Abstract: The invention relates to an ingestible, implantable or wearable medical device comprising a microarray which comprises a bioactive agent capable of interacting with a disease marker biological analyte; a reservoir which comprises at least one therapeutic agent and is capable of releasing the therapeutic agent(s) from the medical device; and a plurality of microchips comprising a microarray scanning device capable of obtaining physical parameter data of an interaction between the disease marker biological analyte with the bioactive agent; a biometric recognition device capable of comparing the physical parameter data with an analyte interaction profile; optionally a therapeutic agent releasing device capable of controlling release of the therapeutic agent from the reservoirs; an interface device capable of facilitating communications between the microarray scanning device, biometric recognition device and the therapeutic agent releasing device; and an energy source to power the medical device.

Abstract: The present invention relates to generation of cell lines expressing recombinant proteins for use in naked and encapsulated cell biodelivery of secreted therapeutic molecules. In one embodiment the cell line is human. In another aspect of the invention the transposon system is used for generating a cell line for secretion of a biologically active polypeptide.

Abstract: Method and system for providing an integrated analyte monitoring system and on-body patch pump with multiple cannulas and a sensor combination is provided.

Abstract: The subject matter disclosed herein provides a response to a dose of a substance and/or controls the administration of the dose. In one aspect, there is provided a system. The system may include a processor and at least one memory configured to provide a response determinator. The response determinator may receive therapeutic and wellness data. Moreover, the response determinator may determine a response based on the received therapeutic and wellness data. The response may represent a reaction to a substance integrated with an ingestible event marker. The determined response may be provided to, for example, a therapy controller. Related systems, methods, and articles of manufacture are also described.

Abstract: A system and a manufacturing process are disclosed in accordance with the present invention that protect an electronic device and allows for placement or combination of the device within a pharmaceutical product or capsule. The system includes circuitry and components that can be placed within certain environments. The device includes an assembly including an electronic unit, a flexible membrane secured to the unit, and a protective coating.

Abstract: A catheter pump is disclosed herein. The catheter pump can include a catheter assembly that comprises a drive shaft and an impeller coupled to a distal end of the drive shaft. A driven assembly can be coupled to a proximal end of the drive shaft within a driven assembly housing. The catheter pump can also include a drive system that comprises a motor and a drive magnet coupled to an output shaft of the motor. The drive system can include a drive assembly housing having at least one magnet therein. Further, a securement device can be configured to prevent disengagement of the driven assembly housing from the drive assembly housing during operation of the pump.

Abstract: Implantable devices and methods for delivering drugs and other substances to locations within the body of a human or animal subject to treat or diagnose sinusitis and a variety of other disorders. The invention includes implantable substance delivery devices that comprise reservoirs and barriers that control the rate at which substances pass out of the reservoirs. The delivery devices may be advanced into the body using guidewires, catheters, ports, introducers and other access apparatus. In some embodiments the delivery devices may be loaded with one or more desired substance before their introduction into the body. In other embodiments the delivery devices are loaded and/or reloaded with a desired substance after the delivery device has been introduced into the body.

Abstract: In one embodiment, an IDDC system utilizes an intelligent therapeutic agent delivery system comprised of one, but more likely an array of “cells” containing therapeutic agent(s) and/or diagnostic agents(s); an integrated bio-sensing system designed to sample and analyze biological materials using multiple sensors that include both hardware and software components. The software component involves biomedical signal processing to analyze complex liquid mixtures and a microcontrollers) acts as interface to the biosensors, to the therapeutic delivery elements, and to a communications system(s) for the purpose of controlling the amount of therapeutic agent to deliver and also to provide information in a useful form to interested parties on the progress of therapy and compliance thereto.

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

Abstract: This document discusses, among other things, an apparatus comprising a lacrimal implant insertable at least partially into a lacrimal punctum. The lacrimal implant comprises an implant core, and an implant body. The implant body includes a cavity sized and shaped to receive the implant core. At least one of the implant core and the implant cavity includes a detection device configured to allow automatic detection of the lacrimal implant with a separate detector device.

