Embodiments of the invention provide swallowable devices, preparations and methods for delivering drugs and other therapeutic agents within the GI tract. Many embodiments provide a swallowable device for delivering the agents. Particular embodiments provide a swallowable device such as a capsule for delivering drugs into the intestinal wall or other GI lumen. Embodiments also provide various drug preparations that are configured to be contained within the capsule, advanced from the capsule into the intestinal wall and degrade to release the drug into the bloodstream to produce a therapeutic effect. The preparation can be operably coupled to delivery means having a first configuration where the preparation is contained in the capsule and a second configuration where the preparation is advanced out of the capsule into the intestinal wall. Embodiments of the invention are particularly useful for the delivery of drugs which are poorly absorbed, tolerated and/or degraded within the GI tract.

Self-actuating articles including, for example, self-actuating needles and/or self-actuating biopsy punches, are generally provided. Advantageously, the self-actuating articles described herein may be useful as a general platform for delivery of a wide variety of pharmaceutical drugs that are typically delivered via injection directly into tissue due to degradation in the GI tract. The self-actuating articles described herein may also be used to deliver sensors and/or take biopsies without the need for an endoscopy. In some embodiments, the article comprises a spring (e.g., a coil spring, a beam, a material having particular mechanical recovery characteristics). Those of ordinary skill in the art would understand that the term spring is not intended to be limited to coil springs, but generally encompass any reversibly compressive material and/or component which, after releasing an applied compressive force on the material/component, the material/component substantially returns to an uncompressed length of the material/component (e.g., the within 95% of the length of the material/component prior to compression).

A drug delivery device for conducting a medical therapy includes a housing with an exit port opening, and an exit port assembly, where said exit port assembly includes a rigid exit port sealing holder and a soft exit port sealing, and provides both a fluid-tight closure of the exit port opening and a fluid-tight connection between the housing and the rigid exit port sealing holder.

A balloon catheter for treating, preventing, or reducing the recurrence of a stricture and/or cancer, or for treating benign prostatic hyperplasia (BPH), in a non-vascular body lumen; the ballon catheter comprising: An elongated balloon; a coating layer overlying an exterior surface of the balloon wherein the coating layer includes one or more water-soluble additives and an initial drug load of a therapeutic agent; and a length-control mechanism (600) which stretches and elongates the balloon during deflation, giving the balloon a smaller cross-sectional deflated profile for tracking through the body lumen and for removal after treatment.

Self-righting articles, such as self-righting capsules for administration to a subject, are generally provided. In some embodiments, the self-righting article may be configured such that the article may orient itself relative to a surface (e.g., a surface of a tissue of a subject). The self-righting articles described herein may comprise one or more tissue engaging surfaces configured to engage (e.g., interface with, inject into, anchor) with a surface (e.g., a surface of a tissue of a subject). In some embodiments, the self-righting article may have a particular shape and/or distribution of density (or mass) which, for example, enables the self-righting behavior of the article. In some embodiments, the self-righting article may comprise a tissue interfacing component and/or a pharmaceutical agent (e.g., for delivery of the active pharmaceutical agent to a location internal of the subject). In some cases, upon contact of the tissue with the tissue engaging surface of the article, the self-righting article may be configured to release one or more tissue interfacing components. In some cases, the tissue interfacing component is associated with a self-actuating component. For example, the self-righting article may comprise a self-actuating component configured, upon exposure to a fluid, to release the tissue interfacing component from the self-righting article. In some cases, the tissue interfacing component may comprise and/or be associated with the pharmaceutical agent (e.g., for delivery to a location internal to a subject).

Actuating components and related methods are generally disclosed. Certain embodiments comprise an actuating component associated with a plurality of microneedles (e.g., for administering a therapeutic agent to a subject). In some embodiments, the actuating component may be administered to a subject such that the plurality of microneedles are deployed at a location internal to the subject (e.g., in the gastrointestinal tract). The actuating component may be contained within, in some embodiments, a capsule (e.g., for oral administration to a subject). In some embodiments, the actuating component has a pre-deployment configuration in which the plurality of microneedles have a first orientation and a deployed configuration in which the plurality of microneedles have a second orientation, different than the first orientation.

An ingestible capsule includes a housing forming a cavity and having a textured outer surface. The textured outer surface forms a helical depression and a plurality of protruding studs disposed in the helical depression. The capsule further includes a therapeutic agent disposed in or on the housing. The capsule also includes a biodegradable coating on the textured outer surface of the housing, the biodegradable coating configured to dissolve in a fluid having a pH of 1.5 to 9.

Various embodiments disclosed relate to drug-coated balloon catheters for treating, preventing, or reducing the recurrence of a stricture and/or cancer, or for treating benign prostatic hyperplasia (BPH), in a non-vascular body lumen and methods of using the same. A drug-coated balloon catheter for delivering a therapeutic agent to a target site of a body lumen stricture includes an elongated balloon having a main diameter. The balloon catheter includes a coating layer overlying an exterior surface of the balloon. The coating layer includes one or more water-soluble additives and an initial drug load of a therapeutic agent. In some embodiments, the balloon catheter includes a length-control mechanism which stretches and elongates the balloon when it is in a deflated state, giving the balloon a smaller cross-sectional deflated profile for tracking through the body lumen and for removal after treatment.

This disclosure features methods and devices for treating diseases with orally-delivered biotherapeutics.

The invention relates to a vacuum treatment array having at least one open-pored contact element, by way of which a negative pressure and/or suction can be generated in a body cavity, wherein the open-pored contact element is configured, at least in sections, in the manner of a tube, having an outer and/or inner boundary surface rotating around a tube axis, at least in part.