DESCRIPTION
The invention relates to a medical guide wire used upon inserting a medical device or equipment (e.g., catheter) into a somatic cavity.
Various types of wires have been used to introduce a catheter for the purpose of vascular examination and treatment so that the guide wires are inserted into a target area of a somatic cavity prior to inserting the catheter.
Among the guide wires, one guide wire has a core line which is tapered off to form a cone-shaped configuration, and having a sheath body which is placed around a distal end portion of the core line. Some guide wires have a synthetic resin film coated on an outer surface of the core line.
In order to smoothly advance the guide wire through an arcuate area of the somatic cavity upon introducing the catheter, physical properties required for the guide wire are a good torque-transmission and supportability to hold the catheter and other related equipments inserted into the somatic cavity along the guide wire. Also required for a distal end portion of the guide wire is a good restitution capable to return the guide wire to an original configuration from a curved configuration.
To the distal end portion of the core line, used is a superelastic alloy wire (e. g. , N i-T i based alloy wire) which has a low rigidity, and a stainless steel wire is used to a proximal end portion of the core line, in an attempt to enable an operator to a good torque-transmission and supportability

at the proximal end portion while insuring a good restitution at the distal end portion of the core line, as disclosed by Japanese Laid-open Patent Application No. 2004-230141.
The prior guide wire of the above reference, however, employs a welding or soldering procedure to connect the two different wires at their butted ends. In order to insure a sufficient strength at the butted ends of the core line, it is necessary for the core line to have a certain amount of diameter (thickness), so that the butted ends are usually located at 200-300 mm on and proximally from the distal end of the core line. This renders the supportability of the guide wire insufficient at 100-200 ram from the distal end of the core line upon holding the catheter and other related equipments inserted into the somatic cavity along the guide wire.
The welding and soldering procedures deteriorate the torque-transmission more as the butted ends position remote from the distal end of the core line. Additionally, these procedures result in the butted ends being heat treated, so as to make the butted ends soften to reduce its physical strength.
Therefore, the present invention is made to overcome the above drawbacks, and it is an object of the invention to provide a medical guide wire which is capable of bonding a proximal side wire and a rigidity-reduced distal side wire at a more diameter-decreased portion of the core line with a sufficient physical strength, so as to attain a good balance

of torque-transmission, supportability and restitution at more distal end portion without losing a good torque-transmission and supportability even when bonded more in the proximity of the distal end portion.
According to the invention, there is provided a
medical guide wire having a core line, a distal end portion of which is tapered off so that the distal end portion diametrically decreases progressively as approaching forward. A flexible sheath body is placed at least around the distal end portion of the core line. The core line has a proximal side wire and a distal side wire, the latter of which is to be bonded to a front end of the proximal side wire, the distal side wire being smaller in rigidity and superior in restitution than the proximal side wire. A concave portion is provided on either the distal end surface of the proximal side wire or a proximal end surface of the distal side wire. A convex portion is provided on the other side wire among the distal end surface of the proximal side wire and the proximal end surface of the distal side wire. The convex portion is interfit to the concave portion to be pressure bonded by means of swaging or drawing procedure.
Since the physical strength of the bonded portion between the proximal side wire and the distal side wire, depends on a frictional force due to the pressure-bonding procedure and the rupture strength of the bonded portion, it is possible to insure a sufficient strength at a diameter-decreased distal portion of the core line even w li e n the

proximal side wire and the distal side wire are bonded at more distally and more diameter-decreased portions of the core line. This enables the operator to achieve a good balance of torque-transmission, supportability and restitution at more distally end portion without losing a good torque-transmission and supportability even more in the proximity of the distal end portion of the core line.
According to other aspect of the invention, a reduction ratio of cross sectional area of the concave portion and the convex portion is 40-60% when the distal side wire and the proximal side wire are subjected to the swaging or drawing procedure at the concave portion and the convex portion.
The reduction ratio this degree makes it possible to bond the two wires with a sufficient physical strength without inviting a disconnection.
According to other aspect of the invention, the distal side wire is composed of stranded wire elements.
The stranded wire elements permit the wire elements to relatively slide slightly each other to insure a positional freedom, thus making it possible to restrain strains to appear on an outer surface of the stranded wire elements, and insuring a good restitution from a curved configuration to an original configuration, compared to a distal side wire helically wound by a consecutive single wire element.
According to other aspect of the invention, the number of the stranded wire elements is 3 - 5.

