JP2008155054A - Medical guide wire - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a high-quality and high-performance medical guide wire, improving the concerned curing performance by eliminating the weak point of background technique. <P>SOLUTION: In a medical guide wire of a flexible filament body having a tip part of high flexibility, a spiral recessed filament part 12 obtained by forming a coiled body of a thick line 8 and a fine line 9 combined in parallel with each other and figuring a spiral recessed groove 10 on the outer periphery is provided in the rear of the tip part. This guide wire 1B has an advantageous effect that the spiral recessed filament part 12 functions to improve the intravascular insertion and advancing force of the guide wire 1B by a blood flow F. <P>COPYRIGHT: (C)2008,JPO&INPIT

Description

  The present invention relates to a medical guide wire mainly used when a catheter is inserted into a cardiac blood vessel.

  A medical guide wire (hereinafter simply referred to as a guide wire) is inserted into a narrow, thin blood vessel, and the hand portion located outside the body is manually operated by “pushing / pulling / rotating”. This is an operation process that guides the part to the lesion. 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. It is necessary to have a high degree of mechanical properties with flexibility and a tilt characteristic that the rear end portion has appropriate rigidity, and a steering property that allows the front end portion to adapt appropriately to the manual operation.

Therefore, the guide wire that requires the above mechanical properties is a tapered shape in which the main wire is constituted by an elongated flexible metal core material, and the slightly long tip portion of the core material is gradually reduced in the distal direction. In general, a resin having a resin coating or a coil spring is widely used. Further, as shown in Patent Document 1, a tip portion of a resin-made flexible filament is tapered. In addition, there are background arts of “a configuration in which a leading sphere is provided at the front end” and “a flow-directed configuration in which intravascular blood flow is improved by using intravascular blood flow” shown in Patent Document 2.
Japanese Patent Publication No.57-55426 JP-T-2002-541877

  For example, when the guide wire of the above background art is inserted into the coronary artery from the aortic arch of the heart system blood vessel, the area occupied by the guide wire with respect to the cross section of the small coronary artery is increased, and the guide branch is branched from the large diameter aortic arch. Since it is an insertion process to bend and deform into a coronary artery with a diameter and to be introduced and inserted into a lesion with a lot of bending meanders, the insertion workability to lead the tip to the lesion in the stenosis of the coronary artery is very difficult. In addition to hindering therapeutic properties, it causes suffering for the patient, and furthermore, there is a difficulty that is contrary to the recent trend toward minimally invasiveness (early healing due to miniaturization of treatment wounds).

  That is, since the tip sphere has a large diameter (diameter = 0.7 mm), it is difficult to introduce and insert a bent meandering lesion in a coronary artery into a narrow blood vessel. Document 2 consists of the idea of improving blood vessel insertion by blood flow due to the flexibility of the guide wire itself, and the rotational steering property of the tip part by the hand part is not good, and it is introduced into the vascular lesion part. Insertability is poor.

  The present invention provides a high-quality, high-performance guidewire that solves the above-mentioned problems of the background art and improves the therapeutic properties.

The assembly of the catheter and medical guide wire according to claim 1 is an assembly in which a medical guide wire of a flexible elongated linear body having a highly flexible tip portion is inserted into the catheter. The guide wire for the medical device has a structure in which a spiral grooved line portion formed by forming a spiral grooved groove on the outer periphery is provided behind the distal end portion in a coil body having a combination of a thick line and a thin line. When the guide wire is inserted in the same direction as the blood flow, the blood flow abuts against the thick line of the partition wall of the spiral groove, and this advancing force acts as a forward thrust action, and into the catheter from the proximal side to the distal side. The advancing force imparting action due to the use of the impact force is amplified by using the injection / injection force of the injecting agent, and the deep blood vessel insertion property is improved.

The assembly of the catheter and medical guide wire of claim 2 is in addition to the structure of claim 1, The tip part is provided with a hemispherical streamline head with a hemispherical tip that has a hemispherical tip and a small diameter on the proximal side, and when inserted in the direction opposite to the blood flow, resistance to the dynamic pressure of the blood flow is reduced. It is characterized by that.

