Abstract: An implantable prosthesis, including a generally tubular substrate and a continuous shape memory member disposed over the outer surface of the substrate. The shape memory member may include a series of zig-zag struts alternating between a first strut with a first length and a second strut with a second length different from the first length. A graft member may be positioned over the substrate and shape memory member.

Abstract: A medical device includes a polymer scaffold crimped to a catheter having an expansion balloon. A single piece sheath is placed over the scaffold immediately following crimping of the scaffold to the balloon. The single piece sheath is replaced by a two-piece sheath, which is removed prior to performing a medical procedure using the medical device.

Abstract: A method of delivering a embolic protection unit to the aorta arch of a patient. The method comprising, introducing a catheter from brachiocephalic artery or through an incision in a wall of the ascending aorta, the catheter comprising an embolic protection unit having an off-center connection point. Advancing the embolic protection unit in a downstream direction from the catheter. Expanding the embolic protection unit in the aorta arch to cover said ostia. Delivering a medical device into the ascending aorta while the embolic protection unit is hold by the catheter covering the ostia.

Abstract: Hydrogel jacketed stents provide the ability to fill in the stent frame in vivo to at least partially cover the interior of the surface of the stent following deployment while having the convenience of attaching the jacket to the exterior of the stent. The hydrogel can be pleated and/or folder over the exterior of the stent to provide for extension of the stent without damaging the hydrogel. The hydrogel sheet can be secured at one or more points along the circumference to associate the sheet of hydrogel with the exterior surface of the stent frame. The stent can be conveniently delivered using similar technology as conventional stents if desired. The hydrogel can provide for drug delivery if desired.

Abstract: An implantable medical device is disclosed having a helical construct including a set of spiral coils for local in vivo application of a therapeutic substance in a biological lumen. The helical construct is configured to apply less than 0.75 Bar of pressure to the biological lumen wall. The helical construct can have at least two sets of spiral coils having opposing helical directions. The device can be used for the treatment of vascular disorders such as restenosis and vulnerable plaque.

Abstract: An inflatable bone tamp for performing a minimally invasive surgical procedure includes a shaft having a primary region and a reduced diameter region, and an inflatable structure surrounding at least a portion of the reduced diameter region. The reduced diameter region of the shaft allows the deflated size of the inflatable structure to be minimized, while at the same time eliminating the need for the conventional dual lumen balloon catheter construction.

Abstract: Methods for delivering a vascular prosthesis to a treatment site of a subject include advancing the vascular prosthesis, rotating a proximal handle in a first direction about a handle body, shifting the position of a first locking component securing the proximal handle to the push rod from a first position to a second position, rotating the proximal handle in a second direction, releasing the proximal end of the prosthesis from the apex delivery device, shifting the second locking component to disengage the push rod from the handle body; and withdrawing the push rod and the guidewire catheter from within the prosthesis, thereby delivering the vascular prosthesis to the treatment site.

Abstract: The invention relates to a system for dilatation of a body passage and delivery of a stent into the body passage of a patient, and related methods of using such a system. The dilatation and stent delivery system may comprise a dilatation catheter having an expandable member on a distal end, and a stent delivery catheter configured to retain a stent and deliver the stent to a body passage. The stent delivery catheter defines a lumen sized to receive the dilatation catheter and permit movement of the dilatation catheter relative to the stent delivery catheter.

Abstract: An apparatus for deploying and retrieving a self-expanding intravascular stent includes an intravascular delivery wire and floating marker band movably retained over the intravascular stent delivery wire and releasably mounting the self-expanding intravascular stent. The floating marker band is movably retained to a fixed marker band, and a distance between the fixed marker band and the floating marker band is variable and self-adjusting. One or more struts of the self-expanding intravascular stent are releasably constrained between a catheter wall and one or more sides of the floating marker band.

