WO2015045371A1 - シート状被覆体 - Google Patents
シート状被覆体 Download PDFInfo
- Publication number
- WO2015045371A1 WO2015045371A1 PCT/JP2014/004874 JP2014004874W WO2015045371A1 WO 2015045371 A1 WO2015045371 A1 WO 2015045371A1 JP 2014004874 W JP2014004874 W JP 2014004874W WO 2015045371 A1 WO2015045371 A1 WO 2015045371A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- sheet
- temperature
- covering
- transparent
- sensitive
- Prior art date
Links
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Images
Classifications
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- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/05—Bandages or dressings; Absorbent pads specially adapted for use with sub-pressure or over-pressure therapy, wound drainage or wound irrigation, e.g. for use with negative-pressure wound therapy [NPWT]
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- A—HUMAN NECESSITIES
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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- A61B5/01—Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue
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- A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
- A61B5/1032—Determining colour for diagnostic purposes
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- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
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- A61F13/00—Bandages or dressings; Absorbent pads
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
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- A61M2025/0266—Holding devices, e.g. on the body using pads, patches, tapes or the like
Definitions
- the present invention relates to a medical sheet-like covering.
- a chemical solution such as an anticancer drug is administered into a blood vessel through a tubular member such as a catheter inserted from outside the body into the blood vessel.
- the distal end portion of the tubular member inserted into the blood vessel may escape from the blood vessel, and the drug solution may leak out of the blood vessel.
- Patent Document 1 there is a film dressing as disclosed in Patent Document 1, for example, for fixing the tubular member to the body surface.
- the film dressing is attached so as to cover the insertion part of the tubular member into the living body, thereby fixing the catheter to the body surface and suppressing the entry of bacteria or the like from the insertion part of the tubular member into the living body.
- the leakage of the chemical solution outside the blood vessel is not limited to the case where the fixation of the tubular member to the body surface as described above is insufficient, and when the leakage of the chemical solution outside the blood vessel occurs, the skin or subcutaneous tissue In addition, not only redness and swelling occur, but also necrosis may occur, so it is desirable to be able to detect it early.
- An object of the present invention is to provide a sheet-like covering that can detect a chemical leak at an early stage even when the chemical leaks out of a blood vessel or the like.
- a sheet-like covering as a first aspect of the present invention is a sheet-like covering attached to a body surface, and is distal to a tubular member inserted from the body surface into the body. With the end indwelled in the body, a temperature-sensitive part that covers the insertion port of the tubular member on the surface of the body, is located in the vicinity of the transparent part, contacts the body surface, and changes color according to temperature. And a section.
- the temperature sensing part in a state in which the sheet-like covering is attached to the body surface so as to cover a part of the vascular vessel in the body, is configured to insert the insertion port in the transparent part. It is preferable to be located in a direction parallel to the extending direction of the vessel with respect to the covered portion.
- the temperature sensing part is configured to insert the insertion port in the transparent part. It is preferable to be located in a direction orthogonal to the extending direction of the vessel with respect to the covering portion.
- the temperature sensing part is located around at least a part of the transparent part.
- the sheet-like covering when the sheet-like covering is viewed from the thickness direction, at least a part of the outline of the temperature-sensitive part is common to a part or all of the outline of the transparent part. Is preferred.
- connection body that connects the transparent portion and the temperature sensitive portion.
- connection body is a transparent resin sheet
- the resin sheet constitutes one layer in the thickness direction of the sheet-like covering of each of the temperature-sensitive part and the transparent part. It is preferable.
- the temperature-sensitive portion includes an adhesive portion that can adhere to the body surface on a contact surface that contacts the body surface.
- the transparent portion includes a transparent adhesive portion on a surface that becomes the body surface side when the sheet-like covering is attached to the body surface.
- the temperature sensing part is laminated on the display surface side opposite to the contact surface that contacts the body surface in the temperature sensing part with respect to the resin sheet and the resin sheet. It is preferable to provide a temperature-sensitive sheet that changes color according to temperature.
- the temperature-sensitive sheet includes an adhesive portion that adheres to the resin sheet on a surface on the resin sheet side.
- the temperature sensitive sheet includes a grip portion that can be gripped when the adhesive portion is peeled from the resin sheet.
- the resin sheet when the adhesive portion of the temperature sensitive sheet is the first adhesive portion, the resin sheet is provided with a second adhesive portion that can be adhered to the body surface.
- the adhesive force of the first adhesive part to the resin sheet is preferably smaller than the adhesive force of the second adhesive part to the body surface.
- the chemical solution leakage can be detected at an early stage.
- FIG. 1 It is a figure which shows the example of the shape of the transparent part in the sheet-like coating body as this invention, a temperature sensitive part, and an extension part. It is a figure which shows the state by which the sheet-like coating body 31 as 4th Embodiment was attached to the body surface. It is a figure which shows the laminated structure in the thickness direction of the sheet-like coating body 31 in the state before use. It is a figure which shows the sheet-like coating body 41 as 5th Embodiment. It is a figure which shows the laminated structure in the thickness direction of the sheet-like coating body 41 in the state which can be attached to a body surface. It is a figure which shows the state by which the sheet-like coating body 51 as 6th Embodiment was attached to the body surface. It is a figure which shows the laminated structure in the thickness direction of the sheet-like covering 51.
- FIG. 1 and 2 show a sheet-like covering 1 which is a first embodiment as a medical sheet-like covering according to the present invention.
- FIG. 1 is a cross-sectional view showing a state in which the sheet-like covering 1 is attached to the body surface so as to cover a part of a vascular vessel in the living body.
- FIG. 2 is a view of the sheet-like covering 1 that can be attached to the body surface as viewed from the thickness direction A of the sheet-like covering 1.
- the state in which the sheet-like covering 1 can be attached to the body surface is, for example, a state in which a later-described peeling layer 61 (see FIG. 14) or the like has been removed, and is used by being attached to the body surface.
- BS represents the body surface
- VE represents the vessel.
- the sheet-like covering 1 is a distal end of a tubular member 100 that is inserted into the body from the body surface when a chemical solution such as an anticancer agent or a nutrient is administered into the body vessel. It is attached to the body surface so as to cover the insertion port 102 of the tubular member 100 on the body surface with the end 101 left in the body. By attaching the sheet-like covering 1 so as to cover the insertion port 102, it is possible to prevent bacteria and the like from entering the body from the outside through the insertion port 102.
- the “vessel” is a tube that passes through a body fluid in a living body, and examples thereof include blood vessels and lymph vessels.
- the venous blood vessels of the arm are usually used as the vascular vessels.
- the “tubular member” is a tubular member that divides a hollow portion, and includes, for example, an indwelling needle including an inner cylinder and an outer cylinder, a winged needle, a chemical solution including these needles as a part thereof, and the like. Examples include tubes for administration.
- the insertion opening of the tubular member on the body surface means an opening formed on the body surface by puncturing the tubular member on the body surface.
- the sheet-like covering 1 is transparent in the transparent portion 2 and the extending direction B of the sheet-like covering 1 (the sheet plane when the sheet-like covering 1 is viewed from the thickness direction A).
- the temperature sensing part 3 located in the vicinity of the part 2 and the extending part 4 other than the transparent part 2 and the temperature sensing part 3 are provided.
- the sheet-like covering 1 is attached on the body surface so that the transparent portion 2 covers at least the insertion port 102 of the tubular member 100 on the body surface.
- the temperature sensing part 3 is in the direction in which the blood vessel extends with respect to at least a part of the transparent part 2. And is in contact with the body surface.
- the temperature sensing unit 3 is a part that changes color according to temperature, and changes color according to temperature change of the body surface. Therefore, the temperature sensing unit 3 can visualize the temperature change of the body surface caused by the administration of a drug solution such as an anticancer agent or a nutrient to the body as a color change.
- the transparent portion 2 is a transparent region in the thickness direction A when the sheet-like covering 1 that can be attached to the body surface is viewed from the thickness direction A. More specifically, when the sheet-like covering 1 in the same state is viewed from the same direction A, the region is configured by a member having light transmittance in the thickness direction A. Since the transparent portion 2 is attached to the body surface so as to cover the insertion port 102 of the tubular member 100, the transparent portion 2 covers and protects the insertion port 102, and a user such as a medical worker inserts the insertion port. 102 can be visually recognized from the outside.
- FIG. 3 is a cross-sectional view taken along the line II in FIG. 2, showing details of the laminated structure in the thickness direction A of the sheet-like covering 1.
