JP6442661B2 - Radiation imaging marker and method for manufacturing radiation imaging marker - Google Patents

Description

  The present disclosure relates to a marker used when imaging a patient with radiation and a manufacturing method thereof.

  There are known methods for imaging a patient using radiation, such as computed tomography (CT) using X-rays. In such imaging, a marker (referred to as a range designation marker, a field marker, or a line marker) attached to the patient's body surface may be used (see, for example, Patent Document 1). The marker has appropriate radiopacity and appears in a radiographic image obtained by imaging the patient. Such a marker contributes, for example, to specifying a lesion range that is difficult to specify in a radiographic image without a marker in the radiographic image. As a result, for example, it is possible to accurately specify a range in which radiation is irradiated in subsequent radiotherapy. That is, a radiotherapy plan can be appropriately made.

  As a marker sold as described above, for example, a tape-like base paper and a linear marker (narrow marker in a narrow sense) provided on the adhesive surface of the base paper and narrower than the base paper. Then, for the sake of convenience, a marker body may be referred to) and a protective paper covering the marker body is known. In using this marker, first, the protective paper is peeled off and the base paper is pasted on the body surface. Next, moisture is contained in the base paper, and the base paper is peeled off leaving the marker body. Thereby, the marker body is transferred to the body surface.

JP-A-5-78534

  Such markers cause various inconveniences. For example, since the base paper is relatively hard and the base paper is wider than the marker main body and the bending in plan view is restricted, it is difficult to apply it accurately according to the shape or range of the affected area. Or poor adhesion to the body surface. In addition, since the workability is low as described above, the burden on doctors and radiographers (users) is large, and it takes time. The patient may feel pain when removing the backing paper. There is a possibility that a so-called tape rash may occur when the base paper is affixed. Therefore, it is desirable to provide a marker and a method for manufacturing the marker that can solve at least one of the above disadvantages.

  The marker which concerns on 1 aspect of this indication consists of a material containing silicone rubber or polyurethane, and a radiopaque material, and has a linear main part which has flexibility, and is more adhesive than the material of the said main part. A pressure-sensitive adhesive layer that covers at least a part of the surface of the main body portion around the cross section of the main body portion and spreads in the length direction of the main body portion. .

  In one example, the main body portion contains barium sulfate as the radiopaque material in a weight ratio of 3% to 5%.

  In one example, the cross-sectional shape of the main body and the adhesive layer as a whole has an outer edge that includes a straight line and a curve that swells to the opposite side of the straight line, and the adhesive layer includes the straight line and Constitutes a surface.

  In one example, the shape of the cross section of the main body and the adhesive layer as a whole is a semicircle having a diameter of 2 mm or more and 4 mm or less, and the height of the string from the chord is 1 mm or more and 2 mm, with one side being the chord of the semicircle. It consists of the following rectangles.

  In one example, the pressure-sensitive adhesive contains a colorant.

  A method of manufacturing a radiation imaging marker according to an aspect of the present disclosure includes: a main body material generation step of mixing a raw material of silicone rubber or polyurethane and a radiopaque material; and a material mixed in the main body material generation step. A main body forming step for forming a main body by molding into a shape, and placing and curing an uncured adhesive on the surface of the main body, and around the cross section of the main body of the surface of the main body A pressure-sensitive adhesive layer forming step of forming a pressure-sensitive adhesive layer extending in the length direction of the main body while covering at least a part.

  In one example, in the body part material generating step, the silicone rubber is generated by mixing the main agent and the curing agent in a weight ratio of 40:60 to 60:40.

  In one example, the manufacturing method further includes a pressure-sensitive adhesive generation step of mixing the main agent and the curing agent at a weight ratio of 40:60 to 60:40 to generate the uncured pressure-sensitive adhesive.

  In one example, in the body portion forming step, the mixed material is formed into a linear shape by compression molding, extrusion molding, injection molding, or supply of the material into a mold.

  In one example, in the pressure-sensitive adhesive layer forming step, the molded main body is disposed in a predetermined mold groove, and the uncured pressure-sensitive adhesive is disposed on the main body in the groove and cured.

  In one example, in the body portion molding step, the material mixed in the body portion material generation step is placed in a first mold groove, the second mold is covered with the second mold groove, and compression molding is performed. In the layer forming step, the uncured pressure-sensitive adhesive is disposed in a third mold groove, and the first mold with the main body portion cured by compression molding is disposed in the third mold groove. Cover with the main body side facing and perform compression molding again.

  According to said structure or procedure, a suitable marker is obtained.

1A and 1B are external perspective views showing a marker according to an embodiment of the present disclosure, and FIG. 1C is a cross-sectional view taken along the line Ic-Ic in FIG. FIGS. 2A to 2D are cross-sectional views showing various examples of cross sections of the marker. FIG. 3A to FIG. 3D are schematic diagrams for explaining a method of manufacturing the marker main body. FIG. 4A to FIG. 4C are schematic views for explaining a method of manufacturing the adhesive layer of the marker. Fig.5 (a)-FIG.5 (c) are the schematic diagrams for demonstrating the modification of the manufacturing method of the main-body part of a marker. The schematic diagram which shows the example of the injection molding machine which manufactures a marker. Fig.7 (a)-FIG.7 (c) are the schematic diagrams for demonstrating the modification of the manufacturing method of the adhesion layer of a marker.

