Abstract: Devices and systems for navigation and positioning a central venous catheter within a patient. In an exemplary embodiment of a system of the present disclosure, the system comprises a first pole and a second pole, the first pole and the second pole configured to generate an electric field within a mammalian body sufficient to obtain a plurality of field measurements therein, and an elongated body configured for at least partial insertion into a blood vessel of the mammalian body and advancement through a vasculature, said advancement dependent upon the plurality of field measurements indicative of one or more locations of a portion of the elongated body within the vasculature. In at least one embodiment, the elongated body is configured as a stylet. In another embodiment, techniques for identifying and locating obstructions in the vessel in which a device is disposed are disclosed.

Abstract: Embodiments of a surgical instrument including an actuation lockout system as well as its method of use are disclosed. In one embodiment, a surgical instrument includes a trigger and a driveshaft coupled to the trigger such that actuation of the trigger causes the driveshaft to move from a first position to a second position, thereby resulting in deployment of a surgical fastener. An actuation lockout system restrains distal movement of the driveshaft until a force greater than or equal to a threshold force is applied to the trigger.

Abstract: An application device for dispensing a fluid, including a liquid, gel, topical fluid, or other flowable substance, stored within a volume of the application device package is disclosed. The application device is manually deformable so as to permit breakage and establish an opening to the volume storing the topical fluid. In one embodiment, the application device comprises a sealed package that defines a volume in which the fluid is disposed. The package includes a partial slit that is configured to provide an opening to the volume when the package is deformed. The opening is configured to enable the fluid to be released from the volume. An applicator element is also included within the package and exposed upon package opening. The applicator element can include a gauze, foam, compliant pad, or other suitable element, and is configured to assist with dispersion of the fluid on a surface, such a patient's skin.

Abstract: An implantable prosthesis is provided for repairing a fistula, such as an anal fistula. The prosthesis or fistula repair device may include a body with a shape configured for placement in the fistula. The prosthesis may also include an anchor or base that is located at one or both ends of the body to facilitate anchoring the prosthesis in position. The prosthesis may include one or more channels to create one or more pathways for drainage and/or irrigation of the fistula. The channel may have a relatively uniform dimension along its length or a tapered shape that increases along its length. The prosthesis may have an adjustable length for accommodating fistula tracts of varying lengths. The prosthesis may include elongated body segments that provide a wicking or capillary function to facilitate drainage of the fistula tract.

Abstract: The stent-graft described herein generally includes a substrate, a helix disposed about the substrate, a covering disposed over at least a portion of the helix, and a support member coupled to the covering.

Abstract: A clamp for selectively compressing a portion of tubing, such as an extension leg of a PICC or other catheter, is disclosed. The clamp is able to be opened or closed with a thumb and finger of a single hand of a user and is slidably attached to the tubing so as to enable its placement as desired along the tube. In one embodiment, the tubing clamp comprises a body including first and second body portions hingedly connected to one another in a clamshell configuration, a latch for releasably latching the first and second body portions together, and at least two tube compression members. The tube compression members cooperate to compress and occlude a portion of tubing passing through the tubing clamp when the first and second body portions are latched to one another.

Abstract: A high aspect ratio biopsy needle achieves reliable performance with large solid sample size by means of a variety of features and combinations thereof, including support to prevent bending, reinforcement of the needle, and cutting edges arranged to resist deformation.

Abstract: A catheter includes an elongate member (12) having a proximal end and a distal end. The distal end has at least one drainage opening (20). At least one of; the at least one drainage opening (20) is a single elongate opening, or is two circumferentially spaced elongate openings (FIG. 5), or is at least three staggered openings (FIG. 3), or is an array of staggered openings (FIG. 3). Alternatively or additionally, a sleeve member (10) is arranged on the elongate member (12) and is movable at least between a first position (FIG. 1) covering the at least one drainage opening (20) and a second position (FIG. 2) which allows fluid to pass into the catheter. A method of using the catheter includes inserting a catheter having a retractable sleeve (10) into a user's body and retracting the retractable sleeve (10) to expose drainage openings (20) and drain fluid from the body.

Abstract: A safety needle assembly of an infusion set for infusing fluids into a subcutaneously implanted access port is disclosed. The needle assembly is configured to prevent fluid/vapor escape therefrom so as to reduce or prevent fluid exposure to a clinician using the needle assembly. In one embodiment, the needle assembly comprises a handle portion including a needle extending therefrom, the needle defining a lumen for passage of a fluid therethrough. The needle assembly also includes a safety assembly defining a needle hole through which the needle initially extends. The safety assembly is selectively and axially slidable along the needle in order to shield a distal tip of the needle and prevent user contact therewith. A fluid isolation component is included in the safety assembly for isolating fluid escape from the needle to prevent exposure to a clinician.

Abstract: A balloon for medical treatments such as percutaneous transluminal coronary angioplasty (PTCA), delivery of a vascular stents or stent grafts, employs reinforcement materials that are patterned so as to promote consistent folding of the balloon. Methods and apparatus for biocidal treatment using such a balloon, including balloons with fiber fabric reinforcements.

