Electron beam irradiation device and method for producing medical instrument

Abstract

[Problem] To provide: an electron beam irradiation device which, while suppressing an increase in the amount of an inert gas used, can improve the product quality of an irradiation target by keeping the distance between the irradiation target and an emission surface of an electron beam irradiation part constant; and a method for producing a medical instrument. [Solution] A baffle part (140) included in an electron beam irradiation device (10) has a suction part (180) and a partition wall part (147) that is positioned on the emission surface side of the suction part (180) and that includes a plurality of holes (146). The suction part includes an open end (181) and a suction path (183) that is in communication with the open end. The open end is disposed so as to face the partition wall part. The suction part suctions a portion of a medical elongated body (300A) from the open end so that the partition wall part and the medical elongated body are in contact with each other in a state where a portion of the medical elongated body is disposed in a space (130a) positioned between the emission surface (111) and the baffle part.

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 smoothly move within a patient's body, a coating liquid (for example, a coating liquid containing a hydrophilic polymer forming 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 liquid to a long medical body and forming a coating layer (a coating layer by the coating liquid or a coating layer obtained by drying the coating liquid) 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 electron beam may be adopted. However, when a method of curing the coating layer by electron beam is adopted, the following points may become problems. <​​​​​​

[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 (10).

[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 to be placed in the space located between the emission surface and the partition unit through the opening, wherein the partition unit comprises a suction unit and a partition wall unit located on the emission surface side of the suction unit and having a plurality of holes; the suction unit comprises an open end and a suction path communicating with the open end; the open end is positioned facing the partition wall unit; and the suction unit is configured to suck a portion of the object to be irradiated from the open end so that the partition wall unit and the object to be irradiated come into contact 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, the plurality of holes are formed in the tip region, the intermediate region, and the base region, and the opening end is located on the tip side of the intermediate region.

[0020] (3) The electron beam irradiation apparatus according to (2), wherein the open end is located only at a position facing the intermediate region.

[0021] (4) The electron beam irradiation apparatus according to (2) or (3), wherein the aperture ratio of the partition wall in the proximal region is smaller than the aperture ratio of the partition wall in the intermediate region.

[0022] (5) The electron beam irradiation apparatus according to any one of (1) to (4), wherein the opening ratio of the partition wall portion at a position opposite the open end is 10% to 40%.

[0023] (6) The electron beam irradiation apparatus according to any one of (1) to (5), wherein each of the plurality of holes has a chamfered outer circumference on the surface facing the emission surface.

[0024] (7) The electron beam irradiation apparatus according to any one of (1) to (6), 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 partition portion extends on the extension of the guide portion and has a recess that guides the straight-line movement of the object to be irradiated.

[0025] (8) The electron beam irradiation apparatus according to (7), wherein 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.

[0026] (9) The electron beam irradiation apparatus according to any one of (1) to (8), 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 is inclined from the discharge surface side toward the partition side.

[0027] (10) An electron beam irradiation device for irradiating a medical elongated body having a coating layer with an electron beam, wherein the electron beam irradiation device 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 suction unit; and a partition wall unit located on the emission surface side of the suction unit and having a plurality of holes, wherein a part of the medical elongated body 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 brought into contact with the partition wall unit using the suction force of the suction unit, and the medical elongated body is irradiated with an electron beam from the emission surface while the medical elongated body is in contact with the partition wall unit, a method for manufacturing a medical device.

[0028] The electron beam irradiation device described above can position a portion of the object to be irradiated 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. The electron beam irradiation device can then bring a portion of the object to be irradiated into contact with the partition wall by using a suction unit to draw in the portion of the object to be irradiated while it is positioned in the space. By maintaining the state in which a portion of the object to be irradiated is in contact with the partition wall, the electron beam irradiation device can maintain a constant distance between the portion of the object to be irradiated and the emission surface of the electron beam irradiation unit, which is located on the side facing the partition, with the space in between. Therefore, the electron beam irradiation device 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 device can improve the product quality of the object to be irradiated while suppressing an increase in the amount of inert gas used.

