Abstract: Disclosed herein is a delivery system for delivering a leadless pacemaker. The delivery system may include a catheter, which may be a guide catheter. The catheter includes a distal end, a proximal end opposite the distal end, a lumen extending between the distal end and the proximal end, and a locking hub operably coupled to the proximal end. The locking hub includes a lumen segment of the lumen. In one implementation, self-biasing of the lumen segment places the lumen segment out of alignment with a rest of the lumen. Deflecting the lumen segment against the self-biasing of the lumen segment places the lumen segment in coaxial alignment with the rest of the lumen. In another implementation, self-biasing of the lumen segment reduces an inner diameter of the lumen segment and actuation of the locking hub expands the inner diameter.

Abstract: A medical device and a treatment method are disclosed that can be applied to body lumina with a wide range of inside diameters and can enhance a property for suction of a substance from the inside of a body lumen by restricting flow within the body lumen. The medical device includes an elongated shaft section; an expanding section that is an elastically deformable tubular body provided with a plurality of openings; a flexibly deformable tubular cover section that is coupled to an end portion on a proximal side of the expanding section, surrounds an outer periphery of the expanding section on the proximal side, but does not surround, and externally exposes, an outer periphery of the expanding section on a distal side; and a sheath capable of accommodating the expanding section and the cover section in a diameter-reduced state.

Abstract: Devices can generally include a fan portion for occluding an aneurysm neck, a channel orifice opening in the fan portion, and an agent channel for delivering a coagulating agent through the orifice into the aneurysm. Devices can be delivered through a catheter to the aneurysm, the fan portion can expand to occlude the aneurysm neck, and coagulating agent can be injected into the aneurysm. During injection of the coagulating agent, the fan portion can inhibit the coagulating agent from exiting the aneurysm. After injection of the coagulation agent, the fan portion can collapse and the device can be extracted from the patient.

Abstract: Intravascular catheters with fluoroscopically visible indicium of rotational orientation. The catheter includes an elongate flexible tubular body, having a proximal end, a distal end and a tubular side wall defining at least one lumen extending therethrough. At least first and second opposing pairs of radiopaque rings are embedded in the side wall, spaced axially apart from each other. A first transverse axis extending through the first pair of rings is rotationally offset from a second transverse axis extending through the second pair of rings. The rings may be supported by a subassembly integrated into the wall of the catheter. The subassembly may include a tubular body having a plurality of aperture portions connected by intervening hinge portions. In one implementation, the catheter is a reentry catheter.

Abstract: In various aspects, present disclosure is directed to methods, devices and systems whereby one or more low viscosity fluids may be introduced into a catheter and whereby the one or more low viscosity fluids may be converted into a high viscosity fluid in the catheter, which high viscosity fluid may be delivered from an exit port of the catheter.

Abstract: The devices and methods described herein relate to improved structures for removing obstructions from body lumens. Such devices have applicability in through-out the ho including clearing of blockages within the vasculature, by addressing the frictional resistance on the obstruction prior to attempting to translate and/or mobilize the obstruction within the body lumen.

Abstract: According to an aspect, a medical device includes an elongate member and a sleeve. The elongate member defines a lumen and has a first end portion and a second end portion. The second end portion has a first configuration and a second configuration. The second end portion has a first size when the second end portion is in its first configuration and a second size when the second end portion is in its second configuration. The first size is smaller than the second size. The second end portion is biased to its second configuration. The sleeve defines a lumen extending from a first end portion of the sleeve to a second end portion of the sleeve.

Abstract: The embodiments described relate to retrieving temporary Inferior Vena Cava (IVC) filters and other endovascular implants or foreign bodies. Features are provided for effective actuation in closing an inner aperture of the embodiments.

Abstract: An aspiration catheter can be used to capture and retrieve vascular debris from blood vessels. The aspiration catheter can include a distal segment having ports positioned along its longitudinal length and about its circumference. The distal segment can capture thrombus at least partially on an exterior of the distal segment when aspiration is applied through the ports, and retrieve the thrombus when the elongate member is retracted proximally. The distal segment can be modified from a non-collapsed configuration to a collapsed configuration when aspiration is applied through the ports. The distal segment can have projections arranged along and around its circumference. The projections can be configured to slide distally through a thrombus within a blood vessel and to pull the thrombus when the elongate member is retracted proximally.

