Auxiliary tool for medical device, guide wire assembly, and medical device assembly

Abstract

To provide an auxiliary tool for medical device, a guide wire assembly, and a medical device assembly, that enable continuous use of a guide wire under use even if size change of the guide wire is required during inspection or therapy, and also allow easy exchange of catheter.SOLUTION: An auxiliary tool for medical device 1 includes a tubular body portion 2 provided with an inner wall 1c and an outer wall 1d extending from a distal side A to a proximal side B while maintaining the same inner diameter and outer diameter, a guide wire 110 being inserted inside the inner wall 1c to be advanced and retracted, and a catheter 120 being removably mounted on the outside of the outer wall 1d from the proximal side B.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to an auxiliary tool for a medical device, a guidewire assembly, and a medical device assembly. [Background technology]

[0002] In recent years, a catheter assisting device has been proposed that enables the use of a catheter with a larger diameter than the size of a guidewire in use without changing the guidewire (see, for example, Patent Document 1).

[0003] In catheter examinations and treatments such as endoscopic retrograde cholangiopancreatography and endoscopic ultrasound-guided biliary drainage, a guidewire is inserted into the body lumen prior to the catheter, and the catheter is advanced to the target site within the body lumen so that it covers the guidewire. Catheters inserted into body lumen are often used by switching between multiple types of catheters depending on the site and purpose of the examination or treatment. When exchanging catheters, if the guidewire does not fit into the lumen of that catheter, it must be exchanged for a compatible guidewire.

[0004] Advances in medical devices, including drug therapy, radiation therapy, and guidewires, have led to an increasing number of cases in which medical devices are delivered to lesions with severe stenosis or deep peripheral areas. As a result, not only is the torque performance of guidewires required, but there has also been a slight increase in the use of thin guidewires of 0.018 inches (approximately 0.46 mm) in addition to the 0.035 inch (approximately 0.89 mm) and 0.025 inch (approximately 0.64 mm) guidewires used in conventional endoscopic treatment.

[0005] However, there are few catheters that are compatible with thin-diameter guidewires (e.g., 0.018 inches (approximately 0.46 mm)), and there are cases where the catheter cannot follow the guidewire due to snagging caused by the large clearance between the catheter and guidewire used in combination, or due to the guidewire's insufficient rigidity, making it difficult to insert other medical devices after the guidewire has been inserted.

[0006] The catheter assist device described in Patent Document 1 is longer than the catheter assist device and comprises a tube having an inner diameter (0.30 mm) that allows a guidewire with an outer diameter of 0.010 inches (0.25 mm) to be inserted therethrough, and an outer diameter (0.04 mm) that fits into a lumen of a catheter with an inner diameter of 0.014 inches (0.36 mm); an enlarged-diameter section provided at the most proximal end (base end) of the tube to prevent the assist device from getting ahead of the catheter and to prevent the catheter assist device from falling off the catheter, and having an outer diameter that increases more than the outer diameter of the tube as it moves toward the proximal end; and a reduced-diameter section provided at the most distal end of the tube, having an outer diameter that decreases more than the outer diameter of the tube as it moves toward the distal end to prevent the assist device from getting caught inside a blood vessel. The catheter assist device is used in treating the coronary arteries, etc., that supply blood to the heart. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] Japanese Patent Application Laid-Open No. 2011-255001 Summary of the Invention [Problem to be solved by the invention]

[0008] Conventional catheter assist devices have an enlarged diameter section at the proximal end (base end), which means that the catheter can only be replaced at the distal end (tip end) of the catheter assist device. Therefore, when replacing a catheter while the guidewire is still inserted, it is necessary to replace not only the catheter but also the catheter assist device, making catheter replacement time-consuming.

[0009] The object of the present invention is to provide an auxiliary device for medical devices, a guidewire assembly, and a medical device assembly that allow the guidewire currently in use to be used as is even if it becomes necessary to change the size of the guidewire during examination or treatment, and that also allows for easy catheter replacement. [Means for solving the problem]

