Abstract: Methods, systems and devices are provided for performing lung volume reduction in patients suffering from chronic obstructive pulmonary disease or other conditions where isolation of a lung segment or reduction of lung volume is desired. The methods are minimally invasive with instruments being introduced through the mouth (endotracheally) and rely on isolating the target lung tissue segment from other regions of the lung and occluding various lung passageways with the use of occlusal stents. The occlusal stents are delivered with the use of an occlusal stent delivery system which is loaded with the occlusal stent with the use of an occlusal stent loading system.

Abstract: A thin-walled introducer sheath is described. In some embodiments, the introducer sheath includes structural support components, such as wires, used in connection with a polymeric inner coating, a polymeric outer coating, or both. Further, in some embodiments, the wire components are annealed to reduce cold-work-related stresses and hardness. Use of annealed components may enable a reduction in the thickness of the polymeric outer coating in some applications.

Abstract: An introducer assembly is composed of an introducer sheath and a dilator which have been previously integrated with each other to permit the hemostatic valve to exhibit its hemostatic function over an extended period of time without significantly adversely affecting the inherent function of the dilator tube. The introducer assembly includes a dilator tube passing through a passage of a hemostatic valve. The introducer assembly has a deforming member arranged between the hemostatic valve and a cap. As the cap is pushed toward the proximal end surface of a sheath hub for engagement with the sheath hub, the cap presses the hemostatic valve and applies a compressive force to the hemostatic valve in such a direction as to close the passage.

Abstract: A lead assembly includes a lead with a distal end and a proximal end. The lead includes a plurality of electrodes disposed at the distal end and a plurality of terminals disposed at the proximal end. The lead also defines at least one central lumen and a plurality of outer lumens. The central and outer lumens extend from the proximal end to the distal end such that the plurality of outer lumens extend laterally from the at least one central lumen. The lead further includes a plurality of conductive wires. Each conductive wire couples at least one of the plurality of electrodes electrically to at least one of the plurality of terminals. At least two conductive wires are disposed in each of the plurality of outer lumens.

Abstract: A tubular body for a medical device for insertion within a body passageway of a patient. The tubular body includes a tubular inner liner. A braided member is disposed along an outer surface of the liner. The braided member includes intersecting filaments and cells defined by the filaments. A securement mechanism, such as radiopaque solder, is disposed along a circumferential region of the braided member. The securement mechanism is attached to portions of the filaments and spans the cells that correspond to the circumferential region to inhibit relative movement of filament ends. An outer surface of the securement mechanism is sized to extend radially outward to a position up to an outer surface of the braided member to not add to the overall wall thickness of the tubular body. An outer jacket is positioned longitudinally around the braided member and connected to the inner liner.

Abstract: A tear-away sheath (8) having a tubular element (10) with a distal end and a proximal end, at least one axial fault line (12), and an integral stop (16) is disclosed. The tear-away sheath may also have a handle (14) or closing element at the proximal end. An angioplasty balloon catheter (22) having the disclosed tear-away sheath is also disclosed.

Abstract: A long catheter can be inserted into a patient while eliminating the need for a sterile field by incorporating the long catheter into an infusion tubing and carrying it in with the infusion. The long catheter has a structure that prevents it from leaving the infusion set when fully extended and therefore becomes a connector for fluids to transfer down the long catheter by infusion through the infusion set. Use of an adjustable seal connector allows the catheter to be stopped at varying points during insertion and even to allow the catheter to be reversed by pulling suction on the infusion set and retracting the catheter back into the tubing. This also remains within the sterile confines of the infusion set and therefore is prevented from becoming contaminated.

Abstract: Introducer sheath for use in inserting a balloon catheter into a patient's vasculature includes a tubular member having an inner diameter, an outer diameter, a proximal end, a distal end, and a length therebetween, the inner diameter being sized to receive a catheter shaft having an attached expandable member in a deflated condition. The inner diameter can be varied from a first inner diameter at the proximal end and a second inner diameter at the distal end, the first inner diameter being greater than the second inner diameter. A method of inserting a balloon catheter into the vasculature of a patient is also disclosed. Additionally, a balloon catheter kit including a catheter and an introducer sheath is disclosed.

