Abstract: A catheter includes a wave guide for transmitting ultrasonic energy from a transducer, and which is also rotated to facilitate enhanced disruption of the concerned obstruction in a transverse direction. Embodiments of waveguide include distal anchors that help focus the energy transmitted to a treatment site, and may also include a deployable filter that may open distal of the obstruction to capture any dislodged debris. Selectively inflatable balloons may cordon off a treatment site, and the wave guide may comprise a tube that may serve the dual purposes of inflating the balloon(s), as well as to transmit ultrasonic energy to an obstruction. A portion of an ultrasonic catheter may include plural curved portions to space an exposed portion of the wave guide away from the catheter body to enhance the vibratory action provided.

Abstract: A method for delivering catheters, and stents composed of soft, compliant polymers through anatomical passages. These devices have a bulbous or enlarged anchorage end with a diameter greater than the rest of the catheter. To facilitate implant and delivery a pusher catheter or sheath with an internal lumen larger than the outer diameter of the catheter but smaller than the outer diameter of the bulbous or enlarged anchorage end is provided. The distal end of pusher catheter or the sheath physically engages the proximal end of the bulbous or enlarged anchorage end and applies an axial force to coaxially advance the catheter over a guidewire through anatomical passages. This method allows a physician to move the catheter to an anatomical site without the device exhibiting buckling due to axial force applied. Similarly, this delivery method will allow more force to be applied to the distal end of the catheter diminishing the likelihood of buckling.

Abstract: A cannula assembly for use in laproscopic surgery includes a cannula having a proximal end for use in orientating the assembly into an abdominal cavity, a distal end for insertion into a patient, and a passage through which surgical instruments can be inserted. An expandable feature in the form of an anchor is located toward the distal end of the cannula and is selectively expandable and collapsible. The feature in its expanded state prevents withdrawal of the cannula. A collar is pushed distally until it releasably cinches to the outside of the abdominal cavity thereby creating an airtight seal and stabilizing the assembly. The collar has a friction fit with the cannula designed to prevent excessive force against the cavity walls.

Abstract: A percutaneous transluminal angioplasty device having an embolic filter mounted to the catheter shaft at a location distal to the angioplasty balloon and downstream from the blockage to capture embolic particles that may be set loose into the blood stream as the angioplasty procedure is performed. The embolic filter is normally collapsed against the catheter shaft to facilitate introduction and withdrawal of the device to and from the operative site. Once the angioplasty balloon is properly positioned, however, means operatively associated with the embolic filter are actuated to erect the filter to operatively position a filter mesh across the lumen of the vessel.

Abstract: A thrombus capture and lysis device including a filter sized to be implanted within a blood vessel. The filter includes a plurality of hollow elements defining a mesh sized to span an area of the blood vessel. Each of the plurality of hollow elements defines a plurality of pores being sized to allow passage of a thrombolytic drug out through the pores and to prevent a thrombus forming component from entering the pores.

Abstract: A device for modeling a pessary is disclosed. A matrix of individually expandable balloons are mounted around a shaft, which holds fill lines for each balloon. The balloons are expandable with fluid to a desired volume and/or pressure, according to comfort and fit determined by real-time patient feedback. Because the volumes and the positions of the balloons are known, a calculation of the dimensions of the vaginal canal can be made, so that the matrix of expandable balloons models the vaginal canal.

Abstract: Surgical devices having a plurality of outwardly-biased flexible fins capable of inward movement such that the fins converge to provide both a passageway for surgical instruments to traverse towards a surgical site, and provide a substantially impermeable seal, thus providing for fluid retention during the surgical procedure. The outwardly-biased flexible fins provide for soft tissue compression, decreasing the length of the lumen or passageway through which instruments pass, allowing for a wider range of movement of instruments and better access to the surgical site, especially in patients with greater amounts of fat tissue that would otherwise require longer lumen lengths in prior art endoscopic cannulas.

Abstract: Apparatus (40) for compressing a transcatheter cardiac stent-valve (10) comprises: a first compressor stage (100) including a hollow channel (42) with a tapered interior surface configured for compressing a stent-valve in response to longitudinal advancement of the stent-valve within the channel; and a second compressor stage (102) comprising a crimper for compressing a portion of the stent-valve without longitudinal advancement.

