medical equipment

Abstract

To provide medical equipment capable of achieving good operability.SOLUTION: Medical equipment 100 is equipped with a tubular body 10, which is a long-sized hollow tube made of resin. In at least a part in a longitudinal direction of the tubular body 10, there are a plurality of air gaps 25 dotted in the resin. and a flexible part 30 is disposed, which can be easily bent in a direction intersecting with an axial direction of the tubular body 10. The plurality of air gaps 25 are disposed dispersed in a circumferential direction and an axial direction. The plurality of air gaps 25 are extended in the circumferential direction respectively or in the axial direction respectively. The lumen of the tubular body 10 is fluid-tightly protected from the outside by a tube wall of the tubular body 10.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] The present invention relates to medical devices. [Background technology]

[0002] There are types of medical instruments that are inserted into a body cavity and used to inject a liquid such as a medicinal solution into the body cavity. For example, an example of such a medical instrument is described in Patent Document 1. The medical instrument of Patent Document 1 (referred to as a catheter in the document) includes a tubular body (referred to as a catheter body in the document) that is a long tubular member, and is capable of supplying a liquid such as a medicinal solution into the body cavity through the lumen of the tubular body. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] JP 2020-162645 A Summary of the Invention [Problem to be solved by the invention]

[0004] According to the investigations of the present inventors, the structure of the medical instrument of Patent Document 1 leaves room for improvement in terms of operability of the medical instrument.

[0005] The present invention has been made in view of the above problems, and provides a medical instrument that can achieve good operability. [Means for solving the problem]

[0006] According to the present invention, there is provided a medical device including a tubular body that is a long hollow tube made of resin, a flexible portion having a plurality of voids scattered in a resin and easily bending in a direction intersecting an axial direction of the tubular body is disposed in at least a portion in a longitudinal direction of the tubular body, The plurality of voids are arranged dispersedly in the circumferential direction and the axial direction, The plurality of voids each extend in a circumferential direction or each extend in an axial direction, The inner cavity of the tubular body is liquid-tightly sealed from the outside by the tubular wall of the tubular body. And, the flexible portion is disposed in a middle portion of the tubular body in a longitudinal direction, The portion of the tubular body that is distal to the flexible portion has a medical tube having a higher bending rigidity than the flexible portion. A therapeutic device is provided. [Effects of the Invention]

[0007] According to the present invention, good operability of the medical instrument can be achieved. [Brief explanation of the drawings]

[0008] [Figure 1] 1 is a schematic diagram showing the overall configuration of a medical device according to a first embodiment. [Figure 2] FIG. 2 is a cross-sectional view of a tubular body in the first embodiment. [Figure 3] FIG. 3 is a partially enlarged view of a gap in the first embodiment. [Figure 4] FIG. 10 is a schematic diagram showing the overall configuration of a tubular main body in a second embodiment. [Figure 5] FIG. 10 is a cross-sectional view showing the flexible portion of the tubular body and its surrounding structure in the second embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0009] Hereinafter, each embodiment of the present invention will be described with reference to Figs. 1 to 5. In all drawings, similar components are denoted by the same reference numerals, and descriptions thereof will be omitted where appropriate. Figs. 2 and 3 are cross-sectional views taken along the axial direction of the tubular body 10. In Fig. 3, the vertical direction of the paper surface corresponds to the radial direction of the tubular body 10, and the horizontal direction of the paper surface corresponds to the axial direction of the tubular body 10.

[0010] The embodiments described below are merely examples for facilitating understanding of the present invention and are not intended to limit the present invention. In other words, the shapes, dimensions, arrangements, etc. of the components described below may be changed or improved without departing from the spirit of the present invention, and the present invention also includes equivalents thereof. The various components of the medical device 100 of the present invention do not need to exist independently of one another. It is acceptable for multiple components to be formed as a single member, for one component to be formed from multiple members, for one component to be a part of another component, or for part of one component to overlap with part of another component. In the following description, the distal side of the medical device 100 is also referred to as the tip side, and the proximal side thereof is also referred to as the base side. The tip portion refers to a certain range including the distal end (the most distal end) and its surroundings, and the base portion refers to a certain range including the proximal end (the most proximal end) and its surroundings. In addition, in the following, the axial direction (longitudinal direction) of the tubular body 10 may be simply referred to as the axial direction, the radial direction of the tubular body 10 may be simply referred to as the radial direction, and the circumferential direction of the tubular body 10 may be simply referred to as the circumferential direction.

