Abstract: Low profile, self-expandable, blood flow restrictors include a hollow channel open at axial ends to allow blood flow through the restrictor installed in a blood vessel. The channel may include a mesh and have a narrowing, or sandglass, profile to reduce blood flow. The sandglass shape is in a central portion of the channel and may be surrounded by a blocking coating impermeable to blood flow or a suture that dissolves over time. The mesh may be formed of a memory alloy. Restrictors include a retrieval connector at an end that is permeable to blood flow and permits attachment for restrictor positioning with a catheter.

Abstract: Methods and devices useful, for example, in the field of angioplasty and stenting are disclosed. In some embodiments, the methods, devices and kits are configured for directional expansion inside a lumen, for example of a blood vessel obstructed by plaque. In some embodiments, the directional expansion displaces the plaque in a desired direction.

Abstract: A prosthetic mitral annuloplasty ring includes a wire, an adjustment member for changing a length of the wire and a jacketing annulus for adjusting a radial dimension of the mitral valve annuloplasty ring. The jacketing annulus is sleeved over the wire and forms, together with the adjustment member, a shape matching that of a native mitral valve annulus. After the prosthetic mitral annuloplasty ring is implanted by suturing in a conventional surgical procedure and the patient's heart starts to beat again, the adjustment member can be connected to the delivery device and the wire length therein can be adjusted by a rotating operation of the delivery device so that the mitral valve annuloplasty ring will be expanded or contracted until the prosthetic mitral annuloplasty ring perfectly fits the native mitral valve annulus in shape, effectively avoiding the problem of incomplete mitral leaflet coaptation.

Abstract: Embodiments disclosed herein are directed towards an endovascular clip comprising a proximal anchoring member and a distal self-expanding member. The proximal anchoring member and distal self-expanding member are configured to extend across opposite sides of a neck of an aneurysm.

Abstract: An example introducer is disclosed. An example introducer sheath includes a tubular member including a first layer and a second layer and a stent disposed between the first layer and the second layer of the tubular member. The stent includes an outer surface and an inner surface. Additionally, the stent is configured to shift from a first configuration to a second expanded configuration and the outer surface of the stent contacts the first layer of the tubular member in the second expanded configuration.

Abstract: A vascular intervention device delivery system, such as for implanting a self expanding stent, includes a thumbwheel rotatably mounted in a handle. The thumbwheel includes a radially outward facing thumb surface and a radially inward facing ratchet surface of a ratchet. 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 ratchet pawl is mounted in the handle and has a catch in contact with the ratchet surface. The ratchet holds the thumbwheel against rotation in a forward direction, and the retractable sheath moves responsive to rotation of the thumbwheel in a reverse direction.

Abstract: A percutaneous transseptal surgical implantation method for replacing a defective atrioventricular (AV) valve with a conical shaped prosthetic valve formed from extracellular matrix (ECM) tissue. When the method is employed to replace a native mitral valve, the method positions the prosthetic tissue valve in the mitral valve region, whereby the valve does not obstruct the outflow tract of the aortic valve and prevents the leaflets of the aortic valve from coapting.

Abstract: Systems for treating an aneurysm in a cerebral vessel and methods of use are described. In one embodiment, the system includes an elongate tubular member having a lumen, an expandable stent, and a delivery device. The expandable stent has a constrained state that is configured for delivery through the lumen of the elongate tubular member, and an expanded state configured for placement within the cerebral vessel adjacent the aneurysm. The delivery device includes an elongate member and a self-expandable portion. The proximal end of the self-expandable portion is coupled to the elongate member at or near the distal end of the elongate member. The self-expandable portion of the delivery device includes a tubular mesh structure having a constrained state and an expanded state. The stent is engaged (e.g., mechanical, frictional, or intermeshing) with the self-expandable portion of the delivery device.

Abstract: A percutaneous transseptal surgical implantation method for replacing a defective atrioventricular (AV) valve with a conical shaped prosthetic valve formed from a polymeric composition. When the method is employed to replace a native mitral valve, the method positions the prosthetic valve in the mitral valve region, whereby the valve does not obstruct the outflow tract of the aortic valve and prevents the leaflets of the aortic valve from coapting.

