JP2001327606A - Medical insertion wirework - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medical insertion wirework, properly flexible corresponding to various curved portions existing in blood vessels, capable of pushing in the blood vessels, without buckling, and controllable transfer of substantially all rotation, given to the base end, to the front end, and superior in tactile reaction permitting a phenomenon happing at the front end to be sensed at the base end. SOLUTION: The medical insertion wirework comprises a core having a plurality of core wirework main wire portions and wirework intermediate portions for connecting the core wirework main wire portions. The intermediate portion of the core wirework has smaller bending rigidity than the main wire portion at its terminal connected to the intermediate portion.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical penetrating body, and more particularly, to a medical procedure requiring operation through a complicated vascular route, such as percutaneous transluminal main coronary angioplasty (PTCA). The present invention relates to a medical insertion wire that can be used.

[0002]

2. Description of the Related Art In PTCA procedures for dilating a stenotic region of the main coronary artery to increase blood flow through the annular artery, generally a medical tubular device, such as a catheter, is placed in the percutaneous puncture of the femoral artery. This is advanced and the tip of the medical tubular device is placed at the entrance of the stenotic main coronary artery. With the medical tubular device properly positioned, a balloon dilatation catheter is inserted through the medical tubular device to reach the entrance of the main coronary artery and into the entrance. Balloon dilatation catheters are commonly used in conjunction with medical traversals that can be steered into selected arterial branches and through stenosis to be dilated.
After the medical insertion wire is steered and guided in place, the balloon catheter is pushed along the medical insertion wire around the medical insertion wire, and the balloon in the contracted state is moved to the above-mentioned state. Place in the stenosis.

[0003] The balloon is then inflated to dilate the stenotic region of the artery.

There are various difficulties in designing steerable medical inserts for use in PTCA. Such difficulties result from the arterial structure of the human body from the normal puncture point, which is the femoral artery in the groin area, to the main coronary artery, including the main coronary artery.

A portion of the arterial structure is shown somewhat schematically in FIG. 1 with a portion omitted.

[0006] The arterial structure extending from the aortic valve 25 comprises, on its downstream side, an upward portion 26 of the main coronary artery, an aortic arch generally designated 27 and the remainder of the main coronary artery (lower portion). Facing portion 18). Many arterial branches
Diverging from the main coronary artery, into internal organs of the human body, and
Including a iliac artery 17 and a femoral artery 19 that directs blood to the legs,
Carry blood to limbs and limbs. The main coronary artery system that returns oxygenated blood to heart tissue (a portion of which is
0 itself), which has two main arteries, a left main coronary artery 21 and a right main coronary artery 22, both of which are close to the aortic valve 25. From the upward portion 26 of the aorta. The main coronary arteries 21, 22 on each of the left and right sides are connected to a system of various arteries. Some of these bifurcated arteries are indicated schematically at 20A, 20B, 20C, 20D and extend over the walls of the myocardium and serve to distribute oxygenated blood throughout the myocardium. .

[0007] Thus, a stenosis that impedes the flow of blood through an artery may, for example, be present in the main coronary system (eg, FIG.
(Position 23), the medical tubular device enters the blood vessel from the thigh and enters the femoral artery 19, the inferior portion 18 of the main coronary artery, and the upward portion of the main coronary artery. 2
6, the distal end abuts on the entrance of the main coronary artery 21 and the medical insertion wire is passed through the greatly curved medical tubular device, and the distal end is inserted into the entrance of the main coronary artery 21. , And further into the small-diameter main coronary artery 21 to reach the stenosis.

[0008] For this reason, a number of characteristics are required of the medical insertion wire so that its function can be effectively exhibited. That is, the medical penetrator has adequate longitudinal flexibility so that it can conform to various bends present in the patient's arteries, including frequent and large tortuous main coronary artery configurations. Need to have The medical traversal line must have adequate longitudinal strength so that it can be pushed in without buckling as it is advanced through the artery. The medical penetrator must have sufficient torsional stiffness to be able to controllably steer, so that substantially all of the rotation imparted to its proximal end
It can be controllably transmitted to its tip. The distal tip of the medical penetrator needs to be flexible to reduce the risk of damaging the delicate inner lining of the artery. The medical insertion wire is also a kink (ki)
nk), that is, kink resistance. Kinking of medical insertion wire (kinkin)
g) (Permanent set) generally results in uncontrolled rapid and abnormal movement of the distal tip of the medical penetrator, rather than a controlled and desired transmission of rotation. Further, it is desirable that the distal tip of the medical insertion wire has high radiopacity so that its movement and position can be easily observed by fluoroscopy. Also important among the characteristics of the medical penetrator is that the physician has a good tactile response at the proximal end of the medical penetrator so that he can feel the event occurring at the tip. .

