Abstract: Medical devices that are formed from a polymeric matrix including a first polymer and a functionalized polymer are provided. The medical devices may include a functionalized polymer such as maleic anhydride functionalized polymer. The burst strength and/or the hoop strength of the medical devices including the functionalized polymer may be greater than the burst strength and/or the hoop strength of control medical devices. However, the durometer of the medical devices may be substantially equal to the durometer of the control medical devices. Methods of manufacturing medical devices including a functionalized polymer are also provided.

Abstract: A catheter-based/intravascular ablation (denervation) system includes a multiplicity of needles which expand open around a central axis to engage the wall of a blood vessel, or the wall of the left atrium, allowing the injection of a cytotoxic and/or neurotoxic solution for ablating conducting tissue, or nerve fibers around the ostium of the pulmonary vein, or circumferentially in or just beyond the outer layer of the renal artery. The expandable needle delivery system is formed with self-expanding materials and include structures, near the end portion of the needles, or using separate guide tubes. The system also includes means to limit and/or adjust the depth of penetration of the ablative fluid into the tissue of the wall of the targeted blood vessel. The preferred embodiment of the catheter delivered through the vascular system of a patient includes a multiplicity of expandable guide tubes that engage the wall of a blood vessel.

Abstract: An example catheter includes a handle assembly having a control member, an elongate body, a pull wire, and at least one radiopaque marker. The elongate body defines a lumen configured to receive a medical electrical lead including at least one electrode array. The elongate body includes a proximal portion coupled to the handle assembly and a distal portion that includes an articulating segment and a preformed curve segment. The at least one radiopaque marker is positioned on the distal portion. The pull wire extends from the control member and is anchored to the elongate body distal to the articulating segment such that actuation of the control member controllably bends the articulating segment in a first curve in a first geometric plane. The preformed curve segment defines a second curve in a second geometric plane different from the first geometric plane.

Abstract: Medical appliances including reinforcing bands and radiopaque marker bands are disclosed. In some embodiments, bands may comprise two or more material layers. A first layer may control the mechanical properties of a multilayered marking band, and a second layer may exhibit greater radiopacity than the first layer. Bands may also comprise a single layer.

Abstract: An attachment configuration for a vascular filter assembly including a self-expanding filter member attached to a catheter body and constrained from expansion in a first configuration by a constraining sheath is presented. The attachment configuration includes an outer tube of material that is overlaid over an end of the filter member and bonded to the catheter body through cutouts disposed through the end of the filter member.

Abstract: An imaging marker for use with a catheter, the imaging marker comprising a plurality of segments including at least two stiff segments and at least one flexible segment, wherein for each pair of stiff segments, one of the flexible segments is located therebetween such that the flexible segment is operable to function as a hinge when the imaging marker is bent. In typical embodiments, the stiff segments are visible under a medical imaging system. In some embodiments, the stiff segments are comprised of a radiopaque material which is visible under an X-ray (fluoroscopy) imaging system.

Abstract: A guide wire control device and methods of use are described herein. A novel method for optimizing a guide wire for a patient is described. The method includes steps of scanning a patient's anatomy and then fabricating, or selecting, a guide wire with optimal geometry for a particular patient and/or procedure. The guide wire may optionally be secured to a guide wire control device for improved control during transcatheter surgical procedures.

Abstract: Adapters for a connector assembly for percutaneous tubing are provided. A male adapter (FIG. 22a, 1000) includes a connector fitting (1002) proximate a first end, the connector fitting configured to join to a connector for a tubing system or device, and a male connector (656) proximate a second end. The male connector includes a plug end with a fluid lumen defined therethrough, the plug end having a circumferential groove defined therein to receive a locking extension of a female connector sized to be received within the circumferential groove of the plug end to allow the female connector to rotate relative to and maintain axial engagement with the male connector when the locking extension is received within the groove. An adapter having a female connector (FIG. 24, 1300) is also provided.

Abstract: Sizing catheters that include an inner member and an outer member. The inner member includes an elongate shaft and a plurality of radiopaque markers spaced axially from each other and secured to an outer surface of the shaft, the span of radiopaque markers defining a first portion of the inner member. The outer member that is disposed snugly around and in substantial contact with the inner member along at least the first portion of the inner member.

Abstract: A catheter includes a catheter body having a lumen and a resin front end tip having a lumen that is in communication with the lumen of the catheter body and that is attached to the front/distal end of the catheter body. The catheter body and front end tip further include a coil body and/or a braid such that the coil body and/or braid are arranged along the lumen. Additionally, the catheter further includes a reinforcement body covering the coil body and/or the braid in the front end tip.

