Abstract: The present invention relates to an in vitro method of prognosis for the arrest of bleeding in a patient suffering from postpartum haemorrhage in the absence of an invasive procedure, comprising the following steps: (a) determining, using a biological sample from said patient, the plasma fibrinogen concentration, the blood troponin concentration and also the prothrombin time; (b) studying at least two clinical markers for said patient, selected from the group comprising heart rate and the presence of placentation abnormalities; (c) calculating a score Z according to the following equation: Z=a+b+v+d+e; where a is associated with the existence of placentation abnormalities in said patient, with a being 0 when no placentation abnormality is observed in said patient and a being 1 when one or more placentation abnormalities are observed in said patient; where b is associated with the heart rate of said patient, with b being 0 when the heart rate of said patient is less than or equal to 115 bpm (beats per minute)

Abstract: Embodiments herein provide an analyte sensor subassembly that provides an integrated structure enabling suitably secure electrical contact between an analyte sensor and the electronic components of an analyte sensor assembly. An analyte sensor subassembly assists the process of inserting the sensor into skin. An analyte sensor subassembly may operate in concert with one or more sensor insertion tools to provide insertion of an analyte sensor into the skin of a subject/patient. Associated devices, such as channel guides and sensor insertion tools, are also provided, as are methods of operation and sensor insertion.

Abstract: An apparatus is disclosed for detecting moisture, which is intended for the use in an apparatus for monitoring an access to a patient for a device by means of which a fluid is conducted to and/or removed from a patient via a hose line, in particular for monitoring the vascular access during an extracorporeal blood treatment, wherein blood of a patient is removed from the patient via an arterial hose line, which has an arterial puncture cannula, and is conducted back to the patient via a venous hose line, which has a venous puncture cannula. The apparatus for detecting moisture is designed as a pad which is made of a flexible material and is to be applied onto the patient's skin and which comprises an upper side facing away from the patient's skin and a lower side facing the patient's skin. The pad comprises an opening for the passage of fluid, in particular blood, and a moisture sensor having contact elements for the connection of the same.

Abstract: An early warning and shutdown system that connects to a fluid loss detection device for dressings at pre-existing port sites, catheter sites, operative sites, ostomy sites, drain sites, line sites such as those utilized in hemodialysis, wound sites, or other areas for which monitoring of fluid or blood loss is medically indicated. The early warning and shutdown system sounds an alarm when the fluid loss detection device senses a loss of fluid, and then compresses a return tube carrying such fluid to stop further fluid loss if the fluid loss continues.

Abstract: A method is disclosed in which a vapor-deposited coating or layer is directly or indirectly applied to at least a portion of the internal wall of the barrel of a capped pre-assembly comprising a barrel, optionally a dispensing portion, and a cap. The cap is secured to the barrel and at least substantially isolates the distal opening of the dispensing portion from pressure conditions outside the cap. A vapor-deposited coating or layer is applied directly or indirectly to at least a portion of the internal wall of the barrel while the pre-assembly is capped. The coating or layer is applied under conditions effective to maintain communication from the barrel lumen to the exterior via the front opening, optionally further via the dispensing portion lumen if present, at the end of the applying step. The capped pre-assembly can be pressure tested easily and rapidly, for example with a test duration between 1 and 60 seconds, to determine whether it has container closure integrity.

Abstract: An apparatus comprises a sheath for introducing a catheter into a blood vessel, at least one electrode provided on the sheath, at least one other electrode; and a measuring device to which at least one pair of electrodes are coupled. The measuring device measures the impedance or conduction velocity between the first electrode on the sheath and the second electrode.

Abstract: A monitor for an extracorporeal therapy access site is disclosed. The monitor includes a bandage atop or adjacent the access site and a sensor for monitoring the bandage. The bandage includes a layer of polymer that expands when wetted with blood. The expansion causes a break in continuity of the sensor, or in an alternate embodiment, causes a sensor to cease detecting a target. When the break occurs, the control circuit monitoring the bandage sends a signal that a break has occurred, and a remote monitor then takes appropriate action, such as ceasing therapy, sending an alert, or sounding an alarm. In another embodiment, connecting wires in a continuity circuit are held apart by a polymer that dissolves when contacted by blood. If a leak occurs and a small portion of the polymer dissolves, the wires make contact, thus detecting a blood leak.

