Abstract: It relates to compositions comprising specific amounts of a hyaluronic acid or a pharmaceutically or veterinary acceptable salt thereof, and two thermoreversible adhesive agents, one of them being a poloxamer, wherein the weight ratio between the poloxamer and the hyaluronic acid or its salt is from 60:1 to 10:1; that may be used as a drug delivery system for the local delivery of active agents to the gastrointestinal tract. It also relates to delivery devices comprising them; and to their uses in medicine, in particular, in the treatment and/or prevention of mucosal lesions; in the prevention of tumor recurrence and reduction of inflammation in the gastrointestinal tract.

Abstract: A bone bioactive composition and kits comprising the composition, means for applying it and/or a metal implant are provided. The bone bioactive composition comprises a water-based salt solution comprising sodium dihydrogen phosphate and sodium chloride, and may also comprise additional elements. The composition and the kits are useful for promoting osteogenesis, particularly when a metal implant is used but also in case of periodontal diseases.

Abstract: This invention of new biomaterials of alternating block polyurethanes (AltPU) based on biodegradable polyester blocks and hydrophilic blocks such as polyethers are created through a selectively coupling reaction between aliphatic polyester diols and diisocyanate-terminated hydrophilic polyethers or between aliphatic polyester diols and diisocyanate-terminated aliphatic polyester blocks under catalysis of organic tin compounds. AltPU possess well-controlled and defined chemical structures as well as regular polymer chain architecture and surface microstructures. The alternating block polyurethane designs endow materials with more special and intriguing properties, such as better biocompatibility, higher hydrophilicity, and favorable mechanical and material processing properties. Medical devices made of AltPU biomaterials show outstanding performance in peripheral nerve repair.

Abstract: The present invention relates to a method of producing a collagen membrane that has particular mechanical properties.

Abstract: An extracellular matrix material is described. The material has a cross-linked scaffold comprising fibrin or fibrinogen, and a bulking agent. Deposited on the scaffold is a calcium phosphate mineral phase. Also described are methods for forming such materials.

Abstract: Apparatuses and methods for producing enriched fibrillated tissue matrices are disclosed herein. Some embodiments include a method including subjecting tissue in a carrier liquid to a fibrillation pressure while maintaining a temperature of the tissue and the carrier liquid to at or below a safe zone temperature; inducing a phasic shift and rapid release of water and biological components from the tissue through a disruptive boil and tissue explosion process to produce a fibrillated tissue matrix; and recapturing the water and biological components.

Abstract: Provided herein are bone marrow stem cell compositions and implants and methods of making and using the same.

Abstract: Disclosed are a regenerative medical material for promoting the repair of soft and hard tissues, a preparation method therefor, and the use thereof. The regenerative medical material has a three-dimensional network structure and is a composite material composed of inorganics and organics, wherein the mass ratio of the inorganics to the organics is 2:1-4:1. Based on the total mass of the inorganics, the inorganics contain 12-38% SiO2, 3-5% Na2O, 15-29% CaO, 10-32.5% P2O5, 1-5% inositol hexaphosphate, 1-5% cyclohexanhexol phosphate, and the balance of impurities, with the content of impurities being less than 0.5%. Based on the total mass of the organics, the organics contain 30-60% carboxymethyl chitosan and 30-60% sodium hyaluronate. The regenerative medical material has a composition and properties better suited to the human body and plays a key role in cell repair and bonding, cell proliferation, and promoting the growth of hair follicles.

Abstract: Subject of the invention is a medical implant comprising a fiber reinforced silicone comprising (A) a silicone matrix and (B) fibers embedded in the silicone matrix, wherein the fibers comprise a comb polymer having a base polymer and side chains, wherein the base polymer is an organic polymer and the side chains comprise polysiloxanes. The invention also relates to outer shells of breast implants and uses and methods.

Abstract: A seal member for use with a replacement heart valve implant may include a tubular polymeric seal element configured to be disposed on an outer surface of a replacement heart valve implant, the tubular polymeric seal element defining a central longitudinal axis; and a reinforcement strip fixedly attached to the tubular polymeric seal element proximate a first end of the tubular polymeric seal element, the reinforcement strip extending circumferentially around the central longitudinal axis. The reinforcement strip may include a radiopaque element extending circumferentially around the central longitudinal axis.

