Abstract: The present disclosure provides devices and methods for treating breasts. The devices can include an acellular tissue matrix having a predefined shape that allows for complete or enhanced coverage of an anterior portion of a breast implant or tissue expander or to support an implant and/or surrounding tissues.

Abstract: A nerve regeneration device comprising a bioresorbable conduit and a matrix contained therein having elongate pores aligned with the longitudinal axis of the conduit. The matrix comprises collagen, fibronectin, laminin-1, and laminin-2, wherein the amount, by weight, of laminin-1 or laminin-2 is greater than the amount of fibronectin in the matrix.

Abstract: Provided herein are drug delivery devices, comprising a scaffold comprising one or more biocompatible materials, one or more chambers containing a plurality of cells, one or more membranes, and one or more nutrient supplementation systems. Also provided are methods of treating or preventing diseases and disorders in a subject in need thereof, comprising administering to the subject the drug delivery devices disclosed herein, and methods of making the drug delivery devices disclosed herein.

Abstract: An ear cartilage tissue engineering complex and a preparation method therefor are provided. The complex includes an ear cartilage gel or ear cartilage patch particles containing ear cartilage cells, and a porous frame structure. The ear cartilage gel or ear cartilage patch particles are inoculated onto the porous frame structure to form an ear cartilage gel/ear cartilage patch particle-frame structure complex. The ear cartilage tissue engineering complex is used for the repair and reconstruction of articular cartilage.

Abstract: Curable compounds, hydrogels, build materials, and methods of 3D printing are described herein. In some embodiments, a build material for 3D printing described herein comprises one or more compounds having the structure(s) of Formula (I) and/or Formula (II) herein. Such a build material may also comprise an additional acrylate component and water.

Abstract: Methods for viscosupplementation in a joint or surgical site of a human or animal subject are disclosed along with unique materials for achieving such beneficial outcomes. The methods generally comprise introducing into the joint or surgical site a plurality of porous viscoelastic solid hydrogel microparticles having a size of greater than about 30 pm, and substantially free of any cells, tissue, or therapeutic compounds. Kits for viscosupplementation in a joint or surgical site of a human or animal subject are also disclosed. The kits comprise the plurality of porous viscoelastic solid hydrogel microparticles having a size of greater than about 30 pm, and substantially free of any cells, tissue, or therapeutic compounds, and instructions for administering the same.

Abstract: The invention provides, inter cilia, ultra-thin conformal coated biological surfaces, such as living cells, cell clusters, tissues, organs, and hybrid synthetic organs, and methods of making the same, e.g., using click reactive water soluble polymers, under conditions that do not damage or significantly modify the biological surfaces. In some embodiments, the coated biological surfaces are suitable for delivery to a subject in need thereof.

Abstract: A process for producing a biocompatible three-dimensional article, the process comprising the steps of providing in an elastin derivative provision step a water-soluble elastin derivative, producing in a hydrogel production step a hydrogel for 3D bioprinting comprising said water-soluble elastin derivative, and 3D bioprinting in a bioprinting step the biocompatible three-dimensional article by extrusion of said hydrogel.

Abstract: A composition for producing a bone replacement material, which composition reacts with water or an aqueous solution in a cementitious setting reaction and forms a solid body. Additionally disclosed is a method for producing a pharmaceutical excipient having the aforementioned composition, the pharmaceutical excipient produced in this way, and the use of such a composition or such a pharmaceutical excipient for the local release of at least one pharmaceutical active ingredient.

Abstract: Anti-staining hydration mediums for medical products and packaged medical products containing the same.

