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: A valve unit capable of being implanted in a patient and having adjustable performance settings, such as pressure settings and/or flow control, to regulate passage of a bodily fluid. A casing defines a port for the bodily fluid, and a valve mechanism positioned at the port includes a movable valve member. The valve unit further includes a rotor disposed at a first location in the casing and having an axle which turns about an axis of rotation. The rotor defines a plurality of arcuate, radially flat cam surfaces. Each cam surface occupies an arc about the axis of rotation. A spring arm unit is disposed at a second location in the casing having a cam follower arm in slidable contact with the cam surfaces of the rotor and having a resilient spring element applying a closing effect with the movable valve member to establish a performance setting for the valve unit.

Abstract: Humanized anti-A? antibodies derived from a murine antibody directed to a N-terminal epitope of A? are described. The humanized antibodies have reduced or no human T cell epitopes and bind A? with an affinity similar to that of the murine antibody.

Abstract: An environmentally sensitive hydrogel material swells or collapses in response to a parameter such as pH level associated with consumption of food by a patient. This swelling or collapsing is harnessed to treat morbid obesity or some other condition of the patient. The swelling or collapsing of the hydrogel may be used to tighten a gastric band or gastric valve when the patient starts eating; then loosen the band or valve when the patient is between meals. The swelling or collapsing of the hydrogel may also be used to increase the size of a space occupying device in the patient's stomach when the patient starts eating; then decrease the size of the space occupying device when the patient is between meals. The swelling or collapsing of the hydrogel may also be used to selectively restrict the absorption of nutrients within a patient's gastrointestinal tract, such as in the duodenum.

Abstract: An implantable infusion device for delivering a fluid medication to a patient. The infusion device has an internal bacterial filter positioned between the reservoir and the pump, configured to provide a pathway for fluid to be pulled from the reservoir to the pump, regardless of the orientation of the infusion device. The configuration of the filter provides a fluid pathway from the reservoir to the pump, even in the presence of a gas bubble.

Abstract: The invention relates generally to implantable drug delivery devices. Devices having a single drug chamber configuration, a divided drug chamber configuration and a compact dual-drug configuration are described. The devices have features to prevent clogging of the dispensing catheter and the creation of a local vacuum caused by the dispensing of the drug fluid. Also provided are features of a failsafe refilling process, automatic refill notification, and performance verification process. The divided drug chamber configuration enables frequent or continuous minute doses. A dual-drug chamber configuration uses self-locking refill containers to prevent mismatching between refill containers and drug chambers.

Abstract: A variable hydraulic resistor for use with implantable pumps is disclosed. The variable hydraulic resistor according to the present invention is particularly useful in varying the flow rate of a medication fluid from an otherwise constant flow implantable pump. An implantable pump is also disclosed, which does not require a complicated clinching system or the like, and which may include an undulating membrane and chamber design to reduce the height of the pump.

Abstract: Integrated tools for noninvasively reading and adjusting an implantable, magnetically adjustable valve, and methods of use are disclosed. The tools include magnetic or electronic reading of the valve, and magnetic or electromagnetic adjustment of the valve. In use, the tools are positioned above or in contact with the patient's skin, in proximity to the valve.

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: An implantable fluid delivery system may include a fluid reservoir configured to hold a supply of fluid, dispense that fluid under the control of an actuator, and be implanted within the body of a living host. The actuator may include a bellows configured to expand in a direction when inflated. The bellows may have folds with surfaces which run substantially perpendicular to the direction of expansion in a collapsed state and which define a stacked set of convolutions. Each convolution may have a collapsed height of no more than 1 mm and a width perpendicular to the direction of expansion of no more than 8 mm. Electrodes may be configured to come in electrical contact with an electrolyte within the bellows and to cause electricity to run through the electrolyte, thereby causing the electrolyte to break down into a gas and, in turn, to cause the bellows to expand.

