Abstract: An osmotic delivery system flow modulator includes an outer shell constructed and arranged for positioning in an opening, an inner core inserted in the outer shell, and a fluid channel having a spiral shape defined between the outer shell and the inner core. The fluid channel is adapted for delivery of an active agent formulation from the reservoir of the osmotic delivery system.

Abstract: An osmotic patch pump may include a dry agent on a die-cut piece of film that may exert an osmotic pressure when dissolved by a fluid. A chamber may contain the dry agent and have a chamber wall made of a semi-permeable membrane that allows fluid to enter the chamber through the membrane, but does not allow dissolved agent to escape from the chamber through the membrane. A sponge may have a surface in contact with an outer surface of the semi-permeable membrane and may be configured to soak up fluid when placed in contact with the sponge. Flow volume and rate may be controlled by user-operated micro valves. The chamber and fluid communication channels may be embossed on a substrate as part of a simple and low cost manufacturing process.

Abstract: A medical device comprising a pressure generating means adapted to deliver a liquid, a sensor adapted to measure a flow resistance, and an implantable member comprising an analyte responsive porous membrane which reversibly changes its porosity subject to changes in analyte concentration occurring in the solution surrounding the implantable member. The analyte may in particular be glucose. The medical device may also be used for drug administration.

Abstract: The present disclosure relates, according to some embodiments, to compositions, methods, devices, and systems for delivering a composition (e.g., a fluid composition) to a subject. For example, the present disclosure relates to non-gassing, direct current (DC), electro-osmotic pumps in some embodiments. A pump may comprise an anode (e.g., a porous silver/silver oxide anode), a cathode (e.g., a porous silver/silver oxide cathode), and a membrane (e.g., a porous ceramic membrane) positioned at least partially between the anode and the cathode in some embodiments. A pump system may comprise an electro-osmotic pump, a reservoir comprising a pump fluid chamber in fluid communication with the electro-osmotic pump and a delivery fluid chamber in fluid communication with the electro-osmotic pump; a controller assembly in electrical communication with the anode and the cathode; and a cannula and/or a needle in fluid communication with the delivery fluid chamber.

Abstract: An osmotic delivery system flow modulator includes an outer shell constructed and arranged for positioning in an opening, an inner core inserted in the outer shell, and a fluid channel having a spiral shape defined between the outer shell and the inner core. The fluid channel is adapted for delivery of an active agent formulation from the reservoir of the osmotic delivery system.

Abstract: This invention relates to a method of delivering ophthalmic drugs, specifically prostaglandins and prostamides. This method may also be applied to other types of intraocular pressure (IOP)-lowering drugs (e.g. carbonic anhydrase inhibitors, beta blockers, alpha-adrenergic agonists, and parasympathomimetics) as well as other types of ophthalmic drugs for other indications (e.g. dry eye, inflammation, and infection).

Abstract: A fluid delivery device can be used to deliver fluid within a living body. The fluid delivery device includes an electrochemical pump, a reservoir, a displaceable member, and a diffuse membrane. The electrochemical pump transports water and includes an electrochemical pump product chamber to retain water transported by the electrochemical pump. The reservoir contains a fluid to be delivered. The displaceable member is positioned between the electrochemical pump product chamber and the reservoir. The displaceable member is responsive to the electrochemical pump transporting water into the electrochemical pump product chamber. The diffuse membrane generates increased pressure within the electrochemical pump product chamber.

Abstract: An implantable delivery device including a housing, a port assembly, and a plurality of grooves. The housing includes an outer wall defining an exterior face. The port assembly includes a septum and a port opening that is exteriorly open relative to the housing face. The plurality of grooves are formed in the exterior face proximate the port opening, and are sized to receive a needle tip to guide the needle tip toward the port opening. In one embodiment, the port assembly is fluidly connected to a reservoir, such that the port assembly constitutes a reservoir refill port.

