Abstract: Intravesical devices are provided that are wholly deployable within the bladder of a patient in need of treatment and are well tolerated by the patient. The device may include an elastic body having a retention shape having (i) dimensions that provide intravesical mobility and that prevent voiding of the medical device through the urethra, and (ii) dimensions, buoyancy, or both, that exclude the medical device from entering the orifices of the ureters. The elastic body may exert a maximum acting force less than 1N when compressed to a shape with a maximum dimension in any dimension of 3 cm. The device may include a drug for controlled release within the bladder, for treatment of the bladder or a regional tissue. Methods of treatment are also provided that include selecting a patient in need of treatment in the bladder where tolerability of the treatment is a primary concern.

Abstract: An implantable medical device is provided for controlled drug delivery within the bladder, or other body vesicle. The device may include at least one drug reservoir component comprising a drug; and a vesicle retention frame which comprises an elastic wire having a first end, an opposing second end, and an intermediate region therebetween, wherein the drug reservoir component is attached to the intermediate region of the vesicle retention frame. The retention frame prevents accidental voiding of the device from the bladder, and it preferably has a spring constant selected for the device to effectively stay in the bladder during urination while minimizing the irritation of the bladder.

Abstract: An implantable medical device is provided for controlled drug delivery within the bladder, or other body vesicle. The device may include at least one drug reservoir component comprising a drug; and a vesicle retention frame which comprises an elastic wire having a first end, an opposing second end, and an intermediate region therebetween, wherein the drug reservoir component is attached to the intermediate region of the vesicle retention frame. The retention frame prevents accidental voiding of the device from the bladder, and it preferably has a spring constant selected for the device to effectively stay in the bladder during urination while minimizing the irritation of the bladder.

Abstract: Provided are formulations and methods for treating one or more genitourinary conditions. The formulations may include a therapeutic agent that includes a calcium channel blocker, a rho kinase inhibitor, or a combination thereof. The methods may include locally administering a therapeutic agent into a ureter. Systems for delivering a therapeutic agent also are provided.

Abstract: A medical probe for guided insertion into soft tissue, such as the brain, is disclosed. The medical probe may include a flexible, elongated body having a proximal end portion and an opposed distal end portion. The elongated body has a length of at least 1 cm and an outer diameter of 80 ?m or less. The distal end portion may comprise a beveled tip such that the distal end portion of the medical probe can be steered independently to a target site in the soft tissue.

Abstract: Provided are formulations and methods for treating one or more genitourinary conditions. The formulations may include a therapeutic agent that includes a calcium channel blocker, a rho kinase inhibitor, or a combination thereof. The methods may include locally administering a therapeutic agent into a ureter. Systems for delivering a therapeutic agent also are provided.

Abstract: The invention features methods for detecting the hydration state or vascular volume of a subject using a device capable of nuclear magnetic resonance (NMR) measurement. The methods involve exposing a portion of a tissue of the subject in vivo to a magnetic field and RF pulse from the device to excite hydrogen nuclei of water within the tissue portion, and measuring a relaxation parameter of the hydrogen nuclei in the tissue portion, the relaxation parameter being a quantitative measure of the hydration state or vascular volume of the subject as a whole. The invention also features devices and computer-readable storage media for performing the methods of the invention.

Abstract: Devices and methods are provided for non-invasive sensing of tissue fluid distribution in a patient. The device includes one or more magnets configured to provide a static magnetic field source; one or more RF transmitter coils connected to a pulse sequence generator which are configured to apply a varying magnetic field to tissues of the patient; one or more RF receiver coils configured to detect a magnetic field generated within tissues of the patient; and a signal acquisition and processor system configured to acquire signals from the RF receiver coils and perform an NMR measurement of a relaxation parameter of hydrogen nuclei within a muscle tissue site of the patient. A single-sided MR sensor device may include permanent magnets arranged in a unilateral linear Halbach array; and RF coils and a processor which are configured to produce a depth-resolved, diffusion-weighted, multicomponent T2 relaxometry measurements of intramuscular fluid shifts in a patient.

Abstract: The invention features methods for detecting the hydration state or vascular volume of a subject using a device capable of nuclear magnetic resonance (NMR) measurement. The methods involve exposing a portion of a tissue of the subject in vivo to a magnetic field and RF pulse from the device to excite hydrogen nuclei of water within the tissue portion, and measuring a relaxation parameter of the hydrogen nuclei in the tissue portion, the relaxation parameter being a quantitative measure of the hydration state or vascular volume of the subject as a whole. The invention also features devices and computer-readable storage media for performing the methods of the invention.

Abstract: Methods for assessing steatosis and fibrosis in a patient's liver include (i) measuring a diffusion-weighted relaxometry signal of the liver, or portion thereof; and determining a fibrosis content of the liver or portion thereof based on the measured diffusion-weighted relaxometry signal, or (ii) measuring a relaxometry signal of the liver, or portion thereof; and determining a fat content of the liver or portion thereof based on the measured relaxometry signal. A system for such non-invasive sensing includes a static magnetic field source; RF transmitter coils connected to a pulse sequence generator; RF receiver coils configured to detect a magnetic field generated within liver tissues; and a signal acquisition and processor system configured to acquire signals from the RF receiver coils and perform a relaxation time (T2) relaxometry measurement, wherein the RF transmitter coils and pulse sequence generator are configured to apply a varying magnetic field to the liver tissues.

