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.

Abstract: Drug solutions (or other combinations of vehicle with entrained drug) are prepared by removing drug from one or more masses of a solid form of the drug. The solid form of the drug may be sparingly soluble or insoluble in water. Examples of devices for holding solid drug and facilitating delivery of such drug to targeted regions are also described.

Abstract: A device includes a first reservoir configured to include a degrading agent, a first valve in fluid communication with the first reservoir, and a reservoir driver configured to manipulate the first reservoir to effect a first reservoir condition based on a first tissue condition. The first valve is configured to open in response to the first reservoir condition associated with the first reservoir.

Abstract: A medical-solution administration device includes a medical-solution reservoir that is filled with at least a medical solution and that feeds the medical solution to a medical solution administration side; a pump that discharges to the medical-solution reservoir a driving liquid that is used in pushing the medical solution filled in the medical-solution reservoir; and a driving liquid reservoir that is filled with the driving liquid, wherein the medical-solution reservoir forms a pipe in which the driving liquid discharged by the pump enters from an opening on one end so that the medical solution is pushed to the medical solution administration side from an opening on other end of the pipe, and a marker is placed between the driving liquid and the medical solution, the marker being used in detecting a pushed quantity of the medical solution pushed by the driving liquid.

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: A method of treating a central nervous system (CNS) disorder, comprises the steps of inserting into a patient's body first and second conduits so that distal ends of the first and second conduits open to a portion of the patient's CNS with direct access to cerebrospinal fluid (CSF) and a proximal end of the first conduit opens into a first reservoir of material to be introduced into the CSF and a proximal end of the second conduit opens to drain CSF withdrawn from the CNS in combination with the steps of detecting and analyzing brain activity of a patient and determining a chemical imbalance present in the CSF by one of a microassay of a sample of CSF withdrawn from the second reservoir and the detected and analyzed brain activity. Based on the determined chemical imbalance, the patient is treated by one of supplying an agent to the CSF via the first conduit and withdrawing a quantity CSF via the second conduit.

Abstract: A medical system comprising an implantable medical device and an external controller. The medical device includes a therapy administration subsystem, a telemetry subsystem, and a control subsystem which includes a microprocessor operable in response to data and/or code provided via said telemetry subsystem for producing an output signal for controlling said therapy administration subsystem. The controller includes a user input means and a telemetry subsystem responsive to said user input means for communicating data and/or code to said medical device telemetry subsystem. The medical device control subsystem includes program means for causing said microprocessor to separately execute at least two software processes to respectively produce separate therapy control output components. Combinatorial logic means responds to the separate output components to produce the output signal for controlling the therapy administration subsystem.

Abstract: A delivery tube assembly is provided, the delivery tube assembly including a delivery tube including a delivery tube attachment end, an open delivery tube second end opposite the delivery tube attachment end, an outer surface, and an inner surface defining a delivery tube cavity; and a dosage form including a therapeutic agent, wherein the dosage form is positioned within the delivery tube cavity. The assembly may also include an engagement mechanism positioned at the delivery tube attachment end. The assembly may also include a containment seal coupled to the delivery tube second end. The assembly may also include an inner containment seal positioned within the delivery tube cavity to seal the dosage form within the delivery tube cavity.

Abstract: Drug depot delivery devices and methods are provided for delivering one or more drug depots to one or more sites beneath the skin of a patient with or without repositioning the cannula. The device has a cannula capable of insertion to the site beneath the skin of the patient and one or more side port openings for delivering a drug depot. The side port openings are spaced a distance from the blunt tip, which will allow the user to implant at a set distance from a nerve. The device may also include an electronic monitor for detecting the proximity of the tip of the cannula to a nerve. In some embodiments, a method of delivering a drug depot is provided by detecting the nerve and delivering the drug depot at or near the nerve.

Abstract: This invention provides devices and apparatuses comprising the same, for efficient pumping and/or mixing of relatively small volumes of fluid. Such devices utilize nonlinear electrokinetics as a primary mechanism for driving fluid flow. Methods of cellular analysis and high-throughput, multi-step product formation using devices of this invention are described.

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 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: An orifice device for delivering a drug includes an inner member having a proximal end and a distal end. A winding is helically wound around the inner member. The winding and the inner member define a first channel for carrying a drug therethrough. An inlet is at the proximal end of the winding and an outlet is at the distal end of the winding.

Abstract: Disclosed are embodiments of a fluid delivery device (300) that combine both anionic electrokinetic and cationic electrokinetic concepts. In one illustrative embodiment, the fluid delivery device (300) may include an electro-osmotic pump (302) having an anion exchange membrane (350) and a cation exchange membrane (351) in the same device.

