Abstract: This invention provides compositions of a viral vector system containing a survivin promotor configured for expressing a reporter gene, wherein the reporter gene is differentially expressed in benign and malignant uterine masses and malignant uterine sarcomas can be bioimaged by preferential labeling with a radiotracer.

Abstract: An apparatus for the treatment of a liquid that includes a chamber having at least one inner surface, the chamber adapted for passage of a fluid therethrough. The chamber is at least 80 percent enclosed. The apparatus also includes an optional ultraviolet-transmissive tube disposed within the chamber and also adapted for the passage of the liquid therethrough. The apparatus further includes an ultraviolet lamp disposed within the chamber and, optionally, within the ultraviolet-transmissive tube. A reflective material is interposed between the chamber and the transmissive tube. The reflective material is adapted so as to reflect at least a portion of light emitted by the ultraviolet lamp, wherein the reflective material is at least 80 percent reflective.

Abstract: A Sterilization Unit includes: a UV-C radiation source configured to emit UV-C radiation; and a room partition selectably configurable between two or more different partition geometrics and configured, in each of the two or more different partition geometrics, to (a) physically separate floor space of a room into sterilization target area and a non-target area, and (b) direct the UV-C radiation to the target area from at least two different directions while shielding the non-target area from the UV-C radiation.

Abstract: A light-coupling cap can sterilize targets including connectors and other devices such as catheters with Luer fittings conforming to ISO 594 or ISO 80369 standards. The cap can be disposable. A light-coupling cap can reversibly attach to a connector of a target, creating a physical seal and barrier between the inside of the connector and the outside environment while at the same time transmitting light into the connector. A sterilizer can be connected to the end cap while the end cap is connected to the target. The sterilizer can include a UV light emitter that emits UV light through the end cap into the target. The light-coupling end cap sterilization system can be self-healing by measuring internal performance indicators and adjusting its operation in response to them. The light-coupling end cap sterilization system can provide to the user an indication of the amount of light dosage applied to the target.

Abstract: Proposed is a UV sterilizer. In a UV sterilizer according to an embodiment of the present disclosure, a light source module that emits ultraviolet (UV) light is provided between an upper body and a lower body where a fluid flows, thereby sterilizing a fluid by irradiating the flowing fluid with UV light.

Abstract: The invention provides a UV illumination device for sterilizing and disinfecting a desired item or area. The UV illumination device comprises a base of a fixed housing. The base comprises a pair of electrical terminals establishing connection with external power source. A movable housing is connected to the fixed housing through a mechanical joint. The movable housing includes a plurality of light sources, a motor, an adjustment lens, a camera unit, a memory unit, and a controlling unit connected to the camera unit and the memory unit. The plurality of light sources, the camera unit, the memory unit and the controlling unit are mounted on a base plate. The controlling unit includes a processor configured to perform certain computing operations in order to control adjustment in the direction of UV illumination by the UV illumination device.

Abstract: A sterilizing apparatus is disclosed. A sterilizing apparatus according to one embodiment comprises: a cover main body unit having an accommodation space formed therein so as to accommodate a device to be sterilized, wherein the accommodation space is open toward a bottom surface on which the device to be sterilized is disposed; an ultraviolet light emitting diode provided on a surface facing the bottom surface of the cover main body unit, and turned on so as to emit ultraviolet rays toward the accommodation space; a power supply unit for supplying power to the ultraviolet light emitting diode so as to turn on the ultraviolet light emitting diode; and a control unit for controlling an operation of the power supply unit.

Abstract: Method, sterilization system and robotic system for improving duty cycle of Ultraviolet (UV) emitter modules disinfecting closed environment. Sterilization system includes robotic system and plurality of UV emitter modules. Robotic system receives signal corresponding to discharge of battery from one of plurality of UV emitter modules. Each of plurality of UV emitter modules includes UV light source for disinfecting closed environment. Robotic system detects location of UV emitter module amongst plurality of UV emitter modules and maneuvers to location of UV emitter module, mounts UV emitter module and maneuvers UV emitter module to charging dock for charging battery of UV emitter module. After charging, robotic system maneuvers UV emitter module to pre-defined area for disinfecting pre-defined area of closed environment.

