Medical sheet

JP7899516B2Active Publication Date: 2026-08-04TOPPAN HOLDINGS INC
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Patent Information

Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
TOPPAN HOLDINGS INC
Filing Date
2021-03-24
Publication Date
2026-08-04

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Benefits of technology

【0009】 本発明の医療用シートは、顕微手術時における組織の正確な寸法把握に寄与する。

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Abstract

To provide a medical sheet capable of contributing to the accurate grasp of dimensions of tissue during microsurgery.SOLUTION: A medical sheet 1 includes: a sheet-like body 10; and a lattice part 20 that is formed on the body 10 by printing and that has a first pattern 21 including a plurality of lines extended in a first direction and a second pattern 22 including a plurality of lines extended in a second direction crossing the first direction. In the first and second patterns 21 and 22, the pitches of the plurality lines are 1 mm or less, and the widths of the first lines are 50% or less of the pitches.SELECTED DRAWING: Figure 1
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Description

Technical Field

[0007] , ,

[0006]

[0001] The present invention relates to a medical sheet, and more particularly to a medical sheet that is placed in an operating field and used for various measurements and the like.

Background Art

[0002] Microsurgery, which involves dissecting and suturing fine tissues such as blood vessels and nerves using a surgical microscope, is widely performed on various organs.

[0003] In microsurgery, a needle with a diameter of about 50 μm to 100 μm and a thread with a diameter of about 10 μm to 20 μm are used. Both the needle and the thread are fine, and extremely precise work is required. In addition, in tissue suturing, it may be required to match the dimensions of the two tissues to be sutured, and it is important to accurately grasp the dimensions of the tissue in the operating field.

[0004] As a measurement member for medical use, Patent Document 1 describes a medical adhesive tape with graduations.

Prior Art Documents

Patent Documents

[0005]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0006] The adhesive tape with graduations described in Patent Document 1 is intended to record the course of treatment with a photograph and is used by being attached to the affected part. That is, use on internal organs is not considered. Furthermore, in microsurgery, it is not possible to attach an adhesive tape with graduations to the tissue to be treated, so the adhesive tape with graduations described in Patent Document 1 cannot be applied.

[0007] In view of the above circumstances, the present invention aims to provide a medical sheet that can contribute to the accurate determination of tissue dimensions during microsurgical procedures. [Means for solving the problem]

[0008] The present invention relates to a medical sheet comprising a sheet-like, opaque body and a grid portion formed on the body, the grid portion having a first pattern including a plurality of lines extending in a first direction and a plurality of lines extending in a second direction intersecting the first direction. The difference in average reflectance (%) of visible light between the main body and the grid section is 30 points or more. In the first and second patterns, the pitch of multiple lines is 1 millimeter or less, and the width of multiple lines is 50% or less of the pitch. [Effects of the Invention]

[0009] The medical sheet of the present invention contributes to the accurate determination of tissue dimensions during microsurgical procedures. [Brief explanation of the drawing]

[0010] [Figure 1] This is a plan view of a medical sheet according to the first embodiment of the present invention. [Figure 2] This is a schematic plan view of a medical sheet according to an embodiment. [Figure 3] This is an enlarged view of the information unit in the same embodiment. [Figure 4] This is a schematic plan view of a medical sheet according to another embodiment. [Figure 5] This is an enlarged view of the information unit in the same embodiment. [Figure 6] This is a schematic plan view of a medical sheet according to another embodiment. [Figure 7] This is a schematic plan view of a medical sheet relating to a comparative example. [Modes for carrying out the invention]

[0011] The following describes one embodiment of the present invention with reference to Figures 1 to 4. Figure 1 is a plan view of the medical sheet 1 according to this embodiment. The medical sheet 1 comprises a sheet-like main body 10 and a grid section 20 and an information section 30 formed on the main body 10.

