Catheter, treatment method, guide wire and catheter system

Abstract

Provided are a catheter for penetration, a treatment method, a guidewire, and a catheter system, which have high penetrability to a lesion site of a vein, and are capable of effectively supporting a device inserted therein and improving the operability of the supported device. A penetration catheter (40) for penetrating a lesion site of a vein is provided with a second tube body (41) having: an outer diameter constant section (45) having an outer diameter constant in the longitudinal direction; an outer tapered section (46), the outer diameter of which decreases in a tapered shape from the tip of the outer diameter constant section (45) toward the tip direction; a constant inner diameter section (47) having a constant inner diameter in the longitudinal direction; the outer diameter of the outer diameter constant part (45) is 2.7 + / -0.1 mm, the inner diameter of the inner diameter constant part (47) is 1.6 + / -0.1 mm, the outer diameter of the foremost end of the pipe body is 1.7 + / -0.1 mm, and the inner diameter of the foremost end of the second pipe body (41) is 1.45 + / -0.1 mm.

Description

Technical Field

[0001] The present invention relates to a catheter and a treatment method, as well as a guidewire and a catheter system. Background Art

[0002] In the treatment of blood vessels, the following operation is performed: when a guide wire is inserted into (through) a lesion site, the guide wire is inserted into and supported in a guide wire insertable instrument (catheter), and the catheter is penetrated to the lesion site together with the guide wire (for example, see Patent Document 1).

[0003] However, in the treatment of deep vein thrombosis (DVT), arterial support catheters, guide catheters, and long sheaths have been used. Deep vein thrombosis affects veins more distal to the inferior vena cava, such as the iliac, femoral, or popliteal veins. Generally speaking, veins have a larger diameter than arteries. For example, the inner diameter of an artery used for catheterization is approximately 3Fr to 8Fr, while the inner diameter of a vein used for catheterization is approximately 6Fr to 24Fr.

[0004] Prior art literature

[0005] Patent Literature

[0006] Patent Document 1: Japanese Patent No. 4906347 Summary of the Invention

[0007] Since there is no known catheter suitable for accessing the lesion site of the vein that is suitable for the diameter of the vein and the lesion site, if a thin catheter used for an artery is used in a vein, the catheter is likely to bend in the thick vein, and the penetration ability to the lesion site may be reduced.

[0008] The present invention is completed to solve the above-mentioned problems. Its purpose is to provide a penetrating catheter and treatment method that have high penetrability into the lesion site of the vein, can effectively support the instrument inserted inside and improve the operability of the supported instrument, and to provide a guide wire and catheter system that have high penetrability into the lesion site of the vein.

[0009] The above-mentioned object is achieved by the invention described in the following (1).

[0010] (1) The penetrating catheter of the present invention is characterized in that it is used for penetrating a lesion site in a vein, and the penetrating catheter has a tubular body, which has: an outer diameter constant portion having an outer diameter constant along the longitudinal direction; an outer tapered portion having an outer diameter tapered from the front end toward the front end of the outer diameter constant portion; an inner diameter constant portion having an inner diameter constant along the longitudinal direction; and an inner tapered portion having an inner diameter tapered from the front end toward the front end of the inner diameter constant portion, wherein the outer diameter of the outer diameter constant portion is 2.7 mm, the inner diameter of the inner diameter constant portion is 1.6 mm, the outer diameter of the front end of the tubular body is 1.6 mm, and the inner diameter of the front end of the tubular body is 1.45 mm.

[0011] Effects of the Invention

[0012] The penetrating catheter described in (1) above has a large wall thickness defined by the constant outer diameter portion and the constant inner diameter portion, resulting in high rigidity. Furthermore, the outer tapered portion is tapered at the distal end, thereby providing high penetration into a lesion. This allows the penetrating catheter itself to penetrate a lesion that is difficult to penetrate. Furthermore, the high rigidity allows for effective support of an instrument inserted into the penetrating catheter, improving the operability of the supported instrument.

[0013] (2) In the penetrating catheter described in (1), the tube body may have a curved portion at the front end thereof, which is curved at an angle of 20 to 30 degrees. Thus, the penetrating catheter can adjust the direction of the front end by rotating it, thereby improving operability.

[0014] (3) The treatment method for achieving the above-mentioned purpose is characterized in that the diseased part of the vein is penetrated. In this treatment method, when the inner catheter is inserted into the penetrating catheter and the guide wire is inserted into the inner catheter, the penetrating catheter is penetrated into the diseased part of the vein together with the guide wire and the inner catheter. The penetrating catheter has a tubular body, which has: an outer diameter constant portion with an outer diameter constant along the longitudinal direction; an outer tapered portion with an outer diameter tapered from the front end toward the front end of the outer diameter constant portion; an inner diameter constant portion with an inner diameter constant along the longitudinal direction; and an inner tapered portion with an inner diameter tapered from the front end toward the front end of the inner diameter constant portion, the outer diameter of the outer diameter constant portion is 2.7 mm, the inner diameter of the inner diameter constant portion is 1.6 mm, the outer diameter of the front end of the tubular body is 1.6 mm, and the inner diameter of the front end of the tubular body is 1.45 mm. The penetrating catheter used in this treatment method has a large wall thickness defined by the constant outer and inner diameter sections of the tube body, resulting in high rigidity. Furthermore, the outer tapered section tapers at the distal end, resulting in high penetration into the lesion. Therefore, this treatment method allows the penetrating catheter itself to penetrate difficult-to-penetrate lesions. Furthermore, this treatment method effectively supports the inner catheter and guidewire inserted into the penetrating catheter through its high rigidity, improving the operability of the supported instruments.

