Abstract: Provided herein are systems, devices and methods to automate and optimize the decellularization process of representative tissues, such as soft tissues, for extracellular matrix (ECM)-based scaffold and biomaterial production. The automated decellularization processes and devices significantly reduce the exposure time to reagents, minimize lot-to-lot variability, and largely preserve the native composition of the ECM from the decellularized tissue or species.

Abstract: Provided herein are constructs of micro-aggregate multicellular, minimally polarized grafts containing Leucine-rich repeat-containing G-protein coupled Receptor (LGR) expressing cells for wound therapy applications, tissue engineering, cell therapy applications, regenerative medicine applications, medical/therapeutic applications, tissue healing applications, immune therapy applications, and tissue transplant therapy applications which preferably are associated with a delivery vector/substrate/support/scaffold for direct application.

Abstract: This disclosure describes bone tissues engineered from a casted bio-nanocomposite comprising chitosan crosslinked with citric acid to cellulose nanocrystals (CNC) where the amount of CNC used was as high as 29.4%. The nanocomposite showed proper characteristics of a bone mimicking structure. Different layers of the bio-nanocomposite showed an average pore size of greater than 26 micrometers in diameter; a porosity of about 90%, firm structure, maximum bioactivity as measured by deposition of calcium phosphate from simulated body fluid (SBF) solution (gaining weight more than 20% after 3 days), decreased rate of in vitro degradation in PBS (7-60 days), about 10% after 7 days, and acceptable bone cell viability (greater than 80%) in 2D and 3D cultures. The compression modulus of the bio-nanocomposites increased about 4 times and exhibited very small changes in size during the swelling process compared to control.

Abstract: The invention provides method of guiding unidirectional movement of a cell comprising exposing the cell to a surface comprising an asymmetric, three-dimensional pattern of one or a plurality of topographical elements for a time period sufficient to bias actin polymerization within the cell. The invention also provides methods of inducing directional movement of a cell, and methods of harnessing an actin wave within a cell. In addition, the invention provides compositions comprising a contact side, wherein at least a portion of the contact side comprises a cell contact portion comprising an asymmetric, three-dimensional pattern of one or a plurality of topographical elements, and methods of inducing healing of a wound of a subject comprising contacting the wound with the composition.

Abstract: Polymeric tubing containing extractable component(s) for use in medical articles include a tube and a vapor-deposited coating of a barrier polymer covering at least a portion of the tube. The barrier polymer is derived from at least one ethylenically unsaturated monomer. The vapor-deposited polymer coating reduces the extraction of extractable component(s) from the tube. The barrier polymer is parylene or a copolymer of parylene. The polymer coated tubing can be used in stethoscopes.

Abstract: Molecular iodine-infused catheters disclosed herein have biocidal effects and may be used to treat or prevent urinary tract infection (UTI). Other molecular iodine-infused polymers, articles, and products, and their preparation and uses are also disclosed.

Abstract: Provided herein is a coated coronary stent, comprising: a. stent framework; b. a plurality of layers deposited on said stent framework to form said coronary stent; wherein at least one of said layers comprises a bioabsorbable polymer and at least one of said layers comprises one or more active agents; wherein at least part of the active agent is in crystalline form.

Abstract: An apparatus for extracorporeal blood treatment comprising a filtration unit, a blood circuit comprising a blood with-line and a blood return line, and a fluid circuit. The fluid circuit comprises at least one or more water inlet ducts for receiving water, a dialysis preparation assembly comprising one or more concentrated sources housing a respective concentrate solution and configured to prepare a mixed solution of a dialysis fluid, wherein the water inlet duct is configured to provide water to the dialysis preparation assembly for preparing said mixed solution of dialysis fluid. The fluid circuit further comprises an infusion preparation assembly comprising one or more concentrated sources housing a respective concentrate solution and configured to prepare a mixed solution of an infusion fluid, wherein the water inlet duct is configured to provide water to the infusion preparation assembly for preparing said mixed solution of infusion fluid.

