Injectable bone mineral substitute material

• US 7,972,630 B2
• Filed: 04/10/2001
• Issued: 07/05/2011
• Est. Priority Date: 04/11/2000
• Status: Expired due to Fees

• Current Assignee: BONE Support NYA AB
• Original Assignee: Bone Support AB (BONESUPPORT HOLDING AB)
• Inventors: Lidgren, Lars
• Primary Examiner(s): Meller; Michael V
• Application Number:
  US10/257,561
• Publication Number:
  US 20030161858A1
• Time in Patent Office: 3,738 Days
• Field of Search: 424/725
• US Class Current: 424/725
• CPC Class Codes: A61L 2300/252 Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
• CPC Class Codes: A61L 2300/406 Antibiotics
• CPC Class Codes: A61L 2300/414 Growth factors
• CPC Class Codes: A61L 2300/428 Vitamins, e.g. tocopherol, riboflavin
• CPC Class Codes: A61L 2300/43 Hormones, e.g. dexamethasone
• CPC Class Codes: A61L 24/0005 Ingredients of undetermined constitution or reaction products thereof
• CPC Class Codes: A61L 24/0015 Medicaments; Biocides
• CPC Class Codes: A61L 24/02 containing inorganic materials
• CPC Class Codes: A61L 2400/06 Flowable or injectable implant compositions
• 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 27/3637 characterised by the origin of the biological material other than human or animal, e.g. plant extracts, algae
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61P 19/08 for bone diseases, e.g. rachitism, Paget's disease
• CPC Class Codes: A61P 19/10 for osteoporosis

Abstract

An injectable bone mineral substitute material composition comprises an inorganic bone cement powder and a biologically compatible oil. The oil is an intermixture with the cement powder at a concentration of less than 10 wt % of the total weight of the composition in order to improve the rheology of the same. In a method of intermixing a powder of an implant material and a biologically compatible oil to a composition the oil is mixed with the powder of implant material at an elevated temperature.

Claims

1. A bone mineral substitute material powder composition comprising:

an inorganic bone cement powder chosen from the group consisting of a calcium sulphate powder, a hydroxylapatite powder, a calcium phosphate powder, and mixtures thereof; and

a biologically compatible oil chosen from the group consisting of cotton seed oil, linseed oil, sunflower oil, olive oil, soybean, oil, maize oil, almond oil, peanut oil, palm oil, whale oil, bone oil, and vitamin E,

wherein said biologically compatible oil and said cement powder is an intermixture which still has the properties of a powder, said biologically compatible oil having a concentration of more than 1 wt % but less than 10 wt % of the total weight of said composition in order to improve the rheology of said composition, said powder composition forms an injectable paste when mixed with water.

2. The powder composition according to claim 1, wherein said biologically compatible oil includes a biologically active substance dissolved, dispersed and emulsified therein, and wherein said biologically active substance is released therefrom, after hardening of said composition over a period of time.

3. The powder composition according to claim 2, wherein said biologically active substance is chosen from the group consisting of an antioxidant, a vitamin, a hormone, an antibiotic, a cytostatic, a bisphosphonate, a growth factor, and a protein.

4. The powder composition according to claim 3, wherein said antioxidant and said biologically compatible oil are both vitamin E.

5. The powder composition according to claim 4, wherein said vitamin E is alpha-tocopherol.

6. The powder composition according to claim 3, wherein said hormone is oxytocin.

7. The powder composition according to claim 3, wherein said hormone is a growth hormone.

8. The powder composition according to claim 2, wherein the bone mineral substitute material comprises from 0.05 wt % to 10 wt % of the biologically active substance.

9. A pre-set bone mineral substitute prepared from the powder composition according to claim 1 comprising:

adding water to the powder composition of claim 1; and

allowing said mixture to harden,

wherein said pre-set bone mineral substitute has the configuration of one of hardened pellets, small beads, rods, and blocks.

10. A method of preparing a bone mineral substitute composition of claim 1, comprising intermixing the inorganic bone cement powder and the biologically compatible oil, wherein said oil comprises more than 1 wt % but less than 10 wt % of the total weight of said composition, at a temperature of between 30°

C. and 120°

C.

11. The method according to claim 10, wherein said intermixing of said oil with said powder occurs at a temperature of between 50°

C. and 90°

C.

12. The method according to claim 10, wherein said intermixing of said oil with said powder occurs by means of rolling.

13. The powder composition according to claim 1, wherein said inorganic bone cement powder comprises a mixture of hydroxylapatite, calcium sulphate dihydrate, and calcium sulphate hemihydrate.

14. The pre-set bone mineral substitute according to claim 9, wherein said inorganic bone cement powder comprises a mixture of hydroxylapatite, calcium sulphate dihydrate, and calcium sulphate hemihydrate.

15. A method of manufacturing pre-set cements for local applications, said method comprising mixing the bone mineral substitute material powder composition according to claim 1 with water and letting the mixture set to have a configuration of one of pre-set square blocks, pellets, rods, and small circular beads.

16. The method according to claim 15, wherein said bone mineral substitute is threaded on a string of a non-bioresorbable or a bioresorbable material.

17. The method according to claim 16, wherein said bioresorbable material is a polylactide or a polyglycol.

18. An injectable paste composition comprising the bone mineral substitute material powder composition according to claim 1 and water.

19. An injectable paste composition comprising the bone mineral substitute material powder composition according to claim 2 and water.

20. An injectable paste composition comprising the bone mineral substitute material powder composition according to claim 13 and water.

21. The powder composition according to claim 13, wherein the total combined amount of calcium sulphate hemihydrate and calcium sulphate dihydrate is 60% by weight of the powder components, wherein the amount of calcium sulphate dihydrate ranges from 0.1% to 10% by weight of the total weight of the powder components, and wherein the amount of hydroxylapatite is 40% by weight of the total weight of the powder components.

22. The pre-set bone mineral substitute according to claim 14, wherein the total combined amount of calcium sulphate hemihydrate and calcium sulphate dihydrate is 60% by weight of the powder components, wherein the amount of calcium sulphate dihydrate ranges from 0.1% to 10% by weight of the total weight of the powder components, and wherein the amount of hydroxyapatite is 40% by weight of the total weight of the powder components.