Abstract: A catheter assembly for cannulating an ostium of a coronary sinus of a heart comprises an outer catheter member and an inner catheter member. The outer catheter member has a distal end portion including a deflectable distal end and a lumen extending through the deflectable distal end, wherein the distal end portion includes regions of varying stiffness and has a pre-formed curvature. The inner catheter member is slidably and rotatably disposed within the lumen of the outer catheter member, and has a distal end portion including a distal end, and a lumen extending through the distal end. The distal end portion of the inner catheter member has regions of varying stiffness and a pre-formed curvature. The outer and inner catheter members are configured such that relative translation and rotation of the outer and inner catheter members causes the distal end of the outer catheter member to assume a plurality of two and three dimensional shapes.

Abstract: A connecting device for a catheter assembly is disclosed allowing a user to connect a catheter assembly to an adhesive pad which is then capable of anchoring the catheter assembly to a patient's leg. The connecting device may have an introducer body with an extension body and an attachment mechanism. The connecting device can be rotated along with or within a collar in a circular manner in order to facilitate the making of the connection with the adhesive pad. Additionally, the connecting device may contain an enlarged portion to enhance operability.

Abstract: The present invention relates generally to devices and systems for detecting infection within catheters. In particular, the present invention provides catheter testing systems configured to sterilely collect a biological sample from the interior of a catheter for purposes of testing the biological sample (e.g., for the presence of fibrin, sepsis, etc.).

Abstract: A support catheter that can be used to aid positioning of a guidewire and other medical devices. The support catheter includes a catheter body having a length, and a supporting structure formed or disposed in or on the catheter body. The catheter support structure, whether alone or in combination with the other portions of the support catheter, provides flexibility, stiffness, and torqueability to the support catheter.

Abstract: Catheter systems and methods for facilitating the delivery of a therapeutic agent directly to the interior of a body organ, and/or the extraction of material from said organ. The catheter distal end is placed within the body organ to be treated. The catheter may carry a fixation device near the catheter distal end. When implanted, the fixation device retains the catheter distal end in the organ despite normal patient activity. The fixation device may include porous material to promote soft tissue ingrowth for anchoring the catheter distal end within the organ.

Abstract: A long catheter can be inserted into a patient while eliminating the need for a sterile field by incorporating the long catheter into an infusion tubing and carrying it in with the infusion. The long catheter has a structure that prevents it from leaving the infusion tubing when fully extended and therefore becomes a connector for fluids to transfer down the long catheter by infusion through the infusion tubing. Use of an adjustable seat connector allows the long catheter to be stopped at varying points during insertion and even to allow the long catheter to be reversed by pulling suction on the infusion tubing and retracting the long catheter back into the infusion tubing. The long catheter also remains within the sterile confines of the infusion tubing and therefore is prevented from becoming contaminated.

Abstract: A valved sheath introducer for venous cannulation, including a valve, sheath, handle and cap. The valve is configured to permit safe introduction and removal of medical instruments through the sheath introducer. The valve may have one or more anchoring members and a thickened central portion through which a slit is formed. The central portion may have one or more concave surfaces and the slit can be angled with respect to the top surface of the valve. The cap is attached to the handle, compressing a portion of the valve therebetween.

Abstract: A method for inserting a multiple catheter assembly into a patient. The assembly includes a first catheter which includes a first distal end region, a first outer surface defining a first lumen, and a first transition region transitioning cross sections of the first outer surface and the first lumen. A second catheter includes a second distal end region, a second outer surface defining a second lumen, and a second transition region transitioning cross sections of the second outer surface and the second lumen. The outer surfaces of the first and second catheters are releasably joined by a splittable bond for allowing first and second distal tips of the assembly to be at least partially longitudinally split from each other. The method includes steps of separating the first and second distal end regions, and inserting the first and second distal tips through an incision and into an area to be catheterized.