Abstract: A peritoneal dialysis system and method includes a control unit configured to enable a pressurization device to pressurize a pressure cavity to a pressure; cause a fluid valve to be opened when the pressure reaches a desired pressure to allow fluid communication with a flexible container located within the pressure cavity; cause a pressure within the pressure cavity to be measured after the fluid valve is opened; and determine that the flexible container is full of fluid or empty of fluid if the pressure within the pressure cavity after the fluid valve is opened becomes or remains at least substantially constant.

Abstract: The invention involves a unique, useful, novel and nonobvious device through which the blood of a patient afflicted with ARDS can have its O2 level augmented while reducing the CO2 level. This is achieved by disclosing a unique, useful, novel and nonobvious complex intravascular catheter which creates a system of intravascular, exo-pulmonary oxygenation of the blood.

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

Abstract: A method of collecting plasma includes receiving donor parameters at a controller of a plasma collection device electronically from a donor management system. The method includes storing a target volume for raw plasma which is based at least in part on donor height and weight used to calculate total donor blood volume, the target volume for raw plasma based on the total donor blood volume. The method includes setting the target volume for raw plasma and controlling the plasma collection device to operate draw and return phases to withdraw whole blood from a donor and separate the whole blood into the plasma product and a second blood component comprising red blood cells and to return the second blood component to the donor. The controller operates the draw and return phases until a volume of raw plasma in the collection container equals the target volume of raw plasma.

Abstract: A fluid processing device includes a controller, a centrifuge, and a pump system. The controller controls the pump system to convey a fluid into a centrifuge chamber received by the centrifuge at first and second rates, with the controller also controlling the centrifuge to rotate the chamber at a first rotation rate when the fluid is being conveyed into the chamber at the first rate and controlling the centrifuge to rotate the chamber at a second rotation rate when the fluid is being conveyed into the chamber at the second rate. The first and second rotation rates are different, with each being based at least in part on a concentration of a fluid component within the fluid, the rate at which the pump system is conveying the fluid into the centrifuge chamber, and a target concentration of the fluid component in one of the first and second constituents.

Abstract: A fluid management system includes a control console and a cassette. The control console includes a housing, a cassette bay defined within the housing, and an actuation mechanism disposed within the housing and including a plurality of actuators. The cassette is insertable into the cassette bay of the control console and includes a chassis supporting a plurality of fluid flow paths through the cassette, and an outer housing defining at least one access opening providing access to the plurality of fluid flow paths. With the cassette positioned within the cassette bay, each actuator of the plurality of actuators is aligned with an access opening of the at least one access opening to enable each actuator, upon actuation thereof, to close a corresponding fluid flow path of the plurality of fluid flow paths.

Abstract: In general, devices, systems, and methods for surgical device activation detection using current sensing are provided. In an exemplary embodiment, a surgical system includes a surgical pump, a detector, and a surgical device. The detector is configured to sense changes in electrical power in an AC power line from an AC power source to the surgical device to detect activation of the surgical device. In response to the detection activation, the pump can properly provide suction pressure to the surgical device to allow the surgical device to provide aspiration at a surgical site during performance of a surgical procedure.

Abstract: A suction device and system utilizing a moveable and/or portable dry vacuum accumulator for vacuum accumulation. The device has at least one accumulator or reservoir for storing a vacuum charge. The device is initially charged by a vacuum source, such as a vacuum from a wall vacuum source as is conventional in a hospital. The vacuum may be boosted using a vacuum boosting pump that may be pneumatic, hydraulic or even electric. The device can be charged to a second predetermined vacuum level which can be different from both atmospheric pressure as well as a first predetermined vacuum level supplied by the vacuum source. Apparatus is also provided for boosting vacuum or for increasing or decreasing a volume in the at least one accumulator or reservoir.

Abstract: The present invention relates generally to methods and systems for performance of collecting fluid emanating from or adjacent to a surgical site or wound. It does so utilizing a highly absorptive biocompatible sponge, such as polyvinyl alcohol or other material, which is connected to wall suction via a common hole running through the base of this sponge. The sponge configuration can vary (e.g. circular, linear, or other) and may be affixed to the drape via Velcro, magnetic, tape, staples or other method, so that abuts the drape surface; a raised portion may also serve as a “dam” to prevent fluid going to unwanted regions (e.g. onto the surgeon's feet, floor, or other undesired draped or undraped region).

