Abstract: The present invention relates to wound care products, devices and a method for the treatment of bacterial infections. In particular it relates to a wound care dressing comprising a foamed polyvinyl acetate with bound gram positive and gram negative bactericidal dyes and a water based enzyme additive containing effective amounts of sodium chloride with iodine, citric acid and organic plant, fungus or animal enzymes to preclude or prevent biofilm.

Abstract: The present invention is directed to compressed hemostatic tablets or forms comprising a fibrous non-woven oxidized cellulose (OC or ORC) multilayer material compressed into a form stable tablet, further comprising calcium salt, with the tablets rapidly expandable on contact with blood or blood plasma. The compressed forms may further comprise a multi-arm PEG-SG and are dimensionally, preferably with regard to length and width, stable for at least 48 hours after compression. In some embodiments, the compressed forms will expand upon contact with blood from 1.5 to 5 times of tablet length in 5 seconds; from 2 to 6 times of tablet length in 20 seconds; and from 3 to 6 times of tablet length in 5 minutes. The compressed forms are effective in hemostasis in heparinized blood.

Abstract: A wound dressing composition having a first layer of a lyophilized hydrogel layer having hydrolyzed collagen and hydrolyzed hyaluronic acid ingredients, wherein the first layer has a water content of 10 percent or less and is configured to lay onto a wound. The first layer can be cut or molded to various shapes such as a rectangle, a square, a polygon, an oval or a circle. The first layer is hermetically sealed in a cover or barrier and placed in final packaging. Alternatively, one or more additional layers are stacked onto the first layer, each additional one or more layers having a water content greater than that of the first layer.

Abstract: A heart valve replacement device and methods of manufacturing same are provided. The heart valve replacement device includes a substrate and a low-profile composite covering in conformal contact with the substrate and suturelessly attached to the substrate. The low-profile composite covering includes a textile base layer and a thermoplastic polymer coating integrated with the textile base layer. The thermoplastic polymer coating or select portions thereof are substantially fluid impermeable.

Abstract: A scaffold for tissue regeneration, particularly for bone regeneration, comprises a three-dimensional supporting structure made of a biocompatible and biodegradable material; the supporting structure is functionalized with secretome, in particular mesenchymal stem cell secretome, preferably in lyophilized form (lyosecretome).

Abstract: Isolated hydrogel compositions derived from adipose tissue and related methods of preparation and use are provided. The isolated hydrogel compositions can include one or more of collagen 1A1, collagen 1A2, collagen 3A1, collagen 4A2, collagen 5A2, and fibrillin-1.

Abstract: A method for realizing cartilage regeneration involves inoculating a gel cartilage into a frame structure. Specifically, cartilage cells are prepared into a gel cartilage by means of amplification and dense inoculation; and the gel cartilage is inoculated into a decalcified bone matrix to prepare a gel cartilage—decalcified bone complex, so that cartilage regeneration is realized, and the gel cartilage—decalcified bone complex is used in various filling treatments and bone repair.

Abstract: The curdlan-based biomaterial containing P-1,3-glucan (curdlan), whey protein isolate (WPI) and hydroxyapatite ceramics (HAp), where the proportions of polymer components to 100 ml of aqueous solution are respectively: 6-20% (w/v)—P-1,3-glucan, 20-50% (w/v)—whey protein isolate (WPI), while the amount of added hydroxyapatite ceramic granules (HAp) to such a polymer mixture is 40 g-100 g. and a method of producing the biphasic biomaterial consisting in that a 20-50% (w/v) aqueous solution of whey protein isolate (WPI), preferably 30% (w/v), is added to the P-1,3-glucan powder (curdlan), so as to obtain a mixture in which the concentration of curdlan in relation to the WPI solution is 6-20% (w/v), preferably 8% (w/v).

Abstract: This invention relates generally to methods of inhibiting arterial rupture and the progression of an arterial aneurysm. In particular, the methods comprise applying a photosensitizer to an arterial wall and irradiating the arterial wall with photo-activating radiation to initiate crosslinking in the arterial wall and inhibit arterial rupture and the progression of an arterial aneurysm.