Abstract: An endovascular delivery system for an endovascular prosthesis includes a radiopaque marker system for accurate delivery of the prosthesis. The radiopaque marker system is disposed within a prosthesis or stent holder within the delivery system. The radiopaque marker system includes a plurality of radiopaque markers that provide different views rotation of the prosthesis or stent holder.

Abstract: Devices and methods for delivering a therapeutic substance to a patient are provided. Embodiments include infusion sets that include an active agent. Also provided are systems and kits.

Abstract: An elastic cap for covering the distal end of a catheter having inner and outer hoses, characterized in that the cap consists essentially of an elastic material, has a cavity in which the distal end of the inner and the outer hose of a catheter can be received, and the cap has a first opening via which the cavity is accessible from the outside, wherein prior to receiving the distal end of the catheter, the first opening has a diameter which is not larger than the outer diameter of the inner hose of the catheter and wherein the first opening is elastically expandable to a diameter which corresponds to the outer diameter of the outer hose.

Abstract: A system orientates and displays intra-vascular ultrasound imaging data using an acquisition processor and an image data processor. The acquisition processor acquires, during navigation of an ultrasound catheter through a vessel, for multiple individual intra-vascular ultrasound images comprising an image sequence, data representing an individual image and orientation data associated with the individual image indicating orientation of the catheter and individual image with respect to a reference position external to patient anatomy. The image data processor aligns the multiple individual intra-vascular ultrasound images with respect to the external reference position by rotating individual images of the image sequence as necessary to have substantially the same orientation with respect to the external reference position in response to the orientation data.

Abstract: In one embodiment, a method for fabricating a neurostimulation stimulation lead comprises: providing a plurality of ring components and hypotubes in a mold; placing an annular frame with multiple lumens over distal ends of the plurality of hypotubes to position a portion of each hypotube within a respective lumen of the annular frame; molding the plurality of ring components and the hypotubes to form a stimulation tip component for the stimulation lead, wherein the molding fills interstitial spaces between the plurality of ring components and hypotubes with insulative material; and forming segmented electrodes from the ring components after performing the molding.

Abstract: A catheter has an outer peripheral portion (15) in the form of a tube and an internal, wall (16, 26) within the tube forming a plurality of lumens (11a, 11b, 21a, 21b). Axially extending linear contrastradiography sections (17a, 17b, 27a, 27b) of radiopaque material are formed at a plurality of intersection points between the outer peripheral section and the wall, the peripheral extent (a, b) of the respective contrastradiography sections being different.

Abstract: A method, system, and program product are provided for x-ray pose recovery during an endoscopic procedure. An x-ray image is taken with a C-arm at a first pose, capturing a region of an endoscope with fiducials thereon. The C-arm is moved from the first pose to a second pose at another viewing angle while maintaining the position of the endoscope. Another x-ray image is taken with the C-arm at the second C-arm pose, capturing the region of the endoscope with the fiducials thereon. The location of the fiducials on each x-ray image is determined using segmentation. An iterative optimization is performed using the locations of the fiducials in the two x-ray images to form two-dimensional projections of the three dimensional curve of the region of the endoscope with fiducials thereon to determine the three-dimensional translation and rotation of the C-arm from the first x-ray pose to the second x-ray pose.

Abstract: A catheter includes a sheath insertable inside a body lumen and provided with a window portion permeable to inspection waves, a detection unit movable in the axial direction of the sheath inside the sheath and which detects the inspection waves, and a reinforcement tube positionable to cover the inner surface or the outer surface of the window portion and movable in the axial direction of the sheath.

Abstract: A lung volume reduction system is disclosed comprising an elongate implantable device adapted to be delivered to a lung airway of a patient in a delivery configuration and to change to a deployed configuration to compress lung tissue. The implant may be longer in axial length than an axial length of the target axial region in which it is deployed. Deployment may involve allowing an end of the implant to move relative to surrounding tissue while the implant is progressively deployed.

Abstract: A body (2) for a catheter or sheath is disclosed. The body (2) includes strips (8, 10) formed longitudinally from the proximal (6) portion of the body (2) to the distal (4) portion of the body (2). The strips are formed of different materials. The strips can have different radiopacities, or can be splittable/peelable. The splittable/peelable body comprises a peel mechanism longitudinally extending along its respective length. The peel mechanism can be formed by longitudinally extending regions of interfacial bonding between first and second longitudinally extending strips of polymer material. A region of stress concentration extends along the region of interfacial bonding. The stress concentration facilitates the splitting of the body (2) along its peel mechanism. The polymer material of the first strip (8) can have a greater amount of radiopaque filler than the polymer material of the second strip (10). Each strip forms at least a portion of an outer circumferential surface of the body (2).

