Abstract: Provided herein are anisotropic muscle implants that have a biodegradable scaffold comprising a plurality of fibers oriented along a longitudinal axis. The implants may include mammalian muscle cells seeded and/or fused into myotubes on the scaffold. Methods of forming the muscle implants are provided, as are methods of treating a subject in need of skeletal muscle reconstruction.

Abstract: The present disclosure provides an implantable medical device comprising a composite graft material including a first biologic component, such as an acellular tissue matrix, and a second non-biologic component.

Abstract: A biohybrid scaffold is provided that is useful in clinical applications for abdominal wall reconstruction, pelvic floor repair, breast reconstruction, as well as other soft tissue repairs. Methods of making and using the biohybrid scaffold are provided.

Abstract: A compound suitable for hydroclaving is disclosed, comprising polyester, polysulfone, and an epoxy-functional styrene-acrylate oligomer. In order for successful repetitious hydroclaving to be possible, the compound must also have a polysulfone content of greater than 45 weight percent of the compound.

Abstract: A reduced-pressure treatment system for treating a tissue site of a patient, the system includes a manifold pad for disposing proximate the tissue site. The manilfold pad includes a hydrogel reservoir member and a manifold member. The hydrogel reservoir member is adapted to receive and store fluid from the tissue site at a first pressure and adapted to release at least a portion of the fluid at a second pressure. The first pressure is greater than the second pressure on an absolute pressure scale. The system also includes a sealing drape for placing over the tissue and manifold pad. The sealing drape forms a fluid seal over the tissue and manifold pad. A reduced-pressure subsystem delivers reduced pressure to the sealing drape. Other systems, apparatuses, and methods are disclosed.

Abstract: A method and system are provided for percutaneously gaining access to oxygenated blood with one or more anastomosis devices and pumping such oxygenated blood directly to the aorta adjacent to the right atrium or left atrium via a VAD system. In one embodiment, a VAD system can be implanted with open surgery.

Abstract: A catheter pump is disclosed herein. The catheter pump can include a catheter assembly that comprises a drive shaft and an impeller coupled to a distal end of the drive shaft. A driven assembly can be coupled to a proximal end of the drive shaft within a driven assembly housing. The catheter pump can also include a drive system that comprises a motor and a drive magnet coupled to an output shaft of the motor. The drive system can include a drive assembly housing having at least one magnet therein. Further, a securement device can be configured to prevent disengagement of the driven assembly housing from the drive assembly housing during operation of the pump.

Abstract: A modular wall-chase system relating to the routing of mechanical elements (plumbing, electrical, data, etc.) within the interior of a new, or already built, structure and particularly relating to the interior of a kidney-dialysis treatment facility.

Abstract: A hemodialysis system includes (i) a plurality of pump rollers: (ii) a fluid heater, the pump rollers and the heater positioned and arranged to accept a horizontally loaded dialysate cassette: (iii) a dialyzer; (iv) a sorbent cartridge; and (v) wherein the dialysate cassette includes first and second tubes for horizontal interaction with the pump rollers and a third tube for horizontal interaction with the heater, the cassette in fluid communication with the sorbent cartridge.

Abstract: A medical fluid delivery cassette configured for use with a medical fluid pumping system and related systems and methods. The medical fluid delivery cassette includes a base and a membrane that together define a fluid pump chamber. The medical fluid delivery cassette further includes a member configured to apply an outward force to an inner surface of the membrane.

Abstract: An compact hydraulic manifold for transporting shear sensitive fluids is provided. A channel network can include a trunk and branch architecture coupled to a bifurcation architecture. Features such as tapered channel walls, curvatures and angles of channels, and zones of low fluid pressure can be used to reduce the size while maintaining wall shear rates within a narrow range. A hydraulic manifold can be coupled to a series of microfluidic layers to construct a compact microfluidic device.

Abstract: Systems and methods are provided for performing a medical procedure within a patient's body that involves a thoracic duct including an ostium communicating with the patient's venous system. A distal end of a catheter is introduced through the patient's venous system into a body lumen adjacent the ostium of the thoracic duct. An expandable member on the distal end of the tubular may be expanded adjacent the ostium, e.g., within the body lumen or the thoracic duct itself, and used to isolate the thoracic duct from the body lumen, whereupon a medical procedure may be performed via the thoracic duct. For example, lymphatic fluid may be removed from the thoracic duct through a lumen of the tubular member and/or one or more agents may be introduced into the thoracic duct through the tubular member.