[0015] (4) A guide wire for achieving the above-mentioned purpose is characterized in that it comprises a core wire formed of a long metal and a coating layer covering at least the distal end of the core wire and being softer than the core wire, the core wire having a core wire constant outer diameter portion having a constant outer diameter and a core wire taper portion having an outer diameter tapering from the distal end of the core wire constant outer diameter portion to the distal end of the core wire, the portion of the guide wire having the core wire taper portion being formed into a straight line, and in a load test in which the weight added when the guide wire is pushed in the distal direction is measured with the distal end of the guide wire in contact with a receiving portion having an anti-slip treatment, the weight added is greater than 0.04 N when pushed 0.05 mm, greater than 0.05 N when pushed 0.1 mm, and greater than 0.05 N when pushed 0.2 mm. The guide wire has a high penetrability to the lesion site due to the high weight added in the load test.

[0016] (5) The guide wire for achieving the above-mentioned purpose is characterized in that it has a core wire formed of a long metal and a coating layer covering at least the front end of the core wire and being softer than the core wire, the core wire having a core wire constant outer diameter portion with a constant outer diameter and a core wire taper portion with an outer diameter that decreases in a tapered shape from the front end of the core wire constant outer diameter portion to the front end of the core wire, the guide wire having a guide wire front end at the front end, a guide wire curved portion that is located on the base end side of the guide wire front end and is curved, and a straight guide wire straight portion located on the base end side of the guide wire curved portion, The angle at which the line segment connecting the front end of the guide wire and the curved base is inclined relative to the extension line of the straight portion of the guide wire, i.e., the front end bending angle, is 25 to 40 degrees. In a load test in which the front end of the guide wire is brought into contact with a receiving portion that has been subjected to anti-slip processing while the guide wire is inserted into an inner catheter and the inner catheter is inserted into a penetrating catheter, and the weight added when the guide wire is pushed toward the front end is measured, the measured weight added exceeds 0.02N when pushed by 0.2mm and exceeds 0.04N when pushed by 2.0mm. Since the guide wire has a curved portion, the direction of the front end can be adjusted by rotation, thereby improving operability. Furthermore, since the weight added to the guide wire in the load test is high, the penetrability to the lesion site is high.

[0017] (6) A catheter system for achieving the above-mentioned object is characterized in that it comprises a penetrating catheter for penetrating a lesion site of a vein, an inner catheter insertable into the penetrating catheter, and the guide wire described in (4) above insertable into the inner catheter, wherein, in a load test in which the load applied when the catheter system is pushed in the distal direction is measured with the inner catheter inserted into the penetrating catheter, the guide wire inserted into the inner catheter, and the tip of the guide wire abutting against a receiving portion having a non-slip treatment, the load applied when the catheter system is pushed in the distal direction exceeds 0.1 N when pushed 0.2 mm. Since the load applied in the load test is high, the above-mentioned catheter system has high penetrability into the lesion site.

[0018] (7) The catheter system for achieving the above-mentioned purpose is characterized in that it has a penetrating catheter for penetrating a lesion site of a vein, an inner catheter that can be inserted into the penetrating catheter, and the guide wire described in (5) above that can be inserted into the inner catheter. In a load test in which the weight added when the catheter system is pushed toward the front end is measured with the inner catheter inserted into the penetrating catheter, the guide wire inserted into the inner catheter, and the front end of the guide wire abutting against a receiving portion that has been subjected to a non-slip treatment, the measured weight added exceeds 0.02N when pushed 0.2mm and exceeds 0.04N when pushed 2.0mm. Since the above-mentioned catheter system has a guide wire bend portion on the guide wire, the direction of the front end can be adjusted by rotation, which can improve operability. Furthermore, since the weight added in the load test is high, the catheter system has high penetration into the lesion site. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 It is a top view showing the assembled state of the catheter system.

[0020] Figure 2 It is a top view showing the duct system in a disconnected state.

[0021] Figure 3 It is a cross-sectional view showing the distal end portion of the penetration catheter according to the present embodiment.

[0022] Figure 4 It is along Figure 1 Cross-sectional view along line AA.

[0023] Figure 5 1 and 2 are cross-sectional views showing guide wires, wherein (A) shows the first example and (B) shows the second example.

[0024] Figure 6 Schematic diagrams showing the states of a load test, (A) showing the state of a catheter system load test, and (B) showing the state of a guide wire load test.

[0025] Figure 7 This is a graph showing the load corresponding to the stroke in the load-added test using the guide wire of the first example.

[0026] Figure 8 It will Figure 7 A graph showing load versus stroke is shown with a partially enlarged portion.

[0027] Figure 9 This is a graph showing the load corresponding to the stroke in the weight-added test using the guide wire of the second example.

[0028] Figure 10 It will Figure 9 A graph showing load versus stroke is shown with a partially enlarged portion.

[0029] Figure 11 This is a graph showing the load corresponding to the stroke in the weight-added test of the guide wire alone. DETAILED DESCRIPTION

[0030] The following describes embodiments of the present invention with reference to the accompanying drawings. It should be noted that, for ease of explanation, the dimensional ratios in the drawings may be exaggerated and differ from the actual ratios. In the following description, the operating side of the catheter is referred to as the "proximal side," and the side inserted into the body is referred to as the "distal side."

[0031] like Figures 1 to 4 As shown, a penetrating catheter 40 according to an embodiment of the present invention, together with other instruments, constitutes a catheter system 10, which is used to penetrate the lesion site in the treatment of deep vein thrombosis (DVT). The catheter system 10 is inserted through a vein in the thigh, knee, or a more distal vein and advanced toward the blood vessel being treated. The blood vessel being treated is a vein more distal to the inferior vena cava (e.g., the iliac vein, femoral vein, or popliteal vein).

[0032] The catheter system 10 includes a penetrating catheter 40 , an inner catheter 30 insertable into the penetrating catheter 40 , and a guidewire 20 insertable into the inner catheter 30 .