[0012] The main body 10 is formed from a biocompatible material. Examples of biocompatible materials include polymers such as silicone, collagen, polyethylene terephthalate (PET), polytetrafluoroethylene, polyester, polyvinyl chloride (PVC), polymethyl methacrylate, polylactic acid, polyglycolic acid, polycaprolactone, polycarbonate, polyethylene, and polypropylene; copolymers of these polymers; metals such as titanium alloys, stainless steel, and cobalt alloys, and their oxides; thermosetting elastomers such as silicone rubber, urethane rubber, fluororubber, natural rubber, and synthetic rubber; and elastic materials such as polystyrene-based (TPS), polyolefin-based (TPO), urethane-based (TPU), and polyester-based (TPEE). Furthermore, the polymer binder may contain inorganic powder. The inorganic powder can be silica, alumina, zinc oxide, or titanium oxide. The inorganic powder content can range from 5% to 70% by weight. Inorganic pigments may also be included. The main body 10 may be in the form of a film or a plate. Furthermore, it may be either a flexible material that can be easily bent or a rigid material that does not bend, and the appropriate choice can be made considering the target organ or procedure.

[0013] The main body 10 only needs to be opaque, specifically, its transmittance should be 1% or less. If the biological tissue in contact with the surface of the main body 10 opposite to the surface on which the grid portion 20 is provided is not visible through the main body 10, the tissue can be accurately identified during microsurgery. The color of the main body 10 is preferably the complementary color of the biological tissue. This complementary color can be formed by colors from blue, blueish green, blue green, greenish blue, green, yellowish green to yellow green. The colors from blue to yellow green correspond to B, BG, G, GY in the Munsell color system. By setting the color of the main body 10 to the colors from blue to yellow green, the biological tissue becomes easier to visually recognize. Specifically, the ranges of L*, a, and b in the L*ab color space of the main body 10 are preferably 25 or more and 80 or less, -80 or more and 0 or less, and -50 or more and 50 or less, respectively.

[0014] In the main body 10, among visible light (wavelength band of about 350 nm to 800 nm), the spectral reflectance at 570 nm to 800 nm is preferably 20% or less. In the case of using the above-mentioned metal plate, etc., the above color can be realized by full-surface printing of paint, etc. When the brightness of the main body 10 is low, the contrast with the biological tissue becomes good, which is preferable. The peak reflectance of visible light of the main body having such brightness is generally 10% or less.

[0015] There is no particular limitation on the thickness of the main body 10, but it can be 15 μm or more and 2 mm or less. In the case of a highly elastic material, it can be about 0.1 mm to 1.0 mm, in the case of a low elastic material, it can be about 0.02 mm to 0.2 mm, and in the case of a metal, it can be about 0.01 mm to 0.1 mm.

[0016] The planar shape of the main body 10 illustrated in this embodiment is a rounded rectangle, but the planar shape is not limited to this and can be appropriately determined, such as a triangle, a circle, etc. The planar shape of the main body 10 is preferably a rounded polygon. In such a form, it is difficult to damage the tissue and it is easy to pick up with tweezers or a manipulator. Also, the polygon can be a convex hull. If it is a convex hull, it is difficult to catch on the tissue.

[0017] The lattice part 20 and the information part 30 are formed on the main body 10 by printing. The lattice part 20 is composed of a first pattern 21 consisting of a plurality of lines extending in the first direction D1 and a second pattern 22 consisting of a plurality of lines extending in a second direction D2 intersecting the first direction. In this embodiment, the first direction D1 and the second direction D2 are orthogonal, but the number of patterns in the grid section 20 and the angles between the patterns can be appropriately set according to the shape of the grid to be formed.

[0018] In this embodiment, the lines of the first pattern 21 are arranged at equal intervals, and the lines of the second pattern 22 are also arranged at equal intervals. Furthermore, since the spacing (pitch) P1 of the first pattern 21 and the pitch P2 of the second pattern 22 are the same, the resulting grid 23 is square. In such a grid section 20, the first pattern 21 functions as a scale provided at equal intervals in the second direction, and the second pattern 22 functions as a scale provided at equal intervals in the first direction.

