Abstract: An infusion set (101) includes an inserter (121) pivotally connected to a base (111). The inserter (121) includes a catheter (173) and an introducer needle (167). The catheter (173) is movable from a first catheter position disposed substantially entirely within the inserter (121) to a second catheter position in which a free end of the catheter (173) is disposed externally of the inserter (121) and the base (111). The introducer needle (167) is movable between a first introducer needle position disposed substantially entirely within the inserter (121) and a second introducer needle position in which a free end of the introducer needle (167) is disposed externally of the inserter (121) and the base (111). An activation button (141) is movable between first and second button positions.

Abstract: A system, for use in determining a volume in a reservoir, includes a bulkhead, a plunger assembly, and a base. The plunger assembly is connected to the bulkhead. The plunger assembly includes a first plunger and a second plunger. The first plunger has a corresponding first biasing member. The second plunger has a corresponding second biasing member. The base of the reservoir is connected to the first plunger. Movement of the base causes compression or expansion of the first biasing member, which causes compression or expansion of the second biasing member. The bulkhead, the first plunger, and the base define a first portion of the reservoir. Positions of the first plunger and the base, relative to the bulkhead, are based on the volume in the reservoir.

Abstract: A system for improving cardiac function is provided. A foldable and expandable frame having at least one anchoring formation is attached to an elongate manipulator and placed in a catheter tube while folded. The tube is inserted into a left ventricle of a heart where the frame is ejected from the tube and expands in the left ventricle. Movements of the elongate manipulator cause the anchor to penetrate the heart muscle and the elongate manipulator to release the frame. The installed frame minimizes the effects of an akinetic portion of the heart forming an aneurysmic bulge.

Abstract: Devices, methods, and assemblies for perfusion therapy including cerebral perfusion therapy such as those for use in the treatment of acute ischemic stroke. The treatment includes delivery of blood to or about the vicinity of a thrombus site.

Abstract: A kit of parts comprises a system and instructions for use for controlling patient temperature which uses a central venous line catheter having a heat exchange element. The central venous line catheter is provided with one or more lumens for providing access to the central blood supply of the patient, and with additional lumens for communicating heat exchange fluid to the heat exchange element. Heat exchange fluid temperature is controlled through a feed back loop in which patient temperature is sensed and used to control a temperature control unit comprising a heating device and/or a cooling device in heat exchange relationship with the heat exchange fluid. A tubing set transports the heat exchange fluid between the central venous line and the temperature control unit, with a pump serving to circulate the fluid in a closed fluid circuit in the system.

Abstract: Devices and methods for securing a catheter with the body of a patient are generally disclosed. In particular, selectively positionable cuffs and methods for attaching selectively positionable cuffs to long-term tunneled catheters are disclosed. In one embodiment, a slidable, selectively-positionable cuff comprises an adhesive on a foldable tab. In another embodiment, a slidable, selectively positionable cuff comprises an activatable adhesive that is convertible from a nonadherent state to an adherent state beneath the skin of the patient. Additionally, the present disclosure teaches a wrappable sheet comprising a harvested extracellular matrix with an adhesive positioned on a side thereon and arranged to be adhered to the surface of a catheter so as to form a cuff. Methods of securing and/or positioning a cuff on a catheter, kits, and other embodiments are disclosed.

Abstract: Torque shafts and other related systems and methods are described herein. In one embodiment, the torque shafts are both flexible and capable of transmitting torque. An apparatus for transmission of torque includes an elongate body, comprising a plurality of joint segments, each joint segment configured to pivot with respect to an adjacent segment and being further configured to have at least two link elements.

Abstract: In a method and system for planning and implementing a selective internal radiation therapy (SIRT), the liver volume and the tumor volume are automatically calculated in a processor by analysis of items segmented from images obtained from the patient using one or more imaging modalities, with the administration of a contrast agent. The volume of therapeutic agent that is necessary to treat the tumor is automatically calculated from the liver volume, the tumor volume, and the body surface area of the patient and the lung shunt percentage for the patient. The therapeutic agent can be administered via respective feeder vessels in respectively different amounts that correspond to the percentage of blood supply to the tumor from the respective feeder vessels, this distribution also being automatically calculated by analysis of one or more parenchymal blood volume (PBV) images.

