Abstract: A device for closing the left atrial appendage. The device has a flexible and elongate pulling element fixed to a flexible material layer connected fixed to a self-expanding stent. The closure implant can be drawn back into the lumen of a catheter by the pulling element, and in so doing the stent framework can be transferred into a compressed state. The device enables a monitored and controllable release of the closure implant.

Abstract: A delivery catheter includes an inner shaft having an atraumatic distal catheter tip. The inner shaft is configured to carry the implant thereon. The catheter tip includes a region that is fixed to the inner shaft and a region that is deformable and not fixed to the inner shaft. An outer shaft surrounds the inner shaft and is displaceable relative thereto. An implant capsule at a distal end of the outer shaft is configured to encase the implant and to release the implant at the target site via relative displacement of the inner and outer shafts. A plunger is axially displaceable with respect to the catheter tip in response to movement of the outer shaft to apply axial compressive force to the catheter tip and deform the region that is deformable and expand that region radially.

Abstract: Systems and methods for screening a subject for a therapy are described. A mechanical stimulation device positioned near at target location of a blood vessel to provide a mechanical stimulus to the blood vessel. The mechanical stimulus increases strain in one or more regions of the blood vessel, such as by modifying the cross-sectional geometry and/or area of the blood vessel to have different regions of different curvature A baroreflex or related physiological response in response to the mechanical stimulation is detected. In response to the detected response, it is determined whether the subject is appropriate for the therapy and/or which of a plurality of implants with different geometries and/or cross-sectional areas is most optimally suited for deployment in the subject.

Abstract: Various aspects of the present disclosure are directed toward prosthesis that may include a first graft component and a second graft component coupled to the first graft component. The prosthesis may also include a gap or a space between the first graft component and the second graft component.

Abstract: A delivery device for a collapsible medical device may include a handle and a delivery assembly having a compartment for receiving the medical device. A catheter member may extend from the handle to the delivery assembly. The catheter member may have a first portion with a first compliance value and a second portion with a second compliance value different from the first compliance value. An internally threaded member may be fixedly connected to the delivery assembly. An externally threaded member may have a first portion operatively connected to the actuation member and a second portion threadedly coupled to the internally threaded member so that manipulation of the actuation member causes axial movement of the compartment relative to the catheter member.

Abstract: Delivery systems with telescoping capsules for delivering prosthetic heart valve devices and associated methods are disclosed herein. A delivery system configured in accordance with embodiments of the present technology can include, for example, a delivery capsule having a first housing, a second housing slidably disposed within a portion of the first housing, and a prosthetic device constrained within the first and second housings. The delivery capsule can further include first and second chamber defined in part by the first and second housings. During deployment, fluid is delivered to the first chamber to move the first housing distally over the second housing, thereby releasing a portion of the prosthetic device. Subsequently, fluid is delivered to the second chamber such that the first and second housings move together in the distal direction to release a second portion of the prosthetic device.

Abstract: A system for delivering an implant including a handle, a trigger, an actuation assembly, and a catheter assembly. The actuation assembly is configured to displace the outer tubular member in the proximal direction and to separately move the inner shaft member distally upon deployment of the trigger from the first position to the second position, and move the inner shaft member proximally with no displacement of the outer tubular member upon return of the trigger from the second position to the first position. The catheter assembly includes an outer tubular member, an inner shaft member, and a pusher assembly.

Abstract: A method of deploying a stent device into an aorta of a patient includes positioning a distal portion of the stent device at least beyond the left subclavian artery into the descending aorta by axially translating a distal end of a rod of a deployment device into the aorta. The stent device is engaged with the deployment device in an initial configuration about the rod. The axial translation occurs in a direction extending from the aortic arch into the descending aorta. The stent device further includes a stent portion in fluid engagement with the distal portion. The stent portion and the distal portion define an uncovered open cell surface. The stent device further includes a proximal portion in fluid engagement with the stent portion. A collar is defined at a terminal end of the proximal portion.

