Abstract: A capsule employing components for detecting blood content or hemoglobin concentration within tissue forming a lumen in vivo advantageously permits screening or diagnosis of certain diseases. In one embodiment, the capsule includes a light source for intermittently illuminating a region of tissue and a light detector for receiving interacted light from the tissue and hemoglobin therein. Methods of validating data of interacted light signal are also disclosed. A power conservation method of detecting the blood content values at different rates is further disclosed.

Abstract: Embodiments of the invention are related to implantable creatinine sensors and related methods, amongst other things. In an embodiment, the invention includes an implantable creatinine sensor including a sensing element. The sensing element can include a creatinine deiminase enzyme covalently bound to a substrate and a pH-indicating compound in ionic communication with the creatinine deiminase enzyme. The implantable creatinine sensor can also include an optical excitation assembly configured to illuminate the sensing element and an optical detection assembly configured to receive light from the sensing element. Other embodiments are also included herein.

Abstract: Apparatus and method to perform therapeutic treatment and diagnosis of a patient's vasculature through the use of an intravascular device having an optical fiber disposed therein. In an embodiment of this invention, the apparatus includes a therapeutic guidewire and at least one optical fiber disposed through the therapeutic guidewire, the optical fiber capable of providing diagnostic information before, during, and after the therapeutic treatment. In an embodiment, diagnostic information includes vessel and blood characteristics such as hemodynamic characteristics, hematological parameters related to blood and blood components, and thermal parameters of the vasculature.

Abstract: An optical sensing catheter system for physiological measurements of vascular or arterial parameters at plurality of location deploys wavelength division multiplexing in a common optical fiber to communicate with each optical sensor. The sensors are preferably passive planar waveguide type devices disposed to interact with the environment external to the catheter or other medical device.

Abstract: The present invention relates to a catheter head comprising: means (104, 108; 306, 304; 320; 322; 326; 338) for directing of radiation to a blood detection volume (220; 310), means (104, 108; 306, 304; 320; 322; 326; 332, 334, 330; 338) for receiving of return radiation from the blood detection volume, means (104; 306; 330) for transmitting of the return radiation to means (122) for analysis of the return radiation for determination of at least one property of the blood.

Abstract: Fibres with an extraction phase coated thereon in combination with a positioning device are described to perform adsorption of components of interest from an animal or animal tissue for the investigation of living systems. A number of interfaces to analytical instrumentation are disclosed including mass spectrometry, LC/MS, MALDI and CE as well as direct spectroscopic on-fibre measurement.

Abstract: An analyte monitor includes a sensor, a sensor control unit, and a display unit. 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, such as blood glucose. An inserter having a retractable introducer is provided for subcutaneously implanting the sensor in a predictable and reliable fashion.

Abstract: A sensor is provided that is appropriate for optical detection of dissolved carbon dioxide. Such a sensor may be used for transcutaneous detection of carbon dioxide in the tissue. Alternatively, such sensors may be inserted into the tissue. Detection of dissolved carbon dioxide in the tissue may serve as a useful clinical marker for physicians.

Abstract: A method and device are provided for the determination of the concentration of compounds in body tissue. The method utilises optical methods based on the interaction of light with compounds, whereby the concentration of the compound under analysis is determined. The method is especially suited for analysis for the concentration of glucose in blood or tissue of diabetic patients, a device being implanted underneath the skin of the patient and the method being carried out by using the implanted device. The device contains photo detectors at different levels connected by wires to an electronic circuit device. A differential analysis is performed on the signals from the detectors to reduce the effect of skin on the analysis.

Abstract: A process for identifying and treating cells in a living organism. The cells are labeled, circulated within the organism, detected with an implanted detector, and then either isolated or ablated.

