Multi-layer biodegradable device having adjustable drug release profile
First Claim
1. A device comprising:
- a first film-layer comprising fibrinogen,the first film-layer formed by processing a first composition comprising a first amount of non-aqueous solvent for a first time interval to produce a first characteristic selected from the group consisting of a release profile of one or more therapeutic agents over time, adhesiveness, solubility, matrix stiffness, porosity, and degradation rate of the first film-layer;
optionally, an intermediate layer comprising an adhesive configured to bond to the first and second film-layers; and
the second film-layer optionally bonded to the first film-layer,the second film-layer comprising fibrinogen,the second film-layer formed by processing a second composition comprising a second amount of non-aqueous solvent for a second time interval to produce a second characteristic selected from the group consisting of a release profile of one or more therapeutic agents over time, adhesiveness, solubility, matrix stiffness, porosity, and degradation rate of the second film-layer,wherein the second composition has the same composition as the first composition except the second amount of non-aqueous solvent is different from the first amount of non-aqueous solvent such that the second film-layer has a physical structure sufficient to produce the second characteristic which is different in value from the first characteristic of the first film-layer.
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Accused Products
Abstract
Methods and apparatus for a biodegradable multi-layer device suitable for medical applications are provided, wherein the device is formed from multiple film-layers configured to have different characteristics from one another such as different release profiles for therapeutic agents, adhesive properties, stiffness properties, and solubility properties. The film-layers may include a solid fibrinogen component. A device having multiple film-layers may take a non-adherent form during delivery to a target location within or on tissue, and thereafter may be exposed to moisture to take an adherent form on the tissue. The device may include a number of additives, including materials to improve the mechanical properties of the device, or one or more therapeutic or contrast agents.
70 Citations
20 Claims
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1. A device comprising:
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a first film-layer comprising fibrinogen, the first film-layer formed by processing a first composition comprising a first amount of non-aqueous solvent for a first time interval to produce a first characteristic selected from the group consisting of a release profile of one or more therapeutic agents over time, adhesiveness, solubility, matrix stiffness, porosity, and degradation rate of the first film-layer; optionally, an intermediate layer comprising an adhesive configured to bond to the first and second film-layers; and the second film-layer optionally bonded to the first film-layer, the second film-layer comprising fibrinogen, the second film-layer formed by processing a second composition comprising a second amount of non-aqueous solvent for a second time interval to produce a second characteristic selected from the group consisting of a release profile of one or more therapeutic agents over time, adhesiveness, solubility, matrix stiffness, porosity, and degradation rate of the second film-layer, wherein the second composition has the same composition as the first composition except the second amount of non-aqueous solvent is different from the first amount of non-aqueous solvent such that the second film-layer has a physical structure sufficient to produce the second characteristic which is different in value from the first characteristic of the first film-layer. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 17, 18, 19, 20)
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16. A device comprising:
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a first film-layer comprising fibrinogen, wherein the first film-layer possesses one or more properties selected from the group consisting of porosity, surface projections, perforations, microstructures, nanostructures, ridges, and dimples sufficient to produce a first characteristic selected from the group consisting of a release profile of one or more therapeutic agents over time, adhesiveness, matrix stiffness, porosity, and degradation rate, the first film-layer formed from a first amount of non-aqueous solvent; optionally, an intermediate layer comprising an adhesive configured to bond to the first film-layer and a second film-layer, and the second film-layer, optionally bonded to the first film-layer, the second film-layer comprising fibrinogen, wherein the second film-layer has the physical structure sufficient to produce a second characteristic which is different in value from the first characteristic of the first film-layer, the second characteristic is selected from the group consisting of a release profile of one or more therapeutic agents over time, adhesiveness, matrix stiffness, porosity, and degradation rate, the second film-layer formed from a second amount of non-aqueous solvent; and wherein the first and second film-layers are formed from the same composition except the first amount of non-aqueous solvent is different from the second amount of non-aqueous solvent.
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Specification