JP7301217B2 - compression device - Google Patents

Description

The present disclosure relates to compression devices and methods of applying compression devices.

In recent years, various types of examinations and treatments have been performed using catheters in medical institutions. A catheter is percutaneously inserted into a blood vessel through a puncture site formed in, for example, the wrist or groin, and carried through the blood vessel to a target site for examination or treatment. After examination and treatment by a medical professional are completed, the elongated insertion member such as the puncture needle, catheter, and sheath used for introducing the catheter into the body should be removed from the puncture site, and the puncture site should be treated to stop bleeding. do.

Patent Literature 1 discloses a dressing as a compression device that applies compression to a patient's wound after removing the sheath. The dressing of U.S. Pat. No. 5,400,002 comprises an inflatable bladder having a deflated state in which the membrane is adjacent to the end wall and an inflated state in which the membrane is spaced from the end wall. The dressing of U.S. Patent No. 5,200,003 also includes retaining means for retaining the bladder against the patient's skin in a position substantially covering the wound. U.S. Pat. No. 6,200,405 discloses a retention means comprising a flexible web connected to and projecting outwardly from the end wall of the bladder, one side of which is adapted to adhere to the patient's skin. An adhesive layer is provided for adhesion.

Japanese Patent Publication No. 2005-521464

In the dressing as a compression device described in Patent Document 1, the adhesive layer provided on one side of the flexible web is adhered to the skin as the biological surface of the patient, and the bladder is inflated, thereby The patient's wound can be compressed.

However, with the dressing described in Patent Document 1, there is still room for improvement in terms of efficiency in aligning the bladder to a predetermined compression position on the living body surface.

An object of the present disclosure is to provide a compression device that can be easily positioned at an appropriate position on a living body surface, and a method of attaching the compression device.

A compression device according to a first aspect of the present disclosure includes an adhesive sheet having an adhesive surface that can be attached to a surface of a living body, and a compression member fixed to the adhesive sheet and capable of pressing the surface of the living body. and the pressing member is fixed to the adhesive sheet on the side opposite to the adhesive surface and a pressing body that can press the biological surface by extending in the thickness direction of the adhesive sheet. and a holding body that holds the pressing body so as to be extensible in the thickness direction, wherein the holding body includes a translucent portion having translucency in the thickness direction, and the sticking surface of the sticking sheet. a marker part provided on the lower surface of the light-transmitting part facing the surface of the living body in a state in which is attached to the surface of the living body, and being visually identifiable through the light-transmitting part.

As one embodiment of the present disclosure, the pressing body is arranged between the biological surface and the holding body in a state in which the adhesive surface of the adhesive sheet is adhered to the biological surface, At least a portion of the marker portion is provided at a position overlapping the extended portion of the pressing body in plan view in the thickness direction.

As one embodiment of the present disclosure, the marker section includes a region marker that defines a predetermined region in the translucent section in plan view in the thickness direction.

As one embodiment of the present disclosure, the region marker is a frame line marker that divides the predetermined region in the translucent portion with a frame line in plan view in the thickness direction.

As one embodiment of the present disclosure, the marker portion is positioned within the predetermined region defined by the region marker in a plan view in the thickness direction, and indicates a predetermined position within the predetermined region. including position markers to indicate.

As one embodiment of the present disclosure, the position marker is a line segment marker extending arcuately in plan view in the thickness direction.

As a second aspect of the present disclosure, a method for attaching a compression device includes: an adhesive sheet having an adhesive surface that can be attached to a surface of a living body; and a pressure member capable of applying pressure to the surface of the living body, wherein the pressure member can press the surface of the living body by extending in the thickness direction of the adhesive sheet. and a holding body that is fixed to the adhesive sheet on the side opposite to the sticking surface and holds the pressing body so as to be extensible in the thickness direction. a light-transmitting part having light-transmitting properties in a direction; a marker part that is visually identifiable through the translucent part, wherein an insertion portion of a medical tubular member inserted into the living body from the surface of the living body, which is located on the same plane as the surface of the living body, is marked by the marker part. The adhesive sheet is adhered to the surface of the living body while being aligned with the body.

As one embodiment of the present disclosure, the marker section includes a region marker that defines a predetermined region of the translucent section in plan view in the thickness direction, and is inserted into the living body from the surface of the living body. The adhesive sheet is adhered to the surface of the living body in a state in which all of the insertion portion of the tubular member for medical use located on the same plane as the surface of the living body is positioned within the area marker.

As one embodiment of the present disclosure, the marker portion is located within the predetermined region defined by the region marker in a plan view in the thickness direction, and is a position indicating a predetermined position within the region. all of the insertion portion of the medical tubular member that includes a marker and is positioned on the same plane as the surface of the living body in the medical tubing that is inserted into the living body from the surface of the living body, and is aligned with the region marker; and attaching the adhesive sheet to the surface of the living body while aligning a part of the insertion portion with the position marker.

SUMMARY OF THE INVENTION An object of the present disclosure is to provide a compression device that can be easily positioned at an appropriate position on a living body surface, and a method for attaching the compression device.

1 is a top perspective view of a compression device according to a first embodiment of the present disclosure; FIG. 2 is a top view of the compression device shown in FIG. 1; FIG. 2 is a bottom view of the compression device shown in FIG. 1; FIG. Figure 2 is an exploded perspective view of the compression device shown in Figure 1; 2 is a cross-sectional view of the compression device shown in FIG. 1 with the extension in a contracted configuration; FIG. 2 is a cross-sectional view of the compression device shown in FIG. 1 with the extension portion in the expanded configuration; FIG. 2 is a flow chart showing an example of a method of compressing a living body surface using the compression device shown in FIG. 1, including a method of attaching the compression device, according to an embodiment of the present disclosure; It is a figure which shows the outline|summary of the sticking process of FIG. It is a figure which shows the outline|summary of the sticking process of FIG. It is a figure which shows the outline|summary of the 1st compression process of FIG. It is a figure which shows the outline|summary of the withdrawal process of FIG. FIG. 8 is a diagram showing an outline of a second pressing step of FIG. 7; Fig. 10 is a top view of a single holder of a compression device according to a second embodiment of the present disclosure; Fig. 10 is a top view of a single holder of a compression device according to a third embodiment of the present disclosure; Fig. 10 is a bottom view of a compression device according to a fourth embodiment of the present disclosure with the pressing body removed; FIG. 5 is a schematic diagram for explaining the effect of the marker portion provided on the lower surface of the holder in the compression device of the embodiment of the present disclosure; FIG. 4 is a diagram showing a state in which the medical insertion member is inserted into the femoral vein from the surface of the living body through the connective tissue. FIG. 12B is a diagram showing a state after the medical insertion member is removed from the state shown in FIG. 12A. Figure 12C shows the compression device shown in Figure 1 constricting or occluding the perforation shown in Figure 12B; 14 is a front view of the state shown in FIG. 13 as viewed from the surface of the living body; FIG.

Hereinafter, embodiments of a compression device and a method of attaching the compression device according to the present disclosure will be described with reference to the drawings. The same reference numerals are given to the members and parts that are common in each figure.

[First embodiment]
1-6 illustrate a compression device 1 according to one embodiment of the present disclosure. Specifically, FIG. 1 is a perspective view of the compression device 1 as viewed from above. 2 and 3 are plan views of the compression device 1. FIG. Specifically, FIG. 2 is a top view of the compression device 1 . FIG. 3 is a bottom view of the compression device 1. FIG. FIG. 4 is an exploded perspective view of the compression device 1. FIG. 5 and 6 are cross-sectional views of the compression device 1 at the same cross-section. 5 and 6 show different states of the compression device 1, details of which will be described later.

A compression device 1 comprises an adhesive sheet 2 and a compression member 3 .

The adhesive sheet 2 has an adhesive surface 11 on one side in the thickness direction A that can be attached to the surface of a living body. A compression member 3 is attached to the adhesive sheet 2 . Specifically, the compression member 3 is fixed to the adhesive sheet 2 on the side opposite to the adhesive surface 11 . The pressing member 3 can press the surface of the living body while the sticking surface 11 is stuck to the surface of the living body. In this manner, the compression device 1 is fixed in position on the surface of the living body by attaching the sticking surface 11 to the surface of the living body. According to the compression device 1, a predetermined site on the surface of the living body can be compressed by the compression member 3 while the adhesive surface 11 of the adhesive sheet 2 is stuck on the surface of the living body. The predetermined site on the surface of the body includes, for example, a wound on the surface of the body formed by inserting a medical insertion member such as a puncture needle, a catheter, or a sheath into a blood vessel of the body, or its vicinity. After the above-described medical insertion member is removed from the body, bleeding can be stopped by pressing the wound on the surface of the body or its vicinity with the compression member 3 for a predetermined period of time.

More specifically, the pressing member 3 comprises a pressing body 4 and a holding body 5 . The pressing body 4 can press the surface of the living body by extending in the thickness direction A of the adhesive sheet 2 . The holder 5 is fixed to the adhesive sheet 2 on the side opposite to the adhesive surface 11, and holds the pressing member 4 so as to be extensible in the thickness direction A. As shown in FIG.