<Marker configuration>
(Outline of marker)
FIG. 1A and FIG. 1B are external perspective views showing a marker 1 according to an embodiment of the present disclosure. FIG. 1C is a cross-sectional view taken along the line Ic-Ic in FIG. 1B, and shows a cross section of the marker 1. In FIG. 1C, hatching indicating a cross section is omitted.

  The marker 1 is a linear (string-like) member as a whole and has flexibility. The marker 1 is affixed to the patient's body surface and imaged with the patient. The imaging uses radiation such as X-rays and is performed by, for example, a CT apparatus. The marker 1 is produced as a disposable thing which is not reused, for example. However, the marker 1 may be reused. The marker 1 may be affixed to the patient's body surface as it is, or may be cut to an appropriate length by the user and affixed to the patient's body surface. From another viewpoint, the length of the marker 1 in the distribution stage may be arbitrarily set.

  In FIG. 1A, the marker 1 is wound. In FIG.1 (b), the marker 1 is linear. 1A shows the marker 1 that is wound when no or little external force is applied, and FIG. 1B shows the case where no or little external force is applied. Alternatively, it may be considered that the marker 1 is a straight line. Unlike this, FIGS. 1A and 1B are identical to each other when no or almost no external force is applied. It may be considered that the marker 1 having a shape shows a state in which it is deformed by receiving different external forces. The shape when no or little external force is applied has been mentioned, but the marker 1 generates almost no restoring force to return to a wound shape or linear shape, and no or little external force is applied. The shape of the time may not be clear.

  The dimension of the marker 1 may be appropriately set according to the needs from the medical site. For example, the length of the marker 1 of the type assumed to be cut and used by the user in the distribution stage is 200 mm or more and 1000 mm or less. Moreover, the diameter (for example, maximum diameter) of the marker 1 is 2 mm or more and 4 mm or less, for example.

  In addition, when the marker 1 is linear (string shape), the length is sufficiently larger than the diameter. For example, the length is 5 times or more or 10 times or more of the maximum diameter. On the contrary, in the present application, the term “linear” does not require any condition other than that the length is sufficiently larger than the diameter. For example, even a cylindrical shape is included in the linear shape.

(Marker structure and cross-sectional shape)
The marker 1 includes a linear main body 3 and an adhesive layer 5 spreading in the length direction of the main body 3 while covering at least a part of the surface of the main body 3 around the transverse section of the main body 3. have. The main body 3 is a main part of the marker 1 and contributes, for example, to ensuring the strength of the marker 1 and exhibiting radiopacity. The adhesive layer 5 is a part that exhibits adhesiveness for attaching the marker 1 to the body surface of the patient.

  As understood from the above, the marker 1 has the adhesive layer 5 side (planar portion) attached to the patient's body surface. When the marker 1 has a shape wound when no or little external force is applied, the relative relationship between the shape of the cross section of the marker 1 and the winding direction is arbitrary. For example, in the example of FIG. 1A, the planar portion faces inward, but the planar portion may face in the axial direction or may face outward.

  The structure of the marker 1 in the cross section (the structure in which the adhesive layer 5 covers the main body 3) and the shape and dimensions of the cross section of the main body 3 and the adhesive layer 5 are constant over the entire length of the marker 1, for example. Therefore, the description made with reference to FIGS. 1C and 1C is common to the entire length of the marker 1. However, the structure, shape and / or dimensions in the cross section may not be constant over the entire length of the marker 1. For example, a flange portion whose diameter is increased in the cross section or a notch portion whose diameter is reduced in the cross section may be provided at predetermined intervals in the length direction. For example, the end surface of the marker 1 may be rounded.

  The shape of the cross section of the main-body part 3 has the semicircle 3a and the rectangle 3b which makes the string of the semicircle 3a one side, for example. In another aspect, the shape has an outer edge including a straight line (one side opposite to the semicircle 3a of the rectangle 3b) and a curve (an arc of the semicircle 3a) that swells to the opposite side of the straight line. Yes. The cross-sectional shape of the adhesive layer 5 is, for example, a rectangle in which one side of the rectangle 3b of the main body 3 opposite to the semicircle 3a is one side. Therefore, the shape of the entire cross-section of the marker 1 is a shape having a semicircle (3a) and a rectangle (3b and 5) having a semicircle diameter as one side. In another aspect, the shape has an outer edge that includes a straight line and a curve that swells away from the straight line.

  Either the height ht and the width w of the entire marker 1 may be large. In the example shown in the figure, both are substantially equal. The overall height h1 of the main body 3 is larger than the thickness t2 of the adhesive layer 5, for example. Alternatively, the overall cross-sectional area of the main body 3 is larger than the cross-sectional area of the adhesive layer 5. Thereby, for example, the main body 3 is dominant in properties such as elasticity and radiopacity of the marker 1 as a whole. Either the thickness t1 of the rectangle 3b of the main body 3 or the thickness t2 of the adhesive layer 5 may be thick.