Abstract: Systems and methods for cleaning and disinfecting contaminated tube lumens are described herein. One system includes an ultraviolet light source and a sterile fluid reservoir fluidly coupled to a liquid light guide. The system is configured to allow simultaneous access and propagation of ultraviolet light and fluid in a tube having a lumen to be cleaned and disinfected. The light guide can be moved inside the tube and simultaneously emit ultraviolet light through its walls and at its distal end into the interior of the contaminated tube. A flush of sterile fluid from an open end of the liquid light guide removes debris and micro-organism detached from the inner surface during light exposure. The sterile fluid can be a high refractive index ionic solution promoting light propagation.

Abstract: A droplet bandpass filter and method of modifying droplet size distribution of a population of droplets suspended in a gas. Droplets suspended in a gas are flowed through a bandpass filter having a tortuous pathway which comprises at least one impactor region located at a position adjacent to a flow direction change. Larger droplets impact at the impactor region while smaller droplets remain suspended in the gas and flow in the first output direction. Other flow restrictors may advantageously be included in the tortuous pathway. The filter is particularly useful in delivering sterilant aerosols (e.g. peroxides) with reduced populations of large droplets.

Abstract: Various aspects of a sterilization cassette system for the sterilization of body art instruments and dental instruments fashioned from material having improved sterilization and configured in various arrangements for improved storage efficiency. One or more trays comprising part of the sterilization cassette are configured and coupled to each other in various arrangements. Each of the one or more trays have a bottom side and four side walls which are disposed substantially perpendicular to the bottom side and the bottom side has a plurality of mutually sized and arranged holes which are configured such as to provided more efficient drainage.

Abstract: The present invention comprises an improvement that embodies an innovation in fire safety. As compared to the typical linear “incense stick”, it is self-extinguishing after releasing a controlled amount of scent, without employing any additional apparatus or fire retardant. Consumers may also save money by not neglecting to extinguish the stick, releasing more scent than desired. Burn times are determined by the length and diameter of the combustible sections, being determined by the manufacturer.

Abstract: Disclosed is an absorbent article with biocompostable properties, such as a baby diaper, adult incontinence product, or a feminine hygiene pad. Particularly, the present invention is directed to a biocompostable absorbent sanitary article with a high degree of biocompostability. The sanitary article comprises, in one embodiment, at least a top layer, a back layer, and absorbent core, wherein the absorbent core includes a superabsorbent polymer, and wherein at least the superabsorbent polymer is biocompostable.

Abstract: A method for processing amniotic membrane to create a suture including cutting dried amnion layer into a designated final strip size, the cut and dried strips are twisted into a thread-like structure, interlacing the thread-like structures and drying the interlaced thread-like structure to form the suture.

Abstract: Disclosed herein is a hydrogel that eradicates biofilm bacteria from wounds and accelerates diabetic wound healing. Also disclosed herein are methods of manufacture and use of said hydrogel.

Abstract: The present disclosure relates to a microgel composition comprising collagen and hyaluronic acid and a method of preparing the same. The microgel according to an embodiment is composed of natural biocompatible substances and is non-toxic and has high mechanical stability or long persistence, and thus can be effectively used in a microgel composition, a three-dimensional scaffold composition, and a tissue-engineering scaffold.

Abstract: A solid suspension for use in bone regeneration and/or the repair of bone defects, comprising a source of at least one group II metal cation and a source of zinc cations, wherein the source of zinc cations comprises zinc oxide and wherein where there is only one group II metal cation this is strontium. A bone graft comprising a solid suspension, a method of preparation of a solid suspension and a use of a solid suspension in bone regeneration and/or in the repair of bone defects.

Abstract: A platelet-rich fibrin (PRF) three-dimensional, adhesive, biocompatible and biodegradable scaffold and/or membrane is obtained by collecting a blood sample, followed by centrifugation of the blood sample to obtain a platelet-rich fibrin clot and an exudate followed by compressing platelet-rich fibrin clot to extract the exudate until the final product being a platelet-rich fibrin three-dimensional, adhesive, biocompatible and biodegradable scaffold is obtained. A hyper-acute serum is obtained by collecting a blood sample, followed by centrifugation of said blood sample to obtain a platelet-rich fibrin clot and an exudate followed by compressing platelet-rich fibrin clot to obtain the membrane and extract the exudate being the final product hyper-acute serum. A process for the preparation of a platelet-rich fibrin three-dimensional, adhesive, biocompatible and biodegradable scaffold and/or membrane and a hyper-acute serum is also provided.

