Apparatus and method for damaging the cutting area of ​​medical glass products.

The ultrafast laser-based cutting apparatus for medical glass products addresses the issue of glass fragment generation by forming internal damage, ensuring aseptic handling and reducing manufacturing time and defects.

JP7874936B2Active Publication Date: 2026-06-17NIPRO CORP

Patent Information

Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
NIPRO CORP
Filing Date
2019-12-18
Publication Date
2026-06-17

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Abstract

An apparatus for damaging a cut portion of a medical glass product according to one embodiment of the present invention may include a laser light source that bursts an ultrafast laser beam; a beam profile forming unit that shapes the ultrafast laser beam so that the ultrafast laser beam has a plurality of focal lengths and an elongated profile; a beam irradiation unit that irradiates the shaped ultrafast laser beam so that the profile is formed inside the glass of the medical glass product, thereby forming inside damage formed by internal defects due to bulk deformation inside the glass of the medical glass product; and a rotation unit that rotates the medical glass product at a predetermined rotation speed. Thus, according to the present invention, a method for processing a medical glass product that minimizes particle generation during cutting is provided.
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Description

Technical Field

[0001] The present invention relates to a damaging device and method for a cutting site of a medical glass product. More specifically, the present invention relates to a damaging processing device and method capable of minimizing the generation of glass fragments by damaging a cutting site of a medical glass product, such as an ampoule using glass as a material or a glass tube for a medical device, with an ultrafast laser.

Background Art

[0002] The present invention relates to a method for damaging a cutting site of a medical glass product, such as a glass ampoule for storing an injection solution or a nutritional supplement, or a medical glass tube.

[0003] Medical glass products, such as glass ampoules for storing injection solutions or nutritional supplements, are manufactured in a form that allows the contents, such as injection solutions and nutritional supplements, to enter the human body. Therefore, it is essential to manufacture them so that they are opened in a completely aseptic / dust-free manner during the process of breaking them to separate the glass container or tube when in use. Accordingly, in the manufacturing process, meticulous consideration and considerable attention are required.

[0004] However, in the conventional manufacturing process of medical glass products, there has always been a possibility that foreign substances, such as glass fragments, may enter the ampoule. For example, an OPC ampoule used as a container for an injection solution or a nutritional supplement is an ampoule devised to minimize the generation of glass fragments. However, even when used normally, fine glass fragments are generated when the user applies force by hand to cut it.

[0005] For example, referring to FIG. 8 showing a conventional injection or nutritional supplement ampoule 20 of the prior art, the conventional injection or nutritional supplement ampoule 20 includes a cutting direction display portion 23, a cutting assist notch 22, and a bottleneck portion 24.

[0006] In this case, the conventional ampoule 20 for injection or nutritional supplements has a cutting-assist notch 22 formed at the cutting site of the ampoule's neck (bottleneck portion 24) by a diamond blade rotating at high speed. To facilitate cutting, the bottleneck portion has a smaller diameter at the cutting site than the surrounding area, and the user cuts the ampoule by hand by applying pressure to the part indicated on the cutting direction indicator portion 23. This causes the ampoule to break open using the cutting-assist notch 22 as a starting point, allowing the injection solution or nutritional supplement inside the ampoule to be used.

[0007] Figures 9(a) and 9(b) are high-speed photographs of the cut portion of a glass ampoule when a user manually opens a glass ampoule that has been prepared using conventional cutting techniques to create a cutting-assist notch 22. Figure 9(a) shows that glass dust is scattered even though the glass ampoule has been opened normally. Figure 9(b) shows that large glass fragments are generated.

[0008] At this time, when a user (e.g., a nurse) cuts the ampoule at the cutting site for injection or oral administration of the injectable solution or nutritional supplement contained in the OPC ampoule, fine glass powder generated during the formation of the cutting aid notch may enter the ampoule.

[0009] To address the problem of fine glass dust being generated when cutting notches are processed using a diamond blade, a method of creating fine gaps with a laser (Japanese Patent Publication No. 11-71124) has also been devised. However, since this method also creates grooves in a limited area of ​​the ampoule's glass surface, it has the disadvantage that large glass fragments can be generated if the user applies force in the wrong direction.

[0010] Therefore, if not used correctly (for example, if the user applies force in a direction different from the direction indicated on the cutting direction indicator 23), the generation of glass fragments may increase significantly. In other words, the OPC ampoule 20 is manufactured to prevent fragment generation by giving directionality when the glass is cut, but if force is applied in a different direction than indicated, even more glass fragments will be generated.

[0011] Such glass fragments and glass powder can cause serious harm to the human body if they enter it. Therefore, in particular, users of injectable solutions should avoid using the entire solution, instead using only the portion where the glass powder settles.