[0029] In the above-described method for manufacturing medical devices, a portion of the medical device is placed in the space within the chamber located between the electron beam irradiation outlet and the partition, and a portion of the object to be irradiated is sucked in by the suction unit, thereby bringing the portion of the medical device into contact with the partition wall. By maintaining the state in which a portion of the medical device is in contact with the partition wall, the method for manufacturing medical devices can keep the distance between the portion of the medical device and the electron beam irradiation outlet located on the side opposite the partition, with the space in between, constant. 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 electron beam irradiation outlet, uneven hardening of the coating layer applied to the medical device can be prevented. Therefore, in the method for manufacturing medical devices, it is not necessary to increase the amount of inert gas sprayed from the inert gas supply unit onto the portion of the object to be irradiated in order to maintain a constant distance between the portion of the medical device and the electron beam irradiation outlet. 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.

[0030] 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 suction 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 a modified example.

[0031] 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.

[0032] 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.

[0033] (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 to be placed in the space 130a located between the emission surface 111 and the partition unit 140 through the opening 133.

[0034] 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."

[0035] 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.

[0036] 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.

[0037] 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.

[0038] (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.

[0039] 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.

[0040] 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.

[0041] The chamber part 130 has a predetermined length along the longitudinal direction. The longitudinal length of the chamber part 130 (the longitudinal length of the internal space 130A) can be arbitrarily set according to the longitudinal length of the irradiation target site of the electron beam in the medical long body 300A. For example, when the irradiation target site of the electron beam is the first region 311 of the main body part 310 of the medical long body 300A as described later, the longitudinal length of the chamber part 130 can be configured to be a length that can accommodate the entire longitudinal range of the first region 311.

[0042] (Transport mechanism 150) As shown in FIGS. 1, 2, 10, and 11, when the electron beam irradiation device 10 irradiates the electron beam on the medical long body 300A, a part of the medical long body 300A (in this embodiment, the first region 311 of the medical long body 300A described later) is arranged in the space 130a located between the emission surface 111 and the partition 140 by the transport mechanism 150.

[0043] As shown in FIGS. 1 and 2, the transport mechanism 150 is located outside the chamber part 130. The transport mechanism 150 arranges a part of the medical long body 300A in the space 130a located between the emission surface 111 and the partition 140 through the opening 133 of the chamber part 130.

[0044] The "space 130a located between the emission surface 111 and the partition wall 140" is composed of a part of the internal space 130A of the chamber part 13o. Specifically, in the internal space 130A, the region located between the emission surface 111 of the electron beam irradiation part 110 and the partition wall 140 corresponds to the "space 130a" (see FIGS. 10 and 11).

[0045] As shown in FIGS. 1 and 2, the transport mechanism 150 includes a rail part 151 extending toward the chamber part 130, and a gripping part 153 that is movable along the rail part 151 and can fix a part of the medical long body 300A.

[0046] The rail part 151 extends substantially linearly along the longitudinal direction of the electron beam irradiation device 10. In this embodiment, the direction in which the rail part 151 extends is substantially the same as the longitudinal direction of the medical long body 300A.

[0047] The gripping portion 153 is configured to fix the hub portion 320 located at one end of the medical elongated body 300A. "One end of the medical elongated body 300A" is the part corresponding to the base end of the medical elongated body 300A, and is the end that is grasped or manipulated by a medical professional such as a doctor with their fingers during a procedure using the medical elongated body 300A.

[0048] The gripping portion 153 can be configured to be connectable to and detachable from the rail portion 151, for example. When the gripping portion 153 is configured to be connectable to and detachable from the rail portion 151, in the preparation stage for starting electron beam irradiation of the medical elongated body 300A by the electron beam irradiation device 10, the operator can fix the medical elongated body 300A to the gripping portion 153 with the gripping portion 153 separated from the rail portion 151. Alternatively, the operator can connect the gripping portion 153 to the rail portion 151 with the medical elongated body 300A fixed to the gripping portion 153. The gripping portion 153 may also have a configuration that prevents it from being connected to and detachable from the rail portion 151.

[0049] The gripping portion 153 can be connected to the rail portion 151 via the sliding portion 154. The rail portion 151 is configured to move linearly along the sliding portion 154. When the sliding portion 154 moves along the rail portion 151, the gripping portion 153 moves along the rail portion 151 in conjunction with the movement of the sliding portion 154.