Abstract: A medical electrical lead body having an outer surface and including at least one lumen having an inner surface treated with a silane surface modifying agent to form a three-dimensional, densely cross-linked lubricious coating over at least a portion of the inner surface of the lumen. The outer surface of the lead body also may be similarly treated. The lubricious silane coating may reduce the coefficient of friction of the coated surface of the lead body by as much as 80% when compared to an uncoated surface. A reduction in the coefficient of friction may enhance the stringing efficiency of a conductor through the lead body lumen and may enhance its abrasion resistance.

Abstract: A medical stent mold includes a tube having an interior passage sized and dimensioned to receive a stent assembly disposed at least partially about a central portion of a stent balloon. The medical stent mold may also include a housing forming a chamber through which the tube extends. The tube may include a thermally conductive material and may have a body portion that extends within the chamber and an end portion that is proximate the body portion and that extends away from the housing. An inner diameter of the end portion of the tube is greater than an inner diameter of the body portion of the tube. Forced convection may be used to quickly heat and cool the tube. Methods of increasing retention of an expandable stent assembly on a stent balloon and of detecting a leak in a stent balloon are also included.

Abstract: A delivery system for delivery of a radially expandable device to an implantation site in a patient, the delivery system including an elongated tubular member comprising a distal tip and an outer surface, first and second balloon portions spaced proximally from each other and the distal tip along a length of the tubular member, an annular space between the first and second balloon portions, a plurality of clip deployment tubes extendably moveable relative to the outer surface of the tubular member, and a plurality of clips, wherein each clip is moveable within a length of one of the clip deployment tubes between a retracted position and a deployed position.

Abstract: The disclosure of the present application provides devices, systems, and methods for the prevention of stroke. In at least one embodiment of a device of the present application, the device comprises an extension portion sized and shaped to fit within an artery extending from an aortic arch, and a flange portion sized and shaped to prevent the device from advancing into the artery extending from the aortic arch in which the device may be positioned. In at least one embodiment of a system for preventing stroke of the present application, the system comprises a hypotube, a folder coupled to a distal end of the hypotube, a sleeve positioned circumferentially around the hypotube proximal to the folder, and a stent, wherein a first part of the stent may be positioned within the folder, and wherein a second part of the stent may be positioned within the sleeve.

Abstract: In one embodiment of the present invention there is provided a method of filtering blood flow in a lumen by positioning an open loop filter support structure within a lumen; maintaining a position of the open loop filter support structure within the lumen using radial force generated by the open loop filter support structure; and filtering blood flow in the lumen using a filter supported by the open loop filter support structure. In one aspect, there is also applying radial force generated by the open loop filter support structure along the axial dimension of the lumen.

Abstract: A device for reshaping the tricuspid valve comprises a stent that is deployed in the right ventricular outflow tract (RVOT) adjacent to the tricuspid valve and expanded to a size sufficient to reduce the annular diameter or size of the tricuspid valve, thereby improving coaptation of the leaflets and reducing regurgitation. Embodiments of the device are deliverable percutaneously.

Abstract: A catheter system for treating lesions is provided. The system is suitable for treatment of bifurcation lesions, has a low profile and provides substantially predictable translational and rotational positioning. In one embodiment, the system includes a fixed wire balloon catheter and a partially attached guidewire lumen, wherein the guidewire lumen is attached to the catheter at a crotch point. The location of the crotch point is predetermined so as to provide substantially predictable positioning. Several embodiments of the system are described for various types of lesions and vessel configurations.

Abstract: The present invention provides for treatment of ostial occlusions through placement of scaffold in a side-branch adjacent the ostium.

Abstract: According to one aspect of the present disclosure, a method and technique for manufacturing a stent are disclosed. The stent is a non-metallic stent having a furled small-diameter state and an expanded large-diameter state where the stent, in the furled small-diameter state, includes a plurality of central lobes arranged at spaced-apart intervals and extending longitudinally defining a stent axis, the plurality of central lobes defining a cylindrical plane of the stent. The stent also includes at least one peripheral lobe formed on at least one of the plurality of central lobes, the peripheral lobe oriented along the cylindrical plane.