Abstract: An apparatus for delivering a bolus of a medical agent to a patient. The apparatus comprises a pump mechanism, a data input device, and a processor in data communication with the keypad and arranged to control the pump mechanism. The processor is programmed to receive data specifying a bolus amount through the data port, receive data regarding duration through the data port, receive a percentage through the data port, the percentage defining a portion of the bolus amount to deliver immediately upon executing a deliver command and a remainder of the bolus amount to deliver over the duration upon executing a deliver command, and execute the deliver command thereby controlling the pump mechanism to deliver the bolus. Also a method of temporarily adjusting the delivery rate of an infusion pump. The infusion pump is programmed to deliver a basal rate.

Abstract: The present invention relates to osmotic delivery devices, formulations, and methods for delivery of two or more beneficial agents. In one aspect, the present invention provides osmotic delivery devices useful for substantially concurrent administration of two or more beneficial agents. In another aspect, the present invention provides beneficial agent formulations for use in the osmotic delivery devices. The formulations include formulations wherein beneficial agents are soluble in the vehicle, suspension formulations comprising particle formulations of one or more beneficial agent, and combinations thereof. Further, methods for treatment of a variety of diseases or conditions using two or more beneficial agents are disclosed, wherein the methods are preferably practiced using the osmotic delivery devices and/or formulations of the invention.

Abstract: An implant comprising a body (1), at least one active pharmaceutical substance (4) and an element (5, 15, 35, 45, 55) deflectable in relation to the body, serving to release the at least one active pharmaceutical substance (4) during or after an external excitation of the deflection. Also disclosed is a system of such an implant and an excitation device (30, 70).

Abstract: An osmotic pump includes a plurality of agent reservoirs; first and second solute chambers; a semi-permeable membrane separating the first and second solute chambers from one another; a flexible membrane separating a first one of the agent reservoirs from the first solute chamber; and a plurality of valves. Each of the valves is moveable between an open position in which a corresponding one of the agent reservoirs is open to an outlet of the pump and a closed position in which the corresponding one of the agent reservoirs is sealed with respect to the pump outlet.

Abstract: Highly concentrated drug particle formulations are described, wherein the drug comprises between about 25 wt % and 80 wt % of the particle formulation. The particle formulations of the present invention comprise, for example, macromolecules, such as proteins and/or small molecules (such as steroid hormones). The particle formulation typically further includes one or more additional component, for example, one or more stabilizer (e.g., carbohydrates, antioxidants, amino acids, and buffers). Such concentrated particle formulations can be combined with a suspension vehicle to form suspension formulations. The suspension formulation comprises (i) a non-aqueous, single-phase vehicle, comprising one or more polymer and one or more one solvent, wherein the vehicle exhibits viscous fluid characteristics, and (ii) a highly concentrated drug particle formulation. Devices for delivering the suspension formulations and methods of use are also described.

Abstract: A system to minimize fluid turbulence inside a tissue cavity during endoscopic procedures. A body tissue cavity of a subject is distended by continuous flow irrigation using a solenoid operated pump on the inflow side and a positive displacement pump, such as a peristaltic pump, on the outflow side, such that the amplitude of the pressure pulsations created by the outflow positive displacement pump inside the said tissue cavity is substantially dampened to almost negligible levels. The present invention also provides a method for accurately determining the rate of fluid loss into the subject's body system during any endoscopic procedure without utilizing any deficit weight or fluid volume calculation, the same being accomplished by using two fluid flow rate sensors. The present invention also provides a system of creating and maintaining any desired pressure in a body tissue cavity for any desired cavity outflow rate.

Abstract: Embodiments of an implantable electrolytic pump include a first expandable diaphragm and a second flexible diaphragm, and first and second chambers each for containing a fluid, wherein the first expandable diaphragm separates the first and second chambers and provides a fluid barrier therebetween, and the second chamber is formed between the first expandable diaphragm and the second flexible diaphragms. The pump may further include electrolysis electrodes within the first chamber for causing generation of a gas therein and to thereby expand the expandable diaphragm so that fluid is forced from the second chamber into a cannula.

Abstract: An osmotic delivery system flow modulator includes an outer shell constructed and arranged for positioning in an opening, an inner core inserted in the outer shell, and a fluid channel having a spiral shape defined between the outer shell and the inner core. The fluid channel is adapted for delivery of an active agent formulation from the reservoir of the osmotic delivery system.