Abstract: Tools and techniques for estimating a probability that a patient is bleeding or has sustained intravascular volume loss (e.g., due to hemodialysis or dehydration) and/or to estimate a patient's current hemodynamic reserve index, track the patient's hemodynamic reserve index over time, and/or predict a patient's hemodynamic reserve index in the future. Tools and techniques for estimating and/or predicting a patient's dehydration state. Tools and techniques for controlling a hemodialysis machine based on the patient's estimated and/or predicted hemodynamic reserve index.

Abstract: A medical device includes an insertable portion capable of being inserted into an orifice associated with a body of a patient. The insertable portion comprising an automated head unit capable of being manipulated in at least two axes of motion based at least in part on one or more control signals. The medical device further includes one or more controllers coupled to the automated head unit. In one particular embodiment, the one or more controllers generate the one or more control signals based at least in part on an input signal.

Abstract: An apparatus comprises a sheathe for introducing a catheter into a blood vessel, a first electrode provided on the sheathe, a second electrode; and a measuring device to which the first and second electrodes are coupled. The measuring device measures the impedance or conduction velocity between the first electrode on the sheathe and the second electrode.

Abstract: An introducer comprise a sheath for introducing a catheter into a blood vessel, a plurality of electrodes on the sheath, and an impedance assessment unit provided on the sheath and connected to the electrodes. The impedance assessment unit fixes one of a current or voltage across a first pair of the electrodes and measures the other of the current or voltage across a second pair of electrodes.

Abstract: A fluid loss detection device for dressings at pre-existing port sites, catheter sites, operative sites, ostomy sites, drain sites, line sites such as those utilized in hemodialysis, wound sites, or other areas for which monitoring of fluid or blood loss is medically indicated. The detection device includes a patch having a primary loop circuit and an early warning alarm circuit loop. In one embodiment, closure of the early warning alarm circuit loop activates an alarm. The alarm may be connected directly to the patch and sound locally or may be activated remotely via radio transmission. The alarm may alternatively cause a medical device such as a hemodialysis system to shut down.

Abstract: Systems and methods that enable physiological monitoring with a mobile communication device and that allow detection of motion artifacts so that the results reported are of acceptable quality are disclosed.

Abstract: An access site disconnection system and method are disclosed. Radio frequency transmitters and receivers are placed near an access site. When a patient receives dialysis treatment, wetness may arise from blood if the access needle becomes disconnected from the access site. Radio-frequency transmitters are mounted on or near gauze or other absorbent material placed adjacent the access site, as are radio-frequency receivers. After the sensors are placed, the dialysis machine and radio-frequency control circuit may be initialized or baselined, and dialysis treatment, such as hemodialysis, begun. If blood leaks from the access site, such as if the access needle is dislodged, the blood attenuates the radio frequency transmissions, which are detected by the receivers. A signal is sent to a controller or to an output device to raise an alert or sound an alarm.

Abstract: A method for recovering blood from a blood-laden surgical sponge for autologous reinfusion, the method comprising the steps of: conveying negative pressure to a housing with the blood-laden surgical sponge; applying a predetermined force to draw the blood from the surgical sponge; and collecting the recovered blood.

Abstract: An optical access disconnect system is useful for detecting the presence of blood. The optical access disconnect system includes one or more optical sensors placed near an access site of a patient, the optical sensors suitable for detecting the presence of blood, especially by detecting a difference in light reflected or absorbed by blood. The optical access disconnect system may also be used as an interlock to assure compliance. A detector may be placed adjacent the access site to detect the access needle, or an object or mark on the access needle or fluid line. A therapy machine, such as a dialysis machine, may be programmed not to start or continue operation unless the needle or fluid line is detected. The detector may be one of the optical sensors, calibrated or adjusted to detect a mark on the needle or access line, or may be another type of detector.

