Abstract: A wearable insulin dispensing device has features and operation characteristics supporting and easing compliance by the users of the device. For example, the device may provide capabilities of rendering a very specific and well-tuned dosage which may be altered according to the specific development of the individual user.

Abstract: A system and process for providing safety limits on the delivery of an infusion formulation by an infusion pump system in response to a sensed biological state. The safety limits may comprise user-initiated event signals corresponding to events that may significantly affect the biological state. The safety limits may further comprise user-initiated event ranking signals for respective events which specify a degree, quantity, or measure for the respective event The user-initiated event and event ranking signals may be communicated to a computing element associated with the infusion pump by an associated communication device having a user interface which comprises a plurality of user-selectable operators for entering information about the events and event rankings.

Abstract: A pump assembly and maintenance system and method. An inventory of pump components has an identifier to track the pump component and a sensor to gather operating data associated with the pump component. A population of pumps is assembled from the pump components. The operating data are correlated with the pump components based on the identifiers in a network-accessible database. The pump components can include interchangeable pump body modules that are separately tracked, whereby the pumps can be repaired by removing and replacing the interchangeable pump body modules.

Abstract: An administration device for the administration of a liquid drug in adjustable doses may comprise an injection unit and an electronic indication unit. The injection unit may comprise a dosing mechanism and a manually operated dose setting component. The manually operated dose setting component may adjust the dosing mechanism to administer an administration dose amount of the liquid drug. The electronic indication unit may indicate a relationship between the administration dose amount and a target dose amount. A method for setting a dose of a liquid drug for administration may comprise providing an administration device, operating a manually operated dose setting component of the administration device, and continuing to operate the dose setting component until an electronic indication unit indicates that the administration dose amount is equal to the target dose amount.

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. Some involve implementing or deploying therapeutic administration systems, for example, for obtaining a priori implant information and signaling a decision whether to initiate implant-site-targeting treatment; or obtaining a flow-change-indicative measurement and signaling a decision whether to administer a clot-reducing agent; or obtaining an indication of a lytic material in a vicinity of a body lumen and accelerating a decrease in a local concentration of the lytic material to extract at least a portion of the lytic material in response to the indication; or a capture component configured to accelerate a decrease in a local concentration of a therapeutic structure along a downstream portion of a vasculature and a dispensation component configured to release the therapeutic structure into an upstream portion of the vasculature.

Abstract: A system comprising means for obtaining a signal representative of the electrocortical activity of the patient, means for analyzing this signal in order to derive from it a signal of depth of anaesthesia, means for monitoring the value and development over time of this signal of depth of anaesthesia, these means being associated with means for calculation of control commands of the injection means, in order to regulate automatically in closed loop the signal of depth of anaesthesia in a predetermined range around a target value, and in that the means for injection of anaesthetics comprise first means for injection of a hypnotic that receive control commands at a first frequency, and second means for injection of a morphinomimetic that receive control commands at a second frequency higher than the first frequency.

Abstract: A method of facilitating delivery of a discretionary dose of insulin to a user includes: enabling the user or a caregiver to specify, via a computer-based user interface, parameters associated with a discretionary delivery of insulin that may be delivered to the user; subsequently receiving data that represents the user's glucose level during a period of time associated with the discretionary delivery; automatically determining, with a computer-based processor, based on the received data, if, when and how much discretionary insulin should be delivered to the user during the period of time associated with the discretionary delivery; delivering insulin to the user during the period of time associated with the discretionary delivery according to the automatic determination; and delivering insulin to the user with the insulin delivery device according to a non-discretionary insulin delivery schedule unless a discretionary insulin delivery mode has been triggered.

Abstract: A microenvironment of a biological body is controlled, and more particularly, is measured, changed, and monitored with respect to temperature, pH level, moisture and other tissue parameters of a region of the body while, optionally, administering a therapeutic agent to that region.