[0011] [First embodiment] First, the first embodiment will be described with reference to Figures 1 to 3. Figure 2 is a cross-sectional view taken along the axial direction of the tubular body 10, and schematically shows the shapes of the plurality of voids 25. As shown in FIGS. 1 and 2, a medical device 100 according to this embodiment is a medical device including a tubular body 10 that is a long hollow tube made of resin. In at least a portion of the longitudinal direction of the tubular body 10, a flexible portion 30 is arranged, which has a plurality of voids 25 scattered throughout the resin and is easily bent in a direction intersecting the axial direction of the tubular body 10. As shown in FIG. 2, the plurality of voids 25 are arranged dispersedly in the circumferential and axial directions. In this embodiment, the plurality of gaps 25 each extend in the circumferential direction, for example. The inner cavity of the tubular body 10 is liquid-tightly sealed from the outside by the tubular wall of the tubular body 10 .

[0012] The medical device 100 is, for example, a catheter, and is used to supply a liquid such as a contrast agent or a medicinal solution into a body cavity through the lumen of the tubular body 10. However, the medical device 100 may be a medical device other than a catheter that is inserted into a body cavity, as in a second embodiment described below. In this embodiment, the body cavity into which the medical device 100 is inserted is, for example, a blood vessel, but the body cavity may also be, for example, a digestive tract such as the trachea or the intestines.

[0013] According to this embodiment, a flexible section 30 that can be easily bent in a direction intersecting the axial direction of the tubular body 10 is arranged in at least a portion of the longitudinal direction of the tubular body 10. This allows the tubular body 10 to bend more easily in accordance with the shape of a branching portion of a body cavity such as a blood vessel, thereby improving the branching selectivity of the medical device 100. More specifically, the flexible portion 30 has a plurality of voids 25, and therefore has lower bending rigidity than the portions of the tubular main body 10 other than the flexible portion 30. Therefore, the flexible portion 30 can be easily bent in a direction intersecting the axial direction of the tubular main body 10. Furthermore, since the plurality of voids 25 are disposed in a dispersed manner in the circumferential direction and the axial direction, flexibility can be imparted in a well-balanced manner to the entire range in which the plurality of voids 25 are dispersed in the tubular main body 10 . Furthermore, the portions of the tubular main body 10 other than the flexible portion 30 do not have multiple voids 25 or have fewer voids than the flexible portion 30, and therefore have a higher bending rigidity than the flexible portion 30, thereby maintaining an appropriate stiffness of the tubular main body 10. In other words, the tubular main body 10 can achieve both branch selectivity and forward force. As described above, according to this embodiment, the medical device 100 can be easily operated. The bending rigidity referred to here is expressed as the product of the moment of inertia, which is determined by the cross-sectional shape and size of the member, and the Young's modulus of the material. In addition, in this embodiment, the tubular body 10 is made liquid-tight by the portions (resin) of the tubular body 10 that are not the voids 25. Therefore, the lumen of the tubular body 10 is configured so that the liquid flowing inside the lumen does not leak from the tubular body 10 to the outside through the voids 25.

[0014] As described above, the tubular body 10 is an elongated hollow tubular member. As shown in Figures 1 and 2, the tubular body 10 has a two-layer structure, for example, including an inner layer 13 and an outer layer 14 disposed around the inner layer 13, and is configured by laminating the inner layer 13 and the outer layer 14 in this order from the axial center side of the tubular body 10. The inner layer 13 is the innermost layer of the tubular body 10 and is formed, for example, into a cylindrical shape with a constant wall thickness regardless of the position in the axial direction. The inner layer 13 is open at both the distal and proximal ends of the tubular body 10. The lumen of the tubular body 10 is defined, for example, by the inner circumferential surface of the inner layer 13. The outer layer 14 is the outermost layer of the tubular body 10. For example, the majority (majority) of the wall thickness of the tubular body 10 is occupied by the wall thickness of the outer layer 14. Each of the inner layer 13 and the outer layer 14 is made of, for example, a fluorine-based thermoplastic polymer resin, but may also be made of a resin material such as polyurethane, polyethylene, silicone, polyamide, polyamideimide, vinyl chloride, or polyethersulfone. The fluorine-based thermoplastic polymer material is not particularly limited, but may be polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF), or perfluoroalkoxy fluororesin (PFA). The inner layer 13 and the outer layer 14 may be made of the same type of material, or may be made of different types of materials.

