Abstract: A penetrator for penetrating a stopper sealing an opening in a container. The penetrator includes a stamped piece of sheet material formed to define a shank having a length. A groove extends along the length of the shank. The shank has a pointed distal. The stamped piece of sheet material further includes a bearing plate extending from the shank at a proximal end opposite the distal end of the shank.

Abstract: The present invention provides a connector device for establishing fluid communication between a first container and a second container. The device has a first sleeve member having a first and a second end, the first sleeve member having at the first end a first attaching member adapted to attach to the first container. The device further has a second sleeve member having a first end and a second end, the second sleeve member being associated with the first sleeve member and movable with respect thereto from an inactivated position to an activated position, the second sleeve member having at the second end a second attaching member adapted to attach the second sleeve member to the second container. First and second piercing members project from one of the first and second sleeve members for providing a fluid flow path from the first container to the second container, and the first and second piercing members are independently hermetically sealed.

Abstract: The multipurpose machine for monitoring and control of locoregional therapies in oncology comprises a head which has a box-like structure, is supported by a stand provided with means for modifying its dimensions, and is provided with adsorbent and/or filtering means and with means for controlling and regulating chemotherapy and chemofiltration which are arranged along a first set of duct circuits accommodated in the head; the first set of circuits is divided into at least two loops, each of which has its own pumping means; the loops are mutually interactive or separable, and the first loop is provided for the infusion of the chemotherapeutic agents and the second loop is provided for the filtration of the chemotherapeutic agents; an emergency electronic circuit is inserted between the two loops in order to detect malfunctions of the pumping means and functionally restore at least the infusion loop; the head furthermore accommodates a second main set of circuits which can be activated alternately with respect

Abstract: A catheter assembly having a sheath, which includes a side wall enclosing an interior bore, and a distal region. The assembly also has a bendable catheter tube, which is carried for sliding movement in the interior bore. A pull wire also runs through the interior bore of the sheath, preferably within a lumen. The catheter tube has a distal portion with a coupling which joins the distal portion of the catheter tube and the distal portion of the pull wire. Relative movement of the pull wire and the sheath causes bending of the catheter tube outwardly through the opening, in response to sliding movement of the catheter tube within the interior bore toward the distal region of the sheath.

Abstract: A system and method for increasing gas concentration in blood which has use as a generalized extracorporeal system and method to treat hypoxemic blood from a patient by mixing the blood with an oxygen supersaturated solution to generate hyperoxemic blood to be infused back to the patient. The extracorporeal system comprises an extracorporeal tubing through which blood from the patient is circulated, a blood pump for withdrawing blood from and delivering blood to the patient, at least one channel for delivering oxygen-supersaturated fluid and a mixing region for introducing supersaturated fluid without bubble formation. By infusing the oxygen-supersaturated fluid into the hypoxemic or normoxemic blood from the patient, hyperoxemic blood is thereby produced. The hyperoxemic blood is then returned to a central vein, right heart or artery of the patient with the blood pump at approximately the same volume delivery rate as blood volume withdrawal rate.

Abstract: A method of supplying ready-to-use dialysis fluid in a machine for extracorporeal blood treatment, is described, said machine having, in addition to a dialyzer, at least one sterile filter divided by a microbe-retaining membrane into a first and second chamber. The temperature and/or conductivity of the dialysis fluid flowing through the sterile filter is monitored. To prevent dialysis fluid whose temperature and/or conductivity does not correspond to a preset temperature and/or conductivity value from flowing out of the second chamber of the sterile filter into the dialyzer after rinsing off the membrane of the sterile filter, the dialysis fluid flowing out of the sterile filter is first removed into the drain through a bypass line until the proper values are established. Only then is the dialyzer connected to the dialysis fluid path. In addition, the invention relates to a machine for extracorporeal blood treatment with a device for supplying ready-to-use dialysis fluid.

Abstract: An apparatus and method for blood oxygenation are provided. The apparatus advantageously comprises a liquid-to-liquid oxygenation assembly. The liquid-to-liquid oxygenation assembly includes a pressurizable chamber having inlets for a first gas-supersaturated fluid and a second fluid, such as blood. The inlets are advantageously positioned on the mixing chamber in such a way that the first fluid and the second fluid enter the mixing chamber normally to each other to promote mixing and liquid-to-liquid gas transfer. The mixed fluid exits the chamber via an outlet for delivery to a patient.