[0012] Therefore, there is an urgent need for a method of manufacturing medical glass products that can prevent the wasteful use of such medical drugs or nutritional supplements, eliminate harmful glass fragments and dust from the human body, and provide a completely dust-free medical glass product manufacturing process by eliminating the possibility of foreign matter entering the ampoule. [Prior art documents] [Patent Documents]

[0013] [Patent Document 1] Japanese Patent Publication No. 11-71124 [Overview of the project]

[0014] The problem that this invention aims to solve is to provide a completely dust-free medical glass product damaging process by eliminating the source of foreign matter entering the ampoule during the manufacturing process of medical glass products.

[0015] Accordingly, the present invention provides a method for processing medical glass products in which the generation of particles during cutting is minimized.

[0016] On the other hand, another object of the present invention is to provide a method for manufacturing an ampoule for injection or nutritional supplementation, and an ampoule for injection, which is manufactured as described above and generates almost no particles regardless of the direction in which the ampoule for injection or nutritional supplementation is cut, even without indicating the cutting direction on the ampoule.

[0017] Another object of the present invention is to provide a method for manufacturing ampoules for injection or nutritional supplements, and an ampoule for injection or nutritional supplements, which eliminates the need to create a bottleneck portion during the manufacturing of the bottleneck, thereby significantly reducing the process time and defects required for bottleneck production.

[0018] To solve the aforementioned problems, a cutting-edge damage-dealing apparatus for medical glass products according to one embodiment of the present disclosure may include: a laser light source that bursts an ultrafast laser beam; a beam profile forming unit that shapes the ultrafast laser beam so that it has multiple focal lengths and an elongated profile; a beam irradiation unit that irradiates the medical glass product so that the shaped ultrafast laser beam profile is formed inside the glass of the medical glass product, thereby forming inside damage inside the glass of the medical glass product due to internal defects caused by bulk deformation; and a rotating unit that rotates the medical glass product at a predetermined rotational speed.

[0019] In this case, the medical glass product cutting portion damage device may further include a control unit that controls the predetermined rotation speed and the burst speed of the laser beam so that a plurality of the inside damages are formed on the cutting portion of the medical glass product.

[0020] Furthermore, the inside damage may be formed along the circumference of the medical glass product in the thickness direction of the glass.

[0021] In addition, the medical glass product can include any one of an ampule for injection or nutritional supplements, a blood collection tube, a syringe, cartridges, a glass medicine bottle, and a glass tube for medical devices.

[0022] Therefore, according to the present invention, a method for processing a medical glass product in which the generation of particles is minimized during cutting can be provided.

[0023] On the other hand, in the case of an injection ampule according to an embodiment of the present invention, cutting errors can be reduced when using the ampule. That is, even if the cutting direction is not indicated on the ampule, since there is almost no generation of particles regardless of the cutting direction, the cutting errors during the use of the ampule can be significantly reduced.

[0024] In addition, when manufacturing an injection ampule, there is no need to deliberately add a process to create a bottleneck portion, so the process time and defects required for manufacturing the bottleneck are significantly reduced.

[0025] The effects according to the present invention are not limited by the contents exemplified above, and various other effects are included in this specification.

Brief Description of the Drawings

[0026] [Figure 1] It is a block diagram of a cutting site damaging device for a medical glass product according to an embodiment of the present invention. [Figure 2] It is a diagram (Part 1) for explaining a laser beam having a plurality of focal lengths by self - diffraction of an axicon lens according to an embodiment of the present invention. [Figure 3] It is a diagram (Part 2) for explaining a laser beam having a plurality of focal lengths by self - diffraction of an axicon lens according to an embodiment of the present invention. [Figure 4] ​ [Figure 5] This is a diagram illustrating the thickness direction of the glass in an ampoule of a medical glass product according to an embodiment of the present invention. [Figure 6] This is a diagram illustrating a medical glass product manufactured according to an embodiment of the present invention. [Figure 7] This is a diagram illustrating a medical glass product manufactured according to an embodiment of the present invention. [Figure 8] This diagram shows an ampoule for injection or nutritional supplements using conventional technology. [Figure 9a] This is a high-speed photograph taken when an ampoule manufactured using conventional technology is opened. [Figure 9b] This is a high-speed photograph taken when an ampoule manufactured using conventional technology is opened. [Modes for carrying out the invention]

[0027] The following is merely illustrative of the principle of the invention. Therefore, those skilled in the art can invent various devices that embody the principle of the invention and fall within the concept and scope of the invention, even if they are not explicitly described or illustrated herein. Furthermore, all conditional terms and examples listed herein are, in principle, explicitly intended solely for the purpose of making the concept of the invention understandable, and should be understood as not being limiting to the examples and conditions thus specifically listed.

