Abstract: The present application provides a drug-delivery device comprising a drug reservoir chamber 16, containing a substance to be delivered, in fluid connection with a drug administration means 18, and an electrically-controlled battery unit 10 comprising at least one displacement-generating battery cell 19 coupled to the drug reservoir chamber 16 by a coupling means 14, the arrangement being such that the displacement derived from the battery unit 10 is conveyed by the coupling means 14 to the drug reservoir chamber 16 such that the substance is expelled from the drug reservoir chamber 16 towards the drug administration means 18.

Abstract: A remotely activated piezoelectric pump for delivery of biological agents to the intervertebral disc and spine in order to achieve spinal fusion. A spinal pump is implanted on the vertebrae of a patient and a spinal cage is inserted in between two adjacent vertebrae after removal of the vertebrae disc. A piezoelectric motor drives the pump and pushes osteogenetic agent through the spinal cage and into a sponge disposed within the cage. The pump is charged by an external removable induction belt worn by the patient. Delivery duration and delivery frequency may be changed before implantation of the spine pump according to the specific needs of the patient. The current device employs a mathematical model that enables the regulation as well as attenuation of the bone fusion process by extending and generalizing the model to enhance and optimize the delivery of osteogenetic agent in a regulated manner.

Abstract: An implantable percutaneous fluid delivery device is described that includes a subcutaneous base portion having one or more ports for supplying fluid to one or more implanted catheter devices and a percutaneous portion including an extracorporeal surface. The one or more ports of the subcutaneous base portion are accessible from the extracorporeal surface of the percutaneous portion. The subcutaneous base portion is at least partially insertable into a complementary recess formed in a bone, the subcutaneous base portion including one or more features for gripping the internal surface of such a complementary recess thereby directly anchoring the subcutaneous base portion to the bone. The device may be used to route fluid to neurosurgical catheters optionally via a router unit.

Abstract: Apparatus is provided including a housing, configured for insertion into a body of a subject, one or more oxygen reservoirs disposed within the housing, at least one layer of functional cells, disposed within the housing, and gaseous oxygen disposed within the one or more oxygen reservoirs. The apparatus is arranged to permit passage of the gaseous oxygen from the one or more oxygen reservoirs to the functional cells. The one or more oxygen reservoirs define first and second air gaps, the first air gap is configured to receive oxygen in a first concentration, and the second air gap is disposed adjacent to the layer of functional cells and stores the oxygen in a second concentration that is lower than the first concentration. Other applications are also described.

Abstract: A volume of an analyte-enriched fluid can be withdrawn out of a user's subcutaneous compartment using a patch unit that includes a reversible pumping mechanism. The volume can be withdrawn out of the body and into the patch unit through a cannula inserted into the subcutaneous compartment so that an analyte concentration in the volume can be measured using a sensing element within the patch unit. After analyte concentration analysis, at least the volume can be delivered back into the subcutaneous compartment by operating the pumping mechanism in a forward direction. biologically compatible fluid can optionally be pumped into the subcutaneous compartment from a reservoir in the patch unit and then allowed to partially or completely equilibrate with the analyte concentration in the interstitial fluid of the subcutaneous compartment via a permeable or semi-permeable cannula surface before being drawn back into the patch unit for analysis. Related systems, apparatus, methods, and/or articles are also described.

Abstract: A number of parameters related to the operation of a fluid delivery device are determined based on a pressure within the device sensed using a pressure sensor. In one example, the volume of therapeutic fluid added to or removed from a reservoir of a fluid delivery device is determined based on a sensed pressure of the reservoir. In another example, the volume of therapeutic fluid added to or removed from the reservoir is determined based on a sensed pressure of a refill port assembly of the device. In another example, an initial temperature of the reservoir as a therapeutic fluid is removed from the reservoir is estimated based on a sensed pressure within the device. In another example, a temperature of a therapeutic fluid added to the reservoir is estimated based on a sensed pressure within the device.

