Abstract: This disclosure relates to drug delivery devices and related systems and methods. In certain aspects, a drug delivery device includes a pump extending from a surface of the drug delivery device and a door that includes a spring-loaded member exposed along its inner surface. The fluid line can be compressed between the spring-loaded member and the pump in a manner such that the fluid line is occluded in at least one location.

Abstract: Systems and methods for selective cooling of a target site include a catheter having a supply lumen and a delivery lumen, with inlet and exit ports. Blood is withdrawn from the supply lumen and cooled or heated in a control unit. The treated blood is sent to the targeted area via delivery lumen. The supply lumen can act as an insulator for the delivery lumen.

Abstract: The invention provides a multi-port fluid access device for medical use, such as in a blood-flow circuit during dialysis. The device has a main tubular body and a needle access port and a needleless access port located at positions axially offset from each other. Each port has a tubular body with a septum sealing the passageway to the main fluid channel of the main tubular body. Alongside the main tubular body are members providing finger-gripping surfaces at or near the axial position of the needle access port. There is also a needle shield located between the finger gripping surfaces and the needle access port. Use of the device permits either or both of needle access and needleless access to a patient's blood during dialysis.

Abstract: The present invention is directed to devices, systems and methods for removing undesirable materials from a sample fluid by contact with a second fluid. The sample fluid flows as a thin layer adjacent to, or between, concurrently flowing layers of the second fluid, without an intervening membrane. In various embodiments, a secondary separator is used to restrict the removal of desirable substances and effect the removal of undesirable substances from blood. The invention is useful in a variety of situations where a sample fluid is to be purified via a diffusion mechanism against an extractor fluid. Moreover, the invention may be used for the removal of components from a sample fluid that vary in size. When blood is the sample fluid, for example, this may include the removal of ‘small’ molecules, ‘middle’ molecules, macromolecules, macromolecular aggregates, and cells, from the blood sample to the extractor fluid.

Abstract: The invention concerns a device for the extracorporeal irradiation of a patient's (P) bodily fluid containing bilirubin, comprising a first (10) and a second (12) line which can be connected to the patient (P), an impermeable irradiation unit for bodily fluids (14) connected therewith and located between the first (10) and the second (12) lines, and at least one adjustable feed unit for bodily fluids (16) located in the first (10) and/or the second (12) line, wherein by means of at least one feed unit for bodily fluids (16) an adjustable flow of bodily fluid through the lines (10, 12) and the irradiation unit for bodily fluids (14) is achievable, in which the first line (10) is designed to continually circulate the bodily fluid drawn from the patient (P) and route it to the irradiation unit for bodily fluids (14), and the second line (12) is designed to continually circulate the irradiated bodily fluid to the patient (P), and in which the irradiation unit for bodily fluids (14) contains an radiation source fo

Abstract: A medical device for insertion into a body having a surface covered by a detachable cover. The cover may be detached from the surface and removed from the body while the device is inserted in the body. The device may be, for example, a catheter, cannula, drain, stent, pacemaker, or electrode.

Abstract: An implantable access post having a port casing core with an aperture therethrough, a patch associated with the port casing core, the patch adapted to be sewn to a vessel to connect the port casing core to the vessel to permit fluid communication from the vessel through the aperture of the port casing core, and an insert disposed within the aperture of the port casing core, the insert adapted to prevent fluid flow through the aperture. The insert may be self-sealing and may include a valve. The port may also include a port outer casing at least partially surrounding the port casing core and further including an anti-vessel-compression mechanism.

Abstract: A method for preventing contrast associated nephropathy includes the steps of providing a multi-lumen dual balloon catheter and inserting the catheter into a patient's coronary sinus. The method also includes the steps of inflating the two balloons to block blood flow from the coronary sinus into the right atrium and draining blood containing contrast solution from between the two balloons through the catheter while the blood flow is blocked. A hemo filtration unit is used to remove contrast solution from the drained blood and the filtered blood returned to the right atrium. A multi-lumen dual balloon catheter is also disclosed.

