Abstract: The present invention is directed to bioresorbable polymers to be used as bone and tissue adhesives. The present invention is also directed to the synthesis of bioresorbable polymeric molecules bearing adhesive moieties and the use of such compounds in methods to glue and stabilize fractured bones and damaged tissues. The present invention is also directed to the use of such compounds as adhesive sealants for applications in wound care. The present invention is also directed to the use of such compounds as biodegradable ink for applications in tissue engineering and 3D printing. The present invention also relates to the use of such compounds as drug delivery platforms.

Abstract: A biodegradable sealant includes: a polyethylene glycol derivative; a photoinitiator; and a solvent, wherein the content of the polyethylene glycol derivative is about 10-75 wt % in the biodegradable sealant. The polyethylene glycol derivative is obtained by a substitution reaction, and in the substitution reaction, the polyethylene glycol is modified with methacrylic anhydride.

Abstract: A composition and medical implant made therefrom, the composition including a thick diffusion hardened zone, and preferably further including a ceramic layer. Also provided are orthopedic implants made from the composition, methods of making the composition, and methods of making orthopedic implants from the composition.

Abstract: Disclosed are devices, systems and/or methods for use in the surgical treatment of vertebrae and/or other bones, particularly implants and/or related devices comprising silicon nitride in some of all of the implant or device body, including portions, layers and/or surface coatings thereof, for use in spinal surgeries and/or other orthopedic procedures.

Abstract: Provided herein are systems and methods for the controlled surface modification of a material substrate, including, for example, generation of nanostructures, crystallographic or morphologic alterations and the removal of defects, changes in chemical composition and bond structure and the creation of thermodynamic metastable states. The provided systems and methods utilize one or more directed energetic particle beams with independently controlled parameters (e.g. incident angle, fluence, flux, energy, species, etc.) to precisely and efficiently generate enhanced surface properties beyond those of conventional plasma kinetic roughening.

Abstract: Described herein are compositions comprising decellularized extracellular matrix derived from skeletal muscle or other suitable tissue, and therapeutic uses thereof. Methods for treating, repairing or regenerating defective, diseased, damage, ischemic, ulcer cells, tissues or organs in a subject preferably a human, with diseases associated with muscular degeneration, using a decellularized extracellular matrix of the invention are provided. Methods of preparing culture surfaces and culturing cells with absorbed decellularized extracellular matrix are provided.

Abstract: The present invention relates to a method of manufacturing collagen for restoring cartilage tissue usable for a joint in an injection manner, and a usage method thereof. The present invention provides a method of obtaining a high-concentration collagen-solution injection by aseptically filling an injection container with collagen separated from pig skin tissue, and a method of using the high-viscosity collagen loaded into the injection container for the purpose of cartilage restoration. Cartilage tissue regeneration is effectively induced when tissue restoration is implemented with respect to a cartilage-deficient portion using collagen, which is a biocompatible material, in a form that is capable of being injected into an application site with an injection needle without a surgical incision. Accordingly, restoration and regeneration of cartilage are easily and quickly induced in an animal, excluding a human, while relieving the burden related to surgery.

Abstract: A cornea, which is ex vivo genetically manipulated in order not to elicit an immune response in an allogeneic recipient. The cornea is isolated, for use in transplantation and a method for production of a cornea, which is performed on an initial ex vivo, e.g. isolated cornea, for use in transplantation, e.g. for use in the treatment of cornea defects.

Abstract: Provided are a method for fabricating a human nasal turbinate-derived mesenchymal stem cell-based 3D bioprinted construct, and a use thereof, wherein the human nasal turbinate-derived mesenchymal stem cell-based, 3D bioprinted construct is advantageous over conventional mesenchymal stem cell-based, 3D bioprinted constructs in that the former can survive and proliferate stably in vitro and/or in vivo and shows high osteogenic differentiation ability as well, therefore is expected to make a great contribution to the practical use of cellular therapeutic agents.

Abstract: A biocompatible material for bone repair is described. The bone repair composition includes a mixture of a type I collagen, a type I collagen-glycosaminoglycan coprecipitate, tricalcium phosphate; and bioactive glass. Methods of using the composition for bone repair, and a kit for the bone repair composition are also described.

