BIOCOMPATIBLE MOLDED PART

Abstract

The invention relates to a biocompatible molded part for supporting new bone formation, in particular the reformation of a jaw bone or a jaw bone portion in a mammal, preferably a human, wherein the molded part is suitable to be placed on the jaw bone and is designed as a solid body. The invention also relates to a composition for producing a biocompatible molded part, a method for producing a biocompatible molded part, a use of a biocompatible molded part and a kit comprising a plurality of molded parts.

Claims

1. A biocompatible molded part for supporting new bone formation, in particular the reformation of a jaw bone or a jaw bone portion in a mammal, wherein the molded part adapted to be placed on the jaw bone and is arranged as a solid body.

2. The biocompatible molded part according to claim 1, wherein the molded part is formed from a composition comprising or consisting of at least one structuring material and a granulate, wherein the structuring material is selected from the group consisting of impression plaster, plaster of Paris, hard plaster, super-hard plaster, glass ionomer cement, carboxylate cement or mixtures thereof, preferably plaster of Paris, and/or the granulate is formed from a basic material selected from the group consisting of aragonite, seashell, allogenic bone material, autogenic bone material, xenogenic bone material, FDBA (freeze-dried bone allografts), DFBA (decalcified freeze-dried bone allografts), algae or algae extract, ceramic, calcium phosphate, tri or tetracalcium phosphate, α- or β-tricalcium phosphate, hydroxylapatite, calcium phosphate ceramic, bioglass, bone replacement material based on aragonite (z.B. BioCoral®) or mixtures thereof, wherein the granulate has a particle size of between 1 and 3 mm.

3. The biocompatible molded part according to claim 2, wherein the composition the structuring material and the granulate are provided in a ratio of between 1:1 and 1:4.

4. The biocompatible molded part according to one claim 2, wherein the composition contains at least one further substance, selected from the group consisting of statins, vitamins, trace elements, antibiotics, hyaluronic acid, hyaluronic acid derivatives, collagen and/or mixtures thereof.

5. The biocompatible molded body according to claim 4, wherein the at least one further substance constitutes between 0.1 and 3%, of the composition.

6. The biocompatible molded part according to claim 1, wherein the solid body is completely reabsorbable by the human or animal body.

7. The biocompatible molded part according to claim 2, wherein the basic material of the granulate consists of: aragonite and 0-50% of at least one of bone material, allogenic bone material and autogenic bone material.

8. The biocompatible molded part according to claim 1, further comprising a sealing material between the molded part and the jaw bone or the bone base, wherein the sealing material is formed from at least one of collagen collagen type 1 and a mixture of collagen type 1 and collagen type 3 and hyaluronic acid or hyaluronic acid-derivative.

9. The biocompatible molded part according to claim 1, wherein the molded part is substantially block-shaped or cuboid, or is adapted in shape to a recess in the jaw bone or jaw bone portion.

10. The biocompatible molded part according to claim 1, wherein the molded part is substantially block-shaped, cuboid or arranged in a shape to a recess in the jaw bone or jaw bone portion.

11. The biocompatible molded part according to claim 1 the molded part which is substantially block-shaped or cuboid or is arranged in a shape to a recess in the bone or jaw bone portion, and has edges with an edge length in each case of between 1 and 5 cm.

12. The biocompatible molded part according to claim 1, wherein the molded part is substantially block-shaped or cuboid or is arranged in a shape to a recess the jaw bone or jaw bone portion, and has at least one bore for passage of a fastener.

