WO2021192972A1 - 圧迫デバイス、及び、圧迫デバイスの貼着方法 - Google Patents

圧迫デバイス、及び、圧迫デバイスの貼着方法 Download PDF

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Publication number
WO2021192972A1
WO2021192972A1 PCT/JP2021/009086 JP2021009086W WO2021192972A1 WO 2021192972 A1 WO2021192972 A1 WO 2021192972A1 JP 2021009086 W JP2021009086 W JP 2021009086W WO 2021192972 A1 WO2021192972 A1 WO 2021192972A1
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WO
WIPO (PCT)
Prior art keywords
marker
living body
thickness direction
region
compression device
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/JP2021/009086
Other languages
English (en)
French (fr)
Japanese (ja)
Inventor
政克 川浦
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Terumo Corp
Original Assignee
Terumo Corp
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 Terumo Corp filed Critical Terumo Corp
Priority to EP21775389.6A priority Critical patent/EP4111986B1/en
Priority to CN202180007685.0A priority patent/CN114901159A/zh
Priority to JP2022509512A priority patent/JP7266747B2/ja
Publication of WO2021192972A1 publication Critical patent/WO2021192972A1/ja
Priority to US17/935,700 priority patent/US12582556B2/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/132—Tourniquets
    • A61B17/135—Tourniquets inflatable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive bandages or dressings
    • A61F13/023—Adhesive bandages or dressings wound covering film layers without a fluid retention layer
    • A61F13/0236—Adhesive bandages or dressings wound covering film layers without a fluid retention layer characterised by the application/handling support layer
    • A61F13/024—Adhesive bandages or dressings wound covering film layers without a fluid retention layer characterised by the application/handling support layer the application or handling support layer being removable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/132—Tourniquets
    • A61B17/1322—Tourniquets comprising a flexible encircling member
    • A61B17/1325—Tourniquets comprising a flexible encircling member with means for applying local pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive bandages or dressings
    • A61F13/0246—Adhesive bandages or dressings characterised by the skin-adhering layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00902—Material properties transparent or translucent
    • A61B2017/00907—Material properties transparent or translucent for light
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00902—Material properties transparent or translucent
    • A61B2017/00924—Material properties transparent or translucent for ultrasonic waves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3937—Visible markers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00361—Plasters
    • A61F2013/00365—Plasters use
    • A61F2013/00412—Plasters use for use with needles, tubes or catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00361—Plasters
    • A61F2013/00365—Plasters use
    • A61F2013/00463—Plasters use haemostatic
    • A61F2013/00468—Plasters use haemostatic applying local pressure

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 expandable in the thickness direction is provided, and the sticking sheet is arranged on the outside of the outer edge of the holding body in a plan view viewed in the thickness direction.
  • an identification unit that can be visually identified in a plan view viewed in the thickness direction is provided.
  • 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 expansion portion that can be expanded in the thickness direction is provided, and at least a part of the identification portion is provided at a position that overlaps with the expansion portion of the pressing body in a plan view in the thickness direction.
  • the identification unit includes a region marker that makes it possible to visually identify a predetermined region in a plan view viewed in the thickness direction.
  • the region marker is a border marker that surrounds a portion having translucency in the thickness direction.
  • the holding body includes a portion having translucency in the thickness direction around an adjacent periphery outside the region marker in a plan view viewed in the thickness direction.
  • the identification unit is a position within the predetermined region that can be identified by the region marker, which is visually identifiable in a plan view in the thickness direction and indicates a predetermined reference position. Includes markers.
  • the position marker is a line segment marker that is curved and extends in an arc shape in a plan view viewed in the thickness direction.
  • the method of attaching the compression device as the second aspect of the present disclosure is a method of attaching the compression device, which is fixed to the attachment sheet having an attachment surface that can be attached to the surface of the living body and pressing the surface of the living body.
  • a method of attaching a compression device including a possible compression member to the surface of the living body, wherein the pressing member extends in the thickness direction of the attachment sheet to press the surface of the living body.
  • the holding body In the outer side of the outer edge of the holding body, there is an area where the sticking sheet is not arranged or a region defined by a recess of the outer edge of the sticking sheet, and a medical insertion member can be accepted.
