Abstract: A balloon disposed near a distal end of the catheter tubing and moving between deflated and inflated states, and proximal and distal stent retention bands concentrically arranged around respective proximal and distal end portions of the balloon. The proximal stent retention band has a distal end located within 2 mm of the proximal end of a stent coaxially received by the balloon and the distal stent retention band has a largest diameter within 2 mm of the distal end of the stent received by the balloon.

Abstract: A gastrointestinal implant device is anchored in the duodenum and extends beyond the ligament of Treitz. All food exiting the stomach is funneled through the device. The gastrointestinal device includes an anchor for attaching the device to the duodenum and an unsupported flexible sleeve. The anchor can include a stent and/or a wave anchor and is collapsible for catheter-based delivery and removal.

Abstract: An implantable medical device includes a housing and a header mounted to the housing, the header including a header body having a bore with an electrical contact located within the bore, wherein the electrical contact includes a helical coil spring having an axial bore, wherein the axial bore of the helical coil spring is aligned with a longitudinal axis of the bore.

Abstract: An introducer assembly (100) including at its distal end a dilator tip (20) and an inner catheter for supporting an implantable medical device (1) for deployment, is provided with a plurality of strut elements (102, 202) extending from the dilator tip (20) to the proximal end of the medical device (1). The strut elements (102, 202) act to apply both a pulling and a pushing force against the proximal end of the medical device (1), having the effect of assisting in the correct positioning of the proximal end of the medical device in a patient's lumen, particularly where this is curved such as with the aortic arch. The strut elements (102, 202) form part of the introducer assembly and are removed from the patient following the deployment procedure. The device avoids the need for bare stents at the end of a stent graft.

Abstract: An endovascular delivery system for an endovascular prosthesis includes a radiopaque marker system for accurate delivery of the prosthesis. The radiopaque marker system is disposed within a prosthesis or stent holder within the delivery system. The radiopaque marker system includes a plurality of radiopaque markers that provide different views rotation of the prosthesis or stent holder.

Abstract: A stent-graft delivery system includes an elongate shaft, a tip capture spindle disposed over the shaft, and a distal tip assembly coupled to the distal end of the shaft. At least one component of the delivery system constrains a stent of the stent-graft engaged with the tip capture spindle during delivery and partial-deployment of the stent-graft, and the at least one component is in a threaded relationship with the distal tip assembly. To fully deploy the stent-graft, the elongate shaft, having the distal tip assembly coupled thereto, is rotated to result in longitudinal movement of the at least one component and thereby release the stent from the tip capture spindle. The at least one component that longitudinally moves to fully deploy the stent-graft may be the tip capture spindle and/or a relatively short sleeve that extends over the tip capture spindle to the distal tip assembly.

Abstract: A stent delivery system including a stent disposed between an inner member and a deployment sheath is disclosed. Additionally, the stent delivery system includes a handle that may be coupled to the inner member and to the deployment sheath. The handle may include an actuation member coupled to the gear rack assembly so that actuation of the actuation member shifts the longitudinal position of the gear rack assembly and the deployment sheath. The gear rack assembly may include an engagement mechanism that may be configured to engage the inner member so that proximal retraction of the gear rack assembly results in proximal retraction of the inner shaft.

Abstract: In one example, this disclosure is directed to a kit for intravascular implantation of an implantable medical device within a patient comprising an elongated outer sheath forming an inner lumen with a distal opening, the outer sheath sized to traverse a vasculature of the patient, and an elongated inner sheath with a stopper. The inner sheath further includes a tether configured to form a loop on a distal side of the stopper, the loop being configured to engage a looped element of the implantable medical device to couple the implantable medical device to the inner sheath. The stopper is slidable relative to the outer sheath. The tether is configured to release the looped element of the implantable medical device from the inner sheath by opening the tether loop when a portion of the stopper is located distally relative to the distal opening of the outer sheath.

Abstract: Expandable sealing means for endoluminal devices have been developed for controlled activation. The devices have the benefits of a low profile mechanism (for both self-expanding and balloon-expanding prostheses), contained, not open, release of the material, active conformation to the “leak sites” such that leakage areas are filled without disrupting the physical and functional integrity of the prosthesis, and on-demand, controlled activation, that may not be pressure activated.