Abstract: To provide a ceramic particle separable composite material having a calcium phosphate sintered body particle with which bioaffinity reduction and solubility change are suppressed as much as possible and which has a smaller particle diameter. A ceramic particle separable composite material comprising a ceramic particle and a substrate, wherein: the ceramic particle and the substrate are chemically bonded to each other, or the ceramic particle physically adheres to or is embedded in the substrate; the ceramic particle has a particle diameter within a range of 10 nm to 700 nm; the ceramic particle is a calcium phosphate sintered body particle; and the ceramic particle contains no calcium carbonate.

Abstract: According to the present invention, there is provided a membrane for immunoisolation, including a porous membrane that contains a polymer, in which Formulas (I) and (II) are satisfied for at least one surface of the porous membrane, B/A?0.7 (I) and A?0.015 (II) (in the formula, A represents a ratio of an N element to a C element on a surface of the membrane, and B represents a ratio of the N element to the C element at a depth of 30 nm from the surface of the membrane); a chamber for transplantation for enclosing a biological constituent therein, including the above-described membrane for immunoisolation on at least a part of a surface forming an inside and an outside of the chamber for transplantation; and a device for transplantation includes the above-described chamber for transplantation enclosing the above-described biological constituent therein. The membrane for immunoisolation of the present invention has a high bioaffinity.

Abstract: A kit includes a mesh substrate and a polymer that is fixed to the mesh substrate. The polymer includes an active agent that is configured to elute over time. The kit further includes a hemostatic agent. The hemostatic agent is separate from the mesh substrate and the polymer. Systems and methods are disclosed.

Abstract: Various aspects of the present invention provide compositions and implantable devices including a water-insoluble therapeutic agent solubilized in a matrix of a gallate-containing compound. Other aspects provide methods of manufacturing and using such compositions and devices.

Abstract: An apparatus includes a cannula, a suction port, and a guidewire channel. The cannula includes a proximal end, a distal end, and a first lumen. The suction port is configured to communicate suction to the distal end of the cannula via the first lumen. The guidewire channel includes an open proximal end, an open distal end, and a second lumen extending from the open proximal end to the open distal end. The guidewire channel is securely attached to the cannula such that the second lumen is laterally offset from the first lumen. The guidewire channel is configured to slidably receive a guidewire within the second lumen. The guidewire channel is formed of an elastic material such that the guidewire channel is configured to resiliently expand the second lumen outwardly to an expanded state in response to slidably receiving a guidewire therein.

Abstract: Systems and methods according to present principles meet the needs of the above in several ways, and in particular provide a product that can continuously monitor and remove air from the stomach without removing liquid from a premature neonate's stomach. The device works by providing suction pressure of, e.g., 10±0.1 mmHg through the feeding tube to continuously remove air from the stomach. In this way the device prevents the problem of gastric distension all together. The pressure may be regulated by using an electronic control valve.

Abstract: Systems, dressings, and related methods, for providing reduced pressure to a tissue site on a patient are presented that involve using a self-contained reduced-pressure dressing. The dressing includes an absorbent pouch and an electronics pouch. The absorbent pouch has an absorbent for absorbing liquid from the tissue site, and the electronics pouch has a pump for applying reduced pressure to the tissue site through the absorbent pouch. The electronics pouch is removably coupled to the absorbent pouch such that the electronics pouch and absorbent pouch may be easily separated for disposal.

Abstract: An air leak detection system for chest tube collection systems includes a light emitting element, such as an LED, and a photodetector that can detect reflected light emission generated by the light emitting element. The air leak detection system can include a securement component, such as a transparent clip or adhesive, so that the air leak detection system is compatible with any conventional chest tube collection system. In certain embodiments, the light emitting element is positioned closer to the bottom portion of the water seal tube than the photodetector. In certain embodiments, the photodetector is positioned closer to a bottom of the water seal chamber than the light emitting element. In certain embodiments, the air leak detection system is part of a chest tube drainage system. A method of detecting an air leak in a chest tube collection system is also disclosed.

