Abstract: A wound care product and related methods of treatment for wound site infection and for healing a wound is disclosed. The wound care product includes alexidine and a substrate and/or a pharmaceutically acceptable carrier.

Abstract: A cost effective bacterial cellulose wound dressing includes a microbial-derived cellulose loaded with natural antibacterial and regenerative substances. This wound dressing is effective for the treatment of burns and chronic wounds. The dressing keeps the wound moist while absorbing exudates from the wound area. The dressings possess antibacterial qualities to protect the wound from infections and help the area to heal faster through the action of bioactive substances.

Abstract: Hemostatic devices for promoting blood clotting can include a substrate (e.g., gauze, textile, sponge, sponge matrix, one or more fibers, etc.), a hemostatic material disposed thereon such as kaolin clay, and a binder material such as crosslinked calcium alginate with a high guluronate monomer molar percentage disposed on the substrate to substantially retain the hemostatic material material. When the device is used to treat a bleeding wound, at least a portion of the clay material comes into contact with blood to accelerate clotting. Moreover, when exposed to blood, the binder has low solubility and retains a majority of the clay material on the gauze. A bandage that can be applied to a bleeding wound to promote blood clotting includes a flexible substrate and a gauze substrate mounted thereon.

Abstract: An open-cell foam wound dressing comprising a formulation of an amphiphilic antiseptic and particular surfactants is provided.

Abstract: A hemostatic device for promoting the clotting of blood includes a gauze substrate, a clay material disposed on the gauze substrate, and also a polyol such as glycerol or the like disposed on the gauze substrate to bind the clay material. When the device is used to treat a bleeding wound, at least a portion of the clay material comes into contact with blood emanating from the wound to cause the clotting. A bandage that can be applied to a bleeding wound to promote the clotting of blood includes a flexible substrate and a gauze substrate mounted thereon. The gauze substrate includes a clay material and a polyol. A hemostatic sponge also includes a gauze substrate and a dispersion of hemostatic material and a polyol on a first surface of the substrate.

Abstract: The present invention is an endoscope hemostatic material comprising a sheet-like nonwoven fabric that is formed from a hydrophobic material that has a bulk density of 40 to 110 mg/cm3 and a film thickness of 400 to 1400 ?m, and also an endoscope hemostatic material comprising a sheet-like nonwoven fabric that is formed from a hydrophobic material and that has an area density of 5.0 to 11.0 mg/cm3 and an average fiber diameter of 0.5 to 0.8 ?m, either of which is suitable for treatment of bleeding through an endoscope.

Abstract: Method to produce a single-piece prosthetic component (110, 210, 310, 410, 510, 610, 620, 710, 810, 910) that comprises making available a substrate (12) and making a coating layer (14) thereon.

Abstract: A solidifying prepolymeric implant composition comprising a biocompatible prepolymer and an optional filler. One such implant composition is a polyurethane implant composition comprising an isocyanate, such as hydroxymethylenediisocyanate (HMDI) and an alcohol, such as polycaprolactonediol (PCL diol). The compositions of the invention are useful for improving bone structure in patients by applying the solidifying implant composition to bone, reinforcing bone structure, improving load bearing capacity and/or aiding healing of microfractures.

Abstract: The technology described herein is directed to compositions comprising at least a first porous biomaterial layer and a second impermeable biomaterial layer and methods relating thereto. In some embodiments, the compositions and methods described herein relate to wound healing, e.g. repair of wounds and/or tissue defects.

Abstract: The present invention relates to the technical field of silk scaffolds, and in particular, to a silk/pet mix-woven scaffold and a preparation method and use thereof. The silk/PET mix-woven scaffold is formed by weaving silk and PET fibers. Sericin of the silk is removed. The silk and the PET fibers are mixed and knitted. The PET fibers provide reliable fixation in an early stage to maintain the stability of mechanical properties, and the silk degrades gradually in a later stage to promote the growth of new tissues to achieve the integration of the scaffold and the body. When the scaffold is used for artificial tendon/ligament recovery, its overall performance is better than that of pure silk or pure PET fiber scaffolds, and the scaffold has excellent clinical transformation potential.