[0019] The values ​​of pitch P1 and P2 can be determined as appropriate, but from the viewpoint of usefulness in microsurgery, it is preferable that they be at least 1.0 mm or less. When used in surgical procedures that use needles with a diameter of 100 μm or less, it is preferable that pitches P1 and P2 be 600 μm or less. When used in surgical procedures with even higher magnification, such as those using robots, pitches P1 and P2 can be set to 200 μm or less. With the evolution of devices, it is quite possible that surgical procedures with even higher magnification will be performed in the future, but the medical sheet 1 can be suitably adapted by changing the values ​​of pitch P1 and P2. The widths of the multiple lines in each pattern of the grid section 20 are the same. In practice, considering printing accuracy and other factors, they are set within ±5% of the set value. With this setting, even when the grid section 20 is magnified and observed during surgery, the irregularities at both ends in the width direction of the lines constituting the grid section 20 are not noticeable, and it stabilizes in a nearly straight line shape. From the viewpoint of visibility, the line width of the grid section 20 is preferably 5 μm or more. Furthermore, if the line width is 50% or less of the pitch, it is easier to grasp the dimensions of tissue during microsurgery. If it is greater than 20% but less than or equal to 50% of the pitch, it is easy to see as a scale during microsurgery. If it is greater than 10% but less than or equal to 20% of the pitch, it is easy to accurately measure biological tissue by visual inspection. If it is less than 10% of the pitch, the reference position can be accurately determined during visual measurement. The line width can also be greater than 50% of the pitch and less than or equal to 80%. Within this range, the scale can be visible even when there is heavy blood contamination. When the pitches P1 and P2 are 600 μm or less, it is preferable that the line width be 25% or less of the pitch. Sheets with a pitch of 600 μm or less are suitable for surgical procedures where thin needles and threads are used, but if the line width is thicker than this, it becomes difficult to determine the position of the needles and threads during such procedures.

[0020] In this embodiment, the height of the grid portion 20 is preferably 1 μm to 10 μm for ease of visibility. Examples of cross-sectional shapes of the grid portion 20 include semicircular, semi-elliptical, triangular, trapezoidal, rectangular, and trapezoidal or rectangular shapes with a convex curved surface at the top. If there are edges at the corners of the cross-sectional shape, blood and cleaning fluid tend to remain on the grid portion 20 due to surface tension, but if the corners are rounded, blood and cleaning fluid are less likely to accumulate on the grid portion 20, which is preferable. Furthermore, if the shape is semicircular, semi-elliptical, triangular, trapezoidal, etc., blood and cleaning fluid are less likely to accumulate on the grid portion 20, and they flow more easily from the medical sheet, making it possible to maintain the visibility of the grid portion 20 during microsurgery.

[0021] The information unit 30 displays information about the medical sheet 1, including information about the specifications of the grid unit 20. In this embodiment, the information unit consists of two strings: "P 500" and "L 50". "P 500" indicates that the pitch (P1=P2 in this embodiment) is 500 μm, and "L 50" indicates that the line width (the same for the first pattern 21 and the second pattern 22 in this embodiment) is 50 μm. The information unit 30 is provided within a portion of the grid 23 in the grid section. The number and spacing of the information units, as well as the content of the information they display, can be set as appropriate. Since medical sheets may be used by cutting out smaller sections depending on the size of the surgical field or operating area, it is preferable to set the number and spacing of the information units so that at least one information unit exists in the cut-out area.

[0022] The ink used to form the grid portion 20 and the information portion 30 comprises a pigment and a binder. In this embodiment, the grid portion 20 and the information portion 30 are formed with the same ink, but they may be formed with different inks.

[0023] Both organic and inorganic pigments can be used as pigments. As inorganic pigments, oxides, hydroxides, sulfides, selenides, ferrocyanides of metals such as titanium, zinc, gold, silver, copper, and iron, or chromates, sulfates, carbonates, silicates, and phosphates of these metals can be used. Furthermore, examples include the elemental form or alloys thereof of the above-mentioned metals, carbon, and pearl pigments such as bismuth oxychloride, titanium mica, and fish scale foil. Among these, titanium dioxide (titania), zinc oxide, talc, silica, mica, alumina, barium sulfate, calcium carbonate, magnesium carbonate, barium silicate, calcium silicate, metal soaps, and silicones are preferred due to their biocompatibility. Examples of organic pigments include nitroso-based, nitro-based, azo-based, lake-based, phthalocyanine-based, condensed polycyclic materials, and other carbon compounds.