According to other aspect of the invention, the stranded wire elements are stainless steel wires, superelastic alloy wires or combination of stainless steel wires and superelastic alloy wires.
According to other aspect of the invention, the flexible sheath body is a helical body placed around a distal end portion of the core line.
According to other aspect of the invention, the flexible sheath body is a synthetic resin film coated on an outer surface of the core line.
Fig, 1 is a side elevational view of a medical guide wire with a main portion partly sectioned according to a first embodiment of the invention',
Fig. 2 is a longitudinal cross sectional view of a main portion of the medical guide wire;
Fig. 3 is a latitudinal cross sectional view taken along line I-I of Fig. 2;
Fig. 4 is a latitudinal cross sectional view taken along line Ii-Ii of Fig. 2;
Fig. 5 is a longitudinal cross sectional view of a main portion of the medical guide wire according to a second embodiment of the invention;
Fig. 6 is a latitudinal cross sectional view taken along line V-V of Fig. 5;
Fig. 7 is a latitudinal cross sectional view taken along line V i-V i of Fig. 5;
Fig. 8 is a latitudinal cross sectional view in the

proximity of a bonded portion between a distal side wire and a proximal side wire;
Fig. 9 is a latitudinal cross sectional view of a distal end portion of the distal side wire;
Fig. 10 is a perspective view of a single wire and stranded wires placed into a round pipe;
Fig. 11 is a graphical representation of a residual angle against the single wire and the stranded wires',
Fig. 12 is a latitudinal cross sectional view of the stranded wires, outer surfaces of which are ground; and
Fig. 13 is a graphical representation between an outer diameter of the stranded wires and a maximum bending load.
In the following description of the depicted embodiments, the same reference numerals are used for features of the same type.
Referring to Figs. 1 through 4 which show a medical guide wire 1 (abbreviated merely as "guide wire 1" hereinafter) according to a first embodiment of the invention, the right hand side of the drawings is a proximal side, and the left hand side of the drawings is a distal side of the guide wire 1.
As shown in Figs. 1, 2, the guide wire 1 has a core line 2 and a helical body 3 placed around a distal end portion 21 of the core line 2 as a flexible sheath body.
The core line 2 has a distal end portion tapered off so that the distal end portion diametrically decreases progressively as approaching forward. The core line 2 has a

proximal side wire 4 and a distal side wire 5, the latter of which is to be bonded to a distal end of the proximal side wire 4. The distal side wire 5 is smaller in rigidity and superior in restitution (anti-kink property) than the proximal side wire 4. The proximal side wire 4 is circular in cross section as shown in Fig. 3.
By way of illustration, the proximal side wire 4 is made of a stainless steel wire, and the distal side wire 5 is made of a superelastic wire (e.g., N i - T i based wire) which is smaller in rigidity and superior in restitution than the stainless steel wire. The distal side wire 5 and the proximal side wire 4 are bonded together as described in detail hereinafter.
The helical body 3 shaped into a coiled structure by a metallic material, is placed around an outer surface of the distal end portion 21 of the core line 2. The helical body 3 has a proximal end secured to the core line 2 by means of a soldering procedure and having a distal end secured to a plug head 7 together with a distal end of the core line 2. The plug head 7 is made of a soldering material. The helical body 3 also has a middle portion (near the distal end) secured to the core line 2 by means of a soldering material 8.
By way example, a proximal side of the helical body 3 acts as a radiot ran spare n t helical line 31 and a distal side of the helical body 3 serves as a radiopaque helical line 32 with the soldering material 8 located at a boundary between the two helical lines 31, 32.

