Abstract: A vascular access device for reproducible insertion of a cannula, comprising a carrier, a holder and a guide device, such that the guide device is designed as an inclined plane on one side and serves to support and guide a cannula, so that accurate guidance of the cannula is ensured, always in the same puncture angle and at the same depth of penetration in a puncture channel.

Abstract: A system for deploying a shape memory catheterization device within a patient, includes a catheter for endovascular insertion of the shape memory catheterization device. A heat source heats the shape memory catheterization device above the transition temperature. A transformation data generator includes a circuit driver for driving a circuit that includes at least one capacitive element of the shape memory catheterization device and a detection circuit for generating transformation data based on a capacitance of the at least one capacitive element, wherein the transformation data indicates a shape transformation of the shape memory catheterization device from a catheterization shape to a transformed shape.

Abstract: The steerable catheter comprises a flexible tube, inside of which different conducts are arranged: one or more conducts for drug administration, vacuum conducts associated with different radiofrequency electrodes, conducts for the conductive wires that conducts the radiofrequency energy to the distal end of the catheter, conducts for the fiber optic cable/s that conducts the laser energy to the distal end of the catheter, a guiding wire for the catherization, and another components; the steerable catheter being connected from the proximal end to a energy unit and other pressure and/or dosing devices; and the steerable catheter optionally including an inflatable balloon to help occluding the vessel; and it also incorporates one or two electrode/s or conductive layer/s in the distal end of the catheter; the objective of the steerable catheter being the obtaining of better results in the embolization and/or chemoembolization treatments.

Abstract: An arterial cannula for cardiac surgery includes a pledget/stopper assembly and an introducer. The pledget/stopper assembly is mechanically mated with an external surface of the cannula in proximity to its tip. The introducer has suitable dimension for being placed coaxially inside the cannula. The introducer has at its end a blade or a sharp edge that protrudes the cannula tip no more than 5 mm.

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: Systems and methods for temporarily pacing a patient's heart are provided. One system includes a hemostasis valve with an adjustable electrical connection, the adjustable electrical connection having one or more adjustable contacts. The adjustable contacts have a first, radially expanded configuration and a second, radially constricted configuration. In the radially constricted configuration, the adjustable contacts are configured to pierce through a layer of an elongate medical device that is disposed in the hemostasis valve. The elongate medical device has a distal electrode and a conductor extending along a portion of the elongate medical device. The adjustable contacts pierce through a make contact with the conductor, providing an electrical pathway to the distal electrode. Also provided are vascular access systems including a hemostasis valve and a guide catheter, guide wire torquers with adjustable contacts and methods of temporarily pacing a patient's heart.

Abstract: Devices and methods for guidewire assisted placement of catheters into blood vessels are described. Some of the devices and methods relate to automated or partially automated or assisted insertion and placement of an intravenous catheter into a vein or artery of a patient. Other of the devices are blood draw devices and methods for insertion and placement of an intravenous device into a vein or artery of a patient or to withdraw a blood sample from the patient. The devices also provide for guide wire tip inspection after use.

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: An venous access catheter is combined with a needle, guidewire, and actuator where the needle is disposed coaxially over the guidewire and the catheter is disposed coaxially over the needle. A hub at a proximal end of the access catheter includes a wiping element to clean blood from the needle and guidewire as they are removed and a side port to allow connection of fluids after the access catheter is placed.

Abstract: The invention generally relates to guidewires for intravascular procedures that include an electroactive polymer. An electroactive polymer can be at one or a number of locations on or within a guidewire. The polymer reacts to an applied electrical potential by changing a dimension (e.g., contracting or expanding). Electroactive polymers can be disposed along or within the guidewires in any pattern, such as wrapped helically within a surface, placed longitudinally parallel to an axis of the guidewire, dispose circumferentially around the guidewire, others, or a combination thereof. Depending on the designed geometry, a potential difference applied by an actuator will cause the guidewire to change a shape, a property, a surface characteristic, a dimension, or a combination thereof.

