Abstract: A physiological parameter system has one or more parameter inputs responsive to one or more physiological sensors. The physiological parameter system may also have quality indicators relating to confidence in the parameter inputs. A processor is adapted to combine the parameter inputs, quality indicators and predetermined limits for the parameters inputs and quality indicators so as to generate alarm outputs or control outputs or both.

Abstract: A methodology for converting venous blood values to arterial blood values provides the advantage of obviating the need for taking arterial blood samples. The method entails (i) measuring arterial oxygenation, (ii) measuring and estimating values of venous blood acid/base status and oxygenation status of a venous blood sample, and (iii) converting the venous blood values by applying a mathematical model for deriving blood acid/base status and oxygenation status into estimated arterial blood values.

Abstract: An apparatus for use with a patient having a vessel carrying blood to ascertain characteristics of the blood. The apparatus includes a display module and a probe having a distal extremity adapted to be inserted into the vessel of the patient and having a proximal extremity coupled to the display module. The probe includes a sensor in the distal extremity for providing an electrical signal to the display module when the probe is disposed in the blood. The probe can have an antithrombogenic surface treatment for inhibiting the adhesion of blood components to the probe when disposed in the blood.

Abstract: An apparatus for use with a patient having a vessel carrying blood to ascertain characteristics of the blood. The apparatus includes a display module and a probe having a distal extremity adapted to be inserted into the vessel of the patient and having a proximal extremity coupled to the display module. The probe includes a sensor in the distal extremity for providing an electrical signal to the display module when the probe is disposed in the blood. The probe can have an antithrombogenic surface treatment for inhibiting the adhesion of blood components to the probe when disposed in the blood.

Abstract: An apparatus for use with a patient having a vessel carrying blood to ascertain characteristics of the blood. The apparatus includes a display module and a probe having a distal extremity adapted to be inserted into the vessel of the patient and having a proximal extremity coupled to the display module. The probe includes a sensor in the distal extremity for providing an electrical signal to the display module when the probe is disposed in the blood. The probe can have an antithrombogenic surface treatment for inhibiting the adhesion of blood components to the probe when disposed in the blood.

Abstract: The invention provides a devices, methods and systems to measure and record uterine tissue environment components such as pH during the course of uterine artery occlusion. The uterus becomes ischemic due to the occlusion thereof, and its pH drops sharply within minutes of uterine artery occlusion and remains relatively low for a period of time. The return of normal pH is an indicator of return of blood to the ischemic tissue. In use, a catheter with a pH measuring tip is advanced through the patient's vaginal canal and into the patient's uterine cavity until the pH measuring active electrode on the distal end of the catheter contacts or penetrates the uterine fundus. The active electrode detects the pH and a signal representing pH is transmitted to a pH recording and monitoring device which preferably displays the pH. The signal may be transmitted through a conductor or by a radio transmitter. Components other than pH may be monitored such a pCO2, and pO2.

Abstract: Moisture buildup inside an alcohol monitor that is securely attached to a human subject is due to the inlet air from the subject's skin surface, which constantly emits water vapor in the form of insensible skin perspiration. As the warm moist air flows along the air flow path through decreasing temperatures within the alcohol monitor, moisture will be removed from the air through condensation. The present invention solves this condensation problem by first simplifying the air flow path, eliminating barriers that can trap water. Second, additional changes to the air flow path take advantage of gravity, allowing water to drain out of the alcohol monitor. Third, by better balancing the volume of air sample between the sample collection chamber and the fuel cell sample chamber, the total volume of air taken in is reduced, resulting in an overall reduction in the volume of potential moisture introduced into the alcohol monitor.

Abstract: One embodiment is a microprobe. An example of the microprobe comprises a housing having an aperture. This example of the microprobe also comprises an ISFET attached to the housing. The ISFET may have a gate located proximate the aperture. This example of the microprobe further comprises a reference electrode attached to the housing proximate the aperture. Another embodiment is a microsensor system. Another embodiment is a method for measuring a characteristic of tissue. Yet another embodiment is a method for monitoring tissue pH.

