Guidewire

Abstract

To provide a guide wire which allows easy visual recognition of a position of a taper of a core wire, by a marker, allows precise confirmation of a position on a tip side under radioscopy, and in which friction resistance on the tip side can be reduced and operation ability is improved, and there is no risk of detachment of the marker.SOLUTION: A guide wire includes a wire main body 11 formed by coating an outer periphery of a core wire 12 with a resin layer. On a tip side of the core wire 12, there is provided a taper part 13 whose diameter gradually decreases toward the tip. The wire main body 11 is divided into: a tip part 20 having contrast property; an index part 30 including a visible marker 31a; and a main body part 40 extending along a proximal base end. The index part 30 is arranged correspondingly to the taper part 13.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to a medical guide wire that is inserted into the body. [Background technology]

[0002] Conventionally, guidewires inserted into the body have been used in medical procedures such as examination and treatment using endoscopes. Here, the guidewire is inserted through the endoscope to reach a specific treatment target within a body cavity, and serves to guide and position catheters and other devices used in various treatments. In general, the distal end of the core wire that forms the core of the guidewire is provided with a tapered portion to add flexibility. In addition, a visible marker is provided at the distal end of the guidewire to confirm its movement and position (see, for example, Patent Document 1).

[0003] To provide a marker on the distal end of a guidewire, it is known to apply a pattern directly to the surface of the core wire using a resin containing a colored pigment (see, for example, Patent Document 1), or to cover the surface with a tubular resin coating containing the pattern. Here, the resin forming the marker, whether applied or coated, has typically been a fluorine-based resin that is compatible with pigments. Because these resins have a relatively low coefficient of friction, which ensures smooth sliding, they have often been used as the outer surface of the guidewire. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Japanese Patent Application Laid-Open No. 2008-220789 Summary of the Invention [Problem to be solved by the invention]

[0005] However, in the conventional guidewires described above, although a marker is provided on the distal end of the guidewire, the position of the marker does not necessarily coincide with the taper of the core wire, and the marker is provided at a location other than the taper. Therefore, it is difficult to visually determine the flexible portion or desired hardness due to the taper by checking the marker, and it is necessary to determine by touch.

[0006] Furthermore, when using a guidewire under X-ray fluoroscopy, the only part of the distal end of the guidewire that exhibits radiographic contrast is the core wire. However, the core wire is thin to begin with and is tapered to an even smaller diameter, making it difficult to accurately confirm the position of the distal end of the guidewire using only this core wire.

[0007] Furthermore, resins that are compatible with pigments, such as fluorine-based resins, that make up the markers, have a higher coefficient of friction than hydrophilic polymers. As a result, when using a guidewire, the actual operability can be worse than the operator intended. Also, if the marker is visible on the outer surface of the guidewire, there is a risk that the marker will peel off due to friction with the medical device used in combination.

[0008] The present invention has been made in view of the above-mentioned problems of the prior art. ,core Line taper position of The object of the present invention is to provide a guide wire that can be easily visualized, allows accurate confirmation of the position of the tip side under radioscopy, reduces frictional resistance on the tip side, is easy to operate, and has no risk of the marker peeling off. [Means for solving the problem]

[0009] In order to achieve the above-mentioned object, one aspect of the present invention is to provide a method for manufacturing a semiconductor device comprising: A medical guide wire having a wire body formed by coating the outer periphery of a core wire with a resin layer and used by being inserted into the body, A tapered portion is provided on the tip side of the core wire, the diameter of which gradually decreases toward the tip, The wire body is divided into, in order from the distal tip, a radiopaque tip portion, an index portion that matches the position of the tapered portion, and a main body portion that extends from the index portion to a proximal base end, The indicator portion and the main body portion each include a visible marker; The outermost layer forming the outer surface of the main body is It is transparent It is formed by closely arranging spiral bumps, The boundary between the indicator portion and the outer surface of the main body portion can be visually distinguished by the spiral irregularities on the outermost layer of the main body portion, and coincides with the start end of the tapered portion. death, On the surface of the metal material itself that forms the core wire, the surface of the tapered portion is visually different from the surface of a portion other than the tapered portion due to minute irregularities, and The marker is formed by applying a predetermined pattern, which allows the movement and position of the indicator portion to be visually recognized, to at least the tapered portion of the surface of the core wire, The pattern includes gaps between the lines forming the pattern, where the surface of the core wire is not covered, aligned in the axial direction, and a transparent resin is applied to a thickness equal to that of the lines so as to fill the gaps, making the minute irregularities on the surface of the core wire visible from the outside through the gaps, The resin layer in the indicator portion is formed by using the pattern applied to the surface of the core wire and the transparent resin filling in the gaps between them as a base layer, covering the surface of the base layer with an intermediate layer made of a transparent resin that serves as a base material for a hydrophilic resin, and applying a transparent hydrophilic resin to the surface of the intermediate layer to form an outermost layer. It is characterized by: [Effects of the Invention]

[0010] According to the guide wire of the present invention, ,core Line taper position of It can be easily seen, the position of the tip can be accurately confirmed under radioscopy, frictional resistance at the tip is reduced, making it easy to operate and there is no risk of the marker coming off, making it easy to use. [Brief explanation of the drawings]