Abstract: Embodiments of a system including a remotely controlled osmotic pump device and associated controller are described. Methods of use and control of the device are also disclosed. According to some embodiments, an osmotic pump device is placed in an environment in order to pump a material into the environment or into an additional fluid handling structure within the osmotic pump device. Exemplary environments include a body of an organism, a body of water, or an enclosed volume of a fluid. In selected embodiments, a magnetic field, an electric field, or electromagnetic control signal may be used.

Abstract: Implantable drug delivery systems target delivery of small volumes of drugs to specific tissues. In some cases, a drug delivery system includes an implantable osmotic pump connected to a drug-containing housing, with that housing connected to a needle, cochlear implant or other type of component for ultimate delivery to the target tissue. In some implementations, a subcutaneous port receives a fluid from an external pump. The port is connected to a needle or other component for delivery of one or more drugs to the target tissue. Both solid and liquid drug formulations can be used. In embodiments using solid drugs, a separate drug vehicle (such as saline) can be used to dissolve a portion of the solid drug, with the drug-loaded vehicle then delivered to the target tissue.

Abstract: Embodiments of the invention disclose a system for controlled oral drug delivery. The system comprising a removable device comprising a drug to be delivered, wherein the drug is delivered based on osmotic pressure generated in the removable device. Further, the system comprises a receptacle to hold the removable device in an oral cavity, and a base station configured to dock the removable device for determining information about one or more characteristics of the removable device.

Abstract: A pressure sensitive adhesive for medicinal application purposes, based on ethylene-vinyl acetate copolymers is characterized in that it contains as polymer component (A) an ethylene-vinyl acetate copolymer or a combination of at least two ethylene-vinyl acetate copolymers, and as component (B) an adhesive resin or a combination of adhesive resins at a portion of up to 55%-wt, relative to the sum of components (A) and (B) without active substances or other auxiliary substances.

Abstract: Embodiments of an implantable electrolytic pump include an electrolysis chamber, a drug chamber and an osmosis chamber, the osmosis chamber having a first portion in contact with the drug chamber and a second portion exposed to facilitate contact with a surrounding fluid. The pump further includes a cannula for conducting liquid from the drug chamber and electrolysis electrodes within the electrolysis chamber for causing generation of a gas therein, the electrolysis and drug chambers being in contact such that gas electrolysis within electrolysis chamber forces fluid from the drug chamber into the cannula, contact between the drug chamber and the osmosis chamber permitting fluid admitted into the osmotic chamber from the surrounding fluid to offset volume loss from the drug chamber and prevent buildup of vacuum pressure thereon.

Abstract: An insulin pump configuration programming approach is disclosed that permits setting parameters of pump configuration files to invalid values. An operator may continue with the programming workflow after setting the invalid value. The configuration file including the invalid value may be saved to a memory location of a computing device, but cannot be saved to the pump. Invalid item icons are presented when a parameter is set to an invalid value, and instructions for correcting the invalidity condition are provided when an invalid item icon is hovered over using a pointing device.

Abstract: A suspension formulation of an insulinotropic peptide (e.g., glucagon-like peptide-1 (GLP-1) or exenatide) is described. The suspension formulation comprises (i) a non-aqueous, single-phase vehicle, comprising one or more polymer and one or more one solvent, wherein the vehicle exhibits viscous fluid characteristics, and (ii) a particle formulation comprising the insulinotropic peptide, wherein the peptide is dispersed in the vehicle. The particle formulation further includes a stabilizing component comprising one or more stabilizers, for example, carbohydrates, antioxidants, amino acids, and buffers. Devices for delivering the suspension formulations and methods of use are also described.

Abstract: An effective method for prolonging localization of therapeutics within the rat gastrointestinal tract of at least about 12 hours is provided. The method includes localization of therapeutic agents that are nanoparticulated or nanoencapsulated. Attractive forces between an orally administered magnetic dose and an external magnet were monitored and internal dose motion in real time using biplanar videofluoroscopy was visualized. Tissue elasticity was quantified as a measure of tissue health by combining data streams. The methods address safety, efficacy, and monitoring capacity of magnetically localized doses and show a platform for testing the benefits of localized drug delivery.

