Drug-Impregnated Encasement

Abstract

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, hi one embodiment, the sleeve may be made in least in part from caprolactone to add stretchability to the sleeve.

1 . A biologically-compatible sleeve comprising:
 a body made of a biologically-compatible, resorbable, material and defining an internal cavity configured to receive a medical implant, the body defining a plurality of apertures extending from the cavity through the body;   a first end openable for receiving the medical implant;   a second end which is closed for retaining the medical implant; and   a drug impregnated into the material.   
     
     
         2 . (canceled) 
     
     
         3 . The sleeve of  claim 1 , wherein the sleeve includes a top and bottom, at least a portion of the top or bottom being substantially planar. 
     
     
         4 . (canceled) 
     
     
         5 . The sleeve of  claim 1 , wherein the sleeve includes a first edge having a seam closing the first edge and the second end includes a seam closing the second end. 
     
     
         6 . (canceled) 
     
     
         7 . The sleeve of  claim 1 , wherein the biologically-compatible, resorbable, material is a resorbable sheet, wherein the resorbable sheet comprises a polymer. 
     
     
         8 - 9 . (canceled) 
     
     
         10 . The sleeve of  claim 1 , wherein the sleeve includes a pocket at each end configured and adapted to receive a portion of the medical implant. 
     
     
         11 . (canceled) 
     
     
         12 . The sleeve of  claim 1 , wherein the drug is selected from the group consisting of antibiotics, antiseptics, analgesics, antineoplastic agents, bisphosphonates, growth factors, peptides, statins, and combinations thereof. 
     
     
         13 . The sleeve of  claim 1 , wherein the plurality of apertures are round perforations. 
     
     
         14 . The sleeve of  claim 1 , wherein the plurality of apertures have a form selected from the group consisting of round holes, elliptical holes, slits, slots, and any combination thereof. 
     
     
         15 . The sleeve of  claim 1 , wherein the biologically-compatible, resorbable, material comprises at least two sheets of resorbable material that are laminated together. 
     
     
         16 . The sleeve of  claim 15 , wherein at least one sheet of the at least two sheets of resorbable material is microporous. 
     
     
         17 . The sleeve of  claim 15 , wherein the at least two sheets of resorbable material include different drugs. 
     
     
         18 . The sleeve of  claim 15 , wherein the at least two sheets of resorbable material contain the same drug. 
     
     
         19 - 21 . (canceled) 
     
     
         22 . A drug-impregnated sleeve comprising:
 at least one bioresorbable sheet comprised of a biologically-compatible material wherein at least one drug is impregnated into the sheet, the sheet further comprising a plurality of apertures;   the sheet folded to create a rolled edge, a pair of free edges opposite the rolled edge, a first end extending between the rolled edge and the pair of free edges, and a second end extending between the rolled edge and the pair of free edges opposite the first end; and   a seam connecting the pair of free edges to one another and closing the second end, wherein the first end defines an opening configured for receiving a medical implant at least partially encased by the sleeve.   
     
     
         23 . The sleeve of  claim 22 , wherein the plurality of apertures are round perforations. 
     
     
         24 - 29 . (canceled) 
     
     
         30 . The sleeve of  claim 22 , wherein the sleeve is made from at least two sheets of resorbable material that are laminated together. 
     
     
         31 . (canceled) 
     
     
         32 . A method of forming a drug-impregnated sleeve comprising:
 providing at least one first generally flat sheet of a biologically-compatible material having at least one drug impregnated into the sheet;   forming a plurality of apertures in the sheet;   folding the at least one first generally flat sheet to form a rolled edge, an opposite free edge, a first open end, and a second open end opposite the first end;   forming a seam along the free edge to close the free edge; and   forming a seam along the second end to close the second end, wherein the seam forming steps for the free edge and second end may be performed in any order.   
     
     
         33 - 36 . (canceled) 
     
     
         37 . The method of  claim 32 , wherein the seam along the free edge and the seam along the second end are formed by a method selected from the group consisting of heat fusion, chemical fusion, and adhesives. 
     
     
         38 - 39 . (canceled) 
     
     
         40 . The method of  claim 32 , further comprising the step of laminating a second generally flat sheet of a biologically resorbable material having at least one drug impregnated onto the at least one first generally flat sheet prior to forming the plurality of apertures. 
     
     
         41 - 43 . (canceled) 
     
     
         44 . The sleeve of  claim 1  further comprising:
 a third end openable for receiving the medical implant and facing the first end; and 
 a fourth end which is closed for retaining the medical implant, 
 wherein the fourth end and the second are configured to each form a pocket that is configured and adapted to receive a portion of the medical implant. 
 
     
     
         45 . A biologically-compatible sleeve comprising:
 a sheet of a biologically-compatible, resorbable, material, the sheet being folded and including at least one pair of edges being fused along a seam to define an internal cavity configured to receive a medical implant, the sheet defining a plurality of apertures extending from the cavity through the sheet, the sheet including two or more layers, the two or more layers configured to release the drug at different rates;   a first end openable for receiving the medical implant;   a second end; and   a drug impregnated into the material.   
     
     
         46 . A biologically-compatible sleeve comprising:
 a sheet of a biologically-compatible, resorbable, material, the sheet being folded and including at least one pair of edges being fused along a seam to define an internal cavity configured to receive a medical implant, the sheet defining a plurality of apertures extending from the cavity through the sheet, the sheet including two or more layers, the two or more layers configured to degrade in vivo at different rates;   a first end openable for receiving the medical implant;   a second end; and   a drug impregnated into the material.   
     
