A61M2205/705

Apparatus and method for testing integrity of an ultrafilter membrane
11571501 · 2023-02-07 · ·

An apparatus for extracorporeal treatment of blood (1) has a supply line (2), a waste line (13) and an ultrafilter (19; 70) inserted in the supply line (2). An air inlet line is connected to the first chamber (21; 72) of the ultrafilter (19; 70) and a pressure sensor (41) configured for detecting pressure in the waste line (13). A controller (50) is configured to carry out, with the hydraulic circuit (100) in by-pass configuration, an integrity test procedure for detecting if the ultrafilter membrane has multiple or single fiber breaks. A method of testing the ultrafilter (19; 70) is also disclosed.

Medical syringe system with filtered filling port

A syringe system includes a syringe and a filtration device connected to the syringe for sterilizing and introducing fluid into the syringe. The syringe includes a syringe barrel having a proximal end defining a barrel opening, a distal end defining a delivery opening, a bore extending between the proximal end and the distal end, and a stopper disposed in the bore of the syringe barrel. The filtration device has an inlet and an outlet coupled in fluid communication with the delivery opening at the distal end of the syringe barrel. The filtration device includes a stem and a filter membrane disposed in line with the stem. The filter membrane optionally has a plurality of pores each with a nominal pore size in a range of approximately 0.1 μm to approximately 0.5 μm such that a pharmaceutical fluid can be introduced as a sterilized pharmaceutical fluid into the bore of the syringe barrel by passing through the filtration device.

METHOD AND INSTALLATION FOR TESTING THE INTEGRITY OF A CAPILLARY DIALYSER

A method is presented for checking the integrity of a hollow-fibre fluid filter, in particular a hollow-fibre dialyzer (1), which is constructed from a plurality of hollow fibres (15) enclosed by a membrane, with the steps of: perfusing the inside or outside of the hollow fibres (15) with a fluid, supplying the outside or inside of the hollow fibres (15) with a gas, wherein the gas has a higher pressure than the fluid, and determining a quantity of the gas which penetrates into the fluid through holes in the membrane. The method is characterized in that, after flowing through the hollow-fibre fluid filter (1), the fluid is channelled through a bubble trap (30), and in that a volume of gas (41) collecting in the bubble trap (30) during a predefined or predefinable reference period is determined. Furthermore, equipment for checking the integrity of a hollow-fibre fluid filter (1) is presented.

CLOSED CIRCULATION SYSTEM TEST APPARATUS FOR BLOOD PURIFICATION DEVICE USING WHOLE BLOOD

A closed circulation system test apparatus independently sets the amount of a liquid such as a dialysate for a blood purification device, facilitates management of operations of multiple pumps, and is capable of evaluating performance for removing wastes in blood and lifespan performance of membranes. The closed circulation system test apparatus includes: a blood sending line for sending blood from the blood bag to the blood purification device via a blood pump; a blood returning line for sending blood exiting from the blood purification device to the blood bag via a resistance imparting means; a filtrate line for sending the filtrate exiting from a dialysate outlet of the blood purification device to the replacement fluid container via a filtrate pump; and a dialysate line for sending, via a dialysate pump, dialysate or replacement fluid from the replacement fluid container to a dialysate inlet of the blood purification device.

Flow path fault detection method for a respiratory assistance apparatus

A respiratory assistance apparatus is configured to provide a heated and humidified glow of gases and has a control system that is configured to detect a fault in the flow path. A flow path is provided for a gases stream through the apparatus from a gas inlet through a blower unit and humidification unit to a gases outlet. A flow rate sensor is provided in the flow path and is configured to sense the flow rate and generate an flow rate signal and/or a motor speed sensor is provided that is configured to sense the motor speed of the blower unit and generate an indicative motor speed signal.

FLOW PATH FAULT DETECTION METHOD FOR A RESPIRATORY ASSISTANCE APPARATUS

A respiratory assistance apparatus is configured to provide a heated and humidified glow of gases and has a control system that is configured to detect a fault in the flow path. A flow path is provided for a gases stream through the apparatus from a gas inlet through a blower unit and humidification unit to a gases outlet. A flow rate sensor is provided in the flow path and is configured to sense the flow rate and generate an flow rate signal and/or a motor speed sensor is provided that is configured to sense the motor speed of the blower unit and generate an indicative motor speed signal.

A SYSTEM AND A METHOD FOR PRODUCING MICROBIOLOGICALLY CONTROLLED FLUID

A method and a system (10a) comprising an integrated water purifying apparatus (110) with a pre-filter circuit (402) including a particle filter and an activated carbon filter arranged to produce pre-treated water; a fluid circuit (404) arranged to receive pre-treated water from the pre-filter circuit (402), the fluid circuit (404) includes an RO-pump (450) and a Reverse Osmosis, RO, device, (301) arranged to produce purified water; a heating device (302) arranged to heat purified water from the RO device (301) to a temperature above 65°; the water purifying apparatus (110) is further arranged to heat disinfect the fluid circuit (404) using the heated purified water. The system (1) further comprises a line set (40) connected to the purified water outlet connector (128) at a water line connector (68) of the line set (40), wherein the line set (40) includes at least one sterile sterilizing grade filter (70a, 70b) arranged to filter the purified water into sterile purified water.

Blood treatment device priming devices, methods, and systems
11679190 · 2023-06-20 · ·

Simple-to-use systems, methods, and devices for priming replacement blood treatment devices, for swapping the blood treatment devices out, for replacing swapped-out blood treatment devices, and other related operations are described. In embodiments, a blood treatment device can be primed while a therapy is still running. When the replacement blood treatment device is needed, the therapy can be stopped momentarily (less than a minute) for the rapid and safe swap of the blood treatment device. Blood loss can be minimized. The down time from therapy can be minimized.

APPARATUS AND METHOD FOR TESTING INTEGRITY OF AN ULTRAFILTER MEMBRANE
20230181806 · 2023-06-15 ·

An apparatus for an extracorporeal treatment of blood has a supply line, a waste line, and an ultrafilter inserted in the supply line. An air inlet line is connected to a first chamber of the ultrafilter. A pressure sensor is configured for detecting pressure in the waste line or a second chamber of the ultrafilter. A controller is configured to perform an integrity test procedure for detecting when an ultrafilter membrane of the ultrafilter has multiple or single fiber breaks. A method of testing the ultrafilter is also disclosed.

METHOD OF DRAINING A DEVICE FOR EXTRACORPOREAL BLOOD TREATMENT
20170296733 · 2017-10-19 ·

A method of draining a device for extracorporeal blood treatment, wherein the device comprises a dialyzer which is divided by means of a membrane into a first chamber and a second chamber, an arterial line connected to a blood inlet of the first chamber, a venous line connected to a blood outlet of the first chamber, a dialysis fluid line for fresh dialysis fluid connected to a dialysis fluid inlet of the second chamber and a dialysis fluid line for used dialysis fluid connected to a dialysis fluid outlet of the second chamber, a blood pump disposed in the arterial line, a venous expansion chamber disposed in the venous line and an air detector unit downstream of the venous expansion chamber, and wherein the method comprises the following steps of: connecting a patient-side port of the arterial line to a patient-side port of the venous line; generating a negative pressure in the second chamber; operating the blood pump in a first direction and draining the arterial and venous lines in the first direction via the membrane and the second chamber; and stopping the blood pump and draining the arterial and venous lines in a second direction opposed to the first direction via the membrane and the second chamber.