Apparatus and method for providing dynamizable translations to orthopedic implants
View Patent ↗The present invention generally relates to orthopedic devices and methods for treating bone defects. The orthopedic devices can provide sufficient support to the bone defect while allowing bone ingrowth and minimizing the risk to stress shield and/or pseudo-arthrodesis. The bone fixation devices include a biodegradable material or component that further resists relative motion of attached bones and allows the device to gradually transfer at least some load from the device to the growing bone structure in vivo and permitting an increase in the relative motion of bones attached to the device.
1. An orthopedic implant comprising:
a bone plate having a top surface and an opposed bottom surface, said bottom surface for lying adjacent to bone, said bone plate including an opening therethrough from said top surface to said bottom surface, said opening having an area of a first dimension;
a biodegradable restricting component disposed at least partially in said plate opening, said restricting component defining an opening within and through said area, said opening of said restricting component having a second dimension smaller than said first dimension; and
a fastener having a portion configured to anchor to bone, said fastener portion extending through said opening of said restricting component and said opening of said bone plate, said fastener portion having a width dimension that is substantially the same as the second dimension of the opening of said restricting component, said width dimension being smaller than said first dimension of said area;
wherein at the time of implantation said restricting component inhibits motion of said fastener with respect to said plate in a first direction, and an edge of said opening of said bone plate inhibits motion of said fastener in a second direction opposite from the first direction; and
wherein after said restricting component has degraded, said fastener remains restricted from motion in the second direction, but is uninhibited from motion within said opening in said bone plate in the first direction.
2. The device of claim 1 , wherein said plate comprises a biocompatible metal.
3. The device of claim 1 , wherein said plate comprises an elastic material.
4. The device of claim 1 , wherein said plate comprises a material selected from the group consisting of: nitinol, titanium, titanium-vanadium-aluminum alloy, cobalt-chromium alloy, cobalt-chromium-molybdenum alloy, cobalt-nickel-chromium-molybdenum alloy, biocompatible stainless steel, tantalum, niobium, hafnium, tungsten, poly(ether, ether ketone), poly(aryl, ether, ketone).
5. The device of claim 1 , wherein said restricting component completely biodegrades within two years while said elongate member remains engaged to the said two or more bone portions.
6. The device of claim 1 , wherein said restricting component is provided to have an initial mass and wherein the restricting component degrades in vivo to less than half its initial mass within one year.
7. The device of claim 1 , wherein said restricting component is provided to have an initial mass and wherein in vivo the restricting component retains greater than half its initial mass for a time period of greater than one year.
8. The device of claim 1 , wherein said biodegradable restricting component composes a material selected from a group consisting of: poly(amino acids), polyanhydrides, polycaprolactones, polylactates, polyglycolates, poly(lactic-glycolic acid), polyorthoesters, and blends thereof.
9. The device of claim 1 , wherein the restricting component is disposed in said plate opening so that said restricting component opening is substantially centered in said plate opening.
10. The device of claim 1 , wherein the restricting component is disposed in said plate opening so that said restricting component opening is closer to one end of said plate opening.
11. The device of claim 1 , wherein said bone plate includes a plurality of openings therethrough from said top surface to said bottom surface, each said opening having an area with a respective first dimension, and each of said openings having a respective biodegradable restricting component disposed at least partially therein, each said restricting component at least partially defining an open portion of said area of its respective opening, said open portions each having a respective second dimension smaller than said first dimension of its respective opening area, and wherein each said opening has a respective fastener extending through the respective restricting component and opening, each said fastener having a width dimension that is substantially the same as the respective second dimension of the open area portion at least partially defined by the respective restricting component, said respective width dimension being smaller than said first dimension of the respective area.
12. The device of claim 11 , wherein the restricting components degrade at substantially the same rate.
13. The device of claim 11 , wherein at least one of said restricting components degrades at a rate different from a degradation rate of another of said restricting components.
14. The device of claim 1 , wherein said fastener is a bone screw.
15. The device of claim 1 , wherein said restricting component is both within said opening and outside said opening in contact with said top surface.
16. The device of claim 1 , wherein said plate has at least one additional opening, and further comprising a second fastener extending through said at least one additional opening, and wherein at the time of implantation there is no synthetic material between said second fastener and said plate.