The assembly of the catheter and the medical guidewire according to claim 3 has a spiral concave striated portion formed by twisting the outer periphery of the core material in addition to the configuration according to any one of claims 1 and 2. It has a structure in which the core material of the spiral concave striated portion is made non-existent and is continuously provided to the rear end.
The assembly of the catheter and the medical guide wire according to claim 4 has a spiral concave striated portion intermittently disposed in the length direction in addition to the configuration according to any one of claims 1 and 2. Yes.

Moth guide wire 1A~1C there is a specific effect of the following.
That is, (see FIG. 2 (A)) When the guide wires 1A to 1C are introduced and inserted into the left coronary artery 21 from the cardiovascular aortic arch 20, the guide wires 1A to 1C are reverse to the blood flow F of the aortic arch 20. When inserting into the left coronary artery 21 branched from the aortic arch 20, the insertion form is in the same direction as the blood flow F.

  In the above process, the guide wire 1A has a tip portion facing the high-speed blood flow F of 200 km / h formed as a “streamline round line portion 3 having a hemispherical streamline head 4” (FIG. 2 ( See B)) In the aortic arch 20, the resistance to the dynamic pressure of the blood flow F in the counterflow is much smaller than that of the background art, so that the introduction and insertion property is extremely good.

  In the left coronary artery 21 (see FIG. 2 (C)), a blood flow F having a high dynamic pressure and a high dynamic pressure is guided to the inclined surface 6 of the saw blade portion 7 to coronate the saw blade filament 5. Since the contact with the saw blade portion 7 group, this contact force acts as a forward thrust P of the guide wire 1, and this blood flow F provides a forward force, so that the intravascular insertion is greatly improved and the insertion is facilitated. At the same time, the deep blood vessel insertability at the distal end can be improved.

  Furthermore, during vascular treatment (see FIG. 2 (D)), a contrast medium and physiological saline for grasping the state and size of the lesion are injected as necessary through the catheter K. -By utilizing the injection force, the above-described forward force imparting action by the blood flow is amplified, and a unique effect of further improving the intravascular insertion property and deep part insertion property can be enjoyed.

Furthermore, by improving the above-mentioned blood vessel insertion property and deep portion insertion characteristics, “the conventional guide wire requires a stress wire diameter (0.35 mm diameter) to prevent buckling due to the pushing force for inserting the blood vessel deep portion. limit the diameter of exists "as the catheter diameter and, catheters 1A is then possible because diameter reduction (0.25 millimeter diameter) having band deep insertion of the inevitably catheter fine The diameter can be changed (for example, the inner diameter of the conventional 7Fr (French) = 1.88 to 2.05 mm to the inner diameter of 1.42 to 1.47 mm of 5Fr (French)). From the above-mentioned unique action, it is possible to meet the recent demand for “miniaturization and minimally invasiveness of the catheter insertion wound” by the patient.

In the following, gas guide wire 1B is "functions to improve well intravascular insertion advancing force of the guide wire 1B by the blood flow F" (see Figure 3) a spiral concave linear portions 12 is operational effects.
That is, (refer to FIGS. 3C and 3D) In the blood flow F of the viscous liquid flow, a fine vortex FA is generated on the surface of the guide wire 1B to form the vortex layer 11, and the blood flow velocity is increased as the distance from the surface of the guide wire 1B increases. The fluid mechanism increases V.

In view of this, the guide wire 1B has a spiral groove 10 having a regular shape arranged in parallel while the thick line 8 is partitioned (see FIG. 3D). since the vortex layer 11 spiral flow in the distal direction from the rear end of the guide wire 1B in abutment on the thick line 8 of the partition wall of the scan Pairaru concave groove 10 occurs, valid in the left coronary artery 21 by the spiral stream 13 Do not forward thrust P acts, specific action to improve the special improvement of the "good vascular insertion resistance and blood vessels deep insertion of good" exists.

And since the spiral thick line 8 constitutes a drill form, the sliding contact resistance with the blood vessel wall and the catheter K is reduced by rotating in the twisting direction of the drill, and the push / pull / rotation by the hand operation is reduced. The operability is further improved, and the drill form can be used to improve the passage of the stenosis of the blood vessel and to remove it (delete it at the outer periphery of the thick line 8 and store it in the concave thin line 9). becomes, further Rutotomoni improve the injection smoothness-flowed guides the saline or the like into a spiral shape by the presence of the drill forms, generates a multiphase flow with blood, it can improve the injection effect of .