Abstract: A heart assist device connection system comprises an inflow connector in fluid-tight communication with an inflow section of a heart assist device. The connector is configured to be releasably connected to an inlet extension inserted into a patient's ventricle. The connector has one or more recesses configured to match a protrusion on the inlet extension. The system also comprises an outflow connector in fluid communication with an outflow section of the heart assist device. The outflow connector is configured to be releasably connected to a conduit attached-to the patient's vasculature.

Abstract: A system is disclosed for removing gas bubbles from blood during circulatory assist procedures. Such bubbles are generated, along with particulate matter, in an extracorporeal circulatory bypass system by the pump, oxygenator and other components. Filters are used in the line to remove particulates and bubbles from the blood before they are pumped back to the patient but current filters are inefficient at removing small bubbles and debris that can cause neurological defects and renal and other organ failures in the patient. An active filter apparatus and method is disclosed that forces the bubbles to the center of the system where they are removed from the blood before the blood exits the filter. The filter comprises an axially elongate cylindrical shell with a blood inlet, a blood outlet and a gas outlet.

Abstract: Methods, devices and device components are presented for blood processing. Particularly, methods, devices and device components are presented for separating blood into blood components and collecting one or more separated blood components, which reduce the incidence of blood vessel infiltration and enhance donor comfort. In one aspect, the invention provides blood processing methods having a return flow rate which decreases systematically during a return time. In another aspect, the invention provides blood processing methods having a removal flow rate, return flow rate or both which are derived from a subject's total blood volume. In another aspect, the present invention provides blood processing methods wherein the fraction by volume of removed blood corresponding to collected components is selected to optimize blood processing efficiency and enhance the purities of collected blood components.

Abstract: A medical clamping assembly includes a housing defining a chamber and a deflecting member operable to slide relative to the housing between a first position and a second position. A conduit is also provided within the housing and is adapted for fluid coupling to a medical device. The medical clamping assembly also includes a biasing element disposed within the housing adjacent to the conduit. The deflecting member is movable relative to the housing between the first position corresponding to an open state of the conduit and the second position corresponding to a closed state of the conduit whereby the biasing element compresses the conduit to substantially close a lumen of the conduit.

Abstract: Vascular catheters are provided that comprise a catheter shaft having one or more lumens. The catheter shaft comprises a polycarbonate polyurethane and bismuth oxychloride.

Abstract: A catheter apparatus is provided for reducing blood clotting in connection with hemodialysis treatment. The catheter apparatus can comprise a first conduit defining an arterial lumen and a second conduit defining a venous lumen. Large staggered apertures can be provided in side walls of the conduits with at least one of the apertures having a cross-sectional area equal or greater than a cross-sectional area of one of the lumens. The catheter apparatus can further include first and second removable obturators adapted for axial insertion into the conduits and for occluding the apertures while so inserted. Advantageously, the obturators can wipe the apertures during removal, causing blood clots incident on the apertures to be dislodged from the apertures. Related methods for using the catheter apparatus in performing hemodialysis treatment are also provided.

Abstract: Systems and methods for selective cooling of a target site include a catheter having a supply lumen and a delivery lumen, with inlet and exit ports. Blood is withdrawn from the supply lumen and cooled or heated in a control unit. The treated blood is sent to the targeted area via delivery lumen. The supply lumen can act as an insulator for the delivery lumen.

Abstract: The joint (36) comprises a tubular body (37) having two connecting zones (38, 39) each connected by an end to a tubular element (40) of a fluid transport line, giving continuity to passage of fluid. The tubular body is made of a mixture of an electrically-conductive material such as PVC, with carbon black to give it electrical conductivity. The joint has an internal surface (41) which is destined to come into contact with the transported fluid, and an external surface which is destined to have a grounded galvanic contact. The joint is inserted in the discharge fluid drainage line of a dialyzer filter, in an apparatus for intensive treatment of acute renal insufficiency, for eliminating ECG artefacts due to functioning of peristaltic pumps in the apparatus.

