Abstract: Medical material and a method for preparing a biological tissue for a medical application are provided. The material is useful as a sealing element in a heart valve prosthesis. A method includes decellularizing the biological tissue by decellularizing solution to obtain an acellular extracellular matrix, solubilizing the extracellular matrix of the biological tissue, and crosslinking collagen fibers of the solubilized extracellular matrix.

Abstract: Described are devices and methods for use in connection with organ replacement or organ assist therapy in a patient.

Abstract: A method for preparing a degradable magnesium-containing calcium phosphate-calcium sulfate porous composite biological scaffold by subjecting a calcined bovine cancellous bone mineral porous scaffold to a treatment using a ternary system containing a magnesium source, a sulfur source and a phosphorus source, taking out and drying, and subjecting to a high-temperature calcination. The degradable magnesium-containing calcium phosphate-calcium sulfate porous composite biological scaffold has good three-dimensional interconnected mesh structure, osteoconductivity, degradability, good mechanical strength and biocompatibility, simultaneously. At the same time, calcium sulfate whiskers with larger length-diameter ratio grow in the mesh, thereby increasing the specific surface area of the material and possibly improve the adhesion of cells.

Abstract: This invention relates to microgel compositions, and in particular, to gel compositions fanned by binding a plurality of individual microgel particles together. The present invention also relates to processes for the preparation of these compositions and their use for particular applications, especially medical applications such as the repair of damaged, degenerated or inappropriately formed load-beating tissue (such as, for example, intervertebral discs).

Abstract: A dental or bone material comprising a polysaccharide, diepoxide and calcium phosphate. The polysaccharide can be a chitosan, and the polysaccharide is modified to be soluble. The combination of the polysaccharide and diepoxide form a gel, which can be cured to form the implant. The curing does not require equipment, but instead the material is self-curing. Methods of making and using the material are also disclosed.

Abstract: The present disclosure relates to a novel sericin-based hydrogel wherein the silk sericin is enzymatically cross-linked for an improved treatment of wound healing, ischemic diseases or cardiovascular diseases, namely chronic wound healing, in particular diabetic wound.

Abstract: The invention provides methods and polymer compositions for treating retinal detachment and other ocular disorders, where the methods employ polymer compositions that can form a hydrogel in the eye of a subject. The hydrogel is formed by reaction of (i) a nucleo-functional polymer that is a biocompatible polymer containing a plurality of thio-functional groups —R1—SH wherein R1 is an ester-containing linker, such as a thiolated poly(vinyl alcohol) polymer and (ii) an electro-functional polymer that is a biocompatible polymer containing at least one thiol-reactive group, such as a poly(ethylene glycol) polymer containing alpha-beta unsaturated ester groups.

Abstract: The present disclosure relates to methods for producing tissue matrix products with active agents to achieve localized distribution and controlled active agent release. The method can include inserting a carrier element comprising a biodegradable material and active agent into surface features of a tissue matrix product. Also provided are tissue matrix products made using the disclosed methods.

Abstract: Methods, systems, and devices for enhancing cancer immunotherapy featuring co-transplantation of encapsulated xenogeneic cells with separately encapsulated autologous or allogeneic cells, e.g., autologous or allogeneic tumor cells. For example, both a first cellular transplantation device housing a patient's own tumor cells and a second cellular transplantation device housing xenogeneic cells may be implanted into a patient. The presence of the xenogeneic cells elicits an enhanced immune response, e.g., the xenogeneic cells will draw in a large number of immune cells. Shed tumor antigens from the first cellular transplantation may then be taken up by the immune cells that were drawn to the xenogeneic cells. This will generate an anti-tumor immune response that is amplified relative to a response elicited by the encapsulated tumor cells alone.