Abstract: A method for pairing a handheld diabetes managing device with an insulin pump for secure wireless communication with limited user interaction. A pump identification code that uniquely identifies the insulin pump can be displayed on the diabetes managing device and insulin pump. The diabetes managing device can receive an insulin pump selection input that selects the pump identification code corresponding to the insulin pump. The diabetes managing device and insulin pump can generate and display a first verification string and second verification string, respectively. Confirmation inputs corresponding to the first verification string matching the second verification string can be received at both the insulin pump and the diabetes managing device such that a secure bidirectional communication link between the diabetes managing device and the insulin pump is established.

Abstract: An infusion system, which may be a closed loop infusion system or “semi-closed-loop” system, uses state variable feedback to control the rate that fluid is infused into the body of a user. The closed loop infusion system includes a sensor system, a controller, and a delivery system. The “semi-closed-loop” system further includes prompts that are displayed or sounded or otherwise provide indications to the user prior to fluid delivery. The sensor system includes a sensor for monitoring a condition of the user. The sensor produces a sensor signal, which is representative of the condition of the user. The delivery system infuses a fluid into the user at a rate dictated by the commands from the controller. The system may use three state variables, subcutaneous insulin concentration, plasma insulin concentration, and insulin effect, and corresponding gains, to calculate an additional amount of fluid to be infused as a bolus and to be removed from the basal delivery of the fluid.

Abstract: Disclosed is a medical device to treat diabetes. The medical device includes a bolus calculator to determine an insulin bolus based on, at least in part, a glycemic index value associated with an intake to be consumed by a user, the bolus calculator further adapted to determine the insulin bolus using one or more inputs selected from the group consisting of a carbohydrate load of the intake, a current glucose level of the user, a residual insulin of the user, a carbohydrate to insulin ration, an insulin sensitivity of the user and a target glucose level of the user. The bolus calculator is housed in one or more of, for example, an insulin dispensing pump, a handheld remote control unit for the insulin dispensing pump and/or a handheld glucose monitor.

Abstract: An integrated system for the monitoring and treating diabetes is provided, including an integrated receiver/hand-held medicament injection pen, including electronics, for use with a continuous glucose sensor. In some embodiments, the receiver is configured to receive continuous glucose sensor data, to calculate a medicament therapy (e.g., via the integrated system electronics) and to automatically set a bolus dose of the integrated hand-held medicament injection pen, whereby the user can manually inject the bolus dose of medicament into the host. In some embodiments, the integrated receiver and hand-held medicament injection pen are integrally formed, while in other embodiments they are detachably connected and communicated via mutually engaging electrical contacts and/or via wireless communication.

Abstract: A medical device is disclosed. The medical device includes an RFID reader for receiving information from at least one RFID transponder. The medical device also includes a memory for storing a database and at least one processor for processing information. Also, a remote controller for a medical device is disclosed. The remote controller includes an information receiver for receiving information related to food. The infusion device also includes a memory for storing a database and at least one processor for processing information. A method for use in a medical device is also disclosed. The method includes receiving information from an RFID transponder related to food. Also, the processing the information by comparing the information to a database is included in the method. The method also includes determining the acceptability of the food and providing information related to acceptability to the user.

Abstract: An internal tourniquet and method for establishing hemostasis within a portion of a limb to facilitate surgery controls flow of a fluid into a capsule surrounding substantially all of a human joint. Blood concentration in the capsule is sensed; and pressure in the capsule is controlled to maintain a fluid pressure in the capsule within a predetermined pressure tolerance window. The concentration of blood in the capsule is maintained below a predetermined maximum concentration while the fluid pressure is within the pressure tolerance window.

Abstract: This document discusses, among other things, an apparatus comprising a pump configured to deliver a fluid, an input and a controller. The controller is configured to receive via the input information related to physical activity of a user and to automatically calculate a change in insulin therapy based on an amount of carbohydrates metabolized by the physical activity.

