Abstract: The invention relates to a method for the controlled delivery of a drug as a function of bioavailable drug concentration, a sensor device for detecting bioavailable drug concentration, and a delivery device that controls delivery of the drug based on the real-time detection of bioavailable drug concentration.

Abstract: The present invention provides advancements in the art of cardiac pacemakers. The invention provides a pacemaker system that comprises at least one pacemaker and that is, to a large extent, self-controlled, allows for long-term implantation in a patient, and minimizes current inconveniences and problems associated with battery life. The invention further includes a mechanism in which at least two pacemakers are implanted in a patient, and in which the pacemakers communicate with each other at the time of a given pacing or respiratory event, without any required external input, and adjust pacing parameters to respond to the patient's need for blood flow. The invention further provides a design for a pacemaker in which the pacemaker electrode is connected to the pacemaker body by a lead that is configured to allow the pacemaker to lie parallel to the epicardial surface and to reduce stress on the pacemaker and heart tissue.

Abstract: Devices, systems, and methods to determine volume reflux. In an exemplary embodiment of a device of the present disclosure, the device comprises an elongated body having a sufficient length so that a distal end of the elongated body can extend to a gastroesophageal junction of a person while a proximal end of the device, or a connector coupled thereto, is present at or distal to a throat of the person relative to the gastroesophageal junction, and a plurality of least ten electrodes positioned at known distances from one another along the elongated body, wherein two or more of the plurality of electrodes can excite an electric field, detect within the electric field, or excite and detect within the electric field, wherein the device is configured to obtain gastric/reflux bolus data at or near the gastroesophageal junction.

Abstract: Disclosed are devices, compositions, and methods for diagnosing eosinophilic esophagitis in a subject. Also disclosed are methods for monitoring the course of eosinophilic esophagitis in a subject before, during, and after treatment.

Abstract: An endoscopic capsule has a biocompatible capsule housing that contains at least one sensor device for acquiring medical data. The sensor is arranged on an outer surface of the housing, and has a first electrode produced of an acid-resistant noble metal, and a second electrode produced of silver. An electrical voltage is applied between the first and second electrodes, and a change in an electrical variable is measured between the first and second electrodes when ammonia is present. The endoscopic capsule allows screening of gastric acid and the tissue of the stomach lining for Helicobacter pylori in a manner that is gentle for the patient.

Abstract: A gastroscope has an insertion tube with a distal end, at which a sensor is located. The sensor has a first electrode produced of an acid-resistant noble metal, and a second electrode produced of silver. An electrical voltage is applied between the first and second electrodes, and a change in an electrical variable is measured between the first and second electrodes, when ammonia is present. The gastroscope allows screening of gastric acid and the tissue of the stomach lining for Helicobacter pylori in a manner that is gentle for the patient.

Abstract: Disclosed herein are biosensor systems and related methods for detecting analytes in aqueous and biologic environments. A biosensor system for detecting binding of an analyte of interest may include a detector configured to detect a change in an electrical property on a surface thereof. The detector may be a FET. The system also may include a passive layer disposed on a top surface of the detector. Further, the system may include a hydrophobic layer disposed on the passive layer. The system also may include a receptor-attachment material configured for binding to an analyte. A receptor may bind to the analyte, and the receptor may be attached to the receptor-attachment material. The binding of the analyte to the receptor can cause the change of the electrical property at the surface. In response to the change for example, a current may change for indicating the binding of the analyte to the receptor.

Abstract: A passive wireless gastroesophageal sensor includes a LC resonance circuit, two or more electrodes and a passive batteryless Radio Frequency Identification (RFID) circuit connected to the LC resonance circuit and the one or more electrodes. The electrodes are configured to measure an impedance within a gastroesophageal tract. The passive batteryless RFID circuit transmits a frequency modulated signal using the LC resonance circuit that varies between a first frequency corresponding to a non-acid reflux condition and a second frequency corresponding to an acid reflux condition based on the measured impedance in response to a signal received from a detector.

Abstract: Respiratory diseases related to gastroesophageal reflux disease in a patient are diagnosed by detecting esophageal or pharyngeal impedance and pH in the patient, detecting oxygen saturation in the patient, and diagnosing the respiratory diseases from the esophageal or pharyngeal impedance, the pH, and the oxygen saturation.