Abstract: A method for a bubble-free oxygenated blood delivery is provided. The method includes a step of selecting a delivery system having a tubular elongated member with a lumen. The selecting step comprises determining an effective diameter of the lumen needed to achieve a bubble-free delivery of the oxygenated blood based on a specified oxygenated blood flow rate and a desired target oxygen partial pressure in the oxygenated blood. The delivery system includes a generally tubular elongated member having a proximal end portion, a distal end portion, and a transition portion located between the proximal end portion and the distal end portion. The transitional portion is relatively flexible compared to the proximal end portion and is relatively stiff compared to the distal end portion. In another embodiment, the delivery system includes a generally tubular elongated member having a proximal end portion and a distal end portion with a plurality of holes.

Abstract: A tubular set is provided for the extracorporeal treatment of blood, for example hemodialysis. The set has a patient arterial line and a patient venous line, each line having a patient connector at one end thereof. Each patient line connects at its other end to a reversing flow valve. The valve also connects to respective first ends of a blood processing unit arterial line and a blood processing unit venous line. Each of the unit lines carry a connector at ends opposed to the first ends for connection respectively to arterial and venous ports of a blood processing device, typically a dialyzer. The reversing flow valve has a first position that respectively connects the patient and unit arterial lines with the patient and unit venous lines. The reversing flow valve has a second position that connects the patient arterial line with the unit venous line, and the unit arterial line with the patient venous line.

Abstract: A “leads-off indicator” for an ECG apparatus for indicating that one or more of a plurality of ECG electrodes is not properly affixed to a patient and that that obviates the need for a conventional high frequency drive signal, but instead, employs common mode input noise as a drive signal to a reference electrode such that if one of the electrodes defining an ECG vector is not properly affixed, an increase in the ambient noise on an ECG vector associated with the detached electrode occurs as a detectable event. A first algorithm is used to identify whether or not the reference electrode itself is properly affixed to the patient's right leg and, if so, the common mode signal presented to the remaining limb electrodes becomes unbalanced should one of the limb electrodes not be properly connected to the patient. An impedance balancing circuit is provided for developing signals allowing identification of a lose electrode when the ECG system does not utilize a right leg electrode as a reference.

Abstract: During hemofiltration, blood is conveyed from an individual through a blood line into a hemofilter to remove waste fluid. Waste fluid is conveyed from the hemofilter through a waste removal line at a waste removal rate. Waste fluid pressure is sensed in the waste removal line. A controller adjusts the waste removal rate to maintain waste fluid pressure at a predetermined set value.

Abstract: A machine and method for preparing dialysis fluid for a dialysis machine. Fresh water is mixed with one or more dialysis fluid concentrates. The mixture of water and concentrates is conveyed into an equalizing chamber by a proportioning unit at a predetermined flow rate independent of the dialysate flow rate. Metered addition of the concentrates is performed volumetrically and is monitored on the basis of the conductivity of the dialysis fluid, which is measured by conductivity sensors. Because the mixture of water and concentrates is always conveyed at the same flow rate, the composition of the dialysis fluid can be determined with a high accuracy and the proportioning can be performed accurately.

Abstract: Vascular access systems, devices and methods for facilitating repeated access to a blood vessel. These systems, devices and methods can be used in external blood treatment, such as dialysis, and in intra-venous administration of medicines, such as heparin, for extended periods of time, while avoiding deleterious effects such as those derived from repeated puncturing of the blood vessel tissues or exposure of such tissues to abnormal fluid flows. The vascular access systems comprise an anastomosis graft vessel, an occlusal device, such as an occlusal balloon, and a port device for accessing the occlusal device. Occlusal devices can be self-contained, they can rely on osmosis, and they can serve as the support of an agent to which the blood stream is exposed, either by transport or by mere contact. In addition, occlusal devices can adopt a distended and a collapsed configuration, the latter allowing for blood flow through the anastomosis graft vessel.