Abstract: A non-invasive blood gas test is carried out by a method that utilizes a venous blood sample together with a pulse oximeter and a plurality of mathematical equations. The method generates the following data points of the blood: (i) the pH level; (ii) the [H+] concentration; (iii) the [HCO3—] concentration; (iv) the partial pressure of carbon dioxide; and (v) the oxygen saturation level. Mathematical formulas, tables, and chemical equations provide a simple method by which a doctor or other medical professional can easily calculate the blood gas data without the need for an arterial blood sample or specialized machines. Blood gas measurements are obtained from a patient in a faster, safer and less painful manner than tests that require an arterial blood sample. In another embodiment of the present invention, a system for locating a dysfunctional organ in a patient is disclosed.

Abstract: A method for measuring and determining urea level in human blood by reverse iontophoresis comprising the following steps of: placing an anode electrode on skin, placing a container comprising a solution including urease and a cathode electrode on skin, applying electric current to the anode electrode and the cathode electrode so that an electrical circuit is established there between, whereby urea molecules migrate from blood into the container, determining the urea level in the blood by the changes in the pH of the urease solution.

Abstract: The invention is directed to conductive polymer compositions, catalytic ink compositions (e.g., for use in screen-printing), electrodes produced by deposition of an ink composition, as well as methods of making, and methods of using such compositions and electrodes. An exemplary ink material comprises a metal catalyst (e.g., platinum black and/or platinum-on-carbon), graphite as a conducting material, a polymer binding material, and an organic solvent. In one aspect, the polymer binding material comprises a polymer binder blend comprising first and second polymers, wherein the first polymer has a glass transition temperature higher than the second polymer. In a second aspect, the polymer binding material comprises a hydrophilic acrylic polymer, copolymer, or terpolymer. The conductive polymer compositions of the present invention may be used, for example, to make electrochemical sensors. Such sensors may be used, for example, in a variety of devices to monitor analyte amount or concentrations in subjects.

Abstract: An inverted sensor module for sensing physical and chemical fluid characteristics in a vessel in a living body. The inverted sensor module includes an inverted sensor bonded to a hollow carrier so that sensing occurs in the lumen of the inverted sensor module. An inverted sensor module comprising one or more inverted sensors is implantable and allows fluid to flow through, thereby allowing for measurements of acute and chronic conditions. The inverted sensor module may be used in series with other inverted sensor modules to assess trends such as pressure gradients along a bloodstream.

Abstract: A method and apparatus for the transcutaneous monitoring of blood gases generally comprises a blood gas data acquisition device, a vacuum source and a blood gas transducer unit. The blood gas transducer unit is adapted for application to a patient's skin and administration of a local vacuum at the area of patient application. It further comprises an electrochemical blood gas transducer, well known to those of ordinary skill in the art, which is disposed entirely within the local vacuum at the area of patient application. The vacuum source is placed in fluid communication with the blood gas transducer unit, through a hydrophobic membrane filter for safety purposes, in order to induce a condition of hyperperfusion in the locality of the electrochemical blood gas transducer. Under the control of a microcontroller, or equivalent means, the blood gas acquisition device is then utilized to capture a measure of skin surface oxygen or carbon dioxide pressure.

Abstract: A delivery system for delivering a sensor to a body cavity includes a catheter and sheath slidably or rotatably coupled to the catheter. The sheath may be retractable and peelable. The delivery device may further include an expandable balloon or a crushable material capable of moving the sensor laterally away from the catheter, to the target site. One embodiment of the delivery system includes a deployment device comprising a cord operably engaged with a pulley, and attached at the distal end to a cap, the cap being engaged with the sensor to be delivered. Another embodiment of the delivery system comprises a catheter having a chamber that can accommodate the sensor, and a sheath slidably coupled to the exterior of the catheter, and covering the chamber when the sheath is in the closed position. Further included in the present invention is a method of delivering a sensor to a body cavity using any of the embodiments of the delivery system.

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: A sensor is disclosed, for implantation within a blood vessel to monitor a substance in or property of blood. In one embodiment, the sensor is retrievable. In another embodiment, the sensor has a layer that minimizes the formation of thrombus. A signal representative of the substance in or property of blood is transmitted to an external receiver. In another embodiment, the sensor detects nitric oxide or a nitric oxide metabolite and can be implanted for a period of hours, days, weeks or years. Methods are also disclosed.

Abstract: A device and method in accordance with the invention for determining the oxygen partial pressure (PO2) of a tissue by irradiating the tissue with optical radiation such that the light is emitted from the tissue, and by collecting the reflected or transmitted light from the tissue to form an optical spectrum. A spectral processor determines the PO2 level in tissue by processing this spectrum with a previously-constructed spectral calibration model. The tissue may, for example, be disposed underneath a covering tissue, such as skin, of a patient, and the tissue illuminated and light collected through the skin. Alternatively, direct tissue illumination and collection may be effected with a hand-held or endoscopic probe. A preferred system also determines pH from the same spectrum, and the processor may determine critical conditions and issue warnings based on parameter values.