Abstract: Configuration technologies for cost-effectively monitoring indicia of regimen compliance or noncompliance in response to one or more indications of symptoms or actions or other data on data-bearing media or in wireless transmissions, such as implementing techniques for providing or preventing access or otherwise acting on or communicating incremental or definitive indicia of compliance or noncompliance.

Abstract: An intra-luminal medical device includes a fixation mechanism to attach the medical device to tissue within a body lumen, and a detachment mechanism to permit selective detachment of the medical device from the tissue attachment site without the need for endoscopic or surgical intervention. An electromagnetic device may be provided to mechanically actuate the detachment mechanism. Alternatively, a fuse link may be electrically blown to detach the medical device. As a further alternative, a rapidly degradable bonding agent may be exposed to a degradation agent to detach the medical device from a bonding surface within the body lumen. The medical device may eliminate problems associated with uncertain and inconsistent detachment of intra-luminal medical devices.

Abstract: A solid dosage form designed to facilitate rapid and reliable oral, esophageal and GI transit has a surface area of the contact patch, i.e., the area of contact between the dosage form and the bodily surface reduced. The dosage form can be an asymmetric oral dosage unit containing a bioactive, the dosage unit being asymmetric with respect to a rotational axis perpendicular to a longitudinal axis of the dosage form, the rotational axis being located substantially at a mid point along the longitudinal axis. The dosage unit may have an outer surface ridged or dimpled or have at least one annular ring so as to reduce the contact patch of the dosage unit with a flat surface compared to non-ridged dosage unit of the same size and shape. The oral dosage unit can also have a spherical shape with or without ridges and/or dimples. Dies for forming these oral dosage units have, in a closed state, a cavity having a shape corresponding to the oral dosage unit.

Abstract: Disclosed is an ambulatory system for monitoring one or more physiological parameters in a body lumen, such as the esophagus. The system includes an implantable probe having a sensor for the physiological parameter and a transmitter for transmitting data to an external receiver. The probe may be used for monitoring any of various physiological parameters, including pH, temperature, and pressure, within the esophagus or other body lumens. Methods and deployment catheters are also disclosed.

Abstract: A system, device, and method for placing a capsule for sensing one or more parameters of a patient by anchoring the capsule to a tissue at a specific site and releasing the capsule from the device, using a single actuator operated during a single motion. As an example, a delivery device may anchor the capsule to the tissue site and release the capsule from the delivery device during a single motion of the actuator. This allows a user to place the capsule by interacting with only a single actuator through one type of motion, thus making delivery of the capsule more reliable and user-friendly.

Abstract: Ultrasonic catheters and methods for determining and/or monitoring reflux volumes during gastroesophageal reflux events.

Abstract: An intra-luminal medical device includes a fixation mechanism to attach the medical device to tissue within a body lumen, and a detachment mechanism to permit selective detachment of the medical device from the tissue attachment site without the need for endoscopic or surgical intervention. An electromagnetic device may be provided to mechanically actuate the detachment mechanism. Alternatively, a fuse link may be electrically blown to detach the medical device. As a further alternative, a rapidly degradable bonding agent may be exposed to a degradation agent to detach the medical device from a bonding surface within the body lumen. The medical device may eliminate problems associated with uncertain and inconsistent detachment of intra-luminal medical devices.

Abstract: A capsule endoscope is disclosed that includes a capsule and a transparent cover having a central axis and that is located in front of an objective optical system within the capsule. The objective optical system has a depth of field, a field of view, and an image surface that has curvature of field, and is arranged on the central axis of the transparent cover and the capsule. The field of view of the objective optical system includes a spherical surface that is tangent to the transparent cover at a periphery of the field of view, and the near point of the depth of field on the optical axis of the objective optical system is positioned farther from the objective optical system than is the transparent cover. Various conditions are satisfied so as to provide high quality imaging.

Abstract: An wireless ambulatory reflux monitoring system capable of monitoring and recording esophageal biological parameters during an ambulatory period. The wireless ambulatory reflux monitoring system is further capable of recording perceived reflux events at the discretion of a patient contemporaneously with the recording of biological data.

Abstract: A device, system and method for in-vivo sensing (e.g., pH sensing, pressure sensing, or other sensing) may include more than one sensor receiving in-vivo data. The sensed data may be analyzed to, for example, determine a gradient or fluid flow. A device including multiple sensors may be held or immobilized in-vivo, and may detect a fluid flow or gradient moving past the sensors.

