A system comprises a fluid generation arrangement (FGA), a user interface (UI), and a control unit. The FGA is operable to mix one or more concentrates with water to generate a treatment fluid for use in renal replacement therapy. The control unit is connected to the UI and arranged to configure the FGA by a computer-implemented method. In the method, the control unit receives (201), from the UI, a candidate set value of a selected component of the treatment fluid, calculates (202), for the candidate set value, a calculated composition of the treatment fluid, and displays (204), on the UI, a respective concentration value of one or more components other than the selected component in the calculated composition. By the system, a caretaker is made aware of consequential changes in the composition of the treatment fluid, in addition the selected component. The system thereby facilitates the use of the on-line fluid generation while maintaining patient safety.
The present disclosure provides a new and innovative method for dynamically managing power and charging rates of multi-pump assemblies. In various embodiments, a computer-implemented method includes monitoring a plurality of pump parameters for a plurality of infusion pumps, assessing a change in the parameter states, establishing charging needs for each infusion pump in the plurality of infusion pumps, and establishing a charging profile for each infusion pump in the plurality of infusion pumps.
G16H 20/17 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
G16H 40/40 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
G16H 40/60 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
The present disclosure provides a new and innovative method and system for flow rate compensation in devices, such as medical devices and other electronic devices. In various embodiments, a computer-implemented method includes dispensing, by a pump controlled by a controller, a fluid from a fluid supply in a pulse mode over a period by determining a pulse volume for a pulse, determining a pulse cycle time, and for the period: controlling the position of the pump to perform a delay and perform a pulse to dispense an amount of the fluid, the pulse performed for the pulse cycle time, calculating an overshoot or undershoot of the amount of the fluid dispensed relative to the pulse volume, adjusting the pulse cycle time based on the calculated overshoot or undershoot, and repeating the dispensing until the period has elapsed.
A61B 17/03 - Surgical instruments, devices or methods, e.g. tourniquets for closing wounds, or holding wounds closed, e.g. surgical staples; Accessories for use therewith
A61B 90/98 - Identification means for patients or instruments, e.g. tags using electromagnetic means, e.g. transponders
A61B 17/00 - Surgical instruments, devices or methods, e.g. tourniquets
A61B 17/128 - Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord for applying or removing clamps or clips
A61B 90/00 - Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups , e.g. for luxation treatment or for protecting wound edges
A61B 17/00 - Surgical instruments, devices or methods, e.g. tourniquets
An inline heating system (10) including an inline heater (20) including a heater element (26a, 26b); a control unit (50) configured to cause one of voltage or current to be applied to power the inline heater; and a current or voltage meter (66, 66a, 66b) positioned and arranged to measure the other of current or voltage at the heater element due to the applied voltage or current, wherein the control unit is further configured to determine a heater element resistance using the applied voltage or current and the measured current or voltage as part of a no flow or low flow condition detection algorithm implemented by the control unit, wherein the voltage or current applied to power the inline heater is stopped if the no flow or low flow condition is detected.
F24H 1/10 - Continuous-flow heaters, i.e. heaters in which heat is generated only while the water is flowing, e.g. with direct contact of the water with the heating medium
7.
SYSTEMS AND METHODS FOR HEAD HEIGHT PRESSURE COMPENSATION
The present disclosure provides a new and innovative method and system for flow rate compensation in devices, such as infusion pumps. In various embodiments, a computer-implemented method includes determining a location of a plurality of infusion pumps in a pump stack including the plurality of infusion pumps and a fluid supply connected to each of the plurality of infusion pumps. The computer-implemented method also includes determining a reference infusion pump, in the plurality of infusion pumps, and adjusting the flow rate for each infusion pump in the plurality of infusion pumps based on the distance between the infusion pump and the reference infusion pump.
G16H 20/17 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
G16H 40/40 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
G16H 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
A61M 5/14 - Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
8.
SYSTEMS FOR MULTI-LEVEL THERMAL MANAGEMENT OF ELECTRONIC DEVICES
The present disclosure provides a new and innovative method and system for the thermal management of devices, such as medical devices and other electronic devices. In various embodiments, a computer-implemented method includes measuring a current temperature of a device drawing power at a charge current level, identifying a current temperature threshold in a plurality of temperature thresholds based on the current temperature, the plurality of temperature thresholds including at least one rising temperature threshold and at least one falling temperature threshold, increasing the charge current level of the device when the current temperature is below a falling temperature threshold for a first period of time, and decreasing the charge current level of the device when the current temperature is above the rising temperature threshold for the first period of time.
The present disclosure relates to a terminally heat-sterilized ready-to-use parenteral nutrition formulation comprising all macronutrients and micronutrients required to meet the clinical guidelines for parenteral nutrition, wherein all said micronutrients and macronutrients are provided in one multi-chamber bag (MCB). The disclosure is also directed to a parenteral nutrition formulation comprising all such macronutrients and micronutrients. More specifically, the present disclosure is directed to a MCB comprising at least five chambers containing a carbohydrate formulation in a first chamber, an amino acid formulation in a second chamber, a lipid formulation in a third chamber, a fourth chamber comprising a vitamin formulation and a fifth chamber comprising a trace element formulation, wherein the carbohydrate formulation, amino acid formulation and/or the lipid formulation may also contain certain vitamins and certain trace elements that can be stably accommodated therein.
A61J 1/20 - Arrangements for transferring fluids, e.g. from vial to syringe
B65D 81/32 - Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents for packaging two or more different materials which must be maintained separate prior to use in admixture
The invention relates to a flexible container/multi-chamber container with selective dissolved gas content for stabilizing at least one compound of a medical product having a selective gas requirement for remaining stable, comprising a solution comprising the at least one compound and a fil material from which the container is made that provides for high gas-barrier for the said gas. The at least one compound may be selenium in the form of Se(IV) and is preferably selected from the group consisting of sodium selenite, selenous acid and selenium dioxide. The selective gas may be oxygen, and the headspace of the oxygen maintains the solution to comprise dissolved oxygen (DO) at a level of 0.5 ppm to 8 ppm.
The present disclosure relates to a pharmaceutical composition for providing phosphorus to an adult or pediatric patient, wherein the composition is an aqueous solution of sodium glycerophosphate which by virtue of an improved process for producing the active pharmaceutical ingredient and the pharmaceutical composition is characterized by a low amount of free phosphate, a low amount of SGP-related substances and by a low amount of aluminum. The pharmaceutical composition is used in clinical nutrition, preferably in the preparation of nutritional formulations by compounding. The compositions can further be used for preventing or correcting phosphorus deficiency (hyperphosphatemia) in said adult or pediatric patients.
A peritoneal dialysis ("PD") system includes a dialysis fluid pump having a reusable pump body that accepts PD fluid for pumping; a dialysis fluid inline heater including a reusable heater body that accepts PD fluid for heating; a patient line connector; a drain line connector; a first reusable PD fluid line including a first connector configured to mate with the patient line connector; a second reusable PD fluid line including a second connector configured to mate with the drain line connector; and a control unit configured to run a heat cleaning (e.g., heat disinfection or heat sterilization) sequence after PD treatment, wherein the first connector of the first reusable PD fluid line is mated with the patient line connector, the second connector of the second reusable PD fluid line is mated with the drain line connector, and the dialysis fluid pump and perhaps the dialysis fluid inline heater are actuated.
A peritoneal dialysis ("PD") system includes a housing; a dialysis fluid pump housed by the housing; a dual lumen patient line extending from the housing; a filter set including a final stage filter located along a first line, and which includes a second line in parallel with the first line, the first line in fluid communication with a first lumen of the dual lumen patient line, and the second line in fluid communication with a second lumen of the dual lumen patient line; a pressure sensor located within the housing and positioned so as to sense a static or substantially static PD fluid pressure in the second lumen while fresh PD fluid is pumped through the first lumen and the final stage filter; and a control unit configured to use the sensed static or substantially static pressure in a pressure control routine for the dialysis fluid pump.
