Electron beam radiation device and electron beam radiation method
Patent Information
- Application Number
- PCT/JP2024/027706
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-08-04
- Filing Date
- 2024-08-02
- Publication Date
- 2025-02-13
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Figure JP2024027706_13022025_PF_FP_ABST
Abstract
Description
Electron beam irradiation device and electron beam irradiation method
[0001] The present invention relates to an electron beam irradiation apparatus and an electron beam irradiation method.
[0002] In the field of medical products, in order to enable smooth movement of elongated medical components such as catheters and guidewires within a patient's body, a coating liquid (e.g., a coating liquid containing a hydrophilic polymer that forms a lubricating coating layer) is sometimes applied to the surface of the elongated medical component to form a coating layer on the surface of the elongated medical component.
[0003] In the manufacturing method of a medical elongated member, a coating liquid is applied to the medical elongated member, a coating layer (a coating layer made from the coating liquid or a coating layer obtained by drying the coating liquid) is formed on the surface of the medical elongated member, and then the coating layer is hardened. There are various methods for hardening the coating layer, but methods using ultraviolet light are often adopted for reasons such as simplifying the energy irradiating device and reducing manufacturing costs.
[0004] For example, Patent Document 1 below discloses an ultraviolet curing system that irradiates ultraviolet light onto a medical elongated member coated with a coating layer. The ultraviolet curing system of Patent Document 1 includes a plurality of ultraviolet light bulbs extending in the longitudinal direction and a housing that holds the plurality of ultraviolet light bulbs.
[0005] US Patent Application Publication No. 2012 / 0319012
[0006] In the method of hardening a coating layer using the ultraviolet curing system of Patent Document 1, multiple medical elongated members coated with a coating layer are arranged at equal intervals inside a housing, and ultraviolet light is irradiated onto each medical elongated member from multiple ultraviolet light bulbs, thereby evenly irradiating ultraviolet light onto each part of the multiple medical elongated members.
[0007] However, when the method of curing the coating layer using ultraviolet light is adopted, the following problems arise.
[0008] Compared to electron beams, ultraviolet light has a higher energy content that is absorbed by the irradiated object and converted into heat. Therefore, when using ultraviolet light to harden a coating layer, the ultraviolet light may be absorbed by the irradiated object, causing heat generation. Therefore, depending on the type of material used for the elongated medical member, the heat generated during ultraviolet light irradiation may cause damage such as deformation to the material, potentially resulting in a decrease in product quality. Furthermore, when using ultraviolet light to harden a coating layer, it typically takes several seconds to several minutes for the coating layer to harden, depending on the material used to form the coating layer. Therefore, when using ultraviolet light to harden a coating layer, it is difficult to improve the production efficiency of elongated medical members.
[0009] One possible solution to the above problems is to use a method for curing the coating layer using an electron beam, which can reduce the heat generation caused by the energy applied to the medical elongated member and shorten the time required to cure the coating layer. However, when using a method for curing the coating layer using an electron beam, the following problems arise.
[0010] When using electron beams to cure a coating layer, the coating layer of the medical elongated member must be exposed to an inert gas while the electron beam is irradiated. Therefore, the device for curing the coating layer must incorporate a chamber capable of filling with inert gas and a transport mechanism for moving the medical elongated member to the position where the electron beam is irradiated. Furthermore, due to the characteristics of the curing reaction, when using electron beams to cure a coating layer, the distance between the electron beam irradiation source and the medical elongated member must be kept relatively constant to prevent uneven curing of the coating layer, compared to when using ultraviolet radiation. Therefore, when using electron beams to cure a coating layer, it is necessary to devise a way to maintain the positional relationship between the electron beam irradiation source and the medical elongated member so that the distance between them does not change during the curing process.
[0011] In particular, when irradiating a long object such as a medical elongated member with an electron beam, the distance between the gripping position of the medical elongated member and the electron beam irradiation position becomes long. Furthermore, when the target to be cured by electron beam is a coating layer applied to the surface of the medical elongated member, it is difficult to grip the portion of the medical elongated member where the coating layer is located, making it difficult to grip both ends of the medical elongated member and secure the medical elongated member to the electron beam irradiation device. Therefore, when the target to be cured by electron beam is a coating layer applied to the surface of the medical elongated member, moving the medical elongated member to the electron beam irradiation position (e.g., moving the medical elongated member into a chamber filled with inert gas) can easily cause inadvertent deformation or displacement of the medical elongated member, which can cause a change in the distance between the electron beam irradiation source and the medical elongated member. Therefore, there is a concern that uneven curing of the coating layer applied to the medical elongated member may occur. As described above, when electron beam irradiation is used to harden a coating layer applied to the surface of a medical elongated member, it is expected that uneven hardening of the coating layer will be likely to occur.However, even if the object to be irradiated with electron beams is something other than a medical elongated member, it is still necessary to take measures to maintain a constant distance between the electron beam irradiation source and the object to be irradiated.
[0012] The present invention has been made in consideration of the above-mentioned problems, and aims to provide an electron beam irradiation device and an electron beam irradiation method that can maintain a constant distance between the exit surface of the electron beam irradiation unit and the object to be irradiated when irradiating an electron beam onto a coating layer applied to the object to be irradiated, thereby preventing uneven curing of the coating layer applied to the object to be irradiated.
[0013] The present invention can be achieved by any one of the following means (1) to (8).
[0014] (1) An electron beam irradiation device comprising: an electron beam irradiation unit having an exit surface for emitting electron beams; an inactivation gas supply unit having an injection port for injecting inactivation gas; a chamber unit accommodating the exit surface and the injection port; a partition unit located within the chamber unit and facing the exit surface; and a transport mechanism configured to be able to place a portion of an irradiated object in the space located between the exit surface and the partition unit, wherein the injection port is located on the exit surface side within the chamber unit and is inclined from the exit surface side toward the partition unit side, and the inactivation gas supply unit is configured to inject inactivation gas through the injection port toward a position on the partition unit facing the exit surface when a portion of the irradiated object is placed in the space located between the exit surface and the partition unit.
[0015] (2) The electron beam irradiation device described in (1) above, wherein the transport mechanism is located outside the chamber portion, the chamber portion has a hole portion that allows a portion of the irradiated object transported by the transport mechanism to be introduced into the chamber, and the transport mechanism is configured to place a portion of the irradiated object in the space located between the exit surface and the partition portion through the hole portion of the chamber portion.
[0016] (3) The electron beam irradiation device described in (1) or (2) above, wherein the transport mechanism comprises a rail portion extending toward the chamber portion and a gripping portion that is movable along the rail portion and configured to fix a portion of the irradiated object, and the transport mechanism is configured to move the gripping portion along the rail portion while the irradiated object is suspended in the direction of gravity by the gripping portion.
[0017] (4) The object to be irradiated is a medical elongated member having a long main body extending in the longitudinal direction and a hub portion arranged at one end of the main body, the main body having a first region coated with a lubricating coating layer that is the target of electron beam irradiation, and a second region arranged closer to the one end than the first region and not coated with the lubricating coating layer, the transport mechanism being configured to position the first region in the space located between the exit surface and the partition portion by moving the gripping portion while fixing only the hub portion with the gripping portion, in the electron beam irradiation device described above in (3).
[0018] (5) An electron beam irradiation device described in any one of (1) to (4) above, wherein the transport mechanism has a rotational movement unit that can drive the rotational movement of the gripping unit when the gripping unit is holding the object to be irradiated.
[0019] (6) The electron beam irradiation device according to any one of (1) to (5) above, wherein the partition has a recess recessed on a side away from the emission surface and the injection port.
[0020] (7) An electron beam irradiation device for irradiating an irradiated object with an electron beam, the electron beam irradiation device comprising: an electron beam irradiation unit having an exit surface for emitting electron beams; an inactivation gas supply unit having an injection port for injecting inactivation gas; a partition portion facing the exit surface; and a transport mechanism configured to be able to place a part of the irradiated object in the space located between the exit surface and the partition portion; an electron beam irradiation method, in which, with a part of the irradiated object placed in the space located between the exit surface and the partition portion, inactivation gas is injected from the injection port located on the exit surface side onto the irradiated object; and, in a state in which the irradiated object is in contact with the partition portion with the inactivation gas, an electron beam is irradiated onto the irradiated object from the exit surface.
[0021] (8) The electron beam irradiation method described in (7) above, wherein the transport mechanism comprises a rail portion and a gripping portion that is movable along the rail portion and that is configured to be able to fix a portion of the irradiated object, the irradiated object being a medical elongated member that comprises a long, longitudinally extending main body portion and a hub portion that is arranged at one end of the main body portion, the main body portion having a first region that is coated with a lubricating coating layer that is to be irradiated with electron beams, and a second region that is arranged on the base end side of the first region and is not coated with the lubricating coating layer, and the transport mechanism moves the gripping portion while fixing only the hub portion with the gripping portion, thereby positioning the first region in the space located between the exit surface and the partition portion, and irradiates the first region with electron beams while spraying an inert gas toward the irradiated object.
[0022] In the electron beam irradiation device described above in (1), the nozzle of the inactivating gas supply unit that supplies inactivating gas is located within the chamber on the side of the exit surface of the electron beam irradiation unit that emits electron beams, and is inclined from the exit surface of the electron beam irradiation unit toward the partition. The inactivating gas supply unit injects inactivating gas through the nozzle toward a position on the partition facing the exit surface of the electron beam irradiation unit, with a portion of the object to be irradiated being placed in the space within the chamber between the exit surface of the electron beam irradiation unit and the partition. The portion of the object to be irradiated onto which the inactivating gas is sprayed comes into contact with the partition. The electron beam irradiation device can maintain a constant distance between the exit surface of the electron beam irradiation unit and the object to be irradiated by bringing a portion of the object to contact the partition with the inactivating gas. The electron beam irradiation device can prevent uneven curing of the coating layer applied to the object to be irradiated by emitting electron beams from the exit surface of the electron beam irradiation unit toward the object to be irradiated while maintaining a constant distance between the exit surface of the electron beam irradiation unit and the object to be irradiated.
