Apparatus and methods for controlled substance delivery from implanted prostheses
First Claim
Patent Images
1. A device for intracorporeal use within a patient'"'"'s body, comprising:
- an implantable scaffold;
at least one source of at least one therapeutic capable agent associated with the scaffold and configured to release the therapeutic capable agent within the patient'"'"'s body at a controlled rate; and
a rate-controlling element layer covering at least a portion of the source and including at least one therapeutic capable agent and providing for an initial relatively more rapid release of the at least one therapeutic capable agent therapeutic from the rate-controlling element layer as well as a sustained, controlled release of the at least one therapeutic capable agent from the source.
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Abstract
The present invention provides improved stents and other prostheses for delivering substances to vascular and other luminal and intracorporeal environments. In particular, the present invention provides luminal prostheses which allow for a programmed and controlled substance delivery protocols for a variety of purposes. The prostheses comprise a scaffold which is implantable within a body lumen and a substance reservoir present over at least a portion of the scaffold. Usually, a rate-controlling element will be formed over the substance-containing reservoir to provide for a number of different substance release characteristics.
125 Citations
76 Claims
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1. A device for intracorporeal use within a patient'"'"'s body, comprising:
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an implantable scaffold;
at least one source of at least one therapeutic capable agent associated with the scaffold and configured to release the therapeutic capable agent within the patient'"'"'s body at a controlled rate; and
a rate-controlling element layer covering at least a portion of the source and including at least one therapeutic capable agent and providing for an initial relatively more rapid release of the at least one therapeutic capable agent therapeutic from the rate-controlling element layer as well as a sustained, controlled release of the at least one therapeutic capable agent from the source. - View Dependent Claims (3, 4, 5, 6, 7)
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2. A device for intracorporeal use within a patient'"'"'s body, comprising:
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an implantable scaffold;
at least one source of at least one therapeutic capable agent associated with the scaffold; and
a rate-controlling element disposed adjacent at least a portion of the source and being configured to control the release of the therapeutic capable agent in the patient'"'"'s body at an initial rate and at a subsequent rate relatively slower than the initial rate.
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8. A device for intracorporeal use within a patient'"'"'s body, comprising:
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a radially expansible implantable scaffold having a plurality of regions exhibiting different mechanical profiles during the expansion of the scaffold and including relatively lower and relatively higher mechanical profiles; and
a source of at least one therapeutic capable agent comprising a plurality of segments and disposed adjacent at least a portion of the scaffold. - View Dependent Claims (9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19)
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20. A device for intracorporeal use within a patient'"'"'s body, comprising:
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an implantable scaffold;
at least one source of at least one therapeutic capable agent associated with at least a portion of the scaffold and configured to release the therapeutic capable agent within the patient'"'"'s body; and
a rate-controlling element disposed adjacent at least a portion of the source and including at least one disruption sufficiently large to permit material transport to or from the source. - View Dependent Claims (21, 22, 23, 24, 32, 33, 34)
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25. A device for intracorporeal use within a patient'"'"'s body, comprising:
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an implantable scaffold;
at least one source of at least one therapeutic capable agent associated with at least a portion of the scaffold and configured to release the therapeutic capable agent within the patient'"'"'s body; and
a rate-controlling element disposed adjacent at least a portion of the source and being configured to mechanically change upon application of mechanical stress or strain. - View Dependent Claims (26, 27, 29, 30, 31)
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28. A device for intracorporeal use within a patient'"'"'s body, comprising:
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an implantable scaffold;
at least one source of at least one therapeutic capable agent associated with at least a portion of the scaffold and configured to release the therapeutic capable agent within the patient'"'"'s body; and
a rate-controlling element disposed adjacent at least a portion of the source and which undergoes a mechanical change upon being implanted in the patient'"'"'s body.
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35. A luminal prosthesis comprising:
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a scaffold which is implantable within a body lumen;
a substance-containing reservoir positioned over at least a portion of a surface of the scaffold; and
a rate-controlling element layer covering at least a portion of the substance-containing reservoir, the rate-controlling element layer having the substance dispersed therein and providing for an initial rapid release of the substance from the rate-controlling element layer as well as a sustained, controlled release of the substance from the reservoir. - View Dependent Claims (44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58)
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36. A luminal prosthesis comprising:
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a scaffold which is implantable in a body lumen, said scaffold being radially expansible and having regions which undergo greater and lesser mechanical stress or strain during radial expansion; and
a substance-containing reservoir or layer comprising individual portions which are preferentially positioned over the regions which undergo lesser stress or strain. - View Dependent Claims (37, 38, 39)
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40. A luminal prosthesis comprising:
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a scaffold which is implantable within a body lumen;
a substance-containing reservoir positioned over at least a portion of a surface of the scaffold; and
a rate-controlling element layer covering at least a portion of the substance-containing reservoir, the rate-controlling element layer having at least one preformed aperture which is sufficiently large to permit the transport of body fluids to the substance-containing reservoir and/or the release of substance from the reservoir.
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41. A luminal prosthesis comprising:
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a scaffold which is implantable within a body lumen;
a substance-containing reservoir positioned over at least a portion of a surface of the scaffold, and a rate-controlling element layer covering at least a portion of the substance containing reservoir, the rate-controlling element layer being configured to fracture when stressed by substantially bending, expanding, stretching, or compressing of the scaffold.
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42. A luminal prosthesis comprising:
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a scaffold which is implantable within a body lumen;
a substance-containing reservoir positioned over at least a portion of a surface of the scaffold; and
a rate-controlling element layer covering at least a portion of the substance containing reservoir, the rate-controlling element layer being configured to swell to permit release of substance from the reservoir when exposed to a luminal environment.
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43. A luminal prosthesis comprising:
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a scaffold which is implantable within a body lumen;
a substance-containing reservoir positioned over at least a portion of a surface of the scaffold; and
a rate-controlling element positioned over at least a portion of the surface of the scaffold and covering less than all of the substance containing reservoir.
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59. A method for making a device for intracorporeal use, comprising:
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providing an implantable structure having a first residual stress and including a scaffold; and
at least one source of at least one therapeutic capable agent associated with the scaffold and configured to release the therapeutic capable agent at a targeted tissue site within the patient'"'"'s body;
changing the structure residual stress to a second residual stress;
disposing a rate-controlling element adjacent at least a portion of the source and being configured to control the release of the therapeutic capable agent in the patient'"'"'s body. - View Dependent Claims (60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76)
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Specification