WO2021192975A1 - Compression device and method for adhering compression device - Google Patents

Compression device and method for adhering compression device Download PDF

Info

Publication number
WO2021192975A1
WO2021192975A1 PCT/JP2021/009089 JP2021009089W WO2021192975A1 WO 2021192975 A1 WO2021192975 A1 WO 2021192975A1 JP 2021009089 W JP2021009089 W JP 2021009089W WO 2021192975 A1 WO2021192975 A1 WO 2021192975A1
Authority
WO
WIPO (PCT)
Prior art keywords
marker
thickness direction
compression device
living body
line segment
Prior art date
Application number
PCT/JP2021/009089
Other languages
French (fr)
Japanese (ja)
Inventor
政克 川浦
Original Assignee
テルモ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Priority to JP2022509515A priority Critical patent/JP7304486B2/en
Publication of WO2021192975A1 publication Critical patent/WO2021192975A1/en

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/132Tourniquets
    • A61B17/135Tourniquets inflatable

Definitions

  • This disclosure relates to a compression device and a method of attaching the compression device.
  • the catheter is percutaneously inserted into a blood vessel from a puncture site formed on the wrist, inguinal region, or the like, and is carried through the blood vessel to a site to be examined or treated.
  • an elongated insertion member such as a puncture needle, a catheter, or a sheath used for introducing a catheter into a living body is removed from the puncture site, and the puncture site is stopped from bleeding. do.
  • Patent Document 1 discloses a dressing as a compression device that applies compression to a patient's wound after removing the sheath.
  • the dressing of Patent Document 1 includes an inflatable bladder having a contracted state in which the film is adjacent to the end wall and an expanded state in which the film is kept at a distance from the end wall.
  • the dressing of Patent Document 1 includes a holding means for holding the bladder against the skin of the patient at a position substantially covering the wound.
  • Patent Document 1 discloses a holding means including a flexible web that is connected to the end wall of the bladder and projects outward from the end wall of the bladder, and one side of the flexible web is attached to the patient's skin. An adhesive layer for adhesion is provided.
  • an adhesive layer provided on one side of a flexible web is adhered to the skin as a living body surface of a patient, and the bladder is in an expanded state by the bladder. Can squeeze the patient's wound.
  • An object of the present disclosure is to provide a compression device that can be easily positioned at an appropriate position on the surface of a living body, and a method of attaching the compression device.
  • the compression device as the first aspect according to the present disclosure is a sticking sheet provided with a sticking surface that can be stuck to the surface of a living body, and a compression member that is fixed to the sticking sheet and can press the surface of the living body.
  • the compression member is fixed to the sticking sheet on a side opposite to the sticking surface and a pressing body capable of pressing the living body surface by extending in the thickness direction of the sticking sheet.
  • a holding body that holds the pressing body so as to be extendable in the thickness direction is provided, and the holding body extends in an arc shape at a position overlapping the pressing body in a plan view seen in the thickness direction. It is equipped with a line segment marker.
  • the pressing body is arranged between the living body surface and the holding body in a state where the sticking surface of the sticking sheet is stuck to the living body surface, and is a fluid.
  • the line segment marker is provided at a position overlapping the expansion portion of the pressing body in a plan view viewed in the thickness direction.
  • the holder has translucency in the thickness direction at a position where the line segment marker is provided.
  • the holding body has translucency in the thickness direction at a position adjacent to the line segment marker in a plan view in the thickness direction.
  • the holding body includes a region marker that partitions a predetermined region surrounding the line segment marker in a plan view viewed in the thickness direction.
  • the retainer is placed in the predetermined region partitioned by the region markers in a plan view in the thickness direction, at least at a position where the line segment markers are not provided. It has translucency in the thickness direction.
  • the region marker is a frame line marker that surrounds the periphery of the line segment marker in a plan view viewed in the thickness direction.
  • the holding body has translucency in the thickness direction at a position adjacent to the outside of the region marker in a plan view in the thickness direction.
  • the method of attaching the compression device as the second aspect according to the present disclosure is a method of attaching the compression device to a attachment sheet having an attachment surface that can be attached to the surface of the living body and the attachment sheet fixed to the attachment sheet.
  • a method of attaching a compression device including a compression member capable of compression to the surface of a living body, wherein the compression member includes a line segment marker extending in an arc shape in a plan view in the thickness direction.
  • a part of the medical tube member inserted into the living body from the surface of the living body, which is located on the same surface as the surface of the living body, is aligned with the line segment marker, and the sticking sheet is attached. It is attached to the surface of the living body.
  • the pressing member includes a region marker that partitions a predetermined region surrounding the line segment marker in a plan view viewed in the thickness direction, and is inserted into the living body from the living body surface.
  • a part of the insertion portion of the medical tube member located on the same surface as the living body surface is aligned with the line segment marker, and the entire insertion portion is partitioned by the region marker.
  • the sticking sheet is stuck to the surface of the living body in a state of being aligned within the region of.
  • a compression device that can be easily positioned at an appropriate position on the surface of a living body, and a method of attaching the compression device.
  • FIG. 5 is a cross-sectional view showing a state in which an expanded portion of the compression device shown in FIG. 1 is in a contracted state.
  • FIG. 5 is a cross-sectional view showing a state in which an expanded portion of the compression device shown in FIG. 1 is in an expanded form.
  • FIG. 12 is a front view of the state shown in FIG. 12 as viewed from the surface side of the living body.
  • FIGS. 5 and 6 are diagrams showing a compression device 1 as an embodiment of the present disclosure.
  • FIG. 1 is a perspective view of the compression device 1 as viewed from the upper surface side.
  • 2 and 3 are plan views of the compression device 1.
  • FIG. 2 is a top view of the compression device 1.
  • FIG. 3 is a bottom view of the compression device 1.
  • FIG. 4 is an exploded perspective view of the compression device 1.
  • 5 and 6 are cross-sectional views of the compression device 1 in the same cross section. Details will be described later, but FIGS. 5 and 6 show different states of the compression device 1.
  • the compression device 1 includes a sticking sheet 2 and a compression member 3.
  • the sticking sheet 2 is provided with a sticking surface 11 that can be stuck to the surface of the living body on one side in the thickness direction A.
  • the compression member 3 is attached to the sticking sheet 2. Specifically, the compression member 3 is fixed to the sticking sheet 2 on the side opposite to the sticking surface 11.
  • the compression member 3 can press the surface of the living body in a state where the sticking surface 11 is attached to the surface of the living body. In this way, the position of the compression device 1 on the surface of the living body is fixed by sticking the sticking surface 11 to the surface of the living body. According to the compression device 1, the compression member 3 can press a predetermined portion on the surface of the living body in a state where the sticking surface 11 of the sticking sheet 2 is stuck on the surface of the living body.
  • the predetermined site on the surface of the living body includes, for example, a wound on the surface of the living body or a vicinity thereof formed by inserting a medical insertion member such as a puncture needle, a catheter, or a sheath into a blood vessel of the living body. After removing the above-mentioned medical insertion member from the living body, bleeding can be stopped by pressing the wound on the surface of the living body or its vicinity with the pressing member 3 for a predetermined time.
  • a medical insertion member such as a puncture needle, a catheter, or a sheath
  • the compression member 3 includes a pressing body 4 and a holding body 5.
  • the pressing body 4 can press the surface of the living body by extending in the thickness direction A of the sticking sheet 2.
  • the holding body 5 is fixed to the sticking sheet 2 on the side opposite to the sticking surface 11, and holds the pressing body 4 so as to be extendable in the thickness direction A.
  • the holding body 5 includes a line segment marker 7a extending in an arc shape at a position overlapping the pressing body 4 in a plan view of the compression device 1 in the thickness direction A.
  • the configuration of the line segment marker 7a is not particularly limited as long as it can be visually identified that the compression device 1 extends in an arc shape in a plan view viewed in the thickness direction A.
  • the line segment marker 7a may be composed of, for example, one rib-shaped convex portion protruding from the upper surface of the holding body 5. Further, the line segment marker 7a has, for example, a plurality of convex portions arranged in a line at intervals so that the compression device 1 has a broken line shape extending in an arc shape as a whole in a plan view in the thickness direction A. It may be an aspect of forming a line segment.
  • the line segment marker 7a may be formed of, for example, a recess such as a groove formed on the upper surface of the holding body 5.
  • the above-mentioned convex portion or concave portion constituting the line segment marker 7a is not limited to the upper surface of the holding body 5, and may be provided on the lower surface of the holding body 5.
  • the position where the convex portion or the concave portion is provided on the upper surface view of the holding body 5. Is configured to have translucency in the thickness direction A from at least the upper surface to the lower surface.
  • the line segment marker 7a may be configured, for example, by making the transmittance different from that of the surroundings.
  • the line segment marker 7a may be composed of a portion having a lower transmittance than the surroundings, which is located in the translucent portion of the holding body 5.
  • the line segment marker 7a may be configured, for example, by making the color different from the surroundings.
  • Such a line segment marker 7a may be composed of, for example, a paint forming a part of the upper surface or the lower surface of the holding body 5.
  • the line segment marker 7a can be identified as a line segment extending in an arc shape, distinguishing from the surroundings, in a plan view under the usage environment of the compression device 1, particularly a top view (see FIG. 2). It is not particularly limited as long as it is an embodiment.
  • the biological surface of the medical insertion member 100 is provided regardless of the outer diameter of the medical insertion member 100 (see FIG. 8A) inserted into the living body from the surface of the living body.
  • a part (for example, a part of the outer surface) of the insertion portion 100a (see FIG. 8A) located on the same plane as the above is in contact with the line segment marker 7a in the plan view of the compression device 1 in the thickness direction A.
  • the medical staff is asked to align the medical insertion member 100 at a predetermined position by using a part of the insertion portion 100a regardless of its outer diameter. Can be guided.
  • the mounting position of the compression device 1 from fluctuating on the surface of the living body due to the difference in the outer diameter of the medical insertion member 100.
  • the compression device 1 that can be easily positioned at an appropriate position on the surface of the living body can be realized regardless of the difference in the outer diameter of the medical insertion member 100. Details of positioning the insertion portion 100a of the medical insertion member 100 with respect to the line segment marker 7a will be described later (see FIGS. 8A and 8B).
  • the line segment marker 7a is curved and extends in an arc shape in a plan view of the compression device 1 in the thickness direction A. Therefore, the compression device 1 is aligned so that a part of the outer surface of the insertion portion 100a (see FIG. 8A) extending in a convex and arc shape in a plan view in the thickness direction A is inserted into the concave portion of the line segment marker. It will be easier.
  • the area where the attachment sheet 2 is not arranged is outside the outer edge of the holding body 5, and is a medical treatment described later.
  • a receiving portion 6 capable of receiving the insertion member 100 is provided.
  • the sticking sheet 2 of the present embodiment has a first portion X1 that overlaps with the holding body 5 and a holding body in a plan view (see FIGS. 2 and 3) in which the compression device 1 is viewed in the thickness direction A.
  • a second portion X2 that does not overlap with 5 is provided. As shown in FIG.
  • the outer edge of the holding body 5 of the compression device 1 of the present embodiment has only a part of the outer edge of the holding body 5 in which the second portion X2 of the sticking sheet 2 is not arranged.
  • the receiving portion 6 of the present embodiment is composed of a region around the holding body 5 in which the second portion X2 of the sticking sheet 2 is not arranged.
  • the receiving portion 6 of the present embodiment has a region in which the sticking sheet 2 is not arranged on the outside of the outer edge of the holding body 5 in a plan view (see FIGS. 2 and 3) of the compression device 1 in the thickness direction A. It is configured, but is not limited to this configuration.
  • the receiving portion 6 may be an area partitioned by a recess on the outer edge of the sticking sheet 2.
  • a recess outside the outer edge of the holding body 5 and a part of the outer edge of the sticking sheet 2 is recessed from the periphery. May be formed.
  • the receiving portion 6 may be a region partitioned by the recess.
  • the receiving portion 6 is formed in a region where the sticking sheet 2 is arranged on the outside of the outer edge of the holding body 5 in a plan view (see FIGS. 2 and 3) when the compression device 1 is viewed in the thickness direction A. You may be.
  • the position where the receiving portion 6 is formed is such that the sticking sheet 2 is arranged outside the outer edge of the holding body 5 in a plan view (see FIGS. 2 and 3) when the compression device 1 is viewed in the thickness direction A. It is not limited to the area that is not.
  • the compression device 1 of the present embodiment is provided with the above-mentioned receiving unit 6, it may be a compression device that does not have the receiving unit 6.
  • the compression device 1 is arranged so that the portion of the medical insertion member 100 (see FIG. 8A or the like) extending outside the living body passes through the receiving portion 6. It can be attached to the surface of a living body.
  • the compression device 1 can be easily attached to a desired position on the surface of the living body even if there is a portion of the medical insertion member 100 (see FIG. 8A or the like) extending outside the living body.
  • the line segment marker 7a of the present embodiment is provided on the side where the expansion portion 8 described later of the pressing body 4 is located with respect to the receiving portion 6 in the plan view of the compression device 1 in the thickness direction A. Further, the line segment marker 7a is curved convexly from the position of the receiving portion 6 toward the position of the expanding portion 8 in a plan view of the compression device 1 in the thickness direction A. Further, in the present embodiment, the maximum width of the line segment marker 7a is smaller than the maximum width of the expansion portion 8 described later of the pressing body 4 in the plan view of the compression device 1 in the thickness direction A.
  • the maximum width of the line segment marker 7a of the present embodiment means the maximum width of the line segment marker 7a in the width direction B as shown in FIG.
  • the maximum width of the expansion portion 8 of the present embodiment means the maximum width of the expansion portion 8 in the width direction B as shown in FIG.
  • the width direction B means a direction orthogonal to the arrangement direction C in which the receiving portion 6 and the expanding portion 8 of the pressing body 4 are arranged in a plan view of the compression device 1 in the thickness direction A. ..
  • the maximum width of the line segment marker 7a is smaller than the minimum width of the receiving portion 6 in the plan view of the compression device 1 in the thickness direction A.
  • the minimum width of the receiving portion 6 means the minimum width of the receiving portion 6 in the width direction B as shown in FIG.
  • the holding body 5 of the present embodiment includes a border marker 7b1 as a region marker 7b in addition to the line segment marker 7a.
  • the frame line marker 7b1 as the area marker 7b of the present embodiment partitions a predetermined area surrounding the line segment marker 7a in a plan view seen in the thickness direction A of the compression device 1.
  • the frame line marker 7b1 as the region marker 7b of the present embodiment is located on the side where the expansion portion 8 described later of the pressing body 4 is located with respect to the receiving portion 6 in a plan view of the compression device 1 in the thickness direction A. It is provided adjacently.
  • the maximum width of the frame line marker 7b1 as the region marker 7b is smaller than the maximum width of the expansion portion 8 described later of the pressing body 4 in the plan view of the compression device 1 in the thickness direction A. .. Further, in the present embodiment, the maximum width of the border marker 7b1 as the region marker 7b is smaller than the minimum width of the receiving portion 6 in the plan view of the compression device 1 in the thickness direction A. Details of the line segment marker 7a and the frame line marker 7b1 as the area marker 7b of the present embodiment will be described later.
  • the sticking sheet 2 includes a sticking surface 11 on one side in the thickness direction A. Further, the sticking sheet 2 includes a mounting surface 12 to which the compression member 3 is mounted on the other side in the thickness direction A, that is, on the side opposite to the sticking surface 11.
  • the sticking sheet 2 has flexibility. Therefore, the sticking sheet 2 can be deformed along the shape of the surface of the living body. In addition, the sticking surface 11 can easily follow the deformation of the living body surface. As a result, it is possible to prevent the compression device 1 from unintentionally peeling from the surface of the living body.
  • the sticking surface 11 of the sticking sheet 2 of the present embodiment is composed of the lower surface of the sticking sheet 2.
  • the mounting surface 12 of the sticking sheet 2 of the present embodiment is composed of the upper surface of the sticking sheet 2.
  • one side of the thickness direction A which is the direction from the mounting surface 12 to the attachment surface 11 in the thickness direction A, may be simply referred to as “downward A1" or “lower side”.
  • the other side of the thickness direction A which is the direction from the sticking surface 11 to the mounting surface 12 in the thickness direction A, may be simply described as “upward direction A2" or "upper side”.
  • the plan view of the sticking sheet 2 seen from the mounting surface 12 side (FIG. 2). (See) is simply referred to as "top view” for convenience of description.
  • the plan view see FIGS.
  • the sticking sheet 2 is composed of, for example, a plurality of layers including a base material layer and an adhesive layer.
  • the base material layer is composed of, for example, a thin resin sheet. More specifically, the base material layer is made of, for example, a white spunlace non-woven fabric of polyester fibers, and the thickness thereof is in the range of 5 ⁇ m to 150 ⁇ m, for example, 30 ⁇ m.
  • the material of the base material layer is not limited to polyester, and for example, an acrylic polymer, polyethylene, an ethylene-vinyl acetate copolymer, polyurethane, a polyamide derivative, or the like may be used.
  • the adhesive layer is composed of, for example, an adhesive such as a rubber-based adhesive, an acrylic-based adhesive, or a silicon-based adhesive.
  • the adhesive layer is laminated directly to the base material layer or indirectly with another layer in between.
  • the sticking surface 11 of the sticking sheet 2 of the present embodiment is composed of an adhesive layer.
  • the sticking sheet 2 may include yet another layer in addition to the above-mentioned base material layer and adhesive layer.
  • the sticking sheet 2 may include, for example, a surface layer.
  • the surface layer is composed of, for example, a resin having a thickness of about 5 ⁇ m to 50 ⁇ m. More specifically, as the material of the surface layer, polyester, polyamide, polyamideimide, polyethylene, polypropylene, polycarbonate, polyurethane, polyvinyl chloride, fluororesin and the like can be used.
  • the surface layer is laminated on the opposite side of the base material layer from the adhesive layer, either directly or indirectly with another layer in between. Therefore, the mounting surface 12 of the sticking sheet 2 may be composed of a surface layer.
  • the sticking sheet 2 may be made of a non-woven fabric tape having an adhesive as an adhesive on one surface. Further, the sticking sheet 2 may be composed of a double-sided tape in which adhesive layers are provided on both sides of the base material layer.
  • the pressing member 3 can be fixed to the sticking sheet 2 by adhering the holding body 5 of the pressing member 3 to one adhesive layer of the sticking sheet. can.
  • the sticking sheet 2 of the present embodiment has a substantially C-shaped outer shape in a plan view seen in the thickness direction A. As shown in FIGS. 2 and 3, the sticking sheet 2 of the present embodiment covers only a part of the lower surface side of the compression member 3. Specifically, the sticking sheet 2 of the present embodiment covers only the outer edge region of the lower surface of the compression member 3. The sticking sheet 2 of the present embodiment is fixed only to the outer edge region of the lower surface of the compression member 3. In other words, the sticking sheet 2 of the present embodiment does not cover the central region of the lower surface of the pressing member 3 where the expansion portion 8 of the pressing body 4 of the pressing member 3 is located. Further, the sticking sheet 2 of the present embodiment does not cover the entire outer edge region of the lower surface of the compression member 3, but partially covers the outer edge region.
  • the sticking sheet 2 of the present embodiment does not cover a part of the outer edge region of the lower surface of the compression member 3.
  • a portion of the outer edge region of the lower surface of the compression member 3 that is not covered by the sticking sheet 2 is a portion adjacent to the receiving portion 6 of the compression member 3.
  • the sticking surface 11 of the sticking sheet 2 is covered with the release sheet in the state before use before being stuck to the surface of the living body.
  • the release sheet is removed by being peeled from the attachment surface 11 by the user when the attachment sheet 2 is attached to the surface of the living body.
  • the attachment surface 11 of the attachment sheet 2 can be attached to the surface of the living body (hereinafter, for convenience of explanation, "use state"). It will be described.)
  • the release sheet can be formed of, for example, a release paper or a sheet material made of resin.
  • the compression device 1 shown in FIGS. 1 to 6 shows a state of use in which the release sheet has been removed.
  • the compression member 3 includes a pressing body 4 and a holding body 5.
  • the pressing body 4 can press the surface of the living body by extending in the thickness direction A.
  • the pressing body 4 can press the surface of the living body at a position where the sticking sheet 2 is not present in a plan view. That is, the pressing body 4 can press the surface of the living body without passing through the sticking sheet 2.
  • the pressing body 4 of the present embodiment includes an expansion portion 8 and an extension portion 9.
  • the expansion unit 8 has the living body surface and the holding body 5 in a state where the sticking surface 11 of the sticking sheet 2 is stuck to the living body surface (hereinafter, referred to as “the sticking state of the compression device 1”). Placed in between.
  • the expansion portion 8 can be expanded in the thickness direction A by supplying a fluid while the compression device 1 is attached. That is, the pressing body 4 of the present embodiment extends in the thickness direction A when the expansion portion 8 expands in the thickness direction A.
  • the expansion unit 8 presses the surface of the living body by receiving a reaction force from the holding body 5.
  • the form before the expansion portion 8 is expanded will be referred to as a “contracted form” of the expansion portion 8. Further, the form in which the expansion portion 8 is expanded from the contracted form is described as the “expansion form” of the expansion portion 8.
  • the compression device 1 of the present embodiment does not press the surface of the living body by the expansion portion 8 when the expansion portion 8 is in the contracted state in the attached state. On the contrary, in the compression device 1 of the present embodiment, when the expansion portion 8 is in the expansion form in the attached state, the expansion portion 8 presses the surface of the living body.
  • FIG. 5 shows a contracted form of the expansion portion 8.
  • FIG. 6 shows an expanded form of the expansion unit 8.
  • the expansion unit 8 of the present embodiment partitions an accommodation space 8a capable of accommodating a fluid such as a gas inside. Further, the expansion portion 8 of the present embodiment is composed of two balloon portions 8b and 8c connected so that the inside communicates with each other.
  • the accommodation space 8a of the present embodiment is composed of an internal space in which two balloon portions 8b and 8c communicate with each other.
  • the expansion portion 8 can be expanded toward the downward direction A1 of the thickness direction A by supplying the fluid to the accommodation space 8a.
  • the expansion unit 8 of the present embodiment expands downward A1 by changing its form from the contracted form (see FIG. 5) described above to the expanded form (see FIG. 6), and becomes a posture capable of pressing the surface of the living body. .. More specifically, when the fluid is supplied to the accommodation space 8a, the expansion portion 8 receives a reaction force from the lower surface of the holding body 5 and expands in the downward direction A1.
  • the fluid supplied to the accommodation space 8a of the expansion unit 8 is not limited to a gas, but may be a liquid.
  • the contracted expansion portion 8 is arranged along the lower surface of the holding body 5 in a state where the accommodation space 8a is contracted.
  • the accommodation space 8a of the expansion portion 8 communicates with a tube 28 extending to the outside of the holding body 5.
  • a fluid such as air is supplied to the accommodation space 8a of the expansion portion 8 through the tube 28 from a fluid supply device connected to an inflation port as a connection portion 29 provided at the end of the tube 28.
  • the expansion portion 8 of the present embodiment includes a portion having translucency in the thickness direction A. More specifically, the expansion portion 8 of the present embodiment is composed of only a portion having translucency in the thickness direction A. As described above, it is preferable that the expansion portion 8 includes at least a portion having translucency in the thickness direction A. By doing so, it is possible to see through the expansion portion 8 from the upper side of the expansion portion 8 to the lower side of the expansion portion 8. Therefore, the position of the wound or the like on the surface of the living body can be visually recognized through the expansion portion 8.
  • the extension section 9 is extended from the extension section 8.
  • the extension portion 9 has flexibility.
  • the extension portion 9 is wound around the holding body 5.
  • the extending portion 9 extends from the expanding portion 8 to the upper surface side of the holding body 5 on the opposite side of the expanding portion 8 with the holding body 5 interposed therebetween.
  • the extension portion 9 is locked to the holding body 5 on the upper surface side of the holding body 5.
  • the holding body 5 of the present embodiment defines a through hole 5a penetrating in the thickness direction A.
  • the extension portion 9 of the present embodiment is wound around the holding body 5 through the through hole 5a. More specifically, the extending portion 9 of the present embodiment extends from the lower side on which the expanding portion 8 is located with the holding body 5 sandwiched between them toward the upper side, which is the opposite side thereof. Then, the extension portion 9 of the present embodiment is wound around the holding body 5 so as to be along the inner surface of the holding body 5 for partitioning the through hole 5a and the upper surface of the holding body 5.
  • the extending portion 9 is formed with a locking hole 9b on the upper surface side of the holding body 5 into which a locking projection 5b protruding from the upper surface of the holding body 5 is fitted.
  • the extension portion 9 is positioned on the holding body 5.
  • the extension portion 9 is wound around the extension portion 8 from the lower surface side to the upper surface side of the holding body 5 at a position on the receiving portion 6 side. That is, the through hole 5a of the present embodiment is located on the receiving portion 6 side with respect to the expanding portion 8. Therefore, in the cross-sectional view shown in FIG. 5, the expansion portion 8 and the extension portion 9 constituting the pressing body 4 of the present embodiment are curved in a substantially U shape by being wound around the holding body 5. As a result, the expansion portion 8 can be expanded while rotating the portion of the extension portion 9 connected to the expansion portion 8 as the hinge portion 9a.
  • the expansion portion 8 can be expanded not only in the thickness direction A but also in a direction inclined with respect to the thickness direction A by rotating by the hinge portion 9a of the extension portion 9.
  • the pressing body 4 of the present embodiment is wound around the holding body 5 in a state where the sheet-shaped extending portion 9 is wound around the upper and lower surfaces of the holding body 5 through the through hole 5a of the holding body 5. It is fixed. Therefore, at the time of expansion, the expansion portion 8 rotates around the rotation center with the hinge portion 9a, which is a portion of the extension portion 9 connected to the expansion portion 8 below the through hole 5a, as the rotation center. Expand while moving. More specifically, the two balloon portions constituting the expansion portion 8 of the present embodiment are arranged so as to be overlapped in the thickness direction A.
  • one end of each of these two balloon portions is attached to the extension portion 9. That is, one end side of the two balloon portions is restrained by the extending portion 9. Therefore, even if the two balloon portions are expanded, the distance between the two balloon portions is not separated on the one end side. On the other hand, the other ends of the two balloon portions are not restrained at all. Therefore, when the two balloon portions are expanded, the distance between the two balloon portions is separated on the other end side. That is, in the two balloon portions constituting the expansion portion 8 of the present embodiment, the one end side attached to the extension portion 9 is the center of rotation, and the other end side not attached to the extension portion 9 is this time. It rotates around the center of motion.
  • the expansion portion 8 of the present embodiment expands in the direction of inclination with respect to the thickness direction A.
  • the perforation P see FIG. 11B
  • the configuration for expanding in the direction of inclination with respect to the thickness direction A is not limited to the configuration of the pressing body 4 of the present embodiment.
  • the extension portion 9 of the present embodiment includes a portion having translucency in the thickness direction A at a position covering the upper surface of the holding body 5. Specifically, all the portions covering the upper surface of the holding body 5 of the extending portion 9 of the present embodiment are composed of portions having translucency in the thickness direction A. More specifically, the extension portion 9 of the present embodiment has a sheet shape, and the extension portion 9 has translucency in the thickness direction at an arbitrary position. However, the extending portion 9 may be configured to include, for example, a portion having translucency in the thickness direction only in a part of the position covering the upper surface of the holding body 5.
  • Examples of the constituent materials of the expansion portion 8 and the extension portion 9 of the pressing body 4 include soft polyvinyl chloride, polyurethane, polyethylene, polypropylene, polyester, ethylene-vinyl acetate copolymer (EVA), silicone, or any of these.
  • EVA ethylene-vinyl acetate copolymer
  • silicone silicone
  • the holding body 5 includes a main body portion 31 that is flat and has a substantially square shape in a plan view, and a pair of gripping plate portions 32 that project upward from the main body portion 31 in the upward direction A2 and are arranged so as to face each other. To be equipped.
  • the above-mentioned through hole 5a is formed in the main body 31. Further, the main body portion 31 includes the above-mentioned locking projection 5b that fits into the locking hole 9b of the extending portion 9 of the pressing body 4.
  • the expansion portion 8 of the pressing body 4 described above is arranged on the lower surface side of the central portion of the main body portion 31.
  • the main body 31 is fixed to the mounting surface 12 of the sticking sheet 2. Specifically, only the outer edge portion of the lower surface of the main body portion 31 is fixed to the mounting surface 12 of the sticking sheet 2 having a substantially C shape in a plan view. The central portion of the lower surface of the main body portion 31 is not covered with the sticking sheet 2. Therefore, the central portion of the lower surface of the main body portion 31 is not fixed to the mounting surface 12 of the sticking sheet 2.
  • the compression device 1 of the present embodiment includes a line segment marker 7a as one of the marks.
  • the expansion portion 8 can appropriately compress the compression position on the surface of the living body to be pressed and compressed by the expansion portion 8 of the pressing body 4.
  • the line segment marker 7a of the present embodiment indicates a position within the frame line marker 7b1 described later where a particularly high compression force can be obtained.
  • the line segment marker 7a of the present embodiment is provided at a position overlapping with the expansion portion 8 of the pressing body 4 in a plan view.
  • the compression device 1 is attached on the surface of the living body in a state where the line segment marker 7a is aligned so as to overlap a predetermined compression position on the surface of the living body in a plan view.
  • a predetermined compression position on the surface of the living body can be appropriately compressed by the expansion unit 8. That is, by providing the line segment marker 7a, the compression device 1 can be easily positioned at an appropriate position on the surface of the living body.
  • the line segment marker 7a can be realized, for example, by forming a part of the upper surface of the main body 31 of the holding body 5 with a resin in which a dye is kneaded, a colored paint, or the like.
  • the color of the line segment marker 7a is not particularly limited, but a green color is preferable. By making it green, medical professionals and the like can easily visually recognize the line segment marker 7a on blood or the surface of a living body.
  • the line segment marker 7a may be composed of a convex portion protruding from the upper surface of the holding body 5 or a concave portion such as a groove formed on the upper surface of the holding body 5.
  • the holding body 5 has translucency in the thickness direction A at the position where the line segment marker 7a is provided. That is, the holding body 5 is preferably translucent or transparent in the thickness direction A at the position where the line segment marker 7a is provided. By doing so, the medical staff can easily visually recognize the degree of overlap between the line segment marker 7a and the position on the surface of the living body to be aligned with the line segment marker 7a.
  • the holding body 5 has translucency in the thickness direction A at a position adjacent to the line segment marker 7a in a plan view. That is, it is preferable that the holding body 5 is translucent or transparent in the thickness direction A at a position adjacent to the line segment marker 7a in a plan view.
  • the medical staff moves the compression device 1 along the surface of the living body so that the line segment marker 7a overlaps the predetermined position on the surface of the living body.
  • the compression device 1 can be moved while visually recognizing the position on the surface of the living body through the surrounding translucent portion.
  • the periphery of the line segment marker 7a of the main body 31 of the holding body 5 is composed of a portion having translucency in the thickness direction A, the operation of attaching the compression device 1 to an appropriate position on the surface of the living body can be performed. , Will be easier.
  • the holding body 5 of the present embodiment includes, in addition to the above-mentioned line segment marker 7a, a region marker 7b that partitions a predetermined region surrounding the line segment marker 7a in a plan view viewed in the thickness direction A.
  • the holding body 5 of the present embodiment includes a border marker 7b1 as a region marker 7b.
  • the region marker 7b of the present embodiment represents a region in which the compression member 3 can compress the surface of the living body with a pressing force equal to or higher than the first predetermined value while the compression device 1 is mounted on the surface of the living body.
  • the line segment marker 7a of the present embodiment is a reference for aligning the medical insertion member 100 (see FIG.
  • the compression member 3 presses the surface of the living body with a second predetermined value or more, which is larger than the above-mentioned first predetermined value.
  • Indicates a position that can be compressed with That is, the region marker 7b indicates a region that can be compressed with a pressing force equal to or higher than the first predetermined value, and the line segment marker 7a indicates a position that can be compressed with a pressing force of a second predetermined value larger than the first predetermined value.
  • the medical insertion member 100 which requires a high compression force, such as a sheath having a large diameter, is aligned in the region marker 7b by using the line segment marker 7a. It is preferable to be done.
  • the compression force such as the first predetermined value and the second predetermined value described above is measured when the compression device 1 is used in accordance with the predetermined usage conditions of the compression device 1 in a state where the compression device 1 is appropriately mounted on the surface of the living body. Means the value to be.
  • the "predetermined usage condition” means a condition determined by a person who manufactures or sells the compression device 1, such as a fluid amount for expanding the expansion portion 8 described later of the compression device 1.
  • region marker 7b By providing the above-mentioned region marker 7b in addition to the line segment marker 7a, a plurality of (two points on the left side of FIG. 8B) are provided in the living body as illustrated in the frame of the alternate long and short dash line on the left side of FIG. 8B. Even when the medical insertion member 100 (three in the chain line frame) is inserted, all the insertion portions 100a can be aligned so as to fit within the region of the region marker 7b. Thereby, the compression device 1 can be easily attached to an appropriate position on the biological surface BS capable of compressing all the insertion portions 100a of the plurality of medical insertion members 100 with a predetermined compression force.
  • the holding body 5 is in the thickness direction A at least in a position where the line segment marker 7a is not provided in a predetermined region defined by the frame line marker 7b1 as the region marker 7b in a plan view seen in the thickness direction A. It is preferably translucent. That is, the holding body 5 is in the thickness direction at least in a position where the line segment marker 7a is not provided in a predetermined region defined by the frame line marker 7b1 as the region marker 7b in the plan view seen in the thickness direction A. It is preferable that A is translucent or transparent. By doing so, the medical staff performs the operation of moving the compression device 1 along the surface of the living body so that the line segment marker 7a overlaps the predetermined position on the surface of the living body.
  • the compression device 1 can be moved while visually recognizing the position on the surface of the living body through a translucent portion in a predetermined region partitioned by the frame line marker 7b1). That is, the inside of the predetermined region partitioned by the region marker 7b of the main body 31 of the holding body 5 is composed of a portion having translucency in the thickness direction A, so that the compression device 1 can be appropriately placed on the surface of the living body. The operation of mounting in the position becomes easier. As described above, it is preferable that the holding body 5 has translucency in the thickness direction A even at the position where the line segment marker 7a is provided.
  • the region marker 7b of the present embodiment is a frame line marker 7b1 that surrounds the periphery of the line segment marker 7a in a plan view seen in the thickness direction A.
  • the holding body 5 preferably has translucency in the thickness direction A at the position where the frame line marker 7b1 is provided. That is, the holding body 5 is preferably translucent or transparent in the thickness direction A at the position where the frame line marker 7b1 is provided. By doing so, the medical staff can easily visually recognize the degree of overlap between the border marker 7b1 and the position on the surface of the living body to be aligned with the border marker 7b1.
  • the holding body 5 has translucency in the thickness direction A at a position adjacent to the outside of the region marker 7b (frame line marker 7b1 in the present embodiment) in a plan view in the thickness direction A. That is, it is preferable that the holding body 5 is translucent or transparent in the thickness direction A at a position adjacent to the outside of the region marker 7b (frame line marker 7b1 in the present embodiment) in a plan view in the thickness direction A. ..
  • the medical staff performs the operation of moving the compression device 1 along the surface of the living body so that the line segment marker 7a overlaps the predetermined position on the surface of the living body.
  • the compression device 1 can be moved at a position outside a predetermined region partitioned by the frame line marker 7b1) while visually recognizing the position on the surface of the living body through the translucent portion. That is, the position adjacent to the outside of the predetermined region defined by the region marker 7b of the main body portion 31 of the holding body 5 is composed of a portion having translucency in the thickness direction A, so that the compression device 1 can be used as a living body. The operation of mounting in the proper position on the surface becomes easier.
  • the area marker 7b such as the frame line marker 7b1 of the present embodiment can be realized, for example, by forming a part of the upper surface of the main body 31 of the holding body 5 with a resin in which a dye is kneaded, a colored paint, or the like. be.
  • the color of the region marker 7b is not particularly limited, but a greenish color is preferable. By making it green, medical professionals and the like can easily visually recognize the region marker 7b on blood or the surface of a living body. Therefore, it becomes easier to align the expansion portion 8 with the compression position on the surface of the living body by using the region marker 7b.
  • the area marker 7b is used as the frame line marker 7b1, it may be composed of a convex portion protruding from the upper surface of the holding body 5 or a concave portion such as a groove formed on the upper surface of the holding body 5.
  • the border marker 7b1 as the area marker 7b of the present embodiment has a rectangular shape, but this shape is not particularly limited.
  • the border marker 7b1 may have a polygonal shape other than a circular shape, an oval shape, or a square shape, for example.
  • the frame line marker 7b1 of the present embodiment is partially divided by the through hole 5a of the holding body 5, but is not limited to this configuration.
  • the frame line marker 7b1 may be provided only on the side opposite to the receiving portion 6 side with respect to the through hole 5a.
  • the holding body 5 of the present embodiment includes a border marker 7b1 as an area marker 7b, but the area marker 7b is not limited to this configuration.
  • the area marker 7b may have a configuration in which a predetermined area is bordered by an outer edge of the area filled with a predetermined color.
  • the expansion portion 8 and the extension portion 9 of the pressing body 4 of the present embodiment are also composed of portions having translucency in the thickness direction A.
  • the extending portion 9 of the pressing body 4 the line segment marker 7a of the holding body 5, the area marker 7b (frame line marker 7b1 in the present embodiment), their surroundings, and the pressing body 4
  • the expansion portion 8 of the above is laminated in the thickness direction A.
  • this portion is referred to as a "laminated portion”.
  • the laminated portion of the present embodiment is preferably configured by laminating portions having translucency.
  • the extending portion 9 of the pressing body 4, the line segment marker 7a of the holding body 5, the area marker 7b and their surroundings, and the expanding portion of the pressing body 4 are used.
  • the other side can be visually recognized from one side of the thickness direction A through 8.
  • the alignment of the line segment marker 7a and the region marker 7b on the surface of the living body becomes easier.
  • the line segment marker 7a and the region marker 7b are in a mode in which they can be distinguished from all other layers of the laminated portion in a plan view. Is preferable. By doing so, the alignment of the line segment marker 7a and the region marker 7b on the surface of the living body becomes even easier.
  • the line segment marker 7a of the present embodiment and the frame line marker 7b as the area marker 7b are provided on the upper surface of the main body 31 of the holding body 5. Therefore, the line segment marker 7a and the area marker 7b of the present embodiment are easily visible to the medical staff who is operating the compression device 1.
  • the line segment marker 7a and the area marker 7b may be provided inside the holding body 5. Further, the line segment marker 7a and the area marker 7b may be provided on the lower surface of the main body 31 of the holding body 5. Details of the configuration in which the line segment marker 7a and the region marker 7b are provided on the lower surface of the holding body 5 will be described later (see FIG. 9).
  • the method of providing the line segment marker 7a and the area marker 7b is not particularly limited, but for example, printing, fusion, adhesion, integral molding, or the like can be used.
  • the line segment marker 7a of the present embodiment is provided at a position between the pair of gripping plate portions 32 in a plan view.
  • the medical staff who operates the compression device 1 can easily visually recognize the line segment marker 7a in a state where the pair of grip plate portions 32 are sandwiched and gripped from both sides. Therefore, the operability of the compression device 1 is improved.
  • all of the line segment markers 7a are arranged between the pair of grip plate portions 32 in a plan view.
  • the pair of grip plate portions 32 are gripped by a medical worker. By providing such a pair of grip plate portions 32, it becomes easy to hold the compression device 1. Therefore, the operability for the medical staff can be improved.
  • Examples of the material of the holding body 5 of the present embodiment include a resin material.
  • the resin material include ABS resin, AS resin, polyethylene, polypropylene, polystyrene, polyvinyl chloride, polyvinylidene chloride resin, polyphenylene oxide, thermoplastic polyurethane, polymethylene methacrylate, polyoxyethylene, fluororesin, polycarbonate, and polyamide.
  • At least the central portion of the main body portion 31 of the holding body 5 is formed of a material having ultrasonic transmission.
  • the above-mentioned pressing body 4 is also preferably formed of a material having ultrasonic wave transparency.
  • a fluid having ultrasonic permeability such as water or gel is used as the fluid supplied to the accommodation space 8a of the expansion portion 8 of the pressing body 4. In this way, the state of obstruction of the blood vessel by the compression device 1 can be detected by the ultrasonic device. The details will be described later.
  • FIG. 7 is a flowchart showing an example of a method of compressing the surface of a living body.
  • the compression method shown in FIG. 7 includes a sticking step S1, a first compression step S2, a removal step S3, and a second compression step S4.
  • 8A and 8B are diagrams showing an outline of the sticking step S1.
  • FIG. 8C is a diagram showing an outline of the first compression step S2.
  • FIG. 8D is a diagram showing an outline of the extraction step S3.
  • FIG. 8E is a diagram showing an outline of the second compression step S4.
  • the compression method illustrated in FIGS. 7 and 8A to 8E is a compression method in which the perforation leading from the biological surface to the vein is narrowed or occluded by compressing the biological surface BS without occluding the vein.
  • the perforation is formed by removing the sheath as the medical insertion member 100 in a state of being inserted into a vein such as a femoral vein through connective tissue from the biological surface BS.
  • hemostasis can be performed after the sheath as the medical insertion member 100 is removed.
  • FIG. 11A shows a state in which the sheath as the medical insertion member 100 is inserted into the femoral vein FV from the biological surface BS through the connective tissue CT.
  • FIG. 11A three sheaths as the medical insertion member 100 are shown, but the number may be two or less, or four or more.
  • FIG. 11B shows a state after removing the sheath as the medical insertion member 100 from the state shown in FIG. 11A. As shown in FIG. 11B, by removing the sheath as the medical insertion member 100, a perforation P is formed between the biological surface BS and the femoral vein FV. In the compression method shown in FIGS.
  • the perforation P can be narrowed or occluded without occluding the femoral vein FV. Therefore, even when bleeding from a vein located deep from the surface of the living body is stopped, it is not necessary to narrow or occlude the vein itself, and bleeding can be stopped more efficiently.
  • the details of each of the steps S1 to S4 will be described with reference to FIGS. 8A to 8E.
  • FIG. 8A shows a state in which a sheath as a medical insertion member 100 is inserted into the femoral vein FV (see FIGS. 11A and 11B) from the biological surface BS.
  • FIG. 8B shows a state in which the compression device 1 is completely attached to a predetermined position on the biological surface BS with the sheath as the medical insertion member 100 inserted in the living body. Further, in FIG. 8B, the details of the alignment of the line segment marker 7a and the insertion portion 100a of the medical insertion member 100 in a plan view are shown enlarged in the frame of the alternate long and short dash line. 8A and 8B show the usage state of the compression device 1 after the release sheet is peeled from the sticking surface 11.
  • the compression device 1 is attached to the surface of the living body by sticking the sticking surface 11 of the sticking sheet 2 to the surface of the living body.
  • a portion of the sheath as the medical insertion member 100 inserted into the living body from the living body surface BS exposed to the outside from the living body surface BS is received by the receiving portion 6.
  • the sticking sheet 2 is stuck to the biological surface BS.
  • a part of the insertion portion 100a of the sheath as the medical insertion member 100 located on the same surface as the biological surface BS is aligned with the line segment marker 7a (FIG. 8B-2). See inside the dotted line frame). In the state of being aligned in this way, the sticking sheet 2 is stuck to the biological surface BS.
  • the entire insertion portion 100a of the sheath as the medical insertion member 100 located on the same surface as the biological surface BS is located within the region marker 7b. It will be matched. In the state of being aligned in this way, the sticking sheet 2 is stuck to the biological surface BS.
  • a region marker 7b as shown in an enlarged example in the frame of the alternate long and short dash line on the left side of FIG. 8B, a plurality of markers (three in the frame of the alternate long and short dash line on the left side of FIG. 8B) are provided.
  • the compression device 1 can be easily attached to an appropriate position on the biological surface BS capable of compressing all the insertion portions 100a of the plurality of medical insertion members 100 with a predetermined compression force.
  • a thin sheath having an outer diameter of less than a predetermined value is not aligned with the line segment marker 7a within the region marker 7b (two points on the left side of FIG. 8B).
  • the line segment marker 7a of the present embodiment indicates a position in the region of the region marker 7b where a particularly high compression force can be obtained. Therefore, for example, even with a large-diameter sheath or the like that requires a high compression force, a predetermined compression force can be secured.
  • the compression device 1 can be attached to a more appropriate position on the biological surface BS according to the outer diameter and number of the medical insertion member 100 and the required compression force. Can be done.
  • the line segment marker 7a extends in an arc shape in the plan view seen in the thickness direction A. Therefore, in the present embodiment, a part of the outer surface of the insertion portion 100a of the medical insertion member 100 is aligned so as to be in contact with or overlap the line segment marker 7a in a plan view.
  • the compression device 1 is mounted on the biological surface BS in such an aligned state.
  • the syringe 30 as a fluid supply device is connected to the connection portion 29 of the tube 28.
  • air is supplied to the accommodation space 8a (see FIG. 6) of the expansion portion 8 of the pressing body 4 of the compression device 1 to expand the expansion portion 8.
  • the vicinity of the wound on the biological surface BS can be pressed in advance before the sheath as the medical insertion member 100 is removed from the biological surface BS.
  • compression of the biological surface BS is started with the sheath as the medical insertion member 100 inserted into the femoral vein FV as a vein from the biological surface BS through the connective tissue CT (see FIGS. 11A and 11B). do.
  • the medical insertion member 100 is pressed before being removed from the biological surface BS.
  • the biological surface BS can be pressed immediately after the sheath as the medical insertion member 100 is removed. Therefore, the perforation P (see FIG. 11B) extending from the biological surface BS to the femoral vein FV (see FIGS. 11A and 11B) can be narrowed or occluded immediately after the sheath is removed.
  • the sheath as the medical insertion member 100 is removed from the biological surface BS. Removal of this sheath forms the perforation P shown in FIG. 11B. If the biological surface BS is not compressed at all in this state, bleeding occurs from the femoral vein FV through the perforation P and the wound on the biological surface BS. However, in the compression method shown here, as shown in FIG. 8C, the biological surface BS is compressed in advance before the sheath as the medical insertion member 100 is removed from the biological surface BS. Therefore, immediately after the sheath is removed, the biological surface BS can be pressed so as to narrow or occlude the perforation P (see FIG. 11B), and the amount of bleeding immediately after the sheath is removed can be suppressed.
  • the syringe 30 as a fluid supply device is reconnected to the connection portion 29 of the tube 28. Air is supplied again to pressurize the accommodating space 8a of the expansion portion 8 of the compression device 1 through the tube 28, or the air is evacuated to reduce the pressure.
  • the compression force of the biological surface BS is adjusted after the sheath as the medical insertion member 100 is removed.
  • the compression force of the biological surface BS is adjusted to further narrow or occlude the perforation P (see FIG. 11B) without occluding the femoral vein FV (see FIGS. 11A and 11B), thereby reducing the amount of bleeding. It can be greatly reduced or bleeding can be stopped.
  • the compression force is slowly increased and pressurized until hemostasis is achieved.
  • the compression force is slowly reduced to reduce the pressure until bleeding is confirmed. Then, after bleeding is confirmed, the compression force is slowly increased and pressurized until hemostasis is achieved.
  • the pressing body 4 and the holding body 5 are formed of a material having ultrasonic wave transmission, and a fluid having ultrasonic wave transmission such as water is supplied to the expansion portion 8 of the pressing body 4.
  • the compression state by the compression device 1 can be diagnosed by ultrasonic waves. That is, the ultrasonic device can detect whether or not the femoral vein FV (see FIGS. 11A and 11B) is occluded.
  • the compression force of the compression device 1 may be adjusted based on the diagnosis result by the ultrasonic device.
  • Hemostasis can be completed by maintaining the compressed state for several hours (for example, 2 to 6 hours). After the hemostasis is completed, the compression device 1 is removed from the biological surface BS by peeling the adhesive surface 11 of the adhesive sheet 2 from the biological surface BS.
  • the compression method shown here narrows or occludes the perforation P (see FIG. 11B) without occluding the femoral vein FV (see FIGS. 11A, 11B).
  • bleeding can be stopped by stenosis or occlusion of perforation P (see FIG. 11B).
  • hemostasis of the femoral artery for example, even if only the perforation is occluded, blood leaks and spreads into the connective tissue CT (see FIGS. 11A and 11B), so that hemostasis cannot be performed.
  • a large-scale measure such as a method of compressing the artery itself so strongly as to narrow or occlude it or a method of closing a hole in the arterial wall is required.
  • the biological surface BS it is preferable to compress the biological surface BS to a position where the compression depth from the biological surface BS is 5 mm to 20 mm.
  • the compression depth is more preferably 5 mm to 15 mm, and even more preferably 8 mm to 12 mm.
  • the biological surface BS it is preferable to press the living body surface BS at 10g / cm 2 ⁇ 600g / cm 2.
  • This compression pressure is the pressure after the sheath as the medical insertion member 100 is removed, and does not mean the compression force before the sheath is removed as described above.
  • the compression pressure is more preferably 50 g / cm 2 to 400 g / cm 2, and even more preferably 100 g / cm 2 to 300 g / cm 2 .
  • the biological surface BS along a direction orthogonal to the extending direction of the perforation P (see FIG. 11B).
  • “Compressing along a direction orthogonal to the extending direction of the perforation” is not limited to compressing only in the direction orthogonal to the extending direction of the perforation, but is orthogonal to the extending direction of the perforation. It also means that the pressure is applied in a direction of inclination at an angle of a predetermined angle or less (for example, 30 degrees or less) with respect to the direction of the squeeze.
  • the compression device 1 of the present embodiment can compress the biological surface BS along a direction orthogonal to the extending direction of the perforation P (see FIG. 11B).
  • the expansion portion 8 of the pressing body 4 of the present embodiment can be expanded in a direction in which it is inclined with respect to the thickness direction A.
  • the surface of the living body can be compressed along the direction orthogonal to the extending direction of the perforation P (see FIG. 11B).
  • the sheath as the medical insertion member 100 is not in a direction orthogonal to the biological surface BS (the same direction as the thickness direction A), but with respect to the biological surface BS. It is inserted in a direction inclined to one side with respect to the orthogonal direction. Therefore, as shown in FIG.
  • the extending direction of the perforation P is also inclined with respect to the direction orthogonal to the biological surface BS. Therefore, the direction in which the perforation P is inclined in the direction opposite to the extending direction of the perforation P with respect to the thickness direction A which is orthogonal to the biological surface BS (hereinafter, may be referred to as “inclination direction F”). If the expansion portion 8 is expandable, it becomes easy to press the biological surface BS along the direction orthogonal to the extending direction of the perforation P. This facilitates the realization of a compression device 1 that narrows or occludes the perforation P without occluding the veins such as the femoral vein FV of FIGS. 11A and 11B.
  • FIG. 12 is a diagram showing a state in which the perforation P shown in FIG. 11B is narrowed or occluded by the compression device 1. As shown in FIG. 12, according to the compression device 1, the perforation P is more likely to be narrowed or occluded without further occluding the vein such as the femoral vein FV.
  • hemostasis can be performed by narrowing or occluding the perforation P (see FIG. 11B) without occluding a vein such as a femoral vein FV. ..
  • a vein such as a femoral vein FV. ..
  • FIG. 13 is a front view of the state shown in FIG. 12 as viewed from the living body surface BS side.
  • FIG. 13 shows a front view of the biological surface BS at a position where it is compressed by the compression device 1.
  • front view of the surface of the living body at a position where it is compressed by the compression device means that the portion of the surface of the living body to be compressed by the compression device is perpendicular to the portion before compression. It means the state seen from the direction.
  • FIG. 13 shows a front view of the inguinal region. In the front view shown in FIG. 13, the direction in which the biological surface BS is compressed (see the white arrow “AR1” in FIG.
  • the extending direction G of the perforation P is inclined with respect to the biological surface BS and is perpendicular to the biological surface BS (vertical direction in FIG. 12). But it's tilted.
  • the compression direction of the biological surface BS by the compression device 1 is also an inclination with respect to the biological surface BS and a vertical direction perpendicular to the biological surface BS (vertical direction in FIG. 12). It is also inclined to.
  • the extending direction G of the perforation P is opposite to the inclination direction F as the compression direction of the living body surface by the compression device 1 with respect to the vertical direction (vertical direction in FIG. 12). Leaning on. That is, the compression of the living body surface by the compression device 1 is executed so that the compression direction intersects with the extension direction G of the perforation P. As a result, the perforation P can be efficiently narrowed or occluded.
  • FIG. 9 is a bottom view of the compression device 301 of the present embodiment in a state where the pressing body 4 (see FIG. 1 and the like) is removed.
  • the compression device 301 of the present embodiment is different from the compression device 1 described above in the positions provided on the holding bodies of the line segment marker and the region marker.
  • FIG. 10 illustrates a state in which a part of the outer surface of the insertion portion 100a located on the same surface as the living body surface of the medical insertion member 100 is positioned with respect to the line segment marker 307a provided on the lower surface of the holding body 305. It is a schematic diagram for this. In other words, FIG. 10 is a schematic diagram for explaining the effect of the line segment marker 307a provided on the lower surface of the holding body 305. In FIG. 10, for convenience of explanation, the line segment marker 1007a provided on the upper surface of the holding body 305 is shown for comparison. As shown in FIG.
  • the thickness of the holding body 305 in the thickness direction A is increased as compared with the configuration in which the line segment marker 1007a is provided on the upper surface of the holding body 305. It is possible to suppress the occurrence of misalignment due to it. That is, when the line segment marker 1007a is provided on the upper surface of the holding body 305, the line segment marker 1007a is separated from the biological surface on the lower surface side of the holding body 305 by at least the thickness of the holding body 305.
  • the line segment marker 1007a is positioned at a predetermined position on the surface of the living body from an erroneous viewpoint deviated from the plan view (for example, the viewpoint PV shown in FIG. 10), the line segment marker 1007a is aligned in the in-plane direction H of the living body surface. And a predetermined position on the surface of the living body (a part of the outer surface of the insertion portion 100a in FIG. 10) may be misaligned.
  • the line segment marker 307a is provided on the lower surface of the holding body 305, the above-mentioned positional deviation due to the difference in viewpoint is less likely to occur.
  • the compression device 301 can be more easily attached to an appropriate position on the surface of the living body.
  • FIG. 10 for convenience of explanation, the effect of providing only the line segment marker 307a on the lower surface of the holding body 305 has been described, but the same applies to the area marker 307b, and the description thereof will be omitted here.
  • the line segment marker 307a of the present embodiment is composed of a groove portion extending in an arc shape formed on the lower surface of the holding body 305.
  • the area marker 307b of the present embodiment is composed of a frame line marker 307b1 for partitioning a predetermined area by a rectangular groove formed on the lower surface of the holding body 305.
  • the area marker 307b of the present embodiment is partially cut off by the through hole 305a of the holding body 305 in a plan view, but is not limited to this configuration.
  • the region marker 307b may be provided on only one side of the through hole 305a of the holding body 305 in a plan view.
  • the border marker 307b1 as the region marker 307b of the present embodiment has a rectangular shape in a plan view, but this shape is not particularly limited.
  • the border marker 307b1 as the region marker 307b may have a polygonal shape other than a circular shape, an oval shape, and a square shape in a plan view.
  • the compression device according to the present disclosure and the method of attaching the compression device are not limited to the specific configurations and methods shown in the first and second embodiments described above, and are not limited to the description of the scope of claims. , Various modifications and changes are possible. Further, the compression device constructed by combining the configurations of each part of the compression device shown in the first embodiment and the second embodiment also belongs to the technical scope of the present disclosure.
  • This disclosure relates to a compression device and a method of attaching the compression device.