13. A composition for production of a biocompatible molded part according to claim 1, comprising or consisting of a structuring material and a granulate, wherein the structuring material is in particular selected from the group consisting of impression plaster, plaster of Paris, hard plaster, super-hard plaster, glass ionomer cement, carboxylate cement or mixtures thereof, preferably plaster of Paris, and/or the granulate is formed from a basic material selected from the group consisting of aragonite, seashell, allogenic bone material, autogenic bone material, xenogenic bone material, FDBA (freeze-dried bone allografts), DFBA (decalcified freeze-dried bone allografts), algae or algae extract, ceramic, calcium phosphate, tri or tetracalcium phosphate, α- or β-tricalcium phosphate, hydroxylapatite, calcium phosphate ceramic, bioglass, bone replacement material based on aragonite (z.B. BioCoral®) or mixtures thereof, wherein the granulate or the basic material preferably has a sheathing layer made of at least one collagen, hyaluronic acid and/or hyaluronic acid derivative or mixtures thereof.

14. The composition according to claim 13, wherein the granulate has a particle size of between 1 and 3 mm.

15. The composition according to claim 13, wherein the structuring material and the granulate are provided in a ratio of between 1:1 and 1:4.

16. The composition according to claim 13, wherein the composition contains at least one further substance selected from the group consisting of statins, vitamins, trace elements, antibiotics, or mixtures thereof.

17. The composition according to claim 16, wherein the at least one further substance constitutes between 0.1 and 3% of the composition, and wherein the composition defines a substantially complete reabsorbability of the components by the mammal body.

18. The composition according to claim 13, wherein the basic material of the granulate consists of: aragonite and 0-50%, bone material, allogenic bone material or autogenic bone material.

19. A method for production of a biocompatible molded part according to claim 1, comprising the steps of: (i) producing a moldable modeling material by mixing the composition. (ii) modeling the molded part as a block-shaped or cuboid molded part, and (iii) drying the molded part.

20. The method according to claim 19, comprising the steps of: (ia) determining a form of a bone structure, in the shape of the jaw bone or jaw bone portion in or on which the molded part to be introduced, and (iia) at least one of: (A) modeling the molded part with reference to the determined form, and (B) creating a negative model of the bone structure.

21. The method according to claim 19, further comprising the step of: (iv) at least one of: (A) sterilizing the molded part and (B) sterilizing the molded part by irradiation with gamma and (C) wherein modeling of the molded part takes place using a mold.

22. The method according to claim 19, wherein at least one through bore is introduced into the molded part before or after the drying.

23. A method of medical treatment using a biocompatible molded part according to claim 1, for supporting the jaw bone, wherein the biocompatible molded part provides a basic structure for the new bone formation and is completely reabsorbed in the course of at least one of new bone formation, and bone augmentation of an existing bone structure.

24. The method according to claim 23, wherein at least one of a length, width and/or height of the molded part is adjusted before use.

25. A kit comprising a plurality of molded parts according to claim 1, in particular wherein the molded parts have the same or different sizes and/or shapes.

26. (canceled)

Description

[0099] Further advantages and expedient embodiments can be seen from following description of the figures and from the drawings. In the drawings:

[0100] FIG. 1 shows a schematic representation of a preferred embodiment of a molded part, and

[0101] FIG. 2 shows the evaluation by computer tomography of the illustrative experiment described above.

[0102] The molded part 1 is shown in perspective in FIG. 1. At the top the molded part 1 has a rounding 2 which is adapted to the shape of the jaw bone. The further end surfaces 3 of the molded part 1 are at right angles with respect to one another. This results in a block-shaped or cuboid molded part 1. This molded part 1 illustrated here as a standard element can be adapted before use to the particular conditions in the patient's jaw. As a result, the end surfaces 3 are correspondingly trimmed or abraded. In this case the size of the molded part 1 can also be adapted. In the embodiment illustrated in FIG. 1 the molded part 1 has a length of 3 cm, a height of 1.5 cm and a width of likewise 1.5 cm. The molded part 1 is formed from a composition which is produced from plaster of Paris and a granulate formed from a bone material. The composition was mixed with distilled water until a compound with a moldable consistency was produced. Next a silicone mold was filled with the modeling material. This silicone mold has the shape of the finished molded part 1. After removal from the mold the molded part 1 was dried. The shrinkage of the material during drying was taken into account in the dimensioning of the silicone mold. After sterilization and packaging the molded part 1 was available for use. Final processing of the molded part 1 takes place before it is inserted or placed on the jaw bone. In addition, two bores 4 are provided in the molded part. Through these bores 4 the molded part 1 can be fastened by means of bone screws to the jaw bone (not shown). After reabsorption of the molded part 1 and conclusion of the new bone formation the screws can be removed again from the jaw. The remaining apertures are, for example, filled with a material which also promotes osteogenesis and subsequently ossified.