Abstract: A barrier of a vacuum pump prevents contamination from entering a vacuum pump air line. The barrier separates parts of the pump and is moveable between an initial state and a distended state. The barrier is assembled within the pump with a pre-load. When the vacuum source is applied to the barrier, the barrier achieves a distended state and when the vacuum source is released, the barrier incrementally self returns to an initial state. The geometry and material construction of the barrier, along with the pre-load, assists in returning the barrier on its own to the initial state from the distended state.

Abstract: A device includes a tissue expanding portion and an enclosure positioned on a surface of the tissue expanding portion. The enclosure includes an enclosure wall and a drug formulation pocket defined by the enclosure wall. A solid drug formulation that includes a drug is housed within the drug formulation pocket.

Abstract: An osmotic delivery system flow modulator includes an outer shell constructed and arranged for positioning in an opening, an inner core inserted in the outer shell, and a fluid channel having a spiral shape defined between the outer shell and the inner core. The fluid channel is adapted for delivery of an active agent formulation from the reservoir of the osmotic delivery system.

Abstract: The present invention provides variable pore size filters. The variable pore size filters of the present invention comprise a fabric matrix, having a set pore size, wherein the fabric matrix is coated with a gel that expands and shrinks in response to a trigger. When the gel is expanded, the pore size of the filter is small and filtering is accomplished. When the gel is shrunken, the pore size of the filter is large and cleaning of the filter by a backwash or forward flush of fluid is accomplished.

Abstract: Embodiments of a system including a remotely controlled osmotic pump device and associated controller are described. Methods of use and control of the device are also disclosed. According to some embodiments, an osmotic pump device is placed in an environment in order to pump a material into the environment or into an additional fluid handling structure within the osmotic pump device. Exemplary environments include a body of an organism, a body of water, or an enclosed volume of a fluid. In selected embodiments, a magnetic field, an electric field, or electromagnetic control signal may be used.

Abstract: An orifice device for delivering one or more drugs includes an inner member having a proximal end and a distal end; and a plurality of windings helically wound around the inner member. Each winding defines a separate layer and each winding includes at least one wire helically wound around the inner member. The plurality of windings and the inner member define at least two separate channels for carrying one or more drugs therethrough. An inlet is at the proximal end of each of the plurality of windings and an outlet is at the distal end of the plurality of windings. At least one of the plurality of windings has a plurality of distinct wires helically wound in parallel around the inner member and at least one of the plurality of windings respectively.

Abstract: A device and method for determining at least one infusion and/or injection region for infusing and/or injecting a medical drug into a heterogeneous body structure in order to achieve a distribution of the medical drug in a desired target region of the heterogeneous body structure is provided. The device and method provide at least one property of the heterogeneous body structure that influences the spatial distribution of the medical drug in the heterogeneous body structure; and determine the at least one infusion and/or injection region from which the medical drug is to be transported through the heterogeneous body structure to the at least one target region as a function of the at least one property of the heterogeneous body structure and a position of the desired target region.

Abstract: An osmotic delivery system flow modulator includes an outer shell constructed and arranged for positioning in an opening, an inner core inserted in the outer shell, and a fluid channel having a spiral shape defined between the outer shell and the inner core. The fluid channel is adapted for delivery of an active agent formulation from the reservoir of the osmotic delivery system.

Abstract: The present invention provides devices, systems, and methods for delivery of an active agent into the eye of a subject. In one aspect, for example, an ocular active agent delivery device (10) can include an active agent reservoir (14) disposed in an annular housing (12), the annular housing (12) being configured to fit inside of a lens capsule and at least partially encircling a line of sight of an intraocular lens within the lens capsule. The device (10) can further include a semipermeable membrane (16) operatively coupled to the active agent reservoir (14), where the semipermeable membrane (16) is configured to allow diffusion of an active agent from the active agent reservoir (14). Additionally, a valve (18) can be operatively coupled to the active agent reservoir (14), where the valve (18) is configured to allow filling of the active agent reservoir (14) with an active agent.

Abstract: An osmotic delivery system flow modulator includes an outer shell constructed and arranged for positioning in an opening, an inner core inserted in the outer shell, and a fluid channel having a spiral shape defined between the outer shell and the inner core. The fluid channel is adapted for delivery of an active agent formulation from the reservoir of the osmotic delivery system.

