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Medical devices including medicaments and methods of making and using same

  • US 9,931,296 B2
  • Filed: 04/02/2011
  • Issued: 04/03/2018
  • Est. Priority Date: 04/03/2010
  • Status: Active Grant
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Assignment
First Claim
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1. A drug delivery, not biodegradable, hydrated contact lens, comprising:

  • a) a not physically modified, complete, solid, dry pre-formed contact lens or a not physically modified, complete, solid, dry pre-made contact lens comprising at least one outer and smooth surface; and

    b) at least one coating provided on at least a portion of said outer and smooth surface as opposed to within at least a portion of said not physically modified, complete, solid, pre-formed contact lens or not physically modified, complete, solid, pre-made contact lens;

    1) said coating comprising at least one predetermined and defined three dimensional structure; and

    2) said predetermined and defined three dimensional structure comprising;

    a. at least one drug reservoir layer;

    wherein said drug reservoir layer comprises at least one drug;

    further wherein said drug reservoir layer is a structure at least in part digitally encoded and printed at least in part by three dimensional printing; and

    b. at least one barrier layer;

    wherein said barrier layer modulates the intermittent release, sustained release, or a combination thereof, of said drug from said drug reservoir layer and through said barrier layer;

    further wherein, said barrier layer modulates the release of said drug from said drug reservoir layer in a therapeutically effective amount to treat or prevent at least one disease, disorder or condition of the eye when in use on the surface of an eye of a subject;

    further wherein said barrier layer is a structure at least in part digitally encoded and printed at least in part by three dimensional printing;

    further wherein said barrier layer modulates the release of said drug from said drug reservoir layer by the diffusivity, thickness, surface area, orientation, capillary structures, porosity, molecular exclusion size, water content, pore size, or a combination thereof, of said barrier layer; and

    wherein said predetermined and defined three dimensional structure is at least in part digitally encoded and printed at least in part by three dimensional printing;

    further wherein, the positioning of said outer and smooth surface of said not physically modified, complete, solid, dry pre-formed contact lens or a not physically modified, complete, solid, dry pre-made contact lens, said barrier layer, and said drug reservoir layer comprise the following positioning;

    two or more barrier layers, each barrier layer made of one of two or more different material compositions, being positioned side by side without intervening spaces between the barrier layers and directly on and perpendicular to a drug reservoir layer, wherein said outer and smooth surface of said not physically modified, complete, solid, dry pre-formed contact lens or a not physically modified, complete, solid, dry pre-made contact lens is positioned below a drug reservoir layer; and

    ;

    wherein said drug delivery, not biodegradable, hydrated contact lens is readily removed from the surface of an eye of a subject on which said medical device is appliedfurther wherein said drug delivery, not biodegradable, hydrated contact lens is hydrated and stored in a hydrated form in a solution comprising said drug; and

    further wherein said drug delivery, not biodegradable, hydrated contact lens functions as a drug delivery contact lens.

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