Endoscope forceps plug
The endoscope forceps plug with a conical cylindrical portion and rib-structured slit valve addresses aerosol leakage issues in ESD procedures, ensuring effective aerosol containment and instrument usability.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- TOP CORPORATION
- Filing Date
- 2022-09-20
- Publication Date
- 2026-07-01
AI Technical Summary
Conventional endoscopic forceps plugs fail to adequately suppress aerosol leakage during endoscopic submucosal dissection (ESD) procedures without impairing the insertion and removal performance of treatment instruments.
An endoscope forceps plug with a conical cylindrical portion, slit valve, and multiple rib portions that form a double valve structure to prevent aerosol leakage while maintaining instrument insertion and removal efficiency.
The plug effectively suppresses aerosol leakage into the operating room without compromising the ease of inserting and removing treatment instruments, enhancing safety and reducing infection risks.
Smart Images

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Abstract
Description
Technical Field
[0001] The present invention relates to an endoscopic forceps plug attached to the forceps port of an endoscope.
Background Art
[0002] Conventionally, as a technique for removing lesions such as cancer that occur in the mucosal layer facing the lumen of the digestive tract, such as the esophagus, stomach, and large intestine, or the submucosal layer, which is the lower layer thereof, endoscopic submucosal dissection (ESD) is known. ESD involves inserting an endoscope and a treatment tool into the lumen of the digestive tract, and while confirming the lesion with the endoscope, excising and peeling off the lesion with the treatment tool.
[0003] An endoscope for ESD is provided with an insertion channel through which a treatment tool is inserted. One end (forceps port) of the insertion channel is arranged outside the subject's body, and the other end of the insertion channel is arranged in the subject's lumen. That is, in ESD, the space inside the subject's body and the space in the operating room are always connected via the insertion channel. Therefore, when the air pressure in the lumen is set higher than the air pressure outside the body (in the operating room) to expand the lumen of the digestive tract in ESD, the gas in the lumen leaks outside through the channel. At this time, there is a risk that the biological substances in the body diffuse into the operating room as aerosol. If the aerosol contains a virus or the like that causes infectious symptoms, there is also a risk that the surgeon will be infected with the virus.
[0004] Japanese Patent Application Laid-Open No. 2002-136475 (Patent Document 1) discloses an endoscopic forceps plug including a first plug portion attached to the forceps port and a second plug portion detachably attached to the first plug portion. A small hole is formed in the first plug portion, and a slit is formed in the second plug portion.
Prior Art Documents
Patent Documents
[0005]
Patent Document 1
Summary of the Invention
[0006] The inventors of the present invention have confirmed that when a treatment instrument is inserted into the endoscopic forceps channel in which the second plug portion is attached to the first plug portion, the leakage of aerosol from the forceps channel into the operating room is not sufficiently suppressed.
[0007] On the other hand, endoscopic forceps plugs are required to have the ability to insert and remove instruments without obstruction (hereinafter referred to as insertion / removal performance). If the opening widths of the first and second plug sections are narrowed to suppress aerosol leakage and improve the airtightness between each plug section and the instrument, the insertion / removal performance will decrease.
[0008] The main objective of the present invention is to provide an endoscope forceps plug that can sufficiently suppress aerosol leakage without impairing insertion and removal performance, compared to conventional endoscope forceps plugs. [Means for solving the problem]
[0009] The endoscope forceps plug according to the present invention is an endoscope forceps plug that is attached to the forceps port of an endoscope through which a treatment instrument is inserted and removed. The endoscope forceps plug has a first channel connected to the forceps port when attached to the forceps port, and a second channel connected to the forceps port via the first channel when attached to the forceps port. The endoscope forceps plug includes a hole valve located in the second channel, a projection located in the first channel and provided such that its inner and outer diameters decrease from the second channel side toward the forceps port side, and a slit valve that closes the end of the projection on the forceps port side when a treatment instrument is not inserted into the first channel and has a slit that is pushed open by a treatment instrument inserted into the first channel. [Effects of the Invention]
[0010] According to the present invention, it is possible to provide an endoscope forceps plug that can sufficiently suppress aerosol leakage without impairing insertion and removal performance, compared to conventional endoscope forceps plugs. [Brief explanation of the drawing]
[0011] [Figure 1] This is a front view of the forceps plug for endoscopes according to this embodiment. [Figure 2] Figure 1 is a plan view of the endoscope forceps plug. [Figure 3] Figure 1 is a bottom view of the endoscopic forceps plug. [Figure 4] This is a cross-sectional view taken from arrow IV-IV in Figure 3. [Figure 5] This is a cross-sectional view taken from arrow VV in Figure 3. [Figure 6] Figure 1 is a front view showing the lid of the endoscope forceps plug fitted onto the main body. [Figure 7] Figure 6 is a cross-sectional view of the endoscopic forceps plug. [Figure 8] This is a schematic diagram illustrating the state in which the endoscopic forceps plug according to this embodiment is attached to the forceps channel of an endoscope. [Figure 9] This image was captured using a Schlieren optical system while the treatment instrument was inserted into sample 2 during an experiment to evaluate aerosol leakage from sample 2. [Figure 10] This image was taken using a Schlieren optical system while the treatment instrument was inserted into sample 3 during an experiment to evaluate aerosol leakage from sample 3. [Figure 11] This image was captured using a Schlieren optical apparatus in an experiment to evaluate aerosol leakage from sample 2. [Figure 12] This image was captured using a Schlieren optical apparatus in an experiment to evaluate aerosol leakage from sample 5. [Figure 13] This is a cross-sectional view showing a first modified example of the forceps plug for endoscopes according to this embodiment. [Figure 14] This is a cross-sectional view showing a second modified example of the endoscope forceps plug according to this embodiment. [Figure 15] This is a front view showing a third modified example of the endoscope forceps plug according to this embodiment. [Figure 16] It is a front view showing a fourth modification of the endoscopic forceps plug according to the present embodiment. [Figure 17] It is a bottom view showing an endoscopic forceps plug according to another embodiment of the present invention. [Figure 18] It is a cross-sectional view taken along arrow XVIII-XVIII in FIG. 17. [Figure 19] It is a cross-sectional view taken along arrow XIX-XIX in FIG. 17.
Embodiments for Carrying out the Invention
[0012] Hereinafter, embodiments of the present invention will be described with reference to the drawings. In the following drawings, the same or corresponding parts are denoted by the same reference numerals, and the description thereof will not be repeated.