Abstract: An irrigation tool that includes a handle configured for grasping by a hand of a user of the tool having a handgrip displaceable using the hand in a manner that selectively controls the rate of flow of irrigation fluid discharged from the tool. The handgrip includes a compressible chamber mounted to the handle via at least one fluid coupling with the chamber compressible by manually squeezing the handgrip to discharge irrigation fluid. The chamber can be provided by a bulb in operable cooperation with a fluid coupling that provides an irrigation fluid flow-modulating control valve arrangement responsive to the magnitude and rate of applied squeezing force. The tool can include an aspirator having a suction passage integrally formed in the handle with a suction control valve operable using the same hand used to control irrigation fluid flow producing a hand-held hand operated combination irrigation and suction tool.

Abstract: Some embodiments of the present disclosure relate to a wound packing material, suitable for use in negative pressure wound therapy, comprising a body of a porous material, the body comprising frangible regions defining a plurality of portions, the frangible regions allowing the portions to be selectively removed from the body. The wound packing material can be shaped to partially or fully surround a secondary wound packing member, such as a stabilizing structure. Some embodiments further relate to methods of manufacturing the wound packing material, and to methods of its use.

Abstract: A cardiac pump (1) includes a cardiac pump housing (7) having a blood inlet (9) that is offset from the longitudinal axis of the cardiac pump housing (7).

Abstract: The present invention relates to a dialysis machine having an extracorporeal blood system; a dialysis fluid system having a dialyzer; having a control unit, wherein the dialysis machine furthermore comprises a balancing chamber having two balancing chamber halves for a balanced infeed and draining of dialysis fluid to and from the dialyzer, wherein a line is provided through which the dialysis fluid is conducted to the balancing chamber, and wherein a mixing chamber is provided in which the fresh dialysis fluid or a component thereof is located and which is directly or indirectly connected to a de-airing line closable by a valve; wherein the dialysis machine has a control unit that is configured such that the control unit opens and closes the valve once, or a number of times, in the operating state of the special air separation of the dialysis machine when the balancing chamber half of the balancing chamber in fluid communication with the named line is in its high-pressure phase.

Abstract: The present invention relates to a dialyzer holder to attach a dialyzer to a dialysis machine. During priming of a bloodline prior to a dialysis treatment, the dialyzer holder grips a dialyzer in approximately the center of the dialyzer, but allows movements of the dialyzer in an arc motion using two axes of rotation. The holder enables the dialyzer to move to a position where air can be primed from the dialyzer and, because the dialyzer can move toward the dialysis machine, this motion eliminates stress on the tubing connected to the bottom and top of the dialyzer and reduces the length of bloodline tubing necessary to accommodate dialyzer movement. The dialyzer holder incorporates an attachment point for a venous chamber for use during the priming procedure, enabling the venous chamber to move with the dialyzer, further reducing the tubing between the dialyzer and the venous chamber.

Abstract: A method and device for performing extracorporeal blood treatment utilizes a first concentrate connection configured to feed a first concentrate into the device as a basis for generating a dialysate, and a second concentrate connection configured to feed a second concentrate into the device as a basis for generating a dialysate. In operation, a first concentrate is fed into the device through the first concentrate connection. The method and device then switch over from feeding the first concentrate into the device through the first concentrate connection to feeding the second concentrate into the device through the second concentrate connection. The switchover step can be performed at a predetermined time during an ongoing blood treatment or after a predetermined period of time.

Abstract: Methods, device, and systems for preparing peritoneal dialysis fluid and/or administering a peritoneal dialysis treatment are disclosed. In embodiments, peritoneal dialysis fluid is prepared at a point of use automatically using a daily sterile disposable fluid circuit and one or more long-term concentrate containers that are changed only after multiple days (e.g. weekly). The daily disposable may have concentrate containers that are initially empty and are filled from the long-term concentrate containers once per day at the beginning of a treatment.

Abstract: The invention relates to a degasser manifold and a vent manifold for use with a degasser in a dialysis system. The degasser manifold and vent manifold include a plurality of fluid passageways that convey dialysate or gases into and out of the degasser. The degasser manifold and vent manifold can also include components such as valves and sensors for control over the degassing of dialysate.

Abstract: Methods, device, and systems for preparing peritoneal dialysis fluid and/or administering a peritoneal dialysis treatment are disclosed. In embodiments, peritoneal dialysis fluid is prepared at a point of use automatically using a daily sterile disposable fluid circuit and one or more long-term concentrate containers that are changed only after multiple days (e.g. weekly). The daily disposable may have concentrate containers that are initially empty and are filled from the long-term concentrate containers once per day at the beginning of a treatment.