Abstract: An intravenous catheter device and system includes: (a) a medical tubing connector at a first end of the intravenous catheter device; (b) a length of flexible, non-kinking, supported medical tubing, a first end of the non-kinking tubing being connected to a first end of the medical tubing connector; (c) an intravenous catheter portion having a first end attached to a second end of the non-kinking tubing, the non-kinking tubing extending between the intravenous catheter portion and the tubing connector; and (d) a cylindrical-shaped cuff attached to a fast outside end portion of the intravenous catheter portion, and a second outside end portion of the non-kinking tubing; wherein a central channel of the intravenous catheter portion is in fluid communication with a channel of the non-kinking, flexible tubing when the intravenous catheter device is in use. This simplified abstract is not intended to limit, and should not be interpreted as limiting, the scope of the claims.

Abstract: Embodiments of the present disclosure are directed to delivery devices, methods, and systems for delivering an implant to a target site. In one embodiment, a delivery device includes a core member defining a proximal end and a distal end and an outer winding defining a proximal end and a distal end, wherein the outer winding surrounds and is coupled to the core member. The outer winding extends at least partially between the proximal end of the core member and the distal end of the core member, and the outer winding is configured for displacement within a delivery catheter. The delivery device further includes a coupling member at the distal end of the core member configured to releasably attach to an implant.

Abstract: Methods and kits for delivering pharmaceutical agents to the adventitia and other regions outside the external elastic lamina (EEL) surrounding a blood vessel utilize a catheter having a needle. The needle is positioned in up to 5 mm beyond the EEL and delivers an amount of pharmaceutical agent sufficient to circumferentially permeate around the blood vessel and, in many cases, extend longitudinally and radially along the blood vessel. Confirmation that a delivery aperture of the needle lies beyond the EEL may be required before delivering the pharmaceutical agent.

Abstract: An improved, injection or blood removal device for intravenous access has a port with a septum at the exterior end of an intravenous catheter, a coupling element having an adhesive surface for securing attachment onto the skin, an injection or blood sampling unit, a connecting cannula piercing the septum of the port, and means to secure functional assembly. Attachment of the device to the skin covering or close to the intravenous puncture site and without long communicating tubes allows ambulant injection of drugs or measuring of concentration-time profiles of exogenous and endogenous analytes to improve treatment modalities on an individualized basis.

Abstract: A method of making catheters is disclosed in which the wall of the catheter has a porous structure for carrying additional agents, such as therapeutic agents, diagnostic agents and/or device enhancements. The method includes applying a base polymer material and an inert material over the outer surface of a core, and curing or consolidating the base polymer material to form a catheter having a porous polymer layer with the inert material contained within the pores thereof. The inert material can be applied with the base polymer material or in a separate step after the base polymer material has been partially cured or consolidated to form the porous polymer layer. Additional agents can be mixed with the inert material before it is applied to the catheter, or can be applied to the porous polymer layer of the catheter in a separate step after the inert material is removed therefrom.

Abstract: A catheter connection system and a method of connecting the catheter connection system to a catheter. The catheter connection system includes a hub assembly and a collar. The hub assembly includes a cannula extending from a distal end thereof, and a collet defining an inner surface spaced apart from the cannula to permit passage of a catheter wall between the body and the cannula.

Abstract: In general, multiple embodiments of a catheter/fistula needle to bloodline connection assurance device, which secures and strengthens a connection between an extension tube end of a catheter or fistula needle and a bloodline, are provided. A first embodiment of the assurance device is configured for use with a bloodline connector having locking clips which are biased slightly outwardly from the bloodline connector. The first embodiment of the assurance device includes clamshell halves that open rotatably about at least one hinge. The first embodiment of the assurance device includes an upper, threaded portion and a lower housing portion. The interior wall of the upper portion defines a plurality of barbs configured to engage with distal or moveable ends of the locking clips. Each locking clip is biased slightly outwardly to enable the distal or moveable end of the locking clip to fit between two respective barbs.

Abstract: In general, multiple embodiments of a catheter/fistula needle to bloodline connection assurance device, which secures and strengthens a connection between an extension tube end of a catheter or fistula needle and a bloodline, are provided. In one embodiment, the assurance device includes a clamshell having two halves that open rotatably about at least one hinge. The assurance device includes a male luer portion that pressure seals to the male luer portion of the bloodline connector. The bloodline male luer portion of the device extends to a female luer portion, which is lined with a compressible material that conforms around any industrial catheter/fistula needle connector when the assurance device is closed about the mated connectors. Once the assurance device is closed, this prevents axial movement of the bloodline connector relative to the assurance device.

Abstract: The invention relates to a calculation and control system for the determination of the state of a vascular access of a patient intended to follow successive sessions of extracorporeal blood treatment by extraction and return of the blood via the vascular access, the system comprising: means for determining the value of at least one hemodynamic extracorporeal parameter of the patient for at least two sessions; means for determining the value of the purification effectiveness of the treatment for at least two sessions; programmed means for determining a risk score relating to the state of the vascular access of the patient as a function of at least two values of the hemodynamic extracorporeal parameter and of at least two determined values of the purification effectiveness.

