Electron beam irradiation apparatus and method for manufacturing medical instrument

Abstract

[Problem] To provide: an electron beam irradiation apparatus capable of improving the product quality of an irradiation target by maintaining a constant distance between an emission surface of an electron beam irradiation unit and the irradiation target, while suppressing an increase in the amount of inert gas used; and a method for manufacturing a medical instrument. [Solution] A screen part (140) provided in an electron beam irradiation apparatus (10) has a magnet body part (146) and a partition part (147) positioned closer to an emission surface (111) than the magnet body part, wherein the magnet body part is configured to attract a part of a medical elongated body to the partition part (147) using the magnetic force of the magnet body part in a state in which a part of a medical elongated body (300A) is disposed in a space (130a) located between the emission surface (111) and the screen part (140), .

Description

Electron beam irradiation device and method for manufacturing medical instruments

[0001] The present invention relates to an electron beam irradiation device and a method for manufacturing medical instruments.

[0002] In the field of medical products, in order to enable a long medical body such as a catheter or a guide wire to move smoothly within a patient's body, a coating solution (for example, a coating solution containing a hydrophilic polymer that forms a lubricating coating layer) is applied to the surface of the long medical body, and a coating layer may be formed on the surface of the long medical body.

[0003] In the method for manufacturing a medical instrument, after applying a coating solution to a long medical body and forming a coating layer (a coating layer by the coating solution or a coating layer obtained by drying the coating solution) on the surface of the long medical body, an operation of curing the coating layer is performed.

[0004] Although there are various methods for curing the coating layer, from the viewpoint of reducing the heat generation effect by the energy of the electron beam and shortening the time required for curing the coating layer, a method of curing the coating layer by an electron beam may be adopted. However, when a method of curing the coating layer by an electron beam is adopted, the following points may become problems.

[0005] When an electron beam is used to cure the coating layer, it is necessary to irradiate the coating layer of the long medical body with an electron beam while exposing the long medical body coated with the coating layer in an inert gas. Therefore, the device for curing the coating layer needs to be provided with a chamber capable of filling with an inert gas.

[0006] In addition, the above chamber needs to be provided with an opening for enabling the movement of the long medical body in and out of the chamber. However, when an opening is provided in the chamber, the inside and the outside of the chamber are always in a communicating state through the opening. Therefore, during the operation of irradiating the long medical body with an electron beam, the inert gas filled in the chamber and the oxygen in the atmosphere existing outside the chamber are replaced through the opening, and the concentration of the inert gas in the chamber may decrease. There is a concern that this may lead to a deterioration in the quality of the coating layer.

[0007] Furthermore, in electron beam curing methods for coating layers, due to the characteristics of the curing reaction, the distance between the electron beam irradiation source and the medical-grade elongated object must be kept relatively constant to prevent uneven curing of the coating layer. Therefore, when using electron beams to cure coating layers, it is necessary to devise ways to maintain the relative positions of the electron beam irradiation source and the medical-grade elongated object so that their distance does not change during the curing process.

[0008] For example, Patent Document 1 discloses an electron beam irradiation system that irradiates a printed material with an electron beam under an inert gas to cure electron beam-curable ink (EB-curable ink) applied to the printed material.

[0009] The electron beam irradiation system described in Patent Document 1 includes an air passage for reducing the oxygen concentration at the electron beam irradiation position set within the chamber, and an air outlet that forms an air curtain of inert gas (nitrogen gas) near the entrance and exit of the chamber, which serve as the entrance and exit for printed materials to and from the chamber.

[0010] In the electron beam irradiation system described in Patent Document 1, an air curtain of inert gas is formed near the inlet and outlet by an air blowing section, thereby preventing oxygen from flowing into the chamber through the inlet and outlet.

[0011] Japanese Patent Publication No. 2008-128969

[0012] For example, if the air blowing unit described in Patent Document 1 is installed in the chamber of an electron beam irradiation device for curing a coating layer on the surface of a long medical object, and an inert gas is continuously blown near the opening of the chamber, it is thought that the replacement of oxygen in the atmosphere with the inert gas in the chamber through the opening, as described above, can be prevented. Furthermore, when irradiating the coating layer on the surface of a long medical object with an electron beam, it is thought that by locally blowing inert gas from the air blowing unit near the electron beam irradiation position of the long medical object, and maintaining a state in which the long medical object is pressed against a predetermined part in the chamber, it is possible to irradiate the long medical object with an electron beam without causing a displacement in the distance between the electron beam irradiation source and the long medical object.

[0013] However, if the system is configured to continuously blow inert gas from an air outlet near the opening of the chamber, while simultaneously blowing inert gas locally from another air outlet near the electron beam irradiation position of the medical elongated body to press it against a predetermined part inside the chamber, this would lead to an increase in the amount of inert gas used, thus increasing the manufacturing cost of the medical elongated body.

[0014] Furthermore, even when an inert gas is locally blown from the air outlet towards the electron beam irradiation position of the medical-grade elongated body to press it against a predetermined part within the chamber, the medical-grade elongated body may vibrate (oscillate) as the distance from the electron beam irradiation source decreases or decreases due to the blowing of the inert gas. Therefore, it is difficult to maintain a constant distance between the electron beam irradiation source and the medical-grade elongated body, making it difficult to prevent deterioration of the coating layer quality.

[0015] Furthermore, components with a predetermined length in the longitudinal direction, such as medical-grade elongated bodies, may develop bends or warps during the manufacturing process. When curing a coating layer on a medical-grade elongated body that has developed bends or warps, it becomes difficult to maintain a constant distance between the electron beam irradiation source and each part of the medical-grade elongated body in the longitudinal direction (axial direction). As a countermeasure to this problem, for example, when irradiating a medical-grade elongated body that has developed bends or warps with an electron beam, it is conceivable to increase the amount of inert gas sprayed and press down on the medical-grade elongated body with a stronger force. However, when the amount of inert gas sprayed is increased, as mentioned above, the medical-grade elongated body may vibrate in conjunction with the spraying of the inert gas.

[0016] The present invention has been made in view of the above problems, and aims to provide an electron beam irradiation apparatus and a method for manufacturing a medical device that can improve the product quality of an irradiated object by suppressing an increase in the amount of inert gas used and maintaining a constant distance between the emission surface of the electron beam irradiation unit and the object to be irradiated.

[0017] The present invention can be achieved by any one of the following means (1) to (9).

[0018] (1) An electron beam irradiation device comprising: an electron beam irradiation unit having an emission surface for emitting an electron beam; an inert gas supply unit having a nozzle for ejecting an inert gas; a chamber unit having an opening for inserting an object to be irradiated and housing the emission surface and the nozzle; a partition unit located inside the chamber unit and facing the emission surface; and a transport mechanism configured to allow a portion of the object to be irradiated, including a ferromagnetic material, to be placed in the space located between the emission surface and the partition unit through the opening, wherein the partition unit comprises a magnetic body unit and a partition wall unit located on the emission surface side of the magnetic body unit, and the magnetic body unit is configured to attract a portion of the object to be irradiated to the partition wall unit using the magnetic force of the magnetic body unit when a portion of the object to be irradiated is placed in the space located between the emission surface and the partition unit.

[0019] (2) The electron beam irradiation apparatus according to (1), wherein the partition wall portion has a tip region, a base region, and an intermediate region located between the tip region and the base region and including a region facing the emission surface, and the magnet portion is located on the tip side of the intermediate region.

[0020] (3) The electron beam irradiation apparatus according to (2), wherein the magnetic body portion is located only in the intermediate region.

[0021] (4) The electron beam irradiation apparatus according to any one of (1) to (3), wherein the nozzle is located on the side facing the partition, which is the side facing the discharge surface, the partition has a plurality of recesses that are recessed toward the side away from the side where the discharge surface is located and the side where the nozzle is located, and the magnet body is arranged along each of the plurality of recesses.

[0022] (5) The electron beam irradiation apparatus according to (4), wherein the width of the magnetic body portion is smaller than the width of the recess.

[0023] (6) The electron beam irradiation apparatus according to any one of (1) to (5), wherein the chamber portion is provided with a cylindrical guide portion at the opening that connects the outside of the chamber portion to the inside of the chamber portion and guides a part of the object to be irradiated from the outside of the chamber portion to the partition portion, and the central axis of the guide portion is offset by a predetermined distance from the bottom surface of the partition wall portion in a direction perpendicular to the extending direction of the guide portion.

[0024] (7) The electron beam irradiation apparatus according to any one of (1) to (6), wherein the nozzle is located on the side of the discharge surface that is opposite to the partition in the longitudinal direction of the chamber, and the inert gas is ejected in a direction that is inclined from the discharge surface side toward the partition side.

[0025] (8) The magnetic body portion is made of a permanent magnet, and the partition portion has a magnetic field of 10 to 1000 gf / cm² in the region facing the emission surface. ２ An electron beam irradiation apparatus having the adsorption force of any one of (1) to (7).

[0026] (9) An electron beam irradiation apparatus for irradiating a medical elongated body having a coating layer with an electron beam, wherein the electron beam irradiation apparatus comprises: a chamber; an electron beam irradiation unit having an emission surface for emitting an electron beam; an inert gas supply unit having a nozzle for spraying an inert gas; and a partition unit located inside the chamber and facing the emission surface, wherein the partition unit comprises: a magnetic body; and a partition wall unit located on the emission surface side of the magnetic body; a part of the medical elongated body containing a ferromagnetic material is placed in the space inside the chamber located between the emission surface and the partition unit; the part of the medical elongated body is attracted to the partition wall unit using the magnetic force of the magnetic body unit; and while the medical elongated body is attracted to the partition wall unit, an electron beam is irradiated onto the medical elongated body from the emission surface.

[0027] The electron beam irradiation apparatus described above can position a portion of the object to be irradiated, including a ferromagnetic material, in the space located between the emission surface of the electron beam irradiation unit and the partition, through the opening of the chamber section using a transport mechanism. When the electron beam irradiation apparatus transports a portion of the object to be irradiated into the space, the magnetic force of the magnet section of the partition attracts the portion of the object to the partition wall. By attracting a portion of the object to the partition wall, the electron beam irradiation apparatus can maintain a constant distance between the portion of the object to be irradiated and the emission surface of the electron beam irradiation unit located on the side opposite the partition, with the space in between. Therefore, the electron beam irradiation apparatus does not need to increase the amount of inert gas supplied from the inert gas supply unit to the portion of the object to be irradiated in order to maintain a constant distance between the portion of the object to be irradiated and the emission surface of the electron beam irradiation unit. As a result, the electron beam irradiation apparatus can improve the product quality of the object to be irradiated while suppressing an increase in the amount of inert gas used.

[0028] In the above-described method for manufacturing medical devices, when a portion of a medical device containing a ferromagnetic material is placed in the space within the chamber located between the emission surface of the electron beam irradiation unit and the partition, the magnetic force of the magnet provided by the partition can attract the portion of the medical device to the partition wall. By attracting the portion of the medical device to the partition wall, the method for manufacturing medical devices can maintain a constant distance between the portion of the medical device and the emission surface of the electron beam irradiation unit located on the side opposite the partition, with the space in between. By irradiating the portion of the medical device with an electron beam while maintaining a constant distance between the portion of the medical device and the emission surface of the electron beam irradiation unit, the method for manufacturing medical devices can prevent uneven hardening of the coating layer applied to the medical device. Therefore, the method for manufacturing medical devices does not require increasing the amount of inert gas supplied from the inert gas supply unit to the portion of the object to be irradiated in order to maintain a constant distance between the portion of the medical device and the emission surface of the electron beam irradiation unit. This allows for improved product quality of long medical devices while suppressing an increase in the amount of inert gas used in the manufacturing process.