[0050] The gripping portion 153 can be configured to have a chuck portion that mechanically and detachably fixes the hub portion 320 by fitting the hub portion 320 into it. However, there are no particular restrictions on the specific configuration of the gripping portion 153 as long as it can fix and release at least a part of the medical elongated body 300A. Furthermore, the part to which the medical elongated body 300A is fixed to the gripping portion 153 may be a part other than the hub portion 320.

[0051] As shown in Figures 1 and 2, the transport mechanism 150 has a rotating mechanism 155 that can drive the rotational movement of the gripping part 153 when the gripping part 153 is fixed to the medical elongated body 300A.

[0052] 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).

[0053] 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.

[0054] The work guide 160 serves to guide the movement of the medical elongated body 300A outside the chamber section 130.

[0055] 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.

[0056] 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.

[0057] 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.

[0058] 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.

[0059] 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.

[0060] 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.

[0061] (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.

[0062] 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.

[0063] 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.

[0064] 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.

[0065] 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.

[0066] (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.

[0067] 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).

[0068] 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.

[0069] 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.

[0070] 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).

[0071] 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.

[0072] 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.

[0073] 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.

[0074] 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°).

[0075] 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.

[0076] (Screen section 140) As shown in Figures 4, 5, and 6, the screen section 140 has a suction section 180 and a partition wall section 147 located on the discharge side (arrow Z2 side) of the suction section 180 and having a plurality of holes 146.

[0077] As shown in Figures 5 and 6, the suction section 180 includes an open end 181 and a suction path 183 that communicates with the open end 181.

[0078] As shown in Figures 5 and 6, the open end 181 is positioned opposite the partition wall 147 (on the opposite side from the bottom surface 147a).

[0079] As shown in Figures 11 and 13, the suction unit 180 is configured to suck a portion of the medical elongated body 300A from its open end 181 so that the partition wall 147 and the medical elongated body 300A come into contact, with the medical elongated body 300A positioned in the space 130a located between the discharge surface 111 and the partition unit 140.

[0080] As shown in Figure 2, a pump mechanism 170 for operating the suction by the suction unit 180 is located outside the chamber 130.

[0081] The pump mechanism 170 is connected to the suction path 183 via the suction tube 187. The electron beam irradiation device 10 operates the pump mechanism 170 to draw inert gas near the space 130a through the open end 181 and the suction path 183.

[0082] The pump mechanism 170 includes a pressure pipe 177 connected to the chamber section 130. The electron beam irradiation device 10 can send the inert gas drawn in by the suction section 180 into the chamber section 130 via the pressure pipe 177. The electron beam irradiation device 10 can circulate the inert gas within the chamber section 130 by repeatedly drawing in and pumping the inert gas using the suction pipe 187 and the pressure pipe 177.

[0083] The suction pipe 187 and the pressure pipe 177 can be drawn out of the chamber section 130 through predetermined openings formed in the chamber section 130.

[0084] 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 of the partition section 140 is partitioned between the pair of wall sections 141 and 142.

[0085] 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).

[0086] 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).

[0087] The partition wall portion 147 extends along the extension of the guide portion 135 and has a plurality of recesses 143 that guide the straight-line movement of the medical elongated body 300A.

[0088] The recess 143 has a cross-sectional shape that is 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.

[0089] 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.

[0090] 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 suction by the suction unit 180. Then, at the electron beam irradiation position on the medical elongated body 300A, the state in which at least a portion of the first region 311 of the medical elongated body 300A comes into contact with the guide surface 145 is maintained by maintaining suction by the suction unit 180.

[0091] As shown in Figures 10, 11, and 12, at a position on the side of the opening 133 (arrow X1 side) 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 the above position, the first region 311 of the medical elongated body 300A is positioned with a gap gb between it and the guide portion 135.

[0092] 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.

[0093] The electron beam irradiation device 10 is configured such that a partition 140 is placed between the open end 181 and the medical elongated body 300A, thereby preventing direct contact between the open end 181 and the medical elongated body 300A, and preventing the medical elongated body 300A from entering the suction path 183 through the open end 181.

[0094] 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.

[0095] 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.

[0096] 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.

[0097] 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.

[0098] As shown in Figure 4, multiple holes 146 can be formed in the tip region 148A, the intermediate region 148C, and the base region 148B.

[0099] As shown in Figures 4 and 5, the open end 181 can be positioned so as to be located towards the tip of the intermediate region 148C. The phrase "located towards the tip of the intermediate region 148C" means that at least a portion of the open end 181 is located in the intermediate region 148C, and no portion of the open end 181 is located in the base region 148B.

