50% by weight, based on the total weight of the implant.

In a further embodiment, the implant further has a reinforcing structure (reinforcing structure). The reinforcing structure is preferably designed to provide a reinforcement, i. a reinforcement or reinforcement to effect the implant.

The reinforcing structure may comprise or consist of an in vivo degradable or in vivo resorbable material. Alternatively, the reinforcing structure may comprise or consist of a partially in vivo degradable or partially in vivo resorbable material. Alternatively, the reinforcing structure may comprise or consist of a non-in vivo degradable or non-in vivo resorbable material. With regard to suitable materials, reference is made to the materials mentioned within the scope of the previous description, in particular with regard to the optionally provided cover.

The reinforcing structure may for example have a textile structure or be constructed from such a structure. With regard to suitable textile structures, reference is made to the textile structures mentioned in connection with the optionally provided sheath.

The reinforcing structure is preferably in the form of a net, in particular in the form of a knitted net. The reinforcing structure may in particular be a polypropylene net, ie a net with polypropylene threads, in particular monofilament polypropylene threads. Preferred is a knitted polypropylene net. For example, it may be in the network to a commercially sold by the applicant under the names Optilene ^® mesh, Optilene ^® mesh record and Optilene ^® Elastic mesh networks.

In an alternative embodiment, the reinforcing structure is a lattice structure, in particular a metal lattice. For example, the reinforcing structure may be a titanium or tantalum lattice.

With regard to further suitable structures and / or materials of the reinforcing structure, reference is made in full to the previous description, in particular to the statements made with regard to the optionally provided sheath.

In a further embodiment, the implant, in particular the envelope, has a fastening device. The fastening device is preferably designed to effect attachment of the implant in the region of a bone defect zone, in particular on a bone tissue adjacent to the defect zone. The fastening device can be configured, for example, as a hole, reinforced hole, eye, sleeve, slot, column or loop. The fastening device may further be textile, in particular thread-like, configured. With particular advantage, the fastening device may be formed of a stiffer material than the implant, in particular the envelope, as such. For example, the fastening device may be formed as a thread or thread loop. With regard to further features and advantages of the thread, reference is made to the explanations concerning the threads of the textile structure in connection with the optionally provided covering.

In a further embodiment, the implant has a plurality of envelopes.

Preferably, in each case the osteoconductive support body and / or the Bone cement, preferably the osteoconductive support body and the bone cement included.

Alternatively, only one of the sheaths may be filled with the osteoconductive support bodies and / or the bone cement, preferably the osteoconductive support bodies and the bone cement. This enclosure can be used with particular advantage as a kind of "reservoir enclosure" to fill the remaining sheaths.

Furthermore, the sheaths can be present in particular in different sizes. In particular, one or more smaller wraps may be contained in a larger wrapper. In this case, the smaller wrapper or the smaller wrappers and / or the larger wrapper may have an in vivo degradable or in vivo resorbable material or consist of such a material.

The embodiments described in the previous paragraphs with respect to the optionally provided sheath apply mutatis mutandis to the case that the implant has several sheaths.

In a further embodiment, the implant, in particular an intermediate region and / or lateral region thereof, has a textile structure. The term "intermediate region" in the sense of the present invention means a region of the implant which spaces two adjacent envelopes of the implant from one another. With regard to further features and advantages of the textile structure, reference is made to the corresponding statements made in connection with the optionally provided covering.

In a further embodiment, the implant, in particular an intermediate region and / or lateral region thereof, has a non-textile structure. With regard to further features and advantages of the non-textile structure, reference is likewise made to the corresponding statements made in connection with the optionally provided enclosure.

According to a further embodiment, the implant, in particular the osteoconductive support body and / or the bone cement and / or one or more optionally provided sheaths, an additive. The implant, in particular the osteoconductive support body and / or the bone cement and / or one or more optionally provided sheaths, may for example be coated with the additive or have an additive-containing coating.

