Multi-modal shape memory polymers

• US 9,308,293 B2
• Filed: 02/05/2015
• Issued: 04/12/2016
• Est. Priority Date: 04/19/2007
• Status: Expired due to Fees

• Current Assignee: Smith & Nephew Incorporated (Smith & Nephew PLC)
• Original Assignee: Smith & Nephew Incorporated (Smith & Nephew PLC)
• Inventors: Brown, Malcolm, Montes De Oca Balderas, Horacio, Hall, Michael, Rose, John
• Primary Examiner(s): Salamon, Peter A
• Application Number:
  US14/615,322
• Publication Number:
  US 20150151023A1
• Time in Patent Office: 432 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2002/2839 Bone plugs or bone graft dowels
• CPC Class Codes: A61L 2400/16 Materials with shape-memory or superelastic properties
• CPC Class Codes: A61L 27/26 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/04 Macromolecular materials
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: C08G 2280/00 Compositions for creating shape memory
• CPC Class Codes: C08L 25/04 Homopolymers or copolymers of styrene
• CPC Class Codes: C08L 2666/04 Macromolecular compounds according to groups C08L7/00 - C08L49/00, or C08L55/00 - C08L57/00; Derivatives thereof
• CPC Class Codes: C08L 2666/06 Homopolymers or copolymers of unsaturated hydrocarbons; Derivatives thereof
• CPC Class Codes: C08L 2666/18 Polyesters or polycarbonates according to C08L67/00 - C08L69/00; Derivatives thereof
• CPC Class Codes: C08L 33/06 of esters containing only carbon, hydrogen and oxygen, which oxygen atoms are present only as part of the carboxyl radical
• CPC Class Codes: C08L 33/08 Homopolymers or copolymers of acrylic acid esters
• CPC Class Codes: C08L 33/10 Homopolymers or copolymers of methacrylic acid esters
• CPC Class Codes: C08L 33/12 Homopolymers or copolymers of methyl methacrylate
• CPC Class Codes: C08L 35/06 Copolymers with vinyl aromatic monomers
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

The present disclosure relates to a multi-modal shape memory polymer material comprising a blend or at least one polymer component having a first molecular weight and at least a second polymer component having a second molecular weight that is less than the first component.

Claims

1. A method for making a bone implant comprising:

preparing a bone implant comprising a multi-modal shape memory polymer material comprising a blend of at least a first polymer component having a first molecular weight and at least a second polymer component having a second molecular weight that is less than the first component, the first polymer component and the second polymer component being miscible, at least one of the first or second polymer components being non-resorbable, wherein if a bone implant so prepared is provided with energy and heated to a temperature higher than the glass transition temperature of the polymer, but lower than its melting temperature, the implant material will flow, and if inserted into bone, will flow into pores of the bone thereby implanting the implant into the bone.

2. The method of claim 1, wherein the first molecular weight is in excess of about 50,000 Daltons and the second molecular weight is up to about 20,000 Daltons.

3. The method of claim 1, wherein the first molecular weight is between about 50,000 and about 1,000,000 Daltons and the second molecular weight is between about 2,000 and about 30,000 Daltons.

4. The method of claim 1, wherein the first polymer component comprises about 80% of the polymer blend and the second polymer component comprises about 20% of the polymer blend.

5. The method of claim 2, wherein the first polymer component comprises about 80% of the polymer blend and the second polymer component comprises about 20% of the polymer blend.

6. The method of claim 1, wherein the multi-modal shape memory polymer is bimodal, and the first polymer component and the second polymer component are both non-resorbable.

7. The method of claim 1, wherein the implant further comprises reinforced polymeric material comprising a composite or matrix including reinforcing material or phases selected from the group consisting of glass fibers, carbon fibers, polymeric fibers, ceramic particulates, rods, platelets, and combinations thereof.

8. The method of claim 1, wherein at least one or both of the at least one polymer component and the second polymer component includes a component selected from the group consisting of polyacrylates, polymethyl methacrylate polymers or copolymers thereof, polybutyl methacrylate polymers or copolymers thereof, polybutyl methacrylate-co-polymethyl methacrylate copolymers, polystyrene copolymers, and combinations thereof.