Abstract: The wound treatment apparatus combines an internal negative pressure (vacuum) pump and an internal positive pressure (compressor) pump connectable to an external oxygen supply for providing both negative pressure wound therapy and hyperbaric oxygen wound therapy to a wound site. The apparatus also includes a user interface operatively connected to an electronic controller that monitors and actuates the vacuum and compressor pumps. The user interface and controller enables the apparatus to provide multiple modes of operation and the ability to selectively change between negative pressure therapy operational modes and hyperbaric oxygen operational modes.

Abstract: A rectal drainage appliance is disclosed comprising a tubular element having an inflatable balloon at a distal end for anchoring the appliance in the rectum. The appliance includes one or more of: (i) first and second auxiliary lumens communicating with the inflatable balloon to provide independent inflation and pressure monitoring paths coupled to the balloon; (ii) a pressure state indicator defined by a mechanical element configured to flip between first and second states or shapes responsive to sensed pressure; and (iii) a collapsible auxiliary lumen larger than the inflation lumen, and configured to permit admission of irrigation fluid. The pressure state indicator may also be used in intestinal drains.

Abstract: Methods and apparatus for sterilizing and filling vessels which are kept in a sterile environment while being filled are capped before filling and immediately thereafter are ready to be displaced into a potentially contaminating environment while retaining a predetermined SAL are disclosed. Such vessels can be syringes use for dispensing Avastin or conventional syringes. Also method and apparatus for making an eye drop bottle using a conventional medical syringe which can be used in kits made according to the present invention are disclosed. In addition, a method for modifying conventional eye drop bottles for use in kits made according to the instant invention is disclosed. Further, a method for linking single convenience kits to form increased numbers of vessels filled by the same single act, used to fill a single convenience kit, is also disclosed.

Abstract: A system for controlling a fluid injection system is disclosed. The system includes at least one processor programmed or configured to determine at least one characteristic of a power injection protocol, where the at least one characteristic of the power injection protocol is associated with a medical fluid involved in the power injection protocol, determine an estimated value of viscosity of the medical fluid based on the at least one characteristic of the power injection protocol, calculate a hydraulic resistance score based on the estimated value of viscosity of the medical fluid, and determine one or more motor controller gains of a motor of a powered fluid injector in the power injection protocol based on the hydraulic resistance score.

Abstract: An IV set corkscrew hand pump includes a body, a corkscrew member disposed in the body, an inlet port disposed on a first end of the body, an outlet port disposed on a second end of the body and a drive mechanism coupled to the corkscrew member. The drive mechanism is configured to cause the corkscrew mechanism to turn within the body to increase fluid flow downstream in an IV set. IV sets with IV set corkscrew hand pumps and methods of operating IV set corkscrew hand pumps are also provided.

Abstract: An apparatus, system and method for regulating fluid flow are disclosed. The apparatus includes a flow rate sensor and a valve. The flow rate sensor uses images to estimate flow through a drip chamber and then controls the valve based on the estimated flow rate. The valve comprises a rigid housing disposed around the tube in which fluid flow is being controlled. Increasing the pressure in the housing controls the size of the lumen within the tube by deforming the tube, therefore controlling flow through the tube.

Abstract: Disclosed is a drug compliance management system including a microneedle applicator configured to infuse a drug by means of a microneedle in the form of a wearable device, a patient terminal configured to process drug compliance information including drug infusion information received from the microneedle applicator and medication information separately input by a patient after administration, a server configured to transmit the drug compliance information received from the patient terminal, and an expert terminal configured to display drug compliance information collected from a plurality of patient terminals.

Abstract: A microneedle applicator according to the present disclosure includes a housing which has a cartridge accommodation space formed to detachably mount a cartridge having a microneedle base and which has a first through-hole formed in a bottom surface to allow the microneedle base to pass, a pressing part which is operated to press the microneedle base or seal the first through-hole, a pressing operation part which is configured to operate the pressing part, a cartridge operation part which is configured to rotate the cartridge so that the microneedle base having a microneedle formed at a lower surface thereof is disposed below the pressing part, a controller which is configured to control the pressing operation part and the cartridge operation part and communicate with an external device, and a battery which is configured to supply necessary power for the pressing operation part, the cartridge operation part, and the controller.

