JP2008155052A - Medical guidewire - Google Patents

Abstract

【Task】 Providing a medical guide wire that eliminates the disadvantages of the background art and improves the therapeutic properties.
[Solution] The guide wire 1 inserts the core wire 13 into the hollow portion of the linear body main portion 12 of the hollow stranded coil body 2, and a leading plug 14 for insertion into the blood vessel at the end of the linear body main portion 12. In the provided guide wire, the filament main part 12 is composed of a coil body in which three groups of coil strands in which a single wire or a plurality of wires are twisted, and both end portions of the core wire 13 are tapered. It is made flexible and flexible, and is formed in a double-headed form in which leading heads 14 are provided at both ends of the striate body main part 12. In this guide wire 1, the core wire 13 that is internally inserted in the hollow stranded wire coil 2 shares and carries the stress of bending deformation, and therefore, the coil wire 3 due to the deformation of the hollow stranded wire coil 2 from the needle tip 6. The guide wire 1 is stabilized in performance by preventing breakage.
[Selection] FIG.

Description

  The present invention relates to a medical guide wire used in a treatment method for inserting a central venous catheter into an internal jugular vein by moving it forward and backward from the tip of a puncture needle previously punctured into the internal jugular vein.

  In a treatment method for inserting a central venous catheter into an internal jugular vein, the “medical guide wire insertion tool exemplified in Patent Document 1” is used to make the catheter insertion operation simple, reliable, and safe. Yes.

  Specifically, the “guide wire insertion tool” of Patent Document 1 has a structure that has a puncture needle at the tip and a side port for guide wire insertion and is detachably attached to the syringe barrel, and the needle tip of this guide wire insertion tool Is characterized by a structure in which a puncture is set in advance at a key point of a vein, and then a guide wire is inserted from the side port to perform the treatment.

  On the other hand, a medical guide wire (hereinafter, simply referred to as a guide wire) is inserted into a narrow, tortuous blood vessel, and the distal portion is located at the lesion by manually “pushing / pulling / rotating” the hand located outside the body. It becomes the operation process that leads to. Therefore, in order to make the insertion operation from the tip portion smooth, it has straightness in the free state and is flexible as a whole so that it has a good resilience from bending deformation and the tip portion is highly flexible. Therefore, it is necessary to have a high mechanical property with a steering characteristic that allows the rear end portion to have an appropriate rigidity and the front end portion to adapt to the manual operation.

Therefore, the guide wire to be inserted into the blood vessel using the “guide wire insertion tool” described above has a coil structure of the outer layer portion coiled with one single wire (a normal single wire that is not a twisted wire) to form a hollow structure, “A form in which a single coil is wound, a thin core material is inserted into the hollow portion, and the end portion is fixed by brazing or the like” is generally used.
Japanese Patent Laid-Open No. 10-118192 (summary, FIG. 1)

  The treatment method for inserting a central venous catheter into the internal jugular vein (see FIG. 5) is performed by puncturing the internal venous vein in which the common carotid artery is in close proximity with the puncture needle 5 of the illustrated guide wire insertion tool. The needle tip 6 of the puncture needle 5 has a sharp shape obtained by inclining the hollow puncture needle 5 to θ2 · θ3 in two steps and cutting it to “θ2 = 18 ° to 22 °”. It is necessary to accurately puncture the inner diameter of the blood vessel smaller than the surface length. Accordingly, the surgeon presses the blood vessel T with his hand to inflate it and puncture (the blood vessel T shown in the solid line is inflated into the dotted line state and punctured), and then confirms the backflow of blood to confirm the proper puncture position.

  Thereafter, the guide wire 20 is inserted into the puncture needle 5 from the side pod and set at a desired position, and then the puncture needle 5 is removed, and then the central venous catheter is inserted using the guide wire 20 as a guide. Has been adopted. Therefore, this treatment method requires a high degree of skill, and the number of cases where the guide wire 20 is pulled out and the puncture is repeated many times is extremely increased.

