Abstract: 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.

Abstract: 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.

Abstract: A peritoneal dialysis system includes (i) a fill container, and (ii) an energizing unit that removably accepts the fill container, the energizing unit including a sterilization source so configured and arranged relative to the fill container when accepted by the energizing unit to place fluid within the fill container in a physiologically safe condition for delivery to the peritoneal cavity of a patient.

Abstract: The invention provides a neck-worn sensor (referred to herein as the ‘necklace’) that is a single, body-worn system that measures the following parameters from an ambulatory patient: heart rate, pulse rate, pulse oximetry, respiratory rate, temperature, thoracic fluid levels, stroke volume, cardiac output, and a parameter sensitive to blood pressure called pulse transit time. From stroke volume, a first algorithm employing a linear model can estimate the patient's pulse pressure. And from pulse pressure and pulse transit time, a second algorithm, also employing a linear algorithm, can estimate systolic blood pressure and diastolic blood pressure. Thus, the necklace can measure all five vital signs along with hemodynamic parameters. It also includes a motion-detecting accelerometer, from which it can determine motion-related parameters such as posture, degree of motion, activity level, respiratory-induced heaving of the chest, and falls.

Abstract: A dialysis system for determining an amount of total chlorine in a partially purified water sample is disclosed. The system includes a water machine that produces at least partially purified water including an at least partially purified water sample and a dialysis machine that provides a dialysis treatment to a patient. The dialysis machine receives the at least partially purified water from the water machine to prepare dialysis fluid for the dialysis treatment. The system also includes a total chlorine detector configured to receive the at least partially purified water sample, at a first time apply a source voltage to the at least partially purified water sample, and at a second time stop applying the source voltage to the at least partially purified water sample and instead monitor a sensed electrical parameter to determine an amount of total chlorine in the at least partially purified water sample.

Abstract: The invention provides a sensor for measuring both impedance and ECG waveforms that is configured to be worn around a patient's neck. The sensor features 1) an ECG system that includes an analog ECG circuit, in electrical contact with at least two ECG electrodes, that generates an analog ECG waveform; and 2) an impedance system that includes an analog impedance circuit, in electrical contact with at least two (and typically four) impedance electrodes, that generates an analog impedance waveform. Also included in the neck-worn system are a digital processing system featuring a microprocessor, and an analog-to-digital converter. During a measurement, the digital processing system receives and processes the analog ECG and impedance waveforms to measure physiological information from the patient. Finally, a cable that drapes around the patient's neck connects the ECG system, impedance system, and digital processing system.

Abstract: Methods and apparatuses for regenerating used dialysis fluid are described herein. In an embodiment, a regenerative dialysis fluid system includes a dialysis unit configured to generate used dialysis fluid including urea, a urea separation unit configured to separate at least a portion of the urea from the used dialysis fluid into a secondary fluid, and a urea removal unit configured to remove at least a portion of the urea from the secondary fluid and return the secondary fluid to the urea separation unit. In an embodiment, the urea separation unit includes a membrane separating a dialysis fluid chamber from a urea chamber, the membrane including at least one of: (i) a positive charge to prevent positive ions from transporting across the membrane; and (ii) a negative charge to prevent negative ions from transporting across the membrane.

Abstract: The invention provides a neck-worn sensor that is a single, body-worn system that measures the following parameters from an ambulatory patient: heart rate, pulse rate, pulse oximetry, respiratory rate, temperature, thoracic fluid levels, stroke volume, cardiac output, and a parameter sensitive to blood pressure called pulse transit time. From stroke volume, a first algorithm employing a linear model can estimate the patient's pulse pressure. And from pulse pressure and pulse transit time, a second algorithm, also employing a linear algorithm, can estimate systolic blood pressure and diastolic blood pressure. Thus, the sensor can measure all five vital signs along with hemodynamic parameters. It also includes a motion-detecting accelerometer, from which it can determine motion-related parameters such as posture, degree of motion, activity level, respiratory-induced heaving of the chest, and falls.

