Abstract: 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.

Abstract: 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.

Abstract: A device includes an inflatable balloon, a reservoir disposed within the inflatable balloon, a needle compartment attached to the balloon and to the reservoir, an injection needle disposed within the needle compartment, and an inflation mechanism. The reservoir contains a therapeutic preparation. The inflation mechanism is structured to inflate the balloon, and upon inflation, the injection needle is structured to enter the reservoir. A method includes making an autoinjector available to a subject with instructions to ingest the autoinjector. The autoinjector is structured to inject a therapeutic preparation into a wall of a gastrointestinal tract of the subject responsive to ingestion of the autoinjector. The autoinjector includes an injection needle disposed in a needle compartment attached to a reservoir. The injection needle is initially separated from the reservoir, and is structured to enter the reservoir for delivery of the fluid therapeutic preparation through the needle into the wall.

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.

Abstract: Embodiments of the invention provide devices and systems to monitor fullness of a patient's bladder. One embodiment of a bladder fullness (BF) measure system comprises a sensor device (SD) and a controller. The SD generates an output signal (OS) based on the force exerted by the bladder against SD the wherein the OS corresponds to a degree of BF. The SD may be attached to the bladder wall or adjoining tissue and positioned between the bladder and the pubic bone such that the SD is not affected by tissues force other than that from the bladder. The controller connects to the SD and causes an associated implant to perform a function when the SD output signal exceeds a predetermined threshold. Embodiments are particularly useful for providing information on BF to patients suffering from spinal injury or other conditions whereby they have lost the ability to sense BF and/or voluntarily urinate.

Abstract: 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.

Abstract: A catheter for measuring pressure in the urinary tract of a patient includes a catheter body having a proximal and distal end. A plurality of lumens is formed in the catheter body, and an adaptor is coupled to the proximal end of the catheter body. The adaptor includes a port for each lumen. A first pressure sensor, typically including a balloon, is fluidically coupled to a first lumen and is configured and positioned to measure pressure in a urethra of the patient. A second pressure sensor, also typically including a balloon, is fluidically coupled to a second lumen and is configured and positioned on the catheter body to measure pressure in a bladder of the patient. An expandable retention member, which may be coupled to a third lumen, is positioned on the catheter body between the first and second expandable pressure sensors so that the catheter body may be retained at a selected location in the urinary tract to properly position the fluid pressure sensors in the bladder and urethra, respectively.

Abstract: A delivery device may include a capsule housing, at least one tissue penetrating member in a sealed compartment in the capsule housing, wherein the at least one tissue penetrating member is configured to release a payload, and an actuator in the capsule housing and at least partially outside the sealed compartment, wherein the actuator is configured to advance the at least one tissue penetrating member out of the sealed compartment.

Abstract: 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.

Abstract: An illustrative drug delivery system implantable in a recipient may include a connection assembly, a source catheter, and a microcatheter. A proximal end portion of the source catheter may be configured to be fluidically connected to a fluid source configured to provide a fluid (e.g., a neurotherapeutic drug). A distal end portion of the source catheter may be configured to be fluidically connected to the connection assembly. The microcatheter may include a proximal end portion configured to be fluidically connected to the connection assembly and a distal end portion comprising an elution opening configured to elute the fluid to a target location (e.g., a brain) within a recipient. The fluid source may be configured to provide the fluid to the target location by way of the source catheter, the connection assembly, and the microcatheter.

Abstract: Embodiments of the invention provide swallowable devices, preparations and methods for delivering therapeutic agents within the GI tract such as neutralizing proteins (NP) particularly antibodies which neutralize interleukins. Many embodiments provide a swallowable device e.g., a capsule for delivering various agents into the intestinal wall (IW). Embodiments also provide agent preparations that are configured to be contained within the capsule, advanced from the capsule into the IW and degrade to release the agent 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 IW.

Abstract: Embodiments provide devices, preparations and methods for delivering therapeutic agents (TAs) such as clotting factors (CFs, e.g., Factor 8) within the GI tract. Many embodiments provide a swallowable device e.g., a capsule for delivering TAs into the intestinal wall (IW). Embodiments also provide TA preparations configured to be contained within the capsule, advanced from the capsule into the IW and/or surrounding tissue (ST) and degrade to release the TA into the bloodstream to produce a therapeutic effect (e.g., improved clotting). 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 IW or ST (e.g., the peritoneal cavity). Embodiments are particularly useful for delivery of CFs for treatment of clotting disorders (e.g., hemophilia) where such CFs are poorly absorbed and/or degraded within the GI tract.