Abstract: A single needle hemodiafiltration apparatus is provided. The single needle hemodiafiltration apparatus includes circuits for blood supply from a patient and blood return to a patient, a dialysis fluid supply system for supplying a dialysis fluid, and a system for controlling the blood flow and dialysis fluid flow in a separation device which is equipped to perform filtration and back-filtration operations. A controller is provided that controls, in a series of coordinated operations, the flow of blood from the patient into the separation device, the flow of filtration fluid and back filtration fluid, and the return of blood to the patient.

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 to be compatible with any industrial catheter/fistula needle female luer connector and is specifically 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 is cylindrical and 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.

Abstract: A hemodialysis catheter assembly adapted for use in a subcutaneous tunneling procedure incorporates a mechanism for securing the catheter hub member to the elongated catheter, and to provide the requisite fluid communication between fluid passages within the hub and the catheter lumens within the catheter. The catheter hub member may be connected to the elongated catheter after implantation of the catheter via a subcutaneous tunneling procedure.

Abstract: The invention relates to a microdialysis catheter comprising a multilumen tube (10) and a membrane (11), said tube exhibiting at least two longitudinally arranged inner channels (13,14), said channels extending from a proximal (20) end of the tube to the distal end (21) of the tube, whereat through-holes (12,15) are provided, one from each of said at least two channels to the outside of said tube, said channels (13,14) blocked for passage of liquid distally of the respective through-holes, a tubular membrane (11) arranged circumferentially around the tube (10) such as to cover the at least two through-holes (12,15), said membrane is sealingly fastened (22) to the tube thereby forming a dialysis chamber (18) between the tube and the membrane.

Abstract: A cannulation system (10) for perfusing a patient's circulatory system, includes an inflow cannula (14) having a first end adapted to be connected to said circulatory system and a second end adapted to be connected to a blood pump (19), an outflow cannula (23) having a first end adapted to be connected to the blood pump (19) and a second end adapted to be connected to said circulatory system at a location downstream of the first end of the inflow cannula. The flow of blood from the pump (19) is in series with the normal blood flow of the circulatory system of the patient and creates a localized region of hypertension.

Abstract: A multilumen catheter assembly and method of making the catheter assembly is provided that involves providing a plurality of tubes, each tube having a first end, a second end, at least one lumen, and at least one surface, selectively heating at least a portion of the surface of at least a first tube of the plurality of tubes, and contacting the selectively heated portion of the tube with a portion of the surface of a second tube to form a multilumen catheter shaft that is joined together along at least a portion of the length of the catheter shaft.

Abstract: Ports for accessing a vessels within a patient include passageways that can guide needles or other access devices directly into the vessels. The ports can be implanted subcutaneously within a patient. Some ports may be used in the creation and use of vascular access buttonholes.

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 process comprises the phases of: activating a pusher, which exerts a push force on a plunger of a syringe containing the infusion liquid; measuring the push force by means of a load cell; comparing the push force with a maximum threshold; halting the pusher when the maximum threshold is exceeded; after a predetermined pause, restarting the pusher and emitting a consent signal indicating correct loading of the syringe if, within a certain time from the restart, the push force again exceeds the maximum threshold. The infusion device serves to inject an anticoagulant into an extracorporeal blood circuit. The control process guarantees against loss of infusion due to an incorrect initial loading of the syringe.

Abstract: A sensor and a lancet are integrated with each other. A thin strip-shaped sensor and a lancet are integrated so that the lancet moves in parallel, along a longitudinal direction of the sensor. A measuring device to which an integrated lancet and sensor is attached is provided with a function of driving the attached lancet.

Abstract: The present invention relates to a device for controlling a system for transporting blood, and a method for transporting blood in a blood line of an extracorporeal blood circuit of an extracorporeal blood treatment system. The present invention also relates to an extracorporeal blood treatment device comprising such a system for transporting blood. The method and device according to the present invention are based on the fact that a defined threshold value for the pressure in the blood line should not be exceeded. The system for transporting blood is controlled in such a way the blood in the blood line is transported in a pre-determined volume flow as long as the pressure in the blood line is below the pre-determined threshold value. When the pressure in the blood line reaches the pre-defined threshold value, however, the system for transporting blood is controlled such that a pressure value corresponding to the threshold value is set when the blood is transported in the blood line.