Abstract: The inventions provided herein relate to compositions, methods, delivery devices and kits for repairing or augmenting a tissue in a subject. The compositions described herein are injectable such that they can be placed in a tissue to be treated with a minimally-invasive procedure (e.g., by injection) and/or be molded flexibly into a tissue void of any shape and/or size. In some embodiments, the composition described herein comprises a plurality of silk fibroin particles, which can retain their original volume within the tissue for a period of time. The compositions can be used as a filler to replace a tissue void, e.g., for tissue repair and/or augmentation, or as a scaffold to support tissue regeneration and/or reconstruction. In some embodiments, the compositions described herein can be used for soft tissue repair or augmentation.

Abstract: Methods and formulations for promoting the healing of fracture nonunion sites under inflammatory conditions. The formulation includes a flexible biodegradable scaffold loaded with therapeutically effective amounts of CXCL12 and SPPI encapsulated in biodegradable microspheres. The method includes applying the formulation directly to a region of a fracture nonunion to effect sustained local release of the therapeutically effective amounts of CXCL12 and SPPI to the fracture nonunion region.

Abstract: The present application provides a composition of corneal implantation, comprising: a collagen film, and renal proximal tubule cells which attached to the collagen film. In addition, the present application further provides a use of the composition of corneal implantation for implanting a patient with damaged cornea endothelium cells and a preparation method of the composition of corneal implantation.

Abstract: This invention provides optimized solid substrates for promoting cell or tissue growth or restored function, which solid substrate comprises aragonite and is characterized by a specific fluid uptake capacity value of at least 75%, or a contact angle value of less than 60 degrees when in contact with a fluid and which is further characterized by tapered sides and tools for implantation of optimized solid substrates.

Abstract: The disclosure relates to an expandable scaffold and a method for fabricating the scaffold. The expandable scaffold includes a three-dimensional porous structure comprising a composite material composed by a first material and a second material. The 3D porous structure has a tunable expansion capacity. When applied in a liquid, the 3D porous structure may uptake the liquid and expand from an original volume to an expansion volume up to 1000 times of the original volume. The 3D porous structure may be formed by a plurality of layers of the composite material, and architecture and shape of the layers of the composite material are arranged in accordance with a shape and a size of the expansion volume. Applications of the scaffold may include a bone or soft tissue regeneration system or a bleed stopping device.

Abstract: Methods are disclosed for dissecting a mucosa and a submucosa from a muscularis propria from a region of an esophagus of a subject. These methods include injecting submucosally into the esophagus of the subject a pharmaceutical composition comprising an extracellular matrix (ECM) hydrogel to form a cushion between the submucosa and the underlying muscularis propria at the region of the esophagus, wherein the ECM hydrogel has the following characteristics: a) a time to 50% gelation of less than 30 minutes at a temperature of about 37° C.; b) a flow viscosity suitable for infusion into the esophagus; and c) a stiffness of about 10 to about 400 Pascal (Pa). The ECM hydrogel is not a urinary bladder ECM hydrogel.

Abstract: A prosthetic implant with improved properties, suitable for implantation to the human body, comprising a composite comprising a base material and a plurality of additives, wherein the additives are selected from radiolucent additives and/or hyperechoic additives; or wherein the additives are selected to reduce the solvent concentration by between 5%-95%; or wherein the additives are selected to increase the elastic modulus by more than 20%; or wherein the additives are selected for combining these effects.

Abstract: The invention features methods and compositions for (i) controlling the amount of peptide bound to calcium phosphate particles; and (ii) for tightly binding peptide to the surface of calcium phosphate particles. The methods and compositions can be useful for preparing implants useful for promoting bone deposition at the site of implantation, and for repairing a variety of orthopedic conditions.

Abstract: A soft tissue filler composition including a cross-linked hyaluronic acid and a benzyl alcohol. The benzyl alcohol can be present at a concentration between about 0.1% and about 2.0% by weight of the composition.

Abstract: A valve including an antimicrobial agent can be used with needleless access connectors. The valve can have an insert that includes an antimicrobial coating thereon and/or the valve can have physical features, such as a series of tunnels or groves or a patterned surface, containing an antimicrobial formulation and/or the valve can be made of a material that includes an antimicrobial agent.

