Abstract: An extra-capillary fluid cycling unit for maintaining and cycling fluid volumes in a cell culture chamber includes a housing and a first flexible reservoir extra-capillary fluid reservoir disposed in the housing. The extra-capillary fluid reservoir is in fluid communication with a cell culture chamber. A second flexible reservoir is also located in the housing, the second flexible reservoir being in fluid communication with a pressure source. A sensor plate is movably disposed in the housing between the extra-capillary reservoir and the second reservoir, wherein the second reservoir is pressurized to move the sensor plate in relation to the extra-capillary reservoir to cause fluid cycling and maintain fluid volumes in the cell growth chamber.

Abstract: Provided herein are systems and methods comprising localization agents. For example, provided herein are systems and methods for the placement of localization devices within biological systems and the detection of such localization devices for targeted surgeries or other medical procedures. For example, provided herein are systems comprising one or more miniature detectable devices that are placed into a target location and activated by remote introduction of a magnetic field.

Abstract: An occluder has a first disk-shaped structure with a grid, wherein the first disk-shaped structure is woven from at least two groups of braided wires, and the two groups of braided wires are crossed to form multiple rings of crossing points. A blocking membrane is also arranged in the disk-shaped structure, with an edge of the blocking membrane connected to the outermost ring of crossing points of the multiple rings of crossing points through a sewing wire, and the number of crossing points in the outermost ring of crossing points sewn with the blocking membrane is smaller than the number of all the crossing points in the outermost ring of the crossing points. The occluder can reduce the possibility of the phenomenon where the edge of the blocking membrane cannot abut against a disk face edge of the occluder, thereby improving the occlusion effect of the occluder.

Abstract: A method of operating a localization array. The method includes providing the localization array in substantially an optimal position. The method also includes maintaining the localization array at substantially the optimal position by controlling movement of the localization array.

Abstract: A system for locating an implanted device including magnetic coils within a subject is provided. The system includes a magnetic sensor array including a plurality of magnetic sensors, the magnetic sensor array configured to measure a magnetic field generated by the implanted device, and a position detection module communicatively coupled to the magnetic sensor array, the position detection module configured to receive the measured magnetic field from the magnetic sensor array, and calculate a position of the implanted device based on the measured magnetic field.

Abstract: An example system includes a distortion reference sensor (DRS) device attachable to a surface adjacent a region of interest within the patient. The DRS device includes at least two sensor coils arranged at a predetermined angle relative to each other and at a predetermined spatial position in a three-dimensional space relative to each other. The system also includes a computing device to determine a sensed angle and a sensed spatial position of the at least two sensor coils in the three-dimensional coordinate system in response to application of an electromagnetic field. Electromagnetic field distortion is indicated based on a difference between the predetermined angle and the sensed angle and/or the predetermined spatial position and the sensed spatial position exceeding an expected difference value.

Abstract: Tissue localization devices and methods of localizing tissue using tissue localization devices are disclosed. The tissue localization device can comprise a handle comprising a delivery control, a delivery needle extending out from the handle, and a localization element within the delivery needle. The localization element can be deployed out of the delivery needle or retracted back into the delivery needle when the delivery control is translated in a first direction or a second direction, respectively. The localization element can be coupled to a flexible tracking wire.

Abstract: Magnetic guided ablation catheters and methods of manufacture are disclosed. In an exemplary embodiment, a catheter includes a unitary flexible tubing having a proximal end and a distal end. A plurality of magnets are positioned along an axis of the unitary flexible tubing, the plurality of magnets provided within the unitary flexible tubing. During operation, the plurality of magnets are responsive to an external magnetic field to selectively position and guide the catheter within a body of a patient.

Abstract: A variable volume infusion port is provided. The infusion port may include a port body having an internal fluid reservoir, a septum, a stem to fluidly couple to a catheter lumen, and a displaceable member disposed in the internal fluid reservoir. In a first position, the displaceable member is disposed proximate the septum, providing a relatively small fluid volume within the infusion port. Insertion of an injection device through the septum causes the displaceable member to move to a second location distal from the septum, providing a relatively large fluid volume within the infusion port for the duration the injection device remains in the infusion port. The displaceable member may include a rigid member operably coupled to a biasing element or a flexible member coupled to a biasing element.