[0023] The electron beam irradiation method (7) described above involves placing a portion of an irradiated object in a space between the exit surface of an electron beam irradiator that emits electron beams and a partition, and then injecting an inert gas onto the irradiated object from an injection port of an inert gas supply unit located on the exit surface side of the electron beam irradiator, thereby bringing the irradiated object into contact with the partition. By bringing the irradiated object into contact with the partition, the electron beam irradiation method can maintain a constant distance between the exit surface of the electron beam irradiator and the irradiated object. The electron beam irradiation method can prevent uneven curing of the coating layer applied to the irradiated object by emitting electron beams from the exit surface of the electron beam irradiator while maintaining a constant distance between the exit surface of the electron beam irradiator and the irradiated object.
[0024] FIG. 1 is a plan view showing an electron beam irradiation apparatus according to a first embodiment of the present invention. FIG. 2 is a side view showing the electron beam irradiation apparatus according to the first embodiment of the present invention, as seen from the direction of arrow 2A in FIG. 1. FIG. 3 is a view showing a work guide provided in the electron beam irradiation apparatus according to the first embodiment, and is a cross-sectional view corresponding to arrow 3A-3A in FIG. 1. FIG. 4 is a view for explaining the operation of the work guide provided in the electron beam irradiation apparatus according to the first embodiment. FIG. 5 is a view for explaining an electron beam irradiation method using the electron beam irradiation apparatus according to the first embodiment, showing a state before an electron beam is emitted from the electron beam irradiation unit and a state before an inert gas is sprayed from the inert gas supply unit. FIG. 6 is a view for explaining an electron beam irradiation method using the electron beam irradiation apparatus according to the first embodiment, showing a state after an electron beam has been emitted from the electron beam irradiation unit and a state after an inert gas has been sprayed from the inert gas supply unit. FIG. 7 is a view for explaining an electron beam irradiation method using the electron beam irradiation apparatus according to the first embodiment, showing a cross-sectional view showing the vicinity of a partition. FIG. 8 is a view for explaining an electron beam irradiation method using the electron beam irradiation apparatus according to the first embodiment, showing a cross-sectional view showing the vicinity of the partition. FIG. 9 is a view for explaining an electron beam irradiation method using the electron beam irradiation apparatus according to the first embodiment, showing an enlarged cross-sectional view of a recess in the partition. 16A and 16B are enlarged cross-sectional views of a recess of a partition for explaining an electron beam irradiation method using the electron beam irradiation device according to the first embodiment; FIG. 17A is a view illustrating an electron beam irradiation method according to a comparative example; FIG. 17B is a view illustrating an electron beam irradiation method according to a comparative example; FIG. 17C is a cross-sectional view illustrating a partition for a modified example; FIG. 17D is a view illustrating an electron beam irradiation method according to a comparative example; FIG. 17E is a view illustrating an electron beam irradiation method according to a comparative example; FIG. 17F is a view illustrating an electron beam irradiation method according to a comparative example; FIG. 17G is a view illustrating an electron beam irradiation method according to a comparative example; FIG. 17H is a view illustrating an electron beam irradiation method according to a comparative example; FIG. 17H is a view illustrating an electron beam irradiation method according to a comparative example;
[0025] Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings. The following description does not limit the technical scope or meaning of terms described in the claims. Furthermore, the dimensional proportions in the drawings are exaggerated for the convenience of explanation and may differ from the actual proportions.
[0026] <First Embodiment> Figures 1 and 2 are simplified views showing the overall configuration of an electron beam irradiation device 10 according to this embodiment. Note that Figures 1 and 2 are partial cross-sectional views of the chamber 130 so that the interior of the chamber 130 can be seen. Figures 3 and 4 are views showing a work guide 160 provided in the electron beam irradiation device 10. Figures 5 to 10 are views for explaining an electron beam irradiation method using the electron beam irradiation device 10. Figures 11 to 13 are views for explaining problems that arise in comparison.
[0027] (Electron beam irradiation device 10) To give an overview with reference to Figures 1, 2, 6, and 8, the electron beam irradiation device 10 has an electron beam irradiation section 110 having an exit surface 111 that emits electron beams, an inactivation gas supply section 120 having an injection port 121 that injects inactivation gas, a chamber section 130 that houses the exit surface 111 and the injection port 121, a partition section 140 that is located within the chamber section 130 and faces the exit surface 111, and a transport mechanism 150 that is configured to be able to position a part of the irradiated object 300 in a space 130a located between the exit surface 111 and the partition section 140.
[0028] In the description of this specification, the direction in which the transport mechanism 150 transports the irradiation object 300 toward the chamber section 130 is referred to as the "first transport direction d1," and the direction in which the transport mechanism 150 transports the irradiation object 300 toward the side away from the chamber section 130 is referred to as the "second transport direction d2." In addition, in each drawing, the longitudinal direction of the electron beam irradiation device 10 (the direction in which the rail section 151 described below extends) is indicated by arrow X1-X2, the width direction of the electron beam irradiation device 10 that is orthogonal to the longitudinal direction in a plan view is indicated by arrow Y1-Y2, and the height direction of the electron beam irradiation device 10 that is orthogonal to both the longitudinal direction and the width direction is indicated by arrow Z1-Z2. In the following description, the respective directions of the electron beam irradiation device 10 are also simply referred to as the "longitudinal direction," the "width direction," and the "height direction."
[0029] In this embodiment, the irradiated object 300 is exemplified by a medical elongated member 300A having a longitudinally extending elongated main body 310. The electron beam irradiation device 10 is configured to simultaneously irradiate 15 medical elongated members 300A arranged at predetermined intervals in the width direction with an electron beam. However, there are no particular limitations on the specific type or shape of the irradiated object 300, or the number that can be set in the electron beam irradiation device 10.
[0030] In this embodiment, each of the 15 elongated medical members 300A has the same configuration. Therefore, one elongated medical member 300A will be described, and descriptions of the other elongated medical members will be omitted. Similarly, with regard to the same components constructed in the electron beam irradiation device 10 corresponding to the 15 elongated medical members 300A, only one of the components will be described, and descriptions of the other components will be omitted as appropriate.
[0031] (Chamber 130) As shown in Figs. 2, 5 and 6, the chamber 130 includes an internal space 130A in which the electron beam irradiation unit 110 and the inert gas supply unit 120 are housed.
[0032] As shown in FIGS. 5 and 6, the chamber section 130 has a hole 135 that allows a part of the irradiation object 300 transported by the transport mechanism 150 to be introduced into the chamber section 130 .
[0033] The holes 135 are provided in a part of the wall located on the second transport direction d2 side of the chamber 130. In this embodiment, the chamber 130 has 15 holes 135 corresponding to the number of objects 300 to be irradiated.
[0034] The hole 135 can be configured to have a shape corresponding to the cross-sectional shape of the elongated medical member 300A. In this embodiment, the elongated medical member 300A has a substantially circular cross-sectional shape (see FIGS. 9 and 10 ). Therefore, the hole 135 is configured to have a circular shape that allows the elongated medical member 300A to be inserted therethrough. However, there are no particular limitations on the shape of the hole 135 as long as it allows the irradiated object 300 to be inserted therethrough.
[0035] The chamber 130 may be provided with an opening / closing mechanism (shutter) (not shown) for opening and closing the hole 135. When the gas in the chamber 130 is replaced with an inert gas, the electron beam irradiation device 10 operates the opening / closing mechanism to close the hole 135. Furthermore, when the medical elongated member 300A is moved into the chamber 130, the electron beam irradiation device 10 operates the opening / closing mechanism to open the hole 135.
[0036] 2, the apparatus main body 20 is disposed below the chamber section 130 in the height direction. The apparatus main body 20 is equipped with a control unit for controlling the emission and stoppage of electron beam emission from the emission surface 111 of the electron beam irradiation section 110 and the emission and stoppage of inert gas ejection from the nozzle 121 of the inert gas supply section 120, as well as a drive source (motor) necessary for driving the operation of each section of the apparatus. In each drawing, the electron beam emitted from the emission surface 111 of the electron beam irradiation section 110 is illustrated by arrow e, and the inert gas ejected from the nozzle 121 of the inert gas supply section 120 is illustrated by arrow a.
[0037] The chamber 130 has a predetermined length along the longitudinal direction. The longitudinal length of the chamber 130 (the longitudinal length of the internal space 130A) is set arbitrarily according to the longitudinal length of the region of the object 300 to be irradiated with the electron beam. For example, in the present embodiment, when the region to be irradiated with the electron beam is the first region 311 of the main body 310 of the elongated medical member 300A, the longitudinal length of the chamber 130 can be configured to accommodate the entire longitudinal range of the first region 311.
[0038] (Transport Mechanism 150) As shown in FIGS. 1 and 2, the transport mechanism 150 is located outside the chamber section 130.
[0039] As shown in Figures 5 and 6, the transport mechanism 150 is configured to place a portion (first region 311) of the medical elongated member 300A in the space 130a located between the emission surface 111 and the partition portion 140 through the hole portion 135 of the chamber portion 130.
[0040] The "space 130a located between the exit surface 111 and the partition 140" is configured as part of the internal space 130A of the chamber 130. Specifically, in the internal space 130A, the area located between the exit surface 111 of the electron beam irradiation unit 110 and the partition 140 corresponds to the "space 130a."
[0041] As shown in Figures 1 and 2, the transport mechanism 150 includes a rail portion 151 extending toward the chamber portion 130, and a gripping portion 153 that is movable along the rail portion 151 and is configured to be able to fix a portion of the medical elongated member 300A.
[0042] The rail portion 151 extends substantially linearly along the longitudinal direction of the electron beam irradiation device 10. In this embodiment, the extending direction of the rail portion 151 is substantially the same as the longitudinal direction of the medical elongated member 300A.
[0043] The gripping portion 153 is configured to fix a hub portion 320 disposed at one end of the elongated medical member 300A. The "one end of the elongated medical member 300A" is the portion corresponding to the base end of the elongated medical member 300A, and is the end that is gripped or manipulated by a medical professional such as a doctor with the fingers or the like during a procedure using the elongated medical member 300A.