[0028] Furthermore, in the following explanation, ordinal expressions such as "1st," "2nd," etc., should be understood as being used to describe mutually equivalent and independent objects, and that their order does not imply main / sub or master / slave.

[0029] The aforementioned objectives, features, and advantages will become clearer through the following detailed description in conjunction with the attached drawings, thereby enabling a person with ordinary skill in the art to readily implement the technical idea of ​​the invention.

[0030] The features of each of the various embodiments of the present invention can be combined or linked together, either partially or entirely, and various technical interlocks and drives are possible, as can be fully understood by those skilled in the art. Each embodiment may be implemented independently of the others, or together in relation to them.

[0031] Various embodiments of the present invention will be described in detail below with reference to the attached drawings.

[0032] Figure 1 is a block diagram of a cutting surface damage device 1000 for medical glass products according to an embodiment of the present invention. According to Figure 1, the cutting surface damage device for glass products may include a control unit 100, a laser light source 200, an energy control module 300, a beam expander 400, a beam profile forming unit 500, a beam irradiation unit 600, a rotating unit 700, and a distance adjustment unit 800. Here, medical glass products refer to medical glass products such as ampoules for injection or nutritional supplements, blood collection tubes, syringes, cartridges, and glass medicine bottles, which have a cut surface processed from glass while including a tubular portion, and in which glass fragments or glass dust must not be allowed to enter the interior.

[0033] Materials used for glass products include soda lime, quartz, and borosilicate glass. In particular, borosilicate glass is preferred for medical glass containers.

[0034] The control unit 100 can control the energy of the laser beam 150, the distance between the workpiece (medical glass product) 10 and the beam irradiation unit 500, and the rotation speed of the rotating unit 700. It can also adjust the magnification by controlling the distance between the first focusing lens 630 and the second focusing lens 650. Furthermore, the control unit 100 can control the number of bursts of the laser beam 150 in accordance with the rotation speed of the rotating unit 700.

[0035] The laser light source 200 is a light source that generates and emits an ultrafast laser beam 150.

[0036] Furthermore, the energy control module 300 and the beam expansion unit 400 are configured to adjust the amount and magnitude of the laser beam that reaches the workpiece 10. In this case, an optical mechanism such as multiple mirrors 410 can be further provided to ensure that the laser beam generated by the laser light source reaches the beam profile forming unit 500 and the beam irradiation unit 600.

[0037] The beam profile forming unit 500 is configured to form a profile of a laser beam having multiple focal lengths due to self-diffraction of an axicon lens, and preferably uses an axicon lens.

[0038] As shown in Figure 2, a laser beam that has multiple focal lengths due to the self-diffraction of an axicon lens is generally formed through the interference of the laser beam as it passes through a conical lens, such as an axicon lens 500. At this time, the wavefront of the laser beam is formed by the diffraction of the Gaussian beam passing through the axicon lens. The interference fringes consist of a central core that is long and has a diameter of micrometers, and several rings with relatively low intensity surrounding these cores. That is, according to an embodiment of the present invention, the beam profile forming unit 500 shapes the ultrafast laser beam so that it has multiple focal lengths and has an elongated profile with a high aspect ratio.

[0039] In this case, the laser beam passes through the glass of the workpiece 10, and some of it is absorbed, transferring energy to the constituent molecules of the glass. At this time, the energy density absorbed is high, and plasma is instantaneously formed inside the glass of the workpiece 10. Referring to Figure 3, the plasma described above forms internal defects inside the glass of the workpiece 10 due to bulk deformation with a high aspect ratio. In this specification, the internal defects formed by the laser beam are called damage, the processing that forms the damage is called damage processing, and the structure in which damage is formed to assist in cutting medical glass products is called inside damage (see Figures 3 and 6) 15.

[0040] In embodiments of the present invention, a process of continuously forming damage with a laser beam is used to create a structure that replaces the cutting-assist notch using a conventional diamond blade. Furthermore, a method and apparatus for cutting medical glass products by forming inside damage is also included in the scope of the present invention.

[0041] In this case, the central core radius (r) of the laser beam, which has multiple focal lengths due to the self-diffraction of the axicon lens, can be expressed by the following equation 1 (the part shown in Figure 2 is the diameter and is represented by 2r).

