Double Concentric Guidewire

20180214675 ยท 2018-08-02

    Inventors

    Cpc classification

    International classification

    Abstract

    A double guide wire includes two guidewires deployed concentrically, one within the other. Each guidewire is formed as an elongated flexible shaft having a distal portion including a deflectable helical coil terminating at a distal tip. The first guidewire is implemented as a hollow guidewire having a central lumen extending along its length, while the second guidewire is configured as a smaller gauge guidewire deployed within the central lumen of the first guidewire. An adjuster mechanism allows the inner guidewire to be advanced and retracted relative to the outer guidewire, transforming the guidewire between: a first state in which the distal tip of the second guidewire is adjacent to the distal tip of the first guidewire; and a second state in which at least part of the distal portion of the inner guidewire is advanced beyond distal tip of the first guidewire.

    Claims

    1. A double guidewire comprising: (a) a first guidewire comprising an elongated flexi shaft having a distal portion that terminates in a distal tip, said distal portion comprising a deflectable helical coil, said first guidewire being a hollow guidewire having a central lumen extending along a length of said first guidewire; (b) a second guidewire comprising an elongated flexible shaft having a distal portion that terminates in a distal tip, said distal portion comprising a deflectable helical coil, said second guidewire being deployed within said central lumen of said first guidewire; and (c) an adjuster mechanism mechanically linked to proximal portions of said first and second guidewires, said adjuster mechanism being operable to displace said second guidewire longitudinally relative to said first guidewire between: (i) a first state in which said distal tip of said second guidewire is adjacent to said distal tip of said first guidewire, and (ii) a second state in which at least part of said distal portion of said second guidewire s advanced beyond distal tip of said first guidewire.

    2. The double guidewire of claim 1, wherein said adjuster mechanism is further operable to displace said second guidewire longitudinally relative to said first guidewire to a third state in which said distal tip of said second guidewire is withdrawn proximally along said central lumen so as to leave empty a part of said central lumen along at least part of said distal portion of said first guidewire.

    3. The double guidewire of claim 2, wherein a region of said distal portion adjacent to said distal tip of each of said first and second guidewires is configured to be inelastically deformable or preshaped to impart a lateral deflection to said distal portion, and wherein, when a first length of said distal portion adjacent to said distal tip of each of said first and second guidewires is deflected, partial withdrawal of said second guidewire from said first state towards said third state causes a second length of the double guidewire to be deflected, said second length being longer than said first length.

    4. The double guidewire of claim 1, wherein an external surface of said distal portion of said first guidewire is coated with a hydrophilic coating, and wherein an external surface of said distal portion of said second guidewire is not coated with said hydrophilic coating.

    5. The double guidewire of claim 1, wherein said first guidewire further comprises a metal strip extending along an inner surface of said helical coil and permanently attached to said helical coil at a plurality of spaced-apart locations along said helical coil.

    6. The double guidewire of claim 1, wherein said second guidewire further comprises a tapered metal core extending within said helical coil and permanently attached to said helical coil at said distal tip.

    7. The double guidewire of claim 1, wherein an outer diameter of said first guidewire is sized for use with 014 compatible over-the-wire devices.

    8. The double guidewire of claim 1, wherein an outer diameter of said first guidewire is sized for use with 038 compatible over-the-wire devices.

    9. A method of performing a surgical procedure on a patient comprising the steps of: (a) providing a double guidewire according to claim 1 with a region of said distal portion adjacent to said distal tip of each of said first and second guidewires having a lateral deflection, the deflected portion of said first guidewire having a first length; (b) introducing the double guidewire into the vascular system of the patient and navigating the double guidewire within the vascular system to reach a location of a lateral branch vessel; and (c) selectively displacing said second guidewire relative to said first guidewire so as to locate deflected portions of said first and second guidewires longitudinally displaced relative to each other, thereby imparting to said double guide wire a lateral deflection extending for a second length, said second length being greater than said first length, to facilitate navigation of said double guidewire into the lateral branch vessel.

    10. The method of claim 9, further comprising selectively displacing said second guidewire relative to said first guidewire so that said distal portion of said second guidewire extends beyond said distal tip of said first guidewire.

    11. The method of claim 9, further comprising advancing along the double guidewire an 014-compatible over-the-wire device selected from the group consisting of: an angioplasty balloon and an expandable stent.