Abstract

This compression device comprises an adhesive sheet which has an adhesive surface that can be adhered to a living body surface, and a compression member which is fixed to the adhesive sheet and is capable of compressing the living body surface, wherein the compression member includes a depressing body that is capable of depressing the living body surface by extending in the thickness direction of the adhesive sheet, and a holding body that is fixed to the adhesive sheet on a side opposite the adhesive surface and holds the depressing body so as to enable the depressing body to extend in the thickness direction, the holding body having a segment marker that extends in an arc shape at a position overlapping the depressing body when seen in plan view in the thickness direction.

Description

圧迫デバイス、及び、圧迫デバイスの貼着方法Compression device and how to attach the compression device
 本開示は圧迫デバイス、及び、圧迫デバイスの貼着方法に関する。 This disclosure relates to a compression device and a method of attaching the compression device.
 近年、医療機関において、カテーテルを用いて、様々な形態の検査や治療が行われている。カテーテルは、例えば、手首や鼠径部等に形成された穿刺部位より経皮的に血管内に挿入され、血管を通じて検査や治療の対象となる部位まで運ばれる。医療従事者による検査や治療が完了した後は、穿刺針、カテーテル、生体内へのカテーテル導入のために利用されるシース等の、細長い挿入部材を穿刺部位から抜去すると共に、その穿刺部位を止血する。 In recent years, various forms of examinations and treatments have been performed at medical institutions using catheters. The catheter is percutaneously inserted into a blood vessel from a puncture site formed on the wrist, inguinal region, or the like, and is carried through the blood vessel to a site to be examined or treated. After the examination or treatment by a healthcare professional is completed, an elongated insertion member such as a puncture needle, a catheter, or a sheath used for introducing a catheter into a living body is removed from the puncture site, and the puncture site is stopped from bleeding. do.
 特許文献1には、シースを抜去した後に、患者の傷に対して圧迫を加える圧迫デバイスとしてのドレッシングが開示されている。特許文献1のドレッシングは、膜が端壁に隣接している収縮状態と、膜が端壁から間隔を保っている膨張状態とを有する膨張式ブラダーを備える。また、特許文献1のドレッシングは、実質的に傷を覆う位置でブラダーを患者の皮膚に対して保持する保持手段を備える。特許文献1には、ブラダーの端壁と連結しブラダーの端壁から外側に突出する可撓性ウェブを含む保持手段が開示されており、この可撓性ウェブの片面には、患者の皮膚に接着するための粘着層が設けられている。 Patent Document 1 discloses a dressing as a compression device that applies compression to a patient's wound after removing the sheath. The dressing of Patent Document 1 includes an inflatable bladder having a contracted state in which the film is adjacent to the end wall and an expanded state in which the film is kept at a distance from the end wall. Further, the dressing of Patent Document 1 includes a holding means for holding the bladder against the skin of the patient at a position substantially covering the wound. Patent Document 1 discloses a holding means including a flexible web that is connected to the end wall of the bladder and projects outward from the end wall of the bladder, and one side of the flexible web is attached to the patient's skin. An adhesive layer for adhesion is provided.
特表2005-521464号公報Special Table 2005-521464
 特許文献1に記載の圧迫デバイスとしてのドレッシングでは、可撓性ウェブの片面に設けられている粘着層を患者の生体表面としての皮膚に接着すると共に、ブラダーを膨張状態にすることで、ブラダーにより患者の傷を圧迫することができる。 In the dressing as a compression device described in Patent Document 1, an adhesive layer provided on one side of a flexible web is adhered to the skin as a living body surface of a patient, and the bladder is in an expanded state by the bladder. Can squeeze the patient's wound.
 しかしながら、特許文献1に記載のドレッシングでは、生体表面上の所定の圧迫位置へのブラダーの位置合わせの効率化については、依然として改善の余地がある。 However, in the dressing described in Patent Document 1, there is still room for improvement in improving the efficiency of positioning the bladder to a predetermined compression position on the surface of the living body.
 本開示は、生体表面上の適切な位置に容易に位置決め可能な圧迫デバイス、及び、圧迫デバイスの貼着方法、を提供することを目的とする。 An object of the present disclosure is to provide a compression device that can be easily positioned at an appropriate position on the surface of a living body, and a method of attaching the compression device.
 本開示に係る第1の態様としての圧迫デバイスは、生体表面に貼着可能な貼着面を備える貼着シートと、前記貼着シートに固定されており、前記生体表面を圧迫可能な圧迫部材と、を備え、前記圧迫部材は、前記貼着シートの厚み方向に伸長することにより前記生体表面を押圧可能な押圧体と、前記貼着面とは反対側で前記貼着シートに固定されており、前記押圧体を前記厚み方向に伸長可能に保持する保持体と、を備え、前記保持体は、前記厚み方向で見た平面視において、前記押圧体と重なる位置に、弧状に延在する線分マーカを備える。 The compression device as the first aspect according to the present disclosure is a sticking sheet provided with a sticking surface that can be stuck to the surface of a living body, and a compression member that is fixed to the sticking sheet and can press the surface of the living body. The compression member is fixed to the sticking sheet on a side opposite to the sticking surface and a pressing body capable of pressing the living body surface by extending in the thickness direction of the sticking sheet. A holding body that holds the pressing body so as to be extendable in the thickness direction is provided, and the holding body extends in an arc shape at a position overlapping the pressing body in a plan view seen in the thickness direction. It is equipped with a line segment marker.
 本開示の1つの実施形態として、前記押圧体は、前記貼着シートの前記貼着面が前記生体表面に貼着されている状態において前記生体表面と前記保持体との間に配置され、流体の供給により前記厚み方向に拡張可能な拡張部を備え、前記線分マーカは、前記厚み方向で見た平面視において前記押圧体の前記拡張部と重なる位置に設けられている。 As one embodiment of the present disclosure, the pressing body is arranged between the living body surface and the holding body in a state where the sticking surface of the sticking sheet is stuck to the living body surface, and is a fluid. The line segment marker is provided at a position overlapping the expansion portion of the pressing body in a plan view viewed in the thickness direction.
 本開示の1つの実施形態として、前記保持体は、前記線分マーカが設けられている位置において、前記厚み方向に透光性を有する。 As one embodiment of the present disclosure, the holder has translucency in the thickness direction at a position where the line segment marker is provided.
 本開示の1つの実施形態として、前記保持体は、前記厚み方向で見た平面視で前記線分マーカと隣接する位置において、前記厚み方向に透光性を有する。 As one embodiment of the present disclosure, the holding body has translucency in the thickness direction at a position adjacent to the line segment marker in a plan view in the thickness direction.
 本開示の1つの実施形態として、前記保持体は、前記厚み方向で見た平面視において前記線分マーカを取り囲む所定の領域を区画する領域マーカを備える。 As one embodiment of the present disclosure, the holding body includes a region marker that partitions a predetermined region surrounding the line segment marker in a plan view viewed in the thickness direction.
 本開示の1つの実施形態として、前記保持体は、前記厚み方向で見た平面視で前記領域マーカにより区画される前記所定の領域内で、少なくとも前記線分マーカが設けられていない位置において、前記厚み方向に透光性を有する。 As one embodiment of the present disclosure, the retainer is placed in the predetermined region partitioned by the region markers in a plan view in the thickness direction, at least at a position where the line segment markers are not provided. It has translucency in the thickness direction.
 本開示の1つの実施形態として、前記領域マーカは、前記厚み方向で見た平面視において、前記線分マーカの周囲を取り囲む枠線マーカである。 As one embodiment of the present disclosure, the region marker is a frame line marker that surrounds the periphery of the line segment marker in a plan view viewed in the thickness direction.
 本開示の1つの実施形態として、前記保持体は、前記厚み方向で見た平面視で前記領域マーカの外側に隣接する位置において、前記厚み方向に透光性を有する。 As one embodiment of the present disclosure, the holding body has translucency in the thickness direction at a position adjacent to the outside of the region marker in a plan view in the thickness direction.
 本開示に係る第2の態様としての、圧迫デバイスの貼着方法は、生体表面に貼着可能な貼着面を備える貼着シートと、前記貼着シートに固定されており、前記生体表面を圧迫可能な圧迫部材と、を備える圧迫デバイスを前記生体表面に貼着する貼着方法であって、前記圧迫部材は、前記厚み方向で見た平面視において弧状に延在する線分マーカを備え、前記生体表面から生体内に挿入されている医療用管部材のうち前記生体表面と同一面に位置する挿入部分の一部を、前記線分マーカに位置合わせした状態で、前記貼着シートを前記生体表面に貼着する。 The method of attaching the compression device as the second aspect according to the present disclosure is a method of attaching the compression device to a attachment sheet having an attachment surface that can be attached to the surface of the living body and the attachment sheet fixed to the attachment sheet. A method of attaching a compression device including a compression member capable of compression to the surface of a living body, wherein the compression member includes a line segment marker extending in an arc shape in a plan view in the thickness direction. A part of the medical tube member inserted into the living body from the surface of the living body, which is located on the same surface as the surface of the living body, is aligned with the line segment marker, and the sticking sheet is attached. It is attached to the surface of the living body.
 本開示の1つの実施形態として、前記押圧部材は、前記厚み方向で見た平面視において前記線分マーカを取り囲む所定の領域を区画する領域マーカを備え、前記生体表面から生体内に挿入されている前記医療用管部材のうち前記生体表面と同一面に位置する前記挿入部分の一部を、前記線分マーカに位置合わせすると共に、前記挿入部分の全部を前記領域マーカにより区画される前記所定の領域内に位置合わせした状態で、前記貼着シートを前記生体表面に貼着する。 As one embodiment of the present disclosure, the pressing member includes a region marker that partitions a predetermined region surrounding the line segment marker in a plan view viewed in the thickness direction, and is inserted into the living body from the living body surface. A part of the insertion portion of the medical tube member located on the same surface as the living body surface is aligned with the line segment marker, and the entire insertion portion is partitioned by the region marker. The sticking sheet is stuck to the surface of the living body in a state of being aligned within the region of.
 本開示によれば、生体表面上の適切な位置に容易に位置決め可能な圧迫デバイス、及び、圧迫デバイスの貼着方法、を提供することができる。 According to the present disclosure, it is possible to provide a compression device that can be easily positioned at an appropriate position on the surface of a living body, and a method of attaching the compression device.
本開示の第1実施形態としての圧迫デバイスを上面側から見た斜視図である。It is a perspective view which looked at the compression device as the 1st Embodiment of this disclosure from the upper surface side. 図1に示す圧迫デバイスの上面図である。It is a top view of the compression device shown in FIG. 図1に示す圧迫デバイスの下面図である。It is a bottom view of the compression device shown in FIG. 図1に示す圧迫デバイスの分解斜視図である。It is an exploded perspective view of the compression device shown in FIG. 図1に示す圧迫デバイスの、拡張部が収縮形態にある状態を示す断面図である。FIG. 5 is a cross-sectional view showing a state in which an expanded portion of the compression device shown in FIG. 1 is in a contracted state. 図1に示す圧迫デバイスの、拡張部が拡張形態にある状態を示す断面図である。FIG. 5 is a cross-sectional view showing a state in which an expanded portion of the compression device shown in FIG. 1 is in an expanded form. 本開示の一実施形態としての、圧迫デバイスの貼着方法を含む、図1に示す圧迫デバイスを用いて行う生体表面の圧迫方法の一例を示すフローチャートである。It is a flowchart which shows an example of the compression method of the living body surface performed by using the compression device shown in FIG. 1, including the method of attaching the compression device as one embodiment of the present disclosure. 図7の貼着工程の概要を示す図である。It is a figure which shows the outline of the sticking process of FIG. 図7の貼着工程の概要を示す図である。It is a figure which shows the outline of the sticking process of FIG. 図7の第1圧迫工程の概要を示す図である。It is a figure which shows the outline of the 1st compression process of FIG. 図7の抜去工程の概要を示す図である。It is a figure which shows the outline of the removal process of FIG. 図7の第2圧迫工程の概要を示す図である。It is a figure which shows the outline of the 2nd compression process of FIG. 本開示の第2実施形態としての圧迫デバイスの押圧体を取り除いた状態での下面図である。It is a bottom view of the compression device as the second embodiment of the present disclosure in a state where the pressing body is removed. 本開示の一実施形態の圧迫デバイスにおいて保持体の下面に設けられる線分マーカによる効果を説明するための模式図である。It is a schematic diagram for demonstrating the effect by the line segment marker provided on the lower surface of the holding body in the compression device of one Embodiment of this disclosure. 医療用挿入部材が生体表面から結合組織を通じて大腿静脈内に挿入されている状態を示す図である。It is a figure which shows the state which the medical insertion member is inserted into the femoral vein from the surface of a living body through connective tissue. 図11Aに示す状態から医療用挿入部材を抜去した後の状態を示す図である。It is a figure which shows the state after removing the medical insertion member from the state shown in FIG. 11A. 図1に示す圧迫デバイスにより、図11Bに示す穿孔を狭窄又は閉塞している状態を示す図である。It is a figure which shows the state which narrowed or closed the perforation shown in FIG. 11B by the compression device shown in FIG. 図12に示す状態を、生体表面側から見た正面図である。FIG. 12 is a front view of the state shown in FIG. 12 as viewed from the surface side of the living body.
 以下、本開示に係る、圧迫デバイス、及び、圧迫デバイスの貼着方法、の実施形態について図面を参照して例示説明する。各図において共通する部材、部位には同一の符号を付している。 Hereinafter, embodiments of the compression device and the method of attaching the compression device according to the present disclosure will be illustrated with reference to the drawings. The same reference numerals are given to common members and parts in each figure.
[第1実施形態]
 図1~図6は、本開示の一実施形態としての圧迫デバイス1を示す図である。具体的に、図1は圧迫デバイス1を上面側から見た斜視図である。図2、図3は、圧迫デバイス1の平面図である。具体的に、図2は、圧迫デバイス1の上面図である。図3は、圧迫デバイス1の下面図である。図4は、圧迫デバイス1の分解斜視図である。図5、図6は、圧迫デバイス1の同断面での断面図である。詳細は後述するが、図5、図6それぞれは、圧迫デバイス1の異なる状態を示している。
[First Embodiment]
1 to 6 are diagrams showing a compression device 1 as an embodiment of the present disclosure. Specifically, FIG. 1 is a perspective view of the compression device 1 as viewed from the upper surface side. 2 and 3 are plan views of the compression device 1. Specifically, FIG. 2 is a top view of the compression device 1. FIG. 3 is a bottom view of the compression device 1. FIG. 4 is an exploded perspective view of the compression device 1. 5 and 6 are cross-sectional views of the compression device 1 in the same cross section. Details will be described later, but FIGS. 5 and 6 show different states of the compression device 1.
 圧迫デバイス1は、貼着シート2と、圧迫部材3と、を備える。 The compression device 1 includes a sticking sheet 2 and a compression member 3.
 貼着シート2は、厚み方向Aの一方側に生体表面に貼着可能な貼着面11を備える。圧迫部材3は、貼着シート2に取り付けられている。具体的に、圧迫部材3は、貼着面11とは反対側で貼着シート2に固定されている。圧迫部材3は、貼着面11が生体表面に貼着されている状態で、生体表面を圧迫可能である。このように、圧迫デバイス1は、貼着面11を生体表面に貼着することにより、生体表面上での位置が固定される。圧迫デバイス1によれば、貼着シート2の貼着面11が生体表面上に貼着されている状態で、圧迫部材3により、生体表面上の所定部位を圧迫することができる。生体表面上の所定部位とは、例えば、穿刺針、カテーテル、シース等の医療用挿入部材を生体の血管内に挿入することにより形成される、生体表面上の傷口又はその近傍が挙げられる。上述の医療用挿入部材を生体外に抜去した後に、生体表面上の傷口又はその近傍を、圧迫部材3によって所定時間圧迫することにより、止血することができる。 The sticking sheet 2 is provided with a sticking surface 11 that can be stuck to the surface of the living body on one side in the thickness direction A. The compression member 3 is attached to the sticking sheet 2. Specifically, the compression member 3 is fixed to the sticking sheet 2 on the side opposite to the sticking surface 11. The compression member 3 can press the surface of the living body in a state where the sticking surface 11 is attached to the surface of the living body. In this way, the position of the compression device 1 on the surface of the living body is fixed by sticking the sticking surface 11 to the surface of the living body. According to the compression device 1, the compression member 3 can press a predetermined portion on the surface of the living body in a state where the sticking surface 11 of the sticking sheet 2 is stuck on the surface of the living body. The predetermined site on the surface of the living body includes, for example, a wound on the surface of the living body or a vicinity thereof formed by inserting a medical insertion member such as a puncture needle, a catheter, or a sheath into a blood vessel of the living body. After removing the above-mentioned medical insertion member from the living body, bleeding can be stopped by pressing the wound on the surface of the living body or its vicinity with the pressing member 3 for a predetermined time.
 より具体的に、圧迫部材3は、押圧体4と、保持体5と、を備える。押圧体4は、貼着シート2の厚み方向Aに伸長することにより生体表面を押圧可能である。保持体5は、貼着面11とは反対側で貼着シート2に固定されており、押圧体4を厚み方向Aに伸長可能に保持する。 More specifically, the compression member 3 includes a pressing body 4 and a holding body 5. The pressing body 4 can press the surface of the living body by extending in the thickness direction A of the sticking sheet 2. The holding body 5 is fixed to the sticking sheet 2 on the side opposite to the sticking surface 11, and holds the pressing body 4 so as to be extendable in the thickness direction A.
 保持体5は、圧迫デバイス1を厚み方向Aで見た平面視において、押圧体4と重なる位置に、弧状に延在する線分マーカ7aを備える。 The holding body 5 includes a line segment marker 7a extending in an arc shape at a position overlapping the pressing body 4 in a plan view of the compression device 1 in the thickness direction A.
 線分マーカ7aは、圧迫デバイス1を厚み方向Aで見た平面視において弧状に延在することを、視覚を通じて識別可能な態様であれば、その構成は特に限定されない。線分マーカ7aは、例えば、保持体5の上面から突出する1つのリブ状凸部により構成されてもよい。また、線分マーカ7aは、例えば、複数の凸部が間隔を隔てて一列に配置されることで、圧迫デバイス1を厚み方向Aで見た平面視において全体として弧状に延在する破線状の線分を形成する態様であってもよい。更に、線分マーカ7aは、例えば、保持体5の上面に形成されている溝部等の凹部により構成されてもよい。また、線分マーカ7aを構成する上述の凸部又は凹部は、保持体5の上面に限られず、保持体5の下面に設けられてもよい。かかる場合には、保持体5の下面に設けられる凸部又は凹部を、上面視(図2参照)で視認できるようにするため、保持体5のうち上面視で凸部又は凹部が設けられる位置は、少なくとも上面から下面まで厚み方向Aに透光性を有する構成とされる。ここで「厚み方向Aに透光性を有する」とは、厚み方向Aで半透明又は透明であることを意味する。更に、線分マーカ7aは、例えば、周囲と透過率を異ならせることにより構成されてもよい。この一例として、線分マーカ7aは、保持体5の透光性を有する部分の中に位置する、周囲より透過率が低い部分により構成されてもよい。この他に、線分マーカ7aは、例えば周囲と色を異ならせることにより構成されてもよい。このような線分マーカ7aは、例えば、保持体5の上面又は下面の一部を形成する塗料等により構成され得る。このように、線分マーカ7aは、圧迫デバイス1の使用環境下の平面視、特に上面視(図2参照)で、周囲から区別して、弧状に延在する線分状であることが識別できる態様であれば特に限定されない。 The configuration of the line segment marker 7a is not particularly limited as long as it can be visually identified that the compression device 1 extends in an arc shape in a plan view viewed in the thickness direction A. The line segment marker 7a may be composed of, for example, one rib-shaped convex portion protruding from the upper surface of the holding body 5. Further, the line segment marker 7a has, for example, a plurality of convex portions arranged in a line at intervals so that the compression device 1 has a broken line shape extending in an arc shape as a whole in a plan view in the thickness direction A. It may be an aspect of forming a line segment. Further, the line segment marker 7a may be formed of, for example, a recess such as a groove formed on the upper surface of the holding body 5. Further, the above-mentioned convex portion or concave portion constituting the line segment marker 7a is not limited to the upper surface of the holding body 5, and may be provided on the lower surface of the holding body 5. In such a case, in order to make the convex portion or the concave portion provided on the lower surface of the holding body 5 visible from the top view (see FIG. 2), the position where the convex portion or the concave portion is provided on the upper surface view of the holding body 5. Is configured to have translucency in the thickness direction A from at least the upper surface to the lower surface. Here, "having translucency in the thickness direction A" means that it is translucent or transparent in the thickness direction A. Further, the line segment marker 7a may be configured, for example, by making the transmittance different from that of the surroundings. As an example of this, the line segment marker 7a may be composed of a portion having a lower transmittance than the surroundings, which is located in the translucent portion of the holding body 5. In addition to this, the line segment marker 7a may be configured, for example, by making the color different from the surroundings. Such a line segment marker 7a may be composed of, for example, a paint forming a part of the upper surface or the lower surface of the holding body 5. In this way, the line segment marker 7a can be identified as a line segment extending in an arc shape, distinguishing from the surroundings, in a plan view under the usage environment of the compression device 1, particularly a top view (see FIG. 2). It is not particularly limited as long as it is an embodiment.
 このような線分マーカ7aを設けることで、生体表面から生体内に挿入されている状態の医療用挿入部材100(図8A参照)の外径にかかわらず、医療用挿入部材100のうち生体表面と同一面上に位置する挿入部分100a(図8A参照)の一部(例えば外面の一部)を、圧迫デバイス1を厚み方向Aで見た平面視において、線分マーカ7aに接するように又は重なるように位置合わせできる。つまり、線分マーカ7aは、圧迫デバイス1を厚み方向Aで見た平面視で所定の閉領域を区画していない。そのため、医療用挿入部材100の外径にかかわらず、医療用挿入部材100の挿入部分100aの一部のみを利用して、線分マーカ7aに位置合わせできる。換言すれば、線分マーカ7aによれば、医療用挿入部材100を、その外径によらず、挿入部分100aの一部を利用して所定の位置に位置合わせするように、医療従事者に誘導できる。これにより、医療用挿入部材100の外径の相違によって、生体表面上での圧迫デバイス1の取り付け位置がばらつくことを抑制できる。その結果、医療用挿入部材100の外径の相違によらず、生体表面上の適切な位置に容易に位置決め可能な圧迫デバイス1を実現できる。医療用挿入部材100の挿入部分100aの線分マーカ7aに対する位置決めの詳細は後述する(図8A、図8B参照)。 By providing such a line segment marker 7a, the biological surface of the medical insertion member 100 is provided regardless of the outer diameter of the medical insertion member 100 (see FIG. 8A) inserted into the living body from the surface of the living body. A part (for example, a part of the outer surface) of the insertion portion 100a (see FIG. 8A) located on the same plane as the above is in contact with the line segment marker 7a in the plan view of the compression device 1 in the thickness direction A. Can be aligned so that they overlap. That is, the line segment marker 7a does not partition a predetermined closed region in a plan view of the compression device 1 in the thickness direction A. Therefore, regardless of the outer diameter of the medical insertion member 100, only a part of the insertion portion 100a of the medical insertion member 100 can be used to align the line segment marker 7a. In other words, according to the line segment marker 7a, the medical staff is asked to align the medical insertion member 100 at a predetermined position by using a part of the insertion portion 100a regardless of its outer diameter. Can be guided. As a result, it is possible to prevent the mounting position of the compression device 1 from fluctuating on the surface of the living body due to the difference in the outer diameter of the medical insertion member 100. As a result, the compression device 1 that can be easily positioned at an appropriate position on the surface of the living body can be realized regardless of the difference in the outer diameter of the medical insertion member 100. Details of positioning the insertion portion 100a of the medical insertion member 100 with respect to the line segment marker 7a will be described later (see FIGS. 8A and 8B).
 特に、線分マーカ7aは、圧迫デバイス1を厚み方向Aで見た平面視において、弧状に湾曲して延在する。そのため、圧迫デバイス1を厚み方向Aで見た平面視で凸形で弧状に延在する挿入部分100a(図8A参照)の外面の一部を線分マーカの凹部分に入り込むように位置合わせし易くなる。 In particular, the line segment marker 7a is curved and extends in an arc shape in a plan view of the compression device 1 in the thickness direction A. Therefore, the compression device 1 is aligned so that a part of the outer surface of the insertion portion 100a (see FIG. 8A) extending in a convex and arc shape in a plan view in the thickness direction A is inserted into the concave portion of the line segment marker. It will be easier.