Abstract: A vascular prosthesis includes a tubular wall disposed between a first open end and an opposed second open end and having an inner surface and an opposed outer surface. The tubular wall includes a textile construction of one or more filaments or yarns, the textile construction by itself being permeable to liquid. The outer surface includes a coating of a water-insoluble elastomeric sealant. The tubular wall having the coating of the water-insoluble elastomeric sealant is, after curing thereof, impermeable to liquid. The inner surface is free of the water-insoluble elastomeric sealant.

Abstract: A scaffold for bone regeneration comprises a three-dimensional support structure made with a composite hybrid formed by a bovine bone-derived matrix reinforced with a polymer and containing collagen fragments; the support structure is functionalized with secretome, in particular mesenchymal stem cell secretome, in lyophilized form (lyosecretome).

Abstract: A drug coated balloon includes a balloon body and a drug loaded coating layer. The drug loaded coating layer includes a first drug loaded coating component having at least two controllable sustained release drugs with different drug release kinetics, and a second drug loaded coating component including an active drug. The second drug loaded coating component is dispersed among the controllable sustained release drugs and couples the controllable sustained release drugs on the balloon body. The first and second drug loaded coating components are both non-hydrophilic compositions. The drug coated balloon provides sufficient initial drug loading dosage to the lesion site, and has adjustable drug release rate, thereby allowing the drug coated balloon to provide bioactive drugs to the treatment site at different stages of the cascade reaction of vascular restenosis, providing the controllable long-acting therapeutic drugs, and improving the overall vascular drug release efficacy.

Abstract: The present disclosure provides compositions and methods relating to the use of stents treated with therapeutic biologics for the treatment of cardiovascular diseases and conditions. In particular, the present disclosure provides novel compositions and methods for conjugating therapeutic extracellular vesicles to a stent to not only regulate vascular remodeling and inflammation, but also promote the regeneration of the injured tissue.

Abstract: A medical treatment machine, such as a home dialysis machine, can receive prescription parameters that define parameters of a medical treatment to be administered to a patient. A medical prescription is entered by a clinician into a clinical information system (CIS) that calls a system to evaluate the compatibility of the entered prescription by transmitting the prescription parameters to a server that has access to a database of medical devices and their operational parameters. The server compares the treatment parameters of the medical prescription to the operational parameters of the medical device and generates a prescription compatibility response indicting if the treatment parameters of the medical prescription can be executed by the medical device. The server returns to the CIS the prescription compatibility response to allow the prescription, e.g. in a digital or program form, to be securely transmitted or delivered via a connected health system to the medical device.

Abstract: Mixing apparatus for producing solutions for medical treatment, in particular for administering dialysis or infusion solutions.

Abstract: Disclosed herein are embodiments of a device that can be powered or charged via ultrasonic energy conducted from another device via a fluid connection. In particular, disclosed herein is a pressure sensor for use with an automatic peritoneal dialysis (APD) cycler wherein power is transferred from the APD cycler to the sensor via ultrasonic wave transmitted through a dialysate fluid. A piezoelectric transducer is used in the device to convert the kinetic energy of the ultrasonic waves in to electrical energy that can be used to power the device or charge a power storage element within the device.

Abstract: Disclosed is a method for treating a heart condition by perfusing a drug through an un-arrested beating heart of a patient. A closed circuit through the patient's coronary arteries and coronary venous system may be formed from a first drug delivery catheter (1822) positioned in the right coronary artery, a second drug delivery catheter (1824) positioned in the left coronary artery, a drug recovery catheter (1826) positioned in a coronary sinus, and an external membrane oxygenation system (1820) fluidly coupled to the various catheters. A drug for treating a heart condition may be perfused through the closed circuit.

Abstract: Embodiments disclosed herein are directed to an access system including a flexible needle configured to negotiate a non-linear pathway to access a subcutaneous port. Optionally, the access system can include a needle guide to facilitate alignment of the needle with the subcutaneous port. The needle can be configured to be flexible enough to have some bending, or deflection capability but also possess sufficient columnar strength to prevent buckling when piercing the skin and entering the port. The flexible needle can be deflected from a central axis to overcome any misalignment with the receiving cup and/or conduit of the port. Once within the port conduit the needle can negotiate the non-linear, or tortuous port conduit pathway, and stream-line the insertion procedure.