[0100] As shown in Figure 5, the open end 181 can be positioned only in the intermediate region 148C. In other words, the intermediate region 148C can be positioned so that it does not protrude beyond the front and base ends in the longitudinal direction of the partition portion 140.

[0101] The opening ratio of the partition wall portion 147 in the base region 148B can be made smaller than the opening ratio of the partition wall portion 147 in the intermediate region 148C. The above-mentioned "opening ratio" is the ratio of the opening portion of the hole 146 per unit area of ​​the bottom surface 147a of the partition wall portion 147 located in each region 148A, 148B, and 148C.

[0102] Furthermore, the statement above that "the opening ratio of the partition wall portion 147 in the base region 148B is smaller than the opening ratio of the multiple holes 146 in the intermediate region 148C" also includes the case where holes 146 are formed in the intermediate region 148C but no holes 146 are formed in the base region 148B, as will be explained in the modified example described later (see Figure 16).

[0103] The opening ratio of the partition wall portion 147 at the position opposite the opening 133 (intermediate region 148C in this embodiment) can be configured to 10% to 40%.

[0104] By adopting the above-mentioned aperture ratio, it becomes possible to adjust the airflow velocity at which the suction section 180 draws in inert gas from the opening end 181 to approximately 0.1 to 10 m / s. The suction force is calculated as follows: "Suction cross-sectional area (cross-sectional area in the direction perpendicular to the extending direction of the hole section 146) m" ２ It can be calculated as "wind speed m / s × time (60 seconds)". For example, the open end 181 of the suction section 180 can be designed to be a rectangle with a long side length of 0.3 m and a short side length of 0.04 to 0.12 m. Therefore, the suction cross-sectional area (cross-sectional area in the direction perpendicular to the extension direction of the hole section 146) is 0.0012 m, since the opening ratio of the partition wall section 147 is 10% to 40%. ２ ~0.0144m ２ It is preferable that the range is within this range. Therefore, the suction force (suction airflow) obtained by the above formula is 0.0072 to 8.64 m ３ It is preferable that the format be / min (minutes).

[0105] As shown in the partially enlarged view in Figure 6, the outer circumference of the surface (bottom surface 147a in this embodiment) on the side facing the ejection surface 111 (arrow Z1 side) of each of the multiple holes 146 is chamfered. The chamfered portion 146a can be formed with a tapered cross-section in which the cross-sectional area gradually decreases from the bottom surface 147a in the height direction (arrow Z1 direction).

[0106] Furthermore, if the hole 146 is chamfered as described above, the suction cross-sectional area used in the calculation of the suction force is the cross-sectional area of ​​a portion having a substantially constant cross-sectional area, located at a predetermined distance in the depth direction from the chamfered position.

[0107] The planar shape of the hole 146 (the shape in plan view shown in Figure 4) can be formed, for example, as a circle. However, there are no particular restrictions on the shape of the hole 146; for example, it can be formed as an elongated hole, a square hole, a tortoise-shell hole, etc. There are also no particular restrictions on the arrangement pattern of the holes 146; for example, it can be formed as a staggered pattern, a parallel pattern, etc. Furthermore, there are no particular restrictions on the number of holes 146 formed in the partition wall 147.

[0108] 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).

[0109] 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.

[0110] (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.

[0111] 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.

[0112] Figure 7 shows a cross-sectional view of the guide portion 135 along its longitudinal direction.

[0113] 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.

[0114] 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.

[0115] 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.

[0116] 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.

[0117] 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.

[0118] 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, the suction section 180 sucks up a portion of the medical elongated body 300A, and while bringing a portion of the medical elongated body 300A into contact with the partition section 147, the electron beam is irradiated from the emission surface 111 of the electron beam irradiation section 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.

[0119] 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.

[0120] 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).

[0121] 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.

[0122] 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.

[0123] 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.

[0124] 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.

[0125] 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.

[0126] 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.

[0127] (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.

[0128] 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.

[0129] 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.

[0130] 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.

[0131] 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 or 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 a mixture thereof, or two or more of the above polymer materials. The main body 310 of the medical elongated body 300A may also contain a linear metal material as a reinforcing member inside the resin material. In such cases, examples of metallic materials include nickel-titanium alloys, cobalt-chromium alloys, magnesium alloys, stainless steel, platinum, and tungsten.