Abstract: An apparatus for delivering a beneficial agent is disclosed in one embodiment of the invention as including a water collection chamber. A water-transporting membrane is provided to communicate with the water collection chamber. An extraction chamber receives water through the water-transporting membrane, expanding the extraction chamber. A dispensing chamber, containing a beneficial agent, is configured to contract upon expanding the extraction chamber. This causes the dispensing chamber to expel the beneficial agent through a subterranean delivery channel, such as a rigid hollow spike. In certain embodiments, a rate adjustment mechanism may control the rate that water is received through the water-transporting membrane, thereby controlling the rate the beneficial agent is expelled. The water-transporting membrane has features that repel osmagent from passing through to the water collection chamber.

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 implantable medicament delivery device includes a core body which further includes a single basin or multiple smaller basins for containing a drug or a medicament. Each basin is covered by a screen. The implantable drug delivery device is placed within the body of an animal, and the drug is allowed to diffuse through the holes in the screen to provide treatment of a disease or condition.

Abstract: Apparatuses and methods for pumping fluids such as fluid medications are disclosed. In illustrative embodiments of the invention, the architectural geometry of one or more fluid containing chambers within a fluid delivery device is constructed to incorporate design parameters that function to control movement of fluids within the device. Typical embodiments of the invention provide osmotic pumps that use such elements to control various fluid delivery parameters.

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: The invention relates to an osmotic pump (1) comprising at least one chargeable material (30) whereby the osmotic pressure is caused by inducing and/or de-inducing charges within the material.

Abstract: A method for treating obesity comprises anchoring at a first target site within a body a first therapeutic agent delivery device including a first therapeutic agent reservoir coupled to a first outlet which, when the first device is anchored at the first target site, is positioned adjacent to a first target treatment location within a GI tract of a patient and releasing a first therapeutic agent from the first reservoir via the first outlet.

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: A device for the dosed output of a substance, the device involving hydrogel-based osmotic drive, wherein output characteristics of the device, including a time profile, may be adjusted by a user. In some embodiments, the device may be used once and, in other embodiments, it may be used several times.

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 implantable medical devices which may be used for controllably releasing a therapeutic agent within a patient and methods for making the same. These medical devices may include porous coatings, which may be polymer-free, located on an outer surface or abluminal surface of the medical device. The medical device may be a stent. The pores of the porous coating may be expandable to facilitate loading of the therapeutic agent. The medical device may be triggerable upon implantation of the medical device such that the volume of the voids shrinks to eject the therapeutic agent. The voids may be slots in the stent. Expandable materials or structures may be positioned in the voids to expand upon implantation and eject the therapeutic agent.

Abstract: A fluid delivery device, comprising an electrochemical pump, wherein the pump is capable of transporting water; a pump product chamber, wherein the pump product chamber is capable of retaining water generated from the pump; a displaceable member positioned between the pump product chamber and a reservoir, wherein the displaceable member is controllably displaced upon generation of water from the electrochemical pump; a reservoir, wherein the reservoir is capable of containing a fluid which is delivered upon displacement of the displaceable member; and an housing for containing the pump, the pump product chamber, the displaceable member, and the reservoir.

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: An osmotic pump includes a capsule having at least one delivery port formed at a first end and a membrane plug retained in a second end of the capsule remote from the delivery port to provide a fluid-permeable barrier between an interior and an exterior of the capsule. The membrane plug has a columnar body and at least one slot formed in the columnar body to vent pressure from the interior to the exterior of the capsule when the columnar body extends a predetermined distance relative to the second end of the capsule, thereby preventing expulsion of the membrane plug from the second end.

Abstract: A high pressure osmotic dispense pump (10) having a substantially continuous delivery rate and extended delivery times is described and disclosed. The dispense pump (10) includes a semi-permeable membrane (12) which is substantially free of distortions and lateral stretching stresses. The membrane housing (14) and configuration of the present invention allows for consistent and accurate flow rates at the micro-liter level and improved control of the surface area of the semi-permeable membrane (12). This osmotic pump (10) also includes optional methods for activating and deactivating the osmotic process and/or controlling flow rates. Along with these features, the pump can be amplified or modulated to increase the dispense rate and/or adjust the flow rate during operation.

Abstract: A four-part method for analyzing data of a patient's blood glucose (BG) tests or other parameters e.g. carbohydrate intakes and discrete insulin doses (boluses): 1. An LCD-button on the portable glucose meter or insulin pump, that allows flagging or assigning a category to each blood glucose test at test-time. Examples of categories: pre-meal BG tests, post-meal BG tests. 2. In the computer-based downloading program, features for changing the boundaries of the meal-oriented time-intervals by the faster methods of: a) mouse-dragging the time-boundary lines on a scatter chart, b) placing stretchable rectangles around the data points of interest. 3. Features in the computer-based downloading program, for digitally identifying the time of the meal and digitally assigning the category to the pre-meal BG tests and to the post-meal BG tests. 4.