    Description

    BRIEF DESCRIPTION OF THE DRAWINGS

    [0027] The invention is herein described, by way of example only, with reference to the accompanying drawings, wherein:

    [0028] FIG. 1 illustrates a preferred embodiment of the invention, including a schematic section of a manual control handle located at the proximal end of a double guidewire having a controlled tip.

    [0029] FIGS. 2A and 2B are schematic longitudinal and transverse cross-sections of the distal portion including the tip of the double guidewire of FIG. 1.

    [0030] FIG. 3 is a detailed view of the schematic cross section of handle of FIG. 2 where a safety ribbon connected to the proximal end of the guide wire.

    [0031] FIG. 4 is a set of views of an example for the handle of FIG. 1

    [0032] FIG. 5 is a pair of schematic axial cross-sectional views of the handle of FIG. 4.

    [0033] FIG. 6 is a schematic cross section of the Guide Wire of FIG. 1 where the tip of it second inner guide wire is protruding out of the tip of the Guide Wire by manipulating the handle of FIG. 1.

    [0034] FIG. 7 is a schematic cross section of the Guide Wire of FIG. 1 where the extant of protruding of the second guide wire tip is adjust be manipulating the handle.

    [0035] FIG. 8 illustrates a preferred embodiment of the invention, including second guide wire having a pre shaped tip such that it curved while it protrude out of the guide wire tip.

    [0036] FIG. 9 is a schematic cross section of the Guide Wire of FIG. 1 where the position of the second guide wire tip within the Guide Wire proximal portion is adjust be manipulating the handle in order to control tip stiffness and curvature.

    [0037] FIG. 10 is another schematic cross section of the Guide Wire of FIG. 1 where the position of the second guide wire tip within the Guide Wire proximal portion is adjust be manipulating the handle in order to control tip stiffness and curvature.

    [0038] FIG. 11 is also another schematic cross section of the Guide Wire of FIG. 1 where the position of the second guide wire tip within the Guide Wire proximal portion is adjusted by manipulating the handle in order to control tip stiffness and curvature.

    [0039] FIG. 12 is a schematic isometric view of a handle of the guidewire of FIG. 1.

    [0040] FIGS. 12A-12C are enlarged views of a region of FIG. 12 illustrating a safety ring in a locked position, an unlocked position, and an unlocked position after further advancing of a slider control, respectively.

    [0041] FIG. 13 is a schematic, partially cut-away side view of the guidewire of FIG. 1 in a first state of deflection.

    [0042] FIG. 14 is a view similar to FIG. 13 in which a distal portion of the guidewire is cut-away along an axial plane.

    [0043] FIG. 15 is a view similar to FIG. 14 showing the guidewire in a second state of deflection.

    [0044] FIG. 16 is a view similar to FIG. 14 showing the guidewire in a third state of deflection.

    DESCRIPTION OF THE PREFERRED EMBODIMENTS

    [0045] The present invention is a double concentric guidewire.

    [0046] The principles and operation of guidewires according to the present invention ma be better understood with reference to the drawings and the accompanying description.

    [0047] By way of introduction, it should be noted that certain preferred embodiments of the present invention are distinguished by providing a double guide wire in which two guidewires, each providing a set of features required of a guidewire, are deployed concentrically, one within the other. Thus, each is formed as an elongated flexible shaft having a distal portion that terminates in a distal tip, where the distal portion includes a deflectable helical coil. The helical coil is a critical feature of the distal portion of a guidewire, providing a combination of an easily deflectable structure which can readily negotiate meandering paths while at the same time allowing application of considerable axial force when the coils of the coil are closed against each other. The first guidewire is implemented as a hollow guidewire having a central lumen extending along its length, e the second guidewire is configured as a smaller gauge guidewire deployed within the central lumen of the first guidewire.