[0033] The penetrating catheter 40 supports the inner catheter 30 and guidewire 20 inserted therein and has high penetrability, enabling it to penetrate venous lesions. The penetrating catheter 40 comprises a second tubular body 41 (tube body) defining a second lumen 42 into which the inner catheter 30 is inserted, and a second seat 43 secured to the base of the second tubular body 41. The penetrating catheter 40 supports the inner catheter 30 and the guidewire 20 inserted within the second lumen 42 and, together with the inner catheter 30 and guidewire 20, penetrates the lesion while dilating the lesion. Furthermore, when the catheter system 10 penetrates the lesion, the penetrating catheter 40 can penetrate the lesion completely or partially. A hemostatic valve may be installed in place of the second seat 43.

[0034] Alternatively, the outer peripheral surface of at least the front end portion of the second tube 41 may be coated with a lubricating coating 44 (see Figure 1 、 2). The lubricating coating 44 is coated in the range from the front end of the second tube 41 to a predetermined distance L2 (for example, 400 mm) in the direction toward the base end. The lubricating coating 44 is, for example, a hydrophilic polymer, and examples thereof include cellulose-based polymers, polyethylene oxide-based polymers, maleic anhydride-based polymers (for example, maleic anhydride copolymers such as methyl vinyl ether-maleic anhydride copolymers), acrylamide-based polymers (for example, polyacrylamide, glycidyl methacrylate-dimethylacrylamide block copolymers), water-soluble nylon, polyvinyl alcohol, polyvinyl pyrrolidone, and derivatives thereof. The hydrophilic polymer forms a strong water-fixed layer on its surface, exhibits high affinity for the blood in the blood vessels and the blood vessel walls, and exhibits low friction. Alternatively, the lubricating coating 44 may be a fluororesin such as polytetrafluoroethylene (PTFE), a low-friction material such as high-density polyethylene (HDPE), and the like. However, compared with thrombi formed in arteries, thrombi formed in veins tend to form longer along the length of the blood vessels. Therefore, the low friction of the outer peripheral surface of the second tube body 41 is very effective when the second tube body 41 penetrates the thrombus in the vein.

[0035] The second tube body 41 includes: a constant outer diameter portion 45 having a substantially constant outer diameter; an outer tapered portion 46 having an outer diameter tapering from the distal end of the constant outer diameter portion 45 toward the distal end; a constant inner diameter portion 47 having a substantially constant inner diameter; an inner tapered portion 48 having an inner diameter tapering from the distal end of the constant inner diameter portion 47 toward the distal end; and a distal constant inner diameter portion 49 having a substantially constant inner diameter from the distal end of the inner tapered portion 48 toward the distal end. The second tube body 41 includes a curved portion 50 within a length L6 of the distal end of the constant outer diameter portion 45. The length L6 is not particularly limited and is, for example, 10 mm. The bending angle θ of the curved portion 50 is not particularly limited but is preferably 20 to 30 degrees, with 30 degrees being an example. Furthermore, the second tube body 41 may not include the curved portion 50.

[0036] The second tube body 41 is formed of an inner layer 51 forming the inner surface of the second tube body 41, an outer layer 52 forming the outer surface of the second tube body 41, and a reinforcement body 53 located between the inner layer 51 and the outer layer 52. The second tube body 41 has a soft portion 55 located further toward the distal end than the region where the reinforcement body 53 is located, where the reinforcement body 53 is not located. The length L7 of the soft portion 55 in the longitudinal direction is 20 mm to 30 mm.

[0037] The reinforcement body 53 is used to reinforce the second tube body 41 and has a plurality of (for example, 16) reinforcement wires 54. The structure is such that the material of the outer layer 52 or the inner layer 51 enters the gaps between the plurality of reinforcement wires 54 in the reinforcement body 53. As the reinforcement body 53, for example, a structure in which the reinforcement wires 54 are networked into a tubular shape can be cited. In addition, the reinforcement body 53 can also be formed by winding one or more reinforcement wires 54 into a spiral shape (coil shape). The reinforcement wire 54 is formed of metal such as stainless steel, NiTi, etc. The cross-sectional shape of the reinforcement wire 54 is not particularly limited, and can be, for example, rectangular, square, circular, oblong or elliptical. In addition, a reinforcement wire 54 can also be formed by bundling two or more wires. The second tube body 41 having the reinforcement body 53 can ensure sufficient rigidity and strength without increasing the wall thickness, that is, making the inner diameter of the second tube body 41 larger.

[0038] The inner layer 51 is preferably formed of a low-friction material. Thus, when inserting or removing instruments such as the inner catheter 30 and the guidewire 20 into or from the second lumen 42, the inner layer 51 allows these instruments to move along the longitudinal axis with minimal sliding resistance, thereby improving operability. Examples of low-friction materials include fluororesins such as polytetrafluoroethylene (PTFE) and tetrafluoroethylene-perfluoroalkoxyvinyl ether copolymer (PFA).

[0039] The constituent materials of the outer layer 52 include, for example, polystyrene, polyolefin, polyurethane, polyester, polyamide, or various thermoplastic elastomers such as styrene, polyolefin, polyurethane, polyester, polyamide, polybutadiene, trans-polyisoprene, fluororubber, and chlorinated polyethylene, and materials combining one or more of them (polymer alloys, blends, laminates, etc.) can also be listed.

[0040] The effective length L1 of the penetrating catheter 40 is not particularly limited, but is preferably between 650 mm and 900 mm, for example, 650 mm. The effective length L1 of the penetrating catheter 40 is the length of the portion that can be inserted into a blood vessel or tubular device. In this embodiment, the effective length L1 of the penetrating catheter 40 is the length from the second seat 43 at the base end or the distal end of the anti-bend sheath to the distal end of the second tubular body 41.