Abstract: Devices, methods, and systems for obtaining one or more biological fluid components, and reducing red blood cell contamination, using a back-flushable filter device, are disclosed.

Abstract: The present disclosure relates generally to systems for processing a unit of whole blood into its components while the unit is still in the centrifuge. The system comprises a container holding whole blood and one or more satellite bags or containers that are installed into a holder, which is then inserted into a bucket of the centrifuge. Tubes interconnect the containers, one or more of which are preferably installed into clamping mechanisms resident in the holder. The holder further preferably includes sensing means, such as optical sensors, to sense the location of the interfaces between the separated layers of the whole blood that result from rotation of the centrifuge.

Abstract: The present invention relates to a blood separation container for extracting self-platelet. According to the present invention, since a second coupling portion is formed at a release prevention member coupled to a lower portion of a main body in a PRP separation container, and an ascending member having a bolt structure is screwed to the second coupling portion to ascend a lower cover disposed in a lower fluid chamber of the main body, a separate second main body is unnecessary unlike the related art. Therefore, the PRP separation container is easy to carry, manufacturing costs can be reduced to thereby ensure competitive price, and a PRP can be easily separated and extracted.

Abstract: This invention relates to a blood processing filter comprising a sheet-like filter element, an inlet-side flexible container and an outlet-side flexible container that sandwich the filter element and are sealed thereto, an inlet port provided in the inlet-side flexible container for accepting blood before being processed by the filter element, and an outlet port provided in the outlet-side flexible container for discharging blood after being processed by the filter element. The blood processing filter also includes a flow channel securing sheet arranged between the filter element and the outlet-side flexible container. A flow channel hole through which blood processed by the filter element passes is formed in the flow channel securing sheet. The outlet port is provided so as to be capable of communicating with the flow channel hole.

Abstract: A delivery system for delivering fluidic media to a user having a second housing portion configured to be selectively operatively engaged with and disengaged from a first housing portion, the first housing portion and the second housing portion configured to be slidable relative to each other to operatively engage each other; and a fluid connector supported by one the housing portions in a position to engage a reservoir supported by an other of the housing portions in a case where the first housing portion and the second housing portion are slid relative to each other to operatively engage each other.

Abstract: A pump set for use with a pumping apparatus having a rotor with a plurality of rollers mounted on the rotor rotatable about an axis of rotation is disclosed. The pump set comprises a cassette body comprising a stator member with a fixed portion secured to the cassette body, a second portion opposite the fixed portion, a reaction surface and a second surface opposite the reaction surface, the reaction surface defined between the fixed portion and the second portion, and a tube secured to the cassette body, at least a portion of the tube is disposed against the reaction surface.

Abstract: An aspect of some embodiments of the current application is a doorstop to a drug delivery apparatus that encourages a user of the apparatus to perform the proper usage steps in the proper order. For example, a user may be expected to receive an injector in a transport state, open it to an open state, insert a cartridge, and/or close the cartridge before operation. The doorstop may have an obstructing mode, optionally preventing closing of the door. The cartridge may optionally have a non-obstructing mode allowing closing of the door. Inserting the cartridge may optionally cause a doorstop to move from the obstructing mode to the non-obstructing mode. In the non-obstructing mode the doorstop may optionally prevent removal of the cartridge.

Abstract: A system and method of processing information regarding medical devices in wireless communication with each other is provided in which a controller device has a first wireless communication link with a first medical device, such as an analyte sensor, and a second wireless communication link with a second medical device, such as a delivery device. A processor in the controller device monitors the status of the first and second wireless links and upon noting a degradation of either one, compares the first wireless link status with the second wireless link status and provides guidance for resolving a communication problem based on the comparison. The latency of the communicating medical devices is considered.

Abstract: The present invention includes systems and methods for detecting fluid flow into or out of a port chamber or a reservoir of an implantable medical device utilizing a pressure sensor and calculating the fluid status of the reservoir. The system detects characteristic pressure profiles associated with fluid flowing into the medical device, out of the medical device, and also whether one or both of the port chamber or reservoir are substantially empty or substantially full. In addition, the present invention may generate a sensory cue to a clinician to indicate the fluid status.