Abstract: The disclosure provides an implantable bioartificial active secretion system for providing a physiological regulating secretion such as insulin necessary for functionality of a physiologic activity such as glucose metabolism of a living-being host. The system includes a housing implantable within the host, in fluidic communication with tissue fluid indicative of a physiological regulating secretion need. A chamber within the housing contains a plurality of physiologically active, autonomously functioning, live secretory cells for producing the physiological regulating secretion. A continually operating two pump apparatus moves tissue fluid into contact with the secretory cells for pick up of the physiological regulating secretion for subsequent physiologically-effective dispensing into the host, while avoiding immunorejection of the host body or of the host to the secretory cells.

Abstract: An implantable infusion device includes a voltage boost circuit configured to selectively generate an output voltage from a first voltage provided by a battery. The voltage boost circuit includes a signal generation circuit configured to generate control signals and a charge pump circuit configured to generate the output voltage in response to the control signals. In response to a request for a predetermined voltage, the signal generation circuit generates the control signals using a first profile for a first period of time, and generates the control signals using a second profile for a second period of time subsequent to the first period. The charge pump circuit increases the output voltage to (i) an intermediate voltage less than the predetermined voltage in response to the first profile of the control signals, and (ii) the predetermined voltage in response to the second profile of the control signals.

Abstract: An implantable infusion device includes a pump, a charge storage unit, and a charging circuit configured to supply current to the charge storage unit from a battery in preparation for actuating the pump. The implantable infusion device also includes a pump actuator circuit configured to actuate the pump using energy from the charge storage unit, and a voltage boost circuit configured to provide a boosted battery voltage generated from the battery. The charging circuit is configured to supply current to the charge storage unit from the voltage boost circuit instead of directly from the battery in response to (i) a comparison of a voltage of the battery with a predetermined threshold and (ii) a comparison of a voltage of the charge storage unit with the voltage of the battery.

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: A communication device (CD) exchanges messages with an implantable infusion pump via telemetry such that commands are supplied thereto and operational information is obtained therefrom. The CD is controlled, at least in part, by a processor IC according to a software program operating therein and provides feedback to a user via a visual display, an audio alarm, and a vibrational alarm, and allows input from the user via a touch sensitive keypad. Certain input functions are restricted by password. The visual display includes an icon and fixed element display region and a bitmap display region. The fixed element display region includes time and date displays, battery and drug level displays that decrement, and a moving delivery state display. Various screens allow operational or log information to be displayed and/or user entry of commands. Program features when disabled are removed from a series of screen options that can be scrolled through.

Abstract: A number of parameters related to the operation of a fluid delivery device are determined based on pressures within the device sensed using multiple pressure sensors. In one example, the volume of therapeutic fluid within a reservoir of a fluid delivery device is estimated based on a measured pressure differential. In another example, the rate at which a therapeutic fluid is added to or removed from the reservoir is estimated based on the measured pressure differential.

Abstract: The present invention relates to aerosols containing magnetic particles, wherein the aerosols comprise magnetic particles and a pharmaceutical active agent. The invention furthermore relates to the use of such aerosols containing magnetic particles for directed magnetic field-guided transfer of the active agents contained therein in aerosol therapy.

Abstract: A volume sensing system for use in determining a volume of a variable volume reservoir can include a lower plunger that can have a first end adapted to move with a bottom of the reservoir. An upper plunger can be slidable relative to the lower plunger. A lower biasing member can be positioned substantially between a base of the reservoir and the upper plunger, and the upper biasing member can be positioned between the upper plunger and an interference member. The upper biasing member can have a predetermined stiffness relative to the lower biasing member such that upon movement of the lower plunger, the upper plunger can move at a predetermined fraction of the amount of movement of the lower plunger, where the predetermined fraction can be determined at least in part by the predetermined stiffness of the upper biasing member relative to the lower biasing member.

