Hybrid implant made of a composite material

Abstract

The present invention relates to a (poly)hybrid implant made of one or more composite materials, having a polymer matrix and a ceramic-inorganic and/or inorganic component, wherein the polymer matrix has at least one component, selected from the group PDLLA; PLGA, PCL, HDPE, PE, UHMWPE, PEAK, PEEK, PP, PUR, and the ceramic-inorganic component has at least one calcium-phosphate-based component, preferably selected from the group HAP, α-TCP, β-TCP and CaCO.sub.3. In addition, metallic components can also be introduced, preferably, but not exclusively containing elements such as Mg, Fe, Zn or Sr.

Claims

1. A hybrid implant made of a composite material comprising a polymer matrix and a ceramic-inorganic component, wherein the polymer matrix has at least one component selected from the group of PDLLA, PLGA, PCL, HDPE, PE, UHMWPE, PEAK, PEEK, PP, and PUR; the ceramic-inorganic component contains biodegradable CaCO.sub.3 as a polymer degradation accelerator, wherein degradation of the hybrid implant uniformly releases calcium ions as an inductive factor on the entire surface of the hybrid implant, and wherein the CaCO.sub.3 is present as substantially spherical particles.

2. The hybrid implant according to claim 1, wherein the CaCO.sub.3 contributes between 15%-65% percentage by weight to the total mass of the hybrid implant.

3. The hybrid implant according to claim 1, wherein the spherical particles comprise at least one group of spherical particles having a diameter selected from 10 μm-15 μm, 20 μm-25 μm, 30 μm-45 μm, or 100 μm-200 μm.

4. The hybrid implant according to claim 3, wherein the spherical particles on their surface show a defined topography.

5. The hybrid implant according to claim 3, wherein the spherical particles on their surface show a hydrophilic surface modification.

6. The hybrid implant according to claim 3, wherein the spherical particles on their surface show a lipophilic surface modification.

7. The hybrid implant according to claim 1, wherein the hybrid implant is formed as a scaffold structure for tissue conduction having a diameter of 100 μm-800 μm.

8. The hybrid implant according to claim 1, wherein the hybrid implant additionally contains tissue-inductive and/or tissue-conductive factors.

9. The hybrid implant according to claim 1, prepared by a sinter-less 3D additive method at a temperature between room temperature and about 250° C.

10. The hybrid implant according to claim 1, prepared by subtractive removal of a starting material.

11. The hybrid implant according to claim 1, wherein the CaCO.sub.3 contributes between 15%-25% percentage by weight to the total mass of the hybrid implant.

12. The hybrid implant according to claim 1, wherein the CaCO.sub.3 contributes between 25%-35% percentage by weight to the total mass of the hybrid implant.

13. The hybrid implant according to claim 1, wherein the CaCO.sub.3 contributes between 50%-65% percentage by weight to the total mass of the hybrid implant.

14. The hybrid implant according to claim 1, wherein the hybrid implant is formed as a scaffold structure for tissue conduction having a diameter of 300 μm-450 μm.

15. The hybrid implant according to claim 1, wherein the hybrid implant further comprises non-proteinogenic chemical messengers and/or ions, and/or other active agents.

16. The hybrid implant according to claim 1, wherein the composite material further comprises at least one metallic component.

17. The hybrid implant according to claim 16, wherein the at least one metallic component shows an irregular shaping or is configured to be substantially spherical, fibrous, twisted or helical.

18. The hybrid implant according to claim 16, wherein the at least one metallic component is at least one selected from the group consisting of magnesium, iron, zinc, and strontium.

Description

(1) The core of the invention consists in the fact that the implant is designed as a “poly”-hybrid implant of a composite material and completely consists of artificially synthesized materials. The composite material has a polymer matrix and at least one ceramic-inorganic or at least one inorganic component or different combinations of said materials. Said components are jointly introduced to the finished implant at defined ratios so as to optimally control bone regeneration.

(2) The polymer matrix may consist, depending on the application, of completely biodegradable polymers, partially biodegradable polymers or else non-biodegradable polymers. In this context, mixed and pure polymers are possible.

