COMPOSITIONS, DEVICES, SYSTEMS, AND METHODS FOR INHIBITING AN INFLAMMATORY RESPONSE
The present disclosure relates, according to some embodiments, to compositions, devices, systems, and methods for inhibiting an inflammatory response (e.g., an inflammatory response associated with spinal surgery). For example, some embodiments of the present disclosure may reduce and/or eliminate an inflammatory response associated with friction between a soft tissue and an implant and/or between a soft tissue and a hard tissue.
1 . A spinal implant, said implant comprising:
a spinal implant body having a surface; and
a surface composition covering at least a portion of the surface, the surface composition comprising a biocompatible lubricant polymer and a pharmaceutically effective amount of a pharmaceutical compound.
2 . A spinal implant according to claim 1 , wherein the spinal implant body comprises a pedicle screw, a polyaxial screw, an interbody spacer, an anterior cervical plate, an open hook, a rod, a rod-to-rod connector, a cable, a cam, a bone plate, a bone screw, a vertical endplate, a cage, an artificial disc, and combinations thereof.
3 . A spinal implant according to claim 1 , wherein the spinal implant comprises a material selected from the group consisting of bioglass, a blood cell, a bone—allograft, a bone autograft, a bone cement, a bone chip, calcium, calcium carbonate, calcium phosphate, calcium sulfate, a ceramic, a demineralized bone, a glass, gold, a liposome, a mesenchymal cell, an osteoblast, a phosphate glass, a platelet, albumin, casein, a whey protein, a plant protein, a fish protein), a steel, a synthetic cancellous bone void filler, a thrombin, titanium, tricalcium phosphate, trimethylene carbonate (TMC), and combinations thereof.
4 . A spinal implant according to claim 1 , wherein the biocompatible lubricant polymer comprises a material selected from the group consisting of a photo polymerizable semi-interpenetrating anhydride network, a crosslinked polymer network with an associated long chain, biocompatible hydrophilic polymer, a hyaluronan hydrogel, a poly(ortho ester), a high molecular weight dextran polymer, high density polyethylene, low density polyethylene, polytetrafluoroethylene, and combinations thereof.
5 . A spinal implant according to claim 4 , wherein the biocompatible lubricant polymer consists of a photo polymerizable semi-interpenetrating anhydride network comprising a photo polymerizable monomer selected from the group consisting of a methacrylic anhydride of sebacic acid (SA-Me 2 ), a methacrylic anhydride of 1,3bis(p-carboxy phenoxy)propane (CPP-Me 2 ), and combinations thereof.
6 . A spinal implant according to claim 4 , wherein the biocompatible lubricant polymer consists of a crosslinked polymer network and an associated long chain, biocompatible hydrophilic polymer, the crosslinked polymer network comprising a polymer selected from the group consisting of a polyacrylate, a polymethacrylate, a polyurethane, a polyethylene and polypropylene co-difunctional polymer, a polyvinyl chloride, a epoxide, a polyamide, a polyester and alkyd copolymer, and combinations thereof.
7 . A spinal implant according to claim 4 , wherein the biocompatible lubricant polymer consists of a crosslinked polymer network and an associated long chain, biocompatible hydrophilic polymer, the associated long chain, biocompatible hydrophilic polymer comprising a polymer selected from a poly(N-vinyl lactam, a poly(vinylpyrrolidone), a poly(ethylene oxide), a poly(propylene oxide). a polyacrylamide, a cellulosic material, methyl cellulose, a polyanhydride, a polyacrylic acid, a polyvinyl alcohol, a polyvinyl ether, and combinations thereof.
8 . A spinal implant according to claim 4 , wherein the hyaluronan hydrogel comprises crosslinked hyaluronan-adipic dyhydrazide and hyaluronan-aldehyde.
9 . A spinal implant according to claim 4 , wherein the poly(ortho ester) is selected from the group consisting of poly(ortho ester) I, poly(ortho ester) II, poly(ortho ester) III, poly(ortho ester) IV, and combinations thereof.
10 . A spinal implant according to claim 4 , wherein the high molecular weight dextran polymer comprises dextran having a molecular weight from about 100,000 daltons to about 2,000,000 daltons.
11 . A spinal implant according to claim 1 , wherein the pharmaceutical compound comprises a compound selected from the group consisting of an adhesive, an arterial vessel wall irritant, a bone morphogenic protein, an extracellular matrix component, an inflammatory cytokine, a polymer, and combinations thereof.