Abstract: A steerable sheath for a catheter delivery system and associated devices and methods are disclosed. In some embodiments, the catheter delivery system includes a catheter sheath having a steerable distal portion and a flexible elongate member connecting to a steering unit. The flexible elongate member has a central lumen through which a therapeutic or diagnostic device of a first modality can be inserted, used to perform a procedure, and then removed and replaced by a different therapeutic or diagnostic device while the catheter sheath remains substantially at the same location within a patient.

Abstract: Thrombectomy catheters are presented that have curved tip portions. A suction lumen extends from at or near the proximal end of the catheter to a suction port at or near the tip portion of the catheter. The curves of the thrombectomy catheter can be selected to place a suction port at or near a vessel wall for the more effective removal of thrombus resulting from directing the suction in the direction of the thrombus. In some embodiments, the tip portion of the catheter can be transitioned from a first configuration for delivery of the catheter into the vessel to a second more curved configuration with a desired design for application of suction. The catheter can be moved in a circumferential and/or lateral direction to cover selected portions of the inner vessel wall. In some embodiments, a partially occlusive structure can be used to reduce and/or redirect flow within the vessel to improve performance of the thrombectomy.

Abstract: Novel catheter systems including those having guidewire lumens that can convert from an Over-the-Wire mode to a Rapid Exchange mode are useful and effective when crafted such that this conversion happens without adjusting the position of the guidewire in a body lumen.

Abstract: Medical devices and methods for making and using medical devices are disclosed. An example medical may include a guide catheter. The guide catheter may include an elongate catheter shaft having a proximal end, a distal end, and a central lumen extending therebetween. An inflatable locking member may be disposed within the lumen. The locking member may be configured to longitudinally secure the position of a medical device extending through the lumen relative to the catheter shaft. The guide catheter may also include an inflation lumen in fluid communication with the inflatable locking member.

Abstract: A method and apparatus for inserting and monitoring the placement of a cannula tip within a peripheral vein of a human body where the cannula includes a sensor located at predetermined location and mounted on the cannula for sensing the biological material of the body to guide the insertion of the cannula tip into the vein and alerts to the withdrawal of the cannula tip from the vein in the body.

Abstract: Anchors for securing a therapy device such as a therapy catheter relative to a burr hole, and systems and methods for using the same. Anchors in accordance with embodiments of the present disclosure may include a connector for securing the therapy catheter to a delivery catheter, wherein the connector is independently and removably attachable to the anchor. The connector may secure the therapy catheter relative to the burr hole and isolate forces that may otherwise tend to disrupt the placement of the therapy catheter.

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: Medical devices and methods for making and using medical devices are disclosed. An example medical device may include a dual function medical device. The dual function medical device may include an inner guidewire. An outer guidewire may be disposed about the inner guidewire. The outer guidewire may include a tubular member having a plurality of slots formed therein. A torque member may be coupled to the dual function medical device. The torque member may be configured to independently attach to the inner guidewire and the outer guidewire.

Abstract: Attachable implements, systems, and methods for identifying the migration of a medical device extending through a percutaneous insertion site of a patient's skin are disclosed. In one embodiment, an attachable implement for identifying migration comprises a attachable implement body having a coupling surface and a skin contacting surface, the coupling surface arranged to couple to a surface of the medical device, and the skin contacting surface arranged to contact the skin of the patient; wherein the attachable implement body is arranged to be side mountable on the medical device and wherein the attachable implement is configured to move from a first position adjacent to the patient's skin to a second position remote from the patient's skin. Systems, methods, and other embodiments are disclosed.

Abstract: An intravascular catheter for peri-vascular and/or peri-urethral tissue ablation includes multiple needles advanced through supported guide tubes which expand with open ends around a central axis to engage the interior surface of the wall of the renal artery or other vessel of a human body allowing the injection an ablative fluid for ablating tissue, and/or nerve fibers in the outer layer or deep to the outer layer of the vessel, or in prostatic tissue. The system also includes means to limit and/or adjust the depth of penetration of the ablative fluid into and beyond the tissue of the vessel wall. The preferred embodiment of the catheter includes structures which provide radial and lateral support to the guide tubes so that the guide tubes open uniformly and maintain their position against the interior surface of the vessel wall as the sharpened injection needles are advanced to penetrate into the vessel wall.