Abstract: A multilumen venous access catheter and method of use and repair is provided. The catheter has a means for identifying at least one physical characteristic of an arterial tube and a means for identifying at least one physical characteristic of a venous tube. The at least one physical characteristic of the respective arterial and venous tubes are different in order to allow a user to distinguish between the arterial and venous catheter tubes during use, manufacture, and repair.

Abstract: The invention relates to a blood line (108) comprising an infusion site (145) intended to inject into the line a solution, comprising: —a first main channel (200) having a first passage section, —a second main channel (220) having a second passage section, —means for the formation (210) of a turbulence area located downstream from the first main channel, located upstream from the second main channel, these formation means comprising a first fluid passage means (224) defining a reduction (225) in the passage section and whose smallest passage section is smaller than the first passage section and smaller than the second fluid passage section, —a secondary channel (230) comprising an inlet (231) for letting in the solution and an outlet (232) in fluid communication with the first main channel or the means for the formation of a turbulence area or the second main channel.

Abstract: Methods and systems are described for creating chronic vascular access or hemodialysis. These methods and systems eliminate the insertion of needles which are now required for using the available methods of obtaining vascular access. Thus multiple complications due to needle insertion through skin, tissue, and vein or graft wall are prevented. A low-profile stable transcutaneous implant's external surface and stability minimizes infection. The implant is readily joined to a connector device that functions substantially automatically and which provides high blood flow volumes for hemodialysis.

Abstract: Catheters used for medical treatment, e.g., hemodialysis are filled with a locking solution, usually heparin between treatments. To prevent infections, antimicrobial or antibiotic substances have been used as locking solution alone or in combination with antithrombotic substances. It has been found that these locking solutions are rapidly washed out from the catheter tip. The invention describes a thixotropic gel that can be used as locking solution. Beneficial substances, e.g., antimicrobial or antibiotic substances can be added to the gel. A preferred antimicrobial substance is taurolidin alone or in combination with salicylic acid or one of its salts.

Abstract: Catheters used for medical treatment, e.g., hemodialysis are filled with a locking solution, usually heparin between treatments. To prevent infections, antimicrobial or antibiotic substances have been used as locking solution alone or in combination with antithrombotic substances. It has been found that these locking solutions are rapidly washed out from the catheter tip. The invention describes a thixotropic gel that can be used as locking solution. Beneficial substances, e.g., antimicrobial or antibiotic substances can be added to the gel. A preferred antimicrobial substance is taurolidin alone or in combination with salicylic acid or one of its salts.

Abstract: An improved intravascular blood pump and related methods involving the broad inventive concept of equipping the intravascular blood pump with guiding features such that the intravascular blood pump can be selectively positioned at a predetermined location within the circulatory system of a patient.

Abstract: The invention relates to support element (4) comprising a main body (6) having a front wall (25) and a peripheral wall (32) projecting away from the front wall. The front wall and the peripheral wall define a housing compartment (33) designed to receive a fluid distribution circuitry cooperating with a treatment unit for defining an integrated blood treatment module.

Abstract: This invention relates to a method for checking the correct coupling of an adding device to a therapeutic appliance, which includes an extracorporeal circuit with which the adding device is connected such that a drug can be introduced into the extracorporeal circuit by means of the adding device during operation of the therapeutic appliance, wherein the adding device is coupled to the extracorporeal circuit on the suction side of a pump disposed in the extracorporeal circuit, wherein a portion in the region of negative pressure of the extracorporeal circuit in connection with a portion of the adding device is closed with respect to the other parts of the extracorporeal circuit, and wherein the pressure in this closed portion is varied and measured.