[0029] This is a plan view showing an electron beam irradiation device according to an embodiment, with a cross-sectional view of the inside of the chamber section. This is a side view showing the electron beam irradiation device as seen from the direction of arrow 2A in Figure 1, with a cross-sectional view of the inside of the chamber section. This is an enlarged view of a part of the plan view in Figure 1. This is a plan view for explaining the positional relationship between the guide section and the partition section. This is a partial cross-sectional view for explaining the positional relationship between the guide section and the partition wall section. This is a cross-sectional view of the partition section and the magnet section. This is a cross-sectional view along the longitudinal direction of the guide section. This is a diagram showing a work guide provided by the electron beam irradiation device, with a cross-sectional view corresponding to arrow 8A-8A in Figure 1. This is a diagram for explaining the operation of the work guide provided by the electron beam irradiation device. This is a diagram for explaining a method of manufacturing a medical device using an electron beam irradiation device, showing the state before the electron beam is emitted from the electron beam irradiation section. This is a diagram for explaining a method of manufacturing a medical device using an electron beam irradiation device, showing the state after the electron beam has been emitted from the electron beam irradiation section. This is a diagram for explaining a method of manufacturing a medical device using an electron beam irradiation device, showing a cross-sectional view near the partition section. This is a diagram for explaining a method of manufacturing a medical device using an electron beam irradiation device, showing a cross-sectional view near the partition section. This is a diagram illustrating a method for manufacturing a medical device using an electron beam irradiation device, showing an enlarged view of a part of the partition. This is a diagram illustrating a method for manufacturing a medical device using an electron beam irradiation device, showing an enlarged view of a part of the partition. This is a plan view showing the partition according to Modification Example 1. This is a cross-sectional view showing the partition according to Modification Example 2. This is a cross-sectional view showing the partition according to Modification Example 3.

[0030] Embodiments of the present invention will be described below with reference to the attached drawings. The following description is not intended to limit the technical scope or the meaning of terms as defined in the claims. Furthermore, the dimensional ratios in the drawings are exaggerated for illustrative purposes and may differ from the actual ratios.

[0031] Figures 1 and 2 show a simplified overall configuration of the electron beam irradiation device 10 according to this embodiment. In Figures 1 and 2, the chamber portion 130 is shown as a partial cross-sectional view so that the inside of the chamber portion 130 is visible. Figures 3 to 7 are diagrams illustrating the configuration and operation and effects of each part of the electron beam irradiation device 10. Figures 8 and 9 show the work guide 160 provided in the electron beam irradiation device 10. Figures 10 to 15 are diagrams illustrating a method for manufacturing a medical device using the electron beam irradiation device 10.

[0032] (Electron beam irradiation device 10) Referring to Figures 1 to 6, 10 and 11, the electron beam irradiation device 10 comprises an electron beam irradiation unit 110 having an emission surface 111 from which an electron beam is emitted, an inert gas supply unit 120 having a nozzle 121 from which an inert gas is ejected, a chamber unit 130 having an opening 133 for inserting an object to be irradiated 300 and housing the emission surface 111 and the nozzle 121, a partition unit 140 located inside the chamber unit 130 and facing the emission surface 111, and a transport mechanism 150 configured to allow a portion of the object to be irradiated 300, including a ferromagnetic material, to be placed in the space 130a located between the emission surface 111 and the partition unit 140 through the opening 133.

[0033] In this specification, the direction in which the transport mechanism 150 transports the object to be irradiated 300 toward the chamber portion 130 is referred to as the "first transport direction d1," and the direction in which the transport mechanism 150 transports the object to be irradiated 300 toward the direction away from the chamber portion 130 is referred to as the "second transport direction d2." In each figure, the longitudinal direction of the electron beam irradiation device 10 (the direction in which the rail portion 151 extends) is indicated by arrows X1-X2, the width direction of the electron beam irradiation device 10 which is perpendicular to the longitudinal direction in a plan view is indicated by arrows Y1-Y2, and the height direction of the electron beam irradiation device 10 which is perpendicular to both the longitudinal direction and the width direction is indicated by arrows Z1-Z2. In the following description, each direction of the electron beam irradiation device 10 will also be simply referred to as the "longitudinal direction," "width direction," and "height direction."

[0034] In this embodiment, the object to be irradiated 300 is exemplified as a medical elongated body 300A having a long main body portion 310 extending in the longitudinal direction (see Figures 1 and 2). Below, an example in which the object to be irradiated 300 is composed of a medical elongated body 300A will be described.

[0035] The electron beam irradiation device 10 is configured to simultaneously irradiate 15 medical elongated bodies 300A, which are arranged at predetermined intervals in the width direction, with electron beams. However, there are no particular restrictions on the specific type or shape of the medical elongated bodies 300A, or the number that can be set in the electron beam irradiation device 10.

[0036] Each of the 15 medical elongated bodies 300A described in this embodiment has the same configuration. Therefore, one medical elongated body 300A will be described, and the descriptions of the other medical elongated bodies will be omitted. Similarly, for each configuration built in the electron beam irradiation device 10 corresponding to the 15 medical elongated bodies 300A, one configuration will be described, and the descriptions of the other configurations will be omitted as appropriate.

[0037] (Chamber section 130) As shown in Figures 1, 2, 10, and 11, the chamber section 130 comprises an electron beam irradiation section 110, an inert gas supply section 120, a partition section 140, and an internal space 130A in which a part of the guide section 135 is housed.

[0038] As shown in Figures 1, 2, 3, 4, 10, and 11, the chamber section 130 is provided with a cylindrical guide section 135 at the opening 133 that connects the outside of the chamber section 130 to the inside of the chamber section 130 and guides a portion of the medical elongated body 300A from the outside of the chamber section 130 to the partition section 140. The dashed line B shown in Figure 4 indicates the boundary position between the internal space 130A of the chamber section 130 and the opening 133 that is in contact with the internal space 130A.

[0039] As shown in Figure 2, the main body of the apparatus 20 is positioned at the lower part of the chamber section 130 in the height direction. The main body of the apparatus 20 is equipped with a control unit for controlling the emission and stopping of electron beams from the emission surface 111 of the electron beam irradiation unit 110, and the ejection and stopping of inert gas from the nozzle 121 of the inert gas supply unit 120, as well as a drive source (motor) necessary to drive the operation of each part of the apparatus. In Figure 11, the electron beam emitted from the emission surface 111 of the electron beam irradiation unit 110 is illustrated by arrow e, and the inert gas ejected from the nozzle 121 of the inert gas supply unit 120 is illustrated by arrow a.

[0040] The chamber portion 130 has a predetermined length along the longitudinal direction. The longitudinal length of the chamber portion 130 (the longitudinal length of the internal space 130A) can be arbitrarily set according to the longitudinal length of the electron beam irradiation target site in the medical elongated body 300A. For example, when the electron beam irradiation target site is the first region 311 of the main body portion 310 of the medical elongated body 300A as described later, the longitudinal length of the chamber portion 130 can be configured to be a length that can accommodate the entire longitudinal range of the first region 311.

[0041] (Transport mechanism 150) As shown in FIGS. 1, 2, 10, and 11, when the electron beam irradiation device 10 irradiates an electron beam to the medical elongated body 300A, a part of the medical elongated body 300A (in this embodiment, the first region 311 of the medical elongated body 300A described later) is disposed in the space 130a located between the emission surface 111 and the partition portion 140 by the transport mechanism 150.

[0042] As shown in FIGS. 1 and 2, the transport mechanism 150 is located outside the chamber portion 130. The transport mechanism 150 disposes a part of the medical elongated body 300A in the space 130a located between the emission surface 111 and the partition portion 140 through the opening 133 of the chamber portion 130.

[0043] The "space 130a located between the emission surface 111 and the partition portion 140" is constituted by a part of the internal space 130A of the chamber portion 130. Specifically, in the internal space 130A, the region located between the emission surface 111 of the electron beam irradiation unit 110 and the partition portion 140 corresponds to the "space 130a" (see FIGS. 10 and 11).

[0044] As shown in FIGS. 1 and 2, the transport mechanism 150 includes a rail portion 151 extending toward the chamber portion 130, and a gripping portion 153 that is movable along the rail portion 151 and is configured to be able to fix a part of the medical elongated body 300A.

[0045] The rail portion 151 extends substantially linearly along the longitudinal direction of the electron beam irradiation device 10. In this embodiment, the direction in which the rail portion 151 extends is substantially the same as the longitudinal direction of the medical elongated body 300A.

[0046] The gripping part 153 is configured to fix the hub part 320 arranged at one end of the medical long body 300A. "One end of the medical long body 300A" corresponds to the base end part of the medical long body 300A, and is the end part on the side where medical workers such as doctors grip or operate with fingers or the like in the procedure using the medical long body 300A.

[0047] The gripping part 153 can be configured to be connectable and separable with respect to the rail part 151, for example. When the gripping part 153 is configured to be connectable and separable with respect to the rail part 151, in the preparation stage of starting the irradiation of the electron beam to the medical long body 300A by the electron beam irradiation device 10, the operator can fix the medical long body 300A to the gripping part 153 in a state where the gripping part 153 is separated from the rail part 151. Further, the operator can connect the gripping part 153 to the rail part 151 in a state where the medical long body 300A is fixed to the gripping part 153. Note that the gripping part 153 may have a configuration in which it cannot be connected and separated with respect to the rail part 151.

[0048] The gripping part 153 can be connected to the rail part 151 via the slide part 154. The rail part 151 is configured to be linearly movable along the slide part 154. When the slide part 154 moves along the rail part 151, the gripping part 153 moves along the rail part 151 in conjunction with the movement of the slide part 154.

[0049] The gripping part 153 can be configured to have, for example, a chuck part that mechanically attaches and detaches and fixes the hub part 320 by fitting the hub part 320. However, as long as the gripping part 153 can fix and release at least a part of the medical long body 300A, there is no particular limitation on the specific configuration. Also, the location where the medical long body 300A is fixed to the gripping part 153 may be a part other than the hub part 320.

[0050] As shown in FIGS. 1 and 2, the conveying mechanism 150 has a rotation operation part 155 that can drive the rotation operation of the gripping part 153 in a state where the gripping part 153 fixes the medical long body 300A.

[0051] The rotating mechanism 155 is integrally configured with the gripping mechanism 153. When the rotation of the rotating mechanism 155 is driven while the gripping mechanism 153 is fixed to the hub mechanism 320, the hub mechanism 320 rotates in conjunction with the operation of the rotating mechanism 155 while maintaining its fixed position with the gripping mechanism 153. The rotating mechanism 155 can rotate the medical elongated body 300A along the central axis 310c of the main body 310 of the medical elongated body 300A (see Figures 14 and 15).

[0052] As shown in Figures 8 and 9, the electron beam irradiation device 10 has a work guide 160 positioned at a predetermined location on the rail section 151. Figure 8 is a cross-sectional view taken along the line 8A-8A shown in Figure 1.

[0053] The work guide 160 serves to guide the movement of the medical elongated body 300A outside the chamber section 130.

[0054] As shown in Figures 8 and 9, the work guide 160 has a first guide 161 and a second guide 162 that are configured to move toward and away from each other.

[0055] As shown in Figure 8, when the first guide 161 and the second guide 162 are positioned at a predetermined distance apart, a support hole 163 is formed between the first guide 161 and the second guide 162 to support the medical elongated body 300A as it is inserted. When the transport mechanism 150 of the electron beam irradiation device 10 transports the medical elongated body 300A, a part of the medical elongated body 300A is supported in the support hole 163, allowing the medical elongated body 300A to move smoothly along each transport direction d1 and d2.