Abstract: An agent delivery catheter that includes an anti-whipping feature, improved assembly of distal parts and/or accuracy/repeatability of needle delivery to a target tissue. Additional features include fitting a catheter with a pneumatic delivery device for delivery of a therapeutic agent without using a needle.

Abstract: An introducer apparatus includes an outer sleeve and an inner cannula received within the lumen of the outer sleeve. The outer sleeve has a profile such that at least a portion of the distal end of the outer sleeve tapers in the distal direction at an angle not exceeding about 2° relative to a longitudinal axis of the apparatus. The distal open end of the outer sleeve has a wall thickness not exceeding about 0.003 inch, and is sized such that a first wire guide is receivable therethrough. The inner cannula includes a tapered distal end portion. The inner cannula distal open end is sized such that a second wire guide is receivable therethrough, and the first wire guide is not receivable therethrough. The tapered distal portion of the inner cannula extends distal to the distal open end of the outer sleeve, such that a generally smooth diametrical transition is provided between the outer sleeve tapered portion and the open distal end of the inner cannula.

Abstract: An implantable biodegradable device having two or more layers composed of one or more biodegradable materials is disclosed. The two or more layers are coated with one or more drugs. The implantable biodegradable device further having one or more inert layers is composed of a biodegradable material. The one or more inert layers of the implantable biodegradable device are degraded in response to introduction of one or more external triggers when the implantable biodegradable medical device is placed within a living organism. Further, a layer of the two or more layers having a position above an inert layer is degraded prior to degradation of the inert layer. Subsequently, a layer of the two or more layers having a position below the inert layer is degraded subsequent to degradation of the inert layer.

Abstract: A needle connector assembly comprises a hemostatic segment and a side tube. The hemostatic segment comprises an opening permitting passage of a guidewire therethrough. The hemostatic segment comprises a proximal portion comprises a perimeter ring and a spanning member. The distal portion comprises a bell or rounded configuration. Upon insertion of a guidewire, the hemostatic segment generally seals around the guidewire such that blood or other fluids are prevented from entering the area proximal to the hemostatic segment. The side tube comprises a closed distal end and is positioned between the proximal end and the distal end of the needle connector assembly. The side tube is in fluid communication with the passageway of the connector assembly and is adapted to receive blood or other fluids. The connector assembly is adapted for connection with a needle assembly.

Abstract: An infrared detector and image projector system is set forth comprising an IR imager/projector for capturing an image of a vein and a needle and projecting the image on a surface; and a discrimination and guidance system for discriminating the needle from the image, calculating parameters of the needle and based on these parameters causing the IR imager/projector to project the image of the needle and vein and additional information to assist in visualizing needle alignment with the vein and insertion through tissue into the vein.

Abstract: An venous access catheter is combined with a needle, guidewire, and actuator where the needle is disposed coaxially over the guidewire and the catheter is disposed coaxially over the needle. A hub at a proximal end of the access catheter includes a wiping element to clean blood from the needle and guidewire as they are removed and a side port to allow connection of fluids after the access catheter is placed.

Abstract: A method of treating a patient includes providing a guidewire having an elongate body defining a proximal end and a distal end, the elongate body including a shapeable portion disposed proximate the proximal end, the shapeable portion being malleable so as to be shaped into a shape and remain in the shape until reshaped. The distal end of the elongate body is advanced into a vasculature of the patient. The shapeable portion of the elongate body is shaped into a first shape that prevents advancement of the guidewire further into the vasculature of the patient.

Abstract: A method and apparatus for treatment of heart failure, hypertension and renal failure by stimulating the renal nerve. The goal of therapy is to reduce sympathetic activity of the renal nerve. Therapy is accomplished by at least partially blocking the nerve with drug infusion or electrostimulation. Apparatus can be permanently implanted or catheter based.

