Methods for loading a drug eluting medical device
First Claim
1. A method of loading a therapeutic substance within a lumenal space of a hollow wire that forms a hollow stent for drug delivery comprising the steps of:
- preparing a suspension of the therapeutic substance and a dispersion medium;
placing the suspension within a high-pressure packing unit;
fluidly connecting a first end of the hollow wire to the packing unit such that the lumenal space of the hollow wire is in fluid communication with the suspension;
attaching an end fitting having a frit to a second end of the hollow wire, wherein a pore size of the frit is selected to prevent particles of the therapeutic substance from passing there through while allowing the dispersion medium to pass there through; and
pressurizing the packing unit to a packing pressure that forces the suspension into the lumenal space of the hollow wire, whereby the therapeutic substance packs within the lumenal space of the hollow wire as the therapeutic substance is separated from the dispersion medium that is forced through the frit at the second end of the hollow wire.
1 Assignment
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Accused Products
Abstract
Methods and apparatus are disclosed for loading a therapeutic substance or drug within a lumenal space of a hollow wire having a plurality of side openings along a length thereof that forms a hollow drug-eluting stent with a plurality of side drug delivery openings. Loading a drug within the lumenal space of the hollow stent includes a drug filling step, in which the drug is mixed with a solvent or dispersion medium. The lumenal space may be filled with the drug solution or suspension in a reverse fill process and/or a forward fill process. After the drug filling step, a solvent or dispersion medium extracting step is performed to extract the solvent or dispersion medium from within the lumenal space such that only the drug remains within the hollow stent. A stent cleaning step may be performed to an exterior surface of the hollow stent.
164 Citations
13 Claims
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1. A method of loading a therapeutic substance within a lumenal space of a hollow wire that forms a hollow stent for drug delivery comprising the steps of:
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preparing a suspension of the therapeutic substance and a dispersion medium; placing the suspension within a high-pressure packing unit; fluidly connecting a first end of the hollow wire to the packing unit such that the lumenal space of the hollow wire is in fluid communication with the suspension; attaching an end fitting having a frit to a second end of the hollow wire, wherein a pore size of the frit is selected to prevent particles of the therapeutic substance from passing there through while allowing the dispersion medium to pass there through; and pressurizing the packing unit to a packing pressure that forces the suspension into the lumenal space of the hollow wire, whereby the therapeutic substance packs within the lumenal space of the hollow wire as the therapeutic substance is separated from the dispersion medium that is forced through the frit at the second end of the hollow wire. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13)
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Specification