Abstract: Disclosed herein are devices for improving coaption of the mitral valve leaflets to reduce or eliminate mitral valve regurgitation. The devices may be used to perform mitral valve annuloplasty, or to serve as a docking station for a transcatheter prosthetic heart valve. The various embodiments of devices are configured for percutaneous and, in some cases, transvascular delivery. Delivery systems useful for routing the devices to the mitral valve are also disclosed, including catheters, balloons and/or mechanical expansion systems. The devices themselves include at least one tissue penetrating member. Methods of delivery include partially embedding the devices in the mitral valve annulus via at least one tissue penetrating member. Tissue penetrating members may be embedded into the tissue in a simultaneous or a nearly simultaneous fashion. Upon embedding, the devices employ various expansion and/or contraction features to adjust the mitral valve diameter.

Abstract: A device is described for crossing the atrial septum to properly size a valve annulus for treatment or replacement, having a catheter with an expandable braided tubular structure attached at its distal end. The proximal and distal end regions of the braided tube have an open structure to allow blood flow to pass freely through the gaps or spaces between the braided fibers. The lumen within the tube includes a temporary, artificial valve that acts similar to a native valve, allowing blood to flow in one direction and preventing blood flow in the opposite direction.

Abstract: A balloon applicator for irradiation of a cavity within living tissue is provided, comprising a double-lumen shaft and with a balloon connected to the shaft at a proximal and a distal position, in which a movement of a first portion of the shaft relative to a second portion of the shaft can be effected. In addition, a tool is provided which can be inserted into a lumen of the shaft and which is designed to effect the relative movement. Furthermore, a system is provided composed of balloon applicator and tool.

Abstract: Described here are devices, systems, and methods for closing the left atrial appendage. The methods described here utilize a closure device for closing the left atrial appendage and guides or expandable elements with ablation or abrading elements to ablate or abrade the left atrial appendage. In general, these methods include positioning a balloon at least partially within the atrial appendage, positioning a closure assembly of a closure device around an exterior of the atrial appendage, inflating the balloon, partially closing the closure assembly, ablating the interior tissue of the atrial appendage with the inflated balloon, removing the balloon from the atrial appendage, and closing the atrial appendage with the closure assembly.

Abstract: A method for endovascularly replacing a patient's heart valve including the following steps: endovascularly delivering an anchor and a replacement valve supported within the anchor to a vicinity of the heart valve in a collapsed delivery configuration, the anchor having grasping elements adapted to grasp tissue in a vicinity of the heart valve; expanding the anchor, thereby rotating the grasping elements; and grasping the tissue with the rotating grasping elements.

Abstract: According to aspects of the present disclosure, a retrieval catheter assembly for retrieving an intragastric balloon may include a tubular member configured to pass through a wall of the intragastric balloon. The retrieval catheter assembly may also include a retrieval member coupled to the tubular member and movable between an undeployed configuration and a deployed configuration. In the undeployed configuration the retrieval member may be substantially aligned with the tubular member. In the deployed configuration at least a portion of the retrieval member may diverge from the tubular member and may be configured to engage the wall of the intragastric balloon.

Abstract: According to one aspect of the present disclosure, ureteral stents are provided that comprise an elongated stent body, at least one deployable retention structure, and at least one sleeve and/or sheet of drug-releasing material. In various embodiments, at least one sleeve and/or sheet of drug-releasing material is deployed concurrently with the deployment of at least one deployable retention structure. The ureteral stents of the present disclosure are adapted to release the urologically beneficial drug into a subject.

Abstract: Arrangement for implanting stent elements in or around a hollow organ, having a plurality of stent elements, more particularly self-expanding stent elements, wherein the stent elements are arranged on an axial line (L) and wherein lateral surfaces of the respective stent elements are defined by material-free regions and material webs.

Abstract: A delivery apparatus comprises a handle portion and at least one rotatable drive shaft. The handle portion has an actuation mechanism and a display. The actuation mechanism includes a motor and one or more actuators. The rotatable drive shaft has a proximal end portion and a distal end portion. The proximal end portion is coupled to the motor, and the distal end portion is configured to be releasably coupled to a prosthetic heart valve. The actuation mechanism is configured to control and monitor expansion of the prosthetic heart valve, and the display is configured to display a diameter of the prosthetic heart valve.