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: An implantable infusion system includes at least two controllable fluid transfer devices that may be used to transfer different fluid flows to the same or different body sites.

Abstract: A module producible inside a living body is provided. The module includes an instructions receiver configured to receive wireless transmissions of instructions from a master controller located outside of the body when the module is inside the body. An energy receiver configured to receive wireless transmission of non-destructive energy from the master controller located outside of the body when the module is inside the body. The module further includes a battery and a communications and guide element electrically connected to the instructions receiver, the energy receiver and the battery.

Abstract: The system of the present invention includes a conductive element, an electronic component, and a partial power source in the form of dissimilar materials. Upon contact with a conducting fluid, a voltage potential is created and the power source is completed, which activates the system. The electronic component controls the conductance between the dissimilar materials to produce a unique current signature. The system can also measure the conditions of the environment surrounding the system.

Abstract: An expiration time of a therapeutic fluid delivered by an implantable fluid delivery device is employed to calculate a fill volume and determine a refill interval for the fluid. The expiration time of the therapeutic fluid may be based on or dictated by a stability time set by the manufacturer of the therapeutic fluid, a clinician treating a patient to whom the fluid is to be delivered, the manufacturer of the device delivering the fluid, or combinations thereof.

Abstract: A drug delivery device utilizing compressible fluid chambers for actuation is disclosed. The device includes a compressible dispensing chamber situated in a first compartment and a compressible filler-fluid chamber in flow communication with the first compartment. The compressible dispensing chamber is attached with a reciprocating plunger for dispensing the drug fluid. The drug chamber is refillable with a refill container that uses a compressible pouch containing the refill drug fluid. The refilling process is failsafe enabled by the insertion of the refill container needle only at the correct position to activate an internal contact switch. The compressible-wall configurations enable low dispensing forces without leakage of the drug fluid.

Abstract: An arteriovenous graft system is described. The arteriovenous graft system includes an arteriovenous graft that is well suited for use during hemodialysis. In order to minimize or prevent arterial steal, at least one valve device is positioned at the arterial end of the arteriovenous graft. In one embodiment, for instance, the arteriovenous graft system includes a first valve device positioned at the arterial end and a second valve device positioned at the venous end. In one embodiment, the valve devices may include an inflatable balloon that, when inflated, constricts and closes off the arteriovenous graft. If desired, a single actuator can be used to open and close both valve devices.

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: A system and method are provided for securing an ingestible electronic device to a pharmaceutical product without damaging the ingestible electronic device. The product includes the ingestible electronic device being placed on the product in accordance with one aspect of the present invention. In accordance with another aspect of the present invention, the ingestible electronic device is placed inside the product. Various embodiments are disclosed in accordance with the present invention for protecting and/or coating of the electronic marker as well as securing the ingestible electronic device onto the product.

Abstract: A controller for an artificial pancreas for automated insulin delivery to patients with type 1 diabetes mellitus (T1DM) that enforces safe insulin delivery throughout both day and night, wherein the controller employs zone model predictive control, whereby real-time optimization, based on a model of a human's insulin response, is utilized to regulate blood glucose levels to a safe zone, and time-dependent zones that smoothly modulate the controller correction based on the time of day, wherein the controller strategically strives to maintain an 80-140 mg/dL glucose zone during the day, a 110-220 mg/dL zone at night, and a smooth transition of 2 hour duration in between.

Abstract: Devices, systems, and methods are described herein for controlling the level of one or more target cell types in the blood fluid and/or lymph fluid of a vertebrate subject. Devices and systems are provided that include a body defining at least one lumen configured for fluid flow; at least one controllable flow barrier to the at least one lumen; one or more sensor configured to detect one or more target cell types in blood fluid or lymph fluid of a vertebrate subject; at least one treatment region disposed within the at least one lumen; at least one reactive component disposed in the at least one treatment region; and at least one controller in communication with the one or more sensor and in communication with the at least one controllable flow barrier to the at least one lumen.