[0024] A resin can be used as a binder. The resin can be a composition, and the composition can be a mixture of oligomers and polymers. The resin can be soluble. The resin may also be a curable resin. The curable resin can be an ionizing radiation curable resin or a thermosetting resin. The ionizing radiation curable resin can be an ultraviolet curable resin or an electron beam curable resin. The type of resin can be an acrylic resin, urethane resin, epoxy resin, polyester resin, thiol resin, or a mixture thereof. As for the acrylic resin, a fluoropolymer acrylic resin, a silicone polymer acrylic resin, an epoxy acrylate resin, an acrylonitrile styrene resin, or a mixture thereof can be used. Other resins that can be used include methylstyrene resin, fluorene resin, polypropylene, PET (polyethylene terephthalate), PC (polycarbonate), PS (polystyrene), COC (cyclic olefin copolymer), COP (cycloolefin polymer), MS (styrene methacrylate copolymer), AS (acrylonitrile styrene copolymer), PEN (polyethylene naphthalate), PI (polyimide), phenolic resin, melamine resin, epoxy resin, alkyd, etc.

[0025] In addition to the above, engineering plastics such as PBT (polybutylene terephthalate), POM (polyoxymethyl), PA (polyamide), and PPS (polyphenyl sulfide), as well as super engineering plastics, can also be used as binders.

[0026] Among the materials mentioned above, it is preferable to use polymer materials such as silicone, polyethylene terephthalate (PET), polytetrafluoroethylene, polyester, polyvinyl chloride (PVC), polymethyl methacrylate, polylactic acid, polyglycolic acid, polycaprolactone, acrylic, polycarbonate, polyethylene, and polypropylene, or copolymers of these polymer materials, as these materials have particular biocompatibility.

[0027] For the ink used to form the grid portion 20 and the information portion 30, it is preferable to use either an aqueous ink or a non-aqueous ink depending on the surface characteristics of the main body 10. If the surface of the main body 10 is hydrophilic, it is preferable to use an aqueous ink. If the surface of the main body 10 is hydrophobic, it is preferable to use a non-aqueous ink. Various solvents can be used to adjust the solid content and viscosity of inks. For example, water (purified water) can be used for water-based inks. For non-water-based inks, solvents with high boiling points that do not evaporate easily at room temperature (aliphatic hydrocarbons, glycol ethers, higher alcohols, etc.) or solvents with low boiling points that evaporate easily at room temperature (MEK, ethanol, acetone, etc.) can be used alone or in combination.

[0028] For printing to form the grid section 20 and the information section 30, offset printing, gravure printing, flexographic printing, screen printing, gravure offset printing, inverted offset printing, screen offset printing, pad printing, and inkjet printing can be applied. Of these, gravure offset printing and screen offset printing are particularly suitable when the line width is 100 μm or less, because they can stably form narrow lines.

[0029] The ink forming the grid portion 20 and the information portion 30 is preferably made of a biocompatible material. Alternatively, the biocompatibility of the medical sheet 1 can be ensured by forming the grid portion 20 and the information portion 30 with an ink that is not made of a biocompatible material, and then covering the ink portion with a transparent, biocompatible coating. In this case, the coating may cover only the grid portion 20 and the information portion 30, or it may cover the entire surface of the main body 10. As the coating material, a biocompatible material that can be used for the ink forming the main body 10, the grid portion 20, and the information portion 30 can be used. Preferably, silicone resin can be used as an example.

[0030] It is preferable for there to be a certain level of brightness difference between the grid section 20 and the information section 30 and the main body 10, as this results in good contrast. For example, a difference of about 30 points in the average reflectance (%) of visible light results in good contrast. Alternatively, the contrast between the grid section 20 and the information section 30 and the main body 10 can be between 0.1 and 2.0 in terms of color density difference, and it is preferable for it to be between 0.5 and 1.5 to further improve visibility.

[0031] The operation of the medical sheet 1, configured as described above, will now be explained. The medical sheet 1 is placed in the operating room where the procedure is to be performed, either as is or cut to an appropriate size. By placing the organ or tissue to be treated in an appropriate position on the medical sheet 1, or slightly above the medical sheet 1, the dimensions of the organ or tissue can be determined based on the grid section 20 and the information section 30. Based on the obtained information, the user can select the tissue, adjust its dimensions, etc.