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 an auger having a plurality of turns coupled to the outer surface of the cannula. A stent has a portion dimensioned to be disposed within a valley of the auger. Rotation of the cannula and the auger advances the portion of the stent in a predetermined longitudinal direction.

Abstract: A delivery device for a collapsible prosthetic heart valve, the delivery device including an inner shaft, a distal sheath disposed about a portion of the inner shaft and forming a compartment with the inner shaft, the compartment adapted to receive the valve, the inner shaft and the distal sheath being movable relative to one another, and a handle including a frame having a longitudinal axis, a proximal end and a distal end, the handle including a deployment actuator and a hub, the deployment actuator and the hub being independently capable of opening and closing the compartment, a resheathing lock configured to alert a user of a position of the distal sheath and to impede movement of the distal sheath, and an indicator disposed on the frame and capable of showing an extent of deployment of the valve.

Abstract: A catheter assembly according to the present invention includes a handle assembly, an introducer sheath, and a distal tip assembly. The distal tip assembly can include first and second retaining sleeves and a slotted tip with a non-traumatic tip guard positioned at the proximal end of the slotted tip. The handle assembly can include a fixed main handle and two or more rotating handles that allow a user to control the distal tip assembly of the catheter. Each control knob on the handle assembly controls a portion of the components on the distal tip of the catheter by allowing for precise manipulation of various delivery shafts. Each delivery shaft extends from the handle assembly to respective positions towards the distal end of the catheter.

Abstract: The present invention relates to a catheter system and methods of using such catheter system for the treatment of vascular and non-vascular pathologies. More specifically, the present invention is directed towards a catheter system for the actuation of a temporarily implantable member elastically deformable by hydraulic means.

Abstract: A device for implanting into an atrial septum of a patient. In some embodiments, the device has a core region to be disposed in an opening in the atrial septum; a distal retention region adapted to engage tissue on a left atrial side of the septal wall; a proximal retention region adapted to engage tissue on a right atrial side of the septal wall; and a retrieval region comprising a plurality of retrieval members, each retrieval member comprising a connector at a proximal end, the connector being adapted to connect to a delivery system. The device has a delivery configuration and a deployed configuration, the core region, distal retention region and proximal retention region each having a smaller diameter in the delivery configuration than in the deployed configuration, the retrieval member connectors being disposed proximal to and radially outward from the opening in the deployed configuration.

Abstract: A method for filtering particulate matter from a blood vessel in a patient, including inserting a device into the blood vessel, the device including at least an outer structure capable of insertion into the blood vessel; and an inner filter anchored to the outer structure, the inner filter having a one-way valve though which a medical instrument may be passed.

Abstract: A prosthetic mitral valve assembly includes a valve component formed with a radially expandable frame and a valve structure supported inside of the frame. In one embodiment, the prosthetic mitral valve assembly further includes an expandable anchor having an annular base. A plurality of cantilevered fixation members extend from the base of the expandable anchor. The fixation members of the expandable anchor are adapted to rotate relative to a longitudinal axis as the valve component is radially expanded within the base of the expandable anchor. As the fixation members rotate, native mitral valve leaflets are securely captured between the fixation members of the anchor and the valve component.

Abstract: Devices and methods for treating vascular defects, such as, for example, balloon-type aneurysms, are described herein. In one embodiment, an apparatus includes an insertion portion and an expandable implant. The expandable implant is configured to be deployed in an aneurysm and is coupled to the insertion portion. The expandable implant has a first portion and a second portion coupled to the first portion. The expandable implant is movable between a first configuration in which the first portion and the second portion are substantially linearly aligned and a second configuration in which the second portion at least partially overlaps the first portion.

Abstract: Described is an apparatus for transcatheter detachment of a stent from a delivery device. A braided suture with an opening is inserted through a restraining hole in a glide (the opening is secured on one side by a knot or a series of knots) and a release line is inserted through the braided suture opening. The braided suture is thus prevented from pulling through the restraining hole while the release line is through the opening. The braided suture is free to pass through the restraining hole after the release line is pulled out of the opening and thereafter pulled free of stent holes formed through a stent, thereby detaching the stent at a desired location.