[0009] Since the first development of steerable medical inserts (Leary, US Patent No. 4,545,390), some of the medical inserts developed above that are desirable are described above. There is no medical insert that has all of the properties.

For example, nitinol
A medical insert formed from a quasi-elastic material such as an alloy provides a desirable distal tip having excellent kink resistance and flexibility. A representative example of such a medical insert is US Pat. No. 4,925,445 (Sakamoto:
Sakamoto). However,
The advantage of such a quasi-elastic medical penetrator is about 0.3
56mm (0.014 inch) to about 0.254mm
(0.010 inches), a type of medical insert currently used for PTCA, has been achieved at the expense of other desirable properties. That is, the other desirable performance of the pseudoelastic medical insertion wire is sufficient when the diameter is large, but the diameter is about 0.3 mm.
When it is less than 56 mm (0.014 inch), it becomes insufficient. In particular, the strength in the longitudinal direction of the medical insertion wire and the function of being able to push without causing buckling are reduced to such an extent that they cannot withstand actual use. Similarly, about 0.356
Pseudoelastic medical inserts having a diameter on the order of mm (0.014 inch) or less, and made for use in PTCA, tend to exhibit poor handling characteristics that are unacceptable for practical use. is there. Such drawbacks also reduce the tactile response properties of the wire.

As a medical insertion wire having the above characteristics in a well-balanced manner, there is a medical insertion wire described in Japanese Patent Application Laid-Open No. 8-510394, which is made of a different material. Since it is necessary to join a plurality of members by a special method, there is a disadvantage that the manufacturing method is complicated and the cost is increased.

In medical treatments other than PTCA, a medical insertion wire that can be effectively operated in a complicatedly curved blood vessel is extremely useful, and its development has been desired.

[0013]

SUMMARY OF THE INVENTION The present invention provides a function that can be pressed without buckling into a blood vessel with appropriate flexibility so that it can conform to various curves present in the blood vessel. A good haptic response that can controllably transmit substantially all of the rotation imparted to the proximal end to the distal end and can sense events occurring at the distal end at the proximal end An object of the present invention is to provide a medical insertion wire having:

[0014]

SUMMARY OF THE INVENTION The present invention for solving the above-mentioned problems is characterized in that a plurality of core wire main wires are provided between the core wire main wires, and the bending rigidity of the core wire main wires is smaller than that of the core wire. And a medical wire insertion body characterized by comprising a formed core wire intermediate part, and in a preferred aspect of the present invention, the core wire body intermediate part is provided on the core wire body intermediate part. The continuous core body has a small diameter portion having a diameter smaller than the end of the main wire portion. In another preferred aspect of the present invention, the core wire intermediate portion is a core wire continuous with the core wire intermediate portion. In a further preferred aspect of the present invention, a small-diameter portion having a smaller diameter than the end portion of the body main line portion and a spiral convex portion provided on the surface of the small-diameter portion are provided. Is smaller than the diameter of the core wire main wire portion. A plurality of independent recesses having different diameters. In another aspect of the present invention, the core wire main wire portion is formed by surface hardening at least a part of the core wire intermediate portion. In a further aspect of the present invention, there are at least two intermediate portions of the core wire.

[0015]

BEST MODE FOR CARRYING OUT THE INVENTION A medical insertion wire according to the present invention has a core having a core main part and a core intermediate part. Furthermore, in the medical insertion wire according to the present invention, a helical wire can be attached to a tip of the core wire.

[0016] The core wire, that is, the core wire, is a medical tubular device inserted into a blood vessel from a predetermined part of a human body,
That is, it is a member that is inserted into the catheter, the tip of which reaches the diseased part, performs predetermined treatment, or guides the balloon catheter to the diseased part.

The length of the core wire is not particularly limited as long as the object of the present invention can be achieved, but is preferably 0.3 to 3 m in consideration of operability and the like.
More preferably, it is 1-2 m.

[0018] It is preferable that the core wire is designed so that its diameter becomes smaller as a whole toward the distal end so that the core wire can smoothly advance inside the medical tubular device.

The core wire has a core wire main wire portion and a core wire intermediate portion.

A plurality of the core wire main wires are present in the core wire, and are formed so as to sandwich the core wire intermediate portion.

The core wire main wire portion is a portion for imparting a predetermined rigidity to the medical insertion wire according to the present invention. The medical insertion wire according to the present invention has a function of being able to be pushed through a blood vessel without buckling by having the core wire main portion, and substantially all rotations given to the proximal end are provided. Can be controllably transmitted to the distal end, and a good tactile response at which the event occurring at the distal end can be felt at the proximal end can be ensured.

