Abstract: A surgical instrument and its method of use are disclosed. In one embodiment, the surgical instrument may include a handle and an elongated shaft assembly extending distally from the handle. The elongated shaft assembly may include an articulable portion with an articulation direction. The elongated shaft assembly may also include a tubular member with a flexible portion with a preferential bending direction and a direction of bending resistance. The tubular member may permit articulation of the elongated shaft assembly when the preferential bending direction is aligned with the articulation direction.

Abstract: A medical balloon with a variable diameter that is reinforced with continuous fibers woven to form a fabric with a varying number of layers and fiber densities. Portions of the balloon having a relatively smaller diameter are reinforced with a fabric having a reduced fiber density and an increased number of layers to facilitate the placement of the layers. The fabric also includes a braiding pattern that facilitates the transition from a single layer fabric to a multiple layer fabric. Also described is a manufacturing method for the braiding and layering.

Abstract: The present invention is an implantable adhesive mesh prosthesis for reinforcing and/or repairing a defect in tissue that is easy to roll into a small diameter cylinder or other low-profile shape for passing through a trocar, incision, or other surgical instrument. More specifically, the adhesive may be applied to the mesh material in a pattern that leaves a significant portion of the surface area of the mesh material free of adhesive. In one embodiment, the adhesive is applied only near the outer perimeter of the mesh product. In another embodiment, the adhesive is applied in spots over all or a portion the surface of the mesh product. In yet another embodiment, the adhesive is applied in parallel lines on the surface of the mesh product and the mesh may be rolled up around an axis parallel to the lines of adhesive.

Abstract: The present invention provides an aortic embolic filter mounted on a catheter. A pair of spaced apart hubs are provided, one hub being a catheter hub mounted on the catheter, the other hub being a tip hub spaced distally of the catheter hub. A filter basket is attached to the hubs and positioned distally of the catheter hub. The basket includes multiple supports that each span the two hubs. A filter material/sheet is supported by the supports, the filter material having concave and convex surfaces, first and second edge portions, and an opening that spans most of the distance between the hubs and in between the filter material edge portions. One of the supports is movable relative to the catheter hub. An operator, controller or handle enables the movable support to change length between the hubs to put more or less of a curvature of the filter basket.

Abstract: An insertion tool for inserting a catheter into a body of a patient is disclosed. The insertion tool unifies needle insertion, guidewire advancement, and catheter insertion in a single device. In one embodiment, the insertion tool comprises a housing in which at least a portion of the catheter is initially disposed, a hollow needle distally extending from the housing with at least a portion of the catheter pre-disposed over the needle, and a guidewire pre-disposed within the needle. A guidewire advancement assembly is also included for selectively advancing the guidewire distally past a distal end of the needle in preparation for distal advancement of the catheter. In one embodiment a catheter advancement assembly is also included for selectively advancing the catheter into the patient. Each advancement assembly can include a slide or other actuator that enables a user to selectively advance the desired component.

Abstract: A method of making an intraluminal device having an implanted configuration and a modified configuration following the implanted configuration. The method includes preparing the implanted configuration of the intraluminal device by forming a support scaffold, creating a patch, and coupling the patch to the support scaffold. The support scaffold can include a lumen defined by a luminal surface. The patch can be coupled to the support scaffold along a length of the luminal surface such that the patch covers less than a full circumference of the luminal surface along the length. The patch is designed to be removed from the support scaffold following implantation of the intraluminal device to transition the intraluminal device from the implanted configuration to the modified configuration.

Abstract: A system for tracking the position of one or more medical devices for insertion into the body of a patient is disclosed. The system may also be used to locate one or medical devices at a later time after placement thereof. The present system employs multiple radiating elements that can be simultaneously detected by a sensor unit of the system, wherein at least one of the radiating elements is included with the medical device. Another of the radiating elements may be placed at a predetermined point on the skin of the patient to serve as a landmark to help determine the location of the medical device with respect to the landmark. Detection of the radiating elements by the sensor unit enables the relative positions of the radiating elements to be ascertained and depicted on a display, to assist a clinician in accurately positioning the medical device, such as a catheter.

Abstract: A hand-held actuator device for releasing into the body from a delivery system a medical prosthesis, like a stent, comprising a frame that acts as a housing, a reel for receiving a wire, a manually operable slider mounted to the frame and a one-way connection between the slider and the reel. Actuating the slider causes the reel to wind up the wire and release the medical prosthesis.

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.

Abstract: An apparatus for performing a medical procedure includes a balloon with a variable profile. The balloon includes at least one inflatable chamber occupied by a fluid, such as air, and solids, such as generally spherical balls. When the chamber is inflated, the solids are spaced apart as a result of their ability to move or flow, but when the chamber is evacuated, the solids become compacted and prevent it from fully collapsing. The balloon may have a plurality of inflatable chambers with solids in different arrangements to achieve different objectives during the medical procedure, such as for example stent deployment. For example, one chamber may be expanded while the other is restrained to alter the balloon geometry, such as for providing focused force or permitting perfusion.

