Abstract: A method for adjusting a position, including: acquiring a real-time position of a positioning marker preset at an affected part; acquiring a reference position of the positioning marker; and outputting position adjustment information, by means of a display and/or a voice, based on the real-time position and the reference position. The position adjustment information is configured to prompt a patient to adjust his/her position.

Abstract: Devices and methods are disclosed for managing and/or treating body tissues obstructing a hollow body lumen, including the prostatic lobe tissues obstructing the urethra, for example conditions including benign prostatic hyperplasia (BPH), bladder outlet obstruction (BOO), benign prostatic obstruction (BPO) and associated lower urinary tract symptoms (LUTS). A retrieval sheath having an elongated shaft member with at least one region of modified flexibility that is configured compress the implant to a reduced profile for removal from the patient's body.

Abstract: In one embodiment, a system for locating a tip of a catheter that has been inserted into a patient includes an implantable catheter having a distal tip, a pulsed light source that is co-located with the distal tip of the implantable catheter, the pulsed light source being configured to emit pulses of light into surrounding patient tissue, an optoacoustic sensor configured to be applied so a skin surface of the patient at a position proximate to the pulsed light source and to sense optoacoustic waves generated when the pulses of light are absorbed by the surrounding patient tissue, and an optoacoustic console configured to receive optoacoustic wave signals from the optoacoustic sensor and to display an indication of the optoacoustic wave signals to a medical professional to provide an indication of the location of the pulsed light source and, therefore, the distal tip of the implantable catheter.

Abstract: Drug delivery articles, resident articles, and retrieval systems e.g., for gram-level dosing, are generally provided. In some embodiments, the articles are configured for transesophageal administration, transesophageal retrieval, and/or gastric retention to/in a subject. In certain embodiments, the article includes dimensions configured for transesophageal administration with a gastric resident system. In some cases, the article may be configured to control drug release e.g., with zero-order drug kinetics with no potential for burst release for weeks to months. In some embodiments, the articles described herein comprise biocompatible materials and/or are safe for gastric retention. In certain embodiments, the article includes dimensions configured for transesophageal retrieval. In some cases, the articles described herein may comprise relatively large doses of drug (e.g., greater than or equal to 1 gram).

Abstract: An example vessel caliper according to the present disclosure includes a scale having a first clamp, and a slider movable relative to the scale such that a length measurement can be determined, the slider having a second clamp. Each of the first and second clamps have a spring action jaw configured to capture a catheter assembly therebetween. An example method of using the vessel caliper is also disclosed.

Abstract: A cannula may include a bowl portion comprising a first opening and a second opening, and an insertion tube extending from the bowl portion. The insertion tube defines a passage extending from the second opening and terminating in a distal end opening. The passage is configured to receive an instrument to be advanced through the cannula. The insertion tube has a transparent portion extending proximally from the distal end opening, and a strengthened portion extending proximally from the transparent portion.

Abstract: An imaging fiducial marker includes a plurality of marker structures and a connection structure that linearly, curvilinearly, or angly, affixes the plurality of marker structures. The imaging fiducial marker is formed from materials having at least two different radiopacities. Each different radiopacity is separately distinguishable during medical imaging, and the connection structure is distinguishable from the plurality of marker structures during medical imaging. The imaging fiducial marker is arranged for implantation in vivo within soft tissue. Deploying the imaging fiducial marker includes identifying a soft tissue area in a patient's body where the marker will be placed in vivo and deploying the marker in the identified soft tissue area.

Abstract: The present disclosure relates to guidewire devices having shapeable tips and effective torquability. A guidewire device includes a core having a proximal section and a tapered distal section. A tube structure is coupled to the core such that the tapered distal section of the core extends into and distally beyond the tube structure. The portion of the core extending distally beyond the tube forms a shapeable tip. One or more coils also extend distally beyond the tube. The tip is configured to reduce the tendency of resilient forces from the tube structure to disrupt a customized shape of the tip.

