JP2004089305A - Guide wire for medical use - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To improve the sensory feeling of a hand part 7 when a leading part 5 inserted into a blood vessel touches a lesion P or a blood vessel wall in a guide wire 1 for medical use of a thin and long flexible wire-like body from the leading part 5 to the hand part 7. <P>SOLUTION: The guide wire 1 for the medical use is in the structure of being divided into three zones of different lubrication degrees which are "a high lubricity zone H, a middle lubricity zone M and a low lubricity zone L" for which the outer periphery of the flexible wire-like body is divided in a length direction. <P>COPYRIGHT: (C)2004,JPO

Description

[0001]
TECHNICAL FIELD OF THE INVENTION
The present invention relates to a medical guidewire used to ensure the safety of insertion of a catheter when the catheter is introduced into a cardiovascular system or the like.
[0002]
[Prior art]
A medical guidewire (hereinafter, simply referred to as a guidewire) is inserted into a complex blood vessel or branch blood vessel which is formed into a very thin flexible striatum from the head and rotates a hand located outside the body. Pushing and pulling to advance the inside of the blood vessel, and confirming the visualization of the radiation projection image of the insertion progression and judging the combination of the sensory feeling transmitted to the proximal part, an insertion method that aims for proper intravascular progression and intravascular setting is adopted. Therefore, high quality with high flexibility and flexibility, high slidability in blood vessels, and the like are required.
[0003]
Therefore, as a guide wire 1A that meets the above required quality, there is a known example described in Japanese Patent No. 2516444 (see FIG. 4) in which only the surface portion of the distal end portion 3 is configured to have a surface exhibiting lubricity during lubrication.
[0004]
[Problems to be solved by the invention]
The above-described guide wire 1A having a lubricating form only at the distal end has the following difficulty in guiding the leading portion 5 inserted into the blood vessel from the insertion point 20 of the femoral artery 21 to the stenosis lesion P of the coronary artery. .
[0005]
That is, since the guide wire 1A of the elongated flexible wire is pushed and inserted into the meandering blood vessel by pushing and pulling from the leading portion 5 (see FIG. 4E), the operation efficiency E of the pushing or pulling operation is obtained. (Percentage ratio where the push-pull resistance in the blood vessel of the guide wire 1A is the numerator and the required push-pull force / pull force is the denominator) is a correlation number proportional to the total bending angle Σθ of the blood vessel in which the insertion proceeds. It shows a correlation line that inclines at an inclination angle θ in proportion to the increase of the total bending angle Σθ. The smaller the inclination angle θ, the smaller the increase in operating force is qualitatively, and the friction coefficient is specified by the inclination angle θ Is done.
[0006]
On the other hand, the curved form of the blood vessel tract into which the guidewire 1A is inserted has a great difference depending on each position zone, and the guidewire 1A in the illustrated "A zone from the insertion point 20 of the thigh to the lower chest 22 of the descending aorta" is shown. The total bending angle of the left main coronary artery 25 following the A zone is approximately 180 °, and the B zone following the A zone is approximately 320 ° through the aortic arch 23 to the ascending aortic left coronary artery entrance 24. , The C zone from the left turning branch 26 to the descending branch 27 is estimated to be approximately 400 °.
[0007]
Because of the total bending angle configuration for each zone as described above, the operation efficiency E of the push-pull operation of the guide wire 1A inserted from the femoral artery 21 and the leading portion 5 is set near the lesion P of the coronary artery is set. As shown in FIG. 4E, (A, B, and C in the figure are the A zone, B zone, and C zone, and the three correlation lines in the figure are those with high lubricity. Indicates a medium lubrication type B and a low lubrication type as a whole), the operating efficiency E decreases with the increase of the total bending angle Σθ in each of the A to C zones, and the inclination depends on the difference in lubrication performance. The angle θ is greatly different, resulting in various composite forms of the inclination angle θ.
[0008]
Therefore (see FIG. 4 (D)), the indentation pushing / pulling force of the guide wire 1A when the leading portion 5 is normally introduced into the true lumen of the blood vessel by the feeling of contact of the leading portion 5 with the lesioned part P is "variable as described above. Due to the complex existence of the operation efficiency E, an excessively large operation resistance is partially generated, and the delicate contact feeling of the head portion 5 is erased to hinder the operation feeling of the hand portion 7. Therefore, the head portion 5 is normal. The judgment of the hand portion 7 as to whether it is 5A in the proper true cavity introduction mode or the leading portion 5B of the defective position which is inserted into the intima 30 / media 31 is inconsistent, and the therapeutic property of the lesion P is impaired.
