EP-3585472-B1 - STEERABLE GUIDE WIRE WITH SHAPE CHANGE IN-SITU

EP3585472B1EP 3585472 B1EP3585472 B1EP 3585472B1EP-3585472-B1

Inventors

VON SEGESSER, LUDWIG K.

Dates

Publication Date: 20260506
Application Date: 20180221

Claims (15)

A device, comprising: a guide wire (104, 122, 202, 710) having a distal end (106), a hollow interior (713), and an anchoring mechanism (108) positioned proximate to the distal end of the guide wire; and a core wire (120) configured to be slidably inserted into the hollow interior of the guide wire and configured to actuate the anchoring mechanism to anchor the guide wire at an anchoring location, wherein the core wire includes a distal end that is configured to be coupled to the distal end of the guide wire.
The device according to any of the preceding claims, wherein the guide wire includes a tip at the distal end of the guide wire, wherein the distal end of the core wire is configured to be coupled to the tip of guide wire.
The device according to any of the preceding claims, wherein the core wire is configured to deactivate the anchoring mechanism for removing of the guidewire from the anchoring location, wherein the core wire includes an actuation mechanism disposed at a proximate end of the core wire, the actuation mechanism is configured to perform activation and deactivation of the anchoring mechanism.
The device according to any of the preceding claims, wherein the anchoring location includes at least one of the following: a target location for delivery of a medical device or a procedure, a location proximate to the target location, and any combination thereof.
The device according to claim 4, wherein the anchoring mechanism includes at least one of a contracted state and an expanded state, wherein in the contracted state, the guide wire is configured for at least one of an insertion into the target location and removal of the guide wire from the target location; in the expanded state, the anchoring mechanism is configured to be activated and is further configured to secure the guide wire at at least one of proximate to the target location and at the target location; wherein in the expanded state, a first section of the guide wire extending from a proximate end of the guide wire to a second section of the guide wire that connects to the anchoring mechanism is configured to be tensioned.
The device according to any of the preceding claims, wherein the anchoring mechanism has at least one of the following shapes: a coil, an angular shape, a Z-shape, a zig-zag shape, and any combination thereof.
The device according to any of the preceding claims, wherein the anchoring mechanism is at least one of a two-dimensional anchoring mechanism configured to anchor the guide wire at the anchoring location in at least two dimensions, and a three-dimensional anchoring mechanism configured to anchor the guide wire at the anchoring location in at least three dimensions.
The device according to any of the preceding claims, wherein the anchoring mechanism includes at least one of the following: a basket, a ball, an ovoid, a diabolo, a cylinder, a cone, an inverted cone, a pyramid, a screw, one or several directional nozzles, a suction cup, a ball or a plug, a covered ball, a plug with a waist, a covered plug with a waist, a cone, an inverted cone, a dual accordion, a triple accordion, a multiple-accordion structure, a torus, a pin, a hook, a balloon, and/or any combinations thereof.
The device according to any of the preceding claims, wherein the guide wire includes a navigation section, the anchoring mechanism, a device transfer section, a device implantation section, and a steering section; wherein the navigation section is configured to be located proximate to the distal end of the guide wire and is further configured to navigate the guide wire to at least a target location; the anchoring mechanism is configured to be located adjacent to the navigation section; the device transfer section is configured to be located adjacent to the anchoring mechanism and is further configured to transfer a medical device to the device implantation section for implantation, wherein the medical device is configured to be delivered over the guide wire to the target location; the device implantation section is configured to be located adjacent to the device transfer section and is further configured for implantation of the medical device at the target location; and the steering section is configured to be located proximate to the proximate end of the guide wire; wherein upon actuation of the anchoring mechanism, the guide wire is configured to form at least one angle between the anchoring section and the device implantation section.
The device according to claim 9, wherein the anchoring mechanism is configured to anchor the guide wire at the anchoring location using at least one of the following: a friction fit, a form fit, an active fixation, a permanent fixation, a temporary fixation, an automatic anchoring, a manual anchoring, and any combination thereof.
The device according to any of the preceding claims, wherein the anchoring mechanism includes at least one steering mechanism for at least one of: dynamically moving, steering, positioning, stabilization, and anchoring of the guide wire to at least the anchoring location; wherein the steering mechanism includes at least one nozzle configured to provide a conduit between the hollow interior of the guide wire and an exterior of the guide wire.
The device according to claim 11, wherein the at least one nozzle is configured to be actuated using at least one of: the core wire and a pressure applied from the hollow interior of the guide wire, wherein the pressure is applied using at least one substance; wherein, upon actuation, the at least one nozzle is configured to expunge the at least one substance from the hollow interior of the guide wire to perform at least one of: movement, steering, positioning, stabilization, and anchoring of the guide wire; wherein the at least one substance includes at least one of the following: a fluid substance, a gaseous substance, an amorphous substance, a solid substance, and any combination thereof; wherein the at least one nozzle is configured to be positioned proximate to the distal end of the guide wire; wherein the guide wire is configured to be at least one of: dynamically moved, steered, positioned, stabilized, and anchored at a predetermined location for performing at least one of a diagnostic procedure and a therapeutic procedure.