Abstract: An apparatus according to an exemplary embodiment of the present disclosure can include a first section(s) and a second section(s) which can have a cross-section that can be smaller than that of the first section. The first and second sections can be a particular section and can include memory-forming characteristics. An imaging arrangement can be in communication with the first section or the second section. The particular section can have a first shape when the particular section can be constrained, and the particular section can have a second shape when the particular section can be unconstrained. The second shape can be more curved than the first shape.

Abstract: Methods for ablating tissue in a patient having atrial fibrillation comprise advancing an elongate flexible shaft through a patient's vasculature into a chamber of a heart. The elongate flexible shaft has an energy source and a sensor. Tissue in the heart is scanned with the sensor and data about the tissue is captured. The captured data is grouped into one of a plurality of tissue classifications and an anatomical map of the tissue showing the grouped data is displayed. At least a portion of the tissue is ablated so as to form a conduction block that blocks aberrant electrical pathways in the heart. The ablated tissue is grouped into one or more predefined tissue classifications during or prior to the ablation.

Abstract: A catheter comprising a proximal end, a distal end and a pair of electrodes spaced apart between the proximal and distal ends; and a catheter guide comprising i) a first positioning indicator distal to the pair of electrodes for indicating if the catheter needs inserting further into the patient; and ii) a second positioning indicator proximate the first positioning indicator for indicating correct positioning of a catheter.

Abstract: Systems and methods for generating three-dimensional fluid flow simulations from two-dimensional (2D) image data are provided. Data is segmented from 2D images of a sample having a biological structure with fluid flow therethrough. Three-dimensional (3D) geometries are generated from the segmented data, and then a 3D reconstruction of the biological structure is generated from the 3D geometries. This 3D geometric computational analysis tool can be used to evaluate fluid dynamics and hemodynamics in the context of the structure anatomy and geometry.

Abstract: Methods and catheters suitable for removing or reducing the formation of cellular occlusion associated the catheters. The catheters include a surface coated or infused with magnetic nanoparticles. Once the catheter is implanted in a subject, the nanoparticles induce localized hyperthermia around the catheter in response to a magnetic field.

Abstract: A connector includes: a male connector portion; a first female connector portion; and a second female connector portion. The connector defines a flow path therein. The male connector portion is shaped to be connectable to a medical device female connector portion that is equal in shape to the first female connector portion. The male connector portion is shaped to not be connectable to a medical device female connector portion that is equal in shape to the second female connector portion.

Abstract: Disclosed is a device for measuring a length of a tubular body structure. The device comprises an elongated tubular member having a proximal end and a distal end. The elongated tubular member comprises a plurality of radiopaque markers uniformly arranged on the distal end and a plurality of non-radiopaque markers uniformly arranged on the proximal end. The elongated tubular member also comprises a guiding head member coupled to the distal end of the elongated tubular member. A number of the radiopaque markers of a portion of the distal end of the elongated tubular member conforming to an affected portion of the tubular body structure enables in measuring a length of the affected portion, when the elongated tubular member is inserted through a skin entry site of the tubular body structure under fluoroscopy.

Abstract: Delivery devices, systems, and methods related thereto may be used in humans for spinal delivery of cells, drugs or vectors. Thus, the system enables subpial delivery, which leads to a near complete spinal parenchymal AAV9-mediated gene expression or distribution in both white and grey matter.

Abstract: In a guide wire of the present invention, a distal end portion of a core has a distal small-diameter body and a combined truncated cone including a first truncated cone in order from a distal end side to a proximal end side. A twist angle of the distal small-diameter body is specified to be larger than the twist angle of the first truncated cone to increase flexibility for easily bending at the distal end. At least one truncated cone is connected on the proximal end side of the first truncated cone to form the structure of a combined truncated cone. Thus, the guide wire of the present invention has high rotation transmission performance toward the distal end side and other performances. Accordingly, the guide wire can be quickly reached to the vascular lesion and has high passability at the vascular lesion.

