Abstract: An apparatus includes a balloon adapted to be placed adjacent a calcified region of a body. The balloon is inflatable with a liquid. The apparatus further includes a shock wave generator within the balloon that produces shock waves that propagate through the liquid for impinging upon the calcified region adjacent the balloon. The shock wave generator includes a plurality of shock wave sources distributed within the balloon.

Abstract: Tissue fasteners carried on a tissue piercing deployment wire fasten tissue layers of a mammalian body together. The fasteners include a first member, a second member, and a connecting member extending between the first and second members. The first and second members are substantially parallel to each other. The fasteners may be deployed in limited spaces and in various applications including the restoration of a gastroesophageal flap valve.

Abstract: A system for breaking obstructions in body lumens includes a catheter including an elongated carrier, a balloon about the carrier in sealed relation thereto, the balloon being arranged to receive a fluid therein that inflates the balloon, and an arc generator including at least one electrode within the balloon that forms a mechanical shock wave within the balloon. The system further includes a power source that provides electrical energy to the arc generator.

Abstract: A pocket sized dispenser houses in coiled form a flexible strip of portions of smokeless tobacco sized for placement between a consumer's cheek and gum, where the flexible strip includes a base tape removably attached to the plurality of portions, and wherein the dispenser and strip are adapted to allow a consumer to separate individual portions from the base tape. The individual portions comprise either a collection of tobacco particles at least partially enclosed by a coating comprising a water-soluble non-crosslinked component and a substantially water-insoluble cross-linked component; or pouches attached to the base tape with a food-grade adhesive, the pouches comprising smokeless tobacco enclosed in a water-permeable wrapper with at least one lap-sealed edge. Methods of preparing such are disclosed.

Abstract: A valvuloplasty system comprises a balloon adapted to be placed adjacent leaflets of a valve. The balloon is inflatable with a liquid. The system further includes a shock wave generator within the balloon that produces shock waves that propagate through the liquid for impinging upon the valve. The shock wave generator is moveable within the balloon to vary shock wave impingement on the valve.

Abstract: A valvuloplasty system includes a balloon adapted to be placed adjacent leaflets of a valve. The balloon is inflatable with a liquid. The system further includes a shock wave generator within the balloon that produces shock waves that propagate through the liquid for impinging upon the valve. The shock wave generator is moveable within the balloon to vary shock wave impingement on the valve.

Abstract: A guide wire, for use, for example, in guiding an elongated catheter through an artery or vein of a mammalian body having a stenosis and/or an occlusion therein, includes an elongated conductor having a longitudinal dimension, a proximal end and a distal end. The guide wire further includes an insulator overlying the elongated conductor. The insulator exposes a portion of the longitudinal dimension of the elongated conductor to form an electrode. The elongated conductor is arranged to be connected to a source of high voltage pulses to cause electrical arcs at the electrode that in turn form steam bubbles and shock waves to break the stenosis and/or open the occlusion and permit the guide wire to pass there through. Other embodiments are directed to a system including the guide wire and a method of using the guide wire.

Abstract: A guide wire, for use, for example, in guiding an elongated catheter through an artery or vein of a mammalian body having a stenosis and/or an occlusion therein, includes an elongated conductor having a longitudinal dimension, a proximal end and a distal end. The guide wire further includes an insulator overlying the elongated conductor. The insulator exposes a portion of the longitudinal dimension of the elongated conductor to form an electrode. The elongated conductor is arranged to be connected to a source of high voltage pulses to cause electrical arcs at the electrode that in turn form steam bubbles and shock waves to break the stenosis and/or open the occlusion and permit the guide wire to pass there through. Other embodiments are directed to a system including the guide wire and a method of using the guide wire.

Abstract: Disclosed is a drug infusion system comprising a drug infusion device having a reservoir, a window for viewing the contents of the reservoir, a cannula arranged to be deployed beneath the skin of a patient, and an actuator configured to be manually actuated to drive a medicament from the reservoir to the cannula. The system also has a cannula cover and a needle handle that holds a needle for insertion into the patient. The cannula cover and needle handle are detachably attached to the drug infusion device, and each is attachable to the other. The device further comprises a septum and a septum pincher to seal the device. The device also comprises a pumping mechanism, part of which are a last-dose lock-out mechanism and an occlusion detection mechanism, both of which operate on the same actuator.

Abstract: Disclosed herein shock wave catheters comprising one or more shock wave electrodes for cracking calcifications located within blood vessels. In some variations, a shock wave catheter has first and second shock wave electrodes each circumferentially disposed over the outer surface of the catheter. In certain variations, the first electrode has a recess and the second electrode has a protrusion that is received by the recess and a spark gap is located along the separation between the recess and the protrusion. The second electrode can also have a recess that receives a protrusion from a third shock wave electrode, where the separation between the second and third electrodes along the separation between the recess and the protrusion forms a second spark gap. A shock wave can be initiated across these spark gaps when a voltage is applied over the electrodes.

Abstract: A transoral gastroesophageal flap valve restoration device has sufficient flexibility and dimension to be passed through the mouth, throat, and esophagus of a patient into the patient's stomach. The device includes a first member and a second member hingedly coupled to the first member. The first and second members are configured to flex in a direction to follow the esophageal path into the stomach and to be substantially rigid when forming the restored gastroesophageal flap valve.