Abstract: The present invention provides a drug delivery device comprising a drug reservoir chamber (15) containing a substance (16) to be delivered in fluid connection with a drug administration means (17) and (18), and a hydraulic control chamber (9) containing an electrically controlled, non-gassing, volume changing means (13), a coupling means (14) coupling said hydraulic control chamber (9) to said drug chamber (15), the arrangement being such that a change in the electrical control means (11) causes a change in the volume of the volume changing means (13), the volume change being conveyed by the coupling means (14) to the drug chamber (15) such that the substance (16) is expelled from the drug chamber (15) towards the drug administration means (17) and (18).

Abstract: A capsule configured for in vivo refilling of a therapeutic agent. In certain embodiments, the capsule may contain methotrexate.

Abstract: An implantable oxygen generator system is disclosed. The implantable oxygen generator system includes a receiver configured to generate an electrical current, and an electrode set configured to deliver the electrical current to water molecules of an interstitial fluid within a tissue, wherein the electrical current electrolyzes the water molecules into oxygen molecules.

Abstract: A system for performing an intraparenchymal drug infusion including a pump device, a delivery tube, a sensor, and a processor. The tube is fluidly coupled to the pump device, establishing an infusate pathway from the pump to an infusate exit port of the delivery tube. The sensor is positioned to sense a parameter indicative of pressure in the infusate pathway. Finally, the processor is programmed to generate information indicative of infusate delivery effectiveness of a drug infusion procedure based upon information from the sensor. In some embodiments, the processor generates a net infusion pressure profile, such as a pressure-time curve, and prompts display of the pressure profile to a neurosurgeon for subsequent evaluation of infusate delivery effectiveness.

Abstract: Described herein are systems, devices, and methods for the delivery of substances to, or the sampling of substances from, a patient using a portable and preferably implantable device. The substances introduced to and/or taken from the patient are preferably fluidic and are driven by a miniature pump, such as a microimpedance pump. A number of design variations are explicitly and implicitly described, such as the use of multiple pumps and multiple reservoirs for containing medicaments. Methods of manufacture of these systems and devices are also described, for instance, using molding, micromachining, or lithographic processes.

Abstract: A nanochannel delivery device and method of manufacturing and use. The nanochannel delivery device comprises an inlet, an outlet, electrodes and a nanochannel. The nanochannel may be oriented parallel to the primary plane of the nanochannel delivery device. The inlet and outlet may be in direct fluid communication with the nanochannel.

Abstract: An implantable medical device is configured with a pressure sensor arranged within the device to reliably and accurately measure the pressure within a propellant gas chamber at least partially surrounding a therapeutic fluid reservoir of the device. In one example, a housing of the IMD includes a protrusion that is configured to provide clearance for fluid communication between a propellant gas chamber pressure sensor and the propellant gas chamber.

Abstract: A portable personal medical device, e.g., a wearable insulin pump, is provided with a web server and is controllable over a network by a browser equipped client, thereby enabling comprehensive and comfortable control, operation and/or configuration of the device.

Abstract: An alarm system (52) for a medical pump (50) associated with delivering a fluid (54) to a patient in connection with treatment of the patient is provided. The alarm system (52) comprises an alarm (60) associated with at least one treatment parameter. The alarm (60) includes a first alarm state (1) associated with a first event relating to the treatment parameter and a second alarm state (2) associated with a second event. The second alarm state (2) is discernable from the first alarm state (1), which will allow each of the events to be treated differently by a caregiver.

Abstract: Provided is a capsule type medical device which is able to be suspended in a body cavity. The capsule type medical device performs continuous treatment while being suspended at a predetermined site.

Abstract: The present invention relates to devices and systems that alter intracranial compliance, cerebral blood flow and/or intracranial pressure pulsatility/waveform by oscillating the contraction and expansion of a compressible composition within the cranial or spinal cavities such that they increase intracranial capacity. The contraction and expansion of the compressible composition in the oscillating compliance devices can be due to an individual's intracranial pressure, the result of the expansion and compression of a reservoir which is mediated by the contractility of the heart or driven by a pump gaited to a biorhythm. The invention also relates to methods for protecting an individual's brain from abnormal arterial pulsations and for altering an individual's cerebral blood flow using the devices and systems of the invention.

Abstract: Provided is a bacterium-based microrobot, wherein bacteria are attached to a part of a surface of a microstructure including at least one or more magnetic particle, for actuating a bacterium-based microrobot more effectively.