Abstract: Embodiments of the invention provide devices, systems, and methods that precisely identify a minimum of one predetermined spot which is hidden under a skin. The system comprises a locator device and corresponding implanted target device. The port locator device preferably comprises one magnet with north and south magnetic pole, a body and a suspending component. The body may utilize specific geometry which improves accuracy. The implanted target device may include at least one magnet and at least one target or a plurality of targets and at least one magnet. Various configurations can be provided that precisely identify a single spot or a plurality of spots which are hidden under a skin.

Abstract: Systems and methods for detecting metal clips inserted within a portion of a body of a patient are disclosed herein. In one embodiment, a clip detector assembly includes a detector having a ferrous member, a transmitting coil around the ferrous member and configured to induce a current in the metal clip, and a receiving coil around the ferrous member and configured to receive a magnetic field generated by the current induced in the metal clip. The assembly can further include a control circuit having a band-pass filter configured to pass electrical signals induced by the magnetic field from the receiving coil that are within at most 35 kHz of a resonance frequency of the metal clip. The assembly still further includes a user notification component configured to alert a user to a location of the metal clip.

Abstract: This invention relates to a method of catheter and radiating coil location in a human body. In particular, when a radiating coil is used in conjunction with a catheter, a coil locating device can be used to determine the distance the coil is from the device and its depth in the patient's body. A display is provided that shows both a reference image of a portion of a non-subject body and an image of the coil located on the display with reference to the reference image. This is achieved by locating the coil-locating device on a predetermined landmark on the patient's body. The coil and its signal wires can be incorporated into a stylet, guide wire or a catheter. The coil locating device can be orientated towards the head of the patient and for an axis of the device to be aligned with the mid sagittal plane of the patient.

Abstract: A medical system tracks the position of a portion of a medical instrument within a body of a patient. In some embodiments, the medical instrument includes a needle, a syringe, and a needle-position-tracking element positioned between the needle and the syringe and in fluid communication with both. The needle-position-tracking element includes an electromagnet structure that includes a core, a conductive coil wrapped around the core, and ancillary circuitry configured to pass a current through the conductive coil to thereby generate a magnetic field. A sensor device senses the magnetic field and generates corresponding sensor signals. A control circuit calculates the position of a portion of the medical instrument based on the sensor signals.

Abstract: Expandable occlusive plugs and methods of using them are disclosed. The devices generally include an expandable framework at least partially covered by a membrane. The occlusive plugs can be used for occlusion of body lumens and/or to limit migration of embolic agents to non-target sites.

Abstract: Surgical systems for use in surgical procedures utilizing robotic devices. The surgical system having one or more components for housing a sensor or one or more tools for anchor or sensor delivery. The surgical system may include a surgical sensor anchor and/or a surgical sensor anchor delivery tool. A method of performing a robotically assisted surgical procedure, comprising using a surgical sensor anchor during a surgical procedure which utilizes a robot to track movement of at least one portion of a body structure undergoing a surgical procedure or to track movement of a body structure near a surgical site.

Abstract: An implantable magnetic marker comprising at least one piece of a large Barkhausen jump material (LBJ) containing at least one loop. The coiled marker is deployed to mark a tissue site in the body for subsequent surgery, and a magnetic detection system with a handheld probe excites the marker above or below the switching field required for bistable switching of the marker causing a harmonic response to be generated in a bistable or sub-bistable mode that allows the marker to be detected and localised.

Abstract: This document discusses, among other things, systems and methods for delivering electrostimulation to specific tissue of a patient. An example of a system can receive a three-dimensional voxelized model representing a plurality of regions each specified as a target region or an avoidance region. The system includes control circuitry to determine a metric value using the voxelized model. The metric value indicates a clinical effect of electrostimulation on the plurality of regions according to a stimulation current and a current fractionalization. The control circuitry can determine a desired stimulation current that results in a first metric value satisfying a clinical effect condition. The system can generate a stimulation configuration including the desired stimulation current and the current fractionalization corresponding to the first metric value, and deliver tissue stimulation according to the stimulation configuration.

Abstract: A medical/technical device comprised of at least two materials. The materials are connected at least partially to each other permanently by a manufacturing process.