Abstract: A joint spacer is provided for treatment of a joint of a human subject, the joint spacer including a pouch having a wall including a dermal graft material. The joint spacer is configured to be inserted into a space of the joint, and is shaped, when the pouch is inserted into the space and filled, to provide mechanical support to the joint. Other embodiments are also described.

Abstract: A biologic composition responsive to inflammation has an allograft scaffold matrix for injection or implantation. The allograft scaffold matrix has donor quiescent and/or senescent cells. The donor quiescent and/or senescent cells react in response to signaling of inflammation from host cells or matrix. The reaction to signaling causes the donor quiescent and/or senescent cells to secrete anti-inflammatory cytokines and secrete exosomes to initiate regeneration of the area of the inflammation. The biologic composition further has a cryoprotectant. The cryoprotectant is a polyampholyte, preferably the polyampholyte is an ?-poly-L-lysine. The cryoprotectant is not DMSO or glycerol based. The cryoprotectant is suitable for direct implantation without washing from the allograft scaffold matrix in either a diluted or non-diluted state.

Abstract: A method of making infused bone particles employs the following steps: cutting or shaving whole bone into bone particles, washing the bone particles, demineralizing or decalcifying at least partially the whole bone or bone particles and infusing the bone particles with a supernatant of biologic material or a polyampholyte cryoprotectant or a combination of both to create infused bone particles. The step of infusing includes exposing the bone particles to a negative pressure or vacuum to draw the supernatant and/or the polyampholyte cryoprotectant into the bone particles, or alternatively, exposing the demineralized whole bone to a positive pressure to drive the supernatant and/or the polyampholyte cryoprotectant into the bone. The resultant method creates an infused bone grafting composition having bone particles taken from whole bone, demineralized or decalcified at least partially and infused with one or more of a supernatant of biologic material or a polyampholyte cryoprotectant or both.

Abstract: Methods and compositions for preparing and priming a tissue graft for an accelerated therapeutic effect are provided herein. In one embodiment, the method includes obtaining a tissue containing viable cells from a donor, wherein the viable cells are endogenous to the tissue and remain resident in the tissue; and priming the viable cells with one or more stimuli comprising simulated hypoxia to produce a primed tissue, wherein when grafted to a recipient the primed tissue provides a benefit compared to non-primed tissue.

Abstract: Biodegradable antimicrobial films are provided that are solid at room temperature and substantially liquefy in situ after implantation into a mammal, such as a human patient. Methods of using the films to cover a medical device, such as a breast implant, prior to insertion into a subject are also provided.

Abstract: The present disclosure provides magnetically templated tissue scaffolds, methods of making the magnetically templated tissue scaffolds, and various methods of employing the scaffolds for tissue growth and repair in vitro and in vivo, including peripheral nerve repair.

Abstract: Antimicrobial formulations and coatings for medical devices and processes therefor are disclosed. The formulations include at least one water permeable polymer with at least one antimicrobial agent in a liquid medium and are prepared by wet milling the components and can form antimicrobial coatings having uniformly dispersed particles having an average size of no greater than 50 microns.

Abstract: Radiation sterilized hydrogels, medical devices containing the same and method of making radiation sterilized hydrogels.

Abstract: This present invention relates to drug eluting polymers, including novel biodegradable drug eluting polymers, which are added to the surface of a medical device to treat device associated complications and to deliver drug locally around the device. Methods of making polymers, for example, drug-eluting polymers, polymer compositions, and materials used therewith also are provided. The drug eluting polymers are obtained from the polymerization of macromonomers made of a connecting moiety, a biodegradable moiety and a cross-linkable moiety that are liquids at a temperature of 10° C. to 40° C.

