Compression device assembly and method of installing a device

Abstract

The compression device assembly of the present disclosure includes a compression device capable of being attached to a living body surface, and a cover member capable of being attached to and detached from the compression device. The compression device includes an attachment sheet having an attachment surface capable of being attached to the living body surface on a lower surface, and a compression member fixed to the attachment sheet on an upper surface side of the attachment sheet and capable of compressing the living body surface in a state where the attachment sheet is attached to the living body surface on the attachment surface. The attachment sheet includes a first portion in contact with the compression member, and a second portion not in contact with the compression member. The cover member is attachable to the compression member in a state where an upper surface of at least a portion of the second portion of the attachment sheet is contactable.

Description

Technical Field

[0001] This disclosure relates to compression equipment components and equipment installation methods. Background Technology

[0002] In recent years, medical institutions have used long, hollow, tubular medical devices called catheters to perform various forms of examinations or treatments. The catheter is inserted percutaneously into a blood vessel through a puncture site formed in a location such as the wrist or groin, and then transported through the blood vessel to the site of the examination or treatment. After the medical practitioner completes the examination or treatment, the catheter and the guide sheath used to insert the catheter are removed from the puncture site, and bleeding at the puncture site is stopped.

[0003] Patent Document 1 discloses a compression device that applies pressure to a patient's wound or vicinity after the guide sheath has been removed. The compression device of Patent Document 1 includes an adhesive sheet with an adhesive surface and a compression member mounted on the adhesive sheet. The adhesive sheet of Patent Document 1 has a first portion with a fixing part to which the compression member is fixed, and a second portion with a fixing part where the compression member is not fixed.

[0004] Existing technical documents

[0005] Patent documents

[0006] Patent Document 1: International Publication No. 2019 / 221201 Summary of the Invention

[0007] The compression device described in Patent Document 1 is difficult to peel off from the surface of a living organism because the adhesive sheet has a second part. However, the second part of the adhesive sheet includes a portion not covered by the compression member. Therefore, when the compression device is installed on the surface of a living organism, the portion of the second part of the adhesive sheet not covered by the compression member is difficult to press onto the surface of the living organism. In other words, in the compression device of Patent Document 1, there is still room for improvement from the viewpoint of operability when attaching the second part of the adhesive sheet to the surface of a living organism.

[0008] The purpose of this disclosure is to provide a compression device assembly and a device installation method that enables a compression device to be easily installed on the surface of a living organism and difficult to peel off from the surface of the organism.

[0009] The compression device assembly of the first aspect of this disclosure includes: a compression device capable of being adhered to the surface of a living organism and capable of compressing the surface of the living organism; and a cover member capable of being attached to and detached from the compression device. The compression device includes: an adhesive sheet having an adhesive surface on its lower surface that can be adhered to the surface of the living organism; and a compression member fixed to the upper surface of the adhesive sheet and capable of compressing the surface of the living organism while the adhesive surface of the adhesive sheet is adhered to the surface of the living organism. The adhesive sheet has a first portion that contacts the compression member and a second portion that does not contact the compression member. The cover member can be installed relative to the compression member while being able to contact at least a portion of the upper surface of the second portion of the adhesive sheet.

[0010] As one embodiment of this disclosure, the pressing member of the pressing device includes: an elongated body capable of elongation; and a retaining body that holds the elongated body in a manner that allows it to elongate in the thickness direction of the adhesive sheet, wherein the cover member can be mounted relative to the retaining body.

[0011] As one embodiment of this disclosure, the second portion of the adhesive sheet has a peripheral portion that is located on the outer side of the retainer when viewed in a plane from the thickness direction of the sheet, and the cover member can be mounted relative to the retainer in a state that can contact the upper surface of the entire area of ​​the peripheral portion.

[0012] As one embodiment of this disclosure, the cover member is engaged with the side end face of the retainer located in the in-plane direction orthogonal to the thickness direction of the sheet, and is locked relative to the retainer.

[0013] As one embodiment of this disclosure, the cover member includes: a clamping portion that clamps the opposite portion of the side end face of the retainer; and a sheet cover portion that protrudes from the clamping portion inward toward the sheet surface and is able to contact the upper surface of at least a portion of the second part of the adhesive sheet while the clamping portion clamps the opposite portion of the side end face of the retainer.

[0014] As one embodiment of this disclosure, the cover member includes a pair of gripping portions extending from the clamping portion in the sheet thickness direction. By changing the relative distance between the pair of gripping portions, a locking position and a locking release position can be switched. In the locking position, the clamping portion clamps the opposite portion of the side end face of the retainer. In the locking release position, the clamping portion does not clamp the opposite portion of the side end face of the retainer.

[0015] As one embodiment of this disclosure, the cover member includes: a side-end engaging portion that engages with the opposite portion of the side end face of the retainer; and a sheet cover portion that protrudes from the side-end engaging portion toward the sheet surface and is able to contact the upper surface of at least a portion of the second part of the adhesive sheet when the side-end engaging portion is engaged with the opposite portion of the side end face of the retainer. A protrusion is provided on one of the side-end engaging portion and the opposite portion of the side end face of the retainer, and a recess or hole is provided on the other of the side-end engaging portion and the opposite portion of the side end face of the retainer to engage with the protrusion.

[0016] As one embodiment of this disclosure, the cover member has a pair of holding portions extending from the side end engaging portion in the thickness direction. By changing the relative distance between the pair of holding portions, the locking position where the protrusion engages with the recess or the hole and the locking release position where the protrusion does not engage with the recess or the hole can be switched.

[0017] The second embodiment of the present disclosure is a device installation method for installing a compression device capable of being adhered to and compressing the surface of a living organism. The compression device comprises: an adhesive sheet having an adhesive surface on its lower surface that can be adhered to the surface of the living organism; and a compression member fixed to the upper surface of the adhesive sheet and capable of compressing the surface of the living organism while the adhesive surface of the adhesive sheet is adhered to the surface of the living organism. The adhesive sheet has a first portion that contacts the compression member and a second portion that does not contact the compression member. The device installation method includes: an installation step of installing a cover member relative to the compression member while it is in contact with at least a portion of the upper surface of the second portion of the adhesive sheet; and an adhesion step of pressing at least a portion of the second portion of the adhesive sheet toward the surface of the living organism via the cover member, thereby adhering the at least a portion of the second portion to the surface of the living organism.

[0018] Invention Effects

[0019] According to this disclosure, a compression device assembly and a device installation method are provided that enable a compression device to be easily installed on the surface of a living organism and difficult to peel off from the surface of the organism. Attached Figure Description

[0020] Figure 1 This is a perspective view showing a compression device assembly as one embodiment of the present disclosure, in a state where the compression device is not fitted with a cover member.

[0021] Figure 2 It means about Figure 1 The diagram shows a perspective view of the compression device assembly, with the cover component installed in a detachable manner relative to the compression device.

[0022] Figure 3 yes Figure 1 A top view of the compression device shown.

[0023] Figure 4 yes Figure 1 The image shows a bottom view of the compression device.

[0024] Figure 5 It means Figure 1 The cross-sectional view of the compression device shown, with the expander in a contracted state.

[0025] Figure 6 It means Figure 1 The cross-sectional view of the compression device shown, with the expander in an expanded state.

[0026] Figure 7 yes Figure 1 The diagram shows a perspective view of the cover component viewed from below.

[0027] Figure 8 yes Figure 1 The top view of the cover component shown.

[0028] Figure 9 yes Figure 1 The bottom view of the cover component shown.

[0029] Figure 10 It is along Figure 2 A sectional view along line II-II.

[0030] Figure 11 This refers to a method of installing a device, including a compression device, onto the surface of a living organism, as one embodiment of this disclosure. Figure 1 A flowchart illustrating an example of a method for applying pressure to the surface of a living organism using the pressure device shown.

[0031] Figure 12A It means Figure 11 A diagram outlining the cover installation process.

[0032] Figure 12B It means Figure 11 A diagram outlining the pasting process.

[0033] Figure 12C It means Figure 11 A diagram outlining the process of removing the cover.

[0034] Figure 12D It means Figure 11 A diagram outlining the first pressing process.

[0035] Figure 12E It means Figure 11 A diagram outlining the extraction process.

[0036] Figure 12F It means Figure 11 A diagram outlining the second pressing process.

[0037] Figure 13A This diagram illustrates the state in which a medical insertable component is inserted into a femoral vein through the connective tissue from the surface of a living organism.

[0038] Figure 13B It means from Figure 13A The diagram shows the state after the medical insert has been removed.

[0039] Figure 14 It means to utilize Figure 1 The compression device shown makes Figure 13B The diagram shows the state of the perforation becoming narrowed or blocked.

[0040] Figure 15 Observation from the surface of the organism Figure 14 The main view showing the status.

[0041] Figure 16 It means Figure 1 A diagram showing a modified example of the pressing device assembly. Detailed Implementation

[0042] The following description, with reference to the accompanying drawings, illustrates the compression device components and installation methods of this disclosure. Common components and parts in all figures are labeled with the same reference numerals.

