JP2016518175A - Fixing guide wire and method of use - Google Patents

Abstract

A fuser guidewire and method of use comprising (a) an outer core, (b) a fuser basket, (c) a steerable tip, and (d) an actuator core. The outer core, the anchoring basket and the steerable tip are coaxially aligned with each other. Further, the actuator core may be movably disposed inside both the outer core and the fixing basket, and may be connected to the steerable chip. [Selection] Figure 1B

Description

RELATED APPLICATION This application is a non-provisional application of US Provisional Application No. 61 / 809,134 entitled “Anchoring Guidewire” filed on April 5, 2013, which is incorporated herein by reference in its entirety. Claims the priority of the provisional application.

BACKGROUND OF THE INVENTION A guide wire can be used to guide a medical device to a desired target vessel for intervention. Conventional guidewire methods and devices may include a steerable guidewire that is not anchored at all. When including serpentine anatomy, a rigid device may act to straighten the guidewire as the device advances beyond the bend of the guidewire, and steerable guidewires are often The steerable guidewire can be reversed from the intended vessel, so it is difficult to use the steerable guidewire as a coaxial rail that guides the device to the appropriate vessel.

SUMMARY OF THE INVENTION The present invention is directed to a method and apparatus that can include a anchoring basket that anchors a guidewire to the vasculature prior to graft placement. These features can improve the ease with which stent grafts can be placed in bifurcated blood vessels, increase the speed and success rate of complex cases, and at the same time reduce the risk of complications. Anchoring the guidewire to the target vasculature can have a stabilizing effect on the tip of the catheter and can provide greater stability and reliability to the operator. Once the anchoring basket is in place, it can be locked in place to tighten the basket and advantageously allow blood to continue to flow downstream from within the basket. Once anchored, the guidewire can be used as a common coaxial rail to improve delivery of treatment devices such as bare metal stents, covered stents, and other over-the-wire devices.

  In other words, in a first aspect, the present invention is a fixing guide wire including (a) an outer core, (b) a fixing basket, (c) a steerable tip, and (d) an actuator core, The outer core, the anchoring basket and the steerable tip are coaxially aligned with each other, the actuator core is movably disposed within both the outer core and the anchoring basket, and the actuator core is steerable. A fuser guidewire is provided that is coupled to a flexible chip.

  In one embodiment, the invention includes the anchoring basket including a plurality of strips defined within an outer core adjacent to the steerable tip, wherein the plurality of strips are substantially in a first neutral state. It is straight and can be defined to curve outward in the radial direction in the second compression state.

  In another embodiment, the present invention provides that the fixing basket includes a plurality of wires each having a proximal end and a distal end, and each proximal end of the plurality of wires is attached to a first holder, A plurality of wires that are substantially straight in the first neutral state and are curved radially outward in the second compressed state. .

  In a second aspect, the present invention is a method of indwelling an anchoring guidewire, wherein (a) the anchoring guidewire according to the first aspect of the present invention is introduced into the arterial form, and (b) the actuator core is tensioned. A method is also provided that includes placing the steerable tip and moving the steerable tip toward the outer core, and (c) moving the anchoring basket from a first neutral state to a second compressed state.

FIG. 3 is a side view of a fixing guidewire in a neutral state according to an embodiment of the present invention. FIG. 3 is a side view of a fixing guidewire in a compressed state according to an embodiment of the present invention. FIG. 6 is a side view of a locking mechanism in a neutral state according to an embodiment of the present invention. FIG. 6 is a side view of a locking mechanism in a compressed state, according to one embodiment of the present invention. FIG. 6 is a side view of a locking mechanism in a locked state according to an embodiment of the present invention. 6 is a flowchart illustrating functions that may be performed by an exemplary embodiment of the disclosed method.

DETAILED DESCRIPTION OF THE INVENTION Exemplary methods and systems are described herein. It should be understood that the term “exemplary” is used herein to mean “serving as an example, instance, or illustration”. Any embodiment or feature described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments or features. The exemplary embodiments described herein are not intended to be limiting. It will be readily appreciated that certain aspects of the disclosed systems and methods can be arranged and combined in a variety of different forms, all of which are contemplated herein.

  Further, the specific sequences shown in the figures should not be considered as limiting. It should be understood that other embodiments may include some of the elements shown in a given figure. Moreover, some of the illustrated elements can be combined or omitted. In addition, exemplary embodiments may include elements not illustrated in the figures.

  In the first aspect, as shown in FIGS. 1A-B, the present invention provides (a) an outer core 102, (b) a fixing basket 104, (c) a steerable tip 106, and (d) an actuator core 108. And a fixing guide wire 100 including the above. The outer core 102, the anchoring basket 104 and the steerable tip 106 may be coaxially aligned with each other. Further, the actuator core 108 may be movably disposed within both the outer core 102 and the fixing basket 104 and may be coupled to the steerable tip 106. The total length of the fixing guidewire 100 may be in the range of about 120 mm to about 10,000 mm.