Abstract: The spiral rotary member includes a main body section, a fin section that is disposed on an outer peripheral surface of the main body section and spirally arranged around a longitudinal axis C and an X-ray cutoff section that cuts off X-rays. The X-ray cutoff section is arranged so that a clear region to be clearly imaged by an X-ray and an unclear region to be unclearly imaged by X-rays are distinguished under X-ray observation in a periaxial direction of the longitudinal axis of the spiral rotary member, the X-ray cutoff sections being further arranged on the same straight line along a longitudinal axis direction of the spiral rotary member or the X-ray cutoff section being further arranged in the form of a band.

Abstract: An atraumatic guidewire kit and method including a guidewire having a soft tip of increased diameter that spreads any force placed on tissue over an increased area resulting in reduced trauma to the tissue.

Abstract: In one instance, a catheter for replacing or adding a guide wire into a patient is provided. The catheter includes a first rapid exchange lumen, a second rapid exchange lumen, and a releasable wire-securing device. A second guide wire is placed in the second rapid exchange lumen and secured into position. The catheter is then advanced along the first guide wire until in position, and then the second guide wire is released from the wire-securing device and advanced into the desired position. The catheter is then removed. Other catheters and methods are also disclosed.

Abstract: Epidural catheters include a tubular member and at least one bend indicator located proximate a distal end of the tubular member to provide a reference point for a user to bend the catheter. Catheter assemblies may include such catheters. Methods of inserting an epidural catheter having a bent distal end into a patient include bending a catheter at a location proximate at least one bend indicator formed proximate a distal end of the catheter and inserting at least a portion of the catheter into a patient. Methods of making an epidural catheter include forming a tubular member having a proximal end and a distal end and forming at least one bend indicator on the catheter proximate the distal end of the tubular member to provide a reference point for a user to bend the catheter.

Abstract: Specified information can be provided to a user, to a machine, or to an automated process using a specified configuration of a plurality of radiopaque rings about at least a portion of an implantable lead.

Abstract: Embolic protection devices and methods for capturing embolic debris. An embolic protection device includes a pigtail catheter having a lumen for housing a guidewire. The distal portion of the catheter has one or more apertures in fluid communication with the lumen and one or more radiopaque markers on the distal-most section. The device includes a self-expanding filter coupled to a side of the catheter and a movable outer sheath surrounding the catheter. The outer sheath holds the filter in a collapsed configuration when surrounding the filter. The outer sheath is proximally retracted to deploy the filter. A method of capturing embolic debris includes inserting a guidewire into a body lumen, tracking the device over the guidewire, retracting the guidewire, positioning the device using the radiopaque marker, retracting the outer sheath and deploying the filter, performing a procedure, and advancing the outer sheath to recapture the filter.

Abstract: According to an embodiment of the present disclosure, a guidewire for performing medical procedures may include a central core. The central core may include a first region having a first width and a distal surface. The central core may also include a second region distal to the first region. The second region may have a second width different than the first width. The second region may also have a proximal surface. At least a portion of the distal surface of the first region may be angled relative to a portion of the proximal surface of the second region. The guidewire may also include a first covering surrounding the first region. The first covering and the first region may form a first covered region having a third width. The guidewire may also include a second covering surrounding the second region. The second covering and the second region may form a second covered region having a fourth width. The third width and the fourth width may be substantially equal.

Abstract: An apparatus for determining a length of a portion of a steering wire disposed within a bendable medical device includes an electrical contact slidably coupled with a steering wire, an electrical source configured to transmit an electrical signal through a portion of the steering wire, and a processor configured to monitor a parameter of the electrical signal at or about the electrical contact and configured to determine a length of a portion of the steering wire using the monitored parameter.

Abstract: A control handle for a steerable catheter body for navigation of the catheter body through a biological lumen and manipulation at a treatment site. The control handle includes a housing assembly that houses a piston assembly and a resistance adjusting assembly. The resistance adjusting assembly can be adjusted to provide the desired frictional characteristics of the user for control of the resistance between the piston assembly and the housing assembly. In one embodiment, the piston assembly is configured to provide a frictional resistance that varies dynamically to substantially match the restorative force across the range of catheter tip deflection. Other embodiments include a vibrating member that provides tactile feedback to the operator to indicate conditions at the distal end of the catheter, such as contact force.

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

Abstract: The present invention provides catheter compositions that provide anti-thrombogenic properties while not adversely impacting mechanical properties. All embodiments of the present invention comprise a catheter that comprises a fluoropolymer additive with specific compositions and/or purity levels.

