Abstract: Provided is a puncture device assembly excellent in operability. Provided is a puncture device assembly which includes an inner needle that can puncture skin, a sheath tube that has a lumen through which the inner needle can be inserted, and a support portion which is provided at a proximal portion of the sheath tube and prevents kink of the sheath tube. The support portion has a cylindrical body which is bendable and can maintain a curved shape in a state where the sheath tube is inserted.

Abstract: An active agent or drug injecting device (10) includes a main housing (16) containing a trigger mechanism (24) which can be manually activated via release bar (32) or remotely triggered via wireless receiver (70) activating motor (74), and a second housing (80) containing an injection- and needle-assembly (22). The needle (30) encloses a dry carrier (26) having an active agent (12) disposed thereon. The trigger mechanism triggers the injection assembly to propel the needle into the skin (via spring (54)), to inject the active agent into a living organism (either by letting the active agent diffuse out of the needle or by actively flushing it out), and to subsequently retract the needle back into the housing (80) (via spring (64)).

Abstract: An endoluminal medical access device (1) is disclosed that is devised for endoluminal delivery to an extravascular target site (5) at a vasculature site of a human or animal body vasculature, such as the microvasculature.

Abstract: An intraluminal member can be used to deliver an adhesive to a vein while causing the vein to spasm, thereby controlling adhesive migration and improving procedure efficacy.

Abstract: The present invention relates to articles and methods of treating vascular conditions with a thixotropic, turbid, bioactive agent-containing gel material capable of being essentially removed from an implantation site upon re-establishment of fluid flow at the implantation site.

Abstract: Methods and devices can be used to harvest fetal blood from a placenta. In some instances, the blood is used in laboratory testing so that no such blood is drawn from an infant for such testing. In other or further instances, harvested blood can be used in an autologous transfusion. Such procedures can eliminate the drawing of any blood directly from the neonate.

Abstract: A catheter assembly for use in accessing a vasculature of a patient during renal replacement or other therapies is disclosed. In one embodiment, the catheter assembly includes a catheter body that defines first and second lumens. The catheter body defines a distal tip region that includes a venous lateral opening that is in fluid communication with the first lumen and an arterial lateral opening that is in fluid communication with the second lumen.

Abstract: The invention provides a bipolar electrosurgical device to treat tissue in a presence of radio frequency energy and a fluid provided from the device. In one embodiment, the device comprises a first electrode and a second electrode at the end of a malleable shaft assembly to be hand shapeable by a user of the device, and at least one fluid outlet. The malleable shaft assembly comprises a first shaft and a second shaft, a length of the first shaft and a length of the second shaft in an outer member comprising a polymer, and at least a portion of the first shaft and at least a portion of the second shaft being malleable.

Abstract: A device and method for delivering a drug from inside a body lumen to tissue surrounding the body lumen. An endoluminal drug delivery device includes a dual-lumen catheter for housing a guidewire and a needle connectable to a drug source. The guidewire exits the catheter through an opening at the distal end, and the needle exits the catheter through an exit port in the outer wall of the catheter. A distal portion of the catheter has a single lumen and includes a taper, allowing the distal tip to act as a dilator. The device optionally includes a catheter lumen splitter and/or a handpiece assembly. A method of delivering fluid to tissue surrounding a body lumen includes inserting a guidewire into the body lumen, tracking the device over the guidewire, deploying the needle through the exit port to the tissue, delivering fluid, and retracting the needle into the catheter.

Abstract: A method of treating an occlusion at a treatment site within a patient's vasculature comprises providing an ultrasonic catheter. The ultrasonic catheter has a distal region, a proximal region opposite the distal region, a fluid delivery lumen having at least one opening in the distal region, and an ultrasound radiating member positioned within the distal region. The method further comprises positioning the ultrasonic catheter at the treatment site, such that at least a portion of the distal region is within the occlusion. The ultrasonic catheter further comprises passing a therapeutic compound through the fluid delivery lumen such that the therapeutic compound is delivered to the treatment site. The ultrasonic catheter further comprises emitting ultrasonic energy from the ultrasound radiating member. The emitted ultrasonic energy has an amplitude that is periodically varied between a low amplitude and a high amplitude.