[0043] Figure 1 This is a diagram illustrating a compression device assembly 1000 as one embodiment of the compression device assembly of this disclosure. (See diagram for details.) Figure 1 As shown, the compression device assembly 1000 includes a compression device 1 and a cover member 51. The cover member 51 can be attached to and detached from the compression device 1. Figure 1 The compression device assembly 1000 is shown in a state where the cover member 51 is not installed relative to the compression device 1. Figure 2 The compression device assembly 1000 is shown with the cover member 51 installed in a detachable manner relative to the compression device 1. Figure 1 , Figure 2 The image shows a compression device 1 with a release tab 4 attached to the adhesive surface 11 of the adhesive patch 2. The release tab 4 is removed when the compression device 1 is attached to the surface of a living organism.

[0044] [Compression Device 1]

[0045] Figure 3 , Figure 4 This is a plan view of the compression device 1. Specifically, Figure 3 This is a top view of the compression device 1. Figure 4 This is a bottom view of the compression device 1. Figure 5 , Figure 6 It is along Figure 3 A cross-sectional view of the compression device 1 at section II. Details will be described later. Figure 5 , Figure 6 Different states of the compression device 1 are shown. Additionally, in Figures 3-6 The image shows the removal of peeling piece 4 (see reference). Figure 1 The compression device 1 in the state after (etc.).

[0046] The compression device 1 can be attached to the surface of a living organism. Furthermore, the compression device 1 can compress the surface of the living organism while it is attached to the surface.

[0047] The compression device 1 includes an adhesive sheet 2 and a compression component 3.

[0048] The adhesive patch 2 has an adhesive surface 11 on its lower surface that can be adhered to the surface of a living organism. The pressure member 3 is fixed to the adhesive patch 2 on its upper surface. In addition, the pressure member 3 can press the surface of the living organism while the adhesive surface 11 of the adhesive patch 2 is adhered to the surface of the living organism.

[0049] In this manner, the compression device 1 fixes its position on the surface of the organism by attaching the adhesive surface 11 of the adhesive patch 2 to the surface of the organism. Furthermore, while the adhesive surface 11 of the adhesive patch 2 is fixed in position on the surface of the organism, the compression device 1 can apply pressure to a predetermined location on the surface of the organism using the compression member 3. A predetermined location on the surface of the organism may, for example, be a wound or its vicinity formed by inserting a long medical instrument such as a puncture needle, catheter, or guide sheath into a blood vessel on the surface of the organism. After the medical instrument is removed from the organism, hemostasis can be achieved by applying pressure to the wound or its vicinity on the surface of the organism using the compression member 3.

[0050] The following details the components and parts of the compression device 1.

[0051] <Paste Sheet 2>

[0052] The adhesive sheet 2 has an adhesive surface 11 on its lower surface on one side in the thickness direction A. Additionally, the adhesive sheet 2 has a mounting surface 12 for mounting the pressure member 3 on its upper surface on the other side in the thickness direction A. The adhesive sheet 2 is flexible. Therefore, the adhesive sheet 2 can be deformed along the shape of the organism's surface. Furthermore, the adhesive surface 11 readily follows the deformation of the organism's surface. As a result, unintentional peeling of the pressure device 1 from the organism's surface can be prevented.

[0053] For ease of explanation, the side along the thickness direction A, from the mounting surface 12 towards the adhesive surface 11, will be simply referred to as "bottom A1". Similarly, for ease of explanation, the other side along the thickness direction A, from the adhesive surface 11 towards the mounting surface 12, will be simply referred to as "top A2". Furthermore, for ease of explanation, the plane of the pressing device 1 observed along the thickness direction A of the adhesive sheet 2 will be used for observation (see reference). Figure 3 , Figure 4 A planar view taken from the mounting surface 12 side of the adhesive patch 2 (see reference). Figure 3 (This is only recorded as a "top view".) Additionally, for ease of explanation, there is a case where the plane of the pressing device 1 is viewed along the thickness direction A of the adhesive sheet 2 (refer to...). Figure 3 , Figure 4 A planar view taken from the adhesive surface 11 side of the adhesive piece 2 (see reference). Figure 4 The case referred to as "looking up". In addition, when there is no distinction between looking down and looking up, it is referred to as "view from a plane". In addition, unless otherwise specified, the cases referred to as "view from a plane", "looking down" and "looking up" indicate the view from a plane, looking down and looking up when the elongated body 21 of the pressure member 3 described later is in the retracted position.

[0054] The adhesive sheet 2 is composed of multiple layers, including a substrate layer and an adhesive layer.

[0055] The substrate layer is, for example, composed of a thin resin sheet. More specifically, the substrate layer is, for example, composed of a white spunlace nonwoven fabric of polyester fibers, with a thickness set in the range of 5 μm to 150 μm, for example, 30 μm. However, the material of the substrate layer is not limited to polyester; for example, acrylic polymers, polyethylene, ethylene-vinyl acetate copolymers, polyurethane, polyamide derivatives, etc., can also be used.

[0056] The adhesive layer is composed of adhesives such as rubber-based adhesives, acrylic adhesives, and silicone adhesives. The adhesive layer is laminated directly or indirectly with respect to the substrate layer, or with other layers in between. In this embodiment, the adhesive surface 11 of the adhesive sheet 2 is composed of the adhesive layer.

[0057] The adhesive patch 2 may also include other layers besides the substrate layer and adhesive layer described above. For example, the adhesive patch 2 may include a surface layer. The surface layer may be composed of a resin with a thickness of approximately 5 μm to 50 μm. More specifically, materials such as polyester, polyamide, polyamide-imide, polyethylene, polypropylene, polycarbonate, polyurethane, polyvinyl chloride, and fluoropolymers can be used as the surface layer material. The surface layer is laminated directly or indirectly, with respect to the substrate layer, on the side opposite to the adhesive layer, separated from the substrate layer. Therefore, the mounting surface 12 of the adhesive patch 2 can also be constructed using the surface layer.

[0058] More specifically, the adhesive sheet 2 can also be made of, for example, nonwoven tape with an adhesive applied to one side as a bonding agent. Furthermore, the adhesive sheet 2 can also be made of, for example, double-sided tape with adhesive layers on both sides of a substrate layer. When the adhesive sheet 2 is made of double-sided tape, the pressure member 3 can be fixed to the adhesive sheet 2 by bonding it to the adhesive layer on one side of the adhesive sheet 2.

[0059] In this embodiment, the adhesive patch 2 is... Figure 3 , Figure 4 When viewed in planar form, it extends in a C-shape. In other words, when viewed in planar form, the adhesive sheet 2 of this embodiment has a central opening area. The receiving portion 6, described later, is formed by the open area in this central opening area that communicates with the outside. The open area in the central opening area refers to the gap area sandwiched between the two ends of the C-shaped adhesive sheet 2 when viewed in planar form.

[0060] As described above, the adhesive sheet 2 of this embodiment extends in a C-shape when viewed in a planar view, but is not limited to this shape. For example, the adhesive sheet 2 may also have a ring-shaped shape when viewed in a planar view. The outer and inner edge shapes of the ring-shaped adhesive sheet are not particularly limited when viewed in a planar view. The outer and inner edge shapes of the adhesive sheet having a ring-shaped shape when viewed in a planar view can be various shapes, such as a circle, an ellipse, or a polygon including a quadrilateral shape.

[0061] Furthermore, it is preferable to have a slit extending from the outer edge to the inner edge formed in the adhesive patch, which has a ring-shaped shape when viewed in planar view. By providing such a slit, the central opening area and the outside are connected through the slit. Therefore, medical devices such as catheters and guide sheaths can be moved from the outside of the adhesive patch to the central opening area through the slit.

[0062] Next, we will explain part 1, X1, and part 2, X2 of the adhesive sheet 2.

[0063] like Figure 3 , Figure 4As shown, the adhesive sheet 2 has a first portion X1 that contacts the pressure member 3 and a second portion X2 that does not contact the pressure member 3. The first portion X1 represents the area in the in-plane direction B of the adhesive sheet 2 that is in contact with the pressure member 3 on the upper surface side. The second portion X2 represents the area in the in-plane direction B of the adhesive sheet 2 that is not in contact with the pressure member 3 on the upper surface side. Therefore, for example, if the portion is covered by the pressure member 3 on the upper surface side and in contact with the pressure member 3, this portion corresponds to the first portion X1 regardless of whether the pressure member 3 is fixed. The adhesive surface 11 is provided on at least a portion of the lower surface of the first portion X1 and at least a portion of the lower surface of the second portion X2. More specifically, in this embodiment, the adhesive surface 11 is provided on the entire area of ​​the lower surface of the first portion X1 and the entire area of ​​the lower surface of the second portion X2. That is, in this embodiment, the adhesive surface 11 is provided on the entire area of ​​the lower surface of the adhesive sheet 2. By pressing the adhesive patch 2 of the device 1, which has a second portion X2, unintentional peeling of the adhesive patch 2 from the surface of the organism can be prevented. This effect is based on the same principle as described in Patent Document 1.

[0064] Moreover, such as Figure 3 As shown, the adhesive sheet 2 of this embodiment has a peripheral portion 13 that is located on the outer periphery relative to the pressure member 3 when viewed in a planar view. The peripheral portion 13 of the adhesive sheet 2 of this embodiment is a second portion X2 that does not contact the pressure member 3. In other words, the second portion X2 of the adhesive sheet 2 has a peripheral portion 13 that is located on the outer periphery relative to the outer edge of the retainer 22 (described later) of the pressure member 3 when viewed in a planar view.