- the laminated structure in the thickness direction A of each of the transparent part 2, the temperature sensitive part 3, and the extending part 4 is omitted, but the actual structure is the laminated structure shown in FIG. Have.
- FIG. 3 shows the lamination relationship in each part, and does not represent the actual thickness of each layer in each part. The actual thickness of each layer is appropriately set according to the purpose and application. It is possible.
- the transparent part 2 in this embodiment is composed of a sheet-like transparent resin layer 2a.
- polyurethane is used as the material of the resin layer 2a, but the material is not limited to this material.
- acrylic polymer, polyethylene, ethylene-vinyl acetate copolymer, polyether polyester, polyamide derivative Etc. can be used.
- acrylic polymers, polyurethanes, polyether polyesters, and polyamide derivatives are suitable as materials for the resin layer 2a because they have excellent water vapor permeability and high transparency.
- the transparent part 2 in this embodiment is made into the single layer structure of the resin layer 2a, as shown, for example in FIG. 4, it is laminated
- the adhesive layer 2b comes into contact with the body surface around the insertion port 102, and bonds the transparent portion 2 and the body surface. Therefore, in the tubular member 100, in the vicinity of the insertion port 102. The movement of the part extending outside the body is suppressed. Furthermore, it is possible to further suppress the entry of bacteria or the like from the outside of the body through the insertion port 102 as compared with the configuration without the adhesive layer 2b.
- the adhesive layer 2b may be provided on a part of one surface of the resin layer 2a.
- a rubber adhesive, an acrylic adhesive, a silicon adhesive, or the like can be used, but an acrylic adhesive having high transparency is preferably used.
- connection body 8 Details of the connection body 8 will be described later.
- the transparent part 2 in this embodiment is a colorless and transparent structure, it may be colored. That is, it is good also as the colored transparent part 2 which absorbs only one part of visible light and permeate
- the transparent portion 2 in the present embodiment has a quadrangular shape when one surface of the sheet-like covering 1 is viewed from the thickness direction A, but is not limited to this shape.
- it is possible to adopt various planar shapes such as a polygonal shape such as a triangular shape, a circular shape, and an elliptical shape.
- the thickness of the transparent portion 2 in the present embodiment is 5 ⁇ m to 150 ⁇ m in consideration of the unevenness of the body surface of the living body in the vicinity of the insertion opening 102 and the followability to the shape of the portion of the tubular member 100 extending outside the body. Although it is within the range, it is possible to adopt any thickness depending on the actual use conditions such as the material and length of the tubular member 100.
- the transparent part 2 in this embodiment does not have the temperature sensitive performance which changes a color according to temperature unlike the temperature sensitive part 3 mentioned later. Therefore, in the predetermined temperature range in which the temperature sensing unit 3 changes color according to the temperature, the transparent unit 2 in the present embodiment remains colorless and transparent. The temperature sensing performance of the temperature sensing unit 3 will be described later.
- the temperature sensing unit 3 is a region that changes color according to temperature within a predetermined temperature region when the sheet-like covering 1 that can be attached to the body surface is viewed from the thickness direction A. Specifically, the temperature sensing unit 3 has a contact surface 5 in contact with the body surface and a display surface 6 on the opposite side of the contact surface 5, and the display is performed in a state where the contact surface 5 is in contact with the body surface. The surface 6 displays a color corresponding to the temperature of the body surface sensed from the contact surface 5. Accordingly, a user such as a medical worker can observe the temperature change of the body surface from the outside through the display surface 6 of the temperature sensing unit 3.
- FIG. 5 is a view showing the same cross section as FIG. 1, and the position of the distal end 101 of the tubular member 100 is different from that shown in FIG.
- the distal end 101 of the tubular member 100 is not completely located in the vessel, and a drug solution such as an anticancer agent to be administered from the tubular member 100 into the vessel
- a drug solution such as an anticancer agent to be administered from the tubular member 100 into the vessel
- the temperature of the body surface near the distal end of the tubular member 100 is changed by the leaked chemical liquid or the like (indicated by “LM” in FIG. 5).
- the temperature change is detected by the surface 5, and the temperature change is displayed as a color change by the display surface 6.
- the “color change” is a concept including not only a change from one color to another (color change) but also a color change from colorless to colored and a color disappearance from colored to colorless.
- the temperature of the body surface along the extending direction of the vessel when the drug solution can be normally administered into the vessel Since the change occurs, in addition to the case where the drug solution leaks out of the blood vessel, it is also possible to confirm that the temperature can be normally administered into the blood vessel by the temperature sensing unit 3.
- the temperature sensing unit 3 in the present embodiment is configured by laminating a plurality of layers in the thickness direction A.
- the temperature sensing part 3 in the present embodiment is laminated on one surface of the base material layer 3a including the base material layer 3a and cholesteric liquid crystal as a temperature sensitive material.
- the layer 3b, the black layer 3c as a dark color layer laminated on the opposite side of the base material layer 3a across the temperature sensitive layer 3b, and the temperature sensitive layer 3b and the black layer 3c opposite to the base material layer 3a And a surface layer 3e laminated on the side.
- the black layer 3c, the temperature sensitive layer 3b, the base material layer 3a, and the surface layer 3e are laminated in this order from the contact surface 5 toward the display surface 6.
- the “dark color” is a color with a low degree of brightness, and means a color such as black, dark green, dark blue, brown, for example.
- the base material layer 3a in the present embodiment is made of a thin transparent sheet-like polyester.
- the material of the base material layer 3a is not limited to the polyester used in the present embodiment, and may be, for example, polyamide, polyamideimide, polyethylene, polypropylene, polycarbonate, polyvinyl chloride, polyurethane, fluorine resin, or the like. .
- the thickness of the base material layer 3a is set in the range of 5 ⁇ m to 200 ⁇ m so that the temperature sensing part 3 has flexibility to follow the unevenness and shape of the body surface.
- the temperature sensitive layer 3b includes cholesteric liquid crystal as a temperature sensitive material.
- Cholesteric liquid crystal has a helical structure, and the helical pitch changes with temperature, so the wavelength of strongly reflected light also changes. Therefore, in the visible light wavelength region, the wavelength of visible light that strongly reflects changes according to the temperature, so that the color perceived through vision also changes reversibly according to the temperature.
- the temperature-sensitive layer 3b is composed of an ink formed by dispersing the above-described cholesteric liquid crystal encapsulated in a suitable binder. That is, the temperature sensitive layer 3b is formed by applying this ink to one surface of the base material layer 3a.
- the one surface of the base material layer 3a to which the ink is applied is a surface on the contact surface 5 side in the base material layer 3a.
- the thickness of the temperature sensitive layer 3b in the present embodiment is in the range of 5 ⁇ m to 100 ⁇ m in consideration of flexibility capable of following irregularities and shapes on the body surface.
- the black layer 3c emphasizes the interference color due to the light selectively reflected by the temperature sensitive layer 3b, and makes the color and color change observed on the display surface 6 clear.
- the black layer 3c is formed by applying or printing a black paint or ink on the temperature-sensitive layer 3b and laminating, but for example, a black resin sheet is laminated on the temperature-sensitive layer 3b.
- the black layer 3c may be formed by
- the thickness of the black layer 3c is preferably 3 ⁇ m to 100 ⁇ m in consideration of flexibility that can follow the unevenness and shape of the body surface.
- the temperature sensitive part 3 in this embodiment is provided with this opaque black layer 3c, it is a structure which is always opaque regardless of the inside or outside of the predetermined temperature range in which the color change can be observed.
- the surface layer 3e is a transparent resin layer having a thickness of about 5 ⁇ m to 50 ⁇ m.
- polyester, polyamide, polyamideimide, polyethylene, polypropylene, polycarbonate, polyurethane, polyvinyl chloride, fluororesin, or the like can be used as the material of the surface layer 3 e, and one surface of the surface layer 3 e constitutes the display surface 6 of the temperature sensing unit 3.
- connection body 8 is a part of the connection body 8 similarly to the resin layer 2a of the transparent part 2 mentioned above. Details of the connection body 8 will be described later.
- the temperature sensing unit 3 in the present embodiment has the above-described four-layer structure, where one surface of the black layer 3c constitutes the contact surface 5 and one surface of the surface layer 3e constitutes the display surface 6.
- one surface of the black layer 3c constitutes the contact surface 5
- one surface of the surface layer 3e constitutes the display surface 6.