Abstract: Methods, device, and systems for preparing peritoneal dialysis fluid and/or administering a peritoneal dialysis treatment are disclosed. In embodiments, peritoneal dialysis fluid is prepared at a point of use automatically using a daily sterile disposable fluid circuit and one or more long-term concentrate containers that are changed only after multiple days (e.g. weekly). The daily disposable may have concentrate containers that are initially empty and are filled from the long-term concentrate containers once per day at the beginning of a treatment.

Abstract: Methods, device, and systems for preparing peritoneal dialysis fluid and/or administering a peritoneal dialysis treatment are disclosed. In embodiments, peritoneal dialysis fluid is prepared at a point of use automatically using a daily sterile disposable fluid circuit and one or more long-term concentrate containers that are changed only after multiple days (e.g. weekly). The daily disposable may have concentrate containers that are initially empty and are filled from the long-term concentrate containers once per day at the beginning of a treatment.

Abstract: Dialysis is enhanced by using nanoclay sorbents to better absorb body wastes in a flow-through system. The nanoclay sorbents, using montmorillonite, bentonite, and other clays, absorb significantly more ammonium, phosphate, and creatinine, and the like, than conventional sorbents. The montmorillonite, the bentonite, and the other clays may be used in wearable systems, in which a dialysis fluid is circulated through a filter with the nanoclay sorbents. Waste products are absorbed by the montmorillonite, the bentonite, and the other clays and the dialysis fluid is recycled to a patient's peritoneum. Using an ion-exchange capability of the montmorillonite, the bentonite, and the other clays, waste ions in the dialysis fluid are replaced with desirable ions, such as calcium, magnesium, and bicarbonate. The nanoclay sorbents are also useful for refreshing a dialysis fluid used in hemodialysis and thus reducing a quantity of the dialysis fluid needed for the hemodialysis.

Abstract: A device for removing noxae from blood, in an extracorporeal perfusion system, includes a housing and a plurality of hollow fibers provided inside the housing, which can be perfused by the blood. The hollow fibers each have a plurality of pores that permit the plasma of the blood to flow through the pores from an inside of the hollow fibers to an outside of the hollow fibers. The hollow fibers are modified or pretreated, in particular chemically, in such a way that they have a functionalized surface which binds the noxae to itself and removes the noxae from the blood. An inside surface of the hollow fibers includes a coating, in particular a hemocompatible and anticoagulant coating, which is arranged to prevent damage to the cellular components of the blood when the blood flows through the hollow fibers. An extracorporeal perfusion system includes the device.

Abstract: Systems and methods are provided for determining an estimated risk of arrhythmia during or after dialysis based on changes in serum potassium concentration of a patient and an amount of fluid removed from the patient during dialysis. The systems and methods allow for a determination of a risk that arrhythmia will occur due to the changes in potassium and fluid volume of a patient during dialysis, and for optimizing a dialysis prescription in order to minimize the risk of arrhythmia.

Abstract: Interventional procedures on the carotid arteries are performed through a transcervical access while retrograde blood flow is established from the internal carotid artery to a venous or external location. A system for use in accessing and treating a carotid artery includes an arterial access device, a shunt fluidly connected to the arterial access device, and a flow control assembly coupled to the shunt and adapted to regulate blood flow through the shunt between at least a first blood flow state and at least a second blood flow state. The flow control assembly includes one or more components that interact with the blood flow through the shunt.

Abstract: A surgical cartridge includes an inner plate; and an outer plate arranged approximately parallel to the inner plate. The flow paths between the inner plate and the outer plate are arranged to form an irrigation flow path for directing fluid towards the surgical site via an irrigation connection and an aspiration flow path for directing fluid away from the surgical site via an aspiration connection. The inner plate includes membranes adapted for cooperation with plungers and/or valves of a membrane pump. The membranes include a main membrane, at least two valve membranes and an auxiliary membrane adapted to cooperate with a main membrane plunger, valve and an auxiliary membrane plunger of the pump, respectively.