(3) The following polymers have turned out to be especially advantageous: poly-DL-lactic acid (PDLLA), polylactic-co-glycolic acid (PLGA), polycaprolactone (PCL), high-density polyethylene (HDPE), polyethylene (PE), ultra-high molecular-weight polyethylene (UHMWPE), polyaryletherketone (PEAK), polyetheretherketone (PEEK), polypropylene (PP), polyurethane (PUR).

(4) The ceramic-inorganic component has at least one calcium-phosphate-based (CaP-based) component which is preferably selected from the group of hydroxyapatite (HAP), α-tricalciumphosphate (α-TCP), β-tricalciumphosphate (β-TCP) and calcium carbonate (CaCO.sub.3).

(5) By the use of an organic component, the polymer matrix and a ceramic-inorganic or inorganic component the characteristics of the hybrid implant can be adjusted in an enhanced manner.

(6) So, for example, a non-biodegradable polymer matrix for permanently adopting a supporting function may be provided, while by releasing calcium ions, for example, the biodegradable ceramic component positively causes tissue induction by activating chondrocytes and/or osteoblasts, for example.

(7) In such case, the inductive factors, in the present case ions, primarily are not provided in solution so that the highly concentrated solutions of molecules such as growth factors utilized in the state of the art can be dispensed with. Rather, the ions are uniformly released on the entire surface of the implant by degradation of the implant, are solubilized and thus do not increase the concentration of the naturally occurring components over the period of the effect of the implants. This process can be adjusted and optimized by the methods of manufacturing the hybrid or “poly”-hybrid implants.

(8) Hence, the release parameters of the factors such as the release rate or the time course of release can be exactly adjusted by adapting the composition of the components of the implant and the arrangement and, resp., the processing of said components (e.g. compacting, presence of particular components in defined geometries or gradients etc.).

(9) Advantageous further developments of an implant according to the invention are the subject matter of the subclaims and shall be described in detail hereinafter.

(10) It has turned out to be particularly advantageous when the ceramic-inorganic component contains CaCO.sub.3 and the CaCO.sub.3 preferably contributes about 10% to about 65%, especially preferred about 15% to about 35%, especially about 15% to about 25% or about 25% to about 35% or about 50% to about 65% percentage by weight to the total mass of the hybrid implant.

(11) CaCO.sub.3 in this context serves as degradation accelerator in degrading particular biodegradable polymers and, in addition, acts as an osteo-conductive substance which promotes tight ingrowing of newly formed tissue into an implant. This is especially desirable when the polymer matrix of the hybrid implant consists at least partially of non-biodegradable polymers and thus forms a permanent scaffold structure for the ingrowing tissue. This helps to bring about a new and innovative option of controlling the implant-tissue reaction during new tissue formation as to quantity and space.

(12) CaCO.sub.3 may be present as substantially spherical particles, the spherical particles comprising at least one group of spherical particles having a diameter selected from the range of about 10 μm-about 200 μm, especially from the ranges of about 10 μm-about 15 μm; about 20 μm-about 25 μm; about 30 μm-about 45 μm; about 100 μm-about 200 μm. In other words, all CaCo.sub.3 particles may have the same diameter or CaCO.sub.3 may be present in the form of particles having differently large diameters. The respective selected diameters thus are always deliberately selected or adjusted in advance.

(13) In addition, the CaCO.sub.3 particles may have a specific surface modification, e.g. for obtaining a lipophilic or hydrophilic surface, and/or may have a defined topography. Even other particles, which are not CaCO.sub.3 particles, or any other components of an implant according to the invention including the polymer matrix may show such surface modification and/or topography.

(14) In addition, an implant according to the invention may also include metallic components, especially at least one out of the metals of magnesium, iron, zinc and strontium. Of course, a mixture is also possible. Said metallic components offer further options of adjusting the characteristics of the implant for producing a particular biological niche. Preferably, the metallic components contribute about 5%-about 15% to the total mass of the hybrid implant.