[0065] like Figure 3As shown, in this embodiment, the peripheral portion 13 of the adhesive patch 2 does not surround the entire area surrounding the compression member 3 when viewed in plan view. That is, there is a position around the compression member 3 where the peripheral portion 13 of the adhesive patch 2 is not provided. At this position where the peripheral portion 13 of the adhesive patch 2 is not provided, the portion extending outward from the body of a medical device such as a guide sheath inserted into the body is received. In other words, a receiving portion 6 for receiving a medical device such as a guide sheath is defined around the compression member 3 at the position where the peripheral portion 13 of the adhesive patch 2 is not provided. Therefore, the compression device 1 can be installed on the surface of the body with the portion extending outward from the body of a medical device such as a guide sheath inserted into the body at its distal end received in the receiving portion 6. Therefore, even with a medical device such as a guide sheath inserted into the body, the elongated body 21 of the compression member 3 (described later) can be easily configured to cover the wound or its vicinity on the surface of the body formed by the medical device. In other words, with this configuration, the compression device 1 can be easily installed on the surface of the body. As a result, in both the state in which a medical device such as a guide sheath is inserted into the body and the state after the medical device is removed from the body, the elongated body 21 of the compression member 3 of the compression device 1 can easily compress the wound or the vicinity on the surface of the body.

[0066] <Compression Component 3>

[0067] The pressure member 3 is fixed to the adhesive sheet 2 on its upper surface. Specifically, in this embodiment, the pressure member 3 is fixed to the mounting surface 12 of the adhesive sheet 2. Furthermore, the pressure member 3 can press against the surface of the organism while the adhesive surface 11 of the adhesive sheet 2 is adhered to the surface of the organism. Specifically, the pressure member 3 of this embodiment includes an elongated body 21 and a retaining body 22 that holds the elongated body 21 in a manner that allows it to elongate in the thickness direction A of the adhesive sheet 2.

[0068] like Figure 3 , Figure 4As shown, the retainer 22 of the pressure member 3 in this embodiment, when viewed in plan view, has a portion that overlaps with the adhesive sheet 2 and a portion that does not overlap with the adhesive sheet 2. More specifically, the retainer 22 of the pressure member 3 in this embodiment is configured to cover the central opening area of ​​the adhesive sheet 2 when viewed in plan view. The portion of the retainer 22 that overlaps with the central opening area when viewed in plan view is the portion that does not overlap with the adhesive sheet 2. The retainer 22 in this embodiment is configured to cover the central opening area, and the outer edge of the retainer 22 overlaps with the adhesive sheet 2 when viewed in plan view. In this embodiment, the portion of the retainer 22 that overlaps with the adhesive sheet 2 when viewed in plan view contacts and is fixed relative to the mounting surface 12 of the adhesive sheet 2. However, it is also possible that not the entire area of ​​the portion of the retainer 22 that overlaps with the adhesive sheet 2 when viewed in plan view contacts and is fixed relative to the mounting surface 12 of the adhesive sheet 2. Therefore, it is possible that only a portion of the portion of the retainer 22 that overlaps with the adhesive sheet 2 when viewed in plan view contacts and is fixed relative to the mounting surface 12 of the adhesive sheet 2. Therefore, the portion of the retainer 22 that overlaps with the adhesive sheet 2 when viewed in a planar manner may, for example, include a portion that contacts but is not fixed relative to the mounting surface 12 of the adhesive sheet 2. The elongated body 21 of this embodiment, described later, extends downwards towards A1 within the central opening region defined by the adhesive sheet 2, and is capable of compressing the surface of a living organism.

[0069] The retainer 22 of this embodiment has a quadrilateral shape with rounded corners when viewed in a planar view and a flat shape in the thickness direction A. The retainer 22 covers the upper A2 of the first expansion portion 41a and the second expansion portion 41b of the expansion body 40, which is described later as an extension body 21. In addition, a through hole 22a is formed on the retainer 22 for the extension portion 42 of the expansion body 40 to pass through. Moreover, a locking protrusion 22c is provided on the upper surface of the retainer 22 for locking the extension portion 42 of the expansion body 40.

[0070] The material used as the retainer 22 can be, for example, a resin material. Examples of such resin materials include ABS resin, AS resin, polyethylene, polypropylene, polystyrene, polyvinyl chloride, polyvinylidene chloride resin, polyphenylene ether, thermoplastic polyurethane, polymethyl methacrylate, polyoxyethylene, fluororesin, polycarbonate, polyamide, acetal resin, acrylic resin, polyethylene terephthalate, and other thermoplastic resins used in injection molding, as well as phenolic resin, epoxy resin, silicone resin, unsaturated polyester, and other thermosetting resins.

[0071] The elongated body 21 is held by the retainer 22. The elongated body 21 protrudes downward A1 relative to the adhesive surface 11 of the adhesive sheet 2 on the side that is the sheet thickness direction A. In the compression device 1, with the adhesive surface 11 of the adhesive sheet 2 attached to the surface of the organism, the elongated body 21 protrudes downward A1 relative to the adhesive surface 11 of the adhesive sheet 2. As a result, the surface of the organism is compressed by the elongated body 21.

[0072] The elongated body 21 in this embodiment is an expander 40 capable of expanding downwards A1 in the sheet thickness direction A by supplying a fluid such as air. The expander 40 in this embodiment expands from... Figure 5 The contraction retreat pattern shown is towards Figure 6 The expanded protruding shape shown undergoes a morphological change, and protrudes downwards towards A1 in the thickness direction A compared to the adhesive surface 11 of the adhesive sheet 2, thus adopting a posture capable of compressing the surface of the organism.

[0073] Specifically, in this embodiment, the compression device 1 is in a retracted state before the expansion body 40 of the elongated body 21 expands (see reference). Figure 5 The expander 40 is attached to the surface of a living organism. With the compression device 1 fixed to the surface of the organism, the expander 40 expands through the operation of a medical professional or other operator. The expander 40 expands into a protruding shape (see reference). Figure 6 The compression device 1 of this embodiment can compress a predetermined location on the surface of a living organism by changing the shape of the expander 40 from a retracted state to a protruding state. As described above, the predetermined location on the surface of the living organism refers to wounds or similar structures formed by inserting a medical instrument such as a guide sheath into the organism. After removing the medical instrument such as the guide sheath from the organism, the expander 40, which serves as the elongation body 21, is used to compress the wound or its vicinity on the surface of the living organism, thereby stopping the bleeding. Details of this series of compression methods will be described later (see [reference]). Figure 11 , Figures 12A to 12F ).

[0074] like Figure 5 As shown, in the retracted state, the expansion body 40 of the elongated body 21 in this embodiment is approximately flush with the adhesive surface 11 of the adhesive sheet 2 and does not protrude downwards from the adhesive surface 11 by A1. The retaining body 22 may also have a locking mechanism for locking the expansion body 40, so that the expansion body 40 does not protrude downwards from the adhesive surface 11 of the adhesive sheet 2 by A1 in the retracted state.

[0075] In this embodiment, the expander 40 is divided into an internal space 40a. The internal space 40a of the expander 40 is connected to a tube 28 that passes through the retainer 22 and extends to the outside of the retainer 22. In the internal space 40a of the expander 40, a fluid supply device such as a syringe, which is connected to an air port provided at the end of the tube 28 as a connection portion 29, supplies fluid such as air through the tube 28. As a result, the expander 40 can be moved from a retracted state (see reference 1) to a retracted state. Figure 5 ) undergoes morphological changes towards prominent forms (refer to) Figure 6 In other words, the expander 40, which is the elongated body 21, can protrude downwards by A1 compared to the adhesive surface 11 of the adhesive sheet 2. The fluid supplied to the internal space of the expander 40 is not limited to gas, but can also be liquid. In addition, by drawing fluid from the internal space 40a of the expander 40, the expander 40 can also be made to protrude from its protruding form (see reference). Figure 6 Towards retreating form (refer to) Figure 5 ) undergoes morphological changes.

[0076] More specifically, such as Figure 6 As shown, the elongated body 21 of this embodiment includes a contact portion 21a that directly presses against the surface of a living organism, and a pushing portion 21b that pushes the contact portion 21a in a predetermined direction to increase the pressing force based on the pressure of the contact portion 21a in the predetermined direction. Specifically, the expansion body 40 of the elongated body 21 of this embodiment includes a first expansion portion 41a as the contact portion 21a and a second expansion portion 41b as the pushing portion 21b.

[0077] The first expansion portion 41a divides into a first internal space 41a1. The second expansion portion 41b divides into a second internal space 41b1. The first internal space 41a1 and the second internal space 41b1 are connected. In the retracted state of the expansion body 40, the first expansion portion 41a and the second expansion portion 41b in the contracted state overlap in the sheet thickness direction A. The first expansion portion 41a in the contracted state is located on the lower side, and the second expansion portion 41b in the contracted state overlaps on the upper side. The upper A2 of the second expansion portion 41b is covered by the holding body 22. In addition, the first expansion portion 41a and the second expansion portion 41b are only on one end side of the in-plane direction B, which is orthogonal to the sheet thickness direction A (in Figure 6 (The middle section is on the left) Continuous.