Abstract: A process for manufacturing a viscoelastic injection agent having first and second poloxamers and at least one other component, the process including: a) mixing a first injection agent by mixing a the first poloxamer with the second poloxamer and a third amount of the at least one other component to obtain a predetermined amount of the injection agent; b) determining the viscosity of the injection agent obtained in step at different temperatures at a predetermined shear rate to obtain a present viscosity-over-temperature-curve; c) verifying if a maximum viscosity of the present viscosity-over-temperature-curve lays at a predetermined specific temperature range in a predetermined maximum viscosity range depending on the predetermined shear rate; and d) mixing a new injection agent, having amended at least the first amount of the first poloxamer and/or the second amount of the second poloxamer based on determined properties of the first injection agent

Abstract: A disposable bag set for separating discrete volumes of a composite fluid includes a separation bag including the composite fluid to be separated; a first bag in fluid communication with the separation bag, the first bag configured to receive a first component of the composite fluid from the separation bag; and a second bag in fluid communication with the first bag and not the separation bag, the second bag configured to receive a product formed using the first component.

Abstract: The present invention relates to a method and an apparatus for treating breast milk, in which a breast pump is applied to the female breast and the breast pump is operated to express and transfer breast milk to a container. The container is sealed, wherein the container is or will be provided with a container identifier that identifies the container. A container identifier identifying the container is generated and assigned to the container. In order to avoid interference with breast milk, it is made available in the container for feeding.

Abstract: A breast pump and method of manufacturing the breast pump are described. The breast pump includes a pair of pads configured to be applied to human breasts of a user, each of the pads containing sensors and actuators, a pressure generator configured to provide vacuum within a first predetermined range and compression within a second predetermined range to operate the actuators in each pad, a temperature control system, and an artificial intelligence (AI) control system configured to control, based on feedback from the sensors, the pressure generator to mimic intra-oral motion of an infant and the temperature control system.

Abstract: A renal therapy system is disclosed. In an example, the renal therapy system includes a home renal therapy machine that stores, to a log file, dates of when renal therapies were performed and a type of each renal therapy that was performed. The system also includes a server that receives the log file from the home renal therapy machine. The server compares the dates and types of performed renal therapies stored in the log file to a device program that specifies dates for performing renal therapies and the types of renal therapies to be performed. The server displays a flag in a user interface of a clinician computer when there is a deviation from the comparison.

Abstract: A method of automatically ensuring against chloramine contamination in purified product water includes supplying input water to the system and purifying the water to generate the purified product water. The purifying includes removing chlorine and chloramine contamination from the water using a carbon filter and supplying chlorine-depleted water to a deionization filter, and deionizing the chlorine-depleted water using said deionization filter. The product water is supplied to a sensor for continuous monitoring of the resistivity of the purified product water by the first sensor, and an alarm is generated indicating possible chloramine breakthrough when the resistivity of the product water falls below a predetermined resistivity level, which is selected to provide a reserve filter capacity before breakthrough would occur. The carbon filter is replaced at least responsively to the alarm to ensure excess capacity of said carbon filter sufficient to prevent chloramine breakthrough in said product water.

Abstract: Methods and devices are disclosed that enable safe, rapid and relatively short and straight access to the cerebral arteries for the introduction of interventional devices to treat acute ischemic stroke. In addition, the disclosed methods and devices provide means to securely close the access site to the cerebral arteries to avoid the potentially devastating consequences of a transcervical hematoma.

Abstract: An extracorporeal blood circuit is provided. The extracorporeal blood circuit includes a blood pump including an inlet, an outlet, and a rotor positioned between the inlet and the outlet, and a controller coupled to the blood pump. The controller is configured to drive rotation of the rotor using a voltage waveform and a current waveform, and adjust a phase angle between the voltage waveform and the current waveform to generate reactive power. The generated reactive power facilitates heating blood as the blood passes through the blood pump.

Abstract: The present disclosure concerns embodiments of multi-lumen cannulae that can be used in various different medical procedures. The multi-lumen cannulae can comprise an elongated body comprising multiple different ports that connect to various different sidewall lumens contained within the elongated body. The multi-lumen cannulae can also comprise a central lumen that extends through the entire elongated body and can be fluidly connected to the various different sidewall lumens. The multi-lumen cannulae can further comprise two balloons on an exterior of the elongated body, which can be used to isolate a right atrium of a patient's heart.