The core wire main wire portion is not particularly limited as long as its bending strength satisfies conditions such as the rigidity and flexibility required for the medical insertion wire according to the present invention. , For example, 150 to 400 gr.

The cross-sectional shape of the core wire main line portion is not particularly limited as long as the object of the present invention can be achieved, and is usually circular, elliptical, square, rectangular, or the like. It is.

The length of the core wire main line portion is not particularly limited as long as the object of the present invention can be achieved, and is appropriately determined depending on the number of the core wire intermediate portions, the position of the core wire intermediate portion, and the like. Can be determined.

In the case where the core body is designed so that the diameter becomes smaller as a whole toward its tip, the core body main line at the tip end side of the core body among the plurality of core wire main lines. The diameter is designed to be small. Note that, in this case, since the core wire body only needs to be tapered as a whole to the distal end portion, it is not necessary that all the core wire main wire portions in the core wire body are gradually tapered toward the distal end. That is, all of the core wire main line portions may be gradually tapered toward the distal end at a fixed rate, and the core wire main line portions disposed on the distal end side are formed in a tapered shape, and other The core wire main wire portion of the portion may have a constant diameter. Further, the portion formed thinner toward the tip of the core wire main line portion does not need to be tapered at a fixed rate, and may be formed stepwise by having a step.

A helical wire can be attached to the core wire main line portion located at the front end as described above. In this case, the tapered portion can be a helical wire mounting portion, and the helical wire can be mounted on the helical wire mounting portion. In other words, in this case, the core wire main line portion located at the tip has a core wire main wire portion main body and a spiral wire body mounted portion which are portions other than the spiral wire mounted portion, and Is a helical wire body mounting portion.

In the core wire main wire portion having the helical wire mounting portion, the core wire serving as the helical wire mounting portion and the core wire main body are separately formed, and thereafter, the helical wire mounting portion is formed. The core can be formed by integrally connecting the core wire and the core wire main body, or by processing a core wire material to be a core wire main wire portion, and drawing or shaving the tip portion to form a spiral. It is also possible to form a wire receiving portion. A preferred core wire body is formed by integrally forming the spiral wire body mounting portion and the core wire body from the beginning.

[0028] The diameter of the core wire main wire portion is small enough that the core wire can smoothly move inside the medical tubular device, and the tip of the core wire is inserted into the medical tubular device with a predetermined diameter. There is no particular limitation as long as it satisfies the condition that the rigidity of the medical insertion wire is large enough to be able to be sent to the position. The core wire main line other than the core wire main line disposed at the forefront has a diameter of, for example, 0.2 to 2 mm.

When the core wire main wire portion located at the tip is not provided with the spiral wire body mounting portion, the diameter of the core wire main wire portion is, for example, 0.2 to 2 mm. If it has, the diameter of the portion other than the helical wire mounting portion is, for example, 0.2 to 2 mm, and the diameter of the tip of the helical wire mounting portion is, for example, 0.05 to 0.3 mm.

The material of the main body of the core body is not particularly limited as long as the object of the present invention can be achieved. For example, it can be formed of a metal material such as a stainless alloy and a Ni-Ti alloy. . Further, the core wire main wire portion may be formed by hardening the surface of a wire made of these alloys, as described later.

The core wire intermediate portion is a portion sandwiched between the core wire main wire portions at both ends thereof and connected thereto.
That is, the core body is configured by connecting a plurality of the core body main lines at the core body intermediate portion.

The intermediate portion of the core wire is set to have a lower bending rigidity than the portion of the main wire portion connected to the intermediate portion of the core wire. In other words, in the core body according to the present invention, the part having a lower bending strength than the parts adjacent to the base end side and the distal end side is the core body middle part, and the part connected to the core body middle part is the core body main line. Department.

The core wire intermediate portion is a portion for imparting a predetermined flexibility to the medical insertion wire according to the present invention. The medical insertion wire according to the present invention, having the core wire intermediate portion, has an appropriate flexibility that can be deformed in response to frequent and large winding various curved portions existing in the blood vessel. Can be secured. In other words, the medical insertion wire according to the present invention can easily bend in the blood vessel that is curved in a complicated manner by easily bending in the middle portion of the core wire body in the blood vessel.

The bending rigidity of the intermediate portion of the core wire is not particularly limited as long as the function required for the medical insertion wire according to the present invention can be ensured. For example, the bending rigidity of the main wire portion of the core wire is not limited. From 30 to 95%, particularly preferably from 50 to 80%. The object of the present invention is particularly effectively achieved when the bending rigidity of the intermediate portion of the core wire is within the above range.

The length of the intermediate portion of the core wire is not particularly limited as long as the object of the present invention can be achieved, but is preferably 50 to 800 mm. When the length of the intermediate portion of the core wire is within the above range, the rigidity and flexibility required for the medical insertion wire of the present invention can be ensured in a well-balanced manner.

