EP-4740971-A1 - ADDITIVE MANUFACTURING ANTIBACTERIAL COMPOSITE MATERIAL AND APPLICATION AND PREPARATION PROCESS THEREOF

Abstract

The present disclosure relates to antibacterial composite materials made by additive manufacturing (AM), and application and preparation process thereof.

Inventors

• CHANG, JEN-HSIEN
• TANG, Wei-cheng
• HUANG, YANG-SHENG
• LIU, Hsi-Sheng

Assignees

• Innojet Technology Co., Ltd.

Dates

Publication Date

20260513

Application Date

20251111

Claims (18)

1. An additive manufacturing antibacterial composite material, comprising: (a) a substrate, made of a substrate metal or alloy comprising at least one metal selected from the group consisting of titanium (Ti), zirconium (Zr), iron (Fe), cobalt (Co), copper (Cu) and magnesium (Mg); (b) an inorganic carrier, comprising a material selected from the group consisting of phosphates of an alkali earth metal(s) or a metal of Group 4 (IVB), carbonates of an alkali earth metal(s), sulfates of an alkali earth metal(s), zeolites, bentonites, diatomaceous earth, bioglass and any mixtures thereof; (c) an antibacterial metal, which is in elemental or ionic form and selected from the group consisting of silver (Ag), copper (Cu), zine (Zn), cobalt (Co), chromium (Cr), iron (Fe), manganese (Mn), nickel (Ni), tantalum (Ta) and any mixtures thereof in non-alloy form; wherein the antibacterial metal is loaded within the inorganic carrier, and the inorganic carrier is presented within or embedded in the substrate metal or alloy.
2. The composite material according to Claim 1, wherein the weight ratio of the antibacterial metal to the inorganic carrier is no greater than 0.03.
3. The composite material according to any of the preceding claims, wherein the antibacterial metal is presented within the inorganic carrier.
4. The composite material according to any of the preceding claims, wherein the substrate is porous.
5. The composite material according to any of the preceding claims, wherein the antibacterial metal in an ionic form is loaded in the inorganic carrier in the absence of ionic bonding between the antibacterial metal and the inorganic carrier.
6. The composite material according to any of the preceding claims, wherein the antibacterial metal in an ionic form is formed in situ during the additive manufacturing process.
7. The composite material according to any of the preceding claims, wherein the antibacterial metal is presented in an amount of at least 0.005 wt.% (50 ppm), based on the total weight of the composite material.
8. The composite material according to any of the preceding claims, wherein the antibacterial metal in combination with the inorganic carrier are presented in an amount of at least 0.1 wt.%, based on the total weight of the composite material.
9. The composite material according to any of the preceding claims, wherein relative density of the composite material to the components (a), (b) and (c) is at least 20%.
10. The composite material according to any of the preceding claims, wherein the substrate is made of Ti, Ti alloys (e.g., Ti-6Al-4V, Ti6242, etc.), Zr, Zr alloys (Zr-Cu-Al-Nb, Zr-Cu-Ni-Al-Ti, Zr-Cu-Ni-Al-Nb), stainless steel, Co alloys (e.g., Co-Cr-Mo, Co-Cr-W, etc.).
11. The composite material according to any of the preceding claims, wherein the inorganic carrier does not exhibit or provide an antibacterial effect.
12. Use of the composite material according to any of the preceding claims in an implant component.
13. The use according to Claim 12, wherein the implant component is a part of or the entirety of an artificial joint, an insert associated with an artificial joint, or a temporary anchorage device cosmetic implants such as facial implants, cranioplasty plates; cardiovascular implants such as pacemakers, stents, and artificial heart valves; or dental implants.
14. A process of preparing an additive manufacturing antibacterial composite material, the composite material comprising: (a) a substrate, made of a substrate metal or alloy comprising at least one metal selected from the group consisting of titanium (Ti), zirconium (Zr), iron (Fe), cobalt (Co), copper (Cu) and magnesium; (b) an inorganic carrier, comprising a material selected from the group consisting of phosphates of an alkali earth metal(s) or a metal of Group 4 (IVB), carbonates of an alkali earth metal(s), sulfates of an alkali earth metal(s), zeolites, bentonites, diatomaceous earth, bioglass and any mixtures thereof; (c) an antibacterial metal, which is in elemental or ionic form and selected from the group consisting of silver (Ag), copper (Cu), zine (Zn), cobalt (Co), chromium (Cr), iron (Fe), manganese (Mn), nickel (Ni), tantalum (Ta) and any mixtures thereof in non-alloy form; the method comprising: (i) providing particles of the substrate metal or the substrate alloy, particles of the inorganic carrier and particles of the antibacterial metal; (ii) conducting powder bed fusion on the particles by selectively melting designated areas of the particles and fusing the particles into a solid layer; and (iii) repeating steps (i) and (ii) to build the additive manufacturing antibacterial composite material, layer-by-layer according to a digital design, such that the antibacterial metal is loaded within the inorganic carrier, and the inorganic carrier is presented within or embedded in the substrate metal or alloy.
15. The process according to Claim 14, wherein the antibacterial metal in an ionic form is formed in situ during the additive manufacturing process.
16. The process according to Claim 14 or 15, wherein the period of the materials (a), (b) and (c) being presented in a molten form and the period of the materials (a), (b) and (c) being presented in a solid form is controlled to reduce the oxidation of these materials.
17. The process according to any one of Claims 14 to 16, wherein the inorganic carrier does not exhibit or provide an antibacterial effect.
18. The process according to any one of Claims 14 to 17, wherein the additive manufacturing is conducted with powder bed fusion.

