DRUG-IMPREGNATED ENCASEMENT
A drug-impregnated sleeve for encasing a medical implant is provided. In one embodiment, the sleeve may include a body made of a biologically-compatible material that defines an internal cavity configured to receive the medical implant. In one embodiment, the biologically-compatible material is bioresorbable. The body may include a plurality of apertures, such as perforations or holes, extending from the cavity through the body. The sleeve may further include a first end, a second end, and a drug impregnated into the resorbable sheet. In one possible embodiment, the first end of the sleeve may be open for receiving the medical implant therethrough and the second end may be closed. The implant may be encased in the sleeve and implanted into a patient from which the drug is dispensed in vivo over time to tissue surrounding the implantation site. In one embodiment, the body is made from at least one sheet of a biologically-compatible material.
1 . (canceled)
2 . A method of locally dispensing drug at an implantation site comprising:
encasing an implantable medical device in a drug-impregnated sleeve, the sleeve comprising one or more drugs and a body made of a resorbable polymer material, the body having a first end and a second end and defining an internal cavity configured to receive the implantable medical device, and the body further defining a plurality of apertures extending from the cavity through the body;
implanting the encased medical device at an implantation site; and,
dispensing the one or more drugs from the sleeve locally to surrounding tissue.
3 . The method of claim 2 , wherein the resorbable polymer material is a resorbable polymer sheet.
4 . The method of claim 3 , wherein the resorbable polymer sheet comprises at least two layers of resorbable polymer material that are laminated together.
5 . The method of claim 2 , wherein the resorbable polymer material is one or more resorbable polymer fibers.
6 . The method of claim 5 , wherein the body further includes at least one bioresorbable coating layer on the one or more resorbable polymer fibers.
7 . The method of claim 2 , wherein the body includes a top and bottom, at least a portion of the top or bottom being substantially planar.
8 . The method of claim 2 , wherein the body includes a first edge having a seam closing the first edge and the second end includes a seam closing the second end.
9 . The method of claim 2 , wherein the plurality of apertures have a combined open area that is about 10% to about 80% of a total surface area of the body.
10 . The method of claim 9 , wherein the plurality of apertures have a combined open area that is about 10% to about 20% of the total surface area of the body.
11 . The method of claim 2 , wherein the resorbable polymer material comprises polymers or copolymers of caprolactone, glycolide, lactide, trimethylene carbonate, or mixtures thereof.
12 . The method of claim 2 , wherein the one or more drugs includes antibiotics, antiseptics, analgesics, antineoplastic agents, bisphosphonates, growth factors, peptides, statins, or combinations thereof.
13 . The method of claim 12 , wherein the one or more drugs is an antibiotic.
14 . The method of claim 2 , wherein dispensing the one or more drugs from the sleeve is controlled by the solubility rate of the one or more drugs in body fluid.
15 . The method of claim 3 , wherein dispensing the one or more drugs from the sleeve is from only one side of the sheet.
16 . The method of claim 4 , wherein the two or more layers each contain at least one drug of the one or more drugs, and wherein dispensing the one or more drugs from the sleeve is at different rates for each of the two or more layers.
17 . The method of claim 6 wherein the one or more drugs are contained within the bioresorbable coating layer and dispensing the one or more drugs from the sleeve is controlled by in vivo degradation of the bioresorbable coating.
18 . The method of claim 2 , wherein dispensing the one or more drugs from the sleeve is controlled by in vivo degradation of the resorbable polymer material.