  • a receiving portion is provided, and the holding body is provided with an identifying portion that can be visually identified in a plan view viewed in the thickness direction at a position adjacent to the receiving portion, and is inserted into the living body from the surface of the living body.
  • the insertion portion of the medical insertion member that is exposed to the outside from the surface of the living body is received by the receiving portion and is located on the same surface as the surface of the living body of the medical insertion member.
  • the sticking sheet is stuck to the surface of the living body in a state of being aligned with the identification portion.
  • the identification unit includes a region marker that makes it possible to visually identify a predetermined region in a plan view viewed in the thickness direction, and is inserted into the living body from the living body surface.
  • a region marker that makes it possible to visually identify a predetermined region in a plan view viewed in the thickness direction, and is inserted into the living body from the living body surface.
  • the identification unit is a position within the predetermined region that can be identified by the region marker, which is visually identifiable in a plan view in the thickness direction and indicates a predetermined reference position.
  • the receiving portion receives a portion of the medical insertion member that includes a marker and is inserted into the living body from the surface of the living body and is exposed to the outside from the surface of the living body.
  • the sticking sheet is placed in a state where the entire insertion portion located on the same surface as the living body surface is aligned within the region marker and a part of the insertion portion is aligned with the position marker. It is attached to the surface of the living body.
  • 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. 13 is a front view of the state shown in FIG. 13 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 living body surface 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 area outside the outer edge of the holding body 5 is a region where the attachment sheet 2 is not arranged, and is a medical insertion described later.
  • a receiving portion 6 capable of receiving the 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 recessed in a part of the outer edge of the sticking sheet 2 is formed. It 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 is placed on the surface of the living body in a state where the portion of the medical insertion member 100 (see FIG. 8A or the like) extending outside the living body is arranged so as to pass through the receiving portion 6. Can be attached. 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.
  • the holding body 5 of the compression member 3 is provided with an identification unit 7 at a position adjacent to the receiving unit 6.
  • the configuration of the identification unit 7 is not particularly limited as long as it can be visually identified in a plan view viewed in the thickness direction A.
  • the identification unit 7 may be composed of, for example, a concavo-convex portion formed by one convex portion or a set of a plurality of convex portions protruding from the upper surface of the holding body 5.
  • the identification portion 7 may be formed of, for example, a recess such as a groove formed on the upper surface of the holding body 5.
  • the identification unit 7 may be composed of, for example, a convex portion formed by one convex portion or a set of a plurality of convex portions protruding from the lower surface of the translucent portion of the holding body 5.
  • the portion having translucency in the thickness direction A means a translucent or transparent portion in the thickness direction A.
  • the identification portion 7 may be formed of, for example, a recess such as a groove formed on the lower surface of the translucent portion of the holding body 5.
  • the identification unit 7 may be configured, for example, by making the transmittance different from that of the surroundings. As an example of this, the identification unit 7 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 identification unit 7 may be configured, for example, by making the color different from the surroundings.
  • Such an identification unit 7 may be composed of, for example, a paint or the like that forms a part of the upper surface or the lower surface of the holding body 5.
  • the identification unit 7 is not particularly limited as long as it can be distinguished and recognized from the surroundings in a plan view under a usage environment, particularly a top view (see FIG. 2).
  • the identification unit 7 of the present embodiment is provided adjacent to the receiving unit 6 on the side where the expansion unit 8 to be described later is located of the pressing body 4 in a plan view of the compression device 1 in the thickness direction A. ing. Further, in the present embodiment, the maximum width of the identification unit 7 is smaller than the maximum width of the expansion unit 8 described later of the pressing body 4 in a plan view of the compression device 1 in the thickness direction A. As shown in FIG. 2, the maximum width of the identification unit 7 of the present embodiment means the maximum width of the region marker 7a described later in the width direction B. 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. ..
  • the maximum width of the identification unit 7 is smaller than the minimum width of the receiving unit 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 identification unit 7 of the present embodiment includes both the area marker 7a and the position marker 7b.
  • the region marker 7a means a marker that makes it possible to visually identify a predetermined region in a plan view viewed in the thickness direction A.
  • the region marker 7a 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 position marker 7b is a marker that can be visually identified in a plan view viewed in the thickness direction A within a predetermined region that can be identified by the region marker 7a.