Abstract: Described herein is a unique sutureless heart valve that includes a deployment mechanism having a plurality of fasteners. The plurality of fasteners may be actuated at least two states: a disengaged state wherein said plurality of fasteners are retracted, and an engaged state wherein said plurality of fasteners are extended; and further comprising a deployed state wherein said plurality of fasteners, when extended, are irreversibly locked such that said heart valve is securely deployed at the target surgical site. The valve deployment mechanism comprises a ring assembly comprising a first annular member onto which said plurality of fasteners are associated and a second annular member peripheral to said first annular member and comprising a series of windows through which individual fasteners of said plurality of fasteners project.

Abstract: Among the various embodiments, objects and features of the present invention may generally be noted an inflation/deflation syringe that enables one-handed operation to inflate a medical device to a given pressure or volume and one-handed operation to deflate said medical device.

Abstract: An intraluminal apparatus including a catheter and device is positionable at a junction of afferent and efferent vessels of a bifurcation having an aneurysm. After positioning the device to substantially conform the device to the shape of the junction, the device acts as a scaffolding to inhibit herniation of objects out of the aneurysm and the device permits perfusion to the efferent vessels. Positioning the device may include deployment and optional release from a catheter. Embolic material may be inserted in the aneurysm before or after positioning the device. The device may have a proximal end, a distal end, and a plurality of filaments extending between and coupled at the proximal end and the distal end. The device may include a central filament configured to reshape the device. The distal end of the device may include a covering. The device may be football shaped, pumpkin shaped, or acorn shaped.

Abstract: In various embodiments, a catheter pump is disclosed herein. The catheter pump can include an elongated catheter body having a distal portion including an expandable cannula having an inlet and an outlet. The expandable cannula can have a delivery profile and an operational profile larger than the delivery profile. An impeller assembly can include an impeller shaft, and an impeller body can include one or more blades. The impeller blades can draw blood into the cannula when rotated. Further, an expandable support can have a mounting portion disposed on the impeller shaft distal of the impeller body and a cannula contact portion for reducing a change in tip gap due to bending of the cannula. The cannula contact portion can be disposed distal of the mounting portion.

Abstract: A device (1) includes at least an inflatable balloon (2), an implantable port (2A), and a conduit (3) intended for connecting the balloon (2) and the implantable port in a sealed manner. The balloon (2), the port (2A), and the conduit (3) are filled with a gas, and the pressure is such that the balloon (1) is normally inflated but is capable of being compressed during systole. A catheter (5) slidingly carries the balloon (2) in a deflated condition. At least one anchoring member (6) is connected to an actuating wire (7) which is slidable in the catheter independently of the balloon (2). The conduit (3) and said actuating wire (7) are connected to the catheter (5) to either prevent or allow sliding of this conduit and of this actuating wire relative to the catheter (5).

Abstract: A blood filter delivery system for delivering a blood filter into a vein includes a push rod for pushing the blood filter through and out of a catheter, the push rod having a filter positioning assembly on one end. The filter positioning assembly includes positioner members, which retain anchor members of the filter. The filter positioning assembly can position the end of the delivery catheter near the blood vessel centerline before releasing the filter's anchor members, thereby helping to align the blood filter along the centerline of the blood vessel.

Abstract: Porous regions are formed using selected additive manufacturing techniques. The porous regions can assist in fibro-inductive regions and/or osteo-inductive regions. A prosthetic member can be formed completely with the additive manufacturing technique and/or the additive manufacturing techniques can be used to form an augment portion that is added to the prosthetic member formed separately.

Abstract: The present invention refers to medical devices comprising a non-metallic micro tube containing FRP (fiber reinforced polymer), especially to respective tubings, used for constructing catheters like balloon dilation catheters, stent delivery catheters, guiding catheters and diagnostic catheters.

Abstract: Methods of treating congenital heart defects in infants and children with bioabsorbable polymer stents are described. The treatments reduce or eliminate the adverse affects of congenital heart defects or may be palliative.

