JP2024047593A - Hemostatic devices - Google Patents

Abstract

[Problem] To provide a hemostatic device that allows easy confirmation of the direction in which an expansion member applies a compressive force to a puncture site and prevents unnecessary strain on a patient when applying pressure to stop bleeding. [Solution] A hemostatic device 100 has an expansion member 110 configured to compress a first puncture site p1, a fixing member 120 configured to fix the expansion member to the first puncture site, a first marker portion 115 located on the expansion member and configured to align the expansion member to the first puncture site, and a second marker portion 125 located on the fixing member and having at least one of a shape, size, and color different from that of the first marker portion, the second marker portion having an outer shape larger than that of the first marker portion, and the first marker portion being located at a position that overlaps with the second marker portion when projected onto the fixing member before the expansion member is expanded. [Selected Figure] Figure 1

Description

The present invention relates to a hemostatic device.

One known catheter technique is to puncture a blood vessel in a patient's limb, such as an arm or hand, and introduce various types of elongated medical objects into the blood vessel through the puncture site to perform treatment or therapy on the affected area. For example, Patent Document 1 discloses a hemostatic device that stops bleeding at a puncture site formed to allow access to blood vessels (including the distal radial artery) running through the hand.

The hemostatic device of Patent Document 1 includes an expansion member that applies a compressive force to a puncture site formed on the patient's hand, a fixing member that includes a band for fixing the expansion member to the patient's hand, and a housing to which the band is connected. In addition, in the hemostatic device of Patent Document 1, a marker portion (target) is provided on the expansion member or the housing for aligning the expansion member with the puncture site.

US Patent Application Publication No. 2019/0133602

When using the hemostatic device of Patent Document 1 to stop bleeding at a puncture site, a surgeon such as a doctor (hereinafter referred to as the "surgeon") can easily position the expansion member at the puncture site by aligning the expansion member with the puncture site while checking the position of the marker part. With the expansion member positioned at the puncture site, the surgeon can fix the expansion member to the patient's body with the fixing member and expand the expansion member, thereby effectively applying a compressive force from the expansion member to the puncture site.

However, in the hemostatic device of Patent Document 1, if the expansion member is not firmly fixed to the patient's body by the fixing member, or if the fixing member shifts while the expansion member is applying pressure to the puncture site, the direction of the pressure applied by the expansion member to the puncture site will be in an unintended direction. In such a state, the expansion member will also apply pressure to sites other than the puncture site, increasing the burden on the patient. For example, when the surgeon is using the above-mentioned hemostatic device to apply pressure to the puncture site, the surgeon can check whether the expansion member has shifted from its position at the puncture site by checking the position of the marker portion arranged on the expansion member when the expansion member applies pressure to the puncture site. However, the surgeon cannot check the direction in which the expansion member applies pressure to the puncture site simply by visually checking one marker portion arranged on the expansion member.

In view of the above problems, the present invention aims to provide a hemostatic device that allows the user to easily confirm the direction in which the expansion member applies pressure to the puncture site, and prevents unnecessary strain on the patient when applying pressure to stop bleeding.

A hemostatic device according to one embodiment of the present invention includes an expansion member configured to compress a puncture site formed in a patient, a fixing member configured to fix the expansion member to the puncture site, a first marker portion located on the expansion member and configured to align the expansion member to the puncture site of the patient, and a second marker portion located on the fixing member and having at least one of a shape, size, and color different from that of the first marker portion, the second marker portion having an outer shape larger than that of the first marker portion, and the first marker portion being located at a position overlapping with the second marker portion when projected onto the fixing member before the expansion member is expanded.

In addition, a hemostatic device according to another embodiment of the present invention has an expansion member configured to compress a puncture site formed in a patient, a fixing member configured to fix the expansion member to the puncture site, a first marker portion located on the expansion member and configured to align the expansion member to the puncture site of the patient, and a second marker portion located on the fixing member and having a shape different from that of the first marker portion, the first marker portion being formed of two or more linear portions intersecting to form an intersection, and the intersection being located at a position overlapping with the second marker portion when projected onto the fixing member before the expansion member is expanded.