Abstract: Methods and systems for manually assisted definition of vascular features are described. In some embodiments, vascular centerlines identified by image analysis are divided into segments. Optionally, one or more candidate paths extending to the vascular root position along chains of segments are generated for each of a plurality of vascular endpoint. Selection of paths which correspond to anatomical paths of blood flow is optionally based on manual review. Optionally, paths are manually defined, for example, based on selection of a plurality of waypoints. Optionally, paths are edited by use of an active contour method that allows relative rough indication of corrections to be transformed into path changes that conform closely to the geometry of nearby vasculature.

Abstract: Meniscal repair devices, systems, and methods are provided.

Abstract: Various methods employing transvascular access devices are described, including a method of placing a central catheter in a peripheral vein in an arm of a patient; a method of providing percutaneous access to the heart of a patient; a method of clearing a clotted arteriovenous dialysis graft; a method of creating multiple access points into a single blood vessel; a method of creating an AV fistula in a patient; and a method of providing a bypass to a blockage in a popliteal artery in a patient.

Abstract: According to one embodiment, a tissue penetrating device includes an elongate shaft having a proximal end, a distal end, and a lumen extending there between. A first needle is disposed within the lumen of the elongate shaft and is extendable therefrom between a first configuration and a second configuration. In the first configuration, the first needle is disposed within the elongate shaft's lumen and is substantially aligned with an axis of the lumen. In the second configuration, the first needle extends distally of the elongate shaft's distal end and bends away from the lumen's axis. A second needle is disposed within a lumen of the first needle and is extendable therefrom when the first needle is positioned in the first configuration and when the first needle is positioned in the second configuration. The second needle may be extended from the first needle to penetrate tissue of a patient.

Abstract: A method is provided for creating a volume graphic via a catheter for introduction into a vessel which has an ultrasound unit, which is embodied to transmit ultrasound, to measure an echo of the transmitted ultrasound, and to create image data for a two-dimensional cross-section of the vessel on the basis of the measured echo. The method involves creating image data of a cross-section with the ultrasound unit at a plurality of different positions on a movement track of the catheter, and, in addition to the image data, creating position data for the current position of the ultrasound unit with a localization device. The method further involves creating the volume graphic from the image data of all cross-sections in which the cross-sections are arranged relative to one another in accordance with the position data.

Abstract: A method for identifying a target anatomy by use of a device having an ultrasound transducer. Using the ultrasound transducer, a portion of a patient's anatomy is scanned during a scanning process. A voltage trace of the patient's anatomy is determined and compared to a predetermined trace. If the voltage trace of the patient's anatomy matches the predetermined trace, a notification may be output.

Abstract: A deflectable catheter including an outer member having a proximal portion and a distal portion, an elongated column member extending distally from the outer member and an inner member positioned coaxial with the outer member and attached to the column member. The inner member extends distally of the outer member and has a distal tip portion. A reinforcement member is positioned over the column member to restrict axial movement of the column member such that when one of the inner member or outer member is moved with respect to the other, axial compression of the column member is restricted by the reinforcement member causing the distal tip portion of the inner member to deflect laterally.

Abstract: An implant capsule (10) and an implant delivery system are disclosed. The implant capsule (10) includes, sequentially from a proximal end to a distal end, a flexural section (102, 102a-102e), a reinforcement section (101, 101a-101e) and a radiopaque reinforcement ring (104a-104e). The reinforcement section (101, 101a-101e) has higher strength than the flexural section (102, 102a-102e). The implant delivery system includes the implant capsule (10). The implant capsule (10) can ensure the implant to be deployed in a coaxial condition and prevent over-expansion due to large expansion forces exerted by a stent of the implant.

Abstract: Cardiac catheterization is carried out by constructing a left atrial model of a heart of a living subject, selecting a global catheter that is dimensioned to conform to the left atrial model, representing the catheter in the left atrial model; extending the length axis of the catheter in the left atrial model to form an intersection with the foramen ovale, and reporting the intersection as a recommended site of transseptal puncture for insertion of the catheter therethrough.

