Abstract: A medical device such as a catheter may have an elongate shaft that includes a hypotube having a cut formed therein. The elongate shaft may define a lumen that extends within the elongate shaft. A polymer may be disposed over at least a portion of the hypotube. A medical device may include a cut hypotube having a constant pitch and may be configured to reversibly and temporarily alter the pitch of at least a portion of the cut hypotube. In some cases, the medical device may be configured to reversibly and/or temporarily alter a compressive strength of at least a portion of the cut hypotube.

Abstract: A compliant catheter adapter may include a catheter adapter body formed of a compliant material. The catheter adapter body may have a generally elongate shape and an inner chamber. The catheter adapter body may include a compression resistant septum disposed toward the proximal end of the catheter adapter body. The compression resistant septum may have a lumen configured to receive an elongate object. The compression resistant septum may also be coupled to a compression cap that imparts a compression force on the compression resistant septum such that the lumen narrows and seals when the elongate object is removed from the lumen.

Abstract: A dilation apparatus comprises an elongate member and a dilation assembly that is slidable along the elongate member. The dilation assembly comprises a platform and an inflatable dilator. The platform and the elongate member cooperate to absorb inflation forces from the dilator directed toward the longitudinal axis of the elongate member, such that the dilation forces are exerted against tissue asymmetrically relative to the longitudinal axis of the elongate member. The dilation apparatus may be used to dilate the ethmoid infundibulum in a human patient. Various devices may be used to maintain the dilated state of an ethmoid infundibulum, including a wedge, a mesh, and a tether. An illuminator may be configured to reach around an uncinate process, retract the uncinate process, and then illuminate the ethmoid infundibulum to provide improved visualization of the ethmoid infundibulum.

Abstract: A device and method for a guidance sheath is provided which is configured to prevent laceration or puncture of nerves, blood vessels and surrounding tissue, during positioning of a coaxially located needle employed for various medical procedures, such as, the administration of an anesthetic blockade, neuromonitoring, electromyography or a therapeutic intervention.

Abstract: A catheter insertion device includes a housing, a needle, a catheter, and a guide wire. The needle has a proximal end positioned in the housing and a distal end extending beyond a distal end of the housing in a first position. The catheter is positioned coaxially over the needle, and may include a flexible tube and a catheter hub on a proximal end of the flexible tube. A proximal portion of the flexible tube and the catheter hub may be positioned in the housing. The guidewire may have a proximal end positioned in the housing and a distal end positioned in a lumen of the needle. The catheter insertion device also may include a handle coupled to the catheter, wherein movement of the handle relative to the housing moves the catheter hub from a position in the housing to a position outside of the housing.

Abstract: A device to assist with the insertion of a nasal bridle includes an insertion guide and an introducer that is attached to bridle tape. The guide is switchable between two configurations: a substantially straight configuration and a second configuration in which an exit aperture at an upper end of the guide is either at a downwardly oriented angle and/or displaced laterally from the guide longitudinal axis, for example by causing the upper end of the guide to adopt a u-bend. The guide is inserted into a nostril while straight and then adopts its second configuration. The introducer is pushed through the guide and, at the exit, is guided beyond the septum into and out of the opposite nostril. Introducer and tape are pulled through the nasal passage before removing the guide. The guide therefore ensures that introducer and tape are held clear of the septum, reducing discomfort.

Abstract: Devices, systems and methods using two, three or more pigtails for precisely imaging an aortic valve complex with minimal contrast and/or for advancing an instrument, such as a wire, or device, such as a transcatheter valve, across an aortic valve. These devices, systems and methods may be used to diagnose and/or treat patients with aortic stenosis, other valvular heart disease or other cardiovascular or non cardiovascular disease, facilitating precise contrast or drug or device delivery, precise pressure measurement and/or precise drainage or sampling.