[0132] 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.

[0133] The medical elongated body 300A may be equipped with a metal wire (core) 200 inserted through its lumen 315 when it is transported by the transport mechanism 150. The metal wire 200 prevents the cross-sectional shape of the lumen 315 from being crushed while the medical elongated body 300A is being processed (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 elongated body 300A.

[0134] The medical elongated body 300A can also 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, examples of constituent materials include superelastic alloys such as nickel-titanium alloys and copper-zinc alloys, and metallic materials such as stainless steel.

[0135] 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.

[0136] 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.

[0137] 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.

[0138] 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.

[0139] 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.

[0140] 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.

[0141] 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.

[0142] 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.

[0143] (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.

[0144] 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.

[0145] 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.

[0146] Next, the worker connects the gripping part 153 to the rail part 151.

[0147] 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.

[0148] 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.

[0149] 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.

[0150] 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.

[0151] 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.

[0152] 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.

[0153] Furthermore, the electron beam irradiation device 10 can prevent the medical elongated body 300A from unintentionally coming into contact with any part 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 part of the medical elongated body 300A that is not in contact with the partition wall 147 (the part of the medical elongated body 300A that is not sucked by the suction part 180) and the guide surface 145 of the partition wall 147. As a result, the electron beam irradiation device 10 can prevent the medical elongated body 300A from coming into contact with the screen part 140 at an unintended location. This prevents the electron beam irradiation device 10 from peeling or falling off the lubricating coating layer 311a applied to the medical elongated body 300A.

[0154] 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.

[0155] 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.

[0156] 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.

[0157] 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 by means of the inert gas ejected from the nozzle 121 over a predetermined range along the first transport direction d1 from near the emission surface 111 of the electron beam irradiation unit 110. As a result, the electron beam irradiation device 10 can effectively suppress the vibration and bending of the medical elongated body 300A within the chamber unit 130, and move a portion of the medical elongated body 300A toward the partition unit 140 (suction unit 180) more smoothly.

[0158] 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 bringing the first region 311 of the medical elongated body 300A into contact with the guide surface 145 of the partition 140 by suction of the suction unit 180, 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 suction from the suction unit 180, 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 unit 140 by inert gas spraying 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.

[0159] 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 continuously move each part of the medical elongated body 300A toward the guide surface 145 of the partition 140 where the suction unit 180 is located, and the suction of the suction unit 180 can maintain each part of the medical elongated body 300A in contact with the guide surface 145 of the partition 140. The electron beam irradiation device 10 performs the following actions: ejection of inert gas by the inert gas supply unit 120, contact of the medical elongated body 300A with the guide surface 145 of the partition unit 140 by the suction unit 180, 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 an equal 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.

[0160] 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.

[0161] As shown in Figures 10 and 11, the electron beam irradiation device 10 starts sucking a portion of the medical elongated body 300A with the suction unit 180 before and after sending the medical elongated body 300A into the internal space 130A of the chamber unit 130 via the guide unit 135, thereby moving a portion of the medical elongated body 300A toward the partition unit 140. By sucking a portion of the medical elongated body 300A as described above, the suction unit 180 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 wall unit 147, which is positioned opposite the emission surface 111 of the electron beam irradiation unit 110 across the space 130a (see Figure 13).

[0162] The electron beam irradiation device 10 moves each part of the medical elongated body 300A in the longitudinal direction into the space 130a sequentially by the transport mechanism 150, while bringing a part of the medical elongated body 300A into contact with the guide surface 145 of the partition wall 147.

[0163] 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.

[0164] Furthermore, the electron beam irradiation device 10 can achieve the following effects by including the guide section 135.

[0165] If the electron beam irradiation device 10 does not have a guide section 135, the medical elongated body 300A is directly inserted into the chamber section 130 through the opening 133. When an inert gas is ejected onto the medical elongated body 300A inserted into the chamber section 130 in this manner, a large vibration occurs due to the ejection 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 contact of the medical elongated body 300A with the guide surface 145 of the partition section 140 does not proceed smoothly, making it difficult to maintain a constant distance between the emission surface 111 of the electron beam irradiation unit 110 and the medical elongated body 300A.