[0044] The gripping portion 153 can be configured to be connectable and detachable to the rail portion 151. When the gripping portion 153 is configured to be connectable and detachable to the rail portion 151, in the preparation stage for starting irradiation of the medical elongated member 300A with an electron beam by the electron beam irradiation device 10, an operator can fix the medical elongated member 300A to the gripping portion 153 in a state where the gripping portion 153 is separated from the rail portion 151. Furthermore, an operator can connect the gripping portion 153 to the rail portion 151 in a state where the medical elongated member 300A is fixed to the gripping portion 153. Note that the gripping portion 153 may be configured to be connectable and detachable to the rail portion 151.
[0045] The gripping portion 153 can be connected to the rail portion 151 via the slide portion 154. The rail portion 151 is configured to be able to move linearly along the slide portion 154. When the slide 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 slide portion 154.
[0046] The gripping portion 153 can be configured to have a chuck portion that mechanically and detachably fastens the hub portion 320 by fitting the hub portion 320 into the gripping portion 153. However, the specific configuration of the gripping portion 153 is not particularly limited as long as it can fasten and release at least a portion of the elongated medical member 300A. Furthermore, the location where the elongated medical member 300A is fastened to the gripping portion 153 may be a portion other than the hub portion 320.
[0047] As shown in FIGS. 1 and 2, the transport mechanism 150 has a rotational movement part 155 that can drive the rotational movement of the gripper 153 in a state in which the elongated medical member 300A is fixed to the gripper 153.
[0048] The rotational motion unit 155 is configured integrally with the gripping unit 153. When the rotational motion unit 155 is driven to rotate while the gripping unit 153 fixes the hub unit 320, the hub unit 320 rotates in conjunction with the operation of the rotational motion unit 155 while remaining fixed by the gripping unit 153. The rotational motion unit 155 can rotate the elongated medical member 300A around the central axis 310c of the main body 310 of the elongated medical member 300A (see FIGS. 9 and 10 ).
[0049] 3 and 4, the electron beam irradiation device 10 has a work guide 160 disposed at a predetermined position on the rail portion 151. Fig. 3 is a cross-sectional view taken along the arrow 3A-3A shown in Fig. 1.
[0050] The work guide 160 has a role of guiding the movement of the elongated medical device 300A outside the chamber part 130.
[0051] As shown in FIGS. 3 and 4, the work guide 160 has a first guide portion 161 and a second guide portion 162 that are configured to be able to move toward and away from each other.
[0052] 3 , when the first guide part 161 and the second guide part 162 are arranged at a predetermined distance from each other, a support hole 163 for supporting the medical elongated member 300A inserted therethrough is formed between the first guide part 161 and the second guide part 162. When the transport mechanism 150 transports the medical elongated member 300A, the electron beam irradiation device 10 supports a portion of the medical elongated member 300A in the support hole 163, thereby enabling the medical elongated member 300A to be smoothly moved along each of the transport directions d1 and d2.
[0053] The size of the support hole 163 formed between the first guide portion 161 and the second guide portion 162 can be adjusted by changing the distance between the first guide portion 161 and the second guide portion 162. For example, as shown in FIG. 4 , the size of the support hole 163 can be reduced by reducing the distance between the first guide portion 161 and the second guide portion 162. Therefore, by adjusting the size of the support hole 163 depending on the size, cross-sectional shape, etc. of the irradiation object 300 (medical elongated member 300A) to be transported by the transport mechanism 150, the work guide 160 can guide the movement of various types of irradiation object 300. Note that each guide portion 161, 162 can be attached to the rail portion 151 via, for example, a support portion 165 having a slide groove formed therein for slidably holding each guide portion 161, 162.
[0054] As described above, the electron beam irradiation device 10 of this embodiment is configured to be able to simultaneously irradiate electron beams onto a maximum of 15 medical elongated members 300 A. To this end, the electron beam irradiation device 10 is provided with 15 gripping units 153, rotating units 155, and work guides 160.
[0055] As shown in Figures 1 and 2, the transport mechanism 150 is configured to move the gripping part 153 along the rail part 151 in a state in which the medical elongated member 300A is suspended by the gripping part 153 in the direction of gravity.
[0056] When transporting the elongated medical member 300A, the transport mechanism 150 fixes the hub portion 320 to the gripping portion 153 and hangs the elongated medical member 300A so that the other end (corresponding to the "tip end" of the elongated medical member 300A) opposite to the end where the hub portion 320 is located is positioned below in the direction of gravity (a state in which the main body 310 of the elongated medical member 300A is naturally stretched without any external force being applied to it). The transport mechanism 150 can linearly move the elongated medical member 300A along the first transport direction d1 and the second transport direction d2 while maintaining the elongated medical member 300A in the hanging state as described above.
[0057] As shown in Figures 5 and 7, the transport mechanism 150 is configured to transport the medical elongated member 300A with a gap g formed between the partition portion 140 and the medical elongated member 300A when no inert gas is being sprayed from the nozzle 121 of the inert gas supply unit 120.
[0058] During electron beam irradiation using the electron beam irradiation device 10, before irradiation of the first region 311 of the main body 310 of the medical elongated member 300A with electron beams is started, the inert gas supply unit 120 has not yet sprayed the inert gas onto the medical elongated member 300A in the chamber 130. In this state, the medical elongated member 300A is not in contact with the partition 140. Therefore, before the inert gas supply unit 120 sprays the inert gas onto the medical elongated member 300A, the transport mechanism 150 can move the medical elongated member 300A with a predetermined gap g between the partition 140 and the medical elongated member 300A.
[0059] (Electron Beam Irradiation Unit 110) As shown in Figs. 5 and 6, the electron beam irradiation unit 110 has an emission surface 111 arranged to face in the direction in which the electron beams are emitted.
[0060] The electron beam irradiation unit 110 is disposed 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 disposed on the side facing the partition unit 140 in the height direction (arrow Z1-Z2 direction) of the chamber unit 130.
[0061] Between the partition 140 and the emission surface 111 of the electron beam irradiation unit 110 , there is a space 130 a located on an extension of the direction in which the inert gas injected from the inert gas supply unit 120 is injected.
[0062] The emission surface 111 is arranged so as to irradiate the electron beam in a direction approximately perpendicular to a partition 140 arranged so as to face the electron beam irradiation unit 110 in the internal space 130A of the chamber unit 130.
[0063] The energy of the electron beam emitted from the emission surface 111 of the electron beam irradiation unit 110 can be set arbitrarily depending on the material to be hardened by the electron beam, etc. When the lubricating coating layer 311a applied to the medical elongated member 300A is to be hardened as in this embodiment, the energy of the electron beam can be set to, for example, 10 keV to 500 keV.
[0064] 5 and 6, the inert gas supply unit 120 has an injection port 121 and a nozzle body 123. The injection port 121 is disposed at one end of the nozzle body 123.
[0065] The nozzle 121 of the inert gas supply unit 120 is located on the side of the emission surface 111 of the electron beam irradiation unit 110 within the chamber unit 130, and is inclined from the emission surface 111 toward the partition unit 140. Therefore, as shown in Fig. 6, the inert gas injected from the nozzle 121 is injected diagonally forward along the inclination direction of the nozzle 121 toward the partition unit 140.
[0066] 6 , the inactivating gas supply unit 120 injects the inactivating gas from the injection port 121 in a state in which a part of the elongated medical member 300A (a part of the first region 311) is placed in the space 130a located between the exit surface 111 of the electron beam irradiation unit 110 and the partition 140. The inactivating gas injected from the injection port 121 is injected toward a position on the partition 140 facing the exit surface 111 of the electron beam irradiation unit 110.
[0067] The inactivated gas sprayed from the nozzle 121 of the inactivated gas supply unit 120 toward the space 130a moves a portion of the elongated medical member 300A arranged in the space 130a toward the partition 140. The inactivated gas sprayed from the nozzle 121 of the inactivated gas supply unit 120 causes a portion of the elongated medical member 300A to come into contact with the partition 140, which is positioned opposite the emission surface 111 of the electron beam irradiation unit 110 across the space 130a.
[0068] While gas continues to be ejected from the nozzle 121 of the inactivating gas supply unit 120, the electron beam irradiation device 10 can press each longitudinal portion of the elongated medical member 300A, which is being sequentially moved into the space 130a by the transport mechanism 150, against the partition 140. The electron beam irradiation device 10 can maintain a constant distance (linear distance LA shown in FIG. 6 ) between the exit surface 111 of the electron beam irradiation unit 110 and the portion of the elongated medical member 300A by pressing a portion of the elongated medical member 300A against the partition 140 with the inactivating gas ejected from the nozzle 121 of the inactivating gas supply unit 120.
[0069] The electron beam irradiation device 10 can emit electron beams from the emission surface 111 of the electron beam irradiation unit 110 while moving the medical elongated member 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 portion of the medical elongated member 300A. Therefore, the electron beam irradiation device 10 can continuously emit electron beams to each portion of the longitudinal direction of the medical elongated member 300A while maintaining a constant distance between the emission surface 111 of the electron beam irradiation unit 110 and each portion of the longitudinal direction of the medical elongated member 300A. This makes it possible for the electron beam irradiation device 10 to prevent uneven curing from occurring in each portion of the longitudinal direction of the first region 311 of the medical elongated member 300A.
[0070] The inert gas used in the electron beam irradiation device 10 may be, for example, helium gas, neon gas, argon gas, xenon gas, or nitrogen gas.
[0071] The injection pressure X MPa of the inert gas injected from the injection port 121 of the inert gas supply unit 120 can be set, for example, in the range of 0.01 MPa<X MPa<1 MPa.
[0072] Furthermore, when the electron beam irradiation device 10 is configured to have at least one inert gas supply unit 120, the injection angle θ1 (see Figure 6) of the inert gas injected from one injection port 121 can be set, for example, in the range of 10° < θ1 < 90° (preferably, 30° < θ1 < 90°).
[0073] In addition, the distance from the nozzle 121 of the inactivating gas supply section 120 to the bottom 144 of the partition section 140 (the straight-line distance between the nozzle 121 and the bottom 144 of the partition section 140 along the injection angle θ1) can be set, for example, in the range of 0 mm < L mm < 500 mm.