 また、圧迫デバイス1を厚み方向Aで見た平面視(図2、図3参照)において、保持体5の外縁の外側には、貼着シート2が配置されていない領域であり、後述する医療用挿入部材100(図8A等参照)を受け入れ可能な受入部6が設けられている。より具体的に、本実施形態の貼着シート2は、圧迫デバイス1を厚み方向Aで見た平面視(図2、図3参照)において、保持体5と重なる第1部分X1と、保持体5と重ならない第2部分X2と、を備える。図2に示すように、圧迫デバイス1の上面視において、本実施形態の保持体5の外縁の外側周囲の大部分は、貼着シート2の第2部分X2により囲まれている。換言すれば、本実施形態の圧迫デバイス1の保持体5の外縁は、その外側に貼着シート2の第2部分X2が配置されていない部分を一部のみ有している。本実施形態の受入部6は、保持体5の周囲で貼着シート2の第2部分X2が配置されていない領域により構成されている。 Further, in a plan view of the compression device 1 in the thickness direction A (see FIGS. 2 and 3), the area where the attachment sheet 2 is not arranged is outside the outer edge of the holding body 5, and is a medical treatment described later. A receiving portion 6 capable of receiving the insertion member 100 (see FIG. 8A and the like) is provided. More specifically, the sticking sheet 2 of the present embodiment has a first portion X1 that overlaps with the holding body 5 and a holding body in a plan view (see FIGS. 2 and 3) in which the compression device 1 is viewed in the thickness direction A. A second portion X2 that does not overlap with 5 is provided. As shown in FIG. 2, in the top view of the compression device 1, most of the outer periphery of the outer edge of the holding body 5 of the present embodiment is surrounded by the second portion X2 of the sticking sheet 2. In other words, the outer edge of the holding body 5 of the compression device 1 of the present embodiment has only a part of the outer edge of the holding body 5 in which the second portion X2 of the sticking sheet 2 is not arranged. The receiving portion 6 of the present embodiment is composed of a region around the holding body 5 in which the second portion X2 of the sticking sheet 2 is not arranged.
 本実施形態の受入部6は、圧迫デバイス1を厚み方向Aで見た平面視(図2、図3参照)において、保持体5の外縁の外側に貼着シート2が配置されていない領域により構成されているが、この構成に限られない。受入部6は、貼着シート2の外縁の凹部により区画される領域であってもよい。例えば、圧迫デバイス1を厚み方向Aで見た平面視(図2、図3参照)において、保持体5の外縁の外側で、貼着シート2の外縁の一部に、周囲よりも窪んだ凹部が形成されていてもよい。かかる場合に、受入部6は、この凹部により区画される領域とされてもよい。つまり、受入部6は、圧迫デバイス1を厚み方向Aで見た平面視(図2、図3参照)において、保持体5の外縁の外側に貼着シート2が配置されている領域において形成されていてもよい。換言すれば、受入部6が形成される位置は、圧迫デバイス1を厚み方向Aで見た平面視(図2、図3参照)において、保持体5の外縁の外側に貼着シート2が配置されていない領域に限られない。 The receiving portion 6 of the present embodiment has a region in which the sticking sheet 2 is not arranged on the outside of the outer edge of the holding body 5 in a plan view (see FIGS. 2 and 3) of the compression device 1 in the thickness direction A. It is configured, but is not limited to this configuration. The receiving portion 6 may be an area partitioned by a recess on the outer edge of the sticking sheet 2. For example, in a plan view (see FIGS. 2 and 3) of the compression device 1 viewed in the thickness direction A, a recess outside the outer edge of the holding body 5 and a part of the outer edge of the sticking sheet 2 is recessed from the periphery. May be formed. In such a case, the receiving portion 6 may be a region partitioned by the recess. That is, the receiving portion 6 is formed in a region where the sticking sheet 2 is arranged on the outside of the outer edge of the holding body 5 in a plan view (see FIGS. 2 and 3) when the compression device 1 is viewed in the thickness direction A. You may be. In other words, the position where the receiving portion 6 is formed is such that the sticking sheet 2 is arranged outside the outer edge of the holding body 5 in a plan view (see FIGS. 2 and 3) when the compression device 1 is viewed in the thickness direction A. It is not limited to the area that is not.
 また、本実施形態の圧迫デバイス1には上述の受入部6が設けられているが、受入部6を有さない圧迫デバイスであってもよい。但し、受入部6を設けることで、圧迫デバイス1は、医療用挿入部材100(図8A等参照)のうち生体外に延在する部分を、受入部6を通過するように配置した状態で、生体表面に取り付けることができる。これにより、圧迫デバイス1は、医療用挿入部材100(図8A等参照)のうち生体外に延在する部分があっても、生体表面上の所望の位置に取り付け易くなる。 Further, although the compression device 1 of the present embodiment is provided with the above-mentioned receiving unit 6, it may be a compression device that does not have the receiving unit 6. However, by providing the receiving portion 6, the compression device 1 is arranged so that the portion of the medical insertion member 100 (see FIG. 8A or the like) extending outside the living body passes through the receiving portion 6. It can be attached to the surface of a living body. As a result, the compression device 1 can be easily attached to a desired position on the surface of the living body even if there is a portion of the medical insertion member 100 (see FIG. 8A or the like) extending outside the living body.
 本実施形態の線分マーカ7aは、圧迫デバイス1を厚み方向Aで見た平面視において、受入部6に対して、押圧体4の後述する拡張部8が位置する側に設けられている。また、線分マーカ7aは、圧迫デバイス1を厚み方向Aで見た平面視において、受入部6の位置から拡張部8の位置に向かって凸状に湾曲している。更に、本実施形態では、圧迫デバイス1を厚み方向Aで見た平面視において、線分マーカ7aの最大幅は、押圧体4の後述する拡張部8の最大幅よりも小さい。本実施形態の線分マーカ7aの最大幅とは、図2に示すように幅方向Bでの線分マーカ7aの最大幅を意味する。また、本実施形態の拡張部8の最大幅とは、図2に示すように幅方向Bでの拡張部8の最大幅を意味する。幅方向Bとは、圧迫デバイス1を厚み方向Aで見た平面視において、受入部6と、押圧体4の拡張部8と、が配列されている配列方向Cと、直交する方向を意味する。 The line segment marker 7a of the present embodiment is provided on the side where the expansion portion 8 described later of the pressing body 4 is located with respect to the receiving portion 6 in the plan view of the compression device 1 in the thickness direction A. Further, the line segment marker 7a is curved convexly from the position of the receiving portion 6 toward the position of the expanding portion 8 in a plan view of the compression device 1 in the thickness direction A. Further, in the present embodiment, the maximum width of the line segment marker 7a is smaller than the maximum width of the expansion portion 8 described later of the pressing body 4 in the plan view of the compression device 1 in the thickness direction A. The maximum width of the line segment marker 7a of the present embodiment means the maximum width of the line segment marker 7a in the width direction B as shown in FIG. Further, the maximum width of the expansion portion 8 of the present embodiment means the maximum width of the expansion portion 8 in the width direction B as shown in FIG. The width direction B means a direction orthogonal to the arrangement direction C in which the receiving portion 6 and the expanding portion 8 of the pressing body 4 are arranged in a plan view of the compression device 1 in the thickness direction A. ..
 また、本実施形態では、圧迫デバイス1を厚み方向Aで見た平面視において、線分マーカ7aの最大幅は、受入部6の最小幅よりも小さい。受入部6の最小幅とは、図2に示すように幅方向Bでの受入部6の最小幅を意味する。 Further, in the present embodiment, the maximum width of the line segment marker 7a is smaller than the minimum width of the receiving portion 6 in the plan view of the compression device 1 in the thickness direction A. The minimum width of the receiving portion 6 means the minimum width of the receiving portion 6 in the width direction B as shown in FIG.
 詳細は後述するが、本実施形態の保持体5は、線分マーカ7aの他に、領域マーカ7bとしての枠線マーカ7b1を備える。本実施形態の領域マーカ7bとしての枠線マーカ7b1は、圧迫デバイス1の厚み方向Aで見た平面視において線分マーカ7aを取り囲む所定の領域を区画している。本実施形態の領域マーカ7bとしての枠線マーカ7b1は、圧迫デバイス1を厚み方向Aで見た平面視において、受入部6に対して、押圧体4の後述する拡張部8が位置する側に隣接して設けられている。また、本実施形態では、圧迫デバイス1を厚み方向Aで見た平面視において、領域マーカ7bとしての枠線マーカ7b1の最大幅は、押圧体4の後述する拡張部8の最大幅よりも小さい。更に、本実施形態では、圧迫デバイス1を厚み方向Aで見た平面視において、領域マーカ7bとしての枠線マーカ7b1の最大幅は、受入部6の最小幅よりも小さい。本実施形態の線分マーカ7a、及び、領域マーカ7bとしての枠線マーカ7b1、の詳細は後述する。 Although details will be described later, the holding body 5 of the present embodiment includes a border marker 7b1 as a region marker 7b in addition to the line segment marker 7a. The frame line marker 7b1 as the area marker 7b of the present embodiment partitions a predetermined area surrounding the line segment marker 7a in a plan view seen in the thickness direction A of the compression device 1. The frame line marker 7b1 as the region marker 7b of the present embodiment is located on the side where the expansion portion 8 described later of the pressing body 4 is located with respect to the receiving portion 6 in a plan view of the compression device 1 in the thickness direction A. It is provided adjacently. Further, in the present embodiment, the maximum width of the frame line marker 7b1 as the region marker 7b is smaller than the maximum width of the expansion portion 8 described later of the pressing body 4 in the plan view of the compression device 1 in the thickness direction A. .. Further, in the present embodiment, the maximum width of the border marker 7b1 as the region marker 7b is smaller than the minimum width of the receiving portion 6 in the plan view of the compression device 1 in the thickness direction A. Details of the line segment marker 7a and the frame line marker 7b1 as the area marker 7b of the present embodiment will be described later.
 以下、本実施形態の圧迫デバイス1の各部材・各部位の詳細について説明する。 Hereinafter, details of each member and each part of the compression device 1 of the present embodiment will be described.
 <貼着シート2>
 貼着シート2は、上述したように、厚み方向Aの一方側に貼着面11を備える。また、貼着シート2は、厚み方向Aの他方側、すなわち、貼着面11とは反対側に、圧迫部材3が取り付けられる取付面12を備える。貼着シート2は可撓性を有する。そのため、貼着シート2を、生体表面の形状に沿って変形させることができる。また、貼着面11が生体表面の変形に追従し易くなる。その結果、圧迫デバイス1が意図せずに生体表面から剥離することを抑制できる。
<Attachment sheet 2>
As described above, the sticking sheet 2 includes a sticking surface 11 on one side in the thickness direction A. Further, the sticking sheet 2 includes a mounting surface 12 to which the compression member 3 is mounted on the other side in the thickness direction A, that is, on the side opposite to the sticking surface 11. The sticking sheet 2 has flexibility. Therefore, the sticking sheet 2 can be deformed along the shape of the surface of the living body. In addition, the sticking surface 11 can easily follow the deformation of the living body surface. As a result, it is possible to prevent the compression device 1 from unintentionally peeling from the surface of the living body.
 より具体的に、本実施形態の貼着シート2の貼着面11は、貼着シート2の下面により構成されている。また、本実施形態の貼着シート2の取付面12は、貼着シート2の上面により構成されている。 More specifically, the sticking surface 11 of the sticking sheet 2 of the present embodiment is composed of the lower surface of the sticking sheet 2. Further, the mounting surface 12 of the sticking sheet 2 of the present embodiment is composed of the upper surface of the sticking sheet 2.
 以下、説明の便宜上、厚み方向Aにおいて取付面12から貼着面11に向かう方向である、厚み方向Aの一方側を、単に「下方向A1」又は「下側」と記載する場合がある。また、説明の便宜上、厚み方向Aにおいて貼着面11から取付面12に向かう方向である、厚み方向Aの他方側を、単に「上方向A2」又は「上側」と記載する場合がある。更に、圧迫デバイス1を、貼着シート2の厚み方向Aに沿って見た平面視(図2、図3参照)のうち、貼着シート2の取付面12側から見た平面視(図2参照)を、説明の便宜上、単に「上面視」と記載する。また、圧迫デバイス1を、貼着シート2の厚み方向Aに沿って見た平面視(図2、図3参照)のうち、貼着シート2の貼着面11側から見た平面視(図3参照)を、説明の便宜上、単に「下面視」と記載する。また、上面視及び下面視を区別しない場合は、単に、「平面視」と記載する場合がある。また、特段の記述がない限り、単に「平面視」、「上面視」、「下面視」と記載する場合は、圧迫部材3の後述する押圧体4の拡張部8が収縮形態にある場合での平面視、上面視、下面視を意味する。 Hereinafter, for convenience of explanation, one side of the thickness direction A, which is the direction from the mounting surface 12 to the attachment surface 11 in the thickness direction A, may be simply referred to as "downward A1" or "lower side". Further, for convenience of explanation, the other side of the thickness direction A, which is the direction from the sticking surface 11 to the mounting surface 12 in the thickness direction A, may be simply described as "upward direction A2" or "upper side". Further, of the plan view (see FIGS. 2 and 3) of the compression device 1 viewed along the thickness direction A of the sticking sheet 2, the plan view of the sticking sheet 2 seen from the mounting surface 12 side (FIG. 2). (See) is simply referred to as "top view" for convenience of description. Further, of the plan view (see FIGS. 2 and 3) of the compression device 1 viewed along the thickness direction A of the sticking sheet 2, the plan view of the sticking sheet 2 seen from the sticking surface 11 side (FIG. 2). 3) is simply referred to as "bottom view" for convenience of explanation. Further, when the top view and the bottom view are not distinguished, it may be simply described as "plan view". Further, unless otherwise specified, the terms "planar view", "top view", and "bottom view" are used when the expansion portion 8 of the pressing body 4 described later of the compression member 3 is in a contracted form. Means plan view, top view, and bottom view.
 貼着シート2は、例えば、基材層と、接着層と、を含む複数層から構成される。 The sticking sheet 2 is composed of, for example, a plurality of layers including a base material layer and an adhesive layer.
 基材層は、例えば、薄肉の樹脂シートにより構成される。より具体的に、基材層は、例えば、ポリエステル繊維の白色スパンレース不織布により構成されており、その厚さは、例えば30μmなど、5μm~150μmの範囲内とされている。但し、基材層の材料は、ポリエステルに限らず、例えば、アクリル重合体、ポリエチレン、エチレン-酢酸ビニル共重合体、ポリウレタン、ポリアミド誘導体などを使用してもよい。 The base material layer is composed of, for example, a thin resin sheet. More specifically, the base material layer is made of, for example, a white spunlace non-woven fabric of polyester fibers, and the thickness thereof is in the range of 5 μm to 150 μm, for example, 30 μm. However, the material of the base material layer is not limited to polyester, and for example, an acrylic polymer, polyethylene, an ethylene-vinyl acetate copolymer, polyurethane, a polyamide derivative, or the like may be used.
 接着層は、例えば、ゴム系接着剤、アクリル系接着剤、シリコン系接着剤等の接着剤により構成される。接着層は、基材層に対して、直接的に又は別の層を挟んで間接的に、積層されている。本実施形態の貼着シート2の貼着面11は、接着層により構成されている。 The adhesive layer is composed of, for example, an adhesive such as a rubber-based adhesive, an acrylic-based adhesive, or a silicon-based adhesive. The adhesive layer is laminated directly to the base material layer or indirectly with another layer in between. The sticking surface 11 of the sticking sheet 2 of the present embodiment is composed of an adhesive layer.
 貼着シート2は、上述の基材層、接着層の他に、更に別の層を含んでもよい。貼着シート2は、例えば、表面層を含んでもよい。表面層は、例えば、厚さが5μm~50μm程度の樹脂から構成される。より具体的に、表面層の材料としては、ポリエステル、ポリアミド、ポリアミドイミド、ポリエチレン、ポリプロピレン、ポリカーボネート、ポリウレタン、ポリ塩化ビニル、フッ素樹脂などを使用できる。表面層は、基材層を挟んで接着層とは反対側に、基材層に対して、直接的に又は別の層を挟んで間接的に、積層されている。したがって、貼着シート2の取付面12は、表面層により構成されてもよい。 The sticking sheet 2 may include yet another layer in addition to the above-mentioned base material layer and adhesive layer. The sticking sheet 2 may include, for example, a surface layer. The surface layer is composed of, for example, a resin having a thickness of about 5 μm to 50 μm. More specifically, as the material of the surface layer, polyester, polyamide, polyamideimide, polyethylene, polypropylene, polycarbonate, polyurethane, polyvinyl chloride, fluororesin and the like can be used. The surface layer is laminated on the opposite side of the base material layer from the adhesive layer, either directly or indirectly with another layer in between. Therefore, the mounting surface 12 of the sticking sheet 2 may be composed of a surface layer.
 より具体的に、貼着シート2は、一面に接着剤としての粘着剤が施された不織布テープにより構成されてもよい。更に、貼着シート2は、基材層の両側に接着層が設けられている両面テープにより構成されてもよい。貼着シート2を両面テープにより構成した場合には、圧迫部材3の保持体5を、貼着シートの片方の接着層に接着することで、圧迫部材3を貼着シート2に固定することができる。 More specifically, the sticking sheet 2 may be made of a non-woven fabric tape having an adhesive as an adhesive on one surface. Further, the sticking sheet 2 may be composed of a double-sided tape in which adhesive layers are provided on both sides of the base material layer. When the sticking sheet 2 is made of double-sided tape, the pressing member 3 can be fixed to the sticking sheet 2 by adhering the holding body 5 of the pressing member 3 to one adhesive layer of the sticking sheet. can.
 本実施形態の貼着シート2は、厚み方向Aで見た平面視で、略C字形状の外形を有している。本実施形態の貼着シート2は、図2、図3に示すように、圧迫部材3の下面側の一部のみを覆っている。具体的に、本実施形態の貼着シート2は、圧迫部材3の下面の外縁領域のみを覆っている。そして、本実施形態の貼着シート2は、圧迫部材3の下面の外縁領域のみに固定されている。換言すれば、本実施形態の貼着シート2は、圧迫部材3の押圧体4の拡張部8が位置する、圧迫部材3の下面の中央領域を、覆っていない。また、本実施形態の貼着シート2は、圧迫部材3の下面の外縁領域の全域を覆っておらず、外縁領域を部分的に覆っている。すなわち、本実施形態の貼着シート2は、圧迫部材3の下面の外縁領域のうち一部の領域を覆っていない。本実施形態では、圧迫部材3の下面の外縁領域のうち貼着シート2に覆われていない部分が、圧迫部材3における受入部6と隣接する部分である。 The sticking sheet 2 of the present embodiment has a substantially C-shaped outer shape in a plan view seen in the thickness direction A. As shown in FIGS. 2 and 3, the sticking sheet 2 of the present embodiment covers only a part of the lower surface side of the compression member 3. Specifically, the sticking sheet 2 of the present embodiment covers only the outer edge region of the lower surface of the compression member 3. The sticking sheet 2 of the present embodiment is fixed only to the outer edge region of the lower surface of the compression member 3. In other words, the sticking sheet 2 of the present embodiment does not cover the central region of the lower surface of the pressing member 3 where the expansion portion 8 of the pressing body 4 of the pressing member 3 is located. Further, the sticking sheet 2 of the present embodiment does not cover the entire outer edge region of the lower surface of the compression member 3, but partially covers the outer edge region. That is, the sticking sheet 2 of the present embodiment does not cover a part of the outer edge region of the lower surface of the compression member 3. In the present embodiment, a portion of the outer edge region of the lower surface of the compression member 3 that is not covered by the sticking sheet 2 is a portion adjacent to the receiving portion 6 of the compression member 3.
 貼着シート2の貼着面11は、生体表面に貼着される前の使用前状態において、剥離シートにより覆われている。剥離シートは、貼着シート2を生体表面に貼着する際に、ユーザーにより貼着面11から剥離されることにより取り除かれる。剥離シートが貼着面11から取り除かれ、貼着面11が露出することにより、貼着シート2の貼着面11が生体表面に貼着可能な状態(以下、説明の便宜上「使用状態」と記載する。)とされる。剥離シートは、例えば、剥離紙や樹脂製のシート材により形成可能である。図1~図6に示す圧迫デバイス1は、剥離シートが取り除かれた使用状態を示している。 The sticking surface 11 of the sticking sheet 2 is covered with the release sheet in the state before use before being stuck to the surface of the living body. The release sheet is removed by being peeled from the attachment surface 11 by the user when the attachment sheet 2 is attached to the surface of the living body. When the release sheet is removed from the attachment surface 11 and the attachment surface 11 is exposed, the attachment surface 11 of the attachment sheet 2 can be attached to the surface of the living body (hereinafter, for convenience of explanation, "use state"). It will be described.) The release sheet can be formed of, for example, a release paper or a sheet material made of resin. The compression device 1 shown in FIGS. 1 to 6 shows a state of use in which the release sheet has been removed.
<圧迫部材3>
 上述したように、圧迫部材3は、押圧体4と、保持体5と、を備える。
<Compression member 3>
As described above, the compression member 3 includes a pressing body 4 and a holding body 5.
 上述したように、押圧体4は、厚み方向Aに伸長することにより生体表面を押圧可能である。押圧体4は、平面視で貼着シート2がない位置で、生体表面を押圧可能である。つまり、押圧体4は、貼着シート2を介さずに生体表面を押圧可能である。 As described above, the pressing body 4 can press the surface of the living body by extending in the thickness direction A. The pressing body 4 can press the surface of the living body at a position where the sticking sheet 2 is not present in a plan view. That is, the pressing body 4 can press the surface of the living body without passing through the sticking sheet 2.
 本実施形態の押圧体4は、拡張部8と、延設部9と、を備える。拡張部8は、貼着シート2の貼着面11が生体表面に貼着されている状態(以下、「圧迫デバイス1の貼着状態」と記載する。)において生体表面と保持体5との間に配置される。拡張部8は、圧迫デバイス1の貼着状態で、流体の供給により厚み方向Aに拡張することができる。つまり、本実施形態の押圧体4は、拡張部8が厚み方向Aに拡張することで、厚み方向Aに伸長する。圧迫デバイス1の貼着状態で拡張部8が拡張すると、拡張部8は保持体5から反力を受けることで生体表面を押圧する。以下、拡張部8が拡張する前の形態を、拡張部8の「収縮形態」と記載する。また、拡張部8が収縮形態から拡張した形態を、拡張部8の「拡張形態」と記載する。本実施形態の圧迫デバイス1は、貼着状態で、拡張部8が収縮形態の場合、拡張部8により生体表面を圧迫しない。逆に、本実施形態の圧迫デバイス1は、貼着状態で、拡張部8が拡張形態の場合、拡張部8により生体表面を圧迫する。図5は、拡張部8の収縮形態を示している。図6は、拡張部8の拡張形態を示している。 The pressing body 4 of the present embodiment includes an expansion portion 8 and an extension portion 9. The expansion unit 8 has the living body surface and the holding body 5 in a state where the sticking surface 11 of the sticking sheet 2 is stuck to the living body surface (hereinafter, referred to as “the sticking state of the compression device 1”). Placed in between. The expansion portion 8 can be expanded in the thickness direction A by supplying a fluid while the compression device 1 is attached. That is, the pressing body 4 of the present embodiment extends in the thickness direction A when the expansion portion 8 expands in the thickness direction A. When the expansion unit 8 expands while the compression device 1 is attached, the expansion unit 8 presses the surface of the living body by receiving a reaction force from the holding body 5. Hereinafter, the form before the expansion portion 8 is expanded will be referred to as a “contracted form” of the expansion portion 8. Further, the form in which the expansion portion 8 is expanded from the contracted form is described as the "expansion form" of the expansion portion 8. The compression device 1 of the present embodiment does not press the surface of the living body by the expansion portion 8 when the expansion portion 8 is in the contracted state in the attached state. On the contrary, in the compression device 1 of the present embodiment, when the expansion portion 8 is in the expansion form in the attached state, the expansion portion 8 presses the surface of the living body. FIG. 5 shows a contracted form of the expansion portion 8. FIG. 6 shows an expanded form of the expansion unit 8.
 本実施形態の拡張部8は、内部に気体等の流体を収容可能な収容空間8aを区画している。また、本実施形態の拡張部8は、内部が連通するように連結された2つのバルーン部8b、8cにより構成されている。本実施形態の収容空間8aは、2つのバルーン部8b、8cの連通する内部空間により構成されている。 The expansion unit 8 of the present embodiment partitions an accommodation space 8a capable of accommodating a fluid such as a gas inside. Further, the expansion portion 8 of the present embodiment is composed of two balloon portions 8b and 8c connected so that the inside communicates with each other. The accommodation space 8a of the present embodiment is composed of an internal space in which two balloon portions 8b and 8c communicate with each other.
 拡張部8は、収容空間8aに流体が供給されることにより、厚み方向Aの下方向A1に向かって拡張可能である。本実施形態の拡張部8は、上述した収縮形態(図5参照)から拡張形態(図6参照)に形態変化することで下方向A1に向かって拡張し、生体表面を圧迫可能な姿勢となる。より具体的に、拡張部8は、収容空間8aに流体が供給されることで、保持体5の下面により反力を受けて、下方向A1に向かって拡張する。拡張部8の収容空間8aに供給される流体は、気体に限らず、液体であってもよい。 The expansion portion 8 can be expanded toward the downward direction A1 of the thickness direction A by supplying the fluid to the accommodation space 8a. The expansion unit 8 of the present embodiment expands downward A1 by changing its form from the contracted form (see FIG. 5) described above to the expanded form (see FIG. 6), and becomes a posture capable of pressing the surface of the living body. .. More specifically, when the fluid is supplied to the accommodation space 8a, the expansion portion 8 receives a reaction force from the lower surface of the holding body 5 and expands in the downward direction A1. The fluid supplied to the accommodation space 8a of the expansion unit 8 is not limited to a gas, but may be a liquid.
 図5に示すように、収縮形態の拡張部8は、収容空間8aが収縮した状態で、保持体5の下面に沿うように配置されている。拡張部8の収容空間8aは、保持体5の外部まで延在するチューブ28に連通している。拡張部8の収容空間8aには、チューブ28の端部に設けられた接続部29としてのインフレーションポートに接続される流体供給器具から、チューブ28を通じて、例えば空気等の流体が供給される。これにより、拡張部8の拡張状態を変化させ、拡張部8を収縮形態(図5参照)から拡張形態(図6参照)に形態変化させることができる。 As shown in FIG. 5, the contracted expansion portion 8 is arranged along the lower surface of the holding body 5 in a state where the accommodation space 8a is contracted. The accommodation space 8a of the expansion portion 8 communicates with a tube 28 extending to the outside of the holding body 5. A fluid such as air is supplied to the accommodation space 8a of the expansion portion 8 through the tube 28 from a fluid supply device connected to an inflation port as a connection portion 29 provided at the end of the tube 28. As a result, the expanded state of the expanded portion 8 can be changed, and the expanded portion 8 can be changed from the contracted form (see FIG. 5) to the expanded form (see FIG. 6).