  Specific values of various dimensions may be set as appropriate. An example is given below. The radius r is 1 mm or more and 2 mm or less. The width w of the marker 1 (the diameter of the semicircle 3a, the width of the main body 3 and the width of the adhesive layer 5) is 2 mm or more and 4 mm or less. The thickness t1 of the rectangle 3b is not less than 0.5 mm and not more than 1 mm. The thickness t2 of the adhesive layer 5 is not less than 0.5 mm and not more than 1 mm. The height h1 of the main body 3 as a whole is 1.5 mm or more and 3 mm or less. The overall height ht of the marker 1 is 2 mm or more and 4 mm or less.

(Marker characteristics)
The marker 1 (main body part 3 and adhesive layer 5) has flexibility. In addition, when described in a confirming manner, the flexibility is a property capable of bending (bending) at room temperature. The normal temperature is, for example, 20 ° C. ± 15 ° C. (5 ° C. or more and 35 ° C. or less) defined by JIS (Japanese Industrial Standard). The bending of the marker 1 is realized by the viscoelasticity of the marker 1, for example. The SS curve may be appropriate. The marker 1 can be bent with a relatively large curvature, for example. For example, even if the marker 1 is bent so as to be folded 180 °, it does not completely break. Since the marker 1 is provided with flexibility, for example, the marker 1 can be in close contact with the body surface having a complicated three-dimensional shape, or can appropriately surround a lesion area having a complicated planar shape.

  The adhesive layer 5 has adhesiveness. In addition, when it is described in a confirming manner, the adhesiveness is a property that adheres to the adherend when it is pressed against the subject at a normal temperature (with a relatively small pressure), and is distinguished from a property that adheres by solidification. . From another viewpoint, the surface of the pressure-sensitive adhesive layer 5 is maintained in a so-called sticky state. The pressure-sensitive adhesive layer 5 is applied to the body surface by the pressure-sensitive adhesive force of the pressure-sensitive adhesive layer 5 itself, for example, without the need for an adhesive or by volatilizing water, because the pressure-sensitive adhesive layer 5 is provided with pressure-sensitive adhesiveness. Can be glued.

  Regarding the adhesiveness of the adhesive layer 5, the adhesive force (peeling force), tack (adhesiveness in a narrow sense), and cohesive force (holding force) may be set as appropriate. However, the adhesive strength of the adhesive layer 5 may be made relatively small. By making the adhesive force relatively small, for example, it is possible to reduce the risk of the patient feeling pain when peeling off. In addition, the user can easily remove his / her finger from the marker 1 and workability is improved. Specifically, for example, when the adhesive force is expressed by a force (N / 10 mm) when a tape of 10 mm width attached to a stainless steel plate is folded back 180 degrees in the longitudinal direction and peeled off, the adhesion of the material of the marker 1 The force is 1 N / 10 mm or less. This size is less than the adhesive strength of the paper adhesive tape used for light packaging and the like.

  The main body 3 is given radiopacity so as to appear in a radiographic image. The impermeability may be due to radiation absorption or due to radiation reflection. The degree of radiopacity may be set as appropriate. For example, the degree of radiopacity is set so that the main body 3 has a CT value (for example, an average value in the entire volume of the main body 3) of 0 or more, 50 or more, 100 or more, or 150 or more. Further, for example, in the main body 3, the degree of radiopacity is set so that the CT value is 800 or less, 300 or less, or 100 or less. Note that the lower limit value and the upper limit value of the CT value of the main body 3 may be appropriately combined as long as the lower limit value does not exceed the upper limit value. Further, the CT value of the main body 3 may be smaller than the lower limit value or larger than the upper limit value.

  Here, the CT value of water is 0, the CT value of soft tissue is about −50, the CT value of brain or liver is 35 to 100, the CT value of lung is −800 to −700, and the CT value of bone is 800 to 1000. It is. Therefore, if the degree of radiopacity of the main body 3 is equal to or higher than the above lower limit value, for example, it can sufficiently function as a marker. In addition, if the degree of radiopacity of the main body 3 is equal to or less than the above upper limit value, for example, the possibility of artifacts caused by the main body 3 is reduced. The main body 3 may be set to a radiopaque degree as a general purpose thing that may be used in any part of the human body, or as a radiopaque substance suitable for a specific part. The degree may be set.

  In addition, you may provide adhesiveness not only to the adhesion layer 5 but to the main-body part 3. Further, not only the main body 3 but also the pressure-sensitive adhesive layer 5 may be imparted with radiopacity.

(Material for main body)
The material of the main body 3 includes silicone rubber or polyurethane (urethane resin) as a main component and includes a radiopaque material (for example, an X-ray opaque material). By using silicone rubber or polyurethane as a main component, for example, it becomes easy to impart appropriate elasticity to the main body 3. In addition, it is also possible to provide adhesiveness. Moreover, by including the radiopaque material in the marker 1, the radiopacity of the marker 1 can be adjusted as appropriate, and the marker 1 can be clearly reflected in the radiographic image. The main component is, for example, a component that exceeds at least 50 wt% of the material.

  The silicone rubber, polyurethane and / or radiopaque material is preferably of medical grade. That is, these materials are preferably manufactured in a factory that has received medical certification for the production process. As for the silicone rubber, a medical grade liquid silicone used as an adhesive for medical devices may be used. Moreover, it is preferable that the material of the main body part 3 after mixing and the marker 1 manufactured using the material are also certified for medical use. The certification authority may be, for example, in the country where the marker 1 is implemented.