[0010] [1] A tubular main body portion having an inner wall and an outer wall, each of which has the same inner diameter and outer diameter, extending from the distal end side to the proximal end side, A guide wire is inserted inside the inner wall so as to be able to advance and retreat, and a catheter is attached to the outside of the outer wall so as to be replaceable from the base end side. [2] The inner wall has an inner diameter that allows the guide wire, which has a small diameter, to be inserted therethrough; The medical device auxiliary device according to [1], wherein the outer wall has an outer diameter corresponding to the outer diameter of a guide wire that is thicker than the guide wire to be inserted. [3] The auxiliary device for medical devices according to [2], wherein the tubular main body includes a reinforcing layer formed by a linear member. [4] The tubular main body comprises an inner layer constituting the inner wall and made of a material having slipperiness relative to the guide wire, and an outer layer constituting the outer wall and made of a material having flexibility and rigidity; The auxiliary device for medical devices according to [3], wherein the reinforcing layer is formed between the inner layer and the outer layer. [5] The auxiliary device for medical devices according to [4], wherein the reinforcing layer includes a coil body formed by spirally winding the linear member. [6] The auxiliary device for medical devices according to [4], wherein the reinforcing layer includes a braid formed by weaving a plurality of the linear members together. [7] Further comprising a tip portion provided on the tip side of the tubular main body portion, at least the surface of which is formed from resin; The auxiliary device for medical devices described in [4] above, wherein the tip portion has a circular cross section, and the outer diameter of the end portion on the tubular main body side is not larger than the outer diameter of the tubular main body, and the outer surface is formed so that the outer diameter becomes smaller toward the tip. [8] A base end portion is provided on the base end side of the tubular main body portion, and at least the surface thereof is formed from a resin, The base end portion has a circular cross section, and the outer diameter of the end portion on the tubular main body side is not larger than the outer diameter of the tubular main body portion, and the outer surface is formed so that the outer diameter becomes smaller toward the base end. [9] The auxiliary device for medical devices according to [4], wherein the Shore hardness of the material constituting the outer layer is 63D or more and 78D or less.

[10] The medical device auxiliary device according to [9], wherein the total length of the medical device auxiliary device is 1500 mm or more.

[11] The total length of the medical device auxiliary device is 4000 mm or more; The medical device auxiliary device described in [9] above.

[12] The medical device auxiliary device according to any one of [1] to

[11] above, A guide wire inserted inside the inner wall of the medical device auxiliary tool; A guidewire assembly comprising:

[13] The medical device auxiliary device according to any one of [1] to

[11] above, A guide wire inserted inside the inner wall of the medical device auxiliary tool; a catheter attached to the outside of the outer wall of the medical device auxiliary; A medical device assembly comprising:

[14] The medical device assembly described in

[13] , wherein the clearance between the outer diameter of the outer wall of the medical device auxiliary and the inner diameter of the lumen of the catheter is 0.005 mm or more and 0.05 mm or less. [Effects of the Invention]

[0011] According to the inventions of claims 1, 12 and 13, even if it becomes necessary to change the size of the guidewire during examination or treatment, the guidewire currently in use can be used as is, and the catheter can be easily replaced. According to the invention of claim 2, by inserting the guide wire inside the inner wall of the tubular main body of the medical device auxiliary, the guide wire can be made thicker in terms of outer diameter, mechanical properties (rigidity, hardness, tensile modulus, etc.). According to the invention of claim 3, the target bending rigidity can be obtained by selecting the material and thickness of the linear members of the reinforcing layer. According to the inventions of claims 4 to 6, the linear member has a smooth surface relative to the guide wire, and by selecting the material and thickness of the linear member and the materials of the inner and outer layers, the desired mechanical properties can be obtained. According to the invention of claim 7, the auxiliary tool for medical equipment can be easily inserted into a body lumen. According to the invention of claim 8, it becomes easy to attach the catheter to the auxiliary tool for medical equipment. According to the invention of claim 9, by inserting a guide wire with a small diameter (e.g., 0.018 inches (approximately 0.46 mm)) inside the inner wall of the tubular main body, the guide wire and the entire medical device auxiliary device can obtain mechanical properties equivalent to those of a guide wire with a large diameter (e.g., 0.025 inches (approximately 0.64 mm)). According to the invention of claim 10, it can be used for catheter examination and treatment without using an ultrasonic endoscope or other endoscope. According to the invention of claim 11, it can be used for catheter examination and treatment under the guidance of an ultrasonic endoscope or other endoscope. According to the invention of claim 14, the clearance between the outer diameter of the outer wall of the auxiliary tool for medical equipment and the inner diameter of the lumen of the catheter is reduced, thereby improving the operability of the catheter. [Brief explanation of the drawings]