Abstract: Calibration of in vivo oxygen and pH sensor systems can be performed by generating a constituent element of an environment proximate to an in vivo sensor electrode via an in vivo generating electrode and determining a level of the constituent element in the tissue via the in vivo sensor electrode. Accordingly, accurate monitoring of tissue can be achieved while reducing the need to calibrate the in vivo sensor systems using invasive procedures. Related electrode assemblies are also discussed.

Abstract: Disclosed is an ambulatory system for monitoring one or more physiological parameters in a body lumen, such as the esophagus. The system includes an implantable probe having a sensor for the physiological parameter and a transmitter for transmitting data to an external receiver. The probe may be used for monitoring any of various physiological parameters, including pH, temperature, and pressure, within the esophagus or other body lumens. Methods and deployment catheters are also disclosed.

Abstract: The invention concerns a method for evaluating measured periodic or quasi-periodic signals, produced by medical sensor systems, by digitizing the signals and comparing measured signal segments with signal segments stored in a databank. A medical result has been stored and with the stored signal segments and on the basis of the frequency of medical results belonging to the signal segments showing greatest similarity with the measured signal segment, it is possible to determine at least by deduction a medical result corresponding to the measured signal segment. According to the present invention, weighting values corresponding to the probability that the given medical results are those expected are stored with the signal segment data, and a weighting value for each of the medical results concerned is formed on the basis of the weighting values, belonging to the stored signal segments identified as being similar to a measured signal segment, of each of the medical results.

Abstract: Disclosed is an ambulatory system for monitoring one or more physiological parameters in a body lumen, such as the esophagus. The system includes an implantable probe having a sensor for the physiological parameter and a transmitter for transmitting data to an external receiver. The probe may be used for monitoring any of various physiological parameters, including pH, temperature, and pressure, within the esophagus or other body lumens. Methods and deployment catheters are also disclosed.

Abstract: Disclosed is an ambulatory system for monitoring one or more physiological parameters in a body lumen, such as the esophagus. The system includes an implantable probe having a sensor for the physiological parameter and a transmitter for transmitting data to an external receiver. The probe may be used for monitoring any of various physiological parameters, including pH, temperature, and pressure, within the esophagus or other body lumens. Methods and deployment catheters are also disclosed.

Abstract: Gastrointestinal probe (2) comprising a sensitive material (4) which is able to be connected to electrical or optical readout means or measurement means (10) characterized in that said sensitive material (4) undergoes an irreversible change when it is submitted to the cumulative action of the external medium, in such a manner that the irreversible change can be measured and/or recorded by said electrical or optical readout means or measurement means (10). The present invention concerns also the production process of the gastrointestinal probe according to the invention and its use.

Abstract: Pharyngoesophageal monitoring systems are provided that monitor the environment of the pharynx and esophagus, and in some embodiments, detect and monitor refluxate, and may further record other physical episode data. The system may be provided, in some embodiments, as a bifurcated, adjustable, multiple internal reference probe, and methods thereof, to detect acid reflux and to monitor pH levels of acid reflux episodes simultaneously at multiple locations within the pharyngoesophageal passage. Some embodiments provide a recorder and one or a plurality of sensor arrangements, the recorder being responsive to the sensors and capable of correlation of signals generated by the sensor arrangements.

Abstract: A GI tract stimulator and/or monitor IMD comprising a housing enclosing electrical stimulation and/or monitoring circuitry and a power source and an elongated flexible member extending from the housing to an active fixation mechanism adapted to be fixed into the GI tract wall is disclosed. After fixation is effected, the elongated flexible member bends into a preformed shape that presses the housing against the mucosa so that forces that would tend to dislodge the fixation mechanism are minimized. The IMD is fitted into an esophageal catheter lumen with the fixation mechanism aimed toward the catheter distal end opening whereby the bend in the flexible member is straightened. The catheter body is inserted through the esophagus into the GI tract cavity to direct the catheter distal end to the site of implantation and fix the fixation mechanism to the GI tract wall.

Abstract: Gastrointestinal probe (2) comprising a sensitive material (4) which is able to be connected to electrical or optical readout means or measurement means (10) characterized in that said sensitive material (4) undergoes an irreversible change when it is submitted to the cumulative action of the external medium, in such a manner that the irreversible change can be measured and/or recorded by said electrical or optical readout means or measurement means (10).