Abstract: Systems are disclosed for facilitating intranasal treatment of a patient's sphenopalatine/pterygopalatine recess. Likewise the instant system is effective for addressing acute pain conditions, and is refined enough to be performed by physician's assistants, nurses, and other well-trained practitioners. Apparatus involved includes a sheath hub, a catheter hub, an arresting element, and an engagement element in embodiments. Engagement between the arresting element and the engagement element prevents rotation of the sheath hub with respect to the catheter hub.

Abstract: A guidewire locking device assembly (200) including a guidewire tube (250) with a tubular passage therethrough having a first diameter and a distal end including a collar (260) having a second diameter larger than the first diameter. A guidewire (202) having a third diameter, smaller than the first diameter is disposed within the tubular passage. When a guidewire locking device (216) is disposed within the guidewire tube distal end in a first position with its biasing member in the tubular passage, the at least one finger (220) is biased by the tubular passage into frictional engagement with the guidewire; when disposed in a second position in the collar, the at least one finger is disposed away from frictional engagement with the guidewire.

Abstract: A medical system comprises a first medical probe having indicia, and a second medical probe in a coaxial arrangement with the first medical probe. The second medical probe has a detector (e.g., an optical detector) configured for detecting a passage of the indicia as the first and second medical probes are moved relative to each other. In one embodiment, the first medical probe is an inner medical probe, and the second medical probe is an outer medical probe. The medical system further comprises an electromechanical driver coupled to the first and second medical probes, and a controller configured for directing the electromechanical driver to move the first and second medical probes relative to each other, and for receiving signals from the detector indicating the relative movement between the first and second medical probes.

Abstract: An apparatus for inserting and reinserting a medical device in a patient comprising a medical device such as an intrathecal catheter, electrical lead and lead wire, a sheath for being inserted into the patient using a hollow medical device so that once the sheath is inserted subcutaneously into the patient, the sheath receives the medical device and the medical device can be positioned in the patient; and, a separation portion carried by the sheath so that the sheath receives the medical device. The sheath can be removed from around the medical device by using the separation portion so that the medical device can be inserted in the patient without having to remove the medical device completely from the patient thus eliminating the requirement for a second incision.

Abstract: The disclosure provides a catheter for positioning in a contralateral femoral approach in highly angulated iliac bifurcations. The catheter comprises an elongate shaft, an adjustable element, and a wire entrance port on the elongate shaft. The elongate shaft has a proximal portion, an intermediate portion, a curved portion, and a distal portion. The curved portion connects the intermediate portion and the distal portion. The adjustable element is configured to encompass the distal portion and the intermediate portion together in a closed position. The adjustable element can be removed away from the distal portion permitting the distal portion in an open position. The wire entrance port is disposed in the intermediate portion near the curved portion. The distal portion is biased to be spaced away from the intermediate portion in the open position. The adjustable element is connected to an operating wire configured to advance and retreat through the wire entrance port.

Abstract: A controller for use with a guidewire, such as a vascular guidewire, provides a mechanism for gripping and applying a torque to the guidewire without the need to thread the guidewire axially through the controller and at a location close to a point of access of the guidewire. In one embodiment, the controller includes a side-access, multi-part assembly including a collet or other gripping element that applies a uniform radially inward force on the guidewire. In another embodiment, for use with guidewires having active electrically controllable elements, the controller integrally or removably incorporates a switch or other mechanism to initiate an energized state. The controller thereby permits ergonomic, single-handed control of an electronically steerable guidewire, including axially displacing, torquing and steering the guidewire.