[0041] The outer diameter D1 of the constant outer diameter portion 45 is 2.7±0.1 mm, the outer diameter D2 of the distal end of the outer tapered portion 46 is 1.7±0.1 mm, the inner diameter D3 of the constant inner diameter portion 47 is 1.6±0.1 mm, and the inner diameter D4 of the distal constant inner diameter portion 49 is 1.45±0.1 mm. The wall thickness T at the overlapping portion of the constant outer diameter portion 45 and constant inner diameter portion 47 is 0.55 mm. Smaller inner diameters D3 and D4 increase frictional resistance with the inner catheter 30, while larger inner diameters D3 and D4 make the penetrating catheter 40 more susceptible to bending. Furthermore, smaller outer diameters D1 and D2 facilitate bending, while larger outer diameters D1 and D2 make bending difficult at the bend 50. The longitudinal length L3 of the outer tapered portion 46 is 12 mm, the longitudinal length L4 of the inner tapered portion 48 is 3 mm, and the longitudinal length L5 of the distal constant inner diameter portion 49 is 7 mm.

[0042] The inner catheter 30 fills the space between the penetrating catheter 40 and the guidewire 20, increasing the rigidity and penetrability of the catheter system 10. It also suppresses deflection of the guidewire 20 within the penetrating catheter 40 and inner catheter 30, and widens the gap in the lesion created by the guidewire 20 entering the lesion. The inner catheter 30 includes a first tubular body 31 defining a first lumen 32 into which the guidewire 20 is inserted, and a first seat 33 secured to the proximal end of the first tubular body 31. The inner catheter 30 covers and supports the guidewire 20 inserted into the first lumen 32, and penetrates the lesion together with the guidewire 20 and the penetrating catheter 40.

[0043] The outer diameter of the first tubular body 31 is not particularly limited, but is preferably a size that allows it to slide smoothly while in close contact with the second lumen 42 of the penetrating catheter 40, for example, 1.4 mm. The inner diameter of the first tubular body 31 is preferably a size that allows the guidewire 20 inserted into the first lumen 32 to slide while in close contact with it, for example, 1.0 mm. As an example, the inner catheter 30 may be the NaviCross (registered trademark) manufactured by Terumo Corporation, which is suitable for inserting a guidewire 20 having an outer diameter of 0.035 inches (0.9 mm).

[0044] The guidewire 20 preferably has high penetrability so as to be able to penetrate the lesion site of the vein. To achieve high penetrability, the guidewire 20 preferably has a tip portion that is more rigid than a typical guidewire 20. For example, the guidewire 20 may be a Glidewire Advantage (registered trademark) with an outer diameter of 0.035 inches (0.9 mm) manufactured by Terumo Corporation, with the soft tip portion (20 to 30 mm from the tip toward the base) removed.

[0045] The catheter system 10 is used in Figure 1In the state where the penetrating catheter 40, the inner catheter 30 and the guide wire 20 are combined as shown, not only the guide wire 20 but also the inner catheter 30 and the penetrating catheter 40 are made to penetrate the lesion site (eg, organized thrombus) of the vein.

[0046] As described above, the penetrating catheter 40 of this embodiment is used for penetrating the diseased part of the vein. The penetrating catheter 40 has a second tube body 41, and the second tube body 41 has: an outer diameter constant portion 45 whose outer diameter is constant along the longitudinal direction; an outer tapered portion 46 whose outer diameter decreases in a tapered shape from the front end of the outer diameter constant portion 45 toward the front end; an inner diameter constant portion 47 whose inner diameter is constant along the longitudinal direction; and an inner tapered portion 48 whose inner diameter decreases in a tapered shape from the front end of the inner diameter constant portion 47 toward the front end. The outer diameter of the outer diameter constant portion 45 is 2.7±0.1 mm, the inner diameter of the inner diameter constant portion 47 is 1.6±0.1 mm, the outer diameter of the front end of the tube body is 1.7±0.1 mm, and the inner diameter of the front end of the second tube body 41 is 1.45±0.1 mm. Thus, because the wall thickness of the penetrating catheter 40, defined by the constant outer diameter portion 45 and the constant inner diameter portion 47, is large and rigid, and because the outer tapered portion 46 is tapered at the distal end, the catheter 40 has high penetrability into the lesion, allowing the penetrating catheter 40 itself to penetrate difficult-to-penetrate lesions (e.g., organized thrombi). Furthermore, the high rigidity allows for effective support of instruments (inner catheter 30, guidewire 20) inserted into the penetrating catheter 40, improving the operability of the supported instruments (inner catheter 30, guidewire 20).

[0047] The second tube body 41 has a curved portion 50 at a distal end portion that is curved at an angle of 20 to 30 degrees.

[0048] The treatment method of this embodiment is to penetrate the lesion site of the vein. The treatment method is characterized in that, in a state where the inner catheter 30 is inserted into the penetrating catheter 40 and the guide wire 20 is inserted into the inner catheter 30, the penetrating catheter 40 is penetrated together with the guide wire 20 and the inner catheter 30 toward the lesion site of the vein. The penetrating catheter 40 has a second tube body 41, and the second tube body 41 has: an outer diameter constant portion 45 with a constant outer diameter along the longitudinal direction; an outer diameter from the front end of the outer diameter constant portion 45 to the front end of the outer diameter constant portion 45; The outer tapered portion 46 tapers toward the distal end; the constant inner diameter portion 47 has a constant inner diameter along the longitudinal axis; and the inner tapered portion 48 tapers toward the distal end of the constant inner diameter portion 47. The outer diameter of the constant outer diameter portion 45 is 2.7±0.1 mm, the inner diameter of the constant inner diameter portion 47 is 1.6±0.1 mm, the outer diameter of the distal end of the second tube body 41 is 1.7±0.1 mm, and the inner diameter of the distal end of the second tube body 41 is 1.45±0.1 mm. Because the penetrating catheter 40 used in this treatment method has a large wall thickness and high rigidity defined by the constant outer diameter portion 45 and constant inner diameter portion 47 of the second tube body 41, and because the outer tapered portion 46 tapers toward the distal end, it has high penetrability into the lesion. Therefore, according to this treatment method, the penetrating catheter 40 itself can penetrate difficult-to-penetrate lesions (such as organized thrombi). Furthermore, according to the present treatment method, the inner catheter 30 and the guide wire 20 inserted into the penetrating catheter 40 can be effectively supported with high rigidity, and the operability of the supported instruments can be improved.