Abstract: A subarachnoid pharmacodialysis apparatus insertable under the scalp, in and under the cranium, with a relatively short and simple neurosurgical procedure, to be kept there safely implanted for a year or longer for the purpose of regulating the neurochemistry of one or more diseased cerebral cortical areas and thus to achieve therapeutic effects via both localized delivery of medication and drainage of local neurotoxic molecules across the subdural meninges and compartments in a feedback-controlled fashion, with or without the additional capability of performing localized neurochemistry regulation in subcortical areas. This apparatus is also used for neurochemical profiling of the diseased brain area or areas by analyzing the removed endogenous molecules and adjusting the composition of the delivered medication based on the patient's specific, abnormal neurochemistry within the treated area or areas.

Abstract: Systems and methods for delivering a drug or other therapy over an extended period of time (e.g., several hours, days, weeks, months, years, and so forth) are disclosed herein, as are systems and methods for monitoring various parameters associated with the treatment of a patient. Systems and methods are also disclosed herein that generally involve CED devices with various features for reducing or preventing backflow.

Abstract: A fluid delivery system includes an implantable fluid source, a first catheter in fluid communication with the implantable fluid source, and an implantable micro-valve in fluid communication with the first catheter, the micro-valve configured to be located within a round window or to be secured to a promontory bone of a cochlea

Abstract: A fluid transfer device with a fluid transfer device housing, including a bore and a valve seat that extends around the bore, configured to be carried within the implantable medical device, a piston located within the bore, and a valve element movable relative to the valve seat. One of the valve seat and the valve element includes a main portion and a seal portion that is less tacky than the main portion and is in contact with the other of the valve seat and the valve element when the valve element is in the closed position.

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, an acoustic control signal may be used.

Abstract: An implantable medical device with a reservoir including a movable reservoir member, a fill port in fluid communication with the reservoir, and a valve that includes a housing including an opening in fluid communication with the fill port and the reservoir and a valve seat adjacent to the opening, and a valve element, operably connected to the movable reservoir member, that is movable relative to the valve seat between a closed position and an open. One of the valve seat and the valve element includes a main portion and a seal portion that is less tacky than the main portion and is in contact with the other of the valve seat and the valve element when the valve element is in the closed position.

Abstract: A method and apparatus for infusing medication into a patient's body using a medication chamber referenced to ambient pressure. The apparatus includes a medication chamber enclosed by a peripheral wall which includes a movable portion configured to transfer exterior ambient pressure into the chamber. Means are provided for exerting a negative bias force acting on the movable portion in a direction opposed to the ambient pressure force. Thus, the resultant pressure in the chamber will be negative with respect to ambient pressure, reducing the risk that the chamber can be overpressurized and produce an unintended medication discharge.

Abstract: A method for evaluating dosing from an implanted infusion system that includes receiving input regarding the identity of a therapeutic agent into an external device. The method further includes displaying on the external device a predetermined set of symptoms associated with the therapeutic agent; receiving input into the external device regarding with which of the symptoms the patient presents; and determining whether the therapeutic agent is being delivered, or has been delivered, at an appropriate dose based on the input identity of the therapeutic agent and the input symptoms.

Abstract: A penis erection stimulation system comprises one or more infusion needles disposed within and implanted along with one or more housings adjacent the patient's left and right corpora cavernosa. A reservoir and a pump are also implanted inside the patient's body to supply the infusion needle with infusion liquid. A drive unit also adapted for implantation inside the patient's body is arranged for advancing and retracting the tip end of the infusion needle such that it penetrates the housing in at least one penetration area, preferably in two different penetration areas either simultaneously or in immediate time succession, thereby injecting drugs along with the infusion liquid into the patient's body for stimulating penis erection. The drive unit is provided for implantation remote from the injection area and comprises a mechanical drive element for transmitting kinetic energy from a remote location within the patient's body to the at least one infusion needle.

Abstract: The filling status of a drug reservoir in a drug pump devices may be determined with mechanical and/or magnetic position sensor associated with a reservoir boundary.

Abstract: A spiral-coil antenna conforming to a non-planar contour is deployed, in various embodiments, in an implantable device for controllably ejecting fluid into an anatomic region. The antenna facilitates wireless communications with the implantable device and external charging thereof. In one implementation, the device has a non-planar contour and the spiral coil defines a non-planar surface conforming to the non-planar contour.

