Abstract: A smart antimicrobial material and dressing to inhibit microbial growth is provided. Endogenous chemicals, such as metabolites produced from bacteria are utilized as chemical substrates and converted by enzymes to produce a disinfecting compound that will in turn inhibit the targeted microorganism. The material shall remain passive until such time as it encounters a microbe which expresses and/or secretes specific metabolites or markers. The enzyme or enzymes embedded in the smart material converts the metabolite into a disinfecting compound, which in turn either kills the microorganism or prevents it from multiplying on the surface of the material.

Abstract: An implant, artificial or semi-artificial at implantation, for repairing an articular cartilage and osteochondral defect site in a mammalian, such as a human. The implant having at least a first surface and a second surface. The first surface shaped for being press-fitted into the defect site to create an interface between the first surface and a bone-cartilage region of the defect site, and the second surface shaped for being press-fitted into the defect site to create an interface between the second surface and an articular cartilage region of the defect site. The implant being seeded, prior to implantation, with chondroprogenitor cells, including superficial zone chondroprogenitor cells.

Abstract: Methods of fabricating a substantially interconnected model vasculature, as well as compositions formed from such methods are provided. In some embodiments, the methods may comprise forming a non-woven fiber network comprising a plurality of fibers and a void space; backfilling the void space of the fiber network; and removing the fibers to form a substantially interconnected vascular network.

Abstract: Disclosed are pepsinized collagen implants, such as membranes and sponges, and methods of making them, which entails solubilizing pepsinized collagen in a buffer containing a polyol, e.g., mannitol or sorbitol, wherein the buffer has a substantially neutral pH. Methods of using the pepsinized collagen implants for clinical applications are also disclosed.

Abstract: A catheter assembly for insertion into the brain. The assembly comprises a first length of tubing made of a first material. A second material surrounds the first length of tubing, the second material being more flexible than the first material and having a hardness of less than 50 Rockwell E. The second material provides damping to the first length of tubing.

Abstract: Antimicrobial metal ion coatings. In particular, described herein are coatings including an anodic metal (e.g., silver and/or zinc and/or copper) that is co-deposited with a cathodic metal (e.g., palladium, platinum, gold, molybdenum, titanium, iridium, osmium, niobium or rhenium) on a substrate (including, but not limited to absorbable/resorbable substrates) so that the anodic metal is galvanically released as antimicrobial ions when the apparatus is exposed to a bodily fluid. The anodic metal may be at least about 25 percent by volume of the coating, resulting in a network of anodic metal with less than 20% of the anodic metal in the coating fully encapsulated by cathodic metal.

Abstract: The invention relates to an implant comprising an active-agent-containing coating which covers the implant at least in sections. The coating is composed of at least two subsections; a first subsection contains the at least one active substance, and a second subsection contains an auxiliary agent.

Abstract: An apparatus for cleansing wounds with means for stressing the wound bed and optionally tissue surrounding the wound, in which irrigant fluid from a reservoir connected to a conformable wound dressing and wound exudate from the dressing are recirculated by a device for moving fluid through a flow path which passes through the dressing and a means for fluid cleansing and back to the dressing. The cleansing means (which may be a single-phase, e.g. micro-filtration, system or a two-phase, e.g. dialytic system) removes materials deleterious to wound healing, and the cleansed fluid, still containing materials that are beneficial in promoting wound healing, is returned to the wound bed. The means for stressing the wound bed and optionally tissue surrounding the wound promotes wound healing. The dressing and a method of treatment using the apparatus.

Abstract: A reduced pressure treatment system includes a reduced pressure source and a reduced pressure dressing. The dressing includes an interface layer adapted to be positioned at a tissue site and an absorbent layer in fluid communication with the interface layer to absorb liquid from at least one of the interface layer and the tissue site. A diverter layer is positioned adjacent the absorbent layer, and the diverter layer includes a plurality of apertures in fluid communication with the absorbent layer to distribute a reduced pressure to the absorbent layer. A cover is positioned over the diverter layer to maintain the reduced pressure at the tissue site.

