DEVICES, SYSTEMS, AND METHODS FOR DELIVERING THERAPEUTIC AGENTS INTO A STOMACH WALL
Embodiments of the invention provide swallowable devices, preparations and methods for delivering drugs and other therapeutic agents (TA) within the GI tract and in particular to an antrum wall (AW). Particular embodiments provide a swallowable device (SD) such as a capsule for delivering drugs or other TA into the AW. The SD may contain a pressure sensitive component or assembly which triggers release and insertion of a therapeutic agent preparation (TAP) comprising at least one TA into the AW in response to external pressure, such as pressure applied to the swallowable capsule or other SD by antrum contractions. Particular embodiments of the SD may be shaped so that they self-align within an antrum to properly orient before injection of the TAP into the AW. Embodiments of the invention are particularly useful for orally delivering drugs or other TAs which are degraded within the GI tract and require parenteral injection.
1 - 51 . (canceled)
52 . A swallowable device for delivering a therapeutic agent preparation into a wall of a patient's gastro-intestinal (GI) tract, the device comprising:
a swallowable capsule having a capsule wall, wherein the therapeutic agent preparation is held inside the capsule;
a driver within the capsule configured to advance the therapeutic agent preparation through the capsule wall and into the GI wall;
a sensor operatively coupled to the capsule wall which senses pressure when the capsule is being squeezed by a peristaltic contraction of the GI wall; and
a trigger operatively coupled to the sensor and the driver within the capsule, wherein the trigger causes the driver to advance the therapeutic agent preparation through the capsule wall and into the GI wall in response to the sensor detecting the pressure exceeding a predetermined threshold pressure value and wherein the therapeutic agent preparation is advanced through the capsule wall while at least a portion of the capsule is being squeezed by the peristaltic contraction of the GI wall.
53 . The device of claim 52 , wherein the capsule wall comprises a cylindrical shell.
54 . The device of claim 52 , wherein at least a portion of the capsule wall is degradable in a patient's intestinal tract.
55 . The device of claim 54 , wherein the at least a portion of the capsule wall degrades at a pH equal to or greater than about 6.5.
56 . The device of claim 52 , wherein at least a portion of the capsule wall is non-degradable in a patient's gastrointestinal tract.
57 . The device of claim 52 , wherein the driver comprises a propellant.
58 . The device of claim 57 , wherein the propellant comprises nitrocellulose.
59 . The device of claim 52 , wherein the driver comprises a balloon.
60 . The device of claim 52 , wherein the driver comprises a compressed spring.
61 . The device of claim 52 , wherein the driver is a first driver configured to drive the therapeutic agent preparation in a first direction, the device further comprising at least a second driver configured to drive the therapeutic agent preparation in a second direction that is different from the first direction.
62 . The device of claim 61 , wherein the first and second directions are diametrically opposed directions.
63 . The device of claim 52 , wherein the sensor comprises an electronic transducer which generates a pressure signal representative of external pressure on the capsule wall.
64 . The device of claim 63 , wherein the trigger comprises an electronic circuit which receives the pressure signal from the sensor and generates a trigger signal when the pressure exceeds a predetermined threshold pressure value.
65 . The device of claim 64 , wherein the predetermined threshold pressure value is in a range from about 300 dynes/cm 2 to about 1100 dynes/cm 2 .
66 . The device of claim 52 , wherein the sensor comprises a mechanical or fluidic pressure transducer which changes state in response to changes in external pressure on the capsule wall above a threshold pressure value.
67 . The device of claim 52 , wherein the therapeutic agent preparation comprises a solid dosage form configured to be advanced into the antrum wall by the driver.
68 . The device of claim 67 , wherein the solid dosage form comprises the therapeutic agent preparation formed or mixed with at least one of an excipient or a binder into an elongate member having a tapered, sharpened, or honed tip.
69 . The device of claim 52 , wherein the therapeutic agent preparation comprises a liquid dosage form advanced into the antrum wall through a hollow needle by the driver.
70 . A swallowable device for delivering a therapeutic agent preparation into a wall of a patient's gastro-intestinal (GI) tract, the device comprising:
a swallowable capsule having a capsule wall, wherein the therapeutic agent preparation is disposed in the capsule;
a driver within the capsule configured to advance the therapeutic agent preparation from the device into the GI wall;
a sensor operatively coupled to the capsule wall, the sensor being configured to sense pressure when the capsule is being squeezed by a peristaltic contraction of the GI wall; and
a trigger operatively coupled to the sensor and the driver within the capsule, wherein the trigger causes the driver to advance the therapeutic agent preparation from the capsule into the GI wall in response to the sensor detecting the pressure exceeding a predetermined threshold pressure value associated with the peristaltic contraction of the GI wall such that the therapeutic agent preparation is advanced into the GI wall when the capsule is being squeezed by the peristaltic contraction.
71 . A method for delivering a therapeutic agent into an antrum wall of a patient's stomach, the method comprising:
the patient orally ingesting a swallowable capsule having a therapeutic agent preparation held therein, the therapeutic agent preparation comprising the therapeutic agent;
such that the capsule passes through the patient's stomach and into the patient's gastric antrum while maintaining the therapeutic agent preparation therein;
wherein the capsule senses pressure applied externally to an exterior surface of the capsule by contractions of the antrum; and
wherein the capsule injects the therapeutic agent preparation into the antrum wall when the sensed pressure exceeds a predetermined threshold pressure value.