Abstract: A method of treating a human subject which is effected by intermittent inhalation of gaseous nitric oxide at a concentration of at least 160 ppm is disclosed. The method can be utilized for treating a human subject suffering from, or prone to suffer from, a disease or disorder that is manifested in the respiratory tract, or from a disease or disorder that can be treated via the respiratory tract. The disclosed method can be effected while monitoring one or more of on-site and off-site parameters such as vital signs, methemoglobin levels, pulmonary function parameters, blood chemistry and hematological parameters, blood coagulation parameters, inflammatory marker levels, liver and kidney function parameters and vascular endothelial activation parameters, such that no substantial deviation from a baseline in seen in one or more of the monitored parameters.

Abstract: A method of treating a human subject which is effected by intermittent inhalation of gaseous nitric oxide at a concentration of at least 160 ppm is disclosed. The method can be utilized for treating a human subject suffering from, or prone to suffer from, a disease or disorder that is manifested in the respiratory tract, or from a disease or disorder that can be treated via the respiratory tract. The disclosed method can be effected while monitoring one or more of on-site and off-site parameters such as vital signs, methemoglobin levels, pulmonary function parameters, blood chemistry and hematological parameters, blood coagulation parameters, inflammatory marker levels, liver and kidney function parameters and vascular endothelial activation parameters, such that no substantial deviation from a baseline in seen in one or more of the monitored parameters.

Abstract: Topical exposure of nitric oxide gas to wounds such as chronic non-healing wounds may be beneficial in promoting healing of the wound and in preparing the wound bed for further treatment and recovery. Nitric oxide gas may be used, for example, to reduce the microbial infection and burden on these wounds, manage exudate secretion by reducing inflammation, upregulate expression of endogenous collagenase to locally debride the wound, and regulate the formation of collagen. High concentration of nitric oxide ranging from about 160 to 400 ppm may be used without inducing toxicity in the healthy cells around a wound site. Additionally, exposure to the high concentration for a first treatment period reduces the microbial burden and inflammation at the wound site and increase collagenase expression to debride necrotic tissue at the wound site.

Abstract: An apparatus for stapling tissue includes a head assembly, a handle actuator in communication with the head assembly, and a staple cartridge. The head assembly is operable to drive a plurality of staples in response to actuating the handle actuator. The staple cartridge is in communication with the head assembly. The staple cartridge comprises a first annular ring of apertures and a second ring of apertures. The first annular ring of apertures includes apertures having a different size than the second annular ring of apertures, such that the apertures accommodate staples having different crown lengths. The staples may include pledgets that are configured to provide a greater staple footprint.

Abstract: Methods and devices for treating excess mucus accumulation in mammals by administering gaseous inhaled nitric oxide or nitric oxide releasing compounds as a mucolytic agent or expectorant are provided. Delivery of gaseous nitric oxide can be made nasally or orally and is preferably substantially coincident with inhalation of the mammal or based on a synchronous parameter of the mammal's respiratory cycle. Varying therapeutic profiles may be used for the delivery of gaseous nitric oxide depending on the severity of the excess mucus accumulation. Parameters for the therapeutic profiles may include flow rate of nitric oxide containing gas, duration of administration of nitric oxide containing gas, number of breaths for which nitric oxide containing gas is to be administered, and concentrations of therapeutic NO delivered to the airways.

Abstract: Methods and devices for treating excess mucus accumulation in mammals by administering gaseous inhaled nitric oxide or nitric oxide releasing compounds as a mucolytic agent or expectorant are provided. Delivery of gaseous nitric oxide can be made nasally or orally and is preferably substantially coincident with inhalation of the mammal or based on a synchronous parameter of the mammal's respiratory cycle. Varying therapeutic profiles may be used for the delivery of gaseous nitric oxide depending on the severity of the excess mucus accumulation. Parameters for the therapeutic profiles may include flow rate of nitric oxide containing gas, duration of administration of nitric oxide containing gas, number of breaths for which nitric oxide containing gas is to be administered, and concentrations of therapeutic NO delivered to the airways.