[0049] like Figure 5 As shown in FIG. 2 (A), the first example of the guide wire 20 includes a long core wire 21 and a coating layer 22 covering the core wire 21 .

[0050] The core wire 21 extends over substantially the entire length of the guide wire 20. The core wire 21 is formed of a single continuous wire. The cross-section of the core wire 21 perpendicular to the longitudinal axis is circular, but may not be circular.

[0051] The core wire 21 includes a core wire constant outer diameter portion 23 and a core wire taper portion 24 extending from the distal end of the core wire constant outer diameter portion 23 to the distal end of the core wire 21. The core wire constant outer diameter portion 23 has a substantially constant outer diameter along its long axis. The core wire taper portion 24 has an outer diameter that gradually decreases from the distal end of the core wire constant outer diameter portion 23 toward the distal end. The outer diameter of the core wire constant outer diameter portion 23 is, for example, 0.65 mm to 0.75 mm. The outer diameter of the distal end of the core wire taper portion 24 is, for example, 0.14 mm to 0.30 mm.

[0052] The constant outer diameter portion 23 of the core wire imparts desired propulsivity to the guide wire 20 due to its constant outer diameter. The core wire taper portion 24 gradually reduces the rigidity of the guide wire 20 from the constant outer diameter portion 23 toward the distal end. This prevents the guide wire 20 from being locally bent or damaged, such as by bending.

[0053] The core wire 21 can be formed of a metal material, and examples thereof include superelastic alloys such as Ni—Ti alloys, Ni—Al alloys, and Cu—Zn alloys, and alloys containing these.

[0054] The coating layer 22 covers at least the front end of the core wire 21. Thus, the coating layer 22 protects the outer surface of the core wire 21 and improves the safety of the guide wire 20 when inserting it into a biological lumen such as a blood vessel. Therefore, the material forming the coating layer 22 is preferably a material with high flexibility, for example, it can be polyolefins such as polyurethane, polyethylene, and polypropylene, polyvinyl chloride, polyester (PET, PBT, etc.), polyamide, polyimide, polystyrene, silicone resin, polyurethane elastomer, polyester elastomer, polyamide elastomer and other thermoplastic elastomers, various rubber materials such as latex rubber and silicone rubber, fluororesin, or a composite material composed of two or more of them. The outer diameter of the coating layer 22 is, for example, 0.60mm to 0.89mm. Alternatively, the entirety can be coated with a resin mixed with polyurethane and tungsten, the front end can be covered with a resin mixed with polyurethane and tungsten, and the base end side can be covered with a fluororesin such as PTFE.

[0055] The coating layer 22 may also be covered with a lubricating layer (not shown). The lubricating layer is formed from a hydrophilic polymer that reduces friction. The hydrophilic polymer forms a strong water-binding layer on its surface, exhibiting a high affinity for blood and the vessel walls within the blood vessels, and exhibiting low friction (a low coefficient of friction). The lubricating layer need only cover at least the distal end of the coating layer 22, or it may cover the entire length.

[0056] like Figure 5 As in the second example shown in (B), the guide wire 20 may also have a guide wire curved portion 25 at the front end portion where the core wire taper portion 24 is located. The guide wire 20 has a guide wire straight portion 26 on the base end side of the guide wire curved portion 25. The guide wire 20 has a guide wire front end 27 at the front end and a curved base 28 between the guide wire straight portion 26 and the guide wire curved portion 25. The angle at which the line segment connecting the curved base 28 and the guide wire front end 27 is inclined relative to the extension line of the guide wire straight portion 26, that is, the front end bending angle α, is not particularly limited and is preferably 25 degrees to 40 degrees. The length of the guide wire 20 from the curved base 28 to the guide wire front end 27 along the long axis is not particularly limited and is preferably 3 mm to 5 mm.

[0057] The end face of the guide wire front end 27 has a curvature and is formed into a roughly hemispherical shape. Therefore, compared with a case where the end face is a horizontal surface, since it can make point contact with the contact object, it is difficult to slide and easily enters the gap. The end face of the guide wire front end 27 can also be covered with a lubricating layer, but it is also possible not to be covered with a lubricating layer. In the case where the guide wire 20 has a lubricating layer on its surface but the end face of the guide wire front end 27 does not have a lubricating layer, the guide wire front end 27 is difficult to slide and easily enters the gap.

[0058] As an example of a combination of the penetrating catheter 40, the inner catheter 30, and the guidewire 20 of the catheter system 10, the penetrating catheter 40 may have a bend 50, the inner catheter 30 may not have a bend, and the guidewire 20 may have a guidewire bend 25. Alternatively, as another example of a combination, the penetrating catheter 40 may have a bend 50, the inner catheter 30 may not have a bend, and the guidewire 20 may not have a guidewire bend 25. Alternatively, as another example of a combination, the penetrating catheter 40 may not have a bend 50, the inner catheter 30 may not have a bend, and the guidewire 20 may not have a guidewire bend 25. When the penetrating catheter 40 has a bend 50, the direction of the tip of the penetrating catheter 40 can be changed by rotation, which is effective, for example, during puncture. When the guidewire 20 has a guidewire bend 25, the direction of the tip of the guidewire 20 can be changed by rotation, which can prevent the guidewire 20 from accidentally entering a side branch within a blood vessel. When none of the penetrating catheter 40 , the inner catheter 30 , and the guidewire 20 has a curved portion, the catheter system 10 can obtain high penetrating power.