Abstract: A catheter assembly includes a catheter, including an inner member and a sheath, extending from a handle. The handle includes a housing, a braking assembly, a carriage and a carriage driver. The braking assembly comprises a braking element within the housing interior and a braking element rotator. The carriage comprises at least one carriage braking surface engaging the braking element. The carriage driver, such as a spring, biases the carriage towards the proximal end of the handle. The inner member has a proximal end secured to the housing. The sheath has a proximal end secured to the carriage. Rotating the braking element causes the carriage to move proximally as the carriage braking surface slides along the braking element. This causes the sheath to move proximally relative to the inner member.

Abstract: Implantable access device for removal and/or return of fluids to a patient, comprising a casing attached to an internal conduit to be connected with a lumen of the patient; a connector attached at the casing and connected to an external conduit, and arranged for attachment of an extracorporeal lumen to the device; and an actuator unit within the casing to selectively allow or block the fluid communication between the internal conduit and the external conduit; the device further comprising a fixation unit integrated in or attached at the casing arranged for fixation of the device to a bone of the patient; wherein the fixation unit extends axially along the longitudinal axis of the device. The disclosed access device can be used for high volume removal and/or return of blood or other fluids from the patient.

Abstract: Methods and devices for providing improved ultrasound visibility of medical devices intended for intravascular use are described. The inclusion of gas/solid boundary regions within a medical devices improves the resolution of the device under ultrasound visualization. Gas/solid boundary regions may be provided through the use of embedded gas-filled microlumens, microwells, or enclosed pockets within the medical device.

Abstract: Medical devices, systems and methods for modifying a left atrial appendage (“LAA”). In one embodiment, a medical device system includes a jailing member or structure positioned over the ostium of an LAA and at least one tissue growth member positioned within the LAA and retained within the LAA by the jailing member. In another embodiment, a medical device includes an atrial stent coupled with a patch that is configured to cover the ostium of an LAA. The patch may have a tissue growth member associated therewith. In another embodiment, the patch may include an open-cell frame which may be used as a jailing member or structure.

Abstract: An endoluminal device comprises a tubular member and a reinforcement member that is separable from, or together with, a wall of the tubular member, and removable in-situ.

Abstract: A device for locating and distending the external jugular vein is provided by a wish-bone shaped apparatus designed to engage the neck of a patent and apply sufficient pressure on the neck that the external jugular vein becomes distended due to pressure placed on the patient's neck. The device includes two distally placed flat portions that resiliently engage the patient's neck without causing choking or hindrance in breathing.

Abstract: Disclosed herein are methods of expressing UDP-GlcNAc 2-Epimerase/ManNAc Kinase enzyme (GNE) peptide in a cell of a subject comprising: delivering into the cell of the subject an isolated nucleic acid expression construct that comprises a promoter operatively linked to a nucleic acid sequence encoding a GNE peptide or a therapeutically active fragment thereof, wherein the GNE peptide has the amino acid sequence of SEQ ID NO:3, wherein upon the delivering into the cell of the subject, the nucleic acid expression construct initiates expression of the GNE peptide or a therapeutically active fragment thereof. Also disclosed are methods of producing a GNE peptide in a cell comprising infecting the cell with an isolated nucleic acid construct that comprises a promoter operatively linked to a nucleic acid sequence encoding a GNE peptide or a therapeutically active fragment thereof, wherein the GNE peptide has the amino acid sequence of SEQ ID NO:3.

Abstract: A vascular access system and method of use for said system. The vascular access system generally comprises a body member; a shuttle member movably coupled to the body member; and a plurality of access needles fixedly coupled to the shuttle member and extending from the body member to penetrate a patient's skin.

