Abstract: Disclosed is a method of navigating a spinal subarachnoid space in a living being, that includes percutaneously introducing a device into the spinal subarachnoid space at an entry location. The device has a first passageway that is sized to slidably receive, and work with, at least a guidewire. The device can be a catheter or a sheath. The method can also include advancing the device within the spinal subarachnoid space at least more than 10 centimeters from the entry location. Alternatively, the method can include advancing the device within the spinal subarachnoid space to facilitate intracranial access with a second device introduced through the first passageway. Also disclosed is a device suited for attachment to a patient's skin, such as a sheath, that includes an elongated member, a skin-attachment apparatus having a flexible skin-attachment flap, and a valve apparatus.

Abstract: The present invention is directed to a system and method for postoperative monitoring of the condition of a tissue or organ utilizing sensors that may be embedded in various types of surgical drains. The system is comprised of a probe and a monitoring unit. The probe may include a surgical drain with fluid draining channels housing one or more sensors to measure various parameters of the adjacent tissue. The monitoring unit which controls the sensors of the probe may include a processor to process, record and display the measured parameters. This system may be valuable for monitoring transplanted organs and tissue grafts during the critical postoperative period when most of the clinical complications, such as vascular thrombosis, may occur.

Abstract: A method includes monitoring an indicator of infection in proximity to an implanted active therapy delivering medical device and providing information regarding the monitored indicator to the implanted medical device. The method further includes determining whether the information regarding the monitored indicator is indicative of infection in proximity to the implanted medical device.

Abstract: Implantable medical devices include a sensor capable of detecting an indicator of infection in proximity to the device. Sensed information regarding the indicator of infection is provided to the device for a time period of between two hours and six months after the device is implanted. A determination may be made as to whether the sensed information is indicative of infection. The determination may be made in the implanted device or in an external device in wireless communication with the implanted device. If the information is indicative of infection, an alert may be issued from the implanted device or an external device.

Abstract: A system for monitoring tissue pH calculates and displays integrated pH values over one or more user-selectable integration time periods. The values can be displayed in a numerical and/or graphical format. In the graphical format, measured values of pH are displayed as curves. A cursor can be positioned along the curves to display an instantaneous measured value at any point. The integration periods are highlighted relative to the curves. If the cursor is positioned within a region corresponding to an integration period, the display indicates the integrated value of pH from the start of that integration period to the time corresponding to the position of the cursor.

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: A method and apparatus for predicting the outcome of head injury trauma by monitoring cerebrospinal fluid (CSF) characteristics, preferably by monitoring the pH of CSF. The apparatus includes a catheter with a wall section adapted to permit CSF to flow therein, and a sensor located within the catheter such that the CSF is permitted to flow adjacent the tip of the sensor.

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 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 present invention pertains to an apparatus for evaluating the signal strength from the pH sensor to determine whether the sensor is hydrated sufficiently to accurately measure pH. This is accomplished by utilizing circuitry that periodically sends a low voltage signal to a suitable pH sensor and then receiving the resulting waveforms which are analyzed by a processing receiver. The electrical connection between a suitable pH sensor and hydration monitoring circuitry is generally hard wired. In one embodiment, a processing receiver is coupled with the hydration monitoring circuitry as a single apparatus. In a second embodiment, the processing receiver can be independent and located remote from the hydration monitoring circuitry. In this embodiment, the hydration monitoring circuitry and the processing receiver are electrically connected using either hard wired techniques or wireless technology. In addition, the processing receiver can include data recording capability.

Abstract: A stress evaluation apparatus includes an impedance measuring unit for measuring an impedance of a fluid discharged from a living body; a temperature measuring unit for measuring a temperature of the fluid discharged from the living body; a pH calculating unit for calculating a pH value based on the impedance and temperature of the fluid discharged from the living body; and a stress evaluating unit for evaluating a stress based on the pH value calculated by the pH calculating unit.

Abstract: In general, the invention is directed to systems and methods for monitoring the gastrointestinal system of a patient. In one embodiment, the invention includes techniques for monitoring the emptying of the patient's stomach. The techniques may employ glucose monitoring, pH monitoring with a consumable sensor, of monitoring the position of a consumable sensor as it exits the stomach. Consumable sensors may be employed to sense conditions, such as temperature or bile concentration, in other segments of the gastrointestinal system. The invention also includes systems for tracking the position of one or more consumable sensors as the sensors transit the gastrointestinal system, and monitoring the conditions sensed by the sensors.