Abstract: Resorbable implants, coverings and receptacles comprising poly(butylene succinate) and copolymers thereof have been developed. The implants are preferably sterilized, and contain less than 20 endotoxin units per device as determined by the limulus amebocyte lysate (LAL) assay, and are particularly suitable for use in procedures where prolonged strength retention is necessary, and can include one or more bioactive agents. The implants may be made from fibers and meshes of poly(butylene succinate) and copolymers thereof, or by 3d printing molding, pultrusion or other melt or solvent processing method. The implants, or the fibers preset therein, may be oriented. These coverings and receptacles may be used to hold, or partially/fully cover, devices such as pacemakers and neurostimulators. The coverings, receptacles and implants described herein, may be made from meshes, webs, lattices, non-wovens, films, fibers, foams, molded, pultruded, machined and 3D printed forms.

Abstract: A method for depositing a coating comprising a polymer and at least two pharmaceutical agents on a substrate, comprising the following steps: providing a stent framework; depositing on said stent framework a first layer comprising a first pharmaceutical agent; depositing a second layer comprising a second pharmaceutical agent; Wherein said first and second pharmaceutical agents are selected from two different classes of pharmaceutical agents.

Abstract: An apparatus for applying a vacuum during a surgical procedure can include a vacuum pump assembly having a port, a first housing, a second housing, a first silencer or tubular magnet and a second silencer. The first housing can define a first cavity receiving the vacuum pump assembly therein. A portion of the first housing can be formed by a portion of the port. The second housing can define a second cavity receiving the first housing therein. A portion of the second housing can be formed by a second portion of the port. The first silencer or tubular magnet can be coupled to the first housing and can have a longitudinal extent along a longitudinal axis. The first silencer or tubular magnet can extend from the first housing within the second cavity. The second silencer can be coupled to the second housing and can have a longitudinal extent along a longitudinal axis. The second silencer can extend from the second housing within second cavity.

Abstract: A pump arrangement (5) for use with abreast pump device comprises a pump element (51), an expression kit air conduit (55) designed to allow for air connection of an expression kit (2) of the device to the pump arrangement (5), a volume element (54) configured to store vacuum in the pump arrangement (5), and a storage switching mechanism (58) arranged between the expression kit air conduit (55) and the volume element (54), configured to switch between a position of direct connection of the expression kit air conduit (55) to the volume element (54) at a bypass position with respect to the pump element (51) and a position of disconnection of the expression kit air conduit (55) from the volume element (54). Through a direct exchange of vacuum between an expression kit (2) and the volume element (54), support of the functioning of the pump element (51) is realized.

Abstract: A method for facilitating milk extraction from a female breast may involve applying a breast contacting portion of a breast pump system to a breast, activating the breast pump system to administer multiple breast pumping cycles, and applying vibrations to the breast during at least a portion of each of the breast pumping cycles, using a vibration device. A vibration generating device may be a component of a breast pump system, an added attachment on a breast pump system or a separate component that works in conjunction with a breast pump system.

Abstract: A breast pump device (100) is provided with a breast receiving portion (130), a pressure source (120) for generating an over- or under pressure, a controller (110) and a breast detector (140) for detecting a first state when no breast is in the breast receiving portion and a second state when a breast is in the breast receiving portion (130). The controller (110) changes a parameter of the breast pump device and/or outputs a notification if the breast detector (140) has detected the second state. The breast detector (140) detects the first or second state based on operating parameters of the pressure source (120). The controller (110) operates the pressure source (120) in a first operating mode if the breast detector (140) has detected the first state or in a second operating mode if the breast detector (140) has detected the second state.

Abstract: A device and method of producing dialysis liquid for extracorporeal blood treatment. The device includes a main line for supplying water. An acidic and a basic fluid are introduced in specific dosages. The dosages are set by a control and regulation unit as a function of a chemical and/or physical parameter of the water/fluid mixture. The chemical and/or physical parameter is detected by a measuring device arranged at a section of the main conduit situated downstream of the introduction points for the acidic fluid and for the basic fluid. The control and regulation unit controls introduction of the acidic fluid and basic fluid so that only one of the acidic and basic fluids is introduced into the main conduit over a predetermined period or a predetermined interval. Delivery and introduction of the basic fluid and acidic fluid take place alternately.

Abstract: The present invention relates to a dialysis machine having a dialyzer, an extracorporeal blood circuit, a dialysis solution circuit, and a control unit, wherein a blood leak sensor is arranged downstream of the dialyzer in the dialysis solution circuit, wherein the control unit is configured to initiate an error routine when the signal of the blood leak sensor shows an indication of a presumed blood leak, and wherein a further sensor is furthermore arranged downstream of the dialyzer in the dialysis solution circuit, wherein the control unit is configured to use the signal of the further sensor correlated in time with the signal of the blood leak sensor as a suppression criterion for the initiation of the error routine.