Abstract: The invention provides a combination treatment for ischemia conditions in or otherwise affecting the CNS, such as stroke. The treatment invoices administration of a PSD-95 inhibitor and performing reperfusion therapy (e.g. by administration of tPA). Administration a PSD-95 inhibitor in combination with reperfusion therapy increases the efficacy of the reperfusion therapy and/or slows the decline in efficacy of reperfusion therapy with time after onset of ischemia thus extending the window in which reperfusion therapy can be administered.

Abstract: A drip chamber having an upper reservoir that is separated from a lower reservoir via a filter assembly, wherein a distance between the filter assembly and a bottom surface of the drip chamber is selected to prevent dislodged air bubbles of the filter assembly from being drawn into an intravenous fluid line that is coupled to the bottom surface of the drip chamber, during an infusion procedure.

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. In a blood component separator 1 for separating collected blood into a plurality of blood components and preserving them, the separator 1 including a blood reservoir 10 for reserving the blood and a component storage part 20 aseptically connected in an air-tight manner to this blood reservoir 10, to the aforementioned blood reservoir 10 being imparted a serum producing function to remove coagulation factors from the blood to an extent enabling use in practical applications as a serum, and the aforementioned component storage part 20 storing each blood component generated by separation of the blood in the blood reservoir 10.

Abstract: Apparatuses for grinding or cutting surgical foam are disclosed herein. Kits for grinding or cutting surgical foam are disclosed herein. Methods of grinding surgical foam with a plurality of teeth are disclosed herein. Methods of cutting surgical foam are disclosed herein. Methods of embolizing with ground or cut surgical foam are disclosed herein.

Abstract: A vena cava filter catheter includes a catheter having a lumen disposed therethrough and at least one strand of biocompatible wire. The at least one strand has a first state in which the at least one strand has an elongate geometry suitable for traversing the lumen of the catheter and a second state in which the at least one strand assumes a pre-set geometry in which the at least one strand assumes a tortuous configuration adapted to occupy a space approximating a luminal diameter of an inferior vena cava.

Abstract: An intravascular foreign matter suction assembly is insertable into a blood vessel having a relatively small diameter and exhibits a high suction force. The intravascular foreign matter suction assembly includes a combination of a guiding catheter for being inserted to an ostium of a coronary artery of the aorta and a suction catheter inserted in the lumen of the guiding catheter and extending farther than the distal end of the guiding catheter for removing foreign matter in a blood vessel which exists at a target location in the coronary artery. The suction catheter includes a tubular portion provided on the distal end side and a wire portion provided on the proximal end side of the tubular portion and wherein the wire portion has a distal end embedded in a wall which forms the tubular portion.

Abstract: An assembly and method for percutaneous placement of a catheter comprising an elongated hollow catheter having a distal end and a reduced cross-section portion at a proximal end thereof. An introducer needle is slidably mounted over said catheter. The introducer needle has an elongated slit adapted to slide over the reduced cross-section portion to separate the needle from the catheter. A syringe may be attached to the proximal end of the catheter. Also, a valve may be attached to the catheter to permit easy collection of fluid.

Abstract: An inline fluid warming apparatus that has a fluid warmer portion and a battery portion for powering the fluid warmer portion. The fluid warmer portion has a housing that connects directly to a housing of the battery portion by an attachment means. The attachment can be a rail system or a snap attachment or any other secure means for attaching the two housings together. The fluid warmer portion has power contacts that engage with power contacts on the battery when the two portions are engaged. When the power contacts are engaged, the battery portion provides power to the fluid warmer portion to warm fluid traveling through the fluid warmer. The apparatus is placed directly onto an arm or leg of a patient. A band or adhesive may be used to hold the apparatus in place against the skin of the patient.

Abstract: Methods, devices, kits and compositions to treat a myocardial infarction. In one embodiment, the method includes the prevention of remodeling of the infarct zone of the ventricle. In other embodiments, the method includes the introduction of structurally reinforcing agents. In other embodiments, agents are introduced into a ventricle to increase compliance of the ventricle. In an alternative embodiment, the prevention of remodeling includes the prevention of thinning of the ventricular infarct zone. In another embodiment, the prevention of remodeling and thinning of the infarct zone involves the cross-linking of collagen and prevention of collagen slipping. In other embodiments, the structurally reinforcing agent may be accompanied by other therapeutic agents. These agents may include but are not limited to pro-fibroblastic and angiogenic agents.