Abstract: Surface selective photoacoustic (PA) medical imaging is introduced. Surface selective PA imaging is responsive to surface features and does not image sub-surface features, in contrast to conventional PA imaging. The surface PA signal can be considerably larger than the bulk PA signal, for an air-coupled (or gas-coupled) acoustic transducer. Distinguishing these two signals based on time of arrival at the transducer can further distinguish the two signals. This approach provides numerous advantages. Non-contact imaging simplifies and expedites imaging, and can serve as a replacement for visual inspection by physicians. Applications include skin screening and endoscopy.

Abstract: An IOP control device for implantation in an eye of a patient is disclosed. The device includes a housing and a multilayer membrane. The housing is sized for implantation into the eye and includes an entrance port and an exit port. The membrane is anchored within the housing to form a flow control chamber on a first side and a fluid flow passageway on a second opposing side of the membrane. The chamber is arranged to contain a gas creating a chamber pressure, and the membrane is configured to affect flow through the passageway from the entrance port to the exit port by deflecting in response to changes in the chamber pressure. The membrane comprises a first layer having a higher permeability and a higher flexibility than the second layer, which is disposed adjacent the first layer and restricts the diffusion of gas in the chamber through the membrane.

Abstract: An analyte monitor includes a sensor, a sensor control unit, and a display unit. The sensor has, for example, a substrate, a recessed channel formed in the substrate, and conductive material disposed in the recessed channel to form a working electrode. The sensor control unit typically has a housing adapted for placement on skin and is adapted to receive a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and configured for coupling to two or more contact pads on the sensor. A transmitter is disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. The display unit has a receiver for receiving data transmitted by the transmitter of the sensor control unit and a display coupled to the receiver for displaying an indication of a level of an analyte.

Abstract: In various embodiments of the invention, a vacuum pump can be used as a stand alone unit to create, monitor and control a vacuum in a variety of surgical procedures. The vacuum pump can be controlled by a processor and automatically increases or decreases the vacuum based on monitoring of parameters selected from the group consisting of heart-rate of the fetus, heart rate of the mother, heart rate of patient, blood pressure of the fetus, blood pressure of the mother and blood pressure of the patient, position of the wound, position of the fetus, condition of the fetus, condition of the mother, condition of the patient. Visual or audio feedback is used to allow the care giver increased control of the pumping device while carrying out the procedure.

Abstract: A local extremum of a function ƒ is determined by computing a Jacobian of ƒ at a test point x by adding an imaginary part to x and a Hessian of ƒ by adding two imaginary parts to a multicomplex copy of x and extracting a third imaginary part. Solving a system of equations defined by the Jacobian and Hessian yields a delta; the process is repeated until convergence. This method is used in each of a series of time intervals to compute an insulin-delivery amount for an insulin pump. ƒ is a model-predictive-control cost function; x is a set of successive candidate insulin delivery amounts beginning from a selected time interval. A system includes a glucose monitor and a controller using glucose measurement data therefrom to determine an insulin delivery amount for a time interval by minimizing ƒ; an insulin pump provides insulin corresponding to the delivery amount.

Abstract: A computer implemented method of determining a clinical variables utilizing an insulin pump that includes initiating blood glucose measurements, initiating ingestion of carbohydrates and receiving input data based on the blood glucose measurements and the ingestion of carbohydrates and utilizing the data to calculate clinical variables. The invention may include presenting instructions to a patient to take various actions and to input various data. The clinical variables determined may be stored in memory and then used to calculate insulin doses and to send a signal to an insulin pump to infuse the insulin dose calculated.

Abstract: We disclose methods and medical device systems for automated delivery of therapies for pain and determination of need for and safety of treatment. In one embodiment, such a medical device system may comprise a sensor configured to sense at least one body signal from a patient; and a medical device configured to receive a first sensed body signal from the sensor; determine a patient pain index based at least in part on said first sensed body signal; determine whether said patient pain index is above at least a first pain index threshold; determine a safety index based at least in part on a second sensed body signal; select a pain treatment regimen based on at least one of said safety index and or a determination that said pain index is above said first pain index threshold; and deliver said pain treatment regimen.