Abstract: A dialysis catheter clearance device is for use with a dialysis catheter. The device includes an infusion catheter having a first end, a second end, and a lumen between the first end and the second end. The device also includes a flexible rod, within the infusion catheter. The rod has a first end and a second end. The first end of the rod is connected to a motor, which imparts movement into the rod, and the second end of the rod is located at or about the second end of the infusion catheter. Actuation of the motor imparts movement to the second end of the rod to induce turbulence in clot dissolving medication, thereby increasing the effectiveness of the clot dissolving medication in dissolving a clot located at the second end of the infusion catheter.

Abstract: A combined bio-artificial liver support system, includes branch tubes that are connected in sequence: a blood input branch tube, an upstream tail end of which is set as a blood input end, a first plasma separation branch tube comprising at least a first plasma separator, a non-biological purification branch tube comprising at least a plasma perfusion device and a bilirubin adsorber, a biological purification branch tube comprising at least a hepatocyte culture cartridge assembly, and a plasma return branch tube, a downstream tail end of which is set as a blood output end.

Abstract: Disclosed are systems and methods for hyperthermic cancer treatment. For example, a system can include a heat exchanger, a control module, a primary fluid delivery line (“FDL”), an intravenous catheter, and a peristaltic pump. The control module can include at least a hydraulic system configured to provide a temperature-controlled fluid. The primary FDL can be configured to convey the temperature-controlled fluid to the heat exchanger as a supply fluid and back to the hydraulic system as a return fluid. The intravenous catheter can include a primary lumen configured to convey blood of the patient to the heat exchanger as well as a secondary lumen configured to convey the blood back to the patient using the peristaltic pump. The catheter can also include a thermistor for determining a core body temperature of the patient to ensure the patient is in a hyperthermic state before administering a cancer treatment to the patient.

Abstract: Centrifuges are useful to, among other things, remove red blood cells from whole blood and retain platelets and other factors in a reduced volume of plasma. Platelet rich plasma (PRP) and or platelet poor plasma (PPP) can be obtained rapidly and is ready for immediate injection into the host. Embodiments may include valves, operated manually or automatically, to open ports that discharge the excess red blood cells and the excess plasma into separate receivers while retaining the platelets and other factors in the centrifuge chamber. High speeds used allow simple and small embodiments to be used at the patient's side during surgical procedures. The embodiments can also be used for the separation of liquids or slurries in other fields such as, for example, the separation of pigments or lubricants.

Abstract: In one exemplary mode, a phacoemulsification system includes a phacoemulsification probe to be inserted into an eye, an irrigation line to provide irrigation fluid into the eye, an aspiration line to convey aspiration fluid from the eye, an aspiration pump to pump the aspiration fluid from the eye, a pump controller to control a flow direction and rate of the aspiration pump, and an aspiration rate user input device to provide a signal indicative of user actuation of the aspiration rate user input device, wherein the pump controller is configured to receive the signal provided by the aspiration rate user input device, and reverse the flow direction and set the flow rate of the aspiration pump at which to pump the aspiration fluid into the eye, the flow rate in the reverse flow direction being set responsively to an actuation rate at which the aspiration rate user input device is actuated.

Abstract: Occlusion detection in a vacuum-based system for ophthalmic surgery includes a handpiece and aspiration and irrigation subsystems. The aspiration subsystem includes an aspiration line coupled to a handpiece, an aspiration pressure transducer, and a vacuum-based aspiration pump. The irrigation subsystem includes an irrigation line coupled to an irrigation source having an irrigation fluid, a handpiece, an irrigation pressure transducer, and a positive displacement pump. The system also includes a processor coupled to the positive displacement pump and a memory coupled to the processor. The memory includes executable instructions that cause the processor to determine a flow rate of irrigation fluid through the irrigation line, based on a rotation rate of the positive displacement pump, and provide an occlusion warning when the flow rate is below a threshold level and a vacuum is being commanded.

Abstract: Systems and methods are described for the filtering and reinfusion of blood during a thrombectomy procedure. An example of such a system includes a pump and a visualization device including a screen to filter thrombi from the blood. The visualization device is configured to be opened to allow the screen and filtered thrombi to be removed during the thrombectomy procedure.

