Abstract: A lock for positioning a first medical device with respect to a second medical device includes a spacer for preventing advancement of the first medical device towards the second medical device. The spacer is movable between a lock position and an unlock position. In the lock position, the spacer is moved transverse to the longitudinal axis with respect to the unlock position. The lock further includes a rotary stop integral with the spacer for fixing the rotational position of the first medical device with respect to the second medical device. The lock further includes a clip integral with the spacer and removably securable to the first medical device in a first position to secure the spacer in the unlock position, and removably securable to the first medical device in a second position to secure the spacer in the lock position.

Abstract: Medical devices are disclosed having improved visualization of a portion of the medical device insertable into a patient's body while minimizing obstruction of fluid flow through a lumen of the device and while minimizing an increase in the outer diameter of the device attributable to the feature providing improved visualization. The device can include, for example, an imaging marker distal to lumen openings (exit ports), or, where the device comprises a tube, such as a metallic tube, an imaging marker embedded into a wall of the tube. Another embodiment includes attaching a marker to the surface on the inside of a lumen of a medical device without embedding the marker. Various alternative embodiments, methods and applications of using such devices are disclosed as well.

Abstract: Methods and apparatus are disclosed for a catheter having a side-port, through which a device, for example, a wire, may be advanced, and a vestibule in the outer surface of the catheter at the distal edge of the side-port. The vestibule is operable for providing a gap between the catheter body and a distal tip of the device positioned through the side-port whereby the vestibule facilitates advancement of the device 5 through the side-port and through tissue towards a desired trajectory. In examples wherein the device is a wire having a distal tip electrode, energy may be delivered to a tissue adjacent the side-port, while avoiding damage to a wall of the catheter body.

Abstract: A method and apparatus are disclosed for a catheter having a side-port through which a wire may be advanced. The catheter comprises a catheter body, the catheter body defining at least a primary catheter lumen and at least one side-port in communication with the primary catheter lumen, and a distal portion of the catheter extending distal to the at least one side-port, the side-port being configured to allow travel of a wire or other component therethrough, wherein the distal portion of the catheter is radially collapsible.

Abstract: Methods and apparatus are disclosed for a needle comprising a distal shaft and a proximal shaft joined at a junction, the needle having a distal tip which includes an electrode for delivering energy to puncture a tissue, wherein the distal shaft is comprised of a superelastic material. In typical embodiments, the needle includes a lumen for delivering and withdrawing fluids from a treatment site. In some embodiments the junction is comprised of a superelastic material.

Abstract: A control system and method are provided for control of a steerable catheter, the catheter including at least two control wires, a distal end of each of the control wires being coupled to the catheter at a distal region thereof, the control system comprising: a housing coupled to the catheter; a slide assembly positioned within the housing and operable to translate linearly therein; a proximal portion of each of the at least two control wires being positioned through the slide assembly; and a control knob rotatably coupled to the housing for linearly translating the slide assembly, thereby enabling the slide assembly to separately manipulate each of said at least two control wires to effect a change in a deflection of said catheter.

Abstract: Embodiments of medical devices and methods are disclosed. The medical devices typically comprise a flexible elongate member defining a lumen, and a support spine affixed to the distal end and extending proximally therefrom within the elongate member lumen. In some embodiments, the support spine is configured to support at least a portion of the elongate member when the elongate member is bent or curved. Some embodiments include apertures at or near the distal end for enabling fluid communication between the lumen and the outside environment. In some embodiments, the support wire extends proximally from the distal end within a distal portion of the lumen such that a proximal portion of the lumen is substantially unobstructed, thereby reducing turbulence of fluid flowing through the lumen.

Abstract: A method and apparatus are disclosed for a needle for gaining access to the pericardial cavity of a heart. The needle includes an elongate member (e.g. a main shaft) defining a lumen and a side-port in communication with the lumen; a blunt atraumatic tip for delivering energy for puncturing tissue; and a guiding surface (e.g. a ramp) for directing a device (e.g. a guidewire) through the side-port. The method includes using the needle for tenting a pericardium and delivering energy for puncturing the pericardium, and advancing a guidewire or other device through the needle and into the pericardial cavity.