Abstract: The present disclosure discloses an electric nasal aspirator with anti-blocking and cleaning functions, including a housing assembly, provided with an exhaust hole and an air suction column penetrating through the housing assembly; a circuit board, fixedly arranged in the housing assembly; a collection cup assembly, detachably arranged on the housing assembly, wherein the collection cup assembly includes an outer cover, a collection cup, and a suction nozzle; the outer cover is detachably hermetically connected to the housing assembly; the collection cup includes a connecting column and a collection chamber; the connecting column is hollowly tubular and detachably arranged on the air suction column.

Abstract: A negative pressure therapy device for inducing negative pressure in a urinary tract includes an inflow member and an outflow member. The inflow member includes (i) a proximal portion, (ii) a retention portion configured to be deployed within a renal pelvis of the urinary tract comprising a drainage hole leading to the inflow lumen, and (iii) an intermediate portion between the proximal portion and the retention portion. The intermediate portion is configured to extend through a portion of the kidney to the renal pelvis. The outflow member includes (i) a proximal portion, (ii) a distal end configured to be positioned in the ureter or bladder, and (iii) at least one intermediate portion extending from the proximal portion to the distal end.

Abstract: An external catheter system can comprise an external catheter comprising an engagement portion that is configured to receive and sealingly engage at least a portion of a penis of a user and an outlet. The system can further comprise a negative pressure source. A conduit can couple the negative pressure source to the external catheter. At least one of the external catheter and the conduit can comprise a portion that, upon application of a negative pressure by the negative pressure source, is configured to collapse to provide a pressure drop between the negative pressure source and the engagement portion of the external catheter.

Abstract: A sensor sheet of a wound monitoring and/or therapy apparatus can include one or more electrical connections. The electrical connections can include multiple conductive inks having different impedances. A track of first conductive ink having a first impedance can be coupled to an electrical connector of an electronic component. A track of second conductive ink having a second impedance can be coupled to the track of first conductive ink.

Abstract: A negative pressure wound therapy system can include multiple sources of negative pressure configured to aspirate fluid from a wound covered by a wound dressing. The multiple sources of negative pressure can be disposed on or within the wound dressing. The negative pressure wound therapy system can include electronic circuitry disposed on or within the wound dressing. The electronic circuitry can be configured to generate a driving signal with a first driving signal magnitude and a first driving signal frequency; and apply the driving signal to the first and second sources of negative pressure causing the first and second sources of negative pressure to provide negative pressure to aspirate fluid from the wound. Two or more of the multiple sources of negative pressure can be pneumatically connected in series to increase available provision of negative pressure to the wound.

Abstract: A rectal catheter assembly includes a rectal catheter that has a plurality of fluid outlets and a balloon positioned around the rectal catheter. The balloon is inflatable thereby facilitating the balloon to seal a patient's rectum to inhibit fluids from leaking outwardly from the patient's rectum. A feed tube is fluidly coupled to the rectal catheter and the feed tube has a first injection port and a second injection port. The first injection port inflates the balloon and the second injection port delivers a medication into the rectal catheter. An extension tube is fluidly coupled to the feed tube and a bag is fluidly attached to the extension tube such that the bag is in fluid communication with the rectal catheter thereby facilitating the bag to deliver and subsequently receive a fluid enema solution to the rectal catheter.

Abstract: A nest and tub arrangement for the storage of medical device components including a tub having a plurality of guide elements extending from at least one surface of the tub and into the interior of the tub, and at least one nest having a plurality of receptacles for the storage of a plurality of medical device components therein. The at least one nest is sized and configured for placement within the tub such that the plurality of guide elements align and removably retain the at least one nest within the tub.