Abstract: A system for applying reduced pressure to tissue includes a multi-lumen reduced pressure delivery tube having a proximate end, a distal end, a primary lumen extending through the conduit from the proximate end to the distal end, and an ancillary lumen extending through the conduit from the proximate end to the distal end. A vacuum pump is coupled to the proximate end of the primary lumen, and a reduced pressure adapter is coupled to the distal end of the reduced pressure delivery tube. The adapter includes channels to direct liquid away from the ancillary lumens and into the primary lumen.

Abstract: The invention refers to a device for the negative pressure wound therapy comprising a cover material for the air-tight sealing of the wound and the wound surroundings; a means suitable for the generation of a negative pressure in the wound area, preferably a means for the functional connection of the wound area with a negative pressure source outside of the cover material in such a way that a negative pressure can be generated in the wound area and fluids can be drawn out of the wound area by suction; and a wound dressing, whereby the wound dressing contains an open-cell foam on the basis of a cross-linked polyorganosiloxane. The invention also refers to the use of open-cell foam on the basis of a cross-linked polyorganosiloxane for use in the negative pressure wound therapy, in particular in patients with a BMI of less than 18.

Abstract: An apparatus for cleansing wounds, in which wound exudate is removed from a wound bed and selectively cleansed and returned to the wound. The cleansing means removes materials deleterious to wound healing, and the cleansed fluid, still containing materials that are beneficial in promoting wound healing, is returned to the wound bed. The associated wound dressing and cleansing means are conformable to the wound, and may have irrigant fluid circulated from a reservoir by a device for moving fluid through a flow path which passes through the dressing and a means for fluid cleansing and back to the dressing.

Abstract: A modular driveline includes a modular portion including a cable and a connector, the cable having terminations, and a percutaneous portion including a cable and a connector, the cable having terminations. The percutaneous portion connector couples to the modular portion connector, and cable terminations at the connectors are captured in the connectors by potting. The cable can include an inner member, conductors disposed about the inner member, a covering about the conductors, a layer extruded onto the covering, an armor braid over the extruded layer, and an outer jacket extruded over the armor braid.

Abstract: A device for pumping blood in an extracorporeal circuit includes a centrifugal pump that suctions the blood to be pumped via a venous hose line connected to a suction side of the pump and releases it via an arterial hose line connected to a release side of the pump. The device includes a flow sensor that detects a released quantity on the release side of the pump and emits a measurement signal corresponding to the released quantity, a pressure sensor that detects the pressure on the release side of the pump and emits a measurement signal corresponding to the pressure, and an evaluation unit to which the measurement signals of the sensors are fed and which determines a value corresponding to the pressure on the suction side of the pump, taking into consideration the two measurements signals and the rotational speed of the centrifugal pump.

Abstract: The degasser can have a degassing membrane that can be constructed from non-porous silica. The degassing membrane can be highly permeable to carbon dioxide but less permeable oxygen or nitrogen gases. Pressure in the dialysate and the degasser can be controlled in order to control the amount of carbon dioxide and other gases in dialysate leaving the degasser. The degassing membrane may be placed in a degassing module in a dialysate flow path to remove dissolved carbon dioxide from the dialysate.

Abstract: The invention relates to a method and a device for monitoring a vascular access during an extracorporeal blood treatment. The method and the device according to the invention are based on the monitoring of the difference between the venous pressure measured by a venous pressure sensor and the arterial pressure measured by an arterial pressure sensor (in the extracorporeal blood circuit. According to the method and the device according to the invention, a test function describing disturbances in the extracorporeal blood circuit is determined. Said test function is used to determine a noise-free differential pressure from the measured venous and arterial pressure, said differential pressure being evaluated in an arithmetic and evaluation unit to identify a defective vascular access.

Abstract: In an extracorporeal blood circuit system or a machine configurable in such a circuit, a bag blood reservoir has an infusion port at the upper end of the bag, an outlet port at the lower end of the bag, an inlet port at the lower end of the bag, and an IV port at the lower end of the bag. A split line is connected to the infusion port, having a first branch line connected to a source makeup fluid into the reservoir and a second branch line that evacuates from the reservoir. An air detector and a vent controller automatically configure a venting path in which the inlet lines to the pump and to the blood reservoir are open such that air rises to the upper end of the blood reservoir from which it can be vented through the infusion port into the air evacuation line.