Abstract: A glucose sensor assembly useful in patient systems includes an oxygen sensor from which glucose levels in the vicinity of the peritoneal cavity may be inferred. The sensor assembly may be associated with electronics, such as any or all of a DC power supply, an LED source of blue light, a photoreceptor for red light, a CPU, and transceiver, by a direct percutaneous connection. Alternatively they may be associated transdermally with the sensor and some of the electronics being located subdurally. Insulin infusion means are contemplated to respond manually or mechanically to information from the sensors through the CPU. Mechanical response may be automatic. Infusion means may be located subdurally. It is contemplated that the present invention enable revitalization or replacement of fluorescing compounds and glucose oxidase within the sensor assembly.

Abstract: A needle with fiber optic capability for spectrophotometric analysis includes a needle assembly including a needle body having an open tip and side radiation ports. A fiber optic element is disposed in the needle assembly for carrying electromagnetic radiation to the open tip area for transmission to a target area. Fiber optic bundles in communication with the radiation ports are disposed in the needle body for transmitting backscattered radiation to a light detector or sensor for spectrophotometric analysis. The needle assembly may include barbs for anchoring the device in place.

Abstract: Sensors located on a sensor carrier are placed adjacent one or more of a surgical patient's major thoracic blood-containing structures such as the aorta or pulmonary artery, and characteristics of blood in the blood-containing structures are determined noninvasively by measuring transmission or reflection of light or other types of energy by the blood. Emitters and receptors included in the sensors are connected electrically with suitable electronic signal generating and processing components in a package remote from the sensor carrier.

Abstract: Provided are methods and a system for the transbronchial reflectance oximetric measurement of mixed venous oxygen saturation in the pulmonary artery of a patient, and a device therefor. Thus, provided is a quick, minimally invasive, method and system for determining an important endpoint of resuscitation, particularly for a patient in shock, because the probe used to measure the venous oxygen saturation is configured to permit insertion through an endotracheal tube until the probe is placed in contact with the bronchial luminus mucosa of the patient's right bronchus, left bronchus or distal trachea, directly adjacent to the patient's pulmonary artery.

Abstract: A catheter system is suitable for the simultaneous, continuous, mutually unaffected measurement of the centrovenous oxygen saturation and the local concentration of injected indocyanine green. It has a centrovenous catheter with a fiber-optic lumen and a fiber-optic probe that can be inserted into the fiber-optic lumen for taking reflecto-oximetric measurements at a first wavelength of 660 nm, a second measuring wavelength of 805 nm and a reference wavelength of 880 nm. To prevent a longitudinal shift of the fiber-optic probe relative to the fiber-optic lumen, a connecting piece, securely connected to the fiber-optic probe, and a counterpart, securely connected to the catheter, are provided which can be joined together. The fiber-optic lumen which continues in the interior of the connecting piece can be cleaned when the connecting piece is attached to the counterpart. For this purpose, the connecting piece has a cleansing attachment for connecting a cleansing device.

Abstract: Activation of an enzyme in a bodily fluid is detected based on the amount of cleavage of a substrate for the enzyme. The substrate is tagged with two fluorescent dyes—a donor and an acceptor. The tagged substrate is presented to the bodily fluid. A device emits energy at a first wavelength into the bodily fluid, and detects energy at second and third wavelengths emitted by the dyes in response to the energy at the first wavelength. Prior to enzymatic cleavage of the substrate, the acceptor emits energy at the third wavelength in response to energy at the second wavelength received through fluorescent resonant energy transfer (FRET) from the donor. After enzymatic cleavage of the substrate, the donor emits energy at the second wavelength. The device can determine the concentration of activated enzyme within the bodily fluid based on the relative intensities of energy at the second and third wavelengths.

Abstract: An optical-based sensor for detecting the presence or amount of an analyte using both indicator and reference channels. The sensor has a sensor body with a source of radiation embedded therein. Radiation emitted by the source interacts with indicator membrane indicator molecules proximate the surface of the body. At least one optical characteristic of these indicator molecules varies with analyte concentration. For example, the level of fluorescence of fluorescent indicator molecules or the amount of light absorbed by light-absorbing indicator molecules can vary as a function of analyte concentration. In addition, radiation emitted by the source also interacts with reference membrane indicator molecules proximate the surface of the body. Radiation (e.g., light) emitted or reflected by these indicator molecules enters and is internally reflected in the sensor body.