Hand, gas guide wire 1C, since (see FIG. 4 (B) refer) twist linear portions 15 are present, rotational flow 16 blood flow F extends along the twisting form of twisted linear portions 15 in the left coronary artery 21 And a unique action of giving and generating the forward thrust P of the guide wire 1C, and a unique action for improving the “good blood vessel insertability / blood vessel deep insertability” as in the first and second inventions. Exists.

  Further, when the twisted wire 15 of the guide wire 1C in the form of a twist drill is bent and bent in the blood vessel, the relative posture of the rectangular cross-section line with respect to the bending center changes at 90 ° intervals, and the 90 ° of the relative posture is obtained. Due to the change in the interval, the second moment of the cross section of the bending characteristic changes, and the strength of the bending characteristic changes continuously at 90 ° intervals.

  Therefore, in a blood vessel portion having a high degree of bending, the guide wire 1C is rotated as necessary to easily bend and deform using the point having a small secondary moment of cross-section, thereby allowing the insertion into the blood vessel easily. In addition, the drilling action of the twisted striated portion 15 enables the perforation processing of the vascular stenosis portion or the like.

  Since both of the above guidewires 1B and 1C have the same “improvement of advancing insertion force by using blood flow” similar to the guidewire 1A, the “advance by infusion saline solution” similar to the guidewire 1A. “Force amplification” and “catheter diameter reduction effect” can be enjoyed.

The Ruga guide wire 1A~1C that Sosu specific action by Analysis of more pairs bloodstream, with improved the vascular treatment properties, to reduce the patient's pain, results in improved minimally invasive in recent years directed together Has a useful effect.

Below, describing good preferable examples.

First, the gas guide wire 1A with reference to FIG. That is, in the metal wire core 2 having the total length provided with the resin coating C, the length L1 of the tip portion is formed in the streamlined round wire portion 3, and the length slightly following the streamlined round wire portion 3 is formed. Is formed in the saw blade linear portion 5 shown in FIG. 1, and the rear portion of the saw blade linear portion 5 has a shape formed in a round wire linear portion of a normal form, and the entire outer periphery is hydrophilic. A polymer coating PC is applied.

Incidentally, this's also is given in the full-length = 1500 millimeter, streamlined round wire portion 3 "diameter D1 = 0.25 millimeter, a length L1 = 3.0 millimeter", "saw blade section 7 saw blade pitch = “2.0 mm, blade height = 0.04 mm” and “saw blade linear portion 5 length L2 = 250 mm, outer diameter D2 = 0.25 mm”. Polyamide / polyester or each of these elastomer materials is used, and polyvinylpyrrolidone or the like is used as the hydrophilic polymer.

More moth guide wire 1A, since the length from the hemispherical streamlined head 4 to the rear end of the saw blade linear portions 5 is roughly 250 millimeter length, the lesions treatment of the left coronary artery 21, the 250 millimeter zone Fits to the length of the guide wire inserted from the aortic arch 20 to the lesioned part, so that the main effects can be enjoyed smoothly and effectively. And since hydrophilic polymer exists in the whole outer periphery, the frictional resistance of a blood fluid falls especially and the further improvement of the said specific effect | action can be performed.

In addition, gas guide wire 1A is or forms a saw blade 7 in a spiral shape, slightly length of the distal end portion of the core member 2 (approximately 30 millimeter), or plated by a radiopaque material, resin film In some cases, a radiopaque material such as bismuth trioxide or tungsten is mixed into C to improve visibility by radiation projection at the time of treatment to improve the treatment.

Incidentally, gas guide wire 1A of this, when retracting the intravascular not damage the vessel wall because the behavior effects below. That is, the blood flow F in the blood vessel is a blood flow form in which the blood vessel wall portion is slow and the center in the blood vessel has the highest speed distribution, and the highest speed portion is in a decompressed state. Accordingly, the thin and light guide wire 1A is about 1/8 of the inner diameter of the blood vessel in the vicinity of the coronary artery entrance, and the streamlined round wire portion 3 and the saw blade linear portion 5 are drawn into the central portion of the blood vessel. Since it moves backward in a floating posture, there is no possibility that the saw blade linear strip portion 5 is in sliding contact with the inner wall of the blood vessel and damaged by the saw blade portion 7.