Abstract: The invention comprises a method for treating a prostate to alleviate prostate cancer, benign prostatic hyperplasia (BPH), and other conditions. The method involves inserting a tool to create a small self-sealing puncture site through tissue to gain access to a portion of a prostate, inserting a probe though the puncture site into the prostate, activating the probe to treat the prostate, withdrawing the probe and inspecting a surgical site for a flow of urine or semen to determine whether a sufficient amount of prostate tissue has been treated, and inspecting for hemostasis. The method may also include delivering a luminally protective sheath before inserting any instruments, using a template to guide insertion of the probe, and delivery of tamponading balloons to assist with attainment of hemostasis after the coring procedure.

Abstract: A safety device for monitoring a vascular access location on a living being includes a housing adapted to surround the vascular access location and a sensor arranged in or on the housing to detect fluid flowing from the vascular access location into the housing.

Abstract: An apparatus for determining an indicator parameter relating to a subject comprising at least an input line for receiving electrical signals coming from a electrodes, receiving a signal coming from a peripheral sensor predisposed to operate in a predetermined peripheral section of the subject's body; a control unit connected to the input line and configured for determining a value of an indicator value (iHAT) as a function of the instant of generation (TGj) of a pressoric wave in relation to the heartbeat.

Abstract: An access disconnect sensor for a patient undergoing extracorporeal blood processing includes an electrochemical fuel cell or sensor to detect blood leakage. The fuel cell includes circuitry for oxidizing glucose in the blood. The sensor also includes a transmitter to send a signal to a remote receiver that the sensor indicates the presence of blood. The circuitry may include a battery or may use electricity generated by the sensor to send a signal indicating a leak of blood or disconnection of the access needle.

Abstract: A device, system and method for detecting bile and blood are provided. The device may comprise a housing having a gap through which in-vivo fluids may flow, illumination sources on one side of the gap, a light detector which is facing the illumination sources and is positioned on the opposite side of the gap for detecting light which passes through the in-vivo fluids, and a transmitter to transmit the detected signals generated according to the detected light. The system may further comprise a receiver to receive the detected signals transmitted by the transmitter, and a processor. The method may comprise comparing the detected signals with a predetermined threshold calculated from the transmission spectra of bile and of blood and determining the presence and/or concentration of bile and blood in-vivo.

Abstract: Methods and systems are disclosed for autonomously building a predictive model of outcomes. A most-predictive set of signals Sk is identified out of a set of signals s1, s2, . . . , sD for each of one or more outcomes ok. A set of probabilistic predictive models ôk=Mk (Sk) is autonomously learned, where ôk is a prediction of outcome ok derived from the model Mk that uses as inputs values obtained from the set of signals Sk. The step of autonomously learning is repeated incrementally from data that contains examples of values of signals s1, s2, . . . , sD and corresponding outcomes o1, o2, . . . , oK. Various embodiments are also disclosed that apply predictive models to various physiological events and to autonomous robotic navigation.

Abstract: The present invention is device for delivering an electrode into a lateral vein of the coronary sinus. The device includes a support structure, a stent, a tether coupled to the stent and a removable sheath disposed about the stent. The stent is carried on the support structure and is deployable from a first collapsed configuration to a second expanded configuration for engaging the inner walls of the selected vessel. The sheath is sized to retain the stent in the first collapsed configuration. The electrode is carried on the stent or on a lead threaded over the tether.

Abstract: A device for detecting a hematoma or subcutaneous hemorrhage after a PCI, which includes a bandage provided with fastening elements for its placement at the PCI access site, and the use of a safety bandage for producing the same. In the device, the bandage includes a flexible and, in its longitudinal direction, non-elastic element connected to a strain sensor so arranged that the strain sensor, when the element after the placement of the bandage at the access site is subjected to a change in tension as a result of a hematoma or subcutaneous hemorrhage after the PCI, emits a signal that is indicative of the hematoma or hemorrhage.

Abstract: The present invention describes examination devices, such as examination gloves, for detecting the presence of blood, and in particular hidden blood, in biological samples. Examination devices according to the present invention include, in certain embodiments, developer and indicator reagents in a single encapsulation, which offers numerous clinical and other benefits. Kits including devices according to the present invention in sterile packaging, and methods of making and using devices according to the present invention, are also described.