[0042]

number

[0043] Here, θ is the angle between the two diffracted wave vectors formed by the axicon lens (see Figure 2). Such an angle is determined by the axicon parameters (for example, the axicon parameters include the angle of the axicon lens vertex and the optical refractive index). Furthermore, the length (L) of the laser beam, which has multiple focal lengths due to the self-diffraction of the axicon lens and is called the depth of focus from a geometric perspective, can be calculated by the following equation 2.

[0044]

number

[0045] Here, w is the diameter of the laser beam 150 incident on the axicon lens.

[0046] In this case, the morphology of the laser beam, which has multiple focal lengths due to the self-diffraction of the axicon lens, is designed to create an elongated and uniform inside damage along the thickness of the glass. Here, "elongated" means that the length (L) of the inside damage processed in the glass of the workpiece 10 is much larger than the radius (R) of the inside damage, or that the length (L) of the inside damage is 10 times or more the radius (R) of the inside damage.

[0047] The beam irradiation unit 600 may include optical mechanisms 630 and 650 that cause the laser beam, which has been deformed in the beam profile deformation unit 500 to have an elongated profile, to enter the glass portion of the workpiece 10, as well as a coaxial CCD camera 610 that can confirm whether the beam is entering accurately, and episcopic illumination 620. In this case, beam splitters 640 and 660 may be included to align the coaxial CCD camera 610 and episcopic illumination 620 with the laser beam 160.

[0048] In this case, the beam irradiation unit 600 described above, including a first focusing lens 630, a second focusing lens 650, and a magnification adjustment device (see Figure 4) 635, can control the laser beam to form locally concentrated energy inside the glass material of the workpiece 10. Thus, the deformed laser beam 160 is imaged through the first focusing lens 630 and the second focusing lens 650 to cause bulk deformation at a reduced rate.

[0049] The wavelength of the laser beam used in this embodiment is in the range of 1030 to 1070 nm, and the focal position is such that the starting point of the laser beam can be formed within the glass product in the thickness direction of the glass from the glass surface of the workpiece, and the self-diffraction of the axicon lens can result in multiple focal lengths.

[0050] On the other hand, the rotating unit 700 is configured to rotate the workpiece 10 in order to form inside damage 15 along the circumference of the workpiece 10 in the thickness direction of the glass. In this case, the thickness direction of the glass means the direction perpendicular to the glass surface of the workpiece 10 (see direction A in Figure 5). In this case, the control unit 100 determines the interval between inside damages by the rotation speed and the burst timing of the laser beam. The control unit 100 can also control the energy of the laser beam provided in the thickness direction of the glass by controlling the number of bursts. The number of bursts means the number of pulses contained in one burst.

[0051] Meanwhile, the distance adjustment unit 800 adjusts the distance between the workpiece 10 and the beam irradiation unit 600 so that the laser beam, which will have multiple focal lengths due to the self-diffraction of the axicon lens, can be accurately imaged into the glass of the workpiece 10.

[0052] Figures 6(a) to 6(c) illustrate inside damage formed in the circumferential direction while the workpiece 10 is rotated by the rotating part 700.

[0053] Figure 6(a) shows a part of the workpiece 10, Figure 6(b) shows a cross-section of the B-B' portion of Figure 6(a), and Figure 6(c) is a photograph of the actual inside damage 15 shown in Figure 6(b).

[0054] As shown in Figures 6(b) and 6(c), it can be seen that the laser beam, which has multiple focal lengths due to the self-diffraction of the axicon lens formed in the beam profile forming unit 500, forms inside damage 15 in the thickness direction of the glass along the circumferential surface of the cut portion of the workpiece 10, for example, an injection ampoule.

[0055] Figures 7(a) and 7(b) are diagrams illustrating embodiments and effects of the present invention.

[0056] In Figures 7(a) and 7(b), an injection ampoule was rotated as the workpiece 10 to form an inside damage with a diameter of 2-4 μm. The length (L) of the laser beam, which has multiple focal lengths due to the self-diffraction of the axicon lens, was processed to be approximately the thickness of the glass. In this case, the circumference around the ampoule was approximately 4 mm, the laser used had a wavelength of 1030 nm to 1070 nm, and the pulse energy was realized at 80 uJ or more. The ultrafast laser beam was then burst at a speed of 1000 kHz or more.

[0057] When processed under the conditions described above, the cross-section of the injection ampoule was reproduced in a form similar to that of a polished surface (2-3 μm), as shown in Figures 7(a) and 7(b), and no modification or cracking of the cross-section occurred at all.

[0058] Therefore, according to the present invention, a completely dust-free medical glass product manufacturing process is provided by eliminating the source from which foreign matter enters the ampoule during the manufacturing process of medical glass products.

[0059] Furthermore, the present invention provides a method for processing medical glass products in which the generation of particles during cutting is minimized.