[0013] <Configuration of Endoscopic Forceps Plug> As shown in FIGS. 1 to 3, the endoscopic forceps plug 100 according to the present embodiment mainly includes a main body portion 1 attached to the forceps opening of the endoscope, a lid portion 2 detachably attached to the main body portion 1, and a connecting portion 3 connecting the lid portion 2 to the main body portion 1.
[0014] <Configuration of Main Body Portion> As shown in FIG. 1, the main body portion 1 has an upper surface 1B and a bottom surface 1C. The bottom surface 1C is the surface into which the forceps opening of the endoscope is inserted. The upper surface 1B is the surface facing the opposite side of the bottom surface 1C, and is the surface that contacts the lid portion 2 in a state where the lid portion 2 is fitted to the main body portion 1.
[0015] As shown in FIGS. 2 to 4, a first channel 1A for inserting a treatment instrument is formed in the main body portion 1. The first channel 1A is provided so as to penetrate between the upper surface 1B and the bottom surface 1C of the main body portion 1, and is provided so as to be continuous with the forceps opening in a state where the main body portion 1 is attached to the forceps opening of the endoscope (see FIG. 8, details will be described later).
[0016] As shown in Figures 2 to 4, the main body 1 includes a conical cylindrical portion 11, a slit valve 12, and a plurality of rib portions 13, which are arranged within the first channel 1A.
[0017] The conical cylinder portion 11 is a projection that is provided such that its inner and outer diameters decrease from the upper surface 1B side to the bottom surface 1C side. The radially inner portion of the conical cylinder portion 11 with respect to the central axis C1 (see Figure 4) protrudes toward the bottom surface 1C side relative to the radially outer portion of the conical cylinder portion 11 with respect to the central axis C1 (see Figure 4). The conical cylinder portion 11 has an inner circumferential surface 11A (see Figures 2 and 4) that is visible in a plan view and an outer circumferential surface 11B (see Figures 3 and 4) that is visible in a bottom view. In each cross-section perpendicular to the central axis of the conical cylinder portion 11, the shapes of the inner circumferential surface 11A and the outer circumferential surface 11B are circular. The central axis C1 (see Figure 4) of the conical cylinder portion 11 is along the extending direction of the first channel 1A. The central axis C1 is perpendicular to the upper surface 1B and the bottom surface 1C, respectively. In this specification, a plan view means viewing the top surface 1B from a direction along the central axis C1, and a bottom view means viewing the bottom surface 1C from a direction along the central axis C1. As shown in Figure 4, the angles that the inner surface 11A and the outer surface 11B each make with respect to the central axis C1 are acute angles.
[0018] As shown in Figure 4, the inner circumferential surface 11A has a straight portion located on the bottom surface 1C side and a curved portion located on the top surface 1B side in a cross-section along the central axis C1. The center of curvature of the curved portion of the inner circumferential surface 11A is located outside the inner circumferential surface 11A. The outer peripheral edge of the inner circumferential surface 11A located on the top surface 1B side is connected to the inner peripheral edge of the annular surface 14. The annular surface 14 is exposed within the first channel 1A and faces the top surface 1B side. The inner peripheral edge of the inner circumferential surface 11A located on the bottom surface 1C side is connected to the outer peripheral edge of the first surface 12A of the slit valve 12 which faces the top surface 1B side.
[0019] The outer circumferential surface 11B faces the inner circumferential surface 15 of the first channel 1A, which is located outside the conical cylindrical portion 11 and faces inward in the radial direction (hereinafter simply referred to as the radial direction) with respect to the central axis C1. In a cross-section along the central axis C1, the outer circumferential surface 11B has a straight portion located on the bottom surface 1C side and a curved portion located on the top surface 1B side. The center of curvature of the curved portion of the outer circumferential surface 11B is located on the bottom surface 1C side than the outer circumferential edge of the outer circumferential surface 11B located on the top surface 1B side. The outer circumferential edge of the outer circumferential surface 11B located on the top surface 1B side is connected to the end of the inner circumferential surface 15 located on the top surface 1B side. The inner circumferential edge of the outer circumferential surface 11B located on the bottom surface 1C side is connected to the outer circumferential edge of the second surface 12B of the slit valve 12, which faces the bottom surface 1C side.
[0020] As shown in Figures 2 to 4, the slit valve 12 has a slit 12C formed therein. The slit 12C closes the end of the conical cylindrical portion 11 located on the bottom surface 1C side when the treatment tool is not inserted into the first channel 1A, and is designed to be pushed open by the treatment tool inserted into the first channel 1A.
[0021] As shown in Figure 4, the slit valve 12 has a first surface 12A (second end surface) facing the upper surface 1B and a second surface 12B facing the opposite side of the first surface 12A. The slit 12C penetrates between the first surface 12A and the second surface 12B.
[0022] As shown in Figures 2 and 4, the slit 12C is formed on the central axis C1 of the conical cylinder portion 11. As shown in Figure 2, the slit 12C has 180 degrees of rotational symmetry with respect to the central axis C1 in a plan view. The direction of extension of the slit 12C is, for example, along the direction of extension of the connecting portion 3.
[0023] As shown in Figure 3, the width W1 of the slit 12C in the extending direction is narrower than the width W2 of the first surface 12A of the slit valve 12. In other words, both ends of the slit 12C in the extending direction are formed inward from the outer edge of the first surface 12A. The thickness T1 of the slit valve 12 shown in Figure 4 (width of the slit 12C in the direction along the central axis C1 of the conical cylinder portion 11) is less than the width W1 of the slit 12C in the extending direction shown in Figure 2. The width W1 of the slit 12C in the extending direction can be arbitrarily set according to the outer diameter of the treatment instrument.
[0024] Preferably, the thickness T1 of the slit valve 12 is 0.5 mm or more and 1.0 mm or less. If the thickness T1 of the slit valve 12 is 0.5 mm or more, the durability of the slit valve 12 is improved compared to when the thickness T1 of the slit valve 12 is less than 0.5 mm. The inventors have experimentally confirmed that if the thickness T1 of the slit valve 12 is 1.0 mm or less, the insertion and removal performance is improved compared to when the thickness T1 of the slit valve 12 is greater than 1.0 mm (details will be described later).