12 . A spinal implant according to claim 1 , wherein the pharmaceutical compound comprises a compound selected from the group consisting of an analgesic, an antimicrobial agent, an anti-inflammatory agent, a fibrosis-inducing agent, and combinations thereof.
13 . A spinal implant according to claim 1 , wherein the surface is from about 0.5 millimeters to about 20 millimeters in its longest dimension.
14 . A spinal implant according to claim 1 , wherein the surface has a surface roughness (R a ) of from about 25 to about 50 measured without the surface composition.
15 . A spinal implant according to claim 1 , wherein the surface has a surface roughness (R a ) of from about 30 to about 45 measured with the surface composition.
16 . A spinal implant according to claim 1 , wherein the surface has a coefficient of friction of from about 0.001 to about 0.2 measured with the surface composition.
17 . A spinal implant according to claim 1 , wherein the surface is from about 0.1 microns to about 1 millimeter thick.
18 . A method of reducing and/or eliminating an inflammatory response comprising:
contacting at least a portion of a subject's spine with a spinal implant comprising a spinal implant body having a surface, and a surface composition covering at least a portion of the surface, the surface composition comprising a biocompatible lubricant polymer and a pharmaceutically effective amount of a pharmaceutical compound.
19 . A method of reducing and/or eliminating an inflammatory response according to claim 18 , wherein the spinal implant body comprises a pedicle screw, a polyaxial screw, an interbody spacer, an anterior cervical plate, an open hook, a rod, a rod-to-rod connector, a cable, a cam, a bone plate, a bone screw, a vertical endplate, a cage, an artificial disc, and combinations thereof.
20 . A method of reducing and/or eliminating an inflammatory response according to claim 18 , wherein the spinal implant comprises a material selected from the group consisting of bioglass, a blood cell, a bone—allograft, a bone autograft, a bone cement, a bone chip, calcium, calcium carbonate, calcium phosphate, calcium sulfate, a ceramic, a demineralized bone, a glass, gold, a liposome, a mesenchymal cell, an osteoblast, a phosphate glass, a platelet, albumin, casein, a whey protein, a plant protein, a fish protein), a steel, a synthetic cancellous bone void filler, a thrombin, titanium, tricalcium phosphate, trimethylene carbonate (TMC), and combinations thereof.
21 . A method of reducing and/or eliminating an inflammatory response according to claim 18 , wherein the biocompatible lubricant polymer comprises a material selected from the group consisting of a photo polymerizable semi-interpenetrating anhydride network, a crosslinked polymer network with an associated long chain, biocompatible hydrophilic polymer, a hyaluronan hydrogel, a poly(ortho ester), a high molecular weight dextran polymer, a high density polyethylene, a low density polyethylene, a polytetrafluoroethylene, and combinations thereof.
22 . A method of reducing and/or eliminating an inflammatory response according to claim 18 , wherein the pharmaceutical compound comprises a compound selected from the group consisting of an adhesive, an arterial vessel wall irritant, a bone morphogenic protein, an extracellular matrix component, an inflammatory cytokine, a polymer, and combinations thereof.
23 . A method of reducing and/or eliminating an inflammatory response according to claim 18 , wherein the pharmaceutical compound comprises a compound selected from the group consisting of an analgesic, an antimicrobial agent, an anti-inflammatory agent, a fibrosis-inducing agent, and combinations thereof.
24 . A method of reducing and/or eliminating an inflammatory response according to claim 18 , wherein the surface is from about 0.5 millimeters to about 20 millimeters in its longest dimension.
25 . A method of reducing and/or eliminating an inflammatory response according to claim 18 , wherein the surface has a surface roughness (R a ) of from about 25 to about 50 measured without the surface composition.
26 . A method of reducing and/or eliminating an inflammatory response according to claim 18 , wherein the surface has a surface roughness (R a ) of from about 30 to about 45 measured with the surface composition.
27 . A method of reducing and/or eliminating an inflammatory response according to claim 18 , wherein the surface has a coefficient of friction of from about 0.001 to about 0.2 measured with the surface composition.
28 . A method of reducing and/or eliminating an inflammatory response according to claim 18 , wherein the surface is from about 0.1 microns to about 1 millimeter thick.