Abstract: A method and apparatus for orienting an implant such as a sensor or other device in a bodily lumen with an external source such as a transmitter or transducer. The apparatus includes a fastener having at least one support leg and a fixture for holding the implant. The implant, fixture, or both may move to achieve alignment of the implant with the external source Mechanical alignment may be used by moving a catheter such as one used to place the implant and fastener in the lumen to align the sensor. A second type of alignment based on gravity may be used so that when a weighed implant is used a patient while lying in certain positions would force the implant into alignment with the source. A third type of alignment uses magnetic force having a magnet on the implant, source or both for aligning the implant relative to the source.

Abstract: Fluorescent biosensor molecules, fluorescent biosensors and systems, as well as methods of making and using these biosensor molecules and systems are described. Embodiments of these biosensor molecules exhibit fluorescence emission at wavelengths greater than about 650 nm. Typical biosensor molecules include a fluorophore that includes an iminium ion, a linker moiety that includes a group that is an anilinic type of relationship to the fluorophore and a boronate substrate recognition/binding moiety, which binds glucose. The fluorescence molecules modulated by the presence or absence of polyhydroxylated analytes such as glucose. This property of these molecules of the invention, as well as their ability to emit fluorescent light at greater than about 650 nm, renders these biosensor molecules particularly well-suited for detecting and measuring in-vivo glucose concentrations.

Abstract: A catheter system is suitable for the simultaneous, continuous, mutually unaffected measurement of the centrovenous oxygen saturation and the local concentration of injected indocyanine green. It has a centrovenous catheter with a fiber-optic lumen and a fiber-optic probe that can be inserted into the fiber-optic lumen for taking reflecto-oximetric measurements at a first wavelength of 660 nm, a second measuring wavelength of 805 nm and a reference wavelength of 880 nm. To prevent a longitudinal shift of the fiber-optic probe relative to the fiber-optic lumen, a connecting piece, securely connected to the fiber-optic probe, and a counterpart, securely connected to the catheter, are provided which can be joined together. The fiber-optic lumen which continues in the interior of the connecting piece can be cleaned when the connecting piece is attached to the counterpart. For this purpose, the connecting piece has a cleansing attachment for connecting a cleansing device.

Abstract: Apparatus for monitoring a plurality of tissue viability parameters of a tissue layer element, in which two different illumination sources are used via a common illumination element in contact with the tissue. One illumination source is used for monitoring blood flow rate and optionally flavoprotein concentration, and collection fibers are provided to receive the appropriate radiation from the tissue. The other illuminating radiation is used for monitoring any one of and preferably all of NADH, blood volume and blood oxygenation state of the tissue element, and collection fibers are provided to receive the appropriate radiation from the tissue. In one embodiment, the wavelengths of the two illumination sources are similar, and common collection fibers for the two illuminating radiations are used. In another embodiment, the respective collection fibers are distanced from the illumination point at different distances correlated to the ratio of the first and second illuminating wavelengths.

Abstract: The present invention provides an optical measurement device of biological tissue having a probe attachable to a moving part of a living body with a high curvature in biophotometry. A member having a high flexibility and a high friction coefficient is disposed on a surface for contact with the living body. In addition, a device for light irradiation and a device for collection of light are fixed with an elastic material for uniform pressure application. The resulting double structure or double layer has solved a problem.

Abstract: A tip assembly for a catheter includes a housing having a recess that receives an optical bench. The optical bench accommodates adjacent fibers, one of which is in optical communication with a first beam re-director. The first beam re-director is oriented to cause a beam incident thereon to travel in a direction away from the optical bench. An engaging structure coupled to the optical bench provides torque coupling between the housing and an end of a torque cable extending axially along the catheter.

