JP7725871B2 - Medical Sheets - Google Patents

Description

The present invention relates to a medical sheet, and more specifically to a medical sheet that is placed in the surgical field and used for various measurements, etc.

Microsurgery, which uses a surgical microscope to dissect and suture minute tissues such as blood vessels and nerves, is widely performed on various organs.

In microsurgery, needles with a diameter of about 50 μm to 100 μm and threads with a diameter of about 10 μm to 20 μm are used. Both the needles and threads are very fine, and require extremely precise work.
Furthermore, when suturing tissues, it is sometimes required to match the dimensions of the two tissues to be sutured, and it is important to accurately grasp the dimensions of the tissues at the surgical site.

Patent Document 1 describes a graduated adhesive tape for medical use as a measuring component for medical applications.

Japanese Patent Application Publication No. 8-56983

The graduated adhesive tape described in Patent Document 1 is intended to record the progress of treatment with photographs and is used by being attached to the affected area, i.e., it is not intended to be used on internal organs.
Furthermore, in microsurgery, it is not possible to attach graduated adhesive tape to the tissue to be treated, and therefore the graduated adhesive tape described in Patent Document 1 cannot be applied.

In addition, medical sheets currently used in microsurgery typically have a grid pitch of 1 mm and a line width of 100 μm or more. However, because surgery requires high levels of skill and precision, there are increasing cases where even finer grid pitches and line widths are required.

In light of the above circumstances, the present invention aims to provide a medical sheet that can contribute to accurate measurement of tissue dimensions during microsurgery.

The present invention is a medical sheet comprising a sheet-like body, a plurality of lines formed on the body by printing and arranged at equal intervals and in parallel , and an information portion formed on the body by printing and indicating the width of the plurality of lines .
The pitch of the lines is 1 millimeter or less, and the width of the lines is 50% or less of the pitch.

The medical sheet of the present invention contributes to accurate measurement of tissue during microsurgery.

1 is a plan view of a medical sheet according to an embodiment of the present invention. FIG. 1 is a schematic plan view of a medical sheet according to an embodiment. FIG. 2 is an enlarged view of an information section in the embodiment. FIG. 10 is a schematic plan view of a medical sheet according to another embodiment. FIG. FIG. 10 is a schematic plan view of a medical sheet according to another embodiment. FIG. 10 is a schematic plan view of a medical sheet according to a comparative example.

Hereinafter, an embodiment of the present invention will be described with reference to FIGS.
1 is a plan view of a medical sheet 1 according to this embodiment. The medical sheet 1 includes a sheet-like main body 10 and a plurality of lines 20 and an information section 30 formed on the main body 10.

The main body 10 is formed of a biocompatible material. Specific examples of biocompatible materials include polymers such as silicone, polyethylene terephthalate (PET), polytetrafluoroethylene, polyester, polyvinyl chloride (PVC), polymethyl methacrylate, polylactic acid, polyglycolic acid, polycaprolactone, polycarbonate, polyethylene, and polypropylene; copolymers of these polymers; metals and their oxides, such as titanium alloys, stainless steel, and cobalt alloys; thermosetting elastomers, such as silicone rubber, urethane rubber, fluororubber, natural rubber, and synthetic rubber; and thermoplastic elastomers, such as polystyrene-based (TPS), polyolefin-based (TPO), urethane-based (TPU), and polyester-based (TPEE). Furthermore, the polymer binders listed above may contain inorganic powder. Examples of inorganic powders include silica, alumina, zinc oxide, and titanium oxide. The inorganic powder content may be 5% to 70% by weight. An inorganic pigment may also be included.
The main body 10 may be in the form of either a film or a plate. Furthermore, it may be either flexible or rigid, and can be appropriately selected taking into consideration the target organ, procedure, etc.

The main body 10 only needs to be opaque, specifically, have a transmittance of 1% or less. If the biological tissue in contact with the surface of the main body 10 opposite to the surface on which the multiple lines 20 are provided is not visible through the main body 10, the tissue can be accurately confirmed during microsurgery.
The color of the main body 10 is preferably a complementary color of the biological tissue. These complementary colors can be blue, greenish blue, blue-green, bluish green, green, yellowish green, and yellow-green, ranging from blue to yellow-green. These colors ranging from blue to yellow-green correspond to B, BG, G, and GY on the Munsell color scale. By making the color of the main body 10 a color ranging from blue to yellow-green, the biological tissue becomes easier to see. Specifically, the ranges of L*, a, and b in the L*ab color space of the main body 10 are preferably 25 to 80, -80 to 0, and -50 to 50, respectively.