Abstract: A system for magnetically suspending tissue includes a grasper placement tool, a tissue grasper, a magnetic coupling element, and a tether which secures the magnetic coupling element to the tissue grasper. The grasper placement tool is used to simultaneously introduce both the tissue grasper and the magnetic coupling element to a body cavity. The grasper then releases the magnetic coupling element and engages a target tissue structure. The tissue grasper is then detached from the placement tool and a conventional laparoscopic or other grasper is used to engage the magnetic coupling element to an external magnet.

Abstract: A transseptal needle or punch wherein the distal end of the transseptal needle is able to articulate laterally out of the longitudinal axis of the steerable transseptal needle. The transseptal needle further comprise a blunted distal end configuration that is minimally traumatic. Under control by the user or a computer, at the proximal end of the transseptal needle can be articulated to generate various curves with high bending force. The transseptal needle is configured for use within a transseptal introducer.

Abstract: A surgical access port is provided with a trocar cannula having a substantially rigid portion and an atraumatic distal tip. The atraumatic distal tip is substantially compliant relative to the rigid portion of the cannula. The trocar cannula provides unobstructed surgical access into a body cavity allowing the insertion and removal of surgical instruments through the trocar cannula and into the body cavity using a minimal sized incision or entryway.

Abstract: A self-slitting open lumen cannula may be used with catheter adapters to reduce manufacturing complexity and costs, as well as improve the safety of the catheter adapters against fluid leakage. The open lumen cannula may also include one or more notches to facilitate flashback visualization. The catheter adapters may further include a catheter adapter body formed of a compliant material that houses one or more compression resistant septa with at least one lumen formed by the proximal end of the needle during a self-slitting process as the catheter adapter is assembled. The compression resistant septum may also be coupled to a compression cap that imparts a radial compression force on the one or more compression resistant septa such that the at least one lumen narrows and seals when the cannula is removed.

Abstract: A cannula includes at least one opening at a distal tip, and further includes multiple fenestrations that are maintainable in position substantially immediately or slightly beyond a site or point of cannula entry into a vessel. The fenestrations, in combination with the opening(s) at the cannula's distal tip, enable the simultaneous perfusion of blood into the cannulated vessel along multiple directions, including opposing or anti-parallel blood flow directions relative to a central axis of the cannulated vessel. During a medical procedure (e.g., an extra-corporeal membrane oxygenation (ECMO) procedure) blood introduced into a vessel such as the femoral artery by way of the cannula can thus exit the cannula in a manner that provides concurrent blood flow in a first direction towards the heart and a second direction away from the heart.

Abstract: The invention relates to a spatial dimension determination device for determining a spatial dimension of a target element like a vessel within an object (9), for instance, within a person. Movement parameters describing a movement of an introduction element (4) moved by a moving unit (2) like a robot and several images showing the introduction element are used for determining a dimensional relation between an image dimension and a real dimension. A further image showing the target element is provided, wherein a real dimension of the target element is determined based on an image dimension of the target element in the further image and based on the determined dimensional relation. An unknown real physical dimension of a target element within the object can therefore accurately be determined from an image of the target element by using, inter alia, the movement parameters.

Abstract: Electrode devices having directional electrodes for use in deep brain stimulation or other uses. In one aspect, an electrode assembly comprises an elongate lead and a lead guide that are engageable with each other in a coaxial relationship. When the elongate lead and the lead guide are engaged with each other, the two components are rotationally fixed in relation to each other. In another aspect, an elongate lead comprises a radiologically-visible feature for indicating the orientation of the elongate lead. In yet another aspect, an electrode system is capable of determining the position and/or orientation of an electrode positioned within a body. In other aspects, methods for electrically stimulating a target site in the body are disclosed.

Abstract: An elongated medical device with a modified drive surface for use with a drive mechanism of a robotic system includes an elongate body having a distal portion configured to navigate the lumen of a human body channel and a proximate portion having a surface different from that of the distal portion and adapted to better interact with the driving mechanism than the surface of the distal portion. The surface of the proximate portion may include at least one of an optical or a magnetic marker.