The holder 5 includes a translucent portion 41 and a marker portion 42 .

The translucent part 41 is a part having translucency in the thickness direction A. As shown in FIG. A portion having translucency in the thickness direction A means a portion that is translucent or transparent in the thickness direction A. The translucent part 41 may be colored and transparent. The color of the translucent portion 41 is not particularly limited.

The marker portion 42 can be visually identified through the translucent portion 41 . The marker part 42 is provided on the lower surface of the translucent part 41 facing the surface of the living body when the sticking surface 11 of the sticking sheet 2 is stuck to the surface of the living body.

By providing such a marker portion 42, the occurrence of positional deviation due to the thickness of the holder 5 in the thickness direction A can be suppressed. Details of this will be described below with reference to FIG. FIG. 11 shows a state in which part of the outer surface of the insertion portion 100a of the medical insertion member 100 such as a sheath positioned on the same plane as the living body surface is positioned with respect to the marker portion 42 provided on the lower surface of the holder 5. It is a schematic diagram for explaining. In other words, FIG. 11 is a schematic diagram for explaining the effect of the marker portion 42 provided on the lower surface of the holder 5. As shown in FIG. FIG. 11 also shows a marker portion 1042 as a comparative example provided on the upper surface of the holder 5 . When the marker portion 1042 is provided on the upper surface of the holder 5 , the marker portion 1042 is separated from the biological surface on the lower surface side of the holder 5 by at least the thickness of the holder 5 . Therefore, when the marker portion 1042 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. 11) deviated from the planar view, the marker portion 1042 and A predetermined position on the living body surface (part of the outer surface of the insertion portion 100a in FIG. 11) may be displaced. On the other hand, in the present embodiment, since the marker portion 42 is provided on the lower surface of the holding body 5, the positional deviation due to the difference in viewpoint is less likely to occur. In other words, providing the marker portion 42 on the lower surface of the holder 5 makes it easier to attach the compression device 1 to an appropriate position on the surface of the living body.

The configuration of the marker portion 42 is not particularly limited as long as it can be visually identified through the translucent portion 41 . The marker portion 42 may be configured by, for example, an uneven portion configured by a single convex portion or a collection of a plurality of convex portions that protrude from the lower surface of the light-transmitting portion 41 of the holding body 5 . The marker portion 42 may be configured by, for example, a concave portion such as a groove portion formed on the lower surface of the translucent portion 41 of the holding body 5 . The marker portion 42 may be configured to be identifiable by forming a portion having a lower transmittance than the translucent portion 41, such as an opaque portion. The marker portion 42 may be configured to be identifiable by, for example, having a color different from that of the translucent portion 41 . In such cases, the marker portion 42 may be translucent or transparent. The marker portion 42 may be made of, for example, a paint or the like laminated on the lower surface of the translucent portion 41 . Also, the marker portion 42 may be configured by a convex portion, a concave portion, or the like integrally formed with the translucent portion 41 . As described above, the marker portion 42 is not particularly limited as long as it is visually identifiable through the translucent portion 41 in a plan view, particularly a top view (see FIG. 2) under the usage environment.

In a plan view of the compression device 1 in the thickness direction A (see FIGS. 2 and 3), an area outside the outer edge of the holding body 5 is an area where the adhesive sheet 2 is not arranged. A receiving portion 6 capable of receiving a member 100 (see FIG. 8A, etc.) is provided. More specifically, the adhesive sheet 2 of the present embodiment includes a first portion X1 overlapping the holder 5 and a holder X1 in a plan view of the compression device 1 in the thickness direction A (see FIGS. 2 and 3). and a second portion X2 that does not overlap with 5. As shown in FIG. 2 , in the top view of the compression device 1 , most of the outer periphery of the outer edge of the holder 5 of this embodiment is surrounded by the second portion X2 of the adhesive sheet 2 . In other words, the outer edge of the holding body 5 of the compression device 1 of this embodiment has only a part of the outer edge where the second part X2 of the adhesive sheet 2 is not arranged. The receiving portion 6 of the present embodiment is configured by a region around the holder 5 where the second portion X2 of the adhesive sheet 2 is not arranged.

The receiving part 6 of the present embodiment is defined by a region where the adhesive sheet 2 is not arranged outside the outer edge of the holding body 5 in a plan view (see FIGS. 2 and 3) of the compression device 1 viewed in the thickness direction A. configured, but not limited to this configuration. The receiving portion 6 may be a region defined by a concave portion on the outer edge of the adhesive sheet 2 . For example, in a plan view of the compression device 1 in the thickness direction A (see FIGS. 2 and 3), a recessed portion recessed from the surroundings is formed in a part of the outer edge of the adhesive sheet 2 outside the outer edge of the holder 5 . may be formed. In such a case, the receiving portion 6 may be defined by the recess. That is, the receiving portion 6 is formed in a region where the adhesive sheet 2 is arranged outside the outer edge of the holder 5 in a plan view of the compression device 1 in the thickness direction A (see FIGS. 2 and 3). may be In other words, the position where the receiving portion 6 is formed is such that the adhesive sheet 2 is arranged outside the outer edge of the holder 5 in a plan view of the compression device 1 in the thickness direction A (see FIGS. 2 and 3). It is not limited to areas that are not covered.

Although the compression device 1 of this embodiment is provided with the receiving portion 6 described above, a compression device that does not have the receiving portion 6 may be used. However, by providing the receiving portion 6, the compression device 1 is arranged such that the part of the medical insertion member 100 (see FIG. 8A etc.) that extends outside the living body passes through the receiving portion 6, It can be attached to a living body surface. As a result, even if the medical insertion member 100 (see FIG. 8A, etc.) has a portion that extends outside the living body, the compression device 1 can be easily attached to a desired position on the surface of the living body.

The translucent part 41 and the marker part 42 of the present embodiment are arranged on the side of the receiving part 6 where the extension part 8 (described later) of the pressing body 4 is located, in a plan view of the compression device 1 in the thickness direction A. are located adjacent to each other. Further, in the present embodiment, the maximum width of the marker portion 42 is smaller than the maximum width of the later-described extension portion 8 of the pressing body 4 in a plan view of the compression device 1 in the thickness direction A. The maximum width of the marker portion 42 in this embodiment means the maximum width of the area marker 7a described later in the width direction B as shown in FIG. Further, the maximum width of the extension portion 8 in this embodiment means the maximum width of the extension 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 extension portion 8 of the pressing body 4 are arranged in a plan view of the compression device 1 in the thickness direction A. .

Further, in the present embodiment, the maximum width of the marker portion 42 is smaller than the minimum width of the receiving portion 6 in a 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.

Although details will be described later, the marker section 42 of the present embodiment includes both the region marker 7a and the position marker 7b. The region marker 7a defines a predetermined region in the translucent portion 41 in a plan view of the compression device 1 in the thickness direction A. As shown in FIG. The region marker 7a of this embodiment defines a region in which the pressing body 4 can compress the surface of the living body with a compression force equal to or greater than the first predetermined value while the compression device 1 is attached to the surface of the living body. The position marker 7b is positioned within a predetermined area defined by the area marker 7a in a plan view of the compression device 1 in the thickness direction A, and indicates a predetermined position within this predetermined area. The position marker 7b of the present embodiment aligns a part of the outer surface of the insertion portion 100a (see FIG. 8A) of the medical insertion member 100 (see FIG. 8A) located on the same plane as the living body surface as a predetermined position. It shows the reference position for More specifically, the position marker 7b of this embodiment is used to align the medical insertion member 100 (see FIG. 8A) that requires a particularly high compressive force within a predetermined region identifiable by the region marker 7a. indicates the reference position of That is, the position marker 7b of the present embodiment is configured such that the pressing body 4 presses the surface of the living body with a force equal to or greater than the second predetermined value, which is greater than the first predetermined value, while the compression device 1 is attached to the surface of the living body. Indicates a position that can be compressed. That is, the area marker 7a indicates an area that can be compressed with a compression force equal to or greater than the first predetermined value, and the position marker 7b indicates a position that can be compressed with a compression force of a second predetermined value larger than the first predetermined value. there is Therefore, in this embodiment, the medical insertion member 100 (see FIG. 8A) that requires a high compressive force, such as a sheath with a large diameter, is aligned in the region marker 7a using the position marker 7b. preferably. The above-described compression forces such as the first predetermined value and the second predetermined value are measured when the compression device 1 is properly attached to the surface of the living body and used under predetermined usage conditions. value. "Predetermined conditions of use" means conditions determined by a person who manufactures or sells the compression device 1, such as the amount of fluid for expanding the expansion portion 8 of the compression device 1, which will be described later.

As described above, the marker section 42 of this embodiment includes both the region marker 7a and the position marker 7b, but is not limited to this configuration. The marker section 42 may be composed of, for example, only one of the region marker 7a and the position marker 7b.