[0078] Fluid supplied to the internal space 40a of the expander 40 through pipe 28 flows into the second internal space 41b1 of the second expander 41b, and then into the first internal space 41a1 of the first expander 41a. Therefore, when fluid is supplied to the internal space 40a of the expander 40, the second expander 41b expands first. As described above, since the upper A2 of the second expander 41b is covered by the retainer 22, the second expander 41b supplied with fluid expands downwards towards A1. Next, fluid flows into the first internal space 41a1, and the first expander 41a expands. At this time, the first expander 41a extends towards one end of its continuous in-plane direction B (in...) Figure 6 The expansion is centered on the left side and rotates around a pivot axis. That is, when fluid is supplied to the first internal space 41a1 of the first expansion section 41a, the first expansion section 41a is pushed by the second expansion section 41b, thereby expanding at the other end (in...). Figure 6 (The middle part is on the right) expands by moving laterally downwards A1 relative to one end in the direction B within the plane, becoming Figure 6 The protruding shape shown. Therefore, it is possible to increase the compressive force based on the first expansion portion 41a pressing in a predetermined direction (in... Figure 6 The middle part represents the compressive force pressing downwards and to the left.

[0079] More specifically, the expander 40 of this embodiment includes a sheet-like extending portion 42 extending from the first expander portion 41a and the second expander portion 41b. The first expander portion 41a and the second expander portion 41b of this embodiment... Figure 5 , Figure 6 In cross-sectional view, the receiving portion 6 in the in-sheet direction B is continuous with the extension portion 42. During expansion, the portions of the first expansion portion 41a and the second expansion portion 41b connected to each other in the extension portion 42 rotate as hinges. In other words, the first expansion portion 41a and the second expansion portion 41b can expand not only in the sheet thickness direction A, but also in a direction inclined relative to the sheet thickness direction A.

[0080] In this embodiment, a sheet-like extension portion 42, extending from the lower surface to the upper surface of the retainer 22 through the through hole 22a, is fixed to the retainer 22 on the upper surface. Thus, the expander 40 of this embodiment is locked relative to the retainer 22. More specifically, a slit is formed on the extension portion 42 of this embodiment. A locking protrusion 22c provided on the upper surface of the retainer 22 is inserted into this slit. Thus, the extension portion 42 is positioned on the retainer 22.

[0081] More specifically, in this embodiment, the first expansion portion 41a and the second expansion portion 41b are each composed of a balloon portion. As described above, the two balloon portions are arranged overlapping along the sheet thickness direction A. Furthermore, one end of each of these two balloon portions is mounted relative to the extension portion 42. That is, one end of each balloon portion is constrained by the extension portion 42. Therefore, even if the two balloon portions expand, the distance between the two balloon portions at the aforementioned one end will not increase. On the other hand, the other end of each balloon portion is not constrained. Therefore, if the two balloon portions expand, the distance between the two balloon portions at the aforementioned other end will increase. In other words, among the two balloon portions constituting the first expansion portion 41a and the second expansion portion 41b of this embodiment, the end portion mounted on the extension portion 42 serves as the rotation center, while the other end portion not mounted on the extension portion 42 rotates around this rotation center. In this way, the first expansion portion 41a and the second expansion portion 41b of this embodiment expand in a direction inclined relative to the sheet thickness direction A. By designing the expansion body 40 to expand in a direction inclined relative to the sheet thickness direction A, it is easier to achieve the perforation P described later (see reference). Figure 13B It may become narrow or blocked. Details will be described later (see reference). Figure 14 However, the structure for expanding in a direction inclined relative to the sheet thickness direction A is not limited to the structure of the elongated body 21 in this embodiment.

[0082] The materials used for the balloon portions constituting the first expansion portion 41a and the second expansion portion 41b can be flexible materials such as soft polyvinyl chloride, polyurethane, polyethylene, polypropylene, polyester, ethylene-vinyl acetate copolymer (EVA), silicone resin, or any mixture thereof.

[0083] The structure of the elongated body 21 is not particularly limited. It may also be an elongated body 21 without the pushing part 21b. In addition, the elongated body 21 may not be an expansion body. Moreover, when the elongated body 21 is composed of an expansion body, it is not limited to the structure of the expansion body 40 described above.

[0084] [Cover component 51]

[0085] Figure 7 This is a perspective view of the cover component 51 as seen from below. Figure 8 This is a top view of the cover component 51. Figure 9 This is a bottom view of the cover component 51. Figure 10 This is a cross-sectional view of the pressure device assembly 1000 with the cover member 51 installed in the pressure device 1. Specifically, Figure 10 It is along Figure 2 A sectional view along line II-II.

[0086] like Figure 2 , Figure 10As shown, the cover member 51 can be mounted relative to the compression member 3. Additionally, as... Figure 10 As shown, the cover member 51 can be installed relative to the pressure member 3 while in contact with at least a portion of the upper surface of the second part X2 of the adhesive sheet 2. Therefore, if the pressure device 1 is pressed against the surface of a living organism while the cover member 51 is installed on the pressure device 1, the second part X2 of the adhesive sheet 2 can be pressed towards the surface of the living organism by the cover member 51. As a result, the adhesive surface 11 on the lower surface of the second part X2 of the adhesive sheet 2 can also be easily adhered to the surface of the living organism. That is, the second part X2 of the adhesive sheet 2, which is difficult to peel off from the surface of the living organism after being adhered, can be easily adhered to the surface of the living organism. As a result, according to the pressure device assembly 1000, a pressure device 1 that is easy to install on the surface of a living organism and difficult to peel off from the surface of the living organism can be realized.

[0087] However, the cover member 51 can also be installed relative to the pressure member 3 in a state where it can contact at least a portion of the upper surface of the second part X2 of the adhesive sheet 2. That is, even when the cover member 51 is installed relative to the pressure member 3, the cover member 51 may not be in constant contact with at least a portion of the upper surface of the second part X2 of the adhesive sheet 2. In the above case, the cover member 51 only needs to be configured to contact at least a portion of the upper surface of the second part X2 of the adhesive sheet 2. As an example, when the cover member 51 is installed on the pressure device 1, a portion of the cover member 51 (e.g., the flange plate portion 51c of the cover portion 53 described later in this embodiment) is configured to be elastically deformable. It is also possible to configure the cover member 51 to contact at least a portion of the upper surface of the second part X2 of the adhesive sheet 2 by elastically deforming a portion of it.

[0088] Furthermore, by using a cover member 51 that can be attached to and detached from the compression member 3, the thickness of the compression member 3 in the sheet thickness direction A can be reduced. As a result, the burden on the patient caused by the compression device 1 placed on the surface of the body can be reduced.

[0089] In this embodiment, the cover member 51 can be installed in the retainer 22 within the pressure member 3. Furthermore, in this embodiment, the cover member 51 is not installed in the elongated body 21 within the pressure member 3. Therefore, the mounting position and posture of the cover member 51 relative to the pressure member 3 are less prone to change. Thus, regardless of changes in the shape of the elongated body 21, the cover member 51 can be installed more reliably relative to the pressure member 3. Additionally, the integrated state of the cover member 51 mounted relative to the pressure member 3 can be further stabilized. As a result, unintentional detachment of the cover member 51 from the pressure member 3 can be prevented.

[0090] Furthermore, the cover member 51 of this embodiment can be mounted relative to the retainer 22 of the compression member 3 while in contact with the upper surface of the entire area of ​​the peripheral portion 13 in the second part X2 of the adhesive sheet 2. This allows the adhesive surface 11 provided on the lower surface of the peripheral portion 13 to be more reliably adhered to the surface of the organism. As a result, the peeling of the compression device 1 from the surface of the organism can be further suppressed.

[0091] Moreover, such as Figure 10 As shown, the cover member 51 is engaged with the side end face 22b of the retainer 22, which is located in the in-plane direction B orthogonal to the thickness direction A, and is thus locked relative to the retainer 22. In this way, if the cover member 51 is engaged with the side end face 22b of the retainer 22, the cover member 51 can also be easily flattened.

[0092] More specifically, such as Figure 10 As shown, the cover member 51 of this embodiment includes a clamping part 52, a sheet cover part 53, and a pair of holding parts 54.

[0093] The clamping part 52 is capable of clamping the opposite portion of the side end face 22b of the retainer 22. The cover member 51 clamps the opposite portion of the side end face 22b of the retainer 22 by the clamping part 52 and is locked relative to the pressing device 1.