The number of the core wire intermediate portions is not particularly limited as long as the object of the present invention can be achieved. Since the medical insertion wire according to the present invention has a larger number of intermediate portions of the core wire body, it has more easily bendable portions, so that it smoothly proceeds in a more complicated blood vessel or a medical tubular device. Becomes possible. For example, PTC
Regarding the medical insertion wire for A, the number of intermediate portions of the core wire is two or more in consideration of the shape of the blood vessel path from the insertion portion of the medical insertion wire into the blood vessel to a predetermined position of the heart. It is preferred that Further, when the number of the core wire intermediate portions is large, the rigidity of the medical insertion wire is reduced. Therefore, the number of the core wire intermediate portions is a balance between the flexibility and the rigidity required for the medical insert wire. Is determined based on

The position of the core body where the core body intermediate portion is provided is not particularly limited as long as the object of the present invention can be achieved, and may be in the shape of a blood vessel or a medical tubular tool through which the medical insertion wire is inserted. It can be determined appropriately depending on the situation. For example, in the case of a medical insertion line for PTCA, considering the shape of the blood vessel path from the insertion portion of the medical insertion line into the blood vessel to a predetermined position of the heart, the core line intermediate portion is At least 40 to 90 cm from the tip of the core wire, and 100 to 15 from the tip of the core wire.
It is preferable that one or more is provided at a position of 0 cm.

The structure of the intermediate portion of the core wire is not particularly limited as long as its bending rigidity is smaller than the bending rigidity of the main wire portion of the core wire and other conditions are satisfied.

As the core wire intermediate portion, for example, a portion having a portion (hereinafter, referred to as a "small diameter portion") formed to have a smaller diameter than a portion of the core wire main wire portion connected to the core wire intermediate portion, And a portion formed of a material having a lower bending rigidity than the core wire main line portion (hereinafter, referred to as a “material difference portion”).

As the shape of the intermediate portion of the core wire having the small diameter portion, for example, the shapes shown in FIGS. 2 includes a small-diameter portion 38 and a tapered portion 39. The small diameter portion 38 has a columnar shape and has tapered portions 39 at both ends thereof, and the tapered portion 39 is connected to the core wire main wire portion 40. The core wire body intermediate portion 43 shown in FIG. 3 has a shape that becomes thinner while bending from a joint portion with the core wire body main wire portion 40. In the core wire intermediate portion 43, the core wire intermediate portion 43 itself corresponds to the small diameter portion. The core wire body intermediate portion 44 shown in FIG. 4 is provided on the surface of the cylindrical small-diameter portion 41 and the small-diameter portion 41.
And a helical convex portion 46 having the same diameter as zero.
A core wire intermediate portion 45 shown in FIG.
And an annular convex portion 48 provided on the surface of the small diameter portion 47 and having the same diameter as the core wire main line portion 40. In other words, the core body intermediate part 45 has a plurality of independent recesses having a diameter smaller than the diameter of the core body main line part 40. When one core wire has two or more core wire intermediate portions, two or more of the small diameter portions can be used in any combination.

In the middle portion of the core body having the small diameter portion, it is preferable that a portion having a smaller diameter than the main line portion of the core body, that is, a concave portion in FIGS. 2 to 5 is not formed at an acute angle. Further, it is particularly preferable that the concave portion is not formed so as to have a fixed angle, but is formed by a curved surface so as not to generate an angle. When the concave portion or the like is formed in an acute angle, when the medical insertion wire is curved, a crack or the like is easily generated from the concave portion or the like, and when the medical insertion wire is formed by a curved surface so as not to generate a corner, This is because cracks and the like hardly occur.

In the core body provided with the core body middle part having the small diameter portion, the core body main part and the core body middle part are separately formed, and then the core body main part and the core body middle part are formed. Can be formed by joining together,
For the core wire material to be made into a core wire, a portion where the core wire intermediate portion is to be provided is drawn or cut out to provide a core wire intermediate portion, and at the same time a portion continuous to both ends of the core wire intermediate portion It can also be formed by providing a core body main wire portion on the main body. A preferred core wire body is formed by integrally forming the core wire main wire portion and the core wire body intermediate portion from the beginning.

When the core wire main portion and the core wire intermediate portion are formed as an integral body from the beginning, the material of the core wire main wire portion and the material of the core wire intermediate portion are usually the same, but the material of the core wire main wire is usually the same. When the portion and the core wire intermediate portion are formed separately and then integrally formed, the material of the core wire main wire portion and the core wire body intermediate portion may be the same, and the material of the core wire body intermediate portion may be the same. The bending stiffness may be different as long as it is smaller than the bending stiffness of the core wire main line portion.

