Apparatus and methods for delivering therapeutic agents

• US 9,308,124 B2
• Filed: 12/19/2008
• Issued: 04/12/2016
• Est. Priority Date: 12/20/2007
• Status: Active Grant

• Current Assignee: University of Southern California
• Original Assignee: University of Southern California
• Inventors: Humayun, Mark, Caffey, Sean
• Primary Examiner(s): Craig, Paula L.
• Application Number:
  US12/340,095
• Publication Number:
  US 20090240215A1
• Time in Patent Office: 2,671 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61F 9/0026 Ophthalmic product dispenser attachments to facilitate positioning near the eye
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/28 for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
• CPC Class Codes: A61P 27/02 Ophthalmic agents
• CPC Class Codes: A61P 27/06 Antiglaucoma agents or miotics
• CPC Class Codes: A61P 27/14 Decongestants or antiallergics
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 31/22 for herpes viruses
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

In various embodiments, a drug-delivery device includes one or more reservoirs that may each contain a therapeutic agent for delivery to a patient.

Claims

1. A method for treating an ophthalmic condition, comprising:

implanting a drug-delivery device in a patient'"'"'s eye, the device comprising (i) a refillable reservoir having a self-resealing upper layer that is pierceable by a needle for refilling and an opposed lower layer that is unpuncturable by the needle so as to protect the eye from injury, (ii) a tapered cannula in fluid communication with the reservoir, and (iii) a valve disposed in the cannula, wherein the valve controls fluid delivery, maintains a constant flow rate independent of variations in pressure driving a fluid flow through the cannula, and prevents backflow; and

filling the reservoir with a liquid that comprises a therapeutic agent selected from the group consisting of acetazolamide, betaxolol, bevacizumab, bimatoprost, brimonidine, brinzolamide, carbidopa, carteolol, cidofovir, cyclosporine, dorzolamide, epinephrine, ketorolac tromethamine, ketotifen fumarate, latanoprost, levobetaxolol, levobunolol, levodopa, levofloxacin, loratadine, loteprednol etabonate, metipranolol, naphazoline, ofloxacin, pegaptanib, pemirolast, pheniramine maleate, pilocarpine, pseudoephedrine, ranibizumab, a steroid, timolol, travoprost, trifluridine, unoprostone isopropyl, valganciclovir, verteporfin, vitravene, a drug that prevents beta amyloid deposition in the retina, an anti-human complement activation blocker that blocks complement H activation in the eye, and siRNA molecules,

wherein the device is implanted with the lower layer placed adjacent to the sclera of the eye and the cannula inserted into the eye through the sclera to facilitate delivery of drug from the reservoir into the eye.

2. The method of claim 1, further comprising directing the liquid to a target site via the cannula.

3. The method of claim 1, further comprising:

(i) executing a stored drug-delivery regimen including a delivery pressure and a delivery flow rate of the liquid, (ii) receiving feedback from the patient, and (iii) modifying the stored drug-delivery regimen based on the feedback.

4. The method of claim 1, further comprising:

(i) detecting the patient'"'"'s position and activity;

(ii) determining at least one of a frequency, time, or dosage of the liquid delivered to the patient based thereon; and

(iii) responsively controlling delivery of the liquid.

5. The method of claim 4, wherein a dosage of the delivered liquid is controlled, at a constant flow rate, based on a duration that the liquid flows through the cannula.