Abstract: A device for hemorrhage detection comprising a detector for detecting the presence of blood, the detector being connected to a fixing, apparatus. The fixing apparatus is fixed to the inner wall of a hollow organ. The device further has a transmitting unit by which data transmitted by the detector are adapted to be transmitted to a receiving unit disposed outside the body.

Abstract: Devices and methods for guidewire assisted placement of catheters into blood vessels are described. Some of the devices and methods relate to automated or partially automated or assisted insertion and placement of an intravenous catheter into a vein or artery of a patient. Other of the devices are blood draw devices and methods for insertion and placement of an intravenous device into a vein or artery of a patient or to withdraw a blood sample from the patient. The devices also provide for guide wire tip inspection after use.

Abstract: An apparatus comprises a sheath for introducing a catheter into a blood vessel, at least one electrode provided on the sheath, at least one other electrode; and a measuring device to which at least one pair of electrodes are coupled. The measuring device measures the impedance or conduction velocity between the first electrode on the sheath and the second electrode.

Abstract: An apparatus comprises a sheathe for introducing a catheter into a blood vessel, a first electrode provided on the sheathe, a second electrode; and a measuring device to which the first and second electrodes are coupled.

Abstract: The present invention provides a method and apparatus for appropriately calculating 3D volume of cerebral hemorrhage lesion. The present invention sets a ROI for normal cerebral parenchymal region and a ROI for cerebral hemorrhage lesion respectively for a plurality of continuous slice images obtained by imaging the head having cerebral hemorrhage onset with an X-ray CT device, determines a mean value of the CT values of pixels within the ROI of normal cerebral parenchymal region for each of a plurality of images, then determines an amount of shift of mean values of images based on the mean value of one image, adjusts the CT value of pixels in the ROI of cerebral hemorrhage lesion for each image by using the amount of shift for each image, specifies the maximum value of the adjusted CT value through a plurality of images, and then calculates the 3D volume of the cerebral hemorrhage lesion.

Abstract: A fluid loss detection device for dressings at pre-existing port sites, catheter sites, operative sites, ostomy sites, drain sites, line sites such as those utilized in hemodialysis, wound sites, or other areas for which monitoring of fluid or blood loss is medically indicated. The detection device includes a patch having a primary loop circuit and an early warning alarm circuit loop. In one embodiment, closure of the early warning alarm circuit loop activates an alarm. The alarm may be connected directly to the patch and sound locally or may be activated remotely via radio transmission. The detection device may additionally cause a medical device such as a hemodialysis system to shut down.

Abstract: A blood loss detection device for a hemodialysis system having a blood intake line, a dialysis machine including a pump, with the dialysis machine in communication with the blood intake line, and a blood return line in communication with the dialysis machine. The detection device includes a patch having an exterior edge and an opening through the patch forming a target for receipt of the return blood line. A slit through the patch extends between the exterior edge and the opening. A primary loop circuit terminates at two ends at the slit. An early warning alarm circuit loop terminates at two ends at the slit. An emergency shut-down circuit loop terminates at two ends at the slit. A modular connector connects the patch to an alarm activated by the early warning alarm circuit and to a switch mechanism activated by the shut-down circuit in order to shut down the dialysis machine and the pump.

Abstract: A venous-arterial detector is disclosed. The detector includes a first chamber in fluid communication with a needle, and an indicator chamber in selective fluid communication with the first chamber through a valve. The indicator chamber is pre-pressurized to a defined pressure that preferably exceeds typical venous pressure, and the valve retains that pressure within the indicator chamber. When the needle is inserted into a vessel, if the pressure in the vessel is greater than the defined pressure in the indicator chamber, blood will flow into the indicator chamber, indicating that the vessel is most likely to be an artery.

Abstract: The present invention describes examination devices, such as examination gloves, for detecting the presence of blood, and in particular hidden blood, in biological samples. Examination devices according to the present invention include, in certain embodiments, developer and indicator reagents in a single encapsulation, which offers numerous clinical and other benefits. Kits including devices according to the present invention in sterile packaging, and methods of making and using devices according to the present invention, are also described.