 本実施形態の拡張部8は、厚み方向Aに透光性を有する部分を備える。より具体的に、本実施形態の拡張部8は、厚み方向Aに透光性を有する部分のみから構成されている。このように、拡張部8は、厚み方向Aに透光性を有する部分を少なくとも備えることが好ましい。このようにすることで、拡張部8を通じて、拡張部8の上側から拡張部8の下側を透視することができる。そのため、拡張部8を通じて、生体表面上の傷口等の位置を視認し得る。 The expansion portion 8 of the present embodiment includes a portion having translucency in the thickness direction A. More specifically, the expansion portion 8 of the present embodiment is composed of only a portion having translucency in the thickness direction A. As described above, it is preferable that the expansion portion 8 includes at least a portion having translucency in the thickness direction A. By doing so, it is possible to see through the expansion portion 8 from the upper side of the expansion portion 8 to the lower side of the expansion portion 8. Therefore, the position of the wound or the like on the surface of the living body can be visually recognized through the expansion portion 8.
 延設部9は、拡張部8から延設されている。延設部9は可撓性を有している。延設部9は、保持体5に巻き掛けられている。これにより、延設部9は、拡張部8から保持体5を挟んで拡張部8と反対側の保持体5の上面側まで延在している。延設部9は、保持体5の上面側で保持体5に係止されている。 The extension section 9 is extended from the extension section 8. The extension portion 9 has flexibility. The extension portion 9 is wound around the holding body 5. As a result, the extending portion 9 extends from the expanding portion 8 to the upper surface side of the holding body 5 on the opposite side of the expanding portion 8 with the holding body 5 interposed therebetween. The extension portion 9 is locked to the holding body 5 on the upper surface side of the holding body 5.
 具体的に、本実施形態の保持体5は、厚み方向Aに貫通する貫通孔5aを区画している。本実施形態の延設部9は、貫通孔5aを通じて、保持体5に巻き掛けられている。より具体的に、本実施形態の延設部9は、保持体5を挟んで拡張部8が位置する下側から、その反対側である上側に向かって延在している。そして、本実施形態の延設部9は、貫通孔5aを区画する保持体5の内面、及び、保持体5の上面、に沿うように、保持体5に巻き掛けられている。また、延設部9には、保持体5の上面側で、保持体5の上面から突出する係止突起5bが嵌合する係止孔9bが形成されている。係止突起5bを係止孔9bに嵌合することで、延設部9が保持体5に位置決めされる。また、延設部9は、拡張部8に対して受入部6側の位置で、保持体5の下面側から上面側へと巻き掛けられている。つまり、本実施形態の貫通孔5aは、拡張部8に対して受入部6側に位置している。そのため、図5に示す断面視において、本実施形態の押圧体4を構成する拡張部8及び延設部9は、保持体5に巻き掛けられることで、略U字状に湾曲している。これにより、拡張部8は、延設部9の拡張部8と連結されている部分をヒンジ部9aとして回動しながら拡張することができる。 Specifically, the holding body 5 of the present embodiment defines a through hole 5a penetrating in the thickness direction A. The extension portion 9 of the present embodiment is wound around the holding body 5 through the through hole 5a. More specifically, the extending portion 9 of the present embodiment extends from the lower side on which the expanding portion 8 is located with the holding body 5 sandwiched between them toward the upper side, which is the opposite side thereof. Then, the extension portion 9 of the present embodiment is wound around the holding body 5 so as to be along the inner surface of the holding body 5 for partitioning the through hole 5a and the upper surface of the holding body 5. Further, the extending portion 9 is formed with a locking hole 9b on the upper surface side of the holding body 5 into which a locking projection 5b protruding from the upper surface of the holding body 5 is fitted. By fitting the locking projection 5b into the locking hole 9b, the extension portion 9 is positioned on the holding body 5. Further, the extension portion 9 is wound around the extension portion 8 from the lower surface side to the upper surface side of the holding body 5 at a position on the receiving portion 6 side. That is, the through hole 5a of the present embodiment is located on the receiving portion 6 side with respect to the expanding portion 8. Therefore, in the cross-sectional view shown in FIG. 5, the expansion portion 8 and the extension portion 9 constituting the pressing body 4 of the present embodiment are curved in a substantially U shape by being wound around the holding body 5. As a result, the expansion portion 8 can be expanded while rotating the portion of the extension portion 9 connected to the expansion portion 8 as the hinge portion 9a.
 拡張部8は、延設部9のヒンジ部9aにより回動することで、厚み方向Aのみならず、厚み方向Aに対して傾斜する方向に向かって拡張可能である。上述したように、本実施形態の押圧体4は、シート状の延設部9が保持体5の貫通孔5aを通じて保持体5の上下面に亘って巻き掛けられた状態で、保持体5に固定されている。そのため、拡張部8は、拡張時に、延設部9のうち貫通孔5aの下側で拡張部8に連結されている部分であるヒンジ部9aを回動中心として、この回動中心周りに回動しながら拡張する。より具体的に、本実施形態の拡張部8を構成する2つのバルーン部は、厚み方向Aに重ねられた状態で配置されている。また、これら2つのバルーン部それぞれの一端は、延設部9に対して取り付けられている。つまり、2つのバルーン部の一端側は、延設部9により拘束されている。そのため、2つのバルーン部が拡張しても、上記一端側では2つのバルーン部の距離は離間しない。その一方で、2つのバルーン部の他端側は、何ら拘束されていない。そのため、2つのバルーン部が拡張すると、上記他端側では2つのバルーン部の距離は離間する。すなわち、本実施形態の拡張部8を構成する2つのバルーン部では、延設部9に取り付けられている一端側を回動中心として、延設部9に取り付けられていない他端側が、この回動中心周りを回動する。このようにして、本実施形態の拡張部8は、厚み方向Aに対して傾斜する方向に向かって拡張する。厚み方向Aに対して傾斜する方向に向かって拡張する拡張部8とすることで、後述する穿孔P(図11B参照)を狭窄又は閉塞し易くなる。この詳細は後述する(図12参照)。但し、厚み方向Aに対して傾斜する方向に向かって拡張するための構成は、本実施形態の押圧体4の構成に限られない。 The expansion portion 8 can be expanded not only in the thickness direction A but also in a direction inclined with respect to the thickness direction A by rotating by the hinge portion 9a of the extension portion 9. As described above, the pressing body 4 of the present embodiment is wound around the holding body 5 in a state where the sheet-shaped extending portion 9 is wound around the upper and lower surfaces of the holding body 5 through the through hole 5a of the holding body 5. It is fixed. Therefore, at the time of expansion, the expansion portion 8 rotates around the rotation center with the hinge portion 9a, which is a portion of the extension portion 9 connected to the expansion portion 8 below the through hole 5a, as the rotation center. Expand while moving. More specifically, the two balloon portions constituting the expansion portion 8 of the present embodiment are arranged so as to be overlapped in the thickness direction A. Further, one end of each of these two balloon portions is attached to the extension portion 9. That is, one end side of the two balloon portions is restrained by the extending portion 9. Therefore, even if the two balloon portions are expanded, the distance between the two balloon portions is not separated on the one end side. On the other hand, the other ends of the two balloon portions are not restrained at all. Therefore, when the two balloon portions are expanded, the distance between the two balloon portions is separated on the other end side. That is, in the two balloon portions constituting the expansion portion 8 of the present embodiment, the one end side attached to the extension portion 9 is the center of rotation, and the other end side not attached to the extension portion 9 is this time. It rotates around the center of motion. In this way, the expansion portion 8 of the present embodiment expands in the direction of inclination with respect to the thickness direction A. By forming the expansion portion 8 that expands in the direction of inclination with respect to the thickness direction A, the perforation P (see FIG. 11B) described later is likely to be narrowed or occluded. The details will be described later (see FIG. 12). However, the configuration for expanding in the direction of inclination with respect to the thickness direction A is not limited to the configuration of the pressing body 4 of the present embodiment.
 本実施形態の延設部9は、保持体5の上面を覆う位置で、厚み方向Aに透光性を有する部分を備える。具体的に、本実施形態の延設部9の保持体5の上面を覆う部分は全て、厚み方向Aに透光性を有する部分により構成されている。より具体的に、本実施形態の延設部9はシート状であり、延設部9は任意の位置で、その厚み方向に透光性を有している。但し、延設部9は、例えば、保持体5の上面を覆う位置の一部のみに、厚み方向に透光性を有する部分を備える構成であってもよい。 The extension portion 9 of the present embodiment includes a portion having translucency in the thickness direction A at a position covering the upper surface of the holding body 5. Specifically, all the portions covering the upper surface of the holding body 5 of the extending portion 9 of the present embodiment are composed of portions having translucency in the thickness direction A. More specifically, the extension portion 9 of the present embodiment has a sheet shape, and the extension portion 9 has translucency in the thickness direction at an arbitrary position. However, the extending portion 9 may be configured to include, for example, a portion having translucency in the thickness direction only in a part of the position covering the upper surface of the holding body 5.
 押圧体4の拡張部8及び延設部9の構成材料としては、例えば、軟質ポリ塩化ビニル、ポリウレタン、ポリエチレン、ポリプロピレン、ポリエステル、エチレン-酢酸ビニル共重合体(EVA)、シリコーン、またはこれらのうち任意の材料を混合した、可撓性を有する材料を用いることができる。 Examples of the constituent materials of the expansion portion 8 and the extension portion 9 of the pressing body 4 include soft polyvinyl chloride, polyurethane, polyethylene, polypropylene, polyester, ethylene-vinyl acetate copolymer (EVA), silicone, or any of these. A flexible material obtained by mixing any material can be used.
 保持体5は、扁平で平面視が略四角形状を有する本体部31と、この本体部31から上方向A2に突設されており、対向して配置されている一対の把持板部32と、を備える。 The holding body 5 includes a main body portion 31 that is flat and has a substantially square shape in a plan view, and a pair of gripping plate portions 32 that project upward from the main body portion 31 in the upward direction A2 and are arranged so as to face each other. To be equipped.
 本体部31には、上述した貫通孔5aが形成されている。また、本体部31は、押圧体4の延設部9の係止孔9bに嵌合する上述の係止突起5bを備える。上述の押圧体4の拡張部8は、本体部31の中央部の下面側に配置されている。 The above-mentioned through hole 5a is formed in the main body 31. Further, the main body portion 31 includes the above-mentioned locking projection 5b that fits into the locking hole 9b of the extending portion 9 of the pressing body 4. The expansion portion 8 of the pressing body 4 described above is arranged on the lower surface side of the central portion of the main body portion 31.
 また、本体部31は、貼着シート2の取付面12に固定されている。具体的に、本体部31の下面の外縁部のみが、平面視で略C字形状の貼着シート2の取付面12に対して固定されている。本体部31の下面の中央部は、貼着シート2に覆われていない。そのため、本体部31の下面の中央部は、貼着シート2の取付面12に対して固定されていない。 Further, the main body 31 is fixed to the mounting surface 12 of the sticking sheet 2. Specifically, only the outer edge portion of the lower surface of the main body portion 31 is fixed to the mounting surface 12 of the sticking sheet 2 having a substantially C shape in a plan view. The central portion of the lower surface of the main body portion 31 is not covered with the sticking sheet 2. Therefore, the central portion of the lower surface of the main body portion 31 is not fixed to the mounting surface 12 of the sticking sheet 2.
 また、保持体5の本体部31には、医療従事者が圧迫デバイス1を生体表面上に取り付ける際に、取り付け位置を医療従事者に誘導する目印が設けられている。本実施形態の圧迫デバイス1は、この目印の1つとして線分マーカ7aを備える。本実施形態では、線分マーカ7aを設けることで、押圧体4の拡張部8により押圧されて圧迫されるべき生体表面上の圧迫位置を、拡張部8により適切に圧迫できる。具体的に、本実施形態の線分マーカ7aは、後述する枠線マーカ7b1内で特に高い圧迫力を得られる位置を示している。また、本実施形態の線分マーカ7aは、平面視において押圧体4の拡張部8と重なる位置に設けられている。そのため、線分マーカ7aを、平面視で生体表面上の所定の圧迫位置と重なるように位置合わせした状態で、圧迫デバイス1を生体表面上に取り付ける。これにより、生体表面上の所定の圧迫位置を、拡張部8により適切に圧迫できる。つまり、線分マーカ7aを設けることで、圧迫デバイス1を生体表面上の適切な位置に容易に位置決めできる。 Further, the main body 31 of the holding body 5 is provided with a mark for guiding the attachment position to the medical worker when the medical worker attaches the compression device 1 on the surface of the living body. The compression device 1 of the present embodiment includes a line segment marker 7a as one of the marks. In the present embodiment, by providing the line segment marker 7a, the expansion portion 8 can appropriately compress the compression position on the surface of the living body to be pressed and compressed by the expansion portion 8 of the pressing body 4. Specifically, the line segment marker 7a of the present embodiment indicates a position within the frame line marker 7b1 described later where a particularly high compression force can be obtained. Further, the line segment marker 7a of the present embodiment is provided at a position overlapping with the expansion portion 8 of the pressing body 4 in a plan view. Therefore, the compression device 1 is attached on the surface of the living body in a state where the line segment marker 7a is aligned so as to overlap a predetermined compression position on the surface of the living body in a plan view. As a result, a predetermined compression position on the surface of the living body can be appropriately compressed by the expansion unit 8. That is, by providing the line segment marker 7a, the compression device 1 can be easily positioned at an appropriate position on the surface of the living body.
 線分マーカ7aは、例えば、保持体5の本体部31の上面の一部を、色素が混錬された樹脂、着色塗料などにより構成することで実現可能である。線分マーカ7aの色は特に限定されないが、緑色系が好ましい。緑色系にすることで、医療従事者等は、線分マーカ7aを血液や生体表面上で容易に視認できる。また、線分マーカ7aは、保持体5の上面から突出する凸部、又は、保持体5の上面に形成されている溝部等の凹部、により構成されてもよい。 The line segment marker 7a can be realized, for example, by forming a part of the upper surface of the main body 31 of the holding body 5 with a resin in which a dye is kneaded, a colored paint, or the like. The color of the line segment marker 7a is not particularly limited, but a green color is preferable. By making it green, medical professionals and the like can easily visually recognize the line segment marker 7a on blood or the surface of a living body. Further, the line segment marker 7a may be composed of a convex portion protruding from the upper surface of the holding body 5 or a concave portion such as a groove formed on the upper surface of the holding body 5.
 また、保持体5は、線分マーカ7aが設けられている位置において、厚み方向Aに透光性を有することが好ましい。つまり、保持体5は、線分マーカ7aが設けられている位置において、厚み方向Aに半透明又は透明であることが好ましい。このようにすることで、医療従事者は、線分マーカ7aと、この線分マーカ7aと位置合わせすべき生体表面上の位置と、の重なり度合いを視認し易い。 Further, it is preferable that the holding body 5 has translucency in the thickness direction A at the position where the line segment marker 7a is provided. That is, the holding body 5 is preferably translucent or transparent in the thickness direction A at the position where the line segment marker 7a is provided. By doing so, the medical staff can easily visually recognize the degree of overlap between the line segment marker 7a and the position on the surface of the living body to be aligned with the line segment marker 7a.
 更に、保持体5は、平面視で線分マーカ7aと隣接する位置において、厚み方向Aに透光性を有することが好ましい。つまり、保持体5は、平面視で線分マーカ7aと隣接する位置において、厚み方向Aに半透明又は透明であることが好ましい。このようにすることで、医療従事者は、線分マーカ7aが生体表面上の所定位置に重なるように、圧迫デバイス1を生体表面に沿って移動させる動作を行う際に、線分マーカ7aの周囲の透光性を有する部分を通じて生体表面上の位置を視認しながら、圧迫デバイス1を移動させることができる。つまり、保持体5の本体部31の線分マーカ7aの周囲が、厚み方向Aに透光性を有する部分で構成されることで、圧迫デバイス1を生体表面上の適切な位置に取り付ける操作が、より容易になる。 Further, it is preferable that the holding body 5 has translucency in the thickness direction A at a position adjacent to the line segment marker 7a in a plan view. That is, it is preferable that the holding body 5 is translucent or transparent in the thickness direction A at a position adjacent to the line segment marker 7a in a plan view. By doing so, the medical staff moves the compression device 1 along the surface of the living body so that the line segment marker 7a overlaps the predetermined position on the surface of the living body. The compression device 1 can be moved while visually recognizing the position on the surface of the living body through the surrounding translucent portion. That is, since the periphery of the line segment marker 7a of the main body 31 of the holding body 5 is composed of a portion having translucency in the thickness direction A, the operation of attaching the compression device 1 to an appropriate position on the surface of the living body can be performed. , Will be easier.
 また、本実施形態の保持体5は、上述の線分マーカ7aに加えて、厚み方向Aで見た平面視において線分マーカ7aを取り囲む所定の領域を区画する領域マーカ7bを備える。本実施形態の保持体5は、領域マーカ7bとして、枠線マーカ7b1を備える。本実施形態の領域マーカ7bは、圧迫デバイス1が生体表面上に取り付けられている状態で、圧迫部材3が生体表面を第1所定値以上の圧迫力で圧迫可能な領域を表している。そして、本実施形態の線分マーカ7aは、領域マーカ7bにより識別可能な所定の領域内で、特に高い圧迫力を必要とする医療用挿入部材100(図8A参照)を位置合わせするための基準位置を示している。つまり、本実施形態の線分マーカ7aは、圧迫デバイス1が生体表面上に取り付けられている状態で、圧迫部材3が生体表面を上述の第1所定値より大きい第2所定値以上の圧迫力で圧迫可能な位置を表している。すなわち、領域マーカ7bは、第1所定値以上の圧迫力で圧迫可能な領域を示し、線分マーカ7aは、第1所定値よりも大きい第2所定値の圧迫力で圧迫可能な位置を示している。したがって、本実施形態では、例えば太径のシースなど、高い圧迫力が必要となる医療用挿入部材100(図8A参照)は、領域マーカ7bの中で、線分マーカ7aを利用して位置合わせされることが好ましい。上述した第1所定値、第2所定値などの圧迫力は、圧迫デバイス1が生体表面上に適切に取り付けられている状態で、圧迫デバイス1の所定の使用条件に沿って使用した場合に測定される値を意味する。「所定の使用条件」とは、例えば、圧迫デイバス1の後述する拡張部8を拡張させるために流体量など、圧迫デバイス1を製造又は販売する者が定めている条件を意味する。 Further, the holding body 5 of the present embodiment includes, in addition to the above-mentioned line segment marker 7a, a region marker 7b that partitions a predetermined region surrounding the line segment marker 7a in a plan view viewed in the thickness direction A. The holding body 5 of the present embodiment includes a border marker 7b1 as a region marker 7b. The region marker 7b of the present embodiment represents a region in which the compression member 3 can compress the surface of the living body with a pressing force equal to or higher than the first predetermined value while the compression device 1 is mounted on the surface of the living body. The line segment marker 7a of the present embodiment is a reference for aligning the medical insertion member 100 (see FIG. 8A) that requires a particularly high compression force within a predetermined region that can be identified by the region marker 7b. Indicates the position. That is, in the line segment marker 7a of the present embodiment, when the compression device 1 is mounted on the surface of the living body, the compression member 3 presses the surface of the living body with a second predetermined value or more, which is larger than the above-mentioned first predetermined value. Indicates a position that can be compressed with. That is, the region marker 7b indicates a region that can be compressed with a pressing force equal to or higher than the first predetermined value, and the line segment marker 7a indicates a position that can be compressed with a pressing force of a second predetermined value larger than the first predetermined value. ing. Therefore, in the present embodiment, the medical insertion member 100 (see FIG. 8A), which requires a high compression force, such as a sheath having a large diameter, is aligned in the region marker 7b by using the line segment marker 7a. It is preferable to be done. The compression force such as the first predetermined value and the second predetermined value described above is measured when the compression device 1 is used in accordance with the predetermined usage conditions of the compression device 1 in a state where the compression device 1 is appropriately mounted on the surface of the living body. Means the value to be. The "predetermined usage condition" means a condition determined by a person who manufactures or sells the compression device 1, such as a fluid amount for expanding the expansion portion 8 described later of the compression device 1.
 線分マーカ7aに加えて、上述の領域マーカ7bを設けることで、図8Bの左側の二点鎖線の枠内に拡大して例示するように、生体内に複数(図8Bの左側の二点鎖線枠内では3本)の医療用挿入部材100が挿入されている場合であっても、すべての挿入部分100aが領域マーカ7bの領域内に収まるように位置合わせできる。これにより、圧迫デバイス1を、複数の医療用挿入部材100の全ての挿入部分100aを所定の圧迫力で圧迫可能な生体表面BS上の適切な位置に、容易に取り付けることができる。 By providing the above-mentioned region marker 7b in addition to the line segment marker 7a, a plurality of (two points on the left side of FIG. 8B) are provided in the living body as illustrated in the frame of the alternate long and short dash line on the left side of FIG. 8B. Even when the medical insertion member 100 (three in the chain line frame) is inserted, all the insertion portions 100a can be aligned so as to fit within the region of the region marker 7b. Thereby, the compression device 1 can be easily attached to an appropriate position on the biological surface BS capable of compressing all the insertion portions 100a of the plurality of medical insertion members 100 with a predetermined compression force.
 保持体5は、厚み方向Aで見た平面視で領域マーカ7bとしての枠線マーカ7b1により区画される所定の領域内で、少なくとも線分マーカ7aが設けられていない位置において、厚み方向Aに透光性を有することが好ましい。つまり、保持体5は、厚み方向Aで見た平面視で領域マーカ7bとしての枠線マーカ7b1により区画される所定の領域内で、少なくとも線分マーカ7aが設けられていない位置において、厚み方向Aに半透明又は透明であることが好ましい。このようにすることで、医療従事者は、線分マーカ7aが生体表面上の所定位置に重なるように、圧迫デバイス1を生体表面に沿って移動させる動作を行う際に、領域マーカ7b(本実施形態では枠線マーカ7b1)により区画される所定の領域内の透光性を有する部分を通じて生体表面上の位置を視認しながら、圧迫デバイス1を移動させることができる。つまり、保持体5の本体部31の領域マーカ7bにより区画される所定の領域内が、厚み方向Aに透光性を有する部分で構成されることで、圧迫デバイス1を生体表面上の適切な位置に取り付ける操作が、より容易になる。上述したように、保持体5は、線分マーカ7aが設けられている位置においても、厚み方向Aに透光性を有することが好ましい。 The holding body 5 is in the thickness direction A at least in a position where the line segment marker 7a is not provided in a predetermined region defined by the frame line marker 7b1 as the region marker 7b in a plan view seen in the thickness direction A. It is preferably translucent. That is, the holding body 5 is in the thickness direction at least in a position where the line segment marker 7a is not provided in a predetermined region defined by the frame line marker 7b1 as the region marker 7b in the plan view seen in the thickness direction A. It is preferable that A is translucent or transparent. By doing so, the medical staff performs the operation of moving the compression device 1 along the surface of the living body so that the line segment marker 7a overlaps the predetermined position on the surface of the living body. In the embodiment, the compression device 1 can be moved while visually recognizing the position on the surface of the living body through a translucent portion in a predetermined region partitioned by the frame line marker 7b1). That is, the inside of the predetermined region partitioned by the region marker 7b of the main body 31 of the holding body 5 is composed of a portion having translucency in the thickness direction A, so that the compression device 1 can be appropriately placed on the surface of the living body. The operation of mounting in the position becomes easier. As described above, it is preferable that the holding body 5 has translucency in the thickness direction A even at the position where the line segment marker 7a is provided.
 上述したように、本実施形態の領域マーカ7bは、厚み方向Aで見た平面視において、線分マーカ7aの周囲を取り囲む枠線マーカ7b1である。保持体5は、枠線マーカ7b1が設けられている位置において、厚み方向Aに透光性を有することが好ましい。つまり、保持体5は、枠線マーカ7b1が設けられている位置において、厚み方向Aに半透明又は透明であることが好ましい。このようにすることで、医療従事者は、枠線マーカ7b1と、この枠線マーカ7b1と位置合わせすべき生体表面上の位置と、の重なり度合いを視認し易い。 As described above, the region marker 7b of the present embodiment is a frame line marker 7b1 that surrounds the periphery of the line segment marker 7a in a plan view seen in the thickness direction A. The holding body 5 preferably has translucency in the thickness direction A at the position where the frame line marker 7b1 is provided. That is, the holding body 5 is preferably translucent or transparent in the thickness direction A at the position where the frame line marker 7b1 is provided. By doing so, the medical staff can easily visually recognize the degree of overlap between the border marker 7b1 and the position on the surface of the living body to be aligned with the border marker 7b1.