Abstract: A sheath with improved kink resistance and/or rupture resistance is provided. The sheath includes an inner liner defining a passageway extending longitudinally therethrough. A coil is fitted around at least a part of the inner liner. An outer layer adapted to adhere to the inner liner between the windings of the coil is positioned longitudinally over the coil. Lateral edges can have inwardly curved and outwardly curved portions. Lateral edges can be further structured and arranged to define an asymmetric spacing therebetween. The asymmetric spacing is configured to improve at least one of kink resistance and rupture resistance of the sheath when in a bent configuration. The compressive and tensile strength of the polymer material can be utilized in a manner to inhibit coil segments from sliding along each other or overlapping one another, thereby preventing premature tearing of the material when the sheath is bent.

Abstract: The present invention relates to a catheter device having a dilatation balloon formed from a polymeric material crosslinked by moisture through —Si—O—Si— linkages, and to a method of making the same. The polymeric material is formed by reacting at least one organofunctional hydrolyzable silane with at least one polymer. The crosslinked polymeric structure is ideal for forming more resilient and durable catheter balloons. In particular, the catheter balloons have excellent abrasion resistance.

Abstract: A sheath can include a sheath body and a sheath hub. The sheath body can have a generally flexible tubular structure, a proximal end, and a distal end. The sheath body can further define a longitudinal axis. The sheath hub can attach to the proximal end of the sheath body and define a longitudinal axis generally aligned with the axis of the sheath body. The sheath body and sheath hub can also form a central cavity along their respective axes. The sheath hub can include two plates: a flexible plate and a rigid plate. The rigid plate can have a relief generally centered on the sheath body's axis. Advantageously, the flexible plate and rigid plate can overlap to substantially seal the central cavity.

Abstract: A protective sheath including a first portion configured to receive a medical instrument and a second portion configured to accommodate movement of a distal end of said medical instrument within the second portion. The second portion is movably coupled to the first portion. The protective sheath is configured to control contamination of the medical instrument when the medical instrument and the protective sheath are placed within a patient. The protective sheath also includes a tube configured to assist the medical instrument when the medical instrument and the protective sheath are placed within said patient. The tube is disposed along a length of the protective sheath.

Abstract: A shieldable needle device including a needle cannula, a hub, a pair of wings extending laterally from opposing sides of the hub, a tip guard axially movable along the needle cannula from a proximal position substantially adjacent the hub to a distal position, and a drive member is disclosed. The drive member includes a first end connected to the hub and a second end connected to the tip guard and is extendable between a folded biased position and an extended position for moving the tip guard from the proximal position to the distal position. The pair of wings, when in a dorsal position, retain the drive member in the folded biased position maintaining the tip guard in a proximal position. Upon release of the wings, the drive member unfolds, extending the tip guard from the proximal position toward the distal position.

Abstract: A releasably locking dilator and sheath assembly and methods for releasing the dilator from the sheath and longitudinally splitting the sheath. The assembly includes a dilator having a dilator hub and a sheath having a sheath hub. The sheath hub may have a valve and has two opposing winged tabs, each tab having a perpendicular portion and an angled portion as well as a female threaded portion. The dilator hub has a male threaded portion designed to engage the female threaded portion of the sheath hub. The dilator is released from the sheath by rotating the dilator 90° in relation to the sheath and pulling the dilator out of the sheath. The sheath is longitudinally split by creating a couple on each of the winged tabs thereby forcing the sheath and the sheath hub to split longitudinally. With the sheath and sheath hub split longitudinally, the sheath is removed from around a catheter while leaving the catheter in place.

Abstract: A valve for surgical or medical instruments including: a passage that can be at least partially sealed by twisting a flexible section (1) of the passage wall; element for rotating a mobile end (3) of flexible section (1), characterized in that the actuating element include a cable for transmitting movement to mobile end (3) of the flexible section. The invention also relates to a surgical or medical instrument including a valve according to the invention.