Abstract: An implantable medical device is disclosed that includes a valve body and a valve rotor adjustable with respect to the valve body. A tool can be utilized to determine and control a position of the valve rotor with respect to the valve body. The tool can include a valve body position reader, a valve rotor position reader and a valve rotor position controller to determine a valve setting for the device and adjust the valve setting as desired.

Abstract: An implantable pump includes a base plate and a can that are parts of the pump housing. The base plate bottom divides the housing into a first electronics chamber and a second chamber. A bellows mechanism is connected to the base plate and is disposed within the second chamber. The bellow mechanism has an expandable sidewall and a bottom plate. The bellow mechanism divides the second chamber into a medicament receiving portion and a non-medicament-receiving portion. The bellow mechanism has an intermediate plate disposed within the medicament-receiving portion. A coil is disposed in a recess on the lower surface of the base plate, and the coil is spaced from an internal wall of the recess. The amount of fluid remaining in the implantable pump can be monitored by energizing the coil. A primary magnetic field is generated by the energized coil.

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: Devices, systems and methods useable for dilating the ostia of paranasal sinuses and/or other passageways within the ear, nose or throat. A dilation catheter device and system is constructed in a manner that facilitates ease of use by the operator and, in at least some cases, allows the dilation procedure to be performed by a single operator. Additionally, the dilation catheter device and system may be useable in conjunction with an endoscope and/or a fluoroscope to provide for easy manipulation and positioning of the devices and real time visualization of the entire procedure or selected portions thereof. In some embodiments, an optional handle may be used to facilitate grasping or supporting a device of the present invention as well as another device (e.g., an endoscope) with a single hand.

Abstract: A cochlear implant electrode includes an implantable electrode carrier having an outer surface with electrode contacts for electrically stimulating nerve tissue of the inner ear of a patient. A drug lumen is within the electrode carrier and adapted to receive a therapeutic fluid. The drug lumen contains delivery openings to the outer surface of the electrode carrier and a hydrogel matrix disposed between the drug lumen and the one or more delivery openings and adapted to swell in volume when exposed to the therapeutic fluid. The hydrogel matrix is adapted to control diffusion of the therapeutic fluid from the drug lumen through the delivery openings to the outer surface of the electrode carrier.

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: Medical devices comprising an electroactive polymer powered by a photovoltaic cell. In one embodiment, the medical device has an electroactive component comprising an electroactive polymer. The medical device further comprises a photovoltaic cell as a source of electrical power for electrically stimulating the electroactive polymer. The medical device further comprises a first electrode and a second electrode, both of which are electrically connected to the photovoltaic cell. The electroactive component covers over at least a portion of the first electrode. Also disclosed is a method of treating a patient using a medical device having an electroactive polymer powered by a photovoltaic cell.

Abstract: An expansion device includes an inflatable balloon moveable from an unexpanded configuration to an expanded configuration configured to pass through soft tissue between two adjacent teeth of a patient when in the unexpanded configuration. The an expansion device also includes an inflation tube having one end connected to the inflatable balloon and another end serving as an entry port for an inflation fluid. The inflatable balloon has a triangular shape when in the expanded configuration.

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 molded from plasticized 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: 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: The invention relates to an infusion device for therapeutic use comprising a water-tight cover in the form of a housing, a housing part or a receptacle for holding said infusion device and a control system which is used for controlling the cover water tightness and comprises c) a medium arranged in the cover and characterized by at least one physical or chemical quantity variable according to the cover water tightness and d) an information system which automatically transmits at least one information signal when said quantity changes in such a way that the loss of the cover water tightness is indicated.

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

Abstract: A delivery system assembly includes an elongate outer tube, an elongate inner member extending within a lumen of the outer tube, and an articulation sheath surrounding the outer tube between a handle of the assembly and a distal-most portion of the outer tube. The outer tube is longitudinally moveable within the sheath; and an inner diameter of the sheath is preferably smaller than that of the handle and the distal-most portion of the outer tube. Navigation of the assembly through a venous system, for deployment of an implantable medical device, is facilitated by deflection of the sheath, to orient a distal-most portion of the outer tube, within which an entirety of the medical device is contained/loaded, and by subsequent advancement of the distal-most portion, with respect to the sheath, to move the distal end of the inner member, along with the contained/loaded device into proximity with a target implant site.