Abstract: A dual taper stent protector having a first stent covering region configured to cover a stent without substantially engaging the stent, a second covering region, and an engagement region for engaging a product mandrel removably disposed within a catheter shaft, and first and second tapered regions connecting the first stent covering region and the second stent covering region and the second covering region and the engagement region respectively, and to methods of making and using the same.

Abstract: An embolic protection device includes a first filter configured to be disposed in a first vessel and a second filter configured to be disposed in a second vessel. A first tether extends from a proximal end of the first filter and a first magnet is coupled to the first tether. A second tether extends from a proximal end of the second filter and a second magnet is coupled to the second tether. The device is configured such that when the first filter is disposed in the first vessel and the second filter is disposed in the second vessel, the first magnet and the second magnet are magnetically coupled to each other to couple the first tether to the second tether.

Abstract: A system and method for deploying an occluding device that can be used to remodel an aneurysm within the vessel by, for example, neck reconstruction or balloon remodeling. The system comprises an introducer sheath and an assembly for carrying the occluding device. The assembly includes an elongated flexible member having an occluding device retaining member for receiving a first end of the occluding device, a proximally positioned retaining member for engaging a second end of the occluding device and a support surrounding a portion of the elongated flexible member over which the occluding device can be positioned.

Abstract: Delivery systems for a polymeric tubular implant, kits that include such delivery systems, and methods of treating patients by implanting tubular implants using the delivery systems. The delivery systems include an inner shaft, an expandable member slidably disposed about the inner shaft and configured to receive the tubular implant, and a tubular outer shaft disposed about the inner shaft.

Abstract: A system and method for deploying an occluding device that can be used to remodel an aneurysm within the vessel by, for example, neck reconstruction or balloon remodeling. The system comprises an introducer sheath and an assembly for carrying the occluding device. The assembly includes an elongated flexible member having an occluding device retaining member for receiving a first end of the occluding device, a proximally positioned retaining member for engaging a second end of the occluding device and a support surrounding a portion of the elongated flexible member over which the occluding device can be positioned.

Abstract: An external bodily vessel support comprising an elongate body with a longitudinal axis and an interior to be brought into apposition with an exterior of the bodily vessel. The elongate body including a tubular fabric of a plurality of threads, the body when in a relaxed configuration having a relaxed length and being sized and shaped to fit over of the exterior of the bodily vessel, the tubular fabric being longitudinally elastic to maintain the length with an axial stiffness of at least 0.1 N/m.

Abstract: A generally spherical vascular remodeling device is permanently positionable at a junction of afferent and efferent vessels of a bifurcation having an aneurysm. After positioning the device at the junction to substantially conform the device to the shape of the junction, the device acts as a scaffolding to inhibit herniation of objects out of the aneurysm and the device permits perfusion to the efferent vessels. Positioning the device may include deployment and mechanical or electrolytic release from a catheter. Embolic material may be inserted in the aneurysm before or after positioning the device. The device may have a first end, a second end substantially opposite to the first end, and a plurality of filaments extending between and coupled at the first end and the second end. Such devices may be football shaped, pumpkin shaped, or twisted. The device may include a plurality of loops forming a generally spherical shape.

Abstract: The present embodiments provide systems and methods for deploying at least a portion of a stent. In one embodiment, the system comprises a cannula having an outer surface, and at least one coiled member having proximal and distal ends and a plurality of turns disposed therebetween. One of the proximal and distal ends of the coiled member is secured to the outer surface of the cannula, and the other of the proximal and distal ends of the coiled member is unsecured relative to the outer surface of the cannula. A portion of a stent is looped around the unsecured end of the coiled member and disposed within spacing between adjacent turns of the coiled member. Rotation of the cannula subsequently causes the portion of the stent to disengage from the coiled member.