[0012] [Figure 1] FIG. 1 is a front view showing an example of a medical device assembly according to an embodiment of the present invention. [Figure 2] FIG. 2 is a schematic diagram for explaining the problem that occurs when the auxiliary tool for medical equipment shown in FIG. 1 is not used. [Figure 3] FIG. 3 is a schematic diagram for explaining the effect when the auxiliary tool for medical equipment shown in FIG. 1 is used. [Figure 4] FIG. 4 is a longitudinal sectional view showing a specific example of the configuration of the auxiliary tool for medical equipment shown in FIG. [Figure 5] FIG. 5(a) is a front view showing a schematic example of a reinforcing layer made of a coil body, and FIG. 5(b) is a front view showing a main part of a modified example of the reinforcing layer made of a coil body. [Figure 6] FIG. 6(a) is a front view showing a schematic example of a reinforcing layer made of a braid, and FIG. 6(b) is an enlarged view of part C in FIG. 6(a). [Figure 7] FIG. 7 is a schematic diagram for explaining an example of endoscopic ultrasound-guided biliary drainage. [Figure 8] FIG. 8 is a longitudinal sectional view showing a first modification of the auxiliary tool for medical instruments according to the present embodiment. [Figure 9] FIG. 9 is a longitudinal sectional view showing a second modification of the auxiliary tool for medical instruments according to the present embodiment. [Figure 10] 10(a) to 10(e) are front views of the main part showing an example of the manufacturing process of the second modification. DETAILED DESCRIPTION OF THE INVENTION

[0013] Hereinafter, embodiments of the present invention will be described with reference to the drawings. In the drawings, components having substantially the same functions are designated by the same reference numerals, and redundant description thereof will be omitted.

[0014] [Embodiment Mode] 1 is a front view showing an example of a medical device assembly according to an embodiment of the present invention. In this specification, the side inserted into a living body is referred to as the distal side A, and the side operated by the surgeon is referred to as the proximal side B.

[0015] (Medical device assembly configuration) This medical device assembly 100 includes a medical device auxiliary 1 having a long tubular main body 2 with an inner wall 1c and an outer wall 1d having a circular cross section and extending from a distal end A (the distal end 1a side) to a proximal end B (the proximal end 1b side) with the same inner and outer diameters, a guidewire 110 inserted inside the inner wall 1c of the tubular main body 2 (a lumen 1e defined by the inner wall 1c) so as to be able to advance and retreat, and a catheter 120 replaceably attached to the outside of the outer wall 1d from either the distal end A or the proximal end B side, and is used for examination and treatment of biological lumens (e.g., the digestive tract, bile duct, pancreatic duct, etc.). The guidewire 110 and the catheter 120 are each an example of a medical device. The medical device auxiliary 1 and the guidewire 110 constitute a guidewire assembly.

[0016] (Overview of the composition of medical device auxiliary equipment) The medical device auxiliary 1 has a lumen 1e into which a guidewire 110 with a small diameter (e.g., 0.018 inches (approximately 0.46 mm)) can be inserted, and an outer wall 1d having an outer diameter equivalent to the outer diameter of a guidewire with a larger diameter (e.g., 0.025 inches (approximately 0.64 mm)) than the small diameter guidewire 110. With this configuration, by inserting the small diameter guidewire 110 into the lumen 1e, the medical device auxiliary 1 increases the diameter of the guidewire 110 (i.e., substantially increases the diameter) in terms of the outer diameter and mechanical properties (rigidity, hardness, tensile modulus, etc.). The function of this configuration will be described later. Note that the guidewire 110 with a diameter of 0.018 inches (approximately 0.46 mm) may also be increased in diameter to an outer diameter equivalent to the outer diameter of a guidewire with a diameter of 0.035 inches (approximately 0.89 mm). Furthermore, the guide wire 110 having a small diameter of 0.014 inches (approximately 0.36 mm) or 0.016 inches (approximately 0.41 mm) may be increased in diameter to 0.025 inches (approximately 0.64 mm) or 0.035 inches (approximately 0.89 mm).

[0017] Furthermore, the medical device auxiliary 1 has a total length (e.g., 1500 mm or more, or 4000 mm or more) corresponding to the total length of the guide wire 110 to be inserted. By making the total length of the medical device auxiliary 1 1500 mm or more and less than 4000 mm, catheter examination and treatment can be performed without using an ultrasonic endoscope or other endoscope. Furthermore, by making the total length of the medical device auxiliary 1 4000 mm or more, catheter examination and treatment can be performed via an ultrasonic endoscope or other endoscope, i.e., catheter examination and treatment can be performed under the guidance of an ultrasonic endoscope or other endoscope. Note that the total length of the medical device auxiliary 1 may be longer or shorter than the total length of the guide wire 110 to be inserted. The catheter 120 may be replaced from either the distal end side A or the proximal end side B, without being limited to a specific side relative to the outer wall 1d of the medical device auxiliary 1.