- an adhesive layer 3d as an adhesive portion 7 is further laminated on the opposite side of the temperature-sensitive layer 3b and the base material layer 3a with the black layer 3c interposed therebetween. Also good.
- the adhesive layer 3d is in direct contact with the body surface, and the sheet-like covering 1 is easily fixed on the body surface.
- one surface of the adhesive layer 3 d constitutes the contact surface 5 of the temperature sensitive part 3.
- the adhesive layer 3d is made of an adhesive, and for example, an adhesive such as a rubber adhesive, an acrylic adhesive, or a silicon adhesive can be used.
- an adhesive such as a rubber adhesive, an acrylic adhesive, or a silicon adhesive
- the adhesive layer 3d as the adhesive portion 7 is provided over the entire contact surface 5 in contact with the body surface, but may be provided in a part of the contact surface 5. .
- the temperature sensing unit 3 of the present embodiment has a configuration in which a black layer 3c, a temperature sensing layer 3b, a base material layer 3a, and a surface layer 3e are laminated in this order from the contact surface 5 to the display surface 6.
- the adhesive layer 3 d ′, the base material layer 3 a ′, and the temperature sensitive layer 3 b as the adhesive portion 7 from the contact surface 5 toward the display surface 6. It is good also as the temperature sensitive part 3 'laminated
- the base material layer 3a ′ preferably has a thickness of 5 ⁇ m to 100 ⁇ m so that the temperature of the body surface can be quickly transmitted to the temperature sensitive layer 3b ′. Furthermore, in order to strengthen interference of light selectively reflected by the temperature-sensitive layer 3b ′, the base material layer 3a ′ is preferably made of a dark resin material such as black. If the base material layer 3a ′ itself is formed of a dark resin material, it is not necessary to separately provide a black layer, so that the structure of the temperature sensing portion 3 ′ can be simplified, and flexibility and thermal conductivity can be achieved by reducing the thickness. Can be better.
- the adhesive layer 3d ′ and the surface layer 3e ′ are the same as the adhesive layer 3d and the surface layer 3e described above.
- cholesteric liquid crystal is used as a temperature-sensitive material.
- metal complex salts such as Ag 2 HgI 4 , Cu 2 HgI 4 , or HgI 2 are used as inorganic materials, and spiropyrans are used as organic materials.
- fused aromatic ring compounds, substituted ethylene derivatives such as anthrone, and lactone ring compounds such as crystal violet lactone can also be used as temperature sensitive materials.
- the processing method for providing the temperature-sensitive layer 3b including the temperature-sensitive material on one surface of the base material layer 3a for example, a method of directly applying the temperature-sensitive material to one surface of the base material layer 3a.
- a method in which a temperature-sensitive material is converted into an ink using an appropriate binder and printed on the base material layer 3a can also be used.
- a temperature sensitive material as shown in FIG. 7 is used.
- the base material layer 3a ′′ is obtained by holding a temperature sensitive material such as cholesteric liquid crystal in a matrix of a polymer material.
- the structure of the surface layer 3e ′′ and the black layer 3c ′′ of the temperature sensitive part 3 ′′ is the same as the surface layer 3e and the black layer 3c of the temperature sensitive part 3 in the present embodiment, and the surface layer 3e ′′ is It becomes a part of the connection body 8 to be described later. It is also possible to laminate an adhesive layer on the black layer 3c ′′ of the temperature sensitive portion 3 ′′.
- the temperature sensing unit 3 in the present embodiment is configured such that the color changes in the range of 28 degrees Celsius to 38 degrees Celsius as a predetermined temperature range. Specifically, when the display surface 6 of the temperature sensing unit 3 is viewed from the thickness direction A, the temperature of the temperature sensing unit 3 observed on the display surface 6 is such that the temperature sensed by the temperature sensing layer 3b is less than 28 degrees Celsius. In this case, the color changes to red, orange, yellow, green, and blue as the temperature sensed by the thermosensitive layer 3b increases from 28 ° C to 38 ° C. When the temperature sensed by the temperature-sensitive layer 3b exceeds 38 degrees Celsius, the blue color remains as it is. The color of the temperature sensing part 3 changes reversibly, and when the temperature sensed by the temperature sensing layer 3b decreases from 38 degrees Celsius, blue, green, yellow, orange, red, It will change again in the order of black.
- the predetermined temperature range described above can be appropriately set by mixing a plurality of types of cholesteric liquid crystals. Therefore, considering that the temperature change on the body surface caused by leakage of chemicals and nutrients outside the blood vessel is expressed on the display surface 6 as a color change with high accuracy, the predetermined temperature range is 31 ° C to 31 ° C. A temperature of 35 ° C. is particularly preferable. If the predetermined temperature range is within the above range, the skin surface temperature of the forearm (approximately 33 ° C) falls within this range, and the temperature change on the body surface due to leakage of liquid medicine administered at a lower temperature (room temperature) Can be displayed as a change in color with higher accuracy.
- the predetermined temperature region in which the temperature sensing unit 3 changes the color is not limited to the above-described range, and can be set as appropriate according to the purpose and application. This is because the skin surface temperature varies depending on the condition of the patient, such as the season, the environment in which the drug solution is administered, the administration site, and the coldness.
- the temperature-sensitive portion is black when it is less than the predetermined temperature region and blue when it is higher than the predetermined temperature region, but the type of the temperature-sensitive material and the method of forming the temperature-sensitive portion are changed. Accordingly, it is possible to provide a temperature-sensitive portion that is colorless outside the predetermined temperature range and develops color within the predetermined temperature range.
- a temperature sensitive part may be formed by mixing a plurality of temperature sensitive materials having different predetermined temperature regions for changing the color.
- the temperature sensing unit 3 can be realized by various existing methods, and is not limited to the configuration described in the present embodiment.
- the temperature sensing unit 3 in the present embodiment has a quadrangular shape when viewed from the thickness direction A, but may be formed in various shapes depending on the positional relationship with the transparent unit 2 as described later. It is possible (see FIG. 8).
- the extending part 4 is an area other than the transparent part 2 and the temperature sensitive part 3 when the sheet-like covering 1 is viewed from the thickness direction A. As shown in FIG. 3, the extension part 4 in this embodiment is provided with the transparent resin layer 4a and the contact bonding layer 4b laminated
- the transparent resin layer 4a can use the same material as that used in the above-described transparent portion 2, and in this embodiment, a polyurethane resin is used.
- the adhesive layer 4b of the present embodiment is an opaque cloth tape made of a nonwoven fabric.
- the extension part 4 of this embodiment uses the above-mentioned opaque cloth tape as the contact bonding layer 4b, it does not comprise a part of transparent part 2.
- the transparent resin layer 4a is a part of the connection body 8 to be described later, like the resin layer 2a of the transparent part 2 and the surface layer 3e of the temperature sensitive part 3 described above. Details of the connection body 8 will be described later.
- the sheet-like covering 1 includes a connection body 8 that connects the transparent portion 2 and the temperature-sensitive portion 3, and the connection body 8 in the present embodiment is a transparent resin sheet.
- the connection body 8 constitutes one layer in the thickness direction A of the transparent portion 2, the temperature sensitive portion 3, and the extending portion 4.
- the transparent portion 2 has a single layer structure of a transparent resin layer 2 a, and the resin layer 2 a is a part of the connection body 8.
- the surface layer 3 e is a part of the connection body 8.
- the resin layer 4 a is a part of the connection body 8.
- the transparent part 2, the temperature sensitive part 3, and the extending part 4 in this embodiment are all provided with a common connection body 8 (2a, 3e, and 4a) as one layer in the thickness direction A. Is integrated.
- the transparent thin resin sheet as the connection body 8 in the present embodiment is made of polyurethane, for example, and has a thickness in the range of 5 ⁇ m to 150 ⁇ m.
- the material of the connection body 8 is not limited to polyurethane, and for example, acrylic polymer, polyethylene, ethylene-vinyl acetate copolymer, polyether polyester, polyamide derivative, and the like can be used.
- connection body 8 (2a, 3e, and 4a) and another layer are connected by adhesion
- connection body 8 in this embodiment has spread over the whole area
- stacked on may be sufficient.
- the connection body 8 constitutes the resin layer 2a of the transparent portion 2, the surface layer 3e of the temperature sensitive portion 3, and the resin layer 4a of the extending portion 4.
- the connection body 8 is limited to these layers.