In particular, the additive may be an active ingredient, preferably selected from the group consisting of medicinal agent, biological agent and mixtures thereof, and / or a contrast agent.

The active ingredient may be selected from the group consisting of osteoactive and osteoinductive and / or osteogenic substances, antimicrobials, antibiotics, anti-inflammatory drugs, cytostatics, cytokines, Bone Morphogenetic Proteins (BMPs), anti-osteoporotic drugs and mixtures of at least two of them called active ingredients.

For example, the active ingredient may be selected from the group consisting of BMP 1, BMP 2, BMP 3, BMP 3B, BMP 4, BMP 5, BMP 6, BMP 7, BMP 8A, BMP 8B, BMP 10, BMP 15, interferons, interleukins , in particular interleukin-1β, interleukin-6, colony-stimulating factors, chemokines, gentamicin, polyhexamethylene biguanide (PHMB), hyaluronic acid, silver, silver compounds, in particular silver salts, preferably in the form of nanoparticles, and mixtures of at least two of said active substances.

The contrast agent may be selected from the group consisting of iodine compounds, heavy metal salts such as barium sulfate, zirconium oxide and mixtures of at least two of said contrast agents.

In a further embodiment, the implant consists of osteoconductive support bodies and an in vivo degradable / in vivo resorbable bone cement and optionally one or more sheaths and / or optionally an additive. With regard to further features and advantages of the implant, in particular the osteoconductive support body and the in vivo degradable / in vivo resorbable bone cement as well as an optionally provided sheath (s) and / or an optionally provided additive, reference is made in full to the previous description.

In a further embodiment, the implant is an implant for use in the treatment and / or biological reconstruction, in particular lining and / or sealing and / or relining and / or at least partial filling, of a bone defect.

As already mentioned, the bone defect may in particular be a joint defect, preferably a hip joint defect, particularly preferably an acetabulum defect.

In another embodiment, the treatment is a revision.

According to a particularly preferred embodiment, the implant is a bone substitute material.

According to a second aspect of the invention, the invention relates to a kit, in particular a surgical kit, preferably for producing an implant according to the present invention and / or for treatment and / or biological reconstruction, in particular lining and / or sealing and / or underfeeding and / or at least partial filling , a bone defect.

• - osteokonduktive Stützkörper und
• - einen in vivo abbaubaren/in vivo resorbierbaren Knochenzement.

The kit has the following components separated from each other:

• - osteoconductive supportive bodies and
• an in vivo degradable / in vivo resorbable bone cement.

The osteoconductive support bodies comprise a support body material or consist of a support body material.

This is characterized in particular by the fact that the support body material is not degradable in vivo / not resorbable in vivo and / or degradable more slowly in vivo / is more slowly resorbable in vivo than the bone cement.

In a preferred embodiment, the kit further comprises at least one component selected from the group consisting of sheath, bone adhesive, reinforcing structure, endoprosthesis, fastener and combinations of at least two of said components.

With regard to the wrapping mentioned in the last paragraph, reference is made to the statements made in the context of the first aspect of the invention with regard to the optionally provided casing. The embodiments described so far apply (mutatis mutandis) to the kit.

The bone adhesive may be, for example, another bone cement. With regard to suitable bone cements, reference is made to the previous description.

With regard to the above-mentioned reinforcing structure, reference is made in full to the statements made in the context of the first aspect of the invention with regard to the optionally provided reinforcing structure. The embodiments described so far apply (mutatis mutandis) to the kit.

The fastening element can be, for example, a bone screw, a bone nail or a thread, in particular a surgical suture.

The endoprosthesis is preferably an artificial joint socket or an artificial joint socket inlay.

With regard to further features and advantages of the kit, in particular the osteoconductive support body and the bone cement, reference is made completely to the statements made in the context of the first aspect of the invention, which also apply mutatis mutandis to the kit.