 更に、保持体5は、厚み方向Aで見た平面視で領域マーカ7b(本実施形態では枠線マーカ7b1)の外側に隣接する位置において、厚み方向Aに透光性を有することが好ましい。つまり、保持体5は、厚み方向Aで見た平面視で領域マーカ7b(本実施形態では枠線マーカ7b1)の外側に隣接する位置において、厚み方向Aに半透明又は透明であることが好ましい。このようにすることで、医療従事者は、線分マーカ7aが生体表面上の所定位置に重なるように、圧迫デバイス1を生体表面に沿って移動させる動作を行う際に、領域マーカ7b(本実施形態では枠線マーカ7b1)により区画される所定の領域の外側の位置において、透光性を有する部分を通じて生体表面上の位置を視認しながら、圧迫デバイス1を移動させることができる。つまり、保持体5の本体部31の領域マーカ7bにより区画される所定の領域の外側に隣接する位置が、厚み方向Aに透光性を有する部分で構成されることで、圧迫デバイス1を生体表面上の適切な位置に取り付ける操作が、より容易になる。 Further, it is preferable that the holding body 5 has translucency in the thickness direction A at a position adjacent to the outside of the region marker 7b (frame line marker 7b1 in the present embodiment) in a plan view in the thickness direction A. That is, it is preferable that the holding body 5 is translucent or transparent in the thickness direction A at a position adjacent to the outside of the region marker 7b (frame line marker 7b1 in the present embodiment) in a plan view in the thickness direction A. .. By doing so, the medical staff performs the operation of moving the compression device 1 along the surface of the living body so that the line segment marker 7a overlaps the predetermined position on the surface of the living body. In the embodiment, the compression device 1 can be moved at a position outside a predetermined region partitioned by the frame line marker 7b1) while visually recognizing the position on the surface of the living body through the translucent portion. That is, the position adjacent to the outside of the predetermined region defined by the region marker 7b of the main body portion 31 of the holding body 5 is composed of a portion having translucency in the thickness direction A, so that the compression device 1 can be used as a living body. The operation of mounting in the proper position on the surface becomes easier.
 本実施形態の枠線マーカ7b1などの領域マーカ7bは、例えば、保持体5の本体部31の上面の一部を、色素が混錬された樹脂、着色塗料などにより構成することで実現可能である。領域マーカ7bの色は特に限定されないが、緑色系が好ましい。緑色系にすることで、医療従事者等は、領域マーカ7bを血液や生体表面上で容易に視認できる。そのため、領域マーカ7bを利用して、生体表面上の圧迫位置に拡張部8を位置合わせすることが、より容易になる。また、領域マーカ7bを枠線マーカ7b1とする場合は、保持体5の上面から突出する凸部、又は、保持体5の上面に形成されている溝部等の凹部、により構成されてもよい。 The area marker 7b such as the frame line marker 7b1 of the present embodiment can be realized, for example, by forming a part of the upper surface of the main body 31 of the holding body 5 with a resin in which a dye is kneaded, a colored paint, or the like. be. The color of the region marker 7b is not particularly limited, but a greenish color is preferable. By making it green, medical professionals and the like can easily visually recognize the region marker 7b on blood or the surface of a living body. Therefore, it becomes easier to align the expansion portion 8 with the compression position on the surface of the living body by using the region marker 7b. When the area marker 7b is used as the frame line marker 7b1, it may be composed of a convex portion protruding from the upper surface of the holding body 5 or a concave portion such as a groove formed on the upper surface of the holding body 5.
 本実施形態の領域マーカ7bとしての枠線マーカ7b1は矩形状であるが、この形状は特に限定されない。枠線マーカ7b1は、例えば、円形状、オーバル状、四角以外の多角形状であってもよい。また、本実施形態の枠線マーカ7b1は、保持体5の貫通孔5aで一部が分断されているが、この構成に限られない。枠線マーカ7b1は、貫通孔5aに対して受入部6側と反対側のみに設けられていてもよい。 The border marker 7b1 as the area marker 7b of the present embodiment has a rectangular shape, but this shape is not particularly limited. The border marker 7b1 may have a polygonal shape other than a circular shape, an oval shape, or a square shape, for example. Further, the frame line marker 7b1 of the present embodiment is partially divided by the through hole 5a of the holding body 5, but is not limited to this configuration. The frame line marker 7b1 may be provided only on the side opposite to the receiving portion 6 side with respect to the through hole 5a.
 本実施形態の保持体5は、領域マーカ7bとしての枠線マーカ7b1を備えるが、領域マーカ7bはこの構成に限られない。領域マーカ7bは、所定の色で塗りつぶされた領域の外縁により、所定の領域を縁取る構成であってもよい。 The holding body 5 of the present embodiment includes a border marker 7b1 as an area marker 7b, but the area marker 7b is not limited to this configuration. The area marker 7b may have a configuration in which a predetermined area is bordered by an outer edge of the area filled with a predetermined color.
 上述したように、本実施形態の押圧体4の拡張部8及び延設部9についても、厚み方向Aに透光性を有する部分から構成されている。本実施形態の圧迫デバイス1では、押圧体4の延設部9、保持体5の線分マーカ7a、領域マーカ7b(本実施形態では枠線マーカ7b1)及びこれらの周囲、並びに、押圧体4の拡張部8が、厚み方向Aに積層されている。以下、この部分を「積層部分」と呼ぶ。本実施形態の積層部分は、透光性を有する部分が積層されて構成されていることが好ましい。このようにすることで、本実施形態の圧迫デバイス1では、押圧体4の延設部9、保持体5の線分マーカ7a、領域マーカ7b及びこれらの周囲、並びに、押圧体4の拡張部8、を通じて厚み方向Aの一方側から他方側を視認することができる。その結果、本実施形態の圧迫デバイス1によれば、線分マーカ7a及び領域マーカ7bの生体表面上での位置合わせが、より容易となる。このように、積層部分の全てが透光性を有する部分で構成される場合は、線分マーカ7a及び領域マーカ7bは、平面視において積層部分の他の全ての層に対して識別可能な態様であることが好ましい。このようにすることで、線分マーカ7a及び領域マーカ7bの生体表面上での位置合わせが、より一層容易となる。 As described above, the expansion portion 8 and the extension portion 9 of the pressing body 4 of the present embodiment are also composed of portions having translucency in the thickness direction A. In the compression device 1 of the present embodiment, the extending portion 9 of the pressing body 4, the line segment marker 7a of the holding body 5, the area marker 7b (frame line marker 7b1 in the present embodiment), their surroundings, and the pressing body 4 The expansion portion 8 of the above is laminated in the thickness direction A. Hereinafter, this portion is referred to as a "laminated portion". The laminated portion of the present embodiment is preferably configured by laminating portions having translucency. By doing so, in the compression device 1 of the present embodiment, the extending portion 9 of the pressing body 4, the line segment marker 7a of the holding body 5, the area marker 7b and their surroundings, and the expanding portion of the pressing body 4 are used. The other side can be visually recognized from one side of the thickness direction A through 8. As a result, according to the compression device 1 of the present embodiment, the alignment of the line segment marker 7a and the region marker 7b on the surface of the living body becomes easier. In this way, when all of the laminated portions are composed of translucent portions, the line segment marker 7a and the region marker 7b are in a mode in which they can be distinguished from all other layers of the laminated portion in a plan view. Is preferable. By doing so, the alignment of the line segment marker 7a and the region marker 7b on the surface of the living body becomes even easier.
 本実施形態の線分マーカ7a、及び、領域マーカ7bとしての枠線マーカ7b、は保持体5の本体部31の上面に設けられている。そのため、本実施形態の線分マーカ7a及び領域マーカ7bは、圧迫デバイス1を操作中の医療従事者にとって視認し易い。但し、線分マーカ7a及び領域マーカ7bは、保持体5の内部に設けられていてもよい。更に、線分マーカ7a及び領域マーカ7bは、保持体5の本体部31の下面に設けられてもよい。線分マーカ7a及び領域マーカ7bを保持体5の下面に設ける構成の詳細は後述する(図9参照)。 The line segment marker 7a of the present embodiment and the frame line marker 7b as the area marker 7b are provided on the upper surface of the main body 31 of the holding body 5. Therefore, the line segment marker 7a and the area marker 7b of the present embodiment are easily visible to the medical staff who is operating the compression device 1. However, the line segment marker 7a and the area marker 7b may be provided inside the holding body 5. Further, the line segment marker 7a and the area marker 7b may be provided on the lower surface of the main body 31 of the holding body 5. Details of the configuration in which the line segment marker 7a and the region marker 7b are provided on the lower surface of the holding body 5 will be described later (see FIG. 9).
 線分マーカ7a及び領域マーカ7bを設ける方法は特に限定されないが、例えば、印刷、融着、接着、一体成形等を利用することができる。 The method of providing the line segment marker 7a and the area marker 7b is not particularly limited, but for example, printing, fusion, adhesion, integral molding, or the like can be used.
 また、本実施形態の線分マーカ7aは、平面視で、一対の把持板部32の間の位置に設けられている。このようにすることで、圧迫デバイス1を操作する医療従事者は、一対の把持板部32を両側から挟み込むようにして把持した状態において、線分マーカ7aを視認し易い。そのため、圧迫デバイス1の操作性が向上する。より具体的に、本実施形態では、線分マーカ7aの全部が、平面視で一対の把持板部32の間に配置されている。 Further, the line segment marker 7a of the present embodiment is provided at a position between the pair of gripping plate portions 32 in a plan view. By doing so, the medical staff who operates the compression device 1 can easily visually recognize the line segment marker 7a in a state where the pair of grip plate portions 32 are sandwiched and gripped from both sides. Therefore, the operability of the compression device 1 is improved. More specifically, in the present embodiment, all of the line segment markers 7a are arranged between the pair of grip plate portions 32 in a plan view.
 一対の把持板部32は、医療従事者により把持される。このような一対の把持板部32を設けることで、圧迫デバイス1を持ち易くなる。そのため、医療従事者にとっての操作性を向上させることができる。 The pair of grip plate portions 32 are gripped by a medical worker. By providing such a pair of grip plate portions 32, it becomes easy to hold the compression device 1. Therefore, the operability for the medical staff can be improved.
 本実施形態の保持体5の材料としては、例えば樹脂材料が挙げられる。この樹脂材料としては、例えば、ABS樹脂、AS樹脂、ポリエチレン、ポリプロピレン、ポリスチレン、ポリ塩化ビニル、ポリ塩化ビニリデン樹脂、ポリフェニレンオキサイド、熱可塑性ポリウレタン、ポリメチレンメタクリレート、ポリオキシエチレン、フッ素樹脂、ポリカーボネート、ポリアミド、アセタール樹脂、アクリル樹脂、ポリエチレンテレフタレート等の射出成形で用いられる熱可塑性樹脂や、フェノール樹脂、エポキシ樹脂、シリコーン樹脂、不飽和ポリエステル等の熱硬化性樹脂等が挙げられる。 Examples of the material of the holding body 5 of the present embodiment include a resin material. Examples of the resin material include ABS resin, AS resin, polyethylene, polypropylene, polystyrene, polyvinyl chloride, polyvinylidene chloride resin, polyphenylene oxide, thermoplastic polyurethane, polymethylene methacrylate, polyoxyethylene, fluororesin, polycarbonate, and polyamide. , Acetal resin, acrylic resin, thermoplastic resin used in injection molding such as polyethylene terephthalate, and thermosetting resin such as phenol resin, epoxy resin, silicone resin, and unsaturated polyester.
 保持体5のうち少なくとも本体部31の中央部は、超音波透過性を有する材料で形成されることが好ましい。また、上述した押圧体4についても、超音波透過性を有する材料で形成されることが好ましい。また、押圧体4の拡張部8の収容空間8aに供給される流体についても、水やゲル等の超音波透過性を有する流体を用いる。このようにすれば、圧迫デバイス1による血管の閉塞状態を、超音波装置により検出できる。この詳細は後述する。 It is preferable that at least the central portion of the main body portion 31 of the holding body 5 is formed of a material having ultrasonic transmission. Further, the above-mentioned pressing body 4 is also preferably formed of a material having ultrasonic wave transparency. Further, as the fluid supplied to the accommodation space 8a of the expansion portion 8 of the pressing body 4, a fluid having ultrasonic permeability such as water or gel is used. In this way, the state of obstruction of the blood vessel by the compression device 1 can be detected by the ultrasonic device. The details will be described later.
<圧迫デバイス1を用いて行う圧迫方法>
 次に、本開示に係る圧迫デバイス1の貼着方法の一例を含む、圧迫デバイス1を用いて行う生体表面の圧迫方法について説明する。図7は、生体表面の圧迫方法の一例を示すフローチャートである。図7に示す圧迫方法は、貼着工程S1と、第1圧迫工程S2と、抜去工程S3と、第2圧迫工程S4と、を含む。図8A、図8Bは、貼着工程S1の概要を示す図である。図8Cは、第1圧迫工程S2の概要を示す図である。図8Dは、抜去工程S3の概要を示す図である。図8Eは、第2圧迫工程S4の概要を示す図である。
<Compression method using compression device 1>
Next, a method of compressing the surface of a living body performed by using the compression device 1 including an example of the method of attaching the compression device 1 according to the present disclosure will be described. FIG. 7 is a flowchart showing an example of a method of compressing the surface of a living body. The compression method shown in FIG. 7 includes a sticking step S1, a first compression step S2, a removal step S3, and a second compression step S4. 8A and 8B are diagrams showing an outline of the sticking step S1. FIG. 8C is a diagram showing an outline of the first compression step S2. FIG. 8D is a diagram showing an outline of the extraction step S3. FIG. 8E is a diagram showing an outline of the second compression step S4.
 図7、図8A~図8Eに例示する圧迫方法は、生体表面BSを圧迫することで、静脈を閉塞することなく、生体表面から静脈まで通じる穿孔を、狭窄又は閉塞する、圧迫方法である。穿孔は、生体表面BSから結合組織を通じて、例えば大腿静脈などの静脈内に挿入されている状態の医療用挿入部材100としてのシースを抜去することで形成される。ここで示す圧迫方法により、医療用挿入部材100としてのシースを抜去した後の止血を行うことができる。まず、医療用挿入部材100を抜去した後に形成される穿孔について図11Aおよび図11Bを参照して説明する。図11Aは、医療用挿入部材100としてのシースが生体表面BSから結合組織CTを通じて、大腿静脈FV内に挿入されている状態を示している。図11Aでは、医療用挿入部材100としてのシースを3本示しているが、2本以下であってもよく、4本以上であってもよい。図11Bは、図11Aに示す状態から医療用挿入部材100としてのシースを抜去した後の状態を示している。図11Bに示すように、医療用挿入部材100としてのシースを抜去することで、生体表面BSと大腿静脈FVとの間に穿孔Pが形成される。図7、図8A~図8Eに示す圧迫方法では、大腿静脈FVを閉塞することなく、穿孔Pを狭窄又は閉塞することができる。そのため、生体表面から深い位置にある静脈からの出血の止血を行う場合であっても、その静脈自体を狭窄又は閉塞する必要がなく、より効率的に止血を行うことができる。以下、図8A~図8Eを参照して、各工程S1~S4の詳細について説明する。 The compression method illustrated in FIGS. 7 and 8A to 8E is a compression method in which the perforation leading from the biological surface to the vein is narrowed or occluded by compressing the biological surface BS without occluding the vein. The perforation is formed by removing the sheath as the medical insertion member 100 in a state of being inserted into a vein such as a femoral vein through connective tissue from the biological surface BS. By the compression method shown here, hemostasis can be performed after the sheath as the medical insertion member 100 is removed. First, the perforation formed after removing the medical insertion member 100 will be described with reference to FIGS. 11A and 11B. FIG. 11A shows a state in which the sheath as the medical insertion member 100 is inserted into the femoral vein FV from the biological surface BS through the connective tissue CT. In FIG. 11A, three sheaths as the medical insertion member 100 are shown, but the number may be two or less, or four or more. FIG. 11B shows a state after removing the sheath as the medical insertion member 100 from the state shown in FIG. 11A. As shown in FIG. 11B, by removing the sheath as the medical insertion member 100, a perforation P is formed between the biological surface BS and the femoral vein FV. In the compression method shown in FIGS. 7 and 8A to 8E, the perforation P can be narrowed or occluded without occluding the femoral vein FV. Therefore, even when bleeding from a vein located deep from the surface of the living body is stopped, it is not necessary to narrow or occlude the vein itself, and bleeding can be stopped more efficiently. Hereinafter, the details of each of the steps S1 to S4 will be described with reference to FIGS. 8A to 8E.
 図8Aは、生体表面BSから大腿静脈FV(図11A、図11B参照)内に医療用挿入部材100としてのシースが挿入されている状態を示している。図8Bでは、医療用挿入部材100としてのシースが生体内に挿入されている状態で、生体表面BS上の所定位置への圧迫デバイス1の取り付けを完了した状態を示している。また、図8Bでは、線分マーカ7aと、医療用挿入部材100の挿入部分100aと、の平面視での位置合わせの詳細を、二点鎖線の枠内に拡大して示している。図8A、図8Bでは、貼着面11から剥離シートを剥離した後の、圧迫デバイス1の使用状態を示している。 FIG. 8A shows a state in which a sheath as a medical insertion member 100 is inserted into the femoral vein FV (see FIGS. 11A and 11B) from the biological surface BS. FIG. 8B shows a state in which the compression device 1 is completely attached to a predetermined position on the biological surface BS with the sheath as the medical insertion member 100 inserted in the living body. Further, in FIG. 8B, the details of the alignment of the line segment marker 7a and the insertion portion 100a of the medical insertion member 100 in a plan view are shown enlarged in the frame of the alternate long and short dash line. 8A and 8B show the usage state of the compression device 1 after the release sheet is peeled from the sticking surface 11.
 図8A、図8Bに示すように、圧迫デバイス1は、貼着シート2の貼着面11を生体表面に貼着することで、生体表面に取り付けられる。具体的には、図8Bに示すように、生体表面BSから生体内に挿入されている医療用挿入部材100としてのシースの生体表面BSから外部に露出する部分が受入部6で受け入れられた状態で、貼着シート2は生体表面BSに貼着される。更に、図8Bに示すように、医療用挿入部材100としてのシースのうち生体表面BSと同一面に位置する挿入部分100aの一部は、線分マーカ7aに位置合わせされる(図8Bの二点鎖線の枠内参照)。このように位置合わせされた状態で、貼着シート2は生体表面BSに貼着される。 As shown in FIGS. 8A and 8B, the compression device 1 is attached to the surface of the living body by sticking the sticking surface 11 of the sticking sheet 2 to the surface of the living body. Specifically, as shown in FIG. 8B, a portion of the sheath as the medical insertion member 100 inserted into the living body from the living body surface BS exposed to the outside from the living body surface BS is received by the receiving portion 6. Then, the sticking sheet 2 is stuck to the biological surface BS. Further, as shown in FIG. 8B, a part of the insertion portion 100a of the sheath as the medical insertion member 100 located on the same surface as the biological surface BS is aligned with the line segment marker 7a (FIG. 8B-2). See inside the dotted line frame). In the state of being aligned in this way, the sticking sheet 2 is stuck to the biological surface BS.
 より具体的には、図8Bに示すように、本実施形態では、医療用挿入部材100としてのシースのうち生体表面BSと同一面に位置する挿入部分100aの全部が、領域マーカ7b内に位置合わせされる。このように位置合わせされた状態で、貼着シート2は生体表面BSに貼着される。このような領域マーカ7bを設けることで、図8Bの左側の二点鎖線の枠内に拡大して例示するように、生体内に複数(図8Bの左側の二点鎖線枠内では3本)の医療用挿入部材100が挿入されている場合であっても、すべての挿入部分100aが領域マーカ7bの領域内に収まるように位置合わせすることができる。これにより、圧迫デバイス1を、複数の医療用挿入部材100の全ての挿入部分100aを所定の圧迫力で圧迫可能な生体表面BS上の適切な位置に、容易に取り付けることができる。また、図8Bに示すように、本実施形態では、外径が所定値未満の細いシースなどについては、領域マーカ7b内で線分マーカ7aには位置合わせせず(図8Bの左側の二点鎖線の枠内参照)、外径が所定値以上の太いシースなどについて、挿入部分100aの外面の一部が領域マーカ7b内で線分マーカ7aに位置合わせされる(図8Bの左側及び右側の二点鎖線の枠内参照)。上述したように、本実施形態の線分マーカ7aは、領域マーカ7bの領域内で特に高い圧迫力を得られる位置を示している。そのため、例えば高い圧迫力が求められる太径のシース等であっても、所定の圧迫力を確保できる。また、例えば、高い圧迫力が求められる太径のシースと、これより細い細径のシースと、が両方含まれている場合(図8Bの左側の二点鎖線の枠内参照)であっても、太径のシースを領域マーカ7b内で線分マーカ7aに位置合わせし、細径のシースを領域マーカ7b内で線分マーカ7aに位置合わせしないことで、領域マーカ7b内での圧迫力の違いに基づき、各シースに求められる所望の圧迫力をそれぞれ実現できる。このように各種の位置合わせが行われた後に、貼着シート2は生体表面BSに貼着される。線分マーカ7a及び領域マーカ7bを共に設けることで、医療用挿入部材100の外径や数、必要な圧迫力に応じて、圧迫デバイス1を生体表面BS上のより適切な位置に、取り付けることができる。 More specifically, as shown in FIG. 8B, in the present embodiment, the entire insertion portion 100a of the sheath as the medical insertion member 100 located on the same surface as the biological surface BS is located within the region marker 7b. It will be matched. In the state of being aligned in this way, the sticking sheet 2 is stuck to the biological surface BS. By providing such a region marker 7b, as shown in an enlarged example in the frame of the alternate long and short dash line on the left side of FIG. 8B, a plurality of markers (three in the frame of the alternate long and short dash line on the left side of FIG. 8B) are provided. Even when the medical insertion member 100 is inserted, all the insertion portions 100a can be aligned so as to fit within the region of the region marker 7b. Thereby, the compression device 1 can be easily attached to an appropriate position on the biological surface BS capable of compressing all the insertion portions 100a of the plurality of medical insertion members 100 with a predetermined compression force. Further, as shown in FIG. 8B, in the present embodiment, a thin sheath having an outer diameter of less than a predetermined value is not aligned with the line segment marker 7a within the region marker 7b (two points on the left side of FIG. 8B). (Refer to the inside of the chain line frame), for a thick sheath having an outer diameter of a predetermined value or more, a part of the outer surface of the insertion portion 100a is aligned with the line segment marker 7a within the region marker 7b (on the left and right sides of FIG. 8B). See inside the frame of the alternate long and short dash line). As described above, the line segment marker 7a of the present embodiment indicates a position in the region of the region marker 7b where a particularly high compression force can be obtained. Therefore, for example, even with a large-diameter sheath or the like that requires a high compression force, a predetermined compression force can be secured. Further, for example, even when both a large-diameter sheath that requires a high compression force and a small-diameter sheath that is thinner than this are included (see the frame of the alternate long and short dash line on the left side of FIG. 8B). By aligning the large-diameter sheath with the line segment marker 7a in the region marker 7b and not aligning the small-diameter sheath with the line segment marker 7a in the region marker 7b, the compression force in the region marker 7b is increased. Based on the difference, the desired compression force required for each sheath can be realized. After various alignments are performed in this way, the sticking sheet 2 is stuck to the biological surface BS. By providing both the line segment marker 7a and the region marker 7b, the compression device 1 can be attached to a more appropriate position on the biological surface BS according to the outer diameter and number of the medical insertion member 100 and the required compression force. Can be done.
 上述したように、線分マーカ7aは、厚み方向Aで見た平面視において弧状に延在する。したがって、本実施形態では、医療用挿入部材100の挿入部分100aの外面の一部が、平面視で、線分マーカ7aに接する又は重なるように位置合わせされる。圧迫デバイス1は、このように位置合わせされた状態で、生体表面BS上に取り付けられる。 As described above, the line segment marker 7a extends in an arc shape in the plan view seen in the thickness direction A. Therefore, in the present embodiment, a part of the outer surface of the insertion portion 100a of the medical insertion member 100 is aligned so as to be in contact with or overlap the line segment marker 7a in a plan view. The compression device 1 is mounted on the biological surface BS in such an aligned state.
 次に、図8Cに示すように、チューブ28の接続部29に流体供給器具としてのシリンジ30を接続する。チューブ28を通じて、圧迫デバイス1の押圧体4の拡張部8の収容空間8a(図6参照)に対して空気を供給し、拡張部8を拡張させる。このようにすることで、医療用挿入部材100としてのシースを生体表面BSから抜去する前に、生体表面BSの傷口近傍を、予め圧迫することができる。換言すれば、医療用挿入部材100としてのシースが生体表面BSから結合組織CT(図11A、図11B参照)を通じて静脈としての大腿静脈FV内に挿入されている状態で生体表面BSの圧迫を開始する。このように、医療用挿入部材100を生体表面BSから抜去する前に圧迫しておく。これにより、医療用挿入部材100としてのシースの抜去直後に、生体表面BSを圧迫することができる。そのため、生体表面BSから大腿静脈FV(図11A、図11B参照)まで延在する穿孔P(図11B参照)を、シースの抜去直後に、狭窄又は閉塞することができる。 Next, as shown in FIG. 8C, the syringe 30 as a fluid supply device is connected to the connection portion 29 of the tube 28. Through the tube 28, air is supplied to the accommodation space 8a (see FIG. 6) of the expansion portion 8 of the pressing body 4 of the compression device 1 to expand the expansion portion 8. By doing so, the vicinity of the wound on the biological surface BS can be pressed in advance before the sheath as the medical insertion member 100 is removed from the biological surface BS. In other words, compression of the biological surface BS is started with the sheath as the medical insertion member 100 inserted into the femoral vein FV as a vein from the biological surface BS through the connective tissue CT (see FIGS. 11A and 11B). do. In this way, the medical insertion member 100 is pressed before being removed from the biological surface BS. As a result, the biological surface BS can be pressed immediately after the sheath as the medical insertion member 100 is removed. Therefore, the perforation P (see FIG. 11B) extending from the biological surface BS to the femoral vein FV (see FIGS. 11A and 11B) can be narrowed or occluded immediately after the sheath is removed.