Abstract: The present disclosure describes a method for targeted delivery of permanently-acting or temporarily-acting neurotoxins, neurosuppressants, or other compounds having a neurologic effect to specific locations of the heart, including for example, but not limited to, nodes of the cardiac autonomic nervous system such as the atrial ganglionated plexi (GP). Chemical ablation of the atrial GP as described herein via magnetically-targeted magnetically-susceptible nanoparticles can effectively suppress GP activity and atrial fibrillation related, thereto without permanent damage to either myocardium or intrinsic CANS.

Abstract: Devices (11, 111) for providing temporary access to the ventricle of the heart and then closing such an access passage when the operation demanding such access has been completed. These devices include an anchor (13, 113) with a wire spiral (19, 119) for implantation in the tissue wall of the heart and a handle (15, 115) detachably connected to the anchor. The handle provides an axial passageway in which a hollow needle (27, 127) is slidably and stably received. With the anchor in juxtaposition with the apex of the heart, the pointed end of the hollow needle is inserted into the ventricle, and its presence traversing the wall of the heart provides a stable axis about which the wire spiral (19, 119) can be rotated to seat the anchor in precise circumscribing fashion about the hollow needle (27, 127).

Abstract: A system and method determine when fluid is not flowing properly from a secondary infusion source during a secondary infusion. The system includes an upstream pressure sensor and a processor programmed to receive signals from the sensor and analyze the signals to determine if secondary fluid flow is proper. The processor samples the output signals from the upstream pressure sensor and analyzes the sampled signals to determine if a pressure rise in the infusion line has occurred when the secondary infusion is initiated. If a pressure rise, indicating that fluid from the secondary container has begun flowing into the infusion line, has not been detected, the processor is programmed to provide a signal indicating that attention should be given to the infusion set up.

Abstract: Infusion systems and methods containing unique inner passage configurations are provided to improve the in-line detection of air in a fluid delivery line of an infusion system by reducing the problems associated with the presence of bouncing air bubbles and stuck fluid droplets in the fluid delivery line.

Abstract: A method of distributing medication is disclosed herein. The method includes the step of opening a fluid pathway for delivering fluid intravenously to a patient. The method also includes the step of placing a medication pump in fluid communication with the pathway. The method also includes the step of locking a user interface of controls for the medication pump to place the medication pump under the exclusive control of medical professionals.

Abstract: An infusion catheter assembly has the ability to infinitely titrate the length of a porous fluid distribution section in situ. The infusion catheter assembly thereby provides a length of infusion that can be infinitely varied over a prescribed range, to control the effective infusion length and the rate of infusion. Using the infusion catheter assembly, a physician has the capability to treat only the length of the vessel desired, thereby preventing excessive drug/patient exposures. The porous fluid distribution section can include an array of spaced apart apertures that vary in size and/or density along the length of the porous fluid distribution section, such that the flow rate remains essentially constant for a given inlet pressure independent of the effective infusion length.

Abstract: Kits, apparatus, devices and methods for treating varicose veins caused by an incompetent venous junction (e.g., the saphenofemoral and/or saphenopopliteal junctions) are disclosed. The kits may include a sheath, a vein closure device, and an injection device. Alternatively, a vein closure device may include an integral injection channel and injection device. Methods may include injecting a vein with a sclerosing agent through a needle that extends in a direction that is not aligned with a longitudinal axis of a sheath or shaft.

Abstract: Vascular access systems for performing hemodialysis are disclosed. The vascular access system contemplates a catheter section adapted for insertion into a vein and a graft section adapted for attachment to an artery. The catheter section may have metal or polymer wall reinforcements that allow the use of thin-walled, small outer diameter conduits for the vascular access system. One or more of the adhered, embedded or bonded conduit reinforcement structures may be removable without significant damage to the conduit sections to facilitate attachment of the sections, or to a connector between the sections. Various self-sealing materials are provided for use in the vascular access system, as well as temporary access sites and flow control/sensor systems.