Systems and methods for detecting an occlusion in an infusion device are disclosed. One method includes generating, during an infusion session at predetermined intervals, a feature vector comprising an initial measurement of a physical force caused by fluid motion through an infusion device at the start of an infusion session, a current measurement of the physical force, a long term change in the measurement of the physical force, and a short term change in the measurement of the physical force. The feature vector is inputted, during the predetermined intervals, into a support vector machine ("SVM") to output an indication of a presence or an absence of an occlusion in the infusion device. The SVM may be trained using reference data from reference infusion sessions having known consequences regarding the presence or the absence of an occlusion at various times during the reference infusion sessions.
G16H 20/17 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
17.
SYSTEM AND METHOD FOR SELF - ALIGNING HUB CONNECTOR
A system and method for self-aligning and connecting a device to a modular rack. The system includes a device comprising a connector receptacle configured to receive a connector plug, a connector seal and a bracket fixed to the device, a modular rack comprising the connector plug, a connector shell seal and a shelf configured to receive the bracket and guide the shelf in a plurality of directions. When the bracket of the device is inserted into the shelf of the modular rack, the shelf travels in the plurality of directions to self-align the connector plug of the modular rack to the connector receptacle of the device to ensure engagement of the connector plug to the connector receptacle. The connector seal is biased towards the connector shell seal to create a seal and ensure engagement of the connector plug relative to the connector receptacle.
A cartridge assembly for a filling machine includes a plurality of containers. Each container includes a volume and a stem connected to the volume. A connection line grid is in fluid communication with each stem of the plurality of containers. The connection line grid includes a first row connected to one or more containers of the plurality of containers and a second row connected to one or more containers of the plurality of containers. A filter assembly is coupled to the connection line grid.
A61J 1/14 - Containers specially adapted for medical or pharmaceutical purposes - Details; Accessories therefor
B65B 3/00 - Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans or jars
B65B 3/12 - Methods of, or means for, filling the material into the containers or receptacles by application of pressure to material mechanically, e.g. by pistons or pumps
B65B 55/12 - Sterilising contents prior to, or during, packaging
C12M 1/32 - Inoculator or sampler multiple field or continuous type
19.
METHOD AND SYSTEM FOR PRODUCING STERILE SOLUTION FILLED CONTAINERS
A method for producing sterile solution-filled containers includes positioning a cartridge onto a filling machine. The cartridge includes a plurality of containers (26), a filter assembly (34), and a connection line 46 in fluid communication with the filter assembly. Each of the plurality of containers includes a volume and a stem in fluid communication with the volume and in fluid communication with the connection line. The method includes coupling the cartridge to a feed line in fluid communication with a mix tank, activating a pump coupled to the feed line, and at least partially filling one or more of the volumes associated with the plurality of containers by pumping fluid through the feed line, the filter assembly, and the connection line to create one or more at least partially filled containers. Further, the method includes sealing and separating each of the filled and sealed containers from the connection line.
B29C 65/00 - Joining of preformed parts; Apparatus therefor
B65B 3/00 - Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans or jars
B65B 3/04 - Methods of, or means for, filling the material into the containers or receptacles
B65B 3/12 - Methods of, or means for, filling the material into the containers or receptacles by application of pressure to material mechanically, e.g. by pistons or pumps
B65B 39/00 - Nozzles, funnels or guides for introducing articles or materials into containers or wrappers
B65B 51/14 - Applying or generating heat or pressure or combinations thereof by reciprocating or oscillating members
B65B 55/12 - Sterilising contents prior to, or during, packaging
B65B 57/04 - Automatic control, checking, warning or safety devices responsive to absence, presence, abnormal feed, or misplacement of binding or wrapping material, containers, or packages and operating to control, or to stop, the feed of such material, containers, or packages
B65B 61/06 - Auxiliary devices, not otherwise provided for, for operating on sheets, blanks, webs, binding material, containers or packages for severing webs, or for separating joined packages by cutting
B65B 65/00 - MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING - Details peculiar to packaging machines and not otherwise provided for; Arrangements of such details
G01N 1/14 - Suction devices, e.g. pumps; Ejector devices
A peritoneal dialysis ("PD") system includes a housing; a dialysis fluid pump housed by the housing and including a reusable pump body that accepts PD fluid for pumping; a dialysis fluid inline heater housed by the housing and including a reusable heater body that accepts PD fluid for heating; at least one reusable PD fluid line extending from the housing; at least one disinfection connector supported by the housing and configured to accept one of the at least one reusable PD fluid line; and a control unit configured to run a disinfection sequence after a PD treatment, wherein each of the at least one reusable PD fluid line is connected to one of the at least one disinfection connectors, and wherein at least one of the dialysis fluid pump or the dialysis fluid inline heater is actuated by the control unit during the disinfection sequence.
A peritoneal dialysis system includes a housing; a dialysis fluid pump housed by the housing; a patient line extendable from the housing; and a hose reel located within the housing, the hose reel configured to coil the patient line when disconnected from a patient. The patient line may be a dual lumen patient line, wherein the dual lumen patient line is coiled about the hose reel during a disinfection sequence for disinfecting the dual lumen patient line and the dialysis fluid pump.
A system and method is disclosed for detecting remaining battery voltage or capacity in an infusion device and generating alarms based on the detection. The battery lifetime extension method includes providing an infusion device that derives its power from a rechargeable battery. The infusion device may derive its power from a rechargeable battery. Furthermore, the infusion device receives, at predetermined intervals of time in real-time sensor data comprising: a voltage, a change in the voltage over the predetermined interval of time, an average current, a temperature, and a remaining voltage or capacity reported by a battery gas gauge integrated circuit ("IC") associated with the rechargeable battery. An improved and customized neural network model utilizes the sensor data to determine an indicia of the actual remaining voltage or capacity of the rechargeable battery in real-time. The indicia may be used to lengthen and/or abate ongoing medical infusion therapy.
G01R 31/36 - Arrangements for testing, measuring or monitoring the electrical condition of accumulators or electric batteries, e.g. capacity or state of charge [SoC]
G01R 31/367 - Software therefor, e.g. for battery testing using modelling or look-up tables
G01R 31/3842 - Arrangements for monitoring battery or accumulator variables, e.g. SoC combining voltage and current measurements
A61M 5/00 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm rests
A61M 5/14 - Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
H02J 7/00 - Circuit arrangements for charging or depolarising batteries or for supplying loads from batteries
A composition for use in the treatment of a patient suffering from or being at risk of developing a gastrointestinal disorder is disclosed. The composition is an aqueous solution for injection comprising arginine butyrate in a concentration of from 150 mg/L to 5500 mg/L of the composition. A method of treating a patient suffering from or being at risk of developing a gastrointestinal disorder by administering the related compositions is also disclosed.
A method for extending the storage lifetime of a battery located in a device is disclosed. The battery lifetime extension method includes providing a device that derives its power from a rechargeable battery. The method further includes providing a rechargeable battery that is capable of communicating with the device. When the device is powered off by a user, a computer implemented program utilized by the device communicates with the battery and automatically powers up the device into a lower power mode upon expiration of a variable duration timer monitored by the computing unit that continuously repeats according to the programed duration cycle, evaluates the state of charge of the rechargeable battery, determines whether the state of charge of the rechargeable battery is above or below a variable programed threshold, and communicates a command to the rechargeable battery to remain in a low power state until a charge is applied to the rechargeable battery.
A61M 5/00 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm rests
A61M 5/172 - Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters electrical or electronic
H02J 7/00 - Circuit arrangements for charging or depolarising batteries or for supplying loads from batteries
H02J 7/02 - Circuit arrangements for charging or depolarising batteries or for supplying loads from batteries for charging batteries from ac mains by converters
An intraperitoneal pressure ("IPP") measurement apparatus is disclosed herein. In an example, the IPP measurement apparatus includes a transfer set or catheter that is fluidly coupled to a patient's peritoneal cavity and a pressure sensor adapted to contact the transfer set or catheter. The pressure sensor is configured to transmit output data indicative of an IPP within the patient's peritoneal cavity. The pressure sensor includes a pressure element configured to measure a pressure imparted by a fluid within the transfer set or catheter. The pressure sensor also includes a pressure amplifier having a first side that contacts a portion of the transfer set or catheter and a second side that contacts the pressure element. The first side has a greater diameter or surface area compared to the second side for amplifying the pressure signal for the IPP measurement.