Abstract: A bristle device for delivery into a body lumen comprises a longitudinally extending stem 1 and a plurality of bristles extending generally outwardly from the stem for anchoring the device in a body lumen. There may be at least two bristle segments and in some cases there are flexible sections between the segments. The flexible sections articulate to enable the device to pass through a catheter placed in a tortuous anatomy or to be deployed in a curved vessel, or across a bifurcation. In some cases at least some of the bristle segments are spaced-apart to accommodate bending of the bristles.

Abstract: A device for fracturing calcifications in heart valves includes a tube formed with at least two longitudinal slits that form at least two struts (4). Each of the struts includes two or more pairs of notches (3) formed on opposite sides of the strut. The struts have a contracted orientation in which the struts are not expanded outwards from the tube and an outwardly expanded orientation in which the struts are expanded outwards from the tube and have sufficient strength and rigidity to impact and fracture a calcification in a heart valve.

Abstract: Provided is a device for delivery into a body lumen having a longitudinally extending stem and a plurality of bristles extending generally radially outwardly from the stem. The device includes at least two different groups or types of bristles.

Abstract: An obturator sleeve for a trocar assembly and method of its use are disclosed for infiltrating a liquid medication such as a local anesthetic into the tissue walls of a port site wound during a laparoscopic procedure. The sleeve includes an internal flow passage for receiving the liquid medication. A diffusion polymer, located within the internal flow passage, first absorbs the liquid medication and then releases the liquid medication through a plurality of apertures in the sleeve. When port site wound tissue contacts the diffusion polymer, the diffusion polymer within the sleeve steadily releases the absorbed medication through the plurality of apertures. The obturator sleeve provides a means to adequately infiltrate medication into the tissues of the port site wound, and can be used to block the free nerve endings of the port site wound as well as nearby sensory and motor nerves.

Abstract: An embodiment includes a uterine manipulator system comprising: a collar including a first shelf connected to the inner surface of the collar; a stabilizer including a stabilizer rim adapted to couple to the first shelf; and a shaft adapted to pass through the stabilizer and a hollow tunnel of the collar with a bulbous tip. Other embodiments are described herein.

Abstract: An infusion system includes an infusion catheter defining a fluid passage extending between a proximal catheter end and a distal catheter end, and having a plurality of infusion ports in communication with the fluid passage and defining an infusion zone. A filtration device is provided which may be retrofitted upon the infusion catheter and includes a filter sleeve coupled to a slidable control sleeve. The filter sleeve is deformable between a first configuration having a radially contracted footprint and a second configuration having a radially expanded footprint, responsive to sliding the control sleeve over the infusion catheter such that the deformable filter sleeve buckles outwardly from the infusion catheter.

Abstract: A biologics delivery device and method of use for promoting angiogenesis in occluded vessels and ischemic tissue of a patient are provided, wherein the biologics delivery device includes a catheter having a proximal end, a distal region having a distal end, a lumen extending there between, and a plurality of through-wall apertures distributed along the distal region, the plurality of through-wall apertures in fluid communication with the proximal end and the lumen, and an expandable member disposed in the distal region, the expandable member configured to transition between a collapsed state and an expanded state. Methods of using the inventive biologics delivery device also are provided to achieve substantially uniform distribution of the biologic into a subintimal space.

Abstract: A vascular graft that includes a biodegradable polyester electrospun tubular core; a biodegradable polyester outer sheath surrounding the biodegradable polyester tubular core; and a biodegradable poly(lactide) copolymer adhesive composition (i) disposed between the polyester electrospun tubular core and the polyester outer sheath, (ii) disposed between the polyester electrospun tubular core and the polyester outer sheath and on an outer surface of the of the polyester outer sheath, (iii) or disposed on an outer surface of the polyester outer sheath.