Abstract: Implantable devices and methods for delivery of lidocaine or other drugs to a patient are provided. In one embodiment, the device includes a first drug portion which has a first drug housing which contains a first drug formulation in a solid form which includes a pharmaceutically acceptable salt of lidocaine; and a second drug portion which includes a second drug housing which contains a second drug formulation which includes lidocaine base. In another embodiment, the device includes a drug reservoir component which has an elastic tube having at least one lumen bounded by a porous sidewall having an open-cell structure, a closed-cell structure, or a combination thereof; and a drug formulation contained within the at least one lumen, wherein the device is deformable between a low-profile deployment shape and a relatively expanded retention shape.

Abstract: Implantable devices and methods for delivery of lidocaine or other drugs to a patient are provided. In one embodiment, the device includes a first drug portion which has a first drug housing which contains a first drug formulation in a solid form which includes a pharmaceutically acceptable salt of lidocaine; and a second drug portion which includes a second drug housing which contains a second drug formulation which includes lidocaine base. In another embodiment, the device includes a drug reservoir component which has an elastic tube having at least one lumen bounded by a porous sidewall having an open-cell structure, a closed-cell structure, or a combination thereof; and a drug formulation contained within the at least one lumen, wherein the device is deformable between a low-profile deployment shape and a relatively expanded retention shape.

Abstract: Intravesical devices are provided that are wholly deployable within the bladder of a patient in need of treatment and are well tolerated by the patient. The device may include an elastic body having a retention shape having (i) dimensions that provide intravesical mobility and that prevent voiding of the medical device through the urethra, and (ii) dimensions, buoyancy, or both, that exclude the medical device from entering the orifices of the ureters. The elastic body may exert a maximum acting force less than 1N when compressed to a shape with a maximum dimension in any dimension of 3 cm. The device may include a drug for controlled release within the bladder, for treatment of the bladder or a regional tissue. Methods of treatment are also provided that include selecting a patient in need of treatment in the bladder where tolerability of the treatment is a primary concern.

Abstract: Intravesical devices are provided that are wholly deployable within the bladder of a patient in need of treatment and are well tolerated by the patient. The device may include an elastic body having a retention shape having (i) dimensions that provide intravesical mobility and that prevent voiding of the medical device through the urethra, and (ii) dimensions, buoyancy, or both, that exclude the medical device from entering the orifices of the ureters. The elastic body may exert a maximum acting force less than 1N when compressed to a shape with a maximum dimension in any dimension of 3 cm. The device may include a drug for controlled release within the bladder, for treatment of the bladder or a regional tissue. Methods of treatment are also provided that include selecting a patient in need of treatment in the bladder where tolerability of the treatment is a primary concern.

Abstract: Urodynamic assessment systems, intravesical devices, and methods of their use are provided. In one embodiment, an intravesical device includes an elastic body including an elongated tube defining a reservoir lumen, and a sensor disposed at least partially in the reservoir lumen and configured to measure or detect one or more parameters. The intravesical device is deformable between a deployment shape for passage of the intravesical device through the urethra into the bladder and a retention shape for preventing voiding of the intravesical device through the urethra.

Abstract: Abstract of the Disclosure Implantable drug delivery devices and methods of making and using the same are provided. The implantable drug delivery devices permit selective activation and deactivation of drug delivery while subcutaneously implanted in a patient without the use of electronic equipment or power. The devices include a bistable member that has two stable states. In a first stable state, the bistable member does not close off a fluidic pathway between a drug reservoir and a drug release aperture, thereby allowing drug release from the device. In a second stable state, the bistable member closes off or narrows the fluidic pathway, thereby reducing or preventing drug release from the device. A patient or another person can reversibly change the bistable member between the first and second stable states by applying pressure on the patient's skin over the site of implantation and/or manipulating the device through the patient's skin at the site of implantation.

Abstract: Systems, devices, and methods are provided for delivering chemical and electrical stimulation across one or more neural circuits. The systems, devices, and methods can also be used for sensing and recording specific neural activity. In certain embodiments, a system includes first and second fluid reservoirs, a manifold, and a delivery tube. The manifold may include first and second chambers therein. The first chamber may be in fluid communication with the first reservoir, and the second chamber may be in fluid communication with the second reservoir. The delivery tube may include a first conduit in fluid communication with the first chamber, a second conduit in fluid communication with the second chamber, and a third conduit configured to house an electrode therein. In this manner, a distal tip of the delivery tube is configured to be positionable adjacent to the one or more neural circuits for providing chemical and electrical stimulation thereto.

Abstract: One aspect of the invention provides a device for delivering material into a biological tissue. The device includes: a reservoir for the material; and a material delivery unit in connection with the reservoir configured to transfer the material from the reservoir to the tissue. Another aspect of the invention provides an implantable or insertable delivery device for delivery of material across or into a biological tissue in a subject. The device includes: a reservoir for holding the material; and a tissue-penetrating member.

Abstract: A sensor is provided for measuring a dissolved oxygen concentration in vivo when implanted at a tissue site and in ex vivo applications. The sensor includes an article comprising a sensing medium retained within the implantable article by an oxygen-permeable material. The sensing medium comprises an MR contrast agent for oxygen. The sensor is configured to indicate the dissolved oxygen concentration of a fluid, e.g., in vivo at the tissue site, when subjected to an MR-based method.

Abstract: One aspect of the invention provides an apparatus for isolating one or more subcellular components including a cell disruption reservoir that generates at least one of a phase change, a thermal change, a physical contact force, an ultrasonic frequency, an osmotic change, a pressure change, a photothermal pulse, a magnetic field, an electromagnetic field, an electric field, and an electrical pulse through the reservoir and a separation instrument configured to specifically isolate the subcellular components based on one or more parameters selected from at least one of density, charge/pH, dielectric polarization, magnetic attraction, spectral dispersion, spectral refraction, spectral diffraction, hydrophobicity, hydrophilicity, structure (presence or absence of a structural feature), function (migration), affinity or binding, and pressure.