[0074] The electron beam irradiation device 10 may have multiple inactivation gas supply units. For example, when the electron beam irradiation device 10 presses a portion of the elongated medical member 300A against the partition 140 with the inactivation gas ejected from the nozzle 121 of the inactivation gas supply unit 120, the electron beam irradiation device 10 may press another portion of the elongated medical member toward the partition 140 with the inactivation gas ejected from the nozzle of another inactivation gas supply unit, thereby further reducing misalignment of the elongated medical member. When the electron beam irradiation device 10 has multiple inactivation gas supply units, the other inactivation gas supply units other than the inactivation gas supply unit 120 may be located between the inactivation gas supply unit 120 and the electron beam irradiation unit 110, or on the opposite side of the inactivation gas supply unit 120 and the electron beam irradiation unit 110 on the emission surface 111 side of the electron beam irradiation unit 110, as shown in FIG. 5 . When an inert gas supply unit other than the inert gas supply unit 120 is placed at the position described above, the spray angle of the inert gas sprayed from the nozzle of the other inert gas supply unit can be set, for example, in the range of 10°<θ≦170°.
[0075] (Partition 140) As shown in Figs. 7 and 8, the partition 140 has a plurality of wall portions 141 and a plurality of recesses 143 defined between a pair of the wall portions 141.
[0076] Note that Figure 7 shows a cross-sectional view of the partition section 140 at a location where the inert gas indicated by the arrow 7A in Figure 6 is not sprayed, and Figure 8 shows a cross-sectional view of the partition section 140 at a location where the inert gas indicated by the arrow 8A in Figure 6 is sprayed.
[0077] Each wall 141 has a shape that protrudes approximately perpendicularly toward the side where the electron beam irradiation unit 110 and the inactivation gas supply unit 120 are arranged within the chamber 130. The recess 143 has a cross-sectional shape that is recessed on the side away from the emission surface 111 of the electron beam irradiation unit 110 and the injection port 121 of the inactivation gas supply unit 120 (in this embodiment, the side indicated by arrow Z1).
[0078] A bottom 144 having a substantially linear cross-sectional shape is provided in the partition 140 at a position furthest from the emission surface 111 and the injection port 121. As shown in Figures 6 and 8, when the inactivated gas is injected onto the elongated medical member 300A, at least a part of the first region 311 of the elongated medical member 300A comes into contact with the bottom 144.
[0079] 7 , when the inert gas is not being sprayed from the nozzle 121 of the inert gas supply unit 120 (or when the inert gas is not being sprayed at a location), the first region 311 of the main body 310 of the medical elongated member 300A is not pressed against the partition 140 by the inert gas. Therefore, the first region 311 of the main body 310 of the medical elongated member 300A is disposed with a gap g between it and the bottom 144.
[0080] 8, when the inert gas is injected from the injection port 121 of the inert gas supply unit 120, the first region 311 of the main body 310 of the elongated medical member 300A is pressed against the partition 140 by the inert gas. As a result, the first region 311 of the main body 310 of the elongated medical member 300A comes into contact with the bottom 144. As described above, in the electron beam irradiation method of this embodiment, electron beams are emitted from the exit surface 111 of the electron beam irradiation unit 110 toward the space 130a in a state in which the first region 311 of the main body 310 of the elongated medical member 300A is in contact with the partition 140 (the bottom 144 of the partition 140) (see FIG. 6).
[0081] (Elongated medical member 300A) As shown in FIGS. 1 and 2, the elongated medical member 300A includes an elongated main body portion 310 extending in the longitudinal direction, and a hub portion 320 disposed at one end of the main body portion 310.
[0082] As shown in Figures 1, 2, 9, and 10, the main body 310 of the medical elongated member 300A can be configured to have a first region 311 on which a lubricating coating layer 311a is applied and which is to be irradiated with electron beams, and a second region 312 located on one end side (base end side) of the first region 311 and on which the lubricating coating layer 311a is not applied.
[0083] The region of the elongated medical member 300A to be irradiated with the electron beam is the first region 311 coated with the lubricating coating layer 311a. Therefore, when irradiating with the electron beam, the transport mechanism 150 moves the elongated medical member 300A along the transport directions d1 and d2 at least within the range in which the first region 311 is positioned in the space 130a of the chamber 130.
[0084] The transport mechanism 150 is configured to move the gripping part 153 while fixing only the hub part 320 of the medical elongated member 300A with the gripping part 153, thereby placing the first region 311 of the medical elongated member 300A in the space 130a in the chamber part 130. Therefore, while the lubricating coating layer 311a is being cured by electron beam irradiation, in the medical elongated member 300A, the part that is gripped by the transport mechanism 150 and thus directly subjected to a gripping force (external force) is only the hub part 320.
[0085] The main body 310 of the medical elongated member 300A can be formed, for example, as a resin tubular member having an internal lumen 315 (see FIGS. 9 and 10 ). When the main body 310 of the medical elongated member 300A is formed as a resin tubular member, examples of the material for the main body 310 include polymeric materials such as polyamide resin, polyolefin resins such as polyethylene resin and polypropylene resin, modified polyolefin resin, cyclic polyolefin resin, epoxy resin, urethane resin, diallyl phthalate resin (allyl resin), polycarbonate resin, fluororesin, amino resin (urea resin, melamine resin, benzoguanamine resin), polyester resin, styrene resin, acrylic resin, polyacetal resin, vinyl acetate resin, phenolic resin, vinyl chloride resin, silicone resin (silicone resin), polyether resin, and polyimide resin, as well as mixtures of these polymeric materials, or two or more of the above polymeric materials. The main body 310 of the medical elongated member 300A may also contain linear metal material as a reinforcing member within the resin material. In such cases, examples of the metallic material include nickel-titanium alloy, cobalt-chromium alloy, magnesium alloy, stainless steel, platinum, tungsten, and the like.
[0086] The elongated medical member 300A is, for example, a catheter including an elongated main body portion 310 and a hub portion 320. Specifically, the catheter is an angiography catheter, a support catheter, a microcatheter, a balloon catheter, or the like.
[0087] The elongated medical member 300A may also be configured, for example, as a guidewire known in the medical field. When the elongated medical member 300A is configured as a guidewire, it is not necessary to attach a hub portion 320 to one end of the elongated medical member 300A. When the elongated medical member 300A is configured as a guidewire, examples of materials that can be used include superelastic alloys such as nickel-titanium alloys and copper-zinc alloys, and metallic materials such as stainless steel.
[0088] The material constituting the lubricating coating layer 311a applied to the medical elongated member 300A may be any material that absorbs water and exhibits lubricity. For example, hydrophilic materials may be used. Specific examples are shown below. In the specific examples, the term "(meth)acrylic" encompasses both acrylic and methacrylic. Thus, for example, the term "(meth)acrylic acid" encompasses both acrylic acid and methacrylic acid. Similarly, the term "(meth)acryloyl" encompasses both acryloyl and methacryloyl. Thus, for example, the term "(meth)acryloyl group" encompasses both acryloyl and methacryloyl groups.
[0089] Examples of hydrophilic materials that make up the lubricating coating layer 311a include hydrophilic polymers such as polyvinylpyrrolidone, polyvinyl alcohol, polyethylene oxide-based polymers, cellulose-based polymers such as carboxymethyl cellulose, acrylamide-based polymers such as polyacrylamide and polydimethylacrylamide, hyaluronic acid, polyacrylic acid, maleic anhydride-based polymers such as maleic anhydride-methyl vinyl ether copolymer, water-soluble nylon (registered trademark), and derivatives thereof.
[0090] 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 a "reactive monomer") and a hydrophilic monomer in order to firmly fix the hydrophilic polymer to the medical elongated member 300A. In this specification, the "reactive functional group" refers to a functional group that can undergo a cross-linking reaction with other monomers or can react (bond) with the surface of the medical elongated member 300A by electron beam irradiation or the like.
[0091] The reactive functional group is not particularly limited, and may be a functional group such as an epoxy group, an acid halide group, an aldehyde group, an isocyanate group, an acid anhydride group, a vinyl group, a (meth)acryloyl group, etc. These reactive functional groups may be present alone or in combination in the reactive monomer.
[0092] The reactive monomer used in the present invention preferably has a reactive functional group and exhibits hydrophobicity in body fluids or aqueous solvents at least more hydrophobicity than the hydrophilic monomer used in the production of copolymer.Specific examples of such reactive monomers include monomers having an epoxy group in the molecule such as glycidyl acrylate, glycidyl methacrylate (GMA), methyl glycidyl methacrylate, allyl glycidyl ether; monomers having an acid halide group in the molecule such as (meth)acrylic acid chloride, (meth)acrylic acid bromide, (meth)acrylic acid iodide; monomers having an aldehyde group in the molecule such as (meth)acrylic aldehyde, crotonaldehyde, acrolein, methacrolein; (meth)acryloyloxymethyl isocyanate, (meth)acryloyloxymethyl methyl methacrylate, (meth)acrylic acid iodide; Examples of reactive 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. Preferred are monomers having an epoxy group in the molecule, such as glycidyl acrylate, glycidyl methacrylate (GMA), methyl glycidyl methacrylate, and allyl glycidyl ether. These reactive monomers can be used alone or in combination of two or more.
[0093] The hydrophilic monomer is not particularly limited, and examples thereof 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 of hydrophilic monomers include acrylate, pentaerythritol tri(meth)acrylate, dipentaerythritol penta(meth)acrylate, neopentyl glycol mono(meth)acrylate, trimethylolpropane di(meth)acrylate, trimethylolethane di(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, and preferably N,N-dimethylacrylamide, acrylamide, acrylic acid, methacrylic acid, N,N-dimethylaminoethyl acrylate, 2-hydroxyethyl acrylate, and vinylpyrrolidone. These hydrophilic monomers can be used alone or in combination of two or more.
[0094] The hydrophilic material constituting the lubricating coating layer 311a may be a material containing only a hydrophilic monomer in order to easily and firmly immobilize the hydrophilic polymer on the elongated medical member 300A. In this case, the hydrophilic monomer contains a (meth)acryloyl group that can crosslink with other hydrophilic monomers or react (bond) with the surface of the elongated medical member 300A upon electron beam irradiation. For example, such a hydrophilic monomer is a hydrophilic monomer containing a (meth)acryloyl group among the hydrophilic monomers described above. A material containing only a hydrophilic monomer is a material containing a single or a combination of two or more hydrophilic monomers containing a (meth)acryloyl group among the hydrophilic monomers described above.
[0095] The hub portion 320 can be made of a material that is harder than the main body portion 310. Examples of materials that can be used to make the hub portion 320 include polyethylene, polypropylene, polyamide, polycarbonate, and polystyrene.