Abstract: Prosthetic heart valves described herein can be deployed using a transcatheter delivery system and technique to interface and anchor in cooperation with the anatomical structures of a native heart valve. Some embodiments of prosthetic mitral valves described herein include an anchor portion that couples the prosthetic mitral valve to the anatomy near the native mitral valve, and a valve portion that is mateable with the anchor portion.

Abstract: In some examples, a catheter defines a longitudinal axis and includes an inner member, a retaining member, and a support member. The inner member has an outer wall, and a portion of the inner member has a first stiffness. The retaining member defines a pocket configured to receive a connecting member of an expandable medical device. The retaining member has a second stiffness that is different from the first stiffness. The support member extends distally from the retaining member. In some examples, the support member is configured to be received radially within the expandable medical device when the connecting member is received within the pocket. The support member is configured to provide a gradual transition between the first stiffness of the inner member and the second stiffness of the retaining member.

Abstract: An endoluminal stent and associated methods for placing the endoluminal stent in a lumen of a trachea of a patient. The stent includes an elongate framework having a first open end, a second open end opposite the first open end, and a lumen extending from the first open end to the second open end. The elongate framework includes a first edge extending from the first open end to the second open end, a second edge extending from the first open end to the second open end, and an opening between the first edge and the second edge extending from the first open end to the second open end such that the stent has a C-shaped cross-section. The stent may be implanted in a trachea with the opening positioned along a posterior wall of the trachea adjacent the trachealis muscle.

Abstract: A delivery device 1010 for a collapsible prosthetic heart valve 200, the delivery device including an inner shaft 1026, a distal sheath 1024 disposed about a portion of the inner shaft and forming a compartment 1023 with the inner shaft, the compartment being adapted to receive the prosthetic heart valve, the inner shaft and the distal sheath being movable relative to one another, and a handle 1020 including a frame 1030 having a longitudinal axis, a proximal end and a distal end, the handle further including a deployment actuator 1021 and a hub 1100, each of the deployment actuator and the hub being independently capable of opening and closing the compartment, the hub further including a hub actuator 1600 coupled to the inner shaft.

Abstract: A system for implanting a prosthesis includes a control lumen and a nose cone affixed at a distal end of the control lumen. At least one supporting wire is affixed at one end, is substantially parallel to a major axis of the control lumen and is free at an opposite end, wherein the free end of at least one of the supporting wires is arcuate.

Abstract: A sheath of a delivery system is retracted by winding in cords coupled to the sheath. More particularly, a helical reel is rotated to wind the cords into a helical cord groove and retract the sheath. Rotation of the helical reel simultaneously causes a cord feed ring to slide ensuring that that the cords are correctly fed into the helical cord groove through cord feedthrough apertures of the cord feed ring. Initially, due to a minimal diameter of the helical cord groove, the cords are retracted slowly and with a high amount of torque, e.g., a high mechanical advantage. After retraction of the sheath has begun, the speed of retraction of the sheath is increased with reduced torque as the cords are wound around the increasing diameter of the helical cord groove.

Abstract: The present disclosure relates to stents and methods of delivering and deploying the same. The stents include fasteners about their periphery and when the stent is radially compressed, the fasteners come into alignment such that a device may be placed through openings in the fasteners to hold the stent in the radially compressed configuration. When the device is removed from the openings, the stent may expand.

Abstract: The disclosure relates to transcatheter stented prosthesis delivery devices including transition elements that route, constrain, support and reduce damage to tension member wear as tension in the tension members is varied to adjust the compression of a stented prosthesis loaded onto the delivery device. Various disclosed tension elements include inserts, edge treatments and guides proximate a distal portion of the delivery device upon which the stented prosthesis is loaded. In some embodiments, the transition feature is positioned proximate a location where at least one tension member transitions from a first orientation that is not parallel to the distal portion to a second orientation that is generally parallel to the distal portion. Further embodiments disclose configurations and methods of selectively locking and unlocking a longitudinal and/or rotational position of the stent frame with respect to the distal portion of the delivery device.