[0015] In the present embodiment, as an example, the flexible portion 30 is disposed in the middle portion 35 of the tubular body 10 in the longitudinal direction. The intermediate portion 35 here refers to the portion between the distal end portion 10a (see FIG. 1) and the proximal end portion 10b (see FIG. 1) in the longitudinal direction of the tubular main body 10. The flexible portion 30 may be formed, for example, over the entire intermediate portion 35 in the longitudinal direction of the tubular body 10, or may be formed in a portion of the intermediate portion 35, or may even be formed in multiple portions that are not continuous with each other in the longitudinal direction. In the present embodiment, as an example, the flexible portion 30 is formed over the entire intermediate portion 35 in the longitudinal direction of the tubular body 10 . However, in the present invention, the flexible portion 30 may be arranged in a location other than the intermediate portion 35 of the tubular body 10; for example, the flexible portion 30 may be arranged in the tip portion 10a of the tubular body 10, or in both the intermediate portion 35 and the tip portion 10a.

[0016] The flexible portion has a smaller diameter than, for example, a portion of the tubular main body 10 that is closer to the distal end than the flexible portion 30 (in this embodiment, the distal end 10a). Similarly, the flexible portion has a smaller diameter than, for example, a portion of the tubular main body 10 that is closer to the proximal end than the flexible portion 30 (in this embodiment, the proximal end 10b). That is, the outer diameter of the flexible portion 30 is set to a dimension smaller than the outer diameters of, for example, the distal end 10a and the proximal end 10b. This allows the bending rigidity of the flexible portion 30 to be further reduced, thereby further improving the branching selectivity of the tubular main body 10.

[0017] As shown in Figures 1 and 2, for example, in the tubular body 10, there is no step in the outer shape at the boundary (in this embodiment, boundary portions 37a, 37b) between the flexible portion 30 and the portion further distal or proximal than the flexible portion 30. This makes it possible to further reduce the sliding resistance when the tubular body 10 slides toward the distal end side.

[0018] Furthermore, in a profile (hereinafter sometimes simply referred to as a profile) in which the axial position of the tubular body 10 is the first axis and the bending rigidity of each part of the axial direction of the tubular body 10 is the second axis, the bending rigidity of the tubular body 10 changes continuously at the boundary between the flexible part 30 and the part further distal or proximal than the flexible part 30, and the part further distal or proximal than the flexible part 30 has a higher bending rigidity than the flexible part 30. That is, in the tubular main body 10, at the boundary between the flexible portion 30 and the portion closer to the distal end or the proximal end than the flexible portion 30, the bending rigidity changes continuously without any step. This results in a configuration in which the bending rigidity of the tubular main body 10 changes gradually from the flexible section 30 toward the distal end 10a or the proximal end 10b, allowing the tubular main body 10 to bend while more effectively following the shape of the bifurcation of the body cavity.

[0019] More specifically, in this embodiment, the flexible portion 30 is disposed in the middle portion 35 of the tubular body 10 in the longitudinal direction. 1 and 2, the outer and inner diameters of the boundary 37a between the flexible section 30 and the distal end section 10a are tapered from the distal end side to the proximal end side. Furthermore, in the tubular main body 10, the bending rigidity of the boundary 37a between the flexible section 30 and the distal end section 10a changes continuously, and the bending rigidity of the distal end section 10a is higher than that of the flexible section 30. Similarly, at the boundary 37b between the flexible portion 30 and the base end 10b, the outer diameter and inner diameter taper from the base end side to the tip end side. Furthermore, at the boundary 37b between the flexible portion 30 and the base end 10b in the tubular main body 10, the bending rigidity changes continuously, and the bending rigidity of the base end 10b is higher than that of the flexible portion 30. As a result, in this embodiment, the bending rigidity of the tubular body 10 changes gradually from the flexible portion 30 to the tip portion 10a, and the bending rigidity of the tubular body 10 changes gradually from the flexible portion 30 to the base end portion 10b. In the present invention, for example, when the flexible portion 30 is disposed at the distal end of the distal end portion 10a (i.e., the most distal end of the tubular main body 10), the portion on the proximal side of the flexible portion 30 is the portion on the proximal side of the most distal end of the tubular main body 10, and the portion on the distal side of the flexible portion 30 does not exist. Similarly, when the flexible portion 30 is disposed at the proximal end of the proximal end portion 10b (i.e., the most proximal end of the tubular main body 10), the portion on the distal side of the flexible portion 30 is the portion on the distal side of the most proximal end of the tubular main body 10, and the portion on the proximal side of the flexible portion 30 does not exist.