[0009]
In addition, the complex feeling of the various operation efficiencies E reduces the feeling of touch during the push / pull operation of the guide wire 1A. It is difficult to say that the “selective introduction of branch blood vessels” for properly selecting and introducing the head portion 5 into the intended blood vessel tract by a small difference in the contact resistance of the head portion 5 to the blood vessel wall by the push-pull operation is not good, and the treatment concerned Inhibits sex.
[0010]
The present invention provides a guide wire that solves the above-described drawbacks of the related art and further improves the guideability of the leading portion 5 into a blood vessel.
[0011]
[Means for Solving the Problems]
The guidewire of the present invention that solves the above technical problem is a high-lubricity medical guidewire of an elongated flexible linear body extending from the leading end to the proximal end, in which the outer periphery of the linear body is divided in the length direction. And a lubrication zone, a medium lubrication zone, and a low lubrication zone.
[0012]
That is, the medical guidewire of the present invention is changed from the “operation efficiency E in the case of performing the push-pull operation of the guidewire in the vascular insertion set state” shown in FIG. 4 (E) to the “A, B, and C zones of the guidewire”. And the inclination angle θ of the correlation line between the operation efficiency E and the total bending angle Σθ is made to approach zero as much as possible. This is intended to particularly improve the "feeling of the contact feeling between the leading portion and the blood vessel wall to the proximal portion in the inching and pulling operation."
[0013]
That is, as a supplement, in the case of the conventional structure having a uniform friction coefficient on the entire outer periphery, as shown in FIG. 4 (E), a constant inclination angle θ at which the operating force is increased by increasing the total bending angle Σθ is increased. Thus, even if the lubricating property of the outer periphery is improved, the inclination angle θ only becomes small and does not become zero.
[0014]
However, according to the present invention having the above-described configuration in which the lubricity and the coefficient of friction are configured differently for each zone, the influence of the total bending angle Σθ is made as small as possible, and the inclination angle θ is made as close to zero as possible. By this, the concept and structure of enhancing the "ability to detect abnormal peak value with constant operating force" by eliminating the significant difference in the operating force of each zone without being affected by the total bending angle ?? To do.
[0015]
Each of the three lubricating zones of high, medium and low is formed by applying a “hydrophilic polymer such as polyvinylpyrrolidone” to the outer periphery of the linear body constituting the guidewire body, and coating the hydrophilic polymer with a film thickness. The medium lubrication is achieved by partitioning into “high lubricating zone” or “medium lubricating zone” depending on the change in lubrication, or by applying a resin coating of a fluororesin or polypropylene with different lubricating properties. A lubricity zone and a low lubricity zone are formed.
[0016]
The lubricating zone groups having different lubricating degrees are arranged in an arrangement of a high lubricating zone, a medium lubricating zone, and a low lubricating zone in the direction of the hand, and the difference in the lubricating degree is referred to as “a hydrophilic polymer”. Or the presence / absence ", or a mode in which the difference in operation efficiency E between the high lubricity zone and the low lubricity zone is set to 10% or less.
[0017]
Note that the guide wire of the present invention is intended for all known forms, and there are the following exemplary changes. That is, "the distal end portion of the elongated flexible linear body has a structure in which a resin tube is attached to the outer periphery of the coil body, and a clearance between the coils is provided in the coil body, and a concave helical groove of the resin tube due to the clearance between the coils is provided. And a structure in which a hydrophilic polymer is applied to the recessed helical groove to form a high lubricity zone "or" a mode in which at least the low lubricity zone has a stranded wire form or a coil spring form whose outer periphery is exposed ".
[0018]
[Action]
In the medical guidewire of the present invention having the above-described configuration, in the state of insertion into a blood vessel in which the total bending angle Σθ changes as a large variable for each zone in the length direction, the operation efficiency E for each zone is made substantially constant, In addition, since the inclination angle θ of the correlation line between the operation efficiency E and the total bending angle Σθ has a characteristic approaching zero as much as possible, when the indentation push-pull operation is performed in the inserted state of the blood vessel, the push-pull abnormality at the full length point of the guide wire Since no value is generated and the operability exhibits a substantially uniform mode, the feeling of contact with the inner wall of the blood vessel at the head can be sharply sensed at the hand.
