Therapeutic agent delivery device with controlled therapeutic agent release rates
First Claim
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1. An implantable medical device comprising:
- an implantable device body having a plurality of holes;
a therapeutic agent provided in a first therapeutic agent layer and contained within the plurality of holes in the device body; and
at least one mixing layer provided adjacent the first therapeutic agent layer in the plurality of holes;
wherein the therapeutic agent layer and the at least one mixing layer together contain a continuous concentration gradient of said therapeutic agent and allow for the controlled release of the therapeutic agent contained within the therapeutic agent layer and the at least one mixing layer.
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Abstract
The present invention relates to implantable medical devices for the localized delivery of therapeutic agents, such as drugs, to a patient. More particularly, the invention relates to a device having a gradient of water soluble therapeutic agents within a therapeutic agent layer and a mixing layer that allows for controlled release of the therapeutic agents.
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Citations
59 Claims
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1. An implantable medical device comprising:
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an implantable device body having a plurality of holes; a therapeutic agent provided in a first therapeutic agent layer and contained within the plurality of holes in the device body; and at least one mixing layer provided adjacent the first therapeutic agent layer in the plurality of holes; wherein the therapeutic agent layer and the at least one mixing layer together contain a continuous concentration gradient of said therapeutic agent and allow for the controlled release of the therapeutic agent contained within the therapeutic agent layer and the at least one mixing layer. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21)
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22. An implantable medical device comprising:
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an implantable device body having a plurality of holes; a therapeutic agent within the plurality of holes in the device body provided in a therapeutic agent layer; and a mixing layer provided in the plurality of holes; wherein the therapeutic agent layer and the mixing layer contain a continuous concentration gradient of said therapeutic agent created by a process comprising delivering a mixing layer material without the therapeutic agent, and liquefying a portion of the therapeutic agent layer with the mixing layer material, wherein the mixing layer has a smaller amount of therapeutic agent contained therein than the therapeutic agent layer. - View Dependent Claims (23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40)
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41. A method for preparing an implantable medical device, which method comprises:
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a) providing an implantable medical device with a plurality of holes; b) loading into the plurality of holes an amount of a liquefied therapeutic agent, which amount is sufficient to form a therapeutic agent layer; c) allowing said liquefied therapeutic agent layer to at least partially solidify; d) loading into the plurality of holes an amount of a liquefied bioresorbable polymer which amount is sufficient to liquefy a portion of the therapeutic agent layer, thereby causing a portion of the therapeutic agent to be disposed within a mixing layer; e) allowing said liquefied bioresorbable polymer and said portion of the therapeutic agent layer to solidify; wherein an amount of therapeutic agent contained within the mixing layer upon solidification is smaller than an amount of therapeutic agent contained in the therapeutic agent layer; and further wherein steps d and e may optionally be repeated to form multiple mixing layers. - View Dependent Claims (42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53)
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54. An implantable medical device comprising:
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an implantable device body having a plurality of through holes; a plurality of layers of a bioresorbable polymer formed in the through holes to form a barrier layer at a first side of the holes; a plurality of layers of a bioresorbable polymer and drug formed in the through holes to form a drug layer adjacent the barrier layer; a plurality of layers of a bioresorbable polymer formed in the through holes to form a cap layer at a second side of the holes; and wherein the drug layer and the cap layer mix to form a continuous concentration gradient. - View Dependent Claims (55, 56, 57, 58, 59)
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Specification