[0018] (Guidewire configuration) Various guidewires are commercially available depending on the purpose. For example, when a thin, long guidewire 110 (e.g., an endoscopic guidewire) having an outer diameter of 0.018 inches (approximately 0.46 mm) and a total length of approximately 4500 mm is used, the guidewire 110 can be inserted into a thin tubular organ (lung of the body) such as the bile duct or pancreatic duct located deep within the body.

[0019] The guidewire 110 includes a main body made of, for example, a rigid material (e.g., stainless steel), and a flexible distal end portion provided at the distal end of the main body, having a length of approximately 50 to 130 mm, and made of a flexible and restorable material (e.g., a coil spring). The surface of the main body is coated (e.g., with polytetrafluoroethylene) to enhance its slipperiness within a biological lumen.

[0020] (Catheter configuration) There are several types of catheters 120 depending on the treatment site and purpose, such as balloon catheters, stent delivery catheters, cannulas (also called cholangiography catheters), etc. In the case of a catheter 120 that is compatible with a 0.25-inch guidewire, the total length is approximately 1800 to 2100 mm.

[0021] (Functions of medical device auxiliary tools) The functions of the medical instrument auxiliary tool 1 will be described with reference to Fig. 2 and Fig. 3. Fig. 2 is a schematic diagram for explaining the problem when the medical instrument auxiliary tool 1 shown in Fig. 1 is not used (comparative example). Fig. 3 is a schematic diagram for explaining the effect when the medical instrument auxiliary tool 1 shown in Fig. 1 is used (this embodiment).

[0022] When the medical device auxiliary tool 1 is not used (comparative example), as shown in Fig. 2(a), a guidewire 110 is inserted into the digestive tract 500 before advancing the catheter 120 to a target site in the digestive tract (e.g., the small intestine, duodenum, bile duct, etc.) 500, and when an attempt is made to advance the catheter 120 along the guidewire 110, bending 110a (or meandering) of the guidewire 110 occurs as shown in Fig. 2(b) due to snagging caused by a large clearance between the catheter 120 and the guidewire 110 or insufficient rigidity of the guidewire 110, making it difficult to advance the catheter 120. For this reason, the catheter 120 is advanced to the target site by replacing the guidewire with one having a larger diameter or higher bending rigidity, or by increasing the number of guidewires used.

[0023] On the other hand, when the medical device auxiliary tool 1 is used (this embodiment), as shown in FIG. 3(a), before advancing the catheter 120 to a target portion of the digestive tract (e.g., the small intestine, duodenum, bile duct, etc.) 500, the guidewire 110 inserted into the lumen 1e of the medical device auxiliary tool 1 is inserted into the digestive tract 500. Next, as shown in FIG. 3(b), even when the catheter 120 is advanced along the guidewire 110, the diameter of the guidewire 110 is substantially increased, so that there is no catching due to clearance with the catheter 120, and the mechanical properties (rigidity, hardness, tensile modulus, etc.) of the guidewire 110 are compensated for, so that the occurrence of deflection 110a as in the comparative example can be suppressed. Therefore, the catheter 120 can be advanced to the target portion of the digestive tract 500.

[0024] (Details of the configuration of medical device auxiliary equipment) Figure 4 is a longitudinal cross-sectional view showing a specific example of the configuration of the medical device auxiliary 1 shown in Figure 1. Note that a reinforcing layer 22, which will be described later, is shown schematically. The medical device auxiliary 1 comprises a long tubular main body 2, a distal end portion 3 provided on the distal end side A of the tubular main body 2, and a proximal end portion 4 provided on the proximal end side B of the tubular main body 2. The tubular main body 2, the distal end portion 3, and the proximal end portion 4 are an example of a tubular member.

[0025] (Configuration of tubular main body) The tubular main body 2 is flexible, and the mechanical properties (e.g., bending rigidity) of the combination of a thin-diameter (e.g., 0.018 inches (approximately 0.46 mm)) guide wire 110 and the tubular main body 2 may be similar to the mechanical properties (e.g., bending rigidity) of the main body of a thicker-diameter (e.g., 0.025 inches (approximately 0.64 mm)) guide wire.

[0026] The tubular main body 2 comprises an inner layer 21 whose inner surface constitutes the inner wall 1c and which is made of a material that is slippery relative to the guide wire 110, a reinforcing layer 22 formed of linear members 22a on the outside of the inner layer 21, and an outer layer 23 whose outer surface constitutes the outer wall 1d and which is provided on the outside of the reinforcing layer 22 and which is made of a material that is flexible and highly hard.