The details of each member and each part of the compression device 1 of this embodiment will be described below.

<Adhesive sheet 2>
The adhesive sheet 2 has the adhesive surface 11 on one side in the thickness direction A, as described above. The adhesive sheet 2 also has an attachment surface 12 to which the compression member 3 is attached on the other side in the thickness direction A, ie, the side opposite to the adhesive surface 11 . The adhesive sheet 2 has flexibility. Therefore, the adhesive 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 surface of the living body. As a result, unintentional detachment of the compression device 1 from the surface of the living body can be suppressed.

More specifically, the adhesive surface 11 of the adhesive sheet 2 of this embodiment is configured by the lower surface of the adhesive sheet 2 . Further, the attachment surface 12 of the adhesive sheet 2 of this embodiment is configured by the upper surface of the adhesive sheet 2 .

Hereinafter, for convenience of explanation, one side in the thickness direction A, which is the direction from the mounting surface 12 toward the sticking surface 11 in the thickness direction A, may be simply referred to as "downward direction A1" or "lower side." For convenience of explanation, the other side of the thickness direction A, which is the direction from the sticking surface 11 to the mounting surface 12 in the thickness direction A, may be simply referred to as "upward direction A2" or "upper side". Furthermore, of the planar views of the compression device 1 along the thickness direction A of the adhesive sheet 2 (see FIGS. 2 and 3), the planar view of the adhesive sheet 2 from the mounting surface 12 side (FIG. 2 ) is simply referred to as “top view” for convenience of explanation. In addition, among the planar views of the compression device 1 along the thickness direction A of the adhesive sheet 2 (see FIGS. 2 and 3), the planar view of the adhesive sheet 2 from the adhesive surface 11 side (FIG. 3) is simply referred to as "bottom view" for convenience of explanation. In addition, when a top view and a bottom view are not distinguished, they may simply be described as a “planar view”. In addition, unless otherwise specified, simply describing "planar view", "top view", and "bottom view" means that the expanded portion 8 of the pressing body 4 of the compression member 3, which will be described later, is in a contracted form. plan view, top view, and bottom view.

The adhesive sheet 2 is composed of multiple layers including, for example, a substrate layer and an adhesive layer.

The base material layer is composed of, for example, a thin resin sheet. More specifically, the base layer is made of, for example, a white spunlace nonwoven fabric of polyester fibers, and its thickness is in the range of 5 μm to 150 μm, such as 30 μm. However, the material of the base material layer is not limited to polyester, and may be acrylic polymer, polyethylene, ethylene-vinyl acetate copolymer, polyurethane, polyamide derivative, or the like.

The adhesive layer is made of, for example, an adhesive such as a rubber adhesive, an acrylic adhesive, or a silicone adhesive. The adhesive layer is laminated on the base material layer directly or indirectly with another layer interposed therebetween. The sticking surface 11 of the sticking sheet 2 of this embodiment is composed of an adhesive layer.

The adhesive sheet 2 may further include another layer in addition to the base material layer and adhesive layer described above. The adhesive sheet 2 may include, for example, a surface layer. The surface layer is made of resin having a thickness of about 5 μm to 50 μm, for example. More specifically, polyester, polyamide, polyamide-imide, polyethylene, polypropylene, polycarbonate, polyurethane, polyvinyl chloride, fluororesin, etc. can be used as the material of the surface layer. The surface layer is laminated on the opposite side of the adhesive layer with the substrate layer interposed therebetween, either directly or indirectly with another layer interposed therebetween. Therefore, the attachment surface 12 of the adhesive sheet 2 may be composed of the surface layer.

More specifically, the adhesive sheet 2 may be composed of a non-woven fabric tape having a pressure-sensitive adhesive applied to one surface thereof. Furthermore, the adhesive sheet 2 may be composed of a double-sided tape having adhesive layers provided on both sides of the base material layer. When the adhesive sheet 2 is composed of a double-sided tape, the pressure member 3 can be fixed to the adhesive sheet 2 by adhering the holder 5 of the pressure member 3 to the adhesive layer on one side of the adhesive sheet. can.

The adhesive sheet 2 of the present embodiment has a substantially C-shaped outer shape in plan view in the thickness direction A. As shown in FIG. As shown in FIGS. 2 and 3, the adhesive sheet 2 of this embodiment covers only a portion of the lower surface side of the compression member 3 . Specifically, the adhesive sheet 2 of this embodiment covers only the outer edge region of the lower surface of the compression member 3 . The adhesive sheet 2 of this embodiment is fixed only to the outer edge region of the lower surface of the compression member 3 . In other words, the adhesive sheet 2 of this embodiment does not cover the central region of the lower surface of the compression member 3 where the expanded portion 8 of the pressing body 4 of the compression member 3 is located. Further, the adhesive sheet 2 of the present embodiment does not cover the entire outer edge region of the lower surface of the compression member 3, but partially covers the outer edge region. That is, the adhesive sheet 2 of this embodiment does not cover a part of the outer edge area of the lower surface of the compression member 3 . In this embodiment, the portion of the outer edge area of the lower surface of the compression member 3 that is not covered with the adhesive sheet 2 is the portion of the compression member 3 adjacent to the receiving portion 6 .

The adhesive surface 11 of the adhesive sheet 2 is covered with a release sheet in a pre-use state before being attached to the surface of the living body. The release sheet is removed by being peeled off from the sticking surface 11 by the user when the sticking sheet 2 is stuck to the surface of the living body. By removing the release sheet from the sticking surface 11 and exposing the sticking surface 11, the sticking surface 11 of the sticking sheet 2 is put into a state in which it can be stuck to the surface of the living body (hereinafter referred to as "use state" for convenience of explanation). 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. 1-6 is shown in use with the release sheet removed.

<Compression member 3>
As mentioned above, the compression member 3 comprises the pressing body 4 and the holding body 5 .

As described above, the pressing body 4 can press the living body surface by extending in the thickness direction A. As shown in FIG. The pressing body 4 can press the surface of the living body at a position where the adhesive sheet 2 does not exist in plan view. That is, the pressing body 4 can press the surface of the living body without the adhesive sheet 2 interposed therebetween.

The pressing body 4 of this embodiment includes an extension portion 8 and an extension portion 9 . The extension part 8 is configured to extend between the surface of the living body and the holder 5 in a state in which the sticking surface 11 of the sticking sheet 2 is stuck to the surface of the living body (hereinafter referred to as the "attached state of the compression device 1"). placed in between. The expansion part 8 can be expanded in the thickness direction A by supplying fluid while the compression device 1 is attached. That is, the pressing body 4 of this embodiment extends in the thickness direction A by expanding the expansion portion 8 in the thickness direction A. As shown in FIG. When the expansion part 8 expands while the compression device 1 is attached, the expansion part 8 receives a reaction force from the holder 5 and presses the surface of the living body. Hereinafter, the form before expansion of the expansion part 8 is described as the "contracted form" of the expansion part 8 . Further, the form in which the expansion part 8 expands from the contracted form is described as the "expansion form" of the expansion part 8 . The compression device 1 of this embodiment does not press the surface of the living body with the extension part 8 when the extension part 8 is in the contracted state in the adhered state. Conversely, the compression device 1 of the present embodiment compresses the surface of the living body with the extension part 8 when the extension part 8 is in the extended form in the attached state. FIG. 5 shows the contracted configuration of the extension 8 . FIG. 6 shows an expanded form of the expansion part 8 .

The expansion part 8 of the present embodiment defines an accommodation space 8a in which fluid such as gas can be accommodated. In addition, the expansion portion 8 of this embodiment is composed of two balloon portions 8b and 8c that are connected so that the inside thereof communicates with each other. The accommodation space 8a of this embodiment is constituted by an internal space in which the two balloon portions 8b and 8c communicate.

The expanding portion 8 can be expanded downward in the thickness direction A by supplying a fluid to the housing space 8a. The expansion part 8 of the present embodiment expands in the downward direction A1 by changing the form from the contracted form (see FIG. 5) to the expanded form (see FIG. 6), and assumes a posture capable of pressing the surface of the living body. . More specifically, when fluid is supplied to the accommodation space 8a, the expanding portion 8 receives a reaction force from the lower surface of the holder 5 and expands downward A1. The fluid supplied to the accommodation space 8a of the expansion part 8 is not limited to gas, and may be liquid.

As shown in FIG. 5, the expanded portion 8 in the contracted form is arranged along the lower surface of the holder 5 with the accommodation space 8a contracted. The housing space 8 a of the extension part 8 communicates with a tube 28 extending to the outside of the holder 5 . A fluid, such as air, is supplied through the tube 28 from a fluid supply device connected to an inflation port as a connecting portion 29 provided at the end of the tube 28 to the accommodation space 8a of the expansion portion 8 . As a result, the expansion state of the expansion portion 8 can be changed, and the expansion portion 8 can be changed from the contracted form (see FIG. 5) to the expanded form (see FIG. 6).