Abstract: An administering device with an osmotic drive for administering an injectable product includes a housing with a first chamber containing a solvent, a second chamber containing a solution and a product chamber for accommodating the product. A semi-permeable membrane is disposed between the first chamber and the second chamber. The second chamber is adjoined by a delivery means for delivering product out of the product chamber. A triggering device for triggering the osmotic drive includes an impermeable separating means between the first chamber and the second chamber. The delivery means is slidable relative to the housing along a longitudinal axis of the housing.

Abstract: An osmotic pump includes a capsule having at least one delivery port formed at a first end and a membrane plug retained in a second end of the capsule remote from the delivery port to provide a fluid-permeable barrier between an interior and an exterior of the capsule. The membrane plug has a columnar body and at least one slot formed in the columnar body to vent pressure from the interior to the exterior of the capsule when the columnar body extends a predetermined distance relative to the second end of the capsule, thereby preventing expulsion of the membrane plug from the second end.

Abstract: An osmotic delivery system flow modulator assembly, an osmotic delivery system with a flow modulator assembly, and a method of assembling an osmotic delivery system. The osmotic delivery system flow modular assembly includes a body having a hole located through the body and communicating two opposing ends of the body. The use of the osmotic delivery system flow modulator assembly lessens the chance that air or gas pockets will form in the enclosure of the osmotic delivery system during assembly of the system. Because less air is within the osmotic delivery system, performance of the system is enhanced. Use of the flow modulator assembly also lessens the chance that beneficial agent will be wasted during assembly of the osmotic delivery system.

Abstract: A method and device for the treatment of an aneurysm are provided. Different therapeutic agents are delivered to the aneurysmal site by a reservoir and delivery means in a localized, and, in some embodiments, time-released regimen, to treat, limit and reduce the severity of the aneurysm.

Abstract: A delivery device for a primary fluid comprises a tubular housing which includes a reservoir for the primary fluid, and a chamber for a displacement fluid which extends coaxially with the reservoir inside the housing and is separated from the reservoir by means of a membrane. The device includes an outlet from the reservoir for the primary fluid, and a device for driving the displacement fluid under pressure into the chamber so that the membrane is deformed into the reservoir to cause primary fluid in the reservoir to be displaced towards the outlet.

Abstract: A delivery device for a primary fluid includes an elongate tubular housing containing a reservoir for the primary fluid and a chamber for an ambient fluid to which the exterior of the delivery device is exposed. The device includes an outlet from the reservoir for the primary fluid and a device for driving ambient fluid under pressure into the chamber so as to expand the chamber and to cause primary fluid in the reservoir to be displaced towards the outlet. The inlet to the driver device communicates with an opening which is exposed to the ambient fluid to which the exterior of the delivery device is exposed.

Abstract: The invention provides devices, kits and methods for delivering an agent to a breast milk duct. Intraductal agent delivery provides an opportunity to treat a breast condition locally and avoid the pitfalls of systemic drug delivery for a local condition. Time-released agents delivered into the ducts using an intraductal device or formulation reduces the frequency of intraductal administration required for desired efficacy over time. The methods include methods of treating a breast condition, including the conditions of cancer or precancer.

Abstract: An anchoring mechanism and method for anchoring a device within a biological conduit include an expandable element configured for retaining the device at a desired angle relative to a central axis of the biological conduit. A steering mechanism is preferably provided for orienting the device prior to operation of the anchoring mechanism. The anchoring mechanism and method are employed in drug delivery devices, brachytherapy devices or for anchoring a catheter or sheath to provide a working channel for reliable guidance of a wide range of tools to a target location within the body.

Abstract: The present invention is disclosed herein as an electrochemical cell having a cell housing with a first half cell and a second half cell, and an ion selective membrane between the cells. The electrochemical cell further has a first electrode positioned within the first half cell, a second electrode positioned within the second half cell, an electrolyte in electrical communication with both the first electrode and the second electrode. The electrodes of the cell are configured so that the electrochemical cell maintains a substantially constant salt concentration level throughout operation. The cell is preferably used in conjunction with an implantable fluid delivery apparatus. A method for using the device is additionally disclosed.

Abstract: A nifedipine controlled release composition is provided comprising a drug-layer and a push-layer at a ratio of 1:0.5˜3 by weight. The drug-layer contains nifedipine and 40˜99 percent by weight of the drug-layer of hydrophilic polyvinylpyrrolidone homopolymer and/or copolymer carrier. The push-layer comprises about 10 to 80 percent by weight of the push-layer of osmopolymers, about 10 to 80 percent by weight of the push-layer of water-insoluble polymers, and about 5 to 50 percent by weight of the push-layer of osmagents. The composition is used in osmotic pump tablets for controlled release of nifedipine useful for administration once a day.