Abstract: A filter formed from a sheet is described herein. In one aspect of the invention, a filter is formed from a sheet of material and, following removal of portions of the sheet, the filter is folded into a shape for insertion into a blood vessel. In another aspect of the invention, features for a filter are formed from a sheet of material and incorporated into the filter.

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 method of treating a patient includes providing a guidewire having an elongate body defining a proximal end and a distal end, the elongate body including a shapeable portion disposed proximate the proximal end, the shapeable portion being malleable so as to be shaped into a shape and remain in the shape until reshaped. The distal end of the elongate body is advanced into a vasculature of the patient. The shapeable portion of the elongate body is shaped into a first shape that prevents advancement of the guidewire further into the vasculature of the patient.

Abstract: A catheter placement system for positioning a catheter in a vasculature of a patient using at least two different modalities. The catheter placement system includes a console with a display, a stylet removably positionable within a lumen of the catheter, a tip location sensor, and an external electrode. The stylet may include an electrocardiogram (ECG) sensor assembly for detecting ECG signals of a node of a heart of the patient, and a first connector in communication with the ECG sensor assembly. The tip location sensor may be configured to detect the stylet when the catheter is disposed within the vasculature of the patient, and to communicate information of the stylet to the console. The console may be configured to receive at least one aspect of the ECG signal detected by the ECG sensor assembly indicative of proximity of the ECG sensor assembly to the node.

Abstract: A surgical fastener deployment system may include a plurality of coil fasteners having a head and coil body. In one embodiment, the head may be larger in diameter than the coil body. The fasteners may also be mounted on a guide rod or mandrel that passes through a through-hole of the head and the coil body. The shaft may also include a guiding element that contacts and stabilizes the coil body as the fastener is deployed from a distal end of the shaft. When the head approaches and contacts the guiding element, the guiding element may deflect to permit the head to pass.

Abstract: A catheter system with a proximal end and a distal end means at the proximal end to actuate a device at the distal end of the system, and an actuator element that runs the length of the system, from the actuator means to the device and actuates the device by transmitting a physical force from the proximal end to the distal end and characterized by a pre-tensioner near the distal end of the system, that can be set in a pre-tensioning disposition prior to actuation of the device, the pre-tensioner thereby reducing the magnitude of the said physical force that must be transmitted from the proximal end when actuation of the device is required.

Abstract: A biopsy device includes a first cannula and a second cannula disposed co-axially with the first cannula. A first gear is fixedly attached to the first cannula. A second gear is fixedly attached to the second cannula. A torsion spring is interposed between the first gear and the second gear. The torsion spring is connected to each of the first gear and the second gear. A ratchet drive mechanism is configured to wind the torsion spring to store energy during a cocking operation, and is configured to release the energy stored by the torsion spring during a firing operation to drivably rotate the first gear to rotate the first cannula relative to the second cannula.

Abstract: A biopsy apparatus includes a biopsy probe assembly that is releasably attached to a driver assembly. The biopsy probe assembly has a vacuum cannula and a stylet cannula coaxially arranged. The vacuum cannula has a flared portion that extends distally from an elongate portion. The stylet cannula is movable between a first extended position and a first retracted position. The stylet cannula has a distal portion having a sample notch and a protrusion member that extends proximally in a lumen of stylet cannula along a portion of a longitudinal extent of the sample notch, wherein when the stylet cannula is in the first retracted position, the protrusion member is received within the flared portion of the vacuum cannula. The biopsy apparatus may further include a controller circuit that has a virtual energy reservoir, and the controller circuit executes program instructions to control current to motors when engaging dense tissue.

Abstract: A method of preparing a filter for delivery into a body vessel. The filter includes a hub disposed along a longitudinal axis and a plurality of anchor members extending from the hub. Each anchor member includes either a cranial extension or a caudal extension at a distal end thereof. At least one anchor member distal end may be spaced from the hub at each of a first, second, and third distance along the longitudinal axis. The filter also includes a plurality of locator members extending from the hub, the locator members alternatingly interposed between the anchor members.

Abstract: Surgical fasteners for use with articulating surgical instruments are disclosed. In one embodiment, a surgical fastener may include a head, a shaft extending distally from the head, and a through bore extending through the shaft from a proximal surface of the head to a distal end of the shaft. A fastener carrier of a surgical instrument may be slidably received in the through bore, and the through bore may be sized and shaped to have two or fewer contact points with the fastener carrier when the fastener carrier is in a fully articulated configuration. In another embodiment, a fastener may include a head, a shaft extending distally from the head and including a distal tip, a sloped surface sloping toward the distal tip, and a through bore passing through the head, shaft, and sloped surface. The sloped surface may terminate at two shoulders located on opposing sides of the through bore.