JP2010227136A - Guide wire - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide technology, achieving reduction in time required for replacement work of a guide wire inserted in a blood vessel or the like and lowering of operation cost. <P>SOLUTION: The guide wire 10 includes a first distal end part 20 as one distal end area and a second distal end part 30 as the other distal end area on the opposite side to the first distal end part 20. The proximal end of the first distal end part 20 and the proximal end of the second distal end part 30 are bonded to each other, and the insert direction of the guide wire 10 is changed to insert both the distal end of the first distal end part 20 and the distal end of the second distal end part 30 in a lumen such as a blood vessel. Since the outside diameter of the first distal end part 20 is smaller than that of the second distal end part 30, the first distal end part 20 has higher flexibility than the second distal end part 30. <P>COPYRIGHT: (C)2011,JPO&INPIT

Description

  The present invention relates to a medical guide wire.

  In treatments such as percutaneous coronary angioplasty (PTCA) and stent implantation, and examinations such as cardiovascular angiography, a catheter is inserted to a predetermined position in the blood vessel. The catheter is made of a flexible material, and the blood vessel into which the catheter is inserted is bent into a complicated shape. Therefore, it is difficult to push the catheter into a predetermined position within the blood vessel. For this purpose, a guide wire is inserted into the blood vessel, and the catheter is pushed along the guide wire to a predetermined position in the blood vessel.

JP 2002-095755 A

  The shape of the blood vessel into which the guide wire is inserted varies depending on the patient. For this reason, doctors typically prepare guidewires with different operability due to flexibility and lubricity, and use multiple guidewires until a guidewire suitable for insertion into a patient's blood vessel is found. Yes.

  When another guide wire is used after being inserted into the blood vessel of the guide wire, the guide wire needs to be replaced. The time required for this replacement work was a factor in lengthening the operation time. In addition, since a plurality of guide wires are used until a guide wire suitable for insertion is determined, the operation cost is increased due to an increase in the number of guide wires used.

  The present invention has been made in view of these problems, and an object of the present invention is to provide a technique capable of shortening the time required for exchanging a guide wire inserted into a blood vessel or the like and reducing the operation cost. It is in.

  One embodiment of the present invention is a guide wire. The guide wire includes a first tip that can be inserted into a lumen such as a blood vessel, and a second tip that is provided on the opposite side of the first tip and can be inserted into a lumen such as a blood vessel. The first tip portion and the second tip portion are characterized in that at least one characteristic among the flexibility, lubricity, and tip curve shape is different.

  In the above aspect, the outer diameter of the first tip portion may be different from the outer diameter of the second tip portion. Moreover, the material which comprises a 1st front-end | tip part may differ from the material which comprises a 2nd front-end | tip part. Further, the hydrophilicity of the surface may be different between the first tip portion and the second tip portion.

  Moreover, the label | marker for identifying the said front-end | tip part may be provided in any one side of a 1st front-end | tip part and a 2nd front-end | tip part.

  A combination of the above-described elements as appropriate can also be included in the scope of the invention for which patent protection is sought by this patent application.

  ADVANTAGE OF THE INVENTION According to this invention, while reducing the time which replacement | exchange operation | movement of the guide wire inserted in the blood vessel etc. requires, it can aim at reduction of operation cost.

FIG. 3 is an external view illustrating a configuration of a guide wire according to the first embodiment. 6 is an external view showing a configuration of a guide wire according to Embodiment 2. FIG. It is sectional drawing which shows the structure of the junction part of the wire core wire which comprises a 1st front-end | tip part, and the wire core wire which comprises a 2nd front-end | tip part. FIG. 6 is an external view illustrating a configuration of a guide wire according to a third embodiment.

  Hereinafter, embodiments of the present invention will be described with reference to the drawings. In all the drawings, the same reference numerals are given to the same components, and the description will be omitted as appropriate.

(Embodiment 1)
FIG. 1 is an external view showing a configuration of a guide wire according to the first embodiment. The guide wire 10 includes a first tip portion 20 that is one tip region, and a second tip portion 30 that is a tip region opposite to the first tip portion 20. The proximal end of the first tip 20 is joined to the proximal end of the second tip 30, and the distal end of the first tip 20 is changed by changing the insertion direction of the guide wire 10. Can be inserted into a lumen such as a blood vessel, and the distal end of the second tip 30 can be inserted into a lumen such as a blood vessel.

