Abstract: Configurations are described for assisting execution of a percutaneous procedure while protecting the vascular pathway to the target treatment area. One example is directed to an embolic protection system for deploying a device to a distal location across a diseased vessel, the embolic protection system which may include an expandable introducer, an embolic protection device, and a loading sleeve.

Abstract: A fluid handling system for a surgical procedure includes a console and a tubing set. The console exhibits a peristaltic pump, a pinch valve, one above the other. Two recessed seats are located to the left and right sides of the pump and valve. The tubing set includes an irrigation tube and an aspiration tube each coupled to a pair of magnetic disks disposable in respective ones of the recessed seats. Upon such disposition, the irrigation tube is disposable in operative engagement with the peristaltic pump and the aspiration tube is insertable into a slot of the pinch valve.

Abstract: Methods are provided for promoting, reducing, or desensitizing various immune responses by delivery of sub-immunogenic doses of an allergen, alone or with other agents, or by delivery of antigens and adjuvants to a cutaneous microenvironment of a subject. Microneedle arrays can be used in connection with this delivery.

Abstract: An infusion apparatus includes a housing and a chamber configured to be connected to the housing. The apparatus further includes a weight sensor coupled to a load connector connected to the housing and an optical sensor disposed in the housing. The weight sensor is configured to generate a first signal based on a measured weight of the fluid container attached to the housing in a weight-bearing configuration. The optical sensor is configured to generate a second signal based on detecting drops of the fluid traversing the chamber. The apparatus also includes a flow control mechanism to control a flow rate of the fluid into an outlet channel. The apparatus includes one or more processing devices configured to perform operations including transmitting a control signal to the flow control mechanism to adjust the flow rate.

Abstract: An intravenous catheter system including a housing, a catheter, and a guide wheel rotatably disposed in the housing and manually engageable by the user. The intravenous catheter system may also include a guidewire contained within the housing and moveable by the guide wheel into and through the catheter with roation of the guide wheel with one finger, and push off tab. The intravenous catheter system may be configured such that once the guidewire is in a vein of a body, the user may use the same finger to advance the catheter by use of the push off tab A blood flash chamber can be incorporated into the housing of the system, method or device to indicate engagement between the catheter and the vein of the patient, and indicate the timing of the use of the wheel to move the guidewire.

Abstract: Systems and methods for Endovascular Perfusion Augmentation for Critical Care (EPACC) are provided. The system may include a catheter having an expandable aortic blood flow regulation device disposed on the distal end of the catheter for placement within an aorta of a patient. The system may also include a catheter controller unit that causes the expandable aortic blood flow regulation device to expand and contract to restrict blood flow through the aorta.

Abstract: Disclosed herein is an RFID tag insertion cartridge comprising a hollow needle in which an RFID tag is disposed. The cartridge comprises an optional housing in the form of a shell that is shown transparently. The cartridge comprises a carriage that is movably mounted and to which the hollow needle is attached for withdrawing the needle. Also disclosed herein is a RFID tag insertion tool.

Abstract: A disclosed drip chamber for an intravenous (IV) therapy system includes a container configured to hold an IV fluid, a drop former suspended over the container, and an inlet port disposed above the drop former and configured to receive the IV fluid from a reservoir. The drop former has an upper end, a lower tip, and an outer surface extending between the upper end and the lower tip. The inlet port is coupled to the outer surface to permit the IV fluid to descend down the outer surface.

Abstract: A fluid handling system for a surgical procedure includes a console and a tubing set. The console exhibits a peristaltic pump, a pinch valve, one above the other. Two recessed seats are located to the left and right sides of the pump and valve. The tubing set includes an irrigation tube and an aspiration tube each coupled to a pair of magnetic disks disposable in respective ones of the recessed seats. Upon such disposition, the irrigation tube is disposable in operative engagement with the peristaltic pump and the aspiration tube is insertable into a slot of the pinch valve.

Abstract: Embodiments of the present disclosure are directed to devices, systems, and methods for controlling environmental conditions for a volume of material. In some embodiments, a handheld, portable environmental control sleeve (ECS) is disclosed which is configured for controlling at least one environmental condition of a drug contained within a drug delivery or storage device (DDSD). The ECS includes an environmental control mechanism (ECM), thermal insulation material, at least one of a power source, a processor, at least one electrical contact, at least one indicator, at least one switch, at least one environmental condition sensor, a wireless transceiver, a phase change material and at least one heat dissipater. Upon the ECS receiving at least a portion of the DDSD, the at least one environmental condition of a drug contained within the DDSD is controlled by the ECM to be within a predetermined range.