[0011] [Figure 1] 1 is an overall view showing a guide wire according to a first embodiment of the present invention (however, a part of the main body is cut away and omitted). [Figure 2] FIG. 2 is an enlarged longitudinal cross-sectional view showing the distal end side of the guide wire according to the first embodiment of the present invention. [Figure 3] FIG. 1 is an overall view showing a guide wire according to a second embodiment of the present invention (although part of the main body is cut away and omitted). [Figure 4] FIG. 10 is an overall view showing a guide wire according to a third embodiment of the present invention (however, a part of the main body is cut away and omitted). [Figure 5]FIG. 10 is an overall view showing a guide wire according to a fourth embodiment of the present invention (however, a part of the main body is cut away and omitted). DETAILED DESCRIPTION OF THE INVENTION

[0012] Various embodiments representative of the present invention will be described below with reference to the drawings. FIG. 1 shows a guidewire 10 according to a first embodiment. FIG. 2 is an enlarged longitudinal cross-sectional view showing the distal end side of the guidewire 10 shown in FIG. 1. FIG. 3 shows a guidewire 10A according to a second embodiment. FIG. 4 shows a guidewire 10B according to a third embodiment. FIG. 5 shows a guidewire 10C according to a fourth embodiment.

[0013] In each drawing, the left side of the drawing will be referred to as the "distal end" and the right side as the "proximal end," but this does not limit the positional relationship when the guidewire 10 is used. Note that the components, shapes, numerical values, etc. shown in each embodiment described below are examples of the present invention and do not limit the present invention. Furthermore, the relative dimensional relationships and shapes of the components shown in each drawing are subject to appropriate design changes and may differ from the actual ones.

[0014] [First embodiment] <Guidewire 10 Overview> A guidewire 10 according to the first embodiment is used, for example, to guide a catheter to a treatment target when inserting the catheter into a blood vessel, organ, or the like inside the body under an endoscope. As shown in FIG. 1, the guidewire 10 includes a wire body 11 formed by coating the outer periphery of a core wire 12 (see FIG. 2) over the entire length with a resin layer. The wire body 11 is partitioned into a tip portion 20, an indicator portion 30, and a main body portion 40, in that order from the tip that is distal from the surgeon. The guidewire 10 of this embodiment is configured to be inserted into the body from the tip portion 20 through an endoscope.

[0015] The total length of the wire body 11 (guide wire 10) is a design item that is set appropriately depending on the medical purpose, for example, within a range of approximately 800 to 5500 mm. Of the total length of the wire body 11, the length of the distal end portion 20 is preferably within a range of approximately 30 to 400 mm from the very tip. The length of the indicator portion 30 may be set appropriately, for example, within a range of approximately 60 to 400 mm, in accordance with the tapered portion 13 of the core wire 12, which will be described below. Furthermore, in the guide wire 10 of this embodiment, the outer diameter of the wire body 11 is approximately constant over the entire length except for the roundness of the front and rear ends, and is preferably, for example, approximately 0.3 to 1.3 mm.

[0016] <About core wire 12> The core wire 12 is made of a metal material such as a nickel-titanium alloy and is formed into a flexible, twist-free line. The core wire 12 has a length that extends over substantially the entire length of the wire body 11 and has a circular cross section. The outer diameter of the core wire 12 is basically constant, for example, about 0.6 to 0.85 mm, but as shown in FIG. 2, the core wire 12 has a tapered portion 13 at its tip end that gradually reduces in diameter toward the tip. The tapered portion 13 adds further flexibility to the inherent flexibility of the core wire 12. The beginning (starting end) of the tapered portion 13 coincides with the boundary between the indicator portion 30 and the main body portion 40 in the wire body 11, as will be described later.

[0017] In the core wire 12 of this embodiment, the end (terminal end) of the tapered portion 13 tapers to the very tip of the core wire 12 and extends to the tip portion 20 of the wire body 11. Alternatively, a small-diameter portion of a predetermined length and having the same diameter as the end of the tapered portion 13 may be provided extending from the tip of the tapered portion 13. Here, it is also possible to align the end of the tapered portion 13, i.e., the beginning (starting end) of the small-diameter portion, with the boundary between the tip portion 20 and the indicator portion 30 of the wire body 11. Note that a metal coil or the like serving as a weight to improve operability may be fitted to the tip side of the tapered portion 13 shown in FIG. 2 or the tip side of the small-diameter portion (not shown).

[0018] The tapered portion 13 can be formed at any inclination angle over a predetermined length in the axial direction by cutting the distal end of the core wire 12 from the entire circumference. The specific length of the tapered portion 13 is a design factor that can be determined appropriately within the combined dimensions of the distal end portion 20 and the indicator portion 30, which will be described later. For example, if the small diameter portion described above is extended, the tapered portion 13 will be shortened accordingly, and the inclination angle will be increased. Furthermore, the surface of the tapered portion 13 has fine irregularities created by the cutting process, giving it a matte finish (loss of gloss), and therefore differs from the surface of other parts of the core wire 12 to an extent that it can be visually distinguished, especially under an endoscope.