[0166] 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.

[0167] 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.

[0168] 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.

[0169] When the long medical device 300A is rotated, the electron beam irradiation device 10 stops the ejection of inert gas from the inert gas supply unit 120 and the suction from the suction unit 180. By stopping the ejection of inert gas from the inert gas supply unit 120 and the suction from the suction unit 180 when the long medical device 300A is rotated, the electron beam irradiation device 10 can prevent the lubricating coating layer 311a from rubbing against the partition unit 140 as the long medical device 300A rotates, thus preventing the lubricating coating layer 311a from falling off. In Figures 14 and 15, the portion of the lubricating coating layer 311a that has hardened due to the electron beam irradiated onto the first region 311 of the main body 310 when the long medical device 300A is moved in the first transport direction d1 is illustrated by reference numeral 311b.

[0170] 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 same procedure as when moving the medical elongated body 300A along the first transport direction d1: ejection of inert gas from the inert gas supply unit 120, suction from the suction unit 180, and irradiation with an electron beam from the electron beam irradiation unit 110. 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.

[0171] 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.

[0172] 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.

[0173] With the above steps, the irradiation of the medical-grade long body 300A with electron beams is completed.

[0174] 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.

[0175] 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 transport unit configured to allow a portion of the medical elongated body 300A to be placed in the space 130a located between the emission surface 111 and the partition unit 140 through the opening 133. The device comprises a mechanism 150, and the partition section 140 has a suction section 180 and a partition wall section 147 located on the discharge surface side of the suction section 180 and having a plurality of holes 146. The suction section 180 has an open end 181 and a suction path 183 communicating with the open end 181. The open end 181 is positioned opposite the partition wall section 147, and the suction section 180 sucks a portion of the medical elongated body 300A from the open end 181 so that the partition wall section 147 and the medical elongated body 300A come into contact, with the medical elongated body 300A being positioned in the space 130a located between the discharge surface 111 and the partition section 140.

[0176] The electron beam irradiation device 10 can position a portion of the medical elongated body 300A in 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 using the transport mechanism 150. With a portion of the medical elongated body 300A positioned in the space 130a, the electron beam irradiation device 10 can bring a portion of the medical elongated body 300A into contact with the partition wall unit 147 by using the suction unit 180 to suck up the portion of the medical elongated body 300A. By maintaining a state in which a portion of the medical elongated body 300A is in contact with the partition wall unit 147, the electron beam irradiation device 10 can 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, 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.

[0177] 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 ejection surface 111. Multiple holes 146 are formed in the tip region 148A, the intermediate region 148C, and the base region 148B, and the opening end 181 is located on the tip side of the intermediate region 148C.

[0178] As described above, since the open end 181 is located in the intermediate region 148C, the medical elongated body 300A can be brought into contact with the partition wall 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 while maintaining a constant distance from the emission surface 111 by bringing it into contact with the intermediate region 148C of the partition wall 147. In addition, since the intermediate region 148C is located towards the tip of the base end region 148B, when the medical elongated body 300A is transported to the partition 140, it is possible to prevent the medical elongated body 300A from being attracted at the base end region 148B. As a result, the electron beam irradiation device 10 can gradually move the medical elongated body 300A towards the intermediate region 148C as it passes through the base end 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.

[0179] Furthermore, the open end 181 can be positioned only in a location facing the intermediate region 148C. This makes it possible to more reliably prevent the medical elongated body 300A from being sucked in at the base end region 148B, as described above. Also, since the suction part 180 is located only in the intermediate region 148C, it is possible to more reliably prevent the medical elongated body 300A from being sucked in at the tip region 148A. Therefore, it is possible to more reliably prevent the medical elongated body 300A from getting caught on the partition 140 when it enters the partition 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 147 other than the electron beam irradiation position when the medical elongated body 300A is transported on the partition 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.

[0180] Furthermore, the aperture ratio of the partition wall 147 in the base region 148B can be configured to be smaller than that of the partition wall 147 in the intermediate region 148C. This allows the electron beam irradiation device 10 to more reliably prevent the medical elongated body 300A from being attracted in the base region 148B while more reliably attracting the medical elongated body 300A in the intermediate region 148C. Therefore, when the electron beam irradiation position is set in a range including the intermediate region 148C, the electron beam irradiation device 10 can more reliably irradiate a portion of the medical elongated body 300A with the electron beam while maintaining a constant distance from the emission surface 111. In addition, it is possible to more reliably prevent the medical elongated body 300A from getting caught on the partition 140 when it enters the partition 140.