- the single-layer connection body 8 constitutes all of the resin layer 2a of the transparent portion 2, the surface layer 3e of the temperature-sensitive portion 3, and the resin layer 4a of the extending portion 4. It is good also as a composite connection body which connects these several connection bodies using these connection bodies. Details of the composite connection body 48 will be described later as a fifth embodiment (see FIGS. 15 and 16A and 16B).
- the transparent part 2 and the temperature sensitive part 3 are located in the vicinity in the extending direction B of the sheet-like covering 1. With such an arrangement, the temperature sensing unit 3 can be brought into contact with the body surface near the distal end 101 of the tubular member 100 inserted from the insertion port 102 covered with the transparent unit 2. It is to become.
- the shortest distance Lmin between the transparent portion 2 and the temperature sensitive portion 3 extends from the insertion port 102 of the tubular member 100 into the body (see FIGS. 1 and 5). ) To be 5 mm.
- the length of the portion of the tubular member 100 extending from the insertion port 102 into the body is, for example, about 20 mm to 30 mm when an anticancer agent as a drug solution is administered from the venous blood vessel of the arm as a vascular vessel. If the shortest distance Lmin between the transparent part 2 and the temperature sensitive part 3 is set to 20 mm or less, the medical staff can observe through the temperature sensitive part 3 whether or not the anticancer agent is leaking from the venous blood vessel. .
- the transparent part 2 and the temperature sensitive part 3 are attached to the body surface along the extending direction of the venous blood vessel of the arm, and the insertion port 102 is covered at a position near the temperature sensitive part 3 in the transparent part 2.
- the temperature sensing part 3 can detect leakage of the anticancer agent.
- the length of the portion of the tubular member 100 that extends from the insertion port 102 into the body varies depending on the type of the tubular member, the position of the body surface into which the tubular member is inserted, and the like.
- the shortest distance Lmin can be made larger than 20 mm in a range where the temperature change of the body surface due to the above can be sensed, it is preferable that the shortest distance Lmin is set to 20 mm or less in consideration of various use conditions.
- the position of the transparent portion 2 that actually covers the insertion opening 102 differs depending on the user who handles the sheet-like covering 1, and the position of the distal end 101 of the tubular member 100 relative to the transparent portion 2 changes according to this position. Therefore, it is most preferable to arrange the transparent portion 2 and the temperature sensitive portion 3 next to each other with the shortest distance Lmin being 0 mm. Details of the configuration in which the transparent portion 2 and the temperature-sensitive portion 3 are arranged next to each other will be described later (see FIG. 10 and the like).
- the temperature sensing part 3 is a transparent part. 2, of the extending direction B of the sheet-like covering 1 with respect to the portion covering the insertion opening, is located in a direction C substantially parallel to the extending direction of the vessels. That is, when the sheet-like covering 1 is viewed from the thickness direction A, a configuration in which at least a part of the transparent part 2 and at least a part of the temperature-sensitive part 3 are arranged along the extending direction of the blood vessel. It has become.
- the transparent portion 2 covers at least the insertion port 102 on the body surface, and a portion of the tubular member 100 extending from the insertion port 102 into the body extends along the extending direction of the blood vessel. Become. Therefore, the distal end 101 of the tubular member 100 is positioned in a direction substantially parallel to the extending direction of the blood vessel with respect to the portion of the transparent portion 2 that covers the insertion port 102.
- the tubular member 100 Even if the distal end 101 of the tubular member 100 is outside the blood vessel, the possibility of positioning the temperature sensing portion 3 in the vicinity of the distal end 101 of the tubular member 100 is increased.
- the transparent portion 2 and the temperature sensitive portion 3 are both rectangular, but the transparent portion 2 and the temperature sensitive portion 3
- the shape is not limited to a quadrangular shape, and the temperature sensing unit 3 is located at least in a direction C parallel to the extending direction of the vessel with respect to the portion of the transparent unit 2 that covers the insertion port 102.
- the shape seen from the thickness direction A of the transparent part 2 and the temperature sensitive part 3 may be any shape as long as it can be attached to the body surface.
- the transparent portion 2 may be trapezoidal and the temperature-sensitive portion 3 may have a rectangular shape. As shown in FIG.
- the transparent portion 2 May have a substantially rectangular shape having a curved contour line at one end in the parallel direction C, and the temperature sensing portion 3 may have an elliptical configuration. Further, as shown in FIG. 8C, the transparent portion 2 may have an annular shape, and the circular temperature-sensitive portion 3 may be surrounded by the transparent portion 2.
- the position of the transparent part 2 and the temperature-sensitive part 3 with respect to the entire region of the sheet-like covering 1 is such that the transparent part 2 and the temperature-sensitive part 3 are in the above-described positional relationship, that is, the temperature-sensitive part 3 is the transparent part 2.
- the arrangement of the transparent portion 2 and the temperature sensitive portion 3 is such that there is no common axis of symmetry such that the transparent portion 2 and the temperature sensitive portion 3 are both line symmetrical. May be.
- each apex has a substantially quadrangular shape, or a hexagon as shown in FIG. It is also possible to use a shape or an elliptical shape as shown in FIG.
- FIG. 9 is a view of the sheet-like covering body 11 attached to the body surface so as to cover a part of the vascular vessel in the body as viewed from the thickness direction A of the sheet-like covering body 11. Similar to the sheet-like covering 1 according to the first embodiment described above, the sheet-like covering 11 is a transparent portion 12 and a temperature sensitive located in the vicinity of the transparent portion 12 in the extending direction B of the sheet-like covering 11. Unit 13.
- the broken line in FIG. 9 represents the vascular VE in the body, and more specifically represents the venous blood vessel of the arm.
- the temperature-sensitive part 13 corresponds to a part of the transparent part 12 that covers the insertion port 102.
- the sheet-shaped covering body 11 is at least positioned in a direction D (hereinafter simply referred to as “orthogonal direction D”) orthogonal to the extending direction of the blood vessels.
- the transparent part 12 is a part that covers at least the insertion slot 102, but the position of the transparent part 12 where the insertion slot 102 is covered is appropriately determined and executed by the user.
- the transparent portion 12 having a substantially rectangular shape with one end formed in a curved shape is arranged such that the long side direction of the substantially rectangular transparent portion 12 is substantially parallel to the extending direction of the blood vessel.
- the position of the transparent portion 12 that actually covers the insertion slot 102 may be close to the curved end by the user, but as shown in FIG. In some cases, it may be a remote location.
- the portion of the tubular member 100 that extends into the body is curved from the insertion port 102.
- the distal end 101 is located in a region covered with the transparent portion 12. That is, the position of the body surface in the vicinity of the distal end 101 of the tubular member 100 is also a position covered with the transparent portion 12. Therefore, in the present embodiment, the temperature sensing part 13 is provided in the vicinity in the orthogonal direction D with respect to the transparent part 12 so that leakage of the chemical solution or the like outside the vessel can be detected by the temperature sensing part 13. ing.
- the shortest distance in the orthogonal direction D between the transparent portion 12 and the temperature-sensitive portion 13 is as follows. The smaller it is, the better.
- the body in the vicinity of the distal end 101 of the tubular member 100 also depends on the width of the transparent portion 12 in the orthogonal direction D, the position in the orthogonal direction D of the portion covering the insertion port 102 with respect to the entire transparent portion 12, etc. Since the shortest distance in the orthogonal direction D between the surface portion and the temperature-sensitive part 13 changes, the shortest distance between the transparent part 12 and the temperature-sensitive part 13 in the orthogonal direction D in the extending direction B of the sheet-like covering 11.
- the transparent portion 12 and the temperature-sensitive portion 13 are arranged adjacent to each other with 0 mm. Details of a configuration in which the transparent portion 12 and the temperature sensitive portion 13 are arranged adjacent to each other in the orthogonal direction D will be described later (see FIG. 10 and the like).
- the width in the orthogonal direction D of the transparent portion 12 in the present embodiment is set to 10 mm or more from the viewpoint of ensuring sufficient visibility of the insertion port 102 and maintaining operability when the user attaches the sheet-like covering body 11.
- the width of the transparent portion 12 in the orthogonal direction D is set so that the temperature sensing portion 13 can easily detect the leakage of the chemical solution outside the vessel from the distal end 101 of the tubular member 100 located in the vicinity of the vessel. 30 mm or less.
- the first temperature sensing unit 130 and the second temperature sensing unit 131 as the temperature sensing unit 13 are provided on both sides of the transparent unit 12.