Abstract: Apparatus and methods providing intra-luminal access and, in particular, to needle, catheter, and guidewire structures and methods of using the same to access a vascular or other body tissue lumen.

Abstract: The present invention is directed to a dilator having a stiffened shaft for use as part of an introducer sheath assembly. The dilator includes a stiffener tube and a tip of the dilator which extends distally to the dilator stiffener tube. The transition between the stiffener tube and the tip of the dilator is positioned such that when the dilator is positioned within the catheter sheath, the transition is also positioned within the catheter sheath. By positioning the transition between the stiffener tube of the dilator and the tip of the dilator inside the catheter sheath, the catheter sheath can provide strain relief subsequent to lateral movement of the tip of the dilator in a manner that can prevent kinking of the dilator tip at the transition between the stiffener tip and the tip of the dilator.

Abstract: A valved catheter is provided which includes a slit that opens readily in both directions either when a fluid is caused to flow from the interior to the exterior thereof or when a fluid is caused to flow from the exterior to the interior thereof, and that prevents inadvertent closure thereof from the opened state. The valve includes an openable slit that penetrates from the inner surface to the outer surface of a distal end section of a valved catheter with a closed distal end, and edge portions on the two sides of the slit are formed along the direction in which the valved catheter extends. The slit includes a linear shape in the cross-section of the distal end section of the valved catheter that extends in a position away from a center line “c” that passes through the center of the valved catheter in parallel with this center line “c” whereupon, either one of the edge portions deforms more readily than either one of the other edge portions.

Abstract: Methods and apparatus for delivery of substances or apparatus to target sites located outside blood vessel lumens. A penetrating catheter is inserted into a blood vessel lumen and a penetrator is advanced from the catheter in the direction of the target site. Thereafter, a delivery catheter is passed through a lumen of the penetrator to the target site. A desired substance or apparatus is then delivered to or obtained from the target site. In some applications, the delivery catheter may remain in place for chronic or continuous delivery of substance(s) to and/or obtaining of information or samples from the target site. Alternatively, a delivery catheter having an occlusion member may be advanced into a vein or venule and used to occlude the lumen of the vein or venule during and after injection of a substance such that the substance will not be carried away by normal venous blood flow.

Abstract: A system for the advancement or retraction of a guide catheter has a base member, support, linear actuator and bedside support. The base member has a hemostasis valve affixed which includes a valve body with a first leg having a proximal port, a distal port and a lumen with a linear axis extending between the proximal port and the distal port. At least one valve is located in the lumen adjacent the proximal port to permit an interventional device to be passed therethrough. The valve body has a second leg extending at an angle relative to the first leg and has a lumen in fluid communication with the lumen of the first leg. The support is affixed to the base member such that it functions to move the base member and its affixed valve in concert with the movement of the linear actuator along its linear axis. The liner actuator to which the support is affixed has a linear axis along which it may be advanced or retracted in a continuous or incremental manner.

Abstract: A combined hemostasis valve and drive mechanism is provided. The hemostasis valve has a valve body with a first and second leg. The first leg has a proximal port, a distal port and a lumen extending between the proximal port and the distal port. At least one valve is located in the lumen adjacent the proximal port to permit an interventional device to be passed therethrough. The second leg extends at an angle relative to the first leg and is in fluid communication with the first leg. A rotating male luer lock connector is rotatably connected to the first leg proximate to the distal port. It is configured to secure a guide catheter and has a driven member. The drive mechanism has a drive member removably interfacing with the driven member and a motor operatively connected to the drive member.

Abstract: A reperfusion system and method of perfusing a blood vessel using the reperfusion system are provided. A sheath has a sheath wall and a lumen that each extend to a distal end to define a distal opening. A distal portion of the sheath wall has at least one wall opening. A balloon catheter has a lumen that extends to the distal end to define a distal opening. The balloon catheter has an inflatable balloon attached to a distal portion. A conduit has a first end in fluid communication with the lumen of the sheath and a second end in fluid communication with the lumen of the balloon catheter. The reperfusion system is configured to allow blood to enter each of the distal opening and the at least one wall opening of the sheath, flow through the sheath, the conduit, and the balloon catheter, and exit through the distal opening of the balloon catheter. The sheath is introduced into body tissue. The balloon catheter is advanced through the sheath to the blood vessel. The balloon is inflated.