Abstract: Drug infusion system capable of delivering a fluid medication to a patient and method for doing same is described. An implantable drug delivery device is capable of delivering the fluid medication at a programmable rate to the patient under control of an original programming cycle having a plurality of steps in a plurality of time slots beginning at a starting time. The programming cycle specifies the programmable rate for each of the plurality of steps. An external controller is capable of storing a program representative of the original programming cycle in the implantable drug delivery device at a programming time. The drug infusion system adjusts the implantable drug delivery device so that the original programming cycle will begin at a time during the original programming cycle adjusted for the programming time.

Abstract: A medication delivery system for delivering medicament to a body of a user. The medication delivery system may include a housing having a plurality of medicament reservoirs therein, a first sensor configured to continuously monitor a parameter of the body, and a pump mechanism configured to pump medicament from each of the plurality of medicament reservoirs to a delivery mechanism having a portion disposed within the body of the user.

Abstract: Methods and apparatus are provided for treating contrast nephropathy, e.g., via a pulsed electric field, via a stimulation electric field, via localized drug delivery, via high frequency ultrasound, via thermal techniques, etc. Such neuromodulation may effectuate irreversible electroporation or electrofusion, necrosis and/or inducement of apoptosis, alteration of gene expression, action potential attenuation or blockade, changes in cytokine up-regulation and other conditions in target neural fibers. In some embodiments, neuromodulation is applied to neural fibers that contribute to renal function. In some embodiments, such neuromodulation is performed in a bilateral fashion. Bilateral renal neuromodulation may provide enhanced therapeutic effect in some patients as compared to renal neuromodulation performed unilaterally, i.e., as compared to renal neuromodulation performed on neural tissue innervating a single kidney.

Abstract: An accumulator is employed in an implantable infusion device to provide compliance in the flow path of the device. The accumulator may act to increase the pumping accuracy and repeatability while simultaneously reducing the energy requirements of the device. In one example, the accumulator is arranged at the outlet of a fluid delivery pump of the infusion device. The accumulator includes a cover and a diaphragm biased away from the cover and configured to deflect toward the cover under pressure generated by the therapeutic agent in a flow path of the infusion device. The cover of the accumulator is configured to withstand the pressure generated by the therapeutic agent in the flow path without deforming.

Abstract: Systems and methods are provided which enable communications to be initiated locally relative to an individual's developing physiological condition and remotely as the condition requires. Physiological sensors and associated medical delivery systems can be coupled to a unit wearable by an individual which can provide various audible or visual outputs and one or more manual inputs indicative of the individual's condition. A global positioning unit can be incorporated so that condition information as well as location information can automatically be provided, wirelessly, to a remote monitoring system for follow up as needed.

Abstract: A fluid flow regulator (1) of the passive type is disclosed which has a fluid inlet adapted to be connected to a fluid reservoir and a fluid outlet (13) adapted to be connected to a patient's body. The regulator comprises a rigid substrate (2) and a resilient membrane (3) tightly linked together so as to define a cavity (6) there between which is disconnected to the fluid outlet while the membrane has a first surface (12) opposite the cavity which is connected to the fluid inlet. The membrane has a plurality of through holes (15) contiguous with the cavity, to define a pathway for a fluid from the fluid inlet to the fluid outlet, and is flexible so as to be able to come into contact with the substrate as a fluid applies a sufficient pressure on the first surface.

Abstract: A implantable pump system comprises an implantable pump motor and an external unit. An inverter comprises respective phases with redundant legs connected in parallel, and respective current sensors in series with each leg generating a respective measured current. A cable redundantly couples the inverter to the motor. The cable includes a respective conductor coupling each redundant leg to a respective phase of the motor. The controller receives the measured currents, monitors for a fault in the conductors by comparing the measured currents in the respective redundant legs. A fault in a pair of redundant conductors is detected if a ratio of the respective measured currents is not within a predetermined range.

