Abstract: The delivery system of the present invention is comprised of at least two chambers which store, individually, an activated blood component and an inactivated blood component. The first chamber comprises an activating agent and a filter which may be one in the same thus allowing the formed clot to be triturated thereby isolating the thrombin from the clot. The second chamber stores the inactivated blood component that when mixed with thrombin will produce a gel. The first or second chamber may further contain agents which are desired to be delivered to a specific site. The unique design of the delivery system allows for ease in operation of combining two agents at a specific time and place.

Abstract: A medical device system including a physiological sensor and ultrafiltration unit senses a physiological signal in a patient and computes a fluid status measurement of the patient using the physiological signal. Ultrafiltration therapy is delivered to the patient according to a therapy delivery control parameter established in response to the fluid status measurement.

Abstract: An apparatus is disclosed that allows for separating and collecting a fraction of a sample. The apparatus, when used with a centrifuge, allows for the creation of at least three fractions in the apparatus. It also provides for a new method of extracting the buffy coat phase from a whole blood sample. A buoy system that may include a first buoy portion and a second buoy member operably interconnected may be used to form at least three fractions from a sample during a substantially single centrifugation process. Therefore, the separation of various fractions may be substantially quick and efficient.

Abstract: The present disclosure provides apparatus and methods for removing thrombus outside of a hemodialysis. The hemodialysis catheter comprises an elongate shaft comprising a plurality of lumens. A first lumen has a first distal port. The first lumen is configured for the flow of a fluid in a first direction. A second lumen has a second distal port proximal to the first distal port. The second lumen is configured for the flow of the fluid in a second direction opposite to the first direction. A third lumen has a third distal port proximal to the second distal port. An elongate device is disposed through the third lumen. The elongate device has an operable member on a distal end or a device to connect to an operable member disposed on the elongate shaft. The operable member is configured to engage and remove thrombus from an exterior surface on the elongate shaft.

Abstract: A system for harvesting a fibrin clot and depositing that fibrin clot into a wound site during a surgical procedure, the system comprising: (i) blood drawing apparatus for drawing blood; (ii) extraction apparatus for extracting fibrin from blood so as to form a fibrin clot; (iii) configuring apparatus for molding, cutting and shaping the fibrin clot into a desired configuration; and (iv) dispensing apparatus for reliably and controllably dispensing the fibrin clot at a selected location in the body.

Abstract: A method and a device to increase the efficiency of dialysis for the removal from blood of substances that are more or less tightly bound to carriers such as albumin. According to the invention this is accomplished by a simultaneous significant increase of the flow rate of the dialysis fluid and of the area of the membrane that separates the blood from the dialysis fluid, compared to conventional dialysis.

Abstract: The invention concerns a method of collecting a biological fluid, in particular blood, with an anticoagulant and/or preservation solution added, in which the biological fluid is collected by natural flow and the anticoagulant and/or preservation solution is added by pumping, the method making provision for measuring the flow of fluid collected and slaving the pumping speed to the measured flow, so as to obtain continuously during collection a given ratio between the quantity of fluid collected and the quantity of anticoagulant and/or preservation solution added. The invention also concerns a collection machine and bag system for implementing the method.

Abstract: A blood treatment device provides a photopheresis treatment using a microfluidic separation channel to separate blood components into layers The layering caused by laminar flow in the microfluidic separation channel allows light to be projected through plasma onto leukocytes without hindrance by erythrocytes

Abstract: A multipurpose hemofiltration system and method are disclosed for the removal of fluid and/or soluble waste from the blood of a patient. The system continuously monitors the flow rates of drained fluid, blood, and infusate. When necessary, the pumping rates of the infusate, drained fluid and blood are adjusted to remove a preselected amount of fluid from the blood in a preselected time period. A supervisory controller can monitor patient parameters, such as heart rate and blood pressure, and adjust the pumping rates accordingly. The supervisory controller uses fuzzy logic to make expert decisions, based upon a set of supervisory rules, to control each pumping rate to achieve a desired flow rate and to respond to fault conditions. An adaptive controller corrects temporal variations in the flow rate based upon an adaptive law and a control law.