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: Apparatus and methods are described herein for use in the transvascular delivery and deployment of a prosthetic mitral valve. In some embodiments, a method includes inverting an outer frame of a prosthetic mitral valve when the valve is in a biased expanded configuration. After inverting the outer frame, the prosthetic mitral valve is inserted into a lumen of a delivery sheath such that the mitral valve is moved to a collapsed configuration. The distal end portion of the delivery sheath is inserted into a left atrium of a heart. The prosthetic mitral valve is moved distally out of the delivery sheath such that the inverted outer frame reverts and the prosthetic mitral valve assumes its biased expanded configuration. In some embodiments, actuation wires are used to assist in the reversion of the outer frame. The prosthetic mitral valve is then positioned within a mitral annulus of the heart.

Abstract: A medical device with an expandable element and slidable constraint of at least two portions surrounding the expandable element which slides away from the middle region and toward the distal and proximal ends of the expandable element upon expansion of the expandable element to influence the rate, shape and/or force required to expand the expandable element and methods for use in a body lumen are provided.

Abstract: Some implementations of an endovascular device include a stent graft with an expandable tubular metallic frame and a covering material disposed on at least a portion of the metallic frame. The stent graft defines a lumen therethrough. In a particular embodiment, a first balloon is disposed around an outer periphery of the stent graft, a second balloon is disposed around the outer periphery of the stent graft and spaced apart from the first balloon, and a third balloon is disposed within the stent graft lumen between the first balloon and the second balloon. The third balloon can be inflated to fully or partially occlude the lumen. The first and second balloons can be individually inflated to fully or partially shunt blood flow from a blood vessel through the stent graft. In some embodiments, sensors and an automated control unit are included to automate the operations of the endovascular device.

Abstract: A branched and fenestrated prosthesis may include a main tubular graft body including a proximal end opening, a distal end opening, a lumen, and a sidewall. A branch may extend from the sidewall and may include a first end opening, a second end opening, and a lumen. A fenestration may be disposed in the sidewall and positioned distal of the second end opening of the branch. The branched and fenestrated prosthesis may include a plurality of branches and a plurality of fenestrations.

Abstract: A stent for transluminal implantation comprises a first, second and third stent section for splinting and/or keeping open a hollow organ which are connected to each other via elastic tubular sections. The stent combines at least three different stent designs in one stent and can therefore be adjusted to the motion behavior of a hollow organ in an improved fashion.

Abstract: The present disclosure is directed to a branched endoprosthesis comprising a graft component and at least one support component. In various embodiments, the branched endoprosthesis comprises a body portion and a plurality of leg portions, wherein the legs are in an aligned configuration for ease of cannulation. In various embodiments, at least one leg is in an open configuration for ease of cannulation. Cannulation methods are also described.

Abstract: A medical device includes a catheter, an expandable balloon on the distal portion of the catheter, and a sheath that is configured to enclose and protect the expandable balloon. The sheath extends within a sheath lumen of the catheter and out from the catheter through a distal opening of the sheath lumen. When in a deployed configuration, the sheath extends proximally to enclose at least a portion of the expandable balloon. The sheath may be axially movable within the sheath lumen of the catheter to actuate from the deployed configuration to a retracted configuration. In moving to the retracted configuration, the sheath may expose the outer surface of the expandable balloon.

Abstract: A delivery device for a collapsible prosthetic heart valve may include a catheter assembly and an operating handle. The catheter assembly may include an inner shaft around which a compartment is defined, and a distal sheath having proximal and distal segments configured to enclose the compartment. The operating handle may include a first lead screw fixedly coupled to the proximal segment, a second lead screw coupled to the distal segment, a knob rotatable relative to a housing of the operating handle and threadedly engaged with the first lead screw, and a coupling assembly. The coupling assembly may have a first condition in which rotation of the knob in one direction moves the first lead screw but not the second lead screw, and a second condition in which rotation of the knob in the one direction simultaneously moves the first lead screw and the second lead screw.