Abstract: The present disclosure provides, according to some embodiments, methods and systems for selectively reducing, blocking or inhibiting at least part of the neural activity in an organ of a subject. In preferred embodiments, the method and system are used for selectively blocking at least part of the neural activity in a duodenum of a subject in need thereof. According to some embodiments, the selective blocking occurs through use of laser radiation. According to some embodiments, the selective blocking comprises causing damage to at least part of sensory nerves located within a target area while maintaining functional activity of tissue surrounding the sensory nerves. According to some embodiments, the sensory nerves include neurons configured to transmit signals triggered by food passing through the duodenum, such as, but not limited to, neurohormonal signals.

Abstract: An intravascular medical device including an elongated member configured to be advanced along a vascular path of a patient, the elongated member having opposite first and second ends, the first end and second ends both being adapted for intravascular insertion, and the first end having a different structure than the second end. The elongated member has sufficient flexibility to be advanced through a human vasculature. Preferably, the first and second ends are adapted to have different operating characteristics. Depending on the operating characteristics needed for a particular procedure, a physician can insert either the first end portion or the second end portion of the elongated member into the patient's vasculature.

Abstract: A delivery system for the delivery of embolic agents to a patient includes a control valve assembly interconnecting first, second, third and fourth conduits, wherein the control valve assembly selectively moves between first, second, and third states under the control of a medical professional. In the first state, the first conduit communicates with the second conduit for transmitting a solution of embolic agents between a first syringe secured to the first conduit and a second syringe secured to the second conduit. In the second state, the second conduit communicates with the third conduit for transmitting the solution of embolic agents from the second syringe to a delivery catheter secured to the third conduit. In the third state, the third conduit communicates with the fourth conduit for flushing the delivery catheter via a third syringe, which is filled with saline, connected to the fourth conduit.

Abstract: An intravenous (IV) set system comprising a primary IV set defining a primary flow line of the IV set system. The primary flow line can include multiple access points along its length and feeds to a merging fluid pathway proximate to the distal terminus of the primary IV set. At least one secondary IV set with corresponding flow lines can be separably joined to the primary IV set to cause the secondary flow lines to be in fluid communication with the primary flow line. At least one of the IV sets can have a unique set of uniform marking indicia to facilitate rapid identification of the IV sets from other IV sets within the IV set system. Such marked and identified primary and/or secondary IV sets can be allocated to specific medical functions and/or can be for use by specific medical personnel to thereby minimize risk of error in administration of an IV to a patient. The IV set system can further comprise a merging fluid pathway about a primary IV set.

Abstract: A device and a method facilitate connecting a vial to a container or to a fluid, line, and transferring the contents of the vial to the container or to the fluid line. The device has a connecting device, a first holder for accommodating the connecting device, a second holder for accommodating the vial, and an actuating means. The connecting device includes an annular housing, an inside part having at least one puncture device, and a tube connection. The annular housing is configured to be rotatable about the inside part so as to function as a valve, so that by rotation of the annular housing, flow paths of the connecting device can be opened and closed.

Abstract: A medical device is disclosed. The medical device may include an elongate member having a proximal end and a distal end an expandable end effector assembly extending distally from the distal end of the elongate member. The end effector assembly may include a plurality of end effector units each having an injector for simultaneously delivering material into tissue.

Abstract: A variety of embodiments of an at least partially flexible actuator are provided. The actuator includes a phase change material contained within an at least partially flexible enclosure of the actuator. Application of heat, using a heater of the actuator, to the phase change material causes the phase change material to boil, increasing the volume of the actuator and/or increasing a pressure within the actuator. As a result, the actuator can be used to apply a force to objects in an environment of interest. The actuator could be incorporated into a wearable blood pressure cuff and used to apply pressure to a body part of a wearer in order to detect a blood pressure of the wearer. In other examples, the actuator could be incorporated into a wearable device and used to secure a sensor or other elements of the device against skin of a wearer.