 次に、図8Dに示すように、医療用挿入部材100としてのシースを生体表面BSから抜去する。このシースの抜去により、図11Bで示す穿孔Pが形成される。仮に、この状態で生体表面BSを全く圧迫しない場合は、大腿静脈FVから穿孔Pおよび生体表面BS上の傷口を通じて、生体外に出血する。しかしながら、ここで示す圧迫方法では、図8Cに示すように、医療用挿入部材100としてのシースを生体表面BSから抜去する前に、予め生体表面BSを圧迫しておく。そのため、シースを抜去した直後に、穿孔P(図11B参照)を狭窄又は閉塞するように、生体表面BSを圧迫でき、シースの抜去直後における出血量を抑制することができる。 Next, as shown in FIG. 8D, the sheath as the medical insertion member 100 is removed from the biological surface BS. Removal of this sheath forms the perforation P shown in FIG. 11B. If the biological surface BS is not compressed at all in this state, bleeding occurs from the femoral vein FV through the perforation P and the wound on the biological surface BS. However, in the compression method shown here, as shown in FIG. 8C, the biological surface BS is compressed in advance before the sheath as the medical insertion member 100 is removed from the biological surface BS. Therefore, immediately after the sheath is removed, the biological surface BS can be pressed so as to narrow or occlude the perforation P (see FIG. 11B), and the amount of bleeding immediately after the sheath is removed can be suppressed.
 次に、図8Eに示すように、チューブ28の接続部29に流体供給器具としてのシリンジ30を再び接続する。チューブ28を通じて、圧迫デバイス1の拡張部8の収容空間8aに対して、再び空気を供給して加圧する、又は、空気を抜いて減圧する。換言すれば、医療用挿入部材100としてのシースを抜去後に生体表面BSの圧迫力を調整する。これにより、生体表面BSの圧迫力を調整して、大腿静脈FV(図11A、図11B参照)を閉塞することなく、穿孔P(図11B参照)を更に狭窄又は閉塞させることで、出血量を大きく低減させる又は出血を止める、ことができる。 Next, as shown in FIG. 8E, the syringe 30 as a fluid supply device is reconnected to the connection portion 29 of the tube 28. Air is supplied again to pressurize the accommodating space 8a of the expansion portion 8 of the compression device 1 through the tube 28, or the air is evacuated to reduce the pressure. In other words, the compression force of the biological surface BS is adjusted after the sheath as the medical insertion member 100 is removed. As a result, the compression force of the biological surface BS is adjusted to further narrow or occlude the perforation P (see FIG. 11B) without occluding the femoral vein FV (see FIGS. 11A and 11B), thereby reducing the amount of bleeding. It can be greatly reduced or bleeding can be stopped.
 より具体的に、シース抜去後に出血が確認された場合には、止血が達成されるまで圧迫力をゆっくり高めて加圧する。これに対して、シース抜去後に止血が確認された場合には、出血が確認されるまで圧迫力をゆっくり低下させて減圧する。そして、出血が確認された後に、止血が達成されるまで圧迫力をゆっくり高めて加圧する。このようにすることで、過加圧による大腿静脈FV(図11A、図11B参照)の閉塞を防止することができる。 More specifically, if bleeding is confirmed after removing the sheath, the compression force is slowly increased and pressurized until hemostasis is achieved. On the other hand, if hemostasis is confirmed after the sheath is removed, the compression force is slowly reduced to reduce the pressure until bleeding is confirmed. Then, after bleeding is confirmed, the compression force is slowly increased and pressurized until hemostasis is achieved. By doing so, it is possible to prevent obstruction of the femoral vein FV (see FIGS. 11A and 11B) due to overpressurization.
 また、生体表面BSが適切に圧迫されているか否かを、超音波装置を用いて検出してもよい。具体的に、押圧体4及び保持体5を、超音波透過性を有する材料で形成し、押圧体4の拡張部8に水等の超音波透過性を有する流体を供給する構成とすることで、圧迫デバイス1による圧迫状態を、超音波により診断できる。つまり、超音波装置により、大腿静脈FV(図11A、図11B参照)が閉塞されているか否かを検出することができる。超音波装置による診断結果に基づき、圧迫デバイス1の圧迫力を調整してもよい。 Further, whether or not the biological surface BS is appropriately compressed may be detected by using an ultrasonic device. Specifically, the pressing body 4 and the holding body 5 are formed of a material having ultrasonic wave transmission, and a fluid having ultrasonic wave transmission such as water is supplied to the expansion portion 8 of the pressing body 4. , The compression state by the compression device 1 can be diagnosed by ultrasonic waves. That is, the ultrasonic device can detect whether or not the femoral vein FV (see FIGS. 11A and 11B) is occluded. The compression force of the compression device 1 may be adjusted based on the diagnosis result by the ultrasonic device.
 そのまま、数時間(例えば2~6時間)、圧迫状態を維持することで、止血を完了することができる。止血完了後は、貼着シート2の貼着面11を生体表面BSから剥離することで、圧迫デバイス1を生体表面BSから取り外す。 Hemostasis can be completed by maintaining the compressed state for several hours (for example, 2 to 6 hours). After the hemostasis is completed, the compression device 1 is removed from the biological surface BS by peeling the adhesive surface 11 of the adhesive sheet 2 from the biological surface BS.
 ここで示す圧迫方法は、大腿静脈FV(図11A、図11B参照)を閉塞せずに、穿孔P(図11B参照)を狭窄又は閉塞する。静脈の止血の場合には、穿孔P(図11B参照)の狭窄又は閉塞により、止血を行うことができる。これに対して、例えば、大腿動脈の止血の場合には、穿孔のみを閉塞しても、結合組織CT(図11A、図11B参照)内に血液が漏れ拡がるため、止血することができない。大腿動脈の止血の場合には、動脈自体を狭窄又は閉塞するほど強く圧迫する方法、動脈壁の孔を塞ぐ方法等、大がかりな対応が必要になる。 The compression method shown here narrows or occludes the perforation P (see FIG. 11B) without occluding the femoral vein FV (see FIGS. 11A, 11B). In the case of venous hemostasis, bleeding can be stopped by stenosis or occlusion of perforation P (see FIG. 11B). On the other hand, in the case of hemostasis of the femoral artery, for example, even if only the perforation is occluded, blood leaks and spreads into the connective tissue CT (see FIGS. 11A and 11B), so that hemostasis cannot be performed. In the case of hemostasis of the femoral artery, a large-scale measure such as a method of compressing the artery itself so strongly as to narrow or occlude it or a method of closing a hole in the arterial wall is required.
 したがって、上述の圧迫方法では、生体表面BSを、生体表面BSからの圧迫深さが5mm~20mmとなる位置まで圧迫することが好ましい。圧迫深さを上記範囲とすることで、静脈を閉塞することなく、穿孔P(図11B参照)を狭窄又は閉塞する圧迫状態を実現し易い。圧迫深さは、5mm~15mmとすることがより好ましく、8mm~12mmとすることが更に好ましい。 Therefore, in the above-mentioned compression method, it is preferable to compress the biological surface BS to a position where the compression depth from the biological surface BS is 5 mm to 20 mm. By setting the compression depth within the above range, it is easy to realize a compression state in which the perforation P (see FIG. 11B) is narrowed or occluded without occluding the vein. The compression depth is more preferably 5 mm to 15 mm, and even more preferably 8 mm to 12 mm.
 更に、上述の圧迫方法では、生体表面BSを、生体表面BSから10g/cm~600g/cmで圧迫することが好ましい。この圧迫圧力は、医療用挿入部材100としてのシースを抜去した後の圧力であり、上述したシース抜去前の圧迫力を意味しない。圧迫圧力を上記範囲とすることで、静脈を閉塞することなく、穿孔P(図11B参照)を狭窄又は閉塞する圧迫状態を実現し易い。圧迫圧力は、50g/cm~400g/cmとすることがより好ましく、100g/cm~300g/cmとすることが更に好ましい。 Further, in the above compression method, the biological surface BS, it is preferable to press the living body surface BS at 10g / cm 2 ~ 600g / cm 2. This compression pressure is the pressure after the sheath as the medical insertion member 100 is removed, and does not mean the compression force before the sheath is removed as described above. By setting the compression pressure in the above range, it is easy to realize a compression state in which the perforation P (see FIG. 11B) is narrowed or occluded without occluding the vein. The compression pressure is more preferably 50 g / cm 2 to 400 g / cm 2, and even more preferably 100 g / cm 2 to 300 g / cm 2 .
 また、生体表面BSを、穿孔P(図11B参照)の延在方向に対して直交する方向に沿って圧迫することが好ましい。「穿孔の延在方向に対して直交する方向に沿って圧迫する」とは、穿孔の延在方向に対して直交する方向のみに圧迫することに限らず、穿孔の延在方向に対して直交する方向に対して所定角度以下(例えば30度以下)の角度で傾斜する方向に圧迫することをも含む意味である。本実施形態の圧迫デバイス1は、生体表面BSを、穿孔P(図11B参照)の延在方向に対して直交する方向に沿って圧迫することができる。 Further, it is preferable to press the biological surface BS along a direction orthogonal to the extending direction of the perforation P (see FIG. 11B). "Compressing along a direction orthogonal to the extending direction of the perforation" is not limited to compressing only in the direction orthogonal to the extending direction of the perforation, but is orthogonal to the extending direction of the perforation. It also means that the pressure is applied in a direction of inclination at an angle of a predetermined angle or less (for example, 30 degrees or less) with respect to the direction of the squeeze. The compression device 1 of the present embodiment can compress the biological surface BS along a direction orthogonal to the extending direction of the perforation P (see FIG. 11B).
 具体的に、本実施形態の押圧体4の拡張部8は、上述したように、厚み方向Aに対して傾斜する方向に向かって拡張可能である。このようにすることで、生体表面を、穿孔P(図11B参照)の延在方向に対して直交する方向に沿って圧迫することができる。具体的に、図11A、図11Bに示すように、医療用挿入部材100としてのシースは、生体表面BSに対して直交する方向(厚み方向Aと同じ方向)ではなく、生体表面BSに対して直交する方向に対して一方側に傾斜した方向に挿入される。そのため、図11Bに示すように、穿孔Pの延在方向についても生体表面BSに直交する方向に対して傾斜する。したがって、生体表面BSに対して直交する方向となる厚み方向Aに対して、穿孔Pの延在方向とは逆側に傾斜する方向(以下、「傾斜方向F」と記載する場合がある。)に拡張可能な拡張部8とすれば、穿孔Pの延在方向に対して直交する方向に沿って生体表面BSを圧迫し易くなる。これにより、図11A、図11Bの大腿静脈FV等の静脈を閉塞せずに穿孔Pを狭窄又は閉塞する圧迫デバイス1を実現し易い。図12は、圧迫デバイス1により、図11Bに示す穿孔Pを狭窄又は閉塞している状態を示す図である。図12に示すように、圧迫デバイス1によれば、大腿静脈FV等の静脈を、より閉塞せずに、穿孔Pを、より狭窄又は閉塞し易くなる。 Specifically, as described above, the expansion portion 8 of the pressing body 4 of the present embodiment can be expanded in a direction in which it is inclined with respect to the thickness direction A. By doing so, the surface of the living body can be compressed along the direction orthogonal to the extending direction of the perforation P (see FIG. 11B). Specifically, as shown in FIGS. 11A and 11B, the sheath as the medical insertion member 100 is not in a direction orthogonal to the biological surface BS (the same direction as the thickness direction A), but with respect to the biological surface BS. It is inserted in a direction inclined to one side with respect to the orthogonal direction. Therefore, as shown in FIG. 11B, the extending direction of the perforation P is also inclined with respect to the direction orthogonal to the biological surface BS. Therefore, the direction in which the perforation P is inclined in the direction opposite to the extending direction of the perforation P with respect to the thickness direction A which is orthogonal to the biological surface BS (hereinafter, may be referred to as “inclination direction F”). If the expansion portion 8 is expandable, it becomes easy to press the biological surface BS along the direction orthogonal to the extending direction of the perforation P. This facilitates the realization of a compression device 1 that narrows or occludes the perforation P without occluding the veins such as the femoral vein FV of FIGS. 11A and 11B. FIG. 12 is a diagram showing a state in which the perforation P shown in FIG. 11B is narrowed or occluded by the compression device 1. As shown in FIG. 12, according to the compression device 1, the perforation P is more likely to be narrowed or occluded without further occluding the vein such as the femoral vein FV.
 図7、図8A~図8Eに示す圧迫方法によれば、穿孔P(図11B参照)を、大腿静脈FVなどの静脈を閉塞することなく、狭窄又は閉塞することで、止血を行うことができる。特に、圧迫デバイス1により上述の圧迫方法を実現することで、医療従事者の手による圧迫や、大がかりな止血器具の使用などを不要にし、簡単な方法で止血を行うことができる。 According to the compression method shown in FIGS. 7A to 8E, hemostasis can be performed by narrowing or occluding the perforation P (see FIG. 11B) without occluding a vein such as a femoral vein FV. .. In particular, by realizing the above-mentioned compression method with the compression device 1, it is possible to stop bleeding by a simple method without the need for pressure by a medical worker or the use of a large-scale hemostatic device.
<圧迫デバイス1による生体表面への圧迫>
 図12に示すように、圧迫デバイス1において、圧迫部材3の押圧体4の拡張部8は、貼着シート2を生体に装着している状態で、生体表面BSに垂直な垂直方向(図12では厚み方向Aと同じ方向であり、図12の上下方向。以下、単に「垂直方向」と記載する。)に対して傾斜する傾斜方向Fに向かって、生体表面を圧迫可能である。このようにすることで、図12に示すように、大腿静脈FV等の静脈を閉塞せずに穿孔Pを狭窄又は閉塞し易くなる。
<Compression on the surface of the living body by the compression device 1>
As shown in FIG. 12, in the compression device 1, the expansion portion 8 of the pressing body 4 of the compression member 3 is in a vertical direction perpendicular to the living body surface BS in a state where the sticking sheet 2 is attached to the living body (FIG. 12). Then, it is the same direction as the thickness direction A, and it is possible to press the surface of the living body in the inclination direction F which is inclined with respect to the vertical direction in FIG. 12; hereinafter, simply referred to as “vertical direction”). By doing so, as shown in FIG. 12, the perforation P is easily narrowed or occluded without occluding the vein such as the femoral vein FV.
 図13は、図12に示す状態を、生体表面BS側から見た正面図である。換言すれば、図13は、生体表面BSのうち、圧迫デバイス1により圧迫される位置での正面視を示している。ここで「生体表面のうち、圧迫デバイスにより圧迫される位置での正面視」とは、生体表面のうち、圧迫デバイスにより圧迫される対象となる部分を、圧迫前の当該部分に対して垂直な方向から見た状態を意味する。図13では、鼠径部の正面視を示している。図13に示す正面視において、生体表面BSが圧迫される方向(図13の白抜き矢印「AR1」参照)は、穿孔Pの延在方向Gのうち生体表面BSから静脈に向かうシースの挿入方向G1(図13の白抜き矢印「AR2」参照)と対向している。つまり、圧迫デバイス1が生体表面BSを圧迫する方向は、図13に示す正面視で、シースの挿入方向G1と対向している。このようにすることで、大腿静脈FV等の静脈を閉塞せずに穿孔P(図11B、図12参照)を狭窄又は閉塞し易くなる。 FIG. 13 is a front view of the state shown in FIG. 12 as viewed from the living body surface BS side. In other words, FIG. 13 shows a front view of the biological surface BS at a position where it is compressed by the compression device 1. Here, "front view of the surface of the living body at a position where it is compressed by the compression device" means that the portion of the surface of the living body to be compressed by the compression device is perpendicular to the portion before compression. It means the state seen from the direction. FIG. 13 shows a front view of the inguinal region. In the front view shown in FIG. 13, the direction in which the biological surface BS is compressed (see the white arrow “AR1” in FIG. 13) is the insertion direction of the sheath from the biological surface BS toward the vein in the extending direction G of the perforation P. It faces G1 (see the white arrow "AR2" in FIG. 13). That is, the direction in which the compression device 1 presses the biological surface BS is opposed to the sheath insertion direction G1 in the front view shown in FIG. By doing so, it becomes easy to narrow or occlude the perforation P (see FIGS. 11B and 12) without occluding the vein such as the femoral vein FV.
 換言すれば、図12に示すように、穿孔Pの延在方向Gは、生体表面BSに対して傾斜しており、かつ、生体表面BSに垂直な垂直方向(図12では上下方向)に対しても傾斜している。また、図12に示すように、圧迫デバイス1による生体表面BSの圧迫方向についても、生体表面BSに対して傾斜しており、かつ、生体表面BSに垂直な垂直方向(図12では上下方向)に対しても傾斜している。更に、図12に示すように、穿孔Pの延在方向Gは、上記垂直方向(図12では上下方向)に対して、圧迫デバイス1による生体表面の圧迫方向としての傾斜方向Fとは逆側に傾いている。つまり、圧迫デバイス1による生体表面の圧迫は、その圧迫方向が穿孔Pの延在方向Gと交差して交わるように、実行される。これにより、穿孔Pを効率的に狭窄又は閉塞することができる。 In other words, as shown in FIG. 12, the extending direction G of the perforation P is inclined with respect to the biological surface BS and is perpendicular to the biological surface BS (vertical direction in FIG. 12). But it's tilted. Further, as shown in FIG. 12, the compression direction of the biological surface BS by the compression device 1 is also an inclination with respect to the biological surface BS and a vertical direction perpendicular to the biological surface BS (vertical direction in FIG. 12). It is also inclined to. Further, as shown in FIG. 12, the extending direction G of the perforation P is opposite to the inclination direction F as the compression direction of the living body surface by the compression device 1 with respect to the vertical direction (vertical direction in FIG. 12). Leaning on. That is, the compression of the living body surface by the compression device 1 is executed so that the compression direction intersects with the extension direction G of the perforation P. As a result, the perforation P can be efficiently narrowed or occluded.
[第2実施形態]
 次に、第2実施形態としての圧迫デバイス301について説明する。ここでは上述の圧迫デバイス1(図1等参照)との相違点について主に説明し、共通する構成については説明を省略する。
[Second Embodiment]
Next, the compression device 301 as the second embodiment will be described. Here, the differences from the compression device 1 (see FIG. 1 and the like) described above will be mainly described, and the description of common configurations will be omitted.
 図9は、本実施形態の圧迫デバイス301のうち押圧体4(図1等参照)を取り除いた状態での下面図である。本実施形態の圧迫デバイス301は、上述した圧迫デバイス1と比較して、線分マーカ及び領域マーカの保持体に設けられている位置が相違する。 FIG. 9 is a bottom view of the compression device 301 of the present embodiment in a state where the pressing body 4 (see FIG. 1 and the like) is removed. The compression device 301 of the present embodiment is different from the compression device 1 described above in the positions provided on the holding bodies of the line segment marker and the region marker.
 本実施形態の線分マーカ307a及び領域マーカ307bは、保持体305の下面に設けられている。図10は、保持体305の下面に設けられる線分マーカ307aに対して、医療用挿入部材100のうち生体表面と同一面上に位置する挿入部分100aの外面の一部を位置決めした状態を説明するための模式図である。換言すれば、図10は、保持体305の下面に設けられる線分マーカ307aによる効果を説明するための模式図である。図10では、説明の便宜上、保持体305の上面に設けられる線分マーカ1007aを比較のため示している。図10に示すように、保持体305の下面に線分マーカ307aを設けることで、保持体305の上面に線分マーカ1007aを設ける構成と比較して、厚み方向Aにおける保持体305の厚みに起因する位置ずれの発生を抑制できる。つまり、保持体305の上面に線分マーカ1007aが設けられていると、線分マーカ1007aは、保持体305の下面側の生体表面と、少なくとも保持体305の厚み分だけ離間している。そのため、平面視からずれた誤った視点(例えば図10に示す視点PV)で、線分マーカ1007aを生体表面上の所定位置に位置合わせすると、生体表面の面内方向Hにおいて、線分マーカ1007aと、生体表面上の所定位置(図10では挿入部分100aの外面の一部)と、が位置ズレしている場合がある。これに対して、本実施形態では、保持体305の下面に線分マーカ307aが設けられているため、視点の相違による上記位置ズレが発生し難くなる。つまり、線分マーカ307aを保持体305の下面に設けることで、圧迫デバイス301を生体表面上の適切な位置に、より取り付け易くなる。図10では、説明の便宜上、線分マーカ307aのみについて保持体305の下面に設けられる効果を説明したが、領域マーカ307bについても同様であり、ここでは説明を省略する。 The line segment marker 307a and the area marker 307b of the present embodiment are provided on the lower surface of the holding body 305. FIG. 10 illustrates a state in which a part of the outer surface of the insertion portion 100a located on the same surface as the living body surface of the medical insertion member 100 is positioned with respect to the line segment marker 307a provided on the lower surface of the holding body 305. It is a schematic diagram for this. In other words, FIG. 10 is a schematic diagram for explaining the effect of the line segment marker 307a provided on the lower surface of the holding body 305. In FIG. 10, for convenience of explanation, the line segment marker 1007a provided on the upper surface of the holding body 305 is shown for comparison. As shown in FIG. 10, by providing the line segment marker 307a on the lower surface of the holding body 305, the thickness of the holding body 305 in the thickness direction A is increased as compared with the configuration in which the line segment marker 1007a is provided on the upper surface of the holding body 305. It is possible to suppress the occurrence of misalignment due to it. That is, when the line segment marker 1007a is provided on the upper surface of the holding body 305, the line segment marker 1007a is separated from the biological surface on the lower surface side of the holding body 305 by at least the thickness of the holding body 305. Therefore, when the line segment marker 1007a is positioned at a predetermined position on the surface of the living body from an erroneous viewpoint deviated from the plan view (for example, the viewpoint PV shown in FIG. 10), the line segment marker 1007a is aligned in the in-plane direction H of the living body surface. And a predetermined position on the surface of the living body (a part of the outer surface of the insertion portion 100a in FIG. 10) may be misaligned. On the other hand, in the present embodiment, since the line segment marker 307a is provided on the lower surface of the holding body 305, the above-mentioned positional deviation due to the difference in viewpoint is less likely to occur. That is, by providing the line segment marker 307a on the lower surface of the holding body 305, the compression device 301 can be more easily attached to an appropriate position on the surface of the living body. In FIG. 10, for convenience of explanation, the effect of providing only the line segment marker 307a on the lower surface of the holding body 305 has been described, but the same applies to the area marker 307b, and the description thereof will be omitted here.
 本実施形態の線分マーカ307aは、保持体305の下面に形成されている弧状に延在する溝部により構成されている。また、本実施形態の領域マーカ307bは、保持体305の下面に形成されている矩形状の溝部により所定の領域を区画する枠線マーカ307b1により構成されている。 The line segment marker 307a of the present embodiment is composed of a groove portion extending in an arc shape formed on the lower surface of the holding body 305. Further, the area marker 307b of the present embodiment is composed of a frame line marker 307b1 for partitioning a predetermined area by a rectangular groove formed on the lower surface of the holding body 305.
 本実施形態の領域マーカ307bは、平面視で保持体305の貫通孔305aにより一部分断されているが、この構成に限られない。領域マーカ307bは、平面視で保持体305の貫通孔305aに対して一方側のみに設けられてもよい。 The area marker 307b of the present embodiment is partially cut off by the through hole 305a of the holding body 305 in a plan view, but is not limited to this configuration. The region marker 307b may be provided on only one side of the through hole 305a of the holding body 305 in a plan view.
 本実施形態の領域マーカ307bとしての枠線マーカ307b1は平面視で矩形状であるが、この形状は特に限定されない。領域マーカ307bとしての枠線マーカ307b1は、平面視で、例えば、円形状、オーバル状、四角以外の多角形状であってもよい。 The border marker 307b1 as the region marker 307b of the present embodiment has a rectangular shape in a plan view, but this shape is not particularly limited. The border marker 307b1 as the region marker 307b may have a polygonal shape other than a circular shape, an oval shape, and a square shape in a plan view.
 本開示に係る圧迫デバイス、及び、圧迫でデバイスの貼着方法は、上述した第1実施形態及び第2実施形態に示す具体的な構成及び方法に限られず、請求の範囲の記載を逸脱しない限り、種々の変形・変更が可能である。また、第1実施形態及び第2実施形態に示す圧迫デバイスの各部の構成を組み合わせて構築される圧迫デバイスについても、本開示の技術的範囲に属する。 The compression device according to the present disclosure and the method of attaching the compression device are not limited to the specific configurations and methods shown in the first and second embodiments described above, and are not limited to the description of the scope of claims. , Various modifications and changes are possible. Further, the compression device constructed by combining the configurations of each part of the compression device shown in the first embodiment and the second embodiment also belongs to the technical scope of the present disclosure.
 本開示は圧迫デバイス、及び、圧迫デバイスの貼着方法に関する。 This disclosure relates to a compression device and a method of attaching the compression device.
1、301:圧迫デバイス
2:貼着シート
3:圧迫部材
4:押圧体
5、305:保持体
5a、305a:貫通孔
5b:係止突起
6:受入部
7a、307a:線分マーカ
7b、307b:領域マーカ
7b1、307b1:枠線マーカ(領域マーカ)
8:拡張部
8a:収容空間
8b、8c:バルーン部
9:延設部
9a:ヒンジ部
9b:係止孔
11:貼着面
12:取付面
28:チューブ
29:接続部
30:シリンジ
31:本体部
32:一対の把持板部
100:医療用挿入部材
100a:挿入部分
1007a:線分マーカ
A:厚み方向
A1:下方向
A2:上方向
B:幅方向
C:配列方向
F:傾斜方向
G:穿孔の延在方向
G1:シースの挿入方向
H:生体表面の面内方向
BS:生体表面
CT:結合組織
FV:大腿静脈
P:穿孔
PV:視点
X1:貼着シートの第1部分
X2:貼着シートの第2部分
1, 301: Compression device 2: Adhesive sheet 3: Compression member 4: Pressing body 5, 305: Holding body 5a, 305a: Through hole 5b: Locking protrusion 6: Receiving portion 7a, 307a: Line segment markers 7b, 307b : Area markers 7b1, 307b1: Border marker (area marker)
8: Expansion part 8a: Accommodation space 8b, 8c: Balloon part 9: Extension part 9a: Hinge part 9b: Locking hole 11: Attachment surface 12: Mounting surface 28: Tube 29: Connection part 30: Vein 31: Main body Part 32: Pair of grip plate parts 100: Medical insertion member 100a: Insertion part 1007a: Line segment marker A: Thickness direction A1: Down direction A2: Up direction B: Width direction C: Arrangement direction F: Inclination direction G: Drilling Extension direction G1: Sheath insertion direction H: In-plane direction of the living body surface BS: Living body surface CT: Bonding tissue FV: Femoral vein P: Perforation PV: Viewpoint X1: First part of the sticking sheet X2: Sticking sheet Part 2 of

