Implant comprising a calcium salt-containing composite powder having microstructured particles
Implant comprising composite powder with microstructured particles, obtained by a process in which large particles are bonded to small particles, wherein the large particles have a mean particle diameter in the range from 10 μm to 10 mm, the large particles comprise at least one polymer, the small particles are arranged on the surface of the large particles and/or are non-homogeneously spread within the large particles, the small particles comprise a calcium salt, the small particles have a mean particle size in the range from 0.01 μm to 1.0 mm, wherein the particles of the composite powder have a mean particle size d50 in the range from 10 μm to less than 200 μm and the fine fraction of the composite powder is less than 50 vol %. Therefore, the subject matter of the invention further are implants obtained by selective laser sintering of a composition comprising a composite powder, especially as an implant for applications in the field of neuro, oral, maxillary, facial, ear, nose and throat surgery as well as of hand, foot, thorax, costal and shoulder surgery.
1. Method for manufacturing an implant, comprising:
providing a composite powder with microstructured particles, wherein the providing the composite powder, comprises bonding large particles to small particles, wherein
the large particles have a mean particle diameter in the range from 10 μm to 10 mm,
the large particles comprise at least one polymer,
the small particles are arranged on the surface of the large particles and/or are non-homogeneously spread within the large particles,
the small particles comprise a calcium salt,
the small particles have a mean particle size in the range from 0.01 μm to less than 20 μm and
forming an implant by selective laser sintering the composite powder,
wherein
the particles of the composite powder have a mean particle size d 50 defining a value based on which 50% of the particles have a particle size of less than the given value and 50% of the particles have a particle size of more than or equal to the given value in the range from 10 μm to less than 200 μm and the fine fraction, which is defined as particles of the composite powder with a size of less than 20 μm, of the composite powder is less than 50 vol %, and
the polymer comprises repeat units of lactic acid, of hydroxybutyric acid and/or of glycolic acid or the polymer is a polyolefin.
2. The method according to claim 1 , wherein the particles of the composite powder have a particle size d 90 of less than 350 μm, wherein
d 90 denotes the particle size of the particle size distribution at which 90% of the particles have a particle size of less than the given value and 10% of the particles have a particle size of more than or equal to the given value.
3. The method according to claim 1 , wherein the particles of the composite powder have an average particle size d 50 within the range from 20 μm to less than 150 μm.
4. The method according to claim 1 , wherein the particles of the composite powder have a d 20 /d 50 ratio of less than 100%, wherein d 20 denotes the particle size of the particle size distribution at which 20% of the particles have a particle size of less than the given value and 80% of the particles have a particle size of more than or equal to the given, and/or that the calcium salt has an aspect ratio of less than 5 and/or that the calcium salt comprises spherical calcium carbonate and/or that the calcium salt comprises calcium phosphate.
5. The method according to claim 1 , wherein the large particles comprise at least one thermoplastic polymer.
6. The method according to claim 1 , wherein the large particles comprise at least one absorbable polymer.
7. The method according to claim 6 , wherein the absorbable polymer has an inherent viscosity, measured in chloroform at 25° C., 0.1% polymer concentration, within the range from 0.3 dl/g to 8.0 dl/g.
8. The method according to claim 1 , wherein the large particles comprise poly-D, poly-L and/or poly-D,L-lactic acid.
9. The method according to claim 1 , wherein the large particles comprise at least one absorbable polyester having a number average molecular weight in the range from 500 g/mol to 1,000,000 g/mol.
10. The method according to claim 1 , wherein the percentage by weight of the calcium salt particle, related to the total weight of the composite powder, is at least 0.1 wt.-%.
11. The method according to claim 1 , wherein the composite powder, related to the total weight of the composite powder, comprises 40.0 wt.-% to 80.0 wt.-% of PLLA and 20.0 wt.-% to 60.0 wt.-% of calcium carbonate particles.
12. The method according to claim 1 , wherein the forming an implant by selective laser sintering the composite powder heats the composite powder to a temperature of less than 300° C.