[0019]
Therefore, normal insertion of the true lumen at the head of the lesion and guidance for introduction of the head into the selected blood vessel path at the blood vessel bifurcation are extremely accurate and easy to operate.
[0020]
BEST MODE FOR CARRYING OUT THE INVENTION
First, a medical guidewire 1 (hereinafter, simply referred to as a guidewire 1) according to a first embodiment of the present invention will be described with reference to FIG. That is, in the guide wire 1 in which the entire length of the core material 2 of the thin metal wire is wrapped with the resin coating 6 and the flexible wire having a uniform outer diameter is formed from the leading portion 5 to the hand portion 7, the leading end including the leading portion 5 is formed. The outer periphery of the portion 3 is set to the high lubricity zone H, and the slightly longer outer periphery of the rear end including the hand portion 7 is set to the low lubricity zone L. The outer periphery of the intermediate portion is formed in a “three-zone outer peripheral form having different lubricity” set in the middle lubricity zone M.
[0021]
Specifically, the high lubricity zone H is lubricated with “18-20 micron film thickness of hydrophilic polymer (polyvinylpyrrolidone)” and the middle lubrication zone M is “5-10 micron film thickness of diluted hydrophilic polymer (polyvinylpyrrolidone)” The low lubricity zone L is formed by a lubricating film 8 made of fluororesin (PTFE).
[0022]
4 (B) and 4 (C), the leading portion 5 is inserted into the posterior descending branch 27 via the left main coronary artery 25 and the left circumflex branch 26 by inserting the leading portion 5 from the insertion point 20 of the femoral artery 21. 4C, the high lubricity zone H is located in the C zone shown in FIG. 4C, the middle lubricity zone M is also located in the B zone, and the low lubricity zone L is also located in the A zone. In a dimension, the high, middle, and low lubricity zones H, M, and L exhibit a substantially uniform operating efficiency E regardless of the increase in the total bending angle Σθ in the blood vessel in the set state. Have been.
[0023]
In this embodiment, the length 9 is 1,750 mm, the length of the high lubricity zone H is about 150 mm, and the length of the medium lubrication zone M is about 300 mm to 400 mm. Then, the lubricating coating 8 is “set to a required thickness by adjusting the passing speed at which the guidewire body passes through the liquid of a lubricating substance such as a polymer liquid, or by adjusting the number of passes (single or plural)”. It is set and provided by a known means or a known means of adjusting the coating thickness by adjusting the dilution degree of the hydrophilic polymer.
[0024]
Since the guide wire 1 of the above embodiment maintains a substantially uniform operation efficiency E in the blood vessel, when the hand portion 7 located outside the body is manually pushed and pulled in the insertion setting state in the blood vessel, FIG. As shown in (B), the operating force W of the guide wire 1 is substantially constant, so that the abnormal resistance 15 generated when the leading portion 5 contacts the blood vessel wall of the lesion P can be sensed very sharply.
[0025]
That is, since the operating force W of the conventional guide wire shown in FIG. 1 (C) gradually increases in proportion to the operating stroke S, the abnormal resistance 15 generated at the head 5 has its proportional gradual increase. Although only the removed hatched portion appears as a sensory-sensible resistance, the guide wire 1 of the embodiment of FIG. 1 essentially has the sensing performance of the hand portion 7 because the entire amount of the abnormal resistance 15 constitutes a sensory-sensing resistance. To improve.
[0026]
In this embodiment, the difference in operation efficiency E between the high lubricity zone H and the low lubricity zone L having the above configuration is within 10%, so that the operation efficiency E of the guidewire 1 as a whole is constant. Very well, the above-mentioned effect is particularly good.
[0027]
Because of the above-described specific actions, it becomes particularly easy to introduce the true lumen guide at the lesioned part P of the leading portion 5 and to arbitrarily select and proceed with a branch blood vessel that guides the leading portion 5 to a required blood vessel tract at the blood vessel bifurcation. Thus, the curability can be improved.