An additive manifold includes a valve side including a plurality of valve mounts; and a tube fitting side including a plurality of integrally formed tube fittings. The additive manifold includes at least one passageway formed between the valve side and the tube fitting side, the at least one passageway allowing fluid communication between the valve mounts and the tube fittings.
The invention relates to a medical product for preventing or correcting vitamin A deficiency in a patient comprising a lipid emulsion in a flexible container, the lipid emulsion comprising (a) vitamin A in the lipid phase of the lipid emulsion, (b) optionally additionally vitamin D, vitamin E and/or vitamin K in the lipid phase of the lipid emulsion, and (c) no more than 1.5 ppm dissolved oxygen (DO), (d) wherein the pH of the lipid emulsion is from 5 to 9.
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 47/14 - Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
A61K 47/44 - Oils, fats or waxes according to two or more groups of ; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
The invention relates to a terminally heat-sterilized multi-chamber container for parenteral nutrition, comprising a first chamber containing a macronutrient formulation and a second chamber comprising a vitamin B12 formulation, wherein the vitamin B12 formulation (a) is essentially free from glucose, amino acids, vitamin B1, ascorbyl palmitate and/or vitamin C; and (b) stably comprises vitamin B12 for at least 6 months at a temperature of from 1°C to 40°C and/or for at least 24 months at a temperature of 25°C.
A61K 31/455 - Nicotinic acid, i.e. niacin; Derivatives thereof, e.g. esters, amides
A61K 31/525 - Isoalloxazines, e.g. riboflavins, vitamin B2
A61K 31/714 - Cobalamins, e.g. cyanocobalamin, vitamin B12
A61K 47/44 - Oils, fats or waxes according to two or more groups of ; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
A61P 43/00 - Drugs for specific purposes, not provided for in groups
A chronic kidney disease ("CKD") machine learning prediction system is disclosed. The example system is configured to provide a projection as to whether a patient may progress to a next stage of CKD and/or whether the patient may need to urgently start dialysis. The machine learning algorithms disclosed herein include dynamic, multifactorial predictive algorithms that are programmed to consider clinical, pharmacological, and extra-clinical factors that adversely impact kidney function. The predictions provided by the machine learning system convey information to clinicians for improving CKD treatment before the disease worsens. In some instances, the predictions may be used for selecting a treatment plan, a dialysis treatment, and/or a renal replacement therapy ("RRT").
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
G16H 20/40 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
G16H 50/20 - ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
Handheld gas spray systems for mixing and dispensing multi- component compositions. The system comprises a fluid conveyance subassembly in fluid communication with a syringe, wherein the syringe houses at least two different sealant components. The system comprises further a housing, a gas cartridge disposed inside the housing and a gas valve assembly disposed inside the housing, wherein the gas valve assembly is configured to control flow of gas from the gas cartridge to the fluid conveyance subassembly. A trigger is configured to actuate the gas valve assembly and a detachable spray tip is configured to dispense the multi-component fluid out of the applicator.
A61B 17/00 - Surgical instruments, devices or methods, e.g. tourniquets
B05B 7/00 - Spraying apparatus for discharge of liquids or other fluent materials from two or more sources, e.g. of liquid and air, of powder and gas
B05B 15/55 - Arrangements for cleaning; Arrangements for preventing deposits, drying-out or blockage; Arrangements for detecting improper discharge caused by the presence of foreign matter using cleaning fluids
B05B 7/04 - Spray pistols; Apparatus for discharge with arrangements for mixing liquids or other fluent materials before discharge
B05B 7/12 - Spray pistols; Apparatus for discharge designed to control volume of flow, e.g. with adjustable passages
B05B 7/24 - Spraying apparatus for discharge of liquids or other fluent materials from two or more sources, e.g. of liquid and air, of powder and gas with means, e.g. a container, for supplying liquid or other fluent material to a discharge device
B05B 12/00 - Arrangements for controlling delivery; Arrangements for controlling the spray area
31.
IV DRESSING WITH EMBEDDED SENSORS FOR MEASURING FLUID INFILTRATION AND PHYSIOLOGICAL PARAMETERS
The invention provides an intravenous (IV) dressing system that helps secure an IV catheter to a patient while simultaneously using embedded peripheral venous pressure (PVP), impedance, temperature, optical, and motion sensors to characterize properties of the IV system (e.g., infiltration, extravasation, occlusion) and the patient's physiological parameters (e.g., heart rate, SpO2, respiration rate, temperature, and blood pressure). Notably, the system converts PVP waveforms into arterial BP values (e.g., systolic and diastolic blood pressure).
The invention provides an IV system for monitoring a patient that is positioned on the patient's body. The IV system includes: 1) a catheter that inserts into the patient's venous system; 2) a pressure sensor connected to the catheter that measures physiological signals indicating a pressure in the patient's venous system; 3) a motion sensor that measures motion signals; and 4) a processing system that: i) receives the physiological signals from the pressure sensor; ii) receives the motion signals from the motion sensor; iii) processes the motion signals by comparing them to a pre-determined threshold value to determine when the patient has a relatively low degree of motion; and iv) process the physiological signals to determine a physiological parameter when the processing system determines that the motion signals are below the pre-determined threshold value.
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
A61B 5/02 - Measuring pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography; Heart catheters for measuring blood pressure
A61B 5/021 - Measuring pressure in heart or blood vessels
A61B 5/0215 - Measuring pressure in heart or blood vessels by means inserted into the body
The present disclosure relates to parenteral nutrition formulations, including ready-to-use parenteral nutrition formulations which are reconstituted from multi-chamber containers and amino acid formulations. More particularly, the present disclosure is directed to formulations comprising butyrate derivatives, specifically arginine butyrate, for use with adult or pediatric patients. The disclosure further provides for methods of reducing or preventing systemic and local inflammation of patients receiving parenteral nutrition, and methods of maintaining or ameliorating their systemic immunity and local immunity, as well as the patients´ gut barrier functions.
An infusion pump includes a housing, a pumping mechanism, an accelerometer configured to detect at least one of pump motion and pump angular orientation, and a temperature control unit. The temperature control unit is configured to receive accelerometer data and determine a pump configuration based on the accelerometer data. The pump configuration may include a contact configuration or a non-contact configuration. The temperature control unit is also configured to establish a threshold housing temperature based on the determined pump configuration. Additionally, the temperature control unit is configured to modify at least one pump feature or function to maintain the housing below the threshold housing temperature.
An infusion pumping mechanism includes a motor, a plurality of pump fingers and an opposing plate. Each finger of the pump fingers includes a body portion and a head portion. The head portion includes a tip that is configured to contact and occlude a tube installed in the pumping mechanism. The opposing plate includes an anvil with a plurality of force concentrators. A force concentrator of the plurality of force concentrators corresponds to a respective pump finger of the plurality of pump fingers. Additionally, the force concentrator includes a concentration surface configured to contact and occlude the tube. The force concentrator is aligned with a tip of the respective pump finger such that as the finger is directed towards the tube and contacts the tube, both the tip and the force concentrator provide pressure to opposite sides of the tube and at least partially occlude the tube.
A system includes a server including a clock and a plurality of medical devices in network communication with the server. Each medical device includes at least one alarm mechanism and an internal clock. A first medical device of the plurality of medical devices is configured to receive a clock synchronization data from the server, update the internal clock of the first medical device based on the clock synchronization data, provide an alarm signal of a first type at a first time, and provide a subsequent alarm signal of the first type at a second time. The second time occurs at a predetermined interval from the first time. Additionally, the second time is the same time the alarm signal of the first type is provided by a second medical device of the plurality of medical device.
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
G16H 20/17 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
G16H 40/20 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
G16H 40/40 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
A digital communication module for transmission of data from a medical device is disclosed. In an example, a digital communication apparatus includes an input interface configured for communicative coupling to a medical device and an output interface configured for communicative coupling to a medical network. A processor of the digital communication apparatus receives a configuration file that specifies one input port of the input interface and at least one output port of the output interface, a first data format, and a second data format. The processor installs drivers for the input and output ports specified by the configuration file, provisions the input interface with the specified input port to receive medical data from the medical device in the first data format, and provisions the output interface with the at least one specified output port to transmit the received medical data using the first data format and the second data format.
G16H 40/40 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
G16H 40/60 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
38.