Abstract: A medical device comprising a syringe barrel, a plunger, and an injectable viscous lifting agent containing a coloring agent loaded in the syringe barrel. The injectable viscous lifting agent is sterilized by a sterilization process, such as an autoclaving process, while inside the syringe barrel. The injectable viscous lifting agent is adapted for injection between an upper mucosal layer and a lower layer at a target treatment site such that the upper mucosal layer separates from the lower layer and the upper mucosal layer is elevated.

Abstract: This disclosure addresses a monitoring device for an infusion system. The device is typically used with an infusion device utilizing a clear reservoir bag holding the supplied fluid. The device uses light sources and sensors to accurately determine the level of the fluid, the amount of fluid being supplied, and when replenishment of the fluid is required. In addition, the device may utilize ultrasound sources and sensors as backups to the light system. The device further includes a data processing module that gathers, stores, and reports data relative to the fluid flow properties of the infusion device.

Abstract: A method of inserting a cannula and a sensor into a user using a cannula and sensor insertion mechanism, the method includes holding the cannula in a first pre-insertion position with a trigger arm, releasing the trigger arm such that a cannula insertion spring moves the cannula from the first pre-insertion position to a second post-insertion position, inserting the introducer needle and the cannula into the user, and retracting the introducer needle from within the cannula with a needle retraction spring.

Abstract: Disclosed are a system, methods and computer-readable medium products that provide safety constraints for an insulin-delivery management program. Various examples provide safety constraints for a control algorithm-based drug delivery system that provides automatic delivery of a drug based on sensor input. Glucose measurement values may be received at regular time intervals from a sensor. A processor may predict future glucose values based on prior glucose measurement values. The safety constraints assist in safe operation of the drug delivery system during various operational scenarios. In some examples, predicted future glucose values may be used to implement safety constraints that mitigate under-delivery or over-delivery of the drug while not overly burdening the user of the drug delivery system and without sacrificing performance of the drug delivery system. Other safety constraints are also disclosed.

Abstract: The subject matter disclosed herein relates to systems, methods and/or devices for calibrating sensor data to be used in estimating a blood glucose concentration. A relationship between sensor measurements and reference readings may be used to estimate a relationship between sensor measurements and blood glucose concentration. Such sensor measurements may be weighted according to a decreasing function of uncertainty associated with sensor values.

Abstract: A system for compounding medications. The system includes one or more compounding devices, and a central computer system. The central computer system receives requests, at least some of which require the compounding of one or more medications, and pushes assignments of respective compounding tasks to the one or more compounding devices. The assignments are made in accordance with a set of rules designed to promote efficient use of compounding resources.

Abstract: An auto-injector for administering a dose of a liquid medicament includes an elongate housing arranged to contain a syringe with a hollow needle and a stopper for sealing the syringe and displacing the medicament, the housing having a distal end and a proximal end with an orifice intended to be applied against an injection site. The syringe is slidably arranged with respect to the housing. A spring capable of, upon activation: pushing the needle from a covered position inside the housing into an advanced position through the orifice and past the proximal end (P), operating the syringe to supply the dose of medicament (M), and retracting the syringe with the needle into the covered position. After delivering the medicament, an activator arranged to lock the spring in a pressurized state prior to manual operation and capable of, upon manual operation, releasing the spring for injection.

Abstract: The disclosure relates to a syringe support for supporting an axial position of a syringe relative to a housing of an autoinjector. The syringe support comprises a projecting portion, which projects from the syringe support in a distal direction and a flexible portion which axially adjoins the projecting portion. The flexible portion is adapted to axially bias the syringe in the distal direction within the housing. The disclosure further relates to an autoinjector.