Abstract: Tissue localization devices and methods of localizing tissue using tissue localization devices are disclosed. The tissue localization device can comprise a handle comprising a delivery control, a delivery needle extending out from the handle, and a localization element within the delivery needle. The localization element can be deployed out of the delivery needle or retracted back into the delivery needle when the delivery control is translated in a first direction or a second direction, respectively. The localization element can be coupled to a flexible tracking wire.

Abstract: An apparatus to determine if a constituent member has been damaged. The constituent member can be a medical product comprising a coating, or a substance kneaded into the product, which emits a fluorescence in the near-infrared region. The apparatus to determine if this constituent member has been damaged includes an irradiation light source, an optical filter, an imaging unit, a display unit and a control unit connected to the light source, the optical filter and the imaging unit to determine and inform that damage has occurred in the constituent member.

Abstract: A medical device for diagnosis or treatment of tissue in a body is provided. The device includes an elongate, tubular shaft configured to be received within the body. The shaft has a proximal portion and a distal portion configured for movement relative to the proximal portion. A flexible member having a predetermined stiffness is disposed between the proximal and distal portions. A plurality of coils are disposed within the shaft with one or more of the coils configured for movement with the distal portion. Electromagnetic fields generated from within or outside of the medical device induce currents in the coils from which movement of the distal portion in response to contact of the distal portion with the tissue may be determined. In one embodiment, several of the coils are connected in series to reduce the space required in the device for conductors.

Abstract: A method comprises advancing a medical instrument and a catheter toward a target tissue within a patient anatomy. The instrument includes a distal sheath marker and is slidably received within the catheter. The distal sheath marker includes a channel and an identification feature. A portion of the instrument is slidably received within the channel. The method further comprises depositing the distal sheath marker at a location at or near the target. The distal sheath marker indicates a farthest advancement point of the instrument within the patient anatomy. The method further comprises: after depositing the distal sheath marker, withdrawing the instrument away from the target; determining an orientation of the distal sheath marker based on the identification feature; and, after withdrawing the instrument, using the location and orientation of the deposited distal sheath marker to determine a trajectory of a distal end of the instrument at or near the target.

Abstract: Magnetic-based electronic valve readers for determining a location and orientation of magnets coupled to implantable medical devices to determine a setting of the device (e.g., setting of a fluid flow control valve of the medical device). The electronic valve readers include an orientation sensing mechanism that is provided and configured to enable the electronic valve reader to: 1) allow for internal offset calculation of an orientation change of the electronic valve reader during a reading process; and/or 2) during the reading process, provide an indication or warning to the clinician that the orientation of the electronic valve reader has changed to an extent at or exceeding a predetermined angular acceptance threshold or window. Systems including the disclosed electronic valve readers and methods of reading a setting of the device are also disclosed.

Abstract: Tissue localization devices and methods of localizing tissue using tissue localization devices are disclosed. The tissue localization device can comprise a handle comprising a delivery control, a delivery needle extending out from the handle, and a localization element within the delivery needle. The localization element can be deployed out of the delivery needle or retracted back into the delivery needle when the delivery control is translated in a first direction or a second direction, respectively. The localization element can be coupled to a flexible tracking wire.

Abstract: A catheter-based imaging system comprises a catheter having a telescoping proximal end, a distal end having a distal sheath and a distal lumen, a working lumen, and an ultrasonic imaging core. The ultrasonic imaging core is arranged for rotation and linear translation. The system further includes a patient interface module including a catheter interface, a rotational motion control system that imparts controlled rotation to the ultrasonic imaging core, a linear translation control system that imparts controlled linear translation to the ultrasonic imaging core, and an ultrasonic energy generator and receiver coupled to the ultrasonic imaging core. The system further comprises an image generator coupled to the ultrasonic energy receiver that generates an image.

Abstract: Intravascular systems can include a catheter having a proximal end, a distal end, a sensor located at the distal end configured to provide sensor information representative of one or more intravascular properties of a patient, and a plurality of magnetic domains. A magnetic pickup can be configured to output a pickup signal based on the magnetic field at the magnetic pickup produced by the plurality of magnetic domains. An intravascular processing engine can be in communication with the catheter sensor and the magnetic pickup. The intravascular processing engine can receive sensor information from the sensor and a position signal representative of the pickup signal. The intravascular processing engine can be used to determine position information related to the position of the catheter sensor and combine the received sensor information and corresponding determined position information.

