JP4272324B2 - Medical guidewire - Google Patents

Description

[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a medical guide wire used as an insertion guide for a catheter to be inserted into a blood vessel when treating a vascular stenosis or the like.
[0002]
[Prior art]
For the purpose of angiography, when inserting a catheter with a very thin flexible tube into a blood vessel or when inserting a balloon catheter into a blood vessel for the treatment of a stenosis of a coronary artery, the catheter must be inserted safely and reliably. Therefore, a medical guide wire made of a flexible wire is used, and there are known examples disclosed in Japanese Patent Publication No. 4-25024 and Japanese Patent Publication No. 4-292175.
[0003]
This medical guide wire (hereinafter simply referred to as a guide wire) is inserted into a blood vessel / branch blood vessel having a complicated path from the tip, so that it is flexible and has a vertical load with respect to a load in the traveling direction. (Buckling resistance) is required, and further, the terminal portion located outside the body is rotated and inserted into the blood vessel to advance. It is necessary to have a mechanical property that can be operated in both directions, and has a basic configuration in which a coil spring is fitted and attached to a core material of a fine wire that is mainly a wire. In this basic form, a bulging bulge is formed in the vicinity of the distal end of the distal end portion with the technical intent to facilitate the indwelling setting of the balloon catheter by expanding the stenotic lesion portion by the distal end portion inserted into the stenotic lesion portion. Japanese Utility Model Publication No. 5-19078 proposes a structure having a portion.
[0004]
[Problems to be solved by the invention]
The above-mentioned “guide wire with a bulging portion” of the above-mentioned known example has a temporary effect of expanding the stenotic lesion by the bulging portion, but the bulging portion is “a cylindrical coil spring in which a wire is tightly wound, Or, a separate bulging tubular body made of a metal pipe is fitted to the guide wire and “braded and fixed” to make it difficult to secure blood flow when the bulging portion reaches the stenotic lesion. Interfere with therapeutic properties. And this bulging part does not have the diameter-expansion treatment effect | action of the stenosis lesion part by the bulging part itself, and is only a temporary diameter expansion holding function for making it easy to insert a balloon catheter. Furthermore, since the separate bulging portion is fixed to the distal end portion of the guide wire, the guide wire is complicated to be formed and the cost is increased.
[0005]
The present invention provides a guide wire that solves the above-mentioned problems of the prior art.
[0006]
[Means for Solving the Problems]
The present invention that solves the above technical problem is as follows: "In a medical guide wire comprising a distal end portion in which a coil spring is loosely fitted to a long flexible core material, the coil spring has an outer diameter of a tightly wound wire coil . A series of a leading coil portion, a bulging coil portion with a large outer diameter of the coil following the leading coil portion, and a succeeding coil portion with a tight outer diameter of the outer diameter of the coil following the bulging coil portion. The part comprises a guide wire of the first invention comprising a structure in which a clearance between coil wire materials is provided, and the outer shape is concentrically changed around the core material to form a substantially spindle shape ,
[0007]
“In a medical guide wire comprising a distal end portion in which a coil spring is loosely fitted on a long flexible core material, the coil spring is connected to a leading coil portion having a thin coil outer diameter and a thick coil outer portion following the leading coil portion. includes a bulging coil portion of the diameter range, the coil portion out further bulging is formed in a substantially spindle-shaped, consists of small-diameter sub-coil wire than the main coil spring and the main coil wire made of the main coil wire It is composed of a combination of sub-coil springs, a sub-coil wire of the sub-coil spring is interposed in the space between the main coil wires of the main coil spring, and a spiral shape based on a wire diameter difference between the main coil wire and the sub-coil wire The guide wire according to the second aspect of the present invention is a "structure consisting of a multi-thread spring with a concave groove on the outer periphery".
[0008]
That is, when the bulging coil portion provided at the distal end portion is in close contact with the stenotic lesion, the guide wire according to the present invention passes through the interstices between the coil spring and the coil. “Blood flow path” and “the blood flow path passing through the spiral groove on the outer periphery of the coil spring in the second aspect of the invention” ensure the blood flow through the stenotic lesion and the coil pitch of the bulging coil section. Increasing the coil pitch increases the coil pitch by moving the swelled coil part forward and backward within the stenotic lesion part. The outer periphery of the bulging coil portion is made to function as a scraping tool, and has a structure that enables a diameter expansion treatment of a stenotic lesion with a guide wire.
[0009]
Note that the loose fitting of the coil spring in the present invention is one having a clearance around the entire circumference of the core material, and one in which a part of the outer circumference of the core material such as a rectangular cross section is joined to the inner circumference of the coil spring. It means what is included. And the bulging coil part of said 1st invention is formed in the long taper wire which gradually increases diameter from the front to back, or makes the form which carries out the serial connection of the bulging coil part of said 1st 2nd invention via the neck part. Sometimes.