Abstract: The present invention features methods of manipulating subdermal fat in a treatment area. Such methods include inserting a needle (e.g., a micro-coring needle) through the dermis to the subdermal fat layer in order to excise a portion of tissue from the treatment area. These insertions result in a portion of the dermis and a portion of subdermal fat to enter into the needle. Removal of the needle results in excision of the portion of dermis and subdermal fat that entered into the needle.

Abstract: Disclosed herein are embodiments of a wound treatment apparatus with electronic components integrated within a wound dressing. In some embodiments, a wound dressing apparatus can comprise a wound dressing. The wound dressing can comprise an absorbent material, an electronics unit comprising a negative pressure source, the electronics unit integrated within the wound dressing and at least partially encapsulated by a flexible film. The electronics unit can include translucent or transparent components that allow light to travel through to reach adhesives or coatings on the electronic components that would otherwise be obscured.

Abstract: The present efficient support portable constant negative pressure suction apparatus for outdoor use includes: a negative pressure suction ball extending from the proximal end to the distal end, the negative pressure suction ball being provided with an internal sac structure; the internal sac structure includes: a round gas exhaust valve, a spherical sac, and an anti-reverse flow flap arranged in sequence from the proximal end to the distal end; and also including: a negative pressure suction tube, the negative pressure suction tube being in communication with the negative pressure suction ball and the negative pressure suction tube being provided with a suction control channel.

Abstract: A system for distributing fluid during a surgical procedure is disclosed, comprising a plurality of valves at least partially enclosed in a surgical cassette, at least one vacuum source fluidly connected to at least one of the plurality of valves, and at least one fluid source fluidly connected to at least one of the plurality of valves, wherein each valve is responsive to at least one received signal indicative of at least one parameter associated with one of fluid pressure and fluid volume.

Abstract: Methods and systems for administering directed fluidics during a medical procedure for removing an object are disclosed. A method includes inserting first and second medical instruments into a treatment site, providing irrigation and aspiration of the treatment site through the first and second medical instruments, determining a characteristic of one of the irrigation and the aspiration, and selecting a characteristic of the other of the irrigation and aspiration based on the determined characteristic.

Abstract: A system for a surgical system is disclosed, comprising a surgical cassette, comprising a cassette for use with a surgical console, further comprising a first set of fluid channels having a first set of ports, a second set of fluid channels having a second set of ports, at least one rotary valve in fluid communication with the first set of fluid channels, at least one rotary valve in fluid communication with the second set of fluid channels, and a plurality of deformable channels, wherein the deformable channels are fluidly connected to ones of the first set of ports and second set of ports.

Abstract: A system for a surgical system is disclosed, comprising system for distributing fluid in a surgical cassette, comprising at least one at least partially deformable bladder at least partially disposed on at least one rigid surface, wherein the bladder forms a portion of a channel, at least a first and second port in fluid communication with the channel, wherein the channel comprises at least two portions having a substantially uniform first dimension separated by a second portion have a second dimension, and wherein at least two pump head rollers are engaged with the bladder.

Abstract: Devices and systems disclosed herein may include a negative pressure pump that includes a reservoir defining a lumen and a longitudinal axis, a piston, and a drive assembly comprising a spring. Motion of the spring may move the piston along the longitudinal axis of the reservoir to create a negative pressure within the reservoir. Methods of manufacturing a negative pressure pump and using a negative pressure pump to remove fluid from a target site are also described.

Abstract: A pressure and vacuum pump including at least two diaphragm pump heads for providing vacuum and pressure simultaneously. The dual function pump reduces number of required pumps, is traditionally quieter, and enables the system to run at a lower duty cycle. A drive in the pump housing causes a connecting rod to oscillate a diaphragm to move up and down thereby causing air to be either drawn into an inlet or forced out via an exhaust.