The device according to any of the preceding claims, wherein the anchoring mechanism, upon actuation, is configured to perform at least one of the following: advance the guide wire in a desired direction, anchor the guide wire at an anchoring location, steer the guide wire in a desired direction, position the guide wire at a predetermined location, stabilize the guide wire at a predetermined location and any combination thereof.
The device according to any of the preceding claims, wherein the anchoring mechanism includes a first configuration for delivery of the guide wire to an anchoring location, and a second configuration for anchoring of the guide wire at the anchoring location, the first configuration having at least one dimension smaller than at least one dimension of the anchoring location and the second configuration having at least one dimension larger than at least one dimension of the anchoring location; upon actuation, the anchoring mechanism is configured to assume the second configuration and anchor the guide wire at the anchoring location.
The device according to dependent claim 14, further comprising a sheathing device configured to sheath the guide wire for delivery of the guide wire to the anchoring location in the first configuration; wherein, upon removal of the sheathing device, the guide wire is configured to assume the second configuration.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS The present application claims priority to U.S. Provisional Patent Appl. No. 62/462,002 to von Segesser, filed February 22, 2017, and entitled "Guide Wire With Shape Change In-Situ". TECHNICAL FIELD In some implementations, the current subject generally relates to advancing and/or positioning of catheters, instruments, and/or other devices, and in particular to use of guide wire systems that are capable of changing shapes in-situ. BACKGROUND A guide wire being capable of guiding a catheter along a vessel is disclosed in WO 2010/119445 A1. The guide wire includes a distal portion which is positionable within a target site and includes a deployable pre-shaped structure capable of occupying a volume. In one embodiment, the guide wire is configured for use in positioning a catheter used for delivering a prosthetic heart valve. Guide wires are an essential requirement for insertion of catheters, instruments, and devices by the so-called Seldinger technique in diagnostic and therapeutic medical procedures. Some of the available guide wires include straight guide wires, curved guide wires, J-tip guide wires, ball tip guide wires, etc. The Seldinger technique can be referred to as the "catheter over the wire" technique. To allow a vascular access using this technique, a vessel is typically punctured using a hollow needle, adequate blood back flow is determined, and a guide wire is inserted through the hollow needle. Once the guide wire is positioned within the vessel, the hollow needle is removed, and a diagnostic and/or therapeutic catheter is inserted over the wire. The position of the catheter is controlled by fluoroscopy, ultrasonography and/or other suitable means. Finally, the guide wire is removed and the inserted, positioned catheter is used for its designated purpose. Alternatively, a device is inserted over the wire. The Seldinger technique has been used for vascular access as well as multitude of other medical and non-medical fields, including angiology, cardiology, thoracic, cardio-vascular surgery radiology, urology, otorhinolaryngology, gastroenterology, etc. Thus, whenever a bodily organ (in particular, a hollow organ) has to be accessed for diagnostic and/or therapeutic procedures, the Seldinger technique is used. Use of a guide wire allows positioning of a number of devices, including catheters, balloons, micro-instruments, sophisticated diagnostic tools (e.g., intra-vascular ultrasound, intracardiac ultrasound, pressure probes etc.), therapeutic devices (e.g., intra-aortic balloons, cannulas for life support systems, stents, covered stents, stent grafts, catheter valves, pacemakers, pressure monitoring systems etc.), and/or any other devices. However, some of the devices designed for insertion over the conventional guide wire are large compared to the dimensions of the access vessel and others are bulky making their insertion over a guide wire, positioning and unloading very difficult, even if a corresponding introducer catheter or wire has been positioned and the initial access has been mastered. To solve this problem, conventional techniques implement a larger and/or stiffer guide wire for the purposes of inserting a larger device. This technique suffers from inability to provide device insertion over a wire via tortuous access paths, e.g., contoured vessels, vessels with many narrow angles, etc. Angular paths can severely hamper control over the positioning of the guide wire tip from a remote location and decrease precision in advancing/positioning of the guide wire especially when narrower angles and/or serial angles are present in the path. One of the further problems using this approach is that a stiff or a larger device typically moves during insertion in the straightest possible direction disregarding a well-positioned guide wire that follows curvature of an access vessel. This can cause the tip of the guide wire to be pulled from the target position (i.e., the larger/stiffer device, because of its size/stiffness, advances using the largest possible radius of a curved access vessel). This can lead to vessel elongation, vessel rupture, a kinked guide wire, penetration of the vessel wall, and/or other problems. Hence, this prevents a successful completion of a planned procedure as well as can lead to adverse impacts to the patient. To resolve the above issues, a conventional technique of a "through-and-through" guide wire, which allows for insertion of larger devices, is used. Here, a very long wire is inserted from, for example, the femoral artery into the ascending aorta, captured there with a lasso coming from the brachial or radial artery, and pulled through. During implantation of the covered stent graft, the "through-and-through" wire can be put under tension and straightened, which, in turn, helps during advancement of the device. Similar techniques have been used for a femoral venous access, puncture of the inter-atrial septum, passing through