The intermediate portion of the core having a small diameter portion is suitable in that the intermediate portion of the core can be formed by a usual mechanical working method, and the core can be manufactured from a single material. .

The material of the different material portion is not particularly limited as long as the bending stiffness of the intermediate portion of the core wire is smaller than the bending stiffness of the main wire portion of the core wire and other conditions satisfying the object of the present invention are satisfied. . The shape of the material different portion, the bending rigidity of the intermediate portion of the core body can be made smaller than the bending rigidity of the main wire portion of the core body, and other restrictions are not particularly limited as long as the conditions for achieving the object of the present invention are satisfied. Instead, for example, the shape can be the same as the shape of the core wire intermediate portion shown in FIGS.

In the case where the intermediate portion of the core wire is the material different portion, the core wire main portion and the core wire intermediate portion are usually formed separately, and then the core wire main wire portion is formed. It can be formed by integrally connecting the core wire intermediate portion.

Further, as a method of manufacturing a core body in the case where the intermediate part of the core body is the different material part, a surface hardening treatment is performed on a core material to be made into a core body except for a part where the core body intermediate part is to be provided. (Hereinafter, referred to as “curing treatment forming method”). According to this method, the portion subjected to the surface hardening treatment becomes the core wire main line portion, and the portion not subjected to the surface hardening treatment becomes the core wire intermediate portion. In this case, as a result, the intermediate portion of the core body is formed of a material having a lower bending rigidity than the main wire portion of the core body, so that it becomes a material different portion.

The method for manufacturing a core body using the above-described curing treatment forming method is preferable in that the core wire main line portion and the core wire body intermediate portion can be formed as an integral body from the beginning, and the manufacturing process is simple. is there.

Further, when performing medical treatment using the medical insertion wire, the bending and torsional stresses applied to the core wire are maximized on the surface thereof. Only the surface of the wire that has been subjected to the surface hardening treatment is hardened, and the internal structure of the wire does not change. Therefore, the toughness based on the internal structure of the wire is maintained. Therefore, the core wire body manufactured by using the above-mentioned hardening treatment forming method has a characteristic that it has high resistance to bending stress and torsional stress received during a medical treatment, is strong, and is hard to break. Further, according to the hardening treatment forming method, it is possible to improve the wear resistance of the core wire and extend the fatigue life.

There is no particular limitation on the material of the core material used in the hardening treatment forming method as long as the object of the present invention can be achieved. In the hardening treatment forming method, the material of the core wire material is used as it is as the material of the intermediate portion of the core wire body. Therefore, when a material having high bending strength is used as the core wire material, the flexibility of the medical insertion wire body is reduced. Therefore, the material of the core wire material used in the hardening process is usually Ni-
It is preferable to use a relatively soft metal such as a Ti alloy.

As the method of the surface hardening treatment, a known metal surface hardening method can be used, and examples thereof include nitriding, carburizing and quenching, surface quenching, embossing, shot peening, PVD, and CVD. it can. Among these, nitriding is easier than other methods in selective treatment of a specific part of the core wire material, the processing operation is simple, and the core wire having a large surface hardness, abrasion resistance, and corrosion resistance. It is particularly suitable in that a body is obtained.

Therefore, in manufacturing a core wire by a hardening process, a method of nitriding a core wire material such as a Ni-Ti alloy is most preferable. The core wire thus obtained has a core wire main wire portion, which is a wire having a nitride layer on the surface of a Ni-Ti alloy or the like, at both ends of a core wire intermediate portion such as a Ni-Ti alloy. It has a concatenated structure.

As a method of subjecting the core wire material to a surface hardening treatment at a portion other than the portion where the core wire intermediate portion is to be provided, a portion where the core wire intermediate portion is to be provided is masked, and only the portion other than the portion is subjected to the surface hardening treatment. Methods and the like can be mentioned.

In the case where there are two or more core wire intermediate portions in the core wire, some of them may be formed as small diameter portions and others may be formed as different material portions.

The helical wire is a coil formed by spirally forming a wire, and is wound around the helical wire mounting portion. This helical wire gives the distal end of the medical insertion wire a moderate flexibility and rigidity.

The cross-sectional shape of the wire forming the helical wire is not particularly limited as long as the object of the present invention can be achieved, but the helical wire is mounted on the helical wire mounting portion. It is preferably rounded and generally circular or oval, so that the medical insert or guidewire can travel smoothly through the medical tubular device and blood vessel. However, in some cases, the cross-sectional shape of the wire forming the spiral wire, that is, the coil, may be rectangular or rectangular. Such wires are sometimes referred to as flat wires.