- the structure which provides the temperature sensing part 13 only in the side may be sufficient.
- the temperature sensitive part 13 is provided on both sides of the transparent part 12 in the orthogonal direction D as in the present embodiment, the distal end 101 of the tubular member 100 is somewhat separated from the vessel in the orthogonal direction D.
- at least one of the first temperature sensing unit 130 and the second temperature sensing unit 131 that is close to the distal end 101 of the tubular member 100 can detect leakage of a chemical solution or the like. Therefore, it is possible to more reliably detect leakage of a chemical solution or the like from the distal end 101, compared to a configuration in which the temperature sensing unit 13 is provided only in one direction.
- the length of the temperature sensing unit 13 in a direction substantially parallel to the extending direction of the blood vessels is longer than the length of the transparent portion 12 in the same direction, and the temperature-sensitive portion 13 and the sensitive portion 13 are positioned in the orthogonal direction D with respect to an arbitrary position in the transparent portion 12.
- a warming part 13 is arranged.
- the shape of the transparent part 12 when viewed from the thickness direction A is substantially rectangular, and the shape of the temperature-sensitive part 13 is rectangular, but the transparent part 12 and the temperature-sensitive part 13 Other shapes can be employed as long as the above positional relationship is satisfied.
- the transparent part 12 and the temperature sensitive part 13 may each have an elliptical shape or a substantially polygonal shape other than a quadrangle.
- the shape of the sheet-like covering 11 itself when viewed from the thickness direction A is a substantially square shape, but is not limited to this, for example, other than a circular shape, an elliptical shape, or a square shape. It may be polygonal.
- FIG. 10 is a view of the sheet-like covering body 21 that can be attached to the body surface as viewed from the thickness direction A of the sheet-like covering body 21.
- the sheet-like covering 21 has at least a part of the transparent portion 22 in the extending direction B of the sheet-like covering 21.
- the transparent portion 22 and the temperature sensitive portion 23 are disposed adjacent to each other in the extending direction B of the sheet-like covering 21 and extend when viewed from the thickness direction A.
- the configuration is different in that there is no part.
- Other configurations are the same as the configurations already mentioned in the description of the first embodiment, and thus the description thereof is omitted here.
- the temperature sensitive part is located around at least a part of the transparent part in the extending direction of the sheet-like covering
- a straight line means a positional relationship between the transparent part and the temperature sensitive part that can be formed at two points in one continuous temperature sensitive part.
- a straight line indicated by a broken line in FIG. 10 is an imaginary line formed by connecting a point X and a point Y in one continuous temperature sensing part 23, and this straight line passes through the transparent part 22. That is, since the sheet-like covering 21 in the present embodiment can create such a straight line on the plane when the sheet-like covering is viewed from the thickness direction A, using two points in the temperature sensitive part.
- the sheet-like covering 21 in the present embodiment has a configuration in which “the temperature-sensitive portion 23 is located around at least a part of the transparent portion 22 in the extending direction B of the sheet-like covering 21”.
- FIG. 11 is a view showing a state where the sheet-like covering 21 shown in FIG. 10 is attached to the body surface so as to cover a part of the vascular body.
- the broken line in FIG. 11 has shown the vascular VE in a body, and has shown the venous blood vessel of the arm more specifically.
- FIG. 11 shows a state in which a part of the distal end 101 of the tubular member 100 is located outside the outer wall of the vessel, and the drug solution leaks out of the vessel from the distal end 101.
- the temperature sensing part 23 in the extending direction B of the sheet-like covering body 21, With respect to at least a part of the transparent portion 22, the transparent portion 22 is continuously provided from a position in the direction C parallel to the extending direction of the blood vessel in an orthogonal direction D orthogonal to the direction C. Therefore, it is possible to reduce the possibility that leakage of a chemical solution or the like cannot be detected in the temperature sensing unit 23 depending on the position of the distal end 101 of the tubular member 100.
- region S in FIG. 11 has shown a part of display surface 6 of the temperature sensing part 23 which changed the color by the temperature change of the body surface which generate
- the transparent portion 22 and the temperature sensitive portion 23 are arranged adjacent to each other in the extending direction B of the sheet-like covering 21. That is, when the sheet-like covering 21 is viewed from the thickness direction A, a part of the outline 27 of the temperature-sensitive part 23 is common with a part of the outline 28 of the transparent part 22.
- leakage of the drug solution or the like outside the blood vessel is already formed even when the distal end 101 is placed in the blood vessel, for example, when the tubular member 100 is repeatedly inserted and removed. It is also conceivable that it occurs from a hole in the outer wall of the vessel near the insertion port 102.
- the temperature sensing part 23 since the temperature sensing part 23 is arranged adjacent to at least a part of the transparent part 22, the temperature sensing part 13 causes the leakage of the chemical solution or the like. There is a high possibility that a change in the temperature of the body surface due to leakage of chemicals or the like can be detected.
- the temperature sensing part 23 in the present embodiment is not configured to completely surround the transparent part 22 when viewed from the thickness direction A, but surrounds the entire transparent part 22 as shown in FIG. It is good also as such a structure.
- the sheet-like covering body 21 in the present embodiment does not have the extending portion 24 and is configured by the transparent portion 22 and the temperature-sensitive portion 23. If it is set as such a structure, the structure of a sheet-like covering body can be simplified. However, as shown in FIG. 12, an extension portion 24 may be further provided so that the extension portion 24 adheres to the body surface.
- the shape of the transparent portion 22 and the temperature sensitive portion 23 when viewed from the thickness direction A is also substantially rectangular (specifically, a circle in which one short side of the rectangular shape protrudes outward) shown in the present embodiment.
- the shape formed in an arc shape is not limited to the above-described positional relationship, that is, the temperature-sensitive portion 23 is positioned around at least a part of the transparent portion 22 in the extending direction B of the sheet-like covering 21.
- Various shapes can be adopted as long as they are in a positional relationship.
- FIG. 13 is a view of a state in which the sheet-like covering 31 is attached to the body surface so as to cover a part of the vascular vessel in the body, as viewed from the thickness direction A of the sheet-like covering 31.
- FIG. 14 shows a state before a state where it can be attached to the body surface, that is, a state where a release layer or the like which is peeled off when attached to the body surface is provided on one side (hereinafter simply referred to as “state before use”). It is a figure which shows the laminated structure in the thickness direction A of the sheet-like coating
- the broken line in FIG. 13 represents the vascular VE.
- FIG. 14 shows a state before use of the sheet-like covering 31 in the section II-II in FIG.
- the sheet-like covering 31 in the present embodiment is configured to include a transparent portion 32, a temperature sensitive portion 33, and an extending portion 34.
- the sheet-like covering body 31 that can be attached to the body surface is one end portion of the extending portion 34 as the one end portion 35 of the sheet-like covering body 31.
- the point where the cutout portion 60 is provided, the temperature-sensitive portion 33 is located around the transparent portion 32 in the extending direction B of the sheet-like covering 31, and the transparent portion 32 and the temperature-sensitive portion 33 Are different from each other in that they are arranged adjacent to each other in the extending direction B of the sheet-like covering 31.
- the temperature-sensitive part 33 is positioned around the transparent part 32 in the extending direction B of the sheet-like covering 31, and the extending direction of the sheet-like covering 31 is the transparent part 32 and the temperature-sensitive part 33.
- the points arranged adjacent to each other in B are the same as those in the third embodiment, and thus the description thereof is omitted here.
- a notch 60 capable of accommodating a part of the tubular member 100 extending outside the body is provided at one end of the extending portion 34 in the present embodiment.
- the extending portion 34 has the adhesive layer 34 b, and therefore, the movement of the portion of the tubular member 100 extending outside the body relative to the body surface is notched in the extending portion 34. As a result, the distal end 101 of the tubular member 100 is hardly pulled out of the vessel.
- the transparent portion 32, the temperature sensing portion 33, and the cutout portion 60 of the extending portion 34 are attached on the body surface so as to be aligned along the extending direction of the blood vessel, in the sheet-like covering body 31, In the extending direction B, the transparent part 32, the temperature sensitive part 33, and the notch part 60 are arranged substantially linearly.
- “in the extending direction of the sheet-shaped covering, the transparent portion, the temperature-sensitive portion, and the cutout portion are arranged in a substantially straight line” means that when the sheet-shaped covering is viewed from the thickness direction, the transparent portion This means that there is an imaginary straight line that passes through all of the temperature sensing part and the notch part. For example, the straight line shown in FIG.