The extended portion 8 of the present embodiment includes a portion having translucency in the thickness direction A. As shown in FIG. More specifically, the extended portion 8 of this embodiment is composed only of a portion having translucency in the thickness direction A. As shown in FIG. That is, the extension part 8 of this embodiment is translucent or transparent in the thickness direction A. As shown in FIG. Thus, it is preferable that the extended portion 8 has at least a portion that is translucent in the thickness direction A. As shown in FIG. By doing so, the lower side of the extended portion 8 can be seen through the extended portion 8 from the upper side of the extended portion 8 . Therefore, the position of a wound or the like on the surface of the living body can be visually recognized through the extended portion 8 .

The extension portion 9 extends from the extension portion 8 . The extension part 9 has flexibility. The extended portion 9 is wound around the holder 5 . As a result, the extended portion 9 extends from the extended portion 8 to the upper surface side of the holder 5 opposite to the extended portion 8 with the holder 5 interposed therebetween. The extended portion 9 is engaged with the holder 5 on the upper surface side of the holder 5 .

Specifically, the holder 5 of the present embodiment defines a through hole 5a penetrating in the thickness direction A. As shown in FIG. The extended portion 9 of the present embodiment is wound around the holder 5 through the through hole 5a. More specifically, the extended portion 9 of the present embodiment extends from the lower side where the extended portion 8 is positioned across the holding body 5 toward the upper side, which is the opposite side. The extended portion 9 of the present embodiment is wound around the holder 5 along the inner surface of the holder 5 defining the through hole 5 a and the upper surface of the holder 5 . Further, the extended portion 9 is formed with a locking hole 9b on the upper surface side of the holder 5 into which a locking projection 5b protruding from the upper surface of the holder 5 is fitted. The extended portion 9 is positioned on the holder 5 by fitting the locking projection 5b into the locking hole 9b. The extended portion 9 is positioned on the receiving portion 6 side with respect to the extended portion 8 and is wound from the lower surface side to the upper surface side of the holding body 5 . That is, the through hole 5a of the present embodiment is located on the receiving portion 6 side with respect to the extension portion 8 . Therefore, in the cross-sectional view shown in FIG. 5 , the extended portion 8 and the extended portion 9 that constitute 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 extension portion 8 can be expanded while rotating the portion of the extension portion 9 connected to the extension portion 8 as a hinge portion 9a.

The expansion part 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 with the hinge part 9 a of the extension part 9 . As described above, the pressing body 4 of the present embodiment is configured such that the sheet-like extension part 9 is wound around the upper and lower surfaces of the holding body 5 through the through-holes 5a of the holding body 5. Fixed. Therefore, when expanded, the extension portion 8 rotates around the hinge portion 9a, which is the portion of the extension portion 9 that is connected to the extension portion 8 below the through hole 5a, as the center of rotation. Expand while moving. More specifically, the two balloon portions that constitute the expansion portion 8 of this embodiment are arranged in a state of being superimposed in the thickness direction A. As shown in FIG. Also, one end of each of these two balloon portions is attached to the extension portion 9 . That is, one end sides of the two balloon portions are restrained by the extended portion 9 . Therefore, even if the two balloon portions are inflated, the two balloon portions are not separated from each other on the one end side. On the other hand, the other end sides of the two balloon portions are not constrained at all. Therefore, when the two balloon portions are inflated, the two balloon portions are separated from each other on the other end side. That is, in the two balloon portions that constitute 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 that is not attached to the extension portion 9 is rotated. Rotate around the center of movement. Thus, the expansion part 8 of this embodiment expands in a direction inclined with respect to the thickness direction A. As shown in FIG. By forming the expanded portion 8 that expands in a direction that is inclined with respect to the thickness direction A, it becomes easier to constrict or close a perforation P (see FIG. 12B), which will be described later. Details of this will be described later (see FIG. 13). However, the configuration for expanding in the direction inclined with respect to the thickness direction A is not limited to the configuration of the pressing body 4 of this embodiment.

The extended portion 9 of the present embodiment has a portion that is translucent in the thickness direction A at a position that covers the upper surface of the holder 5 . Specifically, all the portions of the extended portion 9 of the present embodiment that cover the upper surface of the holding body 5 are formed of portions having translucency in the thickness direction A. As shown in FIG. More specifically, the elongated portion 9 of the present embodiment is sheet-like, and the elongated portion 9 has translucency in its thickness direction at an arbitrary position. However, the extension part 9 may have a structure in which, for example, only a part of the position covering the upper surface of the holding body 5 is provided with a part having translucency in the thickness direction.

The constituent material of the extended portion 8 and the extended portion 9 of the pressing body 4 is, for example, soft polyvinyl chloride, polyurethane, polyethylene, polypropylene, polyester, ethylene-vinyl acetate copolymer (EVA), silicone, or any of these. Any flexible material mixed with any material can be used.

The holding body 5 includes a main body portion 31 that is flat and has a substantially rectangular shape in a plan view, a pair of gripping plate portions 32 that protrude from the main body portion 31 in an upward direction A2 and are arranged to face each other, Prepare.

The body portion 31 is formed with the above-described through hole 5a. Further, the main body portion 31 includes the locking projection 5b that fits into the locking hole 9b of the extension portion 9 of the pressing body 4 . The extension 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 .

Further, the body portion 31 is fixed to the attachment surface 12 of the adhesive sheet 2 . Specifically, only the outer edge portion of the lower surface of the main body portion 31 is fixed to the attachment surface 12 of the adhesive sheet 2 which is substantially C-shaped in plan view. The center portion of the lower surface of the body portion 31 is not covered with the adhesive sheet 2 . Therefore, the central portion of the lower surface of the body portion 31 is not fixed to the attachment surface 12 of the adhesive sheet 2 .

Further, the main body portion 31 of the holding member 5 of the present embodiment includes the translucent portion 41 and the marker portion 42 described above. By providing the holding body 5 with the translucent part 41 and the marker part 42 , the extended part 8 of the pressing body 4 can appropriately press the pressing position on the surface of the living body to be pressed and compressed. Specifically, the marker part 42 of the present embodiment is visible through the translucent part 41 in a top view (see FIG. 2) of the compression device 1 attached to the surface of the living body. A place where the body surface can be compressed with a compression force equal to or greater than a predetermined value is shown. Therefore, the compression device 1 is mounted on the surface of the living body so that the marker portion 42 overlaps a predetermined compression position on the surface of the living body. This allows the compression device 1 to appropriately compress a predetermined compression position on the surface of the living body. A part of the marker portion 42 of the present embodiment is provided at a position overlapping the extended portion 8 of the pressing body 4 in plan view in the thickness direction A. As shown in FIG. Therefore, a portion of the marker portion 42 that overlaps the extension portion 8 in the thickness direction A may be positioned so as to overlap a predetermined pressed position on the surface of the living body through the translucent portion 41 when viewed from above. By providing the marker portion 42 in this manner, the compression device 1 can be easily attached to an appropriate position on the surface of the living body.

The marker portion 42 may not be provided at a position overlapping the pressing body 4 in plan view in the thickness direction A. It is preferably provided at a position overlapping with the extended portion 8 of the pressing body 4 in plan view. Also, the entire marker portion 42 may be provided at a position overlapping the extended portion 8 of the pressing body 4 in plan view in the thickness direction A. As shown in FIG.

Further, as described above, the marker portion 42 is provided on the lower surface of the translucent portion 41 and is not particularly limited in its configuration as long as it can be visually identified through the translucent portion 41 . Details of the marker unit 42 of the present embodiment will be described below by way of example.

As described above, the marker section 42 of this embodiment includes the region marker 7a. As described above, the area marker 7a of the present embodiment defines a predetermined area in the translucent portion 41 in plan view. Specifically, the region marker 7a of the present embodiment defines a region in which the pressing body 4 can compress the surface of the living body with a compression force equal to or greater than a first predetermined value while the compression device 1 is attached to the surface of the living body. are doing. Although the details will be described later, as shown in an enlarged example within the frame of the two-dot chain line on the left side of FIG. Even when the medical insertion member 100 is inserted, all of the insertion portions 100a (see FIG. 8A, etc.) located on the same plane as the living body surface among the plurality of medical insertion members 100 fit within the region of the region marker 7a. so that the compression device 1 can be aligned. In other words, by providing the area markers 7a, even when a plurality of medical insertion members 100 are inserted into the living body, the compression device 1 can be used to cover all the insertion portions 100a of the plurality of medical insertion members 100. It can be easily attached to an appropriate position on a living body surface that can be compressed with a predetermined compression force.