[0020] The inner and outer diameters of the flexible portion 30 are, for example, approximately constant regardless of the position in the axial direction. Similarly, the inner and outer diameters of the distal end portion 10a are, for example, approximately constant regardless of the position in the axial direction, and the inner and outer diameters of the proximal end portion 10b are, for example, approximately constant regardless of the position in the axial direction. However, the inner and outer diameters of the distal end portion of the distal end portion 10a (the most distal end portion of the tubular main body 10) may be tapered, for example, so that the outer and inner diameters decrease from the proximal end side to the distal end side.

[0021] In the present embodiment, the outer layer 14 of the tubular body 10 is entirely molded as a single unit using the above-mentioned resin material, and the inner layer 13 of the tubular body 10 is also entirely molded as a single unit using the above-mentioned resin material. Therefore, since the flexible portion 30 and the distal end portion 10a and the proximal end portion 10b are integrally formed using a common resin material, the flexible portion 30 and the distal end portion 10a and the proximal end portion 10b can be well maintained in a state where they are joined to each other at the boundaries 37a, 37b.

[0022] The total length of the tubular body 10 is not particularly limited, but is preferably 500 mm or more and 2000 mm or less. The dimension of the flexible portion 30 in the axial direction is not particularly limited, but is preferably 1.0 mm or more and 500 mm or less, and more preferably 2.0 mm or more and 200 mm or less. The outer diameter of the flexible portion 30 is not particularly limited, but is preferably 0.2 mm to 20 mm, more preferably 0.4 mm to 15 mm. The inner diameter of the flexible portion 30 is not particularly limited, but is preferably 0.1 mm to 18 mm. The dimension of each of the boundaries 37a and 37b in the axial direction is not particularly limited, but is preferably 0.1 mm or more and 100 mm or less, and more preferably 0.2 mm or more and 50 mm or less. However, the length, outer diameter, and inner diameter of each part of the tubular body 10 may be set to dimensions other than those described above depending on the application of the medical device 100, etc.

[0023] In this embodiment, the plurality of voids 25 are formed in the outer layer 14 of the intermediate portion 35. However, the plurality of voids 25 may also be formed in the inner layer 13 of the intermediate portion 35, or in both the outer layer 14 and the inner layer 13, for example. As shown in FIG. 3, the flexible portion 30 has, for example, a pair of wall surfaces 28 that face each other with a gap 25 therebetween. When viewed in the opposing direction of the pair of wall surfaces 28, the shapes of the pair of wall surfaces 28 are substantially the same. More specifically, a gap 25 is formed by the pair of wall surfaces 28 in the resin of the tubular body 10. In other words, the gap 25 is defined by the pair of wall surfaces 28. However, in the present invention, the flexible portion 30 does not necessarily have to have a pair of wall surfaces 28, and the void 25 may be, for example, substantially spherical or in some other shape.

[0024] 3, the vertical cross-sectional shape of the aggregate of the pair of wall surfaces 28 is, for example, a complex shape including a plurality of projections and recesses. More specifically, the vertical cross-sectional shape of each of the pair of wall surfaces 28 is, for example, not a straight shape extending in the circumferential direction, but typically a shape that is bent in multiple directions. More specifically, the longitudinal cross-sectional shape of the assembly of the pair of wall surfaces 28 has a width dimension (dimension in the axial direction) that gradually narrows toward both ends in the extension direction of the assembly. One end of one of the pair of wall surfaces 28 in the extension direction is connected to one end of the other wall surface 28 in the extension direction. Similarly, the other end of one of the pair of wall surfaces 28 in the extension direction is connected to the other end of the other wall surface 28 in the extension direction. However, in the present invention, the vertical cross-sectional shape of the assembly of the pair of wall surfaces 28 is not particularly limited, and may be, for example, a shape other than the above. In this embodiment, the plate surfaces of the pair of wall surfaces 28 face, for example, approximately in the axial direction, and therefore the opposing direction of the pair of wall surfaces 28 is approximately in the axial direction. However, in the present invention, the opposing direction of the pair of wall surfaces 28 is not limited to approximately in the axial direction, and may be approximately in the radial direction or another direction, as described below. In this embodiment, it is preferable that the flexible portion 30 has such a pair of wall surfaces 28 in at least a part of the gap 25. In other words, the flexible portion 30 does not necessarily have to have such a pair of wall surfaces 28 throughout the entire gap 25.