Abstract: A medical tube includes a first portion, a second portion, a third portion, and a fourth portion in this order from a proximal side to a distal side thereof. The first portion has a tubular resin layer, the second portion has a tubular inner layer and outer layer, the third portion as an inner layer and outer layer, and the fourth portion has a tubular resin layer. When flexural rigidity of the first portion, the second portion, the third portion, and the fourth portion is G1, G2, G3, and G4, respectively, the flexural rigidity of each portion being configured to have a relationship with each other portion based upon the following expression (1): G1>G2>G3>G4??(1).

Abstract: The present invention is a hemostatic plug for use with Extracorporeal Membrane Oxygenation (ECMO) cannulas that allow quick access to the blood vessel as well as maintaining a sterile environment to resume ECMO, if needed. It is designed to be a universal fit for use with adult ECMO circuits. The plug consists of a hemostatic membrane, a collection chamber and a cap. The membrane is designed to allow catheter delivery of up to a 19 French diameter through the ECMO cannula. The collection chamber allows the distribution of blood pressure over a broader surface, which allows additional hemostasis in addition to the membranes. The plug is then further reinforced with a cap that provides additional hemostasis, but when removed, allows hemostatic access into the blood vessel via the ECMO cannula.

Abstract: A guidewire device comprising: a micro-fabricated elongated outer member having an outer surface and an interior surface forming a lumen extending from a proximal end to a distal end, wherein said outer member is formed from two or more stock materials; and an inner member disposed within a portion of said lumen, and embodiments thereof.

Abstract: A remote workstation for the control of percutaneous intervention devices is provided. The remote workstation includes a control system for remotely and independently controlling at least two percutaneous intervention devices. The control system includes at least one input device to control the percutaneous intervention devices. The control system controls movement of at least one of the percutaneous intervention devices along at least two degrees of freedom. The remote workstation also includes a graphical user interface for displaying icons representative of the operational status of each of the percutaneous intervention devices.

Abstract: A flexible tip dilator is disclosed. The flexible tip dilator includes a hollow elongated tubular member with a proximal region and a tapered distal region. The tapered distal region has three regions with a first region made from at least a first material but not a second material and a third region made from at least the second material but not the first material. The second region is includes both the first and second materials overlapping one another.

Abstract: Obtaining a surface image captured by an endoscope inserted in a tubular organ associated with a surrounding blood vessel and representing an inner surface of a wall of the organ, generating, from a three-dimensional image representing a three-dimensional area including the organ, an adjacent blood vessel image depicting a portion of the blood vessel adjacent to the wall from a viewpoint in the three-dimensional image corresponding the viewpoint of the surface image, generating, from a three-dimensional image representing a three-dimensional area including a surrounding area of the organ, a surrounding blood vessel image depicting the blood vessel from a viewpoint in the three-dimensional image corresponding the viewpoint of the surface image, and causing the surface image, adjacent blood vessel image, and surrounding blood vessel image to be displayed in this order on a display unit.

Abstract: An imaging system includes: a first lighting device for irradiating an imaging target object with visible light; a second lighting device for irradiating the imaging target object with near-infrared light; and an image sensor for photodetecting visible light caused by the visible light and coming from the imaging target object and fluorescence caused by the near-infrared light and coming from the imaging target object during a predetermined shutter open period every frame of a predetermined period. The image sensor outputs photodetection signals corresponding to photodetection amounts of the visible light and the fluorescence. The imaging system also includes a controller that generates a composite image of a visible image and a fluorescence image based on the photodetection signals, and has a lighting controller that turns on the second lighting device with optical power corresponding to the shutter open period in synchronism with the shutter open period.

