Abstract: A lead device is provided for a medical treatment apparatus, where the lead device includes protruding anchoring mechanisms for anchoring the lead device in tissue. The anchoring mechanism include permanent anchoring mechanisms, or a combination of permanent and dissolvable anchoring mechanisms, to anchor the device in tissue. The anchoring mechanism resists migration of the lead device in at least one or both axial directions.

Abstract: Embodiments provide methods and apparatus for manufacturing a microtablet from a precursor material such as a pharmaceutical powder. Various embodiments provide a method which includes compressing the powder to form a compressed mass of a selected density and repeatedly compacting the compressed mass to increase the density of the compressed mass and form a microtablet. Related methods and apparatus are provided.

Abstract: A lead device is provided for a medical treatment apparatus, where the lead device includes mechanisms for anchoring the lead device in tissue.

Abstract: Embodiments of the invention provide apparatus, systems and methods for stimulating tissue in the urinary tract to initiate or facilitate urination. One embodiment provides an external urinary sphincter stimulation (EUSS) catheter for stimulating the external urinary sphincter (EUS), where the EUSS catheter includes nerve stimulation electrodes (NSES) for delivering current to nerves within or around the EUS in order to relax the EUS prior to urination. Other embodiments provide a system for stimulating the EUS including the EUSS catheter and a controller operatively coupled to the EUSS catheter, where the controller includes a pulse generator for delivering current to the NSES. Other embodiments provide methods for positioning the EUSS catheter in the patient's body including in the EUS using a urethral approach. Embodiments of the invention are particularly useful for initiating and/or controlling urination for patients who have lost the ability to voluntarily urinate due to neurogenic bladder dysfunction.

Abstract: Various embodiments of the invention provide methods of treating diabetes and other glucose regulation disorders. In one embodiment, the method comprises removing L-cells from a donor, obtaining stem cells from a patient, and culturing the L-cells in the presence of the stem cells under conditions such that the stem cells differentiate into stem cell-derived L-cells (SCDLC). An amount of the SCDLC is introduced into the patient sufficient to cause a lowering of the patient's blood glucose level after ingestion of food. In another embodiment, the method comprises removing K-cells from a donor, obtaining stem cells from a patient, and culturing the K-cells in the presence of the stem cells under conditions such that the stem cells differentiate into stem cell-derived K-cells (SCDKC). An amount of the SCDKC is introduced into the patient sufficient to cause a lowering of the patient's blood glucose level after ingestion of food.

Abstract: Embodiments of the invention provide multi-stage biodegradable drug delivery platforms and methods for the subcutaneous delivery of therapeutic agents (TA). Embodiments of the platform may be configured to subcutaneously deliver a first dose of a first TA which is absorbed into the body and/or blood stream (BBS) to produce a first therapeutic effect for a first selectable time period (STP), and subsequently after a second STP, deliver a second dose of a second TA which is absorbed into the BBS to produce a second therapeutic effect for a third STP. An embodiment of the platform may comprise a body having a tissue-penetrating end, a primary cavity having a first TA dose and a shell having a secondary cavity having a second TA dose. The first TA dose is released after the first STP and the second TA dose is released after the second STP by biodegradation of the shell.

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 stimulating tissue in the urinary tract to initiate or facilitate urination. One embodiment provides an external urinary sphincter stimulation (EUSS) catheter for stimulating the external urinary sphincter (EUS), where the EUSS catheter includes nerve stimulation electrodes (NSES) for delivering current to nerves within or around the EUS in order to relax the EUS prior to urination. Other embodiments provide a system for stimulating the EUS including the EUSS catheter and a controller operatively coupled to the EUSS catheter, where the controller includes a pulse generator for delivering current to the NSES. Other embodiments provide methods for positioning the EUSS catheter in the patient's body including in the EUS using a urethral approach. Embodiments of the invention are particularly useful for initiating and/or controlling urination for patients who have lost the ability to voluntarily urinate due to neurogenic bladder dysfunction.

Abstract: A bladder fullness monitoring systems includes a controller and an active optical sensor that is affixed to a patient's bladder. The sensor emits light onto the bladder and further detects light reflected from the bladder, in order to generate an output signal that indicates an amount of emitted light was reflected back to the detector. The controller is coupled to the optical sensor to receive and interpret the output signals, e.g., to determine when the bladder is full. The controller may be operatively coupled to a urinary control apparatus which uses the output signals to trigger urination in patients who have lost the ability to voluntarily urinate. Embodiments are particularly useful for monitoring bladder fullness in patients who have lost bladder sensation and/or the ability to voluntary urinate and rely on a urinary control apparatus in order to urinate.

Abstract: Embodiments provide methods and apparatus for manufacturing a microtablet from a precursor material such as a pharmaceutical powder. Various embodiments provide a method which includes compressing the powder to form a compressed mass of a selected density and repeatedly compacting the compressed mass to increase the density of the compressed mass and form a microtablet. Related methods and apparatus are provided.

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 compositions including bio degradable polymers, medical implants fabricated from these compositions and methods of using such implants. Many embodiments provide medical implants comprising a first polymer backbone having a first rate of biodegradation and a second polymer backbone having a second rate of biodegradation faster than the first rate. In some embodiments, the second backbone is configured to be replaced by a natural tissue layer. The first backbone provides a scaffold for the implant while the second backbone degrades. This scaffold can enhance mechanical properties of the implant including various aspects of mechanical strength such as tensile, bending, hoop and yield strength; and elasticity. The scaffold also serves to maintain a minimum level of structural support of the implant during the period of degradation of the second backbone or for the entire life of the implant so that the implant does not mechanically fail.

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: 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 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 system for controlling urination in a patient includes an implantable controller and an external device. The implantable controller includes circuitry and electrodes for stimulating the pudenal nerves in order to control urination. In addition, the implantable controller includes sensors for determining information on bladder fullness and for transmitting such information to an external device which is used for controlling the implanted controller. The external device will display when bladder filling exceeds a safe threshold level, allowing the patient and a caregiver to take appropriate steps to allow the patient to urinate.

Abstract: Embodiments of the invention provide shaped masses comprising one or more drugs such as proteins or polypeptides and methods for forming such shaped masses. One embodiment provides a shaped mass comprising a drug such as a protein or polypeptide having a biological activity in the body of a mammal. The shaped mass is formed by compression of a precursor material comprising the drug wherein an amount of biologically active drug in the mass is a preserved above a minimum level. Drugs which may be incorporated into the shaped mass may include one or more glucose regulating proteins such as insulin, incretins; and immunoglobulins such as TNF-inhibiting antibodies or interleukin neutralizing antibodies. Embodiments of the shaped mass may be incorporated into a tissue penetrating member which is inserted into the intestinal wall allowing for the oral delivery of proteins and peptides which would otherwise be degraded in the intestinal tract.

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: An embodiment of a system includes a power source and at least two electrode assembles. The power source that an output current that alternates between a maximum current value and a minimum current value; a pair of electrode assemblies. Each electrode assembly is configured to be held in contact with a skin layer of a user. Additionally, each electrode assembly includes an electrode that is coupled to the power source to receive the output current from the power source. At least one of the electrode assemblies in the pair includes a medium that carries an active agent having a charge, the medium being provided on the at least one electrode assembly to enable the output current to repel the active agent into the skin layer for a duration in which the output current has a polarity that is the same as a polarity of the active agent.