Abstract: The object of the invention is to provide a blood separation device that can reduce the total time for drawing blood to obtain high-concentration platelet liquid, thereby reducing the binding time of the blood donor. The device includes a temporary storage bag (Y2) (also serves as a buffy coat bag) which is a whole blood bag for storing whole blood drawn from a blood donor. The controlling unit of the device controls the device to draw whole blood from the blood donor in parallel with at least either a circulation flow step or an acceleration step, thereby storing the drawn whole blood in the temporary storage bag (Y2).

Abstract: A method and apparatus for a connection interface between a reservoir or syringe, infusion set tubing, and an infusion pump is provided. The reservoir, a base and a cap are connected to form an integrated unit that is capable of being inserted and secured in an infusion pump housing. The cap and the infusion pump are each provided with at least one sensor or at least one detectable feature, arranged to interact with at least one corresponding detectable feature or sensor on the other of the cap and infusion pump device, to detect one or more of the presence, position or other characteristic of the cap when the cap is aligned or coupled with the infusion pump housing. The detectable feature and sensor may be magnetic, RF, mechanical, optical or any combination.

Abstract: A method and apparatus for a connection interface between a reservoir or syringe, infusion set tubing, and an infusion pump is provided. The reservoir, a base and a cap are connected to form an integrated unit that is capable of being inserted and secured in an infusion pump housing. The cap and the infusion pump are each provided with at least one sensor or at least one detectable feature, arranged to interact with at least one corresponding detectable feature or sensor on the other of the cap and infusion pump device, to detect one or more of the presence, position or other characteristic of the cap when the cap is aligned or coupled with the infusion pump housing. The detectable feature and sensor may be magnetic, RF, mechanical, optical or any combination.

Abstract: A system and method is provided for an injectable substance delivery device comprising a limiter, shoulder or post that controls how deep the needle is inserted into the tissue. The limiter is sized in proportions that control the maximum insertion depth of the needle into the tissue without excessively restricting the complete insertion of the needle. The system and method further comprises an normalization or stabilizer ring that prevents distortion of the tissue in the vicinity of the infusion, so that the needle length is the major determining factor as to how deep the infusion is delivered.

Abstract: Systems and methods for integrating a continuous glucose sensor 12, including a receiver 14, a medicament delivery device 16, a controller module, and optionally a single point glucose monitor 18 are provided. Integration may be manual, semi-automated and/or fully automated.

Abstract: Systems and methods for integrating a continuous glucose sensor 12, including a receiver 14, a medicament delivery device 16, a controller module, and optionally a single point glucose monitor 18 are provided. Integration may be manual, semi-automated and/or fully automated.

Abstract: Methods and systems for controlling analyte levels are described. An example method may include receiving a sensor measurement relating to an eye-mountable device. The method also may include determining an analyte concentration based on the one or more sensor measurements, and comparing the analyte concentration to a target analyte concentration. Based on the comparing, the method further may include providing instructions to a drug delivery device, where the instructions are configured to control a drug delivery rate by the drug delivery device.

Abstract: Substance-administration apparatus (20) is provided, including a housing (22), and a needle (80), couplable to the housing (22), having a skin-insertion portion 0.3-2.5 mm in length and an outer diameter less than 0.23 mm. A dosage regulator (60) regulates a dosage of substance injected in a single injection through the needle (80). Dosage is selectable by a setting of the dosage regulator (60) as one of a plurality of selectable dosages. At least one dosage is less than or equal to 10 ul. An injection driver (54), activatable by a user, drives the substance through the needle (80). A motor coupled to the injection driver (54) is actuated by the dosage regulator (60) in a pulsatile manner to produce brief periods of high pressure in the apparatus (20) that expel a predetermined volume of the substance through the needle (80) at a controlled rate. Other applications are also described.

