Abstract: Systems and methods are described for obtaining and acting upon information indicative of circulatory health and related phenomena in human beings or other subjects.

Abstract: The present invention comprises a modular, implantable medical device comprising a body portion capable of receiving a treatment device that accesses a patient's inner physiology while communicating with a device external to the patient. The body portion further includes a first skirt and a second skirt that surround the treatment device at its junction with the body portion. Both skirts are designed to gradually affix themselves into the surrounding tissues of the patient's body during an initial phase of healing. The first skirt is designed to separate from the device at a lower force than the second skirt such that during removal, the device and second skirt can be detached as a unit from patient's skin and first skirt without excessive force or trauma and the first skirt remains attached to the patient's skin as a permanent implant.

Abstract: Lumen-traveling biological interface devices and associated methods and systems are described. Lumen-traveling biological interface devices capable of traveling within a body lumen may include a propelling mechanism to produce movement of the lumen-traveling device within the lumen, electrodes or other electromagnetic transducers for detecting biological signals and electrodes, coils or other electromagnetic transducers for delivering electromagnetic stimuli to stimulus responsive tissues. Lumen-traveling biological interface devices may also include additional components such as sensors, an active portion, and/or control circuitry.

Abstract: Lumen-traveling biological interface devices and associated methods and systems are described. Lumen-traveling biological interface devices capable of traveling within a body lumen may include a propelling mechanism to produce movement of the lumen-traveling device within the lumen, electrodes or other electromagnetic transducers for detecting biological signals and electrodes, coils or other electromagnetic transducers for delivering electromagnetic stimuli to stimulus responsive tissues. Lumen-traveling biological interface devices may also include additional components such as sensors, an active portion, and/or control circuitry.

Abstract: Devices and methods are provided for controlled release of chemical molecules, such as drugs. One device comprises a plurality of reservoirs; a rupturable covering, such as a thin metal film, enclosing a first end of each reservoir; a release formulation in each reservoir comprising chemical molecules for release; an expanding material layer in each reservoir; and a semi-permeable membrane enclosing a second end of each reservoir distal the release formulation, the semi-permeable membrane being operable to permit selected molecules (e.g., water) from outside the reservoir to diffuse to the expanding material layer to expand the expanding material layer and displace the release formulation in an amount effective rupture the rupturable membrane and discharge the release formulation.

Abstract: A drive mechanism for delivery of infusion medium in an implantable medical device includes an inlet for receiving the infusion medium and a piston channel for communication of infusion medium received by the inlet. The piston channel has a distal end and a proximal end. The proximal end is closer to the inlet than the distal end. The drive mechanism further includes a coil surrounding the piston channel and a piston located within the piston channel and moveable axially within the piston channel to drive infusion medium out of the distal end of the piston channel. The mechanism also includes an armature operably coupled to the piston and disposed adjacent the coil. The armature has first and second opposing major surfaces and a plurality of vents extending through the armature from the first major surface to the second major surface. The plurality of vents cumulatively occupy between about 20% and about 40% of the total surface area of the first major surface.

Abstract: Systems and methods are described for implementing or deploying medical or veterinary utility modules comprising a first module operable in a digestive or respiratory tract to engage a second module, optionally by a magnetic field. Alternatively or additionally, systems may be operable to remain in situ and also operable to permit a therapeutic material dispensation. In some contexts, for example, systems or methods may dispense a therapeutic material via a subject's throat or elsewhere in the digestive or respiratory tract.

Abstract: Systems and methods are described for implementing or deploying medical or veterinary utility modules (a) operable for mooring at least partly within a digestive tract, (b) small enough to pass through the tract per vias naturales and including a wireless-control component, (c) having one or more attachment protrusions positionable adjacent to a mucous membrane, (d) configured to facilitate redundant modes of attachment, (e) facilitating a “primary” material supply deployable within a stomach for an extended and/or controllable period, (f) moored by one or more adaptable extender modules supported by a subject's head or neck, and/or (g) configured to facilitate supporting at least a sensor within a subject's body lumen for up to a day or more.