[0056] The size of the support hole 163 formed between the first guide 161 and the second guide 162 can be adjusted by changing the distance between the first guide 161 and the second guide 162. For example, as shown in Figure 9, the size of the support hole 163 can be reduced by reducing the distance between the first guide 161 and the second guide 162. Therefore, by adjusting the size of the support hole 163 according to the size and cross-sectional shape of the medical elongated body 300A to be transported by the transport mechanism 150, the work guide 160 can guide the movement of various types of medical elongated body 300A. Each guide 161 and 162 can be attached to the rail section 151 via a support section 165 having a slide groove that slidably holds each guide 161 and 162.

[0057] As described above, the electron beam irradiation device 10 has a configuration that allows simultaneous irradiation of 15 medical elongated bodies 300A with electron beams. Therefore, as shown in Figures 1 and 2, the electron beam irradiation device 10 is equipped with 15 gripping parts 153, 15 rotating parts 155, and 15 work guides 160.

[0058] As shown in Figures 1 and 2, the transport mechanism 150 is configured to move the gripping part 153 along the rail part 151 while the medical elongated body 300A is suspended in the direction of gravity by the gripping part 153.

[0059] When transporting the medical elongated body 300A, the transport mechanism 150 suspends the medical elongated body 300A in a state where the hub portion 320 is fixed to the gripping portion 153, and the other end (corresponding to the "tip" of the medical elongated body 300A) located opposite the end where the hub portion 320 is located is positioned downward in the direction of gravity (a state in which the main body portion 310 of the medical elongated body 300A is naturally stretched without any external force being applied). While maintaining the medical elongated body 300A in the above-described suspended state, the transport mechanism 150 can move the medical elongated body 300A linearly along the first transport direction d1 and the second transport direction d2.

[0060] (Electron beam irradiation unit 110) As shown in Figures 10 and 11, the electron beam irradiation unit 110 is equipped with an emission surface 111 that faces the direction in which the electron beam is emitted.

[0061] The electron beam irradiation unit 110 is located on the same side as the inert gas supply unit 120 in the internal space 130A of the chamber unit 130. In other words, the electron beam irradiation unit 110 and the inert gas supply unit 120 are located on the side facing the partition unit 140 in the height direction (arrows Z1-Z2 direction) of the chamber unit 130.

[0062] Between the partition section 140 and the emission surface 111 of the electron beam irradiation section 110, there is a space 130a located on the extension of the ejection direction of the inert gas ejected from the inert gas supply section 120.

[0063] The emission surface 111 is positioned to irradiate the electron beam along a direction substantially perpendicular to the partition 140, which is positioned in the internal space 130A of the chamber 130 so as to face the electron beam irradiation unit 110.

[0064] The energy of the electron beam emitted from the emission surface 111 of the electron beam irradiation unit 110 can be arbitrarily set depending on the material to be hardened by the electron beam. In this embodiment, when the target of hardening is a lubricating coating layer 311a applied to a long medical body 300A, the energy of the electron beam can be set to, for example, 10 keV to 500 keV.

[0065] (Inert gas supply unit 120) As shown in Figures 10 and 11, the inert gas supply unit 120 has a nozzle 121 and a nozzle body 123.

[0066] The nozzle body 123 can be configured as a linear nozzle (for example, a linear diffuser nozzle) having a nozzle 121 that extends linearly along the width direction of the chamber portion 130 (the direction indicated by arrows Y1-Y2). The nozzle 121 is located at one end of the nozzle body 123, as shown in Figure 10. Configuring the nozzle body 123 as a linear nozzle with a linear nozzle (a nozzle 121 that extends linearly along the width direction of the chamber portion 130) is preferable because it allows inert gas to be ejected at a uniform flow rate to multiple medical elongated bodies 300A from a single linear nozzle. The nozzle body 123 may also be configured to have a shape that includes multiple nozzles 121 arranged at predetermined intervals along the width direction of the chamber portion 130 (the direction indicated by arrows Y1-Y2).

[0067] As shown in Figures 10 and 11, the nozzle 121 of the inert gas supply unit 120 is located on the base end side (arrow X1 side) of the discharge surface 111 in the longitudinal direction of the chamber unit 130, and on the discharge surface 111 side (arrow Z2 side) which is opposite the partition unit 140. Furthermore, the nozzle 121 is configured to be inclined from the discharge surface 111 side toward the partition unit 140 side. Therefore, as shown in Figure 11, the inert gas ejected from the nozzle 121 is ejected diagonally forward toward the partition unit 140 side along the inclination direction of the nozzle 121.

[0068] As shown in Figures 10 and 11, the inert gas supply unit 120 ejects inert gas through the nozzle 121 toward a position opposite the emission surface 111 of the electron beam irradiation unit 110, with a portion of the medical elongated body 300A (a portion of the first region 311) positioned in the space 130a located between the emission surface 111 of the electron beam irradiation unit 110 and the partition unit 140.

[0069] The inert gas supply unit 120 sprays inert gas, which is ejected from the nozzle 121 toward the space 130a, onto a portion of the medical elongated body 300A placed in the space 130a. This allows a portion of the medical elongated body 300A to be moved toward the guide surface 145 of the partition unit 140, which is positioned opposite the emission surface 111 of the electron beam irradiation unit 110 across the space 130a (see Figure 13).

[0070] Furthermore, the electron beam irradiation device 10 ejects the inert gas ejected from the nozzle 121 diagonally forward towards the guide surface 145 of the partition section 140, along the inclination direction of the nozzle 121. By ejecting the inert gas from the nozzle 121 in this way, the electron beam irradiation device 10 can form a flow of inert gas along the guide surface 145 utilizing the Coanda effect. As a result, the electron beam irradiation device 10 can efficiently form a flow of inert gas along the guide surface 145 toward the second end 137 of the guide section 135.

[0071] Examples of inert gases that can be used in the electron beam irradiation apparatus 10 include helium gas, neon gas, argon gas, xenon gas, nitrogen gas, and the like.

[0072] The injection pressure X MPa of the inert gas ejected from the nozzle 121 of the inert gas supply unit 120 can be set, for example, in the range of 0.01 MPa < X MPa < 0.5 MPa.

[0073] The ejection angle θ1 (see Figure 11) of the inert gas ejected from the nozzle 121 of the inert gas supply unit 120 can be set, for example, within the range of 10° < θ1 < 90° (preferably 30° < θ1 < 90°).

[0074] The distance from the nozzle 121 of the inert gas supply unit 120 to the guide surface 145 (bottom surface 147a) of the partition unit 140 (the straight-line distance between the nozzle 121 and the guide surface 145 of the partition unit 140 along the ejection angle θ1) can be set, for example, in the range of 0 mm < L mm < 500 mm.

[0075] (Screen section 140) As shown in Figures 4, 5, and 6, the screen section 140 has a magnet body section 146 and a partition wall section 147 located on the side of the emission surface 111 (arrow Z2 side) relative to the magnet body section 146.

[0076] As shown in Figures 11 and 13, the magnetic body 146 is configured to attract a portion of the medical elongated body 300A to the partition wall 147 using the magnetic force of the magnetic body 146, with a portion of the medical elongated body 300A positioned in the space 130a located between the emission surface 111 and the partition wall 140.

[0077] As shown in Figures 4, 5, 6, 12, and 13, the partition section 140 has a pair of wall sections 141 and 142. A recess 143 provided by the partition section 140 is partitioned between the pair of wall sections 141 and 142.

[0078] Figure 12 shows a cross-sectional view of the partition section 140 at the location indicated by arrow 12A in Figure 11 (where the medical elongated body 300A is not in contact with the partition section 147), and Figure 13 shows a cross-sectional view of the partition section 140 at the location indicated by arrow 13A in Figure 11 (where the medical elongated body 300A is in contact with the partition section 147).

[0079] Each wall portion 141, 142 has a shape that protrudes substantially perpendicularly within the chamber portion 130 toward the side where the electron beam irradiation unit 110 and the inert gas supply unit 120 are located (towards arrow Z2).

[0080] The partition wall 147 has a plurality of recesses 143 that are recessed toward the side (arrow Z1 side) away from the side where the ejection surface 111 is located and the side where the nozzle 121 is located. In this embodiment, the partition wall 147 has 15 recesses 143, corresponding to the number of openings 133 and guide portions 135.

[0081] The partition wall portion 147 has a bottom surface 147a facing the recess 143. The bottom surface 147a constitutes a guide surface 145 that guides the movement of the medical elongated body 300A along the first transport direction d1 and the second transport direction d2.

[0082] As shown in Figures 11 and 13, at the electron beam irradiation position on the medical elongated body 300A, at least a portion of the first region 311 of the medical elongated body 300A comes into contact with the guide surface 145 due to the magnetic force of the magnet portion 146.

[0083] As shown in Figures 10, 11, and 12, at a position on the side of the opening 133 (towards arrow X1) from the electron beam irradiation position on the medical elongated body 300A, a portion of the medical elongated body 300A does not come into contact with the partition 140. Therefore, at this position, the first region 311 of the medical elongated body 300A is positioned with a gap gb between it and the guide portion 135.

[0084] There are no particular restrictions on the structure or shape of the recess 143 provided in the partition section 140. For example, the partition section 140 can be configured such that the recess 143 has a V-shaped or U-shaped cross-section.

[0085] The partition section 140 can be configured such that at least the portion of the magnet body section 146 located on the emission surface 111 side (the portion or surface of the magnet body section 146 located on the side of arrow Z2) is covered by the partition wall section 147. For example, the partition section 140 can be configured to house the entire magnet body section 146, or to have the magnet body section 146 bonded to a plate-shaped member or the like that constituting the partition wall section 147.

[0086] The electron beam irradiation device 10 prevents direct contact between the magnetic body 146 and the medical elongated body 300A by positioning a partition 140 between the magnetic body 146 and the medical elongated body 300A. This prevents the lubricating coating layer 311a applied to the medical elongated body 300A from adhering to the surface of the magnetic body 146. As a result, the magnetic force of the magnetic body 146 can be maintained over a long period of time.

[0087] The specific configuration of the magnetic body 146 is not limited as long as it is capable of attracting the ferromagnetic material 200 of the medical-grade elongated body 300A using magnetic force. For example, the magnetic body 146 can be made of a permanent magnet and / or an electromagnet that generates magnetic force when electricity is passed through it.

[0088] When the magnetic body portion 146 is made of a permanent magnet, for example, alnico, ferrite, samarium cobalt, neodymium, samarium iron nitrogen magnets, etc., can be used.

[0089] When the magnetic body portion 146 is made of a permanent magnet, the partition portion 140 has a magnetic field of 10 to 1000 gf / cm² in the region facing the emission surface 111 (intermediate region 148C in this embodiment). ２ It can be configured to have an adsorption force.

[0090] The above-mentioned attraction force can be adjusted, for example, by changing the thickness of the partition portion 140 to adjust the distance between the magnet body portion 146 and the bottom surface 147a, or by providing a spacer 149 to the partition portion 140, as will be explained in the modified examples described later (Figures 17 and 18).

[0091] As shown in Figures 4 and 5, the partition wall portion 147 has a tip region 148A, a base region 148B, and an intermediate region 148C located between the tip region 148A and the base region 148B, which includes a region facing the ejection surface 111.

[0092] Figure 4 is a simplified plan view taken from the direction of arrow 4A shown in Figure 2. Figure 5 is a simplified side cross-sectional view taken from the direction of arrow 5A in Figure 4.