Abstract: Disclosed is an implantable device for drug delivery operated by a magnetic force. The device is provided with a body member and an external magnetic controller which is able to move some of the parts in the body member so that the drug inside the body member can be delivered to a site of interest of the animal body without the extra power source.

Abstract: A therapeutic agent reservoir comprises a reservoir body comprising a polymer and a therapeutic agent mixed within the polymer, and an outer coating enclosing the reservoir body, wherein at least a portion of the outer coating comprises a rate-controlling membrane configured to provide a predetermined release rate of the therapeutic agent through the rate-controlling membrane.

Abstract: Electronic pill (1, 11) comprising at least one medicine reservoir (2, 12) with a solid powder or granulate medicine, a discharge opening (3, 13) and an actuator responsive to control circuitry for displacing medicine from the reservoir (2, 12) to the discharge opening (3, 13). The medicine comprises a dispersion of one or more active ingredients—e.g., solids in powder or granulate form—in an inert carrier matrix. Optionally, the active ingredients are dispersed using intestinal moisture absorbed into the pill via a semi-permeable wall section (14).

Abstract: A drug delivery device which includes a fluid drug reservoir, a catheter, a controllable fluid transfer device, e.g., a pump mechanism or valve, and a drug delivery control means: The drug delivery control means comprises a controller, e.g., a microprocessor or microcontroller which is operable to automatically reduce the rate of drug delivery over a certain reduction interval (e.g., multiple days) from an initial dosage value to a final dosage value.

Abstract: Embodiments of a material delivery device including a deformable reservoir and associated controllable output mechanism are described. Methods of use and control of the device are also disclosed. According to some embodiments, a material delivery device may be placed in an animal in order to controllably dispense at least one material into the animal. The material delivery device may include a programmable mechanism to control the release of the material into the animal. In selected embodiments, a remote controller may be used to program or to control the material delivery device. Some embodiments are described wherein a magnetic field, an electric field, or electromagnetic control signal may be used.

Abstract: An at least partly implantable system for injecting a substance into a patient's body, in particular a penis erection stimulation system, comprises an infusion device (11) adapted for implantation inside the patient's body and at least one reservoir (R1, R2) adapted for implantation inside the patient's body in fluid connection with the infusion device to supply to the infusion device a substance to be injected into the patient's body. The reservoir comprises at least one first compartment accommodating or adapted to accommodate a first substance and at least one second compartment accommodating or adapted to accommodate a second substance, in particular a drug for stimulating penis erection. As a penis erection stimulation system, the infusion device preferably comprises one or more infusion needles disposed within and implanted along with one or more housings adjacent the patient's left and right corpora cavernosa.

Abstract: The invention relates to an intraruminal sustained release capsule which is capable of delivering a sustained release dose of a first medicament to an animal, as well as either or both of a dump dose of a second medicament or mineral, and an exit dose of a third medicament or mineral. The capsule can have a dissolvable overcap moulded from plasticised starch enabling a dump dose of medicament to be held between the overcap and one end of the capsule. A piston within the body of the capsule can be modified to enable it to accommodate an exit dose of medicament within its hollow interior which is aligned with an aperture at the end of the capsule which enables release of the medicaments to the rumen. After insertion of the capsule in the animal the overcap (if present) dissolves and separates from the capsule to release the dump dose of medicament. The sustained release medicament is then dispensed via the apertured end, followed by the release of the exit dose of medicament (if present).

Abstract: Disclosed are lacrimal inserts and their method of use for delivery of medication to the eye. The plug includes a body portion sized to pass through a lacrimal punctum and be positioned within a lacrimal canaliculus of the eyelid and includes means for directional release of medication into the lacrimal fluid. The plug may contain a core, or reservoir, at least partially within the body portion comprising a therapeutic agent that is configured to controlled release into the eye.

Abstract: The invention pertains to an applicator (1) for inserting an implant, in particular a rod-like implant (2) containing an active substance, under the skin of a human or animal, comprising a housing (3), a cannula (6) extending from the housing (3), and a handle (15) for grasping and maneuvering the applicator (1) and the cannula (6) during insertion of an implant (2). In accordance with the invention, the handle (15) extends above at least part of the length of the cannula (6). Such a handle facilitates insertion of the cannula and/or accurate positioning of the implant.