Abstract: A sacrificial catheter assembly and method of use for placing a functional catheter within the body of a patient, such as into the patient's vasculature, is disclosed. In one embodiment, the sacrificial catheter assembly comprises a sacrificial catheter including an elongate body that defines a longitudinally extending lumen. A stylet is removably received within the lumen of the sacrificial catheter such that the catheter and stylet can be advanced together to a target destination within the body of the patient. The sacrificial catheter is configured so as to then be proximally slid over the stylet to remove the sacrificial catheter from the body while the stylet remains in place at the target destination. A functional catheter can then be distally slid over the stylet to place the functional catheter at the target destination. The stylet can then be removed from the body of the patient.

Abstract: A medical device includes a substrate having at least a portion thereof functionalized with at least one reactive member and a chemotactic agent functionalized with at least one complementary reactive member. The at least one reactive member and the at least one complementary reactive member are covalently bonded, adhering the chemotactic agent to the substrate.

Abstract: A guide wire includes an elongated wire body and a radiopaque part capable of forming an X-ray image and located at the distal end portion of the wire body. The radiopaque part has a radiopaque member and a resin coating layer. The radiopaque member is composed of a metallic material capable of forming an X-ray image and arranged outside the wire body and in the lengthwise direction of the wire body. The resin coating layer covers the radiopaque member and at least part of coating layer contains a radiopaque material capable of forming an X-ray image. The radiopaque part is divided into a first radiopaque region, a second radiopaque region, and a third radiopaque region which are sequentially arranged from the distal end in the lengthwise direction of the wire body.

Abstract: Embodiments of the present disclosure describe a guide extension catheter with a retractable wire. The guide extension catheter may include a proximal shaft having a first outer diameter. The guide extension catheter may further include a distal sheath attached to the proximal shaft and having a second outer diameter greater than the first outer diameter. Further, the distal sheath may have a central lumen defined therein and a secondary lumen formed along a wall surface of the distal sheath.

Abstract: The present invention relates to a catheter that has adjustable stiffness that enables a user to select the stiffness of at least one region of the catheter during insertion and navigation through a body lumen. A preferred embodiment of the invention works in combination with a guidewire to enable placement of the catheter at a position within the vascular system, for example, to enable treatment of a variety of medical conditions. The catheter can include segments that undergo relative movement in response to actuation by the user to adjust the flexibility of the at least one region, preferably located at or near the distal end of the catheter.

Abstract: The present invention provides catheter compositions that provide anti-thrombogenic properties while not adversely impacting mechanical properties. All embodiments of the present invention comprise a catheter that comprises a fluoropolymer additive with specific compositions and/or purity levels.

Abstract: Materials and methods for reducing or preventing bleeding and associated side effects during and after percutaneous medical procedures.

Abstract: A maneuverable feeding tube system can include: a feeding tube having an internal lumen and distal opening; a maneuverable tube having a flexible distal end being located within the internal lumen of the feeding tube such that the flexible distal end is associated with the distal opening of the feeding tube, wherein the flexible distal end includes one or more flex members; a control member operably coupled to a flexible distal end of the maneuverable tube and extending through the internal lumen of the feeding tube; and a port coupled to a proximal end of the feeding tube with the control member extending therethrough.

Abstract: A medical device including a shaft having an elongated inner member and an elongated tubular reinforcing member disposed over at least a portion of the inner member. In some embodiments, at least a portion of the outer surface of the inner member is spaced from the inner surface of the reinforcing member, defining a space substantially free of any other structures of the device. In some embodiments, the shaft can include a tip structure disposed on a distal portion of the inner member. In some such embodiments, the reinforcing member has a distal end, and the tip structure is disposed on the distal portion of the inner member adjacent the distal end of the reinforcing member. Additionally, in some embodiments, the reinforcing member can include a plurality of apertures defined therein, for example, to enhance the flexibility or other such characteristics of all or portions of the reinforcing member.

Abstract: Devices and methods for penetrating from a vessel lumen in which a catheter device is positioned to a target location outside of that vessel lumen. A tissue penetrator advances from a catheter positioned within the vessel lumen to the target location when properly aimed. An imaging transducer fixedly mounted on or within the catheter body provides an imaging signal from which an image of the target location can be obtained. An imageable marker may be present on the catheter to form on the image obtainable from the imaging signal to predict the path that will be followed by the tissue penetrator when the tissue penetrator exits from the catheter. Alternatively, or addition thereto, the imaging transducer may comprise a plurality of imaging elements which are located so that the penetrator path indication can be obtained electronically without use of an imageable marker on the catheter.