[0025] Furthermore, the flexible portion 30 has, for example, a plurality of string-like portions 29 (see FIG. 3) connecting the pair of wall surfaces 28 together. This ensures sufficient tensile strength of the tubular body 10 in the opposing direction of the pair of wall surfaces 28. In this embodiment, as described above, the pair of wall surfaces 28 are disposed substantially opposite each other in the axial direction. Therefore, each string-like portion 29 extends in a direction having an axial component. One end of each string-like portion 29 in the extending direction is connected to one of the pair of wall surfaces 28, and the other end of the string-like portion 29 in the extending direction is connected to the other of the pair of wall surfaces 28. With this configuration, it is possible to ensure sufficient tensile strength of the tubular main body 10 in the axial direction. Each string-like portion 29 may be, for example, straight or curved. Also, a portion of each string-like portion 29 may be branched in multiple directions.

[0026] The method for forming such voids 25 is not particularly limited, but an example thereof is a method for forming the voids 25 by pulling the molded body of the tubular body 10 in the axial direction. However, in the present invention, the method for forming the voids 25 is not limited to this example, and the voids 25 may also be formed by a method for mixing a foaming agent into the resin when molding the outer layer 14 (or each of the outer layer 14 and the inner layer 13) of the tubular body 10, as will be described later. When the gap 25 is formed by pulling the tubular body 10 in the axial direction, the inner diameter of the flexible portion 30 becomes smaller than the inner diameters of the distal end portion 10a and the proximal end portion 10b. Furthermore, when voids 25 are formed by a method of mixing a foaming agent in a resin, the inner diameter of flexible portion 30 may be smaller than or equal to the inner diameters of distal end portion 10 a and proximal end portion 10 b. Similarly, in this case, the outer diameter of flexible portion 30 may be smaller than or equal to the outer diameters of distal end portion 10 a and proximal end portion 10 b. Furthermore, when the flexible portion 30 is formed by pulling the molded body of the tubular main body 10 in the axial direction, a plurality of voids 25 are distributed in the circumferential and axial directions in the flexible portion 30. Each of the plurality of voids 25 extends in the circumferential direction. Each void 25 has a pair of wall surfaces 28 that face each other approximately in the axial direction, and a plurality of string-like portions 29 connecting the pair of wall surfaces.

[0027] In the present invention, the plurality of voids 25 may each extend in the axial direction, for example. That is, the medical device 100 is a medical device including a tubular body 10 that is a long hollow tube made of resin, and a flexible section 30 having a plurality of voids 25 scattered throughout the resin and easily bending in a direction intersecting the axial direction of the tubular body 10 is arranged in an intermediate section 35 in the longitudinal direction of the tubular body 10, and the plurality of voids 25 are dispersed in the circumferential direction and the axial direction, and each of the plurality of voids 25 extends in the axial direction. This configuration also ensures satisfactory radial flexibility of the tubular body 10. Therefore, the tubular body 10 can be more easily bent in a direction intersecting the axial direction. More specifically, when the flexible portion 30 is formed by a method of mixing a foaming agent in a resin, the foaming agent is oriented so that the axial direction and the longitudinal direction of the foaming agent are substantially aligned when the tubular body 10 is molded (for example, by extrusion molding), and therefore the formed voids 25 also have a shape extending in the axial direction. Each void 25 has a pair of wall surfaces 28 that face each other approximately in the radial direction, and a plurality of string-like portions 29 connecting the pair of wall surfaces.

[0028] In this embodiment, the bending rigidity of the flexible portion 30 can be changed by adjusting the occupancy rate of the voids 25 per unit area in the resin. More specifically, increasing the occupancy rate of voids 25 per unit area in the resin can reduce the bending rigidity of the flexible portion 30. On the other hand, decreasing the occupancy rate of voids 25 per unit area in the resin can increase the bending rigidity of the flexible portion 30. Therefore, the bending rigidity of the tubular main body 10 can be appropriately set depending on the application and dimensions of the medical device 100. In addition, by adjusting the occupancy rate of voids 25 per unit area in the resin at the boundaries 37a, 37b, the gradient of the profile at the boundaries 37a, 37b (the portions where the bending rigidity changes continuously) can be changed. More specifically, the gradient of the profile can be reduced by gradually decreasing the occupancy rate of voids 25 per unit area at boundaries 37a, 37b from the flexible portion 30 side toward the distal end 10a and the proximal end 10b side. On the other hand, the gradient of the profile can be increased by rapidly decreasing the occupancy rate of voids 25 per unit area at boundaries 37a, 37b from the flexible portion 30 side toward the distal end 10a and the proximal end 10b side. This makes it possible to realize, for example, a configuration in which the bending rigidity of the tubular body 10 gradually changes from the flexible portion 30 toward the tip portion 10a and the base portion 10b, or a configuration in which the bending rigidity suddenly changes from the flexible portion 30 toward the tip portion 10a or the base portion 10b. When forming voids 25 by pulling the tubular body 10 in the axial direction, the occupancy rate of voids 25 per unit area in the resin can be adjusted by adjusting, for example, the tensile load, tensile speed, temperature, internal tube pressure, etc. Alternatively, as a method for adjusting the occupancy rate of voids 25 per unit area in the resin, when voids 25 are formed by mixing a foaming agent into the resin of the outer layer 14 of the tubular body 10, for example, a method can be used in which the amount of foaming agent mixed in or the processing temperature is adjusted in the axial direction.