For the main body 10, it is preferable that the spectral reflectance from 570 nm to 800 nm of visible light (wavelength band approximately 350 nm to 800 nm) be 20% or less. If the main body is made of the metal mentioned above, the above colors can be achieved by printing paint all over the surface. A low brightness for the main body 10 is preferable, as it provides good contrast with biological tissue. The peak reflectance of visible light for a main body with such brightness is generally 10% or less.

There are no particular restrictions on the thickness of the main body 10, but it can be between 15 μm and 2 mm. For highly elastic materials, it can be approximately 0.1 mm to 1.0 mm, for low-elasticity materials, it can be approximately 0.02 mm to 0.2 mm, and for metals, it can be approximately 0.01 mm to 0.1 mm.

The planar shape of the main body 10 exemplified in this embodiment is a rounded rectangle, but the planar shape is not limited to this and can be triangular, circular, or other suitable shape. It is preferable that the planar shape of the main body 10 be a polygon with rounded corners. This shape is less likely to damage tissue and is easier to grasp with tweezers or a manipulator. The polygon can also be a convex hull. A convex hull is less likely to get caught on tissue.

The lines 20 and the information section 30 are formed on the main body 10 by printing.
The lines 20 are straight lines extending in the same direction, and are arranged at equal intervals and in parallel. That is, in the medical sheet 1, the pitch (P shown in FIG. 1 ), which is the distance between the centers of two adjacent lines 20 in the width direction, is constant.

In this embodiment, two types of lines 20 are provided: first lines 20a and second lines 20b that are thicker (wider) than the first lines 20a. Four first lines 20a are arranged between two adjacent second lines 20b. Therefore, the pitch between two adjacent second lines 20b is five times the pitch P shown in Figure 1.

The information section 30 displays information about the medical sheet 1, including information about the specifications of the lines 20. The information section of this embodiment consists of three character strings: "P 500,""L150," and "L2 100.""P500" indicates that the pitch P is 500 μm, "L1 50" indicates that the width of the first lines 20a is 50 μm, and "L2 100" indicates that the width of the second lines 20b is 100 μm.
The information sections 30 are provided between some of the lines. The number of information sections, the spacing between them, and the content of the information indicated by the information sections can be set as appropriate. As will be described later, the medical sheet 1 may be used by cutting out small sections depending on the size of the surgical field or operating room. Therefore, it is preferable to set the number and spacing so that at least one information section is present in the smallest anticipated cut-out size.

The ink used to form the lines 20 and the information section 30 contains a pigment and a binder. In this embodiment, the lines 20 and the information section 30 are formed with the same ink, but they may also be formed with different inks.

As the pigment, either an organic pigment or an inorganic pigment can be used.
Examples of inorganic pigments that can be used include oxides, hydroxides, sulfides, selenides, and ferrocyanides of metals such as titanium, zinc, gold, silver, copper, and iron, as well as chromates, sulfates, carbonates, silicates, and phosphates of these metals. Other examples include the above-mentioned metals themselves or their alloys, carbon, and pearl pigments such as bismuth oxychloride, titanium mica, and fish scale foil. Among these, biocompatible materials such as titanium dioxide (titania), zinc oxide, talc, silica, mica, alumina, barium sulfate, calcium carbonate, magnesium carbonate, barium silicate, calcium silicate, metal soap, and silicone are preferred.
Examples of organic pigments include nitroso-based, nitro-based, azo-based, lake-based, phthalocyanine-based, condensed polycyclic materials, and other carbon compounds.

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 can 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, a urethane resin, an epoxy resin, a polyester resin, a thiol resin, or a mixture of these. As the acrylic resin, a fluorine-based acrylic resin, a silicone-based acrylic resin, an epoxy acrylate resin, an acrylonitrile styrene resin, or a mixture of these 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 (methacrylate-styrene copolymer), AS (acrylonitrile-styrene copolymer), PEN (polyethylene naphthalate), PI (polyimide), phenolic resin, melamine resin, epoxy resin, alkyd, etc.