[0019] <About the tip portion 20> As shown in Fig. 1, the tip portion 20 is a portion located at the most distal end of the wire body 11, and is formed by coating the distal end of the core wire 12 that extends to this portion with a resin layer. Here, the distal end of the core wire 12 that is coated with the resin layer corresponds to the tapered portion 13, but it may also be the small diameter portion described above. The resin layer that coats the core wire 12 in the tip portion 20 is formed by laminating, from the bottom up, a base layer 21 made of urethane resin that forms the base material and an outermost layer 22 made of hydrophilic resin that forms the outer surface.

[0020] The urethane resin of the base layer 21 is a general term for polymers containing urethane bonds, and is usually referred to as polyurethane. The urethane resin contains a contrast agent. The contrast agent is a substance that is opaque to radiation, such as X-rays, and examples include tungsten powder and barium sulfate. The urethane resin of the base layer 21 already contains a contrast agent, making it possible to easily identify the position of the tip portion 20 under X-ray fluoroscopy. The base layer 21 at the tip portion 20 does not need to be transparent enough to allow viewing of the interior, and may be colored by mixing a pigment in addition to the color of the contrast agent itself. In general, urethane resins have higher compatibility with hydrophilic resins than fluororesins. The thickness of the base layer 21 roughly corresponds to the outer diameter of the tip portion 20.

[0021] When a coil or the like serving as the weight is fitted to the tip side of the core wire 12 in the tip portion 20, it is preferable to use a metal material that is highly opaque to X-rays, such as a precious metal such as platinum or tungsten. This, in combination with the contrast agent contained in the base layer 21, can improve the contrast of X-rays, etc. In each drawing, for convenience, the outer diameter of the tip portion 20 is shown as being approximately the same as the outer diameter of the indicator portion 30 or the main body portion 40. However, for example, when the surface of the core wire 12 is covered with a resin layer of uniform thickness, the outer diameter of the tip portion 20 may be reduced depending on the inclination angle of the tapered portion 13 of the core wire 12.

[0022] The hydrophilic resin of the outermost layer 22 is a general term for resins that absorb water and become lubricating, such as acrylamide polymers. By using such a hydrophilic resin for the outermost layer 22, frictional resistance can be reduced compared to, for example, fluororesin. The tip portion 20, which comes into contact with the inside of a body cavity, is particularly required to have a further reduction in frictional resistance and high biocompatibility. Furthermore, frictional resistance with the inner wall of a catheter and the lumen of an endoscope is also reduced, thereby improving the operability of the guidewire 10. The thickness of the outermost layer 22 is preferably in the range of, for example, about 1 to 30 μm.

[0023] <Regarding the indicator portion 30> As shown in FIG. 1, the indicator portion 30 is a portion continuing from the distal end portion 20 toward the proximal end, and is formed by coating the core wire 12 located in this portion with a resin layer. Here, the core wire 12 located in the indicator portion 30 is aligned exactly with the tapered portion 13. The indicator portion 30 includes a visible marker 31a. Here, the marker 31a is formed by applying a predetermined pattern 31b, which makes the movement and position of the indicator portion 30 visible, to at least the tapered portion 13 of the surface of the core wire 12. Note that the application of the pattern 31b can be achieved by, for example, well-known printing techniques such as spraying a resin paint with a fine spray or using masking.

[0024] The resin layer in the indicator portion 30 is configured as a base layer 31 consisting of the pattern 31b applied to the surface of the core wire 12 (tapered portion 13) and the gaps 31c therebetween, the surface of which is covered with an intermediate layer 32 made of a transparent resin that serves as a base material for the hydrophilic resin, and the hydrophilic resin is applied to the surface of the intermediate layer 32 to form an outermost layer 33. Here, the outermost layer 33 and the intermediate layer 32 are both transparent, so that the pattern 31b on the base layer 31 and the surface of the core wire 12 (tapered portion 13) in that portion can be seen from the outside through the gaps 31c in the pattern 31b.

[0025] The pattern 31b constituting the marker 31a is provided in a predetermined pattern in a color that is clearly distinguishable from the background surface color of the tapered portion 13 of the core wire 12. In the first embodiment, the pattern 31b is a spiral pattern, and the lines forming the spiral are made of, for example, a fluororesin mixed with a black pigment, and are applied (printed) at a constant width around the entire circumference of the tapered portion 13. Here, the pattern 31b includes gaps 31c where the surface of the core wire 12 is not covered, and the lines constituting the pattern 31b and the gaps 31c between the lines are arranged parallel and evenly along the axial direction of the guide wire 10 in a side view perpendicular to the axial direction.

[0026] The gaps 31c between the wires forming the spiral may be covered with an intermediate layer 32 (described below) as is on the surface of the underlying core wire 12, or a transparent fluororesin may be applied to the same thickness as the wires to fill the gaps 31c. Alternatively, if it is not necessary for the surface of the tapered portion 13 to be visible from the outside, a fluororesin mixed with a pigment that contrasts differently from the color of the wires forming the spiral may be applied to the surface to paint it in two or more colors. In either configuration, the pattern 31b forming the marker 31a and the gaps 31c therebetween form the underlying layer 31 of the indicator portion 30.