Abstract: The disclosure relates to compounds and compositions for bone formation, fracture treatment, bone grafting, bone fusion, cartilage maintenance and repair and methods related thereto. In certain embodiments, the disclosure relates to compositions comprising one or more compound(s) disclosed herein, such as clotrimazole, honokiol, magnolol, tacrolimus, pimecrolimus, sirolimus, everolimus, temsirolimus, spironolactone, fluticasone, fluticasone propionate, fluticasone furoate, linezolid, telmisartan, chlorambucil, retinol, isotretinoin, acitretin, etretinate, retinoic acid (tretinoin), teniposide, mitomycin C, cytarabine, decitabine, vinblastine, vincristine, vindesine, vinorelbine, valrubicin, doxorubicin, daunorubicin, epirubicin, idarubicin, mitoxantrone, pixantrone, plicamycin, pazopanib, topotecan, camptothecin, irinotecan, sunitinib, derivatives, or salt thereof, for use in bone growth processes.

Abstract: Provided are gene-activated materials comprising a scaffold and at least one nucleic acid molecule which may be chemical bound together or in which the at least one nucleic acid is not bound but coated on a surface of the scaffold. Methods for regenerating bone using these gene-activated materials are also provided.

Abstract: The invention features biodegradable materials, and in vitro and in vivo methods of using such compositions to promote bone and soft tissue growth and healing.

Abstract: An inducer is directed to the induction of in situ regeneration in regenerative medicine. The inducer including an extracellular matrix and/or a bone morphogenetic protein, can induce the regeneration of bone and soft tissues surrounding the bone such as muscle, blood vessel and skin at the residual tissues where trauma occurs. The amount of regenerated tissue is associated with the dose of the implanted inducer.

Abstract: An expandable medical balloon including an inner layer formed of a poly (ether-block-amide) copolymer and an outer layer formed of a polyamide, the expandable medical balloon having a burst strength of greater than 50,000 psi, and to methods of making and using the same.

Abstract: The present disclosure provides improved medical delivery devices for delivering a medical device into a subject. In one embodiment, the medical delivery device includes a non-porous composite inner layer constructed of a lubricious material having a plurality of pores and a thermoplastic elastomer reflowed into the plurality of pores. In other embodiments, the medical delivery device further includes a thermoplastic elastomer coated braided metallic member surrounding the nonporous composite inner layer to provide strength and structure to the device.

Abstract: A medical device, such as a catheter, is disclosed, comprising a substrate and having on its surface, on at least a part thereof, a hydrophilic surface layer providing low-friction surface character of the medical device when wetted by a wetting fluid. At least one base layer of the substrate, including the hydrophilic surface layer, is made of a polymer blend comprising at least one base polymer and at least one hydrophilic polymer, and wherein the concentration of the at least one hydrophilic polymer is higher in the hydrophilic surface layer than in the rest of the base layer. A method for producing such a medical device is also disclosed.

Abstract: A liquid excipient is added to a lock solution formulation containing a lower alcohol and an anti-coagulant, antibiotic, and/or anti-microbial, such as the ethanol and tri-sodium citrate lock solution formulation, to prevent citrate from crystallizing in catheters made from silicone. The locking solution could include a liquid excipient, such as glycerol, polysorbate-20, or polyethylene glycol (PEG)-400, along with a lower alcohol, such as ethanol, and an anti-coagulant, such as tri-sodium citrate, antibiotic, and/or anti-microbial.

Abstract: Systems, devices, and methods of the present disclosure assist with management of tubes and hoses during surgical procedures. The systems, devices, and methods provide for the proper opening and closing of tubes to facilitate performance of steps in a surgical procedure.

Abstract: A wound treatment apparatus is provided for treating tissue damage, which comprises a fluid impermeable wound cover sealed over a site for purposes of applying a reduced pressure to the site. The apparatus also can include a cover with protrusions on its surface for purposes of monitoring pressure at the site. One or more sensors can be positioned under the cover to provide feedback to a suction pump controller. The apparatus can have a miniature and portable vacuum source connected to the wound cover.

Abstract: Systems and methods are provided for moving fluids from a patient to a canister and lowering or eliminating the bio-burden of the canister. In one instance, a method for removing fluids from a patient includes using reduced pressure to remove fluids from a patient, delivering the fluids into a reduced-pressure conduit and into a fluid reservoir, exposing the fluids removed from the patient to a UV light source to kill pathogens to create disposable fluids, and disposing of the disposable fluids. Other systems, devices, and methods are presented.