[0094] More specifically, the cover member 51 of this embodiment includes a top plate portion 51a with rounded corners and a quadrilateral shape that covers the upper surface of the retainer 22, and a peripheral wall portion 51b that protrudes from the outer edge of the top plate portion 51a toward one side in the thickness direction of the top plate portion 51a. The peripheral wall portion 51b includes a pair of first plate portions 51b1 that protrude from opposite portions of the outer edge of the top plate portion 51a and are opposite to each other. In addition, the peripheral wall portion 51b includes a pair of second plate portions 51b2 that protrude from the outer edge of the top plate portion 51a at portions different from those for which the pair of first plate portions 51b1 protrude and are opposite to each other. When viewed in a plane in the thickness direction of the top plate portion 51a, the pair of second plate portions 51b2 extend in a direction substantially orthogonal to the pair of first plate portions 51b1. In the state in which the cover member 51 is installed relative to the pressing device 1 (see reference 1) Figure 2 Below, the thickness direction of the top plate portion 51a of the cover member 51 is aligned with the sheet thickness direction A. Hereinafter, as... Figure 1 , Figure 2As shown, the description is based on the state where the cover member 51 is positioned above the pressing device 1 at A2, and the top plate portion 51a of the cover member 51 is aligned with the sheet thickness direction A. Therefore, the thickness direction of the top plate portion 51a of the cover member 51 will be referred to as "sheet thickness direction A" below. Furthermore, the side of the top plate portion 51a of the cover member 51 where the pressing device 1 is located will be referred to as "below A1", and the opposite side will be referred to as "above A2". Moreover, for a planar view of the cover member 51 viewed from the thickness direction of the top plate portion 51a, it will be referred to as "planar view" below. Additionally, for ease of explanation, the state in which the cover member 51 is installed on the pressing device 1 will be referred to as "installed state".

[0095] The clamping portion 52 of this embodiment described above is composed of a pair of first plate portions 51b1. The cover member 51 of this embodiment covers downwards from the upper side of the pressing device 1 towards the lower A1. Through this operation, the pair of first plate portions 51b1, which are the clamping portion 52, slide against opposing portions of the side end faces 22b of the retainer 22 of the pressing member 3 while moving downwards towards the lower A1. The cover member 51 can move downwards towards the lower A1 until the lower surface of the top plate portion 51a contacts the upper surface of the retainer 22. Furthermore, when the cover member 51 reaches a position where it can no longer move downwards towards the lower A1 relative to the retainer 22, the installation of the cover member 51 onto the pressing device 1 is complete, and it enters the installed state.

[0096] like Figure 10 As shown, in this embodiment, the cover member 51 is secured to the pressing device 1 by clamping opposite portions of the side end faces 22b of the retainer 22 with a pair of first plate portions 51b1. However, it is also possible that not only the pair of first plate portions 51b1 clamp, but also the pair of second plate portions 51b2 clamp other opposite portions of the side end faces 22b of the retainer 22.

[0097] In this embodiment, the cover member 51 clamps the side end face 22b of the retainer 22. Thus, the cover member 51 is secured to the pressing device 1. With this structure, a mechanism for attaching and detaching the cover member 51 relative to the pressing device 1 can be implemented with a simple structure.

[0098] In addition, a top plate opening 51a1 is formed on the top plate portion 51a of this embodiment, through which the pipe 28 of the pressure device 1 is inserted in the installed state.

[0099] The cover portion 53 protrudes from the clamping portion 52 in the inward direction B. In this embodiment, the cover portion 53 contacts at least a portion of the upper surface of the second part X2 of the adhesive sheet 2 in the installed state. More specifically, in this embodiment, the cover portion 53 contacts the upper surface of the entire area of ​​the peripheral portion 13 in the second part X2 of the adhesive sheet 2 in the installed state. Therefore, when the pressing device 1 is attached to the surface of a living organism using the pressing device assembly 1000, the cover portion 53 of the cover member 51 can be used to press the entire area of ​​the peripheral portion 13 of the adhesive sheet 2 toward the surface of the living organism. As a result, the peripheral portion 13 of the adhesive sheet 2 can be more reliably attached to the surface of the living organism.

[0100] More specifically, the cover member 51 of this embodiment includes a flange plate portion 51c that extends outward from the lower end of the peripheral wall portion 51b and is substantially parallel to the top plate portion 51a. The sheet cover portion 53 of this embodiment is composed of the flange plate portion 51c.

[0101] As described above, the flange plate portion 51c of the cover portion 53 in this embodiment contacts the upper surface of the second portion X2 of the adhesive sheet 2 in the installed state, but it is not limited to this structure. The cover portion 53 may not contact the upper surface of the second portion X2 of the adhesive sheet 2 in the installed state, as long as it is configured to make contact. It is also possible for the flange plate portion 51c of the cover portion 53 to be able to swing elastically in the sheet thickness direction A with the portion connected to the peripheral wall portion 51b as a fulcrum. In the above case, the flange plate portion 51c may not contact the upper surface of the peripheral portion 13 of the adhesive sheet 2 at all times in the installed state. It is possible to make the flange plate portion 51c contact the upper surface of the peripheral portion 13 of the adhesive sheet 2 by pressing the flange plate portion 51c downward A1 to make it elastically deformed.

[0102] In this embodiment, the installation state is defined as the state in which the lower surface of the top plate portion 51a of the cover member 51 contacts the upper surface of the retainer 22, and the lower surface of the flange plate portion 51c of the cover member 51 contacts the upper surface of the peripheral portion 13 of the adhesive sheet 2. However, the installation state is not limited to the contact relationship described above. For example, the installation state may also be defined solely based on whether the lower surface of the top plate portion 51a of the cover member 51 contacts the upper surface of the retainer 22. Furthermore, the installation state may also be defined solely based on whether the sheet portion 53 of the cover member 51 contacts the second portion X2 of the adhesive sheet 2. Moreover, the installation state may also be defined based on the contact states of other parts.

[0103] A pair of gripping portions 54 extend from the clamping portion 52 in the sheet thickness direction A. Specifically, in this embodiment, the pair of gripping portions 54 are composed of a pair of gripping plate portions 51d that extend upward A2 from a pair of first plate portions 51b1 that serve as clamping portions 52. In other words, the pair of gripping plate portions 51d protrude from the outer edge of the top plate portion 51a in a direction opposite to the protruding direction of the pair of first plate portions 51b1 in the sheet thickness direction A (upward A2 in this embodiment).

[0104] Medical personnel can elastically deform the cover member 51 by operating the pair of gripping plates 51d, which are a pair of gripping parts 54, thereby changing the relative distance between the pair of gripping plates 51d. In this embodiment, if the cover member 51 is deformed in a way that reduces the relative distance between the pair of gripping plates 51d, the relative distance between the pair of first plates 51b1 located on the opposite side of the pair of gripping plates 51d across the top plate 51a will increase. Conversely, in this embodiment, if the cover member 51 is deformed in a way that increases the relative distance between the pair of gripping plates 51d, the relative distance between the pair of first plates 51b1 will decrease. In this way, in this embodiment, by changing the relative distance between the pair of gripping parts 54, the relative distance between the clamping parts 52 can be changed. Therefore, by operating the pair of gripping parts 54, the relative distance between the clamping parts 52 can be changed, thereby changing the engagement relationship between the clamping parts 52 and the retainer 22. In other words, by changing the relative distance between the pair of gripping parts 54, it is possible to switch the locking position of the opposite part of the side end face 22b of the holding body 22 held by the clamping part 52 and the locking release position of the opposite part of the side end face 22b of the holding body 22 not held by the clamping part 52.

[0105] More specifically, in this embodiment, when the pair of gripping plates 51d, which are a pair of gripping parts 54, are pushed closer together, the top plate 51a bends and deforms upwards A2 in the out-of-plane direction. This increases the relative distance between the pair of first plate portions 51b1, which are clamping parts 52. Conversely, by releasing the force that pushed the pair of gripping plates 51d, which are a pair of gripping parts 54, the bent and deformed top plate 51a returns to a flat shape by a restoring force. This restores, i.e., reduces, the relative distance between the pair of first plate portions 51b1, which are clamping parts 52.

[0106] In this embodiment, the top plate portion 51a of the cover member 51 is bent and deformed, thereby changing the relative distance between the pair of first plate portions 51b1 that serve as clamping portions 52, but this is not a limitation. That is, the relative distance between the pair of first plate portions 51b1 that serve as clamping portions 52 can also be changed by other structures. For example, a structure that deforms the portion other than the top plate portion 51a is also possible. However, it is preferable to set up a structure as in this embodiment, where the cover member 51 is elastically deformed by changing the relative distance between the pair of gripping portions 54 to switch the above-mentioned locking position and locking release position. Thus, the above-mentioned locking position and locking release position can be switched with a simple structure.

[0107] like Figure 1 , Figure 2 As shown, a receiving portion 55 is formed on the cover member 51 of this embodiment. Specifically, the flange plate portion 51c of the cover member 51 does not surround the entire area around the top plate portion 51a when viewed in plan view. That is, there are positions around the top plate portion 51a where the flange plate portion 51c is not provided when viewed in plan view. At these positions where the flange plate portion 51c is not provided, the portion extending outside the biological body from a medical device such as a guide sheath inserted into the biological body can be received. In other words, when viewed in plan view, a receiving portion 55 is provided around the top plate portion 51a at the position where the flange plate portion 51c is not provided, which can receive medical devices such as guide sheaths. Figure 1 , Figure 2 , Figures 7-9 As shown, the receiving portion 55 in this embodiment is formed by a cutout portion formed on the outer edge of the cover member 51. The cutout portion constituting the receiving portion 55 extends from the outer edge of the flange plate portion 51c of the cover member 51 to the peripheral wall portion 51b and the top plate portion 51a. In other words, in this embodiment, at the location where the receiving portion 55 is provided, there is no flange plate portion 51c and peripheral wall portion 51b. Furthermore, in this embodiment, at the location where the receiving portion 55 is provided, a recess is formed on the outer edge of the top plate portion 51a.