[0096] (Electron Beam Irradiation Method) Next, an electron beam irradiation method according to this embodiment will be described.
[0097] The electron beam irradiation method according to the present embodiment is an electron beam irradiation device 10 that irradiates an electron beam onto a medical elongated member 300A. The electron beam irradiation device 10 includes an electron beam irradiation unit 110 having an exit surface 111 for emitting electron beams, an inert gas supply unit 120 having an injection port 121 for injecting inert gas, a partition 140 facing the exit surface 111, and a space 130a located between the exit surface 111 and the partition 140. The electron beam irradiation device 10 is configured to inject an electron beam onto the medical elongated member 300A. and a transport mechanism 150 configured so that a portion of the medical elongated member 300A can be positioned, and includes spraying an inactivated gas onto the medical elongated member 300A from an injection port 121 located on the side of the exit surface 111 while a portion of the medical elongated member 300A is positioned in a space 130a located between the exit surface 111 and the partition portion 140, and irradiating an electron beam onto the medical elongated member 300A from the exit surface 111 while the medical elongated member 300A is in contact with the partition portion 140 with the inactivated gas.
[0098] Each step of the electron beam irradiation method will be described below.
[0099] 1 and 2, the worker fixes the elongated medical member 300A to the gripping portion 153. In this embodiment, 15 elongated medical members 300A are set in the width direction (horizontal arrangement direction) of the electron beam irradiation device 10.
[0100] The worker fixes only the hub portion 320 of the medical elongated member 300A to the gripping portion 153. The worker fixes the medical elongated member 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 member 300A to the gripping portion 153, the electron beam irradiation device 10 can prevent unintended deformation or crushing of portions of the main body portion 310 other than the hub portion 320.
[0101] Next, the worker connects the grip portion 153 to the rail portion 151 .
[0102] Next, the operator sends an instruction to the electron beam irradiation device 10 to start the electron beam irradiation operation by the electron beam irradiation device 10. If the electron beam irradiation device 10 is equipped with a work start button, the operator can start the operation by pressing the work start button. Note that the operator can also send a work start command to the electron beam irradiation device 10 by operating an information terminal device, an external controller, or the like.
[0103] When an operator issues an instruction to start work, the electron beam irradiation apparatus 10 starts inactivation gas purging by injecting inactivation gas (e.g., nitrogen gas) from the inactivation gas supply unit 120. At this time, the electron beam irradiation apparatus 10 sends nitrogen gas from the inactivation gas supply unit 120 into the chamber 130, replacing the gas in the chamber 130 with the inactivation gas, thereby removing the gas from the chamber 130. The electron beam irradiation apparatus 10 may be equipped with an exhaust mechanism (e.g., a duct or an exhaust pump) (not shown) for exhausting the gas in the chamber 130 to the outside of the chamber 130. During the inactivation gas purging, the hole 135 is kept closed by an opening / closing mechanism (not shown).
[0104] The electron beam irradiation device 10 emits electron beams from the emission surface 111 of the electron beam irradiation unit 110 after the inside of the chamber unit 130 reaches a predetermined oxygen concentration.
[0105] The electron beam irradiation device 10 opens the hole 135 that is in a closed state by an opening / closing mechanism (not shown).
[0106] The electron beam irradiation device 10 operates the transport mechanism 150 to move the gripper 153, to which the hub 320 of the medical elongated member 300A is fixed, along the rail 151 in the first transport direction d1. At this time, the transport mechanism 150 moves the gripper 153 along the direction of gravity in which the medical elongated member 300A is suspended, thereby moving the medical elongated member 300A into the chamber 130. With only the hub 320 fixed by the gripper 153, the medical elongated member 300A is introduced into the chamber 130 from the other end side of the medical elongated member 300A through the hole 135.
[0107] As described above, the electron beam irradiation device 10 can move the medical elongated member 300A in the direction of gravity while it is suspended by the transport mechanism 150, and therefore can achieve the following effects.
[0108] Generally, the application of the lubricating coating layer 311a to the medical elongated member 300A is often performed by dipping, which is performed by moving the medical elongated member 300A in the same direction as the direction of gravity using the transport mechanism 150. Therefore, considering a series of manufacturing processes in which the medical elongated member 300A is dipped and then the lubricating coating layer 311a is cured, the efficiency of the manufacturing process can be improved by moving the medical elongated member 300A in a suspended state in the direction of gravity while curing the lubricating coating layer 311a.
[0109] Furthermore, the electron beam irradiation device 10 moves the medical elongated member 300A in the direction of gravity while suspended by the transport mechanism 150, thereby preventing the medical elongated member 300A from unintentionally coming into contact with various parts of the electron beam irradiation device 10. For example, a gap g (see FIG. 7 ) can be formed between the partition 140 and a portion of the medical elongated member 300A to which the inactivating gas is not sprayed, thereby preventing the medical elongated member 300A from coming into contact with the partition 140 at an unintended location. This prevents the lubricating coating layer 311a applied to the main body 310 of the medical elongated member 300A from peeling or falling off.
[0110] Furthermore, the electron beam irradiation device 10 can maintain the outer shape of the elongated medical member 300A so that the entire longitudinal direction of the elongated medical member 300A is substantially linear due to its own weight by moving the suspended elongated medical member 300A along the direction of gravity using the transport mechanism 150. Therefore, the electron beam irradiation device 10 can more appropriately maintain the distance between the elongated medical member 300A and the emission surface 111 of the electron beam irradiation unit 110 when irradiating the lubricating coating layer 311a applied to the elongated medical member 300A with electron beams.
[0111] When the electron beam irradiation device 10 moves the elongated medical member 300A using the transport mechanism 150, the work guide 160 disposed between the chamber section 130 and the gripping section 153 can support a portion of the elongated medical member 300A. Therefore, when the electron beam irradiation device 10 moves the elongated medical member 300A using the transport mechanism 150, the electron beam irradiation device 10 can smoothly move the elongated medical member 300A along a linear path that follows the rail section 151.
[0112] 5 and 6 , the electron beam irradiation device 10 moves the elongated medical member 300A using the transport mechanism 150 to pass through the space 130a in the chamber 130. When the first region 311 of the elongated medical member 300A passes through the space 130a, the electron beam irradiation device 10 injects the inactivated gas from the injection port 121 of the inactivated gas supply unit 120 in an oblique direction toward the partition 140. As an example, the inactivated gas supply unit 120 can inject the inactivated gas at an injection angle θ1 of 45° and an injection pressure of 0.05 MPa.
[0113] The injection port 121 of the inactivated gas supply unit 120 is inclined obliquely toward the first transport direction d1. Therefore, the inactivated gas injected from the injection port 121 flows toward the first transport direction d1 while being sprayed toward the elongated medical member 300A. Therefore, the inactivated gas supply unit 120 can cause the elongated medical member 300A to contact the partition 140 over a predetermined range along the first transport direction d1 from near the exit surface 111 of the electron beam irradiation unit 110 by the inactivated gas injected from the injection port 121. This allows the electron beam irradiation device 10 to effectively prevent the elongated medical member 300A from shaking or bending within the chamber 130.
[0114] 6 , the electron beam irradiation device 10 does not directly spray the inactivating gas onto portions of the elongated medical member 300A that are not located in the space 130a within the chamber 130. Therefore, while the transport mechanism 150 is transporting the elongated medical member 300A, the electron beam irradiation device 10 forms a gap g between the portion of the elongated medical member 300A that is not located in the space 130a and the partition 140. This prevents the portion of the elongated medical member 300A that is not located in the space 130a from accidentally coming into contact with the partition 140 while the elongated medical member 300A is being moved by the transport mechanism 150, which could result in the lubricating coating layer 311a applied to the first region 311 being peeled off or falling off.
[0115] The electron beam irradiation device 10 presses the first region 311 of the elongated medical member 300A against the partition 140 by injecting the inactivating gas from the injection port 121 of the inactivating gas supply unit 120. By pressing the first region 311 of the elongated medical member 300A against the partition 140, 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 elongated medical member 300A at a position corresponding to the space 130a.
[0116] The electron beam irradiation device 10 can maintain each longitudinal portion of the elongated medical member 300A in continuous contact with the partition 140 as the elongated medical member 300A passes through the space 130a by continuously injecting the inactivating gas from the injection port 121 of the inactivating gas supply unit 120. The electron beam irradiation device 10 can irradiate each longitudinal portion of the first region 311 of the elongated medical member 300A arranged sequentially in the space 130a with the electron beam at an equal distance from the emission surface 111, while maintaining a constant distance between the emission surface 111 of the electron beam irradiation unit 110 and the main body 310 of the elongated medical member 300A.
[0117] 8, the partition 140 has a recess 143 in which the medical elongated member 300A is placed when the inactivating gas supply unit 120 sprays the inactivating gas onto the first region 311 of the medical elongated member 300A. The recess 143 is recessed toward the side away from the emission surface 111 and the spray nozzle 121. The first region 311 of the medical elongated member 300A onto which the inactivating gas is sprayed moves away from the spray nozzle 121 and is accommodated within the recess 143. Therefore, the electron beam irradiation device 10 can prevent the first region 311 of the medical elongated member 300A from being significantly misaligned in the width direction (direction of arrows Y1-Y2). As a result, when the electron beam irradiation device 10 irradiates the first region 311 of the elongated medical member 300A with an electron beam, it can more reliably maintain a constant distance between the emission surface 111 of the electron beam irradiation unit 110 and the first region 311 of the elongated medical member 300A. Furthermore, when the electron beam irradiation device 10 is configured to irradiate multiple elongated medical members 300A simultaneously with an electron beam as in this embodiment, the partition 140 can also prevent inadvertent contact between adjacent elongated medical members 300A in the width direction (direction of arrows Y1-Y2) by the inactivated gas injected from the injection port 121, using the recess 143.
[0118] After the entire longitudinal range of the first region 311 of the medical elongated member 300A to be irradiated with the electron beam has passed through the space 130a, the electron beam irradiation device 10 operates the rotation operating unit 155 to rotate the medical elongated member 300A by 180 degrees around the central axis 310c of the main body 310, as shown in Figures 9 and 10.