The hemostatic device according to the above embodiment has a first marker portion located on the expansion member and a second marker portion arranged on the fixing member. The second marker portion has at least one of a shape, size, and color different from that of the first marker portion. When the surgeon attaches the hemostatic device to the patient's limb and applies pressure to the puncture site to stop bleeding, the surgeon can visually check the overlapping state of the first marker portion projected onto the fixing member and the second marker portion arranged on the fixing member to check the arrangement state of the fixing member relative to the limb (presence or absence of inclination, etc.). Based on the arrangement state of the fixing member, the surgeon can check the direction of the compressive force applied by the expansion member to the puncture site. In addition, since the second marker portion has an outer shape larger than the outer shape of the first marker portion, the hemostatic device does not need to form the first marker portion, which serves as a reference for aligning the expansion member to the puncture site, excessively large. Therefore, the hemostatic device can form the first marker portion small. Therefore, when aligning the expansion member to the puncture site, the surgeon can use the first marker portion as a reference to more accurately position the expansion member relative to the puncture site.

The hemostatic device according to the above-mentioned other embodiment has a first marker portion located on the expansion member and a second marker portion arranged on the fixing member. The second marker portion has a different shape from the first marker portion, and the first marker portion is formed of two or more linear portions that intersect to form an intersection. When the surgeon attaches the hemostatic device to the patient's limb and applies pressure to the puncture site to stop bleeding, the surgeon can visually check the overlapping state of the intersection of the first marker portion projected onto the fixing member and the second marker portion arranged on the fixing member to check the arrangement state of the fixing member relative to the limb (presence or absence of inclination, etc.). Based on the arrangement state of the fixing member, the surgeon can check the direction of the compressive force applied by the expansion member to the puncture site. In addition, the hemostatic device has a portion that serves as a reference for the first marker portion to align the expansion member to the puncture site, which is composed of the intersection of two or more linear portions. Therefore, when aligning the expansion member to the puncture site, the surgeon can more accurately position the expansion member relative to the puncture site by placing the intersection at the puncture site.

FIG. 2 is a diagram showing a hemostatic device according to an embodiment, and is a plan view seen from the outer surface side of a support member. FIG. 2 is a diagram showing a hemostatic device according to an embodiment, and is a plan view seen from the inner surface side of a support member. 1 is an enlarged view of a portion of the hemostatic device as viewed from the outer surface side of a support member. FIG. 1 is an enlarged view of a portion of the hemostatic device as viewed from the inner surface side of the support member. FIG. 4 is an enlarged plan view showing a portion of the hemostatic device as viewed from the outer surface side of the support member. FIG. 6A is a partial cross-sectional view of the hemostatic device taken along arrows 6A-6A in FIG. 5, illustrating the expansion member when expanded. 7A is a cross-sectional view of the hemostatic device taken along arrows 7A-7A in FIG. 5, illustrating the state when the expansion member is expanded. 1A is a plan view of the hemostatic device as viewed from the outer surface side of the support member, showing the state before and after the first and second bands connected to the support member are rotated. FIG. FIG. FIG. FIG. 2 shows a patient's hand (right hand) on which the hemostatic device is to be used. 1A and 1B are diagrams illustrating a first example of use of a hemostatic device. 1A and 1B are diagrams illustrating a first example of use of a hemostatic device. 1A and 1B are diagrams illustrating a first example of use of a hemostatic device. 15A is a partial cross-sectional view taken along the arrows 15A-15A shown in FIG. 14. 16A is a partial cross-sectional view taken along the arrows 16A-16A shown in FIG. 14. 13 is a plan view showing a state in which the first marker portion and the second marker portion overlap with each other when the hemostatic device is attached to a patient's hand. FIG. 13 is a cross-sectional view showing a state in which the first marker portion and the second marker portion are misaligned when the hemostatic device is attached to a patient's hand. FIG. 13 is a plan view showing a state in which the first marker portion and the second marker portion are misaligned when the hemostatic device is attached to a patient's hand. FIG. FIG. 13 is a diagram illustrating a second example of use of the hemostatic device. FIG. 13 is a diagram showing a hemostatic device according to Modification 1, and is a plan view seen from the outer surface side of a support member. FIG. 13 is a diagram showing a hemostatic device according to Modification 2, and is a plan view seen from the inner surface side of a support member. FIG. 13 is a partial cross-sectional view showing a hemostatic device according to Modification 3. FIG. 13 is a partial cross-sectional view showing a hemostatic device according to Modification 4. FIG. 13 is a diagram showing a hemostatic device according to Modification 5, and is a plan view seen from the outer surface side of the band. 26A is a partial cross-sectional view taken along the arrows 26A-26A in FIG. 25, showing a state in which the first marker portion and the second marker portion do not overlap. 26A is a partial cross-sectional view taken along the arrows 26A-26A in FIG. 25, showing the first marker portion and the second marker portion overlapping each other. 13 is a diagram illustrating a simplified example of use of a hemostatic device according to a fifth modified example. FIG.