[0103] In order to prevent cells of the periosteum or cells of the gingiva from penetrating adversely into the molded part 1, the molded part 1 can be sealed with respect to the surrounding teeth with the aid of collagen.

[0104] In order to attach the molded part 1 to the jaw bone, first of all the upper flap of gingiva is folded back. The surface of the jaw bone is optionally roughened in order to promote the growth of the bone. Then the molded part 1 is applied to the corresponding location and is fixed to the jaw bone by pins or screws. Then the flap of gingiva is folded over the molded part 1 and fixed to the outer face of the molded part 1. The periosteum then grows along the outer face of the molded part 1, so that after some time the original jaw situation with complete jaw bone, periosteum and gingiva is restored. A second operation for removal of the molded part 1 after new bone formation has taken place is not necessary, since the molded part 1 is completely degraded by the body.

[0105] Blood vessels and bone cells grow into the molded part 1 and little by little they pass through it completely. As this happens the jaw bone is successively remodeled. Overall the inserted molded part 1 provides a structure which serves as a base or framework for the formation of new blood vessels. Ultimately this base leads to a new bone formation if osteoblasts have a sufficient supply of nutrients in order to form new bone material. The molded part 1 is completely reabsorbed by the body. The entire insertion site of the molded part 1 can be washed with a hyaluronic acid solution which favors the blood vessel growth in the first growth phase.

[0106] FIG. 2 shows the evaluation by computer tomography of the illustrative experiment described above.

[0107] The implantation site of the molded part A 1 on the calvaria 5 of a pig can be seen and identified on the left in FIG. 2. The molded part B 1 is shown on the right in FIG. 2. For fastening the molded parts 1 to the calvaria 5, bores 4 have been introduced into the calvaria. These bores 4 serve for the passage of screws 6 which can still be seen in the CT image and by means of which the molded parts 1 are screwed to the calvaria 5.

[0108] FIG. 2 shows the result after the experiment has been running for 8 weeks. At the site where the molded part A 1 was implanted the degradation of the material of the molded part 1 and the reabsorption thereof has started. Simultaneously there has been detectable bone regeneration or new bone formation. Good healing and a vertical increase in height can be seen. In the bone 7 which has formed the screws 6 are surrounded by bone material.

[0109] During the time of the experiment, at the sites where the molded part B 1 was implanted there was a reduction or even an absence of degradation of the material. Also, no bone regeneration or new bone formation could be detected there. Some disorders of wound healing occurred.

[0110] The invention comprises:

[0111] A biocompatible molded part for supporting new bone formation, in particular the reformation of a jaw bone or a jaw bone portion in a mammal, preferably a human, wherein the molded part is suitable to be placed on the jaw bone and is designed as a solid body.

[0112] A biocompatible molded part configured as above, wherein the molded part is formed from a composition comprising or consisting of at least one structuring material and a granulate.

[0113] A biocompatible molded part configured as above, wherein the structuring material is selected from the group consisting of impression plaster, plaster of Paris, hard plaster, super-hard plaster, glass ionomer cement, carbon/late cement or mixtures thereof, preferably plaster of Paris.