Abstract: An infusion set (101) includes a base (121), a flexible catheter (142) and an introducer needle (134). The flexible catheter (142) is movable from a first catheter position disposed substantially entirely within the base (121) to a second catheter position in which a free end of the flexible catheter (142) is disposed externally of the base (121). The introducer needle (134) is movable between a first introducer needle position disposed substantially entirely within the base (121) and a second introducer needle position in which a free end of the introducer needle (134) is disposed externally of the base (121). An activation button (161) is movable between first and second button positions.

Abstract: The present disclosure is directed to a catheter for site-specific delivery of a therapeutic agent to a blood vessel of a patient. The catheter further includes an elongated shaft having at least one inner lumen, a distal end and a proximal end and proximal and distal vessel-conforming balloons where each is separately positionable and inflatable, and when inflated, substantially restricts blood flow in the vessel and creates a treatment window of a defined but variable length for delivery of the therapeutic agent. The catheter optionally includes at least one marker band adjacent to the proximal balloon and at least one marker band adjacent to the distal balloon. At least one lateral aperture positioned in the window is in fluid communication with a drug delivery conduit located within either the inner shaft or the outer shaft to provide a homogeneous concentration of the therapeutic agent to the window.

Abstract: A microcatheter for delivery of embolic fluids includes an outer member dimensioned for insertion within a blood vessel adjacent an embolization site. The outer member defines a first longitudinal lumen, and an inner member is selectively positionable within the first longitudinal lumen of the outer member. The inner member defines a second longitudinal lumen and has a delivery port in fluid communication with the second longitudinal lumen for passage and delivery of embolic fluids toward the embolization site. A valve is disposed within the outer member. The valve is dimensioned to establish a substantial seal about the inner member, to minimize entry of the embolic fluids within the first longitudinal lumen of the outer member subsequent to delivery thereof toward the embolization site.

Abstract: Guide extension catheters and methods of manufacturing and using guide extension catheters are disclosed. An example guide extension catheter may include a distal sheath having a proximal opening, a distal opening, and a central lumen extending therebetween. The guide extension catheter may also include a proximal shaft having an outer diameter smaller than an outer diameter of the distal sheath, the proximal shaft including a distal opening. The guide extension catheter may also include a coupling member for securing the distal sheath to the proximal shaft. The coupling member may include a distal portion attached to the distal sheath and a proximal portion disposed within the distal opening of the proximal shaft.

Abstract: An infusion set (201) includes a base (221) and a flexible catheter (242) movable from a first catheter position disposed substantially entirely within the base (221) to a second catheter position in which a free end of the catheter (242) is disposed externally of the base (221). An introducer needle (234) is located within the catheter (242) and is movable between a first introducer needle position disposed substantially entirely within the base (221) and a second introducer needle position in which a free end of the introducer needle (234) is disposed externally of the base (221). A torsion spring (281) is activated to move the catheter (242) from the first to the second catheter position and the introducer needle (234) from the first to the second introducer needle position to facilitate insertion of the catheter (242).

Abstract: Medical devices, systems, and methods reduce the distance between two points in tissue, often for treatment of congestive heart failure and often in a minimally invasive manner. An anchor is inserted along an insertion path through a first wall of the heart. An arm of the anchor is deployed and rotationally positioned according to a desired alignment. Application of tension to the anchor may draw the first and second walls of the heart into contact along a desired contour so as to effect a desired change in the geometry of the heart. Additional anchors may be inserted and aligned with the first anchor to close off a portion of a ventricle such that the ventricle is geometrically remodeled and disease progression is reversed, halted, and/or slowed.