Abstract: A stent graft for placement in a lumen of a patient is disclosed. The stent graft comprises: a main tubular body of a biocompatible graft material having a main lumen, the main tubular body having a proximal end and a distal end; a side arm extending from the main tubular body, the side arm having a side arm lumen, the side arm lumen being in fluid communication with the main lumen through a side arm opening in the main tubular body; and a cannulation pocket. The pocket comprises: an exit aperture positioned opposite the side arm opening; an entry aperture longitudinally spaced from the entry aperture in a direction toward the distal end of the main tubular body; and a wall, the wall laterally spaced from the main lumen so as to provide a guide surface for a cannula fed through the entry aperture.

Abstract: A device to release from an implant bed in the device a self-expanding implant by pulling back proximally, the length of the implant, a rolling membrane with an inner sleeve that extends distally to the distal end of the implant and an outer sleeve that extends proximally, from the distal end of the inner sleeve, the outer sleeve, during said release, pulling the distal end of the inner sleeve back proximally over the abluminal surface of the remainder of the inner sleeve, proximal of its distal end, the device having a slitter, that is caused to move proximally contemporaneously with the outer sleeve, to slit the inner sleeve progressively, starting at a distal point in the inner sleeve, and progressing proximally along the length of the inner sleeve.

Abstract: A balloon catheter assembly for delivering nano-carriers to bifurcation lesions in one or more of a main branch and a side branch of a blood vessel bifurcation within 30 to 90 seconds is provided. The balloon catheter assembly includes two or more balloons designed for use in the blood vessel bifurcation. The balloon catheter assembly may also include one or more stents. A surface of one or more of the two or more balloons is coated with the nano-carriers. Stents, when included, may also be coated with the nano-carriers. The nano-carriers include one or more drugs encapsulated with one or more biological agents.

Abstract: Disclosed is a method of preventing atrial appendage thrombus from entering the blood stream in which an occlusion device placed within the left atrial appendage inhibits compression of the left atrial appendage and facilitates tissue in-growth onto the occlusion member. The occlusion device includes an occlusion member, a plurality of supports and a plurality of barbs associated with the plurality of supports.

Abstract: A medical device-includes a scaffold crimped to a catheter having an expansion balloon. The scaffold is crimped to the balloon by a process that includes one or more balloon pressurization steps. The balloon pressurization steps are selected to enhance scaffold retention to the balloon while retaining, at least partially, the original balloon folds as the balloon is pressurized and de-pressurized within a crimper head. By at least partially retaining the original balloon folds, a uniformity of scaffold expansion by the balloon is improved.

Abstract: The present disclosure provides a delivery system for a self-expanding implant (31) which includes a sheath (41, 42) which surrounds and constrains the implant prior to delivery and a confining element (80) which surrounds the sheath during storage. The confining element preferably includes elongate members (81) 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: Certain embodiments of the present disclosure provide a prosthetic valve (e.g., prosthetic heart valve) and a valve delivery apparatus for delivery of the prosthetic valve to a native valve site via the human vasculature. The delivery apparatus is particularly suited for advancing a prosthetic heart valve through the aorta (i.e., in a retrograde approach) for replacing a diseased native aortic valve. The delivery apparatus in particular embodiments is configured to deploy a prosthetic valve from a delivery sheath in a precise and controlled manner at the target location within the body.

Abstract: In some aspects, a system for applying a fiber matrix on a tubular conduit is provided. The system can include a tubular conduit, a mandrel and a fiber matrix delivery assembly. The mandrel can comprise an elongate shaft and a rolling membrane configured to atraumatically engage the tubular conduit.

Abstract: A device for delivering an expandable member to a luminal structure in a patient is described. In some embodiments, the device has a carrier member, with a carrier lumen extending at least partially therethrough. The device can have an elongate member that extends through the carrier lumen across a first notch in the carrier member. The device can have an expandable member that expands within and engages the luminal structure, can be carried by the carrier member, and has a first portion that fits within the first notch. When the elongate member extends through the carrier lumen and across the first notch, the elongate member secures the first portion to the carrier member. The elongate member is configured to move axially through the carrier lumen such that the elongate member permits release of the first portion from the carrier member and expansion of at least part of the expandable member.