Abstract: An venous access catheter is combined with a needle, guidewire, and actuator where the needle is disposed coaxially over the guidewire and the catheter is disposed coaxially over the needle. A hub at a proximal end of the access catheter includes a wiping element to clean blood from the needle and guidewire as they are removed and a side port to allow connection of fluids after the access catheter is placed.

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: A shape memory material with integrated actuation using embedded particles. One embodiment provides a shape memory material apparatus comprising a shape memory material body and magnetic pieces in the shape memory material body. Another embodiment provides a method of actuating a device to perform an activity on a subject comprising the steps of positioning a shape memory material body in a desired position with regard to the subject, the shape memory material body capable of being formed in a specific primary shape, reformed into a secondary stable shape, and controllably actuated to recover the specific primary shape; including pieces in the shape memory material body; and actuating the shape memory material body using the pieces causing the shape memory material body to be controllably actuated to recover the specific primary shape and perform the activity on the subject.

Abstract: Methods and apparatus are provided for thermally-induced renal neuromodulation. Thermally-induced renal neuromodulation may be achieved via direct and/or via indirect application of thermal energy to heat or cool neural fibers that contribute to renal function, or of vascular structures that feed or perfuse the neural fibers. In some embodiments, parameters of the neural fibers, of non-target tissue, or of the thermal energy delivery element, may be monitored via one or more sensors for controlling the thermally-induced neuromodulation. In some embodiments, protective elements may be provided to reduce a degree of thermal damage induced in the non-target tissues.

Abstract: A single-use, single-patient, or patient-specific tubing set (300) is disclosed. The tubing set (300) includes at least one check valve (304), along with a use indicator (320). This use indicator (320) provides a visual indication when the tubing set (300) has been used for an injection. In this regard, a piston (340) moves from one position to another when exposed to a certain fluid pressure.

Abstract: The present invention relates to a method and device for removing solid matter from a brain and controlling bleeding associated with the removal of the matter. The method involves securing a cranial anchor to a region of the skull in which an opening has been created to expose brain matter and introducing through a passage defined by the anchor a channel member that displaces brain tissue and exposes the solid matter. After removing the solid matter, a flowable hemostat is introduced into the cavity created by removal of the matter. A balloon introduced into the working channel is then inflated to compress the hemostat against the wall of the cavity to control bleeding from blood vessels around the cavity. The device includes a cranial anchor, a channel member defining a working channel, an optional removable trocar, and a catheter for introducing the hemostat and the inflatable balloon into the cavity.

Abstract: The present invention relates to a safe and effective way to deliver and express therapeutic compositions (e.g., transgenes) to the pancreas and lungs of a mammal.

Abstract: Methods and apparatus for delivery of substances or apparatus to target sites located outside blood vessel lumens. A penetrating catheter is inserted into a blood vessel lumen and a penetrator is advanced from the catheter in the direction of the target site. Thereafter, a delivery catheter is passed through a lumen of the penetrator to the target site. A desired substance or apparatus is then delivered to or obtained from the target site. In some applications, the delivery catheter may remain in place for chronic or continuous delivery of substance(s) to and/or obtaining of information or samples from the target site. Alternatively, a delivery catheter having an occlusion member may be advanced into a vein or venule and used to occlude the lumen of the vein or venule during and after injection of a substance such that the substance will not be carried away by normal venous blood flow.

Abstract: Heat transfer catheter apparatus and methods of making and using same are disclosed wherein fluid connection means is provided between the distal portions of two adjacent, thin-walled, high strength fluid lumens to define a closed loop fluid circulation system capable of controlled delivery of thermal energy to or withdrawal of thermal energy from remote internal body locations.

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 thrombus treatment device includes a support wire, a body frame portion that is disposed about an axis defined by the support wire, one or more tethers that each have a first end and a second end, and a filter element extending from the body frame portion. Each of the one or more tethers is attached at its first end to the body frame portion, and at its second end to a collar that couples the second end of each of the multiple tethers to the support wire. When the collar is positioned substantially within a region interior of the body frame portion, a rotational actuation of the support wire causes a swiveling motion of the one or more tethers.