[0027] The inner layer 21 defines the lumen 1e. The inner layer 21 can be made of a material that has slipperiness relative to the guidewire 110, such as a fluorine-based resin (e.g., polytetrafluoroethylene, perfluoroalkoxyalkane polymer, etc.), a polyethylene-based resin (e.g., high-density polyethylene, medium-density polyethylene, low-density polyethylene, etc.). The inner diameter of the inner layer 21 is 0.018 inches (approximately 0.46 mm) and has a small clearance with the main body of the guidewire 110 (e.g., a difference between the outer diameter and the inner diameter of 0.005 mm or more and 0.05 mm or less), allowing smooth advancement and retreat (e.g., 0.48 mm).

[0028] The outer layer 23 must have a certain degree of hardness (e.g., a Shore hardness D of 63D or more and 78D or less according to JIS 6253) to support the mechanical properties (rigidity, hardness, tensile modulus, etc.) of the guidewire 110. At the same time, kink resistance is also required, and therefore a material that also has flexibility, such as a polyester resin or a polyamide resin, can be used. The Shore hardness D range of 63D or more and 78D or less corresponds to a tensile modulus of 280MPa or more and 1300MPa or less. The outer diameter of the outer layer 23 corresponds to the outer diameter of the guidewire of 0.025 inches (approximately 0.64mm). Therefore, the clearance with the lumen 121 of the catheter 120 (excluding the large-diameter proximal end portion, etc., where the inner diameter is enlarged) is small (e.g., a difference between the outer diameter and the inner diameter of 0.005mm or more and 0.05mm or less), and the size is such that the catheter 120 can be smoothly replaced (e.g., 0.66mm).

[0029] The reinforcing layer 22 may be composed of a coil formed by spirally winding the linear members 22a, a braid formed by weaving the linear members 22a, a multi-layer braid or coil, or a layered combination of a braid and a coil. The linear members 22a may be, for example, a metal or non-metal wire. Examples of the shape of the linear members 22a include a circular wire and a flat wire. Examples of the metal linear members 22a include wires made of stainless steel, tungsten steel, titanium-nickel alloy (Ti-Ni), and the like. Examples of the non-metal wires include wires made of fluorine fiber, aramid fiber, polyphenylene sulfide fiber, polyarylate fiber, and the like. Details of the reinforcing layer 22 will be described later.

[0030] (Tip configuration) The distal end portion 3 has an annular cross section, and an outer peripheral surface 31 is formed so that the outer diameter of the end portion on the tubular main body 2 side is not larger than that of the tubular main body 2, and the outer diameter decreases toward the distal end 1a. The distal end portion 31 has rounded corners on the distal end side A, for example, to improve the passage of the medical device auxiliary device 1 through a biological lumen. As shown in FIG. 4(b), the distal end portion 3 may be tapered, with the outer diameter decreasing toward the distal end 1a. To prevent damage to the biological lumen, the distal end portion 3 is preferably free of a reinforcing material, and at least its surface is preferably formed from a resin similar to the resin constituting the outer layer 23 of the tubular main body 2. The distal end portion 3 includes an inner layer 21 of the tubular main body 2 extending therefrom. The distal end portion 3 includes a marker 32 made of a Pt-based metal or the like having radiopaque properties, which fixes the terminal end portion 22b (see FIG. 5) described below, and covers the terminal end portion 22b and the marker 32. The marker 32 allows the position of the tip 1a of the medical device auxiliary tool 1 to be confirmed under X-ray photography. Also, instead of the marker 32, an X-ray impermeable material may be mixed into the resin material to form the tip portion 3. Also, the marker 32 does not have to be provided.

[0031] (Configuration of base end) The proximal end 4 has a circular cross section, and the outer diameter of the end on the tubular main body 2 side is not larger than that of the tubular main body 2. The outer diameter of the outer surface 41 is formed so that it decreases toward the proximal end 1b. The inner layer 21 of the tubular main body 2 extends to the proximal end 4, covering the terminal portion 22b (see FIG. 5 ), which will be described later. The outer surface 41 is formed, for example, with rounded corners on the proximal end side B to facilitate attachment of the catheter 120 to the medical device auxiliary 1. The outer surface 41 may also be formed in a tapered shape, with the outer diameter decreasing toward the proximal end 1b. To prevent damage to the catheter 120, the proximal end 4 is preferably free of reinforcing material, and at least its surface is preferably formed from the same resin as the resin constituting the outer layer 23 of the tubular main body 2. The shape of the outer surface 41 of the proximal end 4 is the same as the shape of the outer surface 31 of the distal end 3, and a marker may also be provided on the proximal end 4. This allows both the distal end 3 and the proximal end 4 to be used as the distal end side A.