Abstract: Gastrointestinal probe (2) comprising a sensitive material (4) which is able to be connected to electrical or optical readout means or measurement means (10) characterized in that said sensitive material (4) undergoes an irreversible change when it is submitted to the cumulative action of the external medium, in such a manner that the irreversible change can be measured and/or recorded by said electrical or optical readout means or measurement means (10). The present invention concerns also the production process of the gastrointestinal probe according to the invention and its use.

Abstract: Disclosed is an ambulatory system for detecting, recording, and analyzing gastroesophageal reflux or intraesophageal pressure. The system includes an implantable sensor and radiofrequency transmitter, an external receiver and recorder, and an analysis software package. This system provides for monitoring any of various physiological parameters, including pH, temperature, and pressure, within the esophagus or other body lumens.

Abstract: The carbon dioxide tension in the wall of the stomach or gastrointestinal tract is determined by inserting into the stomach a semipermeable balloon filled with a saline solution. The result obtained from analyzing the carbon dioxide fraction in the saline solution is multiplied by a correction factor to obtain a stabilized measured value for the carbon dioxide fraction relating to the blood flowing through the wall of the stomach or the gastrointestinal tract, which stabilized measured value corresponds to a measured carbon dioxide fraction pertaining to a retention time of an hour or more, and multiplying the carbon dioxide tension PaCO.sub.2 in the arterial blood with a first factor F.sub.1 to obtain a first correction product, and multiplying the stabilized value of the carbon dioxide tension PiCO.sub.2 in the blood flowing through the wall of the stomach or the gastrointestinal tract by a second factor F.sub.

Abstract: An ambulatory recorder which features a method of configuring the size of data subject to loss in volatile memory. The recorder of the present invention determines how many processor sampling cycles it will take to fill the memory buffer. As discussed above this will vary a great deal and will directly depend upon the programmed parameters, e.g. number of channels to be sampled and the various sampling frequencies. The device then determines the amount of time this number of processor sampling cycles will take. If this amount of time is greater than a pre-selected amount of time, then the number of sampling cycles is reduced to be less than the pre-selected amount of time. The recorder uses these calculations to thereby schedule the transfer of data from the volatile memory to the non volatile memory. Through such an operation the data in the memory buffer subject to loss is limited to only a pre determined amount of time, i.e.

Abstract: A tonometric device for use in hollow viscus tonometry and remote sensing of patient fluid parameters is disclosed. The device is capable of monitoring certain critical fluid properties of interest, such as oxygen gases and carbon dioxide gases in the wall tissue itself of the patient's organ, rather than monitoring such properties in a lumen of the organ. A walled sampling chamber, which is preferably an inflated balloon member, is provided on an elongated tube, with provisions for positioning the sampling chamber in direct contact with a wall portion of the patient's internal organ.

Abstract: Gastrointestinal probe (2) comprising a sensitive material (4) which is able to be connected to electrical or optical readout devices or measurement devices (10) such that the sensitive material (4) undergoes an irreversible change when it is submitted to the cumulative action of the external medium, in such a manner that the irreversible change can be measured and/or recorded by said electrical or optical readout devices or measurement devices (10).

Abstract: A tonometry catheter apparatus comprises an elongate, flexible, multilumen tube having a proximal end to be positioned outside the human body and a distal end to be positioned within a portion of the human body. Provided at the distal end are an ingress lumen through which gas may enter the tube, and an egress lumen through which gas may exit the tube. A hollow connecting member links the ingress lumen and the egress lumen to define a sampling circuit through which the gas may continuously recirculate. In one embodiment, the distal end of the tube is provided with a distensible, gas-permeable vessel in communication with the ingress and egress lumens. In an alternative embodiment, an extracorporeal gas-permeable membrane links the sampling circuit to a separate, gas-containing analyzing circuit. In each embodiment, a pump is provided for propelling gas through the circuits, and a sensor continuously quantifies the level of gas within the circuits.

Abstract: A method and system for the determination of the pH of a fluid by measuring the pH of the fluid and thereafter correcting the pH based upon the determination of measured and/or adjusted values of at least one other parameter, such as PO.sub.2 and PCO.sub.2, which relate to the fluid.