The following describes an embodiment of the present invention with reference to the attached drawings. The following description does not limit the technical scope or the meaning of the terms described in the claims. Also, the dimensional proportions in the drawings have been exaggerated for the convenience of explanation and may differ from the actual proportions.

Figures 1 to 10 are diagrams for explaining the hemostatic device 100 according to this embodiment, Figures 11 to 17 are diagrams for explaining examples of using the hemostatic device 100, and Figures 18 and 19 are diagrams for explaining the effects of the hemostatic device 100.

As shown in Figures 11, 14 to 16, the hemostatic device 100 can be used to stop bleeding at a puncture site (e.g., puncture sites p1 and p2 described below) formed on a patient's hand H located distal (toward the fingertip) from the forearm A when removing a sheath tube of an introducer 200 that has been placed at the puncture site.

The specific location of the puncture site that is the target of hemostasis by the hemostatic device 100 is not particularly limited, but in this embodiment, the following first puncture site p1 and second puncture site p2 are shown as examples.

As shown in Figures 11, 14, 15, and 16, the first puncture site p1 is a puncture site formed in artery B (hereinafter also referred to as "blood vessel B") located in the snuff box of the palmar artery running along the back side of the right hand H1 (hand H) located distal to the patient's forearm A. The snuff box is a cavity in the hand located near the radius when the patient spreads the thumb of hand H.

As shown in Figures 11 and 20, the second puncture site p2 is a puncture site formed in the distal radial artery (not shown) located distal to the snuff box of the palmar artery running along the back of the patient's right hand H1. The second puncture site p2 is located distal to the first puncture site p1 on the right hand H1 based on the extensor pollicis longus tendon t1 located on the back of the patient's right hand H1.

Note that FIG. 11 illustrates a first puncture spot s1 including a first puncture site p1 and its surrounding area formed on the patient's right hand H1, and a second puncture spot s2 including a second puncture site p2 and its surrounding area formed on the patient's right hand H1.

The first puncture spot s1 includes a predetermined area around the snuff box. The first puncture spot s1 has a shape of a roughly isosceles triangle tapering toward the distal side of the patient's right hand H1. In addition, when the patient spreads the thumb of the right hand H1, the first puncture spot s1 forms a recess that is recessed toward the inside of the patient's right hand H1 relative to the extensor pollicis longus tendon t1.

The second puncture spot s2 includes a predetermined range on the distal side of the snuff box of the patient's right hand H1 based on the extensor pollicis longus tendon t1. The second puncture spot s2 has a shape of a roughly isosceles triangle tapering toward the proximal side of the patient's right hand H1. In addition, when the patient spreads the thumb of the right hand H1, the second puncture spot s2 forms a recess that is recessed toward the inside of the patient's right hand H1 relative to the extensor pollicis longus tendon t1.

In the description of the specification, the first puncture site p1 formed on the patient's right hand H1 is also simply referred to as the "first puncture site p1," and the second puncture site p2 formed on the patient's right hand H1 is also simply referred to as the "second puncture site p2."

The hemostatic device 100 is described in detail below.

<Hemostatic instruments>
Generally speaking, as shown in Figures 1, 2, 14, 15, and 16, the hemostatic device 100 comprises an expansion member 110 configured to compress the first puncture site p1, a fixing member 120 configured to fix the expansion member 110 to the first puncture site p1, a first marker portion 115 located on the expansion member 110 and configured to align the expansion member 110 with the first puncture site p1, and a second marker portion 125 located on the fixing member 120 and having at least one of a shape, size, and color different from that of the first marker portion 115.

<Expansion member>
As shown in FIGS. 6 and 7, the expansion member 110 can be formed of a single balloon having an inner cavity 113 defined by a membrane material.

The expansion member 110 can be formed, for example, by joining the edges of two sheet-like membrane materials formed into a substantially rectangular shape with a cavity 113 formed between them. The expansion member 110 may also be formed, for example, from a single membrane member formed into a bag shape with a cavity.

The expansion member 110 expands when a fluid such as air is supplied to the inner cavity 113, and contracts when the fluid supplied to the inner cavity 113 is discharged. Note that Figures 6 and 7 show cross-sectional views of the expansion member 110 when a fluid is supplied to the expansion member 110 and the expansion member 110 expands.

