DRUG ELUTING IMPLANT
Described herein is an implantable medical device that has one or more surfaces that include one or more shallow recesses configured to receive a drug delivery composition comprising a polymeric matrix and one or more biologically active agents. In one embodiment, one or more surfaces comprise a frictional surface. In a more particular embodiment, the implantable medical device comprises a stem configured for insertion into a bone of a patient, wherein the stem comprises one or more surfaces that include one or more shallow recesses configured to receive a drug delivery composition comprising a matrix and one or more biologically active agents. The drug delivery composition can be a durable drug delivery matrix, a biodegradable drug delivery matrix, or a combination thereof. Methods of making such an implant are also provided.
1 . An implantable medical device comprising:
one or more surfaces that include one or more shallow recesses configured to receive a drug delivery composition comprising a polymeric matrix and one or more biologically active agents.
2 . The implantable medical device of claim 1 , wherein one or more surfaces comprises a frictional surface.
3 . The implantable medical device of claim 1 , wherein the implantable medical device comprises a stem configured for insertion into a bone of a patient, wherein the stem comprises one or more surfaces that include one or more shallow recesses configured to receive the drug delivery composition.
4 . The implantable medical device of claim 1 , wherein the shallow recess has a length and a depth and the depth is less than the length.
5 . The implantable medical device of claim 2 , wherein the length of the shallow recess is at least 2 times greater than the depth.
6 . The implantable medical device of claim 2 , wherein the shallow recess has a depth of less than about 500 micrometers and a length of at least about 1 millimeter.
7 . The implantable medical device of claim 1 , wherein the shallow recess defines a volume that is equal to or greater than a volume of drug delivery composition introduced into the recess.
8 . The implantable medical device of claim 1 , wherein the maximum depth of the shallow recess is greater than a thickness of drug delivery composition introduced into the recess.
9 . The implantable medical device of claim 1 , wherein the recess has a surface with one or more surface configurations to improve adhesion of the drug delivery composition.
10 . The implantable medical device of claim 1 , wherein the stem has a length and a circumference and the recess comprises an elongate groove selected from an elongate groove extending longitudinally along the length of the stem, an elongate groove extending partially or completely around the circumference of the stem; an elongate groove extending obliquely or in a spiral around the stem; a pattern of elongate grooves applied to the surface of the stem, or a combination thereof.
11 . The implantable medical device of claim 1 , wherein the number, size and distribution of recesses can be varied to vary dosage of the biologically active agent.
12 . The implantable medical device of claim 1 , wherein the recess has a cross sectional shape that is circular, parabolic, or polygonal, or a combination thereof.
13 . The implantable medical device of claim 11 , wherein the recess has a polygonal cross sectional shape selected from triangular, rectangular, square, trapezoidal, or a combination thereof.
14 . The implantable medical device of claim 1 , wherein the recess has a cross sectional size that is selected from a cross sectional size that is constant along the length of the recess, a cross sectional size that varies along the length of the recess, and combinations thereof.
15 . The implantable medical device of claim 1 , wherein the biologically active agent is selected from an agent that is antimicrobial, antibiotic, anti-inflammatory agent, anticoagulant, growth factor, or other therapeutic agent.
16 . The implantable medical device of claim 1 , wherein the drug delivery composition comprises a durable drug delivery composition, a biodegradable drug delivery composition, or a combination thereof.
17 . The implantable medical device of claim 1 , wherein the drug delivery composition comprises a durable drug delivery composition comprising a bioactive agent in combination with a plurality of polymers, including a first polymer component comprising polyalkyl(meth)acrylate or aromatic poly(meth)acrylate and a second polymer component comprising poly(ethylene-co-vinyl acetate).
18 . The implantable medical device of claim 17 , wherein the first polymer component is selected from poly butyl(meth)acrylate, polyaryl(meth)acrylate, polyaralkyl(meth)acrylate, polyaryloxyalkyl(meth)acrylate, and combinations thereof.
19 . The implantable medical device of claim 1 , wherein the drug delivery composition comprises a biodegradable polymer selected from:
(a) a natural biodegradable polysaccharide selected from amylose, maltodextrin, amylopectin, starch, dextran, hyaluronic acid, heparin, chondroitin sulfate, dermatan sulfate, heparan sulfate, keratan sulfate, dextran sulfate, pentosan polysulfate, chitosan, and combinations thereof;
(b) a synthetic biodegradable polymer selected from polyanhydrides, polycaprolactone, polyglycolic acid, poly-L-lactic acid, poly-D-L-lactic, poly(D-lactic-co-glycolic acid), poly(D,L-lactic-co-glycolic acid), poly(ε-caprolactone), poly(lactic acid-co-lysine), poly(lactic acid-co-trimethylene carbonate), poly(valerolactone), poly(Hydroxyl butyrate), poly(hydrovalerate), polyphosphate esters, poly(hydroxybutyrate), polycarbonate, polyanhydride, poly(ortho esters), poly(phosphoesters), polyesters, polyamides, polyphosphazenes, poly(p-dioxane), poly(amino acid), polydioxanone, poly(propylene fumarate), poly(ethyleneoxide), poly(butyleneterephthalate), and combinations thereof; and
(c) combinations thereof.
20 . A method of making an implantable medical device capable of delivering one or more biologically active agents to a patient:
obtaining a device that comprises one or more frictional surfaces;
forming one or more shallow recesses on one or more frictional surfaces; and
introducing a drug delivery composition into one or more shallow recesses.