    [0048] An adjuster mechanism, which is typically implemented as a manually-controlled slider integrated with a handle of the double guidewire, allows the second, guidewire to be advanced and retracted relative to the first, outer guidewire, thereby providing the user with a range of variations of the properties of the guidewire tip which can typically otherwise only be achieved by swapping guidewires (removing the first one from the body and inserting an alternative one), with all the disadvantages of such replacement as discussed above. Specifically, by operating the adjuster mechanism, the user can preferably transform the guidewire at will between two or more of the following states: [0049] A first state (FIG. 9) in which the distal tip of the second guidewire is adjacent to the distal tip of the first guidewire. In this state, both guidewires contribute to the stiffness of the guidewire, providing a relatively stiff guidewire, and the effective tip diameter of the guidewire is that of the larger outer guidewire. [0050] A second state (FIGS. 6-8) in which at least part of the distal portion of the second (inner) guidewire is advanced beyond distal tip of the first guidewire. In this state, the properties of the distal portion of the overall guidewire are defined by the properties of the inner guidewire alone, providing relatively finer gauge and more flexible leading portion of the guidewire. [0051] A third state (FIGS. 1, 2, 10, 11 and 13-16) in which the distal tip of the second (inner) guidewire is withdrawn proximally along the central lumen so as to leave empty a part of the central lumen along at least part of the distal portion of the first guidewire. The withdrawal of the inner guidewire from the distal portion of the outer guidewire may be used to extend a length of the distal tip which undergoes deflection, as will be described further below with reference to FIGS. 14-16. Additionally, or alternatively, it may be used to enhance the flexibility of the distal portion of the first guidewire.

    [0052] The ability to switch between the first and second states described above allows the user to swap as desired between other properties that may be provided by the first and second guidewires. For example, according to one particularly preferred non-limiting example, the external surface of the distal portion of the first (outer) guidewire is coated with a hydrophilic coating, while the external surface of the distal portion of the second (inner) guidewire is not coated with the hydrophilic coating, being either uncoated or having some other coating, such as a hydrophobic coating. This facilitates smooth insertion of the guidewire in the first state, where the properties distal end of the guidewire are defined by the outer guidewire, and the hydrophilic coating ensures greatly reduced friction compared to an uncoated guidewire. When the user is approaching the target location or otherwise needs enhanced tactile feedback, the relatively higher friction second guidewire is advanced so that the outer surface without a hydrophilic coating becomes the leading exposed guidewire surface, thereby providing the desired enhanced tactile feedback.

    [0053] In order to maintain the structural integrity of the first (outer) guidewire and as a safety feature, the first guidewire preferably includes a metal strip (shaping ribbon) extending along an inner surface of the helical coil and permanently attached (e.g., welded) to the helical coil at a plurality of spaced-apart locations along the helical coil.

    [0054] The inner (second) guidewire is preferably formed with a tapered metal core that extends within the helical spring, and is permanently attached (e.g., welded) to the helical coil at the distal tip. The tapering of the metal core inherently provides gradually varying stiffness to the second guidewire, where the distal end is the most floppy part, becoming gradually stiffer with increasing distance from the tip.

    [0055] The double guidewire of the present invention may be used to advantage in a wide range of applications. By way of one particularly preferred set of application, the double guidewire is used in procedures performed in the coronary arteries. For such applications, an outer diameter of the first (outer) guidewire is sized for use with 014 compatible over-the-wire devices, i.e., with an outer diameter no greater than about 0.014 inch (0.36 mm).

    [0056] In other applications in the peripheral vascular system, implementations of the invention may employ an outer diameter of the first (outer) guidewire sized for use with 038 compatible over-the-wire devices, i.e., with an outer diameter no greater than about 0.038 inch (0.97 mm).

    [0057] A preferred embodiment of the invention as illustrated in FIG. 1 includes a Guide Wire (100) intended to facilitate the placement of catheter during vascular intervention procedure. A typical catheter such as a balloon dilatation catheter (not shown in figures) is not steerable or maneuverable and therefore it cannot reach the desire location by itself. In order to deliver the dilatation balloon to the desire location in the vascular system at least part of the catheter is introduced over the Guide Wire (100).

    [0058] The Guide Wire (100) is hollow and has a distal portion (110) terminating at a distal tip (111) and a proximal portion (120) associated with a handle (200).

    [0059] As illustrated in FIG. 2 the distal portion (110) preferably includes two coils joined one to each other: a distal coil (112) made of radio opaque material such as (but not limited to) platinum/tungsten alloy and a proximal coil made of high elastic material such as (but not limited to) spring temper stainless steel (113). The distal tip (111) of the distal portion located within the radio opaque coil (112). The proximal portion (120) is a hypotube made of high elastic material such as (but not limited to) spring temper stainless steel or super elastic Nitinol. The distal end (121) of the proximal (120) portion and the proximal end of the distal portions (110) are permanently joined together by welding, soldering, adhering, or any other suitable method. In preferred embodiments in order to improve the torquability of the guide wire the distal end of the proximal portion (120) and part of the distal portion(110) are covered with polymeric heat shrink sleeve (130) made of materials such as (but not limited to) PET or PTFE.