[0025] As shown in Figures 3 and 4, each of the multiple rib portions 13 connects the conical cylindrical portion 11 to the inner circumferential surface 15 of the first channel 1A. In a bottom view, each of the multiple rib portions 13 is spaced apart from one another in the circumferential direction with respect to the central axis C1 (hereinafter simply referred to as the circumferential direction). Each of the multiple rib portions 13 is provided to apply a force to a portion of the slit valve 12 in the circumferential direction in a manner that closes the slit 12C.
[0026] As shown in Figures 3 and 4, each of the multiple rib portions 13 has an end face 13A (first end face) facing the bottom surface 1C. The end face 13A is formed on the upper surface 1B side of the second surface 12B (second end face) of the slit valve 12. Preferably, the distance between the end face 13A and the second surface 12B of the slit valve 12 is greater than or equal to the thickness T1 of the slit valve 12. The distance between the end face 13A and the second surface 12B of the slit valve 12 is, for example, equal to the thickness T1 of the slit valve 12.
[0027] As shown in Figure 3, each of the multiple rib portions 13 has rotational symmetry with respect to the central axis C1 of the conical cylinder portion 11. Each of the multiple rib portions 13 has, for example, 90-degree rotational symmetry with respect to the central axis C1. The circumferential width of the end face 13A of each rib portion 13 with respect to the central axis C1 is constant in the radial direction with respect to the central axis C1, for example. The circumferential width of the end face 13A is narrower than, for example, the radial width of the end face 13A. The circumferential width of the end face 13A is narrower than, for example, the minimum distance between two adjacent rib portions 13 in the circumferential direction.
[0028] As shown in Figure 3, in a plan view, the angles θ that the imaginary line segments VR passing through the circumferential centers of each of the multiple rib portions 13 make with respect to the extending direction of the slit 12C are equal to each other. Preferably, the angle θ is 45 degrees.
[0029] The conical cylindrical portion 11, the slit valve 12, and the multiple rib portions 13 are constructed, for example, as a single unit. The main body portion 1 is constructed, for example, as a single component. The material constituting the main body portion 1 is, for example, silicone or a styrene-based thermoplastic elastomer.
[0030] The main body 1 has a first hole 16 (see Figures 2 and 4) that fits into the second annular portion 24 of the lid 2, and a second hole 17 (see Figures 3 and 4) into which the forceps channel of the endoscope is inserted. The first hole 16, the conical cylinder portion 11, the slit valve 12, and the second hole 17 are connected in order from the top surface 1B to the bottom surface 1C. The first channel 1A is composed of the first hole 16, the conical cylinder portion 11, the slit valve 12, and the second hole 17. The first hole 16, the conical cylinder portion 11, and the second hole 17 are arranged coaxially.
[0031] The first hole portion 16 has, for example, a first opening 16A and a first expanded tube portion 16B whose inner diameter relative to the hole axis of the first hole portion 16 is longer than that of the first opening 16A. The first opening 16A opens to the upper surface 1B. The first expanded tube portion 16B is positioned between the first opening 16A and the conical tube portion 11 and is connected to both the first opening 16A and the conical tube portion 11. The annular surface 14 faces the first expanded tube portion 16B. The inner circumferential surface of the first expanded tube portion 16B is connected to the inner circumferential surface 11A of the conical tube portion 11 via the annular surface 14.
[0032] The second hole portion 17 has, for example, a second opening 17A and a second expanded tube portion 17B whose inner diameter relative to the hole axis of the second hole portion 17 is longer than that of the second opening 17A. The second opening 17A opens to the bottom surface 1C. The second expanded tube portion 17B is located on the upper surface 1B side of the second opening 17A. The end of the inner circumferential surface 15 located on the bottom surface 1C side is connected to the second expanded tube portion 17B. The top of the conical cylinder portion 11 and the slit valve 12 are located, for example, within the second expanded tube portion 17B.
[0033] The inner diameter of the second expanded section 17B is, for example, shorter than the inner diameter of the first opening 16A. The inner diameter of the inner circumferential surface 15 is, for example, shorter than the inner diameter of the second opening 17A.
[0034] <Lid structure> As shown in Figures 2, 3, and 5, the lid portion 2 has a second channel 2A through which a treatment instrument is inserted. The second channel 2A is provided so as to be connected to the first channel 1A when the lid portion 2 is attached to the main body portion 1 (see Figures 6 and 7).
[0035] As shown in Figures 2, 3, and 5, the cover portion 2 includes a valve 21 located within the second channel 2A. The valve 21 is open when no instrument is inserted into the second channel 2A and is positioned to be in close contact with the outer surface of the instrument when it is inserted into the second channel 2A. A through hole 22 is formed in the valve 21. The opening shape of the through hole 22 is circular.
[0036] The diameter W3 of the through hole 22 (see Figure 2) can be arbitrarily set according to the outer diameter of the treatment instrument. The diameter W3 of the through hole 22 is, for example, equal to the width W1 in the extending direction of the slit 12C. The thickness T2 of the valve 21 is less than the diameter W3 of the through hole 22. The thickness T2 of the valve 21 is, for example, thinner than the thickness T1 of the slit valve 12.
[0037] As shown in Figure 5, the lid portion 2 includes a first annular portion 23 and a second annular portion 24 projecting from the first annular portion 23. The first annular portion 23 is the portion that is positioned on the upper surface 1B of the main body portion 1 when the lid portion 2 is attached to the main body portion 1. The second annular portion 24 is the portion that is fitted into the first hole portion 16 of the main body portion 1 when the lid portion 2 is attached to the main body portion 1. Each of the first annular portion 23 and the second annular portion 24 is positioned coaxially with the valve 21. The lid portion 2 is constructed, for example, as a single component. The material constituting the lid portion 2 is, for example, general-purpose silicone or styrene-based thermoplastic elastomer.
[0038] As shown in Figure 5, the valve 21 is formed, for example, in the first annular portion 23. The valve 21 is formed, for example, near the portion of the first annular portion 23 that is connected to the second annular portion 24. For example, a recess 23A is formed in the first annular portion 23 on the side opposite to the second annular portion 24, and the valve 21 is formed at the bottom of the recess 23A.
[0039] The second annular portion 24 includes a base portion 24A and an enlarged diameter portion 24B whose outer diameter relative to the central axis of the second annular portion 24 is longer than that of the base portion 24A. The base portion 24A connects the first annular portion 23 and the enlarged diameter portion 24B.