Claims (10)

  1.  生体表面に貼着可能な貼着面を備える貼着シートと、
     前記貼着シートに固定されており、前記生体表面を圧迫可能な圧迫部材と、を備え、
     前記圧迫部材は、
      前記貼着シートの厚み方向に伸長することにより前記生体表面を押圧可能な押圧体と、
      前記貼着面とは反対側で前記貼着シートに固定されており、前記押圧体を前記厚み方向に伸長可能に保持する保持体と、を備え、
     前記保持体は、前記厚み方向で見た平面視において、前記押圧体と重なる位置に、弧状に延在する線分マーカを備える、圧迫デバイス。
    A sticking sheet with a sticking surface that can be stuck on the surface of the living body,
    It is provided with a compression member which is fixed to the attachment sheet and can press the surface of the living body.
    The compression member is
    A pressing body capable of pressing the surface of the living body by extending in the thickness direction of the adhesive sheet,
    It is provided with a holding body which is fixed to the sticking sheet on the side opposite to the sticking surface and holds the pressing body so as to be expandable in the thickness direction.
    The holding body is a compression device including a line segment marker extending in an arc shape at a position overlapping the pressing body in a plan view in the thickness direction.
  2.  前記押圧体は、前記貼着シートの前記貼着面が前記生体表面に貼着されている状態において前記生体表面と前記保持体との間に配置され、流体の供給により前記厚み方向に拡張可能な拡張部を備え、
     前記線分マーカは、前記厚み方向で見た平面視において前記押圧体の前記拡張部と重なる位置に設けられている、請求項1に記載の圧迫デバイス。
    The pressing body is arranged between the living body surface and the holding body in a state where the sticking surface of the sticking sheet is stuck to the living body surface, and can be expanded in the thickness direction by supplying a fluid. Equipped with various expansion parts
    The compression device according to claim 1, wherein the line segment marker is provided at a position overlapping the expansion portion of the pressing body in a plan view in the thickness direction.
  3.  前記保持体は、前記線分マーカが設けられている位置において、前記厚み方向に透光性を有する、請求項1又は2に記載の圧迫デバイス。 The compression device according to claim 1 or 2, wherein the holding body has translucency in the thickness direction at a position where the line segment marker is provided.
  4.  前記保持体は、前記厚み方向で見た平面視で前記線分マーカと隣接する位置において、前記厚み方向に透光性を有する、請求項1から3のいずれか1つに記載の圧迫デバイス。 The compression device according to any one of claims 1 to 3, wherein the holding body has translucency in the thickness direction at a position adjacent to the line segment marker in a plan view in the thickness direction.
  5.  前記保持体は、前記厚み方向で見た平面視において前記線分マーカを取り囲む所定の領域を区画する領域マーカを備える、請求項1から4のいずれか1つに記載の圧迫デバイス。 The compression device according to any one of claims 1 to 4, wherein the holding body includes a region marker that partitions a predetermined region surrounding the line segment marker in a plan view in the thickness direction.
  6.  前記保持体は、前記厚み方向で見た平面視で前記領域マーカにより区画される前記所定の領域内で、少なくとも前記線分マーカが設けられていない位置において、前記厚み方向に透光性を有する、請求項5に記載の圧迫デバイス。 The holding body has translucency in the thickness direction at least in a position where the line segment marker is not provided in the predetermined region partitioned by the region marker in a plan view in the thickness direction. , The compression device according to claim 5.
  7.  前記領域マーカは、前記厚み方向で見た平面視において、前記線分マーカの周囲を取り囲む枠線マーカである、請求項5又は6に記載の圧迫デバイス。 The compression device according to claim 5 or 6, wherein the area marker is a frame line marker that surrounds the periphery of the line segment marker in a plan view viewed in the thickness direction.
  8.  前記保持体は、前記厚み方向で見た平面視で前記領域マーカの外側に隣接する位置において、前記厚み方向に透光性を有する、請求項6又は7に記載の圧迫デバイス。 The compression device according to claim 6 or 7, wherein the holding body has translucency in the thickness direction at a position adjacent to the outside of the region marker in a plan view in the thickness direction.
  9.  生体表面に貼着可能な貼着面を備える貼着シートと、前記貼着シートに固定されており、前記生体表面を圧迫可能な圧迫部材と、を備える圧迫デバイスを前記生体表面に貼着する貼着方法であって、
     前記圧迫部材は、前記厚み方向で見た平面視において弧状に延在する線分マーカを備え、
     前記生体表面から生体内に挿入されている医療用管部材のうち前記生体表面と同一面に位置する挿入部分の一部を、前記線分マーカに位置合わせした状態で、前記貼着シートを前記生体表面に貼着する、貼着方法。
    A compression device including a sticking sheet having a sticking surface that can be stuck to the surface of a living body and a compression member that is fixed to the sticking sheet and can press the surface of the living body is stuck to the surface of the living body. It ’s a sticking method,
    The compression member includes a line segment marker extending in an arc shape in a plan view in the thickness direction.
    The attachment sheet is attached to the medical tube member inserted into the living body from the living body surface in a state where a part of the insertion portion located on the same surface as the living body surface is aligned with the line segment marker. A sticking method that sticks to the surface of a living body.
  10.  前記押圧部材は、前記厚み方向で見た平面視において前記線分マーカを取り囲む所定の領域を区画する領域マーカを備え、
     前記生体表面から生体内に挿入されている前記医療用管部材のうち前記生体表面と同一面に位置する前記挿入部分の一部を、前記線分マーカに位置合わせすると共に、前記挿入部分の全部を前記領域マーカにより区画される前記所定の領域内に位置合わせした状態で、前記貼着シートを前記生体表面に貼着する、請求項9に記載の貼着方法。
    The pressing member includes a region marker that partitions a predetermined region surrounding the line segment marker in a plan view in the thickness direction.
    A part of the insertion portion of the medical tube member inserted into the living body from the surface of the living body, which is located on the same surface as the surface of the living body, is aligned with the line segment marker and all of the insertion parts. The sticking method according to claim 9, wherein the sticking sheet is stuck to the surface of the living body in a state where the sticking sheet is aligned in the predetermined region partitioned by the region marker.
PCT/JP2021/009089 2020-03-27 2021-03-08 Compression device and method for adhering compression device WO2021192975A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2022509515A JP7304486B2 (en) 2020-03-27 2021-03-08 compression device