Abstract: A needleless injection system is provided to deliver therapeutic fluids to an internal treatment site in a patient, where the system is pressurized and is capable of compensating for differences in injection media viscosity and mechanical system characteristics. In one aspect, a needleless therapeutic fluid injection system is provided that includes modular, interchangeable components. In particular, the system includes a console that generally includes the electronic and/or hydraulic control components for the system, an injection chamber, and a shaft or catheter tube.

Abstract: A dosing unit for an infusion pump device is disclosed having a piston pump with a pump cylinder and a plunger arranged within said cylinder, coaxially arranged along a longitudinal axis. The plunger has a shaft with a thread and the cylinder has a threaded sleeve part with a thread. The two threads engaging with each other in such a way that a rotational movement of the plunger around the longitudinal axis results in an additional linear displacement of the plunger along said longitudinal axis. A separate bias force element biases the two threads in regard to each other along the longitudinal axis, such that the threaded engagement of inner thread and outer thread is free of play independent of a direction of a rotational movement and linear displacement of the plunger in regard to the cylinder.

Abstract: The present invention relates to a clot trap that comprises a disc-shaped screen surface for collecting clots in a fluid flowing through the screen surface. It further relates to an external blood cassette and a blood circuit, as well as a treatment apparatus.

Abstract: Device and method embodiments are described which are capable of detecting and alerting a user of an infusion device to a hindrance in the ability to deliver measured quantities of fluids. In some cases, the devices and method embodiments for such occlusion detection do not require significant modification of an infusion device and can be carried out with a minimum of additional components.

Abstract: A system which includes a pressurizing mechanism to pressurize a fluid including a contrast enhancement agent for delivery to a patient and a control system in operative connection with the pressurizing mechanism. The control system includes a system to adjust control of fluid injection based upon a measurement of renal function of the patient.

Abstract: Methods for administering pressure changes to a user for the treatment and prevention of diseases and conditions are disclosed herein. Methods of administering Cyclic Variations in Altitude Conditioning Sessions (CVAC Session(s)) for the treatment of steroidogenesis, steroid levels, and treatment of serum lipid levels are disclosed herein. Also disclosed herein are methods of administering CVAC Session(s) for the treatment of steroid levels and steroidogenesis associated with HIV infection.

Abstract: A system and method for providing balanced, automated regulation of a patient's physiological condition by monitoring at least one physiological parameter and, optionally, monitoring and controlling additional physiological parameters, is disclosed. The system includes a physiological parameter monitor, an intelligent control device and a multi-channel delivery device for providing controlled intravenous delivery of at least two medications that affect the physiological condition being controlled. Control logic in the intelligent control device is derived by an algorithm based on model predictive control. The control logic includes mathematically modeled systems, empirical data systems or a combination thereof. The system of the present invention is optionally included in a networked system to provide centralized data storage and archival of system information as well as data export and query capabilities that can be used for patient file management, health care facility management and medical research.

Abstract: Injection systems comprising a powered injector and one or more hazardous agents are disclosed.

Abstract: A medication injection pen (51) includes a housing (1) and a dose set knob (2) having at least one internal tooth (22). A brake member (5) has a plurality of axially extending splines (52). A driver or setback member (9) includes at least one external tooth (92) engaging the at least one internal tooth (22) of the dose set knob (2) and at least one ratchet arm (96) engaging the plurality of axially extending splines (52). The driver (9) is prevented from rotating with the dose set knob (2) while moving axially with the dose set knob (2) during dose setting and dose correcting, and the driver (9) rotates with the dose set knob (2) during an injection.

Abstract: A drive sleeve is arranged within a body and coupled with a dose member by means of threads. Stop means inhibit a shift of the drive sleeve while allowing a rotation of the drive sleeve. A clutch is provided to lock the dose member rotationally to the body in a releasable manner when a force is exerted on the dose member in the distal direction, the clutch permitting a movement of the dose member in the distal direction with respect to the body.

Abstract: The invention relates to a finger guard for an injection device for administering a dose of a liquid medicament, the finger guard comprising two inwardly biased spring arms arranged for bearing against a protective needle shield arrangeable at a hollow needle, the finger guard further having a respective locking arm assigned to each spring arm biased in a distal direction thus bearing against the respective spring arm when the protective needle shield is in place, wherein the spring arms are arranged to move inwards when the protective needle shield is removed thus allowing the locking arms to move distally into a position where they prevent the spring arms from being pushed outward again.