Abstract: A method to treat cancer uses ultrapheresis, refined to remove compounds of less than 120,000 daltons molecular weight, followed by administration of replacement fluid, to stimulate the patient's immune system to attack solid tumors. In the preferred embodiment, the patient is ultrapheresed using a capillary tube ultrafilter having a pore size of 0.02 to 0.05 microns, with a molecular weight cutoff of 120,000 daltons, sufficient to filter one blood volume. The preferred replacement fluid is ultrapheresed normal plasma. The patient is preferably treated daily for three weeks, diagnostic tests conducted to verify that there has been shrinkage of the tumors, then the treatment regime is repeated. The treatment is preferably combined with an alternative therapy, for example, treatment with an anti-angiogenic compound, one or more cytokines such as TNF, gamma interferon, or IL-2, or a procoagulant compound. The treatment increases endogenous, local levels of cytokines, such as TNF.

Abstract: An apparatus that allows for separating and collecting a fraction of a sample. The apparatus, when used with a centrifuge, allows for the creation of at various fractions in the apparatus. A buoy system that may include a first buoy portion and a second buoy member operably interconnected may be used to form at least three fractions from a sample during a substantially single centrifugation process. Therefore, the separation of various fractions may be substantially quick and efficient. Also selected fractions from the sample can be applied to a patient, either alone or as part of a mixture.

Abstract: Devices, systems, and methods reduce levels of pro-inflammatory or anti-inflammatory stimulators or mediators in blood by selective adsorption. The devices, systems, and methods are useful in situations where abnormal levels of or unregulated or excessive interaction among pro-inflammatory or anti-inflammatory stimulators or mediators occur, or during events that do induce or have the potential for inducing abnormal production of pro-inflammatory or anti-inflammatory stimulators or mediators. The devices, systems, and methods serve to prevent, control, reduce, or alleviate the severity of the inflammatory response and disease states that are associated with abnormal levels of or unregulated or excessive interaction among pro-inflammatory or anti-inflammatory stimulators or mediators.

Abstract: An automatic priming method in which an arterial-side chamber is maintained in a normal position during priming, as in a case of dialysis treatment, and in which forward and backward rotations of a blood pump are employed, and a speed of rotation, in particular, backward rotation, is adjusted to be low, so that air or the like is reliably prevented from entering a dialyzer. The priming method for use in a blood purification circuit in which priming is conducted by supplying physiological saline into a circulation circuit formed by connecting an arterial blood circuit with a venous blood circuit includes filling the venous blood circuit with a priming solution (physiological saline), discharging the priming solution for cleaning the arterial blood circuit, conducting a treatment in a direction opposite to the overflow step, which may be followed by a forward direction re-circulation step, and re-circulating in a forward direction.

Abstract: An improved method for separating whole blood into components and collecting a desired blood component. The method allows a desired blood component to be subjected to centrifugal forces within a separator for prolonged periods of time, yielding a cleaner cut and higher yield of the desired blood component. Whole blood is drawn from a source and pumped into a separator, the undesired blood components are removed from the separator at rates so as to build up the desired blood component in the separator. The desired blood component is only removed after a predetermined amount of the desired blood component has built up in the separator. It is preferred that the desired blood component be buffy coat and that the method be used to perform photopheresis treatments. In another aspect, the invention is a method of performing a full photopheresis treatment to treat diseases in a reduced time, preferably less than about 70 minutes, and more preferably less than about 45 minutes.

Abstract: This invention uses “targeted apheresis” to treat rheumatoid arthritis patients. “Targeted Apheresis” is a process whereby the RF and immune complexes responsible for causing the disease symptoms are selectively removed from the blood by passing the blood through a cartridge containing immobilized IgG. The RF and immune complexes are bound out and the cleaned blood is returned to the patient Removal of circulating RF and immune complexes will ameliorate the symptoms of rheumatoid arthritis.