[0032] (Structure of reinforcing layer) FIG. 5(a) is a front view schematically illustrating an example of a reinforcing layer 22 made of a coil body. FIG. 5(b) is a front view of a main portion illustrating a modified example of the reinforcing layer 22 made of a coil body. As shown in FIG. 5(a), the reinforcing layer 22 may be a coil body formed by spirally winding a linear member 22a. The terminal portion 22b has a closed end (a shape in which the terminal of the coil is in contact with the adjacent coil). The target bending rigidity can be obtained by controlling the pitch and angle of the coil. By forming the reinforcing layer 22 from a coil body and providing the terminal portion 22b, it is possible to prevent the linear member 22a from protruding and becoming exposed from the surface of the outer wall 1d without processing the terminal by crimping or the like.

[0033] 5(b), the reinforcing layer 22 may be formed by spirally winding a linear member 22a on the inner layer 21 to form an inner coil body 221, and by spirally winding the linear member 22a around the outer side of the inner coil body 221 in a direction opposite to the winding direction of the inner coil body 221 to form an outer coil body 222. By doubling the coil body, it is possible to increase the bending rigidity compared to a single coil body.

[0034] FIG. 6(a) is a front view showing a schematic example of a reinforcing layer 22 made of a braid, and FIG. 6(b) is an enlarged view of part C in FIG. 6(a). As shown in FIG. 6, the reinforcing layer 22 may be formed by weaving a plurality of linear members 22a into a mesh shape. The target bending rigidity can be obtained by controlling the pitch and angle of the linear members 22a. Crimps 22c are formed at the ends of the reinforcing layer 22 to prevent the plurality of linear members 22a from coming apart. The reinforcing layer 22 may be formed of a multi-layer braid, or may be formed by combining a braid and a coil in layers.

[0035] (Manufacturing method for medical device auxiliary equipment) Next, an example of a manufacturing method of the medical device auxiliary device 1 will be described. First, a molten resin material constituting the inner layer 21 of the tubular main body 2 is extruded using an extruder. Next, the inner layer 21 and the linear member 22a are rotated relative to each other, and the linear member 22a is spirally wound around the outer surface of the inner layer 21, forming a closed-end terminal portion 22b at the folded-back portion to form the reinforcing layer 22. Next, the outer layer 23 is formed to cover the outside of the inner layer 21 and the reinforcing layer 22. Both ends of the tubular body consisting of the inner layer 21, the reinforcing layer 22, and the outer layer 23 are cut using a cutting means such as a laser cutter to form the tubular main body 2 of a predetermined length. The distal end 3 and the proximal end 4 are formed, for example, by extrusion molding, injection molding, or the like. The distal end 3 is joined to the distal side A of the tubular main body 2 by a known joining method (adhesive, fusion, etc.), and the proximal end 4 is joined to the proximal side B of the tubular main body 2 by a known joining method (adhesive, fusion, etc.). In this manner, the medical device auxiliary tool 1 is manufactured.

[0036] (Example of use in medical device assemblies) Next, an example of use of the medical device assembly 100 will be described with reference to Fig. 7. Fig. 7 is a schematic diagram for explaining an example of endoscopic ultrasound biliary drainage. This figure shows a method of approaching the intrahepatic bile duct from the stomach via the liver as a puncture route in endoscopic ultrasound biliary drainage.

[0037] As shown in the figure, an insertion tube 131 of an ultrasonic endoscope 130 is inserted from the esophagus into a stomach 510, and while observing ultrasonic images by an ultrasonic probe 132 attached to the tip of the insertion tube 131 and X-ray images using a contrast agent, a left bile duct 531 in a liver 530 is punctured from the stomach 510, and a guide wire 110 is inserted deep inside the living body, for example, through the left bile duct 531 and intrahepatic bile duct 532 into a common bile duct 533. Thereafter, a catheter 120 is advanced into the common bile duct 533 following the guide wire 110, and an obstructed portion of the common bile duct 533 is examined and treated.