More specifically, the region marker 7a of the present embodiment is a frame line marker 7a1 that defines a predetermined region in the translucent portion 41 with a frame line in plan view. The frame line marker 7a1 as the area marker 7a can be realized, for example, by layering a resin mixed with a pigment, a colored paint, or the like on a portion of the lower surface of the translucent portion 41 of the main body portion 31 of the holder 5. is. Although the color of the frame line marker 7a1 as the region marker 7a is not particularly limited, it is preferably green. By using a greenish color, a medical worker or the like can easily visually recognize the frame line marker 7a1 on the blood or the surface of the living body. Therefore, it becomes easier to align the frame line marker 7a1 as the area marker 7a with the pressing position on the surface of the living body. Also, the frame line marker 7a1 as the area marker 7a may be configured by a convex portion protruding from the lower surface of the holder 5 or a concave portion such as a groove formed in the lower surface of the holder 5 . The details of the frame line marker configured by the concave portion will be described later (see FIG. 10).

Also, the frame line marker 7a1 as the area marker 7a of the present embodiment has a rectangular shape, but this shape is not particularly limited. The frame line marker 7a1 may have, for example, a circular shape, an oval shape, or a polygonal shape other than a square. Further, the frame line marker 7a1 as the area marker 7a of the present embodiment is partially divided by the through hole 5a of the holder 5, but the configuration is not limited to this. The frame line marker 7a1 may be provided only on the side opposite to the receiving portion 6 side with respect to the through hole 5a.

Furthermore, the region marker 7a is not limited to the frame line marker 7a1. The area marker 7a may have a configuration in which a predetermined area is bordered by the outer edge of the area filled with a predetermined color. However, by using the frame line marker 7a1 that divides a predetermined region in the translucent portion 41 with a frame line as the region marker 7a in plan view, the outline of the predetermined region becomes clear, so that the medical staff can easily determine the predetermined region. The area becomes easier to recognize.

Further, as described above, the marker section 42 of this embodiment includes the position marker 7b. As described above, the position marker 7b is positioned within the predetermined area defined by the area marker 7a in plan view. The position marker 7b of this embodiment indicates a reference position for aligning a portion of the outer surface of the insert portion 100a (see FIG. 8A), as described above. Specifically, the position marker 7b of this embodiment is used for aligning the medical insertion member 100 (see FIG. 8A) that requires a particularly high compression force within a predetermined region that can be identified by the region marker 7a. It shows the reference position. That is, the position marker 7b of the present embodiment is configured such that the pressing body 4 presses the surface of the living body with a force equal to or greater than the second predetermined value, which is greater than the first predetermined value, while the compression device 1 is attached to the surface of the living body. Indicates a position that can be compressed. Although the details will be described later, for a medical insertion member 100 (see FIG. 8A etc.) that requires a high compressive force, such as a thick sheath with an outer diameter equal to or greater than a predetermined value, an insertion portion 100a (see FIG. 8A, etc.) is positioned so as to touch or overlap the position marker 7b in plan view. The compression device 1 is mounted on the biological surface in this aligned state.

By providing the position marker 7b in addition to the region marker 7a, the medical insertion member 100 (see FIG. 8A, etc.) that requires a high compressive force, such as a sheath with a large diameter, can be positioned within the region marker 7a by the position marker 7b. A desired compression state can be achieved by aligning the positions. In other words, by providing the position marker 7b in addition to the region marker 7a, the compression device 1 can be easily placed at a more appropriate position on the body surface BS by considering the difference in compression force within the region of the region marker 7a. can be installed.

Moreover, the position marker 7b of this embodiment is the line segment marker 7b1. By using the line segment marker 7b1, regardless of the outer diameter of the medical insertion member 100 (see FIG. 8A, etc.) that is inserted into the living body from the living body surface, the medical insertion member 100 is the same as the living body surface. A portion (for example, a portion of the outer surface) of the insertion portion 100a (see FIG. 8A, etc.) located on the surface can be aligned so as to touch or overlap the line segment marker 7b1 in plan view. Unlike the region marker 7a, the line segment marker 7b1 does not define a predetermined closed region in plan view. Therefore, even if the medical insertion member 100 has an insertion portion 100a that does not match the area of the predetermined region defined by the region marker 7a or the outline of the outer edge, a part of the insertion portion 100a can be used to match the line segment marker 7b1. can be aligned. Here, the “medical insertion member 100 having an insertion portion 100a that does not match the area of the predetermined region defined by the region marker 7a or the contour of the outer edge” is, for example, an outer diameter that does not fit within the region defined by the region marker 7a. and a medical insertion member 100 having an outer diameter that allows a plurality of medical insertion members 100 to fit within the above region. Thus, by providing the line segment marker 7b1 as the position marker 7b, the compression device 1 can be easily placed at an appropriate position on the surface of the living body regardless of the outer diameter of the medical insertion member 100 inserted into the living body. can be installed.

The line segment marker 7b1 as the position marker 7b can be realized, for example, by layering a resin kneaded with a pigment, a colored paint, or the like on a part of the lower surface of the translucent portion 41 of the main body portion 31 of the holder 5. is. Although the color of the line segment marker 7b1 as the position marker 7b is not particularly limited, a greenish color is preferable. By using a greenish color, a medical worker or the like can easily visually recognize the line segment marker 7b1 on the blood or the surface of the living body. The line segment marker 7b1 as the position marker 7b may be configured by a convex portion projecting from the lower surface of the holder 5 or a concave portion such as a groove formed in the lower surface of the holder 5 . The details of the line segment marker configured by the concave portion will be described later (see FIG. 10).

The planar view shape of the line segment marker 7b1 as the position marker 7b is not particularly limited. Therefore, the shape of the line segment marker 7b1 as the position marker 7b in plan view may be, for example, a configuration extending linearly or a configuration extending in a V shape. However, as in the present embodiment, the position marker 7b is preferably a line segment marker 7b1 extending arcuately in plan view. By using the position marker 7b as the line segment marker 7b1 extending in an arc shape in a plan view, regardless of the outer diameter of the medical insertion member 100 (see FIG. 8A) inserted into the living body from the surface of the living body, A portion extending in a convex arc shape, which is a part of the outer surface of the insertion portion 100a (see FIG. 8A) located on the same plane as the living body surface of the medical insertion member 100, is aligned with the concave portion of the line segment marker 7b1. It becomes easy to perform positioning so as to enter. In other words, by using the position marker 7b as the line segment marker 7b1 extending in an arc shape in plan view, the compression device 1 can be more easily attached to an appropriate position on the surface of the living body.

Moreover, the position marker 7b is not limited to the line segment marker 7b1. The position marker 7b may be, for example, a punctate marker (see FIG. 9B). Furthermore, the position marker 7b may be composed of an aggregate of dot-like markers. An example of an aggregate of dot-like markers is a broken-line marker formed by arranging dot-like markers in a line.

The area markers 7a and the position markers 7b of the present embodiment may be opaque in the thickness direction A, but preferably translucent or transparent in the thickness direction A. Thereby, the medical staff can visually recognize the degree of overlap between the region marker 7a and the position marker 7b and the position on the living body surface to be aligned with the region marker 7a and the position marker 7b.

Furthermore, it is preferable that the translucent portion 41 of the main body portion 31 of the holder 5 extends to the outside of the marker portion 42 in plan view. By doing so, the medical staff can move the compression device 1 along the surface of the living body so that the marker part 42 is superimposed on the predetermined position on the surface of the living body. The compression device 1 can be moved while visually recognizing a range on the surface of the living body that is wider than the marker section 42 . In other words, since the translucent part 41 extends to the outside of the marker part 42 in a plan view, it becomes easier to attach the compression device 1 to an appropriate position on the surface of the living body.

As described above, the extended portion 8 and the extended portion 9 of the pressing member 4 of this embodiment are also composed of portions having translucency in the thickness direction A. As shown in FIG. In the compression device 1 of the present embodiment, the extended portion 9 of the pressing body 4, the translucent portion 41 of the holding body 5, the marker portion 42 and its surroundings, and the extended portion 8 of the pressing body 4 are laminated in the thickness direction A. It is This portion is hereinafter referred to as a "laminated portion". It is preferable that the laminated portion of the present embodiment is configured by laminating portions having translucency. By doing so, in the compression device 1 of the present embodiment, the extending portion 9 of the pressing body 4, the translucent portion 41 of the holding body 5, the marker portion 42 and its surroundings, and the extended portion 8 of the pressing body 4 , from one side in the thickness direction A to the other side. As a result, according to the compression device 1 of the present embodiment, it becomes easier to align the marker portion 42 on the surface of the living body. In this way, when the entire laminated portion is composed of a portion having translucency, it is preferable that the marker portion 42 be identifiable from all other layers of the laminated portion in plan view. . By doing so, the alignment of the marker part 42 on the surface of the living body becomes even easier.

Although the method of providing the marker portion 42 is not particularly limited, for example, printing, fusion bonding, adhesion, integral molding, or the like can be used.

At least part of the marker portion 42 of the present embodiment is provided at a position between the pair of gripping plate portions 32 in plan view. By doing so, a medical worker who operates the compression device 1 can easily visually recognize the marker portion 42 in a state in which the pair of gripping plate portions 32 are sandwiched from both sides and gripped. Therefore, the operability of the compression device 1 is improved. More specifically, in the present embodiment, part of the region marker 7a and all of the position marker 7b of the marker portion 42 are arranged between the pair of grip plate portions 32 in plan view.