9. The method of claim 1, wherein the article comprises active agents selected from the group consisting of bone morphogenic proteins, antibiotics, anti-inflammatories, angiogenic factors, osteogenic factors, monobutyrin, thrombin, modified proteins, platelet rich plasma, platelet rich solution, platelet poor plasma, platelet poor solution, bone marrow aspirate, and combinations thereof, and the active agent is incorporated into the polymeric shape memory material to be released during the relaxation and/or degradation of the polymer material.

10. A method of manufacturing a bone implant that, if implanted and exposed to energy and heat, flows into surrounding bone enhancing implantation comprising:

creating a desired bone implant comprising a multi-modal shape memory polymer material comprising a blend of at least a first polymer component having a first molecular weight and at least a second polymer component having a second molecular weight that is less than the first component, the first polymer component and the second polymer component being miscible, and at least one of the first or second polymer components being non-resorbable, wherein if the implant is inserted into bone and provided with energy and heat to a temperature higher than the glass transition temperature of the polymer, but lower than its melting temperature, the material flows into pores of the bone thereby enhancing implantation of the implant into the bone.

11. The method of claim 10, wherein the first molecular weight is in excess of about 50,000 Daltons and the second molecular weight is up to about 20,000 Daltons.

12. The method of claim 10, wherein the first molecular weight is between about 50,000 and about 1,000,000 Daltons and the second molecular weight is between about 2,000 and about 30,000 Daltons.

13. The method of claim 10, wherein the first polymer component comprises about 80% of the polymer blend and the second polymer component comprises about 20% of the polymer blend.

14. The method of claim 10, wherein the multi-modal shape memory polymer is bimodal, and the first polymer component and the second polymer component are both non-resorbable.

15. The method of claim 10, wherein the implant is porous.

16. The method of claim 10, wherein the implant further comprises reinforced polymeric material comprising a composite or matrix including reinforcing material or phases selected from the group consisting of glass fibers, carbon fibers, polymeric fibers, ceramic particulates, rods, platelets, and combinations thereof.

17. The method of claim 10, wherein at least one or both of the at least one polymer component and the second polymer component includes a component selected from the group consisting of polyacrylates, polymethyl methacrylate polymers or copolymers thereof, polybutyl methacrylate polymers or copolymers thereof, polybutyl methacrylate-co-polymethyl methacrylate copolymers, polystyrene copolymers, and combinations thereof.

18. The method of claim 10, wherein the article comprises active agents selected from the group consisting of bone morphogenic proteins, antibiotics, anti-inflammatories, angiogenic factors, osteogenic factors, monobutyrin, thrombin, modified proteins, platelet rich plasma, platelet rich solution, platelet poor plasma, platelet poor solution, bone marrow aspirate, and combinations thereof, and are incorporated into the polymeric shape memory material to be released during the relaxation and/or degradation of the polymer material.

19. A method of implanting an article into bone comprising:

implanting a bone implant article into a bone, the article comprising a multi-modal shape memory polymer material comprising a blend of at least a first polymer component having a first molecular weight and at least a second polymer component having a second molecular weight that is less than the first component, the first polymer component and the second polymer component being miscible, at least one of the first or second polymer components being non-resorbable, and wherein upon implanting the article into bone and providing the article with energy and heating to a temperature higher than the glass transition temperature of the polymer, but lower than its melting temperature, the material flows into pores of the bone thereby implanting the article into the bone.

20. The method of claim 19, wherein at least one or both of the at least one polymer component and the second polymer component includes a component selected from the group consisting of polyacrylates, polymethyl methacrylate polymers or copolymers thereof, polybutyl methacrylate polymers or copolymers thereof, polybutyl methacrylate-co-polymethyl methacrylate copolymers, polystyrene copolymers, and combinations thereof.

21. The method of claim 19, wherein the article comprises active agents selected from the group consisting of bone morphogenic proteins, antibiotics, anti-inflammatories, angiogenic factors, osteogenic factors, monobutyrin, thrombin, modified proteins, platelet rich plasma, platelet rich solution, platelet poor plasma, platelet poor solution, bone marrow aspirate, and combinations thereof, and are incorporated into the polymeric shape memory material to be released during the relaxation and/or degradation of the polymer material.