Abstract: An aspect of some embodiments of the application relates to a microcatheter comprising a deployment element disposed about around at least a portion of an exterior of a distal end of the microcatheter, the deployment element configured for repeatedly expanding and collapsing, the distal end arranged to allow forward or reverse axial displacement while the deployment element maintains a position, the deployment element arranged for positioning the microcatheter distal end approximately in the middle of a vessel.

Abstract: A system and method are provided for fragmenting a crystalline lens, to facilitate its removal from the lens bag during an ophthalmic laser surgery. First, a predetermined pattern is used to make Laser Induced Optical Breakdown (LIOB) cuts that section the lens into asymmetrical, operational segments. At least one operational segment is then selected and softened with a plurality of compact LIOB cuts. Once softened, the selected segment is aspirated. The remaining operational segments are then subsequently removed. During a procedure, an imaging unit can monitor movements of the lens bag to ensure proper placement of the LIOB cuts on the lens.

Abstract: Catheter systems configured for emergency blood-vessel occlusion and associated devices, systems, and methods are disclosed herein. A catheter system configured in accordance with a particular embodiment includes a catheter, a sheath, and an extracorporeal proximity sensor. The catheter includes an elongated body having a tip, a sealing portion, and a main shaft proximal to the sealing portion. The tip is configured to dilate a blood vessel ahead of the distal end portion of the sheath as the catheter and the sheath are advanced together through the blood vessel. The distal end portion of the sheath is configured to fit snugly around the sealing portion. The catheter further includes a balloon and a proximity-sensor target less than about 10 centimeters from the balloon. The proximity sensor is configured to receive a signal from the proximity-sensor target to aid in positioning the balloon without fluoroscopic guidance.

Abstract: The present invention relates generally to devices and methods for retrieving or manipulating objects within a lumen. More specifically, embodiments of the invention relate to devices and methods for retrieving or manipulating medical devices from a body lumen. One embodiment of the present invention provides a novel and improved retrieval snare and method of fabricating and using the same. The snare includes a snare wire, having a distal end and a proximal end, for use in the human anatomy, such as but not limited to blood vessels, pulmonary airways, reproductive anatomy, gastrointestinal anatomy, and organs such as the kidneys or lungs. The device enables a user to capture a foreign object located within the human anatomy, grasp said object in a controlled manner, and retrieve and remove said object from the human anatomy.

Abstract: An intravascular device is provided having a catheter tube and an expandable portion including a plurality of struts supported in a cantilevered fashion so as to be splayed open when in an opened position. An incising element is provided on at least 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: A vascular occlusion device includes a braided filament mesh structure defining a longitudinal axis. The mesh structure has a relaxed configuration in which it has an axial array of radially-extending occlusion regions, each of which has a proximal side and a distal side meeting at a peripheral edge, the sides of each occlusion region forming a first angle relative to the longitudinal axis. Each occlusion region is axially separated from the adjacent occlusion region by a reduced-diameter connecting region. The mesh structure is radially compressible to a compressed state in which it is deployed intravascularly to a target site through a catheter. Upon deployment, the device radially expands to a constrained configuration in which the peripheral edges of the occlusion regions engage the vascular wall, and the sides of the occlusion regions form a second angle relative to the longitudinal axis that is smaller than the first angle.

Abstract: A surgical device and procedure are provided for smoothly and easily accessing tissue to perform microsurgery, including a capsulotomy of a lens capsule of an eye. The device includes a handpiece with a tip for insertion into an incision in the cornea of the eye. A sliding element is disposed within the handpiece and a suction cup is mounted to the sliding element. The sliding element can be translated to move the suction cup into and out of the handpiece. A compression mechanism associated with the suction cup and the handpiece compresses the suction cup for deployment through the tip of the handpiece. The suction cup can expand inside the anterior chamber into a cutting position on the lens capsule. A cutting element mounted to the suction cup is used to cut a portion of the lens capsule and to remove the portion from the eye.

Abstract: A phacoemulsification system that includes a hand-graspable body and a phacoemulsification needle extending from a distal portion of the body is disclosed herein. The phacoemulsification system may also include an impeller pump carried by the hand-graspable body and configured to convey an aspiration fluid from a surgical site. The impeller pump may include an aspiration motor and a flexible impeller coupled to and rotatably driven by the aspiration motor. The flexible impeller may be arranged to aspirate fluid and emulsified lens tissue from the surgical site.

Abstract: A transcatheter valve delivery system includes a longitudinal member extending between a proximal end and a distal end, and having a compartment adjacent the distal end for holding a medical device in a collapsed condition. An alignment element is connected to the longitudinal member and is movable relative to the longitudinal member between a stowed position and a deployed position. In the deployed position, the alignment element is configured to urge against an anatomical surface to position the longitudinal member at a desired location relative to the anatomical surface.