(15) For example, the metallic components may be provided as particles, fibers or chips, the properties of which in turn may influence, in the case of at least partially biodegradable implants, the degradation of the implant and may also act on the surrounding tissue.

(16) Said metallic components are usually employed in the form of particles. The shaping of the particles may be structured irregularly, substantially spherically or substantially fibrous or substantially twisted or substantially helically.

(17) Furthermore, the completely or non-completely resorbable implant may have a specific “scaffold” structure. Said scaffold structures promote the growth of tissue around and into the implant.

(18) Said scaffold structure may advantageously include hollow structures. Said hollow structures are preferably interconnecting and have diameters of about 100 μm about 800 μm. The configuration of the hollow structures may be adapted to specific applications. By the use of particular production technologies, such as e.g. particular 3D printing methods, hollow structures having a technically exactly defined and adjustable size and distribution or arrangement can be formed. For this purpose, initially one component may be utilized (either polymer or ceramic or inorganic component), subsequently the second component and possibly further components are formed around the primary support and hollow structure.

(19) Said scaffold structure may be formed exclusively by the polymer matrix, but also a compound of a polymer matrix and an inorganic-ceramic component may act as scaffold structure.

(20) By the application-specific design of the implants, especially the structural configuration and chemical composition thereof, spatial niches are enabled to be optimally utilized for endogenous buildup of body tissue.

(21) In order to additionally contribute actively to the production of said biological niche, the hybrid implant may further contain tissue-inductive and/or tissue-conductive factors, especially non-protein-based chemical messengers and/or ions or also antibiotic agents.

(22) Another advantage of the hybrid implant according to the invention consists in the fact that the implant can be manufactured by a sinter-less 3D additive method at a relatively low temperature, i.e. between room temperature (about 25° C.) and about 250° C.

(23) Conventional implants usually are subjected to a sintering step after manufacture so as to obtain the desired mechanical characteristics of the implant. However, when manufacturing the implant according to the invention, due to the properties of the starting materials used the necessity of sintering is removed, thus causing the manufacturing method to be shortened and facilitated.

(24) Advantageously, an implant according to the invention is manufactured in an additive three-dimensional (3D) method. As a possible 3D manufacturing method, especially the methods exemplified in the following are advantageous:

(25) 3D printing with powder (3DP), selective laser sintering (SLS), selective heat sintering (SHS), selective laser melting (SLM), electron beam melting (EBM), fused deposition modeling (FDM), fused filament fabrication (FFF), stick deposition molding (SDM), multi-jet modeling (MJM), stereo-lithography (STL or else SLA), scan-LED method (SLT) as further development of classical stereolithography, film transfer imaging (FTI), digital light processing (DLP), poly-jet laminated object modeling (LOM) or film laminating 3D printing, selective deposition lamination (SDL).

(26) Particular processes have to be carried out under protective gas, e.g. argon or nitrogen.

(27) Basically, an implant according to the invention can also be manufactured in a subtractive method, however, in which initially a starting plate or a starting block is produced from the starting materials in the desired amounts and, resp., with the desired substance composition, for example by pressing, which starting block then can be further machined, for example.

(28) The versatility of the applications of the implant according to the invention is increased by the fact that the implant material can be machined both additively and subtractively and thus also the implant can be produced both by an additive method and by a subtractive method.

(29) An advantageous embodiment of an implant according to the invention is a completely biodegradable implant containing CaCO.sub.3. The CaCO.sub.3 contributes about 15% to about 25% to the total mass of the hybrid implant. The polymer matrix includes PDLLA, PCL or PLGA or a mixture of said polymers.

(30) In addition, the hybrid implant contains Mg particles or alloys such as e.g. the magnesium alloy WE43 or MgCa, having a percentage by weight relative to the total mass of about 5%-about 15%. CaCO.sub.3 is provided in particle shape. CaCO.sub.3 particles have a diameter of about 10 μm about 15 μm and are approximately spherical.

(31) The implant in addition has a scaffold structure including hollows having a diameter of about 300 μm about 450 μm.

(32) It is noted that the invention thus relates to an implant which is completely or partially biodegradable.