  Further, since the separation point from the blood flow generated in the hemispherical stream line head 4 of the streamlined round line portion 3 is rearwardly displaced to prevent the generation of harmful Karman vortex streets of the blood flow, the guide wire 1A is moved up and down. There is no movement and the above-mentioned preferred floating retreat posture is maintained. The blade height of the saw blade portion 7 is about 40 microns in the embodiment of FIG. 3 and a hydrophilic polymer layer having a thickness of about 20 microns is present, so that the saw blade portion 7 contacts the inner wall of the blood vessel. However, the trouble that damages the blood vessel wall does not occur in reality.

Next, a moth guide wire 1B with reference to FIG. Ie upon those having a "spiral concave linear portions 12 consisting of a continuous spiral concave groove 10" shown in the basic form, a thin wire 9 (diameter = 0.04 millimeter) nine, thick line 8 ( One diameter is set to a core material 2 (diameter = 0.10 mm), and the pitch S is set to about 1.04 mm. The products shown in FIG. 6 have the above-mentioned specific action.

  In addition, this guide wire 1B employ | adopts the following form as needed (refer FIG.6 (C) (D)). That is, the spiral groove 16 is formed with one wire 9 missing from the spiral concave line portion 12 or the hollow shape with the central hollow portion 17 without the core material 2. This form has the following specific effects. In addition, what has this center hollow part 17 winds the thick wire 8 and the thin wire 9 around a required core material, and shape | molds it in a coil form, and, after that, the core material is extracted and shape | molded.

  That is, the spiral groove 16 is a missing spiral groove of the thin wire 9 and a gap is formed in the spiral groove groove 10, so that the blood flow F flows into the spiral groove 16 and further increases the pressure resistance to increase the forward thrust P. In addition to the further improvement action, the central hollow portion 17 can be coexisted so that the diameter can be reduced or increased by an external force. For example, a spastic phenomenon in which the blood vessel “convulsions” due to any cause during treatment suddenly occurs. When the blood vessel contracts and the guide wire is trapped and cannot be removed, a treatment method is possible in which the guide wire 1B is reduced in diameter by rotating in the twisting direction of the thin wire 9 and released from the intravascular capture state. become.

  And the thing which has the center hollow part 17 enables weight reduction by the absence of the core material 2, and aims at the further improvement of the forward thrust P by a blood flow, and the blood flow F by coexisting the said spiral groove | channel 16. Can be further improved in the forward thrust P.

Then, to explain the Figure 7. That is, in the guide wire 1C of the basic form, the core material 2 having a rectangular cross section (0.127 mm width, 0.220 mm height) in the middle portion and the latter half portion in the length direction in the absence of the resin coating C is a twist drill. It is formed in a twisted line 15 that is twisted into a shape and is continuous at a pitch S = 0.8 mm. As described above, the guide wire 1C of the reference example 2 in FIG.

Next, another example of the guide wire 1C will be described with reference to FIGS. That is, in the configuration shown in FIG. 7B, the spiral pitch S of the twisted striated portion 15 gradually changes gradually from “large pitch S1 to small pitch SN” from the rear end toward the front end of the guide wire 1C. Is set.

  In this pitch change form, the spiral blood flow due to the spiral shape becomes a compressed flow toward the tip side where the spiral pitch S is small, and a larger forward propulsive force is applied to the guide wire body, and the forward thrust P Further increase is possible.

  On the other hand, the one in FIG. 7C has a form in which a straight wire portion 18 in which a rectangular cross-sectional line of the same size as the twist wire portion 15 is left untwisted exists in the middle of the twisted wire portion 15. Yes. In FIG. 7C, since the straight line portion 18 has a rectangular cross-section line, bending in the thin plate direction is extremely easy, so a mid-bend portion 21A from the left coronary artery 21 to the lesioned portion 21A (FIG. 2). (See (A)), etc., at the point where the minimum bending of the guide wire 1C is necessary, the straight wire portion 18 can be used to be easily bent and inserted.

