Device for in vivo delivery of bioactive agents and method of manufacture thereof
First Claim
1. An implantable drug-eluting medical device, comprising a first member having a plurality of wall surfaces defining a z-axis thickness of the first member, at least one internal chamber enclosed entirely within the z-axis thickness of the first member, at least one of a plurality of openings communicating between the internal chamber and at least one of the plurality of wall surfaces and through a portion of the z-axis thickness of the first member, a bioactive agent within the at least one internal chamber, and a plurality of second members disposed upon the at least one of the plurality of wall surfaces, at least one of the plurality of second members associated with the at least one of a plurality of openings, each of the at least one of a plurality of second members having a first position which covers and occludes an associated opening and a second position which uncovers the associated opening, the plurality of second members being capable of transitioning between the first position and the second position upon encountering a defined stimulus.
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Accused Products
Abstract
The present invention consists of an implantable structural element for in vivo controlled delivery of bioactive active agents to a situs in a body. The implantable structural element may be configured as an implantable prosthesis, such as an endoluminal stent, cardiac valve, osteal implant or the like, which serves a dual function of being prosthetic and a carrier for a bioactive agent. Control over elution of the bioactive agents occurs through a plurality of cantilever-like cover members which prevent drug elution until an endogenous or exogenous stimulus causes the cover members to open and permit drug elution.
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Citations
19 Claims
- 1. An implantable drug-eluting medical device, comprising a first member having a plurality of wall surfaces defining a z-axis thickness of the first member, at least one internal chamber enclosed entirely within the z-axis thickness of the first member, at least one of a plurality of openings communicating between the internal chamber and at least one of the plurality of wall surfaces and through a portion of the z-axis thickness of the first member, a bioactive agent within the at least one internal chamber, and a plurality of second members disposed upon the at least one of the plurality of wall surfaces, at least one of the plurality of second members associated with the at least one of a plurality of openings, each of the at least one of a plurality of second members having a first position which covers and occludes an associated opening and a second position which uncovers the associated opening, the plurality of second members being capable of transitioning between the first position and the second position upon encountering a defined stimulus.
- 9. An endoluminal stent, comprising a generally tubular member having a central lumen passing longitudinally through the tubular member and open at opposing ends of the tubular member, a luminal surface and an abluminal surface and a wall thickness defined therebetween, at least one internal chamber defined entirely within the wall thickness in at least some portions of the tubular member, a plurality of openings communicating between the at least one internal chamber and at least one of the luminal surface, abluminal surface, at least one bioactive agent disposed in the at least one internal chamber and a plurality of cover members operably associated with the plurality of openings and having a closed position which occludes at least one of the plurality of openings and an open position which permits the at least one bioactive agent to elute from the at least one internal chamber and through the at least one opening.
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14. A method of making a drug-eluting medical device, comprising the steps of:
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a) Vacuum depositing a first layer of a biocompatible material onto a substrate;
b) Vacuum deposing a sacrificial layer of material onto the first layer of a biocompatible material;
c) Removing portions of the sacrificial layer to form internal chamber defining regions of the sacrificial layer;
d) Vacuum depositing a second layer of biocompatible material onto the internal chamber defining regions of the sacrificial layer and the first layer of biocompatible material;
e) Forming at least one of a plurality of openings passing through the second layer of biocompatible and communicating with the internal chamber defining regions of the sacrificial layer;
f) Removing the internal chamber defining regions of the sacrificial layer thereby forming at least one of a plurality of internal chambers residing entirely between the first layer of biocompatible material and the second layer of biocompatible material; and
g) Disposing at least one of a plurality of cover members covering the at least one of a plurality of openings, the at least one of a plurality of cover members having a first position which covers at least one of the plurality of openings and a second position which uncovers at least one of the plurality of openings. - View Dependent Claims (15, 16, 17, 18, 19)
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Specification