Abstract: An implantable electrode with a fluid reservoir is described. An implantable electrode carrier has an outer surface with electrode contacts for electrically stimulating nearby neural tissue. An enlarged fluid storage reservoir within the electrode carrier stores a treatment volume of therapeutic fluid for an extended therapeutic treatment period. At least one fluid delivery port connects the fluid storage reservoir to the outer surface of the electrode carrier for delivering the therapeutic fluid from the fluid storage reservoir to the outer surface.

Abstract: An infusion device having a housing with a reusable control portion and an expendable reservoir portion includes a precise drive for an infusion pump. The drive includes a piezoelectric bender assembly, a limiter and at least one contact stop. The piezoelectric bender assembly includes a cantilevered piezoelectric bender having an member of predetermined thickness fixed to move with the second end. A limiter of dimensionally stable material including a gap and at least a first mounting hole extending to the gap. The member of predetermined thickness extends into the gap. A first contact stop is positioned in the gap to define a critical gap distance limiting movement of the member of predetermined thickness in the gap. A base has a mounting surface, a port through the base and extending to the mounting surface. The port includes a first length having a smaller diameter at the mounting surface and a second length displaced from the mounting surface and having a larger diameter.

Abstract: Drug delivery systems, apparatus and methods to treat erectile dysfunction via an implanted drug infusion pump. The drug delivery system incorporates a passively pressurized drug infusion pump, one or more catheters, one or more microfluidic valves, a microcontroller, and one or more patient input mechanisms to deliver therapeutic solutions to the erectile tissues of a patient. The system in operation is entirely implanted and provides for moderated patient control over dosage via subcutaneously implanted input mechanisms, including in certain embodiments, neural control.

Abstract: A device (10) for receiving implanted biological material includes a mechanoprotective surface (16) defining an adjacent space, an assembly (26, 28) for locally delivering media to said space, and a pump or slow/sustained release reservoir structure (14) operatively coupled to the assembly. The device may comprise an additional plunger body for being disposed in said space. The implanted biological material may be encapsulated or non-encapsulated.

Abstract: A micromechanical pumping system is formed on a substrate surface. The pumping system uses a pumping element which pumps a fluid through valves which move in a plane substantially parallel to the substrate surface. An electromagnetic actuating mechanism may also be fabricated on the surface of the substrate. Magnetic flux produced by a coil around a permeable core may be coupled to a permeable member affixed to a pumping element. The permeable member and pumping element may be configured to move in a plane parallel to the substrate. The electromagnetic actuating mechanism gives the pumping system a large throw and substantial force, such that the fluid pumped by the pumping system may be pumped through a transdermal cannula to deliver a therapeutic substance to the tissue underlying the skin of a patient.

Abstract: A flow regulator (19, 208, 308, 408) may be used in a drug delivery system 10. The regulator includes a chamber that is divided by a diaphragm (111, 211, 311, 411) into a first and second subchamber. A third subchamber is in fluid communication with the first subchamber. A valve (26, 217, 317, 417) is operatively connected to the diaphragm, wherein pressure differences between the first subchamber and second subchamber result in movement of the diaphragm and movement of the diaphragm controls operation of the valve. A flow restrictor (116, 216, 316, 416) is in fluid communication between the first and second subchambers. Flow of a drug (11, 101) is thereby regulated.

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: Intravesical devices are provided that are wholly deployable within the bladder of a patient in need of treatment and are well tolerated by the patient. The device may include an elastic body having a retention shape having (i) dimensions that provide intravesical mobility and that prevent voiding of the medical device through the urethra, and (ii) dimensions, buoyancy, or both, that exclude the medical device from entering the orifices of the ureters. The elastic body may exert a maximum acting force less than 1 N when compressed to a shape with a maximum dimension in any dimension of 3 cm. The device may include a drug for controlled release within the bladder, for treatment of the bladder or a regional tissue. Methods of treatment are also provided that include selecting a patient in need of treatment in the bladder where tolerability of the treatment is a primary concern.