Abstract: Treatment of aneurysmal blood vessels with local delivery of therapeutic agents thereby reduces or lessens the severity of an aneurysm, and, where used in conjunction with the placement of an excluding device, provides for more rapid recovery of the blood vessel from any disturbance occurring during placement of the excluding device. Therapeutic agents are placed in the aneurysmal site in a time-release carrier medium, such that the therapeutic agent is released into the aneurysmal site over a period of time without the need to provide systemic introduction of the therapeutic agent. The carrier may be introduced through the patient's dermis, such as with the use of a laparoscope, or intravascularly, through the use of a catheter. The carrier may be in a solid matrix, viscous liquid or liquid form.

Abstract: A hazardous fluid transport container and a hazardous fluid delivery system are disclosed. The hazardous fluid transport container includes a housing enclosing an at least partially shielded enclosure. First and second fluid path elements are disposed within the housing, with the first fluid path element and second fluid path element fluidly coupled together. A pump unit may be provided for dispensing fluid from the first and second fluid path elements optionally into a third fluid path element. Also, methods for priming the hazardous fluid transport container and for mitigating laminar flow injection bolus spreading are disclosed. Additionally, disclosed is a radioactive fluid transport container for a syringe or other container. The radioactive fluid transport container allows the syringe or container to be used in an injection procedure without removal from the container.

Abstract: An infusion pump for infusing a fluid from a syringe, the syringe comprising a syringe barrel and a syringe plunger comprising a piston, a plunger stem and a plunger flange, wherein the infusion pump comprises a housing having a display, a syringe retainer for retaining the syringe in place and a plunger driver for pushing the syringe plunger to expel fluid from the syringe, characterized in that the syringe retainer retains the syringe in a position such that at least a visible part of the display is located behind the syringe barrel. An array of infusion pumps and a docking station for docking infusion pumps is also described.

Abstract: An atherectomy device and method has cannula systems having lumens adapted for insertion of a blood filter and an atherectomy catheter useful for performing atherectomy directly on a patient's cardiovascular tissue. Other embodiments include a lumen for arterial perfusion useful in providing oxygenated blood to the aorta during cardiopulmonary bypass. The distal end of the atherectomy catheter includes an assembly that has a pincer, a loop with or without a mesh, laser, hydraulics, or other suitable mechanism adapted for removing atheroma from a cardiac or vascular tissue. Methods of using the systems for vascular atherectomy are also disclosed herein.

Abstract: Kits, apparatus, devices and methods for treating varicose veins caused by an incompetent venous junction (e.g., the saphenofemoral and/or saphenopopliteal junctions) are disclosed. The kits may include a sheath, a vein closure device, and an injection device. Alternatively, a vein closure device may include an integral injection channel and injection device. Methods may include injecting a vein with a sclerosing agent through a needle that extends in a direction that is not aligned with a longitudinal axis of a sheath or shaft.

Abstract: Provided are methods for inducing preservation in a patient and resuscitating that patient. At least three hours of preservation, with successful resuscitation, are realized using the methods described herein. The methods involve flushing a patient with an oxygenated, cold-flush solution, such as normal saline, having an energy source. The patient may be cooled to deep or profound hypothermia to induce preservation. The patient may be resuscitated by warming to from about 33° C. to about 36° C., and then may be slowly warmed over a 24 to 72 hour period to normothermia. Kits for inducing preservation also are provided.

Abstract: Some embodiments of a method of anchoring a catheter include an anchor device that receives the catheter (or other medical instrument) and secures the catheter in place relative to a skin penetration point. In some embodiments, the anchor device can secure the catheter in an operative position relative to the skin penetration point without use of sutures or skin tapes.

Abstract: A single use pre-filled delivery device comprising a deformable container, a one-way valve, and male luer connector is described. Also described are methods of flushing vascular access devices using a single use pre-filled delivery device as described herein is also disclosed.