     
         47 . The sleeve of  claims 45  or  46 , wherein the sheet has a thickness of about 0.02 mm to about 0.5 mm. 
     
     
         48 . The sleeve of  claims 45  or  46 , wherein the sheet has a thickness of about 0.04 mm to about 0.1 mm. 
     
     
         49 . The sleeve of  claims 45  or  46 , wherein the sheet is capable of stretching without breaking up to about 100% of an initial unstretched dimension. 
     
     
         50 . The sleeve of  claim 45  or  46 , wherein the sheet comprises polycaprolactone. 
     
     
         51 . A biologically-compatible sleeve comprising:
 a sheet of a biologically-compatible, resorbable, material, the sheet being folded and including at least one pair of edges being fused along a seam to define an internal cavity configured to receive a medical implant, the sheet defining a plurality of apertures extending from the cavity through the sheet, the sheet comprising about 30% polycaprolactone and about 70% polylactic acid;   a first end openable for receiving the medical implant;   a second end; and   a drug impregnated into the material.   
     
     
         52 . The sleeve of  claims 45  or  46 , wherein the plurality of apertures have a combined open area that is about 10% to about 80% of a total surface area of the sheet. 
     
     
         53 . A biologically-compatible sleeve comprising:
 a sheet of a biologically-compatible, resorbable, material, the sheet being folded and including at least one pair of edges being fused along a seam to define an internal cavity configured to receive a medical implant, the sheet defining a plurality of apertures extending from the cavity through the sheet, the plurality of apertures having a combined open area that is about 20% of a total surface area of the sheet;   a first end openable for receiving the medical implant;   a second end; and   a drug impregnated into the material.   
     
     
         54 . A biologically-compatible sleeve comprising:
 a sheet of a biologically-compatible, resorbable, material, the sheet being folded and including at least one pair of edges being fused along a seam to define an internal cavity configured to receive a medical implant, the sheet defining a plurality of apertures extending from the cavity through the sheet, the plurality of apertures each have a diameter of at least 1.5 mm;   a first end openable for receiving the medical implant;   a second end; and   a drug impregnated into the material.   
     
     
         55 . The sleeve of  claims 15  or  30 , wherein the at least two sheets of resorbable material are molded. 
     
     
         56 . A biologically-compatible sleeve comprising:
 a sheet of a biologically-compatible, resorbable, material, the sheet being folded and including at least one pair of edges being fused along a seam to define an internal cavity configured to receive a medical implant, the sheet defining a plurality of apertures extending from the cavity through the sheet, the sheet configured to release the drug from only one side of the sheet;   a first end openable for receiving the medical implant;   a second end; and   a drug impregnated into the material.   
     
     
         57 . The sleeve of  claims 15  or  30 , wherein the at least two sheets of resorbable material are configured to release the drug at different rates. 
     
     
         58 . The sleeve of  claims 15  or  30 , wherein the at least two sheets of resorbable material are configured to degrade in vivo at different rates. 
     
     
         59 . The sleeve of  claim 1 , wherein the biologically-compatible, resorbable, material comprises at least one sheet comprising about 30% polycaprolactone and about 70% polylactic acid. 
     
     
         60 . The sleeve of  claim 22 , wherein the at least one bioresorbable sheet comprises about 30% polycaprolactone and about 70% polylactic acid. 
     
     
         61 . The sleeve of  claims 1  or  22 , wherein the plurality of apertures have a combined open area that is about 10% to about 80% of a total surface area of the sleeve. 
     
     
         62 . The sleeve of  claims 1  or  22 , wherein the plurality of apertures have a combined open area that is about 10% to about 20% of a total surface area of the sleeve. 
     
     
         63 . The sleeve of  claims 1  or  22 , wherein the plurality of apertures have a combined open area that is about 20% of a total surface area of the sleeve. 
     
     
         64 . The sleeve of  claims 1  or  22 , wherein the plurality of apertures each have a diameter of at least 1.5 mm. 
     
     
         65 . The sleeve of  claim 1 , wherein the biologically-compatible, resorbable, material is configured to release the drug from only one side of the sheet. 
     
     
         66 . The sleeve of  claim 22 , wherein the at least one bioresorbable sheet is configured to release the drug from only one side of the sheet. 
     
     
         67 . The sleeve of  claim 1 , wherein the internal cavity includes a shape that is complementary with a shape of the medical implant. 
     
     
         68 . The sleeve of  claims 1  or  22 , wherein the medical implant is an orthopedic implant. 
     
     
         69 . The sleeve of  claim 68 , wherein the orthopedic implant is a tibial nail. 
     
     
         70 . The sleeve of  claim 68 , wherein the orthopedic implant is a femoral nail. 
     
     
         71 . The sleeve of  claim 68 , wherein the orthopedic implant is a spinal implant. 
     
     
         72 . The sleeve of  claims 1  or  22 , wherein the medical implant is an uncoated implant. 
     
     
         73 . The sleeve of  claims 1  or  22 , wherein the medical implant is a bone fixation plate. 
     
     
         74 . The sleeve of  claims 1  or  22 , wherein the medical implant is an intramedullary nail. 
     
     
         75 . The sleeve of  claims 1  or  22 , wherein the medical implant is an elongate bone plate.