IMPLANT AND KIT FOR THE TREATMENT AND/OR BIOLOGICAL RECONSTRUCTION OF A BONE DEFECT

Abstract

An implant, in particular for the treatment and/or biological reconstruction of a bone defect, includes osteoconductive supporting bodies and a supporting sheath at least partially surrounding the osteoconductive supporting bodies. The sheath can be formed of a sheath material or can consist of a sheath material that is soluble in water or in water-containing liquids. A kit and method for the treatment and/or biological reconstruction of a bone defect can utilize a sheath for osteoconductive supporting bodies and a material for sheathing the osteoconductive supporting bodies.

Claims

1. An implant for the treatment and/or biological reconstruction of a bone defect, comprising: osteoconductive supporting bodies; and a sheath that at least partially surrounds the osteoconductive supporting bodies, the sheath comprising a sheath material that is soluble in water or in a water-containing liquid.

2. The implant according to claim 1, wherein the sheath material comprises starch, amylose, amylopectin, dextran, methyl cellulose, hydroxymethyl cellulose, ethyl cellulose, hydroxyethyl cellulose, propyl cellulose, hydroxypropyl cellulose, butyl cellulose, hydroxybutyl cellulose, hydroxyethylmethyl cellulose, hydroxypropylmethyl cellulose, carboxymethyl cellulose, hyaluronic acid, chondroitin-4-sulfate, chondroitin-6-sulfate, keratin sulfate, alginic acid, heparin, heparan sulfate, chitosan, salts thereof or mixtures thereof.

3. The implant according to claim 1, wherein the sheath material comprises polyvinyl alcohol, polyethylene glycol, ethylene oxide-propylene oxide copolymers (EO-PO copolymers), ethylene oxide-propylene oxide block copolymers (EO-PO block copolymers), acrylic acid homopolymers, acrylic acid copolymers, polyvinylpyrrolidone homopolymers, polyvinylpyrrolidone copolymers or mixtures thereof.

4. The implant according to claim 1, wherein the sheath has a first section and a second section that are designed differently.

5. The implant according to claim 4, wherein the first and second sections differ from one another with regard to the solubility of the sheath in water or in a water-containing liquid and/or with regard to the thickness of the sheath and/or with regard to the structure of the sheath.

6. The implant according to claim 4, wherein the first and second sections differ from one another with regard to chemical composition.

7. The implant according to claim 4, wherein the first section comprises a sheath material that is more soluble in water or in a water-containing liquid than the second section.

8. The implant according to claim 4, wherein the first section comprises a less cross-linked sheath material that is soluble in water or in a water-containing liquid than the second section.

9. The implant according to claim 4, wherein the first section comprises a non-cross-linked sheath material that is soluble in water or in a water-containing liquid, and the second section comprises a cross-linked sheath material that is soluble in water or in a water-containing liquid.

10. The implant according to claim 4, wherein the first section comprises a higher proportion of a sheath material that is soluble in water or in a water-containing liquid than the second section.

11. The implant according to claim 4, wherein the first section comprises a sheath material that is soluble in water or in a water-containing liquid, and the second section comprises a sheath material that is insoluble in water or in a water-containing liquid.

12. The implant according to claim 4, wherein the first section has a smaller thickness than the second section.

13. The implant according to claim 4, wherein the first section is non-textile, and the second section is textile.

14. The implant according to claim 4, wherein the first section is configured to face a bone in the implanted state, and the second section is configured to face an artificial socket in the implanted state.

15. The implant according to claim 4, wherein the osteoconductive supporting bodies are present in isolated form and comprise apatite, tricalcium phosphate, and/or biphasic calcium phosphate.

16. The implant according to claim 15, wherein the osteoconductive supporting bodies have a porosity of 1% to 50%.

17. The implant according to claim 15, wherein the osteoconductive supporting bodies are non-porous.

Description

DETAILED DESCRIPTION

[0226] Further features and advantages of the invention result from the following description of preferred embodiments with the aid of an exemplary embodiment. Features of the invention can be realized individually or in combination with one another. The exemplary embodiments described below serve to further explain the invention without limiting it thereto.

Exemplary Embodiment

[0227] 1. Materials:

[0228] Carboxymethyl cellulose (Tylopur C), polyvinyl alcohol (Mowiol 56-98, high molar), polyvinyl alcohol (Mowiol 4-98, low molar), water for injections (WVI).

[0229] 2. Execution:

[0230] First, a 20% low molar PVA solution and a 20% high molar PVA solution were made in a Schott flask. For this purpose, 20 g of low molecular weight polyvinyl alcohol and 80 g of water for injection as well as 20 g of high molecular weight polyvinyl alcohol and 80 g of water for injection were filled into separate Schott flasks. The two mixtures were then stored in a warming cabinet at 95° C. for 24 hours until they were completely dissolved. Then a 3% carboxymethyl cellulose solution (3 g sodium carboxymethyl cellulose+97 g water for injection) was prepared in a laboratory mixer (laboratory mixer model ESCO type EL 10) or homogenizer under vacuum (−0.8 bar) at 35° C. and for a mixing time of about 3 to 4 hours.

[0231] A mixture of the low-molar PVA solution and the high-molar PVA solution, a mixture of the low-molar PVA solution and the carboxymethyl cellulose solution and a mixture of the high-molar PVA solution and the carboxymethyl cellulose were then prepared. These mixtures were each prepared using the laboratory mixer or homogenizer mentioned above (maximum temperature 35° C., vacuum −0.8 bar, mixing time at least 2 hours).

[0232] The mixtures prepared were then formed into a film with the aid of a squeegee using a laboratory dryer and fixer (Mathis type LTF 143691) (at approx. 55° C. to 60° C. and during a drying time of approx. 25 minutes).

[0233] The thickness of the films was 38 μm to 45 μm. The films dissolved in water within 20 s to 40 s.

[0234] Depending on the setting of the gap size, films could be made in different thicknesses. The thicker the films, the more slowly they dissolve in water.

[0235] Films prepared with a thickness of 50 μm to 65 μm dissolved in water within approx. 3 minutes to 5 minutes.

[0236] Using a bar welder the films prepared could be successfully welded to form a small bag, which was previously filled with osteoconductive supporting bodies.

[0237] As an alternative to a welding process, it is conceivable to seal the foils by means of a tissue adhesive, such as, for example, a tissue adhesive based on n-butyl-2-cyanoacrylate monomers sold under the registered trademark Histoacryl®.