[0108] The receiving portion 55 is aligned with the receiving portion 6 of the pressing device 1 in the thickness direction A. That is, the cover member 51 is installed on the pressing device 1 with the receiving portion 55 and the receiving portion 6 aligned in the thickness direction A. Conversely, by aligning and installing in this way, the clamping portion 52 can clamp the retainer 22 of the pressing member 3 in the appropriate position.

[0109] By providing a receiving portion 55 on the cover member 51, the portion of a medical device such as a guide sheath inserted into the body at its distal end can be received not only in the receiving portion 6 of the compression device 1 but also in the receiving portion 55 of the cover member 51. Therefore, the compression device 1 can be easily positioned on the surface of the body in such a way that the elongated body 21 of the compression member 3 covers the wound or vicinity of the medical device such as the guide sheath inserted into the body. Furthermore, in this positioned state, the compression device 1 can be installed on the surface of the body. Therefore, even when the medical device such as the guide sheath is inserted into the body, the compression device 1 can be installed in the correct position on the surface of the body while maintaining the cover member 51. As a result, in both the state where the medical device such as the guide sheath is inserted into the body and the state after the medical device has been withdrawn from the body, the elongated body 21 of the compression member 3 of the compression device 1 can be used to compress the wound or vicinity of the body surface.

[0110] The structure of the cover member 51 is not particularly limited as long as it can be installed relative to the pressure member 3 in a state where it can contact at least a portion of the upper surface of the second part X2 of the adhesive sheet 2. Therefore, for example, the shape of each part of the cover member 51 when viewed in plan view is not particularly limited. The top plate portion 51a, the peripheral wall portion 51b, and the flange plate portion 51c of this embodiment can all be appropriately designed in accordance with the shape of the pressure device 1.

[0111] For example, resin materials can be used as the material for the cover component 51. Examples of such resin materials include ABS resin, AS resin, polyethylene, polypropylene, polystyrene, polyvinyl chloride, polyvinylidene chloride resin, polyphenylene ether, thermoplastic polyurethane, polymethyl methacrylate, polyoxyethylene, fluororesin, polycarbonate, polyamide, acetal resin, acrylic resin, polyethylene terephthalate, and other thermoplastic resins used in injection molding, as well as phenolic resin, epoxy resin, silicone resin, unsaturated polyester, and other thermosetting resins.

[0112] <Compression Method Using Compression Device 1>

[0113] Next, an example of a method for pressing a biological surface using the pressing device 1, including the method for installing the pressing device of this disclosure (hereinafter referred to as the "device installation method"), will be described. Figure 11 This is a flowchart illustrating an example of a method of applying pressure to the surface of a living organism. Figure 11 The compression method shown includes cover installation step S1, pasting step S2, cover removal step S3, first compression step S4, pull-out step S5, and second compression step S6. Figure 12A This is a diagram showing the outline of the cover installation process S1. Figure 12BThis is a diagram showing the outline of the pasting process S2. Figure 12C This is a diagram showing the outline of the cover removal process S3. Figure 12D This is a diagram showing the outline of the first pressing process S4. Figure 12E This is a diagram showing the outline of the pull-out process S5. Figure 12F This is a diagram showing the outline of the second pressing process S6.

[0114] Figure 11 , Figures 12A to 12F The illustrated compression method is a method of narrowing or blocking a perforation leading from the surface of a body to a vein by compressing the BS on the surface of the body without blocking the vein. The perforation is formed when the guide sheath of the medical device 100 is inserted into a vein, such as the femoral vein, after being pulled out from the surface of the body through connective tissue. Hemostasis can be achieved after the guide sheath of the medical device 100 has been removed using the compression method shown here. First, refer to… Figure 13A and Figure 13B This describes the perforation that occurred 100 minutes after the medical device was removed. Figure 13A This illustrates the state in which a guide sheath, as a medical device 100, is inserted from the surface of the organism (BS) through the connective tissue (CT) into the femoral vein (FV). Figure 13A The image shows three guide sheaths for the medical device 100, but there can be two or fewer, or four or more. Figure 13B It shows from Figure 13A The state shown is the state after the guide sheath of the medical device 100 has been removed. (As shown) Figure 13B As shown, a perforation P is formed between the BS on the surface of the organism and the femoral vein FV by removing the guide sheath, which serves as a medical device 100. Figure 11 , Figures 12A to 12F In the compression method shown, the femoral vein FV is not blocked, allowing for narrowing or occlusion of the perforation P. Therefore, even when stopping bleeding from veins located deep within the body surface, it is not necessary to narrow or block the vein itself, enabling more effective hemostasis. (See below for reference.) Figures 12A to 12F This section describes the details of each process, S1 to S6.

[0115] Figure 12A The diagram shows the state in which the cover member 51 is installed relative to the pressing member 3 of the pressing device 1. As described above, the cover member 51 can be installed on the pressing device 1 by covering it from the upper side. Furthermore, as described above, in this embodiment, the cover member 51 is attached to the periphery 13 of the adhesive sheet 2 (see reference 1). Figure 3 The upper surface of the device is in contact with the entire area of ​​the pressing member 3 of the pressing device 1. Furthermore, in Figure 12A The image shows the flow from the BS on the surface of the organism to the FV in the femoral vein (see reference). Figure 13A , Figure 13B The guide sheath, which serves as a medical device 100, is inserted inside the device.

[0116] exist Figure 12B The image shows a compression device 1 with a cover member 51 installed at a predetermined position on the surface BS of a living organism, with the guide sheath of the medical device 100 inserted into the organism.

[0117] exist Figure 12C The image shows the situation where the cover component 51 is removed from the compression device 1 after the compression device 1 has been installed on the surface BS of the organism.

[0118] Figure 12A , Figure 12B , Figure 12C Both show the removal of the peeling piece 4 (see reference) from the adhesive surface 11. Figure 1 The usage status of the compression device 1 after stripping (etc.).

[0119] like Figure 12A , Figure 12B As shown, the compression device 1 is attached to the surface BS of the organism while covered by the cover member 51 and the cover member 51 is integrated with it. Specifically, as Figure 12B As shown, with the portion of the guide sheath of the medical device 100 that is inserted into the body from the surface BS of the organism exposed to the outside of the surface BS of the organism being received by both the receiving part 6 of the compression device 1 and the receiving part 55 of the cover member 51, the adhesive surface 11 of the adhesive patch 2 is adhered to the surface BS of the organism.

[0120] By using the cover member 51 to attach the compression device 1 to the surface BS of the organism, the second part X2 (see reference) of the adhesive piece 2 of the compression device 1 can also be attached using the cover member 51. Figure 3 (etc.) is pressed toward the surface BS of the organism. This allows the second portion X2 of the adhesive patch 2 to be easily adhered to the surface BS of the organism. More specifically, in this embodiment, the peripheral portion 13 (see reference 51) of the adhesive patch 2 can be pressed toward the surface BS of the organism via the cover member 51. Figure 3 Press the entire area of ​​the peripheral part 13 toward the surface BS of the organism, thereby attaching the entire area of ​​the peripheral part 13 to the surface BS of the organism.

[0121] like Figure 12C As shown, after the compression device 1 is installed at a predetermined position on the surface BS of the organism, the cover member 51 is removed from the compression device 1. As described above, the cover member 51 deforms by bringing a pair of gripping portions 54 close together, thereby enabling the clamping portion 52 (see reference) to... Figure 10The distance between the components (etc.) increases. This allows the clamping portion 52 of the cover member 51 to change from a state of clamping the holding body 22 of the pressing device 1 to a state of not clamping. Therefore, the cover member 51 can be removed from the pressing device 1. However, the removal of the cover member 51 from the pressing device 1 can also be done without using the aforementioned pair of gripping portions 54. Alternatively, the cover member 51 can be pulled up against the frictional force between the cover member 51 and the pressing device 1, thereby removing the cover member 51 from the pressing device 1.

[0122] Next, as Figure 12D As shown, a syringe 30, serving as a fluid supply device, is connected to a connection 29 of a tube 28. The internal space 40a of the expander 40 (see reference 28) is supplied through the tube 28. Figure 6 Air is supplied to expand the expander 40. This allows for pre-compression of the area near the wound on the surface of the organism (BS) before the guide sheath, serving as the medical device 100, is removed from the surface of the organism (BS). In other words, the guide sheath, serving as the medical device 100, passes through the connective tissue CT (see reference) from the surface of the organism (BS). Figure 13A , Figure 13B Compression of the body surface BS begins while the medical device 100 is inserted into the femoral vein FV, which is a vein. This compression is performed before the medical device 100 is withdrawn from the body surface BS. Therefore, compression of the body surface BS can be initiated immediately after the guide sheath of the medical device 100 is withdrawn. Thus, it is possible to extend from the body surface BS to the femoral vein FV (see reference) immediately after the guide sheath is withdrawn. Figure 13A , Figure 13B The perforation P (refer to) Figure 13B (to narrow or block it)

[0123] Next, as Figure 12E As shown, the guide sheath, serving as a medical device 100, is pulled out from the surface BS of the organism. Due to the removal of this guide sheath, a [structure / condition] is formed. Figure 13B The perforation P is shown. Assuming that there is absolutely no compression of the body surface BS in this state, bleeding will occur from the femoral vein FV through the perforation P and the wound on the body surface BS. However, in the compression method shown here, as... Figure 12D As shown, the surface of the organism BS is pre-pressed before the guide sheath, which serves as the medical device 100, is removed from the surface of the organism BS. Therefore, it is possible to allow the perforation P (refer to...) to be made immediately after the guide sheath is removed. Figure 13B By narrowing or blocking the BS on the surface of the organism, the amount of bleeding immediately after the guide sheath is removed can be suppressed.

