Abstract: Atrial appendage occlusion devices and cardiac monitoring positioned within the left atrial appendage and/or left atrium. In some embodiments the devices include an anchoring portion adapted to anchor the device in place adjacent the left atrial appendage, the anchoring portion comprising distal deformable anchoring portion adapted to be deployed in the left atrial appendage and a proximal deformable anchoring portion being adapted to be deployed in the left atrium, a barrier element secured to the anchoring portion and adapted to cover the left atrial appendage when implanted, and adapted to prevent blood clots from passing through the barrier element, and a cardiac monitoring element secured to at least one of the anchoring portions, the monitoring element including one or more sensors within in the left atrial appendage and/or left atrium and adapted to monitor left atrial cardiac data.

Abstract: This invention pertains to the field of medical devices and specifically relates to an atrial shunt device and its manufacturing method, as well as the application of this device in an atrial shunt system. The atrial shunt comprises a middle channel structure with left atrial wall fixing structures and right atrial wall fixing structures on both sides. The left atrial wall fixing structure is a woven network structure formed by weaving threads through a weaving process, and it includes at least two layers of woven layers. By employing a multi-layer woven structure, this invention enhances the waist support compared to traditional single-layer woven structures, reduces the risk of opening blockage caused by excessive intimalization, lowers atrial pressure, improves patient cardiac function, and prolongs patient life.

Abstract: Snare device with anti-skewing. In one embodiment, the snare device includes a core-wire. The core-wire is made of a superelastic material and includes a proximal portion of greater cross-sectional area and a distal portion of lesser cross-sectional area. The distal portion includes a looped shape in a relaxed state. A flexible coil is mounted around the core-wire and is straight in a compressed state. The distal ends of the core-wire and the coil are coupled together. The proximal end of the core-wire is coupled to a handle of an actuator, and the proximal end of the coil is coupled to a slide of an actuator, the slide being slidably mounted on the handle. The tensile strength of the coil multiplied by the cross-sectional area of the coil is greater than the upper plateau stress of the core-wire distal portion multiplied by the cross-sectional area of the core-wire distal portion.

Abstract: Disclosed is a thrombectomy device with segmented design, and the device includes a thrombectomy net and a push rod fixedly connected with a proximal end of the thrombectomy net, where the thrombectomy net is a tubular hollow self-expanding net capable of automatically expanding radially, which is contracted after being compressed radially, and expands radially after a constraint of radial compression is released. The thrombectomy net includes a slope section, a thrombectomy section, and a gathering section which are sequentially connected from the proximal end to a distal end, where the thrombectomy section includes at least two thrombectomy subsections which are sequentially connected from the proximal end to the distal end and are relatively independent, and two adjacent thrombectomy subsections are locally connected, so that the two adjacent thrombectomy subsections are relatively independent during radial expansion.

Abstract: Systems, devices and methods for occluding the left atrial appendage (LAA). The device excludes the LAA from blood flow. The implantable device is delivered via transcatheter delivery into the LAA and secured within the LAA. The implant comprises an expandable and compliant frame and an expandable and conformable tubular foam body. A delivery and tether retraction system includes a handle for controlling a pusher and tether. The pusher may be moved a distance away from the implant without changing the orientation of the implant, while the tether is still attached to the implant. Severing the tether and proximally retracting a control on the hand piece by a distance causes the severed end to advance distally by at least about twice that distance. A loader includes a conical portion with guides and a reservoir for submerging the foam prior to loading and delivery.

Abstract: Methods for forming an expandable tubular body having a plurality of braided filaments including a first filament including platinum or platinum alloy and a second filament including cobalt-chromium alloy. The methods include applying a first phosphorylcholine material directly on the platinum or platinum alloy of the first filament and applying a silane material on the second filament followed by a second phosphorylcholine material on the silane material on the second filament. The first and second phosphorylcholine materials each define a thickness of less than 100 nanometers.

Abstract: Embodiments of the present invention provide an improved vascular occlusion device for occlusion of a passageway, cavity, or the like. According to one embodiment, a medical device for occluding a left atrial appendage is provided. The medical device includes a first portion having at least one plane of occlusion that is configured to be positioned outside of the left atrial appendage, and a second portion having at least one plane of occlusion that is configured to be at least partially positioned within a cavity defined by the left atrial appendage.