Abstract: The present invention relates to a method and system for using a hemofilter to treat IMRD, hepatic failure, exogenous intoxication and other conditions associated with toxins in a patient's blood. One treatment includes the use of a very large pore hemofilter to remove target complex molecules and/or target molecules from a patient's blood and to infuse a replacement fluid into the patient's blood to maintain a prescribed albumin concentration in the patient's blood.

Abstract: A fluid cassette for a blood processing system includes a cassette housing and a rigid structure. The cassette housing defines the structure of the cassette and has a fluid path at least partially extending through it. The fluid path is configured to allow a fluid to pass through the housing. The rigid structure defines a cavity that is in fluid communication with the fluid path. The rigid structure also has an interface for interfacing and/or connecting with a pressure monitoring device. The interface allows the pressure monitoring device to measure the pressure within the fluid path. The cavity has a volume of air located between the fluid path and the interface.

Abstract: An apparatus that allows for separating and collecting a fraction of a sample. The apparatus, when used with a centrifuge, allows for the creation of at least three fractions in the apparatus. It also provides for a new method of extracting the buffy coat phase from a whole blood sample and mesenchymal stem cells from bone reaming material. A buoy system that may include a first buoy portion and a second buoy member operably interconnected may be used to form at least three fractions from a sample during a substantially single centrifugation process. Therefore, the separation of various fractions may be substantially quick and efficient.

Abstract: A method and apparatus for separating a volume of whole blood contained in a separation bag into at least three components comprising centrifuging the separation bag so as to separate therein a first inner layer comprising plasma, a second intermediate layer comprising platelets, a third intermediate layer comprising lymphocytes, monocytes and granulocytes and a fourth outer layer comprising red blood cells, transferring, into a plasma component bag connected to the separation bag, a plasma component and transferring into a mononuclear cell component bag a mononuclear cell components.

Abstract: This invention provides an apparatus and methods to consistently separate and concentrate selected blood components. The system includes, e.g., a computerized fluid handling system to transfer blood components between a centrifugal blood separation disc, containers and a concentrator.

Abstract: Systems and methods handle air and rinsing fluid during fluid processing. The systems and methods eliminate air from a fluid processing system prior to, during, and after use. The systems and methods provide a connector assembly for establishing fluid flow from a fluid source. The connector assembly has discrete first and second passages that prevent communication between the fluid in first passage and the fluid in the second passage. Prior to system use, the connector assembly may be utilized in a priming function to remove residual air from a fluid circuit prior to use. The connector assembly may also be utilized after use to perform a rinse-back function.

Abstract: A method and apparatus for red blood collection and filtration is provided wherein a red blood cell collection assembly provides for leukoreduction filtration concurrent with or soon after the red blood cell separation and collection procedure. Such procedures involve filtering the separated red blood cells in a diluted state after and/or prior to flushing the filter with storage solution. Storage solution may thus be passed through the leukoreduction filter before, with and/or after the RBCs have been filtered therethrough. The red blood cell collection, filtration and storage assembly is preferably preconnected to a blood component separation disposable assembly, including, for example, a centrifuge vessel and a blood removal/return assembly for removing blood from a donor, passing the blood to the centrifuge vessel for separation of the blood into components for collection and providing for filtration of the separated red blood cell component.

Abstract: A blood processing system is disclosed which is adapted for single or double access draw and return. The blood processing system includes a blood processor for separating blood (or blood components) into one or more components or other components. In one embodiment the blood processor includes an inlet for receiving blood from blood source and an outlet for returning at least one blood component to the source. The processing system includes a first flow path in communication with the inlet, a second flow path in communication with the outlet, a third flow path in communication with a second flow path at two spaced apart locations, a reservoir communicates with the third flow path between the two spaced apart locations, and a flow communication site associated with the second flow path downstream of the spaced apart locations which communication site is adapted to permit communication with the first flow path.