[0038] (Effects of this embodiment) The medical device assembly 100 according to this embodiment provides the following advantages. (a) By inserting a thin-diameter guidewire 110 into the lumen 1e of the medical instrument auxiliary 1, the thin-diameter guidewire 110 can be substantially enlarged in diameter. This provides an appropriate clearance for the lumen 121 of the catheter 120 used in combination with the thin-diameter guidewire 110, regardless of the thin-diameter guidewire 110, and can compensate for the mechanical properties (rigidity, hardness, tensile modulus, etc.) of the guidewire 110. Therefore, the catheter 120 can be advanced to the target site following the guidewire 110 and the medical instrument auxiliary 1. (b) For example, by increasing the diameter to 0.025 inches (approximately 0.64 mm), there are many catheters that are compatible with the increased diameter of 0.025 inches (approximately 0.64 mm), so there is almost no need to replace the guide wire 110. (c) Since the thin-diameter guide wire 110 can be substantially enlarged to assist in the attachment of the concomitant catheter 120, there is almost no need to replace the medical device auxiliary tool 1 every time the concomitant catheter 120 is replaced. (d) Since the guide wire 110 having a small diameter (for example, 0.018 inches (approximately 0.46 mm)) can be made larger in diameter (for example, 0.025 inches (approximately 0.64 mm)), when a long thin guide wire 110 (for example, a total length of 4500 mm) is used or a long medical device auxiliary device 1 (for example, a total length of 4000 mm or more) is used, it is possible to provide a medical device assembly 100 that is suitable for catheter examinations and treatments such as endoscopic retrograde cholangiopancreatography and endoscopic ultrasound biliary drainage, for example, examinations and treatments of lesions accompanied by severe stenosis or deep peripheral areas.

[0039] (Variation 1) FIG. 8 is a longitudinal cross-sectional view showing a first modified example of the medical device auxiliary tool 1 according to the present embodiment. In FIG. 4, a single wire linear member 22a is spirally wound around the outer peripheral surface of the inner layer 21, but in the first modified example, multiple (three in the figure) linear members 22a are spirally wound around the outer peripheral surface of the inner layer 21. This allows for higher bending rigidity than when a single wire linear member 22a is used. The outer peripheral surface 31 of the distal end portion 3 has rounded corners on the distal end side A, but may be tapered so that the outer diameter decreases toward the distal end 1a, as shown in FIG. 4(b). The outer peripheral surface 41 of the proximal end portion 4 has rounded corners on the proximal end side B, but may be tapered so that the outer diameter decreases toward the proximal end 1b.

[0040] (Variation 2) Fig. 9 is a longitudinal cross-sectional view showing a second modification of the medical device auxiliary tool 1 according to this embodiment. In Fig. 4, terminal portion 22b is provided at the end of reinforcing layer 22, but in the second modification, terminal portion 22b is omitted and crimping 22c is added. Although the outer peripheral surface 31 of distal end portion 3 has rounded corners on distal end side A, it may be formed in a tapered shape in which the outer diameter decreases toward distal end 1a, as shown in Fig. 4(b). Furthermore, the outer peripheral surface 41 of proximal end portion 4 has rounded corners on proximal end side B, but it may be formed in a tapered shape in which the outer diameter decreases toward proximal end 1b.

[0041] 10(a) to 10(e) are front views of the main part showing an example of the manufacturing process of Modification Example 2. These figures show the manufacturing process of the distal end side A, but the proximal end side B is also manufactured in the same manner as the distal end side A. An inner layer 21 longer than the desired length (the entire length of the medical device auxiliary 1) is prepared, and a linear member 22a is spirally wound around the outer circumferential surface of the inner layer 21 to both ends to form a reinforcing layer 22. Here, closed-end terminal portions 22b are not formed. Next, an outer layer 23 is formed on the outside of the reinforcing layer 22 to produce a tubular body. Next, the tubular body is cut to the desired length. Next, as shown in FIG. 10(a), the outer layer 23 on both ends of the tubular body is removed by grinding, laser, or the like to expose the linear members 22a.

[0042] Next, as shown in FIG. 10(b), the vicinity of the end of the linear member 22a is fixed by a crimp 22c. Next, as shown in FIG. 10(c), the linear member 22a exposed from the crimp 22c is removed by electrolytic polishing or the like. The crimp 22c of the distal end 3 may be formed from a Pt-based alloy or the like having radiopacity. The crimps 22c of the distal end 3 and the proximal end 4 may be formed from a Pt-based metal or the like having radiopacity. This allows both the distal end 3 and the proximal end 4 to be used as the distal side A.