Abstract: Cannula anchor assemblies are disclosed which consist of a threaded cannula and a cannula anchor. The cannula anchor system allows for secure anchoring into the body wall, and proper cannula height adjustment prior to and during surgery. Sutures through the body wall may be secured to the cannula anchor either directly through the cannula anchor, or around suture posts attached therein. The cannula anchor also prevents excessive plunge of a trocar into the patient. The cannula anchor is generally configured with internal threads that mate with a threaded cannula.

Abstract: An aspect of some embodiments of the invention relates to a microcatheter comprising a deployment element disposed about around at least a portion of an exterior of a distal end of the microcatheter, the deployment element configured for repeatedly expanding and collapsing, the distal end arranged to allow forward or reverse axial displacement while the deployment element maintains a position, the deployment element arranged for positioning the microcatheter distal end approximately in the middle of a vessel. A method of traversing tortuous vessels using the microcatheter, in accordance with an exemplary embodiment of the invention, is also described.

Abstract: An access system for endoscopic operations includes of a trocar, a cover that is fittable on the trocar and at least one spreading element having a retaining portion and an effector portion, wherein the access system has, between the trocar and the cover in the fitted state, a receiving region for the retaining portion of the at least one spreading element. Furthermore, the access system can include an extraction bag which is expanded by the effector portion of the at least one spreading element.

Abstract: An in-situ material delivery device for handheld, stereotactic table or MRI stage use may comprise a work element configured to selectively open and close at least one articulable beak configured to penetrate tissue to a target delivery site, or follow a central lumen of another device or other guiding modality, and then to deliver selected materials. Such a device may deliver a variety of materials such as markers, radio-active pellets, medications, other devices, and other materials of solid, liquid or gaseous form to a target site, and materials of similar nature may also be captured and removed from a target site. A single tube with or without coatings or an inner sheath and an outer sheath which may be co-axially disposed relative to a work element may be configured to actuate a beak or beaks and internal delivery mechanisms simultaneously. One embodiment of this device may be applicable to field use or one time use.

Abstract: In a surgical method for improving cardiac function, an implantable scaffold or valve support device is inserted inside a patient's heart and attached to the heart in a region adjacent to a natural mitral or other heart valve. The scaffold or valve support device defines an orifice and, after the attaching of the scaffold or valve support device to the heart, or temporary support while native valve leaflets and/or subvalvular structures are captured, a prosthetic or bio-prosthetic valve seated in the orifice, and the native valve may be retracted into the scaffold/replacement assembly to create a gasket for sealing the complex.

Abstract: A vitrectomy apparatus is provided, including a pressure source, a cut valve connected to the pressure source, the cut valve configured to be turned on and off to provide pressure to selectively extend and retract a vitrectomy cutting device, a sensor configured to sense pressure provided from the cut valve, and a controller configured to control operation of the cut valve based on pressure sensed by the sensor. The controller is configured to monitor an amount of dwell time the vitrectomy cutting device remains open and monitor aspiration rate, and control a rate of material processed by the vitrectomy cutting device based on amount of dwell time and aspiration rate.

Abstract: The present disclosure provides methods and apparatuses for guiding an endovascular tool, such as a puncturing tool or an angioscope, in a radial direction, such as toward or through the sidewall of a vessel, stent, or stent graft, using elongate members and specialized catheters. The present disclosure provides methods and apparatuses for locating branch vessels from within a grafted main vessel while maintaining continuous blood flow to the branch vessel. Another aspect of the present disclosure involves a reverse cannulation system, particularly useful for stenting the abdominal aorta proximate the renal arteries and stenting the renal artery.

Abstract: A method of preventing ingress of material into the left atrium of a heart includes providing a delivery sheath, advancing the sheath distal end through an opening between the right atrium and the left atrium of the heart, providing an expandable cage, delivering the expandable cage to the left atrium, and expanding the expandable cage within the left atrium. The expandable cage includes a proximal end, a distal end, and a plurality of supports extending therebetween. The expandable cage also includes a first membrane provided at its proximal end and a second membrane provided at its distal end. The expandable cage has a collapsed configuration so that it can be received within the lumen of the delivery sheath, and an expanded configuration for deployment within the heart. When expanded, the first membrane is positioned at an opening between the left and right atria of the heart, and the second membrane is positioned at the ostium of the left atrial appendage.