A pair of gripping plate portions 32 are gripped by a medical worker. By providing such a pair of gripping plate portions 32, the compression device 1 becomes easier to hold. Therefore, the operability for medical staff can be improved.

Examples of materials for the holder 5 of the present embodiment include resin materials. Examples of the resin material include ABS resin, AS resin, polyethylene, polypropylene, polystyrene, polyvinyl chloride, polyvinylidene chloride resin, polyphenylene oxide, thermoplastic polyurethane, polymethylene methacrylate, polyoxyethylene, fluororesin, polycarbonate, and polyamide. , acetal resins, acrylic resins, polyethylene terephthalate, and other thermoplastic resins used in injection molding; and phenolic resins, epoxy resins, silicone resins, unsaturated polyesters, and other thermosetting resins.

At least the central portion of the main body portion 31 of the holder 5 is preferably made of a material having ultrasonic wave permeability. Also, the pressing body 4 described above is preferably made of a material that transmits ultrasonic waves. Further, as the fluid supplied to the accommodating space 8a of the expanded portion 8 of the pressing body 4, a fluid having ultrasonic permeability such as water or gel is used. In this way, the occlusion state of the blood vessel caused by the compression device 1 can be detected by the ultrasonic device. Details of this will be described later.

<Compression method using compression device 1>
Next, a method of compressing a living body surface using the compression device 1, including an example of a method of attaching the compression device 1 according to the present disclosure, will be described. FIG. 7 is a flow chart showing an example of a method for pressing 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 overview of the first compression step S2. FIG. 8D is a diagram showing an overview of the removal 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 that compresses the body surface BS to constrict or block the perforation leading from the body surface to the vein without occluding the vein. The perforation is formed by removing the sheath as the medical insertion member 100 inserted into a vein such as a femoral vein from the body surface BS through the connective tissue. Hemostasis after the sheath as the medical insertion member 100 is removed can be achieved by the compression method shown here. First, the perforation formed after removing the medical insertion member 100 will be described with reference to FIGS. 12A and 12B. FIG. 12A shows a state in which the sheath as the medical insertion member 100 is inserted into the femoral vein FV from the body surface BS through the connective tissue CT. In FIG. 12A, three sheaths are shown as the medical insertion member 100, but the number may be two or less, or four or more. FIG. 12B shows the 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 body surface BS and the femoral vein FV. The compression method shown in FIGS. 7 and 8A-8E allows the narrowing or occlusion of the perforation P without occluding the femoral vein FV. Therefore, even in the case of stopping bleeding from a vein located deep from the surface of a living body, the vein itself does not need to be constricted or occluded, and the bleeding can be stopped more efficiently. The details of the steps S1 to S4 will be described below with reference to FIGS. 8A to 8E.

FIG. 8A shows a state in which a sheath as a medical insertion member 100 is inserted from the body surface BS into the femoral vein FV (see FIGS. 12A and 12B). FIG. 8B shows a state in which the compression device 1 has been attached to a predetermined position on the living body surface BS with the sheath as the medical insertion member 100 inserted into the living body. In addition, in FIG. 8B, details of the alignment between the marker portion 42 and the insertion portion 100a of the medical insertion member 100 in a plan view are shown in an enlarged manner within a two-dot chain line frame. 8A and 8B show how the compression device 1 is used after the release sheet is peeled off from the sticking surface 11. FIG.

As shown in FIGS. 8A and 8B, the compression device 1 is attached to the surface of the living body by attaching the adhesive surface 11 of the adhesive sheet 2 to the surface of the living body. Specifically, as shown in FIG. 8B, the receiving portion 6 receives the portion of the sheath serving as the medical insertion member 100 that is inserted into the living body from the living body surface BS and exposed to the outside from the living body surface BS. Then, the sticking sheet 2 is stuck to the living body surface BS. Furthermore, as shown in FIG. 8B, the insertion portion 100a of the sheath as the medical insertion member 100, which is located on the same plane as the biological body surface BS, is aligned with the marker portion 42 (the frame of the two-dot chain line in FIG. 8B). (see inside). The adhesive sheet 2 is attached to the living body surface BS in such an aligned state.

More specifically, as shown in FIG. 8B, in the present embodiment, all of the insertion portion 100a of the sheath as the medical insertion member 100, which is located on the same plane as the body surface BS, is the region marker of the marker portion 42. 7a. The adhesive sheet 2 is attached to the living body surface BS in such an aligned state. By providing such region markers 7a, a plurality of markers (three markers in the left two-dot chain line frame in FIG. 8B) are provided in the body, as shown in an enlarged example within the two-dot chain line frame on the left side of FIG. 8B. Even if the medical insertion member 100 is inserted, it is possible to align all the insertion portions 100a within the area of the area marker 7a. Thereby, the compression device 1 can be easily attached to appropriate positions on the body surface BS where all the insertion portions 100a of the plurality of medical insertion members 100 can be compressed with a predetermined compression force.

Further, as shown in FIG. 8B, in the present embodiment, a thin sheath having an outer diameter less than a predetermined value is not aligned with the position marker 7b within the region marker 7a (the left two-dot chain line in FIG. 8B). ), a portion of the outer surface of the insertion portion 100a is aligned with the position marker 7b within the region marker 7a (two points on the left and right sides of FIG. See inside the dashed line frame). As described above, the position marker 7b of this embodiment indicates a position where a particularly high compression force can be obtained within the area of the area marker 7a. Therefore, even with a sheath having a large diameter, for example, which requires a high compressive force, a predetermined compressive force can be secured. Also, for example, even if both a large-diameter sheath that requires a high compressive force and a smaller-diameter sheath are included (see the frame of the two-dot chain line on the left side of FIG. 8B) By aligning the sheath with a large diameter with the position marker 7b within the region marker 7a and not aligning the sheath with a small diameter with the position marker 7b within the region marker 7a, the difference in compression force within the region marker 7a can be Based on this, the desired compression force required for each sheath can be achieved. After various types of positioning are performed in this manner, the adhesive sheet 2 is attached to the living body surface BS. By providing the position marker 7b in addition to the region marker 7a, the compression device 1 can be easily attached to a more appropriate position on the body surface BS by considering the difference in compression force within the region of the region marker 7a. can be done.

As described above, the position marker 7b of the present embodiment is the line segment marker 7b1 extending arcuately in plan view in the thickness direction A. As shown in FIG. Therefore, in the present embodiment, a portion of the outer surface of the insertion portion 100a of the medical insertion member 100 is positioned so as to contact or overlap the line segment marker 7b1 as the position marker 7b in plan view. The compression device 1 is mounted on the body surface BS in this aligned state.

Next, as shown in FIG. 8C, a syringe 30 as a fluid supply device is connected to the connecting portion 29 of the tube 28 . Air is supplied through the tube 28 to the housing space 8a (see FIG. 6) of the expanded portion 8 of the pressing body 4 of the compression device 1 to expand the expanded portion 8. As shown in FIG. By doing so, the vicinity of the wound on the body surface BS can be pressed in advance before the sheath as the medical insertion member 100 is removed from the body surface BS. In other words, the sheath as the medical insertion member 100 is inserted into the femoral vein FV as a vein from the body surface BS through the connective tissue CT (see FIGS. 12A and 12B), and the pressure on the body surface BS is started. do. In this way, the medical insertion member 100 is compressed before being removed from the biological surface BS. As a result, the living body 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 body surface BS to the femoral vein FV (see FIGS. 12A and 12B) can be constricted or occluded immediately after removal of the sheath.

Next, as shown in FIG. 8D, the sheath as the medical insertion member 100 is removed from the body surface BS. By removing the sheath, a perforation P shown in FIG. 12B is formed. If the living body surface BS is not pressed at all in this state, the femoral vein FV will bleed outside the living body through the perforation P and the wound on the living body surface BS. However, in the compression method shown here, as shown in FIG. 8C, before the sheath as the medical insertion member 100 is removed from the biological surface BS, the biological surface BS is compressed in advance. Therefore, immediately after the sheath is removed, the body surface BS can be compressed so as to constrict or block the perforation P (see FIG. 12B), and the amount of bleeding immediately after the sheath is removed can be suppressed.

Next, as shown in FIG. 8E, the syringe 30 as a fluid supply device is connected to the connecting portion 29 of the tube 28 again. Through the tube 28, the accommodation space 8a of the expanded portion 8 of the compression device 1 is pressurized by supplying air again, or depressurized by extracting air. In other words, after the sheath as the medical insertion member 100 is removed, the compressive force on the body surface BS is adjusted. By adjusting the compressive force on the body surface BS, the perforation P (see FIG. 12B) is further constricted or occluded without occluding the femoral vein FV (see FIGS. 12A and 12B), thereby reducing the amount of bleeding. It can greatly reduce or stop bleeding.