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

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

There are no particular limitations on the printing method for forming the line 20 and the information portion 30. Examples of printing methods include offset printing, gravure printing, flexographic printing, screen printing, gravure offset printing, reverse offset printing, screen offset printing, pad printing, and inkjet printing.
Among these, gravure offset printing and screen offset printing are particularly suitable for line widths of 100 μm or less, since they can stably form narrow lines.

The ink used to form the lines 20 and information section 30 is preferably made of a biocompatible material. After forming the lines 20 and information section 30 with ink that is not made of a biocompatible material, the biocompatibility of the medical sheet 1 can also be ensured by covering the ink portion with a transparent, biocompatible coating. In this case, the coating may cover only the lines 20 and information section 30, or may cover the entire surface of the main body 10.
The coating material may be a biocompatible material that can be used for the inks forming the main body 10, the lines 20, and the information section 30. A preferred example is silicone resin.

It is preferable for there to be a certain level of difference in brightness between the line 20 and information section 30 and the main body 10, as this will result in good contrast. For example, a difference of approximately 30 points in the average reflectance (%) of visible light will result in good contrast. Alternatively, the contrast between the line 20 and information section 30 and the main body 10 can be a color density difference of 0.1 or more and 2.0 or less, and to further improve visibility, a difference of 0.5 or more and 1.5 or less is preferable.

The operation of the medical sheet 1 configured as above when in use will now be described.
The medical sheet 1 is placed at the surgical site where treatment will be performed, either as is or cut to an appropriate size. By placing the organ or tissue to be treated at an appropriate position on the medical sheet 1 or slightly above it, the dimensions of the organ or tissue can be determined based on the lines 20 and information section 30. The multiple lines 20, arranged at the same pitch, function as a scale indicating the dimensions, and the second lines 20b allow the user to intuitively and easily grasp dimensions equivalent to five pitches. Furthermore, even first-time users of the medical sheet 1 can easily grasp various parameters, such as the width and pitch of the lines 20, using the information section 30.

Because the lines 20 on the medical sheet 1 all extend in the same direction, there are no areas on the main body 10 that are surrounded by lines 20. Therefore, even if blood or other fluids scatter or adhere between the lines 20, they can be easily moved in either direction along which the lines 20 extend. As a result, situations such as blood or bodily fluids accumulating in such areas and interfering with dimensional measurements can be effectively prevented.

In this embodiment, the value of pitch P can be determined as appropriate, but from the perspective of usefulness in microsurgery, it is preferable that it be at least 1.0 mm or less. When used in procedures that use needles with a diameter of 100 μm or less, the pitch is preferably 600 μm or less. When used in procedures with even higher magnification, such as those using robots, the pitch can also be set to 200 μm or less. As devices evolve, it is quite possible that procedures with even higher magnification will be performed in the future, and the medical sheet 1 can be adapted to these situations by changing the pitch value.

From the viewpoint of visibility, the width of the line 20 is preferably 5 μm or more. Furthermore, if the line width is 50% or less of the pitch, it is easy to grasp the dimensions of the tissue during microsurgery. If the line width is greater than 20% and less than 50% of the pitch, it is easy to visually recognize it as a scale during microsurgery. If the line width is greater than 10% and less than 20% of the pitch, it is easy to accurately measure biological tissue visually. If the line width is less than 10% of the pitch, the reference position can be accurately determined in visual measurements. The line width can also be greater than 50% and less than 80% of the pitch. Within this range, the scale can be visible even when there is heavy blood adhesion.
When the pitch is 600 μm or less, the line width is preferably 25% or less of the pitch. Sheets with a pitch of 600 μm or less are suitable for procedures using thin needles and threads, but if the line width is thicker than this, it becomes difficult to grasp the position of the needle or thread during such procedures.
The width of the line 20 is set within ±5% of the set value, taking into consideration printing accuracy, etc. By setting it in this way, even if the line 20 is observed under magnification during surgery, the unevenness at both ends in the width direction is not noticeable, and the line is stable and approximately straight.

The height of the line 20 (the thickness of the layer formed on the main body 10) is preferably 1 μm or more and 10 μm or less for ease of visibility. Examples of the cross-sectional shape of the line 20 include semicircular, semi-elliptical, triangular, trapezoidal, rectangular, and trapezoidal or rectangular shapes with a convex curved top. If the cross-sectional shape has edges, blood and cleaning fluid are more likely to remain on the line 20 due to surface tension, but rounded corners in the cross-sectional shape are preferable because they make it less likely for blood and cleaning fluid to remain on multiple lines 20. Furthermore, semicircular, semi-elliptical, triangular, and trapezoidal shapes are preferable because they make it less likely for blood and cleaning fluid to remain on the line 20 and allow it to flow easily from the medical sheet, making it easier to maintain the visibility of the line 20 during microsurgery.