[0032] The medical sheet 1 of this embodiment will be further described using examples. The present invention is not limited in any way by the specific details of the following embodiments.

[0033] (Example 1) Figure 2 schematically shows the medical sheet 1A of Example 1. A silicone rubber sheet shaped like an isosceles triangle in plan view was used as the main body 10 of the medical sheet 1A. The isosceles triangle has a base of 10 mm and a height of 50 mm, and the thickness of the main body 10 is 0.5 mm. The visible light reflectance of the main body 10 has a peak at 500 nm, and the reflectance at the peak is 64%.

[0034] On the main body 10, the grid section 20 and the information section 30 were formed by gravure offset printing using white ink (binder: silicone resin, pigment: titania). A solvent with a standard drying speed was used for the white ink, and the solid content was 20%. The settings for the grid section 20 and the information section 30 were as follows. • First pattern First direction D1: Parallel to the base of the main body 10. Pitch P1: 100 μm Line width: 10 μm • Second pattern Second direction D2: Perpendicular to the first direction D1 Pitch P2: 100 μm Line width: 10 μm • Information section string P 100 L 10 The grid of the grid section has sides of 90 μm (pitch 100 μm), and it is difficult to fit all of the above text within this grid. Therefore, as shown in Figure 3, it was formed by removing a portion of the pattern in areas of multiple grids. The information section was placed at a frequency of every 5 grids vertically and every 5 grids horizontally.

[0035] When the medical sheet 1A of Example 1 was observed using a binocular microscope at a magnification of 40x, the grid section 20 and the information section 30 were clearly visible relative to the main body 10. When pig blood vessels were placed on medical sheet 1A and observed with a binocular microscope, dimensions such as length and diameter could be easily determined based on the grid section 20 and information section 30.

[0036] (Example 2) Figure 4 schematically shows the medical sheet 1B of Example 2. A square PET film was used as the main body 10 of the medical sheet 1B. The length of one side of the square is 25 mm, and the thickness of the main body 10 is 0.2 mm. The visible light reflectance of the main body 10 has a peak at 540 nm, and the reflectance at the peak is 0.7%.

[0037] A grid section 20 and an information section 30 were formed on the main body 10 by screen offset printing using metallic ink (pigment silver particles). The settings for the grid section 20 and the information section 30 were as follows. • First pattern First direction D1: Parallel to the long side of the main body 10. Pitch P1: 500 μm Line width: 40 μm • Second pattern Second direction D2: Perpendicular to the first direction D1 Pitch P2: 500 μm Line width: 40 μm • Information section string P 500 L 40 The grid of the grid section is large enough to print all of the above text, so the entire information section 30 is formed within a single grid. The information section is placed within the grid every 5 grid vertically and every 5 grid horizontally, as shown in the enlarged view in Figure 5.

[0038] After forming the grid portion 20 and the information portion 30, a silicone resin was applied to the entire surface and dried to form a coating that covers the grid portion 20 and the information portion 30.

[0039] When the medical sheet 1B of Example 2 was observed using a binocular microscope at a magnification of 40x, the grid section 20 and the information section 30 were clearly visible relative to the main body 10. No decrease in visibility due to the coating was observed. When pig nerves were placed on medical sheet 1B and observed with a binocular microscope, dimensions such as length and diameter could be easily determined based on the grid section 20 and information section 30.

[0040] (Example 3) Figure 6 schematically shows the medical sheet 1C of Example 3. A rectangular silicone rubber sheet was used as the main body 10 of the medical sheet 1C. The rectangle had a long side of 15 mm and a short side of 10 mm, and the thickness of the main body 10 was 0.5 mm. The visible light reflectance of the main body 10 has a peak at 500 nm, and the reflectance at the peak is 64%.

[0041] On the main body 10, the grid section 20 and the information section 30 were formed by gravure printing using the same white ink as in Example 1. The settings for the grid section 20 and the information section 30 were as follows. • First pattern First direction D1: Parallel to the long side of the main body 10. Pitch P1: 900 μm Line width: 360 μm • Second pattern Second direction D2: Perpendicular to the first direction D1 Pitch P2: 900 μm Line width: 360 μm • Information section string 900 360 The grid of the grid section 20 is large enough to print all of the above text, so the entire information section 30 is formed within a single grid. The information section is placed within the grid every three grids vertically and every three grids horizontally.