[0181] Furthermore, the opening ratio of the partition wall portion 147 at the position opposite the open end 181 is 10% to 40%. This makes it possible to set the suction force near the partition wall portion 147 at the position opposite the open end 181 to a desired size.

[0182] Furthermore, the outer circumference of the surface (bottom surface 147a) of each of the multiple holes 146 facing the emission surface 111 is chamfered. Therefore, when the electron beam irradiation device 10 moves the medical elongated body 300A along the partition wall portion 147 in which the holes 146 are formed, the medical elongated body 300A can be prevented from getting caught in the holes 146.

[0183] The chamber section 130 is provided with a cylindrical guide section 135 at its opening 133, which 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 partition wall section 147 extends along the extension of the guide section 135 and has a recess 143 that guides the straight-line movement of the medical elongated body 300A.

[0184] The electron beam irradiation device 10, by including a guide section 135, can guide the medical elongated body 300A to the partition section 140 when inserting it into the chamber section 130, and can also guide the movement of the medical elongated body 300A when transporting it out of the chamber section 130 after electron beam irradiation. Furthermore, the electron beam irradiation device 10 can move the medical elongated body 300A, which has been transported from the guide section 135 into the chamber section 130, in a straight line along the recess 143 of the partition wall section 147. As a result, 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. 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 maintaining 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 is enhanced. Furthermore, in the case where the electron beam irradiation device 10 is configured to irradiate multiple medical elongated bodies 300A simultaneously with an electron beam, as in this embodiment, the recess 143 of the partition 140 prevents unintentional contact between adjacent medical elongated bodies 300A in the width direction with the inert gas ejected from the nozzle 121.

[0185] Furthermore, 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. Therefore, when the medical elongated body 300A moves to the space 130a, the electron beam irradiation device 10 can separate the medical elongated body 300A and the metal wire (core) 200 inserted through the medical elongated body 300A from the partition wall section 147 by the offset distance. As a result, when a part of the medical elongated body 300A moves to the space 130a, the electron beam irradiation device 10 can gradually attract the medical elongated body 300A and the metal wire 200 toward the front end of the chamber section 130 and toward the partition section 140. As a result, the electron beam irradiation device 10 can prevent the tip of the medical elongated body 300A from getting caught in the hole 146 of the partition wall 147 when the medical elongated body 300A enters the partition 140. Furthermore, if the medical elongated body 300A is equipped with a metal wire (core) 200 inserted through the medical elongated body 300A, the electron beam irradiation device 10 can prevent the metal wire 200 protruding from the tip of the medical elongated body 300A from hitting the partition 140 when the medical elongated body 300A enters the partition 140.

[0186] 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.

[0187] The electron beam irradiation device 10, by ejecting inert gas from the nozzle 121 as described above, is positioned opposite the emission surface 111 of the electron beam irradiation unit 110 across the space 130a, and can move a portion of the medical elongated body 300A toward the guide surface 145 of the partition unit 140. As a result, the electron beam irradiation device 10 can smoothly bring a portion of the medical elongated body 300A into contact with the guide surface 145 of the partition unit 140 using the suction unit 180, and can 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, by ejecting inert gas in a direction that slopes from the emission surface 111 side toward the partition unit 140 side, the electron beam irradiation device 10 can easily form an inert gas flow along the guide surface 145 utilizing the Coanda effect. Therefore, when the chamber portion 130 of the electron beam irradiation device 10 has a guide portion 135, it can efficiently form a flow of inert gas toward the second end portion 137 of the guide portion 135. As a result, the electron beam irradiation device 10 can effectively prevent oxygen from the atmosphere from flowing into the chamber portion 130 from the outside via the guide portion 135.