  • the position marker 7b indicates a predetermined reference position within a predetermined region that can be identified by the region marker 7a.
  • the position marker 7b of the present embodiment is a reference position for aligning a part of the outer surface of the insertion portion 100a (see FIG. 8A) located on the same surface as the biological surface of the medical insertion member 100 (see FIG. 8A). Is shown. More specifically, the position marker 7b of the present embodiment aligns 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 7a. Indicates the reference position of.
  • the compression member 3 presses the surface of the living body with a pressing force of a second predetermined value or more, which is larger than the above-mentioned first predetermined value. It represents a position that can be compressed. That is, the region marker 7a indicates a region that can be compressed with a pressing force equal to or higher than the first predetermined value, and the position marker 7b indicates a position that can be compressed with a pressing force of a second predetermined value larger than the first predetermined value. There is. Therefore, in the present embodiment, the medical insertion member 100 (see FIG.
  • the above-mentioned compression forces such as the first predetermined value and the second predetermined value are 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 measured in.
  • 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.
  • the identification unit 7 of the present embodiment includes both the area marker 7a and the position marker 7b, but is not limited to this configuration.
  • the identification unit 7 may be composed of, for example, only one of the area marker 7a and the position marker 7b.
  • the compression device 1 includes a receiving unit 6 and an identification unit 7 provided at a position adjacent to the receiving unit 6 of the holding body 5. Therefore, among the medical insertion members 100, the living body is in a state where the receiving portion 6 accepts the portion of the medical insertion member 100 (see FIG. 8A or the like) that is inserted into the living body from the surface of the living body and is exposed to the outside from the surface of the living body. A part or all of the insertion portion 100a (see FIG. 8A and the like) located on the same surface as the surface can be easily aligned with the identification portion 7. Therefore, the compression device 1 can be easily positioned at an appropriate position on the surface of the living body.
  • 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. 12B
  • 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 main body 31 of the holding body 5 is provided with an identification unit 7.
  • the expansion unit 8 can appropriately compress the compression position on the surface of the living body to be pressed and compressed by the expansion unit 8 of the pressing body 4.
  • the identification unit 7 of the present embodiment is a top view (see FIG. 2) of the compression device 1 mounted on the surface of the living body, and the expansion unit 8 presses the surface of the living body with a pressing force of a predetermined value or more. It shows the places where pressure can be applied. Therefore, the compression device 1 is attached on the surface of the living body so that the identification unit 7 overlaps with a predetermined compression position on the surface of the living body.
  • the compression device 1 can appropriately compress a predetermined compression position on the surface of the living body.
  • At least a part of the identification portion 7 of the present embodiment is provided at a position overlapping with the expansion portion 8 of the pressing body 4 in the plan view seen in the thickness direction A. Therefore, at least a part of the identification portion 7 that overlaps with the expansion portion 8 in the thickness direction A may be aligned so as to overlap a predetermined compression position on the surface of the living body in a plan view.
  • the identification unit 7 of the present embodiment is provided on the upper surface of the main body portion 31 of the holding body 5. Therefore, the identification unit 7 of the present embodiment is easily visible to the medical staff who is operating the compression device 1.
  • the identification unit 7 may be provided inside the holding body 5. Further, the identification unit 7 may be provided on the lower surface of the main body portion 31 of the holding body 5. Details of the configuration in which the identification unit 7 is provided on the lower surface of the holding body 5 will be described later (see FIG. 10).
  • the configuration of the identification unit 7 is not particularly limited as long as it can be visually identified in a plan view. Therefore, the shape and mode of the identification unit 7 in a plan view are not particularly limited.
  • the identification unit 7 of the present embodiment includes the area marker 7a and the position marker 7b.
  • the region marker 7a of the present embodiment is a frame line marker that surrounds a portion having translucency in the thickness direction A.
  • the border marker as the region 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 border marker as the region 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 border marker on blood or the surface of the living body.
  • the frame line marker as the area 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 border marker as the area marker 7a of the present embodiment has a rectangular shape, but this shape is not particularly limited.
  • the border marker may be, for example, a polygonal shape other than a circular shape, an oval shape, or a square shape.
  • the frame line marker as the region marker 7a 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 may be provided only on the side opposite to the receiving portion 6 side with respect to the through hole 5a.