Abstract: Multichannel systems for engaging a bodily tissue and methods of using the same. In at least one embodiment of an exemplary multichannel system for engaging a tissue of the present disclosure, the system comprises an engagement catheter comprising a proximal end, a distal end, and defining a first lumen and second lumen extending between the proximal end and the distal end, an inducer sheath having a proximal portion and a distal portion, and defining a lumen extending therethrough, the inducer sheath configured for insertion into the second lumen of the engagement catheter, and a dilator defining a first channel and a second channel extending therethrough and a tapered tip at the distal end of the dilator, the dilator sized and shaped for inserted into the lumen of the inducer sheath.

Abstract: An apparatus for deploying a needle within a lumen is provided. The apparatus includes a housing having a threaded bushing radially disposed therein. The bushing rigidly couples with a nose cone having a guide tip disposed at an end opposite the bushing for penetrating an arterial wall of a lumen. During operation, a user incrementally advances the bushing within the housing, thereby incrementally advancing the guide tip into the lumen. The nose cone also includes a flex guide having a slot configuration which couples with the guide tip which deploys into the lumen along with the guide tip.

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 member having a proximal outer diameter. A distal sheath member may be attached to the proximal member. The distal sheath member may have a proximal sheath portion and a distal sheath portion. The proximal sheath portion may have an outer diameter greater than the proximal outer diameter. The proximal sheath portion may have a first cross-sectional profile. The distal sheath portion may have a second cross-sectional profile different from the first cross-sectional profile.

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: An interventional catheter assembly has an operating head and catheter system that are inserted and navigated within a patient's body while an operator controls the system externally of the operating head. An operating head is positioned at or near a distal end of the catheter system and coupled to a drive shaft and drive system for rotation. A guidewire brake control system interrupt prevents the drive system from being actuated when the guidewire brake is in a released position, and a selectable guidewire brake interrupt override control permits an operator to translate and/or rotate the drive shaft and operating head while the guidewire is simultaneously moved. This allows withdrawal of the guide wire and the operating head from the target site while rotating the operating head.

Abstract: Methods for easy, atraumatic access to areas of the vasculature that are otherwise difficult to access, using steerable guide catheters constructed with components that are selected to provide optimal navigability, torque transfer, and push ability for a variety of typical percutaneous access routes. The catheter wall thickness in the deflecting segment of the guide catheter is about 1 French (? mm) or less, and includes a slotted deflection tube, and this construction allows a very tight turning radius which in turn enables guide catheter access to regions of the vasculature that are otherwise inaccessible.

Abstract: Methods and apparatus are disclosed for inserting flexible, multi-lumen catheters into blood vessels, and in particular, for inserting flexible, split-tip catheters into blood vessels. The invention accomplishes these objects by temporarily stiffening each catheter lumen and tip independently through use of intra-catheter stiffener elements disposed within the catheter lumens. This provides means for advancing the catheter/stiffeners assembly through a subcutaneous tunnel, and over a plurality of guidewires until a distal tip of the catheter is at a desired position within the vessel. The intra-catheter stiffener elements are sufficiently stiffening to allow advancing the catheter over guidewires, but sufficiently flexible to allow bending and looping of the catheter for proper placement within the vessel.

Abstract: One embodiment is directed to a method for creating translumenal vascular access, comprising utilizing a dilator adaptor to assist with forming a substantially atraumatic geometric outer junction between a dilator member/introducer member assembly and a guidewire which may be somewhat undersized relative to a lumen formed through the dilator member, thereby creating a geometric fit gap which may be suboptimal from a tissue interfacing perspective. The dilator adaptor may be interposed between the guidewire and dilator member to assist in remedying this fit mismatch, and in generally providing a preferred outer instrument interface for insertion through a small defect in a vessel to gain access to a lumen defined through the vessel.

Abstract: The methods, devices and systems described herein relate to accessing a hollow organ with increased accuracy and safety. In one example, they relate to transseptal crossings of the atrial septal wall, preferably from the right atrium into the left atrium. Numerous different devices are described for performing access methods, each of which can be used with a piercing stylet that transitions to an atraumatic configuration after piercing the intervening tissue.