Abstract: An endovascular stent graft delivery device has portion to remain outside a patient in use and a proximal portion to be introduced into a patient. The proximal portion has a dilator at the proximal end and a length extending module is fastened to the dilator and extends proximally. The length extending module has a proximal end which in use extends out of the patient. The dilator has a dilator marker and the length extending module has a first and second marker at the distal and proximal ends of the length extending module. The first marker and the second marker are at the same relative circumferential position on the length extending module so that the rotational position of the elongate body within the patient can be determined.

Abstract: A medical tool includes a location sensor at a distal end. While the tool is being maneuvered to a desired region of interest, a control unit records a first location reading obtained according to an output from the sensor when requested by a user, indicative of when a patient's anatomy constrains free movement of the tool in at least one degree of freedom. Once the tool has reached the region of interest, the control unit records a second location reading according to the sensor output indicative of a current location. A relaxation shape of the tool forms a shape constraint on the tool shape reconstruction. The control unit determines a reconstruction representing the current shape of the tool based on the positional constraints and the shape constraint. The reconstruction is graphically superimposed on an image of the region of interest.

Abstract: Methods and systems for automated treatment planning for radiation therapy are disclosed. Such methods and systems may be useful for treatment planning for intensity-modulate radiotherapy (IMRT). Also provided are user interfaces for automated radiation therapy treatment planning.

Abstract: A guidewire includes a wire body having a first wire arranged on a distal end side and a second wire arranged on a proximal end side of the first wire. A proximal end surface of the first wire and a distal end surface of the second wire are joined to each other to form a joint portion. An outer member is arranged on an outer peripheral side of the wire body and forms a tubular shape which covers the wire body at least from a distal end portion of the first wire to the joint portion. An inner member is arranged between an outer peripheral portion of the wire body and an inner peripheral portion of the outer member and covers the joint portion. The inner member is an inner coil formed by winding a wire for the inner member into a coil shape.

Abstract: A remote workstation for the control of percutaneous intervention devices is provided. The remote workstation includes a control system for remotely and independently controlling at least two percutaneous intervention devices. The control system includes at least one input device to control the percutaneous intervention devices. The control system controls movement of at least one of the percutaneous intervention devices along at least two degrees of freedom. The remote workstation also includes a graphical user interface for displaying icons representative of the operational status of each of the percutaneous intervention devices.

Abstract: The present invention relates to a model based positioning system that includes a positioning device having at least one transmitter configured to be in a tracking environment, e.g. inserted into a body, a receiver having a plurality of receiver elements arranged outside the tracking environment, a control unit configured to measure amplitude and/or phase information of a signal transmitted from the at least one transmitter and received at each receiving element, and a memory unit M for storing a model for each receiving element. The control unit is also configured to estimate the position P of the positioning device by comparing the model for each receiving element with the measured received signal for each receiving element.

Abstract: Cryocatheter including an elongated flexible catheter member having a short rigid catheter tip for introduction into a therapy site and a heat exchange arrangement for freezing the catheter tip to a cryo-temperature from between about ?15° C. to about ?30° C. for freezing human tissue at the therapy site. Cerebral medical procedures include inter alia employing a local ice ball for sealing a bleeding rupture in an arterial wall in the case of a stroke hemorrhage, employing a local ice ball for mapping electrical disorder foci in a brain, for example, epileptic foci, and the like.

Abstract: A method of registering a 4D contrast enhanced image data set, wherein the 4D contrast enhanced image data set includes image data of the same volume of interest acquired at different timeframes with changing contrast enhancement, the volume of interest includes moving structure, and the different timeframes correspond to a predetermined motion phase of interest in different motion cycles of the moving structure, the method, comprising: registering image data corresponding to a plurality of the different timeframes with reference image from one of the timeframes.

Abstract: A system for the effective, reliable and foolproof delivery of controlled amounts of a medical fluid to a patient is provided. The system includes an integrated compressed gas unit having an inlet port to which at least one compressed gas cylinder is selectively connected and an outlet port in communication with the inlet port. The integrated compressed gas unit also includes a regulator valve assembly positioned between the outlet port and the inlet port, wherein the regulator valve assembly includes a press button actuator and regulator adjustment dial. The system also includes a flow control system delivering the fluid in precisely controlled amounts.