  • the area marker 7a is not limited to the frame line marker that divides a predetermined area by a frame line.
  • the area marker 7a may have a configuration in which a predetermined area is bordered by an outer edge of the area filled with a predetermined color.
  • the position marker 7b of the present embodiment is a line segment marker that is curved and extends in an arc shape in a plan view viewed in the thickness direction A.
  • the line segment marker as the position marker 7b 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 as the position marker 7b 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 on blood or the surface of the living body.
  • the line segment marker as the position marker 7b 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 biological surface of the medical insertion member 100 is irrespective 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 can be aligned so as to be in contact with or overlap the line segment marker in a plan view. That is, unlike the region marker 7a, the position marker 7b does not partition a predetermined closed region in a plan view.
  • the medical insertion member 100 has an insertion portion 100a that does not match the area of the region of the region marker 7a or the outer edge contour, a part of the insertion portion 100a can be used as a line segment marker as the position marker 7b. It can be aligned.
  • the "medical insertion member having an insertion portion that does not match the area of the region of the region marker or the contour of the outer edge" is, for example, a medical insertion member having an outer diameter that does not fit in the region, or a plurality of medical insertion members that fit in the region. Medical insertion members having such an outer diameter and the like can be mentioned.
  • the position marker 7b as a line segment marker that does not partition a predetermined region, a position that is not related to the outer diameter of the medical insertion member 100 (see FIG. 8A) that is inserted into the living body from the surface of the living body. Matching is possible.
  • the shape of the line segment marker as the position marker 7b in a plan view is not particularly limited.
  • the line segment marker as the position marker 7b of the present embodiment extends in an arc shape in a plan view.
  • the shape of the line segment marker as the position marker 7b in a plan view is not particularly limited and may extend in a straight line, but has a concave portion such as an arc shape or a V shape of the present embodiment. Is preferable.
  • the position marker 7b is not limited to the line segment marker.
  • the position marker 7b may be, for example, a point marker (see FIG. 9B).
  • the position marker 7b may be composed of an aggregate of point markers.
  • An example of an aggregate of dotted markers is a broken line marker formed by arranging dotted markers in a row.
  • the identification portion 7 of the main body portion 31 of the holding body 5 may have an opaque configuration in the thickness direction A, but is preferably translucent or transparent having translucency in the thickness direction A.
  • the region marker 7a and the position marker 7b of the present embodiment are preferably translucent or transparent having translucency in the thickness direction A.
  • the periphery of the identification portion 7 of the main body portion 31 of the holding body 5 is composed of a portion having translucency in the thickness direction A. It is preferable that the holding body 5 of the present embodiment is provided with a portion having translucency in the thickness direction A around the periphery adjacent to the outside of the region marker 7a in a plan view viewed in the thickness direction A. Further, in the holding body 5 of the present embodiment, a portion inside the region marker 7a and excluding the position marker 7b in a plan view in the thickness direction A is composed of a portion having translucency in the thickness direction A. Is preferable.
  • the border marker as the region marker 7a of the holding body 5 of the present embodiment is configured to border a part of the region of the portion having translucency in the thickness direction A of the holding body 5. Is preferable. By doing so, when the medical staff performs an operation of moving the compression device 1 along the surface of the living body so that the identification unit 7 overlaps a predetermined position on the surface of the living body, the medical worker is in the vicinity of the identifying part 7. The compression device 1 can be moved while visually recognizing the position on the surface of the living body through the translucent portion.
  • the operation of attaching the compression device 1 to an appropriate position on the surface of the living body is performed by forming the periphery of the identification portion 7 of the main body portion 31 of the holding body 5 with a portion having translucency in the thickness direction A. It will be easier.
  • 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 identifying portion 7 of the holding body 5 and its surroundings, and the expanding portion 8 of the pressing body 4 are 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 other side can be visually recognized from one side.
  • the positioning of the identification unit 7 on the surface of the living body becomes easier.
  • the identifying portion 7 is in a mode in which it can be identified with respect to all the other layers of the laminated portions in a plan view. .. By doing so, the alignment of the identification unit 7 on the surface of the living body becomes even easier.
  • the method of providing the identification unit 7 is not particularly limited, but for example, printing, fusion, adhesion, integral molding, etc. can be used.