  “About” as used herein in connection with measurement and calculation means +/− 5%.

  The outer core 102 may be made of, for example, polyurethane, polyurethane including tungsten, gold, nitinol, platinum, stainless steel, stainless steel including nickel, tungsten, or any other suitable material. The outer core 102 may have a diameter in the range of about 0.25 mm to about 1 mm, preferably in the range of about 0.254 mm to about 0.9652 mm. In some embodiments, a plurality of radiopaque markers may be disposed on the outer core 102. The plurality of radiopaque makers, such as starting from the proximal end of the anchoring basket 104 and moving along the outer core 102 in a proximal direction within a range of up to about 20 mm, can be spaced 1 cm apart. A plurality of radiopaque markers may be arranged.

  In one embodiment, the anchoring basket 104 may include a plurality of strips defined within the outer core 102 adjacent to the steerable tip 106. These strips may be made by laser cutting the outer core 102. The strip may be substantially straight in the first neutral state (shown in FIG. 1A) and may be curved radially outward in the second compression state (shown in FIG. 1B).

  In another embodiment, the anchoring basket 104 may include a plurality of wires each having a proximal end and a distal end. The plurality of wires may be made of, for example, nitinol, titanium, titanium alloys, various plastics or any other suitable material. In one embodiment, the proximal ends of the plurality of wires may be attached to the first holder 110, and the distal ends of the plurality of wires may be attached to the second holder 112. In another embodiment, the plurality of wires may be directly coupled to the outer core 102 and the steerable tip 106. The plurality of wires may be substantially straight in the first neutral state (shown in FIG. 1A), and in the second compression state, the first holder 110 and the second holder 112 are brought closer together. May be curved outward in the radial direction (shown in FIG. 1B). The fusing basket 104 may have a diameter in the range of about 3 mm to about 70 mm in the second compressed state. The first holder 110 may be in mechanical communication with the outer core 102 and the second holder 112 may be in mechanical communication with the steerable tip 106. In some embodiments, the outer core 102 may be physically connected to the first holder 110 and the steerable tip 106 is physically connected to the second holder 112 as well. Also good.

  Actuator core 108 is movably disposed within outer core 102 and extends within anchoring basket 104 so that actuator core 108 can be coupled to steerable tip 106 and / or second holder 112. May be. In operation, the actuator core 108 may move the fuser basket 104 between a first neutral state and a second compressed state. FIG. 1A shows a first neutral state of the fixing guide wire 100, and FIG. 1B shows a second compressed state of the fixing guide wire 100. In one embodiment, the actuator core 108 may be arranged to advance the steerable tip 206 toward the outer core 102 until the fusing basket 104 is in a second squeezed state. In another embodiment, the actuator core 108 may be arranged to advance the second holder 112 toward the first holder 110 until the fusing basket 104 is in the second compressed state.

  2A-2C illustrate an exemplary locking mechanism according to one embodiment of the present invention. Specifically, the actuator core 108 may be in physical communication with a detachable lock mechanism for holding the fixing basket 104 in the second compressed state. As shown in FIG. 2A, the removable locking mechanism may include a raised element or protrusion 114 coupled to the actuator core 108. In the first neutral state, the raised elements or protrusions 114 may be configured to fit into the slots 116 in the outer core 102. As shown in FIGS. 2B-2C, when the anchoring guidewire 100 moves from the first neutral state to the second compressed state, the actuator core 108 and concomitantly the raised elements 114 move proximally with respect to the outer core 102. Because it is pulled and then rotated, an interference fit with the outer core 102 (shown in FIG. 2C) prevents the bulging element 114 from moving distally. The net result is that the actuator core 108 can be locked in place to hold the fuser basket 104 in the second compressed state. When the plurality of wires 105 of the fixing basket 104 are in the second compressed state, the wires 105 are spring-loaded, so that they attempt to return to the first neutral state. Therefore, when the tension of the actuator core 108 is removed, the second holder 112 is arranged so that the steerable tip 106 is advanced from the outer core 102 until the first neutral state is reached.

  In one embodiment, the actuator core 108 may be rigid so that the actuator core 108 can both push and retract the steerable tip 106. In this case, the wire fixing basket 104 may be returned to the first neutral state by the spring force of the actuator core 108 and / or the plurality of wires.

  The steerable tip 106 may have a variety of stiffnesses and thicknesses to be utilized in different use cases. For example, if the anchoring guide wire 100 has to guide a narrow convoluted portion to travel to the target vessel, the steerable tip 106 can be thinner and / or less stiff. In another example, steerable tip 106 may be thicker and / or more rigid if the target vessel is less sensitive and there is a more direct path to the target vessel . The steerable tip 206 may have a length in the range of about 5 mm to about 200 mm.