Abstract: A pre-loaded stent graft delivery device having a guide wire catheter and a handle including a multi-port manifold with access ports, where an access sheath extends from each access port. A sheath is disposed coaxially around the guide wire catheter and includes two splits that enable the retraction of the sheath while the access sheaths are disposed within the respective access port of the manifold.

Abstract: Apparatus and method for delivering and deploying an intravascular device into the vessel including an outer and inner tube that are axially linked by a housing structure at the proximal end of the catheter, and a retractable sleeve structure having a middle tube and sleeve tip. The sleeve tip is sealed to the inner tube at the distal end, and continuously extends into the middle tube. At the proximal end of the sleeve structure, the middle tube is sealed to either a housing structure or slideable proximal ring, forming a sealed chamber between the inner tube and the sleeve structure. A radial space is formed between the sleeve tip and the inner tube optimized for intravascular device placement. During retraction of the sleeve structure, the fold of the sleeve tip peels away from the device, which expands to its deployed state while minimizing axial forces and friction.

Abstract: Methods and devices are disclosed for passing Chronic Total Occlusion (CTO) from subintimal location and re-entry into a true-lumen of the patient using transient fenestration approach. The transient fenestration is induced by balloon dilatation within the CTO, and a guidewire quickly trails into a true lumen.

Abstract: The present disclosure is directed to a delivery catheter with a mechanism of discharging an adhesive during and/or immediately prior to deployment of the medical device by the delivery catheter.

Abstract: The invention relates to a method of treating pleural abnormalities in a subject in need thereof, comprising the steps of: (a) attaching a biodegradable polymeric membrane onto a pleural wound to elicit fibronectin from fibroblasts to cause fibrous adhesion; and (b) securing the membrane with securement products, including sutures, staples, and sealants. The present invention also relates to a biodegradable adhesion membrane used for treating pleural abnormalities, comprising: a biodegradable base material selected from the group consisting of polycaprolactone (PCL), polylactic acid or polylactide (PLA), polyhydroxybutyrate (PHB), poly(ethylene adipate), poly(butylene adipate) (PBA), chitosan, hyaluronic acid, and polyglycolic acid (PGA); wherein the thickness of the membrane is 0.1-1 mm.

Abstract: Apparatus for delivering stents to body lumens include one or more tubular prostheses carried at the distal end of a catheter shaft, a sheath slidably disposed over the prostheses, and a guidewire tube extending from within the sheath to the exterior of the sheath through an exit port in a sidewall thereof. A guidewire extends slidably through the guidewire tube. The sheath can be moved relative to the catheter shaft and the guidewire tube to expose the prostheses for deployment. Methods of delivering stents are also provided.

Abstract: An apparatus (100) for guiding a catheter within a patient's body, the apparatus comprising: a first wire (112) having longitudinally spaced distal and proximal first wire ends (114,116)) separated by a first wire body; a catheter (102) having longitudinally spaced distal and proximal catheter ends (130,132) separated by a catheter body having a catheter lumen (136) extending longitudinally therethrough between the distal and proximal catheter ends, the catheter having a catheter aperture (138) extending substantially laterally through the catheter body at a location proximally adjacent to the distal catheter end; a second wire (120) having longitudinally spaced distal and proximal second wire ends (122,124) separated by a second wire body.

Abstract: A pusher assembly for a stent delivery device includes a distal end of an elongate member and a stent-engaging member having proximal and distal ends. The proximal end of the stent-engaging member is mechanically coupled to the distal end of the inner member by a connector, or the proximal end of the stent-engaging member is at least partially inside the distal end of the elongate inner member. The stent-engaging member includes a portion that radially outwardly extends towards the distal end of the stent-engaging member, or the stent-engaging member includes a portion that radially outwardly extends towards the distal end of the stent-engaging member. The stent-engaging member is configured to move a stent when distally advanced and configured to not move a stent when proximally retracted. A stent delivery device includes an elongate outer member, an elongate inner member coaxially positioned within the outer member, and the pusher assembly.