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2020-059032 2020-03-27
JP2020059032 2020-03-27

Publications (1)

Publication Number Publication Date
WO2021192975A1 true WO2021192975A1 (en) 2021-09-30

Family

ID=77892504

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2021/009089 WO2021192975A1 (en) 2020-03-27 2021-03-08 Compression device and method for adhering compression device

Country Status (2)

Country Link
JP (1) JP7304486B2 (en)
WO (1) WO2021192975A1 (en)

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP3136037U (en) * 2007-06-07 2007-10-11 川澄化学工業株式会社 Hemostatic device
US20150327871A1 (en) * 2014-05-15 2015-11-19 Abbott Cardiovascular Systems, Inc. Methods, systems, and devices for targeting a radial access puncture site
WO2018181314A1 (en) * 2017-03-29 2018-10-04 テルモ株式会社 Tourniquet and hemostatic method
US20190133602A1 (en) * 2017-11-03 2019-05-09 Merit Medical Systems, Inc. Hemostasis devices and methods of use
JP2019526299A (en) * 2016-07-18 2019-09-19 メリット・メディカル・システムズ・インコーポレイテッドMerit Medical Systems,Inc. Inflatable radial artery compression device
WO2020017653A1 (en) * 2018-07-20 2020-01-23 テルモ株式会社 Pressure device and pressure method
WO2020050420A1 (en) * 2018-09-07 2020-03-12 テルモ株式会社 Adhesive device

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP3136037U (en) * 2007-06-07 2007-10-11 川澄化学工業株式会社 Hemostatic device
US20150327871A1 (en) * 2014-05-15 2015-11-19 Abbott Cardiovascular Systems, Inc. Methods, systems, and devices for targeting a radial access puncture site
JP2019526299A (en) * 2016-07-18 2019-09-19 メリット・メディカル・システムズ・インコーポレイテッドMerit Medical Systems,Inc. Inflatable radial artery compression device
WO2018181314A1 (en) * 2017-03-29 2018-10-04 テルモ株式会社 Tourniquet and hemostatic method
US20190133602A1 (en) * 2017-11-03 2019-05-09 Merit Medical Systems, Inc. Hemostasis devices and methods of use
WO2020017653A1 (en) * 2018-07-20 2020-01-23 テルモ株式会社 Pressure device and pressure method
WO2020050420A1 (en) * 2018-09-07 2020-03-12 テルモ株式会社 Adhesive device

Also Published As

Publication number Publication date
JPWO2021192975A1 (en) 2021-09-30
JP7304486B2 (en) 2023-07-06

Similar Documents

Publication Publication Date Title
WO2021192972A1 (en) Compression device and method for adhering compression device
WO2021192974A1 (en) Compression device and method for affixing compression device
JP7201685B2 (en) compression device
WO2021060297A1 (en) Compression device
US20210186521A1 (en) Adhesion device
WO2019221201A1 (en) Compression device and compression method
WO2021192975A1 (en) Compression device and method for adhering compression device
WO2021192976A1 (en) Compression device and method for adhering compression device
WO2021192973A1 (en) Compression device set and method for attaching device
WO2022196465A1 (en) Compression device
WO2023053883A1 (en) Compression device and method for adjusting compression position
WO2022196467A1 (en) Compression device
WO2023053884A1 (en) Adhesion device and adhesion method
WO2022196464A1 (en) Compression device and living body compression method
WO2023181823A1 (en) Compression device and method for detaching compression device
WO2022196466A1 (en) Compression device set and sticking method
JP2023141311A (en) compression device

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 21776929

Country of ref document: EP

Kind code of ref document: A1

ENP Entry into the national phase

Ref document number: 2022509515

Country of ref document: JP

Kind code of ref document: A

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 21776929

Country of ref document: EP

Kind code of ref document: A1