DAPTOMYCIN FORMULATIONS CONTAINING A COMBINATION OF SORBITOL AND MANNITOL
In an aspect, a method of manufacture of a pharmaceutically acceptable solid composition containing daptomycin includes drying an aqueous solution containing (i) water, (ii) the daptomycin, (iii) sorbitol in an amount of about 1.2 wt.% to about 9.0 wt.% of total volume of the aqueous composition and (iv) mannitol in an amount of about 0.6 wt.% to about 9.5 wt.% of total volume of the aqueous composition to form the solid composition. The drying can include an sublimation drying of about -25 °C to about 50 °C for a time period of about 15 hours to about 120 hours, most preferably about 15 °C for about 20 hours, optionally preceded and/or followed by one or more additional drying steps. Other aspects are the solid composition containing the daptomycin and also methods of treating a bacterial infection including administering a pharmaceutically acceptable product made by reconstituting the solid composition.
A packaged, sealed container system for stable storage of a formulation of an oxygen-sensitive pharmaceutical compound, the packaged, sealed container system comprising a primary container including therein a formulation of an oxygen-sensitive pharmaceutical compound, a secondary outer container comprising a first flexible sheet layer, an opposing second flexible sheet layer, and a seal disposed along a common peripheral edge of the first and second flexible sheet layers, such that the primary container is disposed between and enclosed by the first and second flexible sheet layers of the secondary outer container. An oxygen scavenger is also disposed between and enclosed by the first and second flexible sheet layers of the secondary outer container. The oxygen scavenger is in fluid communication with the contents of the primary container.
A vascular monitoring system includes a collar configured to be positioned about a patient's vessel and a transducer coupled to the collar. The collar may be formed by a strap that is wrapped around the patient's vessel and maintained in a closed configuration. The transducer is configured to emit an ultrasonic signal that is transmitted through the patient's vessel.
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
A61B 8/00 - Diagnosis using ultrasonic, sonic or infrasonic waves
A61B 8/08 - Detecting organic movements or changes, e.g. tumours, cysts, swellings
A61B 90/00 - Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups , e.g. for luxation treatment or for protecting wound edges
The invention relates to a medical product for preventing or correcting selenium deficiency in a patient comprising a solution provided in a flexible container comprising at least one selenium compound in the form of Se (IV), which is preferably selected from the group consisting of sodium selenite, selenous acid and selenium dioxide, characterized in that the solution comprises dissolved oxygen (DO), preferably 0.5 ppm to 8 ppm DO.
The invention relates to a medical product for preventing or correcting selenium deficiency in a patient comprising a solution provided in a flexible container characterized in that the solution comprises at least one of a selenate salt and/or a seleno-amino acid, such as selenomethionine or selenocysteine.
An extracorporeal and drug delivery system includes (i) a renal failure therapy machine operable with a blood filter in fluid communication with an arterial line and a venous line, the machine including (a) an effluent pump for pumping effluent from the blood filter at an effluent flowrate, and at least one of (b) a dialysis fluid pump for pumping dialysis fluid to the blood filter at a dialysis fluid flowrate, (c) a predilution pump for pumping replacement fluid into the arterial line at a predilution flowrate, or (d) a postdilution pump for pumping replacement fluid into the venous line at a postdilution flowrate; (ii) an infusion pump operable to deliver an intravenous ("IV") drug to the patient at an IV drug flowrate; and (iii) a coordinating logic implementor configured to adjust the IV drug flowrate based on an amount of the IV drug removed via the effluent flowrate.
G16H 20/17 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
A61M 1/34 - Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration, diafiltration
A medical fluid delivery system including analytics for managing patient engagement and treatment compliance is disclosed. In an example, an interface device receives treatment data from a dialysis machine for a patient undergoing dialysis. An analytics processor determines dialysis treatment parameter values by comparing the treatment data to a record of a prescribed therapy or program. The dialysis treatment parameter values may include a lost treatment time parameter value, a lost dwell time parameter value, and/or a completed treatment days parameter value. The analytics processor causes the dialysis treatment parameter values to be displayed within a user interface on a clinician device. The dialysis treatment parameter values provide an indication as to how well the patient is complying with the prescribed therapy or program, and may be used by a clinician to help a patient improve compliance if needed.
G16H 20/10 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
G16H 20/17 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
G16H 20/40 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
G16H 40/40 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
G16H 40/63 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
G16H 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
The present disclosure relates to a sterile medical product for parenteral nutrition comprising a polymeric container having at least a first and a second chamber which are separated by a non-permanent peel seal, wherein the first chamber contains a composition of amino acids and optional- ly electrolytes, and wherein the second chamber contains a dextrose solution, and wherein the product is characterized by a high protein (nitrogen) content per volume. The reconstituted solution is configured to be administered periph- erally or centrally for the treatment of patients suffering from malnutrition and/or having a need for increased uptake of amino acids.
A device for transmitting and sensing signals comprises a non-conductive substrate adherable to a skin of a subject, two or more electrical contacts printed on the substrate, and a disposable connector, connectable to a compatible cable connector of a cable which receives signals from the contacts via the disposable connector. The disposable connector has a symmetric shape such that mating between the disposable connector and the compatible cable connector is established at either one of two flipped orientations.
A kit for transmitting and sensing signals comprises: a multi-connection cable having a plurality of cable connectors at a distal end of the cable for establishing electrical communication between each of the cable connectors and a system for measuring bioimpedance that is connectable to a proximal end of the cable, and a plurality of devices for transmitting and sensing signals. Each device comprises a non-conductive substrate adherable to a skin of a subject, a first and a second electrical contacts printed on the substrate, and a disposable connector. Each disposable connector is connectable to a compatible cable connector of the cable in a manner that a combined thickness of the disposable connector and the compatible cable connector, once connected, is less than 4 mm.
A61B 5/0295 - Measuring blood flow using plethysmography, i.e. measuring the variations in the volume of a body part as modified by the circulation of blood therethrough, e.g. impedance plethysmography
A body-worn patch sensor for simultaneously measuring a blood pressure (BP), pulse oximetry (SpO2), and other vital signs and hemodynamic parameters from a patient featuring a sensing portion having a flexible housing that is worn entirely on the patient's chest and encloses a battery, wireless transmitter, and all the sensor's sensing and electronic components. It measures electrocardiogram (ECG), impedance plethysmogram (IPG), photoplethysmogram (PPG), and phonocardiogram (PCG) waveforms, and collectively processes these to determine the vital signs and hemodynamic parameters. The sensor that measures PPG waveforms also includes a heating element to increase perfusion of tissue on the chest.
A61B 5/0295 - Measuring blood flow using plethysmography, i.e. measuring the variations in the volume of a body part as modified by the circulation of blood therethrough, e.g. impedance plethysmography
A61B 5/08 - Measuring devices for evaluating the respiratory organs
A61B 5/1455 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using optical sensors, e.g. spectral photometrical oximeters
Infusion pump alignment features for vertically-oriented IV tubes are disclosed. In an example, an infusion pump housing (312) includes a tube channel (404) having a radial curvature for bending an IV tube (301) from a horizontal orientation to a vertical orientation when the infusion pump (300) is positioned for operation. The housing also includes a hood (402) having a first side and a second side that are divided by the tube channel. The infusion pump has a door (304) that is connected to the housing for enclosing the tube channel and the hood. The door includes a cavity having dimensions to receive the hood when the door is in a closed position. The hood is configured to engage the cavity to prevent the door from closing if the IV tube is not positioned along the tube channel.
A pharmaceutically acceptable insulin premix formulation contains about 0.1-10.0 Unit/mL of insulin for intravenous administration and preferably further contains a tonicity adjuster, and may be aseptically filled into a flexible container assembly to form a pharmaceutical insulin premix product, which can be a sterile and ready-to-use aqueous solution for glycemic control in an individual with metabolic disorders through intravenous infusion. The insulin premix product is unexpectedly stable when freshly prepared and also during its shelf-life of storage at refrigeration temperatures of 2 ºC to 5 ºC for 24 months followed by additional 30 days at room temperatures of 23 ºC to 27 ºC, even without any added preservative, any added zinc, any added surfactant or any other added stabilizing excipient.