  The first tip portion 20 includes a wire core wire 21, a coil 22, and a ball portion 23.

  The wire core wire 21 has a proximal end side large diameter portion 24 and a distal end side small diameter portion 25 having an outer diameter smaller than that of the proximal end side large diameter portion 24. The length of the entire wire core wire 21 is not particularly limited and can be appropriately selected according to the purpose of use of the guide wire 10, but is usually 800 to 3,500 mm. The length of the distal end side small diameter portion 25 is, for example, 100 to 500 mm. As a material for the wire core wire 21, a stainless steel wire such as SUS304 or SUS316, or a superelastic alloy such as NiTi can be used.

  The coil 22 is provided around the distal end side small diameter portion 25 of the wire core wire 21. The outer diameter of the coil 22 is equivalent to that of the proximal end side large diameter portion 24. By making the outer diameter of the coil 22 equal to that of the proximal-end-side large-diameter portion 24, surface irregularities from the distal end to the proximal end of the first tip portion 20 are reduced, and the insertion property of the guide wire 10 is reduced. Can be improved. As the wire of the coil 22, a stainless steel wire such as SUS304 or SUS316 can be used. Stainless steel wires have line types with high tensile strength and have X-ray permeability, so that they do not hinder X-ray fluoroscopy, and it is easy to obtain fine wires. It is desirable to use a radiopaque material such as Pt-8W or Pt-7Ni on the distal end side of the coil 22. According to this, when the guide wire 10 is inserted into the body and X-ray fluoroscopy is performed, the contrast is improved, and the position of the distal end of the guide wire 10 can be easily recognized. The diameter of the wire of the coil 22 is, for example, 0.03 to 0.08 mm. If the diameter of the wire of the coil 22 is less than 0.03 mm, the strength is insufficient, and it may be difficult to process the coil spring for the guide wire. If the diameter of the wire of the coil 22 exceeds 0.08 mm, the outer diameter of the guide wire 10 may be too large.

  The ball portion 23 is provided at the distal end of the wire core wire 21. The ball portion 23 has a curved surface with a smooth distal end surface. By providing the ball portion 23 at the distal end, the distal end of the guide wire 10 can be smoothed and pushed inside the blood vessel without damaging the inner wall of the blood vessel. There is no restriction | limiting in particular in the material of the ball | bowl part 23, For example, metals, such as platinum and gold | metal | money, can be mentioned. There is no restriction | limiting in particular in the joining method to the distal end of the wire core wire 21 of the ball | bowl part 23, For example, welding, brazing, etc. can be mentioned.

  It is preferable that the 1st front-end | tip part 20 is coat | covered with resin with low frictional resistance. By covering the first tip portion 20 with resin, the unevenness of the first tip portion 20 is reduced, so that the lubricity, insertion property and torque transmission property of the first tip portion 20 can be improved. . Examples of the resin having low frictional resistance include a fluororesin, polyacetal, and polyethylene.

  Further, by changing the lubricity and insertion property between the distal end of the first tip 20 and the distal end of the second tip 30, the first tip 20 can be used as a distal end for insertion. Different insertability can be achieved between the case where the second tip 30 is used and the case where the second tip 30 is used as the distal end for insertion.

  Moreover, the lubricity or insertion property of the first tip portion 20 can be further improved by coating the surface of the resin with a hydrophilic polymer. The method for coating with a hydrophilic polymer is not particularly limited. For example, a reaction between a polyethylene glycol containing a trifunctional component and a diisocyanate compound, a reaction between polyethylene glycol and a polyisocyanate compound containing a trifunctional component, polyethylene glycol di ( A coating of a hydrophilic polymer having a crosslinked structure can be formed by a polymerization reaction of (meth) acrylate. In addition, since the resin described above is easily cross-linked with the hydrophilic polymer, the coating with the hydrophilic polymer can be facilitated.

  The second tip portion 30 includes a wire core wire 31, a coil 32, and a ball portion 33.