When the cross section of the wire forming the helical wire is circular, the diameter of the wire is not particularly limited as long as the object of the present invention can be achieved. , And 50 to 100 μm.

When the wire forming the helical wire is a flat wire, its thickness is preferably 10 to 50 μm, and its width is preferably 50 to 300 μm.

The length of the helical wire is not particularly limited as long as the object of the present invention can be achieved. When the helical wire is mounted on the core wire, the length of the helical wire, The axial length of the coil is 60 to 1000
mm.

The diameter and pitch of the coil may be the same as those of a conventional medical insertion wire. For example, the diameter can be 0.05-1 mm and the pitch can be 1-2 times the diameter of the wire.

The material for forming the helical wire and the method for manufacturing the helical wire itself are known, and thus are based thereon.

FIG. 6 is a schematic explanatory view of a medical insertion wire 1 which is a specific example of the medical insertion wire according to the present invention.
The medical insertion wire 1 is a guide wire for PTCA. In addition, the medical insertion wire 1 has two core wire intermediate parts, and does not have a spiral wire. Therefore, in the medical insertion wire 1, the medical insertion wire and the core wire are the same.

The medical insertion wire 1 includes a first core wire main line portion 2, a second core wire main line portion 3, a third core wire main wire portion 4, a first core wire intermediate portion 5, and a second core wire intermediate portion. 6.

In the medical insertion line 1, the first core wire main wire portion 2 is disposed closest to the proximal end, and the first core wire main wire portion 2
Is connected to the first core wire intermediate portion 5. The second core wire main wire portion 3 is connected to the distal end side of the first core wire intermediate portion 5,
The second core wire intermediate portion 6 is connected to the second core wire main wire portion 3. Further, a third core main line portion 4 disposed at the most distal end of the medical insertion wire 1 is connected to the distal end of the second core intermediate portion 6.

Each of the first core wire main line portion 2, the second core wire main line portion 3, and the third core wire main line portion 4 has a circular cross section orthogonal to the axis. The first core wire main line portion 2 has a certain diameter, and the second core wire main wire portion 3 and the third core wire main wire portion 4 have a constant diameter from the base end to the tip end. The size is getting smaller. In addition, the first core wire main wire portion 2
And the diameter of the proximal end of the second core wire main wire portion 3 are the same size, the diameter of the distal end of the second core wire main wire portion 3 and the proximal end of the third wire main wire portion 4 are the same. The diameter of the end is the same size. As described above, the medical insertion wire 1 has a shape such that the diameter becomes smaller as a whole from the base end side to the distal end side.

The first core wire middle part 5 and the second core wire middle part 6 are core wire middle parts having the small diameter portions.

The first core wire intermediate portion 5 includes a small diameter portion 7, a tapered portion 8 and a tapered portion 9. The small diameter portion 7 is a columnar portion having a certain diameter, and is smaller than the diameter of the distal end of the first core wire main line 2 and the diameter of the proximal end of the second core wire main wire 3. Also have a small diameter.
The tapered portion 8 is located between the first core wire main wire portion 2 and the first core wire intermediate portion 5, and the tapered portion 9 is provided on the first core wire main wire portion 2.
And the second core body main wire portion 3.

The intermediate portion 6 of the second core wire has the same structure as the intermediate portion 5 of the first core wire, and includes a small diameter portion 12, a tapered portion 13 and a tapered portion 14. The small diameter portion 12 is a cylindrical portion having a certain diameter, and is smaller than the diameter of the distal end of the second core wire main line 3 and the diameter of the proximal end of the third core wire main line 4. Also have a small diameter. The tapered portion 13 is located between the second core wire main line portion 3 and the second core wire intermediate portion 6, and the tapered portion 16 is formed between the second core wire intermediate portion 6 and the third core wire main line portion 4. Located between.

First core body main line portion 2, second core body main line portion 3
And the third core body main wire portion 4 has a shape that becomes thinner from the base end side toward the front end side as described above, so that the diameters of the small diameter portion 7, the tapered portion 8, and the tapered portion 9 are the small diameter portion 12,
It is smaller than the diameters of the tapered portions 13 and 14.

The diameter of the small diameter portion 7 is 0.3 mm, and the diameter of the small diameter portion 12 is 0.3 mm. The length of the small diameter part 7 is 150
mm, and the length of the small diameter portion 12 is 350 mm. The diameter of the distal end of the first core wire main line portion 2 and the diameter of the proximal end of the second core wire main wire portion 3 are 0.34 mm, and the diameter of the distal end of the second core wire main wire portion 3 is: And the diameter of the proximal end of the third core body main wire portion 4 is 0.3
2 mm, and the diameter of the distal end on the third core wire main wire portion 4 is 0.05 mm. 1st core body main line part 2, 2nd
The lengths of the core body main line portion 3 and the third core body main line portion 4 are 44 cm, 30 cm, and 36 cm, respectively. Further, the first core wire main line portion 2, the second core wire main line portion 3, the third core wire main line portion 4, the first core wire intermediate portion 5, and the second core wire intermediate portion 6
Is made of stainless steel.

