Programmable therapeutic agent delivery from eye mounted device
The present disclosure relates to relates to systems and methods for on-demand delivery of a therapeutic agent from an eye mounted device. Particularly, aspects of the present invention are directed to a method of delivering a therapeutic agent, the method including receiving, at a controller of a therapeutic agent release and delivery device, a first command signal for delivery of a therapeutic agent based on a dosing time window. Upon receipt of the first command signal, the controller determines whether one or more compliance conditions are satisfied. When the one or more conditions are satisfied, the controller initiate a release and delivery protocol that commands a signal generator to generate and send a second command signal causing a capacitor or one or more circuits to deliver an actuation signal causing one or more therapeutic agent delivery mechanisms to open and release the therapeutic agent from one or more reservoirs.
1. A therapeutic agent release and delivery system comprising:
a therapeutic agent delivery device configured to be positioned on a surface of an eye of a patient to deliver a therapeutic agent to a treatment site of an eye of a patient; and
a controller, connected to the therapeutic agent delivery device, comprising a non-transitory memory to store data comprising a dosing regimen for the patient, and executable instructions and a processor to access the memory and execute the instructions to at least:
receive a signal from a sensor comprising an indication of a time;
consult the dosing regimen to determine whether a dosing time window of the dosing regimen is occurring based on the indication of the time; and
when the dosing time window is occurring, direct the therapeutic agent delivery device to release a dose of the therapeutic agent to the treatment site; and
when the dosing window is not occurring, continue operating as normal.
2. The system of claim 1 , wherein the therapeutic agent delivery device comprises a signal generator and a therapeutic agent delivery mechanism,
wherein the signal generator is configured to communicate with the controller and the therapeutic agent delivery mechanism so that when the dosing time window is occurring, the processor further executes the instructions to:
receive a command signal based on the stored dosing regimen to release the therapeutic agent; and
direct the signal generator to deliver an actuation signal to the therapeutic agent delivery mechanism to release the therapeutic agent to the treatment site.
3. The system of claim 2 , wherein the processor further executes the instructions to direct the signal generator to deliver another actuation signal to an iontophoretic electrode system of the therapeutic agent delivery device to facilitate delivery of the therapeutic agent into a target tissue using an iontophoretic electric field.
4. The system of claim 1 , wherein the dosing regimen comprises a type of therapeutic agent and a dose of the therapeutic agent, wherein the processor is further configured to determine at least one delivery profile based on the dosing regimen.
5. The system of claim 4 , wherein the dosing regimen comprises at least two types of therapeutic agent, a dose for each of the at least two types of therapeutic agent, and a dosing time window for each of the at least two types of therapeutic agent.
6. The system of claim 5 , wherein the dosing time window for each of the at least two types of therapeutic agent are independent.
7. The system of claim 5 , wherein the therapeutic agent delivery device comprises a signal generator and a therapeutic agent delivery mechanism,
wherein the processor is further configured to execute the instructions to:
direct the signal generator to actuate a therapy delivery mechanism for a first type of therapeutic agent during a dosing time window for the first type of therapeutic agent; and
direct the signal generator to actuate a therapy delivery mechanism for a second type of therapeutic agent during a dosing time window for the second type of therapeutic agent.
8. The system of claim 1 , further comprising another sensor configured to record a physiological signal, wherein the processor further executes instructions to:
receive the physiological signal from the other sensor;
determine if the physiological signal is abnormal based on a condition of the dosing regimen;
when the physiological signal is abnormal, then direct the therapeutic agent delivery device to release the therapeutic agent to the treatment site during the dosing time window; and
when the physiological signal is not abnormal continue operating as normal.
9. The system of claim 8 , wherein the dosing regimen comprises a condition based on at least one of: spikes in rhythmic activity of the physiological signal, a change in both amplitude and frequency of the physiological signal, and changes in the physiological signal depending on time resolution of the physiological signal measurement data.
10. The system of claim 8 , wherein the processor further executes instructions to:
alter a type of therapeutic agent, a dose of the therapeutic agent and/or the dosing time window of the dosing regimen based on the physiological signal.
11. The system of claim 8 , wherein the physiological signal comprises intraocular pressure.
12. The system of claim 1 , wherein the signal from the sensor triggers the controller to provide a command signal.
13. A method comprising:
receiving, by a controller of a therapeutic agent release and delivery system comprising a processor, a signal from a sensor comprising an indication of a time, wherein the therapeutic agent release and delivery system further comprises a therapeutic agent delivery device in communication with the controller, configured to store a therapeutic agent, and positioned on an eye of a patient;
consulting, by the controller, a dosing regimen for the patient stored in a memory of the controller to determine whether a dosing time window of the dosing regimen for the therapeutic agent is occurring based on the indication of the time;
when the dosing time window is occurring, directing, by the controller, the therapeutic agent delivery device to release a dose of the therapeutic agent to a treatment site on the eye of the patient; and
when the dosing window is not occurring, waiting for another signal.
14. The method of claim 13 , wherein the directing further comprises:
directing, by the controller, a signal generator of the therapeutic agent delivery device to deliver an actuation signal to a therapeutic agent delivery mechanism of the therapeutic agent delivery device to release the therapeutic agent to the treatment site.
15. The method of claim 14 , further comprising:
directing, by the controller, the signal generator to deliver another actuation signal to an iontophoretic electrode system of the therapeutic agent delivery device to facilitate delivery of the therapeutic agent into a target tissue using an iontophoretic electric field.
16. The method of claim 13 , wherein the dosing regimen comprises a type of therapeutic agent and a dose of the therapeutic agent, and the method further comprises:
determining, by the controller, at least one delivery profile based on the dosing regimen.
17. The method of claim 16 , wherein the dosing regimen comprises at least two types of therapeutic agent, a dose for each of the at least two types of therapeutic agent, and a dosing time window for each of the at least two types of therapeutic agent, and the directing further comprises:
directing, by the controller, a signal generator of the therapeutic agent delivery device to actuate a therapeutic agent delivery mechanism of the therapeutic agent delivery device for a first type of therapeutic agent during a dosing time window for the first type of therapeutic agent; and
directing, by the controller, the signal generator to actuate a therapeutic agent delivery mechanism of the therapeutic agent delivery device for a second type of therapeutic agent during a dosing time window for the second type of therapeutic agent.
18. The method of claim 13 , further comprising:
receiving, by the controller, a physiological signal from another sensor of the therapeutic agent release and delivery system, wherein the other sensor is configured to record a physiological signal;
determining, by the controller, if the physiological signal is abnormal based on a condition of the dosing regimen;
when the physiological signal is abnormal, then directing, by the controller, the therapeutic agent delivery device to release the therapeutic agent to the treatment site during the dosing time window; and
when the physiological signal is not abnormal continue operating as normal.
19. The method of claim 18 , wherein the dosing regimen comprises a condition based on at least one of: spikes in rhythmic activity of the physiological signal, a change in both amplitude and frequency of the physiological signal, and changes in the physiological signal depending on time resolution of the physiological signal measurement data.
20. The method of claim 18 , further comprising:
altering, by the controller, at least one of a type of therapeutic agent, a dose of the therapeutic agent, or the dosing time window of the dosing regimen based on the physiological signal.