Abstract: A guidance system for assisting with the insertion of a needle or other medical component into the body of a patient is disclosed. The guidance system utilizes ultrasound imaging or other suitable imaging technology. In one embodiment, the guidance system comprises an imaging device including a probe for producing an image of an internal body portion target, such as a vessel. One or more sensors are included with the probe. The sensors sense a detectable characteristic related to the needle, such as a magnetic field of a magnet included with the needle. The system includes a processor that uses data relating to the detectable characteristic sensed by the sensors to determine a position and/or orientation of the needle in three spatial dimensions. The system includes a display for depicting the position and/or orientation of the needle together with the image of the target.

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 integrated catheter placement system for accurately placing a catheter within a patient's vasculature is disclosed. In one embodiment, the integrated system comprises a system console, a tip location sensor for temporary placement on the patient's chest, and an ultrasound probe. The tip location sensor senses a magnetic field of a stylet disposed in a lumen of the catheter when the catheter is disposed in the vasculature. The ultrasound probe ultrasonically images a portion of the vasculature prior to introduction of the catheter. ECG signal-based catheter tip guidance is included in the integrated system to enable guidance of the catheter tip to a desired position with respect to a node of the patient's heart. Various aspects for visualizing and manipulating display of the ECG signal data acquired via the present system, together with aspects of various ECG sensor configurations, are also disclosed.

Abstract: A deployment device and an associated surgical fastener as well as their methods of use are disclosed. In one embodiment, the deployment device includes a restraining mechanism constructed and arranged to temporarily limiting movement of a surgical fastener back span. The surgical fastener includes two legs extending in a distal direction from opposing ends of the back span. The legs are in a first closed position with a first shape. The deployment device also includes a spreader configured and arranged to engage the legs of the surgical fastener in the first closed position. When the spreader is moved in a distal direction relative to the back span, the spreader spreads the legs of the surgical fastener from the first closed position to a second open position as the back span is limited from distally moving by the restraining mechanism.

Abstract: Surgical instruments and their methods of use are described. In one embodiment, a surgical instrument includes a power transmission including a trigger and a fastener driver operatively coupled to the trigger. Actuation of the trigger from a first configuration to a second configuration moves the fastener driver between at least a first position and a second position. Additionally, an actuation lockout system operatively associated with the power transmission is moveable between a locked configuration and an unlocked configuration. The actuation lockout system prevents movement of the fastener driver from the first position to the second position when the actuation lockout system is in the locked configuration. Actuation of the trigger from the first configuration towards the second configuration moves the actuation lockout system from the locked configuration to the unlocked configuration.

Abstract: A delivery system for a medical implant and a method of delivering the medical implant. The delivery system includes an inner catheter and an outer catheter. The inner catheter includes a wire coil disposed between an inner tube and an outer tube, the wire coil having gaps between turns of the coil at a proximal and a distal region thereof. The outer catheter is disposed about the inner catheter. The system includes a flow path for liquid from a proximal end to a distal end thereof, the flow path including a radially extending portion through the gaps. The method includes inserting the delivery system into a body lumen, injecting visualizing fluid into the proximal end of the system, the visualizing fluid moving through the flow path and exiting the distal end of the system, and retracting the outer catheter to release the medical implant.

Abstract: A vascular graft with trim lines is described, the trim lines providing a guide for precision shaping of the cuff. The trim lines may be printed or otherwise disposed on a surface of the cuff or included on a template designed for disposition over the cuff. The trim lines may also be disposed on a side of a pocket into which the cuff is positioned for trimming. Also described is an apparatus and method for precise trimming of a vascular graft.

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 integrated catheter placement system for accurately placing a catheter within a patient's vasculature is disclosed. In one embodiment, the integrated system comprises a system console, a tip location sensor unit for temporary placement on the patient's chest, and an ultrasound probe. The tip location sensor senses a field produced by a stylet disposed in a lumen of the catheter when the catheter is disposed in the vasculature. The ultrasound probe ultrasonically images a portion of the vasculature prior to introduction of the catheter. ECG signal-based catheter tip guidance is included to enable guidance of the catheter tip to a desired position with respect to a node of the patient's heart. The stylet includes an electromagnetic coil that can be operably connected to the sensor unit and/or console through a sterile barrier without compromising the barrier. The stylet can also be wirelessly connected to the sensor unit and/or console.

Abstract: A guidance system for assisting with the insertion of a needle into a patient body is disclosed. The guidance system utilizes ultrasound imaging or other suitable imaging technology. In one embodiment, the guidance system comprises an imaging device including a probe for producing an image of an internal body portion target, such as a vessel. One or more sensors are included with the probe. The sensors sense a detectable characteristic related to the needle, such as a magnetic field of a magnet included with the needle. The system includes a processor that uses data relating to the sensed characteristic to determine a 3-D position of the needle. The system includes a display for depicting the position of the needle. In other embodiments, a guidance system for guiding rigid or other medical instruments is disclosed, together with various example implementations thereof.