Abstract: A blood chamber for an extracorporeal blood circuit comprises a blood inlet port (2), a blood containment chamber (3), a first conduit (8) which connects the blood inlet port (2) with the blood containment chamber (3) and which has an end tract (8a) that terminates in the blood containment chamber (3) with a horizontal inlet component. The first conduit (8) comprises a pre-terminal tract (8b) which precedes the end tract (8a) and which has at least a second horizontal component which is directed in an opposite direction to the horizontal inlet component. The blood chamber is used in an arterial line of a dialysis set for guaranteeing a regular and gentle blood flow.

Abstract: An apparatus is disclosed that allows for separating and collecting a fraction of a sample. The apparatus, when used with a centrifuge, allows for the creation of at least three fractions in the apparatus. It also provides for a new method of extracting the buffy coat phase from a whole blood sample. A buoy system that may include a first buoy portion and a second buoy member operably interconnected may be used to form at least three fractions from a sample during a substantially single centrifugation process. Therefore, the separation of various fractions may be substantially quick and efficient.

Abstract: This invention provides an apparatus and method for controlling a fluid separation system, preferably a blood apheresis system, by sensing fluid pressure and comparing the sensed fluid pressure to a threshold value.

Abstract: Methods (300), devices, and systems of processing blood are described. The method (300) comprises the steps of: obtaining (312) blood from a patient coupled to a single blood processing device to form a closed loop between the patient and the blood processing device; collecting (314) bulk mononuclear blood cells from the blood by leukapheresis implemented using the blood processing device in the closed loop; and enriching (316) concurrently target cells separated from non-target cells in the bulk mononuclear blood cells using the blood processing device in the closed loop.

Abstract: A first flow path is defined within a first panel that forms a part of an extracorporeal fluid circuit. A second flow path is defined within a second panel that also forms a part of the extracorporeal fluid circuit. The first and second panels are oriented in a fluid processing cartridge for mounting as an integrated unit on a fluid processing machine and for removal as an integrated unit from the fluid processing machine.

Abstract: A biological fluid device (703) comprises a pressure sensor (702), which is arranged on the device. The pressure sensor comprises a compressible container, the compression of which is indicative of the pressure, and is capable of wireless communication.

Abstract: A method and apparatus for preventing and treating septicemia in patient blood is provided. The extracorporeal system includes an antimicrobial device to inactivate at least 99% of bloodborne microorganisms, a hemoconcentrator/filtration unit to remove approximately 50-75% of target molecules from the patient blood and a filter unit to remove target molecules from patient blood from the sieved plasma filtrate. Target molecules are produced by microorganisms, as well as by the patient's cells. These molecules include endotoxins from Gram negative bacteria, exotoxins from Gram negative and Gram positive bacteria, as well as RAP protein mediator from Staphylococcus aureus, and cell mediators such as tumor necrosis factor-alpha, and interleukin 1-beta, interleukin 6, complement proteins C3a and C5a, and bradykinin.

Abstract: Systems and methods for improving medical fluid delivery systems, such as hemofiltration (“HF”) and hemodiafiltration (“HDF”) are provided. In first embodiments, systems and methods for selectively performing pre- and postdilution HF and HDF clearance modes is provided. In other embodiments, systems and methods for providing prime bolus and rinseback fluid volumes before, during and/or after HF and HDF therapies are provided. In further embodiments, improved systems and methods for removing ultrafiltrate from the patient are provided. Still further, improved filtration configurations and methods are provided.

Abstract: The present invention provides a method, and resulting product, for the removal of unwanted molecules from a host's blood using a one-step procedure. The unwanted molecules may be anti-A blood protein and/or anti-B blood protein antibodies that would otherwise cause host rejection of transplanted organs or tissues from a source having a different ABO blood type. The unwanted molecules may also be excess antibodies, or virions, present in a diseased host.

Abstract: The present disclosure relates generally to systems for obtaining a pharmaceutically acceptable immunoglobulin from blood of a donor comprising a first conduit configured to convey blood from the donor to a substrate, wherein said blood includes at least one first component and at least one second component, said first component of the blood including immunoglobulin, and wherein said substrate is adapted to bind immunoglobulin; and a second conduit configured to convey at least a portion of the second component of the blood from the first conduit to the donor.