Abstract: An adjustable shape abscess irrigation device includes a first tube that is slidably associated with a second tube. The irrigation device includes a retainer that defines a variable shape diameter. The diameter of the retainer is selectively adjustable by the relative positioning of the first tube and the second tube such that, once placed relative to an abscess, the shape of the device can be manipulated to allow desired drainage of irrigation and abscess fluids beyond the confines of the abscess. Upon adequate drainage of the abscess, the cross-section shape of the retainer can be reduced to facilitate more comfortable and less detrimental removal of the device from the patient. Preferably, the irrigation device is formed via one or multi-shot injection molding and is formed of more than material.

Abstract: Medical devices, as well as methods of treatment and manufacturing such devices, are provided for applying vascular therapy locally within the body vessel. The medical devices include an expandable tubular frame and a sleeve or graft material. The medical devices can be used for local delivery of a therapeutic agent within a body vessel or a tamponade for a lacerated body vessel, while simultaneously allowing perfusion of fluid or blood flow distal of the implanted medical device. The tubular frame of the medical device may have a proximal non-expanding portion and a distal self-expanding support structure. The self-expanding support structure can expand radially outward to urge the graft material to contact the wall of the body vessel. In the expanded configuration, a portion of the device allows fluid flow to continue while the sleeve is against the body vessel wall.

Abstract: Catheters such as guide catheters can be configured to provide distal occlusion, while still providing sufficient interior lumen space for device delivery. Such catheters can also provide a desired level of flexibility, yet can include sufficient column support. A catheter can include an elongate shaft having a distal region, a proximal region and a lumen extending therebetween. A distal occlusion member can be disposed over a portion of the distal region of the elongate shaft and an occlusion activating member can be disposed over the elongate shaft.

Abstract: An obstruction removal device is described, having one or more engaging members which can engage portions of the clot. The one or more engaging members have a collapsed, delivery state, and an expanded, deployed state.

Abstract: Various methods and devices are provided for accessing an interior surgical site using an access portal which can be inserted and removed with minimal tissue damage and which can form a seal with tissue while inserted. Generally, a device is provided having a rigid elongate surgical access member with a lumen extending therethrough that is configured to receive a surgical tool. The device can also include a flexible sleeve having a lumen extending therethrough that is configured to receive the elongate surgical access member. A substantially rigid collar is provided disposed adjacent to a proximal end of the flexible sleeve and having a lumen extending therethrough that is configured to receive the elongate surgical access member.

Abstract: A cystotomy apparatus includes a sound from which an advancement device having a cutting tip creates a surgical pathway from the bladder through abdominal tissue to the external abdomen along a predetermined path. The cutting tip is captured and removed from the advancement device in a capture cup located in the predetermined path by an alignment structure. The cutting tip is removed from the advancement device while within the capture cup, to allow a dilator, cannula or catheter to be drawn through the surgical pathway into the bladder.

Abstract: A fistula catheter which can be inserted and withdrawn without the use of a replacement tool such as a syringe or an extension tool and a fistula catheter that is sparingly invasive for the fistula are disclosed. The fistula catheter can have a substantially cylindrical catheter part; a rod-like bumper part; a guide part provided with a flexible peripheral wall which is bent in such a way that it can overlap the outer peripheral surface of the catheter part and the outer peripheral surface of the bumper part, wherein a catheter insertion opening into which the catheter part can be inserted is formed in said peripheral wall; a flexible first connecting part for connecting the catheter part and the bumper part in such a way as to extend in the axial direction; and a flexible second connecting part for connecting the bumper part and the guide part in such a way as to extend in the axial direction.

Abstract: A combined multi-lumen central access catheter and an embolic filter, further comprising an imaging modality to facilitate intravascular imaging of the filter.

Abstract: A combined multi-lumen central access catheter and an embolic filter, further comprising an imaging modality to facilitate intravascular imaging of the filter.

Abstract: Non-expandable space-occupying devices for treating voids within the body are disclosed. The devices can have multiple non-expandable space-occupying elements connected to a flexible leaden. Methods of making and using the devices are also disclosed.

Abstract: A guidewire including a spreader or at least one centering device which may be used to open occluded vessels or other biological passages, especially chronic total occlusions. The guidewire may be used to either open the lumen or to center a boring device within the lumen, so that the chronic total occlusion can be crossed, and an interventional procedure can then be performed.

Abstract: A guidewire may include a spreader or at least one centering device which may be used to open occluded vessels or other biological passages, especially chronic total occlusions. The guidewire may be used to either open the lumen or to center a boring device within the lumen, so that the chronic total occlusion can be crossed, and an interventional procedure can then be performed.