Abstract: The present invention relates to a three-dimensional (3D) tissue-like implant for transplanting to a subject in need comprising a cell cluster comprising mesenchymal stem cells (MSCs) and specific cells differentiated therefrom. The present invention also relate to a method of preparing a 3D-tissue-like implant from MSCs, particularly by seeding MSCs in alginate scaffolds and culturing the alginate scaffolds with MSCs in a 3-D perfusion condition. Further, the present invention provides a method for treating a defect in a recipient patient in need by administering a 3D tissue-like implant as described herein to the patient at a defective site e.g. a bone defective site.

Abstract: Orthopedic replacements include are formed at least partially of composite materials including a metal matrix with reinforcing carbon fiber integrated into the matrix. The composite materials have substantially lower density than metal, and are expected to have appreciable strength. The orthopedic replacements can include a bone attachment portion and a load bearing portion. In some versions, the orthopedic replacements can include a core formed of the composite material, with a shape completion portion, formed for example from plastic, at least partially coating the core.

Abstract: The present invention provides a production method of a filament for which a hydrogel having lower strength than a native collagen gel can be used as a raw material. The present invention provides a filament obtained by the above production method and having excellent strength. The production method of the filament includes a step A of irradiating columnar hydrogel with ultraviolet rays; step B of vitrifying the columnar hydrogel after irradiation with the ultraviolet rays to obtain a filamentous hydrogel dried body; and a step C of rehydrating the filamentous hydrogel dried body to obtain a filamentous vitrigel, in this order. The filament is formed of a vitrigel dried body, and to which a hydrophobic solvent is adhered or impregnated.

Abstract: A substrate for transplanting a skin micrograft. The substrate may be configured to receive the tissue micrograft and be positioned at a recipient site. The substrate may have a first surface and a second surface, and may include a bioresorbable material and an adhesive. The bioresorbable material may include oxidized regenerated cellulose (ORC), for example, from about 40% to about 50% by weight of the substrate. The bioresorbable material may include collagen, for example, from about 50% to about 60% by weight of the substrate. The adhesive may include a sugar, for example, glucose from about 8% to about 16% by weight of the substrate. The bioresorbable material may include a plasticizer, for example, glycerol.

Abstract: Disclosed is a method for producing a medical instrument having a lubricating layer (a coating layer) exhibiting excellent durability (particularly, sliding durability). The method for producing a medical instrument is a method for producing a medical instrument having a base layer, and a lubricating layer that is carried on at least a part of the base layer. The method for producing a medical instrument also includes applying, to the base layer, a solution containing a block copolymer having a structural unit (A) derived from a reactive monomer having an epoxy group and a structural unit (B) derived from a hydrophilic monomer, an alkylammonium salt having 8 to 24 carbon atoms, and a solvent; and washing off the solution applied to the base layer.

Abstract: An article for a living body or a biological sample is provided, the article including a first film and a second film, in which the first film includes an amorphous carbon film in which a proportion of the number of carbon atoms having an sp2-hybrid orbital to a total number of carbon atoms having an sp2-hybrid orbital and carbon atoms having an sp3-hybrid orbital is in a range of 23 to 43 atom % or a titanium-doped amorphous carbon film in which a proportion of the number of titanium atoms to the number of carbon atoms is in a range of 3 to 12 atom %, and the second film includes any one film selected from an amorphous carbon film in which a static contact angle with pure water is 10° or less, a titanium-doped amorphous carbon film in which a proportion of the number of titanium atoms to the number of carbon atoms is less than 3 atom % or greater than 12 atom %, or a titanium-doped amorphous carbon film in which a static contact angle with pure water is 10° or less.

Abstract: A method for preparing a laminate coronary stent comprising: providing a stent framework; and depositing a plurality of layers on said stent framework to form said laminate coronary stent; wherein at least one of said layers comprises a bioabsorbable polymer.

Abstract: A medical system includes an insertion device including a delivery shaft with an internal lumen, a coupling tube coupled to the delivery shaft and configured to receive a medical device, and a liner tube inserted through the internal lumen of the delivery shaft.