Abstract: An intra-ventricular pulsatile assist system is provided including an intra-ventricular blood pump including a chamber having a distal portion and a proximal portion opposite the distal portion, the proximal portion and the distal portion defining an axis extending therebetween and the distal portion defining an outlet; a valve at the distal portion of the chamber, the valve including a closed position in which the outlet is sealed and an open position in which the outlet is unsealed; and a control circuit including a processor in communication with the blood pump, the processor having processing circuitry configured to determine a pressure value in the chamber and transition the valve between the closed position and the open position when the pressure value in the chamber deviates from a predetermined threshold value.

Abstract: A controller for an implantable blood pump including processing circuitry configured to operate the implantable blood pump and a piezoelectric element in communication with the implantable blood pump.

Abstract: A medical fluid delivery system including remote machine updating and control is disclosed. An example medical fluid delivery system includes a medical fluid delivery device for a patient. The medical fluid delivery system also includes a server in communication with the medical fluid delivery device and a software application for a mobile device. The software application causes an icon to be displayed representing the medical fluid delivery device. The medical fluid delivery system further includes a first communication link between the medical fluid delivery device and the server, and a second communication link between the server and the software application. The software application receives status updates from the medical fluid delivery device via the server and the first and second links.

Abstract: An extracorporeal circulation management device 10 displays an expected flow rate of blood flowing inside a circulation circuit 1R and an actual flow rate on a display unit 16, together with a standard pressure calculated based on the expected flow rate by referring to standard information representing a relation between the blood flow rate and a pressure loss occurring in each of devices 2, 5, and 6 provided in the circulation circuit 1R and stored in a storage unit, and an actual pressure related to each of the devices 2, 5, and 6, which is calculated based on an actual pressure measured by each of pressure measurement units 21, 22, and 23 as an actually measured value of a pressure of the blood flowing inside the circulation circuit 1R and the actual flow rate.

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

Abstract: A peritoneal dialysis (PD) system for infusing a volume of PD solution into a patient's peritoneal cavity in order to perform peritoneal dialysis on the patient includes a peritoneal cavity monitor (PCM) that measures this volume of fluid in the patient's peritoneal cavity by segmental bioimpedance spectroscopy (SBIS), to thereby determine an ultrafiltration volume of fluid in the patient's peritoneal cavity, and a switch, controlled by the PCM, for filling the patient's peritoneal cavity and draining the patient's peritoneal cavity when the ultrafiltration volume is unchanged over time, significantly decreased, or decreasing at a significant rate.

Abstract: The invention relates to systems and methods for sensing fluid characteristics of peritoneal dialysate infused into and removed from a patient during treatment. The systems and methods include sensors, processors, and flow paths for determining patient health based on the fluid characteristics of the peritoneal dialysate. The system can be a peritoneal dialysis cycler which can include an infusion line; an effluent line; at least one pump positioned in the infusion and/or effluent line; and at least one sensor fluidly connected to the effluent line. The sensor can be at least one of a flow sensor, an ion selective electrode, a pH sensor, a pressure sensor, a refractive index sensor, and a temperature sensor. The method can include infusing peritoneal dialysate through an infusion line; removing peritoneal dialysate through an effluent line; and determining at least one fluid characteristic of the peritoneal dialysate in the effluent line.

Abstract: The present invention relates to an apparatus for performing an automated peritoneal dialysis treatment on a patient, the apparatus comprising: a first dialysis fluid port for receiving a first dialysis fluid having a first composition, which is determined by the concentrations of a set of first dialysis fluid constituents; a dialysis fluid line system connecting the first dialysis fluid port to a patient terminal; at least one dialysis fluid pump acting on the dialysis fluid line system and configured to convey the first dialysis fluid from the first dialysis fluid port to the patient terminal; and a control unit operably connected to the at least one pump; wherein the apparatus further comprises a second dialysis fluid port for receiving a second dialysis fluid having a second composition, which is determined by the concentrations of a set of second dialysis fluid constituents.