More specifically, when bleeding is confirmed after removal of the sheath, the pressure is slowly increased until hemostasis is achieved. On the other hand, when hemostasis is confirmed after removing the sheath, the pressure is slowly reduced until bleeding is confirmed. Then, after bleeding is confirmed, the pressure is slowly increased until hemostasis is achieved. By doing so, it is possible to prevent occlusion of the femoral vein FV (see FIGS. 12A and 12B) due to excessive pressurization.

Also, an ultrasonic device may be used to detect whether or not the body surface BS is appropriately compressed. Specifically, the pressing body 4 and the holding body 5 are formed of a material having ultrasonic wave permeability, and a fluid having ultrasonic wave permeability such as water is supplied to the extended portion 8 of the pressing body 4. , the state of compression by the compression device 1 can be diagnosed by ultrasound. That is, it is possible to detect whether or not the femoral vein FV (see FIGS. 12A and 12B) is occluded by the ultrasonic device. The compression force of the compression device 1 may be adjusted based on the diagnostic results obtained by the ultrasonic device.

Hemostasis can be completed by maintaining the compressed state for several hours (for example, 2 to 6 hours). After hemostasis is completed, the pressure device 1 is removed from the living body surface BS by peeling the sticking surface 11 of the sticking sheet 2 from the living body surface BS.

The compression method shown here constricts or occludes the perforation P (see FIG. 12B) without occluding the femoral vein FV (see FIGS. 12A, 12B). In the case of venous hemostasis, hemostasis can be achieved by constriction or occlusion of the perforation P (see FIG. 12B). On the other hand, for example, in the case of hemostasis of the femoral artery, even if only the perforation is closed, the blood leaks and spreads in the connective tissue CT (see FIGS. 12A and 12B), so the hemostasis cannot be achieved. In the case of hemostasis of the femoral artery, large-scale countermeasures are required, such as a method of compressing the artery so strongly as to constrict or block the artery itself, a method of closing a hole in the artery wall, and the like.

Therefore, in the compression method described above, it is preferable to compress the body surface BS to a position where the compression depth from the body surface BS is 5 mm to 20 mm. By setting the compression depth within the above range, it is easy to achieve a compressed state in which the perforation P (see FIG. 12B) is constricted or occluded without occluding the vein. The compression depth is more preferably 5 mm to 15 mm, even more preferably 8 mm to 12 mm.

Furthermore, in the above-described compression method, it is preferable to compress the body surface BS from 10 g/cm ² to 600 g/cm ² from the body surface BS. This compressive pressure is the pressure after the sheath as the medical insertion member 100 is removed, and does not mean the compressive force before the sheath is removed as described above. By setting the compressive pressure within the above range, it is easy to achieve a compressed state in which the perforation P (see FIG. 12B) is constricted or occluded without occluding the vein. The compressing pressure is more preferably 50 g/cm ² to 400 g/cm ² , still more preferably 100 g/cm ² to 300 g/cm ² .

Moreover, it is preferable to press the body surface BS along a direction orthogonal to the extending direction of the perforations P (see FIG. 12B). "Applying along the direction perpendicular to the extending direction of the perforation" is not limited to applying pressure only in the direction perpendicular to the extending direction of the perforation. It also means pressing in a direction that is inclined at a predetermined angle or less (for example, 30 degrees or less) with respect to the direction in which it is. The compression device 1 of this embodiment can compress the body surface BS along the direction orthogonal to the extending direction of the perforations P (see FIG. 12B).

Specifically, the expanding portion 8 of the pressing body 4 of the present embodiment can expand in a direction inclined with respect to the thickness direction A, as described above. By doing so, the living body surface can be pressed along the direction orthogonal to the extending direction of the perforations P (see FIG. 12B). Specifically, as shown in FIGS. 12A and 12B, the sheath as the medical insertion member 100 is not perpendicular to the surface of the body BS (the same direction as the thickness direction A), but the surface of the body BS. It is inserted in a direction inclined to one side with respect to the orthogonal direction. Therefore, as shown in FIG. 12B, the extending direction of the perforations P is also inclined with respect to the direction perpendicular to the body surface BS. Therefore, the direction inclined opposite to the extending direction of the perforations P with respect to the thickness direction A, which is the direction orthogonal to the biological surface BS (hereinafter, may be referred to as the "tilt direction F"). If the expansion part 8 is made to be expandable, it becomes easier to press the body surface BS along the direction orthogonal to the extending direction of the perforation P. This facilitates realization of the compression device 1 that narrows or closes the perforation P without closing a vein such as the femoral vein FV in FIGS. 12A and 12B. FIG. 13 shows a state in which the compression device 1 narrows or closes the perforation P shown in FIG. 12B. As shown in FIG. 13, according to the compression device 1, the perforation P can be more easily constricted or occluded without occluding a vein such as the femoral vein FV.

According to the compression method shown in FIGS. 7 and 8A to 8E, hemostasis can be achieved by constricting or occluding the perforation P (see FIG. 12B) without occluding a vein such as the femoral vein FV. . In particular, by realizing the above-described compression method using the compression device 1, it is possible to eliminate the need for manual compression by medical personnel and the use of large-scale hemostatic instruments, and to stop bleeding by a simple method.

<Compression to the living body surface by the compression device 1>
As shown in FIG. 13, in the compression device 1, the extension part 8 of the pressing body 4 of the compression member 3 extends in a vertical direction (FIG. 13 , which is the same direction as the thickness direction A, and can press the surface of the living body toward an inclination direction F that is inclined with respect to the vertical direction in FIG. By doing so, as shown in FIG. 13, the perforation P can be easily constricted or occluded without occluding a vein such as the 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. In other words, FIG. 14 shows a front view of the body surface BS at a position compressed by the compression device 1 . Here, "a front view of the surface of the living body at the position compressed by the compression device" means that the part of the surface of the living body to be compressed by the compression device is perpendicular to the part before compression. It means the state seen from the direction. FIG. 14 shows a front view of the groin. In the front view shown in FIG. 14, the direction in which the body surface BS is pressed (see the white arrow "AR1" in FIG. 14) is the insertion direction of the sheath toward the vein from the body surface BS in the extending direction G of the perforation P. It faces G1 (see white arrow “AR2” in FIG. 14). That is, the direction in which the compression device 1 compresses the body surface BS is opposite to the insertion direction G1 of the sheath in the front view shown in FIG. By doing so, the perforation P (see FIGS. 12B and 13) can be easily constricted or occluded without occluding a vein such as the femoral vein FV.

In other words, as shown in FIG. 13, the extending direction G of the perforations P is inclined with respect to the living body surface BS, and is perpendicular to the living body surface BS (vertical direction in FIG. 13). is also slanted. Further, as shown in FIG. 13, the direction in which the body surface BS is compressed by the compression device 1 is also inclined with respect to the body surface BS and is a vertical direction perpendicular to the body surface BS (vertical direction in FIG. 13). is also inclined with respect to Furthermore, as shown in FIG. 13, the extending direction G of the perforations P is on the side opposite to the inclination direction F as the direction of compression of the body surface by the compression device 1 with respect to the vertical direction (vertical direction in FIG. 13). leaning toward That is, the compression device 1 compresses the surface of the living body so that the direction of compression intersects with the extending direction G of the perforation P. As shown in FIG. Thereby, the perforation P can be efficiently constricted or occluded.

[Second embodiment]
Next, a compression device 101 as a second embodiment will be described. Here, differences from the above-described compression device 1 (see FIG. 1, etc.) will be mainly described, and descriptions of common configurations will be omitted.

FIG. 9A is a top view of the holder 105 alone of the compression device 101 of this embodiment. The compression device 101 of this embodiment differs from the compression device 1 described above in the configuration of the marker portion provided on the lower surface of the translucent portion of the main body portion of the holder.

As shown in FIG. 9A , the marker portion 142 is provided on the lower surface of the translucent portion 141 of the main body portion 131 of the holder 105 . Marker portion 142 includes two region markers. One area marker is a frame line marker, which is the same as the area marker 7a of the first embodiment described above. The other area marker is a frame line marker that further partitions a partial area within the area partitioned by the one area marker. Hereinafter, for convenience of explanation, one area marker, which is the same as the area marker 7a of the first embodiment, will be referred to as a "first area marker 107a1". Also, the other area marker is described as "second area marker 107a2".

Since the first area marker 107a1 is the same as the area marker 7a of the first embodiment, description thereof is omitted here.

The second area marker 107a2 defines a part of a predetermined area within the predetermined area defined by the first area marker 107a1 in plan view in the thickness direction A. As shown in FIG. The first area marker 107a1 means, for example, an area where a compression force equal to or greater than a first predetermined value can be achieved. The second area marker 107a2 means, for example, an area in which a compression force equal to or greater than a second predetermined value larger than the first predetermined value can be achieved. By providing the first region marker 107a1 and the second region marker 107a2 in this way, the medical insertion member 100 (see FIG. 8A, etc.) can be switched. If the second area marker 107a2 is an area where a high compressive force can be obtained as described above, the second area marker 107a2 may be, for example, a priority marker that is positioned with priority over the first area 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 defined by the second region marker 107a2, the second region in plan view A region outside the marker 107a2 and inside the first region marker 107a1 may be used for alignment. If the insertion portion 100a (see FIG. 8A etc.) of the medical insertion member 100 (see FIG. 8A etc.) can be arranged only within the region of the second region marker 107a2, the expanded portion 8 (see FIG. ) can be supplied with less fluid. Thereby, peeling of the adhesive sheet 2 (see FIG. 6, etc.) from the surface of the living body can be suppressed.