Abstract: A system for occluding a hollow structure, the system comprising: a plurality of occluders; and an applicator for storing the plurality of occluders and serially delivering the occluders so as to occlude the hollow structure.

Abstract: A device for interventional surgical or medical procedures is presented. The device is generally in the form of a balloon and is used to position itself or other working elements up against or through lumen walls in the body. The balloon is comprised of at least two materials of different elastic modulus, which allows for a flexible but relatively non-distensible, unfolding component of the balloon as well as an elastomeric, inflatable component of the balloon. The elastomeric component is fixedly attached to the flexible but relatively non-distensible component and together they form a pressure vessel that can be inflated within the lumens of the body.

Abstract: Various medical procedures benefit from the creation of multiple access sites in a single anatomical vessel. For example, in some cardiac procedures, a plurality of catheters may be introduced into a single blood vessel through a corresponding plurality of access sites. The present application discloses devices for creating multiple access sites in a vessel and methods of using the same.

Abstract: Described is the use of a parvovirus, preferably H-1PV, for the therapeutical elimination of cancer stem cells (CSCs), preferably neuroblastoma stem cells and glioblastoma stem cells.

Abstract: A micropump including a tube unit and a control unit. The control unit has a plurality of fingers. A cam sequentially presses the plurality of fingers from an inlet side to an outlet side of the tube. A drive unit gives rotation force to the cam, a control circuit unit controls operation of the drive unit, and a device frame holds the plurality of fingers, the cam, the drive unit, and the control circuit unit. A reservoir communicates with an inlet port of the tube; and a power source supplies power to the control circuit unit, wherein the tube unit is detachably attached to the control unit substantially in the horizontal direction with respect to the rotation surface of the cam and attached to the inside of a space produced by the device frame.

Abstract: A vascular closure system includes an expandable anchor, a sealing material, a sealing tip, and a sealing tip release member. The expandable anchor is temporarily positioned through a vessel puncture within a vessel. The sealing material is positioned outside of the vessel and configured to seal the vessel puncture. The sealing tip is positioned distal of the anchor and releasable within the sealing material upon removal of the anchor and sealing tip through the sealing material. The sealing tip release member is operable to release the sealing tip without application of a tactile force.

Abstract: A hemodialysis catheter for use within a vein of a patient includes a catheter body having a proximal end when positioned within and relative to the vein. The catheter body defines an arterial lumen and a venous lumen. The catheter body is shaped with a curved tip which has a distal end. The venous lumen is truncated at a location between the proximal end of the catheter body and the distal end of the curved tip. The truncated location of the venous lumen defines an out-flow opening. The distal end of the curved tip defines an in-flow opening which corresponds to the arterial lumen. The vein has a blood flow direction and the in-flow opening faces the blood flow direction.

Abstract: A liquid embolic delivery system is provided for trapping an injected liquid embolic composition to prevent the liquid embolic from solidifying or otherwise passing outside of an embolization area. The delivery system includes a catheter for delivery of a liquid embolic composition and a containment member positioned at a distal end of the catheter which is shaped to trap the liquid embolic composition delivered through the lumen of the catheter. The containment member is formed as a brush, nest, sponge, swab, flexible sack, or other shape into and around which the liquid embolic composition is injected. The liquid embolic composition is trapped or meshes with the containment member during solidification containing the liquid embolic and preventing the embolic composition from passing into the blood stream.

Abstract: Methods and systems are disclosed for selective drug or fluid delivery in a lumen through a coating or fluid delivery channels. One system includes an elongate catheter having a proximal end and a distal end with an axis therebetween, the catheter having a radially expandable balloon near the distal end and an energy delivery portion proximate the balloon for transmission of energy, a thermally changeable coating having a releasable drug coupled to the balloon, the thermally changeable coating being oriented to be urged against the body tissue when the expandable balloon expands and an energy source operatively coupled to the energy delivery portion configured to energize the energy delivery portion to heat and liquefy the thermally changeable coating to release the drug to the body tissue.

Abstract: A system for manipulating a guide catheter within a patient's nasal passages or sinus cavities includes a guide catheter formed from an elongate flexible member having a lumen passing there through. A wire guide is slidably disposed within the lumen of the guide catheter. The system further includes a steering member fixedly secured to a proximal end of the wire guide and a proximal hub secured to a proximal end of the guide catheter. The system further includes a recessed handle having a first recess for fixedly receiving the proximal hub of the guide catheter and a second recess for receiving the steering member, the second recess being dimensioned to permit axial and rotational movement of the steering member while disposed in the second recess.