Abstract: Apparatuses of the type broadly applicable to numerous medical applications in which it is desirable to insert one or more steerable or non-steerable catheters or similar devices into a working channel of an associated device, such as an endoscope, catheter, etc., or passageway of a patient, are disclosed. The apparatuses may include catheters having a dedicated guide wire channel and one or more of the following: viewing capabilities, a working channel, and auxiliary channels, such as insufflation/irrigation channels. The catheters may include a guide wire channel that is configured to provide the catheter or other device with rapid exchange capabilities.

Abstract: In the present invention, a system and method for selection of an optimal catheter for use in a medical procedure relative to the anatomy of a patient includes the steps of providing a system including a scanning device capable of obtaining image data on a ROI within the anatomy of a patient and reconstructing a 3D image of the ROI from the image data, a display capable of illustrating the 3D image and a 3D catheter model, and a CPU operably connected to the scanning device and the display and operable to analyze the 3D image in comparison with the 3D catheter model, obtaining image data of the ROI of the patient, reconstructing a 3D image of the ROI from the image data and comparing the 3D catheter model with the 3D image of the ROI to determine the catheter with the optimal configuration for use in the procedure.

Abstract: A balloon catheter for insertion in a vessel includes a catheter shaft and an inflatable balloon attached to the catheter shaft. Markings along a longitudinal axis of the catheter are provided in an interior of the balloon, such as for measuring a distance within the vessel. A first distance separating a first marking from a second adjacent marking may be different from a second distance separating the second marking from the third adjacent marking. The markings may also be used for ensuring the proper positioning of the balloon and, in particular, the working surface thereof, relative to a treatment area.

Abstract: Thermoplastic silicone elastomer compositions are disclosed. The thermoplastic elastomer compositions comprise a blend of an organic thermoplastic elastomer and a silicone composition. A process for forming a vulcanized thermoplastic elastomer composition is also disclosed. The thermoplastic elastomer compositions can be used to form functional and/or aesthetic automotive parts such as gear knobs, seat belt connectors, interior mats, airbag protective covers, and over-molded skins for dash boards and armrests; to form appliance parts; to form soft-feel grips for hand held devices; and to form medical devices, sporting goods and general rubber parts. The thermoplastic elastomer compositions provide durable aesthetics, haptic and ergonomic properties along with stability to most commonly used chemicals and high mechanical performance, abrasion and scratch resistance.

Abstract: An introducer for a medical lead, the introducer having an arcuate component for creating an arcuate path in a patient. When used to percutaneously implant a medical device such as a medical lead with electrodes, the implanted lead has an arcuate configuration. The implanted lead can be used to at least partially encircle or bracket a region of chronic pain and provide therapeutic electrical signals to the region.

Abstract: Delivery devices, systems, and methods for delivering implantable leadless pacing devices are disclosed. An example delivery device may include a proximal section including a deflection mechanism for deflecting the proximal section, and a distal holding section extending distally of a distal end of the proximal section and defining a cavity therein for receiving an implantable leadless pacing device. The delivery device may include more than one deflection mechanism for deflecting the proximal section at multiple deflection regions. The delivery device may include more than one tubular member that are translatable relative to one another, and the one or more tubular members may include fixed curve portions. The delivery device may include an atraumatic or bumper tip at the distal end of the holding section.

Abstract: The present disclosure teaches a novel medical device and method of use, employing a unique shape that allows the device to use the lesser (inferior) curve of aortic Arch as a fulcrum of support for a guide catheter, for subsequent prevention of recoil and displacement thereof, while delivering additional catheters or devices into the distal branches of the great vessels. A method for using same.

Abstract: Distal access aspiration guide catheter system and methods for delivering implantable devices, catheters, or substances in or near and/or restoring flow through body lumens, such as blood vessel lumens are described. A Distal access aspiration guide catheter having a proximal, medial, and distal possessing high flexibility, high resistance to kinking and a large lumen to wall thickness ratio.

Abstract: A catheter tip for guiding the catheter through a patient's blood vessels and keeping the catheter in large vessels and preventing entry into smaller branch vessels.

