Apparatus and methods for delivering therapeutic agents

• US 9,271,866 B2
• Filed: 06/28/2013
• Issued: 03/01/2016
• Est. Priority Date: 12/20/2007
• Status: Active Grant

• Current Assignee: University of Southern California
• Original Assignee: University of Southern California
• Inventors: Humayun, Mark S., Caffey, Sean
• Primary Examiner(s): Anderson, Lynne
• Assistant Examiner(s): Craig, Paula L
• Application Number:
  US13/931,074
• Publication Number:
  US 20130289497A1
• Time in Patent Office: 977 Days
• 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 drug-delivery device, comprising:

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 an eye from injury, and containing 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, a growth factor, irinotecan, 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, tumor necrosis factor blocker, unoprostone isopropyl, valganciclovir, verteporfin, vitravene, a drug that prevents beta amyloid deposition in the retina, a drug that prevents beta amyloid deposition in the brain, an anti-human complement activation blocker that blocks complement H activation in the eye, and siRNA molecules;

a cannula in fluid communication with the reservoir, the cannula having an outlet for delivering the therapeutic agent to a patient;

a memory for storing a drug-delivery regimen;

a microprocessor for executing the stored drug-delivery regimen; and

a sensor for detecting a position and an activity of the patient, the microprocessor determining at least one of a frequency, time, or dosage of the liquid delivered to the patient based thereon and responsively controlling delivery of the liquid.

2. The device of claim 1, wherein the device is shaped to conform to a curved contour of the eye.

3. The device of claim 1, wherein the lower layer is implanted adjacent to the sclera of the eye and the cannula is inserted into the eye through the sclera to facilitate delivery of drug from the reservoir into the eye.

4. The device of claim 1, further comprising a sensor for receiving feedback from the patient, the microprocessor being configured to modify the drug-delivery regimen based on the feedback.

5. The device of claim 1, further comprising a sensor for detecting a measured eye pressure for the patient.

6. The device of claim 5, wherein the sensor monitors physiological effects of the therapeutic agent present for determining a residual amount of the therapeutic agent in a tissue of the patient.

7. The device of claim 1, further comprising a transceiver for receiving wireless instructions that reprogram the drug-delivery regimen.

8. The device of claim 1, further comprising:

an electrolysis chamber including a gas-impermeable flexible membrane configured to expand and contract with increases and decreases in pressure in the electrolysis chamber, the flexible membrane also constituting a portion of the reservoir; and

at least two electrodes in the electrolysis chamber, the electrodes being responsive to the microprocessor to produce gas in the electrolysis chamber to expand the membrane and thereby force liquid from the reservoir through the cannula.

9. The device of claim 1, further comprising 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.