Abstract: Some embodiments provide in-line negative pressure wound therapy (NPWT) sampling assessment systems, comprising: a housing; a wound fluid input port configured to fluidly couple with a first wound fluid lumen extending from a wound treatment site; a wound fluid output port configured to fluidly couple with a NPWT control unit; an in-line sampling chamber positioned within the housing and comprising a theranostic sampling element, wherein the first in-line sampling chamber is configured to: removably and fluidly couple between the input port and the output port in-line with a wound fluid path between the wound treatment site and the NPWT control unit with the first theranostic sampling element positioned so that at least some of the wound fluid contacts at least a portion of the first theranostic sampling element; and decouple out of the wound fluid path without interrupting a negative pressure treatment process applied at the wound treatment site.

Abstract: A collapsible, clamping and/or steerable apparatus in conjunction with negative pressure system and methods for using such an apparatus are described. Preferred embodiments of the invention have lengths and bent and/or increase their curvatures along their lengths, by preferentially contracting and transforming upon negative pressure.

Abstract: Provided is a blood component collection cassette, a blood component collection kit, a blood component collection system, and a flow path internal pressure detection method capable of accurately measuring a circuit internal pressure in negative pressure and positive pressure regions. A flow path (42) formed in a cassette body (40) of a blood component collection cassette (28) has a first line (42a) through which blood flows when a blood component separation device is in operation, and a second line (42b) through which blood does not flow when the blood component separation device is in operation. A first line forming member (54) is provided with a first pressure-receiving portion (60) pressed by a first load detector (88) attached to the blood component separation device. A second line forming member (56) is provided with a second pressure-receiving portion (62) pressed by a second load detector (90) attached to the blood component separation device.

Abstract: A flow path is formed in a cassette body of a blood component collection cassette. The cassette body includes a bulging structure in which at least a portion of the flow path is formed. A first gripped member, which is configured to be gripped by a first gripping member provided on a centrifugal separation device, is disposed on one surface of the bulging structure in a thickness direction thereof. A second gripped member, which is configured to be gripped by a second gripping member to which a load detection unit that is provided on the centrifugal separation device is fixed, is disposed on another surface of the bulging structure in the thickness direction thereof.

Abstract: Systems, methods, and apparatus are provided for containing and measuring a fluid in a reservoir. A sensing reservoir comprises a reservoir comprising an opening and a wall, the opening configured to allow passage of the fluid in and out of the reservoir, and the wall defining a chamber configured to contain the fluid. The sensing reservoir further comprises a fluid sensing unit coupled to the sensing reservoir, the fluid sensing unit configured to generate measurement data indicative of a volume of the fluid contained in the reservoir.

Abstract: The application relates to a catheter device with a distal bearing for bearing a distal end of a drive shaft. The distal bearing comprises a heat conducting part for enabling heat transfer away from the distal bearing and/or a spiral sleeve for receiving the distant end of the drive shaft.

Abstract: Disclosed herein is an implantable blood pump assembly that includes a housing defining an inlet, an outlet, a flow path extending from the inlet to the outlet, and an internal compartment separated from the flow path. The blood pump assembly further includes a rotor positioned within the flow path and operable to pump blood from the inlet to the outlet, a stator positioned within the internal compartment and operable to drive the rotor, and an inlet conduit connected to the housing inlet and having a downstream end that has a reduced cross-sectional area that produces a localized region of high velocity blood flow. The blood pump assembly further includes at least one pressure sensor positioned between the inlet and the outlet and configured to detect a pressure of blood flowing through the flow path. The pressure sensor is located adjacent the downstream end of the inlet conduit.