  On the other hand, in order to facilitate insertion into the blood vessel T (see FIG. 5D), the distal end portion of the guide wire 20 is formed in a U-shaped or “shaped” shape that is plastically deformed with a fingertip or the like. The guide wire 20 formed and inserted into the blood vessel T from the puncture needle 5 is inserted and bent upward from the needle tip 6 of the puncture needle 5 with the blood vessel wall and the needle tip 6 as supporting points. .

  The guide wire 20 pulled out from the above usage / usage form is formed in a single wire winding form so that a gap is easily formed when a force is applied in the longitudinal direction like a coil spring. In addition, since a gap between the coil strands 21 is likely to occur when bent and deformed, the peripheral edge 7 of the needle tip 6 that comes into sliding contact is likely to bite between the coil strands 21.

  In the intravascular puncture state, a substantially arcuate upward bending posture (see FIGS. 5A to 5C) is exhibited, and a minute gap between the coil wires 21 has already occurred at any point on the outer peripheral surface. ing.

  In particular, when the guide wire 20 is pulled out (see FIGS. 5B and 5C), the minute gap increases due to resistance with the tube wall, and the coil wire 21 is caught on the edge blades 7A and 7B of the peripheral edge 7, From this catching point as a starting point, it is drawn upward to the angle of the inclined blade surface and becomes easy to bite and engage (θ5 in the figure is approximately 78 to 82 °).

  Thus, the guide wire 20 that is pulled out from the needle tip 6 in this state is very likely to cause a trouble that it is difficult to pull out because the peripheral edge 7 of the needle tip bites between the coil wires 21.

  Therefore, if the guide wire 20 is forcibly pulled in the case of this trouble, the guide wire 20 has an ultrafine single-strand coil structure. As a result, the rupture and reaction force may cause the adjacent common carotid artery to be erroneously punctured, inducing complications due to this puncture. There are severe therapeutic difficulties.

  The present invention provides a medical guide wire that solves the above-described problems of the background art and aims to improve the therapeutic properties.

(Means of Claim 1)
The medical guide wire includes a hollow coil body and a puncture needle formed by moving the hollow coil body forward and backward from the needle tip to form the long axis direction of the needle tip and the blade angle (θ2). The hollow coil is a hollow twisted wire coil body made of multi-strand wire, and the coil wire of the hollow twisted wire coil body is made of a twisted wire, and the twist direction of the coil wire itself and the hollow twisted wire The twist direction of the coil wire constituting the coil body is made opposite to each other, and the twist direction of the twist wire and the long axis direction of the hollow coil body are substantially parallel to facilitate operation from the needle tip. It is characterized by that.
(Means of Claim 2)
A medical guide wire is characterized by a double-headed structure in which the hollow stranded wire coil body according to claim 1 is formed as a main wire, and leading plugs are provided at both ends of the main wire.
(Means of claim 3)
The medical guide wire is a hollow stranded wire coil body according to any one of claims 1 and 2, wherein a U-shaped or a U-shaped pre-shaped portion is provided at a distal end portion.

Figure 1 (A) to indicate to gas guide wire 1, there are specific effects below. That is, when the guide wire 1 is in the form of a single coil, the gap between the lines increases as the total bending angle increases in the bending deformation state.

However , the “ hollow stranded coil body 2 formed by twisting in a rope shape using a plurality of coil wires 3 ” causes a slight relative sliding movement of each strand in the bending deformation state, and the bending deformation state Adjacent coil wires 3 are in sliding contact with each other, and a harmful wire gap into which the peripheral edge 7 bites is less likely to occur.

  And there exists the following specific effect | action based on the said angle limitation requirements.

  That is, the pulling characteristic from the puncture needle 5 by collecting the experimental data is as shown in FIGS. 2 (A) and 2 (B). The twist angle θ1 of the coil wire 3 of the coil body 2 (the coil center line of the coil body 2) There is a characteristic that the “retraction resistance R of the puncture needle 5 from the needle tip 6” is particularly small when the coil lead angle with respect to 4 is 55 °.

  The characteristic according to the requirement “limited to 55 ° or less” is effective against the defect phenomenon that the edge blades 7A and 7B of the peripheral edge 7 of the needle tip 6 bite into the coil wire 3 of the coil body 2 generated in the conventional product shown in FIG. It means to prevent.