Abstract: Peristaltic pump assemblies in which the closing and opening of a pivoting or sliding door is coordinated with movement of the occlusion bed toward and away from the rotor assembly to engage and disengage tubing within the occlusion pathway are disclosed. Linkage mechanisms provided by the interaction of cam surfaces with rollers, as well as bar linkage mechanisms, are disclosed. The linkage mechanism, in addition to providing precise displacement of the occlusion bed, may also provide an over-center feature that enhances safety and pump operation when the door is in a closed position. Latching mechanisms and sensors may be incorporated. Control consoles incorporating such peristaltic pump assemblies are described. Adaptive components such as tubing cassettes routing aspiration and/or infusion tubing in a predetermined configuration to mate with occlusion pathways in aspiration and/or infusion pump assemblies provided in various types of medical devices and control consoles are also provided.

Abstract: Embodiments of the invention provide swallowable devices, preparations and methods for delivering drugs and other therapeutic agents within the GI tract. Many embodiments provide a swallowable device for delivering the agents. Particular embodiments provide a swallowable device such as a capsule for delivering drugs into the intestinal wall or other GI lumen. Embodiments also provide various drug preparations that are configured to be contained within the capsule, advanced from the capsule into the intestinal wall and degrade to release the drug into the bloodstream to produce a therapeutic effect. The preparation can be operably coupled to delivery means having a first configuration where the preparation is contained in the capsule and a second configuration where the preparation is advanced out of the capsule into the intestinal wall. Embodiments of the invention are particularly useful for the delivery of drugs which are poorly absorbed, tolerated and/or degraded within the GI tract.

Abstract: An I.V. infusion or blood collection apparatus comprises an I.V. infusion set (100) and a safety shield (200). The I.V. infusion set has a wing body (105) from which a pair of wings (140) extend outward there from and a grip (145) extending upward there from. One end of the wing body mounts a needle (120) or catheter and medical tubing (130) is connected to the opposite end. The wing body includes a bore so that fluid flows between the needle and the medical tubing. A safety shield has a top, a bottom and opposing side walls and defines a cavity (227) that is adapted to receive the I.V. infusion set. The safety shield has slots (250) in each of the side walls and a slot (255) in the top. The respective wings and grip are adapted to be positioned in the slots and to slidably move therein.

Abstract: A mechanical infusion pump device for injecting medication into a patient's IV, includes an IV reservoir and a syringe communicated to the IV reservoir and having a syringe plunger which is moved in a first direction against a mechanical biasing element by engagement with a manually operable, independently movable filling plunger to fill the syringe with fluid medication. The mechanical biasing element is provided for exerting bias on the syringe plunger in a second syringe-discharging direction to dispense medication from the syringe into the patient's IV when the filling plunger is released. Only a calibrated amount of medicine can be discharged to the patent's IV over time as determined by calibration of the biasing element and a metering element located between the syringe and the patient's IV for a given viscosity of the medication.

Abstract: It has been discovered that compositions comprising magnetically heatable entities (MHEs), therapeutic agents and optional carriers such as hydrogels can be piloted from an injection point in a blood vessel to a specific location of the blood-brain barrier (BBB) using for example, a magnetic resonance imaging (MRI) device for propelling, steering and tracking of MHEs. Once the MHEs have reached their target location at or near the desired blood vessel of the BBB, an alternating magnetic field causes the MHEs to controllably heat up, thereby reversibly increasing the permeability of the BBB and allowing the therapeutic (or cytotoxic) agent to enter brain tissue.

Abstract: An instrument for delivery, deployment, and tamponade of a hemostat. A delivery cannula is included and has a proximal end, a distal end, and a lumen therebetween. A shaft is configured to be introduced into and move relative to the lumen. A hemostat applicator at the distal end of the shaft includes a tamponade surface. The applicator is configured to transition between a first, compact state for introduction into and movement within the lumen, and a second, expanded state as the applicator exits from the delivery cannula.