Abstract: A nonaqueous, single-phase vehicle that is capable of suspending an active agent. The nonaqueous, single-phase vehicle includes at least one solvent and at least one polymer and is formulated to exhibit phase separation upon contact with an aqueous environment. The at least one solvent may be selected from the group consisting of benzyl benzoate, decanol, ethyl hexyl lactate, and mixtures thereof and the at least one polymer may be selected from the group consisting of a polyester, pyrrolidone, ester of an unsaturated alcohol, ether of an unsaturated alcohol, polyoxyethylenepolyoxypropylene block copolymer, and mixtures thereof. In one embodiment, the at least one solvent is benzyl benzoate and the at least one polymer is polyvinylpyrrolidone. A stable, nonaqueous suspension formulation that includes the nonaqueous, single-phase vehicle and an active agent, and a method of forming the same, are also disclosed.

Abstract: A liquid composition in an osmotic drug delivery system and a dosage form in an osmotic drug delivery system is disclosed comprising an amphiphilic molecule, a non-aqueous liquid solvent, and a pharmaceutically active agent.

Abstract: Apparatuses and methods for pumping fluids such as fluid medications are disclosed. Embodiments of the invention provide an osmotic pump fluid delivery apparatus including elements designed to control the fluid delivery rate. Typical embodiments of the invention include an arrangement of elements such as solute reservoirs that can manipulate the solute concentrations within an inner osmotic compartment or compartments of an osmotic pump so as to control fluid delivery from the pump. Other embodiments include sealed electro-osmotic pumps that do not discharge ions into the surroundings or require water from an external source. These embodiments of the invention provide new ways to control fluid delivery in apparatuses that employ osmotic processes to function.

Abstract: A device for drug release including a drug reservoir including a gate, wherein opening of the gate releases a drug stored in the drug reservoir, an electronic command and control (C & C) unit in communication with the gate that produces a gate bias voltage and time profile supplied to the gate for controlling opening of the gate, and a power source for supplying power to the electronic command and control unit.

Abstract: The invention refers to a method for control of a volume flow in an osmotic micropump and an osmotic micropump. According to the invention, the osmotically driven volume flow of the solvent through the sempipermeable diaphragm of an osmotic micropump is controlled by the transfer of a solute, which is not freely permeable through the diaphragm, from a source chamber to the pump's delivery chamber. According to the invention, the delivery chamber is formed as a dilution chamber, wherein the solution is flow out along a convective dilution path close to the semipermeable diaphragm. Due to the entrance of the solvent, a stationary osmotic gradient can be achieved along the convective flow path in the dilution chamber. The invention allows the maintenance and control of the flow rate. It is able to move a volume which is large in comparison to the combined volume of the source chamber and the dilution chamber.

Abstract: An osmotic delivery system is disclosed for delivering an active agent formulation to a fluid environment. The osmotic delivery system typically comprises a reservoir having a lumen that contains the active agent formulation and an osmotic agent formulation and a piston assembly positioned in the lumen to isolate the active agent formulation from the osmotic agent formulation. The piston assembly typically comprises a body constructed and arranged for positioning in the lumen. The body is typically made of a polymeric material that is, for example, resistant to leaching in an organic solvent. In one embodiment, the body is a columnar body having a rim at a distal end thereof for engaging and sealing against a wall of the reservoir and the piston assembly further comprises a spring retained at the distal end of the columnar body for biasing the rim of the columnar body against the wall of the reservoir.

Abstract: The present invention provides devices, small interfering RNAs, and methods for treating a neurodegenerative disorder comprising the steps of surgically implanting a catheter so that a discharge portion of the catheter lies adjacent to a predetermined infusion site in a brain, and discharging through the discharge portion of the catheter a predetermined dosage of at least one substance capable of inhibiting production of at least one neurodegenerative protein. The present invention also provides valuable small interfering RNA vectors, systems, and methods for treating Huntington's disease in vivo without impairment of cell endoplasmic reticulum, spontaneous motor activity, or locomotor activity of a patient.

