Apparatus and methods for delivering therapeutic agents

• US 10,117,774 B2
• Filed: 06/28/2013
• Issued: 11/06/2018
• 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): Craig, Paula L
• Application Number:
  US13/931,007
• Publication Number:
  US 20130296810A1
• Time in Patent Office: 1,957 Days
• Field of Search: None
• 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 first reservoir for containing a first liquid that comprises or consists essentially of a first therapeutic agent;

a second reservoir for containing a second liquid that comprises or consists essentially of a second therapeutic agent different from the first therapeutic agent; and

a cannula having first, second and third portions, the second and third portions branching off from the first portion to communicate fluidically with the first and second reservoirs, respectively;

a first fluid-flow isolation structure located in the second portion;

a second fluid-flow isolation structure located in the third portion;

memory for storing a drug-delivery regimen;

a microprocessor for controlling a delivery of the first and second liquids to a patient through the cannula based on an execution of the stored drug-delivery regimen; and

a sensor for detecting a measured eye pressure for the patient;

wherein the first and second fluid-flow isolation structures prevent fluidic communication between the first and second reservoirs and isolate the first and second reservoirs from an external environment.

2. The drug-delivery device of claim 1, wherein each of the first and second therapeutic agents treats at least one of age-related macular degeneration, macular edema associated with diabetic retinopathy, or macular edema associated with retinovascular occlusive diseases.

3. The drug-delivery device of claim 1, wherein each of the first and second therapeutic agents is selected from the group consisting of ranibizumab, pegaptanib, verteporfin, bevacizumab, a steroid, 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.

4. The drug-delivery device of claim 1, wherein the first and second therapeutic agents treat two different maladies selected from the group consisting of glaucoma, ocular hypertension, age-related macular degeneration, macular edema associated with diabetic retinopathy, macular edema associated with retinovascular occlusive diseases, low tear production, cytomegalovirus retinitis, bacterial conjunctivitis, itching and allergic conjunctivitis, post-operative eye inflammation, inflammation of the cornea due to herpes simplex virus, postoperative inflammation after cataract extraction, corneal ulcers, and Sjö

gren'"'"'s syndrome.

5. The drug-delivery device of claim 1, further comprising first and second pumps for delivering the first and second liquids to the patient, respectively, wherein the microprocessor issues instructions to actuate the first pump separately from the second pump.

6. The drug-delivery 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.

7. The drug-delivery device of claim 1, further comprising a sensor for detecting the patient'"'"'s position and activity, the microprocessor determining at least one of a frequency, time, or dosage of at least one of the first or second liquid delivered to the patient based thereon and responsively controlling delivery of the at least one of the first or second liquid.

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

9. The drug-delivery device of claim 1, wherein the sensor monitors physiological effects of at least one of the first or second therapeutic agent present for determining the residual amount of the at least one of the first or second therapeutic agent in the patient'"'"'s tissue.

10. The drug-delivery device of claim 1, further comprising one or more valves, different from the first and second fluid-flow isolation structures, disposed in the at least one cannula, wherein the one or more valves controls fluid delivery, maintains a constant flow rate independent of variations in pressure driving a fluid flow through the cannula, and prevents backflow.

11. The drug-delivery device of claim 10, further comprising a secondary valve that is independently in fluid communication with the first and second reservoirs for separately controlling fluid delivery therefrom.

12. A drug-delivery device, comprising:

a first reservoir for containing a first liquid that comprises or consists essentially of a first therapeutic agent;

a second reservoir for containing a second liquid that comprises or consists essentially of a second therapeutic agent different from the first therapeutic agent;

a cannula having first, second and third portions, the second and third portions branching off from the first portion to communicate fluidically with the first and second reservoirs, respectively;

a first fluid-flow isolation structure located in the second portion;

a second fluid-flow isolation structure located in the third portion;

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 at least one of the first or second reservoir;

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 at least one of the first or second reservoir through the cannula;

memory for storing a drug-delivery regimen; and

a microprocessor for controlling a delivery of the first and second liquids to a patient through the cannula based on an execution of the stored drug-delivery regimen

wherein the first and second fluid-flow isolation structures prevent fluidic communication between the first and second reservoirs and isolate the first and second reservoirs from an external environment.

13. The drug-delivery device of claim 12, further comprising first and second pumps for delivering the first and second liquids to the patient, respectively, wherein the microprocessor issues instructions to actuate the first pump separately from the second pump.

14. The drug-delivery device of claim 12, further comprising a sensor for receiving feedback from the patient, the microprocessor being configured to modify the drug-delivery regimen based on the feedback.

15. The drug-delivery device of claim 12, further comprising a sensor for detecting the patient'"'"'s position and activity, the microprocessor determining at least one of a frequency, time, or dosage of at least one of the first or second liquid delivered to the patient based thereon and responsively controlling delivery of the at least one of the first or second liquid.

16. The drug-delivery device of claim 12, further comprising a transceiver for receiving wireless instructions that reprogram the drug-delivery regimen.

17. The drug-delivery device of claim 12, further comprising a sensor for detecting a measured eye pressure for the patient.

18. The drug-delivery device of claim 17, wherein the sensor monitors physiological effects of at least one of the first or second therapeutic agent present for determining the residual amount of the at least one of the first or second therapeutic agent in the patient'"'"'s tissue.

19. The drug-delivery device of claim 12, further comprising one or more valves, different from the first and second fluid-flow isolation structures, disposed in the at least one cannula, wherein the one or more valves controls fluid delivery, maintains a constant flow rate independent of variations in pressure driving a fluid flow through the cannula, and prevents backflow.

20. The drug-delivery device of claim 19, further comprising a secondary valve that is independently in fluid communication with the first and second reservoirs for separately controlling fluid delivery therefrom.