[0188] 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 medical elongated body 300A on which a lubricating coating layer 311a is formed, wherein the electron beam irradiation device 10 comprises a chamber section 130, an electron beam irradiation section 110 having an emission surface 111 from which electron beams are emitted, an inert gas supply section 120 having a nozzle 121 for injecting inert gas, and a partition section 140 located inside the chamber section 130 and facing the emission surface 111, wherein the partition section 140 is suction The device has a section 180 and a partition section 147 located on the discharge surface 111 side of the suction section 180 and having a plurality of holes 146. A portion of the medical elongated body 300A is placed in the space 130a within the chamber section 130 located between the discharge surface 111 and the partition section 140. The suction force of the suction section 180 is used to bring a portion of the medical elongated body 300A into contact with the partition section 147, and with the medical elongated body 300A in contact with the partition section 147, an electron beam is irradiated onto the medical elongated body 300A from the discharge surface 111.

[0189] In the method for manufacturing a medical device, a portion of the medical elongated body 300A is placed in the space 130a within the chamber 130 located between the emission surface 111 of the electron beam irradiation unit 110 and the partition 140. By using the suction unit 180 to suck up a portion of the medical elongated body 300A, a portion of the medical elongated body 300A can be brought into contact with the partition 147. By maintaining the state in which a portion of the medical elongated body 300A is in contact with the partition 147, the method for manufacturing a medical device can keep the distance between a 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 140 with the space 130a in between, 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.

[0190] Next, we will describe some modifications to the embodiments described above. We will omit redundant explanations of the same content as already described regarding the configuration and effects.

[0191] <Example of modification> 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.

[0192] As shown in Figure 16, the multiple holes 146 can be arranged, for example, only in the intermediate region 148C and the tip region 148A. With this configuration, it is possible to prevent a part of the medical elongated body 300A from being attracted in the base region 148B when a part of the medical elongated body 300A passes through the base region 148B. Therefore, the electron beam irradiation device 10 can more reliably prevent the medical elongated body 300A from getting caught on the partition 140 when the medical elongated body 300A enters the partition 140. Note that if multiple holes 146 are not provided in the base region 148B as in this modified example, for example, the open end 181 may be arranged to span each of the regions 148A, 148B, and 148C.

[0193] 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.

[0194] 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).

[0195] 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.

[0196] This application is based on Japanese Patent Application No. 2025-017624, filed on 5 February 2025, the disclosures of which are incorporated herein by reference in their entirety.

[0197] 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 Multiple holes 147 Partition wall section 147a Bottom surface of the partition wall section 148A Tip region 148B Base region 148C Intermediate region 150 Transport mechanism 180 Suction section 181 Open end 183 Suction path 200 Metal wire 300 Object to be irradiated 300A Medical long object 310 Main body 311 First region 311a Lubricating coating layer 312 Second region 315 Lumens

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 to be placed in the space located between the emission surface and the partition unit through the opening, wherein the partition unit has a suction unit and a partition wall unit located on the emission surface side of the suction unit and having a plurality of holes; the suction unit has an open end and a suction path communicating with the open end; the open end is positioned facing the partition wall unit; and the suction unit is configured to suck a portion of the object to be irradiated from the open end so that the partition wall unit and the object to be irradiated come into contact 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, the plurality of holes are formed in the tip region, the intermediate region, and the base region, and the opening end is located on the tip side of the intermediate region.

3. The electron beam irradiation apparatus according to claim 2, wherein the open end is positioned only at a location facing the intermediate region.

4. The electron beam irradiation apparatus according to claim 2 or 3, wherein the aperture ratio of the partition wall in the proximal region is smaller than the aperture ratio of the partition wall in the intermediate region.

5. The electron beam irradiation apparatus according to claim 1, wherein the aperture ratio of the partition wall portion at a position opposite the open end is 10% to 40%.

6. The electron beam irradiation apparatus according to claim 1, wherein the outer circumference of the surface of each of the plurality of holes facing the emission surface is chamfered.

7. 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 partition wall portion extends along the extension of the guide portion and has a recess that guides the straight-line movement of the object to be irradiated.

8. The electron beam irradiation apparatus according to claim 7, wherein 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.

9. 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.

10. 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; a partition unit located inside the chamber and facing the emission surface; the partition unit having a suction unit and a partition wall unit located on the emission surface side of the suction unit and having a plurality of holes; a part of the medical elongated body is placed in the space inside the chamber located between the emission surface and the partition unit; a part of the medical elongated body is brought into contact with the partition wall unit using the suction force of the suction unit; and while the medical elongated body is in contact with the partition wall unit, an electron beam is irradiated onto the medical elongated body from the emission surface.

Images