Abstract: The devices and methods described herein may be used to restore left ventricular function to address mitral valve regurgitation. One variation of an implant comprises a plurality of tethered anchors and a plurality of force-distribution members slidably disposed on the tether between the anchors. One or more of the force-distribution members can comprise a bioabsorbable material. Methods comprise deploying the implant to cardiac tissue, cinching the implant to its hard stop (e.g., where further cinching does not cause further tissue tightening), providing a pre-selected amount of slack to the implant after it has been cinched to its hard stop configuration, and securing a lock member on the tether. Also disclosed herein are lock member deployment catheters that provide a pre-selected amount of tether slack as it secures a lock member on the tether.

Abstract: Provided herein is an occlusion device comprising: (a) continuous mesh structure comprising a medial pinch point; (b) a resilient mesh disc-shaped body extending distally and outward from the medial pinch point; and (c) a compressible mesh carriage extending distally from the medial pinch point on an opposing side of the resilient mesh body of (b), wherein the compressible mesh carriage comprises a pinch point on each end of the carriage, wherein one of the pinch points is the medial pinch point of (a); wherein the continuous mesh structure has a first delivery shape and a second expandable deployed shape, and wherein the length (x) of the resilient mesh body is greater than the length (y) of the compressible mesh carriage in free air and in the deployed shape.

Abstract: A medical instrument (1000) includes a stent (100) and a constraining structure (300). The constraining structure (300) constrains, and thereby prevents tangling of, a trailing section of the stent (100), ensuring successful release of the stent (100). Specifically, the stent (100) has a first proximal end and an opposing first distal end. The first distal end is configured with an expanded configuration and a collapsed configuration. The trailing section at the first distal end includes a number of protrusions (111). The constraining structure (300) includes a body (310) and a clamping mechanism (320). The clamping mechanism (320) is disposed at a distal end of the body (310), and the body (310) extends from the first proximal end to the first distal end. The clamping mechanism (320) limits relative movement and thus prevents tangling of the protrusions (111) by passing through all or some of the protrusions (111).

Abstract: A prosthetic heart valve delivery catheter includes an embolic filter to provide integrated embolic protection to inhibit the release of emboli into the aorta, the aortic arch or branch vessels, and other vasculature during transvascular heart valve replacement procedures. The embolic filter will usually be fixedly or movably attached to a shaft of the delivery catheter proximal of the prosthetic heart valve.

Abstract: An example occlusive implant is disclosed. The example occlusive implant includes an expandable framework configured to shift between a first configuration and an expanded configuration and a fixation member disposed along the expandable framework. The fixation member includes a first engagement portion and an anchor portion. Further, the first engagement portion is designed to be secured to the expandable framework and the anchor portion extends away from an outer surface of the expandable framework.

Abstract: A catheter system utilizing one or more sensors is described. The catheter can be used as part of an embolic coil system, guidewire system, or combined embolic coil/guidewire system where the devices interact with the catheter system. A variable detachment embolic coil system and guidewire system are also described.

Abstract: A method for removing a clot from a vessel involves the use of a device that can have dual layers where an inner expandable member runs within an outer expandable member. The inner expandable member can be divided into one or more sections, with a proximal section having a clot pinching structure configured to pinch the clot between the pinching structure and an outer catheter. A distal flow channel section of the inner member can be configured to create a flow channel through the clot to restore blood to the downstream vasculature. The struts of the outer expandable member can form closed cells that are not fully circumferential in a proximal portion to allow a clot to pass inside and engage the pinching structure, and fully circumferential in a distal portion to scaffold the vessel for dislodging the clot. A protective element at the distal end of the device can prevent the escape of clot fragments.

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 occluder portion and an anchor portion. The occluder portion includes a hub that defines an axis, the occluder portion extending between a proximal end coupled to the hub and a distal end defining an occluder eyelet adjacent thereto. The anchor portion extends between a first end and a second end, the first end coupled to an anchor hub and the second end defining an anchor eyelet adjacent thereto and hingeably coupled to the occluder eyelet. With this arrangement, the anchor hub is moveable along the axis to move the anchor portion between a retracted position and a deployed position upon the occluder portion being in an expanded position.