Abstract: A surgical instrument includes a handle assembly having a trigger operable to fire a staple driver to staple tissue. The instrument includes a pointed rod to which an anvil may be coupled. An anvil detection feature is included to determine when the anvil is coupled to the rod. In some versions, the anvil detection feature comprises a translatable rod that inhibits a lockout feature from disengaging. In other versions, an anvil sensing tube is disposed about the pointed rod and interferes with actuation of the trigger in a first position. A recess in the tube permits trigger to actuate when the anvil sensing tube is in the second position. Alternatively, a resilient tab is coupled to the pointed rod and resists actuation of the staple driver. A trigger lockout assembly may include a spring-loaded button that “pops” out when a push rod is actuated, thereby freeing a pivotable lockout feature.

Abstract: A surgical instrument includes a body, a pivotable trigger, and a ratcheting assembly. The ratcheting assembly may include a rotary ratchet coupled to the trigger and a pawl coupled to the body. The rotary ratchet may further include a ramp that disengages the ratchet from the pawl. A release feature may be included to selectively disengage a second member of the ratcheting assembly from a first member. In some versions, the release feature may include a rotation knob or a slidable handle. In another configuration, the ratcheting assembly may have a first member coupled to an actuator and a second member coupled to the body. The assembly may include a lock member coupled to the body that selectively engages a plurality of teeth disposed on the actuator. Alternatively, the assembly may include a pivotable pawl coupled to the actuator that engages one or more notches formed in the body.

Abstract: A surgical stapler comprises an anvil assembly, an anvil shaft, a driver, an actuating arm, a safety switch, and a safety feature. The anvil assembly couples with the anvil shaft. The driver drives a plurality of staples into tissue. The actuating arm is in communication with the surgical stapler and is configured to actuate the driver to drive the plurality of staples into tissue. The safety switch is moveable between a locked and an unlocked position. The safety switch prevents operation of the actuating arm when the safety switch is in the locked position. The safety switch enables operation of the actuating arm when the safety switch is in the unlocked position. The safety feature may prevent operation of the driver even when the safety switch is in the unlocked position or prevent operation of the safety switch.

Abstract: A surgical stapling instrument for performing a circular anastomosis comprises a stapling head assembly, an actuator handle assembly, a shaft assembly, a safety latch, and a locking member. The stapling head assembly includes an anvil that moves relative to a staple holder and a staple driver to drive staples from the staple holder into tissue and against the anvil. The actuator handle assembly has a first actuator that controls motion of the anvil and a second actuator that controls motion of the staple driver. The shaft assembly couples the stapling head assembly to the actuator handle assembly. The safety latch prevents operation of the second actuator when the gap between the anvil and staple holder is outside a predetermined range. The locking member is configured to prevent adjustment of the anvil gap after the desired staple height has been set inside the predetermined range.

Abstract: A surgical instrument includes an anvil selectively coupleable to a stapling head assembly and a trigger operable to fire staples into tissue compressed between the anvil and the stapling head assembly. In some versions, a lockout member may engage a securing feature to prevent actuation of the anvil relative to the stapling head assembly. For instance, a tab may engage a slot on an actuator, a screen door lock may provide frictional resistance or engage teeth on the actuator, a door may actuate into engagement with one or more recesses, geared teeth may mesh with teeth on the actuator, the lockout member may include a ratcheting assembly to engage actuator, and/or a push button may actuate into a recess while disengaging the lockout member. Alternatively, in some versions, the trigger actuation assembly may be disengaged prior to firing. An anvil position indicator may restrict engagement of the trigger actuation assembly.

Abstract: A process of preparing articles having gaseous NO sequestered therein is disclosed, as well as articles prepared thereby. Also disclosed are articles having gaseous NO sequestered therewithin and having reduced amount of oxygen-containing and/or nitrogen-containing reactive species. Also disclosed are processes of preparing packaged articles having a non-gas permeable package that comprises gaseous NO therein and packaged articles made therefrom. Also disclosed are charging devices which can be utilized in the above-described processes. The articles prepared by the above-described processes are preferably medical devices such as indwelling catheters, intubation devices and tampons. Tampons having sequestered therein gaseous NO, uses thereof and processes of preparing same are also disclosed.

Abstract: Tissue thickness compensators for use with circular surgical staplers. Various tissue thickness compensators are disclosed for deployment between a stapler head of a surgical circular stapler and an anvil attached thereto to accommodate variances in tissue thickness during stapling. Some tissue thickness compensator arrangements include means and configurations for deploying healing agents for enhancing the healing process.