[0060] On the other hand, in the case of an injection ampoule according to an embodiment of the present invention, cutting errors during ampoule use can be reduced. That is, even without indicating the cutting direction on the ampoule, since there is almost no particle generation regardless of the cutting direction, cutting errors during ampoule use can be significantly reduced.

[0061] Furthermore, since there is no need to add an extra step to manufacture the bottleneck portion during the production of injection ampoules, the process time and defects required for manufacturing the bottleneck are significantly reduced.

[0062] Although embodiments of the present invention have been described in more detail above with reference to the attached drawings, the present invention is not necessarily limited to these embodiments and can be modified and implemented in various ways within the scope of the technical concept of the present invention. Accordingly, the embodiments disclosed herein are for illustrative purposes only, not to limit the technical concept of the present invention, and the scope of the technical concept of the present invention is not limited by such embodiments. Therefore, the embodiments described above should be understood as illustrative in all respects and not limiting. The scope of protection of the present invention should be interpreted by the following claims, and all technical concepts within an equivalent scope should be interpreted as being included in the scope of the rights of the present invention. [Explanation of Symbols]

[0063] 100 Control Unit 200 laser light sources 300 Energy Control Modules 400 Beam Expansion Section 500 Beam Profile Forming Section 600 Beam irradiation section 630, 650 First and second focusing lenses 700 Rotating part 800 Distance adjustment section

Claims

1. A laser light source that bursts an ultrafast laser beam with a wavelength of 1030 nm to 1070 nm; A beam profile forming unit that shapes the ultrafast laser beam to have multiple focal lengths and an elongated profile; A beam irradiation unit that irradiates the molded ultrafast laser beam so that the profile of the beam is formed inside the glass of the medical glass product, thereby causing inside damage to be formed only inside the glass of the medical glass product due to internal defects caused by bulk deformation; A rotating part that rotates the medical glass product at a predetermined rotational speed so that multiple inside damages are formed along the circumference of the medical glass product; and The control unit includes a control unit that controls the predetermined rotation speed and the number of bursts of the laser beam so that multiple inside damages are formed on the part of the medical glass product to be cut. The control unit controls the number of laser beam bursts in accordance with the rotation speed of the rotating part. A device for damaging the cut edges of medical glass products.

2. The inside damage is formed along the circumference of the medical glass product in the thickness direction of the glass. A device for damaging the cut portion of a medical glass product according to claim 1.

3. The beam irradiation unit and the rotating unit are characterized in that they are targeted at medical glass products, which include ampoules for injection or nutritional supplements, blood collection tubes, syringes, cartridges, glass medicine bottles, and glass tubes for medical devices. A device for damaging the cut portion of a medical glass product according to claim 1.

4. The control unit controls the distance between the medical glass product and the beam irradiation unit, and the rotation speed. A device for damaging the cut portion of a medical glass product according to claim 1.

5. The beam irradiation unit includes a first focusing lens, a second focusing lens, and a magnification adjustment device. The control unit adjusts the magnification by controlling the distance between the first focusing lens and the second focusing lens. A device for damaging the cut portion of a medical glass product according to claim 1.

6. A step of bursting an ultrafast laser beam having a wavelength of 1030 nm to 1070 nm; The step of shaping the ultrafast laser beam so that it has multiple focal lengths and an elongated profile; The step of irradiating the shaped ultrafast laser beam so that the profile of the laser beam is formed inside the glass of the medical glass product, so that inside damage formed by internal defects due to bulk deformation is formed only inside the glass of the medical glass product; The steps of rotating the medical glass product at a predetermined rotational speed; and The steps include controlling the predetermined rotation speed and the number of bursts of the laser beam such that multiple inside damages are formed along the circumference of the part of the medical glass product to be cut, In the control step described above, the number of bursts of the laser beam is controlled in accordance with the rotation speed. Method for damaging the cut edges of medical glass products.

7. The inside damage is formed along the circumference of the medical glass product in the thickness direction of the glass. A method for damaging the cut portion of a medical glass product according to claim 6.

8. The aforementioned medical glass product is characterized by being one of the following: an ampoule for injection or nutritional supplementation, a blood collection tube, a syringe, a cartridge, a glass medicine bottle, or a glass tube for medical devices. A method for damaging the cut portion of a medical glass product according to claim 6.

9. In the control step, the distance between the medical glass product and the beam irradiation unit that irradiates the laser beam, and the rotation speed are controlled. A method for damaging the cut portion of a medical glass product according to claim 6.

10. In the aforementioned control step, the magnification is adjusted by controlling the distance between the first and second focusing lenses. A method for damaging the cut portion of a medical glass product according to claim 6.