The membrane material constituting the expansion member 110 can be made of, for example, a resin material having a predetermined thickness. A tube 193 (see Figures 1 and 2), which will be described later, is connected to the inner cavity 113 of the expansion member 110.

The material of the membrane constituting the expansion member 110 is not particularly limited, but examples of materials that can be used include polyolefins such as polyvinyl chloride, polyethylene, polypropylene, polybutadiene, and ethylene-vinyl acetate copolymer (EVA), polyesters such as polyethylene terephthalate (PET) and polybutylene terephthalate (PBT), various thermoplastic elastomers such as polyvinylidene chloride, silicone, polyurethane, polyamide elastomer, polyurethane elastomer, and polyester elastomer, nylon, nylon elastomer, or any combination of these (blend resins, polymer alloys, laminates, etc.).

As shown in Figures 6, 7, 15, and 16, the expansion member 110 is disposed on the inner surface 130a side of the support member 130 provided in the fixing member 120. The inner surface 130a of the support member 130 is the surface that is disposed on the body surface side of the patient's hand H when the hemostatic device 100 is attached to the patient's hand H. The outer surface 130b of the support member 130 is the surface that is located on the opposite side of the inner surface 130a.

As shown in Figures 6 and 7, the expansion member 110 has a fixed region 117 that is fixed to the support member 130. The fixed region 117 is a region (range) in the planar direction of the expansion member 110 to which the support member 130 is connected.

The extension member 110 can be connected to the support member 130 via a predetermined connecting member 180. The connecting member 180 can be made of, for example, an adhesive, or a pressure-sensitive adhesive or resin material that can bond the extension member 110 and the support member 130 together. The connecting member 180 is connected to the inner surface 130a of the support member 130.

The peripheral portion of the fixing region 117 is arranged so as to surround the second marker portion 125 arranged on the fixing member 120 when projected onto the support member 130. The peripheral portion of the fixing region 117 means the peripheral portion of the connecting member 180 in the plan view shown in FIG. 4.

The connection between the connection member 180 and the support member 130 and the connection between the expansion member 110 and the connection member 180 can be achieved by, for example, fusion or adhesion.

The expansion member 110 may be connected directly to the inner surface 130a of the support member 130 without using the connecting member 180.

The expansion member 110 may also be configured as a single membrane-like member configured to form an internal cavity between the inner surface 130a of the support member 130. For example, the expansion member 110 can be configured to have an internal cavity between the inner surface 130a of the support member 130 and the single membrane-like member by directly connecting the single membrane-like member to the inner surface 130a of the support member 130 without using the connecting member 180.

The expansion member 110 has a circular shape in the plan view shown in Figures 1 to 5. However, the shape of the expansion member 110 in the plan view is not limited to a circular shape. In addition, there are no particular limitations on the cross-sectional shape of the expansion member 110 before and after expansion, or on the specific structure of the expansion member 110. For example, the expansion member 110 can be formed of a single bag-shaped member having an inner cavity 113.

As shown in Figures 5, 6, 7, 14, 15, and 16, the expansion member 110 is provided with a first marker portion 115 for aligning the expansion member 110 with the first puncture site p1.

The first marker portion 115 is arranged on the outer surface of the expansion member 110 on the side opposite to the side on which the support member 130 is arranged (the side that is arranged on the body surface side of the patient's hand H when the hemostatic device 100 is attached to the patient's hand H).

There are no particular limitations on the specific placement location of the first marker portion 115, so long as it is placed on the expansion member 110. The first marker portion 115 may be placed, for example, on the inner surface of the side opposite to the side on which the support member 130 of the expansion member 110 is placed (the side that is placed on the body surface side of the patient's hand H when the hemostatic device 100 is attached to the patient's hand H).

As shown in FIG. 5, the first marker portion 115 is positioned at approximately the center of the surface of the expansion member 110. The first marker portion 115 is also positioned so as to overlap approximately the center of the surface of the support member 130.

The first marker section 115 is formed as a circular marker section that is entirely colored.

The first marker portion 115 is not particularly limited in terms of its specific structure, so long as at least one of the shape, size, and color of the first marker portion 115 is formed to be different from the second marker portion 125 described below. In addition, the specific method of forming the first marker portion 115 is not particularly limited, but the first marker portion 115 can be formed, for example, by printing or a sticker that can be attached.