Abstract: An implantable medical device (402) includes an attachment member (424) having an aperture (428) with a first diameter. A delivery device (400) includes a catheter shaft (406), a tube (450?) within the shaft, and a tether (422?) within the tube. The tube has a main portion (455?) with a second diameter and an expandable distal end (457?). The tether has a body (423?) and a tether member (426?) having a third diameter greater than the second diameter and smaller than the first diameter. The tether is slideable relative to the tube from a released condition in which the tether member is positioned at least partially distal to the distal end of the tube, and a locked condition in which the tether member is at least partially surrounded by the distal end of the tube. The distal end of the tube can pass through the aperture only in the released condition.

Abstract: A medical system includes a probe, an electrooptical measurement unit, a processor and a treatment unit. The probe, which is configured for insertion into a blood vessel of a brain, includes (a) one or more optical fibers configured to guide an optical signal to interact with a brain clot in the blood vessel, and to output the optical signal that interacted with the brain clot, and (b) a channel selected from a group of channels consisting of an irrigation channel and an aspiration channel. The electrooptical measurement unit is configured to collect and measure the outputted optical signal. The processor is configured to identify a composition of the brain clot by analyzing the measured optical signal from the probe. The treatment unit is configured to provide treatment, selected from the group of treatments consisting of dissolving the brain clot by irrigation and aspiring the brain clot through the channel.

Abstract: A method of treating a sinus cavity of a subject includes advancing a distal portion of a light source through a drainage pathway of a sinus cavity and into the sinus cavity and visually observing a transdermal light emitted from the light source. A distal portion of a substantially rigid inner guide member of a balloon dilation catheter is advanced into the drainage pathway, the balloon dilation catheter including a movable shaft including a balloon that is slidably mounted on the substantially rigid inner guide member. The movable shaft and balloon are advanced distally over the substantially rigid inner guide member to place a portion of the balloon in the drainage pathway whereby the balloon is inflated.

Abstract: Various embodiments of wirelessly detectable objects to be used in medical procedures are provided. Such may employ ionizing radiation hard wireless radio frequency identification (RFID) transponders, other wireless transponders and/or integrated circuits, and attachment structures, all of which retain structural and functional integrity when exposed to standard sterilization dosages of ionizing radiation. Additionally or alternatively, the wireless radio frequency identification (RFID) transponders, other wireless transponders and/or integrated circuits, and attachment structures, may retain structural and functional integrity when exposed to standard sterilization temperatures and/or pressures.

Abstract: A method, including calculating locations of first sensors attached to a probe that has been inserted into a human patient, and calculating positions of second sensors attached to a sheath via which the probe is inserted. The method also includes calculating respective shapes of the probe and the sheath, to achieve a best fit to the calculated probe sensor locations and sheath sensor positions, while restricting the probe to pass through the sheath. The calculated respective shapes of the probe and the sheath are used to present an image of the sheath aligned with the probe.

Abstract: Apparatus, systems, and methods are provided for optimizing intracardiac filling pressures and cardiac output in patients with heart failure, conduction disease, and atrial fibrillation. The system is able to adjust and optimize intracardiac filling pressures and cardiac output by adjusting heart rate and the effective amount of total body blood volume. The device includes an adjustable member that may create a mean pressure differential in order to manifest an effective “mechanical diuresis” by sequestering extraneous blood volume to the high-capacitance of the venous vasculature. The system is therefore designed to reduce intracardiac filling pressures while maintaining or even increasing cardiac output.

Abstract: Sensors and methods for measurement of an analyte in a medium within a living animal are described. The sensor may include an inductive element that may receive power from an external device. The sensor may also include a charge storage device (CSD) and a memory. The sensor may perform analyte measurements initiated by the external device using power received from the external device and convey the analyte measurements to the external device using the inductive element. The sensor also may perform autonomous analyte measurements using the on board charge device's power and store the autonomous analyte measurements in the memory. The sensor may convey one or more stored analyte measurements to the external device using the inductive element using power received from the external device. The sensor may include a CSD-powered clock and a CSD-powered measurement scheduler that initiate the autonomous analyte measurements.