[0093] The intermediate region 148C can be formed in a range that includes the center position O1 in the longitudinal direction (direction indicated by arrows X1-X2) of the partition wall portion 147.

[0094] The irradiation position at which the electron beam irradiation device 10 irradiates the partition wall portion 147 with an electron beam can be set to a range approximately 40 mm away from the tip and base ends of the position including the longitudinal center position O1 of the partition wall portion 147.

[0095] As shown in Figures 4 and 5, the magnet body portion 146 can be positioned towards the tip side of the intermediate region 148C. The phrase "positioned towards the tip side of the intermediate region 148C" means that at least a part of the magnet body portion 146 is located in the intermediate region 148C, and no part of the magnet body portion 146 is located in the base end region 148B.

[0096] As shown in Figure 4, the magnet portion 146 can be placed only in the intermediate region 148C. In other words, the magnet portion 146 can be positioned so as not to protrude beyond the front and base ends of the intermediate region 148C in the longitudinal direction of the partition portion 140.

[0097] As shown in Figures 4 and 6, the magnetic body portion 146 is arranged along each of the multiple recesses 143.

[0098] The statement above that "the magnetic body portion 146 is arranged along each of the recesses 143" means that the extending direction of each magnetic body portion 146 is aligned with the longitudinal direction of each recess 143.

[0099] As shown in Figure 6, the width W1 of the magnet body 146 can be made smaller than the width W2 of the recess 143.

[0100] It is preferable that, in the plan view shown in Figure 4, at least a portion of each magnetic body portion 146 is positioned so as to coincide with the center position O2 in the width direction of each recess 143.

[0101] The width W1 of the magnetic body portion 146 is preferably 5 to 20 mm, and more preferably less than 10 mm, when the width W2 of the recess 143 is formed to be 10 mm to 50 mm.

[0102] As shown in Figure 5, the central axis 135c of the guide portion 135 is offset by a predetermined distance from the bottom surface 147a of the partition wall portion 147 in a direction perpendicular to the extension direction of the guide portion 135 (direction of arrow Z2).

[0103] The distance LB at which the central axis 135c of the guide portion 135 is offset from the bottom surface 147a of the partition wall portion 147 can be, for example, 5 mm to 30 mm.

[0104] (Guide section 135) As shown in Figures 3 and 4, the chamber section 130 is equipped with a plurality of guide sections 135 arranged in a first direction (arrow Y1-Y2 direction) that intersects with the direction of movement of the medical elongated body 300A.

[0105] The chamber section 130 includes 15 guide sections 135, each of which is positioned between 15 openings 133 that are spaced apart from one another in a first direction.

[0106] Figure 7 shows a cross-sectional view of the guide portion 135 along its longitudinal direction.

[0107] As shown in Figures 3, 4, and 7, the guide portion 135 has a first end portion 136 having a base end opening 136a located outside the chamber portion 130, a second end portion 137 located on the opposite side of the first end portion 136 and having a tip end opening 137a that opens inside the chamber portion 130, and a main body portion 138 having an internal passage 138a connecting the base end opening 136a and the tip end opening 137a.

[0108] As shown in Figures 3, 10, and 11, the guide portion 135 extends from the position of the opening 133 toward the partition portion 140, at a position closer to the partition portion 140 (arrow Z1 side) than the nozzle 121. The second end portion 137 is located closer to the base end (arrow X1 side) than the discharge surface 111 in the longitudinal direction of the chamber portion 130.

[0109] As described above, when irradiating the medical elongated body 300A with an electron beam, the transport mechanism 150 moves the medical elongated body 300A along the first transport direction d1. The transport mechanism 150 places a portion of the medical elongated body 300A that has been moved along the first transport direction d1 into the internal space 130A of the chamber section 130 where the electron beam irradiation unit 110 is located.

[0110] The medical elongated body 300A, moved by the transport mechanism 150, is introduced into the internal passage 138a of the guide section 135 located at the opening 133 of the chamber section 130 as it passes through the opening 133. Specifically, the medical elongated body 300A is inserted into the base end opening 136a of the guide section 135 from the longitudinal end side of the medical elongated body 300A, and after passing through the base end opening 136a, it is introduced into the internal passage 138a of the main body section 138 of the guide section 135.

[0111] The transport mechanism 150 moves the medical elongated body 300A further along the first transport direction d1 while a portion of the leading edge of the medical elongated body 300A is inserted into the internal passage 138a of the main body 138 of the guide section 135. When the transport mechanism 150 has moved the medical elongated body 300A a predetermined distance along the first transport direction d1, a portion of the leading edge of the medical elongated body 300A is led out from the tip opening 137a of the second end 137 of the guide section 135.

[0112] In the medical elongated body 300A, the portion extending from the tip opening 137a of the second end 137 is transported by the transport mechanism 150 along the first transport direction d1 to the partition section 140, which is positioned a predetermined distance away from the second end 137 in the first transport direction d1. As described above, when the electron beam irradiation device 10 transports the medical elongated body 300A to the partition section 140, it attracts the ferromagnetic material 200 of the medical elongated body 300A to the partition section 147 with the magnetic body section 146 of the partition section 140, while irradiating it with an electron beam from the emission surface 111 of the electron beam irradiation unit 110, which is positioned opposite the partition section 140. The electron beam irradiation device 10 moves the medical elongated body 300A further along the first transport direction d1 using the transport mechanism 150. After the irradiation of the first region 311 of the medical elongated body 300A by the electron beam irradiation unit 110 is completed, the medical elongated body 300A is moved in the second transport direction d2, and the portion of the medical elongated body 300A that has been inserted into the chamber 130 is transported out of the chamber 130.

[0113] The guide section 135 of the chamber section 130 has the role of guiding the medical elongated body 300A to the partition section 140 when inserting the medical elongated body 300A into the chamber section 130 as described above, and guiding the medical elongated body 300A when transporting it out of the chamber section 130 after it has been irradiated with an electron beam.

[0114] As shown in Figure 7, the diameter (opening diameter) of the tip opening 137a of the guide portion 135 can be made smaller than the diameter (opening diameter) of the base opening 136a of the guide portion 135. In addition, the first end portion 136 of the guide portion 135 can be configured to have a tapered portion 136b whose inner diameter gradually decreases toward the second end portion 137 side (tip side).

[0115] As shown in Figure 4, the second end portion 137 of the guide portion 135 can be positioned such that a gap gb is provided between it and the partition portion 140 in the longitudinal direction of the chamber portion 130.

[0116] The electron beam irradiation device 10 irradiates the medical elongated body 300A with an electron beam and ejects an inert gas while a portion of the medical elongated body 300A is positioned in the internal space 130A of the chamber portion 130 (see Figure 11). While this operation is being performed, the first end 136 of the guide portion 135, which has a base end opening 136a, is maintained outside the chamber portion 130. The second end 137 of the guide portion 135, which has a tip end opening 137a, is positioned inside the chamber portion 130. Therefore, the internal space 130A of the chamber portion 130 and the outside of the chamber portion 130 are in fluid communication with each other via the guide portion 135. The electron beam irradiation device 10 guides a portion of the inert gas ejected toward the guide surface 145 of the partition section 140 to the vicinity of the second end 137 of the guide section 135 by the Coanda effect, and further allows a portion of this inert gas to flow into the internal passage 138a of the guide section 135 through the tip opening 137a of the guide section 135. As a result, the electron beam irradiation device 10 can suppress the flow of oxygen from the atmosphere that has flowed into the internal passage 138a through the base end opening 136a of the guide section 135 into the internal space 130A of the chamber section 130 through the tip opening 137a.

[0117] Even if oxygen from the atmosphere flows into the internal space 130A of the chamber section 130 via the guide section 135, the electron beam irradiation device 10 can suppress an increase in the oxygen concentration near the electron beam irradiation position on the medical elongated body 300A due to the gap gb formed between the second end 137 of the guide section 135 and the partition section 140. This is for the following reasons.

[0118] The gap gb formed between the second end 137 of the guide section 135 and the partition section 140 is located between the tip opening 137a formed in the second end 137 and the guide surface 145 of the partition section 140, which is located near the electron beam irradiation position. Therefore, even if oxygen from the atmosphere flows into the internal space 130A of the chamber section 130 through the tip opening 137a of the second end 137, that oxygen moves to the guide surface 145 via the gap gb. As a result, the oxygen from the atmosphere that flows into the internal space 130A of the chamber section 130 through the tip opening 137a passes through the gap gb before reaching the guide surface 145. Then, as the oxygen that is about to flow into the recess 143 of the partition section 140 passes through the gap gb, it collides with the inert gas flowing along the guide surface 145 of the partition section 140 due to the Coanda effect, and is diffused at a position closer to the opening 133 of the chamber section 130 than the electron beam irradiation position on the medical elongated body 300A. Therefore, the electron beam irradiation device 10 can efficiently disperse and circulate the oxygen from the atmosphere that flows into the internal space 130A of the chamber section 130 within the chamber section 130. As a result, the electron beam irradiation device 10 can suppress an increase in oxygen concentration near the electron beam irradiation position on the medical elongated body 300A.

[0119] As shown in Figure 4, the widthwise center position of each guide portion 135 (center position in the direction of arrows Y1-Y2 in the figure) can be positioned to coincide with the widthwise center position of each guide surface 145 (center position in the direction of arrows Y1-Y2 in the figure) which is arranged in correspondence with each guide portion 135. In other words, each guide portion 135 and each guide surface 145 can be arranged with their widthwise center positions aligned.

[0120] The guide portion 135 can be made of cylindrical members in which each part 136, 137, and 138 of the guide portion 135 has a circular cross-section perpendicular to the longitudinal direction. However, the cross-sectional shape of each part of the guide portion 135 is not particularly limited as long as it is possible to insert the medical elongated body 300A through it. For example, the cross-sectional shapes of each part 136, 137, and 138 of the guide portion 135 may be rectangular, elliptical, or other geometric shapes. Furthermore, the cross-sectional shapes of each part 136, 137, and 138 of the guide portion 135 do not have to be the same or similar, and each part 136, 137, and 138 may be configured to have different cross-sectional shapes from each other.

[0121] (Medical elongated body 300A) As shown in Figures 1 and 2, the medical elongated body 300A comprises an elongated main body portion 310 extending in the longitudinal direction and a hub portion 320 located at one end of the main body portion 310.

[0122] As shown in Figures 1, 2, 14, and 15, the main body 310 of the medical elongated body 300A can be configured to have a first region 311 to which a lubricating coating layer 311a that is to be irradiated by an electron beam is applied, and a second region 312 located at one end (base end) of the first region 311 and not to which the lubricating coating layer 311a is applied.

[0123] In the medical elongated body 300A, the area to be irradiated with the electron beam is the first area 311 to which the lubricating coating layer 311a is applied. Therefore, when performing the electron beam irradiation operation, the transport mechanism 150 moves the medical elongated body 300A along the respective transport directions d1 and d2, such that the first area 311 is positioned in the space 130a within the chamber portion 130.

[0124] The transport mechanism 150 is configured to position the first region 311 of the medical elongated body 300A in the space 130a within the chamber portion 130 by moving the gripping portion 153 while fixing only the hub portion 320 of the medical elongated body 300A with the gripping portion 153. Therefore, while the lubrication coating layer 311a is being cured by electron beam irradiation, the only part of the medical elongated body 300A that is directly gripped by the transport mechanism 150 is the hub portion 320.