Abstract: In some embodiments, an electrosurgical device comprises an electrically conductive elongate member for traversing body vasculature defining a hollow lumen with one or more apertures at or near its distal end, wherein electrical energy can flow through the wall of the elongate member; and an energy delivery device in electrical communication with the elongate member located at or about the distal end of the elongate member. The energy delivery device includes an electrode for delivering energy, and a thermal shield positioned between the electrode and the elongate member.

Abstract: A method and apparatus are disclosed for providing forward fluid delivery through an energy delivery device that avoids coring when it delivers energy to a tissue. The device has a distal face defining an opening, with the distal face including at least one electrically exposed portion and at least one electrically insulated portion. An embodiment of the energy delivery device includes an elongate member defining a lumen structured to receive a fluid, and a distal face defining an aperture in communication with the lumen. The distal face includes an electrically exposed conductive portion and an electrically insulated portion. The electrically exposed conductive portion is configured such that the energy it delivers while the energy delivery device is advanced into a tissue punctures the tissue without the tissue substantially occluding the lumen and without creating embolic particles.

Abstract: A steerable catheter control handle and method are provided for bi-directional control of a steerable catheter, the catheter including at least two control wires, a distal end of each of the control wires being coupled to the catheter at a distal region thereof. The control system comprises a housing. A wire actuation mechanism is disposed within the housing and is operably coupled to at least two control wires for enabling actuation of the at least two control wires. The steerable catheter control handle additionally comprises a proximal control knob that is operably coupled to the wire actuation mechanism to enable actuation of the at least two control wires. The control knob is positioned proximal to the wire actuation mechanism to enhance ease of use of the steerable catheter control handle. The rotation of the proximal knob causes movement of the wire actuation mechanism within the housing for tensioning one of the at least two control wires for causing a distal end deflection of the steerable catheter.

Abstract: This disclosure describes embodiments of a kit and its constituent components which together form an apparatus in which fluid communication between a medical device's lumen and the surrounding environment is provided by a conduit cooperatively defined by the medical device and a tubular member into which the device is inserted. The medical device and tubular member are configured to fit together such that an outer surface of the distal region of the medical device cooperates with an inner surface of the tubular member to define the conduit between the side-port of the medical device and a distal end of the tubular member. The conduit is operable to be used for injecting fluid, withdrawing fluid, and measuring pressure, for example. Methods of assembling and using the apparatus are described as well.

Abstract: Novel and unique medical devices and associated methods are disclosed, for facilitating efficient and repeatable puncture of a tissue site while allowing vascular access from various access sites of a patient's body. Disclosed medical devices include dilators and wires usable alone or in combination and configured to facilitate tissue access and puncture at various anatomical locations from desired access sites. The medical devices each include one or more sections having sufficient flexibility for accessing the tissue site from the access site while retaining sufficient stiffness to perform one or more additional functions.

Abstract: A method is disclosed for delivering energy to a region of tissue within a patient's body using a medical treatment system. The medical treatment system comprises an energy delivery device coupled to an energy source and the method includes steps of delivering energy, measuring an energy delivery parameter, determining distance of the energy delivery device from a conductive object and optionally adjusting a position of the energy delivery device based on the determined distance.

Abstract: A method and apparatus are disclosed for an optimized transseptal procedure for providing left heart access, that reduces the number of devices that are used in order to minimize procedural time, complexity and cost. The apparatus comprises a hybrid dilator that comprises the combined functionality of a transseptal sheath and dilator assembly. The hybrid dilator comprises: a dilator shaft defining a lumen for receiving a crossing device therethrough, the dilator shaft being structured to provide support for the crossing device when the crossing device is used to create a puncture in a tissue; and a distal tip having an outer diameter which tapers down to an outer diameter of the crossing device for providing a smooth transition between the crossing device and the distal tip when the crossing device is inserted through the lumen and protrudes beyond the distal tip.

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.