  • the identification unit 7 of the present embodiment is provided at a position between the pair of grip plate portions 32 in a plan view.
  • the medical staff who operates the compression device 1 can easily visually recognize the identification unit 7 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.
  • a part of the region marker 7a and the entire position marker 7b of the identification unit 7 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. 12A 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. 12A three sheaths as the medical insertion member 100 are shown, but the number may be two or less, or four or more.
  • FIG. 12B shows a state after removing the sheath as the medical insertion member 100 from the state shown in FIG. 12A. As shown in FIG. 12B, 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. 12A and 12B) 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 identification portion 7 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.
  • 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 identification portion 7 (frame of the alternate long and short dash line in FIG. 8B). See inside). 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 the region marker of the identification portion 7. Aligned within 7a. In the state of being aligned in this way, the sticking sheet 2 is stuck to the biological surface BS.
  • a region marker 7a As shown in an enlarged example within 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 position marker 7b within the region marker 7a (two-dot chain line on the left side of FIG. 8B).
  • a part of the outer surface of the insertion portion 100a is aligned with the position marker 7b in the area marker 7a for a thick sheath having an outer diameter of a predetermined value or more (two points on the left and right sides of FIG. 8B). See inside the chain line frame).
  • the position marker 7b of the present embodiment indicates a position in the region of the region marker 7a 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 position marker 7b of the present embodiment is a line segment marker that is curved and extends in an arc shape in a 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 as the position marker 7b 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. 12A and 12B). 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. 12B) extending from the biological surface BS to the femoral vein FV (see FIGS. 12A and 12B) 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. 12B. 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. 12B), 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. 12B) without occluding the femoral vein FV (see FIGS. 12A and 12B), 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. 12A and 12B) 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. 12B) without occluding the femoral vein FV (see FIGS. 12A, 12B).
  • bleeding can be stopped by stenosis or occlusion of perforation P (see FIG. 12B).
  • 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. 12A and 12B), 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. 12B).
  • “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. 12B).
  • 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. 12B).
  • 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”).
  • inclination direction F 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.
  • FIG. 13 is a diagram showing a state in which the perforation P shown in FIG. 12B is narrowed or occluded by the compression device 1. As shown in FIG. 13, 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. 12B) without occluding a vein such as a femoral vein FV. ..
  • a vein such as a femoral vein FV. ..
  • FIG. 14 is a front view of the state shown in FIG. 13 as viewed from the living body surface BS side.
  • FIG. 14 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. 14 shows a front view of the inguinal region. In the front view shown in FIG. 14, 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. 13). 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. 13). 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. 13). 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. 9A is a top view of the holding body 105 of the compression device 101 of the present embodiment.
  • the compression device 101 of the present embodiment differs from the compression device 1 described above in the configuration of the identification unit provided in the main body of the holder.
  • the identification portion 107 is provided on the upper surface of the main body portion 131 of the holding body 105.
  • the identification unit 107 includes two region markers.
  • One region marker is the same border marker as the region marker 7a of the first embodiment described above.
  • the other region marker is a border marker that further partitions a part of the region in the region partitioned by the one region marker.
  • first region marker 107a1 one of the same region markers as the region marker 7a of the first embodiment
  • second region marker 107a2 is described as "second region marker 107a2”.
  • first region marker 107a1 is the same as the region marker 7a of the first embodiment, the description thereof will be omitted here.
  • the second region marker 107a2 further partitions a part of a predetermined region within a predetermined region partitioned by the first region marker 107a1 in a plan view viewed in the thickness direction A.
  • the first region marker 107a1 means, for example, a region in which a compression force equal to or higher than the first predetermined value can be realized.
  • the second region marker 107a2 means, for example, a region capable of realizing a compression force larger than the first predetermined value and greater than or equal to the second predetermined value.
  • the area marker for aligning the insertion portion 100a (see FIG. 8A etc.) of FIG. 8A etc.) can be switched.
  • the second region marker 107a2 is a region where a high compression force as described above can be obtained
  • the second region marker 107a2 may be, for example, a priority marker that is positioned in preference to the first region marker 107a1. That is, only when the insertion portion 100a (see FIG. 8A, etc.) of the medical insertion member 100 (see FIG. 8A, etc.) does not fit within the predetermined region partitioned by the second region marker 107a2, the second region in a plan view
  • the region outside the marker 107a2 and inside the first region marker 107a1 may be used for alignment.