Abstract: A device, system and method for exchanging components between first and second fluids by direct contact in a microfluidic channel. The fluids flow as thin layers in the channel. One of the fluids is passed through a filter upon exiting the channel and is recycled through a secondary processor which changes the fluid's properties. The recycled fluid is reused for further exchange. The filter excludes blood cells from the recycled fluid and prevents or limits clogging of the filter. The secondary processor removes metabolic waste and water by diafiltration.

Abstract: An apparatus for carrying out selected fluid management and/or renal replacement patient therapy is characterized by an interactive operator control system having operator inputs for selectively changing a panel kit, replacing a filter cartridge, and/or changing to a different patient therapy during a currently running patient therapy, and providing operator instructions for carrying out tasks for completing same. In one embodiment, the interactive operator control system is also characterized by automatically serially identifying different setup steps to be carried out during system setup, displaying the successive steps substantially throughout the system setup as well as displaying on the operator interface screen sequential tasks to be carried out for each of the different setup steps.

Abstract: Apparatus for use in a dialysis system are disclosed including an apparatus for delivering saline during dialysis treatment, an apparatus for delivering saline to a patient after dialysis treatment has ended, and an apparatus for alerting a patient that dialysis treatment is about to end. In the apparatus for delivering saline during dialysis treatment, a controller is configured to automatically deliver saline in response to a request. In the apparatus for delivering saline to a patient after dialysis treatment has ended, a controller is configured to automatically deliver saline after dialysis treatment has concluded, but before the patient is disconnected in response to a request. In the apparatus for alerting a patient that dialysis treatment is about to end, a controller is configured to monitor a dialysis treatment and activate an alarm when treatment is about to end.

Abstract: An apparatus for collecting blood clots, plaque, and other debris in arteries or veins, said apparatus comprising: a filter assembly having a chamber with a paddle assembly and a porous floor disposed therein; and tubes for coupling said filter assembly to an artery and to a vein.

Abstract: Methods are disclosed for collecting and separating whole blood into one or more components. A disposable blood separation fluid circuit is provided which is adapted to cooperate with a reusable separation controller. The fluid circuit includes a fluid flow path for communication with a blood source and at least one container in fluid communication with the fluid flow path. The fluid flow path is connected to a blood source and quantities of whole blood are collected in the container and one other location within the fluid circuit. The source is then disconnected from the disposable fluid circuit. The quantities of whole blood are centrifugally processed, with processing of at least a portion of one of the quantities beginning after the source is disconnected from the fluid circuit.

Abstract: A rotary valve unit is provided for blending fluid sources to regulate a temperature of fluid flowing to a heat exchange device in an extracorporeal blood perfusion circuit. A valve body includes a valve chamber having a first inlet port, a second inlet port, a first outlet port, and a second outlet port. A wedged-shaped rotary valve is disposed within the valve chamber and is rotatable within the valve chamber for controlling a blending of the cold fluid entering the fluid chamber from the first inlet port and the return fluid entering the fluid chamber from the second inlet port to regulate the desired temperature of fluid provided to the heat exchanger. The wedge-shaped rotary valve is positionable to provide either only cold fluid to the first outlet port, only return fluid to the first outlet port, or blending of the cold fluid and return fluid to the first outlet port.

Abstract: A method and apparatus for obtaining various components of a multi-component material. Generally, a component of a whole blood sample may be concentrated from a patient and re-introduced to the same patient. For example, a clotting component, such as thrombin, from a whole blood sample may be extracted and concentrated in an apparatus and collection to be reapplied or reintroduced into a patient.

Abstract: A preconnected disposable and method for red blood collection is provided wherein the preconnected disposable includes a red blood cell collection assembly comprising a leukoreduction filter and a red blood cell storage bag. Such a red blood cell collection assembly is preferably preconnected to a blood component separation vessel, cassette assembly and a blood removal/return assembly for removing blood from a donor, separating the blood into components for collection and providing for filtration of the separated red blood cell component.