Abstract: A system for monitoring physiological parameters within the stomachs of ruminant animals and including two primary interdependent components. Both components are linked by radio frequency communication and software designed specifically for this application. The first component is a sensing transceiver, battery power and electric components hereafter referred to as the device that is tethered by a cord to a weight in the form of a conventional cow magnet. The second component includes both stationary and portable readers/transmitters capable of initiating radio frequency communication with the device(s) for receiving data from them and sending data to them. Software residing in both components utilizes digitized data and operating commands for transmission between the components, for storing selected data and program commands and manipulating the data for viewing, hearing and related analysis.

Abstract: A method and apparatus for predicting the outcome of head injury trauma by monitoring cerebrospinal fluid (CSF) characteristics, preferably my monitoring the pH of CSF. The apparatus includes a catheter with a wall section adapted to permit CSF to flow therein, and a sensor located within the catheter such that the CSF is permitted to flow adjacent the tip of the sensor.

Abstract: A capnograph which performs an analysis of the breath waveforms measured by the carbon dioxide sensor, interprets the results of this analysis, and outputs to the operator diagnostic information about the respiratory status of the patient, or about the adequacy of the breathing support provided to the patient. The instrument compares a number of parameters characteristic of the waveforms of the patient's breath with an internal library of the values of those parameters expected from normal waveforms stored in its memory. These parameters may either relate to specific features of the waveform in the time domain, or may characterize spectral components of the waveform in the frequency domain. The capnographic waveform analysis may be combined with further non-invasive measurements in order to provide an indication of the deviation of the value of EtCO2 from PaCO2.

Abstract: A multiple lumen catheter having a soft, tapered multiple lumen distal tip for insertion into a body vessel. One of the lumens is sized to pass over a guidewire such that the catheter can be inserted into the body vessel using the Seldinger technique. At least one medical implement lumen is used for placement or positioning of a biomedical sensor or other medical implement. For example, at least one optical fiber passing through the medical implement lumen may transmit and receive light at the distal tip for measuring oxygen saturation of the blood. The catheter may have a cylindrical catheter body to which the soft distal tip attaches. The soft tip reduces the possibility of vessel or tissue puncture and abrasion. The tip is constructed of a soft plastic or pliable material that yields easily when force is applied.

Abstract: The invention relates to a pantyliner, in particular for pregnant women, with a liquid-impermeable lower layer and a liquid-permeable covering layer, where a test insert (3) provided with a test substance is arranged between the lower layer (1) and the covering layer (2).

Abstract: The invention addresses hardware and software products capable to make contemporaneous accurate predictions regarding how a person's biological system will respond to a serious of stimuli. The predictions can then be communicated in real time, enabling confirmation of good control status, need for corrective action, planning future actions, or even outside intervention in case of emergency. Also addressed by the invention is a family of diagnostic hardware based on intelligent optoelectronic sensors that incorporate one or more Wedge-and-Strip Position-Sensitive Photo-Detectors optimized for probabilistic real time evaluation of spectroscopy data from living subjects.

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 comprises an oral platform, a microchip for making physiological tests and/or delivery of drugs, and a stick connected to the platform to serve as a handle or conduit from the microchip for exterior communication. A candy shell coating on the platform incorporates medicinal agents. The platform has a plurality of fluidic ports conducive for communication of saliva to or oral delivery from the microchip. A base unit is connected to the stick and communicates to the microchip. The platform, microchip, and stick are combined together into a lollipop and further comprise a plurality of base units which are interchangeable with a plurality of lollipops. A cradle unit capable of is temporarily coupled to the base unit for recharging the base unit. The cradle unit further provides data processing, communication and/or display. The invention is also a method of making physiological tests and/or delivering drugs with the above device.

Abstract: The invention relates to a device for analysing the physico-chemical properties of a cutaneous surface comprising: a group of sensors which are assembled at an acquisition zone (4), opposite which the cutaneous surface to be analysed is positioned; and a processing unit (1) which is interfaced with the group of sensors, said unit being equipped with analysis means that can be used to determine certain physico-chemical properties of the cutaneous surface to be analysed using signals produced by said group of sensors.