Abstract: A single body port or body flange access device and method for performing laparoscopic surgery are disclosed. The device comprises a plurality of crisscrossing conduits through which surgical instruments may be inserted. The instruments are manipulated so that triangulation is obtained using one patient body flange while standard surgical procedures are performed on the patient.

Abstract: A method for treating a patient having thrombus includes providing a manipulation device including a housing configured to be supported by the hand of a user and having a distal and proximal end, a drive system disposed within the housing, and configured to rotate a rotation member, an engagement member coupled to the rotation member and configured to be removably coupled to an elongate medical device, an activation member carried by the housing such that it can be operated by at least a portion of the hand of the user when the housing is supported by the hand of the user, the drive system configured to apply motive force to the engagement member, securing an elongate member to the engagement member, introducing at least the distal end of the elongate member into a blood vessel adjacent a thrombus, operating the activation member to cause at least some rotation of the rotation member, which in turn causes at least some rotation of the distal end of the elongate member at or near the thrombus, and aspirating a

Abstract: A rapid exchange catheter comprises a guide wire lumen including a substantially sealed portion in which a lumen wall extends around an entire periphery thereof and a channel portion including a channel opening the lumen to an exterior of the catheter, wherein a width of the channel is less than a maximum width of the channel portion. A guide wire ramp extends into the channel portion, with the ramp extending further into the lumen of the channel portion as a distal end of the ramp is approached.

Abstract: A catheter for prevention of stroke by diverting and filtering the blood flow to carotid and vertebral arteries is provided. The catheter includes at least one balloon with an outer mesh cover that expands upon the balloon inflation and stays expanded after the balloon is deflated. The inflation of the balloon in the aortic arch or head vessels provides the deflection of embolic particles from the cerebral circulation and expands the outer mesh that provides for filtering and deflection of cerebral emboli after the balloon is deflated. An associated method of prevention of cerebral emboli and embolic stroke is provided.

Abstract: A catheter device configured to provide access to a hollow organ is provided. It includes a body extending longitudinally from a proximal end to a distal end and a flexible insertion tube extending longitudinally from a proximal end to a distal end, wherein the body includes an elongated channel along the longitudinal length of the body extending from the proximal end of the body to the distal end of the body, wherein the channel is configured to receive an elongate needle. The body further comprises one or more cutting edges extending rearwardly from a distal end of the body. Furthermore, the flexible insertion tube of the catheter device is coupled to the distal end of the body and comprises a tubular elongated passage aligned with the tubular elongated channel of the body forming a lumen. Kits including such catheter devices and methods for accessing a hollow organ are also provided.

Abstract: A delivery sheath includes an outer tubular layer and an initially folded inner tubular layer. When an implant passes therethrough, the outer tubular layer expands and the inner tubular layer unfolds into an expanded lumen diameter. The sheath may also include selectively placed longitudinal support rods that mediate friction between the inner and outer tubular layers to facilitate easy expansion, thereby reducing the push force needed to advance the implant through the sheath's lumen.

Abstract: The invention relates to a device for splinting and/or maintaining a cavity, an organ duct and or a vessel in a human or animal body, said device including at least one compressible and self-expanding stent that is composed of at least three phases.

Abstract: An intravascular device is provided having a catheter tube with an expandable portion located on an end thereof. The expandable portion includes a plurality of struts capable of being moved between an open and a closed position. An incising element is provided along at least a portion of one of the struts and has a sharpened edge for creating an incision in atherosclerotic material located within a blood vessel when the expandable portion is in the opened position.

Abstract: An apparatus for delivering a prosthetic heart valve includes a steerable guide catheter, a balloon catheter, and a flex indicator. The guide catheter has a handle and a guide tube extending from the handle. The guide tube has a distal end portion comprising a steerable section. The guide catheter further includes an adjustment mechanism on the handle and a pull wire connecting the adjustment mechanism to the steerable section for changing flexion of the steerable section. The balloon catheter includes a shaft extending coaxially through the guide tube. The shaft includes a proximal end portion and a distal end portion. The balloon catheter further includes a balloon mounted on the distal end portion of the shaft. The flex indicator moves relative to the handle upon adjustment of the adjustment mechanism. The handle includes visual indicia adjacent the flex indicator to provide visual indication of the flexion of the steerable section.