Abstract: Systems and methods are described for implementing or deploying medical or veterinary utility modules comprising a first module operable in a digestive or respiratory tract to engage a second module, optionally by a magnetic field. Alternatively or additionally, systems may be operable to remain in situ and also operable to permit a therapeutic material dispensation. In some contexts, for example, systems or methods may dispense a therapeutic material via a subject's throat or elsewhere in the digestive or respiratory tract.

Abstract: Systems and methods are described for implementing or deploying medical or veterinary utility modules (a) operable for mooring at least partly within a digestive tract, (b) small enough to pass through the tract per vias naturales and including a wireless-control component, (c) having one or more attachment protrusions positionable adjacent to a mucous membrane, (d) configured to facilitate redundant modes of attachment, (e) facilitating a “primary” material supply deployable within a stomach for an extended and/or controllable period, (f) moored by one or more adaptable extender modules supported by a subject's head or neck, and/or (g) configured to facilitate supporting at least a sensor within a subject's body lumen for up to a day or more.

Abstract: Systems and methods are described for implementing or deploying medical or veterinary utility modules (a) operable for mooring at least partly within a digestive tract, (b) small enough to pass through the tract per vias naturales and including a wireless-control component, (c) having one or more attachment protrusions positionable adjacent to a mucous membrane, (d) configured to facilitate redundant modes of attachment, (e) facilitating a “primary” material supply deployable within a stomach for an extended and/or controllable period, (f) moored by one or more adaptable extender modules supported by a subject's head or neck, and/or (g) configured to facilitate supporting at least a sensor within a subject's body lumen for up to a day or more.

Abstract: This invention provides a device for the controlled release of a substance and a method of controllably releasing a substance from a compartment.

Abstract: An infusion device for continuous infusion of medication is disclosed, in which infusion is controlled over two separate fluid communications. The infusion is in each fluid communication controlled by restricting means and valve means, and one of the fluid communications farther contains a holding device for bolus rate of infusion for a short period. The device comprises a flow regulating device comprising a passage defined by at least a first element and a second element, wherein at least one of the first and second element is a primary deformable element adapted to be elastically deformed so as to change the cross sectional area of the passage. Furthermore the device comprises a container for storage and supply of a medication in fluid form, said container comprising a first and a second chamber being arranged relatively to each other so that when volume of the first chamber Increases the volume of the second chamber decreases.

Abstract: An improved implantable valve accumulator pump for the delivery of medication is disclosed. The implantable pump comprises a pressurized drug reservoir. The medication metering assembly comprises a fixed volume accumulator positioned between a pair of valves. The valves alternately open and close to admit medication from the reservoir into the accumulator and to dispense a precise volume pulse to an outlet catheter. In order to improve the pump's accuracy and to increase pumping volume while optimizing the pump's overall size and energy usage a two way diaphragm accumulator is used. The unit can be externally programmed or can be used in a fixed rate configuration that is never programmed but set at the factory or in the current programmable configuration.

Abstract: A programming device for an implantable drug pump includes a display device, a communication device, and a controller. The communication device is adapted to facilitate a communication link between the programming device and an implantable drug pump. The controller is adapted to receive identification information for the implantable drug pump when the communications link has been established and, when the implantable drug pump has been identified, to control the display device to generate a graphical user interface which permits a user of the programming device to initiate a refill procedure for the implantable drug pump.

Abstract: An implantable medication delivery apparatus including a flow path coupling a medication reservoir to a device outlet port where the flow path includes a regulator means for limiting the magnitude of pressure transferred downstream from the medication reservoir. The regulator means is configured to respond to the reservoir pressure exceeding a certain threshold for closing a valve located downstream from the reservoir. The valve closure functions to isolate the device outlet port from further reservoir pressure increases which otherwise could induce unintended medication flow from the device outlet port.

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: An implantable fluid distribution device is described. The device includes a first inlet for receiving fluid under pressure from a remote pump. A plurality of outlets are also provided, each outlet being connectable to a fluid delivery catheter. A valve mechanism is arranged to control the passage of fluid from the first inlet to the plurality of outlets. Apparatus including the fluid distribution device, an implantable pump and a plurality of drug delivery catheters is also described. The fluid distribution device can be used to delivery drug to multiple regions in the body and the sequential delivery of drugs to different sites in the brain is disclosed.