Abstract: An apparatus comprises a housing and one or more deployable protrusions. The apparatus defines a fluid reservoir and presents an upper surface. The housing is sized and configured to be implanted within a patient. The protrusions are selectively movable from a first position to a second position. The protrusions are at least partially retracted relative to the housing when the protrusions are in the first position. The protrusions are at least partially extended relative to the housing when the protrusions are in the second position. The protrusions may be in the form of substantially cylindraceous posts, semi-circular members, or other shapes. The protrusions may be actuated mechanically, electromechanically, or otherwise. The apparatus may be provided as an injection port, as part of a gastric band system or otherwise. The deployed protrusions may facilitate location of the implanted port through external palpation of the patient's abdomen.

Abstract: A method and corresponding device are described for combating microbes and infections by delivering intermittent high doses of nitric oxide to a mammal for a period of time and which cycles between high and low concentration of nitric oxide gas. The high concentration of nitric oxide is preferably delivered intermittently for brief periods of time that are interspersed with periods of time with either no nitric oxide delivery or lower concentrations of nitric oxide. The method is advantageous because at higher concentration, nitric oxide gas overwhelms the defense mechanism of pathogens that use the mammalian body to replenish their thiol defense system. A lower dose or concentration of nitric oxide gas delivered in between the bursts of high concentration nitric oxide maintains nitrosative stress pressure on the pathogens and also reduces the risk of toxicity of nitric oxide gas.

Abstract: Topical exposure of nitric oxide gas to wounds such as chronic non-healing wounds may be beneficial in promoting healing of the wound and in preparing the wound bed for further treatment and recovery. Nitric oxide gas may be used, for example, to reduce the microbial infection and burden on these wounds, manage exudate secretion by reducing inflammation, upregulate expression of endogenous collagenase to locally debride the wound, and regulate the formation of collagen. High concentration of nitric oxide ranging from about 160 to 400 ppm may be used without inducing toxicity in the healthy cells around a wound site. Additionally, exposure to the high concentration for a first treatment period reduces the microbial burden and inflammation at the wound site and increase collagenase expression to debride necrotic tissue at the wound site.

Abstract: Antimicrobial and biofilm-inhibiting nitric oxide-releasing medical appliances for installation into a patient, and processes for producing the medical appliances. The medical appliances are configured for conveying materials into and out of the patient's body and may comprise tubings or pouching systems. The medical appliances comprise a gas-permeable cured resin material selected from the group consisting of curable silicones, polyvinyl acetates, thermoplastic elastomers, acrylonitrile-butadiene-styrene copolymer rubber, polyurethanes and selected combinations thereof, wherein the gas-permeable cured resin material comprises a matrix suitable for releasably sequestering therein permeating gases. A plurality of nitric-oxide gas-releasing moieties is sequestered within and through the gas-permeable resin material. Nitric oxide is released from at least a portion of said plurality of nitric oxide gas-releasing moieties upon contact of the medical appliance with a moisture source.

Abstract: A method of reducing pathogens in blood by exposure to a nitric oxide containing gas in an extracorporeal circuitry is provided. The method includes: obtaining blood from a mammal or a blood source, separating the blood into plasma and blood cells, exposing the plasma to nitric oxide containing gas, combining the exposed plasma with the blood cells, reducing nitric oxide content in the recombined blood, and returning the blood to the mammal or blood source.

Abstract: A device and method is disclosed for delivering NO to a patient. The device utilizes a single controller that controls two separate flow controllers to deliver an oxygen-containing gas and a NO-containing gas to the patient to provide NO-containing gas at a flow profile that is proportional or quasi-proportional to a flow profile of the oxygen-containing gas throughout patient inspiration. The controller further comprises logic for setting a nitric oxide delivery profile comprising at least two different concentrations of nitric oxide containing gas and for automatically switching between the at least two different concentrations of nitric oxide containing gas on a timed basis.

Abstract: Topical exposure of nitric oxide gas to wounds such as chronic non-healing wounds may be beneficial in promoting healing of the wound and in preparing the wound bed for further treatment and recovery. Nitric oxide gas may be used, for example, to reduce the microbial infection and burden on these wounds, manage exudate secretion by reducing inflammation, upregulate expression of endogenous collagenase to locally debride the wound, and regulate the formation of collagen. High concentration of nitric oxide ranging from about 160 to 400 ppm may be used without inducing toxicity in the healthy cells around a wound site. Additionally, exposure to the high concentration for a first treatment period reduces the microbial burden and inflammation at the wound site and increase collagenase expression to debride necrotic tissue at the wound site.