Abstract: Embodiments include a fiducial deployment system including a needle and at least two adjacent and releasably-engaged fiducials retained within a lumen of the needle by engagement with each other and/or by engagement with a pusher element. A fiducial may include one or more mechanical engagement structures that interengage with and/or are rupturably attached to one or more adjacent fiducials. The needle, which may include echogenic enhancements, may be configured to deliver a plurality of fiducials to a target location in serial fashion, one at a time. A variety of releasably-engaged fiducials are disclosed, as are methods for use.

Abstract: A delivery system for a self-expanding medical device is provided. The delivery system includes an outer sheath that radially restrains the medical device. First and second inner catheters are disposed within the outer sheath. The first inner catheter is a composite structure with a closed coil wire covered by a polymer outer layer. The second inner catheter is disposed within the closed coil wire but is not attached to the closed coil wire.

Abstract: A prosthesis and a method of controlling flow through a bodily lumen are provided. The prosthesis includes a body having a proximal portion, a distal portion and a lumen extending therethrough. The prosthesis also includes a first valve and a second valve operably connected to the body. The first valve has a proximal portion, a distal portion, a distal end extending distally relative to the proximal portion of the body and a lumen extending through the first valve. The first valve is dosed in the absence of a second and third pressure that are greater than a first pressure. The second valve has a proximal portion, a distal portion, a distal end extending distally relative to a proximal portion of the body and a lumen extending through the second valve, the distal end of the first valve extending distal to the distal end of the second valve.

Abstract: An embolic filter having a filter support frame with a collapsed and an expanded configuration and a collapsible filter body supported by the support frame. The filter body has inlet and outlet ends. The filter body includes a proximal section having a longitudinally extending cylindrical shape and a distal section having a longitudinally extending conical shape that tapers in the distal direction. The support frame includes a plurality of alternating first segments such that, when the support frame is in the expanded configuration, the alternating first segments circumferentially extend in a first zigzag path to support the proximal, cylindrically shaped section of the filter body. The support frame includes a plurality of alternating second segments such that, when the support frame is in the expanded configuration, the alternating second segments circumferentially extend in a second zigzag path to support the proximal, cylindrically shaped section of the filter body.

Abstract: A rotary tissue-collection needle configured is provided with a closed distal tip and a distal aperture including a generally longitudinal cutting edge configured to excise tissue into the aperture for collection by rotation of the needle. The needle may be provided as part of a system including an outer sheath within which the needle may be rotated. The needle may be provided with echogenicity-enhancing features.

Abstract: A medical device and a method for controlling flow through a bodily lumen are provided. The medical device includes a valve device positioned within the bodily lumen. The valve device includes a movable member movable within the bodily lumen and a magnetic portion operably connected to the movable member to facilitate positioning the movable member in a first configuration. The magnetic portion has a magnetic attraction to another magnetic portion or a portion of the valve device having a charge opposite a charge of the magnetic portion. The valve device is movable from the first configuration substantially closing the bodily lumen in the presence of a first pressure within the bodily lumen to a second configuration in response to a second pressure that is greater than the first pressure. The valve device is open in the second configuration and the movable member is normally positioned in the first configuration.

Abstract: Implantable medical devices are described. For example, various implantable medical devices having a sleeve with differential wall thicknesses are described. An exemplary medical device comprises a frame and a sleeve that has a first configuration where the sleeve is in an extended position and a second configuration where the sleeve is in an inverted position.

Abstract: A prosthesis and a method for making a prosthesis for controlling flow through a bodily lumen are provided. The prosthesis includes a body having a proximal portion, a distal portion and a lumen extending therethrough and further includes a valve operably connected to the body. The valve has a distal end including a first portion of a surface of the valve lumen and a second portion of the surface that contact each other and form a seal in a closed configuration. The distal end of the valve is formed such that the first portion and the second portion of the surface of the valve lumen contact each other and the distal end is configured to open in response to a pressure that is greater than atmospheric pressure.

Abstract: A prosthesis and a method of manufacturing the prosthesis for controlling flow through a bodily lumen are provided. The prosthesis includes a body having a proximal portion, a distal portion and a lumen extending therethrough. The prosthesis also includes a valve operably connected to the body. The valve has a proximal portion, a distal portion and a lumen extending through the valve, where the valve lumen is connected to the body lumen. The valve is configured to be closed in the absence of an antegrade pressure and a retrograde pressure, the retrograde pressure being greater than the antegrade pressure. The valve includes a material portion operably connected to the valve, the material portion providing increased stiffness to the valve relative to the valve alone, wherein the material portion is configured to facilitate self-reversion of the valve to the closed configuration.

Abstract: Embodiments include a fiducial deployment system including a needle and at least one splayed-end fiducial retained within the needle by frictional engagement and/or by engagement of the splayed end with one or more distal detents in the needle's lumen. A fiducial may include one or more splayed portions configured to engage the wall of the needle lumen, which may include one or more detents. The needle, which may include echogenic enhancements, may be configured to deliver a plurality of fiducials to a target location in serial fashion, one at a time. A variety of splayed-portion fiducials are disclosed.