Abstract: A system, including catheter apparatus, and related method for performing site specific therapy. The catheter apparatus can include one or more semipermeable microcatheters for use in performing site specific microdialysis. The system and method are particularly suited for use in addressing cerebral edema by affecting the osmolar relationship between fluids making up the brain tissue. Also disclosed is an apparatus having a delivery/recovery mechanism in the form of a pump reservoir and one or more catheters in the form of semipermeable microcatheters, for use in delivering and/or recovering fluid to and/or from a tissue site or for performing tissue engineering outside of the body. The apparatus can be used in a method to perform site specific microtherapy, including for the treatment of avascular necrosis, compartment syndrome, cerebral edema, and to improve skin flap survival in the course of reconstructive surgery.

Abstract: An assembly includes at least two medical treatment units, each of which can be allocated to a patient and at least two peripheral devices, each of which can be allocated to a patient. The peripheral devices and the treatment units have means for allocating a peripheral device to a treatment unit and means for verifying the allocation of a peripheral device to a patient. To allocate a peripheral device to a treatment unit, the peripheral device is placed by operators in a receiving unit belonging to the treatment unit. Said receiving unit is preferably designed as a charging station for the battery of the peripheral device. In the event of a successful allocation of peripheral device and patient, confirmed by the receipt of physiological data of the patient, the operators verify the correct allocation of a peripheral device to the patient and must confirm the correct allocation by confirmation means.

Abstract: A measurement method for determining the blood flow rate QF in blood carrying lines is provided. It may be used in particular to determine the blood flow in a patient's vessel, which is connected to the extracorporeal circulation of a blood treatment machine by an arterial line and a venous line. According to the method, the net rate dX/dt of a variable X is determined, with X being derived from a physicochemical variable Y of the blood with the help of values YA and YV which are adequately constant over time and which respectively characterize the physicochemical property in the arterial line and the venous line during the measurement interval. The net rate dX/dt is then used to determine the blood flow rate QF. The targeted use of indicators is not necessary.

Abstract: Systems and methods for selective cooling or heating of a target site in the human body include a catheter having a supply elongated element and a delivery elongated element, with inlet and exit ports. Blood is withdrawn from the supply elongated element and cooled or heated in a control unit. The treated blood is sent to the targeted area via delivery elongated element. The supply elongated element can act as an insulator for the treated blood in the delivery elongated element.

Abstract: A sensor and a lancet are integrated with each other. A thin strip-shaped sensor and a lancet are integrated so that the lancet moves in parallel, along a longitudinal direction of the sensor. A measuring device to which an integrated lancet and sensor is attached is provided with a function of driving the attached lancet.

Abstract: A dialysis catheter includes an elongate catheter member having an outer wall member defining proximal and distal end regions and a longitudinal axis, and defining first and second longitudinal lumens. The outer member includes first and second ports in respective fluid communication with the first and second longitudinal lumens. The first opening and the first lumen define an inflow passage for removal of blood under vacuum for circulation within a hemodialysis machine. The second opening and the second longitudinal lumen define an outflow passage for return of the blood from the hemodialysis machine. A valve is disposed relative to the outer member proximal of the first port. The valve is adapted to move from a closed position to an open position in response to a predetermined vacuum pressure level realized within the first longitudinal lumen to permit flow of blood through the valve and into the first longitudinal lumen.

Abstract: The present invention provides a heart-lung machine which can be carried by one person and can be used independently from an external power supply, consisting of at least three modules (1, 2, 3), wherein a first module (1) contains the blood circulating elements which are necessary for the function of a heart-lung machine, a second module (2) contains a pump drive (9) and an electronic measuring equipment and a control logic (11) and a third module (3) contains the programming unit (14), whereas the second unit is separably connected to the first and the third module.

Abstract: A hemodialysis catheter is provided with an exterior surface that has two or more lumens, wherein at least one large hole extends through the exterior surface for dialysis and at least one small hole extends through the exterior surface, in proximity to the large hole. A first lumen serves as a blood outflow path from the arteriovenous system and a second lumen serves as an inflow path for blood to be returned to the system. The large holes provide for blood exchange and the small holes are strategically placed in proximity to and around the large holes and may comprise an angled wall so as to allow for a jetting of blood or a sterile solution at high force over the surface of the catheter that strips off the biofilm as it is formed on the exterior surface of the catheter.