Abstract: A surgical instrument for treatment of superficial varicose veins in a body is provided. The surgical instrument includes at least one vein-engaging element disposed within or on a housing being adapted for insertion into a tissue. The at least one vein-engaging element is operable to a vein-engaging state whereby it protrudes from the housing at a length thereof.

Abstract: A visceral double-barreled main body stent graft and methods for its use, the stent graft comprises, a main body stent graft having distal and proximal ends, the main body stent graft's length ranges from about 100-120 mm and diameter at the proximal end ranges from about 30-45 mm, first and second lumens defined at the main body stent graft's distal end, the first lumen's diameter ranges from about 18-20 mm, the second lumen's diameter ranges from about 16-18 mm, the first and second lumens have about the same length from about 50-70 mm, the first lumen is secured to the second lumen along a shared length, and the main body stent graft defines a tubular wall that is contiguous with the first and second lumens such that any fluid entering the main body must exit through one of the first or second lumens.

Abstract: A device, system, and method for providing access to, and sealing of, a body organ includes an implant device. An implant device has a main body having an internal access lumen, with a plurality of prongs extending from a distal end of the main body. The main body can include two lumens, one slidable within the other, to form a single continuous lumen with an adjustable length. The main body has an expanded configuration with an expanded diameter, and an unexpanded configuration with an unexpanded diameter. The prongs have a generally straight configuration where they extend distally of the distal end of the main body, and a bent configuration where the prongs bend around so that their tips extend proximally of the distal end of the main body. The device may include a hemostatic barrier to prevent fluid leakage therethrough when the main body is in the unexpanded configuration.

Abstract: The present invention provides an aortic valvuloplasty catheter which, in one preferred embodiment, has a tapered distal balloon segment that anchors within the left ventricle outflow track of the patient's heart and a rounded proximal segment which conforms to the aortic sinuses forcing the valve leaflets open. In addition, this embodiment of the valvuloplasty catheter includes a fiber-based balloon membrane, a distal pigtail end hole catheter tip, and a catheter sheath.

Abstract: A medical implantable occlusion device (100, 200) is disclosed including a fabric of at least one thread (101) and a structural formation (102) thereof having a collapsed and an expanded shape, the formation including a proximal and a distal portion (103, 104), a longitudinal axis (105) extending between the proximal and distal portion, wherein at least one of the proximal and distal portions including a peripheral edge (107, 108) having a first (109, 109?) and a second (110, 110?) radius of curvature in a direction substantially perpendicular to the longitudinal axis, wherein the first radius of curvature is different from the second radius of curvature.

Abstract: A system for sealing a large penetration in the wall of a femoral artery comprises an occlusion catheter and an applicator. An access catheter may further be provided in order to facilitate introduction of the occlusion catheter. The occlusion catheter is introduced through a contralateral penetration, advanced over the aortic bifurcation, and an occlusion element on the occlusion catheter is positioned at the large diameter penetration. The occlusion element is then inflated to temporarily seal the large penetration while blood perfusion past the occlusion element is provided by the catheter. A sealing material, such as a tissue adhesive or other hemostatic agent is then introduced into a tissue tract above the large diameter penetration in order to seal the penetration. The occlusion element may be left in place while the sealing material has time to set, cure or otherwise form a permanent seal of the large penetration. The occlusion catheter and all access sheaths may then be removed from the patient.

Abstract: Ends of an outer spiral and an inner spiral of similar dimensions but wound in opposite directions are joined to form a double spiral stent which may be covered to make it a stent graft. The dimensions are related by the formula of C=(Lw?Ls)/N where C is circumference of the spiral, Lw the length of the wire, N the number of turns and Ls the length of the spiral. Thus when length of spiral (Ls) is increased and decreased by compression and stretching, circumference (C) inversely varies with Ls, as N and Lw do not change. Ls and thus C are controlled by a control wire in a control tube attached to the ends of the double spiral being changed either by screwing male threads on the control wire into and out of female threads in the control tube.