When the expansion member 110 is in a pre-expansion state, the first marker portion 115 is positioned so as to overlap with the second marker portion 125 when projected onto the fixing member 120. Specifically, as shown in Figures 6 and 7, the first marker portion 115 is positioned so as to overlap with the second marker portion 125 with the inner cavity 113 of the expansion member 110 in between.

In this embodiment, as shown in FIG. 5, the first marker portion 115 is positioned so as to overlap the second marker portion 125 on the support member 130 when projected onto the support member 130 provided on the fixing member 120.

In addition, in this embodiment, the first marker portion 115 overlaps with the second marker portion 125 when projected onto the fixing member 120 in both the pre-expansion state of the expansion member 110 and the expanded state of the expansion member 110 shown in Figures 6 and 7.

<Fixing member>
The fixation member 120 includes a support member 130 and a number of straps 140, 150, 160 extending from the support member 130 and configured to be wrapped around the patient's hand H, as shown in Figures 1, 2, 5, 6, and 7.

<Support Member>
As shown in Figures 5, 6, and 7, the support member 130 has a first region 131 in which the expansion member 110 is arranged, and a second region 132 located outside the first region 131 and configured to allow each band 140, 150, and 160 to be connected.

The support member 130 has a circular shape in the plan view shown in FIG. 5.

The first region 131 is a region overlapped by the expansion member 110 in the plan view shown in FIG. 5. The second region 132 is a region located outside the first region 131 in the plan view shown in FIG. 5.

The connecting member 180 (see Figures 6 and 7) that connects the support member 130 and the expansion member 110 is integrally connected to the inner surface 130a of the support member 130 as described above, and constitutes part of the fixing member 120 together with the support member 130.

As shown in Figures 5, 6, 7, and 8, the first region 131 is located at a rotation axis R that is the center of rotation of the first band 140 and the second band 150.

The rotation axis R passes through the second marker portion 125, as shown in Figures 5, 6, and 7. In this embodiment, the rotation axis R is located at approximately the center position in the planar direction of the support member 130. Therefore, the rotation axis R passes through both the first marker portion 115 and the second marker portion 125, as shown in Figures 5, 6, and 7.

As shown in Figures 5, 6, 7, 9, and 10, the second region 132 has a pair of first holes 133a, 133b that face each other with the expansion member 110 therebetween, and a pair of second holes 133c, 133d that face each other with the expansion member 110 therebetween at positions different from the pair of first holes 133a, 133b.

As shown in Figures 3, 4, and 5, the first holes 133a and 133b are arranged in a circle along the outer shape of the support member 130. Similarly, the second holes 133c and 133d are arranged in a circle along the outer shape of the support member 130.

As shown in Figures 5 and 8, the first band 140 is connected to the second hole 133c. The second band 150 is connected to the second hole 133d. The third band 160 is connected to the first hole 133a.

As shown in FIG. 5, the width of one end 141 of the first band 140 is smaller than the hole length of the second hole 133c. Therefore, as shown in FIG. 8, the first band 140 can rotate around the expansion member 110 in the second region 132 around the rotation axis R of the support member 130 with the one end 141 of the first band 140 connected to the second hole 133c.

The width of one end 151 of the second band 150 is smaller than the hole length of the second hole 133d. Therefore, as shown in FIG. 8, the second band 150 can rotate around the expansion member 110 in the second region 132 around the rotation axis R with the one end 151 of the second band 150 connected to the second hole 133d.

The rotatable angle (rotation range) of the first band 140 and the second band 150 around the rotation axis R is not particularly limited, but can be set to, for example, 1° to 45°.

As shown in FIG. 5, the width of one end 161 of the third band 160 is approximately the same as the hole length of the first hole portion 133a. Therefore, when one end 161 of the third band 160 is connected to the first hole portion 133a, the rotation of the third band 160 around the rotation axis R is restricted.

As shown in Figures 9 and 10, in the portion in the second region 132 of the support member 130 where the first holes 133a and 133b are arranged, a first curved portion 134a is formed that is curved in a convex shape toward the side away from the expansion member 110 (the upper side in Figures 6 and 7).

As shown in Figures 9 and 10, in the portion in the second region 132 of the support member 130 where the second holes 133c and 133d are arranged, a second curved portion 134b is formed that is curved convexly toward the extension member 110 side (the lower side in Figures 6 and 7).

As shown in Figures 5, 6, 7, 9, and 10, a second marker portion 125 is disposed on the outer surface 130b of the support member 130.

