Methods and articles for delivering viable cells into solid tissue

Inventors

Imran, Mir • Harris, Joel

Assignees

Incube Laboratories LLC

Abstract

Embodiments provide swallowable devices, preparations and methods for delivering viable cells (VC) into the GI tract including GI wall tissue or other tissue site. Particular embodiments provide a swallowable device such as a capsule for delivering VC into an intestinal wall or other site. The VC can be contained within a tissue-penetrating shell disposed in the capsule that protects the VC as they pass through the GI tract until they are inserted into GI tract tissue or other location. The shell desirably has shape, size and material consistency to be contained in a swallowable capsule, delivered from the capsule into solid tissue by the application of force on the shell and biodegrade within the solid tissue to release the VC into the tissue. Within the shell or other structure the VC can be maintained in a viability-sustaining gel that preserves the viability of the VC for selected time periods.

Core Innovation

The patent describes orally delivering viable cells to intestinal tissue using a swallowable drug delivery device that contains a tissue penetrating article and a mass of viable cells. The article passes through the gastrointestinal tract with the article intact while the cells remain viable, and the device releases the article in response to a condition in the intestine. After release, the article is propelled to penetrate into the intestinal tissue to release the cells or substances produced by the cells.

To maintain viability during gastrointestinal transit, the viable cells are protected within a tissue penetrating biodegradable shell and optionally maintained in a viability-sustaining gel. The cells can also be provided in a suspended reanimatable state so that the cells remain viable during transit and are reanimated after delivery.

Release and penetration are enabled by enteric-protected, pH-sensitive triggering components and tissue-penetrating structures, including pH-triggered valve or coating degradation and propulsion mechanisms such as deployment balloons, aligner/delivery balloons, and chemically generated gas expansion. The delivery platform can include tissue-penetrating articles with fenestrations for fluid and molecule exchange and echogenic acoustic markers for localization by ultrasonic imaging.

The patent also describes alternative delivery mechanisms for propelling tissue penetration, including piston-cylinder and needle delivery concepts and balloon puncture or deflation controls with sequenced inflation valves. The overall system uses a combination of viability protection, intestine-triggered release, and penetration propulsion to deliver viable cells and/or cell-produced substances into intestinal tissue.

Claims Coverage

The provided document includes two independent claims (clm-00001 and clm-00035). Across them, the claim set centers on four inventive elements: an orally swallowed drug delivery device that retains a tissue-penetrating article intact through the gastrointestinal tract, intestinal-condition-triggered release, propulsion for penetration into intestinal tissue, and release of viable cells or substances produced by the cells, with clm-00035 further requiring a suspended reanimatable state and reanimation by conditions in the patient’s body.

Both independent claims require an orally swallowed device with an intact tissue-penetrating article that preserves cell viability through gastrointestinal transit, followed by release in response to an intestinal condition and propulsion to penetrate intestinal tissue for cell/substance release. The second independent claim additionally requires cells in a suspended reanimatable state and reanimation in the patient’s body.

Stated Advantages

Documented Applications