Upon bonding the distal side wire 5 and the proximal side wire 4 together, a concave portion 51 is provided on a proximal end surface of the distal side wire 5, and a convex portion 41 is provided on a distal end surface of the proximal side wire 4 in correspondence to the concave portion 51. The proximal side wire 4 interfits the convex portion 41 into the concave portion 51 of the distal side wire 5. Thereafter, the concave portion 51 is drawn through a pultrusion die (not shown) to stretch the concave portion 51 in its lengthwise direction, thus forcibly reducing a diameter of the concave portion 51 against the convex portion 41 so as to implement the pressure bonding between the distal side wire 5 and the proximal side wire 4.
In this instance, a reduction ratio of a cross
sectional area of the concave portion 51 is preferably 40-60% when the concave portion 51 is drawn through the pultrusion die to lengthwisely stretch the concave portion 51. When the reduction ratio of the cross sectional area terminates short of the 40%, it becomes difficult to insure a required strength at a bonded portion 9 between the concave portion 51 and the convex portion 41. When the reduction ratio of the cross sectional area exceeds 60%, there may arise a disconnection at the core line 2 upon drawing the concave portion 51 through the pultrusion die. After the concave portion 51 is drawn, an outer surface of the concave portion 51 is ground to eliminate a diametrical difference at the bonded portion 9 between the distal side wire 5 and the

proximal side wire 4.
The helical body 3 measures 200-300 mm in length, and a distance measures 60-100 mm between a distal end 11 of the guide wire 1 and the bonded portion 9. Flexibility is required for the guide wire 1 especially within the range of 60-100 mm from the distal end 11 of the guide wire 1 because the range is used when a medical device or equipment is introduced into the coronary and the aorta. The soldering material 8 is located at a boundary between the radiotransparent helical line 31 and the radiopaque helical line 32, which places the soldering material 8 remote by 25-35 mm from the distal end 11 of the guide wire 1. This means that the bonded portion 9 positions near the proximal side more than the boundary (i.e., soldering material 8) approaches near the proximal side.
The helical body 3 has an outer diameter of 0.25-0.4 mm, and the core line 2 has an outer diameter of 0.3-0.4 mm at the proximal end side which is remote from a distal end portion 21 (of the core line 2), around which the helical body 3 is placed.
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Before the concave portion 51 is drawn through the pultrusion die, it is preferable that the distal side wire 5 has the distal end surface, an outer diameter of which measures 0.23-0.32 mm, and having the concave portion 51, an u t e r diameter of which measures 0.15-0.20 mm with the depth as 3.0-10.0 mm.
After the concave portion 51 is drawn, the concave