  The wire core 31 has a proximal end side large diameter portion 34 and a distal end side small diameter portion 35 having an outer diameter smaller than that of the proximal end side large diameter portion 34. The length of the entire wire core 31 is not particularly limited and can be appropriately selected according to the purpose of use of the guide wire 10, but is usually 800 to 3,500 mm. Moreover, the length of the distal end side small diameter portion 35 is, for example, 100 to 500 mm. As a material of the wire core wire 31, a stainless steel wire such as SUS304 or SUS316, or a superelastic alloy such as NiTi can be used.

  The proximal end of the proximal end side large-diameter portion 34 is tapered, and the outer diameter of the proximal end side large-diameter portion 34 at the most proximal position (joint surface with the first tip portion 20) is The diameter of the large diameter portion 24 on the proximal end side of the first tip portion 20 is the same. According to this, since the outer diameter is suppressed from changing suddenly at the joint portion of the wire core wires having different outer diameters, the load applied to the joint portion when torque is applied to the guide wire 10 can be reduced. Can do. As a result, characteristics such as the strength and durability of the entire guide wire 10 can be improved.

  The coil 32 is provided around the distal end side small diameter portion 35 of the wire core wire 31. The outer diameter of the coil 32 is the same as that of the proximal end side large diameter portion 34. The material and shape of the wire of the coil 32 are the same as those of the coil 22.

  The ball portion 33 is provided at the distal end of the wire core wire 31. The structure and function of the ball part 33 are the same as those of the ball part 23.

  The outer diameter of the proximal end side large diameter portion 24 of the first tip portion 20 is, for example, 0.254 to 0.914 mm. The outer diameter of the proximal end side large diameter portion 34 of the second tip portion 30 is, for example, in the range of 0.254 to 0.914 mm, the outer diameter of the proximal end side large diameter portion 24 of the first tip portion 20. Greater value. In other words, in the present embodiment, since the outer diameter of the first tip portion 20 is thinner than that of the second tip portion 30, the first tip portion 20 is more flexible than the second tip portion 30. The feeling of operation when inserting the guide wire is easier to convey at hand. On the other hand, when the second tip portion 30 having a relatively high rigidity is used, the guide wire can be easily pushed through a hard portion such as a closed portion in the blood vessel. The second tip portion 30 having a relatively high frictional resistance is suitable for use when it is necessary to push the guide wire slowly, or when it is desired to keep the guide wire without sliding to some extent.

  The flexibility of the first tip portion 20 and the second tip portion 30 is evaluated by the maximum load (gf) (referred to as the tip load) when the tip of the guide wire is bent in the elastic deformation region.

  The tip load of the first tip portion 20 is, for example, 0.4 to 2.0 gf (highly flexible type) or 2.2 to 3.0 gf (intermediate type). The tip load of the second tip portion 30 is, for example, 2.2 to 3.0 gf (intermediate type) or 3.0 gf or more (high rigidity type). In addition, when the 1st front-end | tip part 20 is a highly flexible type, the 2nd front-end | tip part 30 is a middle type or a highly rigid type, and when the 1st front-end | tip part 20 is an intermediate type, it is 2nd. The tip portion 30 is of a high rigidity type.

  An identification mark 40 that can be visually recognized is provided on the first tip 20 side. In the present embodiment, the identification mark 40 is installed as a mark indicating that the first tip portion 20 is more flexible. In the case where it can be recognized visually, the identification mark 40 may be changed in color from the surroundings, for example. The color of the identification mark 40 is not particularly limited, but the visibility can be enhanced by using a warning color such as red or yellow. Specifically, when the first tip portion 20 is coated with a resin such as polytetrafluoroethylene (PTFE), the region of the identification mark 40 may be coated with a resin having a different color from the surroundings. Or when the 1st front-end | tip part 20 is coat | covered with resin, you may peel the said resin in the area | region of the identification mark 40. FIG.

  Further, the identification mark 40 may be provided on the outer peripheral surface of the region where the distal end side small diameter portion 25 of the wire core wire 21 is provided. In this case, for example, when the first tip portion 20 is covered with resin, the color of the resin may be changed in the region of the distal end side small diameter portion 25. Further, when the coil 22 is exposed in the region of the distal end side small diameter portion 25, the color of the coil 22 may be changed.