Abstract: The present invention relates to a drug delivery device and in particular to temperature sensitive labelling of such devices. The drug delivery device is designed for dispensing of a dose of a medicinal product and includes a housing, and a drive mechanism comprising an axially displaceable piston rod to act on a piston of a cartridge containing the medicinal product to be dispensed. The device is further provided with an indicator adapted to irreversibly change at least one of its visually perceptible properties in response to the ambient temperature rising above and/or dropping below at least one predefined threshold. The indicator is preferably designed as a protective cover arranged across a functional component of the device.

Abstract: The present invention relates to a plunger rod for an injection device, having a distal element slidingly coupled to a proximal element having at least one radially flexible branch. The plunger rod includes a lock for selectively locking the distal element and the proximal element in a plurality of relative axial positions defining a plurality of intermediate positions of the plunger rod, wherein the lock is movable from a locked state, in which the distal element and the proximal element are fixed with respect to each other in the axial direction, and an unlocked state, in which the distal element and the proximal element are displaceable in the axial direction with respect to each other, when the at least one radially flexible branch is displaced radially. The invention also relates to an injection device having such a plunger rod.

Abstract: A pre-filled syringe with excellent air-tightness and liquid-tightness and a mold for forming the gasket are provided. At least a surface of the mold for a gasket laminated with an inactive film for a pre-filled syringe forms a seal sliding surface of an annular protrusion of the gasket is mirror finished to have an arithmetic mean roughness Ra of less than 0.03 ?m.

Abstract: A medication injection pen (50) includes a housing (1) and a dose set knob (2) rotatably connected to the housing (1) for setting a dose. An indicator member (200) is movable between an visible position indicating a zero position of the dose set knob (2) and a non-visible position indicating a non-zero position of the dose set knob (2). The indicator member is visible to a user in the visible position and not visible in the non-visible position. The dose set knob is in the zero position when a set dose has been completely administered. Accordingly, a visible indication is provided to a user when a set dose has been completely administered.

Abstract: The present invention relates to an injection device (1) having a mechanical dose size display wherein a first scale drum (10) carrying a series of first ciphers (11) and a second scale drum (20) carrying a series of second ciphers (21) are both rotatable able and axially moveable relatively to a housing (2) of the injection device in such a way that one of the first ciphers (11) and one of the a second ciphers (21) appears simultaneously in a window provided in the housing (2) thereby informing the user of the set dose. Both the first scale drum (10) and the second drum (20) preferable carries five ciphers (11, 21) around one full circumferential perimeter. The ciphers (11, 21) are provided in different circumferential circles and/or helically provided.

Abstract: An injection device (10) comprising a housing (12), a needle hub (38) slidable within the housing (12), a needle (40) having a distal end piercing tip (42) and a proximal end piercing tip (44), the needle hub being moveable from a first position wherein the distal end piercing tip (42) is within the housing to a second position wherein the distal end piercing tip (42) extends outwardly of the housing (12), a spring (23) biasing the needle hub (38) towards the first position, and a cartridge receiving member (48) mounted within the housing (12), and a plunger rod assembly (66) for exerting pressure on the cartridge receiving member (48) to move the cartridge (26) and the needle hub (38) from the first position to the second position, the plunger rod assembly (66) and the cartridge receiving member (48) being arranged such that when the cartridge rod assembly is pushed, a rotational movement is imparted to the cartridge receiving member (48) to thereby prevent access to the cartridge after injection.

Abstract: Embodiments of a retractable syringe assembly are provided that include a dual syringe barrel configuration. One or more embodiments include reuse prevention features and features that prevent premature activation of the retraction mechanism. Methods for aspirating and expelling liquid from medical devices are also provided.

Abstract: A method for stable support of a needle to be introduced into a patient, a body to be penetrated by the needle is arranged on the patient. The body is made of a substance corresponding in terms of its mechanical properties to body tissue (in particular corresponding to body tissue in terms of visco-elastic coefficients and density) and/or is made of a gel-like substance.

