IMPLANT MOLDING SYSTEM

Abstract

Disclosed is an implant molding system for the molding of an hardenable implant forming material including a mold obtainable from an image of a bone defect by additive manufacturing and having a surface concave along at least one axis; and a tangible unit for retaining the implant forming material in the mold during hardening and for unmolding the implant thereafter; wherein the tangible unit for retaining the implant forming material in the mold during hardening and for unmolding after hardening includes or consists of a coating to be applied onto the concave surface of the mold.

Claims

1-15. (canceled)

16. An implant molding system for the molding of an hardenable implant forming material comprising: a mold obtainable from an image of a bone defect by additive manufacturing; said mold having a surface concave along at least one axis; the concave surface along at least one axis conforms to an arc with a radius ranging from 2 to 20 centimeters; the implant molding system further comprising tangible means for retaining the implant forming material, for instance against gravity, in the mold during hardening and for unmolding the implant after hardening; said tangible means for retaining the implant forming material in the mold during hardening and for unmolding after hardening comprises or consists of a coating, said coating being applied onto the concave surface of the mold; wherein said coating is made of a biocompatible material and said coating has a phase transition temperature ranging from 40 to 100 C.

17. The implant molding system according to claim 16, wherein said coating is selected from vaseline, or Horsley's wax or homopolymer or copolymer of poly(isoprene), poly(chloroprene), poly(vinyl alcohol), poly(acrylonitrile), poly(butadiene), poly(vinyl chloride), poly(ethylene), poly(isobutylene), poly(ethylene glycol), poly(lactic acid) or any mixtures thereof.

18. The implant molding system according to claim 16, wherein said coating forms a solid layer at a temperature ranging from 0 to 30 C.

19. The implant molding system according to claim 16, wherein said coating forms a solid layer at a temperature ranging from 15 to 25 C.

20. The implant molding system according to claim 16, wherein said coating is applied onto the concave surface of the mold in solid form.

21. The implant molding system according to claim 20, wherein said coating further comprises a tab extending outside of the mold enabling peeling said coating off the mold.

22. The implant molding system according to claim 20, wherein said coating is selected from poly(acrylonitrile-co-butadiene).

23. The implant molding system according to claim 16, wherein said coating is applied onto the concave surface of the mold in liquid form.

24. The implant molding system according to claim 23, wherein the coating exhibits a melting temperature above T1 and below T2, wherein T1 is ranging from 0 to 40 C. and wherein T2 is ranging from ranging from 45 to 100 C.

25. The implant molding system according to claim 23, wherein said coating is selected from Horsley's wax or vaseline or homopolymer or copolymer of poly(ethylene glycol) or any mixtures thereof.

26. The implant molding system according to claim 16, further comprising a molding ring having a negative surface profile relative to the mold, an inner edge and a predefined thickness along the edge.

27. The implant molding system according to claim 16, further comprising a forming tool having a negative surface profile relative to the mold, such that joining the forming tool with the mold forms a cavity.

28. The implant molding system according to claim 16, further comprising a forming tool having a negative surface profile relative to the mold, such that joining the forming tool with the mold, and with the molding ring, forms a cavity.

29. The implant molding system according to claim 16, further comprising a counter mold comprising a first and a second counter mold portion, each comprising an inner part and an outer part, wherein the counter mold and the mold form, when mated together, a cavity corresponding to the image of the bone defect.

30. The implant molding system according to claim 16, wherein the surface concave along at least one axis conforms to an arc with a radius ranging from 4.5 to 9.5 centimeters, or substantially equal to 7 centimeters.

31. The implant molding system according to claim 16, wherein the mold and/or the molding ring and/or the forming tool comprises a material selected from ceramics, metals, metal alloys, glasses, polymers, bone or portland like cement, gypsum, sand or mixture thereof.

32. The implant molding system according to claim 16, further comprising an hardenable implant forming composition comprising a liquid phase comprising at least one liquid monomer, and at least one polymerization inhibitor; and a solid phase comprising at least one polymer, at least one initiator.

33. The implant molding system according to claim 16, further comprising an hardenable implant forming composition comprising a liquid phase comprising at least one liquid monomer, and at least one polymerization inhibitor; and a solid phase comprising at least one polymer, at least one initiator, at least one activator.