[0124] Next, as Figure 12FAs shown, the syringe 30, which serves as a fluid supply device, is reconnected to the connection 29 of the tube 28. Through the tube 28, air is supplied again to pressurize the internal space 40a of the expansion body 40 of the compression device 1, or air is evacuated to depressurize it. In other words, the pressure applied to the surface BS of the organism is adjusted after the guide sheath, which serves as the medical device 100, is withdrawn. Thus, by adjusting the pressure applied to the surface BS of the organism, the femoral vein FV (see reference) is not blocked. Figure 13A , Figure 13B ) to make the perforation P (refer to) Figure 13B It can further narrow or block the area, which can significantly reduce or stop the bleeding.

[0125] More specifically, if bleeding is confirmed after removing the guide sheath, the pressure is slowly increased to apply pressure until hemostasis is achieved. Conversely, if hemostasis is confirmed after removing the guide sheath, the pressure is slowly decreased to reduce pressure until bleeding is confirmed. Then, upon confirmation of bleeding, the pressure is slowly increased to apply pressure until hemostasis is achieved. This prevents femoral vein venous varicose vein (FV) caused by excessive pressure (see reference). Figure 13A , Figure 13B ) blockade.

[0126] Alternatively, an ultrasonic device can be used to detect whether the surface BS of a biological organism is being properly compressed. Specifically, an expander 40, which is formed as an elongation body 21, is described as being made of a material that is permeable to ultrasonic waves (see reference). Figure 6 (etc.) and a structure containing a fluid, such as a retainer 22, and supplying water to the expander 40, that is permeable to ultrasound. Therefore, it is possible to diagnose the compression state based on the compression device 1 using ultrasound. In other words, it is possible to detect the femoral vein FV (refer to...) using an ultrasound device. Figure 13A , Figure 13B Whether it is blocked. The pressure of the compression device 1 can also be adjusted based on the diagnostic results from the ultrasonic device.

[0127] By maintaining the pressure for several hours (e.g., 2 to 6 hours), hemostasis can be achieved. After hemostasis is achieved, the compression device 1 is removed from the surface BS of the organism by peeling the adhesive surface 11 of the adhesive patch 2 from the surface BS of the organism.

[0128] The compression method shown here does not block the femoral vein FV (see reference). Figure 13A , Figure 13B ) to make the perforation P (refer to) Figure 13B ( ) narrows or blocks it. In the case of venous hemostasis, it is possible to narrow or block the perforation P (refer to Figure 13B To stop bleeding, the perforation may narrow or be blocked. Conversely, in cases such as when attempting to stop bleeding in the femoral artery, even if the perforation is simply blocked, blood may leak into the connective tissue. (See CT scan for reference.) Figure 13A, Figure 13B The bleeding cannot be stopped because the femoral artery is located inside the canal. When attempting to stop bleeding in the femoral artery, a strong approach is required, such as applying strong pressure to narrow or block the artery, or sealing any openings in the arterial wall.

[0129] Therefore, in the above compression method, it is preferable to compress the surface BS of the organism to a depth of 5mm to 20mm from the surface BS. By setting the compression depth within the above range, it is easy to achieve perforation P (refer to) without blocking the vein. Figure 13B The compression state is such that it narrows or blocks the space. The compression depth is more preferably set to 5mm to 15mm, and even more preferably set to 8mm to 12mm.

[0130] Furthermore, in the aforementioned compression methods, it is preferable to apply pressure of 10 g / cm² from the surface of the organism (BS). 2 ~600g / cm 2 Apply pressure to the surface of the organism (BS). This pressure is the pressure after the guide sheath, which serves as the medical device 100, is removed, and does not represent the pressure applied before the guide sheath is removed. By setting the pressure within the aforementioned range, it is easy to achieve perforation P (refer to...) without blocking the vein. Figure 13B A compressed state that narrows or blocks the area. The compression pressure is more preferably set at 50 g / cm³. 2 ~400g / cm 2 Further optimization was set at 100g / cm³. 2 ~300g / cm 2 .

[0131] Additionally, it is preferable to proceed along the perforation P (reference). Figure 13B The compression device 1 of this embodiment can compress the surface BS of the organism in a direction orthogonal to the extension direction of the perforation. "Compression along a direction orthogonal to the extension direction of the perforation" means that it is not limited to compression only in a direction orthogonal to the extension direction of the perforation, but also includes compression in a direction inclined at an angle less than a specified angle (e.g., less than 30 degrees) relative to the direction orthogonal to the extension direction of the perforation. Figure 13B The direction of extension of the BS is orthogonal to the direction of compression on the surface of the organism.

[0132] Specifically, in this embodiment, the first expansion portion 41a and the second expansion portion 41b of the expansion body 40 can expand in a direction inclined relative to the sheet thickness direction A, as described above. Therefore, it can expand along the direction relative to the perforation P (refer to...). Figure 13B The direction of extension of the ) is perpendicular to the direction of compression on the surface of the organism. Specifically, such as... Figure 13A , Figure 13BAs shown, the guide sheath of the medical device 100 is inserted in a direction tilted to one side relative to the direction orthogonal to the surface BS of the organism, rather than in a direction orthogonal to the surface BS of the organism (the same direction as the sheet thickness direction A). Therefore, as Figure 13B As shown, the extension direction of the perforation P is also inclined relative to the direction orthogonal to the surface BS of the organism. Therefore, as long as the first expansion portion 41a and the second expansion portion 41b are configured to expand in a direction that is inclined to the opposite side of the extension direction of the perforation P relative to the sheet thickness direction A, which is orthogonal to the surface BS of the organism (hereinafter referred to as "inclination direction F"), it is easy to press the surface BS of the organism in a direction orthogonal to the extension direction of the perforation P. As a result, it is easy to achieve non-blocking. Figure 13A , Figure 13B Compression devices 1 that narrow or block the perforation P of the femoral vein FV and other veins. Figure 14 This indicates that the compression device 1 is used to... Figure 13B The diagram shows the state where the perforation P becomes narrowed or blocked. (See figure.) Figure 14 As shown, according to the compression device 1, it is easier to further narrow or block the perforation P by not blocking the femoral vein FV and other veins.

[0133] according to Figure 11 , Figures 12A to 12F The compression method shown allows for perforation P (refer to) without blocking veins such as the femoral vein FV. Figure 13B By narrowing or blocking the area, hemostasis can be achieved. In particular, by using the compression device 1 to achieve the above-mentioned compression method, hemostasis can be achieved in a simple way without relying on the hands of medical practitioners to apply pressure or using hemostatic instruments on a large scale.

[0134] <Based on the pressure exerted by the compression device 1 on the surface of the organism>

[0135] like Figure 14 As shown, in the compression device 1, the expansion body 40 of the compression member 3 is able to be oriented in a vertical direction relative to the surface BS of the organism while the adhesive patch 2 is installed on the organism (in... Figure 14 The middle direction is the same as the thickness direction A. Figure 14 The vertical direction (hereinafter referred to as "vertical direction") is the inclined direction F, which presses against the surface of the organism. Therefore, as... Figure 14 As shown, it is easy to narrow or block the perforation P without blocking veins such as the femoral vein FV.

[0136] Figure 15 Observation from the BS side of the organism's surface Figure 14 The main view showing the state. In other words, Figure 15This shows a frontal view of the part of the organism's surface BS at the location where it is being pressed by the compression device 1. Here, "frontal view of the part of the organism's surface at the location where it is being pressed by the compression device" refers to the state of the part of the organism's surface that is being pressed by the compression device, observed from a direction perpendicular to that part before compression. Figure 15 The image shows a frontal view of the groin area. Figure 15 In the frontal view shown, the direction in which the BS on the surface of the organism is compressed (refer to...) Figure 15 The white arrow “AR1” and the insertion direction of the guide sheath from the surface of the organism BS toward the vein in the extension direction G of the perforation P (refer to) Figure 15 The white arrow "AR2" is opposite. That is, the direction in which the compression device 1 compresses the surface BS of the organism is in... Figure 15 As shown in the frontal view, it is opposite to the insertion direction G1 of the guide sheath. Therefore, it is easy to perforate P (refer to...) without blocking veins such as the femoral vein FV. Figure 13B , Figure 14 (to narrow or block it)

[0137] In other words, such as Figure 14 As shown, the extension direction G of the perforation P is inclined relative to the surface BS of the organism, and also relative to the vertical direction perpendicular to the surface BS of the organism (in Figure 14 The center (in the vertical direction) is tilted. Additionally, as... Figure 14 As shown, the compression direction of the compression device 1 on the surface BS of the organism is also inclined relative to the surface BS of the organism, and also relative to the vertical direction perpendicular to the surface BS of the organism (in Figure 14 The center (in the vertical direction) is tilted. Furthermore, as... Figure 14 As shown, the extension direction G of the perforation P is relative to the aforementioned vertical direction (in Figure 14 The pressure (vertical direction) is tilted to the opposite side of the tilting direction F, which is the direction of pressure applied to the surface of the organism by the pressure device 1. In other words, the pressure applied to the surface of the organism by the pressure device 1 is performed in a manner in which its pressure direction intersects with the extension direction G of the perforation P. As a result, the perforation P can be effectively narrowed or blocked.