Abstract: A recognition, monitoring, and imaging method and system are provided for a thermal ablation region based on ultrasonic deep learning. The recognition method includes obtaining original ultrasonic radiofrequency data, an ultrasonic image, and an optical image during thermal ablation; making ultrasonic radiofrequency data points and pixels in the optical image correspond in a one-to-one manner, and determining a spatial position correspondence between the ultrasonic radiofrequency data points and the optical image; determining a thermal ablation region image according to the spatial position correspondence; constructing a deep learning model according to the thermal ablation region image; superposing a thermal ablation classification image to the ultrasonic image, to determine a to-be-recognized thermal ablation image; and recognizing a thermal ablation region in the ultrasonic image according to the to-be-recognized thermal ablation image.

Abstract: The present disclosure relates to computerized systems and methods for determining the location and orientation of implanted devices. Consistent with some embodiments, power levels of near-field signals are backscattered from an implanted device. The backscattered near-field signals may be detected by an ex-vivo antenna array. The determined power levels may be used to identify candidate location and orientation combinations based on a data set. The data set may be generated by calibrating the antenna array to the implanted device. A candidate location and orientation combination among the identified candidate combinations may be selected as the location and orientation of the implanted device.

Abstract: A marker for use in a living body includes an indicator part to be placed in a living body for a predetermined period of time, and the indicator part is configured to indicate information on the living body or information on the indicator part by means of a difference in X-ray image. Thus, there are provided the marker for use in a living body and an instrument set for inserting the marker for use in a living body capable of identifying a predetermined site in a living body easily and accurately.

Abstract: Medical devices for diagnosis or treatment of tissue in a body. Representative devices include an elongate shaft having a proximal portion and a distal portion configured for movement relative to the proximal portion. A flexible member having a predetermined stiffness is disposed between the proximal and distal portions. One or more coils and an electrically passive element are disposed within the shaft with either the coils or element configured for movement with the distal portion. The element comprises a material effecting an electrical characteristic of the coils. Movement of the distal portion in response to its contact with the tissue and relative movement of the coils and element causes a change in the electrical characteristic in at least one of the coils indicative of at least a contact force magnitude between the distal portion and the tissue. Several embodiments allow determination of both force magnitude and force vector direction.

Abstract: The invention relates to a kit to prepare an hemostatic flowable comprising: —A hemostatic powder having a composition comprising: ?non-cross-linked collagen of the fibrillar type comprising a content of fibrous collagen and/or fibrillar collagen of at least 70% by weight relative to the total weight of the collagen; ?at least one monosaccharide; and ?at least one glycosaminoglycan; —A saline solution to be mixed with the hemostatic powder in order to form the hemostatic flowable. The invention also relates to a method for preparing an hemostatic flowable with such a kit, comprising the steps of: a. Providing the hemostatic powder in a container; b. Adding a quantity of the saline solution in the container enclosing the hemostatic powder, closing and shaking said container in order to promote hydration of the hemostatic powder to form the hemostatic flowable.

Abstract: The present disclosure relates to implantable encapsulation devices for housing a biological moiety or a therapeutic device that contains a biological moiety. Particularly, aspects of the present disclosure are directed to an implantable apparatus that includes a distal end, a proximal end, a manifold including at least one access port positioned either at the distal end or the proximal end, and a plurality of containment tubes affixed to the manifold and in fluid communication with the at least one access port. Additionally, the encapsulation device may contain a flush port and a tube that are fluidly connected to the manifold. The containment tubes may contain therein a biological moiety (e.g., cells) or a therapeutic device (e.g. a cell encapsulation member).

Abstract: A vascular filter comprises includes a proximal support hoop, a plurality of support struts, and a plurality of capture arms. The proximal support hoop extends around the internal wall of the inferior vena cava in a wave pattern having six distal peaks and six proximal peaks. The proximal support hoop includes an enlarged end element at each peak. The support struts extend longitudinally along the internal wall of the inferior vena cava in a curve. Two capture arms are connected to the proximal support hoop at each distal peak. Each capture arm extends from the distal peak to an apex in a curve. The concave portion of the first curve faces inwardly towards the concave portion of the second curve.

Abstract: Improvements for use with tissue expanders are provided. A tissue expander includes: a selectively inflatable and deflatable shell that is configured to be implanted; and an access port for selectively inflating and deflating the shell, the access port comprising a sidewall, a base at a first end, and a membrane at a second end opposite the first end, wherein the sidewall and the base of the access port are constructed of a material that is non-reactive with a magnetic resonance imaging (MRI) machine. In embodiments, the tissue expander includes a magnet at the access port. In embodiments, the magnet is configured with a physical size and magnetic force such that, when the tissue expander is implanted, the magnet is detectable by an external magnetometer sensor but is not detectable by an external dangle-magnet.