[0028]
The lubricating coating 8 of the high, middle, and low lubricity zones H, M, and L of the guide wire 1 of the above embodiment may be in the following mode in addition to the configuration described above. That is, "the high lubricity zone H has a thickness of 5 to 10 microns of a hydrophilic diluent polymer (polyvinylpyrrolidone), the middle lubricity zone M has a fluororesin (PTFE), the low lubricity zone L has a polyethylene or polyamide (12M) and Or its elastomer "or" the high lubricity zone H is a fluororesin (PTFE), the middle lubricity zone M is polyethylene or polyamide (12M) and its elastomer, and the low lubricity zone L is polypropylene or urethane and its elastomer. " Sometimes.
[0029]
Next, a guidewire 1 according to another embodiment of the present invention will be described with reference to FIGS. That is, FIGS. 2 and 3 show another embodiment of the guidewire 1 including the high lubricity zone H, the middle lubricity zone M, and the low lubricity zone L similar to the embodiment of FIG. (A) is a wrapping of a core material 2 having a stranded wire structure with a resin coating 6, in which three types of lubricity zones H, M, and L having different lubricity levels similar to those in the embodiment of FIG. A functional coating 8 is provided.
[0030]
2 (B) is a known type in which the close contact coil spring 12 is fitted only to the distal end portion of the metal core material 2, and the outer periphery of the close contact coil spring 12 is formed in the high lubricity zone H. At the same time, the latter half portion including the hand portion 7 is set as a “low lubricity zone L where the lubricating film 8 is present”, and an intermediate portion between the high lubricity zone H and the low lubricity zone L is the lubricating film 8 In the middle lubrication zone M.
[0031]
2 (C) shows a known form in which a single-turn coil spring 12 is fitted over the entire length of a fine-wire core material 2 and only the tip is bent in a U-shape. A lubricating film 8 is set and applied to the outer periphery of the lubricating zone 12, and the lubricating film 8 is divided and arranged in the direction from the head portion 5 toward the hand portion 7 into the high lubricating zone H and the middle lubricating zone M. The lubricating zone L has no lubricating coating 8.
[0032]
When the guidewire 1 shown in FIG. 2 functions according to each form, it can enjoy the above-described specific action due to the presence of the high, middle, and low lubricity zones H, M, and L.
[0033]
On the other hand, the one shown in FIGS. 3 (A) and 3 (B) has a coil spring 12 having a clearance 13 between the coils fitted on the tip end thereof, and a resin tube 14 (urethane) fitted on the outer periphery of the coil spring 12. In the “known form”, the resin tube 14 is recessed along the inter-coil clearance 13 to form a concave helical groove 16, and a lubricating film 8 of a hydrophilic polymer is provided and set on the outer periphery of the resin tube 14. Thus, it is formed in the high lubricity zone H similar to the embodiment of FIG.
[0034]
In the embodiment shown in FIGS. 3A and 3B, the recessed helical groove 16 functions as a pool portion and a passage for lubricant (lubricant when the catheter is fitted on the guide wire). The function of the sexual zone H can be further improved to stably maintain.
[0035]
3 (C) is a known type in which a rear end portion on the side of the hand portion 7 is fitted with a coil spring 12 which is tightly wound, and the outer periphery of the coil spring 12 has no lubricating coating 8 thereon. The low lubricity zone L is set, and other portions except the rear end portion are set to the high lubricity zone H and the middle lubricity zone M.
[0036]
In the embodiment shown in FIG. 3C, when the user inserts the blood into the blood vessel from the head portion 5 and operates the hand portion 7 located outside the body, the hand portion 7 is an exposed form of the coil spring 12 so that the manual operation can be performed. And the hand portion 7 is unlikely to slip, and the operation is easy and accurate. Then, when an operation tool (torquer) is engaged with the hand portion 7, the engaging force between the tool and the hand portion 7 is stabilized, and good operability of the guidewire 1 can be secured. In addition, the coil spring 12 may be either a single-winding coil or a multi-winding coil. The low-lubricity zone L without the lubricating coating 8 shown in FIGS. 2. A form in which a conventionally known resin coating for ensuring slippage in a blood vessel, which is commonly used as a conventional guide wire, is applied to the outer periphery of the core material 2 and the outer surface of the coil spring 12 instead of the outer periphery of the bare skin of the coil spring 12. Means.