Abstract: The present disclosure includes an endoprosthesis delivery system comprising an elongate member, such as a catheter, an endoprosthesis, a covering member disposed about the endoprosthesis, a tip, and an end cap. The tip and end cap can be integral to each other. The covering member can extend beyond the distal end of the endoprosthesis and onto the end cap. The end cap can comprise a tapered profile, which may assist in retraction of the catheter tip and end cap into an outer sheath. The end cap can further comprise one or more fins.

Abstract: A stent graft includes a tubular graft element to which there are attached a plurality of stent rings. The stent rings are formed of a plurality of stent struts arranged in a zig-zag arrangement with alternating peaks and valleys. The end-most stent is located at the proximal end of the graft tube. Between adjacent peaks of the end most stent, there is provided a series of bridging elements. These are preferably formed of Nitinol wire and to be substantially more flexible than the stent struts. The bridging elements extend in the region of graft material between adjacent stent peaks and are attached to the graft material, for example by suturing. The bridging elements are substantially more flexible than the stent ring and therefore impart little opening force on the graft material in comparison to the force produced by the stent ring. However, the bridging elements impart enough force on the flaps of graft material between the peaks of the stent ring keep these flaps open, that is against the vessel wall.

Abstract: An endovascular prosthesis delivery system is disclosed. The system comprises: an inner cannula; a prosthesis releasably secured to the inner cannula, the prosthesis having a radially-inwardly contracted delivery configuration and a radially-expanded deployed configuration, wherein the prosthesis comprises at least two suture loops secured to an outer surface of the prosthesis and circumferentially spaced from each other; a releasable trigger wire extending along at least a portion of the length of the prosthesis, wherein the releasable trigger wire is wound around at least a portion of the inner cannula and wherein the releasable trigger wire engages at least one of the at least two suture loops to retain the prosthesis in the radially-inwardly contracted delivery configuration.

Abstract: Implant engagement mechanisms are disclosed for maintaining engagement with a stent until it has been fully deployed and expanded from a catheter or sheath. The apparatus, method and system involving these engagement mechanisms allow a physician to withdraw or retract a sheath prior to full deployment, thereby allowing for redeployment of the stent at a more desirable position.

Abstract: A stent delivery system is configured to include an outer tube and an inner tube, with a space between the inner and outer tubes. In the space between the outer tube and the inner tube, a cylindrical mesh reinforcing spacer is provided at a position that is on the base end side of a stent. The reinforcing spacer is provided to be freely movable in the axial direction and radial direction. Even when the outer tube and the inner tube, which have been advanced into the lumen of a living body, are bent, the reinforcing spacer moves in the axial and radial directions and elastically deforms, thereby maintaining a substantially uniform internal circumference for the outer tube along the axial direction.

Abstract: A heart valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The prosthetic valve has a base stent that is deployed at a treatment site, and a valve component configured to quickly connect to the base stent. The base stent may take the form of a self- or balloon-expandable stent that expands outward against the native valve with or without leaflet excision. The valve component has a non-expandable prosthetic valve and a self- or balloon-expandable coupling stent for attachment to the base stent, thereby fixing the position of the valve component relative to the base stent. The prosthetic valve may be a commercially available to valve with a sewing ring and the coupling stent attaches to the sewing ring. The system is particularly suited for rapid deployment of heart valves in a conventional open-heart surgical environment. A catheter-based system and method for deployment is provided.

Abstract: Described herein are systems and methods from delivering prosthetic devices, such as prosthetic heart valves, through the body and into the heart for implantation therein. The prosthetic devices delivered with the delivery systems disclosed herein are, for example, radially expandable from a radially compressed state mounted on the delivery system to a radially expanded state for implantation using an inflatable balloon of the delivery system. Exemplary delivery routes through the body and into the heart include transfemoral routes, transapical routes, and transaortic routes, among others.

Abstract: A capture tube mechanism for delivering and releasing a self-expanding stent includes a core wire on which a proximal portion of the stent is removably retained by a distal portion of a tubular capture sleeve. In one embodiment, one or more elongated members extending through corresponding apertures through the capture sleeve and out the distal end of the capture sleeve can be pulled to split the tubular capture sleeve to release the stent. In another embodiment, the capture sleeve can be pulled proximally over one or more stop members provided on the core wire to release the stent.