Abstract: A microcatheter for delivering embolic agent to a vascular site is provided. The microcatheter has a biocompatible or biocompatible and biodegradable tip which can be detachably engaged to the microcatheter body by a thermoplastic sleeve. Once the embolic agent is delivered to the desired vascular site, the tip of the microcatheter is often entrapped within the mass of the liquid embolic fluid. Using the microcatheter, the clinician can retract the microcatheter at a predetermined retraction force thereby disengaging the tip from the microcatheter body allowing for easier removal of the microcatheter.

Abstract: The present invention provides and apparatus and methods for emboli removal and stenting within the renal arteries having a catheter system having a distal occlusion element, a stent deployment section, and an emboli removal lumen. The occlusion element is disposed at a predetermined distance from the stent deployment section specific for use in the renal artery, and is constructed to reduce the potential for perforation or jailing during stent deployment. The apparatus further includes an array of radio-opaque markers disposed on the stent delivery catheter to facilitate accurate stent deployment within a renal artery.

Abstract: Systems, devices, and methods comprising an instrument for treating an anatomical opening such as a paranasal sinus.

Abstract: Complex steerable catheter visualization and tissue manipulation systems and their methods of use are disclosed herein. The deployment catheter is articulated using various steering mechanisms. Tissue visualization is accomplished from the visualization hood at the distal end of the deployment catheter, the hood having an ability to expand and other features to facilitate visualization and articulation at the tissue surface.

Abstract: A splittable/peelable tubular body (2) of a catheter or sheath wherein the tubular body (2) has a splittable/peelable atraumatic tip (14) is disclosed. The atraumatic tip (4) is generally softer than the tubular body (2). The tubular body (2) and atraumatic tip (4) each comprise a peel mechanism longitudinally extending along their respective lengths. The peel mechanisms are formed by longitudinally extending regions of interfacial bonding (11) between first and second longitudinally extending strips (8, 10) of polymer material. Each strip (8, 10) forms at least a portion of an outer circumferential surface of the tubular body (2) and atraumatic tip (4). A region of stress concentration extends along the region of interfacial bonding. The stress concentration facilitates the splitting of the tubular body (2) and atraumatic tip (4) along their respective peel mechanisms.

Abstract: A balloon catheter having a radiopaque coil embedded in the catheter's body corresponding to a landmark of the balloon or other location on the catheter body. The radiopaque coil can be viewed under fluoroscopy to located the balloon or other structure of the catheter. The coil can be readily inserted in the manufacturing process by inserting it between two layers that form the catheter body, and then sealing the coil inside the catheter at the desired location. This facilitates both the manufacturing process and prevents the marker from being dislodged during the manufacturing, navigation, or inflation process.

Abstract: High radiopacity is achieved in a polymeric marker by combining a polymeric resin, a powdered radiopaque agent having uniformly shaped particles of a specific particle size distribution and a wetting agent. The method to produce the marker calls for the blending and pelletization of these materials followed by extrusion onto support beading. The resulting supported tubing is subsequently cut to length with the beading still in place. After ejection of the beading remnant the marker is slipped into place on the device to be marked and attached by melt bonding. Marking of a guidewire allows lesions to be measured while the marking of balloon catheters allow the balloon to be properly positioned relative to a lesion.

Abstract: Catheter devices having low profile shafts and laterally deployable members (e.g., cannulas, needles, etc.) that may be extended or advanced laterally from the catheter shaft. Also disclosed are methods for bypassing a vascular obstruction (e.g., a chronic total occlusion or other full or partial obstruction) wherein a guidewire is entrapped in a subintimal space adjacent to the obstruction. A catheter of the foregoing character is advanced over the entrapped guidewire and into the subintimal space. The laterally deployable member is then advanced or extended from the subintimal space back into the true lumen of the blood vessel distal to the obstruction. A second guidewire is then advanced through or along the laterally deployable member. The catheter and first guidewire are then removed and one or more working device(s) (balloons, atherectomy devices, setnts, etc.) is/are advanced over the second guidewire and used to establish a subintimal bypass channel through which blood may flow around the obstruction.

Abstract: Medical devices and methods for making and using medical devices are disclosed. An example medical device may include a guide extension catheter. The guide extension catheter may include a proximal shaft having a first outer diameter. A distal sheath may be attached to the proximal shaft and may have a second outer diameter greater than the first outer diameter. A trackable tip member may be attached to the distal sheath and extending distally therefrom. The trackable tip member may define a guidewire lumen therein.