[0059] <Weighted test>

[0060] use Figure 6 The load test apparatus 100 shown in FIG. 1 is used to perform a load test on the catheter system 10 and the guide wire 20. Figure 6 As shown in (A), the load test device 100 can move in a manner that applies a load downward, and has a pressing portion 110 having a chuck mechanism 111 that can fix a long member, and a receiving portion 120 located below the pressing portion 110 and against which the front end of the guide wire 20 can abut without sliding. The receiving portion 120 is formed by sticking sandpaper of #600 (abrasive particle diameter: 28 μm) in the JIS standard to the upper surface of a stainless steel plate using double-sided tape. Figure 6As shown in (A), when the weight test is performed in a state where the guide wire 20 is combined with the penetrating catheter 40 and the inner catheter 30, the chuck mechanism 111 fixes the penetrating catheter 40 without the curved portion 50 at a position 10 mm from the front end to the base end side. In addition, the chuck mechanism 111 deforms the penetrating catheter 40 and the inner catheter 30 when clamping the penetrating catheter 40, thereby fixing the penetrating catheter 40, the inner catheter 30 and the guide wire 20 together. The front end of the inner catheter 30 is located at a position 10 mm from the front end of the penetrating catheter 40 in the downward direction (front end direction). The front end of the guide wire 20 is located at a position 20 mm from the front end of the inner catheter 30 in the downward direction (front end direction). The weight test device 100 can move the pressing portion 110 having the chuck mechanism 111 in the up and down directions relative to the receiving portion 120 that does not move. In the weight test, the pressing portion 110 was moved downward by 2 mm at a speed of 5 mm / min from a state where the distal end of the guide wire 20 was in contact with the receiving portion 120 , and the downward stroke and the weight acting on the pressing portion 110 were measured.

[0061] In addition, if Figure 6 As shown in FIG. 1B , when the weight test is performed using the single guide wire 20 , the chuck mechanism 111 is fixed at a position 40 mm from the distal end of the guide wire 20 toward the proximal end.

[0062] The results of the load test of the guide wire 20 of the first example without the guide wire bending portion 25 are as follows: Figures 7-8 shown. Figure 7 The thick line is the test result of the guide wire 20 combined with the penetrating catheter 40 and the inner catheter 30. The thick solid line is Figure 5 1 is a test result of the guide wire 20 of the first example (a straight guide wire 20 without a guide wire bend 25), and the thick dotted line is the test result of the guide wire 20 as the first reference example. The guide wire 20 as the first reference example is different from the first example, and has a core wire 21 with a front end outer diameter constant portion (not shown) with a constant outer diameter on the front end side of the core wire taper portion 24. The length of the front end outer diameter constant portion in the long axis direction is approximately 20 mm. That is, the guide wire 20 of the first example has a shape without the front end outer diameter constant portion compared to the guide wire 20 of the first reference example, and is accordingly formed to be shorter in the long axis direction.

[0063] Figures 7-8 The thin line represents the test result using the guide wire 20 alone. The thin solid line represents the test result using the guide wire 20 alone in the first example, and the thin dotted line represents the test result using the guide wire 20 alone in the first reference example. Figure 8 Enlarged representation Figure 7 The test results of 20 monomers of guidewires.

[0064] like Figure 7As shown by the thick line, in the state of being combined with the penetrating catheter 40 and the inner catheter 30, the guide wire 20 of the first example is weighted higher than the guide wire 20 of the first reference example. Figures 7-8 As shown by the thin line, in the test using the guidewire 20 alone, there was no significant difference in weight gain between the guidewire 20 of the first example and the guidewire 20 of the first reference example. In other words, it was confirmed that the guidewire 20 of the first example, when combined with the penetrating catheter 40 and the inner catheter 30, achieved higher penetrability than the guidewire 20 of the first reference example.

[0065] The results of the load test of the guide wire 20 of the second example having the guide wire bend 25 are as follows: Figures 9-10 shown. Figure 9 The thick line is the test result of the guide wire 20 combined with the penetrating catheter 40 and the inner catheter 30. The thick solid line is Figure 5 (B) shows the test results of the guidewire 20 of the second example, and the thick dashed line is the test result of the guidewire 20 as the second reference example. The front end bending angle α of the guidewire 20 of the second example is 40 degrees. The length of the guidewire 20 along the long axis from the bending base 28 to the guidewire front end 27 is 3 mm. The guidewire 20 of the second reference example has a guidewire bending portion 25 similar to the second example, and has a core wire 21 with a front end outer diameter constant portion having a constant outer diameter on the front end side of the core wire taper portion 24. The length of the front end outer diameter constant portion in the long axis direction is approximately 20 mm. In other words, the guidewire 20 of the second reference example is longer in the long axis direction than the guidewire 20 of the second example because it has a front end outer diameter constant portion on the front end side of the core wire taper portion 24. The guidewire bending portion 25 of the guidewire 20 of the second reference example has a J-shaped bending shape different from that of the second example, and has a larger curvature radius than the guidewire bending portion 25 of the guidewire 20 of the second example. The distal end bending angle α of the guide wire 20 of the second reference example is 40 degrees. The length of the guide wire 20 of the second reference example from the bending base 28 to the guide wire distal end 27 along the long axis is 15 mm.

[0066] Figures 9-10 The thin line represents the test result of the guide wire 20 alone. The thin solid line represents the test result of the guide wire 20 alone in the second example, and the thin dotted line represents the test result of the guide wire 20 alone in the second reference example. Figure 10 Enlarged representation Figure 9 The test results of 20 monomers of guidewires.

[0067] like Figure 9 As shown by the thick line, in the state of being combined with the penetrating catheter 40 and the inner catheter 30, the guide wire 20 of the second example is weighted higher than the guide wire 20 of the second reference example. Figures 9-10As shown by the thin line, even in the test using the guidewire 20 alone, the guidewire 20 of Example 2 achieved a higher weight gain than the guidewire 20 of Reference Example 2. Specifically, it was confirmed that the guidewire 20 of Example 2 achieved higher penetrability than the guidewire 20 of Reference Example 2 not only when combined with the penetrating catheter 40 and the inner catheter 30, but also when used alone. Furthermore, it was confirmed that the guidewire 20 of Example 2 achieved a greater increase in weight gain than the guidewire 20 of Reference Example 2 when combined with the penetrating catheter 40 and the inner catheter 30, compared to when used alone, and thus achieved higher penetrability than the guidewire 20 of Reference Example 2.