  • the insertion portion 100a (see FIG. 8A, etc.) of the medical insertion member 100 can be arranged only within the region of the second region marker 107a2, the expansion portion 8 (FIG. 6 etc.) of the pressing body 4 is used to stop bleeding.
  • the amount of fluid supplied to (see) can be reduced.
  • peeling of the sticking sheet 2 (see FIG. 6 and the like) from the biological surface can be suppressed.
  • Both the first region marker 107a1 and the second region marker 107a2 of the present embodiment are partially cut off by the through hole 105a of the holding body 105 in a plan view, but the configuration is not limited to this.
  • the first region marker 107a1 and the second region marker 107a2 may be provided on only one side of the through hole 105a of the holding body 105 in a plan view.
  • the border marker as the first region marker 107a1 of the present embodiment has a rectangular shape, but this shape is not particularly limited.
  • the border marker as the first region marker 107a1 may be, for example, a polygonal shape other than a circular shape, an oval shape, or a square shape.
  • the border marker as the second region marker 107a2 of the present embodiment has an oval shape, but this shape is not particularly limited.
  • the border marker as the second region marker 107a2 may have a polygonal shape such as a circular shape or a rectangular shape.
  • the compression device 201 as the third embodiment will be described.
  • 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.
  • FIG. 9B is a top view of the holding body 205 of the compression device 201 of the present embodiment.
  • the compression device 201 of the present embodiment is different from the compression device 1 described above in that the configuration of the identification unit provided on the main body of the holder is different.
  • the identification unit 207 includes a region marker 207a and a position marker 207b.
  • the area marker 207a of the present embodiment is a concave marker formed by recesses formed on the upper surface of the main body portion 231 of the holding body 205. As shown in FIG. 9B, the concave marker as the region marker 207a is bordered in a rectangular shape by the edge portion of the concave portion in a plan view, and a predetermined region is partitioned inside the concave marker.
  • the position marker 207b of the present embodiment is a point marker arranged in a predetermined area partitioned by the area marker 207a in a plan view.
  • the point marker as the position marker 207b indicates a predetermined reference position in a plan view.
  • the predetermined reference position can be, for example, a position within the region marker 207a where a particularly high compression force can be realized.
  • the concave marker as the region marker 207a of the present embodiment has a rectangular shape in a plan view, but this shape is not particularly limited.
  • the concave marker as the region marker 207a may have a polygonal shape other than a circular shape, an oval shape, or a square shape in a plan view.
  • the point marker as the position marker 207b of the present embodiment has a circular shape in a plan view, but this shape is not particularly limited.
  • the point marker as the position marker 207b may have a polygonal shape such as an oval shape or a rectangular shape in a plan view.
  • the identification unit 207 of the present embodiment is provided on only one side of the through hole 205a of the holding body 205 in a plan view, but the present invention is not limited to this configuration.
  • the identification unit 207 may be provided on both sides of the through hole 205a in a plan view.
  • FIG. 10 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 has a different configuration of the identification unit provided on the holding body as compared with the compression device 1 described above.
  • FIG. 11 describes a state in which a part of the outer surface of the insertion portion 100a located on the same surface as the surface of the living body of the medical insertion member 100 is positioned with respect to the identification portion 307 provided on the lower surface of the holding body 305. It is a schematic diagram for. In other words, FIG. 11 is a schematic diagram for explaining the effect of the identification unit 307 provided on the lower surface of the holding body 305. In FIG. 11, for convenience of explanation, the identification unit 1007 provided on the upper surface of the holding body 305 is shown for comparison. As shown in FIG.
  • the identification portion 307 by providing the identification portion 307 on the lower surface of the holding body 305, it is caused by the thickness of the holding body 305 in the thickness direction A as compared with the configuration in which the identifying portion 1007 is provided on the upper surface of the holding body 305.
  • the occurrence of misalignment can be suppressed. That is, when the identification unit 1007 is provided on the upper surface of the holding body 305, the identification unit 1007 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 identification unit 1007 is positioned at a predetermined position on the surface of the living body from an erroneous viewpoint (for example, the viewpoint PV shown in FIG.