Abstract: The invention relates to methods for the diagnosis, amelioration, and treatment of back pain, particularly lumbar back pain, in particular, back pain caused by muscular abnormalities, vertebral body osteoporosis, and disc degeneration. Patients with back pain are categorized into specific subsets that are deemed to have potential to respond to therapy. In particular, the invention includes a therapy involving stimulation of neovascularization so as to increase perfusion of various spine compartments.

Abstract: Methods, devices, and systems for performing a non-invasive form of angioplasty are provided. The device may include one or many magnetically controlled colloidal particles that can be used to scrub the interior walls of arteries or the like. The colloidal particles may be organized in any number of configurations and may also be moved in any number of ways in an effort to maximize the amount of plaque removed from the artery.

Abstract: The present invention relates to devices, systems, and methods for improving memory and/or cognitive function by brain delivery of compositions of small interfering RNA or vectors containing the DNA encoding for small interfering RNA. Such compositions can be administered using devices, systems and methods for direct delivery of the compositions to the brain, or using devices, systems, methods of delivery, and compositions that deliver small interfering RNA or vectors containing the DNA encoding the small interfering RNA across the blood-brain barrier. The present invention also provides valuable small interfering RNA vectors, and methods for reduction of BACE1 levels in the hippocampus, cerebral cortex, or other regions of the brain that have beneficial effects on improving memory and/or cognitive function in a subject.

Abstract: The invention relates to an arrangement for the remote-controlled release of active ingredients which are located with a magnetic body in a cavity and which are released under the influence of heat. A substantially biocompatible device, which avoids unnecessary thermal and electromagnetic loads, is created by producing the heat required for releasing the active ingredients by rotating the body in the fluid.

Abstract: Described herein is a system for intravascular drug delivery system, which includes a reservoir implantable a blood vessel, an intravascular pump fluidly coupled to the reservoir and an anchor expandable into contact with a wall of the blood vessel to retain the system within the vasculature. Delivery conduits may be extend from the reservoir and are positionable at select locations within the vasculature for target drug delivery to select organs or tissues.

Abstract: A device to determine the level of a substance of interest in a patient's body and provide a therapeutic amount of medicament is disclosed. The level of a substance of interest in the patient's body is determined by iontopheretically sampling the patient's blood and then analyzing the resulting sample to determine the level of the substance of interest. The information about the level of a substance of interest is transmitted to an implanted drug pump in the patient's body. In the preferred embodiment, the substance of interest sensor is an external sensor applied to the user's skin. In an alternate embodiment, the sensor may be implanted. The preferred method of transmitting information about the level of a substance of interest determined by the sensor is transmitted to an implanted drug pump in the patient's body is via a so called “body bus”. The “body bus” is a telemetry system where the patient's own body provides the interconnection between the iontopheretic device and the implanted drug pump.

Abstract: A method for titrating a drug to provide a medical therapy to a patient. The method includes the steps of providing an implantable medical device having a controller, providing one or more implantable sensors configured to sense physical parameters of the patient and configured to transmit signals to the controller. The method further includes the step of receiving signals from the one or more sensors at the controller. The method additionally includes processing the received signals to determine at least two cardiopulmonary characteristics of the patient. The method also includes determining a composite index based on the at least two cardiopulmonary characteristics. In addition, the method includes generating a signal based on the composite index. Medical device systems are also disclosed.

Abstract: A device to determine the level of a substance of interest in a patient's body and provide a therapeutic amount of medicament is disclosed. The level of a substance of interest in the patient's body is determined by iontopheretically sampling the patient's blood and then analyzing the resulting sample to determine the level of the substance of interest. The information about the level of a substance of interest is transmitted to an implanted drug pump in the patient's body. In the preferred embodiment, the substance of interest sensor is an external sensor applied to the user's skin. In an alternate embodiment, the sensor may be implanted. The preferred method of transmitting information about the level of a substance of interest determined by the sensor is transmitted to an implanted drug pump in the patient's body is via a so called “body bus”. The “body bus” is a telemetry system where the patient's own body provides the interconnection between the iontopheretic device and the implanted drug pump.

