Wearable auto-injection systems and methods

A wearable autonomous anaphylaxis treatment system comprising:

• a wearable therapeutic unit configured to be worn on a thigh of a user, wherein the wearable therapeutic unit comprises a layered structure having a skin-facing layer, a fluidic layer positioned above the skin-facing layer, an electronics layer positioned above the fluidic layer, and an outer layer positioned above the electronics layer, wherein the skin-facing layer comprises an adhesive interface configured to secure the wearable therapeutic unit to skin of the user and a contact sensor configured to detect contact with the skin, wherein the fluidic layer comprises a drug reservoir containing a therapeutic agent, a needle in fluid communication with the drug reservoir, and a mechanical actuator configured to drive the needle to deliver the therapeutic agent intramuscularly into tissue of the user, wherein the electronics layer comprises a processor and sensor interfaces in communication with the processor, wherein the outer layer comprises a power source and a wireless communication module;
• a plurality of physiological sensors in communication with the processor through the sensor interfaces, wherein the plurality of physiological sensors is configured to generate sensor data indicative of physiological conditions of the user;
• and
• wherein the processor is configured to analyze the sensor data to detect concurrent physiological changes across multiple physiological parameters indicative of anaphylaxis, generate a trigger signal when the concurrent physiological changes are detected, and activate the mechanical actuator in response to both the trigger signal and confirmation from the contact sensor that the wearable therapeutic unit is in contact with the skin to cause delivery of the therapeutic agent into the tissue of the user.

A method of autonomously treating anaphylaxis in a user wearing a wearable device, the method comprising:

• a continuously monitoring a plurality of physiological parameters of the user using a plurality of physiological sensors of the wearable device to generate sensor data, wherein the plurality of physiological parameters comprises respiratory function, cardiovascular function, and autonomic function;
• establishing a baseline physiological state for the user by analyzing the sensor data over a calibration period;
• detecting deviations from the baseline physiological state by comparing real-time sensor data to the baseline physiological state;
• identifying a respiratory distress condition when the sensor data from a respiratory sensor indicates at least one of an increased breathing rate, an irregular breathing pattern, wheeze, stridor, or cough above a baseline respiratory function;
• identifying a cardiovascular shock condition when the sensor data from a cardiovascular sensor indicates at least one of an increased heart rate, decreased heart rate variability, or decreased blood perfusion relative to a baseline cardiovascular function;
• generating a confidence score based on presence of at least two conditions selected from the respiratory distress condition, the cardiovascular shock condition, and an autonomic activation condition;
• generating an injection trigger signal when the confidence score exceeds a predetermined threshold;
• verifying contact between the wearable device and skin of the user using a contact sensor;
• and
• delivering a therapeutic agent intramuscularly into tissue of the user using an injection mechanism of the wearable device in response to both the injection trigger signal and verification of contact between the wearable device and the skin of the user.