A priming sensor for a medical fluid delivery device is disclosed. In an example, the priming sensor includes light emitters and a detector. The detector is configured to detect light emitted by the emitters that interacts with a patient tube connected to the priming sensor. A processor of a medical fluid delivery device causes the emitters to operate in a sweep pattern during a sweep period. The processor receives output data from the detector that is indicative of light detected during the sweep period. The processor creates an output waveform corresponding to the sweep period based on the output data and compares the output waveform to at least one reference waveform to determine one of (a) a no-tube state, (b) a dry tube state, or (c) a wet tube state. The processor provides an output indicative of the comparison for operation of the medical fluid delivery device.
A Doppler blood flow monitoring device (150) includes a signal generation module, a signal reception module, a signal filtration module, a signal conversion module, at least one speaker, and a user interface (304). The signal generation module is configured to send a signal to a probe (106) positioned in a probe receptacle on a vascular coupler positioned about a patient's vessel. The signal reception module is configured to receive a return signal from the probe. The signal filtration module is configured to filter the return signal. The signal conversion module is configured to convert the filtered signal into an audible indication and a visual indication corresponding to a characteristic of blood flow in the patient's vessel. The at least one speaker (214) is configured to emit the first audible indication. Additionally, the user interface is configured to display the visual indication.
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
A61B 8/00 - Diagnosis using ultrasonic, sonic or infrasonic waves
A61B 8/08 - Detecting organic movements or changes, e.g. tumours, cysts, swellings
A61B 8/12 - Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
A61B 17/11 - Surgical instruments, devices or methods, e.g. tourniquets for closing wounds, or holding wounds closed, e.g. surgical staples; Accessories for use therewith for performing anastomosis; Buttons for anastomosis
Delivery devices, delivery systems, and related methods, for precise administration of hemostatic compositions are disclosed, which may include a trigger mechanism, a pusher, a valve, and a cannula. The pusher is configured to engage with the trigger mechanism, retain a first syringe, a least by coupling with a plunger of the first syringe. The valve is fluidly coupled to the first syringe. The valve is further configured to engage with a second syringe, in fluid communication with both the valve and the first syringe. The cannula extends distally from and is fluidly coupled to the valve. Activation of the trigger mechanism causes the pusher and the plunger of the first syringe to translate in a distal direction, to expel a composition out of the first syringe, through the valve, through the cannula, and out of a distal end of the cannula.
A61B 17/00 - Surgical instruments, devices or methods, e.g. tourniquets
A61B 17/03 - Surgical instruments, devices or methods, e.g. tourniquets for closing wounds, or holding wounds closed, e.g. surgical staples; Accessories for use therewith
A patient platform for patient engagement and treatment compliance is disclosed. In an example, a processor is configured to obtain medical information from a patient for engagement and treatment compliance tracking. To obtain the medical information, the processor causes a user interface to be displayed with fields to be populated with medical information. After receiving a selection of a data field, the processor provides an option to enter medical information from an image. If the option is selected, the processor receives a recorded image of a medical device or a screen of a medical device, extracts text from the image, enables a selection of at least a portion of the text from the image, and writes the selected text from the image into the data field of the user interface as the medical information. The processor transmits the medical information to a patient medical record stored in a clinician database.
G16H 10/60 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
G16H 20/10 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
G16H 30/20 - ICT specially adapted for the handling or processing of medical images for handling medical images, e.g. DICOM, HL7 or PACS
G16H 30/40 - ICT specially adapted for the handling or processing of medical images for processing medical images, e.g. editing
G16H 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
55.
DIALYSIS SYSTEM AND METHODS INCLUDING SENSOR FEEDBACK TO IMPROVE PATIENT EXPERIENCE
A peritoneal dialysis system comprises: a cycler including a pump actuator and a control unit in operable communication with the pump actuator; a disposable set including a disposable cassette having a pump chamber, the disposable cassette sized and arranged to be held by the cycler such that the pump chamber is in operable communication with the pump actuator, and including a patient line and a drain line extending from the disposable cassette; a catheter for placement within a patient's peritoneal cavity for fluid communication with the patient line; and an impedance sensor operably coupled to one of the catheter, patient line, or drain line to sense an impedance of peritoneal dialysis fluid residing within the patient, or removed from the patient, the sensed impedance being indicative of a presence or absence of white blood cells to form a patient peritonitis determination, and the control unit configured to communicate the peritonitis determination.
The invention provides a body-worn patch sensor for simultaneously measuring a blood pressure (BP), pulse oximetry (SpO2), and other vital signs and hemodynamic parameters from a patient. The patch sensor features a sensing portion having a flexible housing that is worn entirely on the patient's chest and encloses a battery, wireless transmitter, and all the sensor's sensing and electronic components. It measures electrocardiogram (ECG), impedance plethysmogram (IPG), photoplethysmogram (PPG), and phonocardiogram (PCG) waveforms, and collectively processes these to determine the vital signs and hemodynamic parameters. The sensor that measures PPG waveforms also includes a heating element to increase perfusion of tissue on the chest.
A graph database for outbreak tracking and management is disclosed. In an example embodiment, an outbreak management system includes a memory device storing instructions that define a graph database for disease outbreak tracking. The instructions specify for a given host that a host node is created and an episode node is connected to the host node via a 'case' link. The episode node is associated with episode parameters that are related to a disease classification of the host. In addition, the instructions specify that an outbreak node is connected to the episode node via a 'part of' link to indicate that the host has become part of an outbreak of the disease. The outbreak node is connected to a definition node via a 'defined as' link. The definition node specifies disease parameters of the disease that is related to the outbreak node.
G16H 50/80 - ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for detecting, monitoring or modelling epidemics or pandemics, e.g. flu
58.
DISPOSABLE CASSETTE CONDITIONING SYSTEM AND METHOD
A medical fluid delivery system comprises: (i) a medical fluid delivery machine including a pneumatic manifold having pump and valve actuation areas and a pumping gasket overlaying the pump and valve actuation areas, sources of positive and negative pneumatic pressure, plural pneumatic valves located between the pneumatic sources and the pump and valve actuation areas, and a control unit in operable communication with the plural pneumatic valves; and (ii) a disposable cassette including a fluid pump chamber that aligns with the pump actuation area when the disposable cassette is mated with the pneumatic manifold, the disposable cassette including sheeting overlaying the fluid pump chamber, wherein the control unit is configured to operate the pneumatic valves to perform a conditioning routine that moves the pumping gasket and the cassette sheeting while mated in an attempt to remove small air pockets from between the pumping gasket and the cassette sheeting.
An infusion device for dispensing fluid at a predetermined flow rate includes an elastic bladder, a pressure regulator, and a flow restrictor. The elastic bladder includes a bladder volume portion and a bladder outlet, and the elastic bladder stores fluid in the bladder volume portion and dispenses fluid through the outlet at a bladder pressure. The pressure regulator is in fluid communication with the outlet of the elastic bladder. The pressure regulator includes a fluid inlet and a fluid outlet. The fluid inlet is coupled to the bladder outlet to receive fluid from the bladder. The flow restrictor is in fluid communication with the fluid outlet. The flow restrictor and the pressure regulator cooperate to discharge fluid from the flow restrictor at a predetermined flow rate.
A61M 5/152 - Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. by means of pistons flexible pressurised by contraction of elastic reservoirs
The present disclosure relates to parenteral nutritional formulations, including ready-to-use parenteral nutrition formulations. More particularly, the present disclosure is directed to lipid formulations or emulsions and multi-chamber containers comprising same, wherein the lipid emulsion contains glycerophosphorylcholine as a choline source. The present disclosure further relates to methods of providing choline to a patient in need of parenteral nutrition and methods of avoiding and/or treating choline deficiency and liver damage.
Parenteral nutrition formulations for pediatric patients are disclosed. The nutritional formulations include a lipid formulation that comprises an aqueous phase and an oil phase, wherein the lipid formulation is in the form of an oil-in-water emulsion. Multi-chamber containers for parenteral nutrition administration comprising a carbohydrate formulation present in a first chamber, an amino acid formulation present in a second chamber, and the lipid formulation present in a third chamber also are disclosed.
An infusion pump includes a housing with a door pivotally mounted to the housing, a tube channel on the housing configured to hold a tube in the infusion pump, a pumping mechanism including a shuttle, and a slide clamp ejection device.