Abstract: Biodegradable/bioabsorbable stent anchors are provided to prevent stent migration and permit repositioning and/or removal of the stent after the anchors or portion thereof has sufficiently degraded or been absorbed.

Abstract: Devices are illustrated which provide for accurately controlling the extension of a needle from a protective sheath to increase accuracy and improve the outcome of the treatment procedure.

Abstract: A stent delivery system and a method for implanting a stent are provided. The system includes an elongate shaft including a proximal portion, a distal portion, a lumen extending at least partially therethrough, and a stent-receiving portion on the distal shaft portion. The system also includes a stent positioned at the stent-receiving portion of the elongate shaft, the stent having a constrained configuration and an expanded configuration. Proximal and distal constraining members releasably connected to the stent and having a first position and a second position are also included. The proximal and distal constraining members cooperatively apply longitudinal tensile force to at least a portion of the stent with the proximal and distal constraining members each in the first position. A drive system configured to simultaneously move the proximal and distal constraining members is provided, including a threaded drive shaft in mechanical communication with a rotatable handle.

Abstract: A delivery device for deploying an expandable prosthesis and method of use thereof are described. The delivery device includes an outer sheath that is capable of retracting in a proximal direction and resheathing over the prosthesis in a distal direction. The device includes a drive pulley that can engage gears to retract or resheath the outer catheter in relation to the prosthesis. In some embodiments, the delivery device may include a reinforced outer sheath disposed over an inner elongate member, the reinforced outer sheath comprising a proximal section reinforced with a braid, a distal section reinforced with a coil and an overlapping section extending between the proximal section and the distal section. Additionally or alternatively, the delivery device may include a stabilizing element for releasably holding the stent to the inner catheter.

Abstract: A collapsing structure for collapsing the crowns of a stent and method of use thereof are described. The collapsing structure comprises an inner filament engaged to an outer filament. The outer filament is interwoven through at least a portion of the crowns of the stent end so as to create a plurality of loops. The inner filament is interwoven through at least a portion of the loops of the outer filament. Pulling on the inner filament causes the loops of the outer filament to be pulled radially inward, thereby pulling the crowns towards each other to collapse the stent end.

Abstract: A support 103 for an embolic protection device comprises round wires 116 which may form one or more support hoops for a filter body. The circumferential hoop formed by the wires 116 ensures that in the expanded position, the filter body 102 will be supported by the support frame 103 in circumferential apposition with the interior wall of the vasculature. The wires 116 may have a strain distributing linkage element in the form of a loop 120. The loop 120 acts as a diameter or circumference adjuster allowing an embolic protection device to adapt to different Bessel contours and sizes whilst maintaining apposition with the vessel wall. The strain relieving geometry of the loops enhances the compliance of the bend points without creating a weakened hinge point, thus ensuring that there is no discontinuity in the circumferential seal against the vessel wall.

Abstract: An embolic protection device (2000) comprises a collapsible filter body (102), a filter support (103) for supporting the filter body (102), and a tubular member (108) to which the filter support (103) is mounted. The filter support (103) comprises two round wires (116). Each wire (116) has a “M”-shaped curve (120) in the wire (116) which acts as a strain distributing linking element. In an extended configuration, the concave portion of each curve (120) faces longitudinally in the distal direction. In a collapsed configuration, the concave portion faces radially inwardly towards the tubular member (108) and wraps around part of the tubular member (108) to define a compact, low-profile filter support (103). Tethers (500, 501) extend between the curves (120) and a sleeve (201) slidably mounted to the tubular member (108). The distal end of each tether (500, 501) is fixedly attached to the sleeve (201) and to the filter body (102).

Abstract: An embolic protection device comprises a collapsible filter body and a filter support for the filter body. The filter support comprises a support frame defined by at least two wire segments having terminations. The terminations of adjacent segments are fixed relative to one another and extend generally parallel in a bifilar manner for enhanced trackability and flexibility.

Abstract: A stent delivery system, a dilator system and a method for implanting a stent are provided. The stent delivery system includes an elongate shaft including a proximal portion, a distal portion, a lumen extending at least partially therethrough, and a stent receiving portion on the distal portion of the shaft. The stent delivery system also includes a stent positioned at the stent receiving portion of the elongate shaft, the stent having a constrained configuration and an expanded configuration. A proximal constraining member and a distal constraining member releasably connected to the stent and having a first position and a second position are also included. The proximal constraining member and the distal constraining member cooperatively apply longitudinal tensile force to at least a portion of the stent with the proximal and distal constraining members each in the first position.

Abstract: A support 103 for an embolic protection device comprises round wires 116 which may form one or more support hoops for a filter body. The circumferential hoop formed by the wires 116 ensures that in the expanded position, the filter body 102 will be supported by the support frame 103 in circumferential apposition with the interior wall of the vasculature. The wires 116 may have a strain distributing linkage element in the form of a loop 120. The loop 120 acts as a diameter or circumference adjuster allowing an embolic protection device to adapt to different Bessel contours and sizes whilst maintaining apposition with the vessel wall. The strain relieving geometry of the loops enhances the compliance of the bend points without creating a weakened hinge point, thus ensuring that there is no discontinuity in the circumferential seal against the vessel wall.