Abstract: Methods and systems for controlling an insulin pump in response to glucose measurements are responsive to a base insulin delivery profile and a temporary insulin delivery profile. These can be used, e.g., to control blood glucose level of a subject using a continuous glucose monitor and an insulin infusion pump. During a selected time range, an insulin amount for the pump to supply is determined using the temporary insulin delivery profile. Outside that time range, the insulin amount is determined using the base insulin delivery profile. The temporary insulin delivery profile can specify an exact amount to be supplied (a “hard” profile), a nominal amount to be supplied if doing so does not drive glucose out of a desired zone (“soft”), or a soft profile with a minimum amount of insulin to be delivered (“semi-soft”).

Abstract: Systems and methods for intelligently delivering fluid to a targeted tissue. The systems and methods may include directing a pump to distribute fluid to a targeted tissue and receiving one or more signals from an intracorporeal sensing system, where the one or more signals correspond to one or more sensed feedback parameters at the targeted tissue. The systems and methods may also include determining whether the one or more sensed feedback parameters are within an acceptable range. If the one or more sensed feedback parameters are not within the acceptable range, the systems and methods may include determining an adjusted velocity for the plunger necessary to adjust the pressure of the fluid in the pump so that the one or more sensed feedback parameters move within the acceptable range and directing the pump to distribute the fluid at the adjusted velocity.

Abstract: Portable or ambulatory infusion devices and systems capable of remotely updating an ambulatory fluid delivery device include safety protocols that verify the status of the ambulatory fluid delivery device before and after a field update of software. Methods of accomplishing the same field update of software are also described.

Abstract: A system for diagnosing and/or treating a patient comprising a patient information database for storing and retrieving patient health data related to the patient. The data includes one or more of real-time patient health information, at least one clinical practice guideline, at least one patient questionnaire and a patient medical history. At least one server is operative to access the patient information database. A computing device remotely located from the server, including a microprocessor, configured to store a computer application and is configured for communication with the server for retrieving of the patient health data. The computer application generates at least one of a patient diagnosis or a patient treatment recommendation using the retrieved patient health data.

Abstract: We report a method of treating an epileptic seizure in a patient, comprising: detecting said epileptic seizure, based on body data from said patient; and reducing a flow of blood to a brain of said patient in response to said detected seizure; wherein said reducing is effected by: increasing the parasympathetic input to said patient's heart, such as by electrically stimulating a parasympathetic nervous structure, applying cooling energy to a sympathetic nervous structure, or administering a cholinergic or a sympatho-blocking agent to said patient. We also report a medical device system configured to implement the method. We also report a non-transitory computer readable program storage unit encoded with instructions that, when executed by a computer, perform the method.

Abstract: Devices and methods for detecting meal intake are disclosed herein. In some embodiments, one or more sensors can be used to detect or monitor physiological parameters of a user (e.g., heart rate, body movements, temperature, pH, impedance, gastric stretch, sound emissions, and the like). The outputs of the sensors can be received by a computer system configured to analyze the sensor data and make a determination as to whether meal intake has occurred or is presently occurring. The computer system's determination can be used to trigger, modulate, or otherwise control one or more therapeutic devices. Other types of devices can also be controlled using this determination, such as monitoring or logging devices.

Abstract: Devices, systems, or methods are disclosed herein for treatment of disease in a vertebrate subject. The device can include a quasi-planar substrate; and one or more laterally-mobile effector molecule types at least partially embedded within the quasi-planar substrate, wherein the one or more laterally-mobile effector molecule types is configured to interact with one or more cell types. The device can further include one or more sensors configured to detect at least one aspect of an interaction between the at least one of the one or more laterally-mobile effector molecule types and the one or more cell types; and a controller in communication with the one or more sensors, wherein the controller is configured to responsively initiate modification of at least one of the one or more laterally-mobile effector molecule types, the quasi-planar substrate, and the one or more cell types.