[0010]
[Action]
When the bulging coil portion is inserted into the stenotic lesion, the guide wire of the present invention having the above-described configuration is “a blood flow path passing through the coil hollow portion from the inter-coil space” or “a spiral existing on the outer periphery of the bulging coil portion. A blood flow channel that flows through the stenotic lesion can be secured by the “shaped blood flow channel”. Then, when the inserted bulging coil portion is moved forward and backward, the coil wire outer periphery of the bulging coil portion joined to the stenotic lesion wall functions as a scraping tool for the lesion portion, and the guide wire itself is the stenotic lesion portion. It acts to expand the diameter. Then, since its bulging coil portion having a substantially spindle shape of the, it is possible to gradually inserted without force into the stenotic lesion, intravascular insertion follow interlocked so bonded or tentatively retaining locks to the catheter tube at the rear end The treatment method to become possible.
[0011]
Further, when the swelled coil portion that has reached the stenotic lesion is operated to advance and pass by rotating the rear end of the guide wire located outside the body, the outer periphery of the coil wire that joins the inner wall of the stenosis lesion and leads the advance operation Because of the large lead pitch, the amount of advancement with respect to one rotation of the guide wire is increased as compared with the conventional example, and the operation of passing the lesion part forward becomes extremely easy. The guide wire with the bulging portion of the present invention can be formed by using a bulging coil as a part of the coil spring that is loosely fitted to the distal end portion, so that the conventional separate body is “attached after brazing”. It is easier to form with a simpler structure than the one and can be formed at low cost.
[0012]
DETAILED DESCRIPTION OF THE INVENTION
First, a guide wire according to one embodiment of the first invention will be described with reference to FIG. That is, in the guide wire 1 composed of the distal end portion 2 in which a coil spring is loosely fitted to a flexible elongated core material 3, the coil spring has a coil outer diameter having a round-shaped leading plug 4 attached to the distal end. Consisting of a leading coil portion 5 of D1, a bulging coil portion 6 having a coil outer diameter D2 following the leading coil portion 5, and a subsequent coil portion 7 having a coil outer diameter D1 following the bulging coil portion 6. The leading coil portion 5, the bulging coil portion 6 and the succeeding coil portion 7 are cylindrical coil springs made of a single coil wire 8 having a common coil core 11, and the coil outer diameters D1 and D2 are “ There is a size relationship of D1 <D2.
[0013]
Specifically, the leading coil portion 5 and the subsequent coil portion 7 are coil springs in which a coil wire 8 is tightly wound. The bulging coil portion 6 is a line-gap coil spring in which a clearance C is provided between the coil wires 8, and gradually increases from the coil outer diameter D1 of the leading coil portion 5 to the coil outer diameter D2 of the bulging coil portion 6. The leading coil portion 5 and the succeeding coil portion 7 are integrated with each other via the gradually changing coil diameter gradually changing portion 9A and the coil diameter gradually changing portion 9B gradually decreasing from the coil outer diameter D2 to the coil outer diameter D1 of the succeeding coil portion 7. coil of the coil outer diameter D2 is a substantially spindle shape exists few turns.
[0014]
Then (see FIG. 1B), the bulging coil portion 6 of the guide wire 1 inserted into the blood vessel for the treatment of the stenotic lesion portion 10 (hereinafter simply referred to as the lesion portion 10) is inserted into the lesion portion 10 and expanded. It is easy to insert and indwell a tube-shaped balloon catheter that is inserted into the lesioned part 10 as a guide and guides the guide wire 1 as a guide, or by moving the balloon catheter forward and backward in the direction of the arrow in the illustrated insertion state. The wall portion of the lesioned part 10 is scraped off by the outer periphery of the coil wire rod 8 so as to perform a diameter expansion treatment of the lesioned part 10. 1 has a coil outer diameter D1 of about 0.355 mm, a coil outer diameter D2 of about 0.56 mm, a length of the leading coil portion 5 of about 40 mm, and a bulging coil. The length of the portion 6 is about 5 mm, the total coil length from the leading end of the leading coil portion 5 to the rear end of the succeeding coil portion 7 is about 300 mm, the diameter of the coil wire 8 is about 0.09 mm, and the clearance C between the lines Is set to a minute amount that does not cause thrombus. The distal end portion 2 of the guide wire 1 of FIG. 1 embodiment is not shown, but a separate swelling is provided in the vicinity of the distal end of a single coil spring having a thin coil outer diameter from the leading coil portion 5 to the subsequent coil portion 7. There may be a “combined form of two coil springs” in which the output coil portion 6 is externally fitted and brazed.
