Device, system and methods for the oral delivery of therapeutic compounds

A swallowable device for inserting a therapeutic agent preparation into an intestinal wall of a patient's intestinal tract, the device comprising:

• a swallowable capsule sized to pass through the intestinal tract, the capsule having a capsule wall, a least a portion of which degrades upon exposure to a selected pH in an intestine while protecting the capsule wall from degradation in the stomach;
• at least one expandable member assembly disposed within the capsule comprising a first compartment in at least a partially non-expanded state and a second compartment in at least a partially non-expanded state, the first and second compartments being fluidically separated by a degradable valve which degrades upon exposure to fluid in the intestinal tract;
• a liquid contained in one of the compartments;
• a reactant contained in the other compartment, wherein when the valve degrades, the liquid and the reactant mix to produce a gas which expands at least the second compartment;
• a delivery mechanism coupled to the wall of the second expandable compartment;
• and
• at least one tissue penetrating member comprising:
• a.) a proximal portion detachably coupled to the delivery mechanism;
• and
• b.) tissue penetrating distal portion;
• c.) and a therapeutic agent preparation for delivery into the intestinal wall,
• the tissue penetrating member configured to be retained in the intestinal wall;
• and
• wherein upon expansion of the second compartment the at least one tissue penetrating member is advanced into the intestinal wall by the delivery mechanism where it is retained in the intestinal wall so as to deliver the therapeutic agent into an intestine;
• and
• wherein the delivery mechanism comprises a third compartment having a lower portion and an upper portion, the lower portion being coupled to a wall of the second compartment having one or more tissue penetrating members disposed thereon and directed towards the upper portion and the intestinal wall, the upper portion having one or more puncture needles disposed thereon directed towards the lower portion;
• and
• wherein upon inflation of the second compartment, the lower portion of the third compartment is driven against the upper portion of the third compartment, the one or more tissue penetrating members being driven through the upper portion of the third compartment into the intestinal wall, and the one or more puncture needles being driven through the lower portion of the third compartment thereby puncturing the wall of the second compartment and deflating the expandable member assembly.

A method of delivering a therapeutic agent preparation into an intestinal wall of a patient's intestinal tract, the method comprising:

• providing a swallowable capsule sized to pass through the intestinal tract, the capsule having:
• a capsule wall, a least a portion of which degrades upon exposure to a selected pH in an intestine while protecting the capsule wall from degradation in a stomach of the patient;
• and
• wherein, the swallowable capsule also having:
• at least one expandable member assembly disposed within the capsule comprising a first compartment in at least a partially non-expanded state, a second compartment in at least a partially non-expanded state, wherein the first and second compartments are fluidically separated by a degradable valve which degrades upon exposure to fluid in the intestinal tract;
• and
• degrading the degradable valve with fluid in the intestinal tract thereby allowing a liquid contained in one of the compartments to mix with a reactant contained in the other compartment;
• and
• producing a gas with a reaction of the liquid and the reactant;
• and
• inflating at least the second compartment of the expandable member assembly with the gas produced by the reaction of the liquid and the reactant;
• and
• orienting a cylinder-piston assembly disposed inside the expandable member assembly, the cylinder-piston assembly comprising:
• a piston slidably disposed inside a cylinder, an interface between the piston and the cylinder sealed with an O-ring, the cylinder coupled to a wall of the second compartment in communication with a needle lumen, the needle lumen providing access to an exterior of the second compartment;
• and
• wherein the cylinder-piston assembly is oriented such that the needle lumen is perpendicular to the intestinal wall;
• and
• driving the piston inside the cylinder towards the exterior of the second compartment with pressure from the gas, thereby driving a tissue penetrating member disposed in the needle lumen into the intestinal wall with a piston rod coupled between the piston and the tissue penetrating member, the piston rod sized to be slidable inside the needle lumen;
• and
• wherein the tissue penetrating member comprises at least the therapeutic agent preparation.