Abstract: The present invention relates to methods, devices and systems for performing the removal of thrombus from a vessel lumen. More particularly the present invention relates to a thrombectomy system that includes an elongate catheter and a disposable aspiration pump and methods of performing medical procedures to remove clots, thrombus and emboli to re-establish the normal intravascular flow of blood.

Abstract: The present invention relates to methods, devices and systems for performing the removal of thrombus from a vessel lumen. More particularly the present invention relates to a thrombectomy system that includes an elongate catheter and a disposable aspiration pump and methods of performing medical procedures to remove clots, thrombus and emboli to re-establish the normal intravascular flow of blood.

Abstract: Disclosed herein are systems, devices, and methods for accessing a subdural space. In some embodiments, an apparatus may comprise a shaft configured to be slidably disposed within a lumen of a catheter. The shaft may be configured to be advanced distally from a distal end of the catheter and into a blood vessel of a subject. The shaft may include a perforating tip including an energy element configured to generate radiofrequency energy to form an opening through a wall of the blood vessel and dura of the subject and into an extravascular space of the subject. A curved section may be configured to be radially constrained within the lumen of the catheter and to curve toward the wall of the blood vessel and the dura upon exiting the lumen of the catheter such that the energy element is positioned to form the opening.

Abstract: A surgical device includes a handle portion having a first port and a second portion, and an elongated shaft is rotatably coupled to the handle portion. A first suction tip is removably secured to a distal end of the shaft, the first suction tip having a first cross-sectional shape that is configured to engage a first type of tissue on a patient. When the first port is coupled to the vacuum source, and when the second port is in a closed position, fluid at the first suction tip is passed through the shaft, into a fluid chamber of the handle portion, and out of the first port. When the first port is coupled to the vacuum source, and when the second port is in an open position, the fluid chamber is vented to the atmosphere, and fluid at the first suction tip is not displaced to the first port.

Abstract: A nuclear medicine infusion system may be used to generate and infuse radioactive liquid into a patient undergoing a diagnostic imaging procedure. In some examples, the infusion system includes a frame that carries a radioisotope generator that generates radioactive eluate via elution. The frame may also carry a beta detector and a gamma detector. The beta detector can be positioned to measure beta emissions emitted from the radioactive eluate supplied by the generator. The gamma detector can be positioned to measure gamma emissions emitted from a portion of the radioactive eluate to evaluate a safety of the radioactive eluate delivered by the infusion system.

Abstract: An example system includes a fluid delivery device configured to deliver gas nanobubbles to a target site of a patient from a solution comprising a fluid, supersaturated with a. gas, wherein the fluid delivery' device defines a flow channel configured to flow the solution through the flow channel such that the gas in the supersaturated fluid forms gas nanobubbles as the solution flows through the flow channel towards the target site, and wherein the gas nanobubbles remain in the fluid at least until delivery' to the target site.

Abstract: A wearable fluid delivery system is part of a networked system to collects, transmits, stores, and analyzes data related to enteral nutrition. A method includes inputting patient data; generating a nutrition plan; implementing the nutrition plan with a wearable nutrition device; detecting a parameter with the wearable nutrition device; and generating an updated nutrition plan based on the parameter.

Abstract: An infusion system having an integrated inserter and infusion set (10) for containing and placing a flexible catheter (40), and a retractable introducer needle (26), wherein the catheter (40) is isolated from movement after placement. The integrated inserter and infusion set (10) includes a hub (20), having a user push button (30) to activate the device for catheter (40) placement. An adhesive liner (34) can be provided to cover an adhesive layer (36), such as pressure sensitive adhesive (PSA), on the bottom of the device (10).

Abstract: A method for monitoring a dispensing process of a liquid drug with a drug delivery device involves gradually increasing a motor drive current for a motor of the drug delivery device; measuring, by a sensor, a position or movement of an output member movable by the motor; determining a minimal motor drive current required to initially move the output member from standstill; and determining, from an evolution of successively determined minimal motor drive current values, a delivery device operation status.

Abstract: Infusion devices, systems, and methods can detect a presence or absence of an infusion cartridge in an infusion pump. Embodiments may include a loading sequence, recording loading pulse width modulation (PWM) commands applied to an infusion pump motor during the loading sequence, setting a value of threshold PWM commands based on the commands applied during the loading sequence and comparing values of operational PWM commands applied during pumping operations to the value of the threshold PWM commands. If the value of the operational PWM commands drops below the threshold by a predetermined amount, a missing infusion cartridge warning may be generated.