According to a third aspect, the invention relates to a further kit, in particular a surgical kit, in particular for treating and / or biological reconstruction, in particular lining and / or sealing and / or underfeeding and / or at least partial filling, of a bone defect.

The kit comprises an implant according to the first aspect of the invention and at least one further component which is selected from the group consisting of bone adhesive, reinforcing structure, endoprosthesis, fastening element and combinations of at least two of said components.

With regard to further features and advantages of the kit, in particular the implant, the osteoconductive support body and the bone cement, reference is made completely to the statements made in the context of the first and second aspects of the invention, which apply (mutatis mutandis) to the further kit.

According to a fourth aspect, the invention relates to a method for treating and / or biological reconstruction, in particular lining and / or sealing and / or underfeeding and / or at least partial filling, of a bone defect.

• - Platzieren eines Implantats in einen Knochendefekt, wobei das Implantat Folgendes aufweist:
  • - osteokonduktive Stützkörper,
  • - einen in vivo abbaubaren/in vivo resorbierbaren Knochenzement und
  • - optional eine Umhüllung, welche die osteokonduktiven Stützkörper und/oder den Knochenzement, vorzugsweise die osteokonduktiven Stützkörper und den Knochenzement, wenigstens teilweise, vorzugsweise vollständig, umgibt oder umschließt.

The procedure includes the following step:

• Placing an implant in a bone defect, the implant comprising
  • - osteoconductive support bodies,
  • an in vivo degradable / in vivo resorbable bone cement and
  • Optionally, a sheath, which the osteoconductive support body and / or the Bone cement, preferably the osteoconductive support body and the bone cement, at least partially, preferably completely, surrounds or encloses.

The osteoconductive support bodies comprise a support body material or consist of a support body material.

The method is characterized in particular by the fact that the support body material is not degradable in vivo / not resorbable in vivo and / or degradable more slowly in vivo / is more slowly resorbable in vivo than the bone cement.

• - Beaufschlagen des platzierten Implantats mittels eines sogenannten Nachschlägers, d.h. eines chirurgischen Instruments zum Verdichten, insbesondere Impaktieren, der osteokonduktiven Stützkörper.

In a preferred embodiment, the method further comprises the following step:

• - Applying the placed implant by means of a so-called Nachschlägers, ie a surgical instrument for compacting, in particular impacting, the osteoconductive support body.

• - Aufbringen von zusätzlichem in vivo abbaubaren/in vivo resorbierbaren Knochenzement auf das platzierte, insbesondere beaufschlagte, Implantat.

In a further embodiment, the method further comprises the following step:

• - Applying additional in vivo degradable / in vivo resorbable bone cement on the placed, in particular applied, implant.

• - Aufbringen einer Gelenkpfanne auf das platzierte, insbesondere beaufschlagte, Implantat und/oder den Knochenzement, insbesondere den zusätzlich aufgebrachten Knochenzement.

In a further embodiment, the method further comprises the following step:

• - Applying a joint socket on the placed, in particular acted upon, implant and / or the bone cement, in particular the additionally applied bone cement.

• - Befestigen der Gelenkpfanne an ein umliegendes, d.h. den Knochendefekt umgebendes, Knochengewebe.

In a further embodiment, the method further comprises the following step:

• - Fix the socket to a surrounding, ie surrounding the bone defect, bone tissue.

With regard to further features and advantages of the method, in particular of the implant, reference is made in full to the statements made within the scope of the previous description, which (analogously) also apply to the method.