[0125] The main body 310 of the medical elongated body 300A can be made of, for example, a tubular resin member having a lumen 315 inside (see Figures 14 and 15). When the main body 310 of the medical elongated body 300A is made of a tubular resin member, the materials that make up the main body 310 can be, for example, polyamide resin, polyolefin resin such as polyethylene resin and polypropylene resin, modified polyolefin resin, cyclic polyolefin resin, epoxy resin, urethane resin, diallyl phthalate resin (allyl resin), polycarbonate resin, fluororesin, amino resin (urea resin, melamine resin, benzoguanamine resin), polyester resin, styrene resin, acrylic resin, polyacetal resin, vinyl acetate resin, phenolic resin, vinyl chloride resin, silicone resin (silicon resin), polyether resin, polyimide resin, or mixtures thereof, or two or more of the above polymer materials.

[0126] The medical elongated body 300A can be composed of, for example, a catheter comprising an elongated main body 310 and a hub 320. Specifically, the catheter may be a contrast catheter, a support catheter, a microcatheter, a balloon catheter, etc.

[0127] In this embodiment, the medical-grade elongated body 300A contains a ferromagnetic material 200. The ferromagnetic material 200 can be made up of, for example, a metal wire (core metal) inserted through the lumen 315 of the medical-grade elongated body 300A.

[0128] The metal wire inserted through the lumen 315 of the medical-grade elongated body 300A prevents the cross-sectional shape of the lumen 315 from being crushed while the medical-grade elongated body 300A is being treated (irradiated with an electron beam). As shown in Figures 10 and 11, the metal wire can be positioned, for example, to protrude by a predetermined length from the tip side of the medical-grade elongated body 300A.

[0129] The constituent material of the ferromagnetic body 200 is not particularly limited as long as it is capable of attracting the medical-grade long body 300A to the partition wall 147 by the magnetic force of the magnet body 146. The magnet body 146 can be made of, for example, iron alloy, alloy steel (SUS, etc.), silicon steel, permalloy, Sendust, Permendur, soft ferrite, amorphous magnetic alloy, nanocrystal magnetic alloy, SUS304 (with magnetism imparted by strong processing such as cutting, bending, or drawing), etc.

[0130] In this embodiment, as described above, a medical elongated body 300A containing a ferromagnetic material 200 is exemplified in which a metal wire (core metal) made of the ferromagnetic material 200 is inserted through the lumen 315 of the medical elongated body 300A. However, the medical elongated body 300A containing the ferromagnetic material 200 is not limited to this form. The medical elongated body 300A containing the ferromagnetic material 200 may also have the ferromagnetic material included in a part of the constituent material of the medical elongated body 300A (for example, the resin material mentioned above). For example, the medical elongated body 300A containing the ferromagnetic material 200 may include a linear metal material that becomes ferromagnetic as a reinforcing member inside the resin material that constitutes the main body 310. For example, the linear metal material that becomes ferromagnetic can be made of SUS304 (which has magnetism imparted to it by strong processing such as cutting, bending, or drawing). Furthermore, the medical elongated body 300A containing the ferromagnetic material 200 may be made up of a component composed of the ferromagnetic material 200 (for example, a metal guide wire as illustrated below).

[0131] The medical elongated body 300A can be made of, for example, a guide wire known in the medical field. When the medical elongated body 300A is made of a guide wire, it is not necessary to attach the hub portion 320 to one end of the medical elongated body 300A. Furthermore, when the medical elongated body 300A is made of a guide wire, a guide wire made of a metal material such as magnetic stainless steel, or a guide wire made of a core material made of a superelastic alloy such as nickel-titanium alloy or copper-zinc alloy, with magnetic stainless steel or the like wound in a coil shape around it, can be used.

[0132] The coating layer applied to the medical-grade long body 300A can be, for example, a lubricating coating layer 311a. Any material that absorbs water and exhibits lubricity can be used as the material constituting the lubricating coating layer 311a. For example, hydrophilic materials can be cited as such materials. Specific examples are shown below. In the specific examples, the term "(meth)acrylic" includes both acrylic and methacrylic. Therefore, for example, the term "(meth)acrylic acid" includes both acrylic acid and methacrylic acid. Similarly, the term "(meth)acryloyl" includes both acryloyl and methacryloyl. Therefore, for example, the term "(meth)acryloyl group" includes both acryloyl group and methacryloyl group.

[0133] Examples of hydrophilic materials constituting the lubricating coating layer 311a include hydrophilic polymers such as polyvinylpyrrolidone, polyvinyl alcohol, polyethylene oxide polymers, cellulosic polymers such as carboxymethylcellulose, acrylamide polymers such as polyacrylamide and polydimethylacrylamide, maleic anhydride polymers such as hyaluronic acid, polyacrylic acid, maleic anhydride-methyl vinyl ether copolymers, water-soluble nylon (registered trademark), and derivatives thereof.

[0134] The hydrophilic material constituting the lubricating coating layer 311a may be a hydrophilic copolymer containing a monomer having a reactive functional group (hereinafter also referred to as "reactive monomer") and a hydrophilic monomer, in order to firmly fix the hydrophilic polymer to the medical elongated body 300A. In this specification, "reactive functional group" refers to a functional group that can crosslink with other monomers or react (bond) with the surface of the medical elongated body 300A by electron beam irradiation or the like.

[0135] The above-mentioned reactive functional groups are not particularly limited, but may include epoxy groups, acid halide groups, aldehyde groups, isocyanate groups, acid anhydride groups, vinyl groups, (meth)acryloyl groups, and other functional groups. These reactive functional groups may exist individually or in combination within the reactive monomer.

[0136] The reactive monomers used in the present invention preferably have reactive functional groups and exhibit hydrophobicity in body fluids and aqueous solvents, at least more than hydrophilic monomers used in the production of copolymers. Specifically, such reactive monomers include monomers having epoxy groups in their molecules, such as glycidyl acrylate, glycidyl methacrylate (GMA), methylglycidyl methacrylate, and allyl glycidyl ether; monomers having acid halide groups in their molecules, such as (meth)acrylate chloride, (meth)acrylate bromide, and (meth)acrylate iodide; monomers having aldehyde groups in their molecules, such as (meth)acrylaldehyde, crotonaldehyde, acrolein, and methacrolein; and (meth)acryloyloxymethyl isocyanate. Examples of monomers include monomers having an isocyanate group in the molecule, such as meth)acryloyloxyethyl isocyanate, (meth)acryloyloxypropyl isocyanate, and (meth)acryloyl isocyanate; monomers having an acid anhydride group in the molecule, such as maleic anhydride, itaconic anhydride, and citraconic anhydride; and monomers having a vinyl group in the molecule, such as vinyl chloride. Preferably, the monomers have an epoxy group in the molecule, such as glycidyl acrylate, glycidyl methacrylate (GMA), methylglycidyl methacrylate, and allyl glycidyl ether. These reactive monomers can be used individually or in combination of two or more.

[0137] Furthermore, the hydrophilic monomer is not particularly limited, but examples include acrylic acid, methacrylic acid, N-methylacrylamide, N,N-dimethylacrylamide (DMAA), acrylamide, acryloylmorpholine, N,N-dimethylaminoethyl acrylate, vinylpyrrolidone, 2-methacryloyloxyethyl phosphorylcholine, 2-methacryloyloxyethyl-D-glycoside, 2-methacryloyloxyethyl-D-mannoside, vinyl methyl ether, 2-hydroxyethyl (meth)acrylate, 4-hydroxybutyl (meth)acrylate, 2-hydroxypropyl (meth)acrylate, 2-hydroxybutyl (meth)acrylate, 6-hydroxyhexyl (meth)acrylate, 1,4-cyclohexanedimethanol mono(meth)acrylate, 1-chloro-2-hydroxypropyl (meth)acrylate, diethylene glycol mono(meth)acrylate, 1,6-hexanediol mono(meth)acrylate Examples include acrylate, pentaerythritol tri(meth)acrylate, dipentaerythritol penta(meth)acrylate, neopentyl glycol mono(meth)acrylate, trimethylolpropanedi(meth)acrylate, trimethylolethanedi(meth)acrylate, 2-hydroxy-3-phenyloxypropyl(meth)acrylate, 4-hydroxycyclohexyl(meth)acrylate, 2-hydroxy-3-phenyloxy(meth)acrylate, 4-hydroxycyclohexyl(meth)acrylate, cyclohexanedimethanol mono(meth)acrylate, poly(ethylene glycol) methyl ether acrylate, and poly(ethylene glycol) methyl ether methacrylate. Preferably, these include N,N-dimethylacrylamide, acrylamide, acrylic acid, methacrylic acid, N,N-dimethylaminoethyl acrylate, 2-hydroxyethyl acrylate, and vinylpyrrolidone. These hydrophilic monomers can be used individually or in combination of two or more.

[0138] Furthermore, the hydrophilic material constituting the lubricating coating layer 311a may be a material containing only hydrophilic monomers in order to easily and firmly fix the hydrophilic polymer to the medical elongated body 300A. In that case, the hydrophilic monomers contain (meth)acryloyl groups that can crosslink with other hydrophilic monomers or react (bond) with the surface of the medical elongated body 300A by electron beam irradiation. For example, such hydrophilic monomers are hydrophilic monomers containing (meth)acryloyl groups among the hydrophilic monomers mentioned above. A material containing only hydrophilic monomers is a material obtained by combining one or more hydrophilic monomers containing (meth)acryloyl groups among the hydrophilic monomers mentioned above.

[0139] The hub portion 320 can be made of a harder material than the main body portion 310. Examples of materials that can be used to make up the hub portion 320 include polyethylene, polypropylene, polyamide, polycarbonate, and polystyrene.

[0140] (Method of manufacturing a medical device) Next, a method of manufacturing a medical device using the electron beam irradiation device 10 according to this embodiment will be described.

[0141] As shown in Figures 1 and 2, the operator fixes the medical elongated body 300A to the gripping part 153. In this embodiment, 15 medical elongated bodies 300A are set in the width direction (side-by-side direction) of the electron beam irradiation device 10.

[0142] The operator fixes only the hub portion 320 of the medical elongated body 300A to the gripping portion 153. The operator fixes the medical elongated body 300A to the gripping portion 153 with the gripping portion 153 separated from the rail portion 151. The hub portion 320 is made of a harder material than the main body portion 310. Therefore, by fixing only the hub portion 320 of the medical elongated body 300A to the gripping portion 153, the electron beam irradiation device 10 can prevent unintended deformation or crushing of other parts of the main body portion 310.

[0143] Next, the worker connects the gripping part 153 to the rail part 151.

[0144] Next, the operator sends an instruction to the electron beam irradiation device 10 to begin the electron beam irradiation work. If the electron beam irradiation device 10 is equipped with a start button, the operator can start the work by pressing the start button. Alternatively, the operator can send a command to start the work to the electron beam irradiation device 10 by operating an information terminal or external controller.

[0145] When the operator gives the instruction to start work, the electron beam irradiation device 10 sprays inert gas (for example, nitrogen gas) from the inert gas supply unit 120 and starts inert gas purging. At this time, the electron beam irradiation device 10 sends inert gas from the inert gas supply unit 120 into the chamber unit 130 and removes the gas in the chamber unit 130 by replacing it with inert gas. The electron beam irradiation device 10 may be equipped with a discharge mechanism (such as a duct or exhaust pump) (not shown) for discharging the gas in the chamber unit 130 to the outside of the chamber unit 130.

[0146] The electron beam irradiation device 10 emits an electron beam from the emission surface 111 of the electron beam irradiation unit 110 after the chamber 130 has reached a predetermined oxygen concentration.