Abstract: A dialysis system, such as a hemodialysis system, includes a flow chamber. The flow chamber includes: a tube section having a first end and a second end, a tube section longitudinal axis extending between the first end and the second end, the tube section having an inner wall and outer wall; and a helical flow path disposed in the inner wall of the tube section, the helical flow path extending along at least a portion of the tube section longitudinal axis.

Abstract: An extracorporeal therapy system includes: (i) a dialysis fluid circuit including dialysis fluid preparation structure configured to prepare a dialysis fluid for an extracorporeal therapy treatment; (ii) a blood circuit including a blood filter for use during the extracorporeal therapy treatment; (iii) a blood pump operable to pump blood through the blood circuit and blood filter; and (iv) a control unit operable with the dialysis fluid preparation structure and the blood pump, the control unit programmed to prepare a gas generation fluid different than the dialysis fluid for the extracorporeal therapy treatment, wherein the gas generation fluid generates carbon dioxide (“CO2”) gas, and wherein the CO2 gas is used to prime the blood circuit including the blood filter.

Abstract: The invention pertains to a medical device: an ECMO (extracorporeal membrane oxygenation) catheter which can be used during right heart and lung failure. It pertains to a dual lumen catheter with a single port of entry which when in place bypasses the right heart and lungs while completing the veno-arterial circuit.

Abstract: A bidirectional vascular cannula device includes a tube and a moving mechanism having a through hole. The tube includes a tubular wall which defines therein a passage having opposite proximal and distal opened ends. The tubular wall has a secondary opening formed therethrough. Oxygenated blood infused into the passage from the proximal opened end is delivered to one end of the blood vessel from the distal opened end, and a part of the blood is delivered to the other end of the blood vessel through the secondary opening and the through hole so as to obviate ischemic caused by cannula occlusion. The moving mechanism is operable to be moved to permit a part of the moving mechanism to project outwardly and to be attached to the inner wall of the blood vessel for positioning the cannula device.

Abstract: Disclosed is an extracorporeal blood circulation device including a blood circulation circuit including a blood extraction line and a return line, a blood circulator in the circulation circuit and a control unit including a calculator arranged determining at least one parameter, recording it in a memory, and then comparing the standard value of the parameter with the recorded value. The device also includes a source of solution for liquefying blood clots, a device injecting and conveying the liquefaction solution in the circulation circuit, the control unit including a driver for the injector of the liquefaction solution. The control unit is arranged to actuate the driver when the value is exceeded, meaning that at least one clot has formed, the driver being arranged so that the liquefaction solution is present in the circulation circuit in an amount and for a time determined to be sufficient for liquefying the clot formed.

Abstract: Devices, systems, and methods for medication infusion are described herein. In some embodiments, a system includes a patient access subassembly, a first fluid reservoir, a second fluid reservoir, and an assembly. The assembly can have a first configuration in which the patient access subassembly is in fluid communication with the first fluid reservoir via a first tube, a second configuration in which the first fluid reservoir is in fluid communication with the second fluid reservoir, and a third configuration in which the first fluid reservoir is in fluid communication with the patient access subassembly via a second tube, the first fluid reservoir fluidically isolated from the first tube in the third configuration.

Abstract: Systems and methods are provided for therapeutic red blood cell exchange and/or therapeutic plasma exchange. A blood separation device includes a centrifugal separator, a spinning membrane separator drive unit, a pump system, and a controller. Blood is conveyed through a fluid flow circuit into either the centrifugal separator or the spinning membrane separator, which separates out the target blood component (red blood cells, in the case of therapeutic red blood cell exchange, or plasma, in the case of therapeutic plasma exchange). The target blood component is retained in the circuit as a waste product, while a replacement fluid is added to the remaining blood component(s), which is then conveyed to a recipient. In addition to allowing for execution of an exchange procedure using either a centrifugal separator or a spinning membrane separator drive unit, the blood separation device also allows for the use of differently sized spinning membrane separators.