Further features and advantages of the invention will become apparent from the claims and from the following description of preferred embodiments with reference to the description of the figures, the associated figures and an embodiment. In this case, features of the invention can be realized individually or in combination with each other. The embodiments described below serve to further illustrate the invention, without limiting it thereto.

list of figures

• 1: eine Draufsicht auf ein menschliches Azetabulum,
• 2: eine Ausführungsform eines erfindungsgemäßen Implantats,
• 3: : eine weitere Ausführungsform eines erfindungsgemäßen Implantats,
• 4: eine weitere Ausführungsform eines erfindungsgemäßen Implantats,
• 5: eine weitere Ausführungsform eines erfindungsgemäßen Implantats,
• 6a-d: verschiedene Ausführungsformen von osteokonduktiven Stützkörpern,
• 7: eine weitere Ausführungsform von osteokonduktiven Stützkörpern in Kombination mit einem fadenförmigen Zugelement,
• 8a-c: Behandlung eines defekten Azetabulums mittels eines erfindungsgemäßen Implantats.

The figures show schematically the following:

• 1 : a top view of a human acetabulum,
• 2 : an embodiment of an implant according to the invention,
• 3 : another embodiment of an implant according to the invention,
• 4 a further embodiment of an implant according to the invention,
• 5 a further embodiment of an implant according to the invention,
• 6a-d : various embodiments of osteoconductive support bodies,
• 7 a further embodiment of osteoconductive support bodies in combination with a thread-like tension element,
• 8a-c : Treatment of a defective acetabulum by means of an implant according to the invention.

1 shows schematically a plan view of a human acetabulum 1 , also known as hip joint or pelvic cup. This is the bony part of the hip joint formed by the pelvis. The acetabulum is created by the fusion of parts of the seat, intestine and pubis. The merger is usually completed after about 6 months.

Under ideal conditions, there is a correspondence between the acetabulum and the femoral head, i. The round femoral head fits exactly into the acetabulum, which embeds and encloses it widely. The hip joint is designed as a multi-axis ball joint and thus more or less freely movable in almost any direction. This ensures high mobility and resilience.

The joint-forming parts of the hip joint are surrounded by a connective tissue capsule, whose inner layer, the synovium, constantly produces new synovial fluid. An annular gel-like clot of cartilage forms the edge of the bony pan.

The acetabulum 1 has a front pan edge 2 , also referred to as a so-called front horn, and a rear edge of the pan 4 , also known as so-called rear horn. The intervening pan roof 3 is round or substantially round running out.

2 schematically shows an embodiment of an implant according to the invention 100 ,

The implant 100 has a mixture comprising or consisting of osteoconductive support bodies 110 and an in vivo degradable / in vivo resorbable bone cement 120 on. The bone cement 120 is preferably of kneadable or pasty nature.

The supporting bodies 110 comprise a support body material or consist of a support body material that is either non-biodegradable / not resorbable in vivo, or degradable / degradable more slowly in vivo / resorbable in vivo than the bone cement 120 ,

The support body material is preferably apatite and / or tricalcium phosphate, in particular sintered apatite and / or sintered tricalcium phosphate.

The support body material is particularly preferably hydroxylapatite, in particular sintered hydroxylapatite, and / or beta-tricalcium phosphate, in particular sintered beta-tricalcium phosphate.

The bone cement is preferably a calcium phosphate cement, a magnesium sulfate cement or a magnesium-calcium phosphate cement.

The illustrated implant 100 has the advantage that it can be adapted to a bone defect to be treated during surgery in terms of shape and quantity.

3 schematically shows a further embodiment of an implant according to the invention 100 ,

The implant 100 has osteoconductive support body 110 , a curable, in vivo degradable / in vivo resorbable bone cement 120 as well as a serving 130 on.

The osteoconductive support body 110 and the bone cement 120 are completely in the cladding 130 contain.

The supporting bodies 110 comprise a support body material or consist of a support body material that is either non-biodegradable / not resorbable in vivo, or degradable / degradable more slowly in vivo / resorbable in vivo than the bone cement 120 ,

The support body material is preferably apatite and / or tricalcium phosphate, in particular sintered apatite and / or sintered tricalcium phosphate.