Abstract: A medication reservoir is formed in the lower portion of a nebulizer body and covered to form an enclosed medication reservoir. A nozzle assembly is supported by a reservoir cover and includes an air line having an inlet at one end and an outlet and a venturi nozzle and venturi outlet. The air line, venturi nozzle and discharge outlet are horizontally oriented when in use and the venturi nozzle is located within a patient's oral cavity when the nebulizer is in use. Medication is drawn upward through a suction line and mixed with air passing through the venturi nozzle and nebulized for discharge through the nebulizer outlet. The venturi nozzle and suction line are formed together and replaceable as one unit.

Abstract: A nebulizer assembly configured for removable attachment to an ultrasonic actuator includes a base plate portion, a porous mesh member, and a cover member. The base plate portion includes an opening extending therethrough, and is substantially rigid such that ultrasonic vibrations from the ultrasonic actuator may be transmitted through the base plate portion to the porous mesh member to vibrate the porous mesh member. The porous mesh member is configured for passage therethrough of a nebulized fluid, and is disposed in the opening of the base plate portion proximate a fluid emission side of the nebulizer assembly. The cover member is disposed on a second side of the nebulizer assembly opposite the fluid emission side. The cover member covers the opening and defines a cavity between the cover member and the porous mesh member. The cavity is configured to retain a fluid to be nebulized.

Abstract: A breath-actuated delivery device includes a mouthpiece through which a subject in use exhales, an air channel which is in fluid communication with the mouthpiece, and a flexible diaphragm which is disposed in the air channel. The diaphragm provides for at least a restricted air flow through the air channel until a predeterminable actuation pressure is developed in the mouthpiece, and, on generation of the predeterminable actuation pressure in the mouthpiece, provides for an air flow through the air channel.

Abstract: For cricothyrotomy and the like, a surgical device has, in one embodiment, a device body with a bi-directional scalpel, an end cap, and a tracheal hook that fits within a channel formed in the device body. With the end cap removed to expose the bi-directional scalpel blade and with the tracheal hook fully inserted within the body channel, the device can be held, e.g., in the dominant hand of an operator, and manipulated to make an opening in the patient's neck using the exposed scalpel blade. The tracheal hook can then be slid away from the device body with the hook's barbed tip entering the opening to enable the operator to easily and quickly secure the surgical airway. The design of the surgical device enables an economy of movements that otherwise would typically not be within the skill set of an operator who was not a surgeon.

Abstract: An atomizer has a venturi nozzle positioned at an outlet end of an air line and has a discharge end and is oriented horizontally when in use and forms a mixing chamber at its discharge end. A valve is positioned at a canister port and actuable to allow a metered flow of gas at a predetermined pressure and time through the air line and venturi nozzle. A suction line extends from the venturi nozzle and mixing chamber to a medication receiver and draws medication upward and mixes it with gas passing through the venturi nozzle into the mixing chamber and atomizes the medication into a mist.

Abstract: A relief valve assembly for use with a ventilator to selectively release pressure from within a breathing tube. The relief valve assembly can be attached and removed from the ventilator as a single unit. The relief valve assembly includes a sealing member that is movable by operating components within the ventilator to either seal or open at least one relief port contained within the relief valve assembly.

Abstract: A medical system includes a catheter and a vision probe that can be removed from the catheter and replaced with a medical probe. The vision probe can thus be used to steer and pose the catheter, and then be removed and replaced with the medical probe when a medical task such as a lung biopsy is performed. A sensor system in the catheter at least partly measures a pose of the catheter, and control logic controls actuation of the catheter to maintain the desired working configuration when the medical probe is used. A small diameter catheter can thus provide vision and biopsy functionality.

Abstract: An extension member is has a body with a proximal end and an opposing distal end. It includes a hollow lumen extending therethrough from the proximal end to the distal end. It has a female luer lock connector proximate its proximal end and a male luer lock connector proximate its distal end. Its body has an outer surface with a driven member.

Abstract: A system for implanting a catheter in a urethra. The system includes a catheter having a valve disposed at a distal portion of the catheter. The valve may be operable in response to an external magnetic field. The system also includes a tool having a tip member extending into an opening at the distal portion of the catheter to couple the tool to the catheter. the system also includes an element extending from the tool. The catheter has an internal path that provides a conduit for the element to be extended through the valve to engage a proximal portion of the catheter. The tool is adapted use the element to stress the catheter and stiffen the catheter along the length of the catheter. Stiffening the catheter facilitates implantation of the catheter in the urethra by enabling pull forces, push forces, and torque forces to be transmitted from the tool through the catheter to the proximal portion of the catheter without undue stress on the urethra.