Abstract: The present invention relates to systems and methods for controlling flow through the urinary bladder and, more specifically, systems and methods for controlling continuous bladder irrigation after surgical treatment of lower urinary tract disorders. The control system for continuous bladder irrigation includes a catheter having a first port though which a first fluid enters a bladder and a second port through a second fluid exits the bladder; a first flow speed sensor for measuring a first speed of the first fluid; a second flow speed sensor for measuring a second speed of the second fluid; a control unit for sending, based on the first and second speeds, a warning signal of an abnormality in infusing the first fluid into the bladder and in draining the second fluid from the bladder.

Abstract: The present invention relates to an injection device for injecting a pharmaceutical liquid drug containing a preservative. The injection device comprises a housing (1) supporting a cartridge (20) having an interior chamber (21) holding the pharmaceutical preservative containing liquid drug to be injected, and a needle cannula (10) having a front part (11) and a back part (12), which back part (12) is adapted to be in liquid communication with the interior chamber (21) of the cartridge (20). The injection device is further provided with a telescopic needle covering shield (30) which distally is provided with a reservoir (31) which holds a liquid containing the same preservatives as in the pharmaceutical preservative containing liquid drug contained in the interior chamber of the cartridge. The telescopic needle covering shield (30) is telescopic movable in relation to the needle cannula (10) by a first resilient member between a first position and a second position.

Abstract: A drive mechanism includes a housing, a piston adapted to impart movement to a plunger seal within a drug container, a plurality of biasing members disposed in parallel, and a retainer. The biasing members are disposed to release energy to cause movement of the piston from a retracted first position to the extended second position, the piston bearing against the plunger seal to dispense medicine. The retainer is disposed to maintain the biasing members in the energized position and to release the biasing members to permit the piston to dispense the medicine. The drive mechanism may also include an end-of-dose indicator to identify at least one of when the sleeve assembly is disposed subjacent a window in the housing, the relative motion of the sleeve assembly with reference to the window or another reference component, the stoppage of such motion, and the rated or change of rate of motion.

Abstract: An infusion system determines a volumetric flow rate of infusion fluid delivered by an infusion pump along a flow path based on: an upstream acoustic signal emitted by at least one upstream acoustic sensor and detected by at least one downstream acoustic sensor; a downstream acoustic signal emitted by the downstream acoustic signal and detected by the upstream acoustic sensor; and a phase delay between the upstream acoustic signal and the downstream acoustic signal either upstream or downstream. The infusion system automatically adjusts the infusion pump based on the determined volumetric flow rate to achieve a desired volumetric flow rate of the infusion fluid along the flow path.

Abstract: Safe and effective exercise poses a specific set of challenges for subjects diagnosed with diabetes. These challenges include the coordination of exercise with blood glucose monitoring and insulin administration. Failure to coordinate these factors effectively can lead to various pathologies related to aberrant blood glucose levels. Presented herein are methods, systems, algorithms, computer program products, web portals, real-time live instruction, and computer-executable code for exercise guidance and instruction specific to diabetes relief and management. The systems as disclosed herein can help ameliorate, slow, or reduce a likelihood of developing a diabetic condition.

Abstract: Safe and effective exercise poses a specific set of challenges for subjects diagnosed with diabetes. These challenges include the coordination of exercise with blood glucose monitoring and insulin administration. Failure to coordinate these factors effectively can lead to various pathologies related to aberrant blood glucose levels. Presented herein are methods, systems, algorithms, computer program products, web portals, real-time live instruction, and computer-executable code for exercise guidance and instruction specific to diabetes relief and management. The systems as disclosed herein can help ameliorate, slow, or reduce a likelihood of developing a diabetic condition.

Abstract: A medicament delivery device comprises a device housing for placing on the skin of a patient, the housing comprising a needle aperture; a needle for injecting a medicament, the needle arranged to pass through the needle aperture; and a plurality of sensors configured to provide a signal when the housing is placed on the skin of the patient, wherein the sensors are arranged around the needle aperture.

Abstract: The invention relates to an injection device (1) for the simultaneous administration of several medications. The injection device (1) comprises a carrying housing (5), an activation sleeve (8) surrounding the carrying housing (5), at least two carpules (9,11), a first drive module (13) for the administration of the medications, a securing device (14), a needle arrangement (17), a needle protection element (20), and a second triggerable drive module (21) for the needle arrangement (17). The carpules (9, 11) are arranged next to another. The first drive module (13) comprises a drive element (22) with a number of piston rods (23, 24) equal to the number of carpules (9, 11), which form a composite structural unit. At least one of the piston rods (23, 24) is configured in the form of a hollow cylinder and is formed as closed on the piston side, wherein arranged inside this is a first drive means (26) of the first drive module (13).