    [0060] According to FIG. 2 a shaping ribbon (140) located within the distal portion (110) the distal end of the ribbon attached to the end (115) of the distal tip (111) and to other points (116) along the distal portion. The ribbon prevents the coils of the distal portion from stretching and therefore it enhances the torquability of the Guide Wire (100). Most preferably, shaping ribbon (140) is implemented as part of a metal strip which extends along the entire length of the outer guidewire, attached at spaced-apart locations along the guidewire, serving also as a safety ribbon to prevent any part of the guidewire from separating from the rest of the guidewire, even in the event of a mechanical failure. The shaping ribbon (140) is made of high elastic material such as (but not limited to) spring temper stainless steel, Cobalt alloys (such as L605) and Super elastic Nitinol.

    [0061] Attachment of the metal strip at spaced-apart locations along the guidewire may be achieved by temporarily pressing the strip against the internal surface of the outer guidewire by temporary insertion of an inner rod formed from or coated with a non-stick coating, such as Teflon (PTFE), thereby pressing the strip outwards against the inner surface of the outer guidewire, and then employing a suitable bonding technique, such as welding, to form a permanent connection between the outer guidewire and the metal strip. The temporary inner rod is then removed and the inner guidewire is introduced.

    [0062] The proximal portion (120) is associated with a handle (200). Its proximal end is held by the handle (200) such that it can be turned about its longitudinal axis by using the handle as a torquer. According to a preferred embodiment illustrated in FIG. 3 and FIG. 4 the handle includes a cutter (220) to cut the proximal portion (120) to remove the handle (200) in order to facilitate placement of a catheter over the Guide Wire.

    [0063] Turning back to FIG. 1, the distal tip (111) is pre shaped to form a curve or it is shapeable such that a physician can shape the distal tip (111) to form a curve. The curved tip (111) enables the physician to steer the Guide Wire (100) through the vascular system. In order to steer the tip (111) with safety and efficacy, the distal portion (110) should be on one hand floppy and soft to deflection and on the other hand stiff to torsion such that it transmits torque in one-to-one ratio. Due to it curved shape the floppy tip (111) is pressed gently against the vessel walls (not shown in figures).

    [0064] By rotating the Guide Wire (100) and by moving it axially the floppy tip moves along the vessels walls. Once the tip reaches the ostium (opening) of a branch in the vascular system it falls into the branch. In this situation, pushing the Guide Wire (100) further will cause the tip (111) to advance along the branch. Using this method the physician can steer the distal tip (111) to almost any desired location in the vascular system.

    [0065] The hollow Guide Wire (100) defines a lumen (150) extending along its entire length from the proximal end (122) of the proximal portion (120) to the distal end (115) of the tip (111) of the distal portion (110). In preferred embodiments illustrated in FIG. 2 and FIG. 3, in order to enhance safety, the shaping ribbon (140) extends along the entire length of the Guide Wire (100) and is attached to the proximal end (122) of the proximal portion (120), and preferably also at other locations spaced apart along the guidewire's length, so that, if for some reason a joint between any portions or components of the Guide Wire (100) were to fail, the ribbon (140) would still hold the whole package together allowing the physician to safely withdraw the Guide Wire (100). A single metal strip thus preferably functions both as a shaping ribbon and as a safety ribbon.

    [0066] As illustrated in FIG. 2, a second inner guide wire (300) extends through the lumen (150) from the handle (200) to the distal portion (120). The second guide wire (300) is slidably received within the lumen (150). The second guide wire (300) has a distal portion (310) terminating at a distal tip (311) and a proximal portion (320) associated with handle (200).

    [0067] As illustrated in FIG. 2 the distal portions (310) of the inner guide wire (300) consist of core wire (312) having a tapered end (313) placed within an inner distal coil (314). The distal end of the inner coil (314) is attached to the distal end of the core wire (311). The proximal end (315) of the inner coil (313) is also attached to the tapered portion (312) of the core wire (311). The components of the second inner guide wire (300) are made of highly elastic materials such as (but not limited to) spring tempered stainless steel, Cobalt alloys (such as L605) and Super elastic Nitinol. The inner coil (314) is preferably made of radio opaque material such as (but not limited to) platinum/tungsten alloy. In preferred embodiments the core wire (312) is coated with PTFE or other suitable coating to reduce friction.