Abstract: The stent of the present invention combines a helical strut band interconnected by coil elements. This structure provides a combination of attributes that are desirable in a stent, such as, for example, substantial flexibility, stability in supporting a vessel lumen, cell size and radial strength. The structure of the stent of the present invention provides a predetermined geometric relationship between the helical strut band and interconnected coil.

Abstract: A release device for disengaging a medical implant from an insertion device, in which the implant is releasable by a relative movement between a first insertion element and a second insertion element, comprising a body having a proximal end, which faces toward a user in the usage state, and a distal end, which is remote from the user in the usage state, a toothed rack having a first speed range and a second speed range being provided between the proximal end and the distal end, the toothed rack being provided to generate a targeted relative movement between the first insertion element and the second insertion element of the insertion device. Furthermore, the invention relates to an insertion device having such a release device.

Abstract: A prosthetic valve delivery system for percutaneously delivering and deploying a prosthetic valve within an existing valve is disclosed. The delivery system includes a stented prosthetic valve having a balloon-expandable stent portion with a prosthetic valve disposed therein and at least one self-expanding stent portion. The delivery system further includes a dual balloon catheter having a first balloon on which the stented prosthetic valve is disposed during delivery and a second balloon. Upon delivery within the existing valve, the self-expanding stent portion contacts the existing valve and the first balloon expands the balloon-expandable stent portion to a first diameter such that the stented prosthetic valve is in a first stage deployment configuration.

Abstract: A method of surgically treating occlusive disease in an intraluminal tissue using both a retractor (6) and a retractable one-piece stent. The stent is constructed and arranged such that it can exist in at least a stable initial collapsed state (12) and a stable deployed expanded state (10). In conjunction with the retractor, the stent is positioned at an appropriate location within an occluded intraluminal tissue and converted from a stable initial collapsed state to a stable deployed expanded state, and is then converted to a collapsed state and removed before significant restenosis occurs.

Abstract: The delivery systems disclosed herein can create simultaneous movement of an inner and an outer sheath of the delivery system. The delivery systems can generally include a handle assembly and a delivery catheter. In certain embodiments, the inner shaft and the outer sheath can be slidably controlled by a control element in the handle. The handle assembly can include a housing with a thumbwheel acting as the control element. In certain embodiments, movement of the inner shaft and the outer sheath can be caused via a gear-type system. In certain embodiments, the handle assembly can include a rotatable housing. A control element can rotate the housing, which can cause a first boss associated with the outer sheath and a second boss associated with the inner shaft to move in opposite directions.

Abstract: A prosthetic valve delivery system that is improved in controllability by way of a proximal handle system. Such a handle system of the present invention advantageously permits a controlled fine or micro movement or adjustment of a distal sheath for uncovering a plunger that is to be loaded with a prosthetic valve for deployment thereof. The delivery system of the present invention permits a trigger-release for a gross or macro movement to the sheath relative to the plunger. Also, the control handle of the delivery system is shaped and contoured for ease in manipulation of the micro-control actuator.

Abstract: A two-stage method of compressing a stent entails providing an expandable stent (100,105) in a radially expanded state. An outward pressure is applied to an inner surface of the tubular framework to support the stent, and a diameter of the stent is reduced to a first compressed diameter (D1) while applying the outward pressure. The outward pressure is halted after reaching the first compressed diameter. According to an embodiment in which the stent is balloon-expandable, a delivery balloon catheter (130) comprising an uninflated balloon in a delivery configuration is inserted into the lumen after halting the outward pressure. The diameter of the stent is reduced to a second compressed diameter (D2) smaller than the first compressed diameter to crimp the stent onto the delivery balloon catheter.

Abstract: An adjustment tool enables manipulation of a prosthetic anatomical device such as an annuloplasty ring. The tool includes a compression member which is operative for retarding rotation of the adjustment shaft to preclude inadvertent rotation thereof during use of the tool by the surgeon. A locking device is associated with the adjustment tool to enable the releasable attachment of the tool to the anatomical device during its adjustment by manipulation of the tool. The locking device is oriented into operative and inoperative positions by the engagement and disengagement of locking elements. A scale may be provided on the adjustment tool to assist a surgeon in determining the size or amount of adjustment to the size of the anatomical device during its adjustment.