Abstract: A drug delivery safety system includes a programmer with a display and a communications device adapted to communicate with an ambulatory medical device. The programmer has access to a database of information, and is adapted to receive and process the information and a user input and to control the display to provide a graphical user interface that prompts a user of the programmer to provide an additional user input when the user input requests a drug delivery protocol for the ambulatory medical device that is not already stored in the database as a clinician-approved drug delivery protocol.

Abstract: Devices and methods are provided for the controlled release or exposure of reservoir contents. The device includes a substrate, a plurality of reservoirs in the substrate, reservoir contents disposed in the reservoirs, discrete reservoir caps covering each reservoir to seal the reservoir contents in the reservoirs, and control circuitry for selectively disintegrating the reservoir caps to release or expose the reservoir contents in vivo. At least one of the reservoir caps comprises a first electrically conductive layer coated with one or more protective layers. In one embodiment, the control circuitry comprises an electrical input lead and an electrical output lead connected to and directly contacting each of said reservoir caps and a source of electric power for applying an electrical current through each reservoir cap in an amount effective to rupture each of the reservoir caps.

Abstract: A shape memory material activated device of the present invention uses a shape memory material activator to create a path through a shell wall of the device. The path through the shell wall may release a substance contained in the shell or allow a substance to enter the shell. The path may be created by fracturing, puncturing, exploding, imploding, peeling, tearing, stretching, separating, debonding, abrading or otherwise opening the shell and, may be permanent or reversible. The substance may be released in one location while the device is stationary or along a path while it is traveling, self-powered by the shape memory material activator. In addition, the substance may be delivered to an object upon contact with its surface. The self powering abilities allow these devices to be used as substance delivery devices as well as actuators, transporters, and energy conversion systems with modular characteristics and growth potential.

Abstract: A device to determine the level of a substance of interest in a patient's body and provide a therapeutic amount of medicament is disclosed. The level of a substance of interest in the patient's body is determined by iontopheretically sampling the patients' blood and then analyzing the resulting sample to determine the level of the substance of interest. The information about the level of a substance of interest is transmitted to an implanted drug pump in the patient's body. The preferred method of transmitting information about the level of a substance of interest determined by the sensor is transmitted to an implanted drug pump in the patient's body is via a so called “body bus”. The “body bus” is a telemetry system where the patient's own body provides the interconnection between the iontopheretic device and the implanted drug pump.

Abstract: A body-insertable apparatus is introduced in a subject to perform at least one of input and output of a predetermined fluid to and from the subject. The body-insertable apparatus includes a reservoir (2) in which the predetermined fluid is stored; a first communicating channel (4) whose one end is opened to an inside of the reservoir, the first communicating channel (4) being extended in a predetermined direction; a second communicating channel (5) whose one end is opened to an outside space of the body-insertable apparatus, the second communicating channel (5) being extended in a direction substantially parallel to the first communicating channel (4), and the second communicating channel (5) partially running parallel to the first communicating channel (4); and a control mechanism (6) which controls a communication state between the first communicating channel (4) and the second communicating channel (5).

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: A compact fluid dispenser for use in controllably dispensing fluid medicaments, such as, antibiotics, analgesics, and like medicinal agents from the device reservoir. The fluid dispenser includes a unique stored energy mechanism which takes the form of a constant force spring member of novel design that provides the force necessary to continuously and substantially uniformly expel fluid from the device reservoir. The device also includes novel adjustable flow rate control assembly that is disposed intermediate the fluid reservoir outlet and the outlet port of the device for precisely controlling the rate of fluid flow from the outlet port toward the patient.

Abstract: Embodiments of the present invention provide a device for the local delivery of a substance into a natural tissue conduit in the mammalian body, having a first element capable of contacting the lumen of the conduit and a second element which overlays first element, a reservoir being formed between the first element and the second element, the interior of the reservoir being capable of fluid communication with the conduit such that a substance placed in the reservoir is delivered into the conduit. In embodiments, the first element may be fully or partially microporous or a separate intermediate microporous membrane may be provided. Also provided are methods of mixing or moving a drug within a reservoir using various mixing elements. Also provided are methods of locally delivering a substance into a natural tissue conduit in the mammalian body utilizing a device in accordance with embodiments of the present invention.