Abstract: At the present time, physicians often treat patients with atrial fibrillation (AF) using radiofrequency (RF) catheter systems to ablate conducting tissue in the wall of the Left Atrium of the heart around the ostium of the pulmonary veins. These systems are expensive and take time consuming to use. The present invention circular ablation system CAS includes a multiplicity of expandable needles that can be expanded around a central axis and positioned to inject a fluid like ethanol to ablate conductive tissue in a ring around the ostium of a pulmonary vein quickly and without the need for expensive capital equipment. The expansion of the needles is accomplished by self-expanding or balloon expandable structures. The invention includes centering means so that the needles will be situated in a pattern surrounding the outside of the ostium of a vein. Also included are members that limit the distance of penetration of the needles into the wall of the left atrium.

Abstract: Distal access aspiration guide catheter system and methods for delivering implantable devices, catheters, or substances in or near and/or restoring flow through body lumens, such as blood vessel lumens are described. A Distal access aspiration guide catheter having a proximal, medial, and distal possessing high flexibility, high resistance to kinking and a large lumen to wall thickness ratio.

Abstract: A system for moving particles suspended in a first fluid, and for infusing them into the stream of a second fluid, includes a catheter with a multi-lumen distal tip. The tip is formed with a plurality of parallel lumens, wherein each lumen has a predetermined diameter. Importantly, the diameter of each lumen is dimensioned to sequentially receive particles therethrough, to prevent the particles from flocculating before they enter the stream of the second fluid. A valve, affixed to the outside of the catheter, can be provided to regulate flow of the second fluid and thereby facilitate entry of the particles into the stream of the second fluid.

Abstract: The disclosed devices and methods provide for the minimization of fluid extravasation during use of infusion catheters such as peripherally inserted central catheters and central venous catheters. The anti-extravasation catheter allows a surgeon to drain fluids from soft tissue surrounding an infusion site while also providing fluid inflow to a patient.

Abstract: A method and device for adjusting the unstored length of tubing directed to improving the use of infusion sets that deliver fluids to a user. The device includes a storage module and other features for adjusting, storing and securing the length of the tubing. The method of adjusting the length of the tubing to a desired length typically comprises removably attaching the tubing to the adjuster, adjusting the tubing by wrapping the tubing around a hub or post of the adjuster, and fixing the length of the unstored tubing by attaching the tubing to a securing device such as a friction structure or fastener.

Abstract: An infusion set (101) includes a base (111) and an inserter (121) removably connected to the base (111). A catheter (134) is movable from a first catheter position disposed substantially entirely within the inserter (121) to a second catheter position? in which a free end of the catheter (134) is disposed externally of the base (111). An introducer needle (142) is located within the catheter (134) and is movable with the catheter (134) between a first introducer needle position disposed substantially entirely within the inserter (121) and a second introducer needle position in which a free end of the introducer needle (142) is disposed externally of the base (111). A spring member (171) moves the catheter (134) from the first to the second catheter position and the introducer needle (142) from the first to the second introducer needle position to facilitate insertion of the catheter (134).

Abstract: Catheters with laminar flow bioactive agent delivery properties and methods of using for treating or preventing vascular disease are disclosed.

Abstract: The invention describes a method of treating upper airway disease by administering a composition of one or more proinflammatory cytokine inhibitors sufficient to inhibit inflammation in the upper airways. The proinflammatory cytokines that are inhibited include TNF, IL-1 and IL-8. A medication dispensing unit which includes a container and a delivery system is used to administer the composition. The delivery system further encompasses a one-way valve, a microcatheter, or a liquid-pressure type sprayer.

Abstract: A renal flow system injects a volume of fluid agent into a location within an abdominal aorta in a manner that flows bi-laterally into each of two renal arteries via their respectively spaced ostia along the abdominal aorta wall. A local injection assembly includes two injection members, each having an injection port that couples to a source of fluid agent externally of the patient. The injection ports may be positioned with an outer region of blood flow along the abdominal aorta wall perfusing the two renal arteries. A flow isolation assembly may isolate flow of the injected agent within the outer region and into the renals. The injection members are delivered to the location in a first radially collapsed condition, and bifurcate across the aorta to inject into the spaced renal ostia. A delivery catheter for upstream interventions is used as a chassis to deliver a bilateral local renal injection assembly to the location within the abdominal aorta.

Abstract: A syringe assembly comprises a syringe barrel having an elongated body defining a chamber for retaining fluid, an open proximal end, a distal end and a frusto-conically shaped tip extending from the distal end and having a passageway therethrough in fluid communication with the chamber. The chamber has an inside diameter of at least 13.5 mm. A stopper is in fluid-tight engagement inside the barrel. An elongated plunger rod extends proximally from the stopper through the open proximal end of the barrel. A flange is positioned at the proximal end of the plunger rod. The flange is shaped and positioned to limit the distal motion of the plunger rod in the barrel by contacting the proximal end of the barrel. A tip cap is releasably connected to the tip for sealing the passageway and the chamber contains injectable liquid.