Abstract: In some embodiments provided herein are methods of administering an adductor canal block in a patient, wherein the methods include: (a) selecting an entry point of an injection needle in a leg of the patient; (b) inserting the injection needle into the leg of the patient at the entry point; (c) identifying a first nerve in the leg of the patient; (d) administering to the first nerve saline and a pharmaceutical composition; (e) identifying a second nerve in the leg of the patient; (f) administering to the second nerve saline and the pharmaceutical composition; wherein the first nerve and second nerve are selected from the group consisting of the nerve to vastus medialis (NVM) and the saphenous nerve, and wherein the first nerve is not the second nerve, and wherein the pharmaceutical composition comprises multivesicular liposomes.

Abstract: A method for the fail-safe termination of in vivo drug delivery from an implantable drug delivery system, the method comprising: providing an implantable drug delivery system comprising: a housing having a reservoir for containing a drug, and a port for dispensing the drug to a patient; and an emergency deactivation unit disposed between the reservoir and the port, the emergency deactivation unit comprising a composite structure comprising a biocompatible ferromagnetic mesh open to fluid flow and a hydrophobic meltable material, the hydrophobic meltable material comprising at least one hole therein for enabling a fluid to pass through the hydrophobic meltable material; implanting the implantable drug delivery system within a patient; enabling the drug to flow from the reservoir, through the at least one hole in the hydrophobic meltable material and out the port; and when drug flow is to be terminated, applying a magnetic field to the composite structure, such that a current is induced in the ferromagnetic mes

Abstract: A monitor for measuring the flow rate of a fluid medicament is incorporated into an elastomeric tube that will be used to transfer fluid medicament from a supply source to the patient. Structurally, the monitor includes a hollow shell having a flexible membrane that is affixed across the inside the shell to create a fluid tight barrier which bifurcates the shell's interior into a gas enclosure and a liquid pathway. As fluid passes through the liquid pathway from the supply source and on to the patient, movements of the flexible membrane cyclically indicate changes in the volume of the gas enclosure. Volume changes of the gas enclosure are measured by a pressure gage to indicate the flow rate of the fluid medicament.

Abstract: A system for measuring drip rate may include a drip chamber device comprising an elongated body including an inner surface defining a chamber, and a drip rate measurement device. The drip chamber may be fluidly coupled to a container containing an IV fluid configured to drip droplets of the IV fluid into the chamber. The drip rate measurement device may include a housing configured to be mounted to the elongated body of the drip chamber, and a load cell transducer mounted in the elongated body and extending into the chamber. The load cell transducer may be configured to measure a weight of the droplets of the IV fluid and convert the weight into an electrical signal. The drip rate measurement device may further include a controller electrically coupled to the load cell transducer to process the electrical signal and output at least one parameter associated with the IV fluid.

Abstract: Exemplary embodiments may provide an on-body medicament delivery system that provides basal delivery of a medicament to a type 2 diabetes patient and that automatically performs medicament titration for the patient. The medicament delivery system performs medicament titration based on glucose level readings for the patient. These glucose levels may be provided wirelessly from a glucose sensor, such as a continuous glucose monitor, or may be entered manually by the patient into a management device, such as a smartphone running an application that provides a user interface for the patient to enter the glucose level readings. The medicament delivery system adjusts the basal medicament delivery rate/dose based on the glucose level readings for the patient. The adjustments may be performed by a programmatic mechanism, such as by computer programming instructions executing on a processor.

Abstract: Disclosed herein are apparatuses and methods that account for meal announcements in closed loop insulin delivery systems. Rather than simply increasing an insulin delivery rate in response to the meal announcement, the closed loop algorithm can be modified to increase the insulin on board tolerance during eating periods. This approach utilizes the stability of the cascaded loop in the closed loop algorithm to prevent the oscillations in glucose levels that can occur by simply increasing the basal rate.