Abstract: An apparatus for refilling an implanted delivery device has a needle connected to an output port of a three-way valve. One input port is sealed and the other is connected to a fluid source. When the valve is in a fluid delivery position, fluid from the fluid source flows through the needle, and when the valve is in a stylet insertion position, fluid from the fluid source is prevented from flowing through the needle. When the valve is in the stylet insertion position, a stylet can be inserted through the second input port and into the lumen of the needle, thereby occluding the needle's lumen. In this configuration, a practitioner inserts the needle with stylet therein into the body of the patient to engage the devices's refill port. The stylet is removed, the fluid delivery path is opened, and medication is delivered to the device's reservoir without being contaminated with tissue.

Abstract: A shape memory material activated device of the present invention uses a shape memory material activator to create a path through a shell wall of the device. The path through the shell wall may release a substance contained in the shell or allow a substance to enter the shell. The path may be created by fracturing, puncturing, exploding, imploding, peeling, tearing, stretching, separating, debonding or otherwise opening the shell. The devices according to the present invention may be used as temperature sensors or warning devices, drug delivery devices, and the like.

Abstract: An electronic support system for controlling a biological data sensor and related methods of use are disclosed herein.

Abstract: Methods of making coated implantable medical devices are provided. The methods include positioning a first layer comprising a bioactive on at least a portion of a structure, and positioning at least one porous layer over the first layer. The at least one porous layer has a thickness adequate to provide a controlled release of the bioactive.

Abstract: An implantable drug delivery device includes a pump motor that is asserted by drive currents from a storage capacitor. A programmable rate charge control delivers charging current from a battery to the storage capacitor based upon a programmable charge rate value, a minimum battery voltage value, sensed charging current, and sensed battery voltage. When sensed battery voltage droops to below a threshold value, the charge control reduces the charging rate value until other electrical loads within the drug device have been serviced and battery voltage is restored. The charge control also monitors capacitor voltage and provides a charge complete signal to a motor control, which then connects the pump motor to the storage capacitor to produce a pump stroke. Efficiency of charging is enhanced by controlling the charging at a programmable substantially constant rate.

Abstract: The present invention discloses: (i) a novel, lactone-stable, “flipped” E-ring camptothecin, pharmaceutically-acceptable salts, and/or analogs thereof; (ii) methods of synthesis of said novel, lactone-stable, “flipped” E-ring camptothecin, pharmaceutically-acceptable salts, and/or analogs thereof; (iii) pharmaceutically-acceptable formulations comprising said novel, lactone-stable, “flipped” E-ring camptothecin, pharmaceutically-acceptable salts, and/or analogs thereof, and, optionally, one or more additional chemotherapeutic agents; (iv) methods of administration of said novel, lactone-stable, “flipped” E-ring camptothecin, pharmaceutically-acceptable salts, and/or analogs thereof, and, optionally, one or more additional chemotherapeutic agents, to subjects in need thereof; and (v) devices for the administration of said novel, lactone-stable, “flipped” E-ring camptothecin, pharmaceutically-acceptable salts, and/or analogs thereof, and, optionally, one or more chemotherapeutic agents, to subjects in need ther

Abstract: A body-insertable apparatus according to an aspect of the present invention is introduced into a subject to inject medical agent stored in a casing into a desired part in the subject. The body-insertable apparatus includes a fixing unit which fixes the casing to the desired part; and a projecting unit which projects, from the casing, an injection needle for injecting the medical agent. The fixing unit and the projecting unit are driven by a driving source.

Abstract: A closed system such as a TET system in which self-testing of all components of the implantable medical device whose malfunction could negatively impact on the proper operation of the closed system is automatically and periodically performed without triggering from an external device. In addition, a closed system including automatic, periodic self-testing of the implantable medical device in which, whenever practical, testing of the components is synchronized with telemetric communication of the external device whereby an external RF field generated by the external device is used to supply necessary power to perform self-testing.

