Flexible wearable transdermal drug delivery device

A transdermal drug delivery (TDD) system for delivering a drug or cosmetic product to the skin of a patient, the TDD system comprising:

• a sensing layer (101);
• a multi-modality stimulation layer (105) physically connected on and aligned with the sensing layer (101), the multi-modality stimulation layer (105) comprising:
• an electrical stimulation layer (102) comprising a polymeric flexible layer (130) configured and adapted to deliver the drug or cosmetic product through or around the sensing layer (101), and
• an ultrasonic stimulation layer (103) physically connected on and aligned with the electrical stimulation layer (102);
• and
• a control unit (620) operably connected to the sensing layer (101) and the multi-modality stimulation layer (105), the control unit (620) comprising:
• a signal collector (622),
• an iontophoresis controller (624),
• an ultrasonic generation controller (623),
• a processor (625) in operable communication with the signal collector (622), the iontophoresis controller (624), and the ultrasonic generation controller (623), and
• a machine-readable medium in operable communication with the processor and having instructions stored thereon that, when executed by the processor, perform the following steps:
• a) reading a first signal at a first time from the sensing layer (101),
• b) activating the iontophoresis controller (624) at a first iontophoresis power level based on the first signal, and
• c) activating the ultrasonic generation controller (623) at a first ultrasonic power level based on the first signal, to deliver the drug or cosmetic product to the skin of the patient.

A multilayered flexible transdermal drug delivery (TDD) system comprising:

• a control unit (620) comprising:
• a signal collector (622),
• an iontophoresis controller (624), and
• an ultrasonic generation controller (623);
• a sensing layer (101) operably connected to the control unit (620), the sensing layer comprising:
• a skin friendly contact layer (110), and
• a sensor electrodes layer (120);
• a multi-modality stimulation layer (105) physically connected directly on the sensing layer, the multi-modality stimulation layer comprising:
• an electrical stimulation layer (102) operably connected to the control unit (620), the electrical stimulation layer (102) comprising:
• an iontophoresis electrode layer (140), and
• a substrate layer for electrodes (150);
• and
• an ultrasonic stimulation layer (103) operably connected to the control unit (620) and physically connected directly on the electrical stimulation layer (102), the ultrasonic stimulation layer (103) comprising:
• an ultrasonic generator layer (170), and
• a bottom substrate layer with ultrasonic connectors (190);
• the sensing layer (101) configured and adapted to produce a skin impedance measurement;
• the control unit (620) configured and adapted to receive the skin impedance measurement from the sensing layer (101) through the signal collector, adjust a stimulation intensity through the iontophoresis controller to control an output through the iontophoresis electrode layer (140), and adjust a stimulation intensity through the ultrasonic controller to control an output through the ultrasonic generator layer (170).

A flexible drug delivery device with a multi-layer structure for creating a controllable and precise drug delivery process using ultrasonic and/or electrical stimulations to enhance or control drug penetration, the device comprising:

• a sensing element that provides feedback on skin conditions and drug penetration process in the form of one or more sensing signals;
• a stimulation unit comprising one or both of the following sub-units:
• (1) a piezoelectric unit that generates ultrasonic stimulation, and
• (2) a flexible electrode layer that produces electrical stimulation to skin;
• a control unit that monitors the one or more sensing signals and controls the stimulation unit to modulate drug penetration;
• and
• one or more flexible layers patterned with conductive electrodes that create an electrical connection from one or more of the sensing element, the stimulation unit, and the control unit to one or more external circuits.

An active, embedded, and layered transdermal drug delivery device comprising:

• a stimulation layer, comprising at least one layer selected from the group consisting of:
• an ultrasonic stimulation layer,
• an electrical stimulation layer, and
• a thermal stimulation layer;
• a sensing layer comprising one or more surface impedance measurement electrodes configured and adapted to produce a skin impedance signal;
• and
• a controller configured and adapted to provide a closed loop controlled drug release by driving the stimulation layer in response to the skin impedance signal.

A control system for a transdermal drug delivery device comprising:

• an electric stimulation controller;
• an ultrasonic wave generating and transmitting element;
• an impedance measurement controller;
• an ultrasonic generator controller;
• and
• a central controller configured for generating and transmitting ultrasonic and electrical stimulations.