Abstract: A breast milk collection device includes a reservoir volume and an adaptor having one end to receive a woman's breast. The adaptor has a drip tube communicating with the reservoir. A source of cyclical application and relief of vacuum force is applied to the woman's breast located in the adaptor for the expression of breast milk. A one-way assembly permits breast milk to enter the reservoir and to submerge the valve element. The valve assembly includes a flexible barrier having an interior hollow chamber in fluid communication with said cyclical source of vacuum force and relief pressure, the flexible barrier fluidly isolating the source from the reservoir. The flexible barrier inflatably expands when relief pressure is applied to the interior of the flexible barrier, the flexible barrier becoming deflated when a vacuum force is applied to the hollow interior of the flexible barrier.

Abstract: A catheter apparatus can include a first magnet coupled to a catheter and a second magnet configured to couple to a patient's skin. When the catheter and the first magnet are positioned within a patient's body, the second magnet can exert a magnetic force on the first magnet that stabilizes the catheter relative to the second magnet. The second magnet can be directly attached to the patient's skin or secondary devices such as straps can be used to place the second magnet in a fixed position relative to the patient's body. In some implementations, a plurality of magnets can facilitate holding the catheter in a substantially fixed position within the patient.

Abstract: A fluid pump device changeable in diameter is provided. The device has a pump housing which is changeable in diameter and with a rotor which is changeable in diameter. The device has at least one delivery element for fluid, as well as a drive shaft on which the rotor is rotatably mounted. A bearing arrangement is arranged on the drive shaft or its extension, at the distal end of the drive shaft behind the rotor seen from the proximal end of the drive shaft. The bearing arrangement has struts, which elastically brace between a hub of the bearing arrangement and the pump housing.

Abstract: The catheter device comprises a drive shaft connected to a motor, and a rotor mounted on the drive shaft at the distal end section. The rotor has a frame structure which is formed by a screw-like boundary frame and rotor struts extending radially inwards from the boundary frame. The rotor struts are fastened to the drive shaft by their ends opposite the boundary frame. Between the boundary frame and the drive shaft extends an elastic covering. The frame structure is made of an elastic material such that, after forced compression, the rotor unfolds automatically.

Abstract: The catheter device comprises a drive shaft connected to a motor, and a rotor mounted on the drive shaft at the distal end section. The rotor has a frame structure which is formed by a screw-like boundary frame and rotor struts extending radially inwards from the boundary frame. The rotor struts are fastened to the drive shaft by their ends opposite the boundary frame. Between the boundary frame and the drive shaft extends an elastic covering. The frame structure is made of an elastic material such that, after forced compression, the rotor unfolds automatically.

Abstract: A ventricle assist device comprising a device body with a housing having an inlet and an outlet. A centrifugal pump is disposed in a portion of the housing. The inlet is adapted to allow a flow of blood into the device body housing and an outlet adapted to allow the flow of blood from the device body housing. The flow of blood from the device body housing is primarily directed into the left ventricle, and the inlet and the outlet are positionable in a ventricle.

Abstract: A method and device are provided for non-blood contact mechanically assisting an injured (e.g., infarcted) ventricle by coupling an inflatable bladder or other volume adjustable device to the injured ventricle and selectively inflating the bladder or increasing the size of the volume in systole to apply force against the injured ventricle and deflating the bladder or reducing the size of the volume in diastole to remove force against the injured ventricle. When no mechanical assistance is being provided to the injured ventricle, the inflatable bladder or volume adjustable device is preferably maintained at a predetermined pressure so as to selectively stiffen the injured tissue and alter ventricular geometry a desired amount.

Abstract: Endovascular variable aortic control catheters (EVACC) are provided that are adapted to augment upstream blood pressure and regulate downstream blood flow for patients in shock. The EVACC devices provide improved treatment for truncal wounds, which may be used for example on a battlefield, thereby increasing survivability of injured soldiers. The devices are a catheter-based system having a proximal hand piece for controlled deployment of the device through a delivery sheath. A collapsible, wire framework supports an expandable and collapsible occlusion barrier. The wire basket and occlusion barrier expand to fit within the lumen of the aorta. Various movable elements are used to adjust an adjustable passageway to regulate controlled anterograde blood flow.