[0027] In the indicator portion 30, the intermediate layer 32 covering the base layer 31 is made of a transparent resin that serves as a base material for the hydrophilic resin, and is suitably made of, for example, the same urethane resin as the base layer 21 of the tip portion 20. The fluorine-based resin that makes up the base layer 31 has good compatibility with the pigment used to form the pattern 31b, but the urethane resin has better compatibility with the hydrophilic resin. Therefore, it is important to provide the urethane resin intermediate layer 32 between the base layer 31 and the outermost layer 33 described below in order to firmly laminate them together.

[0028] The outermost layer 33 forming the outer surface of the indicator portion 30 is formed by applying a transparent hydrophilic resin onto the surface of the intermediate layer 32. The hydrophilic resin used here is the same as that of the outermost layer 22 of the tip portion 20, and these hydrophilic resins are applied using the same formulation. As a result, there are no steps or irregularities at the boundary between the tip portion 20 and the outermost layers 22, 33 of the indicator portion 30, and a smooth, continuous outer surface is formed from the tip portion 20 to the indicator portion 30.

[0029] Such an indicator portion 30 is disposed in correspondence with the tapered portion 13 of the core wire 12. In other words, the beginning (starting point) of the tapered portion 13 coincides with the boundary between the indicator portion 30 and the main body portion 40. Here, the pattern 31b forming the marker 31a of the indicator portion 30 is actually also applied to the surface of the core wire 12 located in the main body portion 40, which will be described below, for the convenience of printing the fluororesin that forms the pattern 31b. The boundary and difference on the outer surfaces of the indicator portion 30 and the main body portion 40 are configured to be clearly distinguishable visually due to the differences in their respective surface finishes.

[0030] More specifically, the outermost layer 42 of the main body 40 is visually clearly distinguishable from the outermost layer 33 of the indicator portion 30 due to the presence of the spiral irregularities described below, and the appearance of the core wire 12 from the outside is also significantly different. That is, the spiral irregularities in the main body 40 cause diffuse reflection of light, making the core wire 12 inside difficult to see even though it is transparent. Strictly speaking, the boundary between the indicator portion 30 and the main body 40 is located at the very tip of the spiral irregularities (see line A in Figure 2), and the beginning (starting point) of the tapered portion 13 is aligned with this position.

[0031] <Regarding the main body 40> 1, the main body 40 is a portion that extends further toward the base end than the indicator portion 30, and in terms of length, occupies the main portion of the wire body 11. The main body 40 is formed by covering the core wire 12, which extends over almost the entire length, with a resin layer. The resin layer in the main body 40 is formed by laminating, from the bottom up, a base layer 41 that covers the core wire 12 and an outermost layer 42 that forms the outer surface.

[0032] In this embodiment, the core wire 12 located in the main body portion 40 is also coated with a marker 31a, similar to the indicator portion 30, and the fluororesin forming this marker 31a corresponds to the base layer 31 of the indicator portion 30. However, since the marker 31a is not an essential component of the main body portion 40, the entire resin layer covering it, including the marker 31a, is defined as the base layer 41. The base layer 41 is formed from, for example, a transparent fluororesin, but may also be defined as a resin layer integrated with the outermost layer 42, which will be described below.

[0033] The outermost layer 42 forming the outer surface of the main body 40 does not need to reduce frictional resistance as much as the tip portion 20 and the indicator portion 30, and therefore may be formed from, for example, a transparent fluororesin. However, in this embodiment, even if the outermost layer 42 is made of a fluororesin, it is formed into a sleeve-like shape with densely arranged spiral irregularities to reduce frictional resistance. As described above, the spiral irregularities forming the outermost layer 42 are provided continuously from the boundary with the indicator portion 30 (see line A in Figure 2) to the base end side of the wire body 11. As described above, the outermost layer 42 and the base layer 41 may be formed as an integrated resin layer, and these may be formed into a transparent sleeve-like shape with finely pitched irregularities made of, for example, a transparent fluororesin.

[0034] In the main body 40 of this embodiment, the outermost layer 42 and the base layer 41 are transparent enough to allow the marker 31a to be seen through them, but they are not necessarily transparent. The boundary on the outer surface of the indicator portion 30 and the main body 40 is visually clearly distinguishable by the spiral unevenness of the outermost layer 42, and this position is configured so that it can be easily recognized as the beginning (starting end) of the tapered portion 13 of the core wire 12.

[0035] <About the function of the guide wire 10> Next, the operation of the guide wire 10 according to the first embodiment will be described. In medical procedures using an endoscope (not shown), the endoscope is introduced into the body, for example, orally, and the guidewire 10 is inserted into the body through the endoscope from the distal end portion 20 of the wire body 11. Inside the body, the wire body 11 is manipulated by rotating it about its axis or by pushing or pulling it depending on the required treatment. The tapered portion 13 provided on the core wire 12 adds flexibility to the distal end side of the indicator portion 30 of the wire body 11, thereby improving operability and safety when using the guidewire 10.

[0036] When the guide wire 10 is inserted into the body under X-ray fluoroscopy, the base layer 21 at the distal end 20 of the wire body 11 contains a contrast agent, which allows the position of the distal end 20 to be accurately confirmed, making the guide wire 10 easy to use. If a weight such as a coil fitted on the distal side of the core wire 12 at the distal end 20 is made of a metal material that is highly opaque to X-rays, this, together with the contrast agent contained in the base layer 21, can improve the contrast of X-rays and the like.