(silicone rubber)
The specific composition or structure of the silicone rubber may be a known appropriate one. Silicone (silicone rubber) here has a basic structure consisting of siloxane bonds in which silicon and oxygen are alternately bonded, and has not only a polymer compound (silicone in a narrow sense) with organic groups bonded, but also material properties. It shall include what is conventionally called silicone rubber obtained by mixing various materials with narrowly defined silicone rubber for adjustment and the like.

  The silicone rubber may be a liquid silicone rubber having a relatively low viscosity in the raw material stage (before curing), or may be a millable silicone rubber having a relatively high viscosity. From another viewpoint, the silicone rubber before curing may have a relatively low degree of polymerization or a molecular weight, or may have a relatively high level. The degree of polymerization of the liquid silicone rubber is, for example, 100 or more and 2,000 or less. The degree of polymerization of the millable silicone rubber is, for example, not less than 3,000 and not more than 10,000.

  The liquid silicone rubber may be a one-component type that cures by reacting with moisture in the atmosphere, or a two-component (or three-component) type that cures by mixing a curing agent with the main agent. There may be. The liquid silicone rubber may be a condensation type that generates a condensation product upon curing, or an addition type that cures by an addition reaction. The liquid silicone rubber may be a room temperature curing type that cures at room temperature, or may be a heat curing type that is cured by heating or that accelerates curing.

  In the two-component liquid silicone rubber, the specific composition or structure of the main agent containing the silicone polymer and the curing agent for crosslinking and curing the silicone polymer may be various known ones. The curing agent may be one in which the crosslinking agent and the catalyst are separated and stored until mixing with the main agent, or may be stored in a mixed state. The main agent or curing agent may contain appropriate additives such as a filler that reinforces strength, an additive that adjusts the softness of silicone rubber, or an additive that promotes or inhibits curing.

  Examples of the two-component liquid silicone rubber used for the material of the main body 3 include “QP1-20A & 20B”, “QP1-30A & 30B”, and “QP1-40A & 40B” manufactured by Toray Dow Corning Co., Ltd. In the above, the numerical values 20, 30, and 40 indicate Shore hardness. For example, “QP1-20A & 20B” indicates that the Shore hardness is 20 °.

  In the two-component silicone rubber, it is possible to appropriately adjust properties such as elasticity and / or adhesiveness by appropriately setting the weight blending ratio of the main agent and the curing agent. Depending on the specific composition or structure of the main agent and the curing agent, for example, by setting the weight ratio of the main agent and the curing agent to 40:60 to 60:40 (for example, 1: 1), suitable elasticity and / or Or adhesiveness is obtained. The same applies to “QP1-20A & 20B”, “QP1-30A & 30B” and “QP1-40A & 40B”.

(Polyurethane)
The specific composition or structure of the polyurethane may be various known ones. The polyurethane referred to here is not only a polymer compound having a urethane bond (a narrow definition polyurethane), but also a customary product obtained by mixing various materials with a narrow definition polyurethane in order to adjust the properties of the material. In particular, what is called polyurethane (or urethane resin or urethane resin) is included.

  The polyurethane may be a one-component type that cures by reacting with oxygen or moisture in the atmosphere in the raw material stage (before curing), or a main component containing a polymer compound having a hydroxyl group (for example, a polyol). And a curing agent containing a polymeric compound having an isocyanate group (for example, polyisocyanate) may be mixed and cured. In the two-component polyurethane, the specific composition or structure of the main agent and the curing agent may be various known ones. Moreover, the main agent or the curing agent may contain a plasticizer for softening the polyurethane in a relatively large proportion (for example, a proportion larger than that of the polyol).

  Examples of the polyurethane used for the material of the main body 3 include “Polycrystal PC-00N” manufactured by Polysys Co., Ltd.

  In a two-component polyurethane, elasticity and / or adhesiveness can be adjusted by appropriately setting a weight blending ratio of the main agent and the curing agent. Depending on the specific composition and structure of the main agent and the curing agent, suitable elasticity and / or tackiness can be obtained, for example, by setting the weight ratio of the main agent and the curing agent to 100: 40 to 100: 60. . The same applies to the above-mentioned “polycrystal PC-00N”.

(Radiopaque material)
Since the radiopaque material imparts radiopacity to the main body 3 mainly composed of silicone rubber or polyurethane, it is at least more radiopaque than silicone rubber or polyurethane. Examples of such materials include barium sulfate, kaolin, bentonite, talc, aluminum silicate, magnesium silicate, silica sand, alumina, illite, vermiculite, nontronite, saponite, chlorite, allophane, calcium phosphate, iron powder. And silicon carbide, silicon nitride and zirconia.

  For example, the radiopaque material is added to silicone rubber or polyurethane, which is the main component, in an amount that does not significantly impair their flexibility (viscoelasticity). In addition, the radiopaque material may be added in an amount such that the CT value of the main body 3 is equal to or greater than any one of the lower limit values described above. For example, the radiopaque material is added in a weight ratio of 3% to 5% (for example, 4%) with respect to the total weight of the main body 3.