Abstract: This invention is a device and method for selectively and automatically reducing absorption of unhealthy food in a person's gastrointestinal tract, while allowing normal absorption of healthy food. In an example, such a device can comprise: a food-identifying sensor; an absorption-reducing substance; an implanted reservoir; and a release-control mechanism that selectively and automatically releases the substance into the person's gastrointestinal tract when the sensor detects that the person is consuming unhealthy food.

Abstract: The subject matter described herein relates to controlling and automating a delivery of one or boluses of a fluid medication to a patient. A user interface can display lists of parameters, such as a list of types of fluid in the fluid medication, a list of modes for delivery of the one or more boluses, a list of flow rates of each bolus delivery, a list of durations corresponding to each bolus, a list of initiation times of each bolus, and a list of initiation events for each bolus. In response, a clinician can select and/or specify parameters for the one or more boluses. Subsequently, the infusion device can deliver the one or more boluses based on the selected or specified parameters. Related apparatus, systems, techniques and articles are also described.

Abstract: Some embodiments of an infusion pump system can be configured to provide improved safety monitoring features so that a user receives proper dosage amounts.

Abstract: Methods of establishing an insulin delivery rate in a pump and an insulin pump are disclosed. A method includes selecting a set of alerts from one or more sets of alerts. The method also includes initiating a test process based on the set of alerts. The method further includes, upon activation of each alert in the selected set of alerts, prompting a user to input a blood glucose level.

Abstract: The present disclosure is directed to a method and apparatus to autonomously stimulate a plurality of nerve fiber groups. The method and apparatus predicts stimulus parameters that can activate 0-100% of the nerve fiber groups selectively according to a patient's characteristics and proportional to therapeutic outcomes, such as determined by experimental data. The method and apparatus may further be configured to input experimental third-party data to obtain a high efficacy from a patient without invasive neurosurgery.

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: Receivers, which may be external or implantable, are provided. Aspects of receivers of the invention include the presence of one or more of: a high power-low power module; an intermediary module; a power supply module configured to activate and deactivate one or more power supplies to a high power processing block; a serial peripheral interface bus connecting master and slave blocks; and a multi-purpose connector. Receivers of the invention may be configured to receive a conductively transmitted signal. Also provided are systems that include the receivers, as well as methods of using the same. Additionally systems and methods are disclosed for using a receiver for coordinating with dosage delivery systems.

Abstract: The present invention provides an implanted device that promotes the protection and maintenance of transplanted cells in a host body.

Abstract: An integrated system for the monitoring and treating diabetes is provided, including an integrated receiver/hand-held medicament injection pen, including electronics, for use with a continuous glucose sensor. In some embodiments, the receiver is configured to receive continuous glucose sensor data, to calculate a medicament therapy (e.g., via the integrated system electronics) and to automatically set a bolus dose of the integrated hand-held medicament injection pen, whereby the user can manually inject the bolus dose of medicament into the host. In some embodiments, the integrated receiver and hand-held medicament injection pen are integrally formed, while in other embodiments they are detachably connected and communicated via mutually engaging electrical contacts and/or via wireless communication.

Abstract: A system of a wireless physiological signal integration is provided. The system includes a wireless transmission sensor chip and a drug delivering system, wherein the wireless transmission sensor chip includes a sensor sensing a physiological signal of a patient, a signal conversion module converting the physiological signal into a converted signal, and a wireless transmission module wirelessly transmitting the converted signal, and the drug delivering system determines a dose of a drug and a timing for providing the drug according to the converted signal.

Abstract: An integrated diabetes management (IDM) system includes a safety layer which, in one configuration has two components, one located between a glucose sensor and a controller and a second component located between a controller and a pump, to monitor various aspects of signals and modify those signals for compatibility and safety purposes. In one application, the safety layer receives output control signals from a controller and modifies those control signals as a function of an actual amount of insulin delivered to the user. The safety layer allows for an increased level of safety in the IDM system and permits development of separate hardware and software upgrades with the safety layer assuring that compatibility between components will continue.

