BONE GRAFT SUBSTITUTE

• US 20190321514A1
• Filed: 12/20/2017
• Published: 10/24/2019
• Est. Priority Date: 12/23/2016
• Status: Active Application

• Current Assignee: Collagen Matrix, Inc.
• Original Assignee: Sunstar Suisse S.A (Hosei Gijuku Luxembourg SA)
• Inventors: PFISTER, Lukas, RUFFIEUX, Kurt
• Application Number:
  US16/471,107
• Publication Number:
  US 20190321514A1
• Time in Patent Office: Days
• CPC Class Codes: A61C 8/0012 characterised by the material or composition, e.g. ceramics, surface layer, metal alloy use of specific materials A61K6/00
• CPC Class Codes: A61K 9/0012 Galenical forms characterised by the site of application
• CPC Class Codes: A61K 9/0087 Galenical forms not covered by A61K9/02 - A61K9/7023
• CPC Class Codes: A61K 9/143 with inorganic compounds
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 27/12 Phosphorus-containing materials, e.g. apatite
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 27/46 with phosphorus-containing inorganic fillers
• CPC Class Codes: A61L 27/502 Plasticizers
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61P 1/02 Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
• CPC Class Codes: A61P 19/08 for bone diseases, e.g. rachitism, Paget's disease

Abstract

There is described a bone graft substitute which combines substantially the high mechanical stability of spherical porous granules without the limitation of reduced intergranular space. The structure inside the granules has a high porosity whilst maintaining high stability, so that the granules can be pushed into a defect without risking significant breakage of the granules and, at the same time, the bone cells can grow into the space between the granules. In an exemplary embodiment of the invention, the surface of the granules comprises indentations, when viewed from the exterior of the granules. An indentation increases the porosity within the implanted mass significantly and thus provides more space between the granules for tissue ingrowth. Due to the indentations on the granules, the granules have an irregular shape and thus an increase in the intergranular space is achieved, while mechanical stability is maintained.

Claims

1. A porous implant mass composition for use in treating a defect in a living organism, comprising a plurality of biocompatible granules, at least a portion of the granules having surface indentations;

wherein the individual granules have a specific surface area of less than 20 m²/g, and contain a network of interconnected pores, the interconnected pores within the granules having a homogeneous surface porosity defined by a diameter of at least 75% of the pores being between about 1 μ

m and about 10 μ

m between sintered grains as measured by mercury intrusion porosime-try, such that the single granules can withstand a mean compressive force of at least IN as measured with a universal testing machine.

2. An implant composition as defined in claim 1, wherein the implant mass is synthetic.

3. An implant composition as defined in claim 1, the biocompatible granules comprising a material selected from the group consisting of biocompatible ceramics, biocompatible glasses, and combinations thereof.

4. An implant composition as defined in claim 1, the biocompatible granules comprising a material selected from the group consisting of silicon oxide, calcium sulphate, calcium phosphate, and combinations thereof.

5. An implant composition as defined in claim 4, the biocompatible granules comprising a material selected from the group consisting of monocalcium phosphate monohydrate, monocalcium phosphate anhydrous, dicalcium phosphate dehydrate, dicalcium phosphate anhydrous, tetracalcium phosphate, calcium ortho-phosphate, calcium pyrophosphate, a-tricalcium phosphate, β

-tricalcium phosphate, hydroxyapatite, carbonate hydroxyapatite, apatite, bioglass, and combinations thereof.

6. An implant composition as defined in claim 1, wherein the network of interconnected pores allows the integration of cells.

7. An implant composition as defined in claim 1, wherein the granules have surface indentations, preferably concavities.

8. An implant composition as defined in claim 1, wherein the granules are irregularly-shaped.

9. An implant composition as defined in claim 1, wherein the granules have an irregular surface.

10. An implant composition as defined in claim 1, wherein the granules have a Ferret diameter of 100 μ

ι

η

to about 4000 μ

ι

η

.

11. An implant composition as defined in claim 1, wherein the granules have a Ferret diameter of 500 μ

ι

η

to about 1500 μ

ι

η

.

12. An implant composition as defined in claim 1, wherein at least a portion of granules are coated with a biocompatible polymer and comprises a plasticizer in the implant composition in an amount sufficient to condition at least a portion of the biocompatible polymer so that the implant composition is plastically deformable into a desired shape and then hardenable upon removal of at least a portion of the plasticizer from the implant composition.

13. A method of manufacturing a porous implant mass composition for use in treating a defect in a living organism, comprising a plurality of biocompatible granules wherein at least a portion of the granules have surface indentations, comprising:

manufacturing granules and mixing the granules with a porogen;

pressing the porogen into the surface of at least a portion of the granules;

removing the porogen from the implant mass so that indentations in surface are obtained where the porogen is pressed into the granules.

14. A method as defined in claim 13, wherein at least a portion of the granules are in spherical form.

15. A method as defined in claim 13, wherein the porogen is in the form of particles, and at least a portion of the surface of the particles have a convex shape.

16. A method according to any one of claims 13 wherein the porogen is in the form of particles, and at least a portion of the particles are spherical.

17. A method as defined in any one of claims 13, wherein at least a portion of the porogen has a diameter in the range of 10 to 250% of the diameter of the granules.

18. A method as defined in any one of claims 13, wherein the weight of porogen used is in the range of 20% to 80% by weight of the amount of granules.

19. A method as defined in any one of claims 13, wherein the porogen comprises at least one member selected from the group consisting of ice, salt, polyethylene, silicon, polystyrene and cellulose.

20. A method as defined in any one of claims 13, wherein the porogen comprises cellulose.

21. A method as defined in any one of claims 13, wherein the step of removing the porogen comprises burning out, sieving, dissolving, melting or vaporizing.

22. A method as defined in any one of claims 13, wherein the step of removing the porogen comprises burning out the porogen.