[0015]
The above-described guide wire 1 of FIG. 1 embodiment has the above-described action, and can ensure the through-flow blood flow 12 of the lesioned part 10 passing through the interline gap C in the inserted state of the lesioned part 10. The effective advancement / retraction of the lesioned part 10 enables effective diameter expansion treatment, and when the distal end part 2 is rotated and passed through the lesioned part 10, the advancement amount of the distal end part 2 with respect to one rotation of the guide wire 1 is large. Thus, the passage of the lesioned part 10 is made quicker and easier.
[0016]
Furthermore, the distal end portion 2 of the guide wire 1 is such that the bulging coil portion 6 is a line-gap coil, so that the bending deformation with the coil core 11 as the bending center is more than that of the conventional cylindrical bulging portion. It is particularly easy to bend (because the play C exists, the coil core 11 can be bent easily as a bending neutral surface and can be bent to a small radius of curvature) There is a specific action that facilitates insertion through various types of lesions 10 "such as irregular, complex, and long and large.
[0017]
Next, another embodiment of the bulging coil portion 6 of the first invention will be described with reference to FIG. That is, the one shown in FIG. 2A uses a long taper coil wire 8A in which the coil wire 8 gradually increases in diameter from d1 to d2 from the front to the rear. The bulging coil portion 6 in FIG. 2A has a form in which the front portion is highly flexible and flexible, and the deformation rigidity is increased in the rear direction. There is no unreasonable burden of resistance and it can be made safer and smoother.
[0018]
Then, show another embodiment of a substantially spindle shape of the bulging coil portion 6 is that of FIG. 2 (B) (C), the maximum coil diameter D2 becomes the midpoint those of FIG. 2 (B), this 2 (C) is provided with a step portion 15 due to a difference in coil diameter between the bulging coil portion 6 and the succeeding coil portion 7. The distal end of the catheter tube 16 is joined to the portion 15 and set. In addition, although not shown in figure, the coil wire 8 may use the flat wire of a rectangular cross section as another aspect.
[0019]
Next, a guide wire according to one embodiment of the second invention will be described with reference to FIG. That is, in the tip portion 2 composed of the “leading coil portion 5, the bulging coil portion 6 and the succeeding coil portion 7” as in the embodiment of FIG. 1, the bulging coil portion 6 of this embodiment of FIG. A secondary coil spring 21 having a coil outer diameter D6 and a coil outer diameter D6 smaller than the coil outer diameter D2. Are combined with the coil core 11 being the same, and the clearance C of the coil wire 8B of the main coil spring 20 is integrated with the coil wire 8C of the sub coil spring 21 interposed therebetween, and the two types of coil wires 8B A spiral concave groove 19 having a diameter difference of 8C is provided on the outer periphery, and the concave groove 19 forms a spiral blood flow path 22 that appears along the outer periphery of the bulging coil portion 6. Yes.
[0020]
The guide wire shown in FIG. 3A has the following specific effects. That is, the blood flow around the guide wire that has approached the stenotic lesion 10 from a healthy blood vessel part is narrowed by the approach to the stenosis lesion 10, the speed of the blood flow is increased, and the blood flow enters the spiral blood channel 22 to increase speed. Since the spiral flow, a strong self-advancing force F and a self-rotating force T are generated and imparted to the distal end portion 2 of the guide wire by the fluid dynamic pressure of the high-speed spiral blood flow. Accordingly, the guide wire distal end portion 2 is introduced into the lesioned portion 10 and the indwelling set is obtained by adding the above-mentioned self-advancing force F / self-rotating force T to the manual operation force at the rear end portion outside the body. Since the mobility is improved, the operation becomes easier and the operation force to be transmitted by the intermediate portion of the guide wire is reduced, so that the strict mechanical properties required for the guide wire can be slightly relaxed. The spiral blood flow path 22 has a side effect that can be used as a “slip agent pool groove” when a slip agent is applied to the tip portion with the intention of improving the intravascular insertion property.
[0021]
Note that the multi-helix coil spring shown in FIG. 3 (A) (see FIGS. 3 (B) and (C)) is between the coil wires 8B and 8C in a state where the main coil spring 20 and the sub coil spring 21 are combined. In order to further improve the blood flow action by providing a clearance C1, or the main coil spring 20 made of the large-diameter coil wire 8B and the “two sub-coil springs 21A made of the thin-diameter wires 8C and 8D” "21B" is combined into a triple spring form, and the flow capacity of the spiral blood flow path 22 of the concave groove 19 that appears on the outer periphery of the swollen coil portion 6 by these three types of coil wires is further improved. There is a case in which it is made a mode to achieve.