Abstract: The invention refers to an auto-injector for administering a medicament (M) and to a method for operating it, the auto-injector comprising of a tubular chassis and a carrier subassembly, comprising a tubular carrier slidably arranged in the chassis. The carrier contains a syringe, a drive spring and a plunger for forwarding load of the drive spring to a stopper arranged in the syringe. The syringe is locked for joint axial translation with the carrier. A control spring is connectable to the carrier by first interlock means for needle insertion, wherein the whole carrier subassembly is advanced. Second interlock means are arranged for releasing the drive spring when the carrier has at least almost reached an injection depth thus delivering the medicament (M). The first interlock means are arranged for decoupling the control spring from the carrier and coupling it to the chassis for advancing it over the needle into a needle safe position.

Abstract: A ventilator including a pneumatic system for providing and receiving breathing gas, and a controller operatively coupled with the pneumatic system. The controller is operable to control circulation by the pneumatic system of breathing gas to and from a patient, and to adjust at least one of a volume and pressure of breathing gas delivered to the patient, such adjustment being based upon elastic properties of a component used to fluidly couple the pneumatic system to a patient.

Abstract: A patient interface for use with the administration of CPAP therapy to a patient, comprising: a body for connection with a supply of pressurized breathable gas pressurized above ambient; and a compliant patient contacting element to communicate the pressurized gas to at least the patient's nasal passages, the element including a multilayered cushioning interface, the interface comprising an interior layer and an exterior layer being provided in spaced relation to the interior layer, the exterior layer being elastically and resiliently movable towards and away the interior layer in use. Along at least a portion of the perimeter of the exterior layer, a surface of the exterior layer is deformable from the spaced relation to abut against and contact against a surface of the interior layer in dependence at least in part on a deformation force applied to the exterior layer.

Abstract: A respiratory mask assembly for delivering breathable gas to a patient includes a frame having a front surface and a rear surface adapted in use to face the patient. A cushion having a side wall is removably attachable to the frame. The cushion has a rim extending away from the side wall, and a membrane provided to substantially surround the rim. An inner edge of the membrane defines an aperture, the aperture having a generally trapezoidal shape.

Abstract: A laryngeal tube comprising a tubular component and a nozzle having a central cavity, an anterior opening and a tongue at least partially covering the central cavity. In one example, the laryngeal tube has a first lumen to deliver gases to a patient and a fluid barrier supported by the nozzle. In other examples, the laryngeal tube may include additional lumens including a service lumen to perform a function associated with the thorax and an inflation lumen to inflate the fluid barrier.

Abstract: Apparatus for randomly varying the breathing resistance applied to human and animal subjects to improve their performance.

Abstract: A catheter includes a proximal portion and a distal portion, the distal portion including an arcuate portion. The catheter further includes a rotating portion, the rotating portion connecting the proximal portion and distal portion, the rotating portion including a first piece and a second piece, wherein the first piece and second piece create a snap fit. Methods of using the catheter include threading the inserted catheter through the vasculature and allowing the distal portion to freely rotate about an axis defined by the rotating portion responsive to any tortuosity in the vasculature.

Abstract: Described herein are catheter securement devices that can be used to secure catheters, catheter hubs and other medical devices to the body of a patient. The catheter securement devices can include an adhesive pad and engagement tabs with downwardly extending posts that can engage the holes in suture tabs located on the catheter hub. Adaptors can be used to provide suture tabs to catheters that lack suture tabs.

Abstract: The present disclosure is directed to an IV-catheter insertion device, which comprises a catheter hub at the proximal end of a tubular catheter, a protective barrel releasably joined to the catheter hub in a ready position, a needle hub with an attached hollow needle, the hollow needle extending through the catheter hub and the tubular catheter in the ready position such that that needle tip projects distally of the distal end of the tubular catheter, wherein the needle hub is displaceable in the protective barrel, and a spring clip as a needle guard element whose proximal rear wall is fixed at a distal end area of the protective barrel by means of holding members, wherein the protective barrel and the catheter hub are held by the spring clip in the ready position, and the spring clip is released from the catheter hub in a protected position in which the spring clip covers the needle tip.