Abstract: A drug delivery pump drive which uses a linear piezoelectric motor to advance a syringe piston to deliver a liquid drug and a method thereof are disclosed. The pump drive, provided in a drug delivery pump, provides silent operation and very low energy consumption compared to electric motor-based drives. The small size of the motor helps also to reduce overall size of the pump drive and the resulting drug delivery pump.

Abstract: A device and method for creating a connection with the left ventricle of a heart are provided. A seal member capable of moving between a folded position and an open position is attached to the end of a conduit. An introducer capable of moving between a first and second position allows for the expansion of the seal member into an open position. A clamp component is positioned outside of the heart to provide an axial clamping force with the wall of the heart so that a seal is created between the seal member and the wall of the heart.

Abstract: A structure that can be used to provide an anchor in or adjacent to a patient's soft body tissue (rather than bone) includes an annular array of flexible members that extend between two axially spaced but aligned tubular members. The space between the tubular members can be selectively changed to affect the amount by which portions of the flexible members between the tubular member project radially outward relative to the tubular members. When the flexible members project radially out, the structure resists axial movement relative to adjacent tissue and therefore acts as an anchor. When the flexible members do not project radially out, they permit axial movement of the structure through adjacent tissue.

Abstract: A self-centering central access catheter includes a multi-lumen catheter body, a first port associated with a first lumen, and a second port associated with a second lumen. The first and second ports are disposed proximate a distal end of the multi-lumen catheter. A diametrically expansible member is circumferentially coupled to a multi-lumen catheter body and positioned intermediate the first port and the second port. The diametrically expansible member comprises a first portion that is immovably fixed to the multi-lumen catheter body and a second portion that is movably coupled to the multi-lumen catheter body.

Abstract: A combined multi-lumen central access catheter and an embolic filter including ports proximal and distal the filter for fluid infusion and/or pressure sensing and infusion ports in the catheter to permit infusion of bioactive agents, flushing agents and/or contrast agents. The embolic filter may be removably coupled to the multi-lumen catheter for temporary placement and retrieval under recommended indications.

Abstract: A catheter for the local delivery of therapeutic agents and methods of using the same for the treatment or prevention of disease are disclosed. A catheter may include a tubular net and a guidewire attached to the tubular net longitudinally along the abluminal side of the net. The catheter may further include a tubular member that opens onto the abluminal side of the tubular net.

Abstract: A combined multi-lumen central access catheter and an embolic filter including ports proximal and distal the filter for fluid infusion and/or pressure sensing and infusion ports in the catheter to permit infusion of bioactive agents, flushing agents and/or contrast agents. The embolic filter may be removably coupled to the multi-lumen catheter for temporary placement and retrieval under recommended indications.

Abstract: Catheters with laminar flow bioactive agent delivery properties and methods of using for treating or preventing vascular disease are disclosed.

Abstract: A fluid warming cassette for use in a fluid warming system includes a first sheet, a second sheet and a flexible spacer having a serpentine opening. At least one of the first and second sheets is a flexible plastic sheet. The spacer is positioned between the first and second sheets and the first and second sheets are joined together over the spacer to form a fluid container having a fluid channel. The fluid container includes a fluid channel with inlet and outlet ports in fluid communication with the fluid channel. The fluid warming cassette is capable of operating under negative pressure without collapse of the fluid channel in the cassette.

Abstract: A combined multi-lumen central access catheter and an embolic filter including ports proximal and distal the filter for fluid infusion and/or pressure sensing and infusion ports in the catheter to permit infusion of bioactive agents, flushing agents and/or contrast agents. The embolic filter may be removably coupled to the multi-lumen catheter for temporary placement and retrieval under recommended indications.

Abstract: Disclosed is an expandable transluminal sheath, for introduction into the body while in a first, low cross-sectional area configuration, and subsequent expansion of at least a part of the distal end of the sheath to a second, enlarged cross-sectional configuration. The distal end of the sheath is maintained in the first, low cross-sectional configuration and expanded using a radial dilatation device. In an exemplary application, the sheath is utilized to provide access for diagnostic or therapeutic procedures such as ureteroscopy, cardiac electrophysiology, gastroenterology, and spinal access.

Abstract: Non-expandable space-occupying devices for treating voids within the body are disclosed. The devices can have multiple non-expandable space-occupying elements connected to a flexible leader. Methods of making and using the devices are also disclosed.