Abstract: A biopsy device includes an elongate member and a tissue anchor. The elongate member has a lumen and a sample receiving notch. The sample receiving notch has a proximal end wall, a distal end wall, and a floor between the proximal end wall and the distal end wall. The proximal end wall has a vacuum hole in fluid communication with the lumen. The tissue anchor has a plurality of cantilever portions. Each cantilever portion of the plurality of cantilever portions has a curved end, with a tip of the curved end configured to extend toward the floor of the sample receiving notch.

Abstract: A guidewire comprising a hydrophilic surface coating encasing a core and a metal coil along a longitudinal length of the hydrophilic surface coating to form a distal closed tip, the metal coil circumscribing the core along a predetermined length, the core extending longitudinally beyond the metal coil in both a proximal direction and a distal direction, wherein a proximal section of the guidewire includes a hydrophobic surface coating.

Abstract: An access port for subcutaneous implantation into a body of a patient is disclosed. The port is typically subcutaneously connected to a catheter, a distal portion of which is disposed within a vein or other vessel of the patient. The port is configured with enhanced fluid handling features to improve fluid flow therethrough while reducing the likelihood of clotting or occlusions in the attached catheter, thus improving system patency. In one embodiment, for instance, an implantable access port is disclosed and comprises a body defining a reservoir, a needle-penetrable septum covering an opening to the reservoir, a stem defining an outlet to the reservoir, and a deformable element included in the reservoir. The deformable element is operably connected to a main portion of the septum and deforms in response to displacement of the septum to counteract a change in volume within the reservoir and prevent blood ingress into the catheter.

Abstract: A vena cava filter is described, having one or more frame members or an elongated member arranged in helical fashion. A plurality of filaments connect frame members or portions of the elongated member. The filaments may be made of suture material. Hooks may be placed on a free end of the filaments, along the length thereof, or on one or more frame members to engage the blood vessel wall and anchor the filter. A retrieval member may be positioned on the filter to facilitate withdrawal of the filter from the blood vessel.

Abstract: A patch for repairing a hernia defect including a patch body that is reducible into a small configuration for delivery through a narrow incision or cannula into a patient. A support member assists in unfurling the patch body from the small configuration into an expanded configuration. A sleeve releasably mounts the support member to the patch body.

Abstract: The present invention is a method and an apparatus for packaging lyophilized implants and other medical devices. In accordance with the invention, a lyophilized implant may be packaged for delivery to the surgical site in a sealed, flexible/expandable, sterile inner pouch. The inner pouch may be further packaged within an outer, sterile package. The inner pouch contains a resealable port through which rehydration liquid may be introduced into the inner pouch without opening the inner pouch. The inner pouch may be made of a flexible, substantially non-stretchable material so that the pouch can expand only to a predetermined maximum size to accept a predetermined volume of rehydration liquid. After rehydration, any excess rehydration liquid within the pouch may be removed via the same port. Next, the pouch is opened via a second opening to expose the implant for removal from the package.

Abstract: The present disclosure provides a delivery system for a self-expanding implant which includes a sheath which surrounds and constrains the implant prior to delivery and a confining element which surrounds the sheath during storage. The confining element preferably includes elongate members running axially along the sheath, which compress the sheath and the stent to reduce hoop stress in the system without promoting undesired adhesion between layers of the sheath.

Abstract: A positioning system includes a console, an ultrasound probe, a stylet, a stylet control module, and an external sensor. The console includes a display. The ultrasound probe is designed to communicate imaging information to the console. The stylet includes a radiating element capable of producing an electromagnetic field, the electromagnetic field providing electromagnetic field information. The stylet control module includes a timer circuit designed to send electrical pulses at a pulse signal frequency to the radiating element. The external sensor is designed to detect the electromagnetic field and to determine a position of the radiating element with respect to the external sensor as the stylet is advanced in a vasculature of a patient, the external sensor designed to communicate the electromagnetic field information to the console. The system may include a circuit configured to synchronize at least one of the console and the external sensor with the pulse signal frequency.

Abstract: A filter having a first set of members and a second set of members defining a trap sized to fit into a blood vessel. Each of the first and second members are configured to resiliently extend from the trap. At least one of the first set of members includes a first surface for engaging the vessel wall such that the at least one of the first set of members resists downstream movement within the vessel. At least one of the second set of members includes a second surface for engaging the vessel wall such that the at least one second member resists upstream movement within the vessel.

Abstract: A medical balloon is made radiographic, such as by incorporating a radiopaque foil or film layer. The radiopaque foil or film layer may be placed between an inner layer and an outer layer of a non-compliant balloon wall. The foil or film may provide the balloon with a radiographic quality from a first end to a second end in the absence of an inflation fluid. The balloon may be provided with the foil or film in a manner that provides a first section, such as the barrel, with a first radiographic quality, and a second section, such as the cone, with a second radiographic quality. The film may also be applied as a decal or appliqué to the external surface of a balloon-shaped body. Related methods are also disclosed.