  In addition, the identification mark 40 should just distinguish the 1st front-end | tip part 20 and the 2nd front-end | tip part 30, and the identification mark 40 may be provided in the 2nd front-end | tip part 30 side with higher rigidity.

  According to the guide wire 10 described above, not only one tip of the guide wire but also the other tip can be inserted into a lumen such as a blood vessel. In addition, a single guidewire can be used with tips that vary in flexibility, frictional resistance, lubricity, operability, penetration, and pathology, so the physician operating the guidewire can replace the guidewire. It is possible to select a tip having flexibility or the like that matches the state of the blood vessel without taking time and effort. For this reason, it is possible to shorten the time required for insertion of the guide wire and reduce the number of guide wires to be used, thereby reducing the operation cost. In the case of manufacturing a guide wire, since the number of guide wires that need to be sterilized is reduced, the number of guide wire sterilizations can be reduced, and the manufacturing cost can be reduced.

  Further, since the identification mark 40 is attached, it is easy to identify the first tip portion 20 and the second tip portion 30, and the doctor operating the guide wire selects the desired tip portion quickly and reliably. can do.

  In the present embodiment, wire core wires 21 and 31 having different outer diameters are joined. In this case, if a holder called a torquer used for the operation of the guide wire 10 is attached to the wire core wire having a smaller outer diameter, the load at the joint portion of the wire core wire increases. For this reason, it is desirable to install a torquer at a predetermined position of the wire core wire 31 having a larger outer diameter. However, it is difficult to visually determine the difference in outer diameter between the wire cores 21 and 31. For this reason, it is preferable to provide a marker (not shown) for identifying the outer diameter on the wire core 31 having a larger outer diameter. The outer diameter identification mark (not shown) may be visible, for example, changing its surroundings and color. The position where the outer diameter identification mark is provided is preferably an area suitable for the installation of ToruCa. According to this, since the installation position of ToruCa can be determined easily, the effort and time required for ToruCa installation can be shortened. When the identification mark 40 described above is provided on the second tip portion 30 side, the outer diameter identification mark may also serve as the identification mark 40.

(Embodiment 2)
FIG. 2 is an external view showing a configuration of a guide wire according to the second embodiment. The configuration of the first tip portion 20 of the guide wire 10 of the second embodiment is the same as that of the first embodiment.

  In the present embodiment, the outer diameter of the proximal end side large diameter portion 34 of the second tip portion 30 is equal to the outer diameter of the proximal end side large diameter portion 24 of the first tip portion 20. That is, the shape of the second tip portion 30 of the present embodiment is the same as that of the first tip portion 20. However, the wire core wire 21 and the coil 22 constituting the first tip portion 20 are made of a material having higher flexibility than the wire core wire 31 and the coil 32 constituting the second tip portion 30. For example, specifically, in the first tip portion 20 having higher flexibility, a superelastic alloy such as NiTi is used as the wire core wire 21 and the coil 22, respectively. In the tip portion 30, stainless steel wires such as SUS304 and SUS316 can be used as the wire core wire 31 and the coil 32, respectively.

  FIG. 3 is a cross-sectional view showing a configuration of a joint portion between the wire core wire 21 constituting the first tip portion 20 and the wire core wire 31 constituting the second tip portion 30. In the present embodiment, the wire core wire 21 constituting the first tip portion 20 and the wire core wire 31 constituting the second tip portion 30 are not directly joined, as shown in FIGS. They are connected by a connecting member 50 having a hollow cylindrical shape. Specifically, in a state where the proximal end of the wire core wire 21 is inserted into one opening of the connection member 50, the one opening of the connection member 50 and the proximal end portion of the wire core 21 are joined by solder or the like. It is fixed using the member 52. On the other hand, in a state where the proximal end of the wire core wire 31 is inserted into the other opening of the connection member 50, the other opening of the connection member 50 and the proximal end portion of the wire core wire 31 connect the bonding member 54 such as solder. It is fixed using. Note that NiTi can be used as the material of the connection member 50.