Abstract: A cutting device for repairing a heart valve may include a delivery catheter, a cutting unit including an elongate shaft and a plurality of cutting wires, and a plurality of centralizing wires configured to center the cutting unit within a treatment site. A method of repairing a heart valve may include withdrawing a cutting unit through a treatment site while maintaining a plurality centralizing wires in an expanded centering configuration.

Abstract: A method for positioning a centering introducer in a heart of a patient, which includes the steps of inserting an anchoring wire delivery catheter through a heart wall and to a treatment region of the heart, deploying at least one anchoring wire from the delivery catheter and into tissue in the treatment region of the heart, and removing the delivery catheter from the heart. A centering introducer can then be advanced along the anchoring wire to the treatment region, wherein the centering introducer includes an introducer element and at least one balloon. At least one of the balloons can then be inflated to reorient the introducer element in at least one direction relative to a longitudinal axis of the centering introducer.

Abstract: A catheter for subintimally bypassing an occlusion in a vessel includes a catheter shaft including a guidewire lumen disposed therethrough and having a shaft longitudinal axis, at least two balloons coupled to an exterior of the catheter shaft such that longitudinal axes of the balloons are in a common plane with the shaft longitudinal axis when uninflated and with no external forces on the catheter. The balloons are configured such that when the catheter is disposed in the subintima of a vessel and the balloons are inflated, a tip of the catheter shaft is oriented towards a true lumen of the vessel distal of the occlusion.

Abstract: A drug eluting stent can include a stent body having a polymeric coating with a lipophilic and/or hydrophilic element. A drug that has a bioactivity that inhibits cell proliferation can be disposed in the polymeric coating. The drug can be present in the polymer at an amount greater than or equal to about 150 ?g/cm2. The polymeric coating and drug are configured to cooperate so as to form a diffusion pathway with tissue when the stent is disposed in a body lumen such that the drug preferentially diffuses into the tissue over a body fluid passing through the body lumen such that a maximum systemic blood concentration of the drug is less than about 40 ng/ml.

Abstract: Various embodiments of stents with radiopaque markers arranged in patterns are described herein.

Abstract: A clot retrieval apparatus 1 comprises a clot engaging device 2 and a capture basket 3. The clot engaging device 2 has a collapsed delivery configuration and an expanded deployment configuration. The clot engaging device has a proximal end and a distal end and an elongate body between the proximal end and the distal end. The capture basket 3 has a collapsed delivery configuration and an expanded deployment configuration. The capture basket 3 has a proximal mouth which is open when the capture basket 3 is in the deployment configuration. The clot engaging device 2 is axially movable relative to the capture basket for capture of a clot.

Abstract: A surgical system including an expandable device is provided, including an inflatable body, an inner shaft and an outer shaft. The inflatable body has at least one folded segment, which are housed in a distal portion of the outer shaft. The inflatable body is tethered to a portion of the outer shaft. The inner shaft is affixed to a portion of the inflatable body, and is configured to control an axial and/or a radial inflation pattern of the folded inflatable body.

Abstract: Disclosed is a balloon catheter that can comprise an elongate support member, an inflation tube, a guidewire tube and a balloon. The guidewire tube can define a guidewire port at its proximal end, and can extend from the port through an opening in a wall of the elongate support member and distally through a first lumen of the elongate support member, in some cases to the distal end of the catheter. The inflation tube can be disposed over a distal portion of the elongate support member, a portion of the guidewire tube, a portion of the inner assembly, or any combination thereof, forming a second lumen. The distal end of the balloon can be attached to the guidewire tube and the proximal end of the balloon can be attached to the inflation tube. The inside of the balloon can be in fluid communication with the first lumen and with the second lumen, allowing the balloon to be inflated and/or deflated. The elongate support member can also have cuts in it.