Abstract: Embodiments hereof relate to a delivery system for a transcatheter valve prosthesis, the delivery system having an integral centering mechanism to circumferentially center both the delivery system and the valve prosthesis within a vessel at the target implantation site. The centering mechanism may include expandable wings that may be selectively aligned with openings formed through a sidewall of an outer shaft of the delivery system, a coiled wing that may be selectively exposed through an opening formed through a sidewall of an outer shaft of the delivery system, a plurality of elongated filaments extending through a plurality of lumens of an outermost shaft of the delivery system that may be selectively deployed or expanded, an outer shaft that includes at least one pre-formed deflection segment formed thereon, a tool having a deployable lever arm, and/or a plurality of loops deployable via simultaneous longitudinal and rotational movement.

Abstract: An endoscopic treatment tool according to the present invention including: a sheath an operating wire inserted into a sheath; a basket part positioned at a distal side of the operating wire, a distal end tip binding and fixing distal ends of the plurality of basket wires at a distal end of the basket part, a binding part in which proximal end portions of the plurality of basket wires are bound together and fixed, and a support member disposed so as to pass into the basket part along a central axis of the basket part and of which a distal end portion is fixed to the distal end tip. A proximal end portion of the support member is positioned at a proximal side than the binding part and is connected to the operating wire to be slidable in the central axis direction with respect to the operating wire.

Abstract: A method of delivery a prosthetic heart valve includes inserting a delivery apparatus and a prosthetic heart valve into a patient's vasculature. The delivery apparatus includes a steerable guide catheter, a balloon catheter, and a flex indicator. The balloon catheter extends coaxially through the guide catheter, the prosthetic heart valve is mounted on a distal end portion of the balloon catheter, and the flex indicator is movably coupled to a handle of the guide catheter. The method further includes adjusting flexion of a steerable section of the guide catheter to position the prosthetic heart valve. The flex indicator moves relative to the handle of the guide catheter as the flexion of the steerable section is adjusted, and the handle comprises one or more visual indicators adjacent the flex indicator to provide visual indication of an amount of flexion of the steerable section of the guide catheter.

Abstract: A soft tip applicator with flexible tendrils attaches to a syringe for spreading expressed liquid from the syringe onto a surface, such as skin. A detachable connector engages a cannula hub allowing liquid to be drawn into the syringe for later expulsion onto the surface.

Abstract: A soft tip applicator with flexible tendrils attaches to a syringe for spreading expressed liquid from the syringe onto a surface, such as skin. A detachable microneedle assembly supports microneedling treatment of the skin as the liquid is expressed.

Abstract: A system for delivering an implant including a handle, a trigger, and an actuation assembly. 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: There is described a platform device for use in forming an anastomosis and maintaining a desired curvature of a lumen in a desired shape during an anastomosis assistance period. The platform is formed from one or more bioabsorbable or biodegradable polymer filaments. There is also described a method for inserting a platform device for use in creation of an arteriovenous fistula by identifying a candidate artery and a candidate vein and dissecting the candidate vein. Next, inserting a platform device into the vein and creating a breach in the candidate artery at a desired angle and location. Next, introducing the platform device and vein into the candidate artery and forming the platform device into a curvature angle selected to minimize turbulent blood flow in an anastomosis formed by the vein and the artery. The platform may also be used to maintain potency of supply blood vessels and/or organ blood vessels or the lumens during an organ transplant procedure.

Abstract: A device for accessing tissue within a body lumen comprises an elongated body portion defining a lumen and an anchoring mechanism including an expanding structure on a distal portion of the elongated body portion. The anchoring mechanism moves the expanding structure from an insertion configuration in which the expanding structure is constricted against the device to an operative configuration in a body in which the expanding structure expands away from the device without altering a length of the anchoring mechanism in combination with a control mechanism for selectively engaging the anchoring mechanism.