Abstract: An introducer adapted to facilitate positioning of a catheter, such as an intrauterine catheter, is provided. The introducer includes an elongate member having an outer wall defining a longitudinal axis and a longitudinal lumen for reception of a catheter, e.g., an intrauterine catheter. The outer wall includes first and second longitudinal edges defining a longitudinal slot in communication with the longitudinal lumen. The outer wall has a cross-section orthogonal to the longitudinal axis and defining a thickness at an opposed location generally opposing the longitudinal slot greater than a thickness at edge locations adjacent the first and second longitudinal edges, to thereby permit the first and second longitudinal edges to be displaced relative to each other to increase a dimension of the longitudinal slot to facilitate one of removal or insertion of the catheter via the longitudinal slot and relative to the longitudinal lumen.

Abstract: An implantable fluid management device, designed to drain excess fluid from a variety of locations in a living host into a second location within the host, such as the bladder of that host. The device may be used to treat ascites, chronic pericardial effusions, normopressure hydrocephalus, hydrocephalus, pulmonary edema, or any fluid collection within the body of a human, or a non-human mammal.

Abstract: A system for the treatment of Alzheimer's disease is provided by moving cerebrospinal fluid containing particles know to contribute to onset of Alzheimer's disease from a source of cerebrospinal fluid to the stomach or bladder, where the particles are safely digested by gastric acid or excreted, the system including an implantable pump, an inlet catheter, an outlet catheter, and a one-way valve. The system further includes at least one filter to filter harmful particles from the cerebrospinal fluid and return the filtered cerebrospinal fluid back to the source of cerebrospinal fluid, where the harmful particles blocked by the filter may be rinsed off the filter and transported to the stomach or bladder.

Abstract: An angioplasty pressure transducer includes a cylindrical member defining an inner cavity. The first end of the cylindrical member is provided with a fluid port allowing the passage of fluid into and out of the cylindrical member due to pressure changes in the physiological fluid being monitored. The angioplasty pressure transducer also includes a cylindrical elastomeric sleeve surrounding the cylindrical member. A cylindrical, transparent housing member is positioned about the cylindrical member such that a substantial portion of the outer surface of the cylindrical member, as well as the elastomeric sleeve, are enclosed and encased within the housing member. The cylindrical wall includes a plurality of small apertures spaced cylindrically about the circumference of cylindrical wall at a position substantially located at the longitudinal center of the cylindrical member, the apertures permitting pressurized fluid to pass between the inner cavity and the outer surface of the cylindrical member.

Abstract: A wound management device comprising at least one wall element of flexible sheet material, the device being securable to skin around a wound site to define a space wherein the wound is accessible; and a connector element held to the at least one wall element and affording at least one passage for external communication with the space; wherein the connector element includes at least one formation through which the or a passage extends, for engagement by a member for fluid supply to or removal from the space.

Abstract: An applicator for applying a microprojection member to the stratum corneum of a patient having a housing, a piston moveable within the housing and a cap adapted to activate the applicator. The applicator is self-setting and auto-triggering, which allows the applicator to be used by patient's having neither the strength, nor the manual dexterity to pre-set and activate other types of applicator devices.

Abstract: A method of providing a fluid communication path to an implanted device. The method includes positioning at least a portion of a slender pointed element within a catheter, penetrating a septum of the implanted device with the slender pointed element positioned within the catheter, positioning at least a portion of the catheter within the implanted device, removing the slender pointed element from the catheter, and retaining the at least the portion of the catheter within the implanted device.

Abstract: Methods of manufacturing a length of a flexible polymeric medical tubing of the kind comprising a tubing member defining a lumen, which tubing member is surrounded by spiral convolutions along at least a part of the length of the proximal section and/or the distal section, and which medical tubing has a proximal convoluted section and a distal convoluted section, is disclosed, as well as medical tubings obtained by the methods and their uses. One method comprises the steps of providing a medical tubing wherein the proximal section and the distal section have substantially uniform initial pitch (Pinitial) between adjacent convolutions, and modifying the initial pitch (Pinitial) of at least a part of the proximal section by stretching at least a part of the proximal section to achieve a modified proximal section with a proximal pitch (Pproximal) between adjacent convolutions that is larger than the initial pitch (Pinitial) between adjacent convolutions.

Abstract: A check valve suitable for use with IV sets and the like provides an upstream filter preventing contamination from affecting the sealing of the check valve membrane. The filter may employ filter media that is integrally bonded to the housing of the filter providing simple and robust construction.