Abstract: A deployment device for deploying an expandable endoluminal prosthesis within a body vessel may include an elongate member extending longitudinally along at least a portion of a length of the deployment device. The deployment device may include at least one engagement member coupled to the elongate member and extending outwardly from the elongate member. The deployment device may include a circumferential trigger wire extending at least partially circumferentially around the elongate member and removably received between the engagement member and the elongate member. The circumferential trigger wire may be manipulatable from a distal end of the deployment device, whereby the circumferential trigger wire is removable from between the engagement member and the elongate member.

Abstract: A modular handle assembly for a prosthesis delivery device is disclosed. The modular handle assembly has a stationary main handle and a first handle that extends proximally from the main handle and is rotationally moveable relative to the main handle. A second handle extends distally from the main handle and is rotationally moveable relative to the main handle. The main handle has a first rotational interface and a second rotational interface that are configured to engage with the first handle and the second handle, respectively.

Abstract: Methods for placing a stent in a branched vessel include stretching the stent, aligning the stent within a target location at a branched vessel and releasing it for expansion at the target location.

Abstract: An endoluminal device can be configured for precise positioning during deployment within a vessel. The endoluminal device can be a tack, stent, vascular implant or other type of implant. The endoluminal device can have circumferential member with an undulating configuration having multiple inward and outward apexes and struts extending therebetween. Two of the struts can be used to establish a foot for the precise positioning of the device during deployment. A method of placing the endoluminal device can include withdrawing an outer sheath such that a portion of the endoluminal device is expanded prior to the rest of the endoluminal device.

Abstract: A stent graft and a stent graft system having a scallop at the proximal end of the stent graft and extending below the proximal edge, the scallop having two substantially longitudinally extending opposing side edges and a substantially laterally extending bottom edge parallel to the proximal edge of the stent graft and extending between the two substantially longitudinally extending opposing side edges to define a scallop parameter. The stent graft and stent graft system include side arms extending externally from the stent graft at an acute angle to the body of the stent graft with an open end of the side arms extending toward the proximal end of the stent graft.

Abstract: A system for delivering an implant including a handle, a trigger, and an actuation assembly. The actuation assembly can include a planet carrier, at least one planet gear operatively coupled to the planet carrier, a sun gear shaft operatively engaged with the planet gear, a ring gear operatively engaged with the planet gear, a first clutch driver, and a second clutch driver. The actuation assembly can be configured to displace the outer tubular member in the proximal direction a distance (d) relative to the handle and to separately move the inner shaft member distally a distance (x) relative to the handle upon deployment of the trigger from a first position to a second position, and move the inner shaft member proximally a distance (y) relative to the handle with no displacement of the outer tubular member upon return of the trigger from the second position to the first position.

Abstract: A system for delivering an implant including a handle, a trigger, and an actuation assembly. The actuation assembly can include a planet carrier, at least one planet gear operatively coupled to the planet carrier, a sun gear shaft operatively engaged with the planet gear, a ring gear operatively engaged with the planet gear, a first clutch driver, and a second clutch driver. The actuation assembly can be configured to displace the outer tubular member in the proximal direction a distance (d) relative to the handle and to separately move the inner shaft member distally a distance (x) relative to the handle upon deployment of the trigger from a first position to a second position, and move the inner shaft member proximally a distance (y) relative to the handle with no displacement of the outer tubular member upon return of the trigger from the second position to the first position.

Abstract: An inserter for an intrauterine system includes a handle. The handle has a longitudinal opening at its first end, the opening having a longitudinal axis parallel to the longitudinal axis of the inserter, a first end and a second end, a movable slider arranged in the longitudinal opening and having a first end and a second end. The inserter also includes a movable plunger and an insertion tube arranged around the plunger having a first end and a second end, with its second end attached to the slider. The handle further includes a lock for reversibly locking the intrauterine system in relation to the plunger via a removal string of the intrauterine system, the lock being attached to the plunger and being controllable at least by a part or an extension of the slider and/or of the insertion tube or of the handle.

Abstract: A stent graft has a tubular body with a first bifurcation with first and second legs extending from the bifurcation. One of the legs has a further bifurcation to define a side arm. The stent graft can be deployed into the vasculature of a patient with the tubular body being in an aorta of the patient, a first leg extending down an iliac artery, a second leg being directed towards a contralateral iliac artery and the side arm directed to an internal artery of one of the iliac arteries. One of the legs can include a valved aperture to enable the placement of an indwelling catheter therethrough.