Abstract: Various embodiments are described herein of methods and systems for measuring at least one mechanical characteristic of a soft material are provided according to the teachings herein. The embodiments described herein generally employ the use of a mechanical inclusion in the soft material, measuring at least one pressure and volume data point and applying a mechanical relation associated with the mechanical characteristic(s) to the measured data point(s) to determine the mechanical characteristic(s).

Abstract: A clot retrieval device may include an elongate shaft and an expandable section. The expandable section may include a framework of interconnected strut elements. The connection region between adjacent strut elements may include crown elements. Additionally, the framework may be formed from a substrate material and at least a portion of a plurality of said strut elements may be coated with a coating material. Further, at least a portion of a plurality of said crown elements may not be coated with said coating material.

Abstract: Catheters, sheaths, or other tubular devices are provided that include a proximal end, a distal end sized for introduction into a patient's body, and a steerable distal portion. The tubular device includes a primary lumen extending between the proximal and distal ends; an auxiliary lumen adjacent the primary lumen; and one or more reinforcement members including windings extending helically along at least the distal portion, at least some of the windings passing between the primary and steering element lumens and at least some of the windings surrounding both the primary and steering element lumens. In one embodiment, a steering element is slidably disposed within the auxiliary lumen. Apparatus and methods for making such tubular devices are also provided.

Abstract: The present document describes a pressure guidewire. It comprises a shaft tube having a proximal section and a sensor housing having a distal end, the proximal section and the sensor housing being the continuity of the same shaft tube. A fiber optic pressure sensor is embedded in the sensor housing and comprises an optical fiber extending within the sensor housing, the sensor adapted to measure a pressure of a fluid which is substantially applied in an axis collinear with the longitudinal axis of the guidewire. A marker band, to help in localizing the pressure guidewire in a patient's vessels, is embedded inside the sensor housing and fixed to the optical fiber for holding the pressure sensor inside the sensor housing.

Abstract: The present embodiments provide system and methods for deploying an endoluminal prosthesis. In one example, the system comprises a sheath, and a stent-graft disposed within the sheath in a delivery state. A pusher having proximal and distal sections is disposed at least partially within the sheath in the delivery state. An orientation marker is disposed on the pusher. The orientation marker extends less than 360 degrees around a circumference of the pusher.

Abstract: Systems for less invasive medical procedures comprise a filter device mounted on an integrated guiding structure and an aspiration catheter. These components can be used together or separately, and the system can be used with other medical devices that are designed for less invasive procedures, such as procedures in a patient's vasculature. The filter device can involve improved torque coupling with a torque coupler associated with a resilient member that correspondingly also provides increased flexibility relative to an overtube that forms a tube for the remaining portions of the device. An actuation tool for the filter device used a systematic loading procedure for proper loading of the corewire and overtube into the actuation tool. A fiber cartridge comprises fibers loaded as a bundle into the cartridge for delivery with the ends of the fibers respectively bonded to radiopaque markers that can be visualized to come together when the filter is properly deployed.

Abstract: A high-pressure tube comprises several co-extruded layers which include a reinforcing inner layer. Said reinforcing inner layer exhibits a mixture of a block copolymer and a homopolymer. As a result, a high-pressure tube is obtained the bending stiffness of which is reduced.

Abstract: An elongated medical device with a modified drive surface for use with the driving mechanism of a robotic system. The elongated medical device has a distal portion configured to navigate the lumen of a human body channel and a proximate portion with a surface different from that of the distal portion and adapted to better interact with the driving mechanism than the surface of the distal portion.

Abstract: A guide wire control device and methods of use are described herein. A guide wire is retained by a lock mechanism to a translating assembly within a stationary tubular structure. A rotating actuator controls the translation of the translating assembly and resulting guide wire. The guide wire control device provides improved control of guide wires and angles of a deployment capsule during transcatheter surgical procedures.

Abstract: A guide wire control device and methods of use are described herein. A guide wire is retained by a lock mechanism to a sliding assembly. The sliding assembly controllably moves within a stationary assembly. The guide wire control device provides improved control of guide wires during transcatheter surgical procedures.