[0037] Here, the tip portion 20 is required to have a further reduction in frictional resistance and high biocompatibility, particularly since it comes into contact with the inside of a body cavity. Therefore, the entire surface of the base layer 21 of the tip portion 20 is covered with an outermost layer 22 of a hydrophilic resin. This ensures high slipperiness in the tip portion 20 and reduces frictional resistance with the inside of a body cavity or with concomitant medical devices, thereby improving the operability of the guidewire 10. Note that, unlike the outermost layer 33 of the indicator portion 30, the outermost layer 22 of the tip portion 20 does not need to be transparent enough to allow the interior to be seen.

[0038] The guidewire 10 is inserted into a body cavity to reach a specific treatment target, and then guides and positions a catheter or the like used for various treatments. After the catheter or the like is positioned by the guidewire 10, it is manipulated through an endoscope. The guidewire 10, the catheter, and the area in which they are positioned can be visualized through the endoscope. At this time, the marker 31a on the indicator portion 30 makes it easy to confirm the rotation direction (movement) of the wire body 11 around its axis, the depth (position) relative to the target site within the body, and the like.

[0039] Such an indicator portion 30 is disposed in correspondence with the tapered portion 13 of the core wire 12. That is, as shown in FIG. 2, the beginning of the tapered portion 13 coincides with the boundary between the indicator portion 30 and the main body portion 40. This allows the beginning of the tapered portion 13 of the core wire 12 to be visually confirmed via the indicator portion 30, and the position where the distal end of the wire body 11 becomes soft can be easily determined without touching it with one's hand. Note that, as will be described later, if there are differences in the hardness of the distal end of the wire body 11 (differences in the tapered portion 13), an appropriate selection can be made depending on the type of indicator portion 30, and it can be used for different medical procedures.

[0040] Furthermore, the surface of the tapered portion 13 of the core wire 12 is different and visually distinguishable from the surface of the portion other than the tapered portion 13. Here, "visually distinguishable" does not necessarily mean that it can be distinguished with the naked eye, but also includes the case where it can be confirmed under magnification with an endoscope. The surface of the tapered portion 13 of this embodiment has fine irregularities created by the cutting process, giving it a matte finish (loss of gloss), so it can be easily visually distinguished from the surface of the portion of the core wire 12 other than the tapered portion 13, which does not have a matte finish.

[0041] Therefore, it is preferable that the tapered portion 13 is not entirely covered by the pattern 31b of the marker 31a, but that the pattern 31b include gaps 31c that do not cover the surface of the tapered portion 13. This makes it possible to directly view the tapered portion 13 from the outside through the gaps 31c of the pattern 31b. Therefore, in combination with the correspondence between the indicator portion 30 and the tapered portion 13 described above, the position of the tapered portion 13 can be confirmed more accurately.

[0042] Furthermore, in the indicator portion 30, by covering the base layer 31 forming the marker 31a with a transparent intermediate layer 32, it is possible to prevent problems such as peeling of the coating of the pattern 31b without impairing the visibility of the marker 31a. Furthermore, since the indicator portion 30 comes into contact with the inside of a body cavity, similar to the tip portion 20, a further reduction in the coefficient of friction is required. Therefore, by applying a transparent hydrophilic resin to the surface of the intermediate layer 32 to form the outermost layer 33, it is possible to ensure high slipperiness without impairing the visibility of the marker 31a, and reduce friction with concomitant medical devices, thereby improving the operability of the guidewire 10.

[0043] The resin of the base layer 31 forming the marker 31a is not limited to the fluorine-based resin described above, and other resins such as polyamide-imide resins that are compatible with pigments may also be used. The color of the pattern 31b is not limited to black, and may be another color that contrasts with the surface color of the tapered portion 13. Alternatively, the gaps 31c included in the pattern 31b may not be covered with a transparent resin, but may be painted in two or more colors that conceal the tapered portion 13 but have different contrasts. The pigment of a predetermined color is not limited to being of one type, and two or more types may be mixed together to create the desired color.

[0044] Furthermore, the hydrophilic resin constituting the outermost layer 33 of the indicator portion 30 may be formed by coating using the same formulation as the hydrophilic resin constituting the outermost layer 22 of the tip portion 20. That is, after forming the base layer 21 of the tip portion 20 and the intermediate layer 32 of the indicator portion 30 to have approximately the same diameter, the same hydrophilic resin may be simultaneously coated to the same thickness so as to cover the entire outer surfaces of these. This makes it possible to adjust during processing so as to eliminate any steps between the outer surfaces of the tip portion 20 and the indicator portion 30, and to make the outer surfaces smoothly continuous.

[0045] Therefore, there is no difference in the slipperiness between the tip portion 20 and the indicator portion 30, ensuring smooth operability of the guide wire 10. Note that the base layer 21 of the tip portion 20 is the color of the contrast agent, and the intermediate layer 32 of the indicator portion 30 is transparent, allowing the marker 31a of the base layer 31 to be seen through, so that the tip portion 20 and the indicator portion 30 can be clearly distinguished visually.