Abstract: An injection apparatus can include a hand-held unit having a head portion and a body portion. The head portion can include a base member, a needle fluidly coupled to the base member, a movable portion disposed over the needle and being axially movable relative to the base member between an extended position and a retracted position in which a distal point of the needle is exposed, a safety cover removably coupled to the base member, the safety cover comprising one or more extension members, and an adjustment member removably coupled to the movable portion and configured to adjust a penetration depth of the needle by increasing or decreasing a distance between the movable portion and the base member.

Abstract: The invention relates to a medical high-pressure injector for injecting a liquid provided in a syringe (2.1, 2.2) into a patient, wherein the injector has at least one syringe holder (10) with an associated drive unit for the syringe (2.1, 2.2) held therein as well as connecting lines for transmitting the liquid from the syringe (2.1, 2.2) into a patient tube and/or for filling the syringe (2.1, 2.2) that is held in the syringe holder (10), wherein the connecting lines are embodied in an interchangeable control cassette (3) and the injector has a cassette holder (11) with a receiving chamber (110) that can be opened and closed, into which the control cassette (3) can be inserted.

Abstract: A syringe has an injection mechanism configured to be detachably connected to a medicine vial. The injection mechanism can be manually triggered to convert an injection mode and a standby mode; the injection mechanism has a housing, a spiral pushing assembly, a metering guide sleeve, a total volume control nut, a diagonal tension knob, and a metering screw; after the medicament liquid in the medicine vial is used up, a user can remove the medicine vial, the injection mechanism can be converted into the standby mode, and non-return ratchet buckles of the metering guide sleeve can be disengaged from a one-way ratchet portion of the housing; thus, the metering screw can be pushed back to an original position, and the total volume control nut is pushed back to an initial full volume position of the metering guide sleeve, so that the syringe can be reused.

Abstract: The present disclosure relates to a stopper configured to be positioned inside a barrel of an injection device for injecting at least one composition, said stopper including: a gasket including a proximal end, a distal end, a lateral wall, and a through hole extending from the proximal end to the distal end, an insert inserted in the through hole, wherein the stopper is adapted to deform between: a closed configuration wherein the gasket cooperates with the insert to hermetically close the through hole, for preventing flow of the composition between the proximal end and the distal end of the gasket, and an open configuration wherein the gasket cooperates with the insert to open a fluidic pathway in the through hole between the proximal end and the distal end of the gasket for allowing flow of the composition

Abstract: Disclosed are an injection device and a method of using the same. The injection device includes an injection drive assembly including a pneumatic piston chamber, dose chamber, pneumatic piston slidably positioned in the pneumatic piston chamber and an injectate piston slidably positioned in the dose chamber. The injection drive assembly is configured so that any energy resulting from an application of force to the injection drive assembly is instantaneously available for the initiation of injection. In another aspect, the injection device includes separate respective resilient members for each of the pistons that are configured to position each piston in their respective pre-injection positions. In still another aspect, the injection device includes a valve assembly configured to provide pressurized fluid to the pneumatic piston chamber. The rate of the movement of the valve between open and closed positions is independent of control by a user of the injection device.

Abstract: A syringe plunger loop for improved aspiration and injection is disclosed herein. Generally, the loop disclosed herein improves both aspiration and injection by providing stability to the aspiration or injection finger or thumb of the injector. The loop disclosed herein may be integrally attached to the plunger of the syringe. Alternatively, the loop may be a separate piece from the syringe that may be removably attached to the plunger.

Abstract: A syringe plunger loop for improved aspiration and injection is disclosed herein. Generally, the loop disclosed herein improves both aspiration and injection by providing stability to the aspiration or injection finger or thumb of the injector. The loop disclosed herein may be integrally attached to the plunger of the syringe. Alternatively, the loop may be a separate piece from the syringe that may be removably attached to the plunger.

Abstract: A medication injection pen, including a housing, a dose set knob (DSK) comprising an internal key, and a dose stop member engaging the dose set knob. Rotation of the dose set knob to set a medication dose causes rotation of the dose stop member with respect to the dose set knob, and when the dose set knob is rotated to a last dose setting position, the dose stop member rotationally abuts the internal key thereby preventing further rotational movement of the dose set knob in a dose setting direction.