A syringe pump includes a housing with a syringe accepting region, a syringe holding system configured to hold a syringe in the syringe accepting region, a drive mechanism, and a drive head operatively coupled to the drive mechanism. The drive head is configured to engage a piston of a syringe held by the syringe holding system.
G16H 20/17 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
A61M 5/145 - Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. by means of pistons
A61M 5/172 - Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters electrical or electronic
64.
MEDICAL DEVICE DATA BACK-ASSOCIATION, SYSTEM, APPARATUSES, AND METHODS
A medical device data back-association system, apparatuses, and methods are disclosed. In an example embodiment, a server receives first medical device data from a medical device including a device identifier and stores the first medical device data to an unassociated record in a database after determining that there is no association between the device identifier and any patient identifier or medication order identifier. While the medical device is administering the medication to a patient, the server receives an identifier message including at least two of the device identifier, the patient identifier, and the medication order identifier. The server creates an identifier association between a medical record of the patient and the medical device using the identifier message. The server uses the identifier association to store subsequent medical device data from the medical device to the medical record of the patient.
G16H 10/60 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
G16H 20/10 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
G16H 20/17 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
G16H 40/60 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
G16H 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
A gravity fed peritoneal dialysis ("PD") machine includes: a frame configured to be set on a supporting surface; at least one load cell; a scale platform supported by the frame via the at least one load cell positioned between the frame and the scale platform; a drain container support in mechanical communication with and extending downwardly from the scale platform, the machine configured such that when the frame is set on the supporting surface, at least one fresh PD fluid supply container is supportable by the scale platform above the at least one load cell and at least one used PD fluid drain container is supportable by the drain container support below the at least one load cell, so that a combined weight of fresh PD fluid and used PD fluid may be sensed by the at least one load cell.
Spray-dried thrombin materials obtained from feedstock solutions comprising less than 5% by weight albumin and excluding trehalose or other excipients as well as methods of manufacturing the thrombin materials and methods of treating bleeding wounds are disclosed. The methods of use include applying reconstituted spray-dried thrombin topically to a bleeding site, optionally in conjunction with gelatin.
There is provided an IV infusion set comprising a patient access configured to connect to a vascular system of a patient, a source of medical fluid, an infusion line having one first end configured to connect to the source of medical fluid and one opposite second end configured to deliver the medical fluid towards the patient access, an infusion apparatus arranged on the infusion line, a sensor configured to emit a pressure signal indicative of a pressure of a medical fluid in the infusion line, and a control unit configured to receive the pressure signal and to determine a patient signal indicative of a vital signal of the patient based on the pressure signal. The IV infusion set further comprises a compliance element configured to attenuate pressure variations of medical fluid the infusion line, and a resistance element configured to reflect pressure waves moving along the infusion line. The sensor is arranged on the infusion line at a position downstream from the resistance element with respect to a direction of fluid flow along the infusion line from the medical fluid source towards the patient access. The infusion line may include a main infusion line and/or one or more auxiliary infusion lines connected to a main infusion line.
Devices, systems, and methods for filtering medical device noise artifacts from circulatory waveform signals are disclosed. A circulatory pressure is measured and transformed from the time domain to the frequency domain for analysis to determine patient status. To avoid artifacts of the pumping, the time-domain measurements are filtered to generate a filtered time-domain signal, by removing active pumping periods. The filtered time-domain signal is transformed into a frequency-domain signal, which is analyzed based upon peaks indicating respiratory rate, heart rate, or harmonics thereof. Peaks may be adjusted based on a ratio that considers removed signals. A metric of patient status is then determined from the peaks or corresponding frequencies. The patient status may be related to blood volume of the patient and may be used to control pump operation.
The present disclosure provides wound-treating absorbent kits that comprise a set of hemostatic compositions including at least (1) a first hemostatic composition including a first crosslinked polysaccharide selected from the group consisting of cyclodextrin and dextran, and (2) a second hemostatic composition including a second crosslinked polysaccharide selected from the group consisting of cyclodextrin and dextran. In some embodiments, the first hemostatic composition has a first degree of crosslinking, and the second hemostatic composition has a second degree of crosslinking higher than the first degree of crosslinking. Also provided are methods of treating a wound by selecting a hemostatic composition from the disclosed set of hemostatic compositions, and administering the selected hemostatic composition to a site of the wound.
Polymeric compositions, methods, and delivery devices for inhibiting bleeding are disclosed. The method includes applying a dried material topically to a wound site, where the material may include a cross-linked biologically compatible polymer which forms a hydrogel when exposed to blood and where the material may not include an active agent such as thrombin. A spring-loaded delivery device as described herein may be used to apply the dried material.
A61K 47/42 - Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
A61M 5/315 - Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod; Appliances on the rod for facilitating dosing
A61M 11/00 - Sprayers or atomisers specially adapted for therapeutic purposes
A61M 35/00 - Devices for applying media, e.g. remedies, on the human body
71.
A PORT ARRANGEMENT, A PURIFIED WATER PRODUCING APPARATUS COMPRISING THE PORT ARRANGEMENT AND A METHOD FOR PERFORMING PORT CLEANING OF A PURIFIED WATER PRODUCING APPARATUS
A port arrangement (1) comprising a fluid module (2) incorporating a first port (3) arranged to receive a first connector (4) and a second port (5) arranged to receive a second connector (6). The first port (3) provides a first circumferential space (3c) around a first tube (3a). The second port (5) provides a second circumferential space (5c) around a second tube (5c). The fluid module (2) further incorporates a bypass channel (7) connecting the first circumferential space (3c) and the circumferential second space (5c). The port arrangement (1) further comprises a door (20) comprising a first seal (21) and a second seal (22) arranged to seal the first circumferential space (3c) and the second circumferential space (5c) against the outside. The disclosure also relates to a purified water producing apparatus (100) comprising the port arrangement (1), and a method for performing port cleaning of the water producing apparatus (100).
Therapy device systems, modules, and methods, include memory, one or more processors, in communication with the memory, a plurality of medical therapy devices, a plurality of patient monitoring devices, and a protocol execution module, configured to execute on the one or more processors. The protocol execution module displays a plurality of protocols. The protocol execution module receives a selected protocol, associated with an individual medical therapy device being one of a plurality of medical therapy devices and associated with an individual patient monitoring device being one of a plurality of patient monitoring devices. The protocol execution module executes the selected protocol with the individual medical therapy device.
G16H 40/60 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
G16H 70/20 - ICT specially adapted for the handling or processing of medical references relating to practices or guidelines
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
Medical fluid management assembly includes: a pneumatic manifold including multiple plates forming pneumatic passageways, a pneumatic valve chamber and a pneumatic pump chamber, the valve chamber in pneumatic communication with at least one passageway, the pump chamber in pneumatic communication with at least one passageway; and a fluid manifold including multiple fluid pathways, a fluid valve chamber in selective fluid communication with a fluid pump chamber and at least one fluid pathway, wherein (a) the pneumatic valve chamber and the fluid valve chamber are mated together to compress a membrane and (b) the pneumatic pump chamber and the fluid pump chamber are mated together to compress a membrane, wherein at least one of the pneumatic valve chamber or the pneumatic pump chamber extends from the at least one plate, or the fluid valve chamber or the fluid pump chamber extends from the fluid manifold to aid in compressing the membranes.
A sterile product bag includes a bladder, a stem, a filter, and a vial adaptor. The bladder has a perimeter seal and defining a sterile chamber. The stem extends through the perimeter seal and has an inlet end outside of the perimeter seal and an outlet end in fluid communication with the chamber. The filter is disposed in line with the stem and has a filter membrane with a nominal pore size in a range of approximately 0.1 µ?? to approximately 0.5 µ??. The filter membrane is shaped as a hollow fiber with a wall and pores residing in the wall of the fiber. The vial adaptor includes a sterile hollow cannula, a sheath, and a peelable closure. The cannula is in fluid communication with the chamber of the bladder. The sheath is disposed outside of the bladder and connected to the hollow cannula. The sheath includes an interior cavity into which the hollow cannula extends. The peelable closure extends across an opening of the sheath to seal the interior cavity.