  FIG. 7D shows a preferable aspect ratio of the rectangular section line, and the size of the width B and the height H is set to 1: √3. This structure is a structure that uses a rectangular cross-section material, and has a well-established aspect ratio that is most stable in structural mechanics against the bending external force that the member receives during use. The shape and function of the wire 1C are extremely stable. In addition, this straight line part 18 may be made into the straight form of a round wire instead of the said rectangular cross section line.

  In principle, the above-described wire of the guide wires 1A to 1C is made of a stainless steel wire, a Ni—Ti wire, or a tungsten wire alone or in combination. However, from the viewpoint of weight reduction, resin fibers such as polyethylene fibers, aramid fibers, and PBO fibers (Zylon / Toyobo) may be used alone or mixed with metal wires. In addition, as a method for suppressing thrombus adhesion on the surface of the wire of the guide wires 1A to 1C, it is desirable to form a hydrophilic polymer impregnated with an antithrombotic agent such as heparin on the outer surface of the wire after coating the resin with the resin, A method of impregnating hyaluronic acid with relatively high viscosity is desirable.

Furthermore, gas guide wire 1A~1C are not limited to the examples above, or configure the guide wire 1B · 1C having a tip portion of the "hemispherical streamlined head 4 with streamlined round wire portion 3" of the (Fig. 8) The rear end portion 31 of the round wire form is connected to the front half portion 30 provided with any one of the saw blade linear portion 5, the spiral concave linear portion 12, and the twisted linear portion 15. Alternatively, a highly flexible and flexible tip portion having a known shape in which the coil spring body 32 is fitted to the core member 2 may be used.

The basic form of a medical guide wire is shown, (A) is the whole front view, (B) is the principal part enlarged front view. (A)-(D), action explanatory drawing of the medical guide wire of FIG. The basic form of a medical guide wire is shown, (A) is the whole front view, (B) is the principal part enlarged view, (C) (D) is the action explanatory drawing. The basic form of a medical guide wire is shown, (A) is the whole front view, (B) is the action explanatory drawing, (C) is EE sectional view of (A), (D) is FF section of (A). Figure Front view of an embodiment of a medical guide wire The Example of a medical guide wire is shown, (A) is the front view, (B)-(D) is the cross-sectional view. An example of a medical guide wire is shown, (A) is a front view thereof, (B) and (C) are partial front views thereof, and (D) is a transverse sectional view thereof. It shows the medical Ryoyo guide wire Ya, (A) (B) is a front view

Explanation of symbols

DESCRIPTION OF SYMBOLS 1A Medical guide wire 1B Medical guide wire 1C Medical guide wire 2 Core material 3 Streamlined round wire part 4 Hemispherical stream line head 5 Saw blade linear strip part 6 Backward-increasing slope 7 Saw blade part 8 Thick line 9 Thin line 10 Spiral groove 12 Spiral groove 15 Twist line 16 Spiral groove 17 without wire 17 Central hollow part 20 Aortic arch 21 Left coronary artery C Resin coating F Blood flow FA Vortex K Catheter P Advance thrust V Blood flow Speed

Claims (4)

In an assembly in which a medical guide wire of a flexible elongated linear body having a highly flexible tip portion is inserted into a catheter,
The medical guide wire has a structure in which a spiral grooved line portion is formed on the outer periphery of the coil body, which is a combination of a thick line and a thin line, and a spiral groove formed on the outer periphery, behind the distal end portion.
When the medical guide wire is inserted in the same direction as the blood flow, the blood flow strikes the thick line of the partition wall of the spiral groove, and this thrust force action acts as a forward thrust action, and into the catheter from the hand side Catheter and medical use characterized by amplifying the forward force imparting action by utilizing the impact force by using injection injection / injection force toward the distal end side to improve deep blood vessel insertability Assembly with guide wire. The tip part is provided with a hemispherical streamline head with a hemispherical tip that has a hemispherical tip and a small diameter on the proximal side, and when inserted in the direction opposite to the blood flow, resistance to the dynamic pressure of the blood flow is reduced. It is characterized by
An assembly of the catheter of claim 1 and a medical guidewire. The spiral grooved filament part twisted and configured on the outer periphery of the core material has a structure in which the core material of the spiral grooved line part is made non-existent to the rear end. An assembly of the catheter according to any one of the above and a medical guide wire The assembly of a catheter and a medical guide wire according to any one of claims 1 and 2, wherein the spiral concave strip is intermittently disposed in the length direction.