[0029] In addition, by adjusting the axial dimensions of the boundary portions 37a, 37b, it is possible to realize, for example, a configuration in which the bending rigidity of the tubular body 10 changes abruptly from the flexible portion 30 toward the tip portion 10a and the base portion 10b, or a configuration in which the bending rigidity changes gradually from the flexible portion 30 toward the tip portion 10a and the base portion 10b. As a method for adjusting the axial dimensions of the boundaries 37a, 37b, when the void 25 is formed by pulling the tubular body 10 in the axial direction, for example, a method can be used in which the distance between the clamped portions of the tubular body 10 and the temperature are adjusted when pulling the tubular body 10 in the axial direction. Alternatively, as a method for adjusting the axial dimensions of the boundaries 37a and 37b, when the voids 25 are formed by mixing a foaming agent into the resin of the outer layer 14 of the tubular body 10, for example, a method can be used in which the amount of foaming agent mixed in or the processing temperature is adjusted in the axial direction.

[0030] In this embodiment, the outer peripheral surface of the tubular body 10 is coated with a hydrophilic coating. This makes it possible to further reduce the sliding resistance when the tubular main body 10 slides toward the distal end side. The material for the hydrophilic coating is not particularly limited, but examples thereof include hydrophilic resin materials such as maleic anhydride polymers such as polyvinyl alcohol (PVA) and copolymers thereof, and polyvinylpyrrolidone.

[0031] The tubular body 10 also includes a reinforcing layer 16 (see FIG. 2) formed in a mesh shape from braided metal wires, for example. The reinforcing layer 16 is, for example, embedded in the outer layer 14 and disposed around the inner layer 13. The reinforcing layer 16 is, for example, disposed coaxially with the inner layer 13. The reinforcing layer 16 is disposed, for example, from the distal end to the proximal end of the tubular body 10. The tubular body 10 is reinforced throughout by the reinforcing layer 16. The reinforcing layer 16 may be formed of, for example, a metal wire wound in a coil shape, and may be disposed on, for example, a portion of the tubular body 10 in the axial direction.

[0032] Furthermore, in this embodiment, as shown in Figure 2, the medical device 100 includes, for example, a first marker member 41 embedded in the tip portion 10a of the tubular body 10, a second marker member 42 embedded in the tip portion of the intermediate portion 35 (flexible portion 30), and a third marker member 43 embedded in the base end portion of the intermediate portion 35. More specifically, as shown in FIG. 2, each of the first to third marker members 41 to 43 is embedded in the tip portion of the outer layer 14, for example. Each of the first to third marker members 41 to 43 is a cylindrical member made of an X-ray impermeable material such as platinum, tungsten, etc. Each of the first to third marker members 41 to 43 is embedded in the outer layer 14 in a coaxial arrangement with the tubular body 10. By using the position of the first marker member 41 as an index, the position of the distal end portion 10a of the tubular main body 10 within the body cavity can be accurately recognized under X-ray (radiation) observation. Furthermore, by using the respective positions of the second marker member 42 and the third marker member 43 as indicators, the position of the intermediate portion 35 (flexible portion 30) of the tubular main body 10 within the body cavity can be accurately recognized under X-ray (radiation) observation.

[0033] As shown in FIG. 1 , the base end 10b of the tubular body 10 is provided with a gripping portion 90 that is gripped by a user. The gripping portion 90 has a connecting portion 91 for inserting a drug solution injection device, such as a syringe or injector (not shown), from its base end. A thread groove is formed on the outer periphery of the connecting portion 91 so that a syringe can be detachably fixed. A hub 92 is provided at the center of the gripping portion 90 in the axial direction. A through-hole is formed in the gripping portion 90, penetrating the gripping portion 90 in the axial direction from the tip to the base end. The base end 10b of the tubular body 10 is inserted into the tip-side portion of this through-hole, and the base end 10b of the tubular body 10 is fixed to the gripping portion 90. The hub 92 has two wing portions 93 that face each other across the axis of the gripping portion 90. By rotating the wing portions 93 around the axis of the grip portion 90, it is possible to perform a torque operation to rotate the entire tubular body 10 about its axis, and it is possible to adjust the direction of the tip of the tubular body 10 that has entered the body cavity. A protector 94 is provided on the tip side of the hub 92, and covers the periphery of the base end of the medical device 100.