[0040] As shown in Figure 7, when the lid portion 2 is attached to the main body portion 1, the hole axis C2 of the through hole 22 is positioned to coincide with the central axis C1 of the conical cylinder portion 11. The base portion 24A is positioned to fit with the first opening 16A of the first hole portion 16 of the main body portion 1. The enlarged diameter portion 24B is positioned to fit with the first enlarged tube portion 16B of the first hole portion 16. The enlarged diameter portion 24B has an upper surface 24C and an inner circumferential surface 24D. The upper surface 24C is positioned to be in contact with the annular surface 14. The inner circumferential surface 24D is positioned to be outside the inner circumferential surface 11A of the conical cylinder portion 11 in the radial direction with respect to the central axis C1 and the hole axis C2.
[0041] <Examples of use of endoscopic forceps plugs> As shown in Figure 8, the endoscopic forceps plug 100 is used by being attached to the forceps channel 202 of the endoscope 200.
[0042] The endoscope 200 comprises an operating section, which is positioned outside the patient's body and operated by the operator, and an insertion section, which is inserted into the patient's body. In Figure 1, the boundary between the operating section and the insertion section of the endoscope 200 is not shown, but the part located on the right side of the page is the operating section, and the part located on the left side of the page is the insertion section.
[0043] The endoscope 200 is provided with a treatment instrument channel 211A through which a treatment instrument 300 is inserted, a suction channel 211B which is in communication with the treatment instrument channel 211A and is used to draw out bodily fluids and air from inside the body, a water supply channel 212A which is used to supply a liquid (e.g., water) for cleaning the lens attached to the tip of the insertion part of the endoscope 200, and an air supply channel 212B which is in communication with the water supply channel 212A and is used to supply a gas (e.g., air) to blow away water from the lens.
[0044] The instrument channel 211A extends between the opening 201, which opens at the tip of the insertion section, and the forceps channel 202, which opens at the operating section. The suction channel 211B extends between the opening 201 and the opening 206, which opens at the operating section. In other words, the instrument channel 211A and the suction channel 211B share a portion connected to the opening 201. The opening 206 is connected to a suction device (not shown).
[0045] The water supply channel 212A extends between an opening 207D that opens at the tip of the insertion section and an opening 208 that opens at the operating section. The opening 208 is connected to the water supply device 400 via a water supply pipe 401. The air supply channel 212B extends between an opening 207 and an opening 209 that opens at the operating section. The opening 209 is connected to an air supply device (not shown).
[0046] The operating section of the endoscope 200 has a gripping section 203 for the operator to grasp and a projection 204 that protrudes from the gripping section 203. The forceps channel 202 is formed in the projection 204. A flange 205 is formed on the projection 204. The flange 205 protrudes outward from the outer circumferential surface of the projection 204 in the radial direction with respect to the hole axis of the forceps channel 202.
[0047] The treatment instrument 300 is an arbitrary treatment instrument provided for performing procedures such as traction, resection, lavage, and injection / spraying of drugs on the lumen of the digestive tract. An example of the treatment instrument 300 is an endoscope snare. The treatment instrument 300 comprises, for example, a sheath 301, a cable 302, a snare 303, and a handle 304. Of the treatment instrument 300, the sheath 301, cable 302, and snare 303 are inserted into the treatment instrument channel 211A. The handle 304 is located outside the treatment instrument channel 211A.
[0048] The endoscope forceps plug 100 is attached to the forceps port 202 of the endoscope 200 by fitting the second opening 17A of the second hole 17 with the protruding portion 204 and the second expanded tube portion 17B of the second hole 17 with the flange 205.
[0049] In the example shown in Figure 8, the instrument channel 211A of the endoscope 200, the first channel 1A and the second channel 2A of the endoscope forceps plug 100 are connected in sequence to form a channel for inserting and removing the instrument 300 between the patient's body and the space inside the operating room. In this channel, the conical tube portion 11, the slit valve 12 and the multiple rib portions 13 are provided to suppress the leakage of aerosol from the instrument channel 211A to the first channel 1A. Furthermore, in the above channel, the hole valve 21 is provided to suppress the leakage of aerosol from the second channel 2A into the operating room.
[0050] <Effects of endoscopic forceps plugs> The inventors of the present invention have experimentally confirmed that in an endoscopic forceps plug in which a valve is formed on the main body and a slit valve is formed on the lid, when a treatment instrument is inserted with the lid attached to the main body, the leakage of aerosol from the endoscopic forceps plug into the operating room is not sufficiently suppressed. When a treatment instrument is inserted into the slit, a gap is formed between the slit and the instrument, and this gap is thought to become a path for the aerosol.
[0051] In contrast, the endoscope forceps plug 100 has a main body 1 which includes a conical cylindrical portion 11, a slit valve 12, and a plurality of rib portions 13, and a lid portion 2 which includes a hole valve 21.
[0052] The inventors experimentally confirmed that the leakage of aerosol from the endoscopic forceps plug 100 into the operating room can be sufficiently suppressed when a treatment instrument is not inserted into the endoscopic forceps plug 100, when a treatment instrument is inserted into the endoscopic forceps plug 100, and when a treatment instrument is removed from the endoscopic forceps plug 100. In the endoscopic forceps plug 100, the main body 1 includes a conical cylinder portion 11, a slit valve 12, and a plurality of rib portions 13. Each of the plurality of rib portions 13 applies a force to a portion of the slit valve 12 in the circumferential direction to close the slit 12C, thereby effectively suppressing the leakage of aerosol from the slit valve 12 to the hole valve 21 side. Furthermore, in the endoscopic forceps plug 100, even if aerosol leaks from the slit valve 12, the hole valve 21 can be tightly sealed against the outer surface of the treatment instrument, thus suppressing the leakage of aerosol from the hole valve 21 into the operating room.
[0053] Furthermore, in the endoscope forceps plug 100, in the extending direction of the first channel, the end faces 13A of each of the multiple rib portions 13 facing the bottom surface 1C are formed on the upper surface 1B side of the first surface 12A (second end face) facing the bottom surface 1C of the slit valve 12. As a result, compared to the case where the end faces 13A and the first surface 12A are formed on the same plane, each of the multiple rib portions 13 can apply a force to the slit valve 12 in the direction that closes the slit 12C. The inventors experimentally confirmed that the endoscope forceps plug 100 can suppress aerosol leakage compared to an endoscope forceps plug in which the end faces 13A and the first surface 12A are formed on the same plane.
