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 medical article, such as a catheter, is secured with respect to a patient with a securement device. The securement device may include a retainer and anchor pad. Certain devices may further include, for example, straps, flaps, dressings, slots, and recesses for securing the medical article to the patient. The retainer may include a recess and/or a channel. At least one surface of the retainer may be coated with an adhesive.

Abstract: An implantable prosthesis and a method of repairing an anatomical defect, such as a soft tissue defect, by promoting tissue growth with the prosthetic. The prosthesis includes a body with an inner portion and an outer margin that extends outwardly beyond the inner portion, the outer margin including an inner portion side and an outer peripheral edge. The outer margin includes a tissue infiltratable portion, such as a tissue infiltratable layer, having a thickness that decreases from the inner portion side towards the outer peripheral edge.

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 device for introduction into a body vessel includes a shaft, a balloon positioned at the distal end of the shaft, a guidewire disposed longitudinally within the shaft to receive a guidewire during use, a balloon disposed at the distal end of the shaft, and longitudinal scoring wires to score a vascular lesion attached to the distal end of the shaft. The scoring wires are disposed over the balloon and disposed within the shaft. The proximal ends are welded or otherwise affixed to a spring mounted in the handle. The balloon expands when fluid is delivered to the balloon through the inflation lumen. This expansion pushes the scoring wires against the vascular lesion. The scoring wires attach to a source of vibrations. The scoring wires are made of a helical coil.

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: An implantable prosthesis is provided for reconstructing an anatomical feature, such as a breast nipple. The prosthesis may be formed from a biologic and/or synthetic material. The prosthesis may include a body with a shape that is suitable for reconstructing the anatomical feature. A base may be located at an end of the body to facilitate anchoring the prosthesis in position. The prosthesis may be provided with openings that allow fluid flow therethrough, tissue ingrowth, revascularization, neovascularization and/or fat or stem cell deposition. The prosthesis may include a plurality of layers of biocompatible material arranged in a stacked configuration. The layers may be in spaced relation relative to each other and secured or fixed in position to maintain the spacing therebetween. Each layer may have one or more openings extending therethrough. The spaced layer arrangement may provide a desired tactile response and/or natural movement for the prosthesis.

Abstract: A safety needle assembly of an infusion set 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. In another embodiment, an interface pad is included on the bottom of the needle assembly and includes an antimicrobial and/or haemostatic agent to protect the needle insertion site.

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. A needle assembly including a hub, cannula, and magnetic element is also disclosed, wherein a magnetic axis of the magnetic element is configured to be coaxially aligned with the needle cannula.

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: The present disclosure relates to a packaged urinary catheter assembly and method of making and using the packaged urinary catheter assembly. The urinary catheter assembly includes a urinary catheter having a proximal end and a distal end. The distal end includes at least one aperture for receiving fluid from a patient. The urinary catheter is contained within a sleeve having a length, a width, and a size configured to receive the catheter. According to one embodiment, the urinary catheter and the sleeve may be arranged in a helical coil. The outer surface of the urinary catheter may have a lubricious and/or an antimicrobial coating.

Abstract: A balloon catheter (10) with a shaft (14,24) extending in a longitudinal direction and having a proximal end and a distal end and an inflatable balloon positioned along the shaft. The balloon (12) includes at least one portion connected to the shaft and adapted for moving toward the proximal end thereof when the balloon is inflated. Related aspects are disclosed.

Abstract: A deployment device for positioning a soft tissue repair prosthesis includes a self-expanding support body releasably attachable to the prosthesis. The support body may be removably insertable into a pocket of the prosthesis. A handle coupled to the support body facilitates positioning the patch and/or removal of the support body from the pocket. The support body may substantially occupy the pocket in an expanded configuration. The handle may be arranged to direct a pulling force to the outer peripheral edge of the support body and/or cause a portion thereof to be pulled downward and below the body during withdrawal of the deployment device from the prosthesis. The support body may include support segments pivotally coupled together and foldable to collapse the support body for insertion into and removal from the pocket. One or more resilient support members may be provided for collapsing and expanding the support body and the prosthesis.

Abstract: An embolic filter is disclosed and can include a head. A plurality of bent legs can extend from the head. Each bent leg can be configured to engage an inner wall of a vein and prevent the embolic filter from migrating in a cranial direction. A plurality of straight legs can also extend from the head. Each straight leg can be configured to prevent the embolic filter from migrating in a caudal direction.

Abstract: A filter delivery device for implanting a vessel filter within a blood vessel of a patient's body. The filter delivery device includes a mechanism for preventing hooks and/or legs on a vessel filter from entangling with each other while the vessel filter is loaded within the delivery device. In one variation, the filter delivery device includes a delivery catheter with grooves at the distal end lumen opening. When a vessel filter with radially expanding legs is compressed and inserted into the distal end of the delivery catheter, the hooks on the distal end of the legs are received and separated by the corresponding grooves on the delivery catheter. In another variation, a pusher rod, with a receptacle for receiving the hooks, is positioned within a delivery catheter to prevent the entanglement of the hooks and/or legs of a filter loaded within the delivery catheter.

Abstract: A radially expansible annular stent is disclosed. The stent comprises a plurality of stenting turns around a lumen centered on a longitudinal axis. Adjacent turns of the stent are joined by connector struts. The stent annulus has a wall thickness related to the material from which it is formed. The radial thickness of the connector struts is smaller than that of the stent annulus. A method of making such a stent is also disclosed. The method includes cutting the connector struts from a tubular workpiece with a laser beam. The laser beam is aimed so as to be offset from a longitudinal axis of the workpiece to provide the reduced radial thickness of the connector struts.

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 blood filter delivery system for delivering a filter into a vein includes an introducer and a push rod with a spline member disposed along the push rod. The spline member has a main body, and first and second boss portions spaced apart along the longitudinal axis to provide a gap for retaining anchor member of the filter during delivery via the introducer.

Abstract: A fluid control component configured for controlling fluid flow through the hub of a catheter assembly during and after placement into the patient is disclosed. In one embodiment, the fluid control component comprises a body disposed within a cavity of the hub, the body being movable between a first position and a second position, wherein the body does not pierce a valve disposed in the hub when in the first position and wherein the body pierces the valve when in the second position. The body includes a conduit to enable fluid flow through an internal portion of the body when the body is in the second position, and a plurality of longitudinally extending ribs disposed on an exterior surface of the body. The ribs provide at least one fluid flow channel between the valve and an external portion of the body when the body is in the second position.