Abstract: A method for monitoring blood/tissue gases, blood pH, and other elements of blood and tissue chemistry is described that uses a sensor tip that is placed adjacent to the conjunctiva of a patient to be monitored. Monitors and sensor using optical fiber sensors for performing the monitoring are also described.

Abstract: The invention provides a device for contacting a surface of a tissue within a patient's body to determine a physiologic parameter of the patient. The device typically comprises a sensor responsive to the physiologic parameter and a probe housing the sensor. The probe is constructed to allow the sensor to be secured at a sensing area adjacent to a surface of a patient's tissue, without need for an adhesive and without disturbing the blood flow within the measurement region of the tissue. The device may also include a means for reducing interference in the sensing area. Preferably, the device further comprises an indicating means operably connected to the sensor for indicating an analyte quantity and/or concentration associated with the physiologic parameter. The invention also provides a method for determining a physiologic parameter of a patient.

Abstract: The invention provides a device for contacting a surface of a tissue within a patient's body to determine a physiologic parameter of the patient. The device typically comprises a sensor responsive to the physiologic parameter and a probe housing the sensor. The probe is constructed to allow the sensor to be secured at a sensing area adjacent to a surface of a patient's tissue, without need for an adhesive and without disturbing the blood flow within the measurement region of the tissue. The device may also include a means for reducing interference in the sensing area. Preferably, the device further comprises an indicating means operably connected to the sensor for indicating an analyte quantity and/or concentration associated with the physiologic parameter. The invention also provides a method for determining a physiologic of a patient.

Abstract: Apparatus for ascertaining cardiac output of the heart of a patient comprising a control and display module. A venous probe is inserted into a vein in the forearm of the patient and is coupled into the control and display module and provides an electrical signal representing the dissolved oxygen in the venous blood. An arterial probe is inserted into an artery in the forearm of the patient and is coupled into the control and display module and provides an electrical output signal representing the dissolved oxygen in the arterial blood. The control and display module has a visible display that provides a continuous in vivo cardiac output that utilizes an arterial venous oxygen differential equation which includes an adjustment factor for adjusting for venous blood being sampled rather than mixed venous blood in the pulmonary artery of the patient.

Abstract: A sensing apparatus with a connector, a sensor lead and a sensor module with a spacer placed over electrodes that have been deposited on a substrate. The spacer may have a space for receiving an enzyme. End portions of the sensor module may be encapsulated, such as with molded beads. A sensor lead may attach to the sensor module and may have an outer tubing that passes over the module and attaches to the beads at the end of the sensor module. The sensor lead may also attach to the connector such that the sensing apparatus may be electrically coupled to a pump, electronics or other devices. The sensing apparatus may be implanted into a vein or artery.

Abstract: Methods and apparatus for monitoring gastrointestinal pH levels are disclosed. A gastroesophageal diagnostic device for determining the duration of exposure of a patient's esophagus to pH levels clinically significant for gastroesophageal reflux disease is disclosed.

Abstract: Methods of monitoring and evaluating the status of a tumor undergoing treatment includes monitoring in vivo at least one physiological parameter associated with a tumor in a subject undergoing treatment, transmitting data from an in situ located sensor to a receiver external of the subject, analyzing the transmitted data, repeating the monitoring and transmitting steps at sequential points in time and evaluating a treatment strategy. The method provides dynamic tracking of the monitored parameters over time. The method can also include identifying in a substantially real time manner when conditions are favorable for treatment and when conditions are unfavorable for treatment and can verify or quantify how much of a known drug dose or radiation dose was actually received at the tumor. The method can include remote transmission from a non-clinical site to allow oversight of the tumor's condition even during non-active treatment periods (in between active treatments).

Abstract: A method and apparatus for the transcutaneous monitoring of blood gases generally comprises a blood gas data acquisition device, a vacuum source and a blood gas transducer unit. The blood gas transducer unit is adapted for application to a patient's skin and administration of a local vacuum at the area of patient application. It further comprises an electrochemical blood gas transducer, well known to those of ordinary skill in the art, which is disposed entirely within the local vacuum at the area of patient application. The vacuum source is placed in fluid communication with the blood gas transducer unit, through a hydrophobic membrane filter for safety purposes, in order to induce a condition of hyperperfusion in the locality of the electrochemical blood gas transducer. Under the control of a microcontroller, or equivalent means, the blood gas acquisition device is then utilized to capture a measure of skin surface oxygen or carbon dioxide pressure.