29 . A method of manufacturing a spinal implant, said method comprising:
providing a spinal implant body having a smooth surface; and
depositing on the smooth surface a surface composition comprising a biocompatible lubricant polymer and a pharmaceutical compound, wherein the surface composition is configured and arranged to deliver a pharmaceutically effective amount of the pharmaceutical compound to the subject's spine.
30 . A method of manufacturing a spinal implant according to claim 29 , wherein the depositing further comprises uniformly depositing the surface composition on to the smooth surface.
31 . A method of manufacturing a spinal implant according to claim 29 , wherein the depositing further comprises applying, loading, coating, covering, injecting, spraying, dipping, or jetting the surface composition on to the smooth surface.
32 . A method of manufacturing a spinal implant according to claim 29 , wherein the depositing further comprises printing the surface composition on to the smooth surface.
33 . A method of manufacturing a spinal implant according to claim 32 , wherein the printing further comprises:
(a) providing a fluid-dispenser having a dispensing element operable to dispense the surface composition in discrete droplets, wherein each droplet has a controlled trajectory;
(b) creating relative movement between the dispensing element and the implant (e.g., prosthesis) to define a dispensing path; and
(c) selectively dispensing the surface composition from the fluid-dispenser in a raster format to a predetermined portion of the spinal implant surface along the dispensing path.
34 . A method of manufacturing a spinal implant according to claim 29 , wherein the depositing further comprises depositing a sufficient amount of the surface composition to give from about 1 microgram to about 100 micrograms of the pharmaceutical agent per millimeter of the surface.
35 . A method of manufacturing a spinal implant according to claim 29 further comprising curing the surface composition.
36 . A method of manufacturing a spinal implant according to claim 35 , wherein the curing further comprises hydrating, heating, or irradiating the surface composition.
37 . A method of manufacturing a spinal implant according to claim 29 further comprising sterilizing and/or sanitizing the spinal implant.
38 . A system for reducing and/or eliminating an inflammatory response comprising:
a first spinal implant comprising a spinal implant body having a first surface, and a first surface composition covering at least a portion of the first surface, the first surface composition comprising a first biocompatible lubricant polymer and a pharmaceutically effective amount of a first pharmaceutical compound; and
a second spinal implant.
39 . A system for reducing and/or eliminating an inflammatory response according to claim 38 , wherein the first and second spinal implants are the same.
40 . A system for reducing and/or eliminating an inflammatory response according to claim 38 , wherein the first and second spinal implants are different.
41 . A system for reducing and/or eliminating an inflammatory response according to claim 38 , wherein the second spinal implant further comprises a spinal implant body having a second surface, and a second surface composition covering at least a portion of the second surface, the second surface composition comprising a second biocompatible lubricant polymer and a pharmaceutically effective amount of a second pharmaceutical compound.
42 . A system for reducing and/or eliminating an inflammatory response comprising:
a pharmaceutical composition comprising a pharmaceutically effective amount of a first pharmaceutical agent and a carrier; and
a spinal implant comprising a spinal implant body having a surface, and a surface composition covering at least a portion of the surface, the surface composition comprising a biocompatible lubricant polymer and a pharmaceutically effective amount of a second pharmaceutical compound.
43 . A system for reducing and/or eliminating an inflammatory response according to claim 42 , wherein the pharmaceutical composition is configured and arranged for intravenous delivery, intramuscular delivery, oral delivery, or transdermal delivery to subject.
44 . A system for reducing and/or eliminating an inflammatory response according to claim 42 , wherein the first and second pharmaceutical agents are the same.
45 . A system for reducing and/or eliminating an inflammatory response according to claim 42 , wherein the first and second pharmaceutical agents are different.
46 . An implantable bone screw comprising:
an implantable bone screw body having bone screw threads and a bone screw head having a surface; and
a surface composition covering at least a portion of the surface, the surface composition comprising a biocompatible lubricant polymer and a pharmaceutically effective amount of a pharmaceutical compound.
47 . An implantable bone screw according to claim 46 , wherein the bone screw is configured and arranged as a pedicle screw or a polyaxial screw.
48 . An implantable bone plate comprising:
an implantable bone plate body having a surface; and
a surface composition covering at least a portion of the surface, the surface composition comprising a biocompatible lubricant polymer and a pharmaceutically effective amount of a pharmaceutical compound.
49 . An implantable bone plate according to claim 48 , wherein the bone plate is configured and arranged as a cervical plate.