Abstract: The invention relates to a catheter device (100) comprising a catheter (68) for insertion into a living being and at least one lumen (69, 70, 74, 79) for guiding a fluid flow within a section of the catheter device, and comprising a valve for controlling a fluid flow, in particular through a catheter, having a valve control chamber (12, 12a), into which an inlet opening (1a) of an inlet channel (1) and an outlet opening (2a) of an outlet channel (2) open, and further having a closure element (5, 13, 17) which can be moved in the valve control chamber (12, 12a) in a controlled manner and which, in at least a first position (I), closes the outlet opening (2a), in at least a second position (II) closes the inlet opening (1a), and which, in at least a third position (III), keeps open a connecting channel between the inlet opening (1a) and the outlet opening (2a), a valve train (A, A?, B, B?, 3, 14, 18) being provided and optionally moving the closure element (5, 13, 17) to at least the first, second or third posi

Abstract: A negative-balanced isolated pelvic perfusion method, in which a drug is administered into the closed pelvis while keeping the volume of suction from the vein larger than that of injection into the artery, does not require allogeneic blood transfusion. A perfusion device is for recovering a liquid containing a drug and/or blood from a tube connecting to the inferior vena cava and for injecting the liquid obtained into a tube connecting to the artery, provided with a unit for closing the inside of the pelvis by including a unit for blocking the artery from the heart to the pelvis, a unit for blocking the inferior vena cava from the pelvis to the heart, and a unit for blocking a blood flow from the pelvis to the lower limbs. The perfusion device is provided with a pelvic perfusion unit equipped with a reservoir, an autotransfusion unit, and a dialysis unit.

Abstract: A method of preparing a medical fluid with a medical fluid generating machine includes receiving, at the medical fluid generating machine, a container to be filled with the medical fluid, receiving, at a processor, instructions to prepare the medical fluid, the instructions including an identification a medical fluid type from among a plurality of medical fluids and a desired volume of the medical fluid, preparing the medical fluid according to the received instructions, testing the prepared medical fluid to ensure that one or more characteristics of the prepared medical fluid is within an acceptable range, filling the container with the prepared fluid and labelling the container with information about the medical fluid, the information including the identification of the medical fluid type within the filled container, and an expiration date of the fluid.

Abstract: A fluid extraction implantable system shaped and sized to be implanted in a patient, including: a fluid extraction chamber having a flat and thin shape connected to a draining tube and including at least one external flat surface, wherein the at least one external flat surface is configured to be attached to a tissue surface when a negative pressure is applied on the draining tube, wherein the chamber extracts fluids from the tissue by applying the negative pressure through the flat surface on the attached tissue surface.

Abstract: The invention relates to an external function device which has at least one housing body having at least one chamber integrated into it for holding medical fluids and at least one locking device for releasably holding an accessory part.

Abstract: Constraining adaptive optimizations of a state of an operation module of a medical device includes determining if a new state has at least one operational parameter that is outside a constraint that has been provided to the medical device in a non-repudiable manner, accepting the new state if no operational parameters are outside any of the constraints, and reverting the medical device to a previous valid state if at least one operational parameter is outside at least one of the constraints. The adaptive optimizations may be provided using artificial intelligence along with relevant inputs thereto. The medical device may be a dialysis system. Constraint data may be provided to the medical device along with a one-way hash value of the constraint data using, for example, a SHA 256 hash. The one-way hash value may be digitally signed using a private key that is part of a public/private key pair.

Abstract: Disclosed herein are membrane device embodiments that can be used for separating blood plasma and/or blood serum from blood samples. The membrane device embodiments comprise built-in features that facilitate blood plasma and/or blood serum separation and also provide the ability to detect, quantify, and qualify analytes present in a blood sample. The membrane device embodiments are portable and just a single membrane can be used for a plethora of detection and analysis techniques. Also disclosed herein are embodiments of methods for making and using the membrane device.

Abstract: An object of the present invention is to provide a material which can remove an activated leukocyte-activated platelet complex with high efficiency. The present invention provides a material for removing an activated leukocyte-activated platelet complex, the material being a water-insoluble carrier to the surface of which carrier a compound(s) having a charged functional group(s) is(are) bound, wherein an extending length ratio of the surface is 4 to 7.