[0068] in addition, Figures 9-10 The load ratio of the guide wire 20 in the second example Figures 7-8 The load on the guide wire 20 of the first example is small. It can be considered that this is because the guide wire 20 of the second example has a guide wire bend 25 that the guide wire 20 of the first example does not have, so the position of contact with the receiving portion 120 is offset horizontally from just below the pressing portion 110.

[0069] Figure 11 The results of the load test on the guide wire 20 alone are shown. Figure 11 The solid lines indicate the test results of the first to fourth examples of the guide wire 20 including the core wire 21 that does not include a distal end constant outer diameter portion having a constant outer diameter on the distal end side of the core wire tap portion 24 . Figure 11 The broken lines indicate the test results of the first to fourth reference examples of the guide wire 20 including the core wire 21 having a distal end constant outer diameter portion having a constant outer diameter on the distal end side of the core wire tap portion 24 .

[0070] Figure 11 In addition to the test results of the first case with a front end bending angle α of 0 degrees and the second case with a front end bending angle α of 40 degrees, the solid line also shows the test results of the third case with a front end bending angle α of 30 degrees and the fourth case with a front end bending angle α of 25 degrees. Figure 11 In addition to the test results of the first reference example with a front end bending angle α of 0 degrees and the second reference example with a front end bending angle α of 40 degrees, the dotted line also shows the test results of the third reference example with a front end bending angle α of 30 degrees and the fourth reference example with a front end bending angle α of 25 degrees. Figure 11 As a result, it was confirmed that the guide wires 20 of the first to fourth examples, in which the tip bending angle α was 25 to 40 degrees, were heavier than the guide wires 20 of the first to fourth reference examples and could achieve high penetrability.

[0071] As described above, the guidewire 20 of the first example includes a long metal core wire 21 and a coating 22 that covers the core wire 21 and is softer than the core wire 21. The core wire 21 includes a constant outer diameter portion 23 having a constant outer diameter and a core taper portion 24 whose outer diameter tapers from the distal end of the constant outer diameter portion 23 to the distal end of the core wire 21. The portion of the guidewire 20 having the core taper portion 24 is formed into a straight line. In a load test in which the guidewire 20 is pushed forward in the distal direction with the distal end of the guidewire 20 in contact with the non-slip receiving portion 120, the measured load increases exceeded 0.04 N for 0.05 mm, 0.05 N for 0.1 mm, and 0.05 N for 0.2 mm. Since the guidewire 20 of the first example exhibits a high load increase during the load test, it has high penetrability into the lesion.

[0072] In addition, the guide wire 20 of the second example includes a core wire 21 formed of a long metal and a coating layer 22 covering the core wire 21 and being softer than the core wire 21. In the guide wire 20, the core wire 21 includes a core wire outer diameter constant portion 23 having a constant outer diameter and a core wire taper portion 24 having an outer diameter tapered from the front end of the core wire outer diameter constant portion 23 to the front end of the core wire 21. The guide wire 20 includes a guide wire front end 27 at the front end, a guide wire curved portion 25 located at the base end side of the guide wire front end 27 and curved, and a straight guide wire straight portion 26 located at the base end side of the guide wire curved portion 25. The angle at which the line segment connecting the guidewire tip 27 and the curved base 28 is inclined relative to the extension of the guidewire straight portion 26, i.e., the tip bend angle α, is 25 to 40 degrees. In a load test in which the tip of the guidewire 20 is brought into contact with the non-slip receiving portion 120, with the guidewire 20 inserted into the inner catheter 30 and then inserted into the penetrating catheter 40, and the weight added when the guidewire 20 is pushed forward, the measured weight added exceeded 0.02 N when pushed forward by 0.2 mm and exceeded 0.04 N when pushed forward by 2.0 mm. Because the guidewire 20 of Example 2 includes the guidewire curved portion 25, the orientation of the tip can be adjusted by rotation, improving operability. Furthermore, because the guidewire 20 of Example 2 exhibits a high weight added during the load test, it has high penetrability into the lesion.

[0073] Furthermore, the catheter system 10 includes a penetrating catheter 40 for penetrating a venous lesion, an inner catheter 30 insertable into the penetrating catheter 40, and a first example of a guidewire 20 insertable into the inner catheter 30. In a load test of the catheter system 10, in which the load applied when the catheter system 10 was advanced in the distal direction was measured with the inner catheter 30 inserted into the penetrating catheter 40, the guidewire 20 inserted into the inner catheter 30, and the distal end of the guidewire 20 abutting against the non-slip receiving portion 120, the measured load exceeded 0.1 N when the catheter system 10 was advanced 0.2 mm. Since the catheter system 10 exhibited a high load applied in the load test, it exhibited high penetrability into the lesion.

[0074] Furthermore, the catheter system 10 includes a penetrating catheter 40 for penetrating a venous lesion, an inner catheter 30 insertable into the penetrating catheter 40, and a second guidewire 20 insertable into the inner catheter 30. In a load test measuring the load applied when the catheter system 10 was advanced distally, with the inner catheter 30 inserted into the penetrating catheter 40, the guidewire 20 inserted into the inner catheter 30, and the tip of the guidewire 20 abutting against the non-slip receiving portion 120, the measured load exceeded 0.02 N for 0.2 mm and exceeded 0.04 N for 2.0 mm. Because the catheter system 10 includes a guidewire bend 25 on the guidewire 20, the tip's orientation can be adjusted by rotation, improving operability. Furthermore, the high load applied during the load test indicates that the catheter system 10 has high penetrability into the lesion.

[0075] It should be noted that the present invention is not limited to the above-described embodiments and is capable of various modifications by those skilled in the art within the technical scope of the present invention. For example, the seat portion connected to the proximal end of each catheter body may be equipped with a valve body or port, or may not be equipped with a valve body or port. Furthermore, a kink-preventing sheath may be provided between the catheter body and the seat portion to cover the area between the catheter body.