Abstract: A clot retrieval cleaning instrument can have bristles, fluid sprays, or other techniques to liberate captured clot material from a clot retrieval device so that it can be reinserted into a patient's vasculature for successive capture attempts. The cleaning instrument can be conveniently integrated or connected to a hemo stasis valve assembly so that the cleaning function can be performed without completely removing the clot retrieval device from the delivery system. Aspiration can be applied to remove the freed thrombus material. The cleaning instrument can be removable from the delivery system to facilitate the instrument's washing or disposal.

Abstract: Multi-filter endolumenal methods and systems for filtering fluids within the body. In some embodiments a multi-filter blood filtering system captures and removes particulates dislodge or generated during a surgical procedure and circulating in a patient's vasculature. In some embodiments a dual filter system protects the cerebral vasculature during a cardiac valve repair or replacement procedure.

Abstract: An endovascular system includes inner and outer catheters, a handle system operably coupled one end of the catheters, and a microvalve coupled to the other end of the catheters. The microvalve is constrained in a radially-collapsed closed configuration for advancement within a vessel to a treatment site. The handle system is operable to displace the inner and outer catheters portions relative to each other to move the microvalve between closed and open configurations. An indicator is provided to visually indicate the extent by which the microvalve is opened within the vessel.

Abstract: A handle assembly includes a drive wire coupled to an expandable end effector, the wire having a diameter of no more than 3 French and a handle cannula receiving the wire therethrough, rotation of the handle cannula transferring torque to rotate the wire. The assembly also includes a shaft receiving the handle cannula, rotation of the shaft transferring torque to rotate the handle cannula. The assembly further includes an actuation assembly receiving the shaft, the actuation assembly coupled to a sheath sized to receive the wire and end effector therethrough, the actuation assembly moveable between a proximal configuration in which the sheath is moved proximally to expand the end effector and a distal configuration in which the sheath is moved distally to retract the end effector, the actuation assembly including a rotation mechanism transferring torque to the shaft to rotate the shaft.

Abstract: A vascular filter device (1) has a support frame (2) and filter elements (4). The filter elements (4) extend from the support frame towards filter element ends forming an on-axis apex (5) at which they are interconnected by a holder (6). The filter elements (4) are biased such that if unconnected the filter element ends are located between the support frame and said central axis when the vascular filter device is unconstrained. The filter element unconnected positions are provided by the filter element shapes and the angles at which they extend from the support frame, and in one example this is achieved by laser cutting tubing and heat setting the material.

Abstract: The invention describes catheter systems and methods for accessing the brain during endovascular/neurointervention procedures in the treatment of ischemic stroke. More specifically, a catheter system having a deployable redirection device (RD) is described that improves the process of accessing a clot in a patient with acute ischemic stroke due to large vessel occlusion.

Abstract: A vascular plug comprises a superstructure expandable from a collapsed percutaneous insertion configuration to an expanded deployment or use configuration. The superstructure is comprised of both primary and secondary three-dimensional shapes allowing for the occlusion of a wide range of vessel sizes from small to large through a disproportionately small delivery catheter. The plug includes a shape memory element for the generation of radial force and the creation of the larger secondary three-dimensional twisting or helical superstructure as is needed for target vessel occlusion.

Abstract: A filter, including a main body part. The main body part includes a heart-proximal end, a plurality of connecting segments, and a first filter mesh connecting between the heart-proximal end and the plurality of connecting segments. An end of the connecting segments that is connected to the first filter mesh is bent towards a central longitudinal axis of the filter to form a bending part. A vertical distance between a proximal end of the bending part and the central longitudinal axis of the filter is less than a vertical distance between a distal end of the bending part and the central longitudinal axis of the filter.