Abstract: The invention relates to a coated medical device for rapid delivery of a therapeutic agent to a tissue in seconds to minutes. The medical device has a layer overlying the exterior surface of the medical device. The layer contains a therapeutic agent, a contrast agent, and an additive.

Abstract: Novel methods and imaging agents for functional imaging of lymph structures are disclosed herein. Embodiments of the methods utilize highly sensitive optical imaging and fluorescent spectroscopy techniques to track or monitor packets of organic dye flowing in one or more lymphatic structures. The packets of organic dye may be tracked to provide quantitative information regarding lymph propulsion and function. In particular, lymph flow velocity and pulse frequency may be determined using the disclosed methods.

Abstract: The present invention relates to a system for determining the orientation of a catheter (2). The system comprises a catheter (2), an asymmetric marker (11) attached to the catheter (2), and an imaging unit (25) for generating a projection image of the asymmetric marker (11), wherein the imaging unit (25) comprises a radiation source for generating radiation for projecting the asymmetric marker (11) in a projection plane and a detection unit for generating the projection image of the asymmetric marker (11) projected in the projection plane. The system comprises further an orientation determination unit for determining the orientation of the asymmetric marker (11) from the projection image of the asymmetric marker (11) and for determining the orientation of the catheter (2) from the determined orientation of the asymmetric marker (11). The asymmetric marker (11) is adapted such that the orientation of the asymmetric marker (11) is determinable from the projection image of the asymmetric marker (11) alone.

Abstract: A medical fluid injection system may include a powered injector and a fluid reservoir that contains a simulated contrast medium. The simulated contrast medium may exhibit a fluid flow property substantially equal to that of an active contrast medium but be devoid of any active contrast agent that provides contrast during diagnostic imaging. During operation, a syringe in the powered injector may be filled with the simulated contrast medium and then evacuated to discharge the simulated contrast medium from the syringe. The simulated contrast medium may be used to test and evaluate the performance of the powered injector prior to use in a medical procedure without exposing personnel to an active contrast agent or creating medical waste that contains the active contrast agent.

Abstract: A method for displaying a position of a medical device, such as a catheter, during insertion thereof into a patient. In one example embodiment, the method includes obtaining a first set of detected position data relating to a location marker, such as a permanent magnet, then determining a possible first position thereof. A first confidence level relating to a match between the first set of detected position data and a first set of predicted position data is assigned. A determination is made whether the first confidence level meets or exceeds a first threshold. If the first confidence level meets or exceeds the first threshold, a determination is then made whether the first position of the location marker is within a first detection zone. If the first position of the location marker is within the first detection zone, the first position of the location marker is displayed.

Abstract: A medical examination apparatus including a control unit, an image-generating modality and a controllable injection apparatus for a contrast agent is provided. The control unit is connected to an alarm signal emitter and the control unit switches the modality and the injection apparatus to a safe mode as a function of an alarm signal.

Abstract: Infusion system configurations and assemblies facilitate routing of infusion circuit tubing lines. Tubing lines are routed into and out from compartments of a shielding assembly for the infusion system, at locations which prevent kinking and/or crushing of the lines, and/or provide for ease in assembling the circuit. A plurality of the lines may be held together by a support frame to form a disposable infusion circuit subassembly, that can further facilitate routing of the lines.

Abstract: Embodiments include a fiducial deployment system including a needle and at least two adjacent and releasably-engaged fiducials retained within a lumen of the needle by engagement with each other and/or by engagement with a pusher element. A fiducial may include one or more mechanical engagement structures that interengage with and/or are rupturably attached to one or more adjacent fiducials. The needle, which may include echogenic enhancements, may be configured to deliver a plurality of fiducials to a target location in serial fashion, one at a time. A variety of releasably-engaged fiducials are disclosed, as are methods for use.