[0119] When rotating the elongated medical member 300A, the electron beam irradiation device 10 stops the spray of inactivated gas from the inactivated gas supply unit 120. By stopping the spray of inactivated gas from the inactivated gas supply unit 120 when rotating the elongated medical member 300A, the electron beam irradiation device 10 can prevent the lubricating coating layer 311a from rubbing against the partition 140 as the elongated medical member 300A rotates, thereby preventing the lubricating coating layer 311a from falling off. In Figures 9 and 10, the reference symbol 311b illustrates an example of a portion of the lubricating coating layer 311a that has been hardened by the electron beam irradiated onto the first region 311 of the main body 310 when the elongated medical member 300A is moved in the first transport direction d1.
[0120] After rotating the elongated medical member 300A by 180° as described above, the electron beam irradiation device 10 operates the transport mechanism 150 to move the elongated medical member 300A along the second transport direction d2. The electron beam irradiation device 10 moves the elongated medical member 300A along the second transport direction d2 using the transport mechanism 150, thereby passing the first region 311 of the elongated medical member 300A through the space 130a. When passing the first region 311 of the elongated medical member 300A through the space 130a along the second transport direction d2, the electron beam irradiation device 10 sprays an inert gas from the inert gas supply unit 120 and irradiates the elongated medical member 300A with an electron beam from the electron beam irradiator 110, similar to when moving the elongated medical member 300A along the first transport direction d1. The electron beam irradiation device 10 rotates the elongated medical member 300A by 180°, and then moves the elongated medical member 300A along the second transport direction d2 to pass through the space 130a, thereby irradiating the electron beam onto the other surface of the elongated medical member 300A opposite to the one surface in the circumferential direction that was irradiated with the electron beam when the elongated medical member 300A was moved along the first transport direction d1. This allows the electron beam irradiation device 10 to uniformly irradiate the entire circumferential range of the elongated medical member 300A with the electron beam.
[0121] In this embodiment, when the first region 311 of the elongated medical member 300A is irradiated with an electron beam, the entire longitudinal range of the elongated medical member 300A is not placed within the chamber 130, but only a portion of the longitudinal direction including the first region 311 is placed within the chamber 130. Therefore, the electron beam irradiation device 10 can prevent the chamber 130 from being configured with an increased longitudinal length.
[0122] After completing the irradiation of the first region 311 of the elongated medical member 300A with the electron beam, the electron beam irradiation device 10 moves the gripping part 153 to a predetermined position (the initial position on one end side of the rail part 151). The operator removes the gripping part 153 to which the elongated medical member 300A is fixed from the rail part 151.
[0123] By the above operations, irradiation of the medical elongated member 300A with the electron beam is completed.
[0124] Here, with reference to FIGS. 11 to 13, problems that may arise in comparison with the electron beam irradiation apparatus 10 and electron beam irradiation method according to this embodiment will be described.
[0125] Figure 11 shows a comparative example in which one end (base end) of the medical elongated member 600 is suspended in the weight direction by the gripping portion, and the medical elongated member 600 is moved along the first transport direction d1 and the second transport direction d2 while an electron beam is irradiated onto the medical elongated member 600 from the electron beam irradiation unit 500.
[0126] In this comparative example, only one end of the elongated medical member 600 is fixed by the gripper, leaving the other end (tip) of the elongated medical member 600 unfixed. When the elongated medical member 600 is moved in this state along the first and second transport directions d1 and d2, the elongated medical member 600 "sways" (wobble) in a direction intersecting the transport directions d1 and d2, starting from the one end of the elongated medical member 600. When the elongated medical member 600 sways in this way, it becomes difficult to maintain a constant distance between the exit surface 511 of the electron beam irradiation unit 500 and the elongated medical member 600. As a result, the lubricating coating layer on the elongated medical member 600 is cured unevenly at various locations along the longitudinal direction of the elongated medical member 600.
[0127] 12 and 13 show an example in which the transport directions d1 and d2 of the medical elongated member 600 are set horizontally (perpendicular to the direction of gravity). When the transport directions d1 and d2 are set horizontally, there is a concern that the medical elongated member 600 may "float" in a direction intersecting the transport directions d1 and d2, as shown in FIG. 12, or that the other end of the medical elongated member 600 may "warp" in a direction intersecting the transport directions d1 and d2, as shown in FIG. 13. When the medical elongated member 600 lifts or warps, it becomes difficult to maintain a constant distance between the exit surface 511 of the electron beam irradiation unit 500 and the medical elongated member 600, as in the case where the medical elongated member 600 vibrates. As a result, the lubricating coating layer of the medical elongated member 600 may harden unevenly in various portions along the longitudinal direction of the medical elongated member 600.
[0128] As a measure to prevent the occurrence of the problems described in each comparative example, the following methods can be adopted, for example.
[0129] For example, it is conceivable to insert a mandrel into the elongated medical member 600 to impart rigidity and linearity to the elongated medical member 600 before transporting it. Even if such a measure is adopted, it is considered difficult to impart sufficient rigidity and linearity to the elongated medical member 600 if the elongated medical member 600 has a relatively small diameter (for example, an outer diameter of 0.3 mm to 5.0 mm). Furthermore, not only does it require an additional step of attaching (inserting) the mandrel to the elongated medical member 600, but it also requires management of the mandrel (control of bending and cleanliness), which leads to a decrease in productivity.
[0130] For example, one possible approach is to grasp both ends (one end and the other end) of the medical elongated member 600 and transport the medical elongated member 600 while applying tension along the longitudinal direction. If such a measure is adopted, a load is applied to the other end of the medical elongated member 600 due to the grasping, which may result in crushing or deformation of the other end of the medical elongated member 600. Furthermore, if crushing or deformation occurs at the other end of the medical elongated member 600, an additional step of removing the crushed or deformed portion is required. Furthermore, depending on the product specifications, the other end (tip end) of the medical elongated member 600 may be given a tip shape, such as an R-shape. Considering the situation where the other end of the medical elongated member 600 ultimately needs to be removed, as described above, a measure such as grasping both ends of the medical elongated member 600 cannot be applied to a medical elongated member 600 with a tip shape added. Furthermore, when a mechanism for gripping both ends of the elongated medical member 600 is provided in the electron beam irradiation device, it becomes necessary to configure the chamber large enough to accommodate the entire elongated medical member 600, including both ends thereof, which not only increases the size of the device configuration but also leads to a significant decrease in the efficiency of gas replacement when replacing the inside of the chamber with an inert gas.
[0131] To address the above-mentioned issues, in this embodiment, an inert gas is locally sprayed onto the medical elongated member 300A placed in the space 130a of the chamber 130, thereby bringing a portion of the medical elongated member 300A into contact with the partition 140 and maintaining a constant distance between the medical elongated member 300A and the emission surface 111 of the electron beam irradiation unit 110. This prevents uneven curing of the lubricating coating layer 311a due to the "vibration," "lifting," "warping," and other problems of the medical elongated member 300A described in the comparative examples. Furthermore, there is no need to insert a mandrel into the medical elongated member 300A or grip both ends of the medical elongated member 300A as a countermeasure against such problems. Therefore, issues associated with using a mandrel or gripping both ends of the medical elongated member 300A can be prevented. Therefore, the electron beam irradiation device according to this embodiment can be suitably used for elongated medical components having a length of 10 cm or more and / or an outer diameter of 5.0 mm or less. Furthermore, the electron beam irradiation device 10 according to this embodiment can be suitably used for elongated medical components (especially catheters and guidewires) having a length of 100 cm or more and an outer diameter of 5.0 mm or less.
[0132] As described above, the electron beam irradiation device 10 according to this embodiment includes the electron beam irradiation unit 110 having the emission surface 111 for emitting electron beams, the inactivation gas supply unit 120 having the injection port 121 for injecting inactivation gas, the chamber unit 130 accommodating the emission surface 111 and the injection port 121, the partition unit 140 located within the chamber unit 130 and facing the emission surface 111, and the space 130a located between the emission surface 111 and the partition unit 140, in which a part of the medical elongated member 300A can be positioned. The device is provided with a transport mechanism 150 configured such that the injection port 121 is located on the exit surface 111 side within the chamber section 130 and is inclined from the exit surface 111 side toward the partition section 140 side, and the inert gas supply section 120 is configured to inject the inert gas through the injection port 121 toward a position on the partition section 140 facing the exit surface 111 with a portion of the medical elongated member 300A positioned in the space 130a located between the exit surface 111 and the partition section 140.
[0133] In the electron beam irradiation device 10, an injection port 121 of an inactivating gas supply unit 120 that supplies inactivating gas is located on the side of the exit surface 111 of the electron beam irradiation unit 110 that emits electron beams within the chamber unit 130, and is inclined from the exit surface 111 of the electron beam irradiation unit 110 toward the partition unit 140. With a portion of the elongated medical member 300A disposed in a space 130a within the chamber unit 130 that is located between the exit surface 111 of the electron beam irradiation unit 110 and the partition unit 140, the inactivating gas supply unit 120 injects inactivating gas through the injection port 121 toward a position on the partition unit 140 that faces the exit surface 111 of the electron beam irradiation unit 110. The portion of the elongated medical member 300A onto which the inactivating gas is injected comes into contact with the partition unit 140. The electron beam irradiation device 10 can maintain a constant distance between the exit surface 111 of the electron beam irradiation unit 110 and the elongated medical member 300A by bringing a part of the elongated medical member 300A into contact with the partition 140 using an inactivated gas. The electron beam irradiation device 10 emits electron beams from the exit surface 111 of the electron beam irradiation unit 110 toward the elongated medical member 300A while maintaining a constant distance between the exit surface 111 of the electron beam irradiation unit 110 and the elongated medical member 300A, thereby preventing uneven curing of the lubricating coating layer 311a applied to the elongated medical member 300A.
[0134] In addition, in the electron beam irradiation device 10, the transport mechanism 150 is located outside the chamber section 130, and the chamber section 130 has a hole section 135 that allows a portion of the medical elongated member 300A transported by the transport mechanism 150 to be introduced into the chamber section 130, and the transport mechanism 150 is configured to place a portion of the medical elongated member 300A in the space 130a located between the emission surface 111 and the partition section 140 through the hole section 135 of the chamber section 130.