  And (refer to FIGS. 1 (D) and (E)), and according to an angle requirement of “+ 2 ° or more with respect to the blade surface angle θ2 of the needle tip 6” or “−2 ° or less with respect to the blade surface angle θ2”. The characteristic is that, when the twist angle θ1 is smaller than that of the single coil winding form and coincides with the blade surface angle θ2, a relatively slight catch may occur on either side of the edge blades 7C and 7D. This means that the above-mentioned angle requirement effectively prevents the phenomenon of biting failure starting from the edge blades 7C and 7D.

  This is effective when the tip portion is processed into the precision portion P.

  And the correlation characteristic between the twist angle θ1 of the coil wire 3 of the coil body 2 and the angle difference between the blade surface angle θ2 of the needle tip 6 of the puncture needle 5 and the drawing resistance R from the puncture needle 5 of the coil body 2 is As shown in FIG. 2B, the pulling resistance R is particularly small in the zone where the angle difference is greater than or equal to + 2 ° and less than or equal to −2 °. There is an obvious characteristic that the resistance R increases rapidly.

For details (see FIGS. 1 and 5), when the coil body 2 is set to an angle requirement of “a twist angle θ1 of 55 ° or less”, the coil element wire is compared with the case of “single coil winding configuration”. Therefore, the same coil wire 3 is not contacted and restrained at the point of the edge blades 7A and 7B at the same time. It will be in contact with Di7 . If the angle difference requirement of “plus 2 ° or more” is also set, the inclination angle (blade surface angle θ2) of the knife edge of the peripheral edge 7 of the needle tip 6 and the peripheral edge 7 are joined. Thus, a relative angular difference from the “direction 8 between adjacent coil wires 3” at the joining point of the guide wire 1 exhibiting an “upward bending posture” in the blood vessel T is ensured, and the inclination of the knife blade of the peripheral edge 7 is ensured. A crossing form between the direction and the direction 8 formed between adjacent coil wires 3 can be secured. When the angle difference requirement of “−2 ° or less with respect to the blade angle θ2” is set, the “contact state with the peripheral edge 7”, “relative angle difference”, and “intersection” as described above are set. Can be secured.

Thus, the “penetration phenomenon of the peripheral edge 7 between the coil wires 3” at the peripheral edge 7 portion shown in FIG. 5 is effectively prevented. More specific action or Laga guide wire 1, and out operation to the puncture needle 5 can be very smoothly to better vent sliding resistance ensured.

  Furthermore, if supplemented, the angle difference requirement of 2 ° or more is larger than the “guide wire having an angle difference requirement of 2 ° or less”, and the twist angle θ1 of the coil strand 3 is large. This is effective when the outer diameter is large and flexibility is obtained. Further, the guide wire having an angle difference requirement of minus 2 ° or less has a small twist angle θ1 of the coil wire 3, so that the rigidity of the guide wire 1 is large and the outer diameter of the coil body is small. It is effective when obtaining rigidity, and contributes to the operability of the blood vessel insertion operation from the puncture needle 5, particularly “low invasiveness” by reducing the diameter, and has the merit effect of reducing the burden on the patient.

Therefore, "55 ° or less" and "plus 2 ° or more" or "minus 2 ° less" a mandatory condition and be Ruga guide wire 1 of the angle difference requirement is inserted into a blood vessel through the puncture needle 5 of the guide wire 1・ Drawing performance is particularly improved, and the puncture operation to the vein of the puncture needle 5 in the treatment method in which the central venous catheter is inserted into the internal jugular vein is extremely efficient and smooth, and the patient's pain is alleviated and the treatment is performed. This has a useful effect of improving the performance.

Hereinafter, description of the preferred embodiment based on the basic form.

In other words, the description with reference to Table 1 and FIG. 3. First Table 1 "twisting angle θ1 of the coil wire 3 of the hollow stranded-wire coil body 2""blade face angle θ2 of the needle tip 6 of the puncture needle 5 'in adult Ruga guide wire 1 from the basic form shown in FIG. 1" coil The specification of the example which specified and limited "the structure of the strand 3" is shown.