- the transparent portion 32, the temperature sensitive portion 33, and the cutout portion 60 are arranged in a substantially straight line in the extending direction B of the sheet-like covering 31. It becomes.
- the cutout portion 60 of the present embodiment has an elongated and substantially rectangular shape so that a part of the tubular member 100 can be accommodated when viewed from the thickness direction A, but is not limited to this shape. It is also possible to have a substantially triangular shape.
- the tubular member 100 shown in FIG. 13 includes the indwelling needle 103, the tube 104 extending outside the body, the hollow portion defined by the indwelling needle 103, and the hollow portion defined by the tube 104 in communication with each other. And a connector 105 that connects one end of the tube 104 and one end of the tube 104.
- the connector 105 is accommodated in the notch 60.
- the other end (proximal end) of the tube 104 opposite to the one connected to the connector 105 is connected to the back of the medicinal solution or nutrient to be administered.
- the cutout portion 60 of the present embodiment is provided at one end portion of the extending portion 34.
- the transparent portion 32 extends to the one end portion 35 of the sheet-like covering 31, and the transparent portion 32. It is good also as a structure which provides the notch part 60 in the one end part.
- FIG. 14 shows the lamination
- the actual thickness of each layer is appropriately set according to the purpose and application of use.
- the transparent part 32 includes a resin layer 32a and an adhesive layer 32b.
- the temperature sensing part 33 includes an adhesive layer 33d, a black layer 33c, a temperature sensing layer 33b, a base material layer 33a, and a surface layer 33e.
- the extending part 34 includes a resin layer 34a and an adhesive layer 34b.
- the connection body 38 which is a transparent resin sheet comprises the resin layer 32a of the transparent part 32, the surface layer 33e of the temperature sensitive part 33, and the resin layer 34a of the extending part 34. Specific configurations of these units and layers are the same as those described in the first embodiment.
- the sheet-like covering 31 in a state before use includes a release layer 61 on the surface side attached to the body surface in the thickness direction A.
- the release layer 61 covers, for example, the adhesive layer 32b of the transparent portion 32, the adhesive layer 33d of the temperature sensitive portion 33, and the adhesive layer 34b of the extending portion 34, and when the sheet-shaped covering 31 is actually used. And removed by being peeled off by the user. By removing the release layer 61, the adhesive layer 32b of the transparent portion 32, the adhesive layer 33d of the temperature sensitive portion 33, the adhesive layer 34b of the extending portion 34, and the like are exposed to the outside, and the sheet-like covering 31 is formed on the body. The surface can be bonded.
- the release layer 61 is a resin sheet and may be transparent or opaque.
- the sheet-like covering 41 includes a transparent part 42, a temperature sensitive part 43, and an extending part 44.
- the sheet-like covering 41 is different from the sheet-like covering 1 as the first embodiment in the configuration of the connection body. Since the other configurations have already been mentioned in the description of the above-described embodiment, the description thereof is omitted here.
- FIG. 15 is a view of the sheet-like covering 41 that can be attached to the body surface as viewed from the thickness direction A.
- FIGS. 16A and 16B are views of the sheet-like covering 41 shown in FIG. III-III sectional view and IV-IV sectional view are respectively shown.
- the extending portion 44 in the present embodiment includes a first extending portion 440 positioned around the transparent portion 42, a second extending portion 441 positioned around the temperature sensing portion 43, and And is connected to one surface of the first extending portion 440 and connected to one surface of the second extending portion 441, whereby the first extending portion 440 and the second extending portion 441 are connected.
- a connection body 803 is provided. Note that the first extension portion 440 and the second extension portion 441 mean two separate extension portions that are not connected to each other when the connection body 803 is not present.
- the transparent portion 42 and the first extending portion 440 are connected by a common first connecting body 801, and the temperature-sensitive portion 43 and the second extending portion 440 are connected.
- the extension part 441 is connected by a common second connection body 802.
- the first connecting body 801 constitutes one layer of each of the transparent portion 42 and the first extending portion 440.
- the second connection body 802 constitutes one layer of each of the temperature sensing part 43 and the second extension part 441.
- reference numeral 44 b in FIG. 16 is an adhesive layer of the extending portion 44
- reference numerals 43 b and 43 c represent the temperature sensitive layer and the black layer of the temperature sensitive portion 43.
- connection body 803 is laminated on the first connection body 801 in a part of the first extension part 440 and on the second connection body 802 in a part of the second extension part 441.
- the third connection body 803 connects the first connection body 801 and the second connection body 802 by being stacked.
- the first connection body 801, the second connection body 802, and the third connection body 803 constitute a composite connection body 48, and the connection body 48 as a whole.
- the transparent part 42 and the temperature sensing part 43 are connected.
- the first to third connecting members 801 to 803 are all transparent resin sheets.
- connection body 48 is not limited to the above-described configuration.
- the third connection body 803 is a transparent resin sheet
- the third connection body 803 is replaced with the transparent portion 42 and / or It may be laminated on the temperature sensing part 43 to constitute one layer of the transparent part 42 and / or the temperature sensing part 43.
- the sheet-like covering 51 includes a transparent part 52, a temperature sensitive part 53, and an extending part 54. Compared with the sheet-like covering body 1 as the first embodiment, the sheet-like covering body 51 is mainly different in the layer configuration of the temperature sensing part and the connection body. Since the other configurations have already been mentioned in the description of the above-described embodiment, the description thereof is omitted here.
- FIG. 17 is a view of the sheet-like covering 51 attached to the body surface so as to cover a part of the vascular vessel in the body, as viewed from the thickness direction A
- FIG. 18 is a sheet-like shape shown in FIG. 5 is a VV cross-sectional view of a covering body 51.
- FIG. FIG. 18 shows the stacking relationship in each part, and does not represent the actual thickness of each layer in each part. The actual thickness of each layer is set as appropriate according to the purpose and application. It is possible.
- connection body 58 that connects the transparent portion 52 and the temperature-sensitive portion 53 is a transparent resin sheet, and the resin sheet as the connection body 58 is shown in FIG. 17.
- the resin sheet as the connection body 58 is shown in FIG. 17.
- one layer in the thickness direction A of the sheet-like covering 51 of each of the temperature-sensitive part 53 and the transparent part 52 is configured.
- the temperature sensing part 53 is on the display surface 6 side opposite to the contact surface 5 that contacts the body surface in the temperature sensing part 53 with respect to the transparent resin sheet as the connection body 58 and the resin sheet.
- a temperature-sensitive sheet 70 that changes color according to temperature.
- the temperature sensing unit 53 of the present embodiment includes, from the display surface 6 side, the surface layer 53e, the base material layer 53a, the temperature sensing layer 53b, the black layer 53c, the first adhesive layer 53f, the resin layer 53g,
- the surface layer 53e, the base material layer 53a, the temperature sensitive layer 53b, the black layer 53c, and the first adhesive layer 53f are composed of the temperature sensitive sheet 70, and the resin layer 53g is transparent. It is constituted by a simple resin sheet.
- the first adhesive layer 53f is a layer that adheres the temperature-sensitive sheet 70 as an integrated single member to the resin sheet by directly contacting and bonding the resin sheet as a single member.
- the second adhesive layer 53d is transparent and is a layer that adheres the entire sheet-like covering 51 including the temperature-sensitive sheet 70 and the resin sheet to the body surface by directly contacting and bonding to the body surface. .
- the temperature-sensitive sheet 70 includes the first adhesive layer 53f as an adhesive portion that adheres to the resin sheet on the surface on the resin sheet side as the connection body 58.
- a second adhesive layer 53d as an adhesive portion that can be bonded to the body surface is provided on the body surface side of the resin sheet as the connection body 58.
- an adhesive portion constituted by the first adhesive layer 53f of the temperature-sensitive sheet 70 is referred to as a “first adhesive portion”, and is constituted by a second adhesive layer 53d laminated on a resin sheet as the connection body 58.
- the bonded portion is referred to as a “second bonded portion”.
- the transparent part 52 is provided with the resin layer 52a and the contact bonding layer 52b, and the resin layer 52a is comprised by the transparent resin sheet as the connection body 58 mentioned above.
- the adhesive layer 52b of this embodiment is integral with the 2nd adhesive layer 53d of the temperature sensing part 53, it is also possible to set it as a separate adhesive layer.