Abstract: Embodiments of the invention pertain to cartridges, systems and methods for performing hemodialysis and related extracorporeal blood treatment modalities and therapies, in which blood flows in the inter fiber space and dialysate flows in the lumens of hollow fibers. Appropriate connectors and fitting orientations may be provided. There may be provided orbital distributors, fanning of fibers, and features to promote uniformity of fiber spacing in the fiber bundle. Orbital distributors may contain contoured surfaces, flow redirectors, non-uniform-conductance flow elements, through-wall distributors, and other features. There may be subdivision of the fiber bundle into two groups of fibers with separate control fluid to each group. Appropriate systems may be provided for various therapies. Flow past the fibers may be parallel, transverse or other configuration.

Abstract: A dialysis catheter includes an entirely subcutaneous first section, with an exterior interface via penetration of the overlying subcutaneous skin layer. In addition the first section of the dialysis catheter includes a detachable portion that enables insertion via a guidewire instead of a peel-away sheath. The dialysis catheter has a layered design that minimizes risk of infection.

Abstract: The present invention relates to a method of adding an anticoagulant to the blood of a patient, wherein the addition takes place in the form of a bolus, wherein the bolus application time B depends on the values TBV and CO, with TBV representing the blood volume of the patient and CO the cardiac output of the patient. The present invention furthermore relates to an apparatus for adding a coagulant to the blood of a patient.

Abstract: A method comprising obtaining a bodily fluid from a subject; contacting the bodily fluid with an adsorbent material comprising a synthetic carbon particle (SCP) to produce a first filtrate having a level of disease mediators (y); contacting the first filtrate with an adsorbent material comprising the SCP and an anion exchange resin where the ratio of SCP to anion exchange resin is from about 0.1:100 to 100:0.1 to produce a second filtrate; contacting the second filtrate with an adsorbent material comprising the SCP and a cation exchange resin where the ratio of SCP to cation exchange resin is from about 1:100 to produce a third filtrate; and administering the third filtrate to the subject.

Abstract: Described is an injector system for implementing a split bolus injection procedure. The injector system includes a processor and a non-transitory storage medium having programming instructions stored therein that, when executed by the processor, enable the injector system to operate as a parameter generation system for use in determining parameters associated with a split bolus injection protocol via which injection of the contrast agent by the injector system is controlled. The split bolus injection protocol includes at least a loading injection and a diagnostic injection, wherein the loading injection is performed before the diagnostic injection, and wherein a pause separates the loading injection from the diagnostic injection. Also described is a method for patient imaging using a split bolus injection technique and a system having an imaging device and the injector system described above.

Abstract: Infusion systems, infusion devices, and related operating methods are provided. An exemplary infusion device includes a motor operable to deliver fluid to a body of a user, a first control module to enable input power for the motor and provide a dosage command for operating the motor, and a second control module coupled to the first control module to receive the dosage command and operate the motor using at least a portion of the input power based at least in part on the dosage command. One of the first control module and the second control module detects an anomalous condition, and in response, disables the input power to the motor, stores diagnostic information for the anomalous condition in its internal memory, and automatically resets thereafter.

Abstract: A delivery device includes a base body having an outlet opening and a chamber for receiving a flowable substance to be administered. The base body, having first and second film portions attached to each other by a connection with a plurality of regions, being configured to discharge the substance through the outlet opening by compressing the chamber. The delivery device further includes a pouring adapter tightly connected to the outlet opening. The plurality of regions of the connection include a more resilient region and a less resilient region that are arranged between the chamber and the outlet opening. When the chamber is compressed to discharge the substance through the outlet opening, the less resilient region is configured to come undone and the more resilient region is configured to remain connected so that the substance can be discharged solely through the outlet opening and the pouring adapter by compressing the chamber.

Abstract: The present invention includes a line management device for attaching to a fixture wherein the line management device simultaneously retains one or more patient care lines in an opening, wherein the device comprises: a flexible strap comprising a proximal strap end comprising a single slot positioned through a portion of the proximal strap end; a body portion connected to the proximal strap end, wherein the body portion comprises a channel positioned on top of the flexible strap that forms an opening through which the one or more patient care lines are positioned; and a distal strap end connected to the body portion, wherein the distal strap end extends through the single slot to secure the distal strap end to the proximal strap end.