[0114] A biocompatible molded part configured as above, wherein the granulate is formed from a basic material selected from the group consisting of: aragonite, seashell, allogenic bone material, autogenic bone material, xenogenic bone material, FDBA (freeze-dried bone allografts), DFBA (decalcified freeze-dried bone allografts), algae or algae extract, ceramic, calcium phosphate, in particular tri- or tetracalcium phosphate, α- or β-tricalcium phosphate, hydroxylapatite, calcium phosphate ceramic, bioglass, bone replacement materials based on aragonite (e.g. BioCoral®) or mixtures thereof.

[0115] A biocompatible molded part configured as above, wherein the granulate has a particle size of between 1 and 3 mm, in particular between 1.1 and 2 mm, preferably 1.5 mm.

[0116] A biocompatible molded part configured as above, wherein in the composition the structuring material and the granulate are provided in a ratio of between 1:1 and 1:4, preferably 1:2.

[0117] A biocompatible molded part configured as above, wherein the composition contains at least one further substance, in particular wherein the at least one further substance is selected from the group consisting of statins, vitamins, trace elements, antibiotics hyaluronic acid, hyaluronic acid derivatives, collagen and/or mixtures thereof, in particular wherein the at least one further substance constitutes between 0.1 and 3%, in particular between 0.2 and 1.5%, preferably 0.25% of the composition.

[0118] A biocompatible molded part configured as above, wherein the solid body is completely reabsorbable by the human or animal body.

[0119] A biocompatible molded part configured as above, wherein the basic material of the granulate consists of:

[0120] aragonite and

[0121] 0-50%, in particular between 15 and 35%, preferably 25% bone material, in particular allogenic or autogenic bone material.

[0122] A biocompatible molded part configured as above, wherein a sealing material is provided between the molded part and the jaw bone or the bone base, in particular wherein the sealing material is formed from a collagen, in particular collagen type 1 or a mixture of collagen type 1 and collagen type 3 and hyaluronic acid or hyaluronic acid-derivative.

[0123] A biocompatible molded part configured as above, wherein the molded part is substantially block-shaped or cuboid or is adapted in shape to a recess in the bone, in particular the jaw bone or jaw bone portion.

[0124] A biocompatible molded part configured as above, wherein the molded part is substantially block-shaped or cuboid and is adapted in shape to a recess in the bone, in particular the jaw bone or jaw bone portion.

[0125] A biocompatible molded part configured as before, wherein the molded part which is substantially block-shaped or cuboid or is adapted in shape to a recess in the bone, in particular a jaw bone or jaw bone portion, has edges with an edge length in each case of between 1 and 5 cm, preferably between 1.5 and 3 cm.

[0126] A biocompatible molded part configured as above, wherein the molded part which is substantially block-shaped or cuboid or is adapted in shape to a recess in the bone, in particular the jaw bone or jaw bone portion, is provided with at least one bore for the passage of fastening means, in particular screws.

[0127] Furthermore, the invention comprises a composition for production of a biocompatible molded part as defined above, comprising or consisting of a structuring material and a granulate.

[0128] A composition configured as above, wherein the structuring material is selected from the group consisting of impression plaster, plaster of Paris, hard plaster, super-hard plaster, glass ionomer cement, carboxylate cement or mixtures thereof, preferably plaster of Paris.

[0129] A composition configured as above, wherein the granulate is formed from a basic material selected from the group consisting of: Aragonite, seashell, allogenic bone material, autogenic bone material, xenogenic bone material, FDBA (freeze-dried bone allografts), DFBA (decalcified freeze-dried bone allografts), algae or algae extract, ceramic, calcium phosphate, in particular tri- or tetracalcium phosphate, α- or β-tricalcium phosphate, hydroxylapatite, calcium phosphate ceramic, bioglass, bone replacement material based on aragonite (e.g. BioCoral®) or mixtures thereof.

[0130] A composition configured as above, wherein the granulate or the basic material preferably has a sheathing layer made of at least one collagen, hyaluronic acid and/or hyaluronic acid derivative or mixtures thereof.

[0131] A composition configured as above, wherein the granulate has a particle size of between 1 and 3 mm, in particular between 1.1 and 2 mm, preferably 1.5 mm.