Abstract: According to an aspect of the invention, implantable or insertable medical devices are provided which contain the following: (a) one or more porous regions comprising pores and (b) one or more therapeutic agents which are (i) contained within the porous region, (ii) disposed beneath the porous region, or (iii) both. Moreover, the porous regions are capable of undergoing a change in configuration, such that the pores undergo a change in configuration, upon subjecting the porous regions to activating stimuli.

Abstract: The present invention relates to an implantable infusion pump having a refillable infusate reservoir in fluid communication with a delivery site via a flow path. This flow path includes a flow resistance. The infusion pump includes a sensing device(s), positioned relative to the flow path, to provide data regarding a flow rate along the flow path. The infusion pump effects a division of a total flow period into at least a plurality of unit dose periods, each unit dose period effecting delivery of a unit dose of infusate. The cumulative effect of delivering the total number of unit dose periods is the delivery of a desired dose over the total flow period. The present invention permits a reservoir pressure to vary over any portion of total flow period but effects a constant-pressure state over each unit dose cycle.

Abstract: Improvements in a mini-osmotic pump and coating compositions are described. The dispensing pump includes an inner fluid-filled bag encased by an osmotic layer and outer, semi-permeable membrane. The inner bag is formed with an arcuate edge at the open end of the bag to inhibit formation of fissures in the outer membrane in this edge region. The coating compositions include cellulose acetate butyrate, cellulose acetate propionate, and polymethylmethacrylate polymers, optionally mixed with ethyl cellulose in acetone based solvent systems.

Abstract: An implantable osmotically driven delivery system having a dynamic, two-way valve and a self-adjusting, variable geometry fluid flow channel. As pressure within the agent delivery system increases, the fluid channel narrows, thereby restricting flow. At exceptionally high pressures, the valve can be designed to close altogether at the orifice or delivery end, or it can provide a minimal leak path so that a maximum fluid flow is never exceeded. At zero or very low pressures, the valve will close completely at the beneficial agent reservoir end, isolating the beneficial agent formulation from external fluid infiltration and thereby eliminating diffusion of external fluid into the beneficial agent formulation.

Abstract: The invention provides devices and related methods and composition useful for diagnosis and monitoring the pain generator(s) of axial pain with or without radiculopathy and methods for screening test compounds potentially useful for treating axial pain with or without radiculopathy. Alternatively, degenerated discs can be monitored and treated before occurrence of a pathological pain condition. Pain markers and markers of degenerating disc include markers of neuronal, vascular, immune and matrix elements.

Abstract: There is disclosed a process and device for Forward Osmosis (FO) Pressurized Device (FOPD) in general and one hydraulically coupled to a reverse osmosis (RO device for a FOPRO (Forward Osmosis Pressurized Reverse Osmosis). Specifically, there is disclosed a passive device (that is, not needed energy input) for using forward osmosis to generate significant hydraulic pressure that can be used to drive a reverse osmosis process, wherein the reverse osmosis process (not needed external energy to run pumps) can separate salt from salt water to generate potable water from water with high salt content (such as sea water, urine, sweat, brackish water and the like).

Abstract: The present invention provides a catheter for use in delivering formulation that allows modification of the formulation prior to or concomitant with its transport or at a delivery site. The catheter comprises an elongate body, which defines an inner lumen extending between the proximal and distal ends, and a modifying element, which provides for modification of one or more components of a formulation prior to or concomitant with release at the delivery site.

Abstract: In one aspect, the present invention is directed to an osmotic pump that automatically provides an ascending release rate of active agent as the osmotic pump functions in an environment of operation and may be designed for implantation within a desired animal or human subject. An osmotic pump according to the present invention includes a reservoir, a rate controlling membrane, an expandable osmotic composition, an active agent formulation and an exit orifice. Once administered to an environment of operation, water passes through the rate controlling membrane and into the osmotic composition, which causes the osmotic composition to expand and expel the active agent formulation through the exit orifice at a rate that is directly proportional to the rate at which water passes through the rate controlling membrane.

Abstract: An osmotic delivery system having a space-efficient piston is provided. The enclosure has an interior holding the piston, a protein or peptide, and an osmotic agent. The piston is movable with respect to an interior surface of the capsule, and defines a movable seal with the interior surface of the capsule. The movable seal separates the osmopolymer from the protein or peptide. The piston has a recess that receives at least a portion of the osmotic agent. The osmotic agent imbibes liquid from a surrounding environment to cause the piston to move and, in turn, cause delivery of the beneficial agent from the capsule.

Abstract: A device for delivering a drug includes a body having a proximal end and a distal end and an opening in the distal end thereof. An orifice mechanism at the distal end of the body communicates with the opening. The orifice mechanism includes an inner member having a proximal end and a distal end; a winding helically wound around the inner member; and wherein the winding and the inner member define a first channel for carrying a drug therethrough. An inlet is at the proximal end of the winding and an outlet is at the distal end of the inner member.