Abstract: A method and apparatus for red blood collection and filtration is provided wherein a red blood cell collection assembly provides for leukoreduction filtration concurrent with or soon after the red blood cell separation and collection procedure. Such procedures involve filtering the separated red blood cells in a diluted state after and/or prior to flushing the filter with storage solution. Storage solution may thus be passed through the leukoreduction filter before, with and/or after the RBCs have been filtered therethrough. The red blood cell collection, filtration and storage assembly is preferably preconnected to a blood component separation disposable assembly, including, for example, a centrifuge vessel and a blood removal/return assembly for removing blood from a donor, passing the blood to the centrifuge vessel for separation of the blood into components for collection and providing for filtration of the separated red blood cell component.

Abstract: A connection of a patient's vascular system to an extracorporeal blood treatment machine is monitored to ensure the patient's safety during a procedure. The procedure may be hemodialysis, apheresis, plasmapheresis, a coronary by-pass operation, or other procedure. To ensure safe electrical connection, a contact and a return are connected via a conductive connection into the extracorporeal blood circuit. A current is then generated between the contact and the return and is monitored by a non-contact sensor near an access site of the patient. If the current or other quantity related to the current changes significantly, a signal is sent to the machine or a controller to notify a caregiver or a medical professional. The signal may also be sent to immediately stop a blood pump or other component of the machine.

Abstract: A method and apparatus for red blood collection and filtration is provided wherein a red blood cell collection assembly provides for leukoreduction filtration concurrent with or soon after the red blood cell collection procedure. The procedure preferably involves filtering the separated red blood cells in a high hematocrit (high-crit) state prior to addition of storage solution thereto. Preferably, a storage solution is passed through the leukoreduction filter after the RBCs have been filtered therethrough. The red blood cell collection filtration and storage assembly is preferably preconnected to a blood component separation disposable assembly, including, for example, a centrifuge vessel and a blood removal/return assembly for removing blood from a donor, passing the blood to the centrifuge vessel for separation of the blood into components for collection and providing for filtration of the separated red blood cell component, as described.

Abstract: An apparatus for the treatment of a medical liquid has a liquid treatment machine and a cassette that is insertable in the machine. The cassette has a rigid base body with fitted chambers and passages and a foil that covers the chambers and passages. Actuators and sensors are arranged in the liquid treatment machine for the operation of the apparatus with the inserted cassette such that cassettes are insertable in different integration shapes.

Abstract: A blood treatment apparatus includes a controller and a supervisor, which together monitor various sensors. The controller is equipped with a first alarm system and the supervisor is equipped with a second alarm system. To avoid competition between both alarm systems, the alarm system of the supervisor normally remains mute. A function monitoring device monitors the function of the first alarm system and signals a missing alarm to the supervisor. Only in this case will the second alarm system of the supervisor be activated.

Abstract: Provided herein is an innovative hemoperfusion system and method including a thermal-fused broad-spectrum biocidal iodinated interactive polymer for the treatment of biological contaminants in body fluids. In one exemplary embodiment, the system and method utilizes a Triosyn® thermal fused broad-spectrum iodinated interactive polymer, included in a hemoperfusion column, for devitalizing high levels of cell-free microorganisms in whole blood and biological fluids in relation with the characterization of blood cells viability and function post-treatment.

Abstract: A method and a device to increase the efficiency of dialysis for the removal from blood of substances that are more or less tightly bound to carriers such as albumin. According to the invention this is accomplished by a simultaneous significant increase of the flow rate of the dialysis fluid and of the area of the membrane that separates the blood from the dialysis fluid, compared to conventional dialysis.

Abstract: This invention provides a method for controlling a fluid separation system, preferably a blood apheresis system having a leukocyte reduction chamber. The method utilizes a return-flow alarm system. A return-flow alarm-triggering pressure is specified, and when pressure of the return flow in the system is higher than or equal to the specified pressure, a return-flow alarm is triggered.

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.