The bending rigidity of the first core wire intermediate portion 5 is 220
g, and the bending rigidity of the end portion 7 of the first core body main wire portion 2 which is a portion connected to the first core body intermediate portion 5 is 26.
The bending stiffness of the end of the tapered portion 8 which is the portion of the second core main line 3 connected to the first core intermediate 5 is 300 g. That is, the first core wire intermediate portion 5
Has lower bending stiffness than the connection end portions 11 and 10.

Similarly, the bending rigidity of the second core wire intermediate portion 6 is 180 g, and the second core wire main wire 3 has the second rigidity.
The bending stiffness of the end portion 15 that is a portion connected to the core wire intermediate portion 6 is 220 g, and the bending stiffness of the end portion 16 of the third core wire main wire portion 4 that is connected to the second core wire intermediate portion 6. Is 200 g. That is, the bending rigidity of the second core wire intermediate portion 6 is smaller than that of the end portions 15 and 16.

The location of the first core wire intermediate portion 5 is as follows:
It is a position of 100 to 150 cm from the tip of the core wire, and the position of the second core wire intermediate portion 6 is 40 mm from the tip of the core wire.
９０90 cm. The above dimensions of the medical insertion wire are merely examples, and various design changes can be made as long as the object of the present invention can be achieved.

The medical insertion wire according to the present invention operates as follows.

The medical insertion device is inserted from a predetermined position of the human body into, for example, a medical tubular device inserted into a blood vessel, and is advanced through the medical tubular device. Since the core wire main line portion of the medical insertion wire according to the present invention has appropriate flexibility and rigidity, the medical insertion wire may be bent when it is inserted through a medical tubular tool or a living tissue. And a smooth insertion progress is realized. Further, since the medical insertion wire has a predetermined rigidity as described above, when feeding the medical insertion wire into the medical tubular tool, the medical insertion wire is inserted into the medical tubular tool. , And the force applied to the medical insertion wire is reliably transmitted to the distal end thereof, and the medical insertion wire can be inserted over a long section. With respect to the medical insertion wire 1, the rigidity is secured by the first core wire main line 2, the second core wire main wire 3, and the third core wire main wire 4, and the medical insertion wire 1
As described above.

Further, since the medical insertion wire according to the present invention has a core wire intermediate portion having bending rigidity smaller than that of the core wire main wire portion, the medical insertion wire is easily bent at the core wire intermediate portion. . In other words, the flexibility of the medical insertion wire according to the present invention is further enhanced by the presence of the core wire intermediate portion. Therefore, when the medical insertion wire advances through the medical tubular device, the medical insertion wire can be appropriately bent at the core wire intermediate portion depending on the shape of the medical tubular device, that is, the shape of the blood vessel. Even in a complicatedly curved blood vessel, the medical penetration wire effectively advances. With regard to the medical insertion wire 1, the medical insertion wire 1 is easily bent at the core wire intermediate portion 5 and the core wire intermediate portion 6, and can easily enter a blood vessel having a complicated path.

After the distal end portion of the medical insertion wire reaches the distal end portion of the medical tubular device, the distal end portion of the medical insertion tool exits the medical tubular device through the distal end opening of the medical tubular device, and is placed in a living tissue, for example, a blood vessel. Proceed inside.

The distal end of the medical insertion wire advances through the blood vessel and reaches the embolus existing portion. As described above, since the medical insertion wire has a strong stiffness, the force applied to the medical insertion wire is reliably transmitted to its distal end, and the event occurring at the distal end at the proximal end is clearly described. I can feel it.

For example, when the medical insertion wire according to the present invention is for PTCA, the operation is as follows.
As shown in FIG. 1, when a stenosis that obstructs the flow of blood through the artery is present, for example, at the position indicated by reference numeral 23 in FIG. 1 in the main coronary artery system, the medical tubular device 24 is connected to the thigh. From the part (not shown) into the blood vessel, the femoral artery 19,
The distal port is passed through the inferior portion 18 of the main coronary artery and the upward portion 14 of the main coronary artery so that its distal end abuts on the entrance of the main coronary artery 21.