- the adhesive force of the first adhesive layer 53f as the first adhesive portion to the resin sheet is smaller than the adhesive force of the second adhesive layer 53d as the second adhesive portion to the body surface. Therefore, the temperature-sensitive sheet 70 can be easily peeled from the resin sheet as the connection body 58 in a state where the sheet-like covering 51 is attached to the body surface via the second adhesive portion.
- the transparent region (transparent portion 52) when viewed from the thickness direction A is expanded, The position of the insertion port 102 on the body surface of the tubular member 100 can be easily recognized.
- Such a magnitude relationship of the adhesive force can be realized, for example, by changing the type of adhesive used.
- the first adhesive layer 53 f as the first adhesive portion can be bonded and separated at least a plurality of times (can be peeled off) from the resin sheet as the connection body 58 with the temperature-sensitive sheet 70.
- the adhesive layer has a viscosity.
- the second adhesive layer 53d as the second adhesive portion is also a sticky adhesive layer having a viscosity that allows the sheet-like covering 51 to be bonded to and separated from the body surface at least a plurality of times.
- the pressure-sensitive adhesive layer as the first adhesive layer 53f and the second adhesive layer 53d can be composed of, for example, a silicon-based adhesive such as a silicon gel adhesive, a rubber-based adhesive, an acrylic adhesive, or the like.
- the temperature-sensitive sheet 70 is configured to be capable of being bonded and separated a plurality of times with respect to the resin sheet as the connection body 58.
- the temperature-sensitive sheet 70 has a belt-like fixing portion 71 fixed to the resin sheet by pressure bonding, heat welding, or the like.
- the temperature-sensitive sheet 70 can be peeled off from the resin sheet at a portion other than the fixing portion 71. Since the temperature-sensitive sheet 70 has the fixing portion 71, the position of the temperature-sensitive sheet 70 with respect to the resin sheet when viewed from the thickness direction A changes every time the temperature-sensitive sheet 70 is adhered to the resin sheet.
- the fixing portion 71 of the temperature-sensitive sheet 70 is pressed to the resin sheet side and compressed in the thickness direction A in order to be fixed to the resin sheet. It is also possible to form the fixing part without being compressed.
- the fixing portion 71 of the present embodiment divides the temperature-sensitive portion 53 into two regions when the sheet-like covering 51 is viewed from the thickness direction A.
- a part of the temperature-sensitive sheet 70 corresponding to one region F1 is configured to be able to be bonded and separated from the resin sheet, and the other region F2 A part of the corresponding temperature sensitive sheet 70 is always adhered to the resin sheet.
- the temperature sensitive sheet 70 is provided with a portion that is always adhered to the resin sheet, this portion can be used as a color indicator, and the first adhesive layer is obtained by repeating adhesion and separation.
- the temperature sensitive sheet 70 is in a state where the temperature sensitive sheet 70 is always adhered to the temperature sensitive sheet 70 due to a decrease in the adhesive force of 53f and the occurrence of a gap between the temperature sensitive sheet 70 and the resin sheet that may occur upon re-adhesion after separation. It can be easily determined by comparing with the color of the color index portion.
- fixed part 71 of this embodiment is a linear strip
- a curved belt shape may be used.
- the region of the temperature sensing portion divided by the fixing portion is not limited to two, and can be divided into three or more regions.
- the fixing portion 71 of the present embodiment is viewed from the thickness direction A while being attached to the body surface (see FIG. 17), the direction D perpendicular to the direction C substantially parallel to the vascular extension direction.
- the temperature-sensitive portion 53 has a band shape that divides the temperature sensing portion 53 into two regions in a direction C substantially parallel to the vascular extension direction.
- the direction is substantially parallel to the vascular extension direction. It is good also as a strip
- the fixing portion 71 of the present embodiment constitutes an extended portion 54 that does not change in color according to temperature when viewed from the thickness direction A of the sheet-like covering 51. It is also possible to make it a part of the temperature sensing part exhibiting the change of In such a case, the fixing portion is always adhered to the resin sheet, and thus can be used as the color index portion as described above.
- the first adhesive layer 53f as the first adhesive portion is formed on almost the entire surface of the temperature-sensitive sheet 70 on the resin sheet side (entire surface except the surface on the resin sheet side of the grip portion 72 described later). Although provided, it is good also as a structure which provides a 1st adhesion part only in a part which is a smaller area
- the temperature-sensitive sheet 70 separates the first adhesive layer 53 f as the first adhesive portion from the resin sheet as the connection body 58 and separates it.
- a grip portion 72 that can be gripped is provided. More specifically, the grip portion 72 in the temperature-sensitive sheet 70 of the present embodiment is configured by one end portion in the extending direction B of the sheet-like covering body 51 where the first adhesive layer 53f is not provided. By providing such a grip portion 72, it is possible to improve the operability when the temperature sensitive sheet 70 is separated from the resin sheet.
- the grip portion 72 of the present embodiment is formed at one end of the temperature sensing portion 53 on the side of the direction C substantially parallel to the vascular extension direction. You may form in the other edge part of the direction D side orthogonal to the direction C substantially parallel to the extension direction of a pipe