Abstract: An inflation device that may comprise multiple plungers is disclosed. The inflation device may have multiple configurations wherein certain plungers are locked with respect to a body of the inflation device while others are configured to be displaceable within the body. Each plunger may be configured with a different effective surface area, allowing a practitioner to vary the amount of force required to attain certain pressures.

Abstract: In an aspect of the invention, an array of microprotrusions is formed by providing a mold with cavities corresponding to the negative of the microprotrusions, casting atop the mold a first solution comprising a biocompatible material and a solvent, removing the solvent, casting a second solution atop the first cast solution, removing the solvent from the second solution, and demolding the resulting array from the mold. The first solution preferably contains an active ingredient.

Abstract: A tattooing apparatus including a needle having at least one tip. The needle is configured to move between a first position in which the tip is located above the surface of a skin, and a second position in which the tip is located at a penetration depth underneath the skin surface. The needle is further configured to deposit an ink between the skin surface and the penetration depth. The tattooing apparatus further includes a needle drive mechanism configured to move the needle between the first position and the second position. The tattooing apparatus includes a sensor configured to output a feedback signal corresponding to a skin thickness characteristic. The tattooing apparatus further includes a controller configured to receive the feedback signal, wherein the controller is configured to adjust the penetration depth based on the skin thickness characteristic.

Abstract: The electrode set for a stimulation device, such as a TENS or EMS stimulation device comprises at least a plurality of neighboring electrically active zones close to each other said active zones forming a succession of poles of alternating polarity or being grouped to form groups of poles of alternating polarity, wherein at least one of said active zone or group of zones has a lateral size (D2) of approximately 1 mm to 40 mm, wherein at least one of spacing (D1) between neighboring active zones or groups of zones is approximately of 1 mm to 40 mm, and said set further comprises contacting means connected to said active zones or groups of active zones.

Abstract: A neurostimulation lead includes a lead body having a proximal portion and a distal portion and a first conductor extending through the lead body. An electrode cuff can be secured relative to the distal portion of the lead body. The electrode cuff includes a cuff body, a first tendril extending from a first region of the cuff body, a second tendril extending from a second region of the cuff body and a first electrode disposed on the cuff body and electrically connected to the first conductor.

Abstract: A shield located within an implantable medical lead may be terminated in various ways at a metal connector. The shield may be terminated by various joints including butt, scarf, lap, or other joints between insulation layers surrounding the lead and an insulation extension. The shield may terminate with a physical and electrical connection to a single metal connector. The shield may terminate with a physical and electrical connection by passing between an overlapping pair of inner and outer metal connectors. The metal connectors may include features such as teeth or threads that penetrate the insulation layers of the lead. The shield may terminate with a physical and electrical connection by exiting a jacket of a lead adjacent to a metal connector and lapping onto the metal connector.

Abstract: Aspects of the present invention relate to electroporation devices and methods of using same to effectively facilitate the introduction of a biomolecule into cells of a selected tissue in a body, in particular skin such as intradermic or subcutaneous tissue. In some aspects, the present invention is a skin EP device, which produces a pulse of energy and delivers same to the skin tissue using a skin electrode array and maintains a constant current in the same skin tissue based on user input, including a preset current, and allows the storage and acquisition of current waveform data.

Abstract: Systems and methods are disclosed to stimulate tissue to treat medical conditions involving tissues such as the bone, spine, stomach, nerves, brain and the cochlea. The disclosed invention uses electrical stimulation of the tissue, where vibrational (or acoustic) energy from a source is received by an implanted device and converted to electrical energy and the converted electrical energy is used by implanted electrodes to stimulate the pre-determined tissue sites. The vibrational energy is generated by a controller-transmitter, which could be either implanted or located externally. The vibrational energy is received by a receiver-stimulator, which could be located at or close to the stimulation site.