[0043] Next, as shown in Fig. 10(d), the crimp 22c and the inner layer 21 exposed from the crimp 22c are covered with a molded body obtained by molding the tube constituting the distal end portion 3 by extrusion molding or the like. Next, as shown in Fig. 10(e), the molded body is adhered to the crimp 22c and the inner layer 21 by heat welding or the like to be integrated, and the corners are rounded by polishing or the like to form the distal end portion 3 on the distal side A. The base end portion 4 on the proximal side B is also formed in the same manner as the distal end portion 3.

[0044] According to the second modification, by preparing the inner layer 21 in a length that allows multiple pieces to be obtained, multiple medical instrument auxiliary tools 1 can be easily manufactured.

[0045] Although the embodiments of the present invention have been described above, the embodiments of the present invention are not limited to the above-described embodiments, and various modifications and implementations are possible. [Explanation of symbols]

[0046] 1...medical device auxiliary tool, 1a...tip, 1b...base end, 1c...inner wall, 1d...outer wall, 1e...lumen, 2...tubular main body portion, 3...tip portion, 4...base end portion, 21...inner layer, 22...reinforcing layer, 22a...linear member, 22b...terminal portion, 22c...crimping, 23...outer layer, 31...outer peripheral surface, 32...marker, 41...outer peripheral surface, 42...through hole, 100...medical device assembly, 110 ...guide wire, 110a...flexibility, 120...catheter, 121...lumen, 130...ultrasound endoscope, 131...insertion tube, 132...ultrasound probe, 221...inner coil body, 222...outer coil body, 500...digestive tract, 510...stomach, 520...bile duct, 530...liver, 531...left bile duct, 532...intrahepatic bile duct, 533...common bile duct, A...tip side, B...base side

Claims

1. a tubular main body having an inner wall and an outer wall, the inner diameter and the outer diameter of which are the same and which extend from the distal end side to the proximal end side; A guide wire is inserted inside the inner wall so as to be able to advance and retreat, and a catheter is attached to the outside of the outer wall so as to be replaceable from the base end side. Medical equipment aids.

2. the inner wall has an inner diameter that allows the guide wire, which has a small diameter, to be inserted therethrough; The outer wall has an outer diameter corresponding to an outer diameter of a guide wire thicker than the guide wire to be inserted. The medical device auxiliary according to claim 1.

3. The tubular main body portion includes a reinforcing layer formed by a linear member. The medical device auxiliary according to claim 2.

4. the tubular main body portion includes an inner layer constituting the inner wall and made of a material having slipperiness relative to the guide wire, and an outer layer constituting the outer wall and made of a material having flexibility and rigidity, The reinforcing layer is formed between the inner layer and the outer layer. The medical device auxiliary according to claim 3.

5. The reinforcing layer includes a coil body formed by spirally winding the linear member.

5. The medical device auxiliary according to claim 4.

6. The reinforcing layer includes a braid formed by braiding a plurality of the linear members.

5. The medical device auxiliary according to claim 4.

7. a tip portion provided on the tip side of the tubular main body portion, at least a surface of which is formed from resin; The tip portion has an annular cross section, and the outer diameter of the end portion on the tubular main body side is not larger than the outer diameter of the tubular main body, and the outer diameter is formed so that it becomes smaller toward the tip.

5. The medical device auxiliary according to claim 4.

8. a base end portion provided on the base end side of the tubular main body portion, at least a surface of which is formed from resin, The base end portion has a circular cross section, and the outer diameter of the end portion on the tubular main body portion side is not larger than the outer diameter of the tubular main body portion, and the outer diameter is formed so that it becomes smaller toward the base end. The medical device auxiliary according to claim 7.

9. The Shore hardness of the material constituting the outer layer is 63D or more and 78D or less.

5. The medical device auxiliary according to claim 4.

10. The total length of the medical device auxiliary tool is 1500 mm or more.

10. The medical device auxiliary according to claim 9.

11. The total length of the medical device auxiliary tool is 4000 mm or more.

10. The medical device auxiliary according to claim 9.

12. An auxiliary device for medical equipment according to any one of claims 1 to 11; A guide wire inserted inside the inner wall of the medical device auxiliary tool; A guidewire assembly comprising:

13. An auxiliary device for medical equipment according to any one of claims 1 to 11; A guide wire inserted inside the inner wall of the medical device auxiliary tool; a catheter attached to the outside of the outer wall of the medical device auxiliary; A medical device assembly comprising:

14. a clearance between the outer diameter of the outer wall of the medical device auxiliary and the inner diameter of the lumen of the catheter of 0.005 mm or more and 0.05 mm or less; 14. The medical device assembly of claim 13.

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