Drug Delivery Methods, Structures, and Compositions for Nasolacrimal System
6 Assignments
0 Petitions
Accused Products
Abstract
An implant for insertion into a punctum of a patient comprises a body. The body has a distal end, a proximal end, and an axis therebetween. The distal end of the body is insertable distally through the punctum into the canalicular lumen. The body comprises a therapeutic agent included within an agent matrix drug core. Exposure of the agent matrix to the tear fluid effects an effective therapeutic agent release into the tear fluid over a sustained period. The body has a sheath disposed over the agent matrix to inhibit release of the agent away from the proximal end. The body also has an outer surface configured to engage luminal wall tissues so as to inhibit expulsion when disposed therein. In specific embodiments, the agent matrix comprises a non-bioabsorbable polymer, for example silicone in a non-homogenous mixture with the agent.
-
Citations
129 Claims
-
1-53. -53. (canceled)
- 54. A drug insert adapted for disposition within an implant, the implant being adapted for insertion into or adjacent to an eye of a patient, for providing sustained release of a therapeutic agent to the eye or surrounding tissues or both, the insert comprising a drug core and a sheath body partially covering the drug core, the drug core comprising a therapeutic agent contained in a polymer, the sheath body being disposed over a portion of the drug core to inhibit release of the agent from said portion and so as to define at least one exposed surface of the drug core adapted to release the agent to the eye or surrounding tissues, or both, when the implant is inserted into the patient.
-
70. A method of manufacturing a drug insert for an implant body adapted for insertion within or adjacent to an eye of a patient,
the insert comprising a drug core and a sheath body partially covering the drug core, the drug core comprising a therapeutic agent contained in a matrix, the sheath body being disposed over a portion of the drug core to inhibit release of the agent from said portion and so as to define at least one exposed surface of the drug core adapted to release the agent to the eye or surrounding tissues, or both, when the implant is inserted into the patient, the method comprising: -
injecting into a tube a mixture comprising the therapeutic agent and a polymer such that the tube is substantially filled therewith, the tube being substantially impermeable to the agent; curing the mixture within the tube to form a tube filled with the drug core; and cutting the tube filled with the drug core to form a plurality of drug inserts therefrom, each of the plurality of drug inserts being of substantially the same length, each insert being adapted to fit within a respective implant body and to release, through the exposed surface of the insert, therapeutic quantities of the agent to tear liquid, when the drug insert is contained within an implant that is in contact with tear liquid. - View Dependent Claims (71, 72, 73, 74, 75, 76, 77)
-
- 78. A drug core comprising a therapeutic agent contained in a matrix for disposition into or as a drug insert or an implant, the drug insert or the implant being adapted for disposition within or adjacent to an eye of a patient for providing sustained release of the therapeutic agent to the eye or surrounding tissues or both, wherein the therapeutic agent is dissolved in the matrix or constitutes inclusions in the matrix.
- 82. An implant configured for insertion in or adjacent to an eye of a patient, the implant body comprising a channel therein adapted to receive a drug insert, configured such that an exposed surface of the insert will be exposed to tear liquid when the insert is disposed within the implant and the implant is disposed in or adjacent to the eye, the drug insert comprising a drug core and a sheath body partially covering the drug core, the drug core comprising a therapeutic agent contained in a matrix, the sheath body being disposed over a portion of the drug core to inhibit release of the agent from said portion and so as to define at least one exposed surface of the drug core adapted to release the agent to the eye or surrounding tissues, or both, when the implant is inserted into the patient.
-
95. A method of delivering a therapeutic agent to an eye, the method comprising:
-
placing an implant in a structure of the eye, the implant comprising; an implant body comprising a channel therein adapted to receive a drug insert, configured such that an exposed surface of the insert will be exposed to tear liquid when the insert is disposed within the implant and the implant is disposed in or adjacent to the eye, the drug insert comprising a drug core and a sheath body partially covering the drug core, the drug core comprising a therapeutic agent contained in a matrix, the sheath body being disposed over a portion of the drug core to inhibit release of the agent from said portion and so as to define at least one exposed surface of the drug core adapted to release the agent to the eye or surrounding tissues, or both, when the implant is inserted into the patient, and wherein a release rate of therapeutic agent from the insert to the eye is dependent upon the exposed surface of the drug core; and releasing the therapeutic agent to the eye over an extended period of time. - View Dependent Claims (96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113)
-
-
114. A method of treating a condition of the eye in a patient in need thereof, comprising:
- disposing within or adjacent to an eye of the patient a drug core, the drug core comprising a therapeutic agent contained in a matrix, wherein the therapeutic agent is dissolved in the matrix or constitutes inclusions in the matrix, for providing release of the therapeutic agent to the eye or surrounding tissues or both over an extended period of time, wherein the rate of release of therapeutic agent is dependent upon the area of the exposed surface of the drug core, wherein the therapeutic agent is adapted to treat the condition.
- View Dependent Claims (115, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129)
Specification