A product bag includes a bladder and an elongated filtration device. The bladder includes opposing first and second film layers defining a product chamber. The first and second film layers are sealed together along a perimeter seal extending along at least a portion of a perimeter of the bladder. The elongated filtration device includes a housing, a filtration membrane disposed in the housing, an inlet adapted for receiving a fluid to be filtered, and an outlet in fluid communication with the product chamber. A majority of the elongated filtration device is embedded between the first and second film layers of the perimeter seal of the bladder to provide for a compact form factor.
A61J 1/14 - Containers specially adapted for medical or pharmaceutical purposes - Details; Accessories therefor
B65B 3/00 - Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans or jars
B65D 33/00 - CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES - Details of, or accessories for, sacks or bags
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.
A sterile solution product bag for lyophilizing includes a bladder, a first stem having a first stem inlet end and a first stem outlet end. The first stem outlet end is fluidly connected to the bladder and the first stem inlet end is adapted to receive a liquid. A first filter is disposed in-line with the first stem and includes a first filter membrane, a first filter open end, and a first filter closed end. The first filter closed end is disposed between the first stem inlet end and the first stem outlet end and the first filter open end is disposed in proximity to the first stem inlet end. A second stem having a second stem inlet end fluidly connected to the bladder and a second stem outlet end adapted to receive a vapor. A second filter is disposed within the second stem and includes a filter membrane.
A61J 1/14 - Containers specially adapted for medical or pharmaceutical purposes - Details; Accessories therefor
A61J 1/20 - Arrangements for transferring fluids, e.g. from vial to syringe
A61J 3/02 - Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of powders
A61K 9/19 - Particulate form, e.g. powders lyophilised
A61L 2/00 - Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
B65B 55/02 - Sterilising, e.g. of complete packages
B65B 55/12 - Sterilising contents prior to, or during, packaging
F26B 5/06 - Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing
A system for reconstituting and sterilizing a concentrate includes a mixing container, a filtration device, and a product bag. The a mixing container has an inlet port and outlet port in fluid communication with a mixing chamber disposed between the inlet port and the outlet port. The mixing chamber is adapted to contain a product concentrate. The filtration device has an inlet and an outlet, the inlet of the filtration device coupled to the outlet port of the mixing container. The filtration device includes a filter membrane with a nominal pore size in a range of approximately 0.1 µ?? to approximately 0.5 µ??. The product bag has an inlet port coupled to the outlet of the filtration device, and has a bladder defining an empty sterile chamber for receiving sterilized and reconstituted product resulting from mixing a diluent with a product concentrate in the mixing chamber to obtain a mixture then introduced through the filtration device to obtain the reconstituted and sterilized product.
A medical product includes a bladder, a filtration device, and a sterile product concentrate. The bladder has a perimeter seal and defining a sterile chamber. The filtration device includes a stem and a filter membrane disposed in line with the stem. The stem extends through the perimeter seal and has an inlet end accessible from outside of the perimeter seal and an outlet end in fluid communication with the sterile chamber. The filter membrane can have a nominal pore size in a range of approximately 0.1 µm to approximately 0.5 µm, wherein the filter membrane is shaped as a hollow fiber with a wall and pores residing in the wall of the fiber. The sterile product concentrate is disposed in the sterile chamber and adapted to be reconstituted by the introduction of a pharmaceutical fluid into the chamber through the filtration device.
Devices, systems, and methods for filtering medical device noise artifacts from venous waveform signals are disclosed. A peripheral venous pressure (PVP) is measured and transformed from the time domain to the frequency domain for analysis to determine patient status. To avoid artifacts of the pumping, the time-domain PVP measurements are filtered to generate a filtered time-domain PVP signal by removing active pumping periods. The filtered time-domain PVP signal is transformed into a frequency-domain PVP signal, which is analyzed based upon peaks indicating respiratory rate, heart rate, or harmonics thereof. A metric of patient status is then determined from the peaks or corresponding frequencies. The patient status may be related to blood volume of the patient and may be used to control pump operation.
The present disclosure relates to a water purification apparatus that comprises a reverse osmosis device, RO-device, producing a purified water flow and to a corresponding method. The proposed method comprises detecting at least one fluid property of purified water in the purified water path and regulating a flow rate of water in the recirculation path to fulfil one or more predetermined criteria of the purified water in the purified water path, based on the at least one detected fluid property. The present disclosure also relates to a computer program and a computer program product implementing the method.
C02F 1/469 - Treatment of water, waste water, or sewage by electrochemical methods by electrochemical separation, e.g. by electro-osmosis, electrodialysis, electrophoresis
82.
A WATER PURIFICATION APPARATUS AND METHODS FOR CLEANING THE WATER PURIFICATION APPARATUS
A water purification apparatus (300) capable of being cleaned at a point of care, and methods for cleaning the water purification apparatus (300) at the point of care. The water purification apparatus (300) and the methods provide an efficient use of a heater (302) for heat disinfection the water purification apparatus (300), e.g. by recirculating heated fluid to further heat the fluid. Several different cleaning programs are provided that may be utilized for cleaning different parts of the water purification apparatus (300).
A parenteral nutritional diagnostic system, apparatus, and method are disclosed. In an example embodiment, a parenteral nutritional diagnostic apparatus determines muscle quantity and muscle quality of a patient's psoas muscle to determine a nutritional status of the patient. An image interface is configured to receive a medical image including radiodensity data related to imaged tissue of the patient. The apparatus also includes a processor configured to use the medical image to determine a tissue surface area for each different value of radiodensity and determine a distribution of the tissue surface area for each radiodensity value. The processor is configured to determine muscle quality by locating a soft tissue peak within the distribution that corresponds to a local peak in at a region related to at least one of muscle tissue, organ tissue, and intramuscular adipose tissue. The processor determines the nutritional status of the patient based on soft tissue peak.
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
G16H 20/60 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to nutrition control, e.g. diets
G16H 30/40 - ICT specially adapted for the handling or processing of medical images for processing medical images, e.g. editing
G16H 50/20 - ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
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 °C; 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.
An assembly for mixing and dispensing a multi-component fluid includes a sheath having first and second fluid chambers, a chamber coupler, and a flexible tip. The chamber coupler forms first and second fluid channels. Additionally, the flexible tip forms a mixing chamber with a variable mixing volume and an outlet. The flexible tip is coupled to the chamber coupler near a distal end of the sheath. In the presence of an activation force, the flexible tip is forced out of the sheath and positioned in a dispensing state with a maximum mixing volume. In the absence of the activation force, the flexible tip is housed within the sheath and positioned in a non-dispensing state with a minimum mixing volume such that the outlet is substantially closed.
A61B 17/00 - Surgical instruments, devices or methods, e.g. tourniquets
B65D 81/32 - Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents for packaging two or more different materials which must be maintained separate prior to use in admixture
The disclosure provides a multilayered hemostatic device including a first layer including carboxymethyl cellulose, a second layer including a powdered hemostatic agent provided on the first layer, and a third layer including at least one of gauze, oxidized cellulose, or collagen provided on the second layer, wherein the first layer and the third layer encapsulate the second layer and the hemostatic agent comprises one of fibrinogen, thrombin, fibrin monomers, or the combination of thrombin and gelatin.
A hemostatic device comprising a biomaterial matrix and a polymeric material prepared by combining the polymeric material with a solvent, applying the combination to the biomaterial, removing the solvent, and retaining an effective layer of the polymeric material to the biomaterial to enhance the performance of the hemostatic device in the treatment of wounds.
An infusion pump is provided for pumping fluid through an administrative set at a desired flow rate over a specified duration, and includes a pumping mechanism for releasably receiving and for exerting a pulsing force on the administrative set, thus pressurizing a portion of the set for creating a flow of fluid from a set outlet. A controller is connected to and is configured for operating the pumping mechanism, the controller determines a pulse frequency based on a volume of fluid infused over a portion of the specified duration and the desired flow rate, outputs a control signal to the pumping mechanism for operating the pumping mechanism based on the determined pulse frequency, determines a first pulse frequency based on the desired flow rate; and adjusts the first pulse frequency based on the volume of fluid infused to provide a second pulse frequency being different from the first pulse frequency.