- the user appropriately positions the sheet-shaped covering 51 with respect to the insertion opening 102 on the body surface of the tubular member 100 at one end of the temperature sensing portion 53 of the present embodiment.
- a notch 73 is formed as a mark for this purpose.
- the sheet-like covering according to the present invention can be realized by various specific configurations, and is not limited to the configurations shown in the above-described embodiments.
- the various laminated structures in the thickness direction A of the sheet-like covering 1 described in the first embodiment are used in the sheet-like coverings 11, 21, and 31 as the second to fourth embodiments.
- Technical scope of the present invention such as being applied by replacing with a laminated structure, or applying the cutout portion 60 described in the fourth embodiment to the first to third sheet-like coverings 1, 11, and 21. Belongs to.
- the present invention relates to a medical sheet-like covering.
- Y The sheet-like covering is viewed from the thickness direction
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Abstract
Description
図1、2は、本発明に係る医療用のシート状被覆体としての第1の実施形態であるシート状被覆体1を示すものである。具体的に、図1は、シート状被覆体1が生体の体内にある脈管の一部を覆うように体表面に取り付けられた状態を示す断面図である。また、図2は、体表面に取り付け可能な状態にあるシート状被覆体1を、シート状被覆体1の厚み方向Aから見た図である。ここで、シート状被覆体1が体表面に取り付け可能な状態とは、例えば、後述する剥離層61(図14参照)等が取り除かれている状態であって、体表面に取り付けられて使用される状態と同じ状態を意味する。なお、図1における「BS」は体表面を表し、「VE」は脈管を表している。
透明部2とは、体表面に取り付け可能な状態のシート状被覆体1を厚み方向Aから見た場合に、厚み方向Aにおいて透明な領域である。より具体的には、同状態のシート状被覆体1を同方向Aから見た場合に、厚み方向Aにおいて光透過性を有する部材により構成される領域である。そして透明部2は、体表面に対して管状部材100の挿入口102を覆うように取り付けられることから、透明部2は、挿入口102を覆い保護すると共に、医療従事者などのユーザーが挿入口102を外部から視認することを可能にする。
感温部3は、体表面に取り付け可能な状態のシート状被覆体1を厚み方向Aから見た場合に、所定温度領域内で温度に応じて色を変化させる領域である。具体的に、感温部3は、体表面と接触する接触面5と、接触面5とは反対側の表示面6と、を有し、接触面5が体表面と接触した状態で、表示面6が接触面5から感知される体表面の温度に応じた色を表示する。従って、医療従事者などのユーザーは、外部から体表面の温度変化を、感温部3の表示面6を通じて観察することができる。
延在部4は、シート状被覆体1を厚み方向Aから見た場合の、透明部2及び感温部3以外の領域である。図3に示すように、本実施形態における延在部4は、透明な樹脂層4aと、樹脂層4aに積層される接着層4bと、を備えている。シート状被覆体1を体表面に取り付ける際に体表面側となる面から、接着層4b、樹脂層4aの順に積層されている。
次に、透明部2と感温部3とを接続する構成について、図3を参照して説明する。シート状被覆体1は、透明部2及び感温部3を接続する接続体8を備えており、本実施形態における接続体8は、透明な樹脂シートである。図3に示すように、接続体8は、透明部2、感温部3、及び延在部4の厚み方向Aにおける1つの層を構成している。具体的に、本実施形態では、透明部2は透明な樹脂層2aの単層構造であり、この樹脂層2aは接続体8の一部である。また感温部3については、表面層3eが接続体8の一部である。更に、延在部4については、樹脂層4aが接続体8の一部である。このように、本実施形態における透明部2、感温部3、及び延在部4はいずれも、厚み方向Aにおいて共通の接続体8(2a、3e及び4a)を1つの層として備えており、一体化されている。
ここまでは、シート状被覆体1の各部の構成について説明してきた。次に、シート状被覆体1の1つの特徴として、シート状被覆体1を厚さ方向Aから見た場合の透明部2と感温部3との位置関係について説明する。
次に、本発明の第2の実施形態としてのシート状被覆体11について説明する。図9は、体内の脈管の一部を覆うように体表面に取り付けられたシート状被覆体11を、シート状被覆体11の厚み方向Aから見た図である。シート状被覆体11は、上述の第1の実施形態としてのシート状被覆体1と同様、透明部12と、シート状被覆体11の延在方向Bにおいて透明部12の近傍に位置する感温部13と、を備える。なお、図9における破線は、体内にある脈管VEを表すものであり、より具体的には腕の静脈血管を表している。
次に、第3の実施形態としてのシート状被覆体21について、図10を用いて説明する。図10は、体表面に取り付け可能な状態にあるシート状被覆体21を、シート状被覆体21の厚み方向Aから見た図である。シート状被覆体21は、第1及び第2の実施形態としてのシート状被覆体1と比較して、感温部23がシート状被覆体21の延在方向Bにおいて透明部22の少なくとも一部の周囲に位置している点、透明部22と感温部23とがシート状被覆体21の延在方向Bにおいて隣り合って配置されている点、及び厚み方向Aから見た場合に延在部が存在しない点で、構成が相違している。その他の構成については、第1の実施形態の説明において既に言及した構成と同様の構成を用いているため、ここでは説明を省略する。
次に、第4の実施形態としてのシート状被覆体31について、図13を参照して説明する。図13は、シート状被覆体31が体内にある脈管の一部を覆うように体表面に取り付けられた状態を、シート状被覆体31の厚み方向Aから見た図である。また、図14は、体表面に取り付け可能な状態の前の状態、すなわち、体表面に取り付ける際に剥離される剥離層などが一面に設けられている状態(以下、単に「使用前の状態」と記載する)でのシート状被覆体31の、厚さ方向Aにおける積層構造を示す図である。なお、図13における破線は、脈管VEを表す。また、図14は、図13のII―II断面でのシート状被覆体31の使用前の状態を示している。
次に、第5の実施形態としてのシート状被覆体41について説明する。シート状被覆体41は、透明部42、感温部43、及び延在部44を備える。シート状被覆体41は、第1の実施形態としてのシート状被覆体1と比較して、接続体の構成が相違している。その他の構成については、既に上述の実施形態の説明において言及されているものであるため、ここでは説明を省略する。
次に、第6の実施形態としてのシート状被覆体51について説明する。シート状被覆体51は、透明部52、感温部53、及び延在部54を備える。シート状被覆体51は、第1の実施形態としてのシート状被覆体1と比較して、主に、感温部の層構成及び接続体の構成が相違している。その他の構成については、既に上述の実施形態の説明において言及されているものであるため、ここでは説明を省略する。
2、2´、12、22、32、42、52:透明部
2a、32a、52a:透明部の樹脂層
2b、32b、52b:透明部の接着層
3、3´、3´´、13、23、33、43、53:感温部
3a、3a´、3a´´、33a、53a:感温部の基材層
3b、3b´、33b、43b、53b:感温部の感温層
3c、3c´、3c´´、33c、43c、53c:感温部の黒色層
3d、3d´、33d:感温部の接着層
3e、3e´、3e´´、33e、53e:感温部の表面層
4、14、24、34、44、54:延在部
4a、34a:延在部の樹脂層
4b、34b、44b:延在部の接着層
5:感温部の接触面
6:感温部の表示面
7:接着部
8、38、48、58:接続体
9:透明接着部
27:感温部の輪郭線
28:透明部の輪郭線
53d:感温部の第1接着層(第2接着部)
53f:感温部の第2接着層(第1接着部)
53g:感温部の樹脂層
60:切欠部
61:剥離層
70:感温シート
71:固定部
72:把持部
73:切欠き部
100:管状部材
101:管状部材の遠位端
102:挿入口
103:留置針
104:チューブ
105:コネクタ
130:第1感温部
131:第2感温部
440:第1の延在部
441:第2の延在部
801:第1の接続体
802:第2の接続体
803:第3の接続体
BS:体表面
VE:脈管
LM:脈管外へ漏出している薬液等
A:シート状被覆体の厚み方向
B:シート状被覆体の延在方向
C:脈管の延在方向と平行な方向
D:脈管の延在方向と直交する方向
F1:感温部のうち固定部により分割された一方の領域
F2:感温部のうち固定部により分割された他方の領域
O:シート状被覆体を厚み方向から見た場合の透明部における点
P:シート状被覆体を厚み方向から見た場合の感温部における点
Q:シート状被覆体を厚み方向から見た場合の切欠部における点
X、Y:シート状被覆体を厚み方向から見た場合の感温部における点
Lmin:透明部と感温部との最短距離
Claims (13)
- 体表面に取り付けられるシート状被覆体であって、
体表面から体内へと挿入された管状部材の遠位端を体内に留置した状態で、体表面における前記管状部材の挿入口を覆う透明部と、
前記透明部の近傍に位置するとともに、体表面と接触し、温度に応じて色を変化させる感温部と、を備えることを特徴とするシート状被覆体。 - シート状被覆体が体内にある脈管の一部を覆うように体表面に取り付けられた状態において、前記感温部は、前記透明部のうち前記挿入口を覆う部分に対して、脈管の延在方向と平行な方向に位置することを特徴とする請求項1に記載のシート状被覆体。
- シート状被覆体が体内にある脈管の一部を覆うように体表面に取り付けられた状態において、前記感温部は、前記透明部のうち前記挿入口を覆う部分に対して、脈管の延在方向と直交する方向に位置することを特徴とする請求項1又は2に記載のシート状被覆体。
- 前記感温部は、前記透明部の少なくとも一部の周囲に位置することを特徴とする請求項1乃至3のいずれか1つに記載のシート状被覆体。
- シート状被覆体を厚み方向から見た場合に、前記感温部の輪郭線の少なくとも一部は、前記透明部の輪郭線の一部又は全部と共通することを特徴とする請求項1乃至4のいずれか1つに記載のシート状被覆体。
- 前記透明部と前記感温部とを接続する接続体を有することを特徴とする請求項1乃至5のいずれか1つに記載のシート状被覆体。
- 前記接続体は、透明な樹脂シートであり、
前記樹脂シートは、前記感温部及び前記透明部それぞれのシート状被覆体の厚み方向における1つの層を構成することを特徴とする請求項6に記載のシート状被覆体。 - 前記感温部は、体表面と接触する接触面に、体表面と接着可能な接着部を備えることを特徴とする請求項1乃至7のいずれか1つに記載のシート状被覆体。
- 前記透明部は、シート状被覆体が体表面に取り付けられる際に体表面側となる面に、透明接着部を備えることを特徴とする請求項1乃至8のいずれか1つに記載のシート状被覆体。
- 前記感温部は、前記樹脂シートと、前記樹脂シートに対して、前記感温部における体表面と接触する接触面とは反対側の表示面側に積層された、温度に応じて色を変化させる感温シートと、を備えることを特徴とする請求項7に記載のシート状被覆体。
- 前記感温シートは、前記樹脂シート側の面に、前記樹脂シートに対して接着する接着部を備えることを特徴とする請求項10に記載のシート状被覆体。
- 前記感温シートは、前記接着部を前記樹脂シートから剥離する際に把持することが可能な把持部を備えることを特徴とする請求項11に記載のシート状被覆体。
- 前記感温シートの前記接着部を第1接着部とした場合に、前記樹脂シートには、体表面に対して接着可能な第2接着部が設けられており、
前記第1接着部の前記樹脂シートに対する接着力は、前記第2接着部の体表面に対する接着力よりも小さいことを特徴とする請求項11又は12に記載のシート状被覆体。
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EP3050546A1 (en) | 2016-08-03 |
JPWO2015045371A1 (ja) | 2017-03-09 |
EP3050546A4 (en) | 2017-04-26 |
EP3050546B1 (en) | 2021-01-13 |
JP6442408B2 (ja) | 2018-12-19 |
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