Abstract: A thin-walled scaffold includes a radiopaque marker connected to a link. In a first example, the marker is retained on the strut by a head at one or both ends by swaging. In a second example of a thin-walled scaffold the link is modified to avoid interference during crimping. In a third example a distal end of the thin-walled scaffold is modified to improve deliverability of the thin-walled scaffold. These features are combined in a fourth example.

Abstract: The present disclosure describes treatment of the vasculature of a patient with an expandable implant. The implant is constrained to a reduced delivery diameter for delivery within the vasculature by at least one sleeve. The implant can be constrained to other diameters, such as an intermediate diameter. The sleeves can be expanded, allowing for expansion of the diameter of the expandable implant, by disengaging a coupling member from the sleeve or sleeves from outside of the body of the patient. The expandable implant can comprise an apposition line or lines which facilitate bending of the expandable implant to improve conformation of the expandable implant to the vasculature of the patient.

Abstract: A medical device includes a polymer scaffold crimped to a catheter having an expansion balloon. A sheath is placed over the crimped scaffold after crimping to reduce recoil of the crimped polymer scaffold. The sheath is removed before the medical device is implanted within the body.

Abstract: The present invention provides systems and methods for deploying implantable devices within the body. The delivery and deployment systems include at least one catheter or an assembly of catheters for selectively positioning the lumens of the implant to within target vessels. Various deployment and attachment mechanisms are provided for selectively deploying the implants.

Abstract: Catheter apparatuses and methods are provided for repairing heart valves, particularly mitral valves. The method includes providing a catheter having an elongate, flexible body, with a proximal end and a distal end. The distal end can be transluminally advanced from the left atrium through the mitral valve and along the left ventricular outflow tract into the ascending aorta. A valve repair device is deployed to permanently connect leaflets at a mid-section of a mitral valve while permitting medial and lateral portions of the natural leaflets to open and close. The valve repair device detachably connects the distal and proximal ends of the catheter.

Abstract: Systems, devices, and methods for reducing regurgitation through an atrioventricular heart valve: i.e., the mitral valve and the tricuspid valve. The device includes a flexible anchor rail anchored in the tissue of the ventricle and an offset coaptation element on a catheter that rides over the anchor rail and is positionable between the valve leaflets. The proximal end of the coaptation catheter is fixed subcutaneously adjacent the subclavian vein. The coaptation element includes an inert covering over a foam interior, and is radially offset on the catheter so that the foam body projects away from the septal side of the valve to reduce or minimize deformation from contact with the septal wall of the ventricle. Markers on the coaptation element facilitate positioning in the desired rotational orientation during delivery and implant.

Abstract: Devices, systems, and methods for implanting prostheses in the body lumens rely on tacking or anchoring the prostheses with separately introduced fasteners. After initial placement, a fastener applier system is introduced within the expanded prostheses to deploy a plurality of fasteners to at least one prosthesis end. The fasteners are usually helical fasteners which are releasably restrained on the fastener driver, and are delivered by rotation of the fastener driver. The fasteners may be applied singly, typically in circumferentially spaced-apart patterns about the interior of at least one end of the prosthesis. A lumen extension or lumens may be coupled to the prosthesis to extend the reach of the prosthesis within the implantation site. Fasteners may also be applied to the lumen extensions.

Abstract: A device for intravascular intervention can comprise an intervention element and an elongate manipulation member. The elongate member can comprise a hooked portion extending about a proximal portion of the intervention element. The hooked portion can have a first segment, a second segment, and a bend between the first and second segments, with the first segment and the second segment located on different sides of the intervention element. At least one of the first segment or the second segment can have an extending portion that extends into a region that is (i) between a top side and a bottom side of the intervention element, and (ii) distal to a proximal part of the intervention element. The extending portion and the proximal part can be aligned such that a line extending in a proximal-distal direction intersects the extending portion and the proximal part.

Abstract: A stent and a securely-installed artificial valve replacement device having the same, the stent being of a cylindrical structure; the top of the stent is provided with a fixed ear (60); the fixed ear (60) has a neck portion (601) connected to the top of the stent, and a head portion (602) engaged with the fixed head of the stent; the head portion (602) has a bending structure for improving the overall radial thickness; and the artificial valve replacement device is comprised of a stent and a prosthetic valve fixed on the stent. The stent with a bending structure overcomes the problem of easily disengaging from the fixed head of the stent, while not affecting the release of the stent.