The support body material is particularly preferably hydroxylapatite, in particular sintered hydroxylapatite, and / or beta-tricalcium phosphate, in particular sintered beta-tricalcium phosphate.

The osteoconductive support body 110 For example, as shown, they may be in the form of tetrahedra. The tetrahedral configuration of the support body 110 favors compression, in particular impacting, the support body, whereby a three-dimensional, osteoconductive guide structure can be created.

For the hardenable bone cement 120 it is preferably a calcium phosphate cement, a magnesium phosphate cement or a magnesium-calcium phosphate cement.

After curing, the bone cement can 120 with particular advantage, a cohesion of osteoconductive support body, in particular a stabilization of the mentioned in the previous paragraph lead structure.

The serving 130 has two superimposed layers 131 ; 132 on which edge by means of a seam 135 connected to each other. The layers can 131 ; 132 - As shown - be designed, for example, approximately disc-shaped. The seam 135 For example, it may be formed from a non-in vivo degradable / non-in vivo resorbable suture, such as a polypropylene thread, or an in vivo degradable / in vivo resorbable suture, such as a polyglycolide suture.

The two stitched together layers 131 ; 132 include a cavity which communicates with the osteoconductive support bodies 110 and the bone cement 120 at least partially, in particular only partially, is filled.

The two layers 131 ; 132 preferably consist of an in vivo degradable / in vivo resorbable material. The material may, for example, be collagen, preferably one made from bovine pericardium. This has the advantage that bone tissue can grow into the implant and thus a bone defect. The osteoconductive support body 110 act with particular advantage as a guide structure for ingrowing bone tissue.

Alternatively, the two layers can each have a network structure, in particular a knitted network structure, for example with monofilament polypropylene threads. This also allows bone tissue to grow into the implant and thus into a bone defect.

4 schematically shows a further embodiment of an implant according to the invention 100 ,

The implant 100 has two servings 130a ; 130 b on. The servings 130a ; 130 b are each at least partially, in particular only partially, with osteoconductive support bodies 110 and a curable, in vivo degradable / in vivo resorbable bone cement 120 filled.

The implant 100 also has a central area 150 as well as a lateral area 160 on.

The lateral area 160 can be a fastening device 165 , For example in the form of a sleeve, have. The fastening device 165 is preferably adapted to an attachment of the implant 100 to cause bone tissue adjacent to a bone defect to be treated.

The implant 100 can also be used to form the sheaths 130a ; 130 b and / or to reinforce the implant 100 a seam 135 exhibit. The seam 135 is preferably continuous along edge zones of the implant 100 and / or the two servings 130a ; 130 b educated. The seam 135 may be formed by a shrinkable thread, such as a poly-4-hydroxybutyrate thread. Due to a shrinkage of the seam 135 , For example, by irradiation, with particular advantage, a shape adaptation of the implant 100 be achieved on the patient-specific form of a bone defect.

Both the two servings 130a ; 130 b as well as the sections 150 and 160 can each have a network structure, in particular a knitted network structure, for example with monofilament polypropylene threads possess.

Regarding further features and advantages of the illustrated implant 100 , in particular the osteoconductive support body 110 as well as the bone cement 120 , is related to the 3 made statements made reference.

5 schematically shows a further embodiment of an implant according to the invention 100 ,

The implant 100 has a central area 140 as well as three servings 130a ; 130 b ; 130c on.

The servings 130a ; 130 b ; 130c are radially around the central portion 140 arranged.

The servings 130a ; 130 b ; 130c are each at least partially, in particular only partially, with osteoconductive support bodies 110 and a curable, in vivo degradable / in vivo resorbable bone cement 120 filled.

The central area 140 is preferably adapted for engagement with a bottom area of a bone defect, while the sheaths 130a ; 130 b ; 130c preferably for abutment against side walls, in particular on a bony defect bottom radially encircling bone walls are formed.