Abstract: Selective occlusion of a blood vessel is achieved by selectively damaging endothelial cells at a target location in the blood vessel, resulting in the formation of a fibrin clot proximate to the damaged endothelial cells. Additional fibrinogen can then be introduced into the blood vessel if occlusion is not achieved, as the fibrinogen is converted to fibrin by enzymes released by the exposed thrombogenic tissue and activated platelets. Endothelial cells are selectively damaged using thermal effects induced by ultrasound, by mechanical effects induced by ultrasound, or by mechanical effects produced by a tool introduced into the blood vessel (such as a catheter-based tool). A particularly preferred technique for selectively damaging endothelial cells involves introducing an ultrasound activatable agent into the blood vessel, and causing cavitation in that agent using pulses of high-intensity focused ultrasound having a duration insufficient to induce thermal damage in adjacent perivascular tissue.

Abstract: An apparatus comprises a catheter comprising a first electrode. The apparatus also comprises a second electrode electrically attached to a person and coupled to the first electrode via the person's tissue. Logic is coupled to the electrodes and generates an electrical signal that is provided through the electrodes and computes an impedance or conduction velocity associated with the electrodes based on the electrical signal.

Abstract: A phlebotomy device includes a needle defining a lumen and having a proximal end portion and a distal end portion. The distal end portion includes a sharpened tip configured to pierce tissue. The phlebotomy device further includes a sensor disposed at least partially within the lumen. The sensor has a first state and a second state and is configured to transition from the first state to the second state upon exposure to blood at physiological temperature.

Abstract: A method for disrupting blood flow to undesirable tissue such as cells of a cancerous or non-cancerous tumor is disclosed. It involves the placement of electrodes into or near the vicinity of vessels supplying blood to the undesirable tissue and through the application of electrical pulses causing blood flow disruption. The electric pulses irreversibly permeate the cell membranes, thereby invoking cell death. The irreversibly permeabilized cells are left in situ and are removed by the body immune system. The process may further comprise monitoring blood flow and/or infusion of a material such as a chemotherapeutic agent or marker into the blood.

Abstract: The present invention includes methods and systems for classifying and assigning a measurement to a bleeding event exhibited by an individual. The system includes two or more categories, wherein each category has a different level of severity; two or more bleeding events assigned to each category; and a set of points for each category. Points are assigned to a category depending on the severity of the category, wherein the more severe categories have a greater number of points assigned to it. The classification includes a categorical designation that indicates the category from which the points were assigned. Accordingly, the methods for assigning a measurement to at least one bleeding event exhibited by an individual include assigning one or more points to the bleeding event according to a classification system, and optionally assigning a categorical designation to the measurement.

Abstract: The present invention relates to medical diagnostic techniques and more particularly to compositions and methods for locating an internal bleeding site in a subject.

Abstract: A device for hemorrhage detection comprising a detecting means for detecting the presence of blood, said detecting means being connected to a fixing means. The fixing means is fixed to the inner wall of a hollow organ. The device further has a transmitting unit by which the data transmitted by the detecting means are adapted to be transmitted to a receiving unit disposed outside the body.

Abstract: A method of alerting medical personnel of a problem during hemodialysis includes providing an active, fail-to-safe site sensor for a fistula needle at an access site during hemodialysis; and automatically alerting medical personnel of a problem during hemodialysis using the active, fail-to-safe site sensor during at least the following: failing of the active, fail-to-safe site sensor; insufficient powering to the active, fail-to-safe site sensor; partial fistula needle dislodging from the access site; and complete needle dislodging from the access site.

Abstract: The microwave hemorrhagic stroke detector includes a low power pulsed microwave transmitter with a broad-band antenna for producing a directional beam of microwaves, an index of refraction matching cap placed over the patients head, and an array of broad-band microwave receivers with collection antennae. The system of microwave transmitter and receivers are scanned around, and can also be positioned up and down the axis of the patients head. The microwave hemorrhagic stroke detector is a completely non-invasive device designed to detect and localize blood pooling and clots or to measure blood flow within the head or body. The device is based on low power pulsed microwave technology combined with specialized antennas and tomographic methods. The system can be used for rapid, non-invasive detection of blood pooling such as occurs with hemorrhagic stoke in human or animal patients as well as for the detection of hemorrhage within a patient's body.