Abstract: The invention relates to a tonometric measuring head for bringing a measuring medium to a composition consistent with an individual to be examined non-invasively through the outermost tissue layer. A measuring head comprises a sealed chamber, having a wall whose oppositely facing sides are essentially made of pliable membrane materials, at least one membrane material of said materials being permeable to a gas to be analyzed but effectively impermeable at least to solids and liquids, as well as a measuring medium in a cavity within the wall. The measuring head is provided with a guide member between the chamber and an external device. In addition, the chamber wall is partially constituted by a pliable second membrane material which is effectively impermeable both to a gas to be analyzed and to at least solids and liquids.

Abstract: The apparatus is designed to examine a surface 9 and comprises a polarization analyzer element 14, or analyzer, placed in the path of a light beam 17 reflected by the said surface 9, a means for taking digital images 13 placed in the path of the beam 17 reflected by the said surface 9 downstream of the analyzer 14, and a processing unit 15 capable of calculating the brightness and the intensity of a plurality of pixels of at least one image.

Abstract: In a method and a device for electrochemical determination of the concentration of at least one dissolved chemical entity in a liquid medium, a measurement voltage U is impressed on a working electrode, in contact with the liquid medium, relative to a counter electrode, thereby causing the dissolved chemical entity to react by oxidation or reduction at the working electrode, producing a measurement evoked current. The measurement evoked current is compared to a predetermined value, and the measurement voltage U is adjusted so that the measurement evoked current is substantially equal to the predetermined value, and thus remains substantially constant during measurements. A difference &Dgr;U=U−Umin is formed, which corresponds to an oxidation/reduction reaction at the working electrode, with Umin being a minimum voltage selected as a reference level. This difference is used to calculate concentration variations of the chemical entity in the liquid.

Abstract: A signal processor which acquires a first signal, including a first desired signal portion and a first undesired signal portion, and a second signal, including a second desired signal portion and a second undesired signal portion, wherein the first and second desired signal portions are correlated. The signals may be acquired by propagating energy through a medium and measuring an attenuated signal after transmission or reflection. Alternatively, the signals may be acquired by measuring energy generated by the medium. A processor of the present invention generates a noise reference signal which is a combination of only the undesired signal portions and is correlated to both the first and second undesired signal portions. The noise reference signal is then used to remove the undesired portion of each of the first and second measured signals via an adaptive noise canceler, preferably of the joint process estimator type.

Abstract: The invention relates to a method for compensating measured concentration values of a first chemical compound (A) within a first internal tract (1*) of a patient, which concentration values (PA) are rendered by a second chemical compound (B), which is becoming present in the body of said patient, to deviate from actual concentration when mixing with the first chemical compound within said first internal tract. Concentration values (EB) of at least said second chemical compound (B) in a second tract (2*) of said patient is measured or derived several times and estimated concentration values (CB) of said second chemical compound is determined simulating its non-detected concentrations in said first internal tract of the patient. The measured initial concentration values (PA) of said first chemical compound (A) in the first internal tract (1*) is corrected by a compensating factor (Fc), whereafter said successive and corrected concentration values (CA) are the respective one for display and/or further use.

Abstract: An artificial capillary testing apparatus (ACTA) is provided for evaluation of gas transport/exchange properties of a fluid. A sample fluid, having a known of measured partial gas pressure, is introduced from a gas-tight dispenser into an artificial capillary of known diameter located within an exchange chamber containing a flowing exchange gas. The artificial capillary is formed from a permeable material which permits gas exchange between the interior and exterior of the capillary. After exit from the artificial capillary, the effluent fluid is collected in a gas-tight collection cell, then removed from the apparatus to a gas analyzer to measure partial gas pressure, The dispenser, exchange chamber and collection cell are all enclosed within a temperature controlled cabinet, useful in measurement of oxygen transport properties of hemoglobin in blood or blood-substitutes.