  FIG. 3 is a simplified flowchart illustrating a method according to an exemplary embodiment. Although the blocks are shown in a sequential order, these blocks may be performed in parallel and / or in a different order than that described herein. Similarly, based on the desired implementation, various blocks may be combined into fewer blocks, divided into additional blocks, and / or omitted.

  At block 302, the method includes introducing a fixation guidewire according to any one of the previous embodiments into any suitable arterial configuration, including a synthetic lumen. In block 304, the method includes placing the actuator core under tension and advancing the steerable tip toward the outer core. At block 306, the method includes moving the anchoring basket from a first neutral state to a second compressed state. At block 308, the method includes locking the actuator core in place to hold the anchoring basket in a second compressed state. The actuator core may be locked in place utilizing the exemplary locking mechanism described above in connection with FIGS. 2A-2C, or through some other locking mechanism. In another embodiment, the method may further include unlocking the actuator core. In yet another embodiment, the method may further include removing tension from the actuator core and moving the anchoring basket from the second compressed state to the first neutral state.

  While various aspects and embodiments have been described herein, other aspects and embodiments will be apparent to those skilled in the art. Unless explicitly indicated otherwise, all embodiments within or between different aspects of the invention can be combined. The various aspects and embodiments disclosed herein are for purposes of illustration and are not intended to be limiting, with the true scope and spirit being indicated by the following claims.

Claims (20)

With an external core;
With a fixing basket;
A steerable tip;
An actuator core;
A fixing guide wire comprising:
The outer core, the fixing basket and the steerable tip are coaxially aligned with each other, the actuator core is movably disposed within both the outer core and the fixing basket, and the actuator core is A fuser guidewire coupled to the steerable tip.   The anchoring basket includes a plurality of strips defined in the outer core adjacent to the steerable tip, the plurality of strips being substantially straight in a first neutral state; The fixing guide wire according to claim 1, wherein the fixing guide wire is curved outward in a radial direction.   The fixing basket includes a plurality of wires each having a proximal end and a distal end, each proximal end of the plurality of wires is attached to a first holder, and each distal end of the plurality of wires is a second The fixing guidewire of claim 1 attached to a holder, wherein the plurality of wires are substantially straight in a first neutral state and are radially outwardly curved in a second compression state. .   The fuser guidewire of claim 3, wherein the first holder is in mechanical communication with the outer core and the second holder is in mechanical communication with the steerable tip.   The fuser guidewire according to any one of claims 2 to 4, wherein an actuator core is arranged to move the fuser basket between the first neutral state and the second compressed state.   6. The actuator core according to claim 2, wherein the actuator core is arranged to advance the steerable tip toward the outer core until the fixing basket is in the second compressed state. The fixing guide wire described in 1.   The actuator core is disposed so as to advance the second holder toward the first holder until the fixing basket is in the second compressed state. The fixing guide wire according to the item.   The fixing according to any one of claims 2 to 7, wherein the actuator core is in mechanical communication with a detachable locking mechanism configured to hold the fixing basket in a second compressed state. Guide wire.   The second holder is arranged to advance the steerable tip in a direction away from the outer core until the first neutral state is reached in the second compressed state. 9. The fixing guide wire according to any one of 8 above.   20. A fuser guidewire according to any one of the preceding claims, wherein the actuator core is rigid so that the actuator core can both push and retract the steerable tip.   11. The fixing guidewire according to any one of claims 2 to 10, wherein the fixing basket has a diameter in the range of about 3 mm to about 70 mm in the second compressed state.   12. A fuser guidewire according to any one of the preceding claims, wherein the steerable tip has a length in the range of about 5 mm to about 200 mm.   The fusing guidewire of any one of the preceding claims, wherein the outer core has a diameter in the range of about 0.254 mm to about 0.9652 mm.   The fixing guidewire according to claim 1, wherein a length of the fixing guidewire is in a range of about 120 mm to about 10,000 mm.   The fixing guide wire according to claim 1, wherein a plurality of radiopaque markers are disposed on the outer core.   Such that the plurality of radiopaque makers begin at the proximal end of the anchoring basket and move proximally within the range up to about 20 mm along the outer core, with a 1 cm spacing; The fixing guide wire according to claim 1, wherein the plurality of radiopaque markers are arranged. A method of placing a fixing guide wire,
Introducing the anchoring guidewire of any one of claims 1 to 16 into an arterial form;
Placing the actuator core in tension and moving the steerable tip toward the outer core; and moving the anchoring basket from a first neutral state to a second compressed state;
Including a method. Removing tension from the actuator core; and moving the anchoring basket from a second compressed state to a first neutral state;
The method of claim 17, further comprising: Locking the actuator core in place to hold the anchoring basket in the second compressed state;
The fixing guide wire according to claim 17, further comprising: Unlocking the actuator core;
20. The method of claim 19, further comprising:

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