Abstract: An apparatus for treating blood with veno-venous access comprising: a blood circuit (C1, C2) provided with an inlet branch (C3) and an outlet branch (C4), an oxygenator (OX), a blood pump (P) adapted for drawing blood from the patient and returning it to the patient at a first blood flow value. The blood pump (P) is a volumetric peristaltic pump; the blood circuit (C1, C2) comprises a high-speed portion (C1) and a recirculation circuit (C2); the apparatus (100) comprises at least one pressure measuring means (PA; PR; PP), as well as automatic flow regulation means (FD) acting on the recirculation circuit to determine a second blood flow value in the same recirculation circuit (C2) so that in the high speed portion (C1) the flow value is the sum of said first and second flow values.

Abstract: Dialysis systems and methods are described which can include a number of features. The dialysis systems described can be to provide dialysis therapy to a patient in the comfort of their own home. The dialysis system can be configured to prepare purified water from a tap water source in real-time that is used for creating a dialysate solution. The dialysis systems described also include features that make it easy for a patient to self-administer therapy. For example, the dialysis systems include disposable cartridge and patient tubing sets that are easily installed on the dialysis system and automatically align the tubing set, sensors, venous drip chamber, and other features with the corresponding components on the dialysis system. Methods of use are also provided, including automated priming sequences, blood return sequences, and dynamic balancing methods for controlling a rate of fluid transfer during different types of dialysis, including hemodialysis, ultrafiltration, and hemodiafiltration.

Abstract: Devices, systems, and methods for medication infusion are described herein. In some embodiments, a system includes a patient access subassembly, a first fluid reservoir, a second fluid reservoir, and an assembly. The assembly can have a first configuration in which the patient access subassembly is in fluid communication with the first fluid reservoir via a first tube, a second configuration in which the first fluid reservoir is in fluid communication with the second fluid reservoir, and a third configuration in which the first fluid reservoir is in fluid communication with the patient access subassembly via a second tube, the first fluid reservoir fluidically isolated from the first tube in the third configuration.

Abstract: Provided herein are bedside systems and methods for performing customized cell-based therapies and treatments in a patient-connected, closed-loop continuous-flow manner, including cellular modifications and treatments, e.g., to produce chimeric antigen receptor-T (CAR-T) cells among other cellular modifications and treatments.

Abstract: A blood treatment apparatus is disclosed. The example apparatus includes a blood treatment unit including a fluid inlet and a fluid outlet and a blood line. The apparatus also includes a fluid line including an upstream fluid line configured to receive electrically conductive treatment fluid from a fluid source and pass the electrically conductive treatment fluid to the fluid inlet of the blood treatment unit and a downstream fluid line connected to the fluid outlet of the blood treatment unit for delivering the used electrically conductive treatment fluid to a fluid sink. The apparatus further includes a flow divider arranged in the downstream fluid line and configured to separate the used electrically conductive treatment fluid in the downstream fluid line into to a first fluid section and a second fluid section, thereby electrically isolating the first and second fluid sections.

Abstract: A self-contained ocular surgery instrument, including a power module having a body presenting a mating coupler and including a compressed gas supply; a fluid reservoir; an aspiration pump; an aspirated material reservoir and a control panel. The mating coupler is structured to receive and couple to at least one module that facilitates performance of an eye surgery task. The compressed gas supply is coupled to the aspiration pump and the aspirated material reservoir is in fluid communication with the aspiration pump to receive aspirated material from the mating coupler. The fluid reservoir is in fluid communication with the mating coupler such that fluid is supplied under pressure to the mating coupler and thus to the at least one module that facilitates performance of an eye surgery task. The control panel is in controlling communication with the compressed gas supply, the aspiration pump and the aspirated material reservoir.

Abstract: A reduced pressure dressing for applying reduced pressure treatment to a tissue site includes an interface layer adapted to be positioned at the tissue site. An absorbent layer is in fluid communication with the interface layer to absorb liquid from at least one of the interface layer and the tissue site. A pump is in fluid communication with the absorbent layer to deliver a reduced pressure to the tissue site. A cover is positioned over the pump, the absorbent layer, and the interface layer to maintain the reduced pressure at the tissue site, and a liquid-air separator is positioned between the absorbent layer and the pump to inhibit liquid from entering the pump.