Description

TECHNICAL FIELD OF THE INVENTION The present disclosure relates to antibacterial composite materials made by additive manufacturing (AM), and application and preparation processes thereof. BACKGROUND OF THE INVENTION Medical implant components are used in various clinical and healthcare applications to provide benefits during or after medical treatments. Developments in material science and medical sciences continue to benefit patients receiving surgery or implants. As an example, artificial joints, which can improve motor function for those suffering from age-related conditions or diseases, and may prolong the active lifetime of patients. However, concerns regarding prognoses of surgery or medical implants remain, in particular with bacterial infection or related implications, which can warrant additional surgery or even lead to failure and retrieval of implants. Hence, there is a need for novel and cost-effective antibacterial composite materials, in particular for medical implants, and processes for preparation of the same. SUMMARY OF THE INVENTION The present disclosure thus relates to an additive manufacturing antibacterial composite material, comprising: (a) a substrate of metal or alloy comprising at least one metal selected from the group consisting of titanium (Ti), zirconium (Zr), iron (Fe), cobalt (Co), copper (Cu) and magnesium (Mg);(b) an inorganic carrier comprising a material selected from the group consisting of phosphates of an alkali earth metal(s) or a metal of Group 4 (IVB), carbonates of an alkali earth metal(s), sulfates of an alkali earth metal(s), zeolites, bentonites, diatomaceous earth, bioglass and any mixtures thereof, and(c) an antibacterial metal in an elemental or ionic form and selected from the group consisting of silver (Ag), copper (Cu), zine (Zn), cobalt (Co), chromium (Cr), iron (Fe), manganese (Mn), nickel (Ni), tantalum (Ta) and any mixtures thereof in a non-alloy form, wherein the antibacterial metal is loaded within the inorganic carrier, and the inorganic carrier is presented within or embedded in the substrate metal or alloy. The present disclosure also relates to use of the composite material in an implant component. The present disclosure also relates to a method of preparing an additive manufacturing antibacterial composite material, the composite material comprising: (a) a substrate of a substrate metal or alloy comprising at least one metal selected from the group consisting of titanium (Ti), zirconium (Zr), iron (Fe), cobalt (Co), copper (Cu) and magnesium (Mg);(b) an inorganic carrier comprising a material selected from the group consisting of phosphates of an alkali earth metal(s) or a metal of Group 4 (IVB), carbonates of an alkali earth metal(s), sulfates of an alkali earth metal(s), zeolites, bentonites, diatomaceous earth, bioglass and any mixtures thereof, and ;(c) an antibacterial metal, in an elemental or ionic form and selected from the group consisting of silver (Ag), copper (Cu), zine (Zn), cobalt (Co), chromium (Cr), iron (Fe), manganese (Mn), nickel (Ni), tantalum (Ta) and any mixtures thereof in a non-alloy form, the method comprising: (i) providing particles of the substrate metal or the substrate alloy, particles of the inorganic carrier, and particles of the antibacterial metal;(ii) conducting powder bed fusion on the particles by selectively melting designated areas of the particles and fusing the particles into a solid layer; and(iii) repeating steps (i) and (ii) to build the additive manufacturing antibacterial composite material, layer-by-layer according to a digital design. The thus-prepared additive manufacturing antibacterial composite material is characterized in that, the antibacterial metal is loaded within the inorganic carrier, and the inorganic carrier is presented within or embedded in the substrate metal or alloy. In one embodiment, the antibacterial metal in combination with the inorganic carrier are presented in an amount of at least 0.1 wt.%, e.g., at least 0.2 wt.%, at least 0.3 wt.%, at least 0.4 wt.%, at least 0.5 wt.%, at least 0.75 wt.%, at least 1 wt.%, at least 2 wt.%, at least 3 wt.%, at least 4 wt.%, or at least 5 wt.%, based on the total weight of the composite material. In any preceding embodiment, the antibacterial metal is presented in an amount of at least 0.005 wt.%, e.g., at least 0.01 wt.%, at least 0.02 wt.%, at least 0.03 wt.%, at least 0.04 wt.%, at least 0.05 wt.%, at least 0.075 wt.%, at least 0.1 wt.%, at least 0.2 wt.%, at least 0.3 wt.%, at least 0.4 wt.%, or at least 0.5 wt.%, based on the total weight of the composite material. In any preceding embodiments, the antibacterial metal is presented within the inorganic carrier. In any preceding embodiments, the inorganic carrier is presented within and embedded in the substrate metal or alloy. In any preceding embodiments, examples of phosphates include, but are not limited to, apatites (e.g., hydroxy-/chloro-/fluoro-apatites) or pure phosphate, prefer