Abstract: Disclosed is an access catheter for identifying and providing access through a tissue structure such as the fossa ovalis on the intraatrial septum. The access catheter comprises an elongate flexible tubular body having a proximal and a distal end, and a retractable piercing structure such as a needle carried by the distal end. A detector such as a red, green, and blue light detector is associated with the access catheter, such that placement of the distal end of the catheter against the fossa ovalis can be detected. The piercing structure is thereafter advanceable to provide access to the left atrium through the fossa ovalis.

Abstract: The invention provides methods and apparatus to reference or normalize optical measurements, by removing or accounting for background factors and artifacts, such as motion artifacts, that arise during use of optical catheters.

Abstract: A medical device comprising a medical device component, the medical device component having an outer surface and an inner surface, a universal coating applied to at least the outer surface or the inner surface of the medical device component, wherein the coating is made from a material selected from the group consisting of diamond, diamond-like, borosilicate glass, carbides and nitrides. The medical device can further be a smart medical device by incorporating a sensor capable of measuring chemical and/or electrical conditions.

Abstract: An apparatus and method for positioning sensors relative to one another and anatomic features in a non-invasive device for measuring and monitoring multiple physiological variables from a single site uses an earpiece incorporating a shielded pulse oximetry sensor (POS) having a miniaturized set of LEDs and photosensors configured for pulse oximetry measurements in the reflectance mode and located in the earpiece so as to position the POS against a rear wall of an ear canal. The earpiece also includes a thermopile of no larger than 7 mm. in diameter located on the earpiece to so as to position the thermopile past a second turn of an external auditory meatus so as to view the tympanic membrane. The thermopile includes a reference temperature sensor attached to its base for ambient temperature compensation.

Abstract: Device for measuring human blood sugar levels with a catheter, the free end of which is positioned in a blood vessel, wherein the catheter consists of at least one optical waveguide comprising a light source for coupling light into the at least one optical waveguide, a measurement point at the free end of the catheter at which point the light is emitted from the at least one optical waveguide, wherein the light is dispersed by the blood and/or transmitted by the blood and wherein the dispersed and/or transmitted light is coupled again into the minimum of one return optical waveguide, a detector to receive the light which is returned, and a computer unit for analysing the light received by the detector.

Abstract: Disclosed is an electrode placement with a series of electrodes disposed therein to be used for a one-step placement of electrodes. The device is shaped to allow it to be positioned and placed on a patient so that accurate placement of electrodes is achieved.

Abstract: An optical-based sensor for detecting the presence or amount of an analyte using both indicator and reference channels. The sensor has a sensor body with a source of radiation embedded therein. Radiation emitted by the source interacts with indicator membrane indicator molecules proximate the surface of the body. At least one optical characteristic of these indicator molecules varies with analyte concentration. For example, the level of fluorescence of fluorescent indicator molecules or the amount of light absorbed by light-absorbing indicator molecules can vary as a function of analyte concentration. In addition, radiation emitted by the source also interacts with reference membrane indicator molecules proximate the surface of the body. Radiation (e.g., light) emitted or reflected by these indicator molecules enters and is internally reflected in the sensor body.

Abstract: An optical-based sensor for detecting the presence or amount of an analyte using both indicator and reference channels. The sensor has a sensor body with a source of radiation embedded therein. Radiation emitted by the source interacts with indicator membrane indicator molecules proximate the surface of the body. At least one optical characteristic of these indicator molecules varies with analyte concentration. For example, the level of fluorescence of fluorescent indicator molecules or the amount of light absorbed by light-absorbing indicator molecules can vary as a function of analyte concentration. In addition, radiation emitted by the source also interacts with reference membrane indicator molecules proximate the surface of the body. Radiation (e.g., light) emitted or reflected by these indicator molecules enters and is internally reflected in the sensor body.