Abstract: Devices and methods are provided for transmucosal drug delivery. The transmucosal drug delivery device may include a housing configured for intralumenal deployment, such as intravaginally, into a human or animal subject; a drug-dispensing portion which contains at least one drug, the drug-dispensing portion being configured to dispense the drug from the housing by positive displacement; and a permeability enhancer-dispensing portion configured to release or generate a permeability enhancing substance to disrupt at least one region of a mucosal barrier adjacent to the housing at a selected time while intralumenally deployed in the human or animal subject. The device may be operable to dispense the drug from the housing to a region of the mucosal barrier disrupted by the permeability enhancing substance.

Abstract: Systems, devices, methods, and compositions are disclosed which include an actively-controllable implantable device configured to, for example, capture and/or release biochemical and/or biological cells in a subject.

Abstract: Systems, devices, methods, and compositions are disclosed which include an actively-controllable implantable device configured to, for example, capture and/or release biochemical and/or biological cells in a subject.

Abstract: Devices of this invention include replaceable cartridges for delivery of doses of fluids. Cartridges having a fluid supply reservoir comprising an expandable element are designed to be connected with non-disposable actuating module supplied with a sensor, a mechanism to apply a force to the fluid, thereby forcing a predetermined dose out of the reservoir, and a processor providing control outputs from a sensor system according to preprogrammed instructions. Methods of this invention include delivery of microdoses of fluids using devices of this invention.

Abstract: Embodiments of the invention provide swallowable devices, preparations and methods for delivering drugs and other therapeutic agents within the GI tract. Some embodiments provide a swallowable device such as a capsule for delivering drugs into the intestinal wall or other GI lumen. The device comprises a capsule sized to be swallowed and pass through the intestinal tract. The capsule can include at least one guide tube, one or more tissue penetrating members positioned in the guide tube, a delivery member, an actuating mechanism and a release element. The release element degrades upon exposure to various conditions in the intestine so as to release and actuate the actuating mechanism. Embodiments of the invention are particularly useful for the delivery of drugs which are poorly absorbed, tolerated and/or degraded within the GI tract.

Abstract: A venous access port assembly having a housing base, a flange, and a septum. The housing base defines an interior reservoir. The flange includes integrally molded X-ray discernable indicia identifying that the assembly is rated for power injection. The X-ray discernable indicia may extend through a height of the flange from a top surface to a bottom surface of the flange. According to one aspect, the flange may be formed from X-ray discernable material, and the X-ray discernable indicia may be formed from the X-ray discernable material of the flange, or they may be formed by voids in the X-ray discernable material. According to another aspect, the flange may be formed from a radiotransparent or radiolucent material and applied with a radiopaque agent, and the X-ray discernable indicia may be one or more voids in the radiopaque agent or may be portions of the flange applied with the radiopaque agent.

Abstract: Methods and systems for transvenously accessing the pericardial space via the vascular system and atrial wall, particularly through the superior vena cava and right atrial wall, to deliver a pharmacologic agent, particularly a NO-donor drug, to the heart are disclosed. A proximal connector of an infusion catheter is coupled to an infusion pump, and a distal catheter segment having a distal infusion catheter lumen end opening is disposed in the pericardial space. The implantable infusion pump is operable in conjunction with an implantable ischemia monitor to monitor the ischemic state and trigger delivery or regulate the periodic delivery of the pharmacologic agent to optimally treat ischemia. The patient may operate a patient activator that the patient when feeling ischemia symptoms to transmit a signal that is received by the implantable infusion pump and triggers delivery of a bolus and/or continuous infusion.

Abstract: An implantable intragastric volume occupying device system is provided which generally includes a volume occupying device and an active agent, for example, a metabolic agent or satiety inducing agent. The volume occupying device may be structured to contain the agent and permit controlled release of the agent to the patient while the volume occupying device is positioned within the patient's stomach. Methods for treating obesity are also provided which include positioning a volume occupying device in the stomach of a patient and administering a satiety inducing agent to the patient while the volume occupying device is positioned in the stomach. In one embodiment, the active agent may be contained in a reservoir and dispensed to a portion of the patient's body.