Abstract: Disclosed herein is a medical implant component comprising a composite biotextile, which biotextile comprises i) a polyolefin fibrous construct comprising at least one strand with titer of 2-250 dtex, tensile strength of at least 10 cN/dtex and comprising high molar mass polyolefin fibers and ii) a coating comprising a biocompatible and biostable polyurethane elastomer comprising a polysiloxane segment and/or having one or more hydrophobic endgroups, wherein the polyurethane coating is present on at least part of the surface of the biotextile and in an amount of 2.5-90 mass % based on composite biotextile. Such composite biotextile, like a partly coated woven fabric, shows an advantageous combination of good biocompatibility, especially hemocompatibility, high strength and pliability, and laser cuttability; allowing to make pieces of fabric having well-defined regular edges that have high suture retention strength. The invention also provides a method of making said composite biotextile.

Abstract: Disclosed herein is a method of making a composite fabric for use in or as a medical implant component, the method comprising steps of providing a textile comprising at least one strand having titer of 2-250 dtex and comprising fibers made from a biocompatible and biostable synthetic polymer; determining locations on the textile where a cut is to be made for an intended use of the textile; optionally pretreating the textile at least at the determined locations on at least one side of the textile with a high-energy source to activate the surface; solution coating the textile at least at a determined location with a coating composition comprising a biocompatible and biostable polyurethane elastomer and a solvent for the polyurethane; removing the solvent from the coated textile; and laser cutting the coated textile as obtained at least a one coated location with an ultra-short pulse laser; to result in a composite biotextile wherein polyurethane is present in an amount of 2.

Abstract: An implant detachment system is described which utilizes a catheter utilizing an LC or tank circuit with an inductor and capacitor. The catheter electrically interacts with an implant delivered through the catheter to detach the implant.

Abstract: A method for forming an ultra-high temperature (UHT) composite structure includes dispensing a first polymeric precursor with a spinneret; forming a first plurality of nanofibers from the first polymeric precursor; depositing the first plurality of nanofibers with a collector; and applying a fluid, with a nozzle, onto the first plurality of nanofibers disposed on the collector. The fluid includes a second polymeric precursor.

Abstract: Single filter and multi-filter endolumenal methods and systems for filtering fluids within the body. In some embodiments a blood filtering system captures and removes particulates dislodged or generated during a surgical procedure and circulating in a patient's vasculature. In some embodiments a filter system protects the cerebral vasculature during a cardiac valve repair or replacement procedure.

Abstract: Systems, devices and methods for occluding the left atrial appendage (LAA). The device excludes the LAA from blood flow. The implantable device is delivered via transcatheter delivery into the LAA and secured within the LAA. The implant comprises an expandable and compliant frame having anchors and an expandable and conformable tubular foam body. A delivery and tether retraction system includes a handle for controlling a pusher and tether. The pusher may be moved a distance away from the implant without changing the orientation of the implant, while the tether is still attached to the implant. A loader includes a conical portion with guides and a reservoir for submerging the foam implant prior to loading and delivery.

Abstract: A system includes a device having inner and outer catheters, and a filter valve attached to the distal end of the inner and outer catheters. Longitudinal displacement of the inner catheter relative to the outer catheter moves the filter valve from a non-deployed configuration to a deployed configuration. The device has a first configuration in which the distal end of the inner catheter is longitudinally advanced by a first distance relative to the distal end of the outer catheter and the filter valve assumes a stretched configuration, and a second configuration in which the distal end of the inner catheter is longitudinally advanced by a second distance relative to the distal end of the outer catheter to cause the filter valve to assume a diameter larger than in the stretched configuration.

Abstract: Various systems and methods of deploying an implant to a target location of a body vessel are disclosed. A delivery system can include a tubular body having a lumen extending therethrough. A pull wire can extend through the lumen with the pull wire including a distal portion. An elastic loop wire can include a loop opening which is positioned approximate a distal end of the tubular body and can include a proximal attachment point that is affixed to the pull wire. The elastic loop wire and the pull wire can be positioned to secure the implantable medical device to the delivery system. The elastic loop wire can be effective to inhibit premature detachment of the implantable medical device from the delivery system by inhibiting proximal translation of the pull wire with respect to the loop opening of the elastic loop wire.