Abstract: A supplemental device is configured to be coupled to an injection device. The supplemental device comprises a sensor arrangement and a processor arrangement. The processor arrangement is configured to cause the supplemental device to use the sensor arrangement to sense an identification feature of the injection device and to determine a type of the injection device based on the sensed identification feature.

Abstract: The present disclosure relates to a dose detection system and method for a medication delivery device. The dose detection system may include a dosing component attached to an actuator and rotationally and axially moveable relative to a coupling component attached to a dose setting member. The dose detection system may further comprise a module including an electronic sensor operative to detect a relative rotation of the coupling component and the dosing component to detect a dose delivered by the medication delivery device.

Abstract: Drug delivery systems, devices and methods of use for recording a drug dose completion signal in a data management system are provided. Aspects of the invention include drug delivery systems comprising a syringe stopper rod that comprises a sensor component comprising a wireless transmitter module and an activation component configured to activate the sensor component when the syringe stopper rod has completed a delivery stroke, wherein the wireless transmitter module is configured to transmit a report comprising a drug dose completion signal when the sensor component is activated.

Abstract: The present invention relates to cover for a medical injection device, said medical injection device having a hub portion defined at its distal end. The said cover includes an outer casing formed of a first material, said outer casing having a distal end and a proximal end,—an inner casing formed of a second material different from the said first material and defining a cavity capable of receiving in a sealing way, at least part of the hub portion, said inner casing having a distal end and a proximal end, and being at least partly inserted within the outer casing and at least partially in contact with the outer casing and—at least one substantially ring-shaped Radio Frequency Identification RFID tag embedded within the cover, said ring-shaped RFID tag including a RFID chip connected to at least one ring-shaped RFID antenna. The present invention also relates to a medical injection device and a method for manufacturing a cover.

Abstract: The present invention relates to a cover for medical injection device, said medical injection device having a hub portion defined at its distal end.

Abstract: The present invention relates to the intravenous injection aid for indicating vein, comprising: a compression strap; a binding means disposed at the opposite ends of the compression strap; a near-infrared lamp disposed at the compression strap; and a controller disposed on the compression strap for controlling the near-infrared lamp. The present invention as mentioned above may not only indicates vein with high visibility but also keep the vein from swaying or moving even during intravenous injection, so the intravenous injection can be carried out safely and efficiently.

Abstract: Proposed is a hemostatic sprayer for stopping a flow of blood from a bleeding portion of the human body, the hemostatic sprayer including a powder casing inside which an accommodation space is formed and which includes inlet and outlet ports, hemostatic in the form of powders being pre-stored in the accommodation space, and the inlet and outlet ports connecting thereto, and a receptacle inside which gas is compressed and pre-stored and which has a supply port on one side, the supply port separably connecting to the inlet port, wherein the supply port is open as a result of pressing by the powder casing, wherein, through the open supply port, the gas is supplied with a preset pressure toward the inlet port and flows into the accommodation space through the inlet port, and wherein the gas flowing is discharged together with the hemostatic through the outlet port while scattering the hemostatic.

Abstract: A battery-operated foam inhalation device which comprises a cartridge (610) having a liquid for producing a foam and a foam outlet (654). Agitation means agitates the liquid to produce the foam, and the agitation means comprises an electric motor (762) and a battery (760) for energising the electric motor (762). A carrier (672) receives the cartridge (610) and has a carrier foam inlet (680) for fluid communication with the foam outlet (654) of the cartridge (610). A carrier foam outlet (682) dispenses the foam to a user.

Abstract: A dry powder inhaler for delivering medicament from at least one medicament carrier having a plurality of spaced-apart medicament doses. The inhaler includes a housing having regions for accommodating unused and used portions of the medicament carrier, a mouthpiece component extending from the housing and through which a user is able to inhale, a dispensing mechanism arranged in the housing for moving a medicament dose of the medicament carrier to the dispensing position, and a mouthpiece cover being rotatably connected to the housing for sequential movement about a rotation axis from a first position in which the mouthpiece component is completely covered to a second position in which the mouthpiece component is completely covered, and from the second position to a third position in which the mouthpiece component is completely uncovered, the second position being between the first and third positions.