Abstract: A medical device may include a handle housing having a side wall defining an interior space and proximal and distal apertures extending through the side wall, an elongated outer sheath, an elongated inner member, a proximal flush port disposed within the interior space and in fluid communication with the elongated inner member, and a distal flush port disposed within the interior space and in fluid communication with the elongated outer sheath. A control knob may be rotated to move the distal flush port within the interior space.

Abstract: Methods, systems and devices are provided for performing lung volume reduction in patients suffering from chronic obstructive pulmonary disease or other conditions where isolation of a lung segment or reduction of lung volume is desired. The methods are minimally invasive with instruments being introduced through the mouth (endotracheally) and rely on isolating the target lung tissue segment from other regions of the lung and occluding various lung passageways with the use of occlusal stents. The occlusal stents are delivered with the use of an occlusal stent delivery system which is loaded with the occlusal stent with the use of an occlusal stent loading system.

Abstract: An implantable, radially distensible stent includes a plurality of helically wound elongate members. The members include an overlapping portion having a longitudinal extent, opposed and convexly rounded sides defining a width of the members and opposed luminal and exterior surfaces. The members include shape memory polymer. The side of one elongate member slidingly overlaps the side of an adjacent elongate member to form a self-supporting wall structure of a stent. The stent wall is self-supporting without other support structure incorporated into or abutting the elongate members. Further, the shape memory polymer may include a biodegradable or bioabsorbable elements.

Abstract: A balloon catheter is provided that may be used to dilate hardened regions of a stenosis on a vessel wall. The balloon catheter is provided with cutting elements that extend along a surface of a balloon. At least one bioactive is present, either on the cutting element, within the interior of the balloon, within the material of the balloon or on an outside surface of the balloon. The bioactive is delivered to the vessel wall upon dilation of the balloon.

Abstract: A dual-balloon delivery catheter system includes a carrier segment that is a lead/carrier balloon or mandrel at a distal portion of a catheter. The carrier segment is sequentially arrayed with a more proximally positioned delivery segment, wherein the delivery segment is a delivery balloon or mandrel. The first carrier segment expands the stent-valve a sufficient amount to receive the delivery segment after the carrier segment is moved away from the sent-valve. The delivery segment is then positioned at the target site and the stent-valve is then deployed.

Abstract: An introducer system includes a release wire and wire receivers forming a constraining mechanism that facilitates constraining at least one segment of an implant while permitting the remainder of the implant to expand during deployment. The constrained segment includes wire receivers associated with the implant that couple to the release wire and hold the constrained segment in its constrained state until it is released to expand.

Abstract: A delivery device for an implantable medical device having at least one retention member at an end thereof includes a shaft extending in a longitudinal direction, an elongated sheath surrounding a longitudinal portion of the shaft, a compartment defined inside of the sheath and adapted to receive the medical device in an assembled condition, a retainer positioned at one end of the compartment, and at least one acceptance in the retainer adapted to receive the retention member of the medical device in the assembled condition. The sheath is slidable relative to the shaft in the longitudinal direction to uncover and deploy the medical device. The retainer may be rotatable relative to the shaft to reduce torsional forces in the medical device during delivery and deployment. The retainer may have at least one recess facing the compartment for receiving a strut at an end of a stent of the medical device.

Abstract: A guidewire loaded stent for delivery through a catheter is described herein. The stent delivery assembly can deliver and place a stent within tortuous regions of the body which are accessible to guidewires but inaccessible to stenting catheters. The assembly comprises a guidewire covered in part by a retractable sheath and a radially expandable stent near or at the distal end of the guidewire. The whole assembly is advanced through conventional catheters or it may be used alone. In either case, when the stent is adjacent to a treatment site within the body, the sheath is retracted proximally to expose the stent for radial expansion into contact with the vessel wall. Radio-opaque marker bands are optionally located on either side or both sides of the stent on the guidewire body to aid in visual placement. The assembly can optionally include an expandable balloon on the guidewire for different treatment modalities.