[0046] In the guide wire 10 of this embodiment, the pattern 31b forming the marker 31a in the indicator portion 30 is actually also applied to the surface of the core wire 12 located in the main body portion 40. As described above, this is for the convenience of printing the pattern 31b (fluorine-based resin) on the core wire 12. Here, the outermost layer 42 of the main body portion 40 is formed in a sleeve shape with spiral irregularities densely arranged. This allows the boundaries and differences on the outer surfaces of the indicator portion 30 and the main body portion 40 to be clearly visually distinguished due to the differences in their surface finishes.

[0047] Even if the outermost layer 42 of the main body 40 is formed of, for example, a fluororesin, the densely arranged spiral irregularities reduce the contact area with the concomitant medical device, etc. This allows for relatively better slipperiness than when the outermost layer is made of a fluororesin peripheral surface, as in conventional guide wires. Note that, as with the main body 40, a continuous pattern 31b may also be printed continuously around the outer periphery of the core wire 12 in the distal end portion 20. Here, even if there is a pattern 31b on the core wire 12 of the distal end portion 20, it is covered by the opaque base layer 21 and is therefore not visible from the outside.

[0048] [Second embodiment] FIG. 3 shows a second embodiment of the present invention. The guide wire 10A according to the second embodiment is basically configured in the same manner as the first embodiment, but differs in the pattern of the design 31e of the marker 31d in the indicator portion 30. Note that the same parts as those in the first embodiment are denoted by the same reference numerals and redundant explanations will be omitted.

[0049] 3, the pattern 31e of the marker 31d in the second embodiment is a spiral pattern similar to the pattern 31b in the first embodiment, but the lines forming the pattern 31e and the pitch of the gaps 31f between the lines are not parallel and uniform along the axial direction. That is, the pitch of the pattern 31e and the gaps 31f is varied so that it gradually widens over a long span from the start end of the tapered portion 13 of the core wire 12 toward the end end.

[0050] The pattern of the pattern 31e of the marker 31d makes it possible to clearly distinguish, for example, the tapered portion 13 of the first embodiment from the tapered portion 13 in terms of appearance. The gaps 31f of the pattern 31e may be coated with a transparent resin to ensure the visibility of the tapered portion 13, or may be coated with a resin of a different color from the pattern 31e. Coating the gaps 31f with a transparent resin makes it possible to determine the insertion depth of the guidewire 10A under endoscopic observation during the procedure. In particular, gradually widening the width of the gaps 31f on the distal end side improves the visibility of the tapered portion 13 under endoscopic observation from that site. The specific dimensions of the pattern 31e and the gaps 31f, such as the width and inclination, are design factors that can be determined as appropriate.

[0051] [Third embodiment] FIG. 4 shows a third embodiment of the present invention. The guide wire 10B according to the third embodiment is basically configured in the same manner as the first embodiment, but differs in the pattern of the design 31h of the marker 31g on the indicator portion 30. Note that the same reference numerals are used for the same parts as those in the first embodiment, and redundant explanations will be omitted.

[0052] 4, the pattern 31h of the marker 31g in the third embodiment is a circular pattern in which the lines forming the circular pattern 31h around the entire circumference and the gaps 31i between the lines are arranged parallel to each other and at equal intervals along the axial direction. Here, the width of the pattern 31h is set to a span longer than the width of the gaps 31i, but the width of the gaps 31i may also be set to a span longer than the width of the pattern 31h.

[0053] The pattern of the pattern 31h of the marker 31g makes it possible to distinguish from the tapered portion 13 of the first or second embodiment, for example, in an easily visible manner. The gaps 31i of the pattern 31h may be coated with a transparent resin to ensure the visibility of the tapered portion 13, or may be painted with a resin of a different color from the pattern 31i. The specific dimensions of the pattern 31h and the gaps 31i, such as the width and inclination, are design matters that can be determined as appropriate.

[0054] [Fourth embodiment] FIG. 5 shows a fourth embodiment of the present invention. The guide wire 10C according to the fourth embodiment is basically configured in the same manner as the first embodiment, but differs in the patterns of the designs 31k, 31m of the markers 31j in the indicator portion 30. Note that the same parts as those in the first embodiment are denoted by the same reference numerals, and redundant explanations will be omitted.

[0055] 5, the marker 31j in the fourth embodiment is divided into two parts in the circumferential direction on the outer circumferential surface of the core wire 12, and patterns 31k and 31m are different between one half of the circumferential surface (the upper half in FIG. 5) and the other half of the circumferential surface (the lower half in FIG. 5). That is, on one half of the circumferential surface of the core wire 12, striped patterns 31k that are perpendicular to the axial direction and have the same width are arranged so as to be repeated with gaps 31l of the same width as the striped patterns 31k, and on the other half of the circumferential surface, patterns 31m that are wider than the striped patterns 31k (approximately twice as wide) and have the same width as the striped patterns 31m are arranged so as to be repeated with gaps 31n of the same width as the striped patterns 31k.

[0056] In this way, the patterns 31k, 31m are different for each half surface obtained by dividing the outer peripheral surface of the core wire 12 in the circumferential direction, and therefore, the rotational movement of the guide wire 10 can be easily confirmed through the marker 31j when rotating the guide wire 10. Furthermore, it is also possible to use different patterns 31k, 31m for each region in the circumferential direction of the core wire 12 as separate measure marks.