Abstract: Systems and methods are provided for removing air from a medical device, such as a stent-graft and/or its delivery device. In an exemplary embodiment, the stent-graft or its delivery system or both are exposed to perfluorocarbon, by immersing the stent-graft or flushing the delivery device to remove air from the stent-graft. Optionally, the stent-graft and/or delivery system may be flushed multiple times, e.g., with perfluorocarbon before or after flushing with carbon dioxide, saline, a bio-inert gas, and the like. Thereafter, the stent-graft may be introduced into a patient's body and deployed at a target location, such as the site of an abdominal aortic aneurysm.

Abstract: A delivery device can include several different features including, at least: a shuttle and trigger retraction of an outer sheath; an interlock device to prevent actuation of the trigger; a retraction override switch and lock; and an inner shaft adjuster to ensure correct alignment of the inner shaft and the outer sheath prior to device deployment. The inner shaft adjuster may include, at least: a proximal portion of the handle housing having slots therethrough: pins operatively fixed to the inner shaft and extending through and slidable within the slots: and a cap having an inner helical groove that mates with the pins. Rotation of the cap may push the pins and the inner shaft in a proximal-distal direction. The cap may have a distal lip configured to accept a proximal extension of the interlock and retain it in a locked position until the inner shaft has been adjusted or moved.

Abstract: A balloon coating method and apparatus are disclosed which can perform coating while freely controlling, for example, the thickness of a coating layer and/or the morphological form of a drug. The method includes pulling a distal tip of the balloon in an axial direction of the balloon to straighten a bend of the balloon; rotating the balloon about an axis of the balloon; and coating the outer surface of the balloon with a coating liquid.

Abstract: Apparatus is provided for use with a prosthetic valve for implantation at a patient's native heart valve. The apparatus includes an implant and a tool. The implant includes a plurality of metal segments coupled at a plurality of joints to define a ring having upper joints and lower joints disposed along the ring. The implant also includes a plurality of anchors coupled to the ring at the joints. The tool is couplable to the implant, and is configured to anchor the implant at the native heart valve by rotation of the tool. Other embodiments are also described.

Abstract: A deployment system (10, 410) includes an inner shaft (36, 436), removably disposed in a self-expanding stent-graft (40), and shaped so as to define (a) at least one conduit therealong (50, 450), which is (i) not coaxial with the inner shaft (36, 436), and (ii) shaped so as to define at least first (52, 452) and second enclosed longitudinal segments (54, 454), and (b) a restraining longitudinal portion (56, 456) that is longitudinally disposed between the first (52, 452) and second enclosed longitudinal segments (54, 454).

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 braid implant delivery and retraction device having a catheter, an expandable element and a delivery wire with distal, pusher, and recapture bumps. The expandable element having compressed, partially delivered, and implanted configurations. Delivering the braid can include engaging the distal bump till the braid is in the partially delivered configuration. If the user needs to recapture the braid, the recapture bump engages the braid proximally. To fully implant the braid, the distal bump is used until the braid is partially delivered and the distal bump disengages, now the pusher bump completes implanting by proximally pushing the braid completely out of the catheter.

Abstract: An example medical device includes a balloon that is inflatable to an inflated configuration. The balloon includes a non-compliant layer coextruded on an inner layer, and an outer layer coextruded on the non-compliant layer. The non-compliant layer is configured to delaminate from the inner and the outer layers in the inflated configuration. The non-compliant layer may be configured to rupture in the inflated configuration. An example technique includes inflating the balloon to a predetermined pressure sufficient to rupture the non-compliant layer and insufficient to rupture both the inner and outer layers. The example technique further includes deflating the balloon, and introducing the balloon into a vasculature. Another example technique includes coextruding a non-compliant layer on an inner layer, coextruding an outer layer on the non-compliant layer, and forming a balloon from the inner layer, the non-compliant layer, and the outer layer.