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: 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: 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: A device is provided for assessing impairment of blood circulation in a patient, such as that in perfusion failure, by measurement of blood flow adjacent a mucosal surface accessible by a mouth or nose and connecting with the gastrointestinal tract or upper respiratory/digestive tract of a patient. The device includes a blood-flow sensor adapted to be positioned adjacent a mucosal surface with a patient's body and measuring blood flow in adjacent tissue and a PCO2 sensor adapted to be positioned adjacent the mucosal surface and measuring PCO2. In addition a pH sensor may be used in combination with the blood flow determination. A method of detecting perfusion failure is also disclosed. The method includes utilizing blood-flow measurements in conjunction with a surface perfusion pressure index and/or an optical plethysmography index to more accurately assess perfusion failure. These measurements may also be supplement by taking measurements of pH, sublingual PCO2, and Sa O2.

Abstract: The present invention provides for an apparatus and a method for monitoring, in vivo, the ruminal pH of an animal. The apparatus has an external aspect at the outside of the animal, an indwelling ruminal aspect; and an intermediate aspect between the external and indwelling aspects. The indwelling aspect further has a pH sensor; and the external aspect further having a housing and a means for storing data from the pH sensor in said housing. The apparatus may further comprise a means for transmitting signals corresponding to the pH data collected and a means for receiving said signals. The method of monitoring, in vivo, the pH of the rumen of an animal includes installing any of the embodiments of the apparatus to the animal and taking a plurality of measurements of the pH from the apparatus, and transmitting signals corresponding to said measurements to a receiving device.

Abstract: The present invention provides for an apparatus and a method for monitoring, in vivo, the ruminal pH of an animal. The apparatus has an external aspect at the outside of the animal, an indwelling ruminal aspect; and an intermediate aspect between the external and indwelling aspects. The indwelling aspect further has a pH sensor; and the external aspect further having a housing and a means for storing data from the pH sensor in said housing. The apparatus may further comprise a means for transmitting signals corresponding to the pH data collected and a means for receiving said signals. The method of monitoring, in vivo, the pH of the rumen of an animal includes installing any of the embodiments of the apparatus to the animal and taking a plurality of measurements of the pH from the apparatus, and transmitting signals corresponding to said measurements to a receiving device.

Abstract: A method and apparatus for assessing tissue perfusion of a patient. The apparatus includes a probe for contacting the mucosa tissue in the upper respiratory/digestive tract of the patient, and a sensor coupled to the probe for directly detecting a pH measurement of the mucosa tissue and for generating an electrical signal in response to the detected pH measurement.

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 system for monitoring a site in vivo comprising a housing configured for being immobilized in vivo; at least one sensing device for obtaining data of the site, the sensing device connected to the housing; a transmitter for transmitting the data obtained by the sensing device;, and a receiving system for receiving the data transmitted by the sensor

Abstract: The invention addresses hardware and software products capable to make contemporaneous accurate predictions regarding how a person's biological system will respond to a series of stimuli. The predictions can then be communicated in real time, enabling confirmation of good control status, need for corrective action, planning future actions, or even outside intervention in case of emergency. Also addresses by the invention is a family of diagnostic hardware based on intelligent optoelectronic sensors that incorporate one or more Wedge-and-Strip Position-Sensitive Photo-Detectors optimized for probabilistic real time evaluation of spectroscopy data from living subjects.

Abstract: A device for implantation on the cervix of a pregnant female that provides a means by which a female patient or her health caregiver is notified of the rupture of membranes by the release of amniotic fluid. The device comprises a housing manufactured from biocompatible material having a hole through which amniotic fluid in the patient's vagina may pass. The housing contains a pH meter and a transmitter in electronic communication therewith as well as a power source for the sensor and transmitter. When amniotic fluid is released through the cervix into the vagina, a quantity thereof may pass into the housing and sensed by the sensor, causing the sensor to direct a signal to the transmitter. The transmitter issues an electronic signal to a second electronic device such as a pager or PDA, notifying the patient or her health caregiver that her water has broken.

Abstract: An article for the identification of the premature rupture of a membrane during pregnancy is disclosed. In its preferred embodiment, the article comprises a pad having an upper outer layer, a lower outer layer, and an intermediate pH-responsive component. A double-sided adhesive strip is attached to the lower outer layer. The upper outer layer is composed of a liquid permeable material. Intermediate of the upper out layer and the inner outer layer is a pH-sensitive component. This intermediate layer is a pH-sensitive material and may be one of a variety of such materials, although a preferred material is nitrazine paper. In the presence of an alkaline fluid, such as amniotic fluid, the pH-sensitive material responds by turning to a purple-blue color. The change in color acts as a visual indicator to the wearer of the possible presence of amniotic fluid outside of the amniotic sac.

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: An ambulatory recording system for medical and especially diagnostic purposes is described having synchronized communication between two processors. The recorder features two processors which are of differing architectures—the first processor being a real time processor which handles the sampling function, the second processor being a non real time processor which handles the operating system function. The invention further includes a protocol for communication between the two processors which permits the two processors to have synchronized and reliable communication.

Abstract: A urine sugar detecting device including (a) a urine sugar sensor including a contact electrode and a cover film covering the contact electrode therewith, (b) a cartridge encasing the urine sugar sensor in fluid tight except the contact electrode, and (c) at least one contact pin having a straightly extending proximal portion and an obliquely, downwardly inclining distal portion, the contact pin being kept deformed in the cartridge so as to have a force with which the contact pin pierces the cover film to thereby have electrical connection with the contact electrode.

Abstract: An ambulatory recorder having real time non-real time processors is described. The real time processor handles sampling functions while the non real time processor handles other functions, such as high processing operations associated with multitasking, graphical user interface, floating point calculation, Infra Red communication and long term memory storage. The second processor is primarily provided to operate a Windows CE operating system as well as one or more embedded applications. Through this design, electrical power provided by a battery is only consumed by those components essential to device operation at any particular time.

Abstract: An ambulatory data recorder having a slidable patient activity period switch. The slidable patient activity period switch permits the patient to slide the switch from a first position to a second position upon the start of a pre-defined activity, e.g. eating. Upon completion of the pre-defined activity, the switch is slide from the second position back to the first position. While in either the first or second position the switch position corresponds to a marking on the recorder enclosure such that the patient can readily understand which activity the switch is indicating. The slidable patient activity period switch is further configured to have minimal power consumption. In one embodiment the switch is provided through a standard keyboard interrupt service routine.

Abstract: An ambulatory recorder having a volatile and a non-volatile memory is described. The recorder actively manages the transfer of the data in the volatile to the non-volatile memory. In particular, the sampling frequency and number of channels to be sampled are monitored. These parameters, along with the total buffer size available, are used to determine the final complete data set which can be stored in the buffer. Thereafter, the contents of the buffer are transferred to the non-volatile memory. In such a manner the recorder avoids filling the buffer in the middle of a sampling tick, in which case the remaining data to be sampled would be lost.

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 device having a case with an integral splash cover about the area of the catheter input ports is described. Moreover, the ports are angled such that when the device is carried in its intended manner by a patient, the ports are angled downwards. Through the case design, in combination with the angle of the ports, the device is relatively more resistant to splash-related problems as compared to prior devices.

Abstract: An ambulatory recorder which features an enhance technique for sampling. The ambulatory recorder has a programmable number of channels, each channel having a programmable sampling frequency rate. The multi channel ambulatory recorder is fashioned so as to sample and records data only from each channel as desired at the frequency as desired. The recorder examines the frequencies on the channels for which data is to be sampled and recorded, and selects a common tick frequency for the microprocessor to awaken, sample and sleep again. Moreover, the microprocessor is directed to only sample at each tick on each channels as needed reducing the amount of required memory and shortening the time it is consuming power.

Abstract: An ambulatory recording system, for medical and especially diagnostic purposes, is described having a communication watchdog between two processors. The two processors may be of differing types. For example, the first processor may be real time processor ("RTP") which handles the sampling function, while the second processor may be a non real time processor ("NRTP") which handles the operating system function. This dual processor design permits relatively low power consumption for data recording (which is handled by the relatively lower power consuming RTP), while also providing a graphical user interface for user simple user operation (which is handled by the relatively higher power consuming NRTP). A communication watchdog between the two processors is provided to reset the device upon the detection of a processor failure or communication failure between the two processors.

Abstract: An ambulatory data recorder having a selectable device control interface. The selectable device control interface permitting a selection to be made between a first device control interface, in which the full device control set is accessible, and a second control interface, in which only a partial amount of the device control set is accessible. Typically the first control interface is intended for use by physicians and the second control interface is intended for use by patients. The selectable device control interface is provided by a combination of device controls and a moveable device cover. The cover moveable from a first opened position in which the full device control set is accessible and a second closed position in which only a partial amount of the device control set is accessible. Preferably the cover permits operation of at least one of the device controls regardless of its position.

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: 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 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 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.