[0034] Second Embodiment Next, a second embodiment will be described with reference to Figures 4 and 5. Figure 5 is a cross-sectional view taken along the axial direction of the tubular body, and schematically shows the shapes of the plurality of voids 25. The medical device 100 of this embodiment differs from the medical device 100 of the first embodiment described above in the points described below, but is otherwise configured in the same way as the medical device 100 of the first embodiment described above.

[0035] In the first embodiment, an example was described in which the medical device 100 was a catheter. In the present embodiment, the medical device 100 is, for example, a suction tube used to suction body fluids and the like from a body cavity. In this case, the distal end 10a of the tubular body 10 is placed in the body cavity, and the proximal end 10b is connected to a negative pressure suction source (not shown). The intermediate portion 35 of the tubular body 10 is routed, for example, in a bent state at one or more locations. In this embodiment, too, a flexible portion 30 is arranged in the middle portion 35 in the longitudinal direction of the tubular body 10, which has multiple voids 25 scattered throughout the resin and is easily bent in a direction intersecting the axial direction of the tubular body 10. Therefore, when the tubular main body 10 is placed inside a body cavity, the tubular main body 10 can be easily bent at multiple locations, thereby improving the operability of the medical device 100. Also, the invasiveness of the tubular main body 10 to the inner wall of the body cavity can be reduced. Furthermore, since stress can be prevented from concentrating at the bent portions of the tubular body 10, cracks and breaks due to deterioration over time of the tubular body 10 can be prevented.

[0036] As shown in FIGS. 4 and 5, in this embodiment, a plurality of flexible portions 30 are arranged spaced apart from one another in the axial direction of the tubular body 10. By configuring it in this way, it is possible to realize a configuration that allows the tubular body 10 to be easily bent in a direction intersecting the axial direction, while also obtaining appropriate stiffness in the middle portion 35 of the tubular body 10. More specifically, for example, flexible portions 30 and non-forming regions 31 where no flexible portions 30 are formed are alternately and repeatedly arranged in the axial direction of the tubular body 10. As in the first embodiment, of the boundaries 38a, 38b between the flexible portions 30 and the non-forming regions 31, the boundary 38a on the distal side is tapered such that the outer diameter and inner diameter decrease from the proximal side to the distal side. Similarly, the boundary 38b on the proximal side is tapered such that the outer diameter and inner diameter decrease from the distal side to the proximal side. The number of flexible portions 30 included in the medical device 100 is not particularly limited, and can be set appropriately depending on the axial dimension and application of the tubular body 10. Also, in this embodiment, as in the first embodiment, the number of flexible portions 30 included in the medical device 100 may be one.

[0037] The total length of the tubular body 10 is not particularly limited, but is preferably 100 mm or more and 2000 mm or less. The dimension of the flexible portion 30 in the axial direction is not particularly limited, but is preferably 1.0 mm or more and 500 mm or less, and more preferably 2.0 mm or more and 200 mm or less. The outer diameter of the flexible portion 30 is not particularly limited, but is preferably 0.2 mm to 20 mm, more preferably 0.4 mm to 15 mm. The inner diameter of the flexible portion 30 is not particularly limited, but is preferably 0.1 mm to 18 mm. The dimension of each of the boundaries 38a, 38b in the axial direction is not particularly limited, but is preferably 0.1 mm or more and 100 mm or less, and more preferably 0.2 mm or more and 50 mm or less.

[0038] Although the embodiments have been described above with reference to the drawings, these are merely examples of the present invention, and various other configurations may also be employed.

[0039] For example, in the first embodiment, an example has been described in which the medical device 100 is a non-active catheter, but the medical device 100 may be, for example, an active catheter. In this case, the medical device 100 may include a plurality of lumens, an operating wire (not shown) inserted into any one of the plurality of lumens, and an operating unit (not shown) connected to the base end of the operating wire, and may be configured so that the distal end 10a of the tubular body 10 can be bent by operating the operating unit, thereby allowing the medical device 100 to be selectively directed.