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: 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: Implantable prostheses for repairing soft tissue defects near an anatomical tube and methods for their manufacture are described. Exemplary prostheses may be implanted at a soft tissue repair site, for example, in treating an inguinal hernia. An implantable prosthesis may include a patch made up of two co-knit fabric layers, and a passageway for receiving an anatomical cord extending through the fabric layers. The passageway is configured through the first fabric layer so as to minimize the prospects of the cord-like structure contacting the portion of the second fabric layer defining the passageway therethrough. The passageway through the first fabric layer may include a barrier.

Abstract: A hernia repair device is provided which may include a soft tissue repair prosthesis and an expandable device configured to be removably connected with the soft tissue repair prosthesis. When expanded, the expandable device may be configured to position the soft tissue repair prosthesis adjacent a hernia defect. The soft tissue repair prosthesis may include at least one loop or slit configured to receive a portion of the expandable device. The prosthesis may include a tether to hoist, locate or position the soft tissue repair prosthesis. The expandable device may include indicia for positioning the prosthesis relative to the edge of the hernia defect.

Abstract: A stent device includes a first graft member, a second graft member and a stent frame defining a central axis. The frame has an abluminal surface engaged with the first graft member and a luminal surface engaged with the second graft member such that the first graft member and the second graft member encapsulates the stent frame along the length of the central axis. The stent frame includes a configuration where the stent frame is disposed on a curvature such that the abluminal surface has a radius of curvature of approximately 20 millimeters about a center of the curvature and the luminal surface defines a substantially constant effective cross-sectional area at any portion generally transverse to the central axis of the stent frame disposed about the curvature.

Abstract: An instrument for delivering a suture transfascially may include a handle, a shaft extending from the handle, and a pair of needles that are moveable to an extended position beyond the end of the shaft. One or more sutures are carried by the instrument and may be delivered transfascially. A transfascial suture assembly includes a suture having a first segment, a second segment, and an intermediate segment therebetween. A force distributing member is locatable at the intermediate segment. Suture retainers may be provided at the end of each suture segment, and may have a connection that is moveable relative to the portion of the suture segment connected therewith. A method of delivering transfascial sutures includes inserting a twin-needle instrument loaded with one or more sutures into an abdominal cavity and deploying, from within the abdominal cavity, the suture carrying needles through a soft tissue repair patch and then through at least part of the abdominal wall.

Abstract: A removable blood clot filter includes a number of locator members and anchor members disposed radially and extending angularly downward from a hub. The locator members include a number of linear portions having distinct axes configured to place a tip portion approximately parallel to the walls of a blood vessel when implanted and to apply sufficient force to the vessel walls to position the filter near the vessel centerline. The anchor members each include a hook configured to penetrate the vessel wall to prevent longitudinal movement due to blood flow. The hooks may have a cross section sized to allow for a larger radius of curvature under strain so that the filter can be removed without damaging the vessel wall.

Abstract: A guidance system for assisting with the insertion of a needle or other medical component into the body of a patient is disclosed. The guidance system utilizes ultrasound imaging or other suitable imaging technology. In one embodiment, the guidance system comprises an imaging device including a probe for producing an image of an internal body portion target, such as a vessel. One or more sensors are included with the probe. The sensors sense a detectable characteristic related to the needle, such as a magnetic field of a magnet included with the needle. The system includes a processor that uses data relating to the detectable characteristic sensed by the sensors to determine a position and/or orientation of the needle in three spatial dimensions. In yet another embodiment, systems and methods for determining the length of the needle to be guided by the guidance system are disclosed.

Abstract: A catheter, with one or more lumens, having a first portion and a second portion and an arcuate transition region extending between the first portion and the second portion. The first portion is nonparallel to the second portion.

Abstract: The invention provides a delivery system for a prosthesis, said delivery system comprising a catheter shaft with a distal end, a proximal end and a longitudinal axis, a space for a prosthesis with a distal end and a proximal end, the space being at the distal end of the catheter shaft, a sheath with a proximal end and a distal end, the sheath being disposed at the distal end of the catheter shaft so as to surround the space, a pusher element attached to the distal end of the catheter shaft and arranged at the proximal end of the space for abutting prosthesis, a pull element with a longitudinal axis, the pull element running the length of the catheter shaft and having a distal end attached to the proximal end of the sheath and a proximal end for pulling the pull element proximally, thereby retracting the sheath proximally relative to the prosthesis space, and at least one fixation element having a proximal end and a distal end and being disposed within a flexible portion of the length of the shaft that lies be