Abstract: A delivery device includes a handle, a central elongate member extending from the handle, a sheath configured to slide over and relative to the central elongate member, a distal tether retainer at a distal end of the central elongate member, a proximal tether restraining mechanism positioned along the central elongate member distal of the handle and proximal of the distal tether retainer, and a plurality of tethers. The tethers are configured to extend from the proximal tether restraining mechanism to the distal tether retainer.

Abstract: A clot retrieval device for removing occlusive clot from a blood vessel. The device comprises an inner elongate body having a collapsed delivery configuration and an expanded deployed configuration. An outer elongate body is at least partially overlying the inner elongate body. The outer elongate body is expandable to a radial extent which is greater than the radial extent of the inner body in the deployed configuration to define a clot reception space. The outer elongate body has a plurality of clot receiving openings and a plurality of clot engaging regions. The clot engaging regions are adapted, on engagement with clot, to urge clot towards the clot receiving openings and into the reception space between the outer elongate body and the inner elongate body, wherein the radial force profile of the device varies along the length of the device.

Abstract: In an example, a scoring device is configured for retention of a catheter shaft. The scoring device incudes a proximal portion and a distal portion. A retention sleeve extends between the proximal and distal portions. The retention sleeve has a catheter socket configured to selectively receive and mechanically engage the catheter shaft. The scoring device includes a scoring tool coupled with the retention sleeve, for instance proximate to the distal portion. The scoring tool includes a balloon socket configured to selectively receive a balloon of the catheter shaft. The scoring tool includes one or more scoring elements extending around the balloon socket, the one or more scoring elements configured to provide localized scoring to vasculature.

Abstract: Endovascular variable aortic control catheters (EVACC) are provided that are adapted to augment upstream blood pressure and regulate downstream blood flow for patients in shock. The EVACC devices provide improved treatment for truncal wounds, which may be used for example on a battlefield, thereby increasing survivability of injured soldiers. The devices are a catheter-based system having a proximal hand piece for controlled deployment of the device through a delivery sheath. A collapsible, wire framework supports an expandable and collapsible occlusion barrier. The wire basket and occlusion barrier expand to fit within the lumen of the aorta. Various movable elements are used to adjust an adjustable passageway to regulate controlled anterograde blood flow.

Abstract: A method of preparing a filter for delivery into a body vessel. The filter includes a hub disposed along a longitudinal axis and a plurality of anchor members extending from the hub. Each anchor member includes either a cranial extension or a caudal extension at a distal end thereof. At least one anchor member distal end may be spaced from the hub at each of a first, second, and third distance along the longitudinal axis. The filter also includes a plurality of locator members extending from the hub, the locator members alternatingly interposed between the anchor members.

Abstract: A mechanical thrombectomy device includes several clot arrestors mounted on a support wire. The clot arrestors have rings of expandable frame cells. The frame cell rings include an open frame cell ring, having a gap between adjacent frame cells in the ring, and a closed frame cell ring, having no gap between adjacent frame cells. The gap allows clots to enter the clot arrestor for retrieval from a target anatomy. Other embodiments are also described and claimed.

Abstract: Implants comprising electrically-responsive hydrogel are described. Systems to provide electricity to induce response in hydrogel-containing implants are described. Methods for utilizing said system and methods for utilizing said hydrogel-containing implants are described.

Abstract: Vascular filters and deflectors and methods for filtering bodily fluids. A blood filtering assembly can capture embolic material dislodged or generated during an endovascular procedure to inhibit or prevent the material from entering the cerebral vasculature. A blood deflecting assembly can deflect embolic material dislodged or generated during an endovascular procedure to inhibit or prevent the material from entering the cerebral vasculature.

Abstract: A platform of devices for removing obstructions and other objects within a blood vessel or other interior lumen of an animal is provided. The system may be deployed in the lumen from a catheter(s) and the system includes a proximal junction, and a distal basket comprised of a plurality of cells. A number of different basket designs are disclosed.