[0054] Furthermore, in the endoscopic forceps plug 100, when viewed from a direction along the central axis, the angle θ formed by the imaginary line segment passing through the circumferential center of each of the multiple rib portions 13 with respect to the extending direction of the slit 12C is 45 degrees. As a result, compared to the case where the angle is other than 45 degrees, each of the multiple rib portions 13 can apply a more uniform force to the slit valve 12 in the direction that closes the slit 12C.
[0055] Furthermore, the inventors experimentally confirmed that the multiple rib portions 13 do not impair the insertion and removal performance of the endoscopic forceps plug 100.
[0056] Furthermore, in the endoscopic forceps plug 100, the thickness of the slit valve 12 is less than the width of the slit 12C. Preferably, the thickness of the slit valve 12 is 0.5 mm or more and 1.0 mm or less. If the thickness of the slit valve 12 is 0.5 mm or more, the durability of the slit valve 12 is higher and the airtightness of the slit valve 12 after the treatment instrument is removed from the slit valve 12 is higher compared to when the thickness of the slit valve 12 is less than 0.5 mm. As the thickness of the slit valve 12 increases, the durability and airtightness of the slit valve 12 increase, but the insertion resistance when inserting a treatment instrument into the slit valve 12 increases, which deteriorates the insertion and removal performance. The inventors experimentally confirmed that the insertion and removal performance of the endoscopic forceps plug 100 with a slit valve 12 thickness of 1.0 mm or less is high through sensory evaluation tests by endoscopists. Details will be described later.
[0057] <Example 1: Aerosol leakage evaluation test> In this first embodiment, samples 1 and 2 of the endoscope forceps plug 100 according to this embodiment, and samples 3 to 7 of the endoscope forceps plug according to a comparative example which differs from samples 1 and 2 in its double valve structure, were prepared, and an aerosol leakage evaluation test was performed on each sample.
[0058] Samples 1 and 2 were endoscope forceps plugs 100, differing only in the thickness of the slit valve 12. The slit valve 12 of sample 1 had a thickness of 0.5 mm, and the slit valve 12 of sample 2 had a thickness of 1.0 mm. The width of each slit valve in the extending direction of samples 1 and 2 was 1.5 mm. The materials constituting the main body 1 and lid 2 of the endoscope forceps plugs of samples 1 and 2 were styrene-based thermoplastic elastomers.
[0059] Sample 3 was an endoscope forceps plug as described in Patent Document 1. Specifically, Sample 3 was an endoscope forceps plug in which a valve was formed in the main body (first plug portion) and a slit valve was formed in the lid portion (second plug portion). Note that no ribs were formed around the slit valve of Sample 3.
[0060] Samples 4-7 differ from the endoscopic forceps plug 100 only in that both ends of the slit 12C in the extending direction are located outside the outer peripheral edge of the first surface 12A and are formed on the outer peripheral surface 11B of the conical cylindrical portion 11, and that multiple rib portions are not formed. The thickness of the slit valves of samples 4-7 were 0.5 mm, 1.0 mm, 1.5 mm, and 2.0 mm, respectively. The creepage distance between the ends of each slit valve of samples 4-7 was 1.5 mm. The material constituting the main body and lid of the endoscopic forceps plugs of samples 4-7 was styrene-based thermoplastic elastomer.
[0061] (Method for evaluating aerosol leakage) An aerosol leakage evaluation test was performed using the following procedure. First, a pig stomach was prepared, the pyloric end was closed with a string, and an overtube was inserted into the cardia end. Second, a valve with a stopcock was attached to the overtube. Third, the air insufflation device and the stopcock were connected with a tube, and the gastric pressure was set to 8 mmHg. Fourth, the tip of the endoscope was passed through the overtube and inserted into the stomach. Fifth, each of the forceps plugs (samples 1-7) was attached to the forceps channel of the endoscope. Sixth, an endoscopist performed insertion and removal of instruments through each of the forceps plugs (samples 1-7), and aerosol leakage from the forceps plug was evaluated using a Schlieren optical system during instrument insertion (working time 3 seconds), while holding the instrument in the inserted state (holding time 1 second), and during instrument removal (working time 3 seconds).
[0062] (Evaluation results) Figure 9 shows an image taken with a Schlieren optical apparatus during an aerosol leakage evaluation test of sample 2, with the treatment instrument still inserted into sample 2. Figure 10 shows an image taken with a Schlieren optical apparatus during an aerosol leakage evaluation test of sample 3, with the treatment instrument still inserted into sample 2. Figure 11 shows an image taken with a Schlieren optical apparatus immediately after the treatment instrument was removed from sample 2 during an aerosol leakage evaluation test of sample 2. Figure 12 shows an image taken with a Schlieren optical apparatus immediately after the treatment instrument was removed from sample 5 during an aerosol leakage evaluation test of sample 5.
[0063] Furthermore, Table 1 shows the evaluation results for samples 1 to 7.
[0064] [Table 1]
[0065] In this evaluation test, firstly, it was confirmed that the leakage of aerosols from samples 1 to 7 with the treatment instrument inserted was highly dependent on the double valve structure of each sample.
[0066] As shown in Figure 10, a large amount of aerosol leaked from sample 3, in which the instrument was inserted. This is thought to be because sample 3 lacks a structure to prevent aerosol leaking from the slit valve, which is pushed open by the instrument, from leaking outside the forceps port. In contrast, as shown in Figure 9, no aerosol leaked from sample 2, in which the instrument was inserted. Similarly, no aerosol leaked from samples 1 and 4-7, in which the instrument was inserted.
[0067] In the double valve structure of samples 2,4-7, the valve 21 is thought to act as a structure that suppresses the leakage of aerosol from the slit valve, which is pushed open by the treatment instrument, to the outside of the forceps plug. From these results, it has been experimentally confirmed that the double valve structure of the endoscopic forceps plug 100 can significantly suppress aerosol leakage when a treatment instrument is inserted, compared to the double valve structure described in Patent Document 1.
[0068] Secondly, this evaluation test confirmed that the leakage of aerosols from samples 1, 2, 4-7 during the removal of the treatment instrument depended on the structure of the conical tube portion and slit valve of each sample.