Abstract: A stand-on physiological sensor (e.g. floormat) measures vital signs and various hemodynamic parameters, including blood pressure and ECG waveforms. The sensor is similar in configuration to a common bathroom scale and includes electrodes that take electrical measurements from a patient's feet to generate bioimpedance waveforms, which are analyzed digitally to extract various other parameters, as well as a cuff-type blood pressure system that takes physical blood pressure measurements at one of the patient's feet. Blood pressure can also be calculated/derived from the bioimpedance waveforms. Measured parameters are transmitted wirelessly to facilitate remote monitoring of the patient for heart failure, chronic heart failure, end-stage renal disease, cardiac arrhythmias, and other degenerative diseases.

Abstract: A reconstitution device includes: a piercing member having a first end and a second end, the first end of the piercing member configured to engage an administration port; a delivery member having a first end and a second end, the first end of the delivery member configured to engage a delivery site; a collar configured to engage a vial; and a cap extending from the collar and holding the piercing member and the delivery member such that the second end of the piercing member and the second end of the delivery member are disposed within the cylindrical collar.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: Dialysis is enhanced by using nanoclay sorbents to better absorb body wastes in a flow-through system. The nanoclay sorbents, using montmorillonite, bentonite, and other clays, absorb significantly more ammonium, phosphate, and creatinine, and the like, than conventional sorbents. The montmorillonite, the bentonite, and the other clays may be used in wearable systems, in which a dialysis fluid is circulated through a filter with the nanoclay sorbents. Waste products are absorbed by the montmorillonite, the bentonite, and the other clays and the dialysis fluid is recycled to a patient's peritoneum. Using an ion-exchange capability of the montmorillonite, the bentonite, and the other clays, waste ions in the dialysis fluid are replaced with desirable ions, such as calcium, magnesium, and bicarbonate. The nanoclay sorbents are also useful for refreshing a dialysis fluid used in hemodialysis and thus reducing a quantity of the dialysis fluid needed for the hemodialysis.

Abstract: The present invention provides a glucose sensor having a glucose receptor containing a binding site of formula (I): wherein X, n, m and R1 are defined herein. Also provided is a glucose sensor molecule for use in such a glucose sensor, the glucose sensor molecule containing the binding site of formula (I). The binding site has been found to have particularly good selectivity for glucose.

Abstract: Methods, sorbent cartridges and cleaning devices are disclosed for refurbishing sorbent materials. In one implementation among multiple implementations, a medical fluid delivery method includes: providing a sorbent cartridge including H+ZP within a casing for a treatment; and after the treatment, refurbishing the H+ZP while maintained within the casing via (i) regenerating the non-disinfected H+ZP by flowing an acid solution through the casing, (ii) rinsing the regenerated H+ZP while maintained within the casing, (iii) disinfecting the regenerated and rinsed H+ZP by flowing a disinfecting agent through the casing, and (iv) rinsing the regenerated and disinfected H+ZP while maintained within the casing. Multiple batch sorbent refubishing implementations are also disclosed.

Abstract: 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.

Abstract: A handheld device measures all vital signs and some hemodynamic parameters from the human body and transmits measured information wirelessly to a web-based system, where the information can be analyzed by a clinician to help diagnose a patient. The system utilizes our discovery that bio-impedance signals used to determine vital signs and hemodynamic parameters can be measured over a conduction pathway extending from the patient's wrist to a location on their thoracic cavity, e.g. their chest or navel. The device's form factor can include re-usable electrode materials to reduce costs. Measurements made by the handheld device, which use the belly button as a ‘fiducial’ marker, facilitate consistent, daily measurements, thereby reducing positioning errors that reduce accuracy of standard impedance measurements. In this and other ways, the handheld device provides an effective tool for characterizing patients with chronic diseases, such as heart failure, renal disease, and hypertension.

Abstract: The present invention provides a hemostatic composite sponge comprising oxidized cellulose and an essentially gelatin-free bioadhesive material stably associated with said sponge and present in an organized pattern on said sponge.