Abstract: A membrane separation device is disclosed along with systems and methods employing the device in blood processing procedures. In one embodiment, a spinning membrane separator is provided in which at least two zones or regions are created in the gap between the membrane and the shell, such that mixing of the fluid between the two regions is inhibited by a radial rib associated with the membrane that decreases the gap between the membrane and the shell to define two fluid regions, the ridge isolating the fluid in the two regions to minimize mixing between the two. Automated systems and methods are disclosed for separating a unit of previously collected whole blood into components, such as concentrated red cells and plasma, for collecting red cells and plasma directly from a donor in a single pass, and for cell washing. Data management systems and methods and priming methods are also disclosed.

Abstract: A single use delivery device is disclosed having a manually deformable liquid container defining an inner chamber, the container having a distal end, a body, a proximal end, and an outlet on the distal end; a tip projecting from the outlet on the distal end of the container, the tip in fluid communication with the inner chamber of the container; and a primer element for removing one or more air bubbles from the chamber, said primer element being attached to and in fluid communication with the deformable container. A method of administering a fluid to or flushing a vascular access device using a single use pre-filled delivery device as described herein is also disclosed.

Abstract: A method of age management, by consulting with a patient, performing comprehensive testing on the patient, determining the physiological, functional, and biological age of the patient, and recommending and performing treatments based on the physiological, functional, and biological age of the patient. The performing comprehensive testing is further defined as performing a test of standard plus functional medicine testing, complete hormonal panel, infectious disease panel, tumor markers panel, and combinations thereof.

Abstract: A system for detecting and removing a gas bubble from a vascular infusion line, comprising a disposable cassette adapted for disposition intermediate the fluid line, the disposable cassette comprising a body comprising an inlet port, a chamber, an outlet port, and a purge port, a first passageway connecting the inlet port to the chamber, the first passageway comprising a first bubble detection section where a gas bubble may be detected within the first passageway, a second passageway connecting the chamber with the outlet port, and a first pinch valve disposed along the second passageway intermediate the chamber and the outlet port, and a third passageway connecting the chamber with the purge port, the third passageway comprising a second bubble detection section where a gas bubble may be detected within the third passageway, and a second pinch valve disposed along the third passageway intermediate the chamber and the bubble detection section.

Abstract: Methods and devices for treating patients using high partial pressures of dissolved gas in a liquid. Greater than hyperbaric partial pressures of gas may be dissolved and maintained in the liquid when mixing occurs at ambient pressure. Additional increases in dissolved gas partial pressure may be achieved when the temperature of the liquid is further decreased. The method further includes administering the liquid intravenously via a conventional catheter. Gas exchange occurs due to diffusion upon mixing of the liquid and blood within the vasculature of the patient.

Abstract: The invention provides methods for treating an obstructed biological conduit that include administering to the conduit an agent that can degrade extracellular matrix of obstructing tissue. Particular methods include delivery of an enzyme or a mixture of several enzymes to the area or region of obstruction wherein the enzyme(s) have the capability to degrade extracellular matrix components within the obstruction thereby restoring the normal flow of transported fluid through the conduit. The invention also includes prophylactically dilating a section of conduit to minimize the risk of obstruction formation.

Abstract: A hemodialysis and vascular access system comprises a subcutaneous composite PTFE silastic arteriovenous fistula having an indwelling silastic venous end which is inserted percutaneously into a vein and a PTFE arterial end which is anastomosed to an artery. Access to a blood stream within the system is gained by direct puncture of needle(s) into a needle receiving site having a tubular passage within a metal or plastic frame and a silicone upper surface through which needle(s) are inserted. In an alternate embodiment of the invention, percutaneous access to a blood stream may be gained by placing needles directly into the system (i.e. into the PTFE arterial end). The invention also proposes an additional embodiment having an arterialized indwelling venous catheter where blood flows from an artery through a tube and a port into an arterial reservoir and is returned to a vein via a port and a venous outlet tube distinct and distant from the area where the blood from the artery enters the arterial reservoir.