(Adhesive layer material)
The material (adhesive) constituting the adhesive layer 5 may be an appropriate material having higher adhesiveness than the material of the main body 3. For example, the pressure-sensitive adhesive may be mainly composed of silicone rubber or polyurethane. The description of the silicone rubber or polyurethane as the material of the main body 3 may be the description of the silicone rubber or polyurethane as the material of the adhesive layer 5 except for a specific composition.

  For example, the silicone rubber or polyurethane as the material of the pressure-sensitive adhesive layer 5 is not limited to a narrow sense, and the viscosity before curing may be an appropriate value, may or may not be two-component, The curing chemical reaction may also be appropriate. In addition, it is preferable that the material contained in the adhesive layer 5, the material of the adhesive layer 5 after mixing, and the marker 1 produced using the material be certified for medical use, as described in the main body 3. is there.

  As described in the explanation of the material of the main body 3, the two-component silicone rubber or the like can be adjusted in characteristics such as adhesiveness by appropriately setting the weight blending ratio of the main agent and the curing agent. It is. Although it depends on the composition or structure of the specific main agent and curing agent, suitable adhesiveness can be obtained, for example, by setting the weight ratio of the main agent and the curing agent to 40:60 to 60:40 (eg, 1: 1). can get.

  Examples of the two-component silicone rubber used for the material of the adhesive layer 5 include “MG7-9800A & B”, “MG7-9850A & B”, and “MG7-9900A & B” manufactured by Toray Dow Corning Co., Ltd. In these cases, suitable tackiness can be obtained by setting the weight ratio of the main agent and the curing agent to 40:60 to 60:40 (for example, 1: 1).

  In addition, with respect to the above “MG7-9800A & B”, “MG7-9850A & B” or “MG7-9900A & B”, “QP1-20A & 20B”, “QP1-30A & 30B”, or “QP1- 40A & 40B "may be mixed. Thereby, the intensity | strength of the adhesion layer 5 can be improved, for example. As described above, the mixing ratio of the main agent and the curing agent in the former (“MG7-9800A & B”, etc.) and the mixing ratio of the main agent and the curing agent in the latter (“QP1-20A”, etc.), for example, are as follows. The weight ratio is 40:60 to 60:40 (for example, 1: 1). Further, the ratio of the latter (“QP1-20A” or the like) in the adhesive layer 5 is, for example, 50% or less by weight.

  The material of the adhesive layer 5 may contain an appropriate colorant. Thereby, for example, when the colors of the material of the main body 3 and the material of the adhesive layer 5 are close, it is easy to distinguish between them, and it is easy to recognize the adhesive surface. The colorant may be a pigment or a dye. The colorant may be an inorganic material or an organic material. The amount of the colorant added may be, for example, as long as the distinction between the adhesive layer 5 and the main body 3 can be facilitated as described above.

(Modified example of cross-sectional shape of marker)
The cross-sectional shape of the marker 1 may be an appropriate shape other than that shown in FIG. Below, some modified examples are given. In the following, for convenience of explanation, the same reference numerals as those in the embodiment are used.

  FIGS. 2A to 2D are cross-sectional views showing examples of cross sections of the marker 1. However, hatching indicating a cross section is omitted.

  In FIG. 2A, the arcuate portion (the semicircle 3a in the embodiment) of the main body 3 has a shape obtained by cutting an ellipse along the long axis. Thus, the arcuate portion of the main body 3 is not limited to a semicircle. In another aspect, the curvature of the curve may not be constant. In addition, the arcuate portion may be, for example, a shape obtained by cutting a circle with a chord closer to the arc than the center thereof, a shape obtained by cutting an ellipse with a short axis, or a curved portion as appropriate. It may be expressed by a function of a certain order. In the illustrated example, the height ht is smaller than the width w. However, in such a modified example, either the height ht or the width w may be larger.

  In FIG.2 (b), the shape of the cross section of the main-body part 3 is a shape which eliminated the rectangle 3b from the main-body part 3 of embodiment. In the illustrated example, the shape of the main body 3 is a semicircle, but as described in the description of the modified example of FIG. 2A, it may have various shapes other than the semicircle. It is the same as in FIG. 2A that either the height ht or the width w may be large.

  In FIG.2 (c), the shape of the cross section as the marker 1 whole is a square. Thus, the marker 1 may not have a curved portion. Although a square is illustrated here, it may be a polygon other than a rectangle.

  In FIG.2 (d), the shape of the cross section as the marker 1 whole is a rectangle with which the main-body part 3 and the adhesion layer 5 were laminated | stacked on the transversal direction. That is, the height ht is smaller than the width w. However, even when the cross section of the marker 1 is a rectangle or a polygon other than a rectangle, either the height ht and the width w may be larger.

  2 (a), 2 (b), and 2 (d), the shape of the modified example illustrated in FIGS. 2 (a), 2 (b), and 2 (d) is the height of the marker 1 in the stacking direction of the main body 3 and the adhesive layer 5 from another viewpoint. It is thin that ht is smaller than the width w of the marker 1. Such a thin shape facilitates the bending of the marker 1 to the adhesive layer 5 side or the opposite side, for example. On the contrary, when the width w of the marker 1 is smaller than the height ht of the marker 1, the marker 1 is easily bent in a direction parallel to the adhesive surface. Depending on the performance required of the marker 1, the height ht and the width w may be set as appropriate.