The second marker portion 125 has a ring shape with a blank space formed on the inside in the plan view shown in FIG. 5. The second marker portion 125 has a different shape from the first marker portion 115, which has a completely filled-in circular shape.

The second marker portion 125 has a larger outer shape than the first marker portion 115 in the plan view shown in FIG. 5. Therefore, when the hemostatic device 100 is not being operated or used (for example, when it is packaged in packaging material or the like and distributed as a product or when it is stored), the first marker portion 115 projected onto the support member 130 is located inside the second marker portion 125, and the first marker portion 115 and the second marker portion 125 overlap.

The specific method for forming the second marker portion 125 is not particularly limited, but it can be formed, for example, by printing or by using an attachable sticker.

The second marker portion 125 may be provided at any location on the fixing member 120. For example, it may be provided on the inner surface 130a of the support member 130, on the surface of the connecting member 180 located on the support member 130 side, or on the surface of the connecting member 180 located on the expansion member 110 side.

The support member 130 can be made of a material harder than the expansion member 110. When the expansion member 110 is made of the aforementioned materials, the support member 130 can be made of, for example, acrylic resin, polyvinyl chloride (particularly rigid polyvinyl chloride), polyolefins such as polyethylene, polypropylene, and polybutadiene, polystyrene, poly-(4-methylpentene-1), polycarbonate, ABS resin, polymethyl methacrylate (PMMA), polyacetal, polyacrylate, polyacrylonitrile, polyvinylidene fluoride, ionomer, acrylonitrile-butadiene-styrene copolymer, polyethylene terephthalate (PET), etc.

The portion of the expansion member 110 where the first marker portion 115 is provided, the portion of the support member 130 where the second marker portion 125 is provided, and the portion that overlaps with the marker portions 115, 125 of the connection member 180 in the plan view shown in FIG. 5 can be formed transparent. When the members 110, 130, 180 are configured in this manner, as shown in FIGS. 12, 13, and 14, when attaching the hemostatic device 100 to the patient's right hand H1, the surgeon can easily visually confirm the position of the first marker portion 115 and/or the first puncture site p1 through the members 110, 130, 180. Note that the above "transparent" includes colored transparent, colorless transparent, and translucent.

<Belt>
As shown in Figures 1 to 5, the first band 140 has one end 141 configured to be connectable to the second hole portion 133c of the support member 130, a free other end 143 that is not connected to the support member 130, and a main body portion 145 extending between the one end 141 and the other end 143.

As shown in Figures 1 to 5, the second band 150 has one end 151 that is configured to be connectable to the second hole 133d of the support member 130, the other end 153 that is free and not connected to the support member 130, and a main body 155 that extends between the one end 151 and the other end 153.

The first band 140 extends from the support member 130 in a predetermined first direction. The second band 150 extends from the support member 130 in a predetermined second direction that is different from the first direction.

As shown in Figures 12, 13, and 14, when the hemostatic device 100 is attached to the patient's right hand H1, the first band 140 and the second band 150 can be positioned so as to be wrapped around the outer circumference of the right hand H1.

As shown in Figures 1 to 5, the third band 160 has one end 161 that is configured to be connectable to the first hole 133a of the support member 130, a free other end 163 that is not connected to the support member 130, and a main body portion 165 that extends between the one end 161 and the other end 163.

The third band 160 extends from the support member 130 in a third direction different from the first direction in which the first band 140 extends and the second direction in which the second band 150 extends.

As shown in FIG. 14, the third band 160 can be positioned so that it is hooked onto the inter-finger area fb located between the thumb and index finger of the patient's right hand H1, with the expansion member 110 positioned at the first puncture site p1.

Each one end 141, 151, 161 of each band 140, 150, 160 can be inserted into and wrapped around each hole 133a, 133b, 133c, 133d of the support member 130. The structure for connecting each one end 141, 151, 161 of each band 140, 150, 160 to the support member 130 is not particularly limited. For example, each one end 141 can be provided with a member (e.g., a hook-and-loop fastener) that can hold and release the state of being wrapped around each hole 133a, 133b, 133c, 133d of the support member 130.

The material of each of the strips 140, 150, and 160 is not particularly limited, but may be, for example, polyvinyl chloride resin, polyurethane resin, polyester resin, etc. Furthermore, there are no particular limitations on the shape, length, thickness, etc., of each of the strips 140, 150, and 160.

As shown in Figures 1, 2, 3, and 4, the hemostatic device 100 has four fixing parts: a first fixing part 171, a second fixing part 172, a