Both the first area marker 107a1 and the second area marker 107a2 of the present embodiment are partially cut off by the through hole 105a of the holder 105 in plan view, but the configuration is not limited to this. The first area marker 107a1 and the second area marker 107a2 may be provided only on one side with respect to the through hole 105a of the holder 105 in plan view.

Also, although the frame line marker as the first area marker 107a1 in this embodiment has a rectangular shape, this shape is not particularly limited. The frame line marker as the first region marker 107a1 may be circular, oval, or polygonal other than square, for example.

Furthermore, the frame line marker as the second region marker 107a2 of the present embodiment has an oval shape, but this shape is not particularly limited. A frame line marker as the second area marker 107a2 may be polygonal such as circular or rectangular, for example.

[Third Embodiment]
Next, a compression device 201 as a third embodiment will be described. Here, differences from the above-described compression device 1 (see FIG. 1, etc.) will be mainly described, and descriptions of common configurations will be omitted.

FIG. 9B is a top view of the holder 205 alone of the compression device 201 of this embodiment. The compression device 201 of this embodiment differs from the compression device 1 described above in the configuration of the marker portion provided on the lower surface of the translucent portion of the main body portion of the holder.

As shown in FIG. 9B, the marker portion 242 is provided on the lower surface of the translucent portion 241 of the main body portion 231 of the holder 205 . The marker section 242 includes a region marker 207a and a position marker 207b.

The region marker 207a of the present embodiment is a recessed marker configured by a recessed portion formed on the lower surface of the translucent portion 241 of the main body portion 231 of the holder 205 . As shown in FIG. 9B, the recessed marker as the region marker 207a is bordered in a rectangular shape by the edges of the recessed portion in plan view, and defines a predetermined region inside.

The position marker 207b of the present embodiment is a point marker arranged within a predetermined area defined by the area marker 207a in plan view. A dotted marker as the position marker 207b indicates a predetermined reference position in plan view. The predetermined reference position can be, for example, a position within the area marker 207a where a particularly high compressive force can be achieved.

The concave marker as the area marker 207a of the present embodiment has a rectangular shape in plan view, but this shape is not particularly limited. The recessed marker as the area marker 207a may have, in plan view, a circular shape, an oval shape, or a polygonal shape other than a square, for example.

Further, the dot-like marker as the position marker 207b of the present embodiment has a circular shape in plan view, but this shape is not particularly limited. A dot-like marker as the position marker 207b may have a polygonal shape such as an oval shape or a rectangular shape in plan view.

Furthermore, the marker portion 242 of the present embodiment is provided only on one side with respect to the through hole 205a of the holder 205 in plan view, but the configuration is not limited to this. The marker portions 242 may be provided on both sides of the through hole 205a in plan view.

[Fourth Embodiment]
Next, a compression device 301 as a fourth embodiment will be described. Here, differences from the above-described compression device 1 (see FIG. 1, etc.) will be mainly described, and descriptions of common configurations will be omitted.

FIG. 10 is a bottom view of the compression device 301 of this embodiment with the pressing body 4 (see FIG. 1, etc.) removed. The compression device 301 of this embodiment differs from the compression device 1 described above in the configuration of the marker portion provided on the lower surface of the translucent portion of the main body portion of the holder.

As shown in FIG. 10 , the marker portion 342 is provided on the lower surface of the translucent portion 341 of the main body portion 331 of the holder 305 . The marker section 342 includes a region marker 307a and a position marker 307b.

The region marker 307a of this embodiment is a frame line marker that divides a predetermined region by a rectangular groove formed on the lower surface of the transparent portion 341 of the holding body 305 . In addition, the position marker 307b of the present embodiment is a line segment marker that is configured by a groove portion formed in the lower surface of the translucent portion 341 of the holder 305 and that extends in an arc shape in a plan view. Thus, the region marker 307a and the position marker 307b may be configured by grooves.

The region marker 307a of the present embodiment is partially cut off by the through hole 305a of the holder 305 in plan view, but the configuration is not limited to this. The region marker 307a may be provided only on one side with respect to the through hole 305a of the holder 305 in plan view.

The frame line marker as the area marker 307a of this embodiment has a rectangular shape in plan view, but this shape is not particularly limited. The frame line marker as the region marker 307a may have, in plan view, a circular shape, an oval shape, or a polygonal shape other than a square, for example.

In addition, although the line segment marker as the position marker 307b of this embodiment extends in an arc shape in plan view, this shape is not particularly limited. A line segment marker as the position marker 307b may extend linearly or in a V shape, for example, in plan view. However, for the same reason as the line segment marker 7b1 of the first embodiment, the position marker 307b is preferably a line segment marker extending arcuately in plan view.

The compression device according to the present disclosure and the method of attaching the device by compression are not limited to the specific configurations and methods shown in the above-described first to fourth embodiments, as long as they do not deviate from the scope of claims. , various modifications and changes are possible. Compression devices constructed by combining the configurations of the components of the compression devices shown in the first to fourth embodiments also belong to the technical scope of the present disclosure.

The present disclosure relates to compression devices and methods of applying compression devices.

1, 101, 201, 301: compression device 2: adhesive sheet 3: compression member 4: pressing bodies 5, 105, 205, 305: holding bodies 5a, 105a, 205a, 305a: through holes 5b: locking projections 6: Receiving units 7a, 207a, 307a: area marker 7a1: frame line marker (area marker)
7b, 207b, 307b: position marker 7b1: line segment marker (position marker)
8: Expansion part 8a: Accommodating space 8b, 8c: Balloon part 9: Extension part 9a: Hinge part 9b: Locking hole 11: Adhering surface 12: Mounting surface 28: Tube 29: Connecting part 30: Syringe 31, 131 , 231, 331: body portion 32: pair of gripping plate portions 41, 141, 241, 341: translucent portions 42, 142, 242, 342: marker portion 100: medical insertion member 100a: insertion portion 107a1: first region Marker 107a2: Second region marker 1042: Marker portion A: Thickness direction A1: Downward direction A2: Upward direction B: Width direction C: Arrangement direction F: Tilt direction G: Perforation extension direction G1: Sheath insertion direction H: In-plane direction of living body surface BS: living body surface CT: connective tissue FV: femoral vein P: perforation PV: viewpoint X1: first part of adhesive sheet X2: second part of adhesive sheet

Claims (5)

an adhesive sheet having an adhesive surface that can be attached to the surface of a living body;
a pressing member fixed to the adhesive sheet and capable of pressing the biological surface;
The compression member is
a pressing body capable of pressing the biological surface by extending in the thickness direction of the adhesive sheet;
a holder that is fixed to the adhesive sheet on the side opposite to the adhesive surface and holds the pressing body extensibly in the thickness direction;
The holding body is
a translucent portion having translucency in the thickness direction;
A marker portion provided on the lower surface of the light-transmitting portion facing the surface of the living body in a state where the sticking surface of the sticking sheet is stuck to the surface of the living body, and is visually identifiable through the light-transmitting portion. and
In a plan view in the thickness direction, a receiving portion is provided on the outside of the holding body so as to receive a portion of the medical insertion member inserted into the living body through the living body surface and exposed to the outside from the living body surface. and
The pressing body is
an expansion part that is arranged between the biological body surface and the holder in a state where the adhesive surface of the adhesive sheet is adhered to the biological body surface and that is expandable in the thickness direction;
extended from the extended portion and wound around the retainer through a through hole defined by the retainer and located on the receiving portion side with respect to the extended portion in a plan view seen in the thickness direction; , a flexible extension, and
The marker section defines a predetermined area in the light-transmitting section in plan view in the thickness direction, and the extension section presses the surface of the living body to apply pressure equal to or greater than a predetermined value on the surface of the living body. including a region marker indicating the region from which the force is obtained ;
The region markers are divided by the through holes in a plan view in the thickness direction, and are divided by the through holes on the receiving portion side and on the opposite side of the through hole from the receiving portion side. A compression device provided on both the . The compression device according to claim 1, wherein at least part of the marker portion is provided at a position overlapping with the expanded portion of the pressing body in a plan view in the thickness direction. The compression device according to claim 1 or 2, wherein the region marker is a frame line marker that divides the predetermined region of the translucent portion with a frame line in plan view in the thickness direction. 2. The marker portion includes a position marker positioned within the predetermined area defined by the area markers in a plan view in the thickness direction and indicating a predetermined position within the predetermined area. 4. A compression device according to any one of 1-3. The compression device according to claim 4, wherein the position marker is a line segment marker extending arcuately in plan view in the thickness direction.

Images