Abstract: A distal perfusion sheath (DPS) is provided for cases where blood perfusion is needed for downstream arteries (distal) to the insertion point of the DPS within the target artery. The ability to provide distal perfusion with the DPS allows the DPS to be positioned in the target artery for long periods without causing lack of blood flow (ischemia) to an extremity that the target artery supplies. In embodiments, the DPS can still be used for surgical arterial access while allowing blood flow downstream. In addition, embodiments of the DPS configured with longer perfusion shunts can allow a contra-lateral extremity downstream to a large DPS to have blood flow while the sheath is in place.

Abstract: A device and method secure a blood vessel for cannulation. The device includes two parallel skids. The device is placed on the skin of a patient with a skid on each side of a blood vessel to be phlebotomized. When the skids are pressed on the skin, fluid in the tissue is displaced to the space between the skids. The blood vessel becomes secured and unable to move or roll. With the skids still pressed on the skin, the cannula can be inserted into the blood vessel. The width and spacing of the skids are adjusted to maximize the securing effect on the blood vessel.

Abstract: An apparatus, systems, and methods related to determining an identity and a concentration of an intravenous fluid. The apparatus, the systems, and the methods described herein may provide near real-time monitoring and/or determination of an identity of components of the intravenous fluid. A concentration and the identity of all of the components of the intravenous fluid may be identified simultaneously.

Abstract: A balloon catheter having a shaft, a balloon, and an external delivery tube, as well as methods of use thereof. In one example, the balloon catheter is an agent delivery catheter including a catheter body extending between catheter proximal and distal portions. An inflatable balloon assembly is coupled with the catheter body. An agent delivery assembly, which is coupled with the catheter body and the inflatable balloon assembly, includes a delivery lumen extending through the catheter body and an agent delivery tube extending along an exterior balloon surface. The agent delivery tube includes at least one delivery orifice directed outside of the exterior balloon surface. The agent delivery assembly is isolated from fluid communication with the inflatable balloon assembly.

Abstract: A blood storage container suitable for quick and efficient production of a large amount of serum while ensuring high safety, and a method of separating blood and a regenerative medical process using the same are provided. A blood component separation storage apparatus is provided for separating a plurality of blood components of blood so as to be stored therein. The blood component separation storage apparatus includes a blood reservoir for holding the blood and a component storage part connected to the blood reservoir aseptically and in an air-tight manner. The blood reservoir contains an anticoagulant which suppresses coagulation of the blood. The blood reservoir has a serum producing function to remove coagulation factors from the blood to an extent enabling use in practical applications as a serum, and the component storage part stores each blood component generated by separation of the blood in the blood reservoir.

Abstract: A fluid flow manager executing on first hardware controls a flow of fluid outputted from a fluid delivery pump to a recipient. A monitor resource, executing on second hardware operating independently of the first hardware, monitors for an occurrence of a failure condition associated with the delivery of fluid. In response to detecting occurrence of a failure condition associated with delivery of the fluid, the monitor resource generates a control output. The control output can be used to perform operations such as discontinue delivery of the fluid, notify a respective caregiver of the delivery failure, etc.

Abstract: The invention relates to an adapter for a syringe plunger. The adapter of some embodiments may include a first side adapted to interface with a syringe plunger and an opposing a second side adapted to interface with a drive ram of a medical fluid injector. The adapter may include a peripheral side surface exhibiting a thickness and may include what may be characterized as at least one mating section adapted to engage with the syringe plunger. The mating section(s) may include a channel extending through the entire thickness of the adapter. In some embodiments, the mating section(s) may include a stop adjacent the channel that extends less than the entirety of the thickness of the adapter.

Abstract: A means and a method is disclosed to diminish or eliminate the pain associated with a sharp object penetrating the skin, during such procedures as an injection, biopsy, or deriving a blood sample. To this end, repeated tapping, pressing, or rubbing or vibrating is performed over the skin at or near the site of penetration of the sharp object in conjunction with applying electricity on the skin. The invention discloses a method of using a skin-puncturing means, with enhanced features, to provide local anesthesia at the site of penetration of a sharp object.

Abstract: The invention includes a universal transvalvular insertion tool for providing a passage through a multiplicity of differently designed hemostatically valved introducers, each having a valve within a valved body coupled to a cardiac introducer. The tool includes a longitudinally rigid sheath having a lumen and for insertion through the valve of any one of the multiplicity of differently designed hemostatically valved introducers to provide a substantially obstruction free path for delivery of a lead or vascular device through the valve and valved body to the introducer, the sheath having a length selected to extend through the valve without substantial deformation of the lumen of the sheath. A mechanism is provided for separating the rigid sheath to allow removal from the lead or device without removal of the transvalvular insertion tool over either end of the lead or vascular device.