Since all of the above three examples have the angle requirement of the basic form, the above-described effects can be enjoyed. In the examples of B and C, the coil wire 3 is composed of a stranded wire, so that the characteristic of improving the flexibility of the guide wire 1 is based on the flexibility of the twisted wire. There is a working effect.

And see Table 2, the hollow stranded-wire coil of multi-thread mode comprising a plurality of coil wire 3, the guide wire consisting of a single strip coiled form of the background art uses a twisted form of multi-striations Therefore, since the tensile breaking strength is significantly increased, there is a specific action for accurately preventing the breakage of the guide wire 1 during treatment.

  In each of these three examples, each angle requirement is an indispensable condition. Therefore, a mode in which the convenience of the user is improved by combining the “puncture needle 5 and the guide wire 1 having a paired angle requirement” into a combined set form. Adopt as needed.

  In addition, if supplemented, the hollow stranded coil body 2 of the three examples described above, the coil element wire 3 is twisted using the rope-shaped stranded wire machine on the outer periphery of the core member, and then the core member is subjected to heat treatment or the like. It is formed as a coil body that is drawn out by using the above-mentioned means, or twisted and hollowed on the same circumference. And the provision formation means of twist angle (theta) 1 is mainly determined by the outer diameter of the coil strand 3, and the number of twists. In addition, it can also adjust a little with the strength of the twisting force of a twist direction.

Next, description will be made with reference to FIG. That is, first, as shown in FIG. 4 (A), the core wire 13 is inserted into the hollow portion of the filament main portion 12 of the hollow stranded wire coil body 2, and a blood vessel is provided at the end of the filament main portion 12. In a known form of guide wire provided with a leading plug 14 for internal insertion, this linear body main portion 12 is "a coil body in which a plurality of single wires shown in Example A of Table 1 are twisted" or "implementation of Table 1" It consists of a “coil body in which three groups of coil strands in which a plurality of wires are twisted” shown in “Example product B / C”, and both ends of the core wire 13 are tapered at both ends to be highly flexible and flexible. And it forms in the double-headed form which provided the leading head 14 in the both ends of the filament main part 12. FIG.

  The guide wire 1 shown in FIG. 4 (A) has the above-described effects, and the core wire 13 embedded in the hollow stranded wire coil 2 shares and carries the stress of bending deformation, so that the hollow stranded wire coil 2 The coil wire 3 is prevented from being broken due to deformation of the needle tip 6 in and out, thereby stabilizing the performance of the guide wire 1. And since it is a double-headed form, it enables the optional use of intravascular insertion from either of the two heads and from either one depending on the lesion, and the guide wire has a durable use frequency and usability. improves.

  On the other hand, in the guide wire 1 shown in FIGS. 4B and 4C, the twisting direction 15 of the strands constituting the coil strand 3 is substantially matched with the major axis 4 direction of the hollow stranded coil body 2. 4B and 4C, the slidability with the puncture needle 5 is improved, and the insertion property and the pullability of the guide wire 1 into the puncture needle 5 are improved.

Specifically, air-twisted coil body 2 in this, together with the coil diameter makes with by twisting the coil wire 3 to 18 present Z direction coiled 0.81 millimeter, the coil wire 3 is diameter = 0. A twisted wire of “diameter = 0.12 mm” is used by twisting 04 mm wire in the S direction of “1 × 7” configuration. In this combination, the twist direction 15 of the stranded wire constituting the coil wire 3 and the direction of the long axis 4 of the hollow stranded coil body 2 are substantially the same. If the angle difference between the major axis direction and the twist direction is within 6 °, the sliding characteristics of the puncture needle 5 with the peripheral edge 7 of the needle tip 6 are not affected. In addition, the twist direction of the “18” coil strands 3 of the hollow stranded coil body 2 does not necessarily have to be the Z direction, and may be the S direction, but a coil made of a stranded wire (1 × 7). It is necessary that the strands 3 are opposite to the twisting direction of the strand 3 itself.