[0037]
On the other hand, the one shown in FIG. 3 (D) is a known type comprising a twisted wire-shaped hand portion 7 in which a group of wires 18 are tightly twisted and a hollow portion 19 is provided at the center portion. The outer periphery of the portion 7 is set in the low lubricity zone L where the lubricating film 8 is not present. In FIG. 3D, the operability is stable because the concave helical groove 16 appears on the outer periphery of the hand portion 7, and there is no gap between the wires 18 because the wires 18 are in a tight spiral shape. It becomes easy to rotate and press.
[0038]
Note that the guide wire of the present invention is not limited to the above embodiment, and it is sufficient that the operation efficiency E is substantially constant over the entire length of the guide wire and the inclination angle θ is close to 0. A “cognition marker by radiation projection” may be installed internally at the tip.
[0039]
Furthermore, the three types of lubricity zones having different lubrication levels of the guide wire according to the present invention do not necessarily have to be arranged in a “high / middle / low” order from the head 5 to the hand 7, and may be inserted into the body cavity. In the insertion set state, it is only necessary to have the technical idea that "each zone of the entire length has a substantially uniform operation efficiency E and maintains the operation force of the reciprocating operation in the body cavity substantially constant". Thus, for example, an arrangement of “middle / high / low” from the head portion 5 to the hand portion 7 may be used.
[0040]
【The invention's effect】
As described above, the medical guidewire of the present invention is useful in that the contact sensing information on the blood vessel wall / lesion at the leading end inserted into a blood vessel is particularly refined and the therapeutic stability is particularly improved. effective.
[Brief description of the drawings]
1A and 1B show a medical guidewire according to a first embodiment of the present invention, in which FIG. 1A is an overall front view, FIG. 1B is an explanatory view of an operation state of the medical guidewire in FIG. 1A, and FIG. FIG. 2 shows a medical guidewire according to another embodiment of the present invention, and FIG. 3 (A), (B), and (C) are front views thereof. FIG. 3 shows another embodiment of the present invention. (A) is a partial front view thereof, (B) is an enlarged partial view of (A), (C) is an overall front view thereof, and (D) is a partial perspective view thereof. 2A shows a conventional medical guide wire, FIG. 2A is an overall front view, FIG. 2B is an explanatory view of a state of insertion set in a blood vessel in FIG. 1A, FIG. 2C is a partially enlarged view of FIG. (E) is an explanatory view of the operation state.
DESCRIPTION OF SYMBOLS 1 Medical guide wire 1A of the present invention Conventional medical guide wire 2 Core material 3 Tip part 5 Head part 6 Resin coating 7 Hand part 8 Lubricity coating 12 Coil spring 13 Coil clearance 15 Abnormal resistance 16 Depressed helical groove 20 Insert Point 21 Femoral artery L Low lubricity zone M Medium lubricity zone H High lubricity zone P Lesions E Operation efficiency W Operation force S Operation stroke Σθ Total bending angle θ Tilt angle

Claims (7)

In a medical guidewire of an elongated flexible striated body extending from a head to a hand, a high lubricity zone, a middle lubricity zone, and a low lubricity zone in which the outer periphery of the linear body is divided in the length direction are different. A medical guidewire characterized by a structure configured in three zones of lubrication. The medical guidewire according to claim 1, wherein the medical guidewire has an arrangement of a high lubricity zone, a medium lubricity zone, and a low lubricity zone in the direction from the head to the hand. 3. The medical guidewire according to claim 1, wherein the difference in lubricating degree comprises a difference in film thickness of the hydrophilic polymer. The medical guidewire according to any one of claims 1 to 3, wherein different degrees of lubrication are defined by the presence and absence of the hydrophilic polymer coating. The medical guidewire according to any one of claims 1 to 4, wherein a difference in operation efficiency between the high lubricity zone and the low lubricity zone is 10% or less. The distal end portion of the elongated flexible linear body has a structure in which a resin tube is attached to the outer periphery of the coil body, a clearance between the coils is provided in the coil body, and a concave helical groove of the resin tube is provided by the clearance between the coils, The medical guidewire according to any one of claims 1 to 5, comprising a structure in which a hydrophilic polymer is applied to the concave helical groove to form a high lubricity zone. The medical guidewire according to any one of claims 1 to 6, wherein at least the low lubricity zone is in the form of a stranded wire or a coiled wire having an exposed outer periphery.

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