Abstract: In a capsule endoscope, on an inside of a capsule type housing including a cylindrical main body section and two semispherical end cover sections and having a rotationally symmetrical shape with respect to a center axis of the housing, an image pickup board section, a transmission board section, and a reception board section are housed such that principal planes of the image pickup board section, the transmission board section, and the reception board section are orthogonal to the center axis. A coil wire of at least one of a transmission coil formed by a transmission coil wire and a reception coil formed by a reception coil wire, respective principal planes of which are orthogonal to the center axis, is disposed on the end cover section side of the housing.

Abstract: An introducer assembly includes an introducer element (80), which may have a catheter or sheath (82), a pusher element (84) holding an implantable medical device (88) and a dilator tip (90). The assembly also includes a protective sleeve (72) within which the introducer element (80) is disposed. The protective sleeve (72) is made of an absorbable hydrophilic material which is deployed in a wetted condition and acts as a cushion or barrier between the introducer element (80) and the vessel wall (60). The sleeve can prevent trauma to the vessel during the deployment of the introducer element (80) and as a result can avoid vessel spasm which can occur in delicate vessels such as the cerebral vessels. The introducer assembly may be used for cerebral applications.

Abstract: Medical devices and methods for making and using the same. An example medical device may include a tubular member and a liner disposed within the tubular member. The tubular member may have a plurality of slots formed therein. A space may be defined between the tubular member and the liner. One or more bonding members may be disposed in the space.

Abstract: A system for providing a remote center of motion for robotic control includes a marker device (104) configured to include one or more shapes (105) to indicate position and orientation of the marker device in an image collected by an imaging system (110). The marker device is configured to receive or partially receive an instrument (102) therein, the instrument being robotically guided. A registration module (117) is configured to register a coordinate system of the image with that of the robotically guided instrument using the marker device to define a position in a robot coordinate system (132) where a virtual remote center of motion (140) exists. Control software (136) is configured to control a motion of the robotically guided instrument wherein the virtual remote center of motion constrains the motion of a robot (130).

Abstract: The present disclosure is directed to devices for approximating body vessels and method for performing the same. In accordance with one aspect of the present disclosure, the device includes an inner member having a first expandable anchor operatively coupled near a distal end thereof, an outer member having a second expandable anchor, and a sleeve disposed about at least a portion of the inner member and the outer member.

Abstract: The present disclosure is directed to devices for approximating body vessels and method for performing the same. In accordance with one aspect of the present disclosure, the device includes an inner member having a first expandable anchor operatively coupled near a distal end thereof, an outer member having a second expandable anchor, and a sleeve disposed about at least a portion of the inner member and the outer member.

Abstract: An apparatus for monitoring EMG signals of a patient's laryngeal muscles includes an endotracheal tube having an exterior surface and a first location configured to be positioned at the patient's vocal folds. A first electrode is formed on the exterior surface of the endotracheal tube substantially below the first location to receive EMG signals primarily from below the vocal folds. A second electrode is formed on the exterior surface of the endotracheal tube substantially above the first location to receive EMG signals primarily from above the vocal folds. The first and second electrodes are configured to receive the EMG signals from the laryngeal muscles when the endotracheal tube is placed in a trachea of the patient.

Abstract: An access device places a medical article within a body space of a patient. The device has a needle that includes an elongated body and a needle hub. The device further includes a dilator disposed on and slideable along the elongated body of the needle and a medical article. The medical article is disposed on and slideable along the dilator. A track extends in a proximal direction from the dilator. The needle hub slides along at least a portion of the track between a first position and a second position. The device further includes a locking mechanism operably disposed between the track and the needle hub so as to inhibit further axial movement of the needle in the proximal direction when the needle hub is in the second position.

Abstract: Mechanical delivery system for neurovascular embolization apparatus and method of use. A mechanical system for delivery of implants, such as coils for endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and ateriovenous fistulae, may include a detachment system for the release of a coil that deforms a detent to release (or eject) the implant.