The medical sheet 1 of this embodiment will be further described using examples. The present invention is not limited in any way to the specific content of the following examples.

Example 1
FIG. 2 is a schematic diagram showing a medical sheet 1A according to the first embodiment.
A silicone rubber sheet having an isosceles triangle shape in plan view was used as the main body 10 of the medical sheet 1A. The isosceles triangle had a base of 10 mm and a height of 50 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%.

The lines 20 and the information portion 30 were formed on the main body 10 by gravure offset printing using white ink (binder: silicone resin, pigment: titania). The settings of the lines 20 and the information portion 30 were as follows.
Line extension direction: perpendicular to the bottom side (short side) of the main body 10 Pitch P: 100 μm
Width of first line 20a: 10 μm
Width of second line 20b: 20 μm
・Information section character string P 100
L1 10
L2 20
The width of the inter-line area was 90 μm or 85 μm, and since it was difficult to fit all of the above character strings in it, some of the lines were removed to form the inter-line area, as shown in Figure 3. The information sections were arranged every 500 μm vertically and every 500 μm horizontally.

When the medical sheet 1A of Example 1 was observed using a binocular microscope at a magnification of 40 times, the two types of lines 20 and the information section 30 were clearly visible.
When a pig's blood vessel was placed on the medical sheet 1A and observed under a binocular microscope, the dimensions such as length and diameter could be easily determined based on the lines 20 and the information portion 30.

Example 2
FIG. 4 is a schematic diagram showing a medical sheet 1B according to a second embodiment.
A square PET film was used as the main body 10 of the medical sheet 1B. The length of each side of the square was 25 mm, and the thickness of the main body 10 was 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%.

The lines 20 and the information portion 30 were formed on the main body 10 by screen offset printing using metallic ink (pigment: silver particles). The settings of the lines 20 and the information portion 30 were as follows.
Line extension direction: parallel to one side of the main body 10 (the side extending in the vertical direction in FIG. 4) Pitch P: 500 μm
Width of first line 20a: 50 μm
Width of second line 20b: 100 μm
・Information section character string P 500
L1 50
L2 100
Since the inter-line area was large enough to print the entire character string, the entire information section 30 was formed in the inter-line area without removing any part of the lines. The information section 30 was arranged every 500 μm vertically and every 500 μm horizontally, as shown in FIG.

After forming the wire 20 and information section 30, silicone resin was applied to the entire surface and dried to form a coating that covered the wire 20 and information section 30.

When the medical sheet 1B of Example 2 was observed using a binocular microscope at a magnification of 40 times, the lines 20 and the information portion 30 were clearly visible. No decrease in visibility due to the coating was observed.
When a pig nerve was placed on the medical sheet 1B and observed under a binocular microscope, the dimensions such as length and diameter could be easily determined based on the lines 20 and the information portion 30.

Example 3
FIG. 6 is a schematic diagram showing a medical sheet 1C according to a third embodiment.
A rectangular silicone rubber sheet was used as the main body 10 of the medical sheet 1C. The rectangle had long sides of 15 mm and short sides 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%.

The lines 20 and the information section 30 were formed on the main body 10 by gravure printing using white ink (binder: silicone resin, pigment: titania). The ink used was a solvent with a standard drying speed and a solids content of 20%. The settings for the lines 20 and the information section 30 were as follows:
Line extension direction: perpendicular to the short side of the main body 10 Pitch P: 900 μm
Width of first line 20a: 300 μm
Width of second line 20b: 450 μm
・Information section character string P 900
L1 300
L2 450
The inter-line area was large enough to print the entire character string, so the entire information section 30 was formed in the inter-line area without removing any part of the lines. The information sections were arranged every 4500 μm vertically and every 4500 μm horizontally.

When the medical sheet 1C of Example 3 was observed using a binocular microscope at a magnification of 40 times, the multiple lines 20 and information portion 30 were clearly visible on the main body 10.
When a pig's blood vessel was placed on the medical sheet 1C and observed under a binocular microscope, the dimensions such as length and diameter could be easily determined based on the multiple lines 20 and information portion 30.