Abstract: A dual chamber syringe facilitates selective drug mixing, dosing, and administration, as well as pre- or post-administration flushing with a single syringe instrument. A syringe barrel incorporates an outlet, as well as variable-volume, primary and secondary fluid chambers, separated by a floating stopper. The floating stopper defines a dome-shaped split septum with a central slit at its apex. The split septum is a bi-stable valve, closing the central slit by compression in its meridial dimension when the septum is in a first, relaxed state, and opening the central slit when the septum is buckled or flipped under tension in the meridial dimension in a second state. Buckling of the septum wall is caused solely by differential fluid pressure applied by a single plunger, without physical contact of the septum with any other structure within the syringe.

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

Abstract: An injection device for subcutaneously administrating a maximum content of a product container through a cannula at a distal end of the product container, comprising a device housing having an opening at a proximal end, a module housing for covering the opening, which module housing is separable from the device housing by a separating operation, a drive which is arranged in the device housing, for moving an advancing element and for the one-time automatic ejection of the contents of the product container. An electronics module is held in the module housing, with a sensor for detecting the discharging, and a mechanical securing mechanism is provided for enabling the separating operation as or after the automatic ejection is triggered.

Abstract: Disclosed are an ampoule-fixing holder for an intraosseous anesthetic solution injection device and an anesthetic solution injection device including the same. The ampoule-fixing holder includes a cylindrical holder body including an open portion formed at the rear end thereof to allow an ampoule containing an anesthetic solution to be inserted thereinto or removed therefrom, a head configured to enable mounting of an injection needle to the front end of the holder body, a rotary body disposed between the head and the holder body to withstand rotational force and an axial load, and a fixing member configured to firmly hold the ampoule inserted into the holder body to effectively transmit rotational force to the ampoule.

Abstract: A drug administration management system according to an embodiment of the present disclosure may include a smart case configured to accommodate a drug administration device, display drug administration information including whether or not a drug is administered and a drug administration dose for each drug administration site input button based on an input of a user, and transmit the drug administration information externally; and a terminal configured to receive the externally transmitted drug administration information from the smart case, and monitor the drug administration information based on a drug administration plan input from a user.

Abstract: In some embodiments, an adjunct device for tracks time and/or dosage of a medicine. The device may include a connector for mounting the device to a deposable pen injector. The device may be configured to allow use of the native controls and injectors of the injector. For example the device may include a view port for viewing a dose indicator of the injector. The device may include one or more vibration sensors. A processor may be configured to differentiate increasing a dose, decreasing a dose and/or discharging the medicine based on the output of the sensors. Optionally a display of the device may be positioned for simultaneous viewing with the dosage indicator of the injector. For example a user may verify the accuracy of the adjunct device before performing a discharge.

Abstract: An auto-injector for administering a dose of a liquid medicament (M) is present having a tubular chassis telescopable in a tubular case, a carrier subassembly comprising a tubular carrier slidably arranged relative to the chassis inside the case, where the carrier is adapted to contain a syringe with a hollow injection needle. The injector also has a drive spring and a plunger for forwarding load of the drive spring to a stopper of the syringe, wherein the syringe is lockable for joint axial translation with the carrier. A control spring is arranged around the carrier for translating the carrier in a proximal direction (P) for insertion of the needle through the chassis into an injection site.

Abstract: A needle actuator assembly for a drug delivery system includes a housing, a needle having retracted and extended positions, a needle actuator body received within the housing and configured to move from a pre-use position where the needle is in the retracted position to a use position where the needle is in the extended position and to a post-use position where the needle is in the retracted position, with the needle actuator having a button contact surface, and an actuator button received by the housing.

Abstract: A fluid injector system has at least one reciprocally operable piston having a piston head, and a plunger engagement mechanism associated with the piston head. The plunger engagement mechanism has a cam sleeve disposed within the piston head and movable relative to the piston head, the cam sleeve having one or more tracks defining a cam surface. The plunger engagement mechanism further has an actuator operatively connected to the cam sleeve for moving the cam sleeve relative to the piston head, and one or more pins disposed within the cam sleeve. The one or more pins are movable within the one or more tracks with movement of the cam sleeve between a first or withdrawn position, wherein the one or more pins are radially withdrawn into the piston head and a second or extended position, wherein the one or more pins protrude radially outward relative to an outer surface of the piston head.