Both the servings 130a ; 130 b ; 130c as well as the central area 140 each have a seam running at the edge 135 on. Also in this case, the seam can 135 For example, be formed by a shrinkage thread, such as a thread of poly-4-hydroxybutyrate. Through a targeted shrinkage of the seam 135 , For example, by irradiation, a plant of sheaths 130a ; 130 b ; 130c to a bone defect floor radially encircling bone walls are facilitated.

The servings 130a ; 130 b ; 130c as well as the central area 140 can each have two superposed network layers, in particular knitted network layers, which over the seam 135 are connected to each other at the edge.

This will define the wrappings 130a ; 130 b ; 130c as well as the central area 140 each cavities, each at least partially, in particular only partially, with the osteoconductive support bodies 110 as well as the bone cement 120 are filled.

The implant 100 Overall is preferably designed in the manner of a three-bladed propeller, wherein the central region 140 the "wave" and the servings 130a ; 130 b ; 130c forming the "wings" of the propeller.

Regarding further features and advantages of the illustrated implant 100 , in particular the osteoconductive support body 110 as well as the bone cement 120 , is related to the 3 made statements made reference.

6a-d show various embodiments for the osteoconductive support body 110 , which each favor a compression, in particular impacting the support body, for example by means of a Nachschlägers.

The in 6a illustrated support body 110 has elongated and rectilinear structural elements 112 which are assembled into a tetrahedral arrangement. That by the mutual arrangement of the structural elements 112 generated void volume 114 contributes in a particularly advantageous manner to an increase of the absolute cavity volume of the support body 110 , in particular a three-dimensional and osteoconductive structure which is obtainable by compacting, in particular impacting, the osteoconductive support body. As a result, it is advantageously possible to imitate the cancellous bone of human or animal bone, in particular with regard to porosity.

On top of that, the favored in 6a embodiment illustrated an interlocking, in particular a mutual pinching or wedging, the osteoconductive support body under force and thus the generation of an osteoconductive conductive structure formed by the support body.

The in 6b illustrated support body 110 is in the form of a tetrapod. A tetrapod-like configuration of the support body 110 also favors a meshing, in particular a mutual pinching or wedging, the osteoconductive support body upon application of force and thus the production of an osteoconductive guide structure formed by the support body.

The in 6c illustrated support body 110 is in the form of a tetrahedron. A tetrahedral configuration of the support body 110 also favors engagement, in particular a mutual wedging, the osteoconductive support body upon application of force and thus the production of an osteoconductive guide structure formed by the support body.

The in 6d illustrated support body 110 is in the form of a pyramid. A pyramidal configuration of the support body 110 also favors engagement, in particular a mutual wedging, the osteoconductive support body upon application of force and thus the production of an osteoconductive guide structure formed by the support body.

7 shows schematically osteoconductive support body 110 and an elongated tension element 170 , as they can be used in the context of the present invention.

The supporting bodies 110 each have through openings 116 and can - as shown - be formed, for example cuboid. Through the openings 116 can the elongated tension element 170 , as in 6 represented, are passed. In this way, a compacting, in particular lashing, the support body 110 achievable with formation of an osteoconductive guide structure. Another advantage is that, as a result, a smaller amount of bone cement may be required, as part of the stability by the tension element 170 The tension element is preferably a thread, for example made of polypropylene or a polyhydroxyalkanoate, for example polylactide or polyglycolide.

In the 8a-c is shown schematically the treatment of a defective acetabulum by means of an implant according to the invention.

8a shows an acetabulum 10 with a defect 12 and surrounding bone tissue 14 ,

The implant has osteoconductive support bodies 110 , a curable and in vivo degradable / in vivo resorbable bone cement 120 as well as a serving 130 on. Both the support body 110 as well as the bone cement 120 are in the serving 130 included (see 8b ).

First, the implant 100 in the broken acetabulum 10 placed.

After placing the implant 100 become the osteoconductive support bodies 110 preferably converted into a compacted, in particular impacted, state (see 8c ). This can be done for example by means of a so-called Nachschlägers.