Abstract: Medical device loading apparatuses, systems, methods and kits are described. A loading apparatus comprises a main body having a proximal end defining a proximal opening, a distal end defining a distal opening, and a passageway extending between the proximal and distal openings. The passageway defines a proximal chamber having a first inner diameter, a distal chamber having a second inner diameter, and a transition chamber disposed between the proximal and distal chambers. The transition chamber has an inner diameter that transitions from the larger second inner diameter to the smaller first inner diameter. The main body has a separable connection that divides the main body between proximal and distal portions when disrupted.

Abstract: A delivery apparatus for a prosthetic implant can include an elongate first shaft, a first suture guide coupled to the first shaft, an elongate second shaft, and a second suture guide coupled to the second shaft. The first shaft can extend coaxially through the second shaft and the second suture guide, the first suture guide can be disposed distal to the second suture guide, and the first suture guide and the second suture guide can be configured to be axially movable relative to each other.

Abstract: An atrioventricular prosthesis device is provided. The device includes a frame at least partially defining and enclosing a central cavity, the frame having a distal portion, a proximal portion, and a middle portion connected therebetween. The device further includes a valve construct formed, at least in part, from a cell growth scaffold, at least partially disposed within the central cavity defined by the frame. The valve construct includes: an annular portion defining an aperture and being connected to the frame for positioning the valve construct within the central cavity of the frame, and a plurality of leaflets extending longitudinally and radially inward from the annular portion. The frame and valve construct are transitionable to a deployed state, in which a diameter of at least a portion of the frame and the valve construct substantially conform to a diameter of a tricuspid and/or mitral valve opening.

Abstract: This invention concerns a pharmaceutically-acceptable composition of radioactive metals, which are used for treating various diseases in animals or humans, such as cancer and arthritis.

Abstract: A medical device, deployment systems and methods of use thereof are provided. The medical device includes at least one anchor element coupled to a device body. The anchor element has a first configuration disposed about an anchor axis and configured to pierce a body tissue wall. In a second configuration, the anchor elements have an enlarged shape, and in response to a temperature rise in the anchor element, the pierced body tissue wall is drawn closer to the device body. The anchor element maintains alignment substantially with the anchor axis to inhibit tearing of the pierced body tissue wall by the anchor element. The system may include balloons for targeting the radial pressure of the anchor elements into the body vessel wall. The anchor elements may be made of shape memory materials capable of localized heating due to an induction device.

Abstract: Devices, systems and methods are described for implantation of a prosthesis within a lumen or body cavity and delivery systems for delivering the prosthesis to a location for implantation. A delivery system can include a tether connected to a single directional handle knob for release of the prosthesis within the lumen or body cavity and retraction of the tether towards the handle.

Abstract: Apparatus and methods are described for regulating blood flow in an ascending aorta of a subject including inserting a device (20) into the ascending aorta. When in a deployed state, the device defines an inner surface (24) that defines a conduit (26) through the device, at least a portion (25) of the inner surface diverging, such that a cross-sectional area of the conduit at the downstream end (34) of the diverging portion is greater than a cross-sectional area of the conduit at the upstream end (30) of the diverging portion. The device is deployed within a longitudinal portion of the ascending aorta, such that blood flow through the portion of the ascending aorta, via any flow path other than through the conduit, is less than 20 percent of total blood flow through the portion of the ascending aorta. Other applications are also described.

Abstract: A medical assembly includes a balloon expandable endoprosthesis comprising a plurality of ringed stent elements flexibly connected to each other via at least one flexible connector, the endoprosthesis being deployable from an undeployed state with an undeployed diameter to a deployed state with a deployed diameter. The medical assembly further includes a catheter assembly comprising a balloon, and a cover along the balloon. The endoprosthesis is coaxially located about the balloon and the cover. One or more portions of the balloon and the cover reach an intermediate diameter between the undeployed diameter and the deployed diameter in which the portions of the balloon and the cover are inflated by increasing an inflation pressure within the balloon and approximately maintained at about the intermediate diameter until the inflation pressure increases by at least 1 atmosphere to overcome a yield strength of the cover.