Abstract: A surgical instrument including an elongated tubular body portion and an irrigation assembly. The elongated tubular body portion extending distally to an end effector and defining an interior cavity. The irrigation assembly includes an inlet port and a shaft assembly supported by the elongated tubular body portion. The inlet port and the shaft assembly are disposed in fluid communication with one another to deliver fluid from the inlet port into the interior cavity of the elongated tubular body portion to irrigate the interior cavity with positive fluid pressure.

Abstract: A package (116) for a medical cannula, including a plurality of medical cannula outer shields (29), the outer shields each being configured for receiving a medical cannula therein. The package also includes a web (100) having a plurality of holes (104) therethrough corresponding to the plurality of outer shields. Each of the corresponding plurality of holes retains one of the plurality of medical cannula outer shields therein.

Abstract: An injection system is proposed which comprises at least one supply station for supplying a medical fluid to be injected into a patient's vasculature, a pressurizing unit comprising a motor for pressurizing said medical fluid, a delivery arrangement in fluid communication with the at least one supply station and a patient set assembly in fluid communication with the delivery arrangement. The patient set assembly comprises a delivery tube for delivering the pressurized fluid to the patient and a peristaltic pump component comprising a casing which includes an inlet port and an exit port, the inlet port being in fluid communication with the delivery arrangement and the exit port being in fluid communication with the delivery tube. According to an embodiment of the present invention, in proximity of the inlet port, the casing of the peristaltic pump component has a substantially U-shaped configuration. The present invention also relates to a patient set assembly and to a peristaltic pump component.

Abstract: An apparatus is provided which includes a plurality of conduits and a plurality of valves in fluidic communication with the plurality of conduits. The plurality of conduits is configured to receive liquid from at least one liquid reservoir configured to be implanted on or within a recipient. Each conduit of the plurality of conduits has a corresponding flow resistance to the liquid. The plurality of valves is configured to controllably allow flow of the liquid through a selected set of the conduits to be administered internally to the recipient with a selected flow rate.

Abstract: A method may include measuring a first side capacitance value from a first side capacitor of an infusion pump, measuring a second side capacitance value from a second side capacitor of the infusion pump, and measuring a central capacitance value from a central capacitor of the infusion pump. The method may include determining a total side capacitance value by totaling the first side capacitance value and the second side capacitance value. The method may also include comparing the total side capacitance value with the central capacitance value. The method may also include detecting the presence of air within a fluid delivery tube coupled to the infusion pump when the central capacitance value is different from the total side capacitance value. Related methods and articles of manufacture, including apparatuses and computer program products, are also disclosed.

Abstract: The exemplary embodiments attempt to identify impending hypoglycemia and/or hyperglycemia and take measures to prevent the hypoglycemia or hyperglycemia. Exemplary embodiments may provide a drug delivery system for delivering insulin and glucagon as needed by a user of the drug delivery system. The drug delivery system may deploy a control system that controls the automated delivery of insulin and glucagon to a patient by the drug delivery system. The control system seeks among other goals to avoid the user experiencing hypoglycemia or hyperglycemia. The control system may employ a clinical decision support algorithm as is described below to control delivery of insulin and glucagon to reduce the risk of hypoglycemia or hyperglycemia and to provide alerts to the user when needed. The control system assesses whether the drug delivery system can respond enough to avoid hypoglycemia or hyperglycemia and generates alerts when manual action is needed to avoid hypoglycemia or hyperglycemia.

Abstract: Exemplary embodiments described herein relate to a closed loop artificial pancreas system. The artificial pancreas system seeks to automatically and continuously control the blood glucose level of a user by emulating the endocrine functionality of a healthy pancreas. The artificial pancreas system uses a closed loop control system with a cost function. The penalty function helps to bound the infusion rate of insulin to attempt to avoid hypoglycemia and hyperglycemia. However, unlike conventional systems that use a generic or baseline parameter for a user's insulin needs in a cost function, the exemplary embodiments may use a customized parameter in the cost function that reflects the individualized insulin needs of the user. The use of the customized parameter causes the cost function to result in insulin dosages over time better suited to the individualized insulin needs of the user. This helps to better avoid hypoglycemia and hyperglycemia.