<Marker manufacturing method>
(Manufacturing method of main body)
FIG. 3A to FIG. 3D are schematic views for explaining an outline of an example of a method for manufacturing the main body 3.

  First, as shown in FIG. 3A, the material of the main body 3 is generated. Specifically, for example, two-component liquid silicone rubber or two-component polyurethane main agent 11 and curing agent 13 are mixed. Moreover, the radiopaque material 15 is added to these. Note that any two of the main agent 11, the curing agent 13, and the radiopaque material 15 may be mixed first, or three may be mixed simultaneously.

  In FIG. 3A, the case where the silicone rubber or polyurethane is two-component is taken as an example, but it may be one-component as described above. In this case, for example, when forming uncured silicone rubber or uncured polyurethane, the radiopaque material 15 may be added.

  Next, as shown in FIGS. 3B to 3D, a mixed material 17 in which the radiopaque material 15 is added to uncured silicone rubber or uncured polyurethane is molded by compression molding.

  For example, a lower mold 71 (first mold) having a groove 71a formed on the upper surface and an upper mold 73 (second mold) having a flat lower surface are prepared. The shape and length of the cross section of the groove 71 a are the same as the shape and length of the cross section of the main body 3, and the bottom side of the groove 71 a is the curved side of the main body 3.

  Then, as shown in FIG. 3C, the mixed material 17 is disposed on the upper surface (groove 71a) of the lower mold 71, the upper mold 73 is disposed thereon (the upper mold 73 is placed on the groove 71a), and the lower mold 71 is disposed. The mixed material 17 is heated while being compressed (pressurized) with the mold 71 and the upper mold 73 to cure the mixed material 17. The pressurization and heating are performed by, for example, a compression molding machine. An oven can be used instead of the compression molding machine.

  Although not particularly illustrated, before the mixed material 17 is placed on the lower mold 71, a process such as defoaming may be appropriately performed. Moreover, as already described, a room temperature curable type may be used as the silicone rubber or polyurethane, and the mixed material 17 compressed by the lower mold 71 and the upper mold 73 may be cured at room temperature.

(Method for producing adhesive layer)
FIG. 4A to FIG. 4C are schematic views for explaining an outline of an example of a method for manufacturing the adhesive layer 5.

  First, as shown to Fig.4 (a), the material (adhesive) of the adhesion layer 5 is produced | generated. Specifically, for example, a two-component liquid silicone rubber or a two-component polyurethane main agent 81 and a curing agent 83 are mixed. Moreover, the coloring agent 85 is added to these. Any two of the main agent 81, the curing agent 83, and the colorant 85 may be mixed first, or three may be mixed simultaneously. As described above, the pressure-sensitive adhesive may be one-component, and the colorant 85 may not be added.

  As shown in FIG. 4 (b), the prefabricated main body 3 is placed in the groove 87a of the mold 87 before the production of the material as described above, in parallel with the production or without much time after the production. To do. The shape and length of the cross section of the groove 87a are, for example, the same as the shape and length of the cross section of the entire marker 1. In other words, the groove 87a is deeper than the height h1 of the main body 3 by the thickness t2 of the adhesive layer 5. Therefore, the main body 3 is fitted in the groove 87a, and a groove having a thickness t2 is formed above the main body 3.

  And as shown in FIG.4 (c), the adhesive produced | generated by Fig.4 (a) is poured into the groove | channel 87a in which the main-body part 3 is arrange | positioned. At this time, for example, the adhesive is supplied so that the adhesive substantially fills the groove 87a. Thereafter, the pressure-sensitive adhesive is cured. Thereby, the adhesion layer 5 is formed. Curing may be performed at normal temperature or by heating by an oven 75.

  As described above, when the adhesive layer 5 is formed by disposing the adhesive in the groove 87 a and on the main body 3, it is easy to ensure the thickness of the adhesive layer 5. Note that the difference between the depth of the groove 87a and the height h1 of the main body 3 may be larger or smaller than the thickness t2 of the adhesive layer 5.

(Modification of the molding method of the main body)
The main body 3 may be molded by various methods other than compression molding. Below are some examples.

  In the example of FIG. 5A, the main body 3 is produced by extrusion molding. That is, when the mixed material 17 in the cylinder 19 is pushed out of the opening 19h of the cylinder 19 by the plunger 21, the main body 3 is formed in a linear shape having the same shape and dimensions as the opening 19h. The plunger 21 may have a screw shape.

  In the example of FIG. 5B, the main body 3 is produced by molding the mixed material 17 in the mold 25. Specifically, a groove is formed on the upper surface of the mold 25, and the marker 1 is formed by pouring the mixed material 17 into the groove.

  In the example of FIG. 5C, the main body 3 is manufactured by molding the mixed material 17 in the molds 29 and 31 as in FIG. 5B. However, specifically, the main body 3 is molded by injection molding. That is, the mixed material 17 is extruded and filled by the plunger 33 into the hole formed between the molds 29 and 31. The plunger 33 may have a screw shape.

  FIG. 6 is a schematic diagram showing an example of the configuration of an injection molding machine 41 called LIM (Liquid Injection Molding). The main body 3 may be formed using such an injection molding machine 41.

  In the illustrated example, the injection molding machine 41 injects the mixed material 17 in the cylinder 43 into the molds 47 and 49 with the screw 45. The mixed material 17 is mixed by an apparatus in the injection molding machine 41 immediately before injection.