Abstract: A sample retention apparatus for use in a device for measuring hemostasis. The device for measuring hemostasis may include a sample articulation apparatus including a guide shaft coupled for articulating motion to a drive motor, a sample carrier secured to and axially moveable along the guide shaft between a sample ready position, a sample testing position and a sample ejection position. The sample carrier therefore articulates in unison with the articulating motion of the guide shaft. A measuring apparatus may include a sensing column. The sample retention apparatus may include a sample cup defining a volume within which a sample may be disposed. The sample cup may be adapted to be operably positioned within an aperture formed within the sample carrier. The sample testing apparatus may also include a sample pin that is engageable with the sensing column. The sample pin may include a tip portion for extending into the sample cup.

Abstract: An apparatus for detecting dislodgement of a needle inserted into a patient includes a sensor for detecting wetness due to blood and a sensor holder to secure the sensor to the patient such that the sensor detects wetness due to blood loss from the patient upon dislodgement of the needle. Methods and apparatuses for detecting, monitoring and/or controlling blood loss from a patient due to needle dislodgement are also provided.

Abstract: Apparatuses, devices, systems and methods for detecting access disconnection during medical therapy are provided. The present invention includes an electric circuit coupled to, for example, a blood circuit used during dialysis therapy. The electric circuit can inject an electrical signal into the blood circuit such that changes in an electrical value in response to access disconnection, such as needle drop-out or catheter drop-out, can be effectively detected.

Abstract: A method of alerting medical personnel of a problem during hemodialysis includes providing an active, fail-to-safe site sensor for a fistula needle at an access site during hemodialysis; and automatically alerting medical personnel of a problem during hemodialysis using the active, fail-to-safe site sensor during at least the following: failing of the active, fail-to-safe site sensor; insufficient powering to the active, fail-to-safe site sensor; partial fistula needle dislodging from the access site; and complete needle dislodging from the access site.

Abstract: A system for simulating a medical procedure performed on a subject, featuring: (a) a simulated organ; (b) a simulated instrument for performing the medical procedure on the simulated organ; (c) a locator for determining a location of the simulated instrument within the simulated organ; and (d) a visual display for displaying images from the medical procedure, such that the images simulate visual data received during the medical procedure as performed on an actual subject, the visual display including: (i) a three-dimensional model of the simulated organ, the model being divided into a plurality of segments; (ii) a loader for selecting at least one of the plurality of segments for display, the at least one of the plurality of segments being selected according to the location of the simulated instrument within the simulated organ; (iii) a controller for selecting each image from the selected segment according to the location of the simulated instrument; and (iv) a displayer for displaying the image according to

Abstract: A focused ultrasound system includes a transducer array including a plurality of sub-arrays, each sub-array defining an acoustic emission surface and including a plurality of transducer elements thereon. A mechanical controller is coupled to the sub-arrays that includes actuators for moving the sub-arrays to adjust an orientation of the acoustic emission surfaces of respective sub-arrays to facilitate steering of acoustic energy emitted by the transducer elements towards a target tissue region. Drive circuitry provides drive signals to the transducer elements, whereby the transducer elements emit acoustic energy from their respective acoustic emission surfaces to ablate the target region, such as a tumor within a patient's brain.

Abstract: A method and apparatus are provided for measuring hemostasis. The apparatus includes a torque sensing column having a torque sensing element and a drive ring disposed around a body of the column and in registration with the column so as to allow rotation of the drive ring around a longitudinal axis of the column. The apparatus further includes a first guide shaft rigidly secured to the drive ring, the guide shaft extending parallel to the longitudinal axis of the column and a cup holder movably attached to the guide shaft, allowing the cup holder to move parallel to the longitudinal axis of the column. The apparatus also includes a sample cup adapted to engage the cup holder on a outer surface and the torque sensing element of the torque sensing column on an inner surface.