[0135] In the electron beam irradiation device 10 configured as described above, the transport mechanism 150 is located outside the chamber section 130, so there is no need to increase the size of the chamber section 130 to accommodate the transport mechanism 150. Furthermore, in the electron beam irradiation device 10, the medical elongated member 300A transported by the transport mechanism 150 can be introduced into the chamber section 130 through the hole 135 of the chamber section 130, so that a portion of the medical elongated member 300A can be smoothly disposed in the space 130a within the chamber section 130.
[0136] In addition, in the electron beam irradiation device 10, the transport mechanism 150 includes a rail portion 151 extending toward the chamber portion 130, and a gripping portion 153 that is movable along the rail portion 151 and is configured to be able to fix a portion of the medical elongated member 300A, and the transport mechanism 150 is configured to move the gripping portion 153 along the rail portion 151 while the medical elongated member 300A is suspended in the direction of gravity by the gripping portion 153.
[0137] The electron beam irradiation device 10 configured as described above moves the elongated medical member 300A in the direction of gravity while suspended by the transport mechanism 150, thereby preventing the elongated medical member 300A from unintentionally coming into contact with various components of the electron beam irradiation device 10. In particular, a gap g can be formed between the portion of the elongated medical member 300A to which the inactivating gas is not sprayed and the partition 140, thereby preventing the elongated medical member 300A from coming into contact with the partition 140 at an unintended location. Furthermore, by moving the elongated medical member 300A in the direction of gravity while suspended by the transport mechanism 150, the electron beam irradiation device 10 can maintain the outer shape of the elongated medical member 300A so that the entire longitudinal direction of the elongated medical member 300A is substantially linear due to its own weight. Therefore, when irradiating the lubricating coating layer 311a applied to the medical elongated member 300A with electron beams, the electron beam irradiation device 10 can more appropriately maintain the distance formed between the medical elongated member 300A and the exit surface 111 of the electron beam irradiation unit 110.
[0138] In addition, in the electron beam irradiation device 10, the irradiated object 300 is a medical elongated member 300A having a long main body portion 310 extending in the longitudinal direction and a hub portion 320 arranged at one end of the main body portion 310, and the main body portion 310 has a first region 311 on which a lubricating coating layer 311a is applied and which is the target of electron beam irradiation, and a second region 312 arranged closer to the one end of the main body portion 310 than the first region 311 and on which the lubricating coating layer 311a is not applied, and the conveying mechanism 150 is configured to position the first region 311 in the space 130a located between the emission surface 111 and the partition portion 140 by moving the gripping portion 153 while only the hub portion 320 is fixed by the gripping portion 153.
[0139] The electron beam irradiation device 10 configured as described above moves the elongated medical member 300A and irradiates the first region 311 of the main body 310, on which the lubricating coating layer 311a is applied, with electron beams while only the hub portion 320 of the elongated medical member 300A is fixed to the gripping portion 153. Therefore, the electron beam irradiation device 10 can prevent unintended deformation or crushing of the main body 310 of the elongated medical member 300A while performing various tasks using the device 10. Furthermore, because the electron beam irradiation device 10 moves the elongated medical member 300A with only the hub portion 320 of the elongated medical member 300A fixed to the gripping portion 153, the other end (tip) of the elongated medical member 300A can be moved without being restrained by any other components. Therefore, the electron beam irradiation device 10 can smoothly move the other end of the elongated medical member 300A inside and outside the chamber 130.
[0140] In the electron beam irradiation device 10, the transport mechanism 150 has a rotational movement part 155 that can drive the rotational movement of the gripper 153 in a state in which the gripper 153 fixes the medical elongated member 300A.
[0141] The electron beam irradiation device 10 configured as described above can rotate the elongated medical member 300A by 180° around the central axis 310c of the main body 310 by operating the rotation unit 155 after the entire longitudinal range of the first region 311 of the elongated medical member 300A to be irradiated with the electron beam has passed through the space 130a once. After rotating the elongated medical member 300A by 180°, the electron beam irradiation device 10 again moves the elongated medical member 300A to pass through the space 130a while irradiating the elongated medical member 300A with the electron beam, thereby irradiating both one circumferential surface and the opposite circumferential surface of the main body 310 with the electron beam. This allows the electron beam irradiation device 10 to uniformly irradiate the entire circumferential range of the elongated medical member 300A with the electron beam.
[0142] In the electron beam irradiation device 10 , the partition 140 has a recess 143 recessed on the side away from the emission surface 111 and the injection port 121 .
[0143] The electron beam irradiation device 10 configured as described above can be positioned so that the first region 311 of the main body 310 is contained within the recess 143 when inactivating gas is sprayed onto the elongated medical member 300A placed in the space 130a. Therefore, the electron beam irradiation device 10 can prevent the first region 311 of the elongated medical member 300A from being significantly misaligned in the width direction (the direction of the arrows Y1-Y2). This allows the electron beam irradiation device 10 to more reliably maintain a constant distance between the emission surface 111 of the electron beam irradiation unit 110 and the first region 311 of the elongated medical member 300A when irradiating the first region 311 of the elongated medical member 300A with an electron beam. In addition, when the electron beam irradiation device 10 is configured to irradiate electron beams simultaneously onto multiple medical elongated members 300A, the partition portion 140 can also prevent inadvertent contact between adjacent medical elongated members 300A in the width direction (arrow Y1-Y2 direction) by the inactivated gas sprayed from the nozzle 121, using the recess 143.
[0144] In the electron beam irradiation method according to this embodiment, the electron beam irradiation device 10 for irradiating the medical elongated member 300A with the electron beam comprises an electron beam irradiation unit 110 having an exit surface 111 for emitting the electron beam, an inert gas supply unit 120 having an injection port 121 for injecting the inert gas, a partition 140 facing the exit surface 111, and a space 130a between the exit surface 111 and the partition 140, in which a part of the medical elongated member 300A is disposed. The method includes a transport mechanism 150 configured to be capable of transporting the medical elongated member 300A, and includes spraying an inert gas onto the medical elongated member 300A from an injection port 121 located on the side of the exit surface 111 while a part of the medical elongated member 300A is placed in a space 130a located between the exit surface 111 and the partition portion 140, and irradiating the medical elongated member 300A with an electron beam from the exit surface 111 while the medical elongated member 300A is in contact with the partition portion 140 with the inert gas.
[0145] In the electron beam irradiation method, a part of the elongated medical member 300A is placed in a space 130a located between the exit surface 111 of the electron beam irradiation unit 110 that emits electron beams and the partition 140, and then an inactivating gas is sprayed onto the elongated medical member 300A from the spray nozzle 121 of the inactivating gas supply unit 120 located on the exit surface 111 side of the electron beam irradiation unit 110, thereby bringing the elongated medical member 300A into contact with the partition 140. In the electron beam irradiation method, by bringing the elongated medical member 300A into contact with the partition 140, a constant distance can be maintained between the exit surface 111 of the electron beam irradiation unit 110 and the elongated medical member 300A. The electron beam irradiation method emits electron beams from the exit surface 111 of the electron beam irradiation unit 110 toward the medical elongated member 300A while maintaining a constant distance between the exit surface 111 of the electron beam irradiation unit 110 and the medical elongated member 300A, thereby preventing uneven hardening of the lubricating coating layer 311a applied to the medical elongated member 300A.
[0146] In addition, in the electron beam irradiation method, the transport mechanism 150 includes a rail portion 151 and a gripping portion 153 that is movable along the rail portion 151 and is configured to be able to fix a portion of the medical elongated member 300A, and the irradiated object 300 is the medical elongated member 300A that includes an elongated main body portion 310 extending in the longitudinal direction and a hub portion 320 arranged at one end of the main body portion 310, and the main body portion 310 has a first region 311 that is coated with a lubricating coating layer 311a and is the target of electron beam irradiation, and a second region 312 that is arranged closer to the one end than the first region 311 and is not coated with the lubricating coating layer 311a, and the method includes irradiating the first region 311 with an electron beam while spraying an inert gas toward the medical elongated member 300A with the first region 311 being placed in a space 130a located between the exit surface 111 and the partition portion 140.
[0147] In the above-described electron beam irradiation method, the medical elongated member 300A is moved and the first region 311 of the main body 310, on which the lubricating coating layer 311a is applied, is irradiated with electron beams while only the hub portion 320 of the medical elongated member 300A is fixed to the gripping portion 153. Therefore, the electron beam irradiation method can prevent the main body 310 of the medical elongated member 300A from being unintentionally deformed or crushed while various operations are being performed by the electron beam irradiation device 10. Furthermore, since the electron beam irradiation method moves the medical elongated member 300A while only the hub portion 320 of the medical elongated member 300A is fixed to the gripping portion 153, the other end (tip) of the medical elongated member 300A can be moved without being restrained by other members. Therefore, the electron beam irradiation method allows the other end of the medical elongated member 300A to be moved smoothly inside and outside the chamber 130.
[0148] Next, a modified example and a second embodiment of the present invention will be described. In the description of the modified example and the second embodiment, explanations of content that overlaps with content that has already been explained will be omitted. Furthermore, content that is not specifically explained can be the same as the above-mentioned embodiment.
[0149] <Modifications> Fig. 14 shows a partition section 140A according to Modification 1. Fig. 15 shows a partition section 140B according to Modification 2.
[0150] In the above-described embodiment, the recess 143 of the partition 140 is formed between the wall 141 extending substantially perpendicularly from the bottom 144 (see FIGS. 7 and 8). However, there are no particular limitations on the structure or shape of the recess of the partition.
[0151] 14 , the recess 143 a can be formed between a pair of V-shaped walls 141 a extending in a substantially linear manner so as to widen toward the exit surface 111 of the electron beam irradiation unit 110 and the injection port 121 (arrow Z2 side) of the inactivating gas supply unit 120. Furthermore, for example, as in the partition 140B shown in FIG. 15 , the recess 143 b can be formed between a pair of walls 141 b extending in a curved manner so as to widen toward the exit surface 111 of the electron beam irradiation unit 110 and the injection port 121 of the inactivating gas supply unit 120.