Abstract: Presented herein are methods, systems, and apparatus for performing one or more steps of a gene therapy using an infusion device, e.g., a rapid infusion device, e.g., for the treatment of a disease or condition. For example, it is presented herein that a reduction in the time required to perform one or more of the following steps of a gene therapy—(i) return of red blood cells and plasma to the subject following harvesting of T cells, as part of leukapheresis; (ii) delivery of chemotherapy to the subject to avoid later rejection of the CAR T-cells by the immune system, and/or (iii) administration of genetically modified T-cells to the subject via infusion—can be achieved using the rapid infusion systems, methods, and/or devices described herein.

Abstract: Disclosed herein are various embodiments of clutching mechanisms applicable to a dual reservoir pumping mechanism for a drug delivery device, the clutching mechanisms serving to allow translation of one of the reservoirs during the filling process and thereafter connecting the reservoirs together such that one can be driven relative to the other one by means of a leadscrew or other driving mechanism.

Abstract: A liquid medicine injection device includes: a liquid medicine storage unit including a cylinder including a space configured to store liquid medicine therein and a discharge hole connected to the space, and a piston arranged inside the cylinder and moving toward the discharge hole depending on discharge of the liquid medicine; a first electrode on an outer surface of the cylinder; a second electrode on the outer surface of the cylinder, the second electrode facing the first electrode with the piston therebetween; and a circuit unit including a substrate electrically connected to the first electrode and the second electrode.

Abstract: A first venous rhythm of a patient is detected above a venous insertion site when a venous catheter connected to an infusion set is inserted into the venous insertion site and, concurrently with the first venous rhythm, a second venous rhythm is detected at a location remote from the venous insertion site. An irregularity between the first and second venous rhythms is identified, and a failure of the venous catheter is determined based on the identified irregularity satisfying a irregularity threshold. An alarm may be provided on detecting the irregularity or the failure of the venous catheter.

Abstract: The invention relates to a system for managing multiple infusions to a patient, comprising a control device (2) configured to control a multiplicity of infusion devices (10) for administering a multiplicity of medical fluids through at least one infusion line (100) of an infusion set to the patient (P), the multiplicity of medical fluids to the multiplicity of infusion devices (10) being assigned, preferably by a user characterized in that: —the control device (2) determines compatibility and non-compatibility of the assigned multiplicity of medical fluids, —In that the control device (2) displays to a user compatibility information regarding the compatibility or non-compatibility of the multiplicity of medical fluids, —and in that at least one of the multiplicity of medical fluids to the at least one infusion line is assigned, preferably by a user, in accordance with the compatibility information.

Abstract: A system for regulating the pressure of an intravenous fluid supply is provided. An example intravenous fluid supply system may include an intravenous fluid supply tube supplying intravenous fluid to a patient from an intravenous fluid supply bag. A pressure may be applied to the intravenous fluid supply bag by a pressure bag adjacent to the intravenous fluid supply bag. A pump may be fluidly connected to the pressure bag, such that a fluid may be pumped into the pressure bag, applying pressure to the intravenous fluid supply bag. The system may further include a pressure sensor positioned to measure a pressure within the intravenous fluid supply tube. The intravenous fluid supply may include a controller communicatively connected to the pressure sensor and the pump, wherein the controller regulates an output of the pump based at least in part on one or more measurements of the pressure sensor.

Abstract: A drug delivery device for delivering a medicament includes a housing, a pump, drive component, an inlet fluid path, an outlet fluid path, an inlet pressure sensor, an outlet pressure sensor, and a controller. The pump is coupled with the housing. The drive component is for driving the pump. The inlet fluid path is configured to deliver medicament to the pump. The outlet fluid path is configured to receive medicament from the pump. The inlet pressure sensor is positioned along the inlet fluid path and configured to measure inlet fluid pressure. The outlet pressure sensor is positioned along the outlet fluid path and configured to measure outlet fluid pressure. The controller is workingly coupled with the inlet pressure sensor, the outlet pressure sensor, and the drive component, wherein the controller is configured to adjust at least one parameter of the drive component based on input information received from the inlet pressure sensor and/or the outlet pressure sensor.