Abstract: The present invention relates to a deployment system (10) for deploying an expandable cardiac valve prosthesis. The deployment system comprises a first tube (11) being designed to carry an expandable cardiac valve prosthesis; further, a tip (13), being firmly connected to the first tube at a distal end of the first tube, wherein the tip is designed such, that it detachably accommodates and holds a proximal end (21) of a cardiac valve prosthesis (20); a sheath (15) designed to be disposed over and holding the prosthesis (20) in a compressed state, and a first actuating mechanism (16) being linked to the sheath (15) and being slidable in a proximal direction for stepwise retracting the sheath (15).

Abstract: A vascular intervention device delivery system, such as for implanting a stent, includes a thumbwheel rotatably mounted in a handle. A catheter has a proximal end attached to the handle, and a distal carrier segment for mounting a vascular intervention device thereon. A retractable sheath is movable from a first position covering the distal carrier segment to a second position retracted proximally uncovering the distal carrier segment. A pull extends between the thumbwheel and the retractable sheath. A latch is positioned in the handle and moveable from a locked position at which the latch engages the radially outward thumb surface, and an unlocked position at which the latch is out of contact with the thumbwheel. A pusher, which is partially positioned outside of the handle, is operable to move the latch from the locked position to the unlocked position. The retractable sheath moves responsive to rotation of the thumbwheel.

Abstract: The present invention relates to set comprising an apparatus (100) for folding or unfolding at least one medical implant (300) by means of at least one tension thread (11, 11?), wherein the apparatus (100) comprises a shaft (1) and a tensioning device for altering a form or shape of the foldable and/or unfoldable implant (300) by means of the tension thread (11, 11?). In at least one shaft section thereof, the shaft (1) comprises a plurality of individual shaft fibers (13).

Abstract: In one representative embodiment, a prosthetic valve assembly comprises a valve component comprising a radially compressible and expandable frame and a valve structure supported inside of the frame. The valve structure is configured to allow blood to flow through the valve component in one direction and block the flow of blood in the opposite direction. The assembly further comprises a radially compressible and expandable anchor comprising an annular base and a plurality of cantilevered fixation members extending from the base. The fixation members are configured to pivot inwardly toward the valve component when the valve component is radially expanded within the anchor.

Abstract: A delivery system for delivering an endovascular prosthesis is disclosed. A handle assembly is disposed at the distal end of the delivery system. The handle assembly includes a main handle and a second handle disposed at least partially on the main handle and longitudinally moveable relative to the main handle. A trigger wire release mechanism is disposed in the interior or the main handle. A sheath is operatively connected to the second handle, such that longitudinal movement of the second handle relative to the main handle retracts the sheath in a distal direction. Movement of the trigger wire release mechanism from a first position to a second deployed position is prevented when the sheath is in the first position. Methods for accessing the iliac arteries and deploying an endovascular prosthesis therein using the delivery system and handle assembly are also disclosed.

Abstract: Methods and devices are disclosed for passing Chronic Total Occlusion (CTO) from subintimal location and re-entry into a true-lumen of the patient using transient fenestration approach. The transient fenestration is induced by balloon dilatation within the CTO, and a guidewire quickly trails into a true lumen.

Abstract: Devices and methods for deploying an anastomotic stent between portions of the gastrointestinal (GI) tract are disclosed. The anastomotic stents are configured to atraumatically engage the tissue walls and to permit the flow of fluid, partially digested food, and food. The stents can be deployed using endoscopic catheter devices, laparoscopic tools, and combinations of both endoscopic tools and laparoscopic tools. Examples of anastomoses include anastomoses between the stomach and a portion of the intestines such as the jejunum. Anastomoses can also be formed between two closed ends of the intestines, such as two closed ends of the colon formed during a colon resection procedure. Anastomoses can also be formed between a fundal pouch formed during a gastric bypass procedure and the jejunum. Laparoscopic tools are disclosed to deploy a stent by selectively removing a radial restraint on a self expanding stent with the restraint removed through the laparoscopic access points.