Above that are specific action of FIG. 4 (B) (C) to indicate to the guide wire 1 is as follows. That is, the guide wire of the single-strand winding form of the background art is an extra fine wire in a single-wire coil winding form after sliding with the peak portion of the coil when sliding with the peripheral edge 7 of the needle tip 6. The peripheral edge 7 bites into and engages the valley of the coil where the adhesion between the coils is weak and the gap is easy to open.

On the other hand, in the above-mentioned configuration, there are no gaps between the coil wires 3 because of the multiple coil winding form, and the coil wires 3 are formed of stranded wires, and the direction of the twist is a hollow stranded coil. The shape is substantially parallel to the long axis direction of the body 2, that is, coincides with the long axis direction of the puncture needle 5, and any position of the edge blades 7 </ b> A to 7 </ b> D of the peripheral edge 7 when sliding with the coil crest. However, the guide wire 1 is guided and slid in the long axis direction of the puncture needle 5 having a certain angle, and there is a special effect that drastically improves the slipperiness. Incidentally, this of those of Example 1 without being restricted before Symbol angle requirements, and functions as an independent invention to solve the problems of the background art (claim 1).

Contact name Guy Dowaiya 1 is not shown figures, part or the entire length of the outer circumference of the hollow stranded-wire coil body 2, or forced shrink the outer periphery of the coil wire 3 by conventional means "swaging dies machining "Improvement of slidability with the puncture needle 5 and operability of insertion into the blood vessel through the puncture needle 5" by taking advantage of the merit effect of improving the surface smoothness and rigidity by reducing the diameter. The form which aims at is implemented as needed.

In addition, gas guide wire 1, while twisting formed "group twisting resistance load disclosed in Japanese Patent Application No. 2002-358851 of the prior art of those the art, and was heated for residual stress relief due to processing “Hollow twisted wire coil body formed in a form of imparting high rotational followability and straightness” “Hollow twisted wire coil body in which coil wire 3 is made of austenitic stainless steel wire” and “shape memory property / superelastic characteristics” A combination of Ni-Ti alloy wire and austenitic stainless steel wire shown, or a hollow stranded coil body of all forms including "a coil strand 3 form of a multi-stranded stranded wire part of a hollow stranded coil body" It becomes a configuration requirement.

The basic form and use state of a medical guide wire are shown, (A) is a partial front view showing the relative structure and use state of a pair of puncture needles, (B) is a plan view of (A), (C) is Front sectional view of a hollow stranded wire coil body, (D) and (E) are explanatory diagrams of its action state Both (A) and (B) are characteristic explanatory views of the basic form of FIG. The hollow stranded wire coil body of Table 1 is shown, and (A), (B), and (C) are cross-sectional views thereof. Shows the medical guide wire Ya, (A) is the overall front view, (B) is a partial front view, a perspective view of (C) is (B) FIG. 2 shows a medical guide wire of the background art, (A) is a front view of its structure and usage state explanation, (B) and (C) are its action state explanation views, and (D) is a shape explanation view of the tip portion

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Medical guide wire 2 Hollow stranded wire coil body 3 Coil strand 5 Puncture needle 6 Needle tip 7 Peripheral edge 7A-7D Edge blade 8 Direction between coil strands 20 Conventional guide wire θ1 Coil strand of hollow stranded coil body Twist angle θ2 Blade surface angle R of puncture needle R Pull-out resistance

Claims (3)

In a medical guide wire comprising a hollow coil body and a puncture needle in which the hollow coil body is advanced and retracted from the needle tip to form the major axis direction of the needle tip and the blade surface angle (θ2),
The hollow coil is a hollow twisted wire coil body made of multi-strand wire, and the coil wire of the hollow twisted wire coil body is made of a twisted wire, and the twist direction of the coil wire itself and the hollow twisted wire The twist direction of the coil wire constituting the coil body is made opposite to each other, and the twist direction of the twist wire and the long axis direction of the hollow coil body are substantially parallel to facilitate operation from the needle tip. A medical guide wire characterized by that. A medical guide wire comprising a double-ended structure in which the hollow stranded coil body according to claim 1 is formed as a main wire and leading plugs are provided at both ends of the main wire. The medical guide wire according to any one of claims 1 and 2, wherein a U-shaped or a U-shaped precipe portion is provided at a distal end portion.