Subsequently, an artificial joint socket 200 on the implant 100 or, if applicable, to the implant previously 100 implanted additionally applied bone cement (see also 8c )

By degradation / absorption of the coating 130 and / or an open-pored embodiment of the enclosure 130 Advantageously, an ingrowth of bone tissue, in particular new bone tissue, into the implant occurs within the first four weeks after the surgical procedure 100 and therefore into the broken acetabulum 10 ,

In this case, the preferably compacted, in particular impacted, present supporting body act 110 of the implant 100 as an osteoconductive lead structure for the ingrowing bone tissue, while the bone cement 120 with particular advantage the mechanical stability of the through the support body 110 additionally formed lead structure formed. In this way, the implant can 100 a Effectively increase the secondary stability of the implanted socket 200 cause.

Regarding further features and advantages of the implant 100 is related to the 3 made statements made reference.

Furthermore, reference is made to the general description for further features and advantages of the implants shown in the figures.

embodiment

For the preparation of the support body, a calcium phosphate cement of Powder Liquid type PL was used. The starting components for the powder were .alpha-TCP and for the liquid 2.5 wt% Na ₂ HPO ₄ solution. The cement made therefrom is a calcium-deficient hydroxyapatite CDHA. For the preparation of the calcium phosphate cement tetrapods, two-part silicone molds were produced by means of metal prototypes. The cured tetrapods had an extension of 4 mm. These tetrapods were wetted with a magnesium phosphate cement (struvite, MgNH ₄ PO ₄ -H ₂ O) prepared from the powder Mg ₃ (PO ₄ ) 2 and the liquid 3 , 5M (NH ₄ ) ₂ HPO ₄ . The weight ratio tetrapods to magnesium cement was 3 to 1. After curing of the magnesium cement, a macroporous composite was formed. The supporting bodies - consisting of the apatite cement - do not dissolve in vivo. The magnesium cement (struvite) will almost dissolve within 10 months, this is from the dissertation of Britta Kanter "osseointegration of cold-curing bone cements in sheep model" made at the Ludwig-Maximilians-University Munich ( 2014 ) known.

Overall, the implant of the present invention due to its load-bearing properties with particular advantage the treatment, especially biological reconstruction, larger bone defects, such as the acetabulum, especially in the context of hip revision surgery. With good healing, the bone tissue can integrate the osteoconductive support body. In the case of a poor healing process, the support bodies can be retained as load-bearing structures, at least for a sufficiently long period, in order to ensure sufficient secondary stability without bone growth.

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

• US 8562613 B2 [0012]
• EP 0764008 B1 [0013]
• EP 1408888 B1 [0014]
• WO 2012/061024 A1 [0015]
• WO 2009/103273 A1 [0195]

Cited non-patent literature

• "Bone Regeneration by the Combined Use of Tetrapod-Shaped Calcium Phosphate Granules with Basic Fibroblast Growth Factor-Binding Ion Complex Gel in Canine Segmental Radial Defects (J. Vet. Med. Sci. 76 (7): 955-961, 2014)" by Honnami et al. [0016]

Claims (24)