  The injection molding machine 41 is configured to mix the mixed material 17, for example, separately supply the main agent and the curing agent and supply them by a pump or the like, and supply the main agent and the curing agent from the supply units 51 A and 51 B. It has weighing units 53A and 53B for individually weighing, and a mixing unit 55 for mixing the main agent and the curing agent weighed by the weighing units 53A and 53B. The mixing unit 55 has, for example, a dynamic mixer (not shown) or a static mixer.

  The radiopaque material may be included in the main agent or the curing agent in the supply unit 51A or 51B, and is supplied to the mixing unit 55 by a supply unit and a metering unit (not shown) in the same manner as the main agent or the curing agent. May be.

(Modified example of manufacturing method of adhesive layer)
Fig.7 (a)-FIG.7 (c) are schematic diagrams for demonstrating the modification of the manufacturing method of an adhesion layer.

  This modification is based on, for example, the manufacturing method of the main body 3 according to the embodiment described with reference to FIGS. 3 (a) to 3 (d). That is, the main body 3 is formed by compression molding using the lower mold 71 and the upper mold 73. Moreover, the production | generation method of the material of the adhesion layer 5 may be the same as the method of embodiment demonstrated with reference to Fig.4 (a).

  As shown in FIG. 7A, in this modification, a lower mold 89 (third mold) having a groove 89a on the upper surface is prepared. The shape and length of the cross section of the groove 89a are, for example, the same as the shape and length of the cross section of the adhesive layer 5.

  Then, as shown in FIG. 7B, the material 91 to be the adhesive layer 5 generated in FIG. 4A is poured into the groove 89a. At this time, the material 91 is supplied in an amount slightly larger than the volume of the groove 87a, for example.

  Next, as shown in FIG. 7C, the lower mold 71 is put on the groove 89 a of the lower mold 89. The lower die 71 has been described with reference to FIG. 3D, and the main body 3 that has been cured by being compressed and heated by compression molding is disposed in the groove 71a of the lower die 71. Has been. The lower mold 71 is arranged with the groove 71 a side facing the groove 89 a of the lower mold 89, and the main body 3 abuts on the material 91.

  Then, the material 91 is heated and pressurized by the lower mold 89 and the lower mold 71. That is, compression molding is performed again. Here, the lower mold 71 functions as an upper mold. By compression molding, the material 91 is cured, and the adhesive layer 5 bonded to the main body 3 is formed.

  Heating and pressurization are performed by, for example, a compression molding machine. It is also possible to carry out with an oven. During the compression molding, the overflowing material 91 flows out of the groove 89a. The main body 3 may be completely cured at the stage of FIG. 3D, or may be completely cured at the stage of FIG. The heat at the time of FIG.3 (d) may remain in the lower mold | type 71 and / or the main-body part 3 in the case of FIG.7 (c), and does not need to remain.

  As described above, in the present embodiment, the marker 1 includes the main body 3 and the adhesive layer 5. The main body 3 is made of a material 17 containing silicone rubber or polyurethane and a radiopaque material 15 and has a flexible linear shape. The adhesive layer 5 is made of an adhesive having higher adhesiveness than the material of the main body 3, covers at least a part of the surface of the main body 3 around the cross section of the main body 3, and extends the length of the main body 3. It spreads in the direction.

  Therefore, for example, the marker 1 can be in close contact with the body surface, and its adhesion is maintained. As a result, for example, the protective paper and the base paper are not necessary for the marker 1. And flexibility is not restrict | limited by a base paper, and a patient does not feel pain when peeling a base paper. Furthermore, for example, it is possible to peel off a part of the marker 1 attached to the patient and to apply it again with a slight shift in position, so that fine adjustment of the attachment position of the marker 1 is easy. That is, workability is high. Further, for example, silicone rubber and polyurethane have a low influence on the human body, and the burden on the patient is reduced. Since a radiopaque material is included, it is possible to clearly display a marker on a radiographic image while selecting a material (for example, silicone rubber or polyurethane) preferable in terms of flexibility and elasticity as a main component of the main body 3. it can. By configuring the marker 1 with the main body 3 and the adhesive layer 5, for example, the elasticity (main body 3) and the adhesiveness (adhesive layer 5) are separately adjusted to realize a suitable marker 1 as a whole. it can.

  In the present embodiment, for example, the main body 3 includes barium sulfate as the radiopaque material 15 in a weight ratio of 3% to 5%. Therefore, moderate impermeability can be imparted to the silicone rubber or polyurethane.

  In this embodiment, the shape of the cross section as the main-body part 3 and the adhesion layer 5 whole has an outer edge containing a straight line and the curve which swells on the opposite side to the said straight line. The pressure-sensitive adhesive layer 5 constitutes a surface that becomes the straight line.

  Therefore, for example, adhesion to a relatively flat body surface is improved. On the other hand, since the opposite side is rounded, for example, when the marker 1 is deformed, the risk of the marker being damaged due to stress concentration is reduced.

  In this embodiment, the shape of the cross section of the main body 3 and the adhesive layer 5 as a whole is such that the height from the string is a semicircle 3a having a diameter of 2 mm or more and 4 mm or less, and the string of the semicircle 3a is one side. It consists of a rectangle (3b and 5) of 1 mm or more and 2 mm or less.