Abstract: A system and method for vessel catheterization is provided, having an introducer sheath and a catheter. The introducer sheath can include a handle and a sheath body extending from the handle. An access lumen is provided in the introducer sheath, and can include a tapered portion that is sized to receive a tapered outer surface of the catheter. The catheter may be a central venous catheter, such as a peripherally inserted central catheter, including a hub, a catheter body with at least one lumen extending distally from the hub, and at least one tube extending proximally from the hub. The introducer sheath is preferably a splittable sheath. The catheter can be inserted into the access lumen, and translated until confronting surfaces of the tapered outer surface of the catheter body and the tapered portion of the introducer sheath contact one another. This arrangement can inhibit buckling and/or kinking of the catheter during insertion, and improve initial catheter tip positioning.

Abstract: A protector comprising an inner tube, a lid connected to an upper opening of the inner tube through a hinge, and an outer tube for holding the inner tube in an inner cavity part of the outer tube. A blood collecting needle to which a tube is connected is stored in the inner tube. The inner tube comprises an annular seat face which seats on the base end part of a hub formed integrally with the blood collecting needle when the blood collecting needle moves downward. An operation lever extending downward is installed at the side of the lid, and an end part of the operation lever is slightly projected outward. When the blood collecting needle is moved, the inner tube is pulled integrally with the tube by the annular seat face to be slid relative to the outer tube until the end part abuts on the lower end part of an operation hole. Then, the lid is closed and the blood collecting needle is stored in the inner tube.

Abstract: A method for percutaneously implanting a medical catheter, such as a gastrostomy feeding tube, and a medical catheter implanting assembly. In one embodiment, the implanting assembly includes a gastrostomy feeding tube, an inner sheath and an outer sheath. The feeding tube has an internal bolster integrally formed at its distal end. The inner sheath includes a bore extending distally from its proximal end to a point prior to its distal end and a transverse window communicating with the bore. The outer sheath includes a proximal end, a distal end and a longitudinal bore. The outer sheath is inserted over the inner sheath, and the feeding tube is inserted into the inner sheath, with the internal bolster being folded and tucked into the window and retained therein by the outer sheath. Movement of the outer sheath relative to the inner sheath to expose the window allows the bolster to decompress.

Abstract: A vascular introducer sheath includes a sheath body having an interior lumen for accommodating a dilator. The vascular introducer further includes a guidewire positioning means operatively associated with the interior lumen of the sheath body for directing a guidewire in either a vascular direction or an arterial direction within a venous system.

Abstract: A method of forming a reinforced tubular medical device in a continuous operation, and a medical device formed by the continuous method. An elongated core capable of movement about a line is provided. An elongated tubular member is formed around a moving length of the core by extruding a coating of a functionalized polymer around the moving core length, applying a reinforcing member to an outer surface of the functionalized polymer coating along the moving length, and extruding a polymeric outer jacket over the functionalized polymer and reinforcing member along the moving length, such that a bond is formed between the functionalized polymer and the polymeric outer jacket. The elongated tubular member is cut to desired length to form the tubular medical device, and the core is removed from the device.

Abstract: Systems for gaining access into a body of a patient around an implanted body of an elongate medical device include a sheath having a deformable wall that allows insertion of the device body into a lumen surrounded by the sheath wall. The sheath wall may include first and second edges that extend from a proximal end to a distal end of the lumen, or just extend along a distal portion of the lumen. A tool, which includes a groove sized to grasp about a circumference of the device body, may facilitate insertion of the device body into the lumen of those sheath embodiments that include the first and second edges, by spreading at least one of the first and second edges of the wall apart from the other of the first and second edges while the device body is grasped within the tool.

Abstract: A catheter assembly is disclosed comprising a catheter and a receptacle enclosing said catheter. The receptacle has a first part and a second part, which parts are foldable over each other. Further, at least one sticky adhesive area is arranged on the surface of one of the parts of the receptacle in such a way that the sticky adhesive area is covered by the other part when the receptacle is in a folded disposition, and exposed to the environment when the receptacle is in an unfolded disposition.