Abstract: A system for intraluminally delivering and deploying stents and other prostheses includes an outer catheter, an inner catheter movable axially relative to the outer catheter, and an anchoring device mounted to a distal end region of the inner catheter. The anchoring device includes one or more control features that interact with a linking structure proximally disposed on the prosthesis, preferably including one or more loops. The control features and loops interact by surface engagement to anchor the prosthesis relative to the inner catheter in a nonfrictional manner, thus to maintain lower axial prosthesis deployment and retraction forces. In one version of the anchor, the control features extend radially outward from a sleeve. In another version, the control features are formed in respective recesses which also receive the loops or other linking structure.

Abstract: The present invention provides methods and devices for placement of a stent in a bifurcation or ostial lesion. The stent comprises a main body and a flaring portion. The main body is designed to expand and support a main vessel while the flaring portion deploys at least partially in response to expansion of the main body and is designed to open into and support a side branch or bifurcation ostium area. The stent may also comprise a therapeutic agent which can be delivered to a blood vessel.

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 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 betwee

Abstract: A device includes a first end portion, a second end portion, an intermediate portion between the first end portion and the second end portion, and a graft material coupled to at least the intermediate portion. The first end portion has a first end diameter. The second end portion has a second end diameter larger than the first end diameter. The intermediate portion tapers between the first end portion and the second end portion. A method of diverting fluid flow from a first passage to a second passage comprising deploying the device in a third passage between the first passage and the second passage, expanding the first end portion against sidewalls of the first passage, and expanding the second end portion against sidewalls of the second passage.

Abstract: An implantable device system for controlling the dimensions of internal anatomic passages corrects physiologic dysfunctions resulting from a structural lumen which is either too large or too small. Implantable devices are disclosed which employ various mechanisms for adjusting and maintaining the size of an orifice to which they are attached. Systems permit the implants to be implanted using minimally invasive procedures and permit final adjustments to the dimensions of the implants after the resumption of normal flow of anatomic fluids in situ.

Abstract: An active annuloplasty ring holder having a template that can be folded or pivoted to the side allowing the template to align longitudinally with the handle and enter the patient's chest through a small incision. The holder may include a mechanism to remotely detach sutures fastening the ring to the holder, thereby detaching the ring while avoiding the risk associated with introducing a scalpel into the operating field. A detachment mechanism may include a movable pin actuated by a pull wire that releases a plurality of holding sutures, or a hot wire, knives, or pull wire that severs the sutures. The holder may have a built-in light source for better visualization of the ring inside the heart. The holder may also have an optical means of visualizing the inside of the heart from the proximal end of the handle.

Abstract: Stent-graft delivery systems having a tip capture mechanism with a plurality of elongated cables that allow for gradual deployment and repositioning of a stent-graft prosthesis. The tip capture mechanism includes a guiding assembly, a distal tip assembly, and a plurality of cables. In a first relative position, the distal tip assembly extends the guiding assembly to temporarily constrain the distal ends of the cables and an intermediate portion of each cable constrains an endmost crown of the prosthesis. In this first relative position, tension on the cables may be selectively adjusted to allow for both gradual continuous radial expansion and contraction of the endmost crowns of the stent-graft prosthesis. In a second relative position, the distal tip assembly does not extend over the guiding assembly and thus does not constrain the distal ends of the cables, and thereby the cables do not constrain the endmost crowns.

Abstract: A method of reducing blood flow within an aneurysm includes: injecting a contrast agent into a blood vessel including an aneurysm; deploying an occlusion device across the aneurysm; producing an image of the aneurysm including the contrast agent; and withdrawing the delivery device from the vessel after observing that the aneurysm has been obstructed by a desired amount. The image may be two-dimensional or three-dimensional. Observing that the aneurysm has been obstructed may include determining a degree of obstruction, for example by comparing an area or volume of the contrast agent in a first image and a second image. The desired amount may be a certain degree of obstruction, identification of a shape indicative of stasis such as a flat surface, an approximate hemisphere, a mushroom, or a crescent. If the occlusion device does not achieve the desired amount, a second occluding device may be deployed.