Abstract: An extracorporeal fluid circuit for performing hemofiltration defines within a flexible panel a flow channel that is free of an air interface. The flexible panel includes an in-line sensor region through which fluid pressure in the flow channel can be measured by an external sensor. The systems and methods enable sensing fluid pressure through the in-line sensor region using the external sensor. The flow channel can convey, e.g., waste from the hemofilter or replacement fluid for return to the individual.

Abstract: An external transmitter circuit drives an implantable neural stimulator having an implanted coil from a primary coil driven by a power amplifier. For efficient power consumption, the transmitter output circuit (which includes the primary coil driven by the power amplifier inductively coupled with the implanted coil) operates as a tuned resonant circuit. When operating as a tuned resonant circuit, it is difficult to modulate the carrier signal with data having sharp rise and fall times without using a high power modulation amplifier. Sharp rise and fall times are needed in order to ensure reliable data transmission. To overcome this difficulty, the present invention includes an output switch that selectively inserts a resistor in the transmitter output coil circuit in order to de-tune the resonant circuit only during those times when data modulation is needed. Such de-tuning allows sharp rise and fall times in the data modulation without the need for using a high power modulation amplifier.

Abstract: Self-powered, bio- implantable, pressure adjustable mini-pump systems for medical applications including body fluid pressure control, drainage control, and drug delivery systems. The mini-pump systems include a primary mini-pump chamber having an anterior end attached to an implantable intake conduit. The device of the invention is further equipped with an adjustable variable flow valve or shunt in the form of a first cantilever slab, in combination with an anterior end one-way valve in the form of another cantilever slab. The posterior end of the mini-pump chamber is connected to a drainage conduit, via another one-way valve. Opposing diaphragm elements in the form of a pair of oscillatory flexing miniature ionic polymer metal composite IPPC artificial muscles, is used to vary the volume of the primary mini-pump chamber and thereby effect pumping action.

Abstract: A shunt for draining cerebral spinal fluid from the brain is provided. In an embodiment, the shunt includes a master control unit that is located in the abdomen, which interconnects a ventricular catheter and a second catheter, typically located in the peritoneal cavity. In a specific embodiment, the master control unit includes a variety of ‘smart’ features including at least one access port to allow the injection of solutions for the prevention or removal of blockages in the catheter, and/or antibiotics. The access port can have other uses, such as allowing a point of access for physical navigation of a catheter or the like within the shunt, thereby providing another option for breaking-up blockages, and/or allowing an access point for repairing the shunt's components. Additionally, the master control unit includes a diagnostic unit that transmits, either wirelessly or through a wired connection via the access port, diagnostic information about the status of the patient and/or the shunt.

Abstract: A catheter for use with a radioactive source within the catheter to irradiate a selected area of a blood vessel in combination with angioplasty procedures, to prevent restenosis of that area of the blood vessel. The catheter has a guidewire channel formed near its distal end to facilitate use of the catheter as a rapid exchange catheter, allowing insertion of the catheter over a guidewire also used in performance of an angioplasty procedure. The catheter also has a radiation lumen with a sealed end to retain the radioactive source within the catheter. The radiation lumen is sufficiently longer than the guidewire channel to extend into a non-sterile field, keeping the radiation source segregated from the blood, allowing the use of a non-sterile radiation source. The catheter can also be provided with a centering balloon or a set of centering wire loops to center the radioactive source radially within the blood vessel.

Abstract: A hemofiltration system is provided in which ultrafiltrate is purified by reverse osmosis for reinfusion. Non-sterile infusate concentrate is dialyzed into the purified ultrafiltrate and combined with cleared blood which is returned to the patient. In another system, a hemofilter is used to sterilize essentially pure, non-sterile water for dilution of sterile infusate concentrate, then the hemofilter is used to filter blood, the infusate concentrate being combined with cleared blood for return to the patient.

Abstract: A device and method for extracorporeal whole body hyperthermia treatment of a patient's blood using alpha-stat regulation of blood pH and pCO2 is described. The respiratory rate of a patient is either increased or decreased in accordance with the changes in pH, pCO2, and base excess. The regulation of blood during the hyperthermic treatment of the patient's blood stabilizes the biochemical reactions fundamental to the metabolic welfare of the organisms within the patient's blood while the viruses within the patient's blood are eliminated.