[0138] The compression device components and installation method disclosed herein are not limited to the specific structures and processes shown in the above embodiments. Various modifications and alterations can be made as long as they do not depart from the description in the claims. Figure 16 This is a diagram showing a modified example of the compression device assembly 2000, which is a compression device assembly 1000 described above.

[0139] Figure 16 The pressure device assembly 2000 shown is the same as the pressure device assembly 1000 described above (see reference). Figure 1Compared to other components, the structure used to lock the cover member relative to the pressing device differs, while other structures are common. Therefore, this section mainly describes the structure in the pressing device assembly 2000 that differs from that in the pressing device assembly 1000 (see reference 1000). Figure 1 Differences between (etc.).

[0140] Figure 16 This is a cross-sectional view of the compression device assembly 2000 in its installed state. Figure 16 It is related to the aforementioned compression device assembly 1000 (refer to...) Figure 1 (etc.) Figure 10 A cross-sectional view of the compression device assembly 2000 at the same location as the cross-section shown. (See also...) Figure 16 As shown, the cover member 51 includes side-end engaging portions 252. The side-end engaging portions 252 engage with the opposite portions of the side end faces 22b of the retainer 22 of the pressing device 1. Figure 16 In the example shown, the side engagement portion 252 is composed of a pair of first plate portions 51b1 of the cover member 51.

[0141] Here, a protrusion 252a is provided on the side end engaging portion 252 of the cover member 51. Additionally, a recess 22b1 that engages with the protrusion 252a is provided on the opposite portion of the side end face 22b of the retainer 22. Figure 16 In the example shown, by making the relative distance between the pair of gripping parts 54 ( Figure 16 The distance between the left and right sides can be varied to switch the locking position where the protrusion 252a and the concave part 22b1 are engaged, and the locking release position where the protrusion 252a is not engaged with the concave part 22b1.

[0142] More specifically, in this embodiment, the cover member 51 has protrusions 252a on opposite surfaces of a pair of first plate portions 51b1. Furthermore, recesses 22b1 are formed on opposite portions of the side end faces 22b of the retainer 22 sandwiched between the pair of first plate portions 51b1. By replacing clamping based on clamping or by providing such fitting protrusions and recesses, the clamping state of the cover member 51 and the pressing device 1 can be made more stable.

[0143] exist Figure 16In the example shown, a protrusion 252a is provided on the cover member 51 and a recess 22b1 is provided on the pressing device 1, but the structure is not limited to this. A recess may be provided on the cover member 51 and a protrusion on the pressing device 1. Alternatively, both a protrusion and a recess may be provided on the cover member 51, and a recess that engages with the protrusion of the cover member 51 and a protrusion that engages with the recess of the cover member 51 may be provided on the pressing device 1. In other words, any structure that achieves the locking state of the cover member 51 and the pressing device 1 by the engagement of the side end engaging portion 252 of the cover member 51 and the side end face 22b of the retainer 22 of the pressing device 1 with concave and convex portions is acceptable, and the shape of the concave and convex portions is not particularly limited.

[0144] exist Figure 16 In the cover member 51 shown, a cover portion 53 protruding from the side end engaging portion 252 in the inward direction B is also provided, similar to the embodiment described above. When the side end engaging portion 252 is partially engaged with the side end face 22b of the retainer 22, the cover portion 53 engages with at least a portion of the second portion X2 of the adhesive sheet 2 (in... Figure 16 In the example shown, the upper surface of the entire area of ​​the peripheral part 13 is in contact.

[0145] Industrial applicability

[0146] This disclosure relates to compression equipment and methods for installing such equipment.

[0147] Explanation of reference numerals in the attached figures

[0148] 1: Compression equipment

[0149] 2: Adhesive sheet

[0150] 3: Compression components

[0151] 4: Peeling tablets

[0152] 6: Reception Department

[0153] 11: Adhesive Surface

[0154] 12: Mounting surface

[0155] 13: Surrounding Area

[0156] 21: Elongated body

[0157] 21a: Contact part

[0158] 21b; Pressing part

[0159] 22: Maintain body

[0160] 22a: Through hole

[0161] 22b: Side end face

[0162] 22b1: concave part

[0163] 22c: Carding protrusion

[0164] 28: pipe

[0165] 29: Connecting part

[0166] 30: Syringe

[0167] 40: Expansion body

[0168] 40a: Interior space

[0169] 41a: First expansion section

[0170] 41a1: First internal space

[0171] 41b: Second expansion section

[0172] 41b1: Second Internal Space

[0173] 42: Extension Installation Section

[0174] 51: Cover component

[0175] 51a: Top plate section

[0176] 51a1: Top plate opening

[0177] 51b: Peripheral wall portion

[0178] 51b1: First plate section

[0179] 51b2: Second plate section

[0180] 51c: Flange plate portion

[0181] 51d: Holding plate section

[0182] 52: Clamping part

[0183] 53: Sheet cover section

[0184] 54: Control Department

[0185] 55: Reception Department

[0186] 100: Medical devices

[0187] 252: Side-end locking part

[0188] 252a: convex part

[0189] 1000, 2000: Compression equipment components

[0190] A: Thickness direction

[0191] A1: Below

[0192] A2: Above

[0193] B: In-plane direction

[0194] F: Inclination direction

[0195] G: Direction of perforation extension

[0196] G1: Insertion direction of the guide sheath

[0197] H: In-plane direction of the surface of an organism

[0198] BS: Surface of organisms

[0199] CT scan: Connective tissue

[0200] FV: Femoral vein

[0201] P: Perforation

[0202] X1: Part 1 of the adhesive patch

[0203] X2: Part 2 of the patch.

Claims

1. A compression device assembly, characterized in that, have: A compression device that can be adhered to the surface of a living organism and can compress the surface of the organism; and The cover component is detachable from the compression device. The compression device includes: An adhesive patch having an adhesive surface on its lower surface capable of adhering to the surface of the organism; and A compression member is fixed to the upper surface of the adhesive patch and is capable of compressing the surface of the organism while the adhesive surface of the adhesive patch is adhered to the surface of the organism. The adhesive patch has a first portion that contacts the pressure member and a second portion that does not contact the pressure member. The compression member includes: Elongated bodies capable of stretching; and A retainer that holds the elongated body in a manner that allows it to elongate in the thickness direction of the adhesive sheet. The cover component includes: A clamping portion that clamps the opposite portions of the side end faces of the retainer located in the in-plane direction, wherein the in-plane direction is orthogonal to the sheet thickness direction; and The cover portion, which protrudes inward from the clamping portion, is capable of contacting at least a portion of the upper surface of the second part of the adhesive sheet while the clamping portion is holding the opposite portion of the side end face of the holder. The cover member can be mounted relative to the retainer in a state where it can contact the upper surface of at least a portion of the second part of the adhesive piece, and is locked relative to the retainer by engaging with the side end face of the retainer.

2. The compression device assembly according to claim 1, characterized in that, The second portion of the adhesive sheet has a peripheral portion that is located on the outer side compared to the outer edge of the retainer when viewed in a plane from the thickness direction of the sheet. The cover member can be mounted relative to the retainer in a state where it can contact the upper surface of the entire area of ​​the peripheral portion.

3. The compression device assembly according to claim 1, characterized in that, The cover member has a pair of gripping portions extending from the clamping portion in the sheet thickness direction. By changing the relative distance between the pair of gripping parts, a locking position and a locking release position can be switched, wherein in the locking position, the gripping parts clamp the opposite portions of the side end faces of the retainer, and in the locking release position, the gripping parts do not clamp the opposite portions of the side end faces of the retainer.

4. The compression device assembly according to claim 1, characterized in that, The cover component has a side-end engaging portion that engages with the opposite portion of the side end face of the retainer. The cover portion protrudes from the side-end engaging portion inwards towards the sheet surface, and is able to contact at least a portion of the upper surface of the second part of the adhesive sheet while the side-end engaging portion is engaged with the opposite portion of the side end face of the retainer. A protrusion is provided on one of the opposing portions of the side end engagement portion and the side end face of the retainer. A recess or hole is provided on the other side of the opposite portion of the side end face of the retainer to engage with the protrusion.

5. The compression device assembly according to claim 4, characterized in that, The cover member has a pair of holding portions extending from the side end engaging portion in the direction of sheet thickness. By changing the relative distance between the pair of gripping parts, it is possible to switch between the locking position where the protrusion engages with the recess or the hole, and the locking release position where the protrusion does not engage with the recess or the hole.

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