  If the diameter is such a size, for example, the marker 1 is copied sufficiently clearly in the radiation image. Moreover, flexibility is improved by the relatively small diameter, for example. In addition, since the height ht and the width w are about the same size, flexibility can be exhibited in various directions. As a result, for example, it can be easily pasted on a body surface having a complicated three-dimensional shape, or pasted so as to surround a lesion area having a complicated planar shape. Further, the small diameter makes it possible to accurately indicate the boundary of the lesion range, for example.

  In addition, this invention is not limited to the above embodiment, You may implement in a various aspect.

  In the embodiment, the marker is composed only of a main body part that includes silicone rubber or polyurethane as a main component and includes a radiopaque material, and an adhesive layer that covers a part of the main body part. However, a part formed of a material other than the above material may be present in a part of the longitudinal direction and / or a part of the cross section. For example, the marker may have a core wire made of another material, or may have a mark made of another material and arranged at a predetermined interval in the length direction. The marker may be covered with an appropriate paper or film before being attached to the body surface (for example, at the distribution stage).

  In the embodiment, the adhesive layer covered only a part of the surface of the main body portion around the cross section. However, the pressure-sensitive adhesive layer may cover the entire circumference around the transverse section of the main body.

  In embodiment and the modification, the case where the surface where the adhesion layer of a main-body part is arrange | positioned, and the outer surface of an adhesion layer are planes was illustrated as the shape of the cross section of a marker. However, the adhesive layer may be disposed on the curved surface of the main body, or the outer surface of the adhesive layer may be formed in a curved shape. Further, in the embodiment and the modification, the cross section shows only the shape that bulges outward (the shape that is convex in mathematics), but it may be a non-convex shape. For example, the marker may have a recess in the cross section by forming a spiral groove on its outer peripheral surface or by forming a groove parallel to the length direction.

  The marker manufacturing method is not limited to that exemplified in the embodiment. For example, a 3D printer may be used as appropriate, a sheet may be cut to form a linear marker, or a marker may be formed by attaching a material to the core wire.

  Moreover, the formation method of an adhesion layer is not limited to the method of arrange | positioning an adhesive on the main-body part arrange | positioned at the groove | channel of a type | mold, You may just apply | coat an adhesive to a main-body part.

DESCRIPTION OF SYMBOLS 1 ... Marker, 3 ... Main-body part, 5 ... Adhesive layer, 15 ... Radiopaque material.

Claims (10)

A linear body portion made of a material containing silicone rubber or polyurethane and a radiopaque material, and having flexibility;
It is made of an adhesive having higher adhesiveness than the material of the main body, and covers at least a part of the surface of the main body around the cross section of the main body while spreading in the length direction of the main body. An adhesive layer;
A has,
The shape of the cross section of the main body and the adhesive layer as a whole has an outer edge including a straight line and a curve that swells to the opposite side of the straight line,
The adhesive layer is a marker for radiation imaging that constitutes the straight surface . The radiation imaging marker according to claim 1, wherein the main body includes barium sulfate as the radiopaque material in a weight ratio of 3% to 5%. The cross-sectional shape of the main body and the adhesive layer as a whole is a semicircle with a diameter of 2 mm or more and 4 mm or less, and a rectangle with a height from the string of 1 mm or more and 2 mm or less, with the semicircle string as one side. radiographic marker according to claim 1 or 2 comprising a. Radiographic marker according to any one of claims 1 to 3, wherein the adhesive contains a colorant. A main body material generating step of mixing a raw material of silicone rubber or polyurethane and a radiopaque material;
A body part molding step for forming the body part by linearly molding the material mixed in the body part material generation step;
An uncured adhesive is disposed on the surface of the main body and cured, and spreads in the length direction of the main body while covering at least part of the surface of the main body around the cross section of the main body. An adhesive layer forming step for forming an adhesive layer;
The manufacturing method of the marker for radiation imaging provided with this. The manufacturing method of the marker for radiographic imaging according to claim 5 , wherein in the main body material generation step, the silicone rubber is generated by mixing a main agent and a curing agent at a weight ratio of 40:60 to 60:40. The radiation imaging marker according to claim 5 , further comprising an adhesive generation step of mixing the main agent and the curing agent at a weight ratio of 40:60 to 60:40 to generate the uncured adhesive. Production method. The radiographic imaging marker according to any one of claims 5 to 7 , wherein, in the main body forming step, the mixed material is formed into a linear shape by compression molding, extrusion molding, or supply of the material into a mold. Manufacturing method. Wherein in the adhesive layer forming step, the body portion of the molded placed in a groove of a predetermined type, according to claim 5-8, wherein the curing by placing the uncured adhesive in the groove on the main body portion The manufacturing method of the marker for radiation imaging of any one of these. In the main body portion molding step, the material mixed in the main body portion material generation step is placed in the first mold groove, and the second mold is put on the first mold groove to perform compression molding,
In the pressure-sensitive adhesive layer forming step, the uncured pressure-sensitive adhesive is disposed in a third mold groove, and the main body portion cured by compression molding is disposed in the third mold groove. The manufacturing method of the marker for radiographic imaging of any one of Claims 5-8 which covers the main body part side and performs compression molding again.

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