Abstract: A device for detaching parietal thrombi from a bodily vessel is described having a catheter including at least one catheter section with a catheter wall with at least one wall opening which passes completely through the catheter wall. The catheter wall along the least one catheter section is made of a resiliently deformable material in which the at least one wall opening includes a separating helical gap wound around the catheter wall at least in parts along the catheter section. A fixing device permits releasable fixing of the catheter on a bodily vessel so that the catheter can be converted, exclusively by an external mechanical constraint in the form of a torque acting torsionally on the catheter, from a state of smaller catheter outer diameter to a state of larger catheter outer diameter.

Abstract: The present invention relates to a catheter insertion system and method. The system comprises an IV catheter comprising a distal cannula attached to a proximal hollow hub; a forward arm attachably connected to a proximal portion of said IV catheter or element connected thereto, and extending distally therefrom; and a needle configured to pass through and protrude from the cannula.

Abstract: An expandable helical stent is provided, wherein the stent may be formed of an amorphous metal alloy or other non-amorphous metal with a securement. The stent is formed from flat or tubular metal in a helical coiled structure which has an undulating pattern. The main stent component may be formed of a single helically coiled component. Alternatively, a plurality of helically coiled ribbons may be used to form a stent heterogeneous in design, material, or other characteristic particular to that stent. The helical tubular structure may be secured with a securement, such as a weld, interlock or a polymer, to maintain the helical coils in a tubular configuration. The helical coils of the main stent component may be spaced apart or nestled to each other-maintain the tubular shape of the helically coiled stent and prevent the polymer layer from sagging at any point between cycles of the coils.

Abstract: A urine flow control device, such as an incontinence device, for insertion into a urethra, device comprising: a body having a first end and an opposite second end and a middle part connecting the first end and the second end, a hollow chamber formed in the middle part allowing a mounting tool to extend from the first end to the second end, a fluid channel defined from the second end to the first end via the hollow chamber, a head part at the first end, the head part being integral with said body and comprising a chamber with a displaceable valve member and a valve seal surface, the head part formed so that when a mounting tool is positioned in the device the valve member is displaced inside the head part by the mounting tool and when the mounting tool is not in the device the valve member seals the valve seal surface so as to seal the fluid channel, the head part having an opening for receiving the mounting tool and for urine discharge, the second end being formed so that the distal end of the mounting tool e

Abstract: Described herein are bone graft material (BGM) delivery devices having a tray configured to provide a mixing and/or holding area for BGM to substantially prevent BGM from inadvertently being delivered to an unacceptable surgical site.

Abstract: Disclosed are implantable medical devices for the occlusion of a bodily lumen, cavity, vessel, or organ, as well as methods for manufacturing such occlusion devices, and methods for treating a subject using the occlusion devices. The devices generally include a wire having shape memory properties and a flexible membranous material disposed about the wire. Some embodiments include a lateral fringe on the membranous material. Some embodiments include a fluid capture cup affixed to the wire.

Abstract: Devices and methods for treating obesity are provided. More particularly a device for assisting a patient in swallowing an intragastric balloon is provided, comprising an elongate tube, a gastric balloon assembly reversibly attached to an orifice of the elongate tube and comprising an inflation catheter engaged with a gastric balloon, a handle member, and an engagement subassembly comprising a female portion and a male portion and configured and arranged for threading the inflation catheter into and engaging the elongate tube.

Abstract: In a transseptal crossing needle device for inserting an outer sheath through a septum, an inner dilator sheath is received within the outer sheath and a needle having a curved end portion adjacent a tip of a tip portion of the needle is provided, the needle being received in the inner dilator sheath. The needle tip portion comprises an angled transverse end surface terminating at said tip and slanting away from an inner concave curved wall of said inner sheath curved by the needle curved end portion, the needle tip being spaced not only away from said inner concave curved wall of said inner sheath but also away from an inner convex curved wall of said inner sheath opposite said concave wall to reduce or eliminate skiving of material from the concave and convex inner walls of the inner sheath.

Abstract: A filter system comprises an expandable filter, with a first end of the filter attached to an end of a first tube, and a second end of the filter attached to an end of a second tube. The tubes are arranged telescopically with respect to each other such that telescopic movement of the first and second tubes with respect to each other causes the filter to move between a first collapsed, position and a second expanded position, where the filter extends outwardly. The filter may be a folded-over member, when in the expanded position, or a spiraling member.