[0057] Furthermore, the patterns of the patterns 31k, 31m of the marker 31j make it possible to clearly distinguish, in appearance, the tapered portion 13 from those of the first, second, and third embodiments, for example. The gaps 31l of the pattern 31k and the gaps 31n of the pattern 31m may be coated with a transparent resin to ensure the visibility of the tapered portion 13, or may be painted with a resin of a different color from the patterns 31k, 31m. The specific dimensions of the patterns 31k, 31m and the gaps 31l, 31n, such as the width and slope, are design matters that can be determined as appropriate.

[0058] <Configuration and effects of the present invention> Although the embodiments of the present invention have been described above, the present invention is not limited to the above-described embodiments. The present invention derived from the above-described embodiments will be described below.

[0059] First, in the medical guide wires 10, 10A to 10C, which are provided with a wire body 11 formed by coating the outer periphery of a core wire 12 with a resin layer and are used by being inserted into the body, A tapered portion 13 is provided on the tip side of the core wire 12, the diameter of which gradually decreases toward the tip, The wire body 11 is divided into, in order from the distal tip, a contrast-sensitive tip portion 20, an indicator portion 30 including visible markers 31a, 31d, 31g, and 31j, and a main body portion 40 extending from the indicator portion 30 to the proximal base end, The guide wire (10) is characterized in that the indicator portion (30) is disposed in correspondence with the tapered portion (13).

[0060] According to such a guide wire 10, the distal end 20 of the wire body 11 has contrast properties, and therefore, when used under radioscopy, the position of the distal end 20, which leads the entire wire body 11, can be accurately confirmed, making it easy to use. The contrast properties of the distal end 20 can be obtained by impregnating the resin layer with a contrast agent or by embedding a component that is highly opaque to radiation.

[0061] Furthermore, the visible markers 31a, 31d, 31g, and 31j included in the indicator portion 30 of the wire body 11 allow the surgeon to easily confirm the movement and position of the guidewire 10, particularly the portion distal to the indicator portion 30, when manipulating the guidewire 10 through an endoscope. The indicator portion 30 is disposed in correspondence with the tapered portion 13 of the core wire 12. For example, the starting end of the tapered portion 13 coincides with the boundary between the indicator portion 30 and the main body portion 40.

[0062] This allows the tapered portion 13 of the core wire 12 to be visually confirmed via the indicator portion 30, making it easy to determine the hardness (flexibility length) at the tip end of the wire body 11 without touching it with one's hand. On the other hand, with conventional guide wires, in order to confirm and select the tip end (tapering) of the desired hardness when in use, it was necessary to judge by touch with one's hand, and it was inconvenient because it could not be judged by appearance.

[0063] Furthermore, in the present invention, in the core wire 12, the surface of the tapered portion 13 and the surface of the portion other than the tapered portion 13 are different and visually distinguishable from each other, The markers 31a, 31d, 31g, and 31j are formed by applying predetermined patterns 31b, 31e, 31h, 31k, and 31m, which make it possible to visually recognize the movement and position of the indicator portion 30, to at least the tapered portion 13 of the surface of the core wire 12, The patterns 31b, 31e, 31h, 31k, and 31m include gaps 31c, 31f, 31i, 31l, and 31n that do not cover the surface of the core wire 12 and are aligned in the axial direction, and are characterized in that the surface of the core wire 12 in that portion can be seen from the outside through the gaps 31c, 31f, 31i, 31l, and 31n.

[0064] With such a guide wire 10, the position of the tapered portion 13 of the core wire 12 can be confirmed not only indirectly from the indicator portion 30 as described above, but also directly visually by comparing the difference between the tapered portion 13 and other portions on the surface of the core wire 12. Here, the tapered portion 13 is not entirely covered by the patterns 31b, 31e, 31h, 31k, and 31m of the markers 31a, 31d, 31g, and 31j, and can be seen from the outside through gaps 31c, 31f, 31i, 31l, and 31n.

[0065] In the present invention, the tapered portion 13 has different inclination angles or lengths relative to the axis of the core wire 12, In accordance with the difference in the tapered portion 13, the predetermined patterns of the patterns 31b, 31e, 31h, 31k, and 31m forming the markers 31a, 31d, 31g, and 31j are also made different.

[0066] According to this configuration, the type of tapered portion 13 is not limited to one type, but there are multiple types depending on the inclination angle or length with respect to the axis of the core wire 12. Therefore, depending on the difference in tapered portion 13, the predetermined patterns of the patterns 31b, 31e, 31h, 31k, and 31m forming the markers 31a, 31d, 31g, and 31j are also made different.

[0067] This makes it possible to easily select the desired type of guide wire 10 (hardness of the tip end of the wire body 11 (flexibility length, etc.)) for each medical procedure simply by looking at the visual differences between the markers 31a, 31d, 31g, and 31j on the indicator portion 30, without having to touch the tip end of each guide wire 10 with one's hand.

[0068] In addition, in the present invention, the resin layer in the indicator portion 30 is characterized in that the patterns 31b, 31e, 31h, 31k, 31m and the gaps 31c, 31f, 31i, 31l, 31n applied to the surface of the core wire 12 form a base layer 31, the surface of the base layer 31 is covered with an intermediate layer 32 made of a transparent resin that serves as a base material for the hydrophilic resin, and a transparent hydrophilic resin is applied to the surface of the intermediate layer 32 to form the outermost layer 33.