portion 51 is tapered off at its inner surface so that the concave portion 51 preferably has a bottom portion Tb 4/10 times as diametrically large as an open entrance periphery Te of the concave portion 51. In correspondence to the inner shape of the concave portion 51, the convex portion 41 is formed into a cone-shaped configuration. The concave portion 51 thus tapered off prevents a stress-concentration and keep a continuity of rigidity at the bonded portion 9 when the convex portion 41 is bonded to the concave portion 51 for connection.
After the concave portion 51 is drawn, the bonded portion 9 measures 0.1-0.2 mm in outer diameter with the depth of the concave portion 51 as 5.0-15.0 mm. The distal side wire 5 has a distal end 52 ground until its outer diameter reduces to 0.045-0.065 mm, and pressed flat with 0.06-0.09 mm in breadth and 0.025-0.035 mm in thickness as shown in Fig. 4.
With the structure thus described, the distal side wire 5 and the proximal side wire 4 are pressure bonded by interfitting the convex portion 41 into the concave portion 51 to form the bonded portion 9.
The pressure-bonding procedure is such that it is possible to insure a sufficient strength at the bonded portion 9 even when the two side wires 4, 5 are bonded at a more distal end side of the core line 2 because the strength of the bonded portion 9 depends on the frictional force between t li e convex portion 41 and the concave portion 51.
In the guide wire 1 in which the reduction ratio of the cross sectional area of the concave portion 51 is 40-60%, the strength of the bonded portion 9 is far greater than the rupture strength (350-800 gf) of a distal end of the distal side wire 5, so as to produce a sufficinet strength at the bonded portion 9. It is to be noted that the bonded portion 9 substantially remain the rupture strength unchangeable regardless of the depth of the concave portion 51,
The pressure-bonding procedure accompanies no amount of heat which causes to reduce the material strength, as opposed to the brazing, soldering and welding procedures.
Since it is possible to insure a sufficient strength at a diameter-decreased distal portion of the core line 2 when the proximal side wire 4 and the distal side wire 5 are bonded at more distally and more diameter-decreased portions of the core line 2 . This enables the operator to achieve a good balance of torque-transmission, supportability and restitution at a more distal end portion without losing a good torque-transmission and supportability even more in the proximity of the distal end portion of the core line 2.
Because of the sufficient strength insured at the bonded portion 9 even when the bonded portion 9 is placed in less than 100 mm from the distal end 11 of the guide wire 1, it becomes possible to ameliorate the supportability at a linear region 100-300 mm from the distal end 11 of the guide wire 1 while maintaining a good restitution of the distal end portion of the guide wire 1 with an improved t o q r u e-
transmission. As opposed the present invention, the prior guide wire has been insufficient in supportability at the linear region 100-300 ram from the distal end of the prior guide wire.
Figs. 5 through 13 show a second embodiment of the invention in which the right hand side indicates the proximal side, and the left hand side represents the distal side of the guide wire 1 in the drawings. Described in the second embodiment of the invention are component parts different from those of the first embodiment of the invention.
In the second embodiment of the invention, the distal side wire 5 of the guide wire 1 is stranded wires as shown in Figs. 5-7. Namely, the distal side wire 5 has five wire elements with four side wires 55 stranded around one thin core wire 54. The side wires 55 are thicker than the thin core wire 54 with both the wires 54, 55 made of high tensile strength stainless steel. Instead of the five wire elements, three wire elements 56 may be used as shown in Figs. 8, 9.
For the five wire elements, the thin core wire 54 measures 0.03-0.04 mm in outer diameter, and the side wire 55 measures 0.06-0.08 mm in outer diameter. For the three wire elements 56, each of the wire elements 56 measures 0.08-0.10 mm in outer diameter with an outer diameter of the stranded wires constituted preferably as 0.15-0.20 mm in terms of a good flexibility and restitution.
The reason why the structure of the stranded wires (consisting of 2-3 wire elements) is preferable, is explained
below in reference to Figs. 10, 11.
Firstly, a single wire or stranded wires (each diameter: A) are prepared as specimens S. The curved portion Sp of the specimens S are pushed into a round pipe P (diameter: B = 3.0 mm) as shown in Fig. 10. After pulling the curved portion Sp out of the pipe P, the specimens S remains residual angles ( co ) at the curved portion Sp, and measures the residual angles ( co ) in Fig. 11.
In Fig. 11, a first specimen L is a single stainless steel wire with the outer diameter A as 0.19 mm. A second specimen M (two-stranded wires) is stranded wires consisting of two wire elements (each outer diameter: 0.1 mm) to represent its outer diameter A as 0. 19 mm. A third specimen N (three-stranded wires) is stranded wires which consist of three wire elements (each outer diameter: 0.09 mm) to represent its outer diameter A as 0.19 mm. A fourth specimen Q (five-stranded wires) is stranded wires consisting of one core wire (outer diameter: 0.04 mm), around which four side wires are stranded (each outer diameter: 0.08 mm) to represent its outer diameter A as 0.19 mm. It is to be noted that the wire elements of the two-stranded wires M, the three-stranded wires N and the five-stranded wires Q are all of high tensile strength stainless steel.
As shown in Fig. 11, it is apparent that the residual angles ( co ) of the three-stranded wires N and the five-stranded wires Q a .r e less than half the residual angle (