Abstract: A method of performing an endoscopic submucosal resection includes using two magnet-attached hemostatic clips that are selectively coupled to one another via their respective magnets.

Abstract: There is provided a method for controlling a flow of intestinal contents in the intestinal passageway of a patient's intestines. The method comprises gently constricting (i.e., without substantially hampering the blood circulation in the intestinal tissue wall) at least one portion of the intestinal tissue wall to influence the flow in the intestinal passageway, and stimulating the constricted wall portion to cause contraction of the wall portion to further influence the flow in the intestinal passageway. The method can be used for restricting or stopping the flow in the intestinal passageway, or for actively moving the fluid in the intestinal passageway, with a low risk of injuring the intestines.

Abstract: A surgical delivery instrument for delivering a vascular hole closure device having first and second flexible members and a first and second engagement members extending from the respective flexible member. The delivery instrument includes a housing having first and second longitudinally extending openings and first and second projecting surfaces, the first projecting surface extending into the first opening for engagement by the first engagement member and the second projecting surface extending into the second opening for engagement by the second engagement member. The first engagement member is held by the first projecting surface until a predetermined force is applied to the first engagement member during placement of the closure device at a target site.

Abstract: An air delivery system for providing a supply of air from a source of air at positive pressure to an interfacing structure located at the entrance to the airways of a patient includes a manifold adapted to connect with the supply of positive air pressure and at least one tube connected to the manifold and adapted to deliver the supply of air to the interfacing structure. Each tube is structured to allow movement between an open phase in which the tube allows the passage of air and a collapsed phase in which the tube is collapsed. Each tube is structured such that weight of a typical patient's head against bedding apparel is sufficient to collapse the tube from the open phase to the collapsed phase.

Abstract: Biodegradable antimicrobial films are provided that are solid at room temperature and substantially liquefy in situ after implantation into a mammal, such as a human patient. Methods of using the films to cover a medical device, such as a breast implant, prior to insertion into a subject are also provided.

Abstract: A system is provided for causing hemostasis at a puncture and a puncture tract. The system includes an inner member comprising an expandable member at its distal end and an inflation lumen that extends from inner member proximal end to an interior of the expandable member. The system further includes an outer member comprising a lumen sized and shaped to allow the inner member to slide therein, an occlusion balloon at its distal end, and an inflation lumen that extends from its proximal end to the interior of the occlusion balloon. The expandable member can be inflated by fluid flowing through the inner member inflation lumen so that the expandable member can close a puncture in a subcutaneous vessel of a living being. The occlusion balloon can be inflated by fluid flowing through the outer member inflation lumen so that the occlusion balloon can contact and apply pressure to a puncture tract extending from the skin of the living being to the puncture.

Abstract: An apparatus includes a memory and a processor. The memory is configured to hold values indicative of known relative positions of multiple position sensors of a position tracking system that are coupled to a medical device. The processor is configured to receive one or more signals indicative of estimated positions of the position sensors, as measured by the position tracking system, and to initiate a responsive action in response to detecting a discrepancy between the known relative positions and the estimated positions.

Abstract: A test system for measuring a volume of fluid dispensed by a fluid infusion device includes a test housing. The test housing includes an inlet and an internal channel. The inlet is to be coupled to the fluid infusion device to receive the volume of fluid, and the internal channel is in fluid communication with the inlet. The test system includes an input electrode coupled to the internal channel to be in fluid communication with the volume of fluid, and an output electrode coupled to the internal channel to be in fluid communication with the volume of fluid. The test system includes a power source configured to create a voltage potential between the input electrode and the output electrode. The volume of fluid in the internal channel conducts current between the input electrode and the output electrode to facilitate measurement of the volume of fluid dispensed.

Abstract: A device for supplying energy to a medical device is disclosed, comprising an external energy source, an external control unit, an external signal receiver, and a coil displacement unit connected to the external control unit and configured to adjust an energy transfer efficiency by repeatedly adjusting a position of a primary coil relative to a secondary coil by displacing the primary coil relative to the secondary coil in a plurality of different directions.