  • the identification unit 1007 and the identification unit 1007 are arranged in the in-plane direction H of the living body surface.
  • the predetermined position on the surface of the living body a part of the outer surface of the insertion portion 100a in FIG. 11
  • the identification portion 307 is provided on the lower surface of the holding body 305, the above-mentioned positional deviation due to a difference in viewpoint is less likely to occur. That is, by providing the identification portion 307 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.
  • the identification unit 307 includes a region marker 307a and a position marker 307b.
  • the area marker 307a of the present embodiment is a frame line marker that divides a predetermined area by a rectangular groove formed on the lower surface of the holding body 305.
  • the position marker 307b of the present embodiment is a line segment marker formed by a groove portion extending in an arc shape formed on the lower surface of the holding body 305.
  • the area marker 307a 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 307a may be provided on only one side of the through hole 305a of the holding body 305 in a plan view.
  • the border marker as the area marker 307a of the present embodiment has a rectangular shape in a plan view, but this shape is not particularly limited.
  • the border marker as the region marker 307a may have a polygonal shape other than a circular shape, an oval shape, or a square shape in a plan view.
  • the line segment marker as the position marker 307b of the present embodiment extends in an arc shape in a plan view, but this shape is not particularly limited.
  • the line segment marker as the position marker 307b may extend in a straight line or a V shape in a plan view, for example.
  • 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 to fourth 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 to fourth embodiments 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.
  • Compression device 2 Adhesive sheet 3: Compression member 4: Pressing body 5, 105, 205, 305: Holding body 5a, 105a, 205a, 305a: Through hole 5b: Locking protrusion 6: Receiving parts 7, 107, 207, 307: Identification parts 7a, 207a, 307a: Area markers 7b, 207b, 307b: Position markers 8: Expansion parts 8a: Accommodation space 8b, 8c: Balloon parts 9: Extension parts 9a: Veins Part 9b: Locking hole 11: Adhesion surface 12: Mounting surface 28: Tube 29: Connection part 30: Vein 31, 131, 231: Main body part 32: Pair of grip plate parts 100: Medical insertion member 100a: Insertion part 107a1: First region marker 107a2: Second region marker 1007: Identification part A: Thickness direction A1: Downward direction A2: Upward direction B: Width direction C: Arrangement direction F: Inclined

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PCT/JP2021/009086 2020-03-27 2021-03-08 圧迫デバイス、及び、圧迫デバイスの貼着方法 Ceased WO2021192972A1 (ja)

Priority Applications (4)

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EP21775389.6A EP4111986B1 (en) 2020-03-27 2021-03-08 Compression device
CN202180007685.0A CN114901159A (zh) 2020-03-27 2021-03-08 压迫设备、以及压迫设备的粘贴方法
JP2022509512A JP7266747B2 (ja) 2020-03-27 2021-03-08 圧迫デバイス
US17/935,700 US12582556B2 (en) 2020-03-27 2022-09-27 Compression device and method for adhering compression device

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JP2020059035 2020-03-27

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EP4111987A4 (en) * 2020-03-27 2023-08-23 TERUMO Kabushiki Kaisha COMPRESSION DEVICE AND METHOD FOR ATTACHING IT
JP1695810S (https=) * 2021-03-05 2021-09-27
JP1695812S (https=) * 2021-03-05 2021-09-27
JP1695811S (https=) * 2021-03-05 2021-09-27

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JP2016090250A (ja) * 2014-10-30 2016-05-23 セイコーエプソン株式会社 分光測定装置及び保管ケース
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US20120116444A1 (en) * 2010-11-05 2012-05-10 Zodnik Richard C Apparatuses and methods for treating wounds
WO2018181314A1 (ja) * 2017-03-29 2018-10-04 テルモ株式会社 止血器具および止血方法
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EP4111986A1 (en) 2023-01-04
CN114901159A (zh) 2022-08-12
EP4111986A4 (en) 2023-08-30
JP7266747B2 (ja) 2023-04-28
US12582556B2 (en) 2026-03-24
EP4111986B1 (en) 2026-04-15
US20230015031A1 (en) 2023-01-19

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