Abstract: Described herein are shock wave devices and methods for the treatment of calcified heart valves. One variation of a shock wave device includes three balloons that are each sized and shaped to fit within a concave portion of a valve cusp when inflated with a liquid and a shock wave source within each of the three balloons. Each balloon is separately and/or independently inflatable, and each shock wave source is separately and/or independently controllable. Methods of treating calcified heart valves using a shock wave device can include advancing a shock wave device having one or more balloons and a shock wave source in each of the balloons to contact a heart valve, inflating the one or more balloons with a liquid such that the balloon is seated within a concave portion of a valve cusp, and activating the shock wave source.

Abstract: A system includes a catheter including an elongated carrier, a balloon about the carrier in sealed relation thereto, the balloon being arranged to receive a fluid therein that inflates the balloon, and first and second electrodes within the balloon arranged to carry a voltage there-across including an initial high electrical voltage at an initial low current. The initial high electrical voltage causes an electrical arc to form across the first and second electrodes within the balloon. The electrical arc causes a gas bubble within the liquid, a high current to flow through the first and second electrodes, a decrease in the initial high electrical voltage, and a mechanical shock wave within the balloon. The system further includes a power source that provides the first and second electrodes with a drive voltage that creates the initial high electrical voltage at the initial current and that terminates the drive voltage in response to the decrease in the initial high electrical voltage.

Abstract: Described herein are shock wave devices and methods for the treatment of calcified heart valves. One variation of a shock wave device includes three balloons that are each sized and shaped to fit within a concave portion of a valve cusp when inflated with a liquid and a shock wave source within each of the three balloons. Each balloon is separately and/or independently inflatable, and each shock wave source is separately and/or independently controllable. Methods of treating calcified heart valves using a shock wave device can include advancing a shock wave device having one or more balloons and a shock wave source in each of the balloons to contact a heart valve, inflating the one or more balloons with a liquid such that the balloon is seated within a concave portion of a valve cusp, and activating the shock wave source.

Abstract: A transoral gastroesophageal flap valve restoration device has sufficient flexibility and dimension to be passed through the mouth, throat, and esophagus of a patient into the patient's stomach. The device includes a first member and a second member hingedly coupled to the first member. The first and second members are configured to flex in a direction to follow the esophageal path into the stomach and to be substantially rigid when forming the restored gastroesophageal flap valve.

Abstract: A system includes a catheter including an elongated carrier, a balloon about the carrier in sealed relation thereto, the balloon being arranged to receive a fluid therein that inflates the balloon, and first and second electrodes within the balloon arranged to carry a voltage there-across including an initial high electrical voltage at an initial low current. The initial high electrical voltage causes an electrical arc to form across the first and second electrodes within the balloon. The electrical arc causes a gas bubble within the liquid, a high current to flow through the first and second electrodes, a decrease in the initial high electrical voltage, and a mechanical shock wave within the balloon. The system further includes a power source that provides the first and second electrodes with a drive voltage that creates the initial high electrical voltage at the initial current and that terminates the drive voltage in response to the decrease in the initial high electrical voltage.

Abstract: Described herein are low-profile electrodes for use with an angioplasty shockwave catheter. A low-profile electrode assembly may have an inner electrode, an insulating layer disposed over the inner electrode such that an opening in the insulating layer is aligned with the inner electrode, and an outer electrode sheath disposed over the insulating layer such that an opening in the outer electrode sheath is coaxially aligned with the opening in the insulating layer. This layered configuration allows for the generation of shockwaves that propagate outward from the side of the catheter. In some variations, the electrode assembly has a second inner electrode, and the insulating layer and outer electrode may each have a second opening that are coaxially aligned with the second inner electrode. An angioplasty shockwave catheter may have a plurality of such low-profile electrode assemblies along its length to break up calcified plaques along a length of a vessel.

Abstract: A valvuloplasty system comprises a balloon adapted to be placed adjacent leaflets of a valve. The balloon is inflatable with a liquid. The system further includes a shock wave generator within the balloon that produces shock waves. The shock waves propagate through the liquid and impinge upon the valve to decalcify and open the valve.

Abstract: Described herein are low-profile electrodes for use with an angioplasty shockwave catheter. A low-profile electrode assembly may have an inner electrode, an insulating layer disposed over the inner electrode such that an opening in the insulating layer is aligned with the inner electrode, and an outer electrode sheath disposed over the insulating layer such that an opening in the outer electrode sheath is coaxially aligned with the opening in the insulating layer. This layered configuration allows for the generation of shockwaves that propagate outward from the side of the catheter. In some variations, the electrode assembly has a second inner electrode, and the insulating layer and outer electrode may each have a second opening that are coaxially aligned with the second inner electrode. An angioplasty shockwave catheter may have a plurality of such low-profile electrode assemblies along its length to break up calcified plaques along a length of a vessel.

Abstract: A SAS expander includes a switch core, a number of SAS expander phys coupled to the switch core, an SMP originator coupled to the switch core and an SMP receptor coupled to the switch core. In an embodiment, the SMP originator is configured to only send connection requests and the SMP receptor is configured to only receive connection requests. Program instructions stored in non-transient digital storage media include code segments detecting a new connection request, code segments determining whether the new connection request is in conflict with an existing connection request and code segments determining if there is a free destination receptor phy. In an embodiment, the free destination receptor phy is never operationally used for an origination of a connection request.