Abstract: A mechanical patient-controlled analgesia device for injecting medicine into a patient's IV, includes an IV reservoir and a syringe communicated to the IV reservoir and having a syringe plunger. A mechanical biasing element is provided for exerting bias on the syringe plunger in a first syringe-filling direction to draw medicine from the IV reservoir into the syringe. An injection plunger is operable by the patient to move the syringe plunger in a second injection direction against the bias to inject the medicine in the syringe into a patient's IV. The injection plunger is movable independently of the syringe plunger and is engaged with but unconnected to the syringe plunger when the patient moves the injection plunger to inject the medicine. The patient can inject only a calibrated amount of medicine drawn into the syringe as determined by calibration of the biasing element and a metering element for a given viscosity of the medication.

Abstract: Devices, systems, and methods for autoretroperfusion.

Abstract: Paracentesis apparatus providing increased fluid transfer capacity, comprising a single centesis needle and at least two vacuum sources. The centesis needle is connected to the vacuum sources by a conduit which is split to form a flow path to each vacuum source. The conduit may comprise flexible tubing, and may include an in-line valve and a connector for engaging the vacuum sources. The vacuum sources may comprise evacuated bottles. Albumin may be administered to patients undergoing paracentesis.

Abstract: A protector (1) is used by being attached to a puncture device (50). The protector (1) includes an outer tube (2) and an inner tube (9). The outer tube (2) includes an outer tube main body (3) including an outer tube lumen (4) for housing the puncture device (50), a holding part (5) for holding a hub (52), and an extended part (8) extended from the holding part (5) in a proximal end direction. The inner tube (9) includes an inner tube main body (10) and a lumen inclined part (12). The inner tube main body (10) is held in a proximal end side of the outer tube lumen (4) and movable in a proximal end direction of the outer tube lumen (4). The inner tube main body (10) includes an inner tube lumen (11) into which a tube (53) is inserted. In the lumen inclined part (12), an inner diameter of the inner tube lumen (11) gradually increases toward a distal end side of the inner tube main body (10).

Abstract: The present invention relates to the regional delivery of therapeutic agents for the treatment of vascular diseases wherein regional delivery refers to delivery of a therapeutically effective amount of the therapeutic agent to an area of the vessel that includes not only afflicted tissue but non-afflicted tissue at the periphery of the afflicted tissue as well.

Abstract: An intravenous (IV) set system comprising a primary IV set defining a primary flow line of the IV set system. The primary flow line can include multiple access points along its length and feeds to a merging fluid pathway proximate to the distal terminus of the primary IV set. At least one secondary IV set with corresponding flow lines can be separably joined to the primary IV set to cause the secondary flow lines to be in fluid communication with the primary flow line. At least one of the IV sets can have a unique set of uniform marking indicia to facilitate rapid identification of the IV sets from other IV sets within the IV set system. Such marked and identified primary and/or secondary IV sets can be allocated to specific medical functions and/or can be for use by specific medical personnel to thereby minimize risk of error in administration of an IV to a patient. The IV set system can further comprise a merging fluid pathway about a primary IV set.

Abstract: An access port for the introduction of a needle cannula tip into an IV tube set includes a rigid tubular housing and a resilient member disposed adjacent an inlet of the housing. The resilient member includes an axial perforation extending through the resilient member, and is normally closed by a resilient character of the resilient member. A depression is defined in a proximal face of the resilient member, and includes sidewalls extending between the proximal face and the axial perforation to guide the needle cannula tip toward the axial perforation as a needle cannula associated with the needle cannula tip is introduced into the access port.

Abstract: In order to inhibit thrombotic processes locally rather than systemically, higher levels of antithrombotic drugs in the deep veins of the legs than in the systemic circulation are obtained using devices and methods that provide venous cannulation in the dorsum of the foot of a patient while applying pressure to the foot proximal to the venous cannulation, potentially as far up the leg as the knee, in an amount sufficient to compress the superficial veins and divert the venous drainage in the deep venous system into the venous plexus.