Abstract: A liquid medicament administration device includes a body configured to contain and support a medicament container. The body includes an aperture. The aperture includes a viewing window that is coincident with the medicament container when the medicament container is present. The device is configured such that the viewing window is size-adjustable. Also disclosed are associated methods of manufacture.

Abstract: An image capture device with a housing comprising a capture opening and a viewing opening arranged opposed to the capture opening. The image capture device comprises a camera for capturing an image of at least a portion of an object arranged in register with the capture opening, as well as a beam-splitter arranged to cover the capture opening, the beam-splitter allowing a first portion of light reflected from an observed object to pass through the beam-splitter, this allowing a user to effectively watch the object during image capture.

Abstract: Various embodiments disclosed herein relate to needle-based injectors that incorporate a power assembly comprising a stored energy source and a rate control assembly. The power assembly may be further configured to allow the injection to be performed with more force than a user may be capable of delivering, while also allowing the user to maintain control of the injection process after the stored energy source has been released and the injection has begun, such the user may increase or decrease the rate of injection, or stop the injection, during the injection process. In various embodiments, the power assembly may comprise spring- or gas-based stored energy sources, and/or may comprise friction- or tension-based rate control assemblies. Described herein are also methods for injecting an agent using embodiments of the devices described here.

Abstract: A plunger head to measure fluid in a drug cartridge includes a transducer coupled to emit ultrasonic signals, and a power source. A controller is coupled to the transducer and the power source, and the controller includes logic that when executed by the controller causes the plunger head to perform operations. For example the plunger head may emit the ultrasonic signals along a length of the drug cartridge, when the plunger head is disposed in the drug cartridge, and receive the ultrasonic signals after the ultrasonic signals are reflected from a dispensing end of the drug cartridge. The plunger head may then determine when the ultrasonic signals received by the transducer have an absolute value of amplitude greater than a first threshold value, and associate a timestamp with the ultrasonic signals received that have the absolute value of amplitude greater than the first threshold value.

Abstract: In one aspect the present disclosure refers to a supplementary device (10) for a manually operable injection device (1), the supplementary device comprising: —a body (11) attachable to an elongated housing (2) of the injection device (1), —at least one connector (12, 14) connected to the body (11) and connectable to the housing (2), wherein the body (11) is attachable to the housing (2) via the at least one connector (12, 14), —a sensor arrangement (20) coupled to at least one of the body (11) and the at least one connector (12, 14) and configured to measure a longitudinal force component (F) acting between the at least one connector (12, 14) and the body (11) in a direction parallel to the elongation of the housing (2).

Abstract: An assembly for a drug delivery device comprises a housing, a dose member which is displaceable in a proximal direction with respect to the housing for setting of a dose of a drug, a clutch member which is displaced in the proximal direction with respect to the housing when setting the dose, and a stop member configured to define a clutch stop position. The clutch member and the dose member are configured to mechanically cooperate with one another when the clutch member is in the clutch stop position, thereby preventing further displacement of the dose member in the proximal direction with respect to the housing during setting of the dose.

Abstract: An injection device comprises a housing (12) having a longitudinal axis. The injection device further comprises a dose selector (16) capable of setting a dose to be ejected from the injection device and a dose indicator comprising a units wheel (18) operatively connectable to the dose selector so that rotation of the dose selector about the longitudinal axis also rotates the units wheel, and a tens wheel (19) selectively engageable with the units wheel so that rotation of the units wheel also rotates the tens wheel. A biasing means biases the dose indicator axially-rearwardly in the housing. An internal surface of the housing is provided with a tens housing feature selectively engageable with the tens wheel to prevent rotation thereof.

Abstract: A syringe is provided having a hub with an orifice, first and second barrels having interior surfaces to form respective lumens, a slider, and an optional test indicator. The first and second barrels slideably receive respective first and second plungers for movement therein. The slider is operable to provide a fluidly communicative path between the orifice of the hub and the first and second barrel lumens. The optional test indicator is responsive to at least one characteristic of bodily fluid, the test indicator positioned to be exposed to any bodily fluid drawn into the first barrel lumen and visible from an exterior of the first barrel.