    [0068] The proximal portion (320) of the second guide wire (300) is associated with side handle (200) by a slider member (210). The proximal end (321) is attached to the slider by using welding soldering, adhering or any other suitable method. By sliding the slider member (210) along the handle (200) the physician can displace the second inner guide wire (300) within the lumen (150) of the Guide Wire (100).

    [0069] The distal tip (311) of the second guide wire is configured to protrude out of the distal tip (111) of the Guide Wire by manipulating the handle (200). As illustrated in FIG. 6 the distal tip (311) of the second guide wire (300) can be made to protrude out beyond the distal tip of the outer Guide Wire by moving the slider toward the distal end of the handle (230).

    [0070] The second, inner guide wire is of small diameter that can vary from 0.005 to 0.024 depending on the Guide Wire (100) outer diameter. In a preferred embodiment the diameter of at least a distal portion of the second guidewire (300) is smaller than 0.014, and in certain particularly preferred implementations, 0.0070.002. This renders the inner guidewire particularly suitable to allow the physician to negotiate the thin micro channels of the proximal cap of a CTO lesion in order to cross through.

    [0071] As illustrated in FIG. 7, the extent of protruding (340) of the second guide wire tip (311) is controlled by the distance (240) between the slider (210) and the distal end of the handle (230). By moving the slider (210) the physician can accurately position the tip within the lesion. In addition the physician can control its stiffness. The tip (311) becomes floppy as the extent of protruding (340) increases. And in addition the physician can produce tapping by repeatedly moving the slider (210) back-and-forth.

    [0072] In another preferred embodiment of the invention illustrated in FIG. 8 the second guide wire (300) has a pre-shaped tip (311) such that it curves when it protrudes beyond the outer Guide Wire tip (111).

    [0073] The embodiments of the guide wire described herein are preferably in the same sizes as a conventional guide wires. Hence the diameter of the Guide Wire (100) is 0.038 or smaller with respect to the conventional sizes of 0.038, 0.024, 0.018 and 0.014.

    [0074] Balloon dilatation catheters for percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA) are usually intended to be introduced over a 0.014 guide wires, referred-to herein as 014 compatible. Therefore if the Guide Wire (100) of the present invention is intended to facilitate the placement of Balloon dilatation catheters during those procedures it is of advantage that the Guide Wire is 0.014 or smaller.

    [0075] It is well accepted among interventional cardiologist physicians that workhorse guide wires (guide wires that intended to be the first to negotiate the coronary vessels for navigation during PTCA procedures) should be coated with a hydrophilic coating to reduce surface friction to enhance trackability. It is also well accepted that the distal tips of guide wires that are intended to negotiate with CTO should not be coated because the hydrophilic coating disturbs the tactile sense the physician has regarding the position of the guide wire within the lesion.

    [0076] It would be of advantages to have a single tool that offers the physician an option to navigate to the CTO lesion with a hydrophilic tip and then negotiate the CTO with an uncoated tip. Therefore in the preferred embodiments illustrated in FIG. 6 the distal tip (111) of the Guide Wire (100) is coated with hydrophilic coating (160) whereas the distal portion (310) of the second guide wire (300) is un-coated (130) (or may be coated with a coating other than a hydrophilic coating).

    [0077] As illustrated in FIG. 8, FIG. 9, FIG. 10 and FIG. 11 the position of the distal tip (311) of the second guide wire (300) within the distal portion (110) of the Guide Wire (100) is adjusted by moving the slider (210) with respect to the distal end (230) of the handle (200). FIG. 9 illustrates position where the tip of the second guide wire is located at the distal end of the tip (115) of the Guide Wire (100). In this position stiffness is at a maximum. In FIGS. 10 and 11, the tip (311) is withdrawn such that a 45 degrees curve or a right-angle curve, respectively, is formed according to the initial shape of the outer Guide Wire tip (111) in a case where the inner guide wire does not induce additional curvature. Additional options providing additional control over the curvature and deflection will be described below with reference to FIGS. 13-16.

    [0078] By using the slider (210) to displace the tip (311) of the second inner guide wire (300) within the distal portion (110) of the Guide Wire (100) the physician adjust the stiffness and curvature of the distal tip (111) of the Guide Wire (100) on demand. Hence by using the device of the present invention, the physician can immediately change the character of the Guide Wire he or she currently use from floppy to stiff and vice versa with no need to switch between wires.