Abstract: Treatment of aneurysmal blood vessels with local delivery of therapeutic agents thereby reduces or lessens the severity of an aneurysm, and, where used in conjunction with the placement of an excluding device, provides for more rapid recovery of the blood vessel from any disturbance occurring during placement of the excluding device. Therapeutic agents are placed in the aneurysmal site in a time-release carrier medium, such that the therapeutic agent is released into the aneurysmal site over a period of time without the need to provide systemic introduction of the therapeutic agent. The carrier may be introduced through the patient's dermis, such as with the use of a laparoscope, or intravascularly, through the use of a catheter. The carrier may be in a solid matrix, viscous liquid or liquid form.

Abstract: A drug delivery system and method in which an implantable medical device communicates with and controls an external drug delivery device with low energy potential signals. The implantable device generates potential signals modulated with digitally encoded command information by operating a current source to cause corresponding electrical potentials that can be sensed at the skin surface by the external drug delivery device. The drug delivery device then demodulates the sensed potentials and decodes the digital data to extract command information therefrom to deliver a drug accordingly.

Abstract: A method is provided for selectively opening a containment reservoir. The method includes providing a device which comprises a substrate in which at least one reservoir is located and covered by a reservoir cap; and directing laser light to said reservoir cap to cause the reservoir cap to disintegrate or become permeable. The device may be an implantable medical device. The reservoirs may contain a drug for controlled release or a biosensor.

Abstract: There are three distinct improvements on the Instant Face-Lifter -the prior art-: Field of Use “A”, an intra-scalp round or oval-shaped device made of a biocompatible material, typically measuring 5 12/16? long×4 12/16? wide, stretches the face's skin, instantly producing a younger look, by injecting saline through a septum into an accordion-type side walls saline reservoir located inside the device thus allowing the user to control at will the amount of skin-stretching. Field of Use “B” uses an Instant Face-Lifter as a stand or support for an intra-scalp metering pump fitted with an in-vein catheter, a liquid drug reservoir, a septum, and a rechargeable battery, as to allow the automated daily intravenous supply of pharmaceutical drugs, thus circumventing the need of uncomfortable daily shots.

Abstract: Coatings are provided in which surfaces may be activated by covalently bonding a silane derivative to the metal surface, covalently bonding a lactone polymer to the silane derivative by in situ ring opening polymerization, and depositing at least one layer of a polyester on the bonded lactone. Biologically active agents may be deposited with the polyester layers. Such coated surfaces may be useful in medical devices, in particular stents.

Abstract: The application provides a device (10) for the controlled release of a predefined quantity of a substance from a compartment (20). The device comprises a matrix arrangement of compartments in a substrate, each compartment being closed by at least one release mechanism, at least one first electrode (40) and at least one second electrode (50) being assigned to each compartment, the device comprising a plurality of selection lines (60) and a plurality of signal lines (70), the number of compartments exceeding the sum of the number of selection lines and the number of signal lines, each first electrode or each second electrode being electrically connected via at least one active component to one of the plurality of selection lines and/or to one of the plurality of signal lines.

Abstract: Disclosed herein are biointerface membranes including a macro-architecture and a micro-architecture co-continuous with and bonded to and/or located within at least a portion of the macro-architecture. The macro- and micro-architectures work together to manage and manipulate the high-level tissue organization and the low-level cellular organization of the foreign body response in vivo, thereby increasing neovascularization close to a device-tissue interface, interfering with barrier cell layer formation, and providing good tissue anchoring, while reducing the effects of motion artifact, and disrupting the organization and/or contracture of the FBC. The biointerface membranes of the preferred embodiments can be utilized with implantable devices such as devices for the detection of analyte concentrations in a biological sample (for example, from a body), cell transplantation devices, drug delivery devices, electrical signal delivering or measuring devices, and/or combinations thereof.

Abstract: An implantable bolus injector having a battery, an electronic control unit and an injector including a shape memory alloy spring, a standard low-tension spring, and a threaded top part with a stainless steel cannula. The electronic control unit is connected to the shape memory alloy spring via a direct connection to the lower part of the spring and via the low-tension spring that ensures a connection between the spring and the control unit during the expansion of the shape memory alloy spring.