Abstract: The invention relates to a method for testing at least one function of a medical functional device which is inserted in and connected and compressed with a medical treatment apparatus, and/or a function of this treatment apparatus, wherein between a hydraulic device or a pneumatic unit of the treatment apparatus and the functional device at least one fluid communication is established. It further relates to a detection device which is programmed and/or configured for executing the method according to the invention as well as a medical treatment apparatus which comprises at least one detection device and/or is in signal transmission or is connected for signal transmission with it, a digital storage medium, a computer program product as well as a computer program.

Abstract: The present disclosure is a machine that permits intra-corporeal dialysis, which machine may be carried by the patient and include a canister of dialysate and a small pump. Filtration of toxins from blood takes place in the patient's own blood stream via a catheter. The catheter is inserted into a major blood vein. Dialysate is pumped from a first end of a canister into the central channel of the catheter. At the other end of the catheter, the dialysate passes to an annular region and reverses direction. The exterior wall of the exterior region of the catheter is permeable to blood, but not to the dialysate. Blood passes through the exterior wall of the catheter and is exposed to the dialysate in the annular region. There the dialysate absorbs toxins before it returns to the second side of the canister.

Abstract: The invention relates to devices, systems, and methods for recharging zirconium phosphate. The devices, system, and methods use a patient pre-dialysis BUN level to set one or more recharge parameters for recharging the zirconium phosphate. The devices, systems, and methods allow for precision recharging of the zirconium phosphate based on the patient pre-dialysis BUN level.

Abstract: A wearable mobile continuous ambulatory peritoneal dialysis (mCAPD) system, includes an mCAPD module mounted on a front portion of a wearable belt, wherein the mCAPD module comprises a micro-peristaltic pump disposed in a corresponding front portion, and an electronic control board connected to the micro-peristaltic pump for controlling and managing the mCAPD process, a fluid bag containing a dialysate fluid, attached to the wearable belt and to the electronic control board, and a sterile connector having a tube portion fixed into a guide section of the micro-peristaltic pump, and a first connecting end for connecting to a first tube inserted into a peritoneum cavity of the human body, and a second connecting end for connecting to a second tube attached to the fluid bag.

Abstract: An apparatus for generating dialysate for dialysis comprising a dialysate outlet and a dialysate inlet and dialysate purifying means, wherein the purifying means comprise a cryopurifier for generating pure water, wherein the inlet of the cryopurifier is connected to the dialysate outlet and the outlet of the cryopurifier is connected to the dialysate inlet; and a method for reclaiming of fresh dialysate from ultrafiltrate and wasted dialysate extracted from a dialysis patient, comprising the following steps: preparing an ice slurry from the dialysate, wherein the ice slurry contains ice crystals and a liquid containing solutes; and separating the ice crystals from the liquid containing the solutes.

Abstract: A trans-anal irrigation (TAI) device has a pump base unit, an irrigation fluid reservoir, a wireless electronic controller, fluid tubing, and a disposable rectal catheter in fluid communication with the tubing. The rectal catheter has a retention balloon and a waste control valve. The fluid tubing contains two or three separate lumens for irrigation fluid and retention balloon inflation/deflation and optionally for waste control valve actuation. None of the lumens ever communicates with any other lumen. A hydraulic control circuit has a pump that pumps in one direction only but, with suitable control valves, is able to pump water to and from the retention balloon and to and from an optional waste control valve. A water temperature sensor is mounted in the pump base unit at a thin-wall section. The temperature sensor sends a signal to a controller which provides an indication of whether the water temperature is suitable for use.

Abstract: A container for holding a liquid, in particular an infusion liquid or irrigating liquid, comprising a liquid phase containing the liquid and a gas phase, wherein, in the operating position, a liquid opening is formed in the lower region of the container and wherein the container has a gas opening. The gas opening is formed by a gas pipe which is inseparably connected to the container and has a first gas pipe end and a second gas pipe end. The first gas pipe end extends into the gas phase of the container and is provided with a closure. The second gas pipe end leads to the outside of the container.

Abstract: A suture storage, dispensing, and disposal device is disclosed. The device provides a method for storing sutures or other medical consumables, dispensing the sutures or other medical consumables, and disposing of used sutures or other medical consumables.