Abstract: A medical catheter assembly includes a catheter tip coupled to a distal end of an elongate catheter member and is symmetric about a plane defined by a septum of the elongate catheter member. The catheter tip defines first and second lumens, and the catheter tip defines first and second openings in the distal portion of the catheter tip. Each opening of the catheter tip is defined by a respective side surface of the catheter tip. Each opening is in fluid communication with a respective one of the first and second lumens of the catheter tip and with a respective one of a pair of lumens defined by the elongate catheter member. The distance between upper and lower surfaces of the catheter tip decreases from a distal end of the proximal portion toward a closed distal end of the catheter tip.

Abstract: An instrument includes a handle portion, an actuator, a shaft, a rigid member, and an angular control mechanism. The shaft has a proximal end and a distal end with an electrode region, and a flexible region in between. Moving the actuator causes portions of the flexible region distal of a pivot region to bend such that an angular orientation and a radial offset of the electrode region reach an angular orientation and a radial offset, respectively, when the actuator reaches the end position. A distal portion of the rigid member defines the pivot region. Moving the rigid member along the shaft causes the pivot region to translate. The radial offset varies depending on the position of the pivot region.

Abstract: A delivery system for delivering a medical device through a vasculature can include a capsule for housing the medical device during delivery and a marker band rotatably fixed to the capsule. The marker band can include a band portion and a single indicator protruding from the band portion. The indicator can allow the rotational orientation of the marker band to be determined while the medical device is in the vasculature, the rotational orientation being around a central axis of the vasculature. A delivery system for delivering a medical device through a vasculature includes a capsule for housing the medical device during delivery and a marker band attached to a proximal end of the capsule. The marker band can include a base portion and a protrusion that can be configured to extend from the base portion towards a distal end of the capsule. Related methods are also described.

Abstract: Sinusitis and other disorders of the ear, nose and throat are diagnosed and/or treated using minimally invasive approaches with flexible or rigid instruments. Various methods and devices are used for remodeling or changing the shape, size or configuration of a sinus ostium or duct or other anatomical structure in the ear, nose or throat; implanting a device, cells or tissues; removing matter from the ear, nose or throat; delivering diagnostic or therapeutic substances or performing other diagnostic or therapeutic procedures. Introducing devices (e.g., guide catheters, tubes, guidewires, elongate probes, other elongate members) may be used to facilitate insertion of working devices (e.g. catheters e.g. balloon catheters, guidewires, tissue cutting or remodeling devices, devices for implanting elements like stents, electrosurgical devices, energy emitting devices, devices for delivering diagnostic or therapeutic agents, substance delivery implants, scopes etc.

Abstract: Peripheral catheters having diffusion holes can be reinforced by embedding stripe material within the material of the catheter tube body. The stripe material can be embedded using a coextrusion process. The stripe material may consist of one or more stripes which may be arranged in a straight or non-linear pattern such as a helical pattern. The diffusion holes can be positioned between adjacent stripes or between adjacent portions of a single stripe. The diffusion holes can be formed after the stripe material has been embedded. A lubricant may be applied to a peripheral catheter that includes stripe material and diffusion holes.

Abstract: An introducer sheath/temperature probe assembly that is insertable into a blood vessel of a human or veterinary patent to measure the temperature of blood flowing through that blood vessel. The introducer sheath/temperature probe assembly may be used in conjunction with an indwelling heat exchange catheter system to warm or cool all or a portion of the patient's body to a desired target temperature and to maintain such target temperature for a desired period of time.

Abstract: An introducer is configured to distinguish an introducer provided with a sheath tube whose wall thickness is reduced, from an introducer provided with a sheath tube whose wall thickness is not reduced, and to recognize the relationship between the inner diameter and the outer diameter for the sheath tube in which the wall thickness is reduced. The introducer includes an introducer sheath and a three-way stopcock portion. The introducer further includes a first information piece on at least one of the introducer sheath and the three-way stopcock portion and has an inner diameter dimension of the sheath tube as an index. Furthermore, a second information piece having an outer diameter dimension of the sheath tube as an index is on at least one of the introducer sheath and the three-way stopcock portion.