[0132] A composition configured as above, wherein in the composition the structuring material and the granulate are provided in a ratio of between 1:1 and 1:4, preferably 1:2.

[0133] A composition configured as above, wherein the composition contains at least one further substance, in particular wherein the at least one further substance is selected from the group consisting of statins, vitamins, trace elements, antibiotics or mixtures thereof, in particular wherein the at least one further substance constitutes between 0.1 and 3%, in particular between 0.2 and 1.5%, preferably 0.25% of the composition.

[0134] A composition configured as above, wherein a complete reabsorbability of the components by the human or animal body is provided.

[0135] A composition configured as above, wherein the basic material of the granulate consists of:

[0136] aragonite and

[0137] 0-50%, in particular between 15 and 35%, preferably 25% bone material, in particular allogenic or autogenic bone material.

[0138] The invention also comprises a method for producing a biocompatible molded part, in particular a molded part defined as above, comprising the steps:

[0139] (iv) producing a moldable modeling material by mixing the composition as defined in claims 12 to 20 with water, preferably distilled water,

[0140] (ii) modeling the molded part as a block-shaped or cuboid molded part and

[0141] (iii) drying the molded part.

[0142] The method referred to above, alternatively comprising the steps:

[0143] (ia) determining a form of a bone structure, in particular the shape of the jaw bone or jaw bone portion in or on which the molded part is to be introduced, and (iia) modeling the molded part with reference to the determined form.

[0144] The method referred to above, optionally comprising the step:

[0145] (ib) creation of a negative model of the bone structure.

[0146] The method referred to above, further comprising (iv) sterilizing the molded part, in particular by irradiation with gamma radiation.

[0147] The method referred to above, wherein the modeling of the molded part takes place using a mold.

[0148] The method referred to above, wherein at least one through bore is introduced into the molded part before or after the drying.

[0149] The invention also comprises a use of a biocompatible molded part as defined above, formed from the composition referred to above and produced according to the aforementioned method, in medicine, in particular in plastic medicine or dental medicine, preferably for supporting a new bone formation, in particular in the jaw bone, wherein the biocompatible molded part provides a basic structure for the new bone formation and is completely reabsorbed in the course of new bone formation.

[0150] The aforementioned use, for bone augmentation of an existing bone structure.

[0151] The aforementioned use, wherein an adaptation of the length, width and/or height of the molded part is provided before use.

[0152] The invention also comprises a kit comprising a plurality of molded parts as defined above.

[0153] The aforementioned kit, wherein the molded parts have the same or different sizes and/or shapes.

[0154] The aforementioned kit, wherein an adaptation of the length, width and/or height of the molded part is provided before use.

[0155] The claims filed now with the application and later are attempts at formulation without prejudice for the achievement of more far-reaching protection.

[0156] If closer examination, in particular also of the relevant prior art, reveals that one or the other feature is favorable for the object of the invention, but is not crucially important, then of course a formulation will be sought which no longer includes such a feature, in particular in the main claim.

[0157] It should also be noted that the configurations and variants of the invention described in the various embodiments and illustrated in the drawings can be combined with one another in any way. In this case individual features or a plurality of features are interchangeable with one another in any way. These combinations of features are also disclosed.

[0158] The dependencies set out in the dependent claims refer to the further embodiment of the subject matter of the main claim by the features of the respective subordinate claim. However, these are not to be understood as a renunciation of the achievement of independent objective protection for the features of the dependent subordinate claims.

[0159] In the course of the proceedings features which hitherto have only been disclosed in the description may be claimed as of essential significance to the invention, for example for differentiation from the prior art, claimed are being.

[0160] Features which have only been disclosed in the description or also individual features from claims which include a plurality of features can be incorporated into claim 1 in order to distinguish them over the prior art at any time, even when such features have been mentioned in connection with other features or also achieve particularly favorable results in connection with other features.