Abstract: A medicament delivery device for delivering a dose of medicament into an injection site comprises an expandable reservoir (130) for receiving the medicament, a holder (102) for receiving the reservoir (130), attachment means (104, 110) for securing the holder (102) to the injection site, a cannula (174) moveable from a stowed position in which the cannula (174) does not project from the device (100) to a deployed position in which the cannula (174) provides fluid connection between the reservoir (130) and the injection site, and an elastic element (106). In use, the elastic element (106) is held under strain by the medicament in the reservoir (130) and delivery of the medicament through the cannula (174) is driven by relaxation of the elastic element (106) when the cannula (174) is in the deployed position. The device is preferably in the form of an arm band or a patch.

Abstract: Disclosed is an infusion device controller, the infusion device controller being designed to control a drive for metered drug infusion out of a drug reservoir according to a set of infusion regimes. The infusion device controller is designed to control infusion in a series of scheduled infusion events and is further designed to determine, for an infusion event volume that is infused in a given scheduled infusion event, an assignment between volume fractions of the infusion event volume and infusion regimes in an interlaced manner.

Abstract: The present disclosure relates to systems and methods for controlling physiological glucose concentrations in a patient using a closed loop artificial pancreas. The systems and methods may utilize a controller with control logic operative to execute a multi-model predictive controller algorithm to determine a medication dose to the patient.

Abstract: An automated system of regulation of a patient's blood glucose, including: a blood glucose sensor; an insulin injection device; and a processing and control unit capable of predicting, from a physiological model, the future evolution of the patient's blood glucose over a prediction period, and of controlling the insulin injection device by taking the prediction into account, wherein the processing and control unit is capable of: a) calibrating the physiological model, taking into account the blood glucose measured by the sensor during a past observation period; b) at the end of the calibration, calculating an indicator representative of the error between the blood glucose estimated from the model and the real blood glucose measured by the sensor; and c) adjusting the prediction period by taking into account the value of the indicator.

Abstract: Systems comprising: an analyte sensor for providing an analyte signal representative of an analyte level; a controller in data communication with the analyte sensor and programmed to provide a recommended medication dose based on the analyte level and a medication type, the controller comprising a user interface for inputting the medication type; and a model-based safety mechanism integrated with the controller for evaluating the recommended medication dose. Wherein the model-based safety mechanism overrides the recommended medication dose and provides a safety medication dose when the model-based safety mechanism detects a risk of insulin deprivation.

Abstract: The embodiments described herein may relate to methods and systems for adjusting insulin delivery. Some methods and systems may be configured to adjust insulin delivery to personalize automated insulin delivery for a person with diabetes. Such personalization may include adjusting user specific dosage parameters in response to one or more back-filled time segments associated with a diurnal time block.

Abstract: A computer-controlled injector for use with a medicament cartridge and including a housing having a medicament cartridge receiving volume and a medicament cartridge insertion and removal opening communicating with the medicament cartridge receiving volume; a pivot mount element mounted onto the housing for selectably enabling access to the medicament cartridge receiving volume via the opening; a mechanical latch selectably locking the pivot mount element in a closed operative orientation; and an injection drive mechanism including a computer-controlled motor for driving a piston, forming part of the medicament cartridge, for injecting a medicament, the computer-controlled motor also being operative for operating the mechanical latch.

Abstract: Auto-injector for administering a dose of a liquid medicament includes a housing 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 to apply against an injection site. A spring means, upon activation, can push the needle from inside the housing through the orifice and past the proximal end, operate the syringe to supply the dose of medicament, and retract the syringe with the needle after delivering the medicament. An activating means can lock the spring means in a pressurized state prior to manual operation and capable of, upon manual operation, releasing the spring means for injection.

Abstract: Automatic injection devices (i.e., auto-injectors) and methods are disclosed that use gas-generating chemical reactions for parenteral delivery of therapeutic fluids. The generated gas may place the auto-injector in a punctured configuration to puncture a patient's skin with a needle, an injected configuration to deliver the therapeutic fluid through the needle and into the puncture site, and/or a retracted configuration to withdraw the needle from the puncture site.