Abstract: A pacifier pulse oximeter sensor includes pulse oximeter sensor elements located within the nipple of a pacifier. The pulse oximeter sensor elements may be completely within the nipple material, embedded within the nipple material, nested within the nipple material, or adjacent to the nipple material while not being exposed to the outside environment. The pulse oximeter sensor elements include a light source and a light detector. The pulse oximeter sensor elements communicate with an oximeter through wiring, an electrical connector, and/or wirelessly. An alternative embodiment adds oximeter processing capabilities to the pacifier pulse oximeter sensor.

Abstract: A system and method for measuring total circulating blood volume and cardiac output employing an analyte diffusion approach. The analyte sensor as well as the analyte-containing fluid infusion procedure may be carried out with instruments which are inserted in the bloodstream at peripheral locations of the body spaced from the heart. A controller is provided to automatically carry out these measurements as well as to provide threshold comparisons for alerting the practitioner to excursion in the parameters. The preferred analyte containing fluid is an ammoniacal fluid and the preferred sensed components is ammonia gas.

Abstract: A compliant controller implements a biological model of a primate muscle so as to provide simultaneous position and force control with nonlinear damping for an actuator. The compliant controller uses one or more position sensors but does not require the use of a force sensor to provide force control. The compliant controller implements a force determining algorithm that is a function of an initial actuator position, a subsequently sensed actuator position, a desired actuator position and a position calculated from a nonlinear damping function. The algorithm updates or resets the initial actuator position or the calculated position depending upon the amount of actuator movement sensed. The compliant controller in accordance with the force determining algorithm and resetting of the various position values allows a desired position to be quickly attained while allowing the controller to compliantly respond to the presence or removal of an unknown or unexpected disturbing force.

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: 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: This invention is an implantable sensor and system capable of measuring, controlling, monitoring and reporting blood constituent levels. The implantable sensor for sensing in vivo the level of at least one blood constituent in mammalian vascular tissue having at least one source of radiation from infrared through visible light, arranged to direct the radiation at the tissue where it is affected by interaction with the tissue, and at least one detector. The invention also encompasses a device for measuring and controlling the level of a blood constituent, such as glucose or oxygen, and includes an implantable infrared source module for generating an output signal representative of the sensed infrared radiation. The system includes a processor module responsive to the output signal which performs spectral analysis of the output signal and generates a control signal. The system further includes other devices for dispensing doses of medications or controlling organ function in response to the control signal.

Abstract: A miniaturized spectrometer is adapted for placement within a body near tissue to be characterized. The spectrometer includes a light source and a plurality of light detectors. The light source generates light to illuminate the tissue. The detectors detect optical signals from the illuminated tissue and convert these optical signals to electrical signals. The miniaturized spectrometer can be disposed at the distal end of an interventional device. Optical conduits, such as fiber optic cables or strands, extending the length of the interventional device are not required when the miniature spectrometer is employed.

Abstract: A system for detecting Barrett's metaplasia utilizes an illumination and imaging probe at the end of a catheter. The probe illuminates the wall of the esophagus and returns reflected light to be processed to provide a visual indication of the color of the esophageal wall. The position of the probe along the length of the esophagus is also measured to allow a medical practitioner to determine the location of the transition from the pink stomach lining to the white esophageal lining.

Abstract: The invention provides non-invasive methods and apparati for measurement of the concentration of a selected constituent of a subject's blood. The invention cools a segment of the subject's tympanic membrane and employs the thermal radiation that the subject's inner ear emits and is transmitted through this cold segment to directly obtain absorption information related to the concentration of various constituents of blood flowing through the membrane. In particular the invention utilizes optical devices inserted into the external ear cavity to direct a portion of the transmitted radiation onto an infrared detection and analysis device. The signal from the detection device is analyzed to obtain the concentration of the constituent of interest. The invention can employ both traditional spectrophotometric techniques and also non-spectrophotometric techniques to derive the concentration of a particular constituent.