[0147] The electron beam irradiation device 10 operates the transport mechanism 150 to move the gripping portion 153, to which the hub portion 320 of the medical elongated body 300A is fixed, along the rail portion 151 in the first transport direction d1. At this time, the transport mechanism 150 moves the gripping portion 153 along the direction of gravity from which the medical elongated body 300A is suspended, thereby inserting the medical elongated body 300A into the internal passage 138a through the base end opening 136a of the guide portion 135, and further moving it into the chamber portion 130 by passing it through the tip opening 137a of the guide portion 135. The medical elongated body 300A is introduced into the chamber portion 130 from the other end side of the medical elongated body 300A via the guide portion 135, with only the hub portion 320 fixed by the gripping portion 153.

[0148] As described above, the electron beam irradiation device 10 can move along the direction of gravity while the medical elongated body 300A is suspended by the transport mechanism 150, and therefore can exhibit the following effects.

[0149] Generally, the application of the lubricating coating layer 311a to the medical elongated body 300A often employs a dipping coating method, in which the transport mechanism 150 moves the medical elongated body 300A in the same direction as gravity. Therefore, considering a series of manufacturing processes that proceed from dipping the medical elongated body 300A to curing the lubricating coating layer 311a, the efficiency of the manufacturing process can be improved by performing the curing of the lubricating coating layer 311a while the medical elongated body 300A is suspended and moved along the direction of gravity.

[0150] Furthermore, the electron beam irradiation device 10 can prevent the medical elongated body 300A from unintentionally coming into contact with various parts of the electron beam irradiation device 10 by moving it along the direction of gravity while the medical elongated body 300A is suspended by the transport mechanism 150. For example, the electron beam irradiation device 10 can form a gap ga (see Figure 12) between the area where the ferromagnetic material 200 of the medical elongated body 300A is not attracted to the partition 147 and the guide surface 145 of the partition 147. As a result, the electron beam irradiation device 10 can prevent the medical elongated body 300A from coming into contact with the screen 140 at unintended locations. This prevents the electron beam irradiation device 10 from experiencing peeling or detachment of the lubricating coating layer 311a applied to the medical elongated body 300A.

[0151] Furthermore, the electron beam irradiation device 10 can maintain the external shape of the medical elongated body 300A such that its entire longitudinal direction forms a substantially straight line due to its own weight, by moving the medical elongated body 300A along the direction of gravity while it is suspended by the transport mechanism 150. Therefore, when the electron beam irradiation device 10 irradiates the lubricating coating layer 311a applied to the medical elongated body 300A with an electron beam, it can more appropriately maintain the distance between the medical elongated body 300A and the emission surface 111 of the electron beam irradiation unit 110.

[0152] When the electron beam irradiation device 10 moves the medical elongated body 300A using the transport mechanism 150, a portion of the medical elongated body 300A can be supported outside the chamber 130 by the work guide 160 positioned between the chamber 130 and the gripping section 153. Therefore, when the electron beam irradiation device 10 moves the medical elongated body 300A using the transport mechanism 150, the medical elongated body 300A can be smoothly moved along a straight path along the rail section 151.

[0153] As shown in Figures 10 and 11, the electron beam irradiation device 10 moves the medical elongated body 300A through the space 130a within the chamber section 130 using the transport mechanism 150. When the first region 311 of the medical elongated body 300A passes through the space 130a, the electron beam irradiation device 10 ejects inert gas from the nozzle 121 of the inert gas supply unit 120 at an oblique angle toward the partition section 140. As an example, the inert gas supply unit 120 can eject inert gas at an ejection angle θ1 of 45° and an ejection pressure of 0.05 MPa.

[0154] The nozzle 121 of the inert gas supply unit 120 is inclined diagonally toward the first transport direction d1. Therefore, the inert gas ejected from the nozzle 121 flows toward the first transport direction d1 while being sprayed onto the medical elongated body 300A. The inert gas supply unit 120 can move the medical elongated body 300A toward the partition unit 140 over a predetermined range along the first transport direction d1 from near the emission surface 111 of the electron beam irradiation unit 110 by the inert gas ejected from the nozzle 121. As a result, the electron beam irradiation device 10 can effectively suppress the medical elongated body 300A from shaking or bending within the chamber unit 130, and can more reliably move a portion of the medical elongated body 300A toward the partition unit 140 where the magnetic force of the magnet unit 146 acts.

[0155] The electron beam irradiation device 10 moves the first region 311 of the medical elongated body 300A toward the guide surface 145 of the partition 140 by ejecting inert gas from the nozzle 121 of the inert gas supply unit 120. By moving the first region 311 of the medical elongated body 300A toward the guide surface 145 of the partition 140 and using the magnetic force of the magnet unit 146 to attract a part of the medical elongated body 300A to the partition wall 147, the electron beam irradiation device 10 can maintain a constant distance between the emission surface 111 of the electron beam irradiation unit 110 and the first region 311 of the medical elongated body 300A at a position corresponding to the space 130a. Therefore, the electron beam irradiation device 10 can reduce the force with which inert gas is sprayed onto the first region 311 of the medical elongated body 300A by the magnetic body 146, compared to the case where the first region 311 of the medical elongated body 300A is pressed against the guide surface 145 of the partition 140 by the spraying of inert gas alone. Consequently, the electron beam irradiation device 10 can reduce the amount of inert gas used to spray onto the first region 311 of the medical elongated body 300A from the inert gas supply unit 120 in order to maintain a constant distance between the emission surface 111 of the electron beam irradiation unit 110 and the first region 311 of the medical elongated body 300A.

[0156] The electron beam irradiation device 10 can continuously move each part of the medical elongated body 300A toward the partition 140 side as each part of the medical elongated body 300A passes through the space 130a by continuously ejecting inert gas from the nozzle 121 of the inert gas supply unit 120. As a result, the electron beam irradiation device 10 can smoothly move each part of the medical elongated body 300A toward the partition 140 side where the magnetic force of the magnet unit 146 acts, and can maintain a state in which each part of the medical elongated body 300A is in contact with the partition 140. The electron beam irradiation device 10 performs the following actions: ejection of inert gas by the inert gas supply unit 120, attraction of the medical elongated body 300A to the partition unit 140 using the magnetic force of the magnet unit 146, movement of the medical elongated body 300A along the first transport direction d1 by the transport mechanism 150, and irradiation with an electron beam from the electron beam irradiation unit 110. This allows the electron beam to be irradiated at a uniform distance from the emission surface 111 to each longitudinal part of the first region 311 of the medical elongated body 300A, which is sequentially arranged in the space 130a, while maintaining a constant distance between the emission surface 111 of the electron beam irradiation unit 110 and the main body 310 of the medical elongated body 300A.

[0157] As shown in Figure 12, the first region 311 of the medical elongated body 300A, to which the inert gas is sprayed, moves away from the nozzle 121 and is contained within the recess 143. Therefore, the electron beam irradiation device 10 can prevent the first region 311 of the medical elongated body 300A from shifting significantly in the width direction (arrow Y1-Y2 direction). As a result, when the electron beam irradiation device 10 irradiates the first region 311 of the medical elongated body 300A with an electron beam, the effect of keeping the distance between the emission surface 111 of the electron beam irradiation unit 110 and the first region 311 of the medical elongated body 300A constant is enhanced. Furthermore, in this embodiment, when the electron beam irradiation device 10 is configured to irradiate multiple medical elongated bodies 300A simultaneously with electron beams, the recess 143 of the partition 140 can prevent unintentional contact between adjacent medical elongated bodies 300A in the width direction (arrow Y1-Y2 direction) with the inert gas ejected from the nozzle 121.

[0158] As shown in Figures 10 and 11, when the electron beam irradiation device 10 sends the medical elongated body 300A into the internal space 130A of the chamber section 130 via the guide section 135, it uses the magnetic force of the magnet section 146 to attract a portion of the medical elongated body 300A to the partition section 147. As a result, a portion of the medical elongated body 300A positioned in space 130a moves towards the partition section 140. By using magnetic force as described above to attract a portion of the medical elongated body 300A to the partition section 147, the magnet section 146 can maintain a state in which a portion of the medical elongated body 300A is in contact with the guide surface 145 of the partition section 147, which is positioned opposite the emission surface 111 of the electron beam irradiation section 110 across the space 130a (see Figure 13).

[0159] The electron beam irradiation device 10 uses a transport mechanism 150 to sequentially move each part of the medical elongated body 300A in the longitudinal direction into the space 130a, while adsorbing a portion of the medical elongated body 300A to the partition wall 147.

[0160] The electron beam irradiation device 10 moves the medical elongated body 300A along the first transport direction d1 using the transport mechanism 150, while maintaining a constant distance between the emission surface 111 of the electron beam irradiation unit 110 and a part of the medical elongated body 300A. This allows the electron beam irradiation device 10 to continuously emit electron beams to each part of the medical elongated body 300A in the longitudinal direction while maintaining a constant distance (straight line distance LA shown in Figure 11) between the emission surface 111 of the electron beam irradiation unit 110 and each part of the medical elongated body 300A in the longitudinal direction. Therefore, the electron beam irradiation device 10 can prevent uneven hardening of the lubricating coating layer 311a in each part of the first region 311 of the medical elongated body 300A in the longitudinal direction.

[0161] Furthermore, the electron beam irradiation device 10 can achieve the following effects by including the guide section 135.

[0162] If the electron beam irradiation device 10 does not have a guide section 135, the medical elongated body 300A is inserted directly into the chamber section 130 through the opening 133. When an inert gas is sprayed onto the medical elongated body 300A inserted into the chamber section 130 in this manner, a large vibration occurs due to the spraying of the inert gas. In such a case, the electron beam irradiation device 10 cannot smoothly move the medical elongated body 300A toward the partition section 140 due to the vibration generated in the medical elongated body 300A. As a result, the suction of the medical elongated body 300A to the partition section 147 does not proceed smoothly, and it becomes difficult to maintain a constant distance between the emission surface 111 of the electron beam irradiation section 110 and the medical elongated body 300A.

[0163] In the electron beam irradiation device 10, the medical elongated body 300A is inserted into the chamber 130 via a guide portion 135 provided at the opening 133 of the chamber 130. Furthermore, when an inert gas is ejected onto the medical elongated body 300A, a portion of the medical elongated body 300A located on the proximal end side (arrow X1 side) of the electron beam irradiation position on the medical elongated body 300A is maintained in a state where it is inserted into the internal passage 138a of the main body 138 of the guide portion 135. Therefore, when an inert gas is ejected onto a portion of the medical elongated body 300A placed inside the chamber 130, the vibration that occurs in the medical elongated body 300A can be effectively suppressed by the guide portion 135.

[0164] Furthermore, in the electron beam irradiation device 10, the tip opening 137a of the guide section 135 is located closer to the partition section 140 than the opening 133 of the chamber section 130 (it is located closer to the partition section 140). As a result, the distance from the tip opening 137a to the partition section 140 is shorter than the distance from the opening 133 to the partition section 140. For example, if a relatively large distance is provided between the opening 133 and the partition section 140, the starting point of the vibration that occurs when an inert gas is sprayed onto the medical elongated body 300A will be near the opening 133 that comes into contact with the medical elongated body 300A. Therefore, when vibration occurs in the medical elongated body 300A, the amplitude of the vibration becomes large. To address this problem, the electron beam irradiation device 10, by providing the guide section 135, can shift the starting point of the vibration to the vicinity of the tip opening 137a, which is located closer to the partition section 140 than the opening 133, even when vibration occurs in the medical elongated body 300A. Therefore, the electron beam irradiation device 10 can reduce the amplitude of the vibration that occurs when an inert gas is sprayed onto the medical elongated body 300A.