Abstract: This medical device (2) comprises a pre-filled syringe (3) comprising a syringe body (4) and a piston (16) mounted sliding in the syringe body (4), the syringe body (4) and the piston (16) delimiting an internal chamber (17) containing a fluid to be administered; and a package (21) in which the pre-filled syringe (3) is arranged, the package (21) comprising first and second package portions (22, 23) mounted movable relative to each other between a storage configuration in which the first and second package portions (22, 23) prevent the pre-filled syringe (4) from being removed from the package (21), and an open configuration in which the first and second package portions (22, 23) allow the pre-filled syringe (3) to be removed from the package (21), a movement of the first and second package portions (22, 23) from the storage configuration to the open configuration causing the piston (16) to move from a first piston position to a second piston position.

Abstract: A medical injector including at least one syringe port for engaging at least one syringe and having a locking mechanism. The locking mechanism enables the syringe to self-align with the syringe port for locking engagement upon insertion of the syringe into the syringe port and to axially eject the syringe from the port upon rotational disengagement of the syringe from the port.

Abstract: A syringe manifold (300) for a fluid injector assembly includes a middle body member (304) defining an upper cavity (308) and a lower cavity (309), the middle body member defining at least one fluid path in an upper surface of the middle body member and at least one fluid path in a lower surface of the middle body member, the middle body member defining at least two ports extending through the middle body member, the middle body member comprising an outlet (302) for connection of the syringe manifold to at least one fluid delivery device; a lower body member (303) received within the lower cavity of the middle body member, the lower body member comprising at least one connector for connection of the lower body member to a syringe assembly (700); and an upper body member (305) received within the upper cavity of the middle body member.

Abstract: All infusion device (1) for administering a medical fluid to a patient comprises a receptacle (11) for receiving a syringe (2), a pusher device (12) movable in a pushing direction (P) for acting onto a piston (21) of the syringe (2) received in the receptacle (11), a driving rod (14), an electric drive device (141) for driving the driving rod (14), and a clutching device (13) comprising a frame member (131) and at least one clutch element (130A, 130B) movably arranged on the frame member (131). The at least one clutch clement (130A, 130B) is constituted to operatively connect, in a clutched stole, the driving rod (14) to the pusher device (12) for driving the pusher device (12) by the electric drive device (141). The clutching device (13) is actuatable to assume an unclutchcd state in which the operative connection between the driving rod (14) and the pusher device (12) is released.

Abstract: A needle assembly including a needle (15, 115) having a sharpened end and an opposing end and a needle tip shield (10, 110) for shielding the needle. The needle tip shield (10, 110) includes a needle shield (20, 120) connectable to a base (80, 180) and a needle hub (40, 140) fixedly connected to the opposing end of the needle (15, 115). The needle shield (20, 120) and needle hub (40, 140) are displaceable relative to each other from a first state, in which the sharpened end of the needle (15, 115) is exposed outside the needle shield (20, 120), to a second state, in which the sharpened end of the needle (15, 115) is shielded by the needle shield (20, 120).

Abstract: A repeater system may control a pump by using a repeater and a user interface. An adhesive patch system may be used for affixing a pump or other object to a human body. Such an adhesive patch system may include two sets of adhesive members, each member including an adhesive material on at least one side so as to attach to the body. The members of the first set are spaced to allow the members of the second set to attach to the body in spaces provided between the members of the first set, and the members of the second set are spaced to allow members of the first set to detach from the body without detaching the members of the second set. Also, fill stations and base stations are provided for personal pump systems.

Abstract: A repeater system may control a pump by using a repeater and a user interface. An adhesive patch system may be used for affixing a pump or other object to a human body. Such an adhesive patch system may include two sets of adhesive members, each member including an adhesive material on at least one side so as to attach to the body. The members of the first set are spaced to allow the members of the second set to attach to the body in spaces provided between the members of the first set, and the members of the second set are spaced to allow members of the first set to detach from the body without detaching the members of the second set. Also, fill stations and base stations are provided for personal pump systems.