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: Disclosed herein are various embodiments of catheters configured to reduce, minimize or prevent occlusion of blood flow resulting from thrombus or fibrin sheath formation, related systems, and methods of use.

Abstract: A device for delivering fluid to a user includes a housing, a drive motor assembly in the housing, a force sensor, and an electronics module. The drive motor assembly regulates delivery of fluid by actuating a piston of a fluid reservoir, and the force sensor generates output levels in response to force imparted thereto during, for example, fluid delivery operations. The electronics module processes the output levels of the force sensor to assess the operating health of the force sensor, to check for occlusions in the fluid delivery path, and to monitor the seating status of the fluid reservoir.

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: Systems, methods, and articles for delivering an antimicrobial composition to the proximal elements of a trans-dermal catheter and into the lumen of the transdermal catheter are disclosed. In an embodiment, an antimicrobial composition placed on an interior surface a cap element, and transfers antimicrobial to the exterior of the proximal end of the transdermal catheter. The system comprises an elongate member configured for insertion into a lumen of a catheter, the elongate member containing an antimicrobial.

Abstract: Devices, methods, and assemblies for perfusion therapy including cerebral perfusion therapy such as those for use in the treatment of acute ischemic stroke. The treatment includes delivery of blood to or about the vicinity of a thrombus site.

Abstract: Systems, methods, and articles for delivering an antimicrobial composition into the lumen of a trans-dermal catheter and to proximal elements of the transdermal catheter are disclosed. In an embodiment, the system comprises an elongate member configured for insertion into a lumen of a catheter, the elongate member containing an antimicrobial. In an alternative embodiment, an antimicrobial composition placed on an interior surface a cap element, and transfers antimicrobial to the exterior of the proximal end of the transdermal catheter.

Abstract: Systems, devices and methods for delivery of a chemical substance to the body of the patient are provided. Such embodiments may include an infusion catheter configured to be inserted into tissue, a catheter securing element configured to be adhered to the skin of the patient and further configured to secure the infusion catheter to the skin, a drug delivery pump configured to infuse a drug into the infusion catheter for delivery to a drug infused region on the body of the patient, and a treatment element configured to apply a treatment to the drug infused region to improve pharmacodynamics of the drug during a period of delivery of the drug to the patient.

Abstract: The present application relates to high flow rate isolated regional treatment of cancer and proliferative disorders and conditions. For example, provided are methods, systems and devices for treating a cancer in a region of a subject using high flow rate isolated infusion.

Abstract: The invention provides a device for extracorporeal photo-isomerization of bodily fluid containing bilirubin. The bodily fluid derives from a patient suffering from an elevation of unconjugated bilirubin. The device includes a sterile tubing which accesses the patient's bodily fluids (especially blood), routes the fluid into an extracorporeal chamber within which irradiation of bodily fluids takes place, and returns bodily fluids to the patient. Bodily fluids are continuously circulated through a single length of sterile tubing using an adjustable pump to regulate the flow, and as the fluid passes into the extracorporeal chamber it is irradiated by blue light within the chamber with an emission wavelength range of approximately 450 to 530 nm. This irradiation induces a photochemical reaction in bilirubin that changes its structure and facilitates improved excretion of bilirubin once it is returned to the patient. The extracorporeal photo-isomerization turns the bilirubin into a more readily excreted form.

Abstract: An implantable system for monitoring a hydration state of a patient and adjusting fluid removal from the patient includes a pressure sensor implantable within an inferior vena cava of the patient and a processor. The pressure sensor senses and generates an output representative of a baseline inferior vena caval pressure value of the patient and chronically senses and generates outputs representative of an inferior vena caval pressure value of the patient. The processor compares differences between the baseline inferior vena caval pressure value and subsequent inferior vena caval pressure values. The processor can reside in another implantable device or in an external device/system.

Abstract: An impedance spectroscopy system for monitoring ischemic mucosal damage in hollow viscous organs comprises a sensor catheter and an impedance spectrometer for electrically driving the catheter to obtain a complex tissue impedance spectrum. Once the catheter is in place in one of a patient's hollow viscous organs, the impedance spectrometer obtains the complex impedance spectrum by causing two electrodes in the tip of the catheter to inject a current into the mucosal tissue at different frequencies, while two other electrodes measure the resulting voltages. A pattern recognition system is then used to analyze the complex impedance spectrum and to quantify the severity of the mucosal injury. Alternatively, the complex impedance spectrum can be appropriately plotted against the spectrum of normal tissue, allowing for a visual comparison by trained personnel.