[0165] After the entire longitudinal range of the first region 311 of the medical elongated body 300A to be irradiated by the electron beam has passed through the space 130a, the electron beam irradiation device 10 operates the rotation unit 155 to rotate the medical elongated body 300A 180° with respect to the central axis 310c of the main body 310, as shown in Figures 14 and 15.

[0166] When the electron beam irradiation device 10 rotates the medical elongated body 300A, it stops the ejection of inert gas from the inert gas supply unit 120. By stopping the ejection of inert gas from the inert gas supply unit 120 when the electron beam irradiation device 10 rotates the medical elongated body 300A, it can release the force that presses the medical elongated body 300A toward the partition unit 140 caused by the ejection of inert gas. As a result, when the electron beam irradiation device 10 rotates the medical elongated body 300A, the load on the lubricating coating layer 311a is reduced to only the magnetic force of the magnet unit 146, and the risk of the lubricating coating layer 311a rubbing against the partition unit 140 and falling off as the medical elongated body 300A rotates can be reduced. In Figures 14 and 15, the portion of the lubricating coating layer 311a that has hardened due to an electron beam irradiated onto the first region 311 of the main body 310 when the medical elongated body 300A is moved in the first transport direction d1 is illustrated by reference numeral 311b.

[0167] After rotating the medical elongated body 300A by 180° as described above, the electron beam irradiation device 10 operates the transport mechanism 150 to move the medical elongated body 300A along the second transport direction d2. By moving the medical elongated body 300A along the second transport direction d2 using the transport mechanism 150, the electron beam irradiation device 10 causes the first region 311 of the medical elongated body 300A to pass through the space 130a. When the electron beam irradiation device 10 causes the medical elongated body 300A to pass through the first region 311 of the medical elongated body 300A along the second transport direction d2, it performs the ejection of inert gas from the inert gas supply unit 120 and the irradiation of an electron beam from the electron beam irradiation unit 110, in the same manner as when moving the medical elongated body 300A along the first transport direction d1. The electron beam irradiation device 10 rotates the medical elongated body 300A by 180°, then moves the medical elongated body 300A along the second transport direction d2, passing it through the space 130a. This allows the electron beam to be irradiated to the opposite side of the circumferential surface of the medical elongated body 300A that was irradiated when it was moved along the first transport direction d1. As a result, the electron beam irradiation device 10 can irradiate the entire circumferential surface of the medical elongated body 300A with the electron beam uniformly.

[0168] In this embodiment, when an electron beam is irradiated onto the first region 311 of the medical elongated body 300A, the entire length of the medical elongated body 300A is not placed within the chamber portion 130, but only a portion of the length including the first region 311 is placed within the chamber portion 130. Therefore, the electron beam irradiation device 10 can be prevented from having a device configuration in which the length of the chamber portion 130 in the longitudinal direction is enlarged.

[0169] After the electron beam irradiation of the first region 311 of the medical elongated body 300A is completed, the electron beam irradiation device 10 moves the gripping part 153 to a predetermined position (initial position on one end of the rail part 151). The operator removes the gripping part 153, to which the medical elongated body 300A is fixed, from the rail part 151.

[0170] With the above steps, the irradiation of the medical-grade long body 300A with electron beams is completed.

[0171] The following describes the effects and advantages of the electron beam irradiation device 10 and the method for manufacturing the medical device according to this embodiment.

[0172] The electron beam irradiation apparatus 10 according to this embodiment includes an electron beam irradiation unit 110 having an emission surface 111 for emitting electron beams, an inert gas supply unit 120 having a nozzle 121 for ejecting inert gas, a chamber unit 130 having an opening 133 for inserting a medical elongated body 300A (object to be irradiated 300) and housing the emission surface 111 and the nozzle 121, a partition unit 140 located inside the chamber unit 130 and facing the emission surface 111, and a space located between the emission surface 111 and the partition unit 140 through the opening 133. The device includes a transport mechanism 150 configured to allow a portion of a medical elongated body 300A containing a ferromagnetic material 200 to be placed in space 130a, and the partition section 140 has a magnetic body section 146 and a partition wall section 147 located on the side of the emission surface 111 that is closer to the magnetic body section 146, and the magnetic body section 146 is configured to attract a portion of the medical elongated body 300A to the partition wall section 147 using the magnetic force of the magnetic body section 146 when a portion of the medical elongated body 300A is placed in the space 130a located between the emission surface 111 and the partition section 140.

[0173] The electron beam irradiation device 10 can use a transport mechanism 150 to place a portion of the medical elongated body 300A containing the ferromagnetic material 200 into the space 130a located between the emission surface 111 of the electron beam irradiation unit 110 and the partition unit 140, through the opening 133 of the chamber unit 130. When the electron beam irradiation device 10 transports a portion of the medical elongated body 300A into the space 130a, the magnetic force of the magnetic body 146 of the partition unit 140 can attract the portion of the medical elongated body 300A to the partition wall 147. By attracting a portion of the medical elongated body 300A to the partition wall 147, the electron beam irradiation device 10 can maintain a constant distance between the portion of the medical elongated body 300A and the emission surface 111 of the electron beam irradiation unit 110, which is located on the side facing the partition unit 140 with the space 130a in between. Therefore, the electron beam irradiation device 10 does not need to increase the amount of inert gas supplied from the inert gas supply unit 120 to a portion of the medical elongated body 300A in order to maintain a constant distance between a portion of the medical elongated body 300A and the emission surface 111 of the electron beam irradiation unit 110. As a result, the electron beam irradiation device 10 can improve the product quality of the medical elongated body 300A while suppressing an increase in the amount of inert gas used.

[0174] Furthermore, the partition wall portion 147 has a tip region 148A, a base region 148B, and an intermediate region 148C located between the tip region 148A and the base region 148B, including a region facing the emission surface 111, and the magnet body portion 146 has the intermediate region 148C also located on the tip side.

[0175] As described above, since the magnetic body portion 146 is located in the intermediate region 148C, the medical elongated body 300A can be attracted to the partition portion 147 in the intermediate region 148C. Furthermore, by setting the electron beam irradiation position to include the intermediate region 148C, the electron beam can be more reliably irradiated to a portion of the medical elongated body 300A, which is attracted to the intermediate region 148C of the partition portion 147, while maintaining a constant distance from the emission surface 111. In addition, since the intermediate region 148C is located towards the tip of the base region 148B, when the medical elongated body 300A is transported to the partition portion 140, it is possible to prevent the medical elongated body 300A from being attracted to the base region 148B. As a result, the electron beam irradiation device 10 can gradually attract the medical elongated body 300A towards the intermediate region 148C as it passes the base region 148B. Therefore, the electron beam irradiation device 10 can prevent the medical elongated body 300A from getting caught on the partition 140 when it enters the partition 140.

[0176] Furthermore, the magnetic body portion 146 can be configured to be located only in the intermediate region 148C. This makes it possible to more reliably prevent the medical elongated body 300A from being attracted to the base end region 148B, as described above. Also, because the magnetic body portion 146 is located only in the intermediate region 148C, it is possible to more reliably prevent the medical elongated body 300A from being attracted to the tip region 148A. Therefore, when the medical elongated body 300A enters the partition portion 140, it is possible to more reliably prevent the medical elongated body 300A from getting caught on the partition portion 140. In addition, when the electron beam irradiation position is set in the intermediate region 148C, the electron beam irradiation device 10 can prevent the medical elongated body 300A from being attracted to a location on the partition portion 147 other than the electron beam irradiation position when the medical elongated body 300A is transported on the partition portion 140. Therefore, the electron beam irradiation device 10 can reduce friction between the medical elongated body 300A and the partition wall 147, and effectively prevent peeling or detachment of the lubricating coating layer 311a applied to the medical elongated body 300A.

[0177] Furthermore, the nozzle 121 is located on the side facing the partition 140, which is the discharge surface 111 side, and the partition wall 147 has a plurality of recesses 143 that are recessed toward the side away from the discharge surface 111 and the side where the nozzle 121 is located, and the magnet body 146 is arranged along each of the plurality of recesses 143.

[0178] The electron beam irradiation device 10 can move a portion of the medical elongated body 300A into the recess 143 of the partition 140 by ejecting an inert gas from the discharge surface 111 side, which is the side facing the partition 140. Since the electron beam irradiation device 10 has a magnet body 146 arranged along each of the multiple recesses 143, the portion of the medical elongated body 300A that has been moved to the recess 143 can be moved linearly along the recess 143 which extends in approximately the same direction as the longitudinal direction of the chamber 130. Furthermore, by moving the medical elongated body 300A along the longitudinal direction of the chamber 130 with a portion of the medical elongated body 300A positioned in the recess 143, the movement path of each medical elongated body 300A can be divided in the width direction when simultaneously irradiating multiple medical elongated bodies 300A with electron beams. This prevents multiple medical-grade elongated objects 300A from being attracted to the same magnetic body 146 in the electron beam irradiation device 10.

[0179] Furthermore, the width W1 of the magnet body 146 is smaller than the width W2 of the recess 143. Therefore, when the medical elongated body 300A moves within the recess 143, the magnetic force of adjacent magnet body 146 in the width direction is prevented from acting on multiple medical elongated bodies 300A. As a result, the recess 143 can appropriately guide the movement of the medical elongated body 300A, allowing it to move smoothly along the longitudinal direction of the chamber 130.

[0180] Furthermore, the chamber section 130 is provided with a cylindrical guide section 135 at the opening 133 that connects the outside of the chamber section 130 to the inside of the chamber section 130 and guides a part of the medical elongated body 300A from the outside of the chamber section 130 to the partition section 140. The central axis 135c of the guide section 135 is offset by a predetermined distance from the bottom surface 147a of the partition wall section 147 in a direction perpendicular to the extension direction of the guide section 135.

[0181] The electron beam irradiation device 10 is equipped with a guide section 135, which allows the medical elongated body 300A to be guided to the partition section 140 when it is inserted into the chamber section 130, and also allows the medical elongated body 300A to be guided when it is removed from the chamber section 130 after it has been irradiated with electron beams. Furthermore, the electron beam irradiation device 10 has a central axis 135c of the guide section 135 that is offset by a predetermined distance from the bottom surface 147a of the partition wall section 147 in a direction perpendicular to the extending direction of the guide section 135. As a result, when the medical elongated body 300A moves into the space 130a, the ferromagnetic material 200, which is made of a core metal or the like, can be separated from the partition wall section 147 by the offset distance. As a result, when the electron beam irradiation device 10 moves a portion of the medical elongated body 300A into space 130a, it can gradually attract the ferromagnetic material 200 toward the front end of the chamber portion 130 and diagonally toward the partition portion 140. Therefore, the electron beam irradiation device 10 can prevent the ferromagnetic material 200, which is made of a core metal or the like, from colliding with the partition portion 140 when it enters the partition portion 140.

[0182] Furthermore, the nozzle 121 is located on the base end side of the discharge surface 111 in the longitudinal direction of the chamber section 130, and is located on the discharge surface 111 side, which is opposite the partition section 140, and inert gas is ejected in a direction that slopes from the discharge surface 111 side toward the partition section 140 side.