[0022]
Next, another embodiment of the first second invention will be described with reference to FIG. That is, in the one having the bulging coil portion 6 shown in FIG. 1 and FIG. 3 embodiment, two tandem arrangements of 6A and 6B or three tandem arrangements of 6A, 6B and 6C in which the bulging coil portion 6 is connected in series via the neck portion 13 In some cases, the outer diameter of the coil 6A at the front 6A is gradually increased from the outer diameter D3 of the coil 6B and 6C at the rear of the coil 6D. In this configuration, by setting the coil outer diameter D2 of the distal end 6A to an appropriate amount, the insertion resistance to the lesioned part 10 is reduced as much as possible, and the insertion passing operation and the enlargement treatment are performed more safely and smoothly. Can do. In addition, the coil spring of the guide wire of this invention may make the subsequent coil part 7 absent.
[0023]
Because it has a guide wire 1 is substantially spindle-shaped bulging coil unit 6 of the present invention described above in each embodiment can be effectively used in the treatment methods described below. That is, when a known stent placed in the lesioned part 10 that has undergone diameter expansion treatment has an abnormality such as strain reduction or deformation and requires retreatment, the distal end of the bulging coil part 6 that is reinserted into the lesioned part 10 A balloon catheter for gradually expanding the diameter of the abnormally deformed stent to return to a normal shape and maintaining the normal shape can be set very easily and accurately inside the stent.
[0024]
【The invention's effect】
As described above, the medical guide wire according to the present invention makes the insertion and passage of the guide wire for introducing and setting the catheter into the stenotic lesion more rapid and easy, and at the time of insertion and passage into the stenosis lesion. To ensure the flow of blood through the affected area, alleviate the pain and improve the treatment of patients with stenotic lesions, and further improve the therapeutic properties by enabling diameter expansion treatment of stenotic lesions with the guide wire itself . And the above-mentioned useful guide wire with a bulging part can be mass-produced and provided at low cost. There are the above various effects.
[Brief description of the drawings]
1A and 1B show a guide wire according to a first embodiment of the first invention, wherein FIG. 1A is a front view of a tip portion thereof, and FIG. 1B is a front view of a use state thereof. The bulge coil part of an example is shown, (A), (B), and the front view of (C). FIG. 3 shows the bulge coil part of the guide wire of one embodiment of the second invention. Front view, (B) and (C) are partial front views of other forms. FIG. 4 is an explanatory view of another form of the bulging coil portion of the guide wire according to the first and second inventions.
DESCRIPTION OF SYMBOLS 1 Guide wire 2 Tip part 3 Core material 4 Lead plug 5 Lead coil part 6 Swelling coil part 7 Subsequent coil part 8 Coil wire 9A and 9B Diameter gradually changing part 10 Stenosis lesion part 11 Coil core 12 Blood flow path 13 Neck part 15 Step 16 Balloon catheter 19 Spiral groove 20 Main coil spring 21 Sub coil spring 22 Spiral blood flow path D Coil outer diameter d Coil wire diameter

Claims (4)

In a medical guide wire including a distal end portion in which a coil spring is loosely fitted to a long flexible core material, the coil spring continues to a lead coil portion having a wire rod tightly wound thin coil outer diameter , and the lead coil portion. a bulging coil portion of the thick coil outer diameter, the evagination with subsequent coil portion of the subsequent coil portion diameter coil outer径密adhesive wound into a series, further evagination coil unit provided with a clearance between the coil wire A medical guide wire having a structure in which the outer shape is concentrically changed around a core material and wound in a substantially spindle shape .   The medical guide wire according to claim 1, wherein the coil wire of the bulging coil portion is a long taper coil wire having a diameter gradually increasing from the front to the rear. In a medical guide wire comprising a distal end portion in which a coil spring is loosely fitted to a long flexible core material, the coil spring has a leading coil portion having a thin coil outer diameter and a large coil outer diameter following the leading coil portion. comprising a bulging coil portion into a series, the coil portion out further bulging is formed in a substantially spindle-shaped, consists of small-diameter sub-coil wire than the main coil spring and the main coil wire mainly composed coil wire sub A spiral recess based on a difference in wire diameter between the main coil wire and the sub-coil wire, wherein the sub-coil wire of the sub-coil spring is interposed in the space between the main coil wires of the main coil spring. A medical guide wire characterized by a multi-spring structure having a groove on the outer periphery.   The bulging coil portion is connected in series via the neck portion, and the outer diameter of the coil gradually increases from the bulging coil portion at the front of the series linking to the bulging coil portion at the rear. Item 3. A medical guide wire according to Item 3.

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