Abstract: This invention relates to stable non-aqueous single phase viscous vehicles and to formulations utilizing such vehicles. The formulations comprise at least one beneficial agent uniformly suspended in the vehicle. The formulation is capable of being stored at temperatures ranging from cold to body temperature for long periods of time. The formulations are capable of being uniformly delivered from drug delivery systems at an exit shear rate of between about 1 to 1×10?7 reciprocal second.

Abstract: An infusion media delivery device includes a housing having a base adapted to be secured to a user's skin. An infusion media reservoir is supported by the housing. A moveable hollow needle is selectively engageable with the reservoir to communicate infusion media from the reservoir. The needle is supported for movement relative to the housing base between a first position and a second position. The needle is spaced apart from a user's skin when in the first position and the base is secured to the user's skin, and the needle is arranged to pierce the user's skin when in the second position and the base is secured to the user's skin.

Abstract: The present invention is directed to treatment methods for a disease or condition, in a subject in need of such treatment, that provide alternatives to treatment by injection that give, relative to treatment by injection, improved treatment outcomes, 100% treatment compliance, reduced side effects, and rapid establishment and/or termination of substantial steady-state drug delivery. The method typically includes providing continuous delivery of a drug from an implanted osmotic delivery device, wherein substantial steady-state delivery of the drug at therapeutic concentrations is typically achieved within about 7 days or less after implantation of the osmotic delivery device in the subject and the substantial steady-state delivery of the drug from the osmotic delivery device is continuous over a period of at least about 3 months. In one embodiment, the present invention is directed to treatment of type 2 diabetes mellitus using incretin mimetics.

Abstract: A container for storing a product to be injected, e.g., a therapeutic or diagnostic liquid, wherein the container includes a container body and a piston body arranged in the container body in a sliding manner, the piston body moveable between a rear end position that determines a maximum filling of the container and a front end position to dispense the product, and wherein the container has a maximum opening ratio H/L of approximately 1.25 to 1.0, H corresponding to the maximum height of the container body and L corresponding to the maximum distance between the lateral wall or walls of the container body.

Abstract: Embodiments of a system including a remotely controlled osmotic pump device and associated controller are described. Methods of use and control of the device are also disclosed. According to some embodiments, an osmotic pump device is placed in an environment in order to pump a material into the environment or into an additional fluid handling structure within the osmotic pump device. Exemplary environments include a body of an organism, a body of water, or an enclosed volume of a fluid. In selected embodiments, a magnetic field, an electric field, or electromagnetic control signal may be used.

Abstract: The present invention is directed to an apparatus and method for controllably adjusting a fluid delivery device. The device includes an electrochemical pump capable of transporting a fluid. A displaceable member is positioned between a pump product chamber and a reservoir, wherein the pump product chamber is capable of retaining water generated from the pump. The displaceable member is controllably displaced upon generation of water from the electrochemical pump and the reservoir contains the fluid that is delivered upon displacement of the displaceable member.

Abstract: A device includes a first reservoir configured to include a degradation agent, a first control element configured to provide access to the first reservoir, and an expandable component configured to extend to engage an osteal structure.

Abstract: An osmotic delivery system is disclosed for delivering an active agent formulation to a fluid environment. The osmotic delivery system typically comprises a reservoir having a lumen that contains the active agent formulation and an osmotic agent formulation and a piston assembly positioned in the lumen to isolate the active agent formulation from the osmotic agent formulation. The piston assembly typically comprises a body constructed and arranged for positioning in the lumen. The body is typically made of a polymeric material that is, for example, resistant to leaching in an organic solvent. In one embodiment, the body is a columnar body having a rim at a distal end thereof for engaging and sealing against a wall of the reservoir and the piston assembly further comprises a spring retained at the distal end of the columnar body for biasing the rim of the columnar body against the wall of the reservoir.

Abstract: Embodiments of a system including a remotely controlled reaction device and associated controller are described. Methods of use and control of the device are also disclosed. According to various embodiments, a reaction device is placed in an environment in order to perform a chemical reaction in an environment. Exemplary environments include a body of an organism, a body of water, or an enclosed volume of a fluid. In selected embodiments, a magnetic field, an electric field, or electromagnetic control signal may be used.