[0069] As shown in Table 1 and Figure 12, slight aerosol leakage was observed in samples 4-7 during the insertion and removal procedure. Possible reasons for this include the fact that in samples 4-7, both ends of the slit were formed on the outer surface of the conical cylinder, preventing the slit from being completely closed after the instrument was removed from the slit valve, and that minute tears occurred at both ends of the slit during the insertion and removal procedure.
[0070] In contrast, as shown in Table 1 and Figure 11, no aerosol leakage was observed in samples 1 and 2 during the insertion and removal process. In samples 1 and 2, both ends of the slit 12C in the extending direction are formed inward from the outer peripheral edge of the first surface 12A. Therefore, the slit is completely closed after the treatment instrument is removed from the slit valve, and minute tears are unlikely to occur from both ends of the slit during the insertion and removal process. Furthermore, in samples 1 and 2, multiple rib portions 13 connect the conical cylindrical portion 11 and the inner circumferential surface 15 of the first channel 1A. Each of the multiple rib portions 13 applies a force to a portion of the slit valve 12 in the circumferential direction that closes the slit 12C, and as a result, aerosol leakage from the slit valve 12 to the hole valve 21 side is effectively suppressed.
[0071] <Example 2: Evaluation test of insertion / extraction performance> Furthermore, the insertion and removal performance was evaluated for samples 1 and 2, as well as samples 3 to 7 of the endoscopic forceps plugs related to the comparative example.
[0072] (Evaluation test of insertion / extraction performance) The insertion and removal performance evaluation test was conducted using the following procedure. First, each of the forceps plugs (1-7) was attached to the forceps channel of the endoscope. Second, an endoscopist performed the insertion and removal of the instruments through each forceps plug, and the resistance felt by the endoscopist during insertion and removal of the instruments was evaluated on a 5-point scale. Multiple endoscopists served as evaluators. The evaluation value for each sample was the average of the evaluation values from all evaluators.
[0073] An endoscopic puncture needle (sheath outer diameter φ: 2.6 mm) was used as the treatment instrument. Table 1 shows the evaluation results for samples 1 to 7. In Table 1, the average of the evaluation values for each sample was used as the baseline. Samples with evaluation values near the baseline were classified as Grade B, samples with evaluation values higher than the baseline were classified as Grade A, and samples with evaluation values lower than the baseline were classified as Grade C.
[0074] (Evaluation results) As shown in Table 1, the insertion / extraction performance of samples 3 and 5 was rated B, and the insertion / extraction performance of samples 6 and 7 was rated C, while the insertion / extraction performance of samples 1, 2, and 4 was rated A.
[0075] Furthermore, evaluation results for samples 4-7 confirmed that the insertion / extraction performance decreased as the thickness of the slit valve increased. In particular, the insertion / extraction performance of samples 6 and 7 was significantly lower than that of samples 4 and 5. To confirm this, the inventors conducted an insertion resistance evaluation test on samples 4-7.
[0076] (Insertion resistance evaluation test) The insertion resistance of samples 4-7 was evaluated using the following procedure. First, one of samples 4-7 and a sheath of a treatment instrument, cut to a predetermined length, were attached to a Strograph manufactured by Toyo Seiki Seisakusho Co., Ltd. Second, the tube was inserted into samples 4-7 at a constant speed. Third, after the resistance value measured by the Strograph became constant, this resistance value was recorded as the insertion resistance value of that sample.
[0077] The evaluation results showed that the insertion resistance of sample 6 was more than 2.6 times that of sample 5. From this result, it can be inferred that the insertion resistance of the endoscopic forceps plug, which differs from sample 2 only in that the thickness of the slit valve 12 is 1.5 mm, is significantly higher than that of sample 2, and furthermore, the insertion and removal performance of such an endoscopic forceps plug is significantly lower than that of sample 2, and also lower than that of samples 4 and 5.
[0078] <Variation> The endoscope forceps plug 100 according to this embodiment can be modified as follows, for example.
[0079] The endoscope forceps plug 100 comprises a main body 1 and a lid 2 that is detachable from the main body 1, but is not limited to this. The endoscope forceps plug 101 shown in Figure 13 differs from the endoscope forceps plug 100 in that a first channel 1A and a second channel 2A are formed in the main body 1, and the main body 1 comprises a conical tube portion 11, a slit valve 12, a plurality of rib portions 13, and a hole valve 21. In the endoscope forceps plug 101, the conical tube portion 11, the slit valve 12, a plurality of rib portions 13, and a hole valve 21 are formed between the bottom surface 1C and the top surface 1D of the main body 1. Since the endoscope forceps plug 101 also comprises a conical tube portion 11, a slit valve 12, a plurality of rib portions 13, and a hole valve 21, it can achieve the same effects as the endoscope forceps plug 100.
[0080] The conical cylinder portion 11 may have a substantially conical shape in which at least one of the inner and outer circumferential surfaces in each cross-section perpendicular to the central axis of the conical cylinder portion 11 is elliptical. The outer shape of the slit valve 12 may also be elliptical.
[0081] As shown in Figure 14, the inner circumferential surface 11A of the conical cylinder portion 11 may have a first straight portion 11A1, a second straight portion 11A2, and a curved portion 11A3, which are sequentially connected from the bottom surface 1C to the top surface 1B in a cross-section along the central axis C1. The angle that the second straight portion 11A2 makes with respect to the central axis C1 is, for example, greater than the angle that the first straight portion 11A1 makes with respect to the central axis C1. In this way, the inner circumferential surface 11A can better adhere to the outer circumferential surfaces of the outer barrel and the tip of a typical syringe used as a syringe barrel. This is because, in a typical syringe, the angle that the outer circumferential surface of the tip makes with respect to the hole axis is smaller than the angle that the outer circumferential surface of the tip of the outer barrel makes with respect to the hole axis.
[0082] As shown in Figure 15, the circumferential width of each rib portion 13 with respect to the central axis C1 may, for example, increase as it moves outward in the radial direction. The maximum circumferential width of each rib portion 13 may be, for example, narrower than the maximum radial width of the rib portion 13 and narrower than the minimum distance between two adjacent rib portions 13 in the circumferential direction.
[0083] As shown in Figure 16, the direction in which the slit 12C extends may be perpendicular to the direction in which the connecting portion 3 extends, for example. The angle that the direction in which the slit 12C extends with respect to the direction in which the connecting portion 3 extends is not particularly limited.