[0042] When the medical sheet 1C of Example 3 was observed using a binocular microscope at a magnification of 40x, the grid section 20 and the information section 30 were clearly visible relative to the main body 10. When pig blood vessels were placed on the medical sheet 1C and observed with a binocular microscope, dimensions such as length and diameter could be easily determined based on the grid section 20 and the information section 30.

[0043] (Comparative example) Figure 7 schematically shows the comparative example medical sheet 1D. The comparative example differs from Example 3 only in the configuration of the grid and information sections. The specific configurations of the grid and information sections are as follows. • First pattern First direction D1: Parallel to the long side of the main body 10. Pitch P1: 900 μm Line width: 600 μm • Second pattern Second direction D2: Perpendicular to the first direction D1 Pitch P2: 900 μm Line width: 600 μm • Information Department: None

[0044] When the comparative medical sheet 1D was observed using a binocular microscope at a magnification of 40x, the grid portion 20 was clearly visible relative to the main body 10. However, when pig blood vessels were placed on the sheet and observed with a binocular microscope, the line width was thick and there was no informational area, making it difficult to determine dimensions such as length and diameter.

[0045] Although each embodiment of the present invention has been described in detail above with reference to the drawings, the specific configuration is not limited to these embodiments, and modifications and combinations of the configuration that do not depart from the spirit of the present invention are also included. Some modifications are given below as examples, but these are not all, and other modifications are also possible. Two or more of these modifications may be combined as appropriate.

[0046] • In the examples described above, there are areas without a grid on the peripheral edge of the main body when viewed from above, but this is not essential, and a grid may be provided over the entire surface of the main body. • Small protrusions may be provided on the periphery of the main body to facilitate grasping with forceps or similar tools. The visible light reflectance of the main body may have multiple peaks. Even in this case, if at least one peak is located within the wavelength range of 450 nm to 570 nm, good contrast with biological tissue will be achieved, resulting in excellent visibility.

[0047] Even if the ink forming the grid or information area is biocompatible, a coating may still be applied. During use of medical sheets, saline solution or the like is continuously applied to prevent drying, so the coating can suppress attacks on the grid or information area by saline solution or the like.

[0048] The grid section may have multiple regions with different line widths and pitches, and information sections corresponding to each region may be formed. [Explanation of symbols]

[0049] 1, 1A, 1B, 1C Medical Sheets 10 Main unit 20 Lattice section 21 First Pattern 22. Second Pattern 30 Information Department D1 First direction D2 Second direction P1, P2 pitch

Claims

1. The main body is sheet-like and opaque, A grid portion comprising a printed layer formed on the main body, having a first pattern including a plurality of lines extending in a first direction, and a second pattern including a plurality of lines extending in a second direction intersecting the first direction, Equipped with, The difference in average reflectance (%) of visible light between the main body and the grid section is 30 points or more. In the first pattern and the second pattern, The pitch of the aforementioned multiple lines is 1 millimeter or less. The width of the aforementioned plurality of lines is 50% or less of the pitch. Medical sheet.

2. A sheet-like, opaque body, A grid portion comprising a printed layer formed on the main body, having a first pattern including a plurality of lines extending in a first direction, and a second pattern including a plurality of lines extending in a second direction intersecting the first direction, Equipped with, In the first pattern and the second pattern, The pitch of the aforementioned plurality of lines is 100 μm or more and 900 μm or less. The width of the plurality of lines is 8% or more and 40% or less of the pitch. The visible light reflectance of the main body has a peak within the wavelength range of 500 nm to 540 nm. Medical sheet.

3. The medical sheet according to claim 1 or 2, further comprising an information section that displays at least one of the pitch and the width, comprising a printed layer formed on the main body.

4. The aforementioned grid portion has a cross-sectional shape in which the upper part is a convex curved surface. A medical sheet according to claim 1 or 2.

5. The system further comprises a coating that covers the grid portion and the information portion. The medical sheet according to claim 3.

6. The peak value of the visible light reflectance of the main body is 10% or less. A medical sheet according to claim 1 or 2.