Abstract: The present invention includes systems and methods for detecting fluid flow into or out of a port chamber or a reservoir of an implantable medical device utilizing a pressure sensor. The system detects characteristic pressure profiles associated with fluid flowing into the medical device, out of the medical device, and also whether one or both of the port chamber or reservoir are substantially empty or substantially full. In addition, the present invention may generate a sensory cue to a clinician to indicate the fluid status.

Abstract: The invention is directed to a device for delivering an active agent formulation for a predetermined administration period. An impermeable reservoir is divided into a water-swellable agent chamber and an active agent formulation chamber. Fluid from the environment is imbibed through a semipermeable plug into the water-swellable agent chamber and the active agent formulation is released through a back-diffusion regulating outlet. Delivery periods of up to 2 years are achieved.

Abstract: The present invention relates to phase separated polymeric regions and to their use in conjunction with implantable or insertable medical devices. In some aspects of the invention, phase separated polymeric regions are provided that include (a) at least one biostable polymeric phase and (b) at least one biodisintegrable polymeric phase, which is of nanoscale dimensions and which undergoes biodisintegration such that the phase separated polymeric region becomes a nanoporous polymeric region in vivo. Other aspects of the invention are directed to methods of making implantable or insertable medical devices having at least one nanoporous polymeric region. These methods include (a) providing a phase separated polymeric region comprising a stable polymeric phase and a disintegrable polymeric phase of nanoscale dimensions, (b) selectively removing the disintegrable polymeric phase thereby producing the nanoporous polymeric region.

Abstract: Embodiments of a system including a remotely controlled substance delivery device and associated controller are described. Methods of use and control of the device are also disclosed. According to some embodiments, a delivery device or related device may be placed in an environment in order to pump a material into the environment or into an additional fluid handling structure within the device. Exemplary environments include a body of an organism, a body of water, or an enclosed volume of a fluid. The concentration of a substance in the fluid to be delivered may be modified by a remote control signal. In selected embodiments, an acoustic control signal may be used.

Abstract: Catheter systems and methods for implanting helical or dart-like implants into the myocardium or other body tissue. The catheter system includes a helix for fixing the distal end of the catheter to the myocardium, an implant held by the helix, mechanisms for driving the fixation helix into the myocardium, and mechanisms for driving the implant into the myocardium, removing the fixation helix and leaving the implant behind. The implant may be coated, filled, or made of a drug or drug eluting compound, or drug delivery matrix of any composition.

Abstract: Implantable drug delivery devices, and kits and methods incorporating them are described. The devices may, for example, be configured for implantation into an ocular region of a subject. The drug delivery devices may comprise multiple, selectively-triggerable drug reservoirs for administration of sequential or concomitant drug regimens. Some variations of devices may comprise one or more reservoirs that may be triggered by an optical stimulus, e.g., light having a wavelength within a certain wavelength range. The devices, methods, and kits may be useful in the treatment chronic ocular conditions, such as age-related macular degeneration.

Abstract: Integrated tools for noninvasively reading and adjusting an implantable, magnetically adjustable valve, and methods of use are disclosed. The tools include magnetic or electronic reading of the valve, and magnetic or electromagnetic adjustment of the valve. In use, the tools are positioned above or in contact with the patient's skin, in proximity to the valve.

Abstract: An implantable infusion device includes a housing and a collapsible member and an interference member disposed within the housing. The collapsible member defines a reservoir for containing fluid and has an outer surface that moves between an empty position and a full position in response to a change in volume of fluid contained in the reservoir. The interference member is configured to engage the outer surface of the collapsible member as the reservoir approaches the full position and to cause pressure in the reservoir to increase following engagement with the surface of the collapsible member and concomitant fluid introduction into the reservoir. The infusion device further includes a pressure sensor in communication with the reservoir, which can be used to determine whether the reservoir is full by measuring characteristic pressures associated with the interference member engaging the outer surface of the collapsible member and concomitant fluid introduction into the reservoir.