An infusion pump for delivering an intravenous ("IV") fluid includes a housing comprising an actuation area that engages a portion of an IV tube. The actuation area includes a first end that receives the IV tube from a fluid container and a second end that provides the IV tube to a patient. The housing also includes a seal section located along a perimeter of at least a portion of the actuation area. The seal section includes a gasket rib positioned along the seal section and a tube channel configured to cradle the IV tube. The example infusion pump also includes a door connected to the housing and configured to engage the gasket rib to enclose the actuation area of the housing.
An infusion pump (100) includes a housing (110). The housing includes a tube port (150) adapted to receive an intravenous ("IV") tube (120). The tube port includes a tube channel (240) and a rib (280). The tube channel has an inlet and an outlet end. The rib is positioned along the channel adjacent the outlet end. The rib is formed to extend towards the tube when the tube is passed through the tube port thereby indenting the tube and tending to prevent full occlusion of the tube. The tube port may also include a plurality of ribs positioned around a perimeter of the tube port on the exterior side of the housing. The plurality of ribs are configured to prevent an occlusion in the tube when the tube is bent on the exterior side of the housing.
A medical fluid delivery system includes a medical fluid delivery machine configured to generate a message indicating that the medical fluid delivery machine is ready to perform a task; and at least one server in data communication with the medical fluid delivery machine via a first link to receive the message, the at least one server configured to (i) relay the message from the medical fluid delivery machine to a remote mobile communication device via a second link, (ii) receive a response from the remote mobile communication device indicating to start the task via the second link, and (iii) send a notification to the medical fluid delivery machine to start the task via the first link.
Devices, systems, and methods for monitoring patient hemodynamic status, systemic vascular resistance, reversal of cardiac and respiratory rates, and patient respiratory volume or effort are disclosed. A peripheral venous pressure is measured and used to detect levels, changes, or problems relating to patient blood volume. The peripheral venous pressure measurement is transformed from the time domain to the frequency domain for analysis. A heart rate frequency is identified, and harmonics of the heart rate frequency are detected and evaluated to determine, among other things, hypovolemia or hypervolemia, systemic vascular resistance, and cardiac and respiratory rates, and patient respiratory volume or effort.
A61B 5/0215 - Measuring pressure in heart or blood vessels by means inserted into the body
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
A61B 5/02 - Measuring pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography; Heart catheters for measuring blood pressure
A connection apparatus for sealing to a pathway of a mounting structure includes a body; and a port including a threaded portion extending from the body and a non-threaded portion extending from the threaded portion, the non-threaded portion carrying a gasket, the gasket positioned along the non-threaded portion such that the mounting structure to which the connection apparatus is mounted contacts the gasket prior to the threaded portion engaging a mating threaded portion of the mounting structure, the port providing fluid communciation between the body and the pathway of the mounting structure. The body may be that of a valve that supplies any of air, water or oil as an operating fluid to, for example, inlet and outlet valves and a pump chamber of a medical fluid pump of a medical fluid delivery machine.
A61M 60/113 - Extracorporeal pumps, i.e. the blood being pumped outside the patient’s body incorporated within extracorporeal blood circuits or systems in other functional devices, e.g. dialysers or heart-lung machines
F16L 41/10 - Joining pipes to walls or pipes, the joined pipe axis being perpendicular to the plane of a wall or to the axis of another pipe the extremity of the pipe being screwed into the wall
94.
MEDICAL FLUID THERAPY MACHINE INCLUDING PNEUMATIC PUMP BOX AND ACCUMULATORS THEREFORE
A medical fluid delivery machine including: a medical fluid pump including a pneumatically actuated pump chamber and first and second pneumatically actuated medical fluid valve chambers located respectively upstream and downstream of the pneumatically actuated pump chamber; a compressor for creating positive pressure air; and an accumulator storing the positive pressure air for delivery to at least one of the pneumatically actuated pump chamber, the first pneumatically actuated medical fluid valve chamber, or the second pneumatically actuated medical fluid valve chamber, the accumulator holding an elastic bladder that inflates under positive pressure air from the compressor, creating additional positive pressure that increases the amount of positive pressure air that the accumulator can provide.
A welding apparatus (100) for use in welding first (102a) and second (102b) sheets of material together includes a seal die (110), a platen (120), a control unit (130), and a power source (140) adapted to provide energy to the seal die (110). The seal die (110) is made of a conductive material and is configured to impart thermal-mechanical energy to the first (102a) and second (102b) sheets of material. The seal die (110) includes a bottom surface (310) configured to contact the first sheet (102a), an inner edge (320), a chamfer (330) extending between the bottom surface (310) and the inner edge (320), a first blend radius (340), and a second blend radius (350). The first radius (340) extends between the chamfer (330) and the bottom surface (310), while the second radius (350) extends between the chamfer (330) and the inner edge (320). The platen (120) is configured to support the second sheet (102b), while the control unit (130) is programmed to cause the seal die (110) to be directed towards the platen (120).
A medical fluid delivery system includes: a medical fluid delivery machine including a component having at least one of associated output data or associated test data; at least one of a (i) component output replacement limit and a component output soft limit for the component or (ii) a component testing replacement limit or a component testing soft limit for the component; and a computer programmed to store at least one of (i) or (ii), and for (i) analyze the output data to provide a first indication of how well the component is performing relative to the component output replacement limit and the component output soft limit, and for (ii) analyze the test data to provide a second indication of how well the at least one component is testing relative to the component testing replacement limit and the component testing soft limit.
G16H 40/40 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
The present disclosure provides methods of improving adhesion of a non-di-(2- ethylhexyl)phthalate (DEHP) plasticized polyvinyl chloride (PVC) to an acrylic-based polymer or an ABS-based polymer. Such methods may comprise blending the acrylic-based polymer or ABS-based polymer with an impact modifier so that a rubber content in the acrylic-based polymer or ABS-based polymer is greater than 12% (w/w). Also provided are components of a device (e.g., a medical device) made by the disclosed methods.
ABSTRACT A method of providing filled product bags of sterile fluid using a machine comprises loading a product bag onto a loaded cradle of a plurality of movable cradles carried by a carousel, the loaded cradle occupying a loading position, the product bag including a bladder, a stem fluidly connected to an opening of the bladder, and a filter disposed in-line with the stem; moving the loaded cradle and the product bag to a filling station that includes a nozzle by rotating the carousel and moving the loaded cradle from the loading position to a filling position adjacent the nozzle; connecting an inlet of the stem to the nozzle by moving the loaded cradle and the product bag toward the nozzle; and at least partially filling the product bag with a fluid dispensed through the nozzle to create a filled product bag. Date Recue/Date Received 2020-10-27
B65B 31/02 - Filling, closing, or filling and closing, containers in chambers maintained under vacuum or superatmospheric pressure or containing a special atmosphere, e.g. of inert gas
A61J 3/00 - Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
B65B 3/00 - Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans or jars
B65B 43/60 - Means for supporting containers or receptacles during the filling operation rotatable
A sterile solution product bag includes sterilization grade filter integrated directly into the product bag such that microbial and particulate matter filtration can be performed using the filter directly at the point of fill. The filter can include a hollow fiber filter membrane contained in a stem connected to a bladder of the product bag.
A method of providing filled product bags of sterile and particulate-free fluid includes securing a product bag to one of a plurality of movable cradles, wherein the product bag has a bladder, a stem fluidly connected to an opening of the bladder, and a filter disposed in-line with the stem. After securing the bag, an inlet of the stem is connected to an outlet of a nozzle assembly and at least partially filling the product bag with a fluid through a nozzle of the nozzle assembly to create a filled product bag, wherein filling the product bag includes passing the fluid through the filter and into the bladder. After filling, the stem of the filled product bag is sealed at a location below the filter. The stem is cut at a location above the seal and below the filter. The method including performing an integrity test on the filter, removing the filled product bag from the cradle, and depositing the filled product bag into a first bin for rejected bags if the filter fails the integrity test and a second bin for accepted bags if filter passes the integrity test.
B65B 31/02 - Filling, closing, or filling and closing, containers in chambers maintained under vacuum or superatmospheric pressure or containing a special atmosphere, e.g. of inert gas
A61J 3/00 - Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
B65B 3/00 - Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans or jars
B65B 43/60 - Means for supporting containers or receptacles during the filling operation rotatable
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