Implant, in particular for treating a bone defect osteoconductive support bodies which comprise a support body material or consist of a support body material, and an in vivo degradable / in vivo resorbable bone cement wherein the support body material is not degradable in vivo / not resorbable in vivo and / or degradable more slowly in vivo / more slowly resorbable in vivo than the bone cement. Implant after Claim 1 characterized in that the support body material is apatite. Implant after Claim 2 , characterized in that the apatite is selected from the group consisting of hydroxyapatite, fluoroapatite, chloroapatite, carbonate fluoroapatite and mixtures of at least two of said apatites. Implant after Claim 1 , characterized in that the support body material is tricalcium phosphate, preferably selected from the group consisting of alpha tricalcium phosphate, beta tricalcium phosphate and a mixture of alpha tricalcium phosphate and beta tricalcium phosphate. Implant according to one of the preceding claims, characterized in that it is the support body material is a combination, in particular mixture, comprising or consisting of apatite, in particular hydroxyapatite, and tricalcium phosphate, in particular beta-tricalcium phosphate. Implant according to one of the preceding claims, characterized in that the osteoconductive support body are regularly shaped, ie present as a shaped body. Implant according to one of the preceding claims, characterized in that the osteoconductive support body polyhedral, in particular cuboid, cube, tetrahedral, prism, pyramid, truncated pyramid or spatulate, are formed. Implant after one of Claims 1 to 6 , characterized in that the osteoconductive support body non-polyhedral, in particular spherical, conical, truncated cone, ring, toroidal or circular cylindrical, are formed. Implant after one of Claims 1 to 6 , characterized in that the osteoconductive support body are formed oligopodenförmig, preferably tetrapod-shaped. Implant after one of Claims 1 to 5 , characterized in that the osteoconductive support body are irregularly shaped. Implant according to one of the preceding claims, characterized in that the osteoconductive support body as bulk material, in particular as granules, are present. Implant according to one of the preceding claims, characterized in that the osteoconductive support body at least one dimension or dimension in a size range of 0.4 mm to 5 mm, in particular 0.8 mm to 4.5 mm, preferably 1 mm to 4 mm. Implant according to one of the preceding claims, characterized in that the bone cement contains a bone cement powder or is present in the form of a bone cement powder. Implant according to one of the preceding claims, characterized in that the bone cement is in the form of a modelable, in particular pasty, preparation. Implant after Claim 14 , characterized in that the preparation in addition to a bone cement powder contains an organic carrier liquid and / or water. Implant according to one of the preceding claims, in particular according to one of the Claims 13 to 15 , characterized in that the bone cement, in particular the bone cement powder, at least one calcium and / or magnesium compound from the group consisting of calcium silicates, calcium phosphates, calcium sulfates, calcium carbonates, calcium oxides, calcium hydroxides, magnesium silicates, magnesium phosphates, magnesium sulfates, magnesium carbonates, magnesium oxides, magnesium hydroxides and mixtures comprising at least two of said calcium and / or magnesium compounds. Implant according to one of the preceding claims, characterized in that it is the bone cement is a calcium phosphate cement, a magnesium phosphate cement, a magnesium-calcium phosphate cement or a mixture of at least two of said bone cements. Implant according to one of the preceding claims, characterized in that the implant further comprises a sheath, which the osteoconductive support body and the bone cement preferably completely surrounds. Implant after Claim 18 , characterized in that the envelope dimensionally stable or preformed, in particular pillow, bag, wedge, sickle, sickle wedge, ring, toroidal or cloverleaf, is formed. Implant after Claim 18 or 19 , characterized in that the sheath is non-textile, preferably in the form of a biological, in particular animal, tissue or a metal construct, in particular metal lattice, is present. Implant after Claim 18 or 19 , characterized in that the envelope textile, preferably reticulated, in particular in the form of a knitted network, is formed. Implant according to one of the preceding claims, characterized in that it is the implant is a bone substitute material. Kit, in particular for producing an implant according to one of the preceding claims and / or for treating a bone defect, comprising, spatially separated from each other, the following components: osteoconductive support bodies which comprise a support body material or consist of a support body material, and an in vivo degradable / in vivo resorbable bone cement wherein the support body material is not degradable in vivo / not resorbable in vivo and / or degradable more slowly in vivo / more slowly resorbable in vivo than the bone cement. Kit after Claim 23 characterized in that the kit further comprises at least one component selected from the group consisting of sheath, bone cement, reinforcing structure, endoprosthesis such as socket, fastener such as suture, bone screw or bone nail, and combinations of at least two of said components. (description only)

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