Abstract: A catheter delivery device for a self-expanding stent is described. The delivery device includes a distal catheter component and a distal sheath that releases the stent by moving proximally relative to the distal catheter component and the stent. A proximal catheter shaft including a tube and a pull wire within a lumen of the tube may be provided, the pull wire being attached to the distal sheath such that pulling the pull wire proximally relative to the tube pulls the distal sheath proximally to release the stent progressively. A casing tube may be provided to surround the catheter shaft, the casing tube having a distal end that receives telescopically a proximal end of the distal sheath. A method of making a delivery device for implantation of a self-expanding stent is also described.

Abstract: Disclosed herein is an automated urinary output measuring system. The automated urinary output measuring system includes an automated urinary output measuring device configured to be suspended from a rim of a sanitary hardware device and receive a volume of voided urine. The automated urinary output measuring device can include a receiving trough having an opening, a door configured to cover the opening in a fluid tight seal, the door coupled to the receiving trough by a hinge, and a lip extending from the receiving trough configured to detachably couple the automated urinary output measuring device to the sanitary hardware device. The system can further include an ultrasonic measuring system having a console coupled to one or more ultrasonic sensors, and a flushing mechanism coupled to the sanitary hardware device.

Abstract: Medical device kits for use in placing, maintaining, altering, and/or removing medical devices in, on, and/or from the body of a patient are disclosed. Such medical device kits can include one or more wrap assemblies for use in the placement/maintenance procedure. In accordance with present embodiments, the one or more wrap assemblies of the medical device kit can include various features to assist the clinician performing the particular procedure. In one embodiment, a medical wrap assembly is disclosed, comprising a foldable wrap body that includes a front surface, wherein the front surface is configured to define a sterile field. A plurality of pockets is included on the front surface of the wrap body. The pockets are configured to contain therein a plurality of medical components. The medical components are arranged in the pockets in a predetermined order of use for the medical procedure.

Abstract: A catheter assembly including one or more conductive pathways to assist with placement of the catheter assembly into a patient's vasculature by enabling ECG signals emanating from the patient's heart to be detected, and a method for reconfirming an initial position of a distal end of a catheter tube of the catheter assembly. The conductive pathways can be configured to reconfirm via ECG signal detection proper placement of the catheter tube at a time subsequent to initial catheter placement into the vasculature. The catheter assembly can include an outer conductive pathway deposited on an outer surface of the catheter tube. The outer conductive pathway can have a distal end located distal to a portion of the catheter tube at a skin insertion site when the catheter tube is inserted into a patient.

Abstract: Disclosed herein are systems, pads, and methods thereof for targeted temperature management. A system, for example, can include a control module and a pad. The pad can include a multilayered pad body and one or more comfort-enhancing features integrated into the pad for mitigating or eliminating skin irritation along at least edges of the pad. The multilayered pad body can include a conduit layer, an impermeable film over the conduit layer, and an adherable layer over the impermeable film. The conduit layer can include one or more conduits configured to convey a fluid through the conduit layer. The impermeable film can be configured to retain the fluid in the conduit layer when the fluid is conveyed through the conduit layer. The adherable layer can be configured to adhere to a body portion of a patient. Methods of the systems and pads can include methods of use.

Abstract: A securement device holds a medical article having flexible portions in position upon the body of a patient and inhibits movement of the medical article. The medical article may be insertable into the securement device from above from below or along a longitudinal axis of the device. The securement device may have abutment surfaces which interact with the flexible portions of the medical article to further inhibit rotation of the device. A securement kit can include a securement device and a catheter.

Abstract: An insertion tool for inserting a catheter into a patient's body includes a housing in which at least a portion of the catheter is initially disposed, a hollow needle distally extending from the housing with the catheter pre-disposed over the needle, and a guidewire pre-disposed in the needle. The insertion tool can include a guidewire advancement assembly that can include a first finger pad for selectively advancing the guidewire distally past a distal end of the needle in preparation for distal advancement of the catheter. The insertion tool can further include a catheter advancement assembly that can include a second finger pad for selectively advancing the catheter into the patient. The first and second finger pads can be positioned such that a user can begin to advance the second finger pad after advancing the first finger pad without substantially re-positioning the thumb or finger of the user.

Abstract: A catheter for actively scoring or slicing a lesion. A catheter body includes first and second lateral openings. A selectively deployable cutter is connected to the catheter body. The cutter has a retracted configuration in which it does not perform a slicing or scoring function, such as while tracking through the vasculature, and a deployed configuration for slicing or scoring an obstruction. The cutter may include a plurality of retractable blades, such that when deployed, each blade projects in a different direction, such as from one of the lateral openings. Related methods are also disclosed.

Abstract: A catheter assembly for use in accessing a vasculature of a patient is disclosed. In one embodiment, the catheter assembly includes a catheter body that includes a flattened oval outer surface and defines first and second lumens. The catheter body defines a distal tip region that includes a venous lateral opening that is in fluid communication with the first lumen and includes a distal-facing portion. The distal tip region further includes an arterial lateral opening that is in fluid communication with the second lumen, includes a distal-facing portion, and is substantially un-staggered with respect to the venous lateral opening. A distal end opening is in fluid communication with a power injectable third lumen. In another embodiment, the first and second lumens each generally include a reniform cross-sectional shape. In yet another embodiment, a dual-lumen catheter includes first and second lumens that each define a modified ellipse cross-sectional shape.

Abstract: An apparatus for demonstrating the use of a medical device includes a body adapted for receiving the medical device. The body includes at least a portion adapted for viewing the medical device when positioned in the body. A cover is provided for selectively covering the portion of the body adapted for viewing the medical device. A kit and related methods are also disclosed.