Abstract: Injection device for delivering a defined number (n) of equal doses of a fluid substance contained in a reservoir (P), the device having a housing (1) within which an arming mechanism and a dose delivery mechanism are arranged along the longitudinal axis of the housing, the housing (1) being coupled to an enclosure (3) adapted for receiving the reservoir (P) with the fluid substance, the arming mechanism comprising a setting sleeve (5) which is axially non-displaceable and rotatable around the axis of the housing in two opposite directions by a defined setting angle (a), the setting sleeve (5) being coupled with a spring (10) which is strained by the rotation of the setting sleeve (5) during arming of the device; the dose delivery mechanism comprising a screw ring (6) and a piston rod (4) which is non-rotatable and axially displaceable within the setting sleeve (5), the piston rod (4) cooperating with the screw ring (6) so that during arming of the device the screw ring (6) and the piston rod (4) are immobili

Abstract: An injection device comprising a housing (12) and a dose selector (16) to set a dose of medicament to be ejected from the injection device. A spring (20) coupled to the dose selector stores energy necessary for ejecting the dose from the injection device. A ratchet (25) arrangement is provided to rotationally couple a ratchet component and an internal surface of the housing in a coupled state and to allow relative rotation between the ratchet component and the internal surface of the housing in an uncoupled state. An over-torque feature (27) located between the dose selector and the spring is actuatable, when the rotation of the dose selector causes the charging force to exceed a defined limit, to reduce the charging force transferred from the dose selector to the spring. Both the ratchet component and the over-torque feature are provided on a single component (28).

Abstract: The present disclosure relates to a medicament delivery device comprising a housing, a reservoir for medicament disposed in the housing and a dispensing member. The dispensing member is moveable relative to the housing from a first position to a second position to dispense medicament from the reservoir when the reservoir contains medicament. The medicament delivery device further comprises first and second biasing members. The first biasing member is configured to urge the dispensing member from the first position to an intermediate position. The second biasing member is configured to urge the dispensing member from the intermediate position to the second position.

Abstract: This device is intended to receive an injection syringe. The injection syringe has: a syringe body, a piston mounted slidably in the syringe body, and an injection needle fixed to a distal end of the syringe body. The automatic injection device includes a piston control member, which is displaceable in translation with respect to the syringe body, parallel to an axis X, in order to control the displacement of the piston in the syringe body, a piston rod intended to push a proximal end of the piston of the injection syringe, releasable coupling means for coupling the piston control member and the piston rod, an injection spring which bears on the piston control member and elastically stresses the piston control member towards a distal end of the injection needle. The releasable coupling means are positioned axially between the two axial ends of the injection spring.

Abstract: A part of a device for injecting a liquid product having an end sleeve and a syringe support which is able to move with respect to the end sleeve. The syringe support is designed to bear an injection syringe fitted with a removable protective cap. A deformable ring is kinematically connected to the syringe support. This ring can be deformed elastically between a configuration which is designed to axially immobilize the injection syringe in the syringe support, and a configuration designed to allow the protective cap to pass through the deformable ring.

Abstract: Certain embodiments of the present invention relate to a pharmaceutical injection device, and it is an object thereof to optimize the mixing of pharmaceutical in a pharmaceutical cartridge. To achieve this object, a pharmaceutical injection device may comprise a main case, a piston, a drive motor, a buzzer, and a controller. The main case has a cartridge holder. The piston is inserted into a pharmaceutical cartridge mounted to the cartridge holder. The drive motor drives the piston. The buzzer emits a sound that tells the user to shake the pharmaceutical cartridge to mix or dissolve its contents. Before activating the drive motor and injecting the pharmaceutical, the control unit controls the buzzer so that a sound is emitted at specific intervals to prompt shaking.

Abstract: An optical decoding system including an optical sensor integral with or attachable to a housing of a drug delivery device and configured to be directed at first and second rotatable components of a dose setting and dispensing mechanism of the drug delivery device and a processor configured to: (i) cause the optical sensor to capture images of the first and second rotatable components at least at the beginning and end of a medicament dose dispensing process; (ii) determine a rotational position of both the first and second rotatable components in each of the captured images; and (iii) determine from the rotational positions of the first and second rotatable components an amount of medicament delivered by the dose setting and dispensing mechanism of the drug delivery device.