Abstract: Embodiments of the present disclosure are directed to apparatuses, devices, and methods for secure connections between tubular structures. In one implementation, a first tube constructed of nitinol may have windows formed on an end thereof. A second tube constructed of stainless steel tube may be inserted within the first tube, and the windows may be filled with adhesive or solder. The adhesive or solder may bond with the first tube, forming connection pins which secure the tubes together. In some embodiments, the connected tubes may form an endoscopic needle. The nitinol portion of the needle may be sufficiently flexible for positioning within the bending section of an endoscope without deformation. The stainless steel portion of the needle may render the needle significantly less expensive than prior needles constructed solely of nitinol.

Abstract: A prosthetic valve structure, in a collapsed state thereof, is transcatheterally advanced toward a native valve of a subject, the native valve including native leaflets, and the prosthetic valve structure including prosthetic leaflets. An annular portion of the prosthetic valve structure is positioned between the native leaflets. Subsequently, the prosthetic valve structure is rotated such that curved anchors of the prosthetic valve structure gather the native chordae tendineae of the heart between the anchors and the annular portion.

Abstract: A robotic catheter system includes a base and a robotic mechanism having a longitudinal axis and being movable relative to the base along the longitudinal axis. A flexible track is releasably secured to the base and includes an outer surface having a longitudinal opening slit extending therethrough to an inner channel. A rigid guide has a non-linear portion fixed relative to the robotic mechanism. A portion of the flexible track moves along the non-linear portion of the rigid guide away from the longitudinal axis when the robotic mechanism moves along the longitudinal axis.

Abstract: Systems and methods for cryoablation of a tissue. In at least one embodiment of a cryoablation system of the present disclosure, the cryoablation system comprises an expandable stent comprising a proximal end and a distal end, a sidewall defining a lumen extending between the proximal end and the distal end, and a cryoablation chamber at the distal end, the expandable stent configured to permit blood flow therethrough, and a cryoablation device comprising at least one coolant tube at least partially positioned within the cryoablation chamber, wherein the at least one coolant tube is operable to produce a cryogenic environment sufficient to ablate at least a portion of a tissue engaged within the cryoablation chamber.

Abstract: In one embodiment according to the present invention, a stent is described having a generally cylindrical body formed from a single woven nitinol wire. The distal and proximal ends of the stent include a plurality of loops, some of which include marker members used for visualizing the position of the stent. In another embodiment, the previously described stent includes an inner flow diverting layer.

Abstract: Medical tool positioning and control devices, systems, and methods. Handle assemblies that allow a steerable shaft to be steered, while allowing the separate movement of a medical tool. The handle assemblies can allow for rotation and axial movement of the medical tool, and optionally with an actuator disposed distal to a second actuator that controls steering of the steerable shaft.

Abstract: A catheter assembly for delivery of an expandable implant having at least one branch portal, which utilizes a secondary sleeve for releasably constraining a middle portion of the expandable implant after releasing a primary constraining sleeve used for constraining the expandable implant toward a delivery configuration for endoluminal delivery; and methods of using the same.

Abstract: Disclosed herein is an intraluminal support device including a closed cell design on at least one end of the device. In such a device, the closed cell structure is formed by connecting all peaks of an ultimate ring to all peaks of a penultimate ring, and all valleys of the ultimate ring to all valleys of the ultimate ring. The support device expands evenly due to this structure.

Abstract: An apparatus includes a handle, a guide member, a dilation catheter, a guidewire, and first and second movement assemblies. The dilation catheter is slidably housed within the handle and is slidable relative to the guide member. The guidewire is translatable relative to the dilation catheter. The first movement assembly is configured to actuate relative to the handle and includes a first body fixed with the dilation catheter and a first coupling member. The second movement assembly is proximal in relation to the first movement assembly and includes a second body and a second coupling member. The second body is configured to selectively fix to the guidewire and actuate relative to the handle. The first coupling member and the second coupling member are configured to connect the first movement assembly and the second movement assembly to translate together relative to handle in response to distal translation of the first movement assembly.