Abstract: Urinary catheter-insertion kits can include a working tray, a storage tray, a protective paperboard, and a urinary catheter assembly, including a urinary catheter and a drainage system. The working tray can be nested on top of the storage tray. The working tray includes preformed sections configured to accommodate components of the urinary catheter-insertion kit. Methods of urinary catheterization include use of the urinary catheter-insertion kits.

Abstract: An imaging system includes an ultrasound probe, and an interventional medical device having a tracking device. The ultrasound probe includes an ultrasound transducer to generate an ultrasound field-of-view, a tracking field generator to generate an electromagnetic locator field, and a wireless receiver. The interventional medical device has a distal end portion to which the tracking device is mechanically coupled. The tracking device includes a plurality of tracking coils, a wireless transmitter, and a power supply circuit. The plurality of tracking coils interact with the electromagnetic locator field to determine a location within the electromagnetic locator field and to generate tracking data. The wireless transmitter is configured to transmit the tracking data from the tracking device of the interventional medical device to the wireless receiver of the ultrasound probe. The power supply circuit is configured to supply electrical power to the wireless transmitter of the tracking device.

Abstract: An automated urine-output-measurement system can include single-patient equipment and multi-patient equipment. The single-patient equipment can include a urinary catheter and a urine-collection system. The urine-collection system can include drainage tubing and a drainage receptacle. The multi-patient equipment can include a urine monitor. The urine monitor can include a housing having a cavity configured to house the drainage receptacle, a urine-measurement means for measuring urine-output into the drainage receptacle, and an integrated display screen configured to display patient information including measurements of the urine output. A method of the automated urine-output-measurement system can include placing the drainage receptacle in the urine monitor of the automated urine-output-measurement system, and confirming a volume of urine in the drainage receptacle with that indicated on the urine monitor once a patient has produced urine.

Abstract: A blood filter extraction system for extracting a blood filter from within a blood vessel. The system includes an extraction wire, or plurality of such wires, positioned within an elongated tubular member. A plurality of extraction wires coupled to the distal end of the extraction member each include a hook for engaging filter members. Alternatively, the extraction wires may be one or more wires configured in a helical shape which engage filter members when the extraction member is rotated. The system may also include an elongated tubular member with the distal end having a conical shape. To extract a filter, the extraction wires are then pushed out of the tubular member and into the filter members. The extraction member is then withdrawn or rotated so the wires engage and draw in the filter members, after which the catheter is pushed over the conical portion of the tubular member.

Abstract: Surgical instruments and their methods of use are disclosed. In some embodiments, the surgical instrument may include a handle and an elongated shaft assembly extending distally from the handle. The surgical instrument may also include a fastener deployment system for deploying fasteners from the elongated shaft assembly including a reciprocating driveshaft disposed within the elongated shaft assembly. The driveshaft may include an internal channel and at least one guide surface shaped and arranged to maintain an orientation of at least one fastener in the channel of the driveshaft. In other embodiments, the fastener deployment system may include a follower disposed within the elongated shaft assembly for displacing one or more fasteners within the elongated shaft assembly towards a distal fastener deployment position.

Abstract: An apparatus for cutting a wall of a vessel, such as scoring or slicing a lesion associated therewith. A catheter (10) includes a shaft (12) having a distal portion supporting a housing (20) including a first lateral passage (20a). A cutter (22) is adapted for moving from a retracted position within the housing (20) to a deployed position for at least partially projecting from the passage (20a). A expandable actuator (24) within the housing (20), such as an inflatable balloon (26), actuates the cutter (22) to move from the retracted position fully within the housing (20) to the deployed position at least partially projecting from the housing (20). More than one cutter (22?) may be provided, which cutters (22?) may be simultaneously actuated by the same actuator (26?).

Abstract: A catheterization package including a catheterization tray and contents for a catheterization procedure. The catheterization tray can include a structural configuration for maintaining a sterile field about a patient throughout the catheterization procedure, the sterile field including at least a portion of the tray. The structural configuration of the tray can provide a sterile side of the tray designated for a first person performing sterile steps of the catheterization procedure in the sterile field. The structural configuration of the tray can also provide a non-sterile side of the tray designated for either the first person or a second person performing non-sterile steps of the catheterization procedure outside the sterile field. The contents for the catheterization procedure can include a perineal care kit, two or more pairs of gloves, and a drainage system including a catheter.

Abstract: Disclosed herein are catheter assemblies and methods thereof that address various aspects of at least the retrograde tunneling technique. The catheter assemblies include, but are not limited to, catheter assemblies configured for vascular access, catheter assemblies configured for priming, catheter assemblies configured for tunneling, and mechanisms for connecting catheter tubes to their respective catheter assemblies. The methods include, but are not limited to, priming, tunneling, and connecting catheter tubes to their respective catheter assemblies.

Abstract: A method of making an access port, includes providing a port body defining a fluid cavity, positioning a septum over the fluid cavity, and securing the septum to the port body. The septum includes a lower portion having a first diameter, an upper portion joined to the lower portion at a juncture, the upper portion having a second diameter less than the first diameter at the juncture, and a plurality of palpation features joined to the upper portion. Each of the palpation features includes a first end adjacent a central axis of the septum, and a second end extending radially outward, overlapping the juncture.

Abstract: A surgical instrument including a power assist device, and its method of use for deploying surgical fasteners, is disclosed. The surgical instrument may include a handle, an elongated shaft extending from the handle, and a surgical fastener deployment system including a driveshaft. The driveshaft is actuatable between at least a first proximal position and a second distal position. A striker is movable relative to the driveshaft and an impact surface is associated with the driveshaft. The impact surface is constructed and arranged to be struck by the striker member to displace the driveshaft to the second distal position and deploy the surgical fastener.