Abstract: Total ammoniacal concentration (TAC) in blood is measured and displayed on a repetitive basis by a controller driven sensor arrangement which may be utilized either with a catheter structure or with a bypass system. The catheter based sensors may be employed with a peripheral region of the vascular system of the body. Repetitive measurements are carried out and these measurements are subjected to a moving average filtering procedure, whereupon the filtered TAC values are displayed numerically and graphically. The controller functions to compute the rate-of-rise of TAC and compares that value with a threshold rate-of-rise valuation which is inputted by the practitioner. Threshold values for TAC also may be inputted and the system not only provides alarm warnings for threshold excursions in TAC above threshold or excursions in rate-of-rise of TAC above threshold but also provides a visual cuing as a warning that TAC is elevating from one filtered measurement to the next.

Abstract: Methods and apparatus for determining the difference between a regional CO2 partial pressure of a selected body organ of a mammalian subject, such as the gut, and a systemic CO2 partial pressure of the subject. The regional CO2 partial pressure value is tonometrically obtained at body temperature using a gaseous sampling medium. A systemic CO2 partial pressure value is obtained from the blood. The systemic CO2 partial pressure value can be that for the body temperature or for a standard temperature. If the systemic CO2 partial pressure value is that for the body temperature, the regional CO2 partial pressure value is compared to the systemic CO2 partial pressure value and the difference therebetween is provided as a CO2 partial pressure gap measurement.

Abstract: A signal processor which acquires a first signal, including a first desired signal portion and a first undesired signal portion, and a second signal, including a second desired signal portion and a second undesired signal portion, wherein the first and second desired signal portions are correlated. The signals may be acquired by propagating energy through a sodium and measuring an attenuated signal after transmission or reflection. Alternatively, the signals may be acquired by measuring energy generated by the medium. A processor of the present invention generates a noise reference signal which is a combination of only the undesired signal portions and is correlated to both the first and second undesired signal portions. The noise reference signal is then used to remove the undesired portion of each of the first and second measured signals via an adaptive noise canceler, preferably of the joint process estimator type.

Abstract: The present invention relates to an implantable diagnostic apparatus for determining analytes in body fluids, which comprises a plurality of identical and/or different measurement units for determining an analytic parameter, in which a signal is generated which is specifically related to the variable to be determined and is transmitted by means of suitable measures to a receiver situated outside the body.

Abstract: A signal processor which acquires a first signal, including a first desired signal portion and a first undesired signal portion, and a second signal, including a second desired signal portion and a second undesired signal portion, wherein the first and second desired signal portions are correlated. The signals may be acquired by propagating energy through a medium and measuring an attenuated signal after transmission or reflection. Alternatively, the signals may be acquired by measuring energy generated by the medium. A processor generates a noise reference signal which is a combination of only the undesired signal portions and is correlated to both the first and second undesired signal portions. The noise reference signal is then used to remove the undesired portion of each of the first and second measured signals via an adaptive noise canceler, preferably of the joint process estimator type.

Abstract: A method and an equipment for determining components, particularly pH, pO.sub.2 and pCO.sub.2 in blood. In order to facilitate the determination of blood gases, one sensor is used for measurement of more than one component. The components are measured at the same measuring point, using an electrode based on antimony. The electrode potential is measured both with and without a known voltage applied over the electrode.

Abstract: A signal processor which acquires a first signal, including a first desired signal portion and a first undesired signal portion, and a second signal, including a second desired signal portion and a second undesired signal portion, wherein the first and second desired signal portions are correlated. The signals may be acquired by propagating energy through a medium and measuring an attenuated signal after transmission or reflection. Alternatively, the signals may be acquired by measuring energy generated by the medium. A processor of the present invention generates a noise reference signal which is a combination of only the undesired signal portions and is correlated to both the first and second undesired signal portions. The noise reference signal is then used to remove the undesired portion of each of the first and second measured signals via an adaptive noise canceler, preferably of the joint process estimator type.

Abstract: A signal processor which acquires a first signal, including a first desired signal portion and a first undesired signal portion, and a second signal, including a second desired signal portion and a second undesired signal portion, wherein the first and second desired signal portions are correlated. The signals may be acquired by propagating energy through a medium and measuring an attenuated signal after transmission or reflection. Alternatively, the signals may be acquired by measuring energy generated by the medium. A processor generates a noise reference signal which is a combination of only the undesired signal portions and is correlated to both the first and second undesired signal portions. The noise reference signal is then used to remove the undesired portion of each of the first and second measured signals via an adaptive noise canceler, preferably of the joint process estimator type.