[0084] <Other Embodiments> Next, other embodiments of the present invention will be described. The endoscope forceps plug 102 shown in Figures 17 to 19 has basically the same configuration as the endoscope forceps plug 100 and provides the same effects, but differs from the endoscope forceps plug 100 in that the main body 1 includes a projection 18 instead of a conical cylinder 11 and does not include a plurality of rib portions 13. Furthermore, the endoscope forceps plug 102 differs from the endoscope forceps plug 100 in that the valve 21 includes a valve body 21A in which a through hole 22 is formed and a support portion 21B that supports the valve body 21A in the second channel, and the thickness of the valve body 21A is greater than the thickness of the support portion 21B. The following will mainly describe the differences between the endoscope forceps plug 102 and the endoscope forceps plug 100.
[0085] As shown in Figure 17, the slit valve 12 is connected to the inner circumferential end of the projection 18. The slit 12C is formed on the central axis C1 of the projection 18. The extending direction of the slit 12C is perpendicular to, for example, the extending direction of the connection 3. Preferably, the thickness T1 of the slit valve 12 is 1.0 mm or more and 2.0 mm or less. More preferably, the thickness T1 of the slit valve 12 is 1.5 mm. The thickness T1 of the slit valve 12 is equal to, for example, the width W1 of the slit 12C in the extending direction.
[0086] As shown in Figure 17, in a bottom view, the projection 18 has an outer peripheral surface 18B (bottom surface) that is exposed inward from the inner peripheral surface 15 of the first channel 1A. The inner peripheral edge of the outer peripheral surface 18B of the projection 18 is connected to the outer peripheral edge of the second surface 12B of the slit valve 12. The outer peripheral edge of the outer peripheral surface 18B of the projection 18 is connected to the inner peripheral surface 15 of the first channel 1A. In a bottom view, the projection 18 has, for example, an annular shape. In a bottom view, the radial length of the projection 18 is shorter than, for example, the length of the slit 12C of the slit valve 12. From a different viewpoint, in a bottom view, the shortest distance from the inner peripheral surface 15 of the first channel 1A to the slit 12C is shorter than, for example, the length of the slit 12C of the slit valve 12.
[0087] In the endoscope forceps plug 102, the inner surface 15 of the first channel 1A is positioned closer to the slit 12C than the inner surface of the second opening 17A. In the endoscope forceps plug 102, the shortest distance from the inner surface 15 of the first channel 1A to the slit 12C is shorter than the shortest distance from the inner surface 15 of the first channel 1A to the inner surface of the second opening 17A. In contrast, in the endoscope forceps plug 100, the inner surface 15 of the first channel 1A is positioned closer to the inner surface of the second opening 17A than the slit 12C. In the endoscope forceps plug 100, the shortest distance from the inner surface 15 of the first channel 1A to the slit 12C is longer than the shortest distance from the inner surface 15 of the first channel 1A to the inner surface of the second opening 17A.
[0088] As shown in Figure 17, the support portion 21B is positioned to surround the valve body portion 21A in the circumferential direction with respect to the hole axis C2 of the through hole 22. In a bottom view, the valve body portion 21A has, for example, a circular shape. In a bottom view, the support portion 21B has, for example, an annular shape.
[0089] As shown in Figure 18, the projection 18 further has an inner circumferential surface 18A (upper surface) that is visible in a plan view. The projection 18 is arranged such that the distance between the inner circumferential surfaces 18A that are facing each other in the radial direction with respect to the central axis C1 (inner diameter) and the distance between the outer circumferential surfaces 18B that are facing each other in the radial direction with respect to the central axis C1 (outer diameter) decrease as you move from the upper surface 1B side toward the bottom surface 1C side.
[0090] Each of the inner circumferential surface 18A and the outer circumferential surface 18B includes a portion of a sphere. Each of the inner circumferential surface 18A and the outer circumferential surface 18B does not have a straight portion in a cross-section along the central axis C1 of the protrusion 18. Each of the inner circumferential surface 18A and the outer circumferential surface 18B consists only of a curved portion in a cross-section along the central axis C1. The center of curvature of each of the inner circumferential surface 18A and the outer circumferential surface 18B is located on the central axis C1, on the upper surface 1B side of the outer edge of the inner circumferential surface 18A.
[0091] As shown in Figure 18, the slit valve 12 is connected to the end (top) of the projection 18 located on the bottom surface 1C side. The inner edge of the inner circumferential surface 11A located on the bottom surface 1C side is connected to the outer circumferential edge of the first surface 12A facing the top surface 1B side of the slit valve 12. The inner edge of the outer circumferential surface 11B located on the bottom surface 1C side is connected to the outer circumferential edge of the second surface 12B facing the bottom surface 1C side of the slit valve 12.
[0092] As shown in Figure 18, each of the first surface 12A and the second surface 12B of the slit valve 12 includes a portion of a sphere. The centers of curvature of each of the first surface 12A and the second surface 12B are located on the central axis C1, on the upper surface 1B side of the outer edge of the inner surface 18A.
[0093] As shown in Figure 18, the first surface 12A of the slit valve 12 and the inner circumferential surface 18A of the projection 18 form, for example, part of the same sphere. The radius of curvature and center of curvature of the first surface 12A of the slit valve 12 coincide, for example, with the radius of curvature and center of curvature of the inner circumferential surface 18A of the projection 18. The second surface 12B of the slit valve 12 and the outer circumferential surface 18B of the projection 18 form, for example, part of the same sphere. The radius of curvature and center of curvature of the second surface 12B of the slit valve 12 coincide, for example, with the radius of curvature and center of curvature of the outer circumferential surface 18B of the projection 18. From a different perspective, the slit valve 12 and the projection 18 together have a bowl shape (dome shape). The thickness of the slit valve 12 is, for example, less than the width of the slit 12C.
[0094] As shown in Figure 18, the inner circumferential surface 18A is, for example, parallel to the outer circumferential surface 18A. The first surface 12A is, for example, parallel to the second surface 12B. The thickness of the projection 18 and the thickness of the slit valve 12 are constant, for example, in the radial and circumferential directions with respect to the central axis C1.
[0095] As shown in Figure 19, the valve 21 has a third surface 21C facing the recess 23A and a fourth surface 21D facing the opposite side from the third surface 21C. The through hole 22 penetrates between the third surface 21C and the fourth surface 21D. A step is formed on the fourth surface 21D due to the difference in thickness between the valve body 21A and the support portion 21B. No step is formed on the third surface 21C due to the difference in thickness between the valve body 21A and the support portion 21B. However, a step may also be formed on the third surface 21C due to the difference in thickness between the valve body 21A and the support portion 21B.
