Biodegradeable putty compositions and implant devices, methods, and kits relating to the same

Patent metadata

Field	Value
Publication number	US-9498558-B2
Application number	US-201414218509-A
Country	US
Kind code	B2
Filing date	Mar 18, 2014
Priority date	Sep 28, 2011
Publication date	Nov 22, 2016
Grant date	Nov 22, 2016

Abstract

Disclosed are phospholipid based compositions and implant devices, as well as methods and kits that include such compositions or components thereof. In particular, the present compositions include a polymer component such as a poloxamer or PEG component and a phospholipid component, such as a Phosal. The present compositions may include at least one additional component, such as granules, powder and/or particulates. The present compositions may further include one or more bone graft materials and/or active ingredients. The compositions may be used on their own or incorporated on or in a surgical implant.

First claim

What is claimed is:

1. A method of preparing a carrier composition comprising:
combining at least one polymer component and at least one phospholipid component to form a carrier composition;
combining the carrier composition with one or more active ingredients selected from the group consisting of ceramic beads, particulates, granules, calcium phosphate particles, hydroxyapatite particles, silicated hydroxyapatite particles, bioactive glass particles, cancellous chips, cortical bone chips, and demineralized bone matrix chips; and
mixing the carrier composition with blood or bone marrow aspirate.

2. The method of claim 1 , wherein said at least one polymer component is present in an amount of about 22-70% by weight.

3. The method of claim 1 , wherein said at least one phospholipid component is present in an amount of about 17-65% by weight.

4. The method of claim 1 , wherein the carrier composition further comprises one or more graft materials, wherein the one or more graft materials comprise synthetic bone graft substitute (BGS).

5. The method of claim 1 , further comprising combining the at least one polymer component and the at least one phospholipid component with at least one component selected from the group consisting of granules, powder, particulates, graft materials, and one or more active ingredients to form the carrier composition.

6. The method of claim 5 , further comprising, subsequently, kneading the carrier composition to form a putty, a dough, or a paste.

7. The method of claim 1 , further comprising combining the carrier composition with one or more graft materials selected from the group consisting of bone, autogenous graft, blood, bone morphogenic protein (BMP), growth factors, and ceramic particles.

8. The method of claim 1 , wherein the at least one phospholipid component comprises a soybean derived phospholipid.

9. The method of claim 1 , wherein the at least one polymer component comprises at least one poloxamer or polyethylene glycol polymer.

10. The method of claim 1 , further comprising heating the at least one polymer component to substantially melt the at least one polymer component before combining the at least one polymer component with the at least one phospholipid component.

11. The method of claim 10 , further comprising kneading and cooling the carrier composition until a temperature of about 38-48° C. is reached.

12. The method of claim 1 , wherein the blood or bone marrow aspirate is mixed with the carrier composition using a luer lock syringe.

13. The method of claim 1 , wherein the carrier composition is packaged in a 2.5 cc, 5 cc, 10 cc, or 20 cc syringe.

14. A method of preparing a carrier composition comprising:
combining about 22-70% by weight of at least one polymer component, about 17-65% by weight of at least one phospholipid component, and one or more graft materials including synthetic bone graft substitute (BGS) to form a carrier composition; and
mixing the carrier composition with blood or bone marrow aspirate.

15. A method of treating a mammal by administering to a mammal at least one carrier composition prepared according to claim 1 .

16. The method of claim 15 , wherein the carrier composition further comprises at least one component selected from the group consisting of granules, powders, and particulates.

17. The method of claim 15 , wherein the carrier composition further comprises an effective amount of at least one component selected from the group consisting of one or more graft materials and one or more active ingredients.

18. A method of treating a mammal by administering to the mammal an implant device for placement in a mammal, said implant device comprising the composition prepared according to claim 1 thereon or therein.

19. A method of preparing a carrier composition comprising:
combining at least one polymer component, at least one phospholipid component, and one or more graft materials including synthetic bone graft substitute (BGS) to form a carrier composition; and
mixing the carrier composition with blood or bone marrow aspirate.

Assignees

• Globus Medical Inc
• Globus Medical Inc

Inventors

• Kunjachan Vipin

Classifications

• A61P19/08

  for bone diseases, e.g. rachitism, Paget's disease · CPC title

• A61L27/502

  Plasticizers · CPC title

• A61L27/58

  Materials at least partially resorbable by the body · CPC title

• A61K38/00

  Medicinal preparations containing peptides (peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00) · CPC title

• A61L2430/02

  for reconstruction of bones; weight-bearing implants · CPC title