Abstract: This disclosure relates to systems and methods for diabetes management.

Abstract: Methods, devices and systems are disclosed for inter-app communications between software applications on a mobile communications device. In one aspect, a computer-readable medium on a mobile computing device comprising an inter-application communication data structure to facilitate transitioning and distributing data between software applications in a shared app group for an operating system of the mobile computing device includes a scheme field of the data structure providing a scheme id associated with a target software app to transition to from a source software app, wherein the scheme id is listed on a scheme list stored with the source software app; and a payload field of the data structure providing data and/or an identification where to access data in a shared file system accessible to the software applications in the shared app group, wherein the payload field is encrypted.

Abstract: This invention relates to a feedback predictive controller, systems comprising and methods employing the same. Preferably the feedback predictive controller and/or systems comprising the feedback predictive controller are part of an automatic insulin delivery system. The methods described herein can be used to control blood glucose concentration in a patient with diabetes. Preferably, the insulin delivery system is an artificial pancreas.

Abstract: A plastic flange for a medical container, the plastic flange defining an opening, the opening being surrounded by a peripheral collar, the collar providing a support to a user's fingers, wherein the flange comprises connecting means for connecting the flange to an external surface of a tubular barrel of the medical container, and wherein the flange further comprises a remotely readable electronic component for remote identification of the medical container, the remotely readable electronic component being embedded into the plastic flange.

Abstract: A medical container, comprising a barrel having an inner surface partially treated with a friction reducing agent, the barrel having at least one substance chamber and wherein the at least one substance chamber defines a portion of the inner surface, which is not treated with the friction reducing agent.

Abstract: The present invention relates to an autoinjector device (10) for use in combination with a syringe (30), said syringe 0 comprising a movable plunger; a needle; and a tubular needle shield (34). The claimed autoinjector device (10) comprises: an elongated housing having a proximal (11) and a distal end (12); a drive mechanism; a syringe holder (40) in order to support the fragile Csyringe and to prevent damage to the syringe. The invention furthermore relates to a method for assembly of the autoinjector device according to the invention.

Abstract: Aspects of the present invention relate to an injection device comprising a drive means, a plunger, and an intermediate member disposed between the drive means and the plunger and releasably engaged with the plunger thereby to selectively transmit force from the drive means to the plunger.

Abstract: The disclosure describes a medicament delivery device having an actuation mechanism configured to act on a medicament container for expelling a medicament, where mechanism has a rear assembly configured to hold said actuation mechanism in a pre-tensioned state, wherein the rear assembly further comprises a transport lock mechanism a support and holding mechanism for a feedback member and activation member an activation member guard. Further an elongated housing having a proximal end and an opposite distal end, accommodating the rear assembly, the medicament container, the actuation mechanism and the activation member guard, wherein the housing further comprises guiding members able to interact with the transport lock mechanism of the rear assembly and/or a container holder for the medicament container. A biased activation member guard is axially slidable with respect to the housing from a proximal extended position to a retracted position and operably connected to a tubular coupling member.

Abstract: An autoinjector and method of injection are described. A power spring causes rotation of a drive nut about the central axis of the autoinjector that, in turn, causes a middle screw to rotate in the same direction as the drive nut and also to move in the distal direction while pushing a center screw in the distal direction that pushes the syringe and needle. The center screw also pushes a plunger that pushes the fluid out of the syringe. After injection, a locked retract screw is freed and rotates in the same direction as the middle screw causing the syringe to retract the syringe into the housing.