Abstract: A catheter shaft including a metallic tubular member including a plurality of apertures formed in the tubular wall of the metallic tubular member to provide a desired degree of flexibility to the metallic tubular member. The metallic tubular member includes a tapered region intermediate a region and a second, reduced diameter region relative to the first region.

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: The apparatus includes a catheter having a combined infusion/aspiration lumen, a three lumen proximal portion and a two lumen distal portion. An infusion/aspiration valve located at the distal end of the catheter facilitates performing infusion and aspiration through the same lumen, which in turn reduces the number of lumens, and enables the combined infusion/aspiration lumen to be made larger without the need to increase the diameter of the catheter. Differing material properties in the proximal and distal portions of the catheter enable the proximal portion to be made stiffer for pushability, while the distal portion is more flexible to navigate tortuous vasculature and enable a greater amplitude agitator to be received within the catheter.

Abstract: The apparatus includes a catheter having a combined infusion/aspiration lumen, a three lumen proximal portion and a two lumen distal portion. An infusion/aspiration valve located at the distal end of the catheter facilitates performing infusion and aspiration through the same lumen, which in turn reduces the number of lumens, and enables the combined infusion/aspiration lumen to be made larger without the need to increase the diameter of the catheter. Differing material properties in the proximal and distal portions of the catheter enable the proximal portion to be made stiffer for pushability, while the distal portion is more flexible to navigate tortuous vasculature and enable a greater amplitude agitator to be received within the catheter.

Abstract: A coaxial dual lumen pigtail catheter utilizes coaxial construction incorporating a thin wall guiding catheter technology for the outer lumen and using a strong braided diagnostic technology for the central lumen to accommodate high-pressure injections. The catheter includes a manifold body to provide for connection to each of the dual lumens. The distal end of the coaxial dual lumen pigtail catheter tapers to a more flexible portion that is perforated by spiral side holes to provide for more undistorted pressure readings in the left ventricle. The coaxial dual lumen pigtail catheter also utilizes proximal straight sideholes at the end of the dual lumen portion and a taper between the dual lumen portion and the single lumen portion.

Abstract: The present invention provides bariatric therapy systems. One system includes a gastrointestinal implant device and a delivery mechanism therefor. The device can include a sleeve for placement into a small intestine and to minimize absorption of nutrients by its walls. An anchoring mechanism coupled to a proximal end of the sleeve and designed to be secured within the stomach can be provided. A passageway extending through the anchoring mechanism and the sleeve can also be provided, along which food can be directed from the stomach to the small intestine. The delivery mechanism can include a housing for accommodating the device, and a deploying balloon situated within the housing and which can be actuated to direct the sleeve of the device from within the housing to the site of implantation. Methods for providing bariatric therapy are also provided by the present invention.

Abstract: A medical device for collecting cells includes an inflatable balloon and a perforated sleeve surrounding the balloon. The sleeve includes a plurality of openings therein for collecting cells when inserted into a body cavity. The balloon and sleeve can be housed in a sheath in a compressed delivery condition for being delivered to a target site for cell collection. The balloon and sleeve can then be inflated to expand into contact with the target site. The openings in the sleeve create a mildly abrasive surface for enhancing cell collection while limiting patient trauma. The balloon and sleeve can be reciprocated back and forth to collect cells from the surface of the body cavity. The balloon and sleeve having the collected cells can then be deflated and retracted from the body cavity.

Abstract: A catheter for use with a subintimal reentry guidewire includes a proximal portion having a proximal guidewire lumen and a proximal inflation lumen, a distal portion having a distal guidewire lumen and a distal inflation lumen, and an intermediate portion disposed between the proximal portion and the distal portion and having an intermediate inflation lumen in fluid communication with the proximal and distal inflation lumens. The intermediate portion is devoid of a guidewire lumen. A blocking mechanism disposed in the distal portion of the catheter is transformable from a non-blocking configuration in which a guidewire is free to translate through the distal guidewire lumen and a blocking configuration in which a guidewire disposed in the distal guidewire lumen is prevented from translating through the distal guidewire lumen.