[0076] In addition, this application is based on Japanese Patent Application No. 2023-114344 filed on July 12, 2023, the disclosure of which is incorporated herein by reference and in its entirety.

[0077] Description of Reference Numerals

[0078] 10 Catheter system

[0079] 20 Guidewire

[0080] 21 core wire

[0081] 22 coating layer

[0082] 23 Core wire outer diameter constant part

[0083] 24 core tap section

[0084] 25 Guidewire bend

[0085] 26 Guidewire straight part

[0086] 27 Guidewire front end

[0087] 28 curved base

[0088] 30 inner catheter

[0089] 40 Penetrating catheter

[0090] 41 2nd pipe body (pipe body)

[0091] 45 outer diameter constant part

[0092] 46 outer cone

[0093] 47 Constant inner diameter portion

[0094] 48 medial cone

[0095] 49 Front end inner diameter constant part

[0096] 50 bend

[0097] 100 Load test device

[0098] 110 Pressing part

[0099] 120 Undertaking Department

[0100] α Front bend angle.

Claims

1. A penetrating catheter, characterized in that: Used for penetration of venous lesions, The penetrating catheter has a tubular body, which includes: an outer diameter constant portion having a constant outer diameter along the longitudinal direction; an outer tapered portion having an outer diameter tapered from the front end of the outer diameter constant portion toward the front end; an inner diameter constant portion having a constant inner diameter along the longitudinal direction; and an inner tapered portion having an inner diameter tapered from the front end of the inner diameter constant portion toward the front end. The outer diameter of the constant outer diameter portion is 2.7±0.1 mm, the inner diameter of the constant inner diameter portion is 1.6±0.1 mm, the outer diameter of the front end of the tube body is 1.7±0.1 mm, and the inner diameter of the front end of the tube body is 1.45±0.1 mm.

2. The penetrating catheter according to claim 1, wherein The tube body has a bent portion at a front end portion that is bent at an angle of 20 to 30 degrees.

3. A disposal method, characterized in that: The lesion site of the vein is penetrated. In this treatment method, When the inner catheter is inserted into the penetrating catheter and the guide wire is inserted into the inner catheter, the penetrating catheter, the guide wire and the inner catheter are penetrated into the diseased part of the vein. The penetrating catheter has a tubular body, which has: an outer diameter constant portion with a constant outer diameter along the longitudinal direction; an outer tapered portion with an outer diameter that decreases in a tapered shape from the front end toward the front end of the outer diameter constant portion; an inner diameter constant portion with an inner diameter that is constant along the longitudinal direction; and an inner tapered portion with an inner diameter that decreases in a tapered shape from the front end toward the front end of the inner diameter constant portion. The outer diameter of the outer diameter constant portion is 2.7±0.1 mm, the inner diameter of the inner diameter constant portion is 1.6±0.1 mm, the outer diameter of the front end of the tubular body is 1.7±0.1 mm, and the inner diameter of the front end of the tubular body is 1.45±0.1 mm.

4. A guide wire, characterized in that: The invention comprises a long core wire formed of metal, and a coating layer covering at least the front end of the core wire and being softer than the core wire. The core wire includes a core wire outer diameter constant portion having a constant outer diameter, and a core wire taper portion having an outer diameter that decreases in a tapered shape from a front end of the core wire outer diameter constant portion to a front end of the core wire. The portion of the guide wire having the core tap portion is formed into a straight line. In a load test in which the increase in weight when the guide wire is pushed toward the front end direction is measured while the front end of the guide wire is in contact with a receiving portion that has been subjected to an anti-slip treatment, the measured increase in weight exceeds 0.04N when the guide wire is pushed forward by 0.05mm, exceeds 0.05N when the guide wire is pushed forward by 0.1mm, and exceeds 0.05N when the guide wire is pushed forward by 0.2mm.

5. A guide wire, characterized in that: The invention comprises a long core wire formed of metal, and a coating layer covering at least the front end of the core wire and being softer than the core wire. The core wire includes a core wire outer diameter constant portion having a constant outer diameter, and a core wire taper portion having an outer diameter that decreases in a tapered shape from a front end of the core wire outer diameter constant portion to a front end of the core wire. The guide wire comprises a guide wire front end at the front end, a guide wire curved portion located at the base end side of the guide wire front end and curved, and a straight guide wire straight portion located at the base end side of the guide wire curved portion. The angle at which the line segment connecting the guide wire front end and the curved base is inclined relative to the extension line of the guide wire straight portion, i.e., the front end bending angle α, is 25 to 40 degrees. In a load test in which the front end of the guide wire was brought into contact with a receiving portion having an anti-slip treatment while the guide wire was inserted into the inner catheter and the inner catheter was inserted into the penetrating catheter, and the weight added when the guide wire was pushed toward the front end was measured, the measured weight added exceeded 0.02N when pushed by 0.2mm and exceeded 0.04N when pushed by 2.0mm.

6. A catheter system, characterized in that: A penetrating catheter for penetrating a lesion site of a vein, an inner catheter insertable into the penetrating catheter, and the guide wire according to claim 4 insertable into the inner catheter, In a load test in which the inner catheter is inserted into the penetrating catheter, the guide wire is inserted into the inner catheter, and the front end of the guide wire is abutted against the receiving portion having an anti-slip treatment, the weight added when the catheter system is pushed toward the front end is measured. The measured weight added exceeds 0.1N when pushed 0.2mm.

7. A catheter system, characterized in that: A penetrating catheter for penetrating a lesion site of a vein, an inner catheter insertable into the penetrating catheter, and the guide wire according to claim 5 insertable into the inner catheter, In a load test in which the increase in weight when the catheter system is pushed toward the front end is measured while the inner catheter is inserted into the penetrating catheter, the guide wire is inserted into the inner catheter, and the front end of the guide wire is in contact with the receiving portion that has been subjected to an anti-slip treatment, the measured increase in weight exceeds 0.02N when pushed forward by 0.2mm and exceeds 0.04N when pushed forward by 2.0mm.

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