Abstract: The invention relates to a stent for transluminal implantation in hollow organs, in particular in blood vessels, ureters, esophagi, colons, duodena, or bile ducts, comprising a substantially tubular body, which can be transferred from a compressed state having a first cross-sectional diameter into an expanded state having an enlarged second cross-sectional diameter, wherein the stent comprises a plurality of cells, which are defined by bordering elements formed by the tubular body. The stent is distinguished in that some of the cells are extended in the longitudinal direction of the stent in comparison with the remaining cells in order to form a slanted end face of the stent.

Abstract: Disclosed is a tattoo needle nozzle with rounded silicone rubber grains. The rounded silicone rubber grains are placed in the space between the outer and inner walls of the nozzle to stabilize tattoo needle in operation in order to reduce tattoo pain, and enhance the levels of precision and clarity of tattoo designs.

Abstract: A surgical instrument includes a shaft assembly and an end effector. The shaft assembly includes a shaft having a proximal end and a distal end. A lumen extends along at least a portion of the shaft. A lateral opening is formed in the shaft at a longitudinal position between the proximal and distal ends. The lateral opening is in fluid communication with the lumen. The shaft assembly further includes a movable member that is configured to selectively cover the opening. The end effector is at the distal end of the shaft. The lumen and the lateral opening may be used to flush debris and bodily fluids from the lumen and other regions of the shaft assembly.

Abstract: A guide extension catheter includes a push member and a distal shaft. The push member includes a segment having a first surface and a second surface opposite the first surface. The segment includes a groove in the first surface. The second surface is substantially flat. The distal shaft is coupled to the push member and includes a passageway. The segment of the push member including the groove is adjacent to the distal shaft.

Abstract: A prosthetic aortic valve includes an annular, annulus inflow portion that is designed to reside in or near the patient's native aortic valve annulus, and an annular, aortic outflow portion that is designed to reside in the patient's aorta downstream from at least a portion of the valsalva sinus. The annulus inflow portion and the aortic outflow portion are connected to one another by a plurality of connecting struts that are confined to regions near the commissures of the patient's native aortic valve. The connecting struts are designed to bulge out into the valsalva sinus to help anchor the prosthetic valve in place. The valve is circumferentially collapsible to a relatively small diameter for less-invasive delivery into the patient. The valve circumferentially expands to a larger operational diameter when deployed at the implant site.

Abstract: Apparatus and methods are provided for flaring a stent deployed within a branch vessel including an ostium communicating with a main vessel, a first end of the stent extending at least partially from the branch. A catheter is provided that includes a balloon having a reinforced region adjacent an unreinforced region. When the balloon is positioned at a desired location, e.g., within a stent, prosthetic valve, or other tubular prosthesis, the balloon may be inflated to a first pressure causing the reinforced and unreinforced regions to expand substantially simultaneously. Upon inflation of the balloon beyond the first pressure, the reinforced region of the balloon remains at the first diameter and the unreinforced region continues to expand, e.g., to flare one or more ends of the prosthesis.

Abstract: A gastrointestinal assembly may be deployed within a patient's gastrointestinal tract in order to facilitate drainage of an abscess. The gastrointestinal assembly may include an outer stent and an inner stent disposed within the outer stent. The inner stent divides a volume within the outer stent into a primary passageway through which nutritional contents may pass and a secondary passageway protected from nutritional contents and configured to accommodate a passive drainage system for draining the abscess.

Abstract: A prosthetic heart valve includes a collapsible and expandable frame having a main body, an atrial portion, and at least one ventricular anchor. The atrial portion extends radially outwardly relative to the main body and the ventricular anchor extends from a ventricular end of the main body. The main body and the atrial portion are preferably separate metal components that are coupled together via sutures or a fabric member. The prosthetic heart valve also includes a valve structure that is supported in the main body of the frame. The valve structure has a plurality of leaflets for regulating the flow of blood in one direction.