    [0079] In the preferred embodiment illustrated in FIG. 2 the handle of FIG. 4 has a safety ring illustrated in FIG. 12 such that when the slider (210) is stopped by the ring (250) as illustrated in V1 of FIG. 12 the distal tip (311) is advanced to the distal end (115) of the tip (111) of the Guide Wire (100) as illustrated in FIG. 9.

    [0080] In order to make the tip (311) protrude out of the Guide Wire (100) the physician turns the ring as illustrated in V2 of FIG. 12 to align a slot with the radially-projecting part of slider (210), so that he or she is able to advance the slider (210) toward the distal end (230) of the handle (200) as illustrated in V3 of FIG. 12.

    [0081] In a preferred embodiment illustrated in FIG. 13 and FIG. 14 the distal tip (111) is pre-shaped to form a first curve (111a). The distal tip (111) could also be shapeable such that a physician can shape it to form a first curve (111a). As illustrated in FIG. 14, the second inner guide wire (300), extending through the lumen (150) from the handle (200) to the distal portion (111), also has a pre-shaped or user-shapeable distal tip (311).

    [0082] The distal tip (311) of the second guide wire thus induces a second curve (111b) in the outer guidewire at a corresponding position along the outer guidewire, thereby allowing adjustment of the shape of the tip of the Guide Wire by manipulating the slider (210) of the handle (200). In other words, the presence of the bent tip of inner guidewire within the flexible distal portion of the outer guidewire generates an additional region of deflection which can be displaced relative to the outer guidewire by operating slider (210), thereby adjusting the overall extent, angle and geometry of the curvature of the tip portion of the double guidewire.

    [0083] The effect of this feature is illustrated in FIG. 13, FIG. 14, FIG. 15 and FIG. 16, which illustrate how the radius of curvature and/or length of the tip portion undergoing deflection and/or a total lateral deflection from the axis (160) of the distal tip (111) of the Guide Wire (100) can be adjusted by manipulating the handle: Advancing slider (210) relative to the handle body (230) advances the curved tip (311) within the Guide Wire (100) toward the end (115) of its distal tip (111). This in turn reduces the total lateral deflection (160) of the Guide wire (100) as the distance between the first curve (111a) and second curve (111b) became shorter. More specifically, in FIGS. 13 and 14, each curve (111a) and (111b) corresponds to roughly a 45 degree deflection, and a relatively straight portion lies between the two curves. In FIG. 15, after advancing the inner guidewire slightly relative to the outer guidewire, the two curves are brought close together, resulting in what approximates to a continuous curve of roughly 90 degrees, and a reduced overall lateral deflection compared to FIG. 14. Further advancing of the inner guidewire relative to the outer guidewire results in at least partial overlap of the deflected portions of the inner and outer guidewires, so that the overall curvature is less than 90 degrees and the overall lateral deflection is further reduced, as illustrated in FIG. 16. Parenthetically, it should be noted that the principles of operation described with reference to FIGS. 13-16 for adjusting the curvature and deflection of a guidewire correspond to an aspect of the present invention which can be implemented independent of the details of the structure of inner wire (300). Thus, an alternative implementation of this aspect of the present invention provides adjustable curvature and deflection as described with reference to FIGS. 13-16 where the inner element is not implemented as a guidewire with a distal coil but instead is a curvature adjusting element of some other type, such as, for example, a solid wire of suitable diameter with a pre-shaped deflected tip or a user-shapeable tip. In such an embodiment, the adjustment mechanism, such as slider (210), preferably limits motion of the inner curvature adjusting element so as not to be advanced beyond the tip of the outer guidewire.

    [0084] As illustrated in FIG. 8, by advancing the Slider (210) further, the pre-shaped (or user-shaped) curved tip (311) of the second guide wire (300) is made to protrude out of the Guide Wire tip (111), thereby providing the fine-gauge highly-flexible guidewire functionality already discussed above.

    [0085] The various features of the device of the invention described herein thus provide various improvements to the efficacy of devices for opening CTO lesions and other vascular applications in the coronary and peripheral vascular systems, typically offering time saving and/or reduced risk of perforating the artery compared to conventional techniques.

    [0086] To the extent that the appended claims have been drafted without multiple dependencies, this has been done only to accommodate formal requirements in jurisdictions which do not allow such multiple dependencies. It should be noted that all possible combinations of features which would be implied by rendering the claims multiply dependent are explicitly envisaged and should be considered part of the invention.

    [0087] It will be appreciated that the above descriptions are intended only to serve as examples, and that many other embodiments are possible within the scope of the present invention as defined in the appended claims.