Abstract: A delivery device may generally include a support member, a distal sheath, an outer shaft and a straightening member. The support member is adapted to hold a prosthetic heart valve. The distal sheath is slidable relative to the support member between a first position in which the distal sheath is adapted to maintain the prosthetic heart valve in a collapsed condition, and a second position in which the distal sheath is adapted to expose the prosthetic heart valve. The outer shaft is connected to the distal sheath and has a curved portion. The straightening member is slidable on the outer shaft between a proximal position in which the straightening member does not cover the curved portion of the outer shaft, and a distal position in which the straightening member covers and substantially straightens at least a portion of the curved portion of the outer shaft.

Abstract: An apparatus may be used after a surgical procedure to protect against leaks and to separate healing tissue from foreign materials such as nutritional contents. In some cases the apparatus may be easily delivered to a surgical site before, during or after a surgical procedure such as gastric bypass surgery, but this is only an example. The apparatus may include expandable anchors at either end and a collapsible central portion extending between the two expandable anchors.

Abstract: A stent device delivery system and method of making. The stent device delivery system includes a stent device, an outer sheath overlaying the stent device in a radially compact, delivery configuration of the stent device, and an inner catheter extending axially and radially within a lumen of the stent device. The inner catheter provides a stent bed upon which the stent device is located so that a radially inner surface of the stent device engages a radially outer surface of the stent bed. The stent bed may define an inwardly tapering profile, narrowing in radius from a distal portion of the stent device to a proximal portion of the stent device.

Abstract: A stent placement assembly is disclosed.

Abstract: The present invention provides an anti-fracture sheath. The anti-fracture sheath comprises a tube body and an expansion section for accommodating an implantable device, wherein one side of the distal end of the tube body is joined with the expansion section, at least two reinforcing ribs are axially arranged on the tube wall of the expansion section in an internally extending manner, and the proximal ends of the reinforcing ribs extend from the expansion section and are fixedly connected with the tube wall of the tube body; and the materials of the reinforcing ribs are Kevlar fibers, the diameter of each reinforcing rib is from 0.03 mm to 0.12 mm, and the number of the reinforcing ribs is from two to four. The anti-fracture sheath provided by the present invention has the advantage that the strength of the expansion section is improved when the whole compliance of the sheath is maintained, thereby avoiding fracture of the sheath in an implantable device releasing process.

Abstract: [Subjects] To provide a biliary tract drainage tube in which both an external drainage tube and an internal drainage tube can be installed in a single endoscopic procedure. [Method to Solve] A biliary tract drainage tube used to drain a biliary tract is provided with long external drainage tube 2 and internal drainage tube 3 that is provided on the tip of the external drainage tube so as to be separable from the external drainage tube. Both external drainage tube 2 and internal drainage tube 3 are placed in biliary tract Cd. Since internal drainage tube 3 can be left behind in the biliary tract by removing external drainage tube 2, another endoscopic procedure is not required when switching from external drainage tube 2 to internal drainage tube 3, and the burden placed on the patient can be lessened.

Abstract: A delivery system that includes a catheter, a balloon, a self-expanding prosthesis, and a sheath. The sheath including an opening in a wall of the sheath that initiates rupturing of the sheath so that the self-expanding prosthesis may move from its compressed state to its expanded state. Additionally, a distal end portion of the balloon that is distal to a distal end of the sheath includes an enlarged diameter portion, the enlarged diameter portion having approximately the same outer diameter as an outer diameter of the sheath when the self-expanding prosthesis is in its compressed state, and the enlarged diameter portion being the maximum outer diameter of the balloon when the self-expanding prosthesis is in its compressed state.