Abstract: In at least one embodiment, a hemostatic valve for use with a splittable introducer (10) is provided. The hemostatic valve (22) comprises a seal (24) molded in a first configuration of polymeric material and having two adjacent end surfaces (34,35). The seal is deformable from the first configuration into a second configuration. In the first configuration, the seal is substantially non-planer with the two adjacent end surfaces exposed. In the second configuration, the two adjacent end surfaces are unexposed so as to form a split extending through the seal.

Abstract: Introducer sheath (10,30,40) having a flexible kink-resistant distal tip portion (26,32,42). A multilayer sheath structure is used, with an inner tube (12) such as PTFE having a coil (14) of wire wound therearound. A first length of outer tubing (20) such as of nylon is inserted over most of the coil-wound inner tube (12) in a manner exposing a distal length of coil-wound inner tube. A second length of outer tubing (22) with a softer durometer than first outer tubing length (20), is inserted over the exposed coil-wound inner tube and extends for a slight distance beyond the end of the coil. During heat application, the outer tubing lengths (20,22) are melted to bond to each other and to flow between the spacings of the coil turns to bond to the roughened outer surface of the inner tube (12). The distal tip region corresponding to the second tubing length is flexible and is kink-resistant due to the coil (14).

Abstract: A sheath and a method for making said sheath are provided. The sheath includes with an inner liner defining a passageway about a longitudinal axis extending longitudinally therethrough. A coil is fitted around at least a part of the inner liner. The coil has a series of windings that are locatable at a continuously smaller distance from the longitudinal axis to form a taper in a distal direction. The tube further includes an outer layer positioned longitudinally over the coil that is adapted to adhere to the inner liner. The coil may be spirally wound such that the windings are disposed at a continuously smaller distance from the longitudinal axis in a longitudinal direction. The sheath can have a tapered passageway or a passageway with a uniform diameter. The sheath preferably has a continuous taper along its outer surface from the proximal end to the distal end.

Abstract: A catheter enables measuring and approximating its distal end position within the body to facilitate catheter insertion and improve accuracy and control. By wrapping a long infusion catheter with an outer coating, the catheter can be guided into a vein or vessel by pulling on the outer coating and forcing its separation in a Y-shaped separation housing anchored close to the insertion point. Since there is no need for a guidewire or stylet and the outer coating acts as a sterile peel package, the catheter can be placed while infusing and maintain its own closed sterile environment during insertion.

Abstract: A needle protection device for use with an injection device, the needle protection device including a moveable needle protection element which moves through a release course of movement into a locking engagement position as a result of an elastic force, the locking engagement position being achieved when the needle protection element moves from a starting position to a triggering position, when the needle protection element moves over a small portion of the release course, and being maintained when the needle protection element is no longer subjected to an external force in the triggering position.

Abstract: In one embodiment, an introducer is provided for implanting an electrical stimulation lead to enable electrical stimulation of nerve tissue. The introducer includes an outer sheath and an inner penetrator. The outer sheath may accommodate insertion of the electrical stimulation lead and may be inserted into a human body near the nerve tissue. The inner penetrator is removably housed within the outer sheath and includes an inner channel configured to accommodate a guide wire, a tip end having a shape and size substantially conforming to that of the guide wire, a body region having a shape and size substantially conforming to that of the outer sheath, and one or more transition regions substantially connecting the tip end with the body region. At least a portion of the transition regions of the inner penetrator may flex to substantially follow flexures in the guide wire during advancement of the inner penetrator.

Abstract: A cannula for insertion through a biologic tissue. The cannula includes a shaft having proximal and distal end portions with a lumen therebetween. The cannula further includes a tip having a proximal end portion, a distal tip end, and a lumen therebetween. The proximal end portion of the tip is secured to the distal end portion of the shaft so that the lumen of the tip is in fluid communication with the lumen of the shaft. The tip includes an opening that extends proximally relative to the distal tip end to permit the flow of fluid into the lumen of the tip even in the event that the distal tip end becomes obstructed.