Abstract: An apparatus is provided for remotely powering an implantable medical device (IMD) positioned at a target treatment location within a patient. The apparatus is configured to be positioned at or near an external skin surface of the patient in proximity to the target treatment location. The apparatus includes an induction coil which, when placed in proximity to the IMD, forms an inductive transcutaneous power link with the IMD such that when the induction coil is supplied with a current, the induction coil inductively and transcutaneously delivers power to the IMD. An aerogel layer is disposed between the induction coil and the patient's skin surface. The aerogel layer is configured to receive heat generated from the induction coil and regulate heat dissipation from the aerogel layer to minimize heat transfer to the patient.

Abstract: This application relates to cell delivery articles and methods for delivering cells into the body in a manner that allows them to incorporate into surrounding tissue and express cell products. The cell delivery articles are generally capable of maintaining viability of the cells for a period of time that allows such incorporation to occur. Additionally, a cell delivery article may include a bio-ghost coating that prevents the cell delivery article from being recognized by the immune system, and/or minimizes or prevents development of fibrotic tissue which can interfere with nutrients and oxygen entering the cell delivery article and reaching the cells. A cell delivery article may be formulated for delivery by various routes of administration.

Abstract: Embodiments of the invention provide apparatus and methods for stimulating L cells in the intestinal tract to produce incretins for the treatment of conditions including diabetes and obesity. Many embodiments provide a method and apparatus for the treatment of diabetes by electrically stimulating L-cells to secrete incretins to stimulate or otherwise modulate the production of insulin. Particular embodiments provide a swallowable capsule for stimulating L-cells in the intestinal tract as the capsule moves through the tract. The capsule can include two or more electrodes for providing electrical stimulation to L-cells, a power source for powering one or more components of the capsule, a sensor for sensing the location of the capsule in the intestinal tract: a controller and a waveform generator for generating the electrical signals emitted by the electrodes to stimulate the L-cells to secrete incretins such as GLP-1 to stimulate insulin production for glucose regulation of diabetic conditions.

Abstract: Embodiments of the invention provide apparatus, systems and methods for facilitating introduction of a urinary drainage catheter (UDC) into the urinary tract (UT). One embodiment provides a UDC including electrodes for delivering high frequency current to a patient's pudendal nerves to relax the urinary sphincter (US) before passing the UDC therethrough so as reduce the resistance force on the UDC and discomfort to the patient. The electrodes can comprise at least one pair of bipolar electrodes and may be flexible so as to bend and flex within the urethra. The UDC includes one or more lumens including a drainage lumen and an inflation lumen for inflating an anchoring device on the UDC. The UDC can include a pressure sensor to assess relaxation of the US. The UDC may include a second set of electrodes and irrigation lumen for relaxing the US and flushing the urethra with the UDC in place.

Abstract: A catheter for measuring pressure in the urinary tract of a patient includes a catheter body having a proximal and distal end. A plurality of lumens is formed in the catheter body, and an adaptor is coupled to the proximal end of the catheter body. The adaptor includes a port for each lumen. A first pressure sensor, typically including a balloon, is fluidically coupled to a first lumen and is configured and positioned to measure pressure in a urethra of the patient. A second pressure sensor, also typically including a balloon, is fluidically coupled to a second lumen and is configured and positioned on the catheter body to measure pressure in a bladder of the patient. An expandable retention member, which may be coupled to a third lumen, is positioned on the catheter body between the first and second expandable pressure sensors so that the catheter body may be retained at a selected location in the urinary tract to properly position the fluid pressure sensors in the bladder and urethra, respectively.

Abstract: 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.

Abstract: Embodiments of the invention provide swallowable devices, preparations and methods for delivering drugs and other therapeutic agents within the GI tract. Some embodiments provide a swallowable device such as a capsule for delivering drugs into the intestinal wall or other GI lumen. The device comprises a capsule sized to be swallowed and pass through the intestinal tract. The capsule can include at least one guide tube, one or more tissue penetrating members positioned in the guide tube, a delivery member, an actuating mechanism and a release element. The release element degrades upon exposure to various conditions in the intestine so as to release and actuate the actuating mechanism. Embodiments of the invention are particularly useful for the delivery of drugs which are poorly absorbed, tolerated and/or degraded within the GI tract.

Abstract: Embodiments provide devices, preparations and methods for delivering therapeutic agents (TAs) such as clotting factors (CFs, e.g., Factor 8) within the GI tract. Many embodiments provide a swallowable device e.g., a capsule for delivering TAs into the intestinal wall (IW). Embodiments also provide TA preparations configured to be contained within the capsule, advanced from the capsule into the IW and/or surrounding tissue (ST) and degrade to release the TA into the bloodstream to produce a therapeutic effect (e.g., improved clotting). 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 IW or ST (e.g., the peritoneal cavity). Embodiments are particularly useful for delivery of CFs for treatment of clotting disorders (e.g., hemophilia) where such CFs are poorly absorbed and/or degraded within the GI tract.