Abstract: A drug delivery device (50) is provided comprising a drug reservoir (10) and a piston (11). The drug reservoir (10) is provided for comprising a drug and comprises a flexible wall (22) and a dispensing hole (15) for dispensing the drug into an environment of the drug de delivery device (50). The piston (11) is provide for pressing against the flexible wall (22) to compress the drug reservoir (10) for pushing an amount of the drug through the dispensing hole (15). An adhesion interface (51) between a surface of the piston (11) and the flexible wall (22) prevents sliding between the surface of the piston (11) and the flexible wall (22).

Abstract: IMDs and methods are provided for electroporation treatment of subcutaneous tumors. In some embodiments, IMDs of the present invention may store and introduce chemotherapy drugs into the body prior to electroporation therapy. High frequency stimulation of tissue in or around the tumor may also be provided to increase tissue temperature prior to electroporation therapy. Still further, delivery of the electroporation therapy may be synchronized with cardiac qRs complex to avoid impeding normal cardiac rhythm. Algorithms to suspend therapy in the event of edema may also be incorporated.

Abstract: The present invention is directed to systems and methods for delivering therapy for a cardiac disorder, wherein the system comprises a source for supplying a protein formulation containing a protein that is otherwise deficient in cardiac cells in a patient with a cardiac disorder, and a catheter having a proximal end and a distal end for delivering the protein formulation to the pericardial sac region of a human heart.

Abstract: Implantable infusion apparatus, systems and methods that involve the use of a sensor that is associated with the catheter outlet.

Abstract: Medical implants can comprise various instrumentation to impart desirable functionality to the implant. In some embodiments, the implants comprise functional structures, such as sensors, energy propagating transducers, drug delivery systems and the like. Additional instrumentation to facilitate the functionality of these devices can include, for example, microprocessors, communication systems, power sources or the like. Drug delivery systems can comprise, for example, an isolated reservoir with a control system to control the delivery of a biological agent from the reservoir. The implants can be orthopedic implants that are designed to interface with a patient's skeletal system wherein the orthopedic implant may itself embody sensors, processors, power supplies, memory and/or communication capability.

Abstract: Instruments, systems, implants, and methods are provided for performing submucosal medical procedures in a desired area of the digestive tract using endoscopy. Instruments include a safe access needle injection instrument, a submucosal tunneling instrument, a submucosal dissection instrument, and a mucosal resection device. A submucosal implant device for diagnosing and treating disorders of the body may be implanted. A passive submucosal implant device may take the form of a drug delivery depot in which a therapeutic agent within the depot elutes from the depot according to a predetermined elution profile. An active submucosal implant device may take the form of a drug delivery device that incorporates a self-contained diagnostic system to determine the appropriate delivery time and dosage of a therapeutic agent to be administered.

Abstract: An orifice device for delivering one or more drugs includes an inner member having a proximal end and a distal end; and a winding helically wound around the inner member. The winding includes a plurality of distinct wires helically wound in parallel around the inner member. The winding and the inner member define at least three separate channels for carrying one or more drugs therethrough. An inlet is at the proximal end of the winding and an outlet is at the distal end of the winding for the plurality of distinct wires. In some embodiments, at least two of the plurality of distinct wires have a different dimension. An outer member is used over the winding. Also, at least two of the at least three separate channels have a different fluid flow rate. And, in some embodiments, at least two of the at least three separate channels carry a different drug.

Abstract: A dispensing device for dispensing medicaments to a patient that is made up of first and second stand-alone, interconnectable assemblies. The first of these assemblies comprises a fluid reservoir assembly that houses a fluid reservoir defining component while the second assembly comprises a fluid delivery and control assembly that includes a novel flow control means that functions to control the flow of medicinal fluid from the fluid reservoir of the first assembly toward the patient via a plurality of fluid flow control passageways. Because the stand-alone fluid delivery and control assembly is initially totally separate from the fluid reservoir assembly of the apparatus, the fluid flow passageways of the fluid delivery and control assembly can be effectively sterilized using conventional gamma ray sterilization techniques without adversely affecting the medicament contained within the fluid reservoir of the apparatus.