Abstract: A method and apparatus for controlling blood withdrawal and infusion flow rate with the use of a pressure controller. The pressure controller uses pressure targets based upon occlusion limits that are calculated as a function of flow. The controller has the ability to switch from controlling withdrawal pressure to controlling infusion pressure based upon the detection of an occlusion. The controller distinguishes between partial and total occlusions of the withdrawal vein providing blood access. Depending on the nature of occlusion, the controller limits or temporarily reverses blood flow and, thus, prevents withdrawal vessel collapse or reverses blood flow to quickly infuse blood into the vessel without participation from operator.

Abstract: In renal haemodialysis there is a condition whereby the patient can by at serious risk of harm if the venous line becomes disconnected or the venous needle becomes dislodged and the haemodialysis machine does not detect this condition. The invented device is designed to safeguard haemodialysis patients from serious losses of blood through venous line disconnection or venous needle dislodgement. The invented device is designed to clamp the venous line automatically before venous needle dislodgement or venous line disconnection becomes a serious problem and to make the haemodialysis machine stop drawing blood from the patient This will cause the haemodialysis machine to alarm in the normal way so as to alert the patient or healthcare worker to the problem. The invented device will have to be manually reset before therapy can continue.

Abstract: A blood line connector for a blood circuit of a hemodialysis unit with an ability to make two different types of fluid tight connections, e.g., a screw-type connection with a luer connector at a patient access and a press-in type connection with a dialysate circuit. The blood line connector may include a tube connection end arranged to sealingly engage with a blood circuit tube, and a patient access connection end with a frustoconical member having an internally threaded portion arranged to engage with an externally threaded patient access, and a pair of locking arms extending rearwardly from the frustoconical member. The locking arms may each have a finger depression portion and a barbed portion, and may be arranged to engage with a mating connector on the dialysis unit at the barbed portions to lock the frustoconical member in sealing engagement with the mating connector when making a press-in type connection.

Abstract: The invention relates to a method for priming a blood tubing set comprising a venous and an arterial line whose connections at the patient side are in communication with two separate inlets of a chamber of in particular a bag and whose connections at the machine side are in communication with a dialyzer comprising the steps: parallel filling of both the venous and the arterial line via a feed line so that priming liquid flows through both inlets into the chamber; and circulation of the priming liquid in the circuit of the lines, the dialyzer and the chamber via a pump so that one of the inlets of the chamber acts as an inlet and the other as an outlet. The invention likewise comprises a corresponding blood tubing set and a bag as well as methods for providing them.

Abstract: A catheter assembly includes catheter having proximal and distal ends and at least one lumen extending between the ends. At least one end of the catheter is formed from a material that can be trimmed to achieve a selected length for the catheter. A tubular connector is telescoped over the catheter and a hub is joined to the tubular connector. Proximal portions of the hub are configured for connection to a medical apparatus. A cuff is mounted around the tubular connector or the catheter. The cuff is formed from a material that will permit or promote the growth of scar tissue for anchoring the catheter device at least on a semi-permanent basis in a patient.

Abstract: Novel devices which can be used to both collect blood samples from and administer medical fluids to a patient on a repeated and continual basis using one rather than multiple needle insertions. The device typically includes a main tubing segment confluently connected to a cannula for insertion in the patient's vein. A syringe port and a volumeter for collecting blood branch separately from the main tubing segment. The device is used to collect blood by attaching an empty blood collection syringe to the syringe port, inserting the cannula in the patient's vein, allowing passive flow of blood from the main tubing segment into the volumeter under intrinsic venous blood pressure and capillary action, and then facilitating active flow of blood from the volumeter into the blood collection syringe by extending the syringe plunger. The device may be used to administer medical fluids to the patient through the main tubing segment from a medical fluid syringe or catheter attached to the syringe port.

Abstract: A self expanding cannula with improved drainage properties based upon its greater length is provided, along with methods of using the cannula in cardiopulmonary bypass.