Abstract: Disclosed are systems, methods, and devices for percutaneous retrieval of objects, such as endovascular devices, from an internal body space. The present inventions have vascular, non-vascular (gastrointestinal), and surgical (laproscopic) applications. The inventions include a a wire woven distal end that is formed from wires and includes a substantially cylindrical main body section comprising a leading end, a trailing end, and a middle portion extending between the leading end and the trailing end and defining a longitudinal axis of the main body section, and a flare defining a mouth of the wire woven distal end that projects circumferentially from the leading end of the main body section, wherein when at least a portion of the retrieval end is transitioned to a compressed state following capture of an object, the retrieval end exerts an inward force that at least partially collapses or compresses the object.

Abstract: An occlusive implant system may include a catheter having a lumen extending from a proximal opening to a distal opening, a core wire slidably disposed within the lumen, and an occlusive implant having an expandable framework configured to shift between a collapsed configuration and an expanded configuration, and an occlusive element disposed on the expandable framework. The expandable framework may include a plurality of anchor members extending radially outward from the expandable framework, at least some of the plurality of anchor members each have a barb projecting circumferentially therefrom. The occlusive implant may be releasably connected to a distal portion of the core wire.

Abstract: An example occlusive implant is disclosed. The example occlusive implant includes an expandable framework configured to shift between a collapsed configuration and an expanded configuration, an occlusive member disposed along at least a portion of the expandable framework and a sealing member disposed along the occlusive member.

Abstract: Described herein are systems, devices, and methods for aspiration and mechanical thrombectomy. In some embodiments, a thrombectomy device for removing a thrombus from a vessel can include a handle assembly, a vacuum source, an aspiration catheter with an expandable distal portion, and a flexible shaft configured to rotate within the aspiration catheter.

Abstract: Aspects of the present disclosure are directed to an apparatus and/or method involving an asymmetrical frame connected to an extension arm, and a filter having opposing surface areas terminating around a perimeter of the filter. The filter is configured with the frame and the extension arm to conform one of the opposing surface areas to an inner sidewall of a tubular structure.

Abstract: The present disclosure relates to an implantable device having a frame and a flow restrictor. The frame includes a central portion and an end portion on either end of the frame. The flow restrictor is disposed within a lumen of the frame. The flow restrictor is configured to transition between a collapsed configuration and a deployed configuration. The flow restrictor may include a porosity configured to reduce fluid flow through the flow restrictor without completely occluding fluid flow.

Abstract: Delivery and detachment of an implant can be enhanced by a retraction mechanism to secure portions of a delivery wire within an interior space of the implant. A delivery system can include an implant having a proximal end portion. A delivery wire can include (i) a detachment zone proximal to the proximal end portion and (ii) a distal region distal to the proximal end portion. An expansion member can be located between the proximal end portion and the distal region of the delivery wire. The expansion member can be biased to move the distal region of the delivery wire distally away from the proximal end portion when severed at the detachment zone.

Abstract: Medical apparatus includes an insertion tube configured for insertion into a body cavity of a patient and a distal assembly, including a plurality of spines having respective proximal ends that are connected distally to the insertion tube. Each spine includes a rib extending along a length of the spine, a flexible polymer sleeve disposed over the rib and defining a lumen running parallel to the rib along the spine, and one or more electrodes disposed on the sleeve and configured to contact tissue within the body cavity.

Abstract: The disclosed technology includes a clot retrieval device being configured to retrieve a clot from a blood vessel and having a constrained delivery configuration and a clot engaging configuration. The device can include a first expandable framework having a first plurality of struts that form a first body and a second expandable framework having a second plurality of struts that form a second body upon the clot retrieval device transitioning from the constrained delivery configuration to the clot engaging configuration. In the clot engaging configuration, the first body can be configured to move from a first position to a second position in relation to the second body. Upon moving from the first position to the second position, the clot retrieval device can pinch the clot between the first body and the second body.

Abstract: A clot removal device has an expandable treatment member having a distal tip and a proximal end, a delivery wire having a distal end coupled to the proximal end of the expandable treatment member, and a flow restrictor carried along the delivery wire at a location that is separate and proximal from the expandable treatment member. The flow restrictor has a body with a distal section and a proximal section, the distal section being covered and the proximal section being uncovered. The expandable treatment member is moveable relative to the flow restrictor, and can be retracted into the distal section.