Abstract: A method and system for non-vascular sensor implantation. An implant unit is implanted in an area of a body and a foreign body capsule is allowed to form around the area of the implant unit. The sensor may be directed into a body cavity such as, for example, the peritoneal space, subcutaneous tissues, the foreign body capsule, or other area of the body. A subcutaneous area of the body may be tunneled to place the sensor. The system may include an implant unit such as, for example, for delivering drug to a human body and a sensor for detecting a physiological parameter. The sensor may be separate from and connectable to the implant unit and may be placed in a non-vascular area of the human body.

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 drug-delivery chip and a method of fabricating the same are provided. The drug-delivery chip has a main body having at least one drug receiving space individually formed with an opening for storing drugs therein; a thin film for sealing up the at least one drug receiving space; a first conductive wire connecting to one end of the thin film; a second conductive wire connecting to another end of the thin film; a signal-receiving module for receiving actuated signals; and a control module for applying voltages to first and second wire conductive s according to the actuated signal, thereby generating heat to break off the thin film for the release of a drug or drugs received in the at least one drug receiving space.

Abstract: The present invention relates to a medical device for analyzing cardiac related input signals. The device is capable of receiving an ECG-signal and a nerve activity signal, such as vagus nerve signal in order to detect a cardiac related neural activity, such as epilepsy. The device is programmed for detecting a trigger feature (e.g. the R-peak) in the signal and extracting a nerve activity signal segment from the nerve activity signal in response to detecting the trigger feature. An activity related feature is generated either based on a combined signal obtained from a number of nerve activity signal segments, or as a segment-based activity related feature obtained from a number of nerve activity signal segments. Moreover, the device is adapted for comparing the activity related feature to a predefine criterion in order to detect the cardiac related neural activity.

Abstract: Featured is a method for instilling one or more bioactive agents into ocular tissue within an eye of a patient for the treatment of an ocular condition, the method comprising concurrently using at least two of the following bioactive agent delivery methods (A)-(C): (A) implanting a sustained release delivery device comprising one or more bioactive agents in a posterior region of the eye so that it delivers the one or more bioactive agents into the vitreous humor of the eye; (B) instilling (e.g., injecting or implanting) one or more bioactive agents subretinally; and (C) instilling (e.g., injecting or delivering by ocular iontophoresis) one or more bioactive agents into the vitreous humor of the eye.

Abstract: Apparatus is provided, including a housing (22), configured for insertion into a body of a patient; a photosynthetic oxygen supply (24) configured to supply oxygen; and functional cells (30), coupled to the housing (22). The functional cells (30) are adapted to receive the oxygen and to secrete at least one factor that induces vascularization in a vicinity of the housing (22) when the housing (22) is in the body of the patient. Other embodiments are also described.

Abstract: Methods, systems and devices for assessing residual insulin time of a patient are provided. In one embodiment, the method and the device can be implemented by receiving a confirmation that an insulin dose has been administered to the patient; repetitively receiving a value corresponding to the patient's blood glucose level; identifying at least two consecutively received values based on a predetermined criteria; and, selecting the residual insulin time corresponding to a time period between the confirmation that the insulin dose has been administered and a time corresponding to the identification of the at least two consecutively received values.

Abstract: A system for the controlled administration of a substance by means of an infusion device implanted in the human body is described. The system has an implantable unit for detecting a shortage or an excess of such substance or a physiological parameter correlatable to the shortage or excess of such substance, an infusion group of this substance implantable in the peritoneal cavity and having a central control unit for processing data received from the detection unit, and energy storage means to power such infusion group. The system also has a carrier of such substance adapted to be ingested, and a refilling device for refilling the infusion group with such substance.

Abstract: Implanted drug pump devices can be refilled via a fill port in the drug reservoir that includes a self-resealable septum.