[0152] When the partitions 140A, 140B are configured to include recesses 143a, 143b formed with the cross-sectional shapes according to the modifications shown in Figures 14 and 15, the elongated medical member 300A can be held in contact with the narrower bottom 144. Therefore, by configuring the partitions 140A, 140B to include recesses with the shapes shown in the modifications, it is possible to effectively prevent the elongated medical member 300A from shifting in the width direction (the direction of the arrows Y1-Y2 in the figure) when the elongated medical member 300A is brought into contact with the partition 140. On the other hand, the partition 140 described in the above-described embodiment (see Figure 7) can have a greater depth of the recess 143 than the partitions 140A, 140B of the modifications. Therefore, compared to the partitions 140A and 140B of the respective modifications, the partition 140 can more effectively prevent the elongated medical member 300A from slipping out of the recess 143 when a higher pressure inert gas is sprayed onto the elongated medical member 300A placed in the recess 143. From this perspective, it is more preferable that the electron beam irradiation device 10 be provided with the partition 140.
[0153] Second Embodiment FIGS. 16 and 17 show an electron beam irradiation apparatus 10A according to a second embodiment.
[0154] Fig. 16 is a plan view of the electron beam irradiation apparatus 10A, and Fig. 17 is a side view of the electron beam irradiation apparatus 10A as seen from the direction of arrow 17A shown in Fig. 16. Figs. 16 and 17 are partial cross-sectional views of the chamber section 130 so that the interior of the chamber section 130 can be seen.
[0155] In the above-described embodiment, the transport mechanism 150 of the electron beam irradiation device 10A was configured to transport the elongated medical member 300A while it was suspended in the direction of gravity. That is, the electron beam irradiation device 10 was configured such that the rail portion 151 extended in the up-down direction (vertical direction) and the entire device was laid out vertically. On the other hand, the transport mechanism 150 provided in the electron beam irradiation device 10A according to the present embodiment is configured to transport the elongated medical member 300A in the lateral direction (horizontal direction) that intersects with the direction of gravity.
[0156] 17, the rail section 151 is installed on a predetermined stand 30. The apparatus main body 20 is installed on the upper side (arrow Z1 side) of the chamber section 130.
[0157] 18 shows the electron beam irradiation performed by the electron beam irradiation device 10A. As shown in FIG. 18, the electron beam irradiation unit 110 and the inactivation gas supply unit 120 are disposed on the upper side (the side indicated by the arrow Z1) of the chamber unit 130.
[0158] The partition 140 is disposed on the lower side (the side indicated by the arrow Z2) of the chamber 130 so as to face the electron beam irradiation unit 110 and the inert gas supply unit 120. As in the above-described embodiment, the inert gas supply unit 120 is disposed closer to the hole 135 in the chamber 130 than the electron beam irradiation unit 110.
[0159] When irradiating electron beams using the electron beam irradiation device 10A, as in the previously described embodiment, the inactivating gas supply unit 120 sprays inactivating gas toward the portion of the elongated medical member 300A positioned in the space 130a. The portion of the elongated medical member 300A positioned in the space 130a comes into contact with the partition 140 as the inactivating gas is sprayed toward it. The inactivating gas supply unit 120 sprays inactivating gas obliquely from the upper side of the chamber 130 toward the lower side of the chamber 130. Therefore, the electron beam irradiation device 10A can efficiently press the elongated medical member 300A against the partition 140 positioned on the lower side of the chamber 130.
[0160] The electron beam irradiation device 10A can maintain a constant distance between the emission surface 111 of the electron beam irradiation unit 110 and the elongated medical member 300A at a position corresponding to the space 130a by bringing a part of the elongated medical member 300A into contact with the partition 140. The electron beam irradiation device 10 emits electron beams from the emission surface 111 of the electron beam irradiation unit 110 while maintaining a constant distance between the emission surface 111 of the electron beam irradiation unit 110 and the elongated medical member 300A, thereby preventing uneven curing at each portion in the longitudinal direction of the elongated medical member 300A.
[0161] The electron beam irradiation apparatus and electron beam irradiation method according to the present invention have been described above through the embodiments and modifications. However, the present invention is not limited to the content described in the specification, and can be modified as appropriate based on the claims.
[0162] In the embodiments and modifications, a medical elongated member coated with a lubricating coating layer has been described as an example of an irradiated object. However, the irradiated object to which the present invention is applicable can be various components for which a constant distance between the emission surface of the electron beam irradiator and the irradiated object is desired. For example, the irradiated object may be a medical device such as a stent or an injection needle, or a non-medical device such as a string, rope, or hose. Furthermore, the object to be hardened by electron beam irradiation is not limited to a lubricating coating layer. For example, it may be an antibacterial coating layer, an antithrombotic coating layer, or a drug coating layer containing a material that hardens when irradiated by electron beam irradiation. Furthermore, if an intermediate coating layer exists between the surface of the medical elongated member and the lubricating coating layer to enhance adhesion between the surface of the medical elongated member and the lubricating coating layer, the intermediate coating layer may be hardened by electron beam irradiation. Furthermore, the object to be irradiated with electron beams may be the surface of an irradiated 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).
[0163] The electron beam irradiation device of the present invention is not particularly limited in its specific configuration, as long as it can bring the irradiated object into contact with the partition using the inactivating gas injected from the inactivating gas supply unit, and can irradiate the irradiated object from the exit surface of the electron beam irradiation unit while the irradiated object is in contact with the partition. For example, the injection port 121 of the inactivating gas supply unit 120 is preferably inclined obliquely toward the first transport direction d1, as in the first and second embodiments, but may also be inclined obliquely toward the second transport direction d2. In this case, the inactivating gas supply unit 120 is positioned closer to the arrow X2 side (the arrow d1 side along which the transport mechanism 150 moves the irradiated object 300) than the electron beam irradiation unit 110. Therefore, the structure and arrangement of each component of the electron beam irradiation device are not limited to those described in the specification.
[0164] This application is based on Japanese Patent Application No. 2023-127578, filed on August 4, 2023, the disclosure of which is incorporated herein by reference in its entirety.
[0165] REFERENCE SIGNS LIST 10 Electron beam irradiation device 10A Electron beam irradiation device 110 Electron beam irradiation section 111 Emission surface 120 Inactivation gas supply section 121 Injection nozzle 130 Chamber section 130A Internal space of chamber section 130a Space between emission surface and partition section 135 Hole section 140 Partition section 140A Partition section 140B Partition section 143 Recess 143a Recess 143b Recess 150 Transport mechanism 151 Rail section 153 Grip section 155 Rotational operation section 160 Work guide 300 Irradiated object 300A Medical elongated member 310 Main body section of medical elongated member 311 First region 311a Lubricating coating layer before hardening 311b Lubricating coating layer after hardening 312 Second region 315 Lumen 320 Hub portion LA Linear distance between the emission surface and the object to be irradiated d1 First conveying direction d2 Second conveying direction g Gap θ1 Spray angle
Claims
1. An electron beam irradiation device comprising: an electron beam irradiation unit having an exit surface for emitting electron beams; an inactivating gas supply unit having an injection port for injecting inactivating gas; a chamber unit accommodating the exit surface and the injection port; a partition unit located within the chamber unit and facing the exit surface; and a transport mechanism configured to be able to position a part of an object to be irradiated in a space located between the exit surface and the partition unit, wherein the injection port is located on the exit surface side within the chamber unit and is inclined from the exit surface side toward the partition unit side, and the inactivating gas supply unit is configured to inject inactivating gas through the injection port toward a position on the partition unit facing the exit surface with a part of the object to be irradiated being positioned in the space located between the exit surface and the partition unit.
2. The electron beam irradiation device of claim 1, wherein the transport mechanism is located outside the chamber portion, the chamber portion has a hole portion that enables a portion of the irradiated object transported by the transport mechanism to be introduced into the chamber, and the transport mechanism is configured to place a portion of the irradiated object in the space located between the exit surface and the partition portion through the hole portion of the chamber portion.
3. The electron beam irradiation device described in claim 2, wherein the transport mechanism comprises a rail portion extending toward the chamber portion, and a gripping portion movable along the rail portion and configured to fix a portion of the irradiated object, and the transport mechanism is configured to move the gripping portion along the rail portion while the irradiated object is suspended in the direction of gravity by the gripping portion.
4. The electron beam irradiation device of claim 3, wherein the object to be irradiated is a medical elongated member having a long main body extending in the longitudinal direction and a hub portion located at one end of the main body, the main body having a first region coated with a lubricating coating layer that is to be irradiated with electron beams, and a second region located closer to the one end side than the first region and not coated with the lubricating coating layer, and the transport mechanism is configured to position the first region in the space located between the exit surface and the partition by moving the gripping portion while only the hub portion is fixed by the gripping portion.
5. The electron beam irradiation device according to claim 3, wherein the transport mechanism has a rotational motion part capable of driving the rotational motion of the gripper while the gripper is holding the object to be irradiated.
6. The electron beam irradiation device according to claim 1, wherein the partition has a recess recessed on a side away from the emission surface and the injection port.
7. An electron beam irradiation apparatus for irradiating an irradiated object with an electron beam, the electron beam irradiation apparatus comprising: an electron beam irradiation section having an exit surface for emitting electron beams; an inactivation gas supply section having an injection port for injecting inactivation gas; a partition section facing the exit surface; and a transport mechanism configured to be able to position a part of the irradiated object in a space located between the exit surface and the partition section, wherein a method of irradiating an electron beam comprises: injecting inactivation gas from the injection port located on the exit surface side onto the irradiated object with a part of the irradiated object being placed in the space located between the exit surface and the partition section; and irradiating an electron beam onto the irradiated object from the exit surface with the irradiated object in contact with the partition section with the inactivation gas.
8. The electron beam irradiation method according to claim 7, wherein the transport mechanism comprises a rail portion and a gripping portion configured to be movable along the rail portion and to be capable of fixing a portion of the irradiated object, the irradiated object being a medical elongated member comprising a long main body portion extending in a longitudinal direction and a hub portion disposed at one end of the main body portion, the main body portion having a first region coated with a lubricating coating layer to be irradiated with the electron beam, and a second region disposed closer to the one end side than the first region and not coated with the lubricating coating layer, the transport mechanism moves the gripping portion while fixing only the hub portion with the gripping portion, and irradiates the first region with the electron beam while spraying an inert gas toward the irradiated object in a state where the first region is positioned in the space located between the exit surface and the partition portion.
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