Abstract: In some embodiments, a method for delivery and deployment of a prosthetic mitral valve into a heart includes inserting an introducer sheath having a prosthetic mitral valve disposed therein in a collapsed configuration into the left atrium of a patient's heart, through a gap between the native mitral valve leaflets, the left ventricle and apex of the heart. An epicardial pad device coupled to the prosthetic valve via a tether is moved distally out of the sheath. The introducer sheath is withdrawn into the left atrium of the heart. An inner delivery sheath is extended distally from within the introducer sheath and disposed within the left atrium. The prosthetic mitral valve is moved distally out of the inner delivery sheath and assumes a biased expanded configuration. The valve is positioned within the mitral annulus of the heart, and secured in place via the tether and epicardial pad device.

Abstract: A release device for releasing a medical implant from an insertion device, in which the implant can be released by a relative movement between a first and a second insertion element, wherein the insertion device has a proximal end, which faces the user during use, and a distal end, which is distanced from the user during use. Between the proximal and the distal end, a shortening region is provided, in which, when generating a targeted relative movement between the first and the second insertion element of the insertion device, a length of at least one of the insertion elements between the proximal end and the distal end can be shortened.

Abstract: An improved medical device reduces the loss of longitudinal length during expansion of a stent-graft from a compressed state to an expanded state. For example, the stent-graft is placed over a cover that provides resistance to expansion of the balloon during inflation, which reduces longitudinal compressing forces exerted on the stent-graft.

Abstract: A self-expanding element delivery apparatus includes a catheter having an inner lumen, a self-expanding element, and a delivery wire disposed within and extending through the inner lumen and the self-expanding element. The self-expanding element has a proximal, distal, and an intermediate portion. The element has anchor members, a compressed configuration fitting within the inner lumen, and an expanded configuration dimensioned larger than the catheter. The delivery wire also has proximal and distal portions, an intermediate portion, a dual function bump member disposed approximate to the intermediate portion, and a pusher bump member disposed approximate to the proximal portion of the delivery wire. A bump member distance between the dual function bump member and the pusher bump member is such that so that only one of the dual function bump member and the pusher bump member can contact one of the anchor members.

Abstract: Methods and apparatus for treating bones, including, in one or more embodiments, methods and apparatus for treatment of vertebral fractures that include a containment assembly for cement containment and/or a balloon assembly for maintaining vertebral height. A containment assembly comprising a containment jacket adapted to be deployed inside bone; and a dividing wall that separates the interior of the containment jacket into a proximal region and a distal region, the dividing wall having an opening for providing access to the distal region from the proximal region.

Abstract: A medical device, for insertion into an anatomical vessel, can include a sheath, a delivery wire, and a frame or vessel-engaging member. The delivery wire can have a first stop, a second stop, and a coupling area between the first and second stops. The coupling area can be disposed within and movable relative to the sheath. The frame or vessel-engaging member can have a matrix of cells, first and second tapered sections, and interlocking members. The interlocking members can be attached to the tapered sections. The interlocking members can be releasably coupled to the delivery wire at the coupling area with the interlocking members surrounded and held in the coupling area by the sheath. The interlocking members can be movable relative to the sheath, and the interlocking members can separate from each other when the interlocking members are positioned distal to the sheath.

Abstract: A delivery device for delivering a stent device that is expandable from a radially reduced, delivery configuration to a radially expanded, deployed configuration. A retaining sheath is disposed over the stent device for maintaining the stent device in the delivery configuration. A pull line to be pulled upon is provided to retract the retaining sheath in a rolling manner such that the retaining sheath is folded back on itself to provide a radially inner sheath of the retaining sheath, a radially outer sheath of the retaining sheath and a fold portion therebetween. The retaining sheath may be made of a cold drawn plastic at least along the path of travel of the fold portion in retracting the retaining sheath from over the stent device.

Abstract: A vascular graft suitable for implantation, and more particular to a vascular graft having an expandable outflow region for restoring patency of the graft after implantation into a body lumen.

Abstract: The present embodiments provide prosthesis deployment systems. In one embodiment, a sleeve has proximal and distal regions and a lumen extending therebetween, and further comprising a first exit aperture, a first entrance aperture, and a second exit aperture. A trigger wire is disposed at least partially within the lumen of the sleeve. A prosthesis has a delivery state and an expanded state, and further has first and second regions. In the delivery state, the trigger wire extends out of the lumen through the first exit aperture of the sleeve, restrains the first region of the prosthesis, reenters the lumen through the first entrance aperture of the sleeve, extends out of the lumen through the second exit aperture of the sleeve, and restrains the second region of the prosthesis.