[0069] According to this guidewire 10, defects such as peeling of the coating of the patterns 31b, 31e, 31h, 31k, and 31m can be prevented without impairing the visibility of the markers 31a, 31d, 31g, and 31j by covering the base layer 31 forming the markers 31a, 31d, 31g, and 31j with the transparent intermediate layer 32. Furthermore, by applying a transparent hydrophilic resin to the surface of the intermediate layer 32 to form the outermost layer 33, high slipperiness can be ensured without impairing the visibility of the markers 31a, 31d, 31g, and 31j, and friction with concomitant medical devices can be reduced, thereby improving the operability of the guidewire 10.

[0070] Furthermore, the present invention is characterized in that the hydrophilic resin constituting the outermost layer 33 of the resin layers in the indicator portion 30 is formed by application using the same formulation as the hydrophilic resin constituting the outermost layer 22 of the resin layers in the tip portion 20.

[0071] With this guide wire 10, the hydrophilic resin that forms the outermost layers 22, 33 of the tip portion 20 and the indicator portion 30 is applied rather than coated, which allows adjustment during processing to eliminate any unevenness between the outer surfaces of the tip portion 20 and the indicator portion 30, making the outer surfaces smooth and continuous. Therefore, there is no difference in slipperiness between the tip portion 20 and the indicator portion 30, ensuring smooth operability of the guide wire 10.

[0072] On the other hand, some conventional guidewires have a coating formed by combining tubular components made of different materials as a means for forming the outermost layer. Products with this type of structure have a high number of components, which increases costs. Furthermore, there is a risk that unevenness may occur at the boundaries between components due to dimensional tolerances of the individual components, which may impair slippage or cause breakage starting from the unevenness.

[0073] Although various embodiments of the present invention have been described above with reference to the drawings, the specific configurations are not limited to the above-described embodiments, and modifications and additions that do not depart from the gist of the present invention are also included in the present invention. For example, the specific length, diameter, and shape of both ends of each guidewire 10, 10A-C are not limited to those shown in the drawings. Furthermore, catheters are not necessarily limited to use in medical procedures using endoscopes.

[0074] Furthermore, although the guidewires 10 and 10A-C in each embodiment are configured to be inserted into the body through an endoscope from only the distal end portion 20, they may also be configured as double-ended guidewires that can be inserted into the body from the proximal end portion as well as the distal end portion 20. In this case, it is preferable to provide a tapered portion 13 on the core wire 12 on the proximal end side and to provide an indicator portion between the proximal end portion and the main body portion 40. [Industrial Applicability]

[0075] The guide wire according to the present invention can be applied to guide wires used in various medical procedures. [Explanation of symbols]

[0076] 10, 10A, 10B, 10C...Guide wire 11...Wire body 12...Core wire 13...Tapered section 20...Tip 21…base layer 22…Outermost layer 30…Indicator section 31…base layer 31a,31d,31g,31j…マーカー 31b,31e,31h,31k,31m…Module 31c, 31f, 31i, 31l, 31n… gap 32…Middle layer 33…outermost layer 40…Main part 41…lower stratum 42…outermost layer

Claims

1. A medical guide wire having a wire body formed by coating the outer periphery of a core wire with a resin layer and used by being inserted into the body, A tapered portion is provided on the tip side of the core wire, the diameter of which gradually decreases toward the tip, The wire body is divided into, in order from the distal tip, a radiopaque tip portion, an index portion that matches the position of the tapered portion, and a main body portion that extends from the index portion to a proximal base end, The indicator portion and the main body portion each include a visible marker; The outermost layer forming the outer surface of the main body is transparent and has spiral concaves and convexes densely arranged, a boundary between the indicator portion and the main body portion on the outer surface can be visually distinguished by the spiral irregularity on the outermost layer of the main body portion, and the boundary coincides with a start end of the tapered portion; On the surface of the metal material itself that forms the core wire, the surface of the tapered portion is visually different from the surface of a portion other than the tapered portion due to minute irregularities, and The marker is formed by applying a predetermined pattern, which allows the movement and position of the indicator portion to be visually recognized, to at least the tapered portion of the surface of the core wire, The pattern includes gaps between the lines forming the pattern, where the surface of the core wire is not covered, aligned in the axial direction, and a transparent resin is applied to a thickness equal to that of the lines so as to fill the gaps, making the minute irregularities on the surface of the core wire visible from the outside through the gaps, The resin layer in the indicator portion has a base layer made of the pattern applied to the surface of the core wire and the transparent resin filling in the gaps between them, the surface of the base layer is covered with an intermediate layer made of a transparent resin that serves as a base material for a hydrophilic resin, and a transparent hydrophilic resin is applied to the surface of the intermediate layer to form the outermost layer.

2. The guide wire according to claim 1, characterized in that the hydrophilic resin constituting the outermost layer of the resin layers in the indicator portion is formed by coating the same hydrophilic resin as the hydrophilic resin constituting the outermost layer of the resin layers in the tip portion.

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