Bone stabilization device and method of production
The present disclosure discloses a bone stabilization device (also referred to as a bone tape), which includes a composite flexible construct including a rigidifiable biocompatible sheet structure having first and second opposed surfaces. A biocompatible cement is located on the first surface. In use the composite flexible construct is applied to a bone with the cement contacted directly to the bone. The cement is made of a material that, once adhered to the bone, is curable to mechanically and/or ionically bond to the sheet structure and to chemically bond to the bone to achieve a permanent bond. The bone tape allows simultaneous alignment and stabilization of multiple articulated fragments for successful 3D reconstruction of shattered bones. Initial flexibility and translucency provided by the bone tape can facilitate the temporary stabilization and alignment adjustment of multiple fragments, prior to permanent rigid bonding.
1. A bone tape, comprising:
a composite flexible construct including
a flexible rigidifiable biocompatible sheet structure having first and second opposed surfaces,
a biocompatible cement located on said first surface,
said cement being made of a material that, once said first surface is adhered to bone, forms a permanent bond, and
wherein the bone tape has flexibility to allow for alignment and stabilization of multiple bone fragments prior to the flexible rigidifiable biocompatible sheet structure being rigidized, and when rigid, acts to hold the bone fragments fixed with respect to each other.
2. The bone tape according to claim 1 wherein a main constituent of said biocompatible sheet structure is a biodegradable and/or bioresorbable polymer material.
3. The bone tape according to claim 2 wherein said biocompatible sheet structure includes a plurality of separate designated bonding sites to form a plurality of bonds between said composite flexible construct and the bone.
4. The bone tape according to claim 3 wherein said separate designated bonding sites include pores extending through said biocompatible sheet structure, and wherein said cement fills said pores.
5. The bone tape according to claim 3 wherein said separate designated bonding sites include open porous regions of the polymer material which are filled with said cement to form a plurality of bonding sites.
6. The bone tape according to claim 2 wherein said composite flexible construct further comprises a porous biocompatible, biodegradable and bioresorbable material such that said composite flexible construct is a porous bioresorbable material composite.
7. The bone tape according to claim 6 wherein said porous biocompatible, biodegradable and bioresorbable material contains a porous ceramic.
8. The bone tape according to claim 7 wherein said porous ceramic is selected from the group consisting of calcium polyphosphate, tricalcium polyphosphate, mixed calcium phosphate, and calcium sulphate-calcium phosphate mixtures.
9. The bone tape according to claim 6 wherein said porous biocompatible, biodegradable and bioresorbable material includes a plurality of rigid bioresorbable structures.
10. The bone tape according to claim 9 wherein said rigid bioresorbable structures are any one of biodegradable inorganic structures and organic biodegradable structures.
11. The bone tape according to claim 10 wherein said inorganic structures are ceramic structures.
12. The bone tape according to claim 11 wherein said ceramic structures are calcium polyphosphate structures.
13. The bone tape according to claim 9 wherein said rigid bioresorbable structures are arranged in a pre-selected periodic repeating pattern along said biodegradable and/or bioresorbable polymer material.
14. The bone tape according to claim 9 wherein said rigid bioresorbable structures have
first sections that are penetrated by polymer of which the sheet structure is made thus forming a polymer-bioresorbable structure composite, and
second sections that are penetrated by the cement for binding the bioresorbable structures to the bone.
15. The bone tape according to claim 14 wherein said sheet structure includes at least an oligomer containing degradable moieties.
16. The bone tape according to claim 1 including a veneer on the second surface to produce a modified biocompatible sheet structure, wherein said modified biocompatible sheet structure has a higher stiffness than the biocompatible sheet structure by said veneer being made of a material that is curable to stiffen the modified polymer sheet structure.
17. The bone tape according to claim 16 wherein said veneer comprises any one or combination of poly(D,L-lactide-co-glycolide), polycarbonates, poly(glycolide), poly(glycolic acid-co-l-lactic acid), poly(I-lactide), poly(l-lactic acid-co-e-caprolactone), poly(e-caprolactone), poly(p-dioxanone), and poly(orthoester).
18. The bone tape according to claim 17 wherein said poly(D,L-lactide-co-glycolide) polymer has a composition in a range of 5% to 95% lactide relative to glycolide, and has a molecular weight in a range from 10,000 to 200,000 Daltons.
19. The bone tape according to claim 1 wherein said cement is any one or combination of glass ionomer cements, resin-modified glass ionomer cements and cyanoacrylate cements.
20. The bone tape according to claim 1 wherein said rigidifiable biocompatible sheet structure is made of a translucent material.