(Comparative Example)
7 is a schematic diagram of a medical sheet 1D of a comparative example. The comparative example differs from Example 3 only in the manner of the lines and information portions. The specific manner of the lines and information portions is as follows.
Line extension direction: perpendicular to the short side of the main body 10 Pitch P: 900 μm
Width of first line 20a: 600 μm
Second line: None (one line width)
Information Department None

When the comparative example medical sheet 1D was observed using a binocular microscope at 40x magnification, the lines 20 were clearly visible on the main body 10. However, when a pig's blood vessel was placed on the sheet and observed with the binocular microscope, it was difficult to determine the blood vessel diameter due to the large line width. Also, since there was only one type of line width, it was difficult to determine the blood vessel length. Furthermore, since there was no information section, it was not easy for first-time users to determine the dimensions.

Each embodiment of the present invention has been described in detail above with reference to the drawings, but the specific configuration is not limited to this embodiment, and configuration changes and combinations may be made without departing from the spirit of the present invention. Some examples of changes are given below, but these are not all inclusive and other changes are also possible. Two or more of these changes may be combined as appropriate.

In the above-described examples, there is an area without lines on the peripheral edge of the main body in a plan view, but this is not essential, and lines may be provided over the entire surface of the main body.
Small pieces may be provided protruding from the periphery of the main body to make it easier to grip with forceps or the like.
The visible light reflectance of the main body may have multiple peaks. Even in this case, as long as at least one peak is present in the wavelength range of 450 nm to 570 nm, the contrast with biological tissue will be good and visibility will be excellent.

The medical sheet of the present invention may have lines extending in different directions in areas that do not form a lattice. For example, a line may be provided in the middle of multiple lines extending in the same direction in the longitudinal direction, perpendicular to the multiple lines.
In order for the multiple lines to function as a precise scale, the object must be placed on the medical sheet so that the area to be measured is perpendicular to the multiple lines. The provision of the single line described above serves as a guide for placing the object, facilitating accurate measurements. Meanwhile, the single line provided in the middle of the longitudinal direction does not form a grid with line 20, so liquids and the like located between the multiple lines can be easily moved to either side in the longitudinal direction. Therefore, blood, bodily fluids, and the like are less likely to accumulate and interfere with dimensional measurements.

- Even if the ink that forms the lines and information areas is biocompatible, a coating may be applied. During use, saline or other liquid is continuously sprayed on the medical sheet to prevent it from drying out, and a coating can prevent the saline or other liquid from attacking the lines and information areas.

The line widths of the lines may be one type or three or more types. The medical sheet may also have multiple areas with different line pitches. Depending on the variation, an information section may be formed to display the content corresponding to each area.
Alternatively, only one second line may be provided. For example, by designating the leftmost or rightmost line of a plurality of lines arranged in the left-right direction as the second line, the second line can be easily used as a reference line for measurement. Furthermore, by forming a thin auxiliary line in a different color at the center of the width of the second line, it becomes easier to measure the dimensions of the object more accurately by aligning the edge of the object to be measured with the auxiliary line.

- The information section is not required for the sheet of the present invention and may not be provided.

1, 1A, 1B, 1C Medical sheet 10 Main body 20 Line 20a First line 20b Second line 30 Information portion P Pitch

Claims (7)

A sheet-like main body,
a plurality of lines formed on the body by printing and arranged at equal intervals and in parallel ;
an information section formed on the main body by printing and indicating widths of the plurality of lines;
Equipped with
the pitch of the lines is 1 millimeter or less;
The width of the lines is 50% or less of the pitch.
Medical sheets. The lines include a first line and a second line that is wider than the first line.
The medical sheet according to claim 1. A predetermined number of the first lines are arranged between adjacent second lines.
The medical sheet according to claim 2. a plurality of the information units are formed on the main body;
The medical sheet according to claim 1 . further comprising a coating covering the lines and the information portion;
The medical sheet according to claim 1 . The medical sheet according to claim 1, wherein at least one peak in the visible light reflectance of the main body is in the wavelength range of 450 nm to 570 nm. The visible light transmittance of the main body is 1% or less,
The peak value of the visible light reflectance of the main body is 10% or less;
The medical sheet according to claim 1.