[0096] As shown in Figure 19, the valve body 21A has a recess 21E that is recessed relative to the third surface 21C. The bottom surface and walls of the recess 21E also face the recess 23A. The through hole 22 opens to the bottom surface of the recess 21E. As shown in Figure 17, in a bottom view, the recess 21E has an annular shape centered on the hole axis C2.
[0097] The inventors experimentally confirmed that the endoscopic forceps plug 102 can significantly suppress aerosol leakage when a treatment instrument is inserted, compared to the endoscopic forceps plug having a double valve structure described in Patent Document 1. Furthermore, the inventors experimentally confirmed that the insertion and removal performance of the endoscopic forceps plug 102 is equivalent to or better than that of the endoscopic forceps plug 100.
[0098] In the endoscopic forceps plug 102, the protruding portion 18 can apply a force to the slit valve 12 in the direction of closing the slit 12C, thereby effectively suppressing aerosol leakage from the slit valve 12 to the hole valve 21 side without relying on multiple rib portions 13. Furthermore, in the endoscopic forceps plug 102, the thickness of the valve body portion 21A of the hole valve 21 in which the through hole 22 is formed is greater than the thickness of the support portion 21B, so the length of the through hole 22 in the direction along the hole axis C2 can be made longer than that of the endoscopic forceps plug 100. As a result, the inner circumferential area of the through hole 22 that can contact the outer circumferential surface of the treatment instrument can be made larger in the endoscopic forceps plug 102 compared to that of the endoscopic forceps plug 100, so that even if aerosol leaks from the slit valve 12, the leakage of aerosol from the hole valve 21 into the operating room can be suppressed more effectively.
[0099] Furthermore, in the endoscopic forceps plug 102, the recess 21E formed in the valve body portion 21A of the valve valve 21 can function as a guide to guide the treatment instrument into the through-hole 22. Therefore, endoscopists can easily insert the treatment instrument into the second channel of the endoscopic forceps plug 102.
[0100] While embodiments of the present invention have been described above, various modifications of these embodiments are possible. Furthermore, the scope of the present invention is not limited to the embodiments described above. The scope of the present invention is indicated by the claims and is intended to include all modifications within the meaning and scope equivalent to the claims. [Explanation of symbols]
[0101] 1 Main body, 1A First channel, 1B, 24C, 1D Top surface, 1C Bottom surface, 2 Lid, 2A Second channel, 3 Connection part, 11 Conical cylinder part, 11A, 15, 24D Inner surface, 11B Outer surface, 12 Slit valve, 12A First surface, 12B Second surface, 12C Slit, 13 Rib part, 13A End surface, 14 Annular surface, 16 First hole part, 16A First opening, 16B First expanded pipe part, 17 Second hole part, 17A Second opening, 17B Second expanded pipe part, 18 Protrusion, 21 Hole valve, 21A Valve body part, 21B Support part, 21C Third surface, 21D Fourth surface, 21E Recess, 22 Through hole, 23 First annular part, 23A Recess, 24 Second annular part, 24A Base portion, 24B widened portion, 25 protruding portion, 100 endoscope forceps plug.
Claims
1. An endoscope forceps plug that is attached to the forceps channel of an endoscope through which a treatment instrument is inserted and removed, When attached to the forceps channel, a first channel connected to the forceps channel and a second channel connected to the forceps channel via the first channel are formed. A valve located within the second channel, A projection is provided within the first channel, such that its inner and outer diameters decrease as it moves from the second channel side toward the forceps opening side, A slit valve having a slit formed therein that closes the end of the protrusion on the forceps channel side when the treatment instrument is not inserted into the first channel, and is pushed open by the treatment instrument inserted into the first channel, Equipped with, The valve includes a valve body having a through hole and a support portion that is arranged to surround the valve body in the circumferential direction with respect to the axis of the through hole and supports the valve body within the second channel. The valve body is thicker than the support portion in the endoscope forceps plug.
2. The endoscope forceps plug according to claim 1, wherein the inner and outer circumferential surfaces of the protruding portion include a part of a sphere.
3. The endoscope forceps plug according to claim 2, wherein the curvature of the spherical surface on the inner circumferential surface is equal to the curvature of the spherical surface on the outer circumferential surface.
4. The endoscope forceps plug according to any one of claims 1 to 3, wherein the thickness of the slit valve is equal to the width of the slit.
5. The endoscopic forceps plug according to any one of claims 1 to 3, wherein the thickness of the slit valve is 1.5 mm.
6. An endoscope forceps plug that is attached to the forceps channel of an endoscope through which a treatment instrument is inserted and removed, When attached to the forceps channel, a first channel connected to the forceps channel and a second channel connected to the forceps channel via the first channel are formed. A valve located within the second channel, A projection is provided within the first channel, such that its inner and outer diameters decrease as it moves from the second channel side toward the forceps opening side, A slit valve having a slit formed therein that closes the end of the protrusion on the forceps channel side when the treatment instrument is not inserted into the first channel, and is pushed open by the treatment instrument inserted into the first channel, Equipped with, The first channel is connected to the inner circumferential surface and the protrusion, and further comprises a plurality of rib portions that are spaced apart from each other in the circumferential direction of the protrusion, In the extending direction of the first channel, the first end face of each of the plurality of rib portions facing the forceps channel side is formed on the second channel side than the second end face of the slit valve facing the forceps channel side, wherein the forceps plug for endoscopes.
7. Each of the aforementioned rib portions has rotational symmetry with respect to the central axis of the protruding portion. The circumferential width of the first end face is narrower than the radial width of the protrusion of the first end face, and narrower than the minimum distance between two adjacent rib portions in the circumferential direction, as described in claim 6.
8. The slit is formed on the central axis, The endoscope forceps plug according to claim 7, wherein, when viewed from a direction along the central axis, the angle formed by the imaginary line segment passing through the circumferential center of each of the plurality of rib portions with respect to the extending direction of the slit is 45 degrees.
9. The endoscope forceps plug according to any one of claims 6 to 8, wherein the thickness of the slit valve is less than the width of the slit.
10. The endoscopic forceps plug according to any one of claims 6 to 8, wherein the thickness of the slit valve is 0.5 mm or more and 1.0 mm or less.