[0183] As described above, the electron beam irradiation device 10 ejects inert gas from the nozzle 121, allowing it to move a portion of the medical elongated body 300A toward the guide surface 145 of the partition 140, which is positioned opposite the emission surface 111 of the electron beam irradiation unit 110 across the space 130a. This allows the electron beam irradiation device 10 to smoothly attract a portion of the medical elongated body 300A to the partition 147, and to more reliably maintain a constant distance between the portion of the medical elongated body 300A positioned in the space 130a and the emission surface 111. Furthermore, if the chamber 130 of the electron beam irradiation device 10 has a guide section 135, it becomes easier to form an inert gas flow along the guide surface 145 using the Coanda effect. This allows the electron beam irradiation device 10 to efficiently form an inert gas flow toward the second end 137 of the guide section 135. As a result, the electron beam irradiation device 10 can effectively prevent oxygen from the atmosphere from flowing into the chamber 130 from the outside via the guide section 135.

[0184] Furthermore, the magnetic body portion 146 can be made of a permanent magnet. When the magnetic body portion 146 is made of a permanent magnet, the partition portion 140 has a magnetic field of 10 to 1000 gf / cm² in the region facing the emission surface 111. ２ It can be configured to have a suction force. By the partition 140 adsorbing the medical elongated body 300A with the above-mentioned suction force, the medical elongated body 300A can be prevented from separating from the partition 140, while the medical elongated body 300A can be moved smoothly along the partition 140.

[0185] The manufacturing method of the medical device according to this embodiment is an electron beam irradiation device 10 that irradiates an electron beam onto a chamber portion 130 and a medical elongated body 300A on which a lubricating coating layer 311a is formed, wherein the electron beam irradiation device 10 comprises an electron beam irradiation unit 110 having an emission surface 111 from which electron beams are emitted, an inert gas supply unit 120 having a nozzle 121 for injecting inert gas, and a partition unit 140 located inside the chamber portion 130 and facing the emission surface 111, wherein the partition unit 140 is The device has a magnetic body portion 146 and a partition portion 147 located on the side of the emission surface 111 that is closer to the emission surface 111 than the magnetic body portion 146. A portion of a medical elongated body 300A containing a ferromagnetic material 200 is placed in the space 130a within the chamber portion 130 located between the emission surface 111 and the partition portion 140. The magnetic force of the magnetic body portion 146 is used to attract a portion of the medical elongated body 300A to the partition portion 147. With the medical elongated body 300A attracted to the partition portion 147, an electron beam is irradiated onto the medical elongated body 300A from the emission surface 111.

[0186] In the method for manufacturing medical devices, by placing a portion of a medical elongated body 300A containing a ferromagnetic material 200 in the space 130a within the chamber portion 130 located between the emission surface 111 of the electron beam irradiation unit 110 and the partition portion 140, the magnetic force of the magnetic body portion 146 of the partition portion 140 can cause the portion of the medical elongated body 300A to be attracted to the partition portion 147. In the method for manufacturing medical devices, by attracting a portion of the medical elongated body 300A to the partition portion 147, the distance between the portion of the medical elongated body 300A and the emission surface 111 of the electron beam irradiation unit 110, which is located on the side facing the partition portion 140 with the space 130a in between, can be kept constant. The method for manufacturing medical devices prevents uneven hardening of the lubricating coating layer 311a applied to the medical elongated body 300A by irradiating a portion of the medical elongated body 300A with an electron beam while maintaining a constant distance between the portion of the medical elongated body 300A and the emission surface 111 of the electron beam irradiation unit 110. Therefore, the method for manufacturing medical devices does not require increasing the amount of inert gas supplied from the inert gas supply unit 120 to the portion of the medical elongated body 300A in order to maintain a constant distance between the portion of the medical elongated body 300A and the emission surface 111 of the electron beam irradiation unit 110. As a result, the method for manufacturing medical devices can improve the product quality of the medical elongated body 300A while suppressing an increase in the amount of inert gas used.

[0187] Next, we will describe various modifications to the embodiments described above. We will omit redundant explanations of content that is identical to the configurations and effects already described.

[0188] <Modification Example 1> Figure 16 shows a part of the partition section 140 according to Modification Example 1. Figure 16 is a plan view corresponding to Figure 4.

[0189] As shown in Figure 16, the magnetic body portion 146 may be arranged to span, for example, the intermediate region 148C, the tip region 148A, and the base region 148B. However, in order to prevent the medical elongated body 300A from getting caught on the partition portion 140 when it enters the partition portion 140, it is preferable to position the base end of the magnetic body portion 146 at a distance of 10 mm or more toward the tip of the partition portion 140 than the base end of the partition portion 140, and to position the tip of the magnetic body portion 146 at a distance of 10 mm or more toward the tip of the partition portion 140.

[0190] <Modification Example 2> Figure 17 shows a part of the partition section 140 according to Modification Example 2. As shown in Figure 17, the attractive force with which the magnetic body section 146 attracts the ferromagnetic material 200 can be adjusted, for example, by the thickness of the partition wall section 147. In the example shown in Figure 17, the thickness of the partition wall section 147 is increased compared to the embodiment described above, thereby reducing the attractive force with which the magnetic body section 146 attracts the ferromagnetic material 200 compared to the embodiment described above.

[0191] <Modification Example 3> Figure 18 shows a part of the partition section 140 according to Modification Example 3. As shown in Figure 18, the attractive force with which the magnetic body section 146 attracts the ferromagnetic material 200 can also be adjusted, for example, by placing a spacer 149 in the partition wall section 147. In the example shown in Figure 18, a non-magnetic metal spacer is placed between the partition wall section 147 and the magnetic body section 146. This makes it possible to increase the distance between the magnetic body section 146 and the ferromagnetic material 200 compared to the embodiment described above. As a result, the partition section 140 according to Modification Example 3 is adjusted to reduce the attractive force with which the magnetic body section 146 attracts the ferromagnetic material 200 compared to the embodiment described above.

[0192] The manufacturing method of the electron beam irradiation apparatus and medical device according to the present invention has been described above through embodiments and modifications. However, the present invention is not limited to what has been described in the specification and can be modified as appropriate based on the claims.

[0193] In the description of the electron beam irradiation apparatus of the embodiment, a medical elongated body coated with a coating layer (lubricating coating layer) was used as an example of the object to be irradiated. However, the object to be irradiated with the electron beam irradiation apparatus can be various components for which it is desirable to maintain a constant distance between the emission surface of the electron beam irradiation unit and the object to be irradiated. For example, the object to be irradiated may be a medical device such as a stent or injection needle, or a component other than a medical device such as a string, rope, or hose. Furthermore, the object to be hardened by electron beam irradiation is not limited to the lubricating coating layer, but may also be an antibacterial coating layer, an antithrombotic coating layer, or a drug coating layer containing a material that hardens by electron beam irradiation. In addition, if there is an intermediate coating layer between the surface of the medical elongated body and the lubricating coating layer to improve the adhesion between the surface of the medical elongated body and the lubricating coating layer, the object to be hardened by electron beam irradiation may be that intermediate coating layer. Furthermore, the target of electron beam irradiation may be the surface of an object without a coating layer, for the purpose of surface modification (e.g., surface hydrophilization, improved adhesion) or physical property modification (e.g., improved heat resistance, improved mechanical strength).

[0194] In the description of the embodiment, an example was shown in which the transport mechanism 150 of the electron beam irradiation device 10 was configured to transport the object to be irradiated 300 (medical elongated body 300A) while suspended in the direction of gravity. In other words, the electron beam irradiation device 10 was configured such that the rail section 151 extended in the vertical direction, and the entire device was laid out in the vertical direction. However, the transport mechanism of the electron beam irradiation device may be configured such that the transport direction of the object to be irradiated 300 (medical elongated body 300A) is in the horizontal direction intersecting the direction of gravity, and each component, including the chamber section, may be arranged to accommodate horizontal transport by the transport mechanism.

[0195] This application is based on Japanese Patent Application No. 2025-017621, filed on 5 February 2025, the disclosures of which are incorporated herein by reference in their entirety.

[0196] 10 Electron beam irradiation device 20 Device body 110 Electron beam irradiation section 111 Emission surface 120 Inert gas supply section 121 Nozzle 123 Nozzle body 130 Chamber section 130A Internal space of the chamber section 130a Space between the emission surface and the partition section 133 Opening 135 Guide section 135c Central axis of the guide section 140 Partition section 143 Recess 145 Guide surface 146 Magnet section 147 Partition section 147a Bottom surface of the partition section 148A Tip region 148B Base region 148C Intermediate region 150 Transport mechanism 200 Ferromagnetic material 300 Object to be irradiated 300A Medical long object 310 Main body section 311 First region 311a Lubrication coating layer 312 Second region 315 lumens; W1: Width of the magnet body; W2: Width of the recess.

Claims

1. An electron beam irradiation device comprising: an electron beam irradiation unit having an emission surface for emitting an electron beam; an inert gas supply unit having a nozzle for ejecting an inert gas; a chamber unit having an opening for inserting an object to be irradiated and housing the emission surface and the nozzle; a partition unit located inside the chamber unit and facing the emission surface; and a transport mechanism configured to allow a portion of the object to be irradiated, including a ferromagnetic material, to be placed in the space located between the emission surface and the partition unit through the opening, wherein the partition unit comprises a magnetic body unit and a partition wall unit located on the emission surface side of the magnetic body unit, and the magnetic body unit is configured to attract a portion of the object to be irradiated to the partition wall unit using the magnetic force of the magnetic body unit when a portion of the object to be irradiated is placed in the space located between the emission surface and the partition unit.

2. The electron beam irradiation apparatus according to claim 1, wherein the partition wall portion has a tip region, a base region, and an intermediate region located between the tip region and the base region and including a region facing the emission surface, and the magnet portion is located on the tip side of the intermediate region.

3. The electron beam irradiation apparatus according to claim 2, wherein the magnetic body portion is located only in the intermediate region.

4. The electron beam irradiation apparatus according to claim 1, wherein the nozzle is located on the side facing the partition, which is the side facing the discharge surface, the partition has a plurality of recesses that are recessed toward the side away from the side where the discharge surface is located and the side where the nozzle is located, and the magnet body is arranged along each of the plurality of recesses.

5. The electron beam irradiation apparatus according to claim 4, wherein the width of the magnetic body portion is smaller than the width of the recess.

6. The electron beam irradiation apparatus according to claim 1, wherein the chamber portion is provided with a cylindrical guide portion at the opening that connects the outside of the chamber portion to the inside of the chamber portion and guides a part of the object to be irradiated from the outside of the chamber portion to the partition portion, and the central axis of the guide portion is offset by a predetermined distance from the bottom surface of the partition portion in a direction perpendicular to the extending direction of the guide portion.

7. The electron beam irradiation apparatus according to claim 1, wherein the nozzle is located on the base end side of the discharge surface in the longitudinal direction of the chamber and on the discharge surface side which is opposite to the partition, and the inert gas is ejected in a direction that slopes from the discharge surface side toward the partition side.

8. The magnetic body portion is made of a permanent magnet, and the partition portion has a magnetic field of 10 to 1000 gf / cm² in the region facing the emission surface. ２ The electron beam irradiation apparatus according to claim 1, having the adsorption force.

9. An electron beam irradiation apparatus for irradiating a medical elongated body having a coating layer with an electron beam, wherein the electron beam irradiation apparatus comprises: a chamber; an electron beam irradiation unit having an emission surface for emitting an electron beam; an inert gas supply unit having a nozzle for spraying an inert gas; and a partition unit located inside the chamber and facing the emission surface, wherein the partition unit comprises a magnetic body and a partition wall unit located on the emission surface side of the magnetic body unit; a portion of the medical elongated body containing a ferromagnetic material is placed in the space inside the chamber located between the emission surface and the partition unit; the portion of the medical elongated body is attracted to the partition wall unit using the magnetic force of the magnetic body unit; and while the medical elongated body is attracted to the partition wall unit, an electron beam is irradiated onto the medical elongated body from the emission surface.

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