Abstract: An object of the present invention is to provide a medical tubular body that is excellent in visibility under X-ray fluoroscopic control, insertion property into a catheter and sliding property in a catheter, that suppresses contact of a marker with a tubular body or an adjacent marker in a diameter reduction state, and that is able to further reduce its diameter. The present invention provides a medical tubular body 100 comprising a tubular body whose diameter is expandable and a marker 121 provided inside the tubular body.

Abstract: A delivery system for transcatheter implantation of a heart valve prosthesis. The delivery system includes an outer sheath component defining a lumen therethrough, an elongate tube having at least two flat wires longitudinally extending from a distal end thereof, and self-expanding first and second frames disposed in series within a distal portion of the outer sheath component and held in a compressed delivery configuration therein. The elongate tube and the at least two flat wires are slidably disposed within the lumen of the outer sheath component. In the compressed delivery configuration the at least two flat wires longitudinally extend along exterior portions of the first and second frames and are woven through adjacent ends of the first and second frames to releasably couple them to each other. Proximal retraction of the at least two flat wires from the first and second frames releases at least the first frame from the delivery system.

Abstract: A delivery system and method for delivering a prosthetic heart valve to the aortic valve annulus via a transaortic approach. The system includes a balloon catheter for delivering a balloon-expandable prosthetic heart valve through an introducer from an approach from outside the patient, through a minimally-invasive opening in the chest cavity through an incision in the aorta, and into the aorta and aortic annulus. The balloon catheter includes a flexible, tapered tip just distal of the balloon to facilitate positioning of the prosthetic heart valve in the proper orientation within the aortic annulus. The prosthetic heart valve may be installed over the existing calcified leaflets, and a pre-dilation valvuloplasty procedure may also be utilized.

Abstract: A lubricated tubular graft is implanted in the inferior vena cava and the superior vena cava in order to control the inflow of blood to the right atrium. A bifurcated leg with a non-collapsing stent extends across the tricuspid valve. A bioprosthetic valve is positioned proximal of the stent in the bifurcated leg in order to regulate flow through the tricuspid valve and to eliminate tricuspid regurgitation.

Abstract: Methods for delivering and deploying an endovascular graft to the common and internal iliac arteries are described. A system including a pre-loaded delivery device with a releasably attached extension cannula and an extension sheath for use with such methods is also described.

Abstract: A prosthesis including a self-expanding stent, a graft body, and one or more sleeves is disclosed, in addition to methods of treatment using the prosthesis. The proximal and distal ends of the prosthesis may include one or more sleeves and one or more barbs. The sleeves may be removable or dissolvable, for example, upon exposure to an activating agent. The prosthesis may be used to treat lacerated vessels and transected vessels.

Abstract: A sheath is placed over a crimped scaffold to reduce recoil of the crimped polymer scaffold and maintain scaffold-balloon engagement relied on to hold the scaffold to the balloon when the scaffold is being delivered to a target in a body. The sheath has an opening spanning the length of the sheath. The opening spans an arc length of about 90 degrees with respect to the circumference of the scaffold or balloon. The sheath may be removed from the scaffold by pinching the sheath between a thumb and forefinger, or bending or peeling back the sheath from the edges of the opening using fingertips.

Abstract: Devices, methods and systems are provided for occluding an opening within the tissue of a body, such as a left atrial appendage. In one embodiment, a medical device includes an anchor portion and an occluder portion. The anchor portion includes frame segments, each anchor frame segment extending between a first end and a second end such that the second end of each anchor frame segment is coupled to an anchor hub. The occluder portion includes a hub that defines an axis. The occluder portion includes multiple occluder frame segments that extend between a proximal end and a distal end such that the proximal end of the occluder frame segments are pivotably coupled to the hub and the distal end of the occluder frame segments are pivotably coupled to the first end of the anchor frame segments.