[0040] The present embodiment encompasses the following technical ideas. (1) A medical device having a tubular body that is a long hollow tube made of resin, a flexible portion having a plurality of voids scattered in a resin and easily bending in a direction intersecting an axial direction of the tubular body is disposed in at least a portion in a longitudinal direction of the tubular body, The plurality of voids are arranged dispersedly in the circumferential direction and the axial direction, The plurality of voids each extend in a circumferential direction or each extend in an axial direction, A medical device in which the lumen of the tubular body is liquid-tightly sealed from the outside by a tubular wall of the tubular body. (2) The flexible portion has a pair of wall surfaces facing each other with the gap therebetween, The medical device according to (1), wherein the pair of wall surfaces have substantially the same shapes when viewed in opposing directions. (3) The medical device according to (2), wherein the flexible portion has a plurality of string-like portions connecting the pair of wall surfaces. (4) A medical device according to any one of (1) to (3), wherein the boundary between the flexible portion and the portion of the tubular body that is distal or proximal to the flexible portion has no step in its external shape. (5) A medical device according to (4), wherein the flexible portion has a smaller diameter than the portion of the tubular body that is distal to the flexible portion, and a smaller diameter than the portion of the tubular body that is proximal to the flexible portion. (6) Regarding a profile in which the position in the axial direction of the tubular body is defined as a first axis and the bending rigidity of each part in the axial direction of the tubular body is defined as a second axis, A medical device according to any one of (1) to (5), wherein the flexural rigidity of the tubular body changes continuously at the boundary between the flexible portion and the portion distal or proximal to the flexible portion, and the portion distal or proximal to the flexible portion has a higher flexural rigidity than the flexible portion. [Explanation of symbols]

[0041] 10 Tubular body 10a Tip 10b Base end 13 Inner layer 14 Outer layer 16 Reinforcement layer 25 void 28 Pair of Walls 29 Cord-like portion 30 Flexible section 31 Non-formation area 35 Middle section 37a, 37b border 38a, 38b border 41 first marker member 42 second marker member 43 Third marker member 90 Gripping part 91 Connecting part 92 Hub 93 Wings 94 Protector 100 Medical equipment

Claims

1. A medical device comprising a tubular body that is a long hollow tube made of resin, a flexible portion having a plurality of voids scattered in a resin and easily bending in a direction intersecting an axial direction of the tubular body is disposed in at least a portion in a longitudinal direction of the tubular body, The plurality of voids are arranged dispersedly in the circumferential direction and the axial direction, The plurality of voids each extend in a circumferential direction or each extend in an axial direction, The lumen of the tubular body is liquid-tightly sealed from the outside by a tube wall of the tubular body, the flexible portion is disposed in a middle portion of the tubular body in a longitudinal direction, A medical device in which a portion of the tubular body that is distal to the flexible portion has higher bending rigidity than the flexible portion.

2. the flexible portion has a pair of wall surfaces facing each other with the gap therebetween, The medical device according to claim 1 , wherein the pair of wall surfaces have substantially the same shape when viewed in the opposing direction.

3. A medical device comprising a tubular body that is a long hollow tube made of resin, a flexible portion having a plurality of voids scattered in a resin and easily bending in a direction intersecting an axial direction of the tubular body is disposed in at least a portion in a longitudinal direction of the tubular body, The plurality of voids are arranged dispersedly in the circumferential direction and the axial direction, The plurality of voids each extend in a circumferential direction or each extend in an axial direction, The lumen of the tubular body is liquid-tightly sealed from the outside by a tube wall of the tubular body, the flexible portion has a pair of wall surfaces facing each other with the gap therebetween, The shapes of the pair of wall surfaces when viewed in the opposing direction of the pair of wall surfaces are substantially equal to each other, The medical device wherein the flexible portion has a plurality of string-like portions connecting the pair of wall surfaces.

4. The medical device according to claim 1 , wherein the tubular body has no step in its outer shape at the boundary between the flexible portion and a portion of the tubular body that is distal or proximal to the flexible portion.

5. The medical device according to claim 4 , wherein the flexible portion has a smaller diameter than a portion of the tubular body that is distal to the flexible portion and that is proximal to the flexible portion.

6. Regarding a profile in which the position in the axial direction of the tubular body is defined as a first axis and the bending rigidity of each part in the axial direction of the tubular body is defined as a second axis, 6. The medical device according to claim 1, wherein the tubular body has a boundary between the flexible portion and a portion distal or proximal to the flexible portion, and the portion distal or proximal to the flexible portion has a higher flexural rigidity than the flexible portion.

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