The medical insertion wire 34 according to the present invention advances inside the medical tubular tool 24. Medical insertion wire 3
Since 4 has a predetermined rigidity, it can travel without breaking inside the medical tubular device 24. Further, the medical tubular tool 24 has a curved portion 30 and a curved portion 32 which are largely curved in accordance with the shape of the blood vessel, but the medical insertion wire 34 is easily bent at the center of the core wire, By passing through these curved portions without difficulty, it is possible to reach the entrance of the main coronary artery 21 where the distal opening of the medical tubular device 24 abuts. The distal end 37 of the medical penetrating body 34 goes out of the medical tubular device 24 and enters the main coronary artery 21, and thereafter the medical penetrating body 34 similarly bends appropriately and has a small diameter in the main coronary artery 21. Inside the stenosis.

Even if the stenosis is located in a more complicated blood vessel path, for example, at a position indicated by reference numerals 20A, 20B, 20C and 20D in FIG. By providing the intermediate portion of the core wire at a necessary position of the insertion wire, the distal end of the medical wire can reach the stenosis.

Then, the balloon catheter 36 is advanced along the medical insertion wire 34, and the balloon in the contracted state is positioned in the stenosis, and a predetermined treatment can be performed.

[0083]

Since the medical insertion wire according to the present invention has a core wire main line portion for securing a predetermined rigidity, the medical insertion wire has a function of being able to be pushed without buckling in a blood vessel, and is provided at the base end. Substantially all of the rotation imparted can be controllably transmitted to the distal end, and the event occurring at the distal end at the proximal end can be clearly sensed.

The medical insertion wire according to the present invention has improved flexibility by having a core wire intermediate portion having a lower bending rigidity than the core wire main wire portion, and is adaptable to various curved portions existing in a blood vessel. And can easily bend, and can easily advance into complicated blood vessels.

The medical insertion wire according to the present invention can be manufactured by partially mechanically processing or hardening one core wire material. Therefore, the manufacturing is easy and the cost does not increase.

[Brief description of the drawings]

FIG. 1 is an explanatory diagram showing a structure of a blood vessel around a heart and a state of a medical insertion wire reaching the heart.

FIG. 2 is an explanatory plan view showing a core wire intermediate portion 42;

FIG. 3 is an explanatory plan view showing a core wire intermediate portion 43; .

FIG. 4 is an explanatory plan view showing a core wire intermediate portion 44;

FIG. 5 is an explanatory plan view showing a core wire intermediate portion 45;

FIG. 6 is a schematic explanatory view of a medical insertion wire 1 which is a specific example of the medical insertion wire according to the present invention.

[Explanation of symbols]

1. ··· Medical insertion wire body 2. ··· First core wire main wire portion, 3.
・ Second core body main line section, 4 ・ 3rd core body main line section, 5 ・ ・
1st core wire middle section, 6 second core wire body middle section, 7 small diameter section, 8 taper section, 9 taper section, 10 end section, 11 end section, 12 end section Small diameter part, 13 taper part, 14 taper part, 15 end part, 16 end part, 17 iliac artery, 18 downward part, 19 femoral artery, 20 ... Code, 20A ... code, 20B ... code, 20C ... code, 20D ... code, 21 ... main coronary artery, 22 ... main coronary artery, 23 ... code, 24 ... medical tubular tool, 26 ..Upward portions, 30.Bending portions, 3
2 ... bending part, 34 ... medical penetration wire, 37 ... tip, 38 ... small diameter part, 39 ... tapered part, 40 ... core body main part, 41 ... small diameter part, 42 ... Core wire middle part, 4
3 ··· Core wire body middle part, 44 ··· Core wire body middle part, 45 ···
Core wire middle part, 46 .. convex part, 47 .. small diameter part, 48.
・ Protrusion,

Claims (6)

[Claims] 1. A medical system comprising: a plurality of core wire main wire portions; and a core wire intermediate portion that is located between the core wire body main wire portions and that has a smaller bending rigidity than the core wire body main wire portions. For insertion wire. 2. The medical insertion line according to claim 1, wherein the intermediate portion of the core wire has a small-diameter portion smaller in diameter than an end of the main wire portion continuous with the intermediate portion of the core wire. body. 3. The core wire intermediate portion has a small diameter portion formed to have a smaller diameter than an end portion of the core wire main wire portion continuous with the core wire body intermediate portion, and a spiral provided on the surface of the small diameter portion. The medical insertion wire according to claim 1, comprising a convex portion having a shape of a circle. 4. The medical insertion line according to claim 1, wherein the core body intermediate portion has a plurality of mutually independent concave portions having a diameter smaller than a diameter of the core wire main line portion. body. 5. The medical insertion wire according to claim 1, wherein the core wire main wire portion has a bending composition larger than that of the core wire intermediate portion by subjecting at least a part of the wire to a surface hardening treatment. 6. The medical insertion wire according to claim 1, wherein at least two intermediate portions of the core wire are present.