| CPC A61M 5/155 (2013.01) [A61K 38/13 (2013.01); A61K 38/21 (2013.01); A61K 38/26 (2013.01); A61K 38/27 (2013.01); A61K 38/28 (2013.01); A61K 38/29 (2013.01); A61K 38/30 (2013.01); A61K 38/55 (2013.01); A61M 5/14244 (2013.01); A61M 31/002 (2013.01); A61K 9/4808 (2013.01); A61M 37/0069 (2013.01); A61M 2205/3331 (2013.01); A61M 2210/1042 (2013.01)] | 20 Claims |

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1. A method of delivering a therapeutic agent preparation into a gastrointestinal (GI) wall of a patient, the method comprising:
administering, by swallowing by a patient, a swallowable device sized to pass through a GI tract, wherein the device comprises a capsule, the therapeutic agent preparation disposed within the capsule, an aligner, and a delivery mechanism for advancing the therapeutic agent preparation from the capsule into the GI wall, wherein the delivery mechanism comprises an expandable member and a piston-cylinder assembly operably coupled to the expandable member, wherein the piston-cylinder assembly comprises a piston slidably disposed in a cylinder, and wherein the piston-cylinder assembly is at least partially disposed in the expandable member;
wherein, upon swallowing of the device, the piston-cylinder assembly is oriented relative to the GI wall via the aligner such that a long axis of the piston-cylinder assembly is perpendicular to a surface of the GI wall; and
wherein the expandable member causes the piston to advance through the cylinder to deliver the therapeutic agent preparation into the GI wall.
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