Abstract: An injector device includes a housing having a slot with a locking portion and a needle unit that has a needle and a slot engagement portion that extends through the slot in the housing to an external side of the housing. The needle unit is movably mounted in the housing such that movement of the needle unit relative to the housing is restricted by the slot. The injector device also includes a cartridge that is mounted in the housing, the cartridge having a reservoir for medicament. Prior to use of the injector device, the reservoir is sealed from the needle. The slot in the housing is arranged such that the needle unit can be rotated to move the slot engagement portion out of the locking portion such that the needle unit can be moved into engagement with the cartridge to place the needle in fluid communication with the reservoir.

Abstract: A delivery device for delivering liquid from a flexible container is presented having a housing having a first wall provided with a housing first linear gear having housing first linear gear teeth, the housing being configured to receive the flexible container, a first roller having a first compound gear having a first gearwheel provided with first gearwheel teeth and a second gearwheel provided with second gearwheel teeth, and an actuator comprising an actuator first linear gear provided with actuator first linear gear teeth, wherein the first gearwheel teeth are configured to mesh with the housing first linear gear teeth and the second gearwheel teeth are configured to mesh with the actuator first linear gear teeth, wherein the actuator is configured to be moved linearly from a first position to a second position along a longitudinal axis defined by the longitudinal extension of the housing first linear gear.

Abstract: A drug delivery system for injecting a medicament includes a housing, a container configured to receive a medicament including a stopper configured to move within the container and a closure, a needle in fluid communication with the container, a spacer configured to be engaged with the stopper, a first plunger, a first spring configured to bias the first plunger in an axial direction, second plunger disposed about the first plunger, a second spring configured to bias the second plunger in an axial direction. The first plunger is configured to move the spacer and the container relative to the housing via the first spring to establish fluid communication between the container and the patient needle, and the second plunger is configured to move the spacer and the stopper relative to the container via the second spring.

Abstract: An electronic system for a drug delivery device is provided, the electronic system comprising at least one user interface member configured to be manipulated by a user for performing a dose operation, e.g.

Abstract: A handheld injection device includes a housing containing a cartridge, a dose setting means being operable in a first direction to set a desired dose to be dispensed, a piston rod being adapted to cooperate with a piston so as to cause a set dose to be injected from the cartridge, and a first clicker component, which is largely rotationally constrained to the housing, and a second clicker component, which is rotatable relative to the housing during dose dispensing. The clicker components are adapted to contact each other only at the end of dispensing of a set dose to thereby provide an audible and/or tactile first feedback to a user. The first clicker component is displaceable relative to the housing between a proximal dose setting position and a distal dose dispensing position.

Abstract: An administration device for intravitreal administration of a fluid wherein a second actuation part of the administration device is configured to axially block a plunger rod and/or a first actuation part of the administration device, where in the second actuation part is to be actuated in order to axially release the plunger rod and/or the first actuation part such that the first actuation part can be actuated. The administration device has a securing member that is configured to block a back-movement of the plunger rod and/or the first actuation part at least in an initial position and/or in an administration position of the plunger rod and wherein the securing member is configured to block actuation of the second actuation part before reaching the administration position of the plunger rod.

Abstract: A medication delivery device includes a disposable portion and a reusable portion. The disposable portion includes a therapeutic agent delivery assembly, and the therapeutic agent delivery assembly includes a needle. The therapeutic agent delivery assembly is translatable from a stowed configuration to a deployed configuration. The reusable portion includes a first rack and pinion mechanism and a second rack and pinion mechanism. The first rack and pinion mechanism is actuatable to translate the therapeutic agent delivery assembly from the stowed configuration to the deployed configuration. The second rack and pinion mechanism is actuatable to translate a plunger and thereby cause the therapeutic agent delivery assembly to deliver a therapeutic agent from the needle.

Abstract: Systems and methods for continuous injection of fluid, in some examples these apparatuses may include a manifold, a pair of reciprocating pistons, and an actuation control that may apply both suction (aspiration) and injection of fluid as part of the same actuation. The systems and methods may be configured to simplify the operation of a continuous fluid injection system, including one that aspirated prior, to injection to confirm the absence/presence of blood.