Ingestible device with multi-stage actuator

A delivery system for an ingestible device, the delivery system comprising:

• a first housing having a piston chamber, the piston chamber defining a longitudinal axis;
• a first piston disposed in the piston chamber;
• a needle coupled to the first piston;
• a drug container coupled to the first housing and in selective fluid communication with the piston chamber, the drug container oriented laterally relative to the first housing;
• and
• a fluid preparation disposed in the drug container;
• wherein the drug container comprises a flexible material structured to deform upon ingestion of the device to expel the fluid preparation into the piston chamber.

An ingestible device for delivering a therapeutic preparation into a GI lumen wall or surrounding tissue of a subject, the device comprising:

• an expandable component;
• a modular delivery system coupled to the expandable component;
• and
• a therapeutic preparation disposed in the modular delivery system, the therapeutic preparation comprising at least one therapeutic agent;
• wherein the expandable component comprises a first gas generating mechanism structured to generate a first gas pressure within the expandable component to cause the expandable component to expand in a GI lumen to position the modular delivery system relative to a surface of the GI lumen wall;
• and
• wherein the modular delivery system comprises a second gas generating mechanism structured to generate a second gas pressure within the modular delivery system in response to the first gas pressure to deliver the therapeutic preparation into the GI lumen wall or surrounding tissue.

An ingestible device for delivering a therapeutic preparation into a GI lumen wall or surrounding tissue of a subject, the device comprising:

• an expandable component;
• a modular delivery system coupled to the expandable component;
• and
• a therapeutic preparation disposed in the modular delivery system, the therapeutic preparation comprising at least one therapeutic agent;
• wherein the expandable component is structured to expand in response to a condition in the GI tract of the subject to position the delivery system relative to a surface of the GI lumen wall;
• wherein the expandable component comprises a first actuation mechanism structured to generate a first force within the expandable component;
• wherein the modular delivery system comprises a second actuation mechanism structured to generate a second force within the modular delivery system upon the first force reaching a first threshold value;
• and
• wherein the modular delivery system is structured to deliver the therapeutic preparation into the GI lumen wall or surrounding tissue upon the second force reaching a second threshold value.

A modular delivery system for use in an ingestible device to deliver a therapeutic preparation into a GI lumen wall or surrounding tissue of a subject, the modular delivery system comprising:

• a housing defining a first chamber and a second chamber;
• a gas generating mechanism coupled to the housing in the first chamber, the gas generating mechanism being structured to generate a gas pressure within the first chamber in response to a force applied to the modular delivery system;
• a therapeutic preparation disposed in the second chamber, the therapeutic preparation comprising at least one therapeutic agent;
• and
• a delivery component movably disposed in the housing between the first chamber and the second chamber, the delivery component being structured to eject the therapeutic preparation from the second chamber in response to the gas pressure generated within the first chamber.

A modular delivery system for use in an ingestible device to deliver a therapeutic preparation into a GI lumen wall or surrounding tissue of a subject, the modular delivery system comprising:

• a housing defining a first chamber and a second chamber;
• a first substance disposed in the first chamber;
• a second substance disposed in the first chamber;
• a separator coupled to the housing in the first chamber, the separator separating the first substance from the second substance;
• a delivery piston movably disposed in the housing;
• and
• a therapeutic preparation disposed in the second chamber, the therapeutic preparation comprising at least one therapeutic agent;
• wherein the modular delivery system is structured such that the first and second substances mix to form a gas within the first chamber in response to a force applied to the modular delivery system;
• wherein the gas creates a pressure within the first chamber to cause the delivery piston to eject the therapeutic preparation from the second chamber into the GI lumen wall or surrounding tissue.

A method for delivering a therapeutic preparation into a GI lumen wall or surrounding tissue of a subject, the method comprising:

• ingesting, by the subject, an ingestible device, the device comprising an expandable component, a modular delivery system coupled to the expandable component, and a therapeutic preparation comprising at least one therapeutic agent disposed in the modular delivery system, the expandable component including a first gas generating mechanism and the modular delivery system including a second gas generating mechanism;
• wherein when the device reaches a desired location in the GI tract of the subject, the first gas generating mechanism generates a first gas pressure within an interior of the expandable component to cause the expandable component to expand to position the modular delivery system relative to a surface of the GI lumen wall;
• and
• wherein the second gas generating mechanism generates a second gas pressure within the modular delivery system in response to the first gas pressure to deliver the therapeutic preparation into the GI lumen wall or surrounding tissue.

A method for delivering a therapeutic preparation into a GI lumen wall or surrounding tissue of a subject, the method comprising:

• ingesting, by the subject, an ingestible device, the device comprising an expandable component, a modular delivery system coupled to the expandable component, and a therapeutic preparation comprising at least one therapeutic agent disposed in the modular delivery system, the expandable component including a first actuation mechanism and the modular delivery system including a second actuation mechanism;
• wherein when the device reaches a desired location in the GI tract of the subject, the first actuation mechanism generates a first force within an interior of the expandable component;
• wherein when the first force reaches a first threshold value, the second actuation mechanism generates a second force within the modular delivery system;
• wherein when the second force reaches a second threshold value, the device is structured to deliver the therapeutic preparation into the GI lumen wall or surrounding tissue.