Abstract: A needle catheter with an axially elongating and contracting needle and methods of using for delivering therapeutic materials to the heart are disclosed.

Abstract: An infusion media delivery device includes a housing having a base adapted to be secured to a user's skin. An infusion media reservoir is supported by the housing. A moveable hollow needle is selectively engageable with the reservoir to communicate infusion media from the reservoir. The needle is supported for movement relative to the housing base between a first position and a second position. The needle is spaced apart from a user's skin when in the first position and the base is secured to the user's skin, and the needle is arranged to pierce the user's skin when in the second position and the base is secured to the user's skin.

Abstract: A connecting device for a catheter assembly is disclosed allowing a user to connect a catheter assembly to an adhesive pad which is then capable of anchoring the catheter assembly to a patient's leg. The connecting device may have an introducer body with an extension body and an attachment mechanism. The connecting device can be rotated along with or within a collar in a circular manner in order to facilitate the making of the connection with the adhesive pad. Additionally, the connecting device may contain an enlarged portion to enhance operability.

Abstract: A catheter assembly for cannulating an ostium of a coronary sinus of a heart comprises an outer catheter member and an inner catheter member. The outer catheter member has a distal end portion including a deflectable distal end and a lumen extending through the deflectable distal end, wherein the distal end portion includes regions of varying stiffness and has a pre-formed curvature. The inner catheter member is slidably and rotatably disposed within the lumen of the outer catheter member, and has a distal end portion including a distal end, and a lumen extending through the distal end. The distal end portion of the inner catheter member has regions of varying stiffness and a pre-formed curvature. The outer and inner catheter members are configured such that relative translation and rotation of the outer and inner catheter members causes the distal end of the outer catheter member to assume a plurality of two and three dimensional shapes.

Abstract: A tearaway introducer sheath assembly (10) for use in implantation of a catheter into a patient, having an elongated polytetrafluoroethylene sheath tube (12) and a proximal polyethylene hub component (16). The hub comprises two halves (22) insert molded about the sheath tube proximal end and joined to each other by frangible webs (28) enabling manual splitting. At least one pair of opposed holes (42) is formed through the tube proximal end portion 44, and a polyethylene liner (46) is inserted into the tube's proximal end portion. The polyethylene flows into the at least one pair of holes (42) to fuse with the liner, establishing a pair of physical joints (50?) integrally joining the liner (46) to a respective hub half (22). Upon manual splitting of the hub halves, the sheath tube easily splits along its length as a result of a property of the polytetrafluoroethylene material.

Abstract: A splittable cannula includes a radiopaque marker placed at or near the distal end of the cannula. The radiopaque marker may be a unitary piece, or may consist of several portions. The cannula may include a sheath or catheter body with a grooved score line running along a portion of the sheath body and a radiopaque marker located at a distal end of the body and abutting the body. The radiopaque marker may be located within the lumen of the sheath, may be embedded in the sheath wall, or may be affixed to the external sheath wall. The radiopaque marker may be scored, notched, grooved, or contain apertures longitudinally. The notches, grooves, apertures, and/or score lines in both the sheath or catheter body and the radiopaque marker serve to provide a weakened tear path. An electrode lead may be coupled with the radiopaque marker.

Abstract: An insertion sheath and related methods include a tube member and a shape memory feature. The tube member defines an insertion lumen. The shape memory feature is positioned at a distal end portion of the tube member. The shape memory feature provides a monofold shape in the tube member when in a first state, and a radially expanded shape in the tube member in a second state upon application of an expansion force. The shape memory feature returns the monofold shape after removal of the expansion force. The insertion sheath may function as an access to closure sheath that is suitable for use as a procedural insertion sheath when treating the patient and a closure insertion sheath when sealing closed the vascular puncture.