34. The implant molding system according to claim 16, further comprising an hardenable implant forming composition comprising a liquid phase comprising at least one liquid monomer, and at least one polymerization inhibitor; and a solid phase comprising at least one polymer, at least one initiator, at least one activator, and at least one radio-opaque filler.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0211] The foregoing summary and detailed description of the invention will be better understood when read in conjunction with the appended drawings. For the purpose of illustrating the invention, there are shown in the drawings, certain embodiments which are presently preferred. It should be understood, however, that the invention is not limited to the precise arrangements and instrumentalities shown.

[0212] FIG. 1 illustrates a bone defect 1 to be repaired or restored.

[0213] FIGS. 2A and 2B illustrate a mold 2 according to one embodiment of the invention.

[0214] FIG. 3 illustrates a bone defect 1 to be repaired or restored together with a molding ring 3 and a mold 2 according to one embodiment of the invention. The mold 2 has the curvature of the bone defect 1 to be repaired or restored while the inner edge of the molding ring 3 has the thickness and shape of the bone defect 1 at its periphery.

[0215] FIGS. 4A and 4B illustrate a mold 2 and a molding ring 3 according to one embodiment of the invention.

[0216] FIGS. 5A and 5B illustrate a mold 2 according to one embodiment of the invention positioned in a bone defect 1 in order to test in situ the hardening implant.

[0217] FIG. 6 illustrates a counter mold 4 divided into two parts and a mold 2 with a handle 23.

[0218] FIG. 7 illustrates an assembled counter mold 4 and a mold 2 with a handle 23.

[0219] FIGS. 8A and 8B illustrate an assembled counter mold 4 and a mold 2 with a handle 23 with a view from each face.

[0220] FIGS. 9A and 9B illustrate the two portions, 41 and 42, of the counter mold 4 and mold 2 assembled wherein the cavity has the desired shape for the implant.

[0221] FIGS. 10A, 10B, 10C and 10D illustrate a counter mold 5 divided into two portions 51, 52.

[0222] The drawings are not drawn to scale and are not intended to limit the scope of the claims to the embodiments depicted.

REFERENCES

[0223] 1Bone defect of a patient; [0224] 2Mold; [0225] 21Outer face of the mold; [0226] 22Inner face of the mold; [0227] 23Handle; [0228] 24First mold portion; [0229] 241Handle; [0230] 25Second mold portion; [0231] 251Handle; [0232] 3Molding ring; [0233] 4Counter mold; [0234] 41First counter mold portion; [0235] 411Inner part; [0236] 4111Inner face; [0237] 4112Outer face; [0238] 412Outer part; [0239] 4122Outer face; [0240] 413Fixing systems; [0241] 42Second counter mold portion; [0242] 421Inner part; [0243] 4211Inner face; [0244] 4212Outer face; [0245] 422Outer part; [0246] 4222Outer face; [0247] 423Fixing systems; [0248] 43Fixing systems; [0249] 5Counter mold; [0250] 51First counter mold portion; [0251] 52Second counter mold portion.

EXAMPLE

[0252] The following example will be better understood when read in conjunction with the drawings.

[0253] In order to confirm the ability of a PEG 1000-coating on a polyamide mold to resolve the adhesion and contamination issues, an implant has been manufactured according to the present invention using the following steps: [0254] obtaining an image of a bone defect of a patient 1 by means of CT-scans, as represented in FIG. 1; [0255] manufacturing a mold 2, as represented in FIGS. 2A and 2B, in polyamide (PA12) having the curvature of the bone defect 1 and a surface larger than the bone defect 1 itself by mean of 3D printing; [0256] manufacturing a molding ring 3, as represented in FIG. 3, in polyamide (PA12) wherein the inner edge of the molding ring 3 has the thickness and shape of the bone defect 1 at its periphery by mean of 3D printing; [0257] heating a PEG 1000 composition at 80 C. during 5 minutes in order to melt it; [0258] impregnating a gauze with the melted PEG 1000 composition; [0259] rubbing the impregnated gauze on the mold; [0260] let the PEG 1000 coating hardened on the mold at room temperature during 5 minutes; [0261] inserting/cooperating the molding ring 3 with the mold 2, as illustrated in FIGS. 4A and 4B; [0262] shaping a Palacos composition on the coated mold; [0263] let the implant hardened on the mold; as the hardening reaction is exothermic, the PEG 1000 coating shall melt; and [0264] demolding the implant from the mold.

[0265] According to one embodiment, during the shaping of the Palacos composition, the molding ring 3 may be removed from the mold 2 and the implant may be tested on the patient by means of the mold 2, as illustrated in FIGS. 5A and 5B.