Abstract: Embodiments include an apparatus responsive to an event detected at a glucose monitoring device. The apparatus includes circuitry to select an action to occur remote to the glucose monitoring device in response to the event. Embodiments include a response center responsive to an event at a glucose monitoring device to contact a person in response to the event.

Abstract: An apparatus comprising a pump, an input configured to receive information related to a user, a user interface, and a controller communicatively coupled to the pump, the input, and the user interface. The controller includes a timing module configured to initiate delivery of a drug in time and to adjust delivery according to the received information. Other devices, systems, and methods are disclosed.

Abstract: Techniques for controlling an insulin pump include determining values for parameters selected from a group including a first prediction time horizon, a predicted glucose threshold (Goff) for turning the insulin pump off, a maximum shut off time within a time window, and duration of the time window. A safety rule is determined based on the maximum shut off time within the duration. Glucose readings are collected up to a current time. An expected current glucose value G and glucose temporal rate of change are determined based only on the glucose readings and a Kalman filter configured for noisy glucose readings. A glucose level (Gh1) is predicted for a future time that is the prediction time horizon after the current time. A command is issued to shut off the insulin pump if it is determined both that Gh1 is less than Goff and that the safety rule is satisfied.

Abstract: Systems for delivery of therapeutic agents and related methods are disclosed. A sensing system is configured to detect a chemical in the vicinity of a patient and transmit a signal to a controller upon detection. A controller is configured to release a therapeutic agent which is transported to the site of interest. The controller communicates with an electronic medical records database, an alarm and a nurse call system.

Abstract: Systems, apparatuses, and methods for delivery of an active agent in response to the changes in electrical activity of a subject's lower esophageal sphincter. Changes in electrical activity can be monitored by a monitoring unit containing a microprocessor. A reservoir and pump can be used to store and release the active agent. The active agent can be cholecystokinin, peptide YY, glucagon-like peptide 1 or 2, and ghrelin, or a combination thereof.

Abstract: A low profile and volumetrically efficient medication delivery device configured to be placed on the body of a patient during fluid delivery to the patient is provided. The device incorporates a low profile actuator assembly that causes fluid delivery by displacing a collapsible reservoir in response to receiving an electrical current or charge input from a programmable controller and a power supply. Additional components help prevent drug theft or abuse, measure actuator pressure, displacement and temperature in real time providing active feedback to the controller that is controlling the actuator. The device also has wireless communication capabilities.

Abstract: Drug-delivery systems for local drug delivery to kidneys and associated systems and methods are disclosed herein. One aspect of the present technology is directed to drug-delivery systems that include a physiological sensor, an implantable medical device, and a control module configured to communicate with the physiological sensor and to control delivery of a drug in response to a physiological parameter measured by the physiological sensor. The implantable medical device can be configured to be surgically implanted in a patient with a delivery opening at or near a renal capsule of a kidney of the patient. Suitable drugs for local delivery to a kidney can include diuretics, aldosterone antagonists, vasodilators, renin inhibitors, and combinations thereof. In some embodiments, local drug delivery to a kidney can be used to treat hypertension, heart failure, or another condition associated with renal activity.

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: An arrangement for administering a predetermined amount of a substance into an organism is presented. The arrangement includes a member adapted to provide information indicative of a tissue resistance against flow of a fluid containing the substance upon administration into the tissue and a controller adapted to adjust an administration characteristic of the fluid based on the information such as to achieve an intended absorption rate of the substance.

Abstract: The present invention provides a module for a computer interface including a transducer wherein the transducer receives a measurement value and makes this measurement value available for monitoring an individual's health by means of the computer interface, for example, for monitoring an individual's blood glucose level, wherein the measurement value is obtained by means of a sensor.