Abstract: Apparatus and methods for implanting ocular implants in eyes are provided which include a bent cannula having a lumen extending therethrough, the lumen having a length and a diameter and being configured to receive an ocular implant. The ocular implant is made up of a plurality of substantially uniformly sized particles, preferably a plurality of uniformly sized microspheres, arranged in a one-by-one array along the length of the lumen. The apparatus further comprises a mechanism for delivering the implant through the distal end of the lumen and into the eye, preferably without the use of a liquid or gel carrier medium located in the lumen along with the implant.

Abstract: A therapy system includes a therapy module implantable within a mammalian body that provides a given therapy and a control module implantable within the mammalian body that effects the therapy provided by the therapy module. The control module is physically separate from the therapy module.

Abstract: Devices and systems for transmitting information within a body are disclosed. An example system includes a signal generator configured for transmitting an acoustic interrogation signal, a sensor for sensing at least one parameter within the body and generating an electrical sensor signal, an acoustic transducer configured to convert a received acoustic interrogation signal into an electrical signal, and a switching element adapted to modulate a reflected acoustic wave from the acoustic transducer. The switching element is configured to controllably change the mechanical impedance of the acoustic transducer.

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

Abstract: 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: A device includes a first reservoir configured to include a degradation agent, a second reservoir configured to include an osteogenerative agent, and a controller configured to selectively initiate access to the first reservoir or the second reservoir.

Abstract: A device includes a sensor configured to determine a condition associated with a nucleus pulposus, a reservoir configured to include a first agent capable of affecting the condition associated with the nucleus pulposus, a control element configured to provide access to the reservoir, and a controller in communication with the sensor and the control element. The controller is configured to manipulate the control element to provide access to the reservoir in response to the condition determined by the sensor.

Abstract: Methods and systems for delivering toxin and toxin fragments to a patient's nasal cavity provide for both release of the toxin and delivery of energy which selectively porates target cells to enhance uptake of the toxin. The use of energy-mediated delivery is particularly advantageous with light chain fragment toxins which lack cell binding capacity.

Abstract: A method including introducing a treatment agent at a treatment site within a mammalian host; and introducing a bioerodable gel material at the treatment site. An apparatus including a first annular member having a first lumen disposed about a length of the first annular member and a first entry port at a proximal end of the first annular member, and a second annular member coupled to the first annular member having a second lumen disposed about a length of the second annular member and a second entry port at a proximal end of the second annular member, wherein the first annular member and the second annular member are positioned to allow a combining of treatment agents introduced through each annular member at the treatment site.

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

Abstract: A medical pump subassembly comprises a magnetic cup forming a recess. The magnetic cup includes a protrusion within the recess. The cup forms a central aperture through the protrusion. The medical pump subassembly further comprises an electromagnetic coil within the recess and circumscribing the protrusion, a weld ring surrounding the recess, a barrier plate covering the recess, and a seal between the weld ring and the barrier plate to fluidically separate an interior of the cup from an external surface of the barrier plate.

Abstract: Disclosed are methods and systems for automatically estimating the length of an implantable catheter by measuring the pressure decay response to pumping fluid through the catheter. The decay time for a unit fluid pressure pulse generated within the catheter is proportional to the catheter length, i.e. as the catheter length increases so does the decay time. The catheter length can therefore be estimated based on, e.g., the decay time of the pressure pulse. The estimated catheter length can also be analyzed to determine if it is representative of the actual catheter length, or, e.g., is affected by one or more catheter malfunctions including cuts and occlusions. Systems for automatically estimating the catheter length include an implantable catheter, a pumping mechanism, a pressure sensor configured to measure pressure within the catheter, and a processor that calculates the catheter length from a pressure pulse measured while delivering fluid through the catheter.