Abstract: A vaso-occlusive treatment system includes a delivery assembly; and a vaso-occlusive device detachably coupled to the delivery assembly by a delivery assembly junction. The vaso-occlusive device includes a braided portion formed out of one or more composite wires, a coiled portion coupled to the braided portion, and an intra-device junction coupling the braided portion to the coiled portion. Each composite wire includes a core made from a core metallic material, and an external layer made from an external metallic material different from the core metallic material. One of the core and the external layer has a greater radiopacity and a lesser stiffness, respectively, than the other one of the core and the external layer.

Abstract: Method and apparatus for implanting radially expandable prostheses in the body lumens rely on tacking or anchoring of the prostheses with separately introduced fasteners. The prostheses may be self-expanding or balloon expandable. After initial placement, a fastener applier system is introduced within the expanded prostheses to deploy a plurality of fasteners at least one prosthesis end, usually as each end of the prosthesis. The fasteners are usually helical fasteners which are delivered from a helical track in the fastener applier by rotation with a rotator wire. The fasteners will be applied singly, typically in circumferentially spaced-apart patterns about the interior of each end of the prosthesis.

Abstract: The present invention relates to an adjustable length dilatation balloon catheter that includes a balloon catheter, a sheath that is slidably disposed around the balloon catheter, and an inverting tethering system that permits the selective adjustment of the exposed balloon length.

Abstract: Funnel-trap type devices or systems made of braid are described for capture and retrieval or, instead, capture and subsequent release of Inferior Vena Cava (IVC) filters or other medical devices. Delivery and/or retrieval devices, kits in which they are included, methods of use and methods of manufacture are all contemplated.

Abstract: A tool for manipulating a foreign body (e.g., a deployed medical device) can include an operative portion. The operative portion can be used to move the foreign body in the proximal and/or distal directions with respect to the removal/repositioning tool and/or the tissue surrounding the foreign body. In some embodiments, the tool can include a compressing portion that can be used to compress the foreign body as the foreign body is pulled by the operative portion in the proximal direction. The tool can further include a sleeve that can be used to transition the operative portion and/or compressing portion between an opened configuration and a closed configuration. In some embodiments, the tool can be used in conjunction with an endoscope to navigate the tool to the site of a foreign body within the body of a patient.

Abstract: The present disclosure relates to surgical port assemblies including a plurality of inflatable members for applying a force to a portion of a shaft of a surgical instrument which is inserted through an interior space of the surgical port assembly, and to surgical systems including a surgical port assembly, an endoscopic camera, and a control mechanism for controlling inflation and deflation of the plurality of inflatable members of the surgical port assembly.

Abstract: A robotic catheter procedure system for performing a procedure to treat a vascular lesion including a bedside system and a remote workstation is provided. The bedside system includes a first percutaneous device including an end section, the end section structured to allow the first percutaneous device to create a bore through the vascular lesion. The bedside system includes a second percutaneous device. The bedside system also includes a first actuating mechanism configured to engage and to impart movement to the first percutaneous device and a second actuating mechanism configured to engage and to impart movement to the second percutaneous device. The remote workstation includes a user interface and a control system operatively coupled to the user interface and to the bedside system.

Abstract: A vascular stent (1) for scaffolding a vessel (11) from the inside, wherein the stent is provided with a plurality of tube-forming elements (3A), (3B), and (3C) for forming a tube (2), the tube-forming elements combining with each other to construct a single flow path. Each of the tube-forming elements is formed by bending a strand comprising a single continuous biodegradable polymer, and first and second projecting parts (4, 5) are formed by successive alternation. Formation occurs in multiple stages in the axial direction of the tube by connecting using connecting legs (6) for successively connecting one side of the first projecting part and the other side of the second projecting part where the first and second projecting parts successively alternate. Elastic displacement parts (9) for performing elastic displacement by applying a pressing force to the tube are formed in the middle of the connecting legs successively connecting the first and second projecting parts of the tube-forming elements.