  According to the guide wire 10 according to the present embodiment, the flexibility of the first tip portion 20 can be made more flexible than the second tip portion 30 while keeping the outer diameter of the wire core wire constant. Different operability can be realized when the first tip portion 20 is inserted into a blood vessel or the like and when the second tip portion 30 is inserted into the blood vessel or the like.

  When the outer diameters of the first tip portion 20 and the second tip portion 30 are the same as in the present embodiment, the wire core wire 21 and the wire core wire 31 are configured by a single wire. Good.

(Embodiment 3)
FIG. 4 is an external view showing a configuration of a guide wire according to the third embodiment. The outer diameter of the proximal end side large diameter portion 34 of the second tip portion 30 is the same as the outer diameter of the proximal end side large diameter portion 24 of the first tip portion 20, except for the third embodiment. The configuration of the guide wire 10 is the same as that of the first embodiment. That is, in the present embodiment, the first tip portion 20 and the second tip portion 30 have the same flexibility.

  In the present embodiment, the distal end of the first tip 20 is pre-shaped at the time of manufacture. That is, the first distal end portion 20 and the second distal end portion 30 have different distal end bending shapes. According to this, by making the 1st front-end | tip part 20 into the side inserted in the blood vessel etc., the effort which bends a guide wire front-end | tip part by hand before an operation can be saved, and the operation time can be shortened. .

  The present invention is not limited to the above-described embodiments, and various modifications such as design changes can be added based on the knowledge of those skilled in the art. The form can also be included in the scope of the present invention.

  For example, the first tip portion 20 and the second tip portion 30 may be different in at least one characteristic among flexibility, lubricity, and tip bending shape, such as flexibility, lubricity, and bending shape. Among them, the characteristics of a plurality of combinations may be different.

  As a modification for changing the flexibility between the first tip portion 20 and the second tip portion 30, the first tip portion 20 and the second tip portion 30 have the same shape, and the first tip portion The material constituting the portion 20 may be more flexible than the material constituting the second tip portion 30. Specifically, in the first tip portion 20 having higher flexibility, a superelastic alloy such as NiTi is used as the core material, and in the second tip portion 30 having higher rigidity (lower flexibility), the core is used. A stainless steel wire such as SUS304 or SUS316 can be used as the material.

  Further, as a modification for changing the frictional resistance between the first tip portion 20 and the second tip portion 30, both of them are coated with resin, and the first tip portion 20 and the second tip portion are formed on the resin surface. 30 may be coated with a hydrophilic polymer having a different hydrophilicity.

  Further, as a modification for changing the tip bending shape between the first tip portion 20 and the second tip portion 30, pre-shaping is performed on the tips of both the first tip portion 20 and the second tip portion 30. The curvature of the tip portion curved by the first tip portion 20 and the second tip portion 30 may be changed.

  When the diameters of the wire core wires are the same between the first tip portion 20 and the second tip portion 30 as in the second embodiment, a marker for identifying the outer diameter is not necessary. A marker for installing ToruCa may be provided in a region suitable for the above (for example, the center position of the guide wire 10).

  DESCRIPTION OF SYMBOLS 10 Guide wire, 20 1st front-end | tip part, 21 Wire core wire, 22 coils, 30 2nd front-end | tip part, 31 Wire core wire, 32 coils, 40 Identification mark, 50 Connection member.

Claims (5)

A first tip that can be inserted into a lumen such as a blood vessel;
A second tip provided on the opposite side of the first tip and insertable into a lumen such as a blood vessel;
With
The guide wire, wherein the first tip portion and the second tip portion are different in at least one characteristic among flexibility, friction resistance, and tip bending shape.   The guide wire according to claim 1, wherein an outer diameter of the first tip portion is different from an outer diameter of the second tip portion.   The guide wire according to claim 1 or 2, wherein a material constituting the first tip portion is different from a material constituting the second tip portion.   The guide wire according to any one of claims 1 to 3, wherein the first tip portion and the second tip portion have different surface hydrophilicity.   The guide wire according to any one of claims 1 to 4, wherein a mark for identifying the tip portion is provided on one side of the first tip portion and the second tip portion. .

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