Abstract: A system for irrigating a patient's skin. The system includes a fluid container that includes a first compartment and a second compartment, the first compartment being adapted to retain a first fluid on a first side of a divider and the second compartment being adapted to retain a second fluid on a second side of the divider. The system also includes an irrigation sleeve adapted cover a portion of the patient's skin. The system also includes a fluid charging portion adapted to receive a portion of the first fluid and a portion of the second fluid, wherein the portion of the first fluid reacts with the portion of the second fluid to form a charged compound in the fluid charging portion. The system also includes a compound delivery portion that extends at a first end of the compound delivery portion from the fluid charging portion, the compound delivery portion being adapted to deliver the charged compound from the fluid charging portion to the irrigation sleeve.

Abstract: A phacoemulsification probe for use with eye surgery comprises a probe tip defining a channel there in the probe tip defining an opening having a first diameter for aspirating material from a surgical area long a first vector. The probe tip further defining a channel therein the channel having a second diameter greater than the first diameter of the opening. A flexible sleeve surrounding a body of the probe tip. A first end of the flexible sleeve forming a seal between the probe tip and the flexible sleeve. A remainder of the flexible sleeve defines a second channel between the body of the probe tip and the flexible sleeve. The flexible sleeve further defines an opening for injecting a fluid from the second channel into the surgical area along a second vector.

Abstract: Devices and methods for filling a medicament cartridge of a pump, including a user-wearable, ambulatory infusion pump. A device for supporting a medicament cartridge can comprise a body portion resembling a tray, with recesses disposed therein to support one or more of a cartridge body, cartridge tubing, interconnect fitting, and vial adapter. The recesses of the tray may be shaped to correspond to that component intended to be placed in its respective recess so to provide a visual indication to a user how to couple and align the various components necessary to fill the cartridge.

Abstract: A modular power and connectivity assembly and system are provided. The modular power and connectivity assembly includes a housing, a power assembly and a communication assembly. The modular power and connectivity assembly is reusable and provides power and communications to a removably coupled infusion device. The system includes multiple modular power and connectivity assemblies, a charging station for recharging the modular power and connectivity assemblies, a connectivity hub for communicating with the modular power and connectivity assemblies, and a cloud interface to a healthcare system for sending and receiving information to and from the modular power and connectivity assemblies. A method of operating a modular power and connectivity system is also provided.

Abstract: A tubing organizer is described herein. The tubing organizer comprising a cellular sheet comprising a base sheet having a first major surface and a second major surface, a top sheet periodically connected to the second major surface of the base sheet forming an array of fluid filled cells, wherein the fluid filled cells are separated by gutters, and an adhesive layer disposed on the first major surface of the base sheet.

Abstract: The subject invention provides a drug delivery device for injecting medicament which includes a tubular reservoir; a stopper slidably disposed in the reservoir; a spring for moving the stopper in the reservoir; at least one needle, the needle having a distal end for insertion into a patient, and a lumen extending proximally from the distal end, the lumen being in direct or indirect communication with the reservoir; a needle driver for displacing the needle; and an actuator. Activation of the actuator causes the spring to move the stopper and the needle driver to displace the needle. The needle moves relative to, and separately from, the reservoir with the needle being displaced. Advantageously, with the subject invention, a drug delivery device is provided wherein a needle is moved, relative to the reservoir, in being displaced for injection. This permits control of the needle displacement separate from the reservoir.

Abstract: Briefly, a kinkless infusion set has a setting control that engages a curved or helical cannula to simultaneously rotate the helical cannula as the helical cannula is moved toward a patients skin and then under the patient's skin to position the curved or helical cannula to a desired depth and position. In one example, the helical cannula is set between 3 mm and 5 mm under the patient's skin. Also, the curved or helical cannula may have side ports to allow medicine to be presented over a larger area for more effective therapeutic treatment. In some constructions the patient rotates the setting control, and in other cases the patient may push, pull or translate the setting control.