Abstract: An implantable device for sensing in vivo the level of at least one blood constituent in mammalian vascular tissue has at least one source of radiation from infrared through visible light, arranged to direct the radiation at the tissue where it is affected by interaction with the tissue, and a plurality of detectors. Each detector has associated with it a filter transparent to a discrete narrow band of radiation, and each detector provides an output signal representative of detected radiation in that narrow band. The detectors are located with respect to the tissue to receive radiation affected by the tissue.

Abstract: An intrauterine pulse oximetry apparatus and method are provided to measure fetal blood oxygen saturation at sites in a preferred region on the fetus. The sensor of the apparatus is attached to a stiff cable which can be inserted into the uterus past the presenting part and transcervical region of the fetus. The cable may have visual and tactile markings by which the user, without seeing or feeling the sensor, can guide it to an appropriate site on the fetus and for use in determining the depth of the sensor in the vagina.

Abstract: A fiber optic sensor for D dimer (a fibrinolytic product) can be used in vivo (e.g., in catheter-based procedures) for the diagnosis and treatment of stroke-related conditions in humans. Stroke is the third leading cause of death in the United States. It has been estimated that strokes and stroke-related disorders cost Americans between $15-30 billion annually. Relatively recently, new medical procedures have been developed for the treatment of stroke. These endovascular procedures rely upon the use of microcatheters. These procedures could be facilitated with this sensor for D dimer integrated with a microcatheter for the diagnosis of clot type, and as an indicator of the effectiveness, or end-point of thrombolytic therapy.

Abstract: Cardiac output is measured utilizing a catheter in conjunction with the indicator dilution technique. Non-thermal analyte-containing fluid is used as the injectate. This fluid is biocompatible with and metabolizable within the body of the patient. An analyte concentration sensor is mounted upon the catheter and located downstream within the bloodstream from the port from which the analyte-containing fluid is expressed. Because of the matching of rapid concentration sensor response with an analyte-containing fluid which is metabolizable, the measurement of cardiac output may be carried out as often as about one to three minutes in conjunction with an infusion interval substantially less than the measurement frequency interval. The analyte-containing fluids are selected from a group consisting of ammoniacal fluid, heparin, ethanol, a carbon dioxide releasing fluid, glucose, and anesthesia agent.

Abstract: Methods and apparatus for the measurement of oxygen, pH and CO.sub.2 in human and animal tissue is provided, in which the compounds preferably include a chromophore and/or fluorphor capable of absorbing an amount of energy and subsequently releasing the energy as phosphorescent and/or fluorescent light, and wherein the phosphorescence is quenched by molecular oxygen according to the Stern-Volmer relationship, CO.sub.2 is measured by fluorphor which alters fluorescence with pH.

Abstract: A physical-information-image displaying apparatus for use with an endoscope including an image pick-up which picks up an endoscopic image from a living subject and produces an endoscopic-image signal representing the picked-up endoscopic image, and a display which displays the picked-up endoscopic image represented by the endoscopic-image signal, the apparatus including a physical-information obtaining device which obtains a physical information from the subject and produces a physical-information signal representing the obtained physical information, a physical-information-image-signal producing device which produces, based on the physical-information signal produced by the physical-information obtaining device, a physical-information-image signal representing a physical-information image corresponding to the obtained physical information, and a superimposing device which superimposes the physical-information-image signal produced by the physical-information-image-signal producing device, on the endoscopic-i

Abstract: An apparatus for informing an operator of an abnormality of a physical information obtained from a living subject, including a physical-information obtaining device which obtains the physical information from the subject via an endoscope and outputs a physical-information signal representing the obtained physical information, a signal converting device which converts the physical-information signal into an analog speech signal having a waveform representing a speech corresponding to the obtained physical information, a speech outputting device which outputs the speech represented by the speech signal, a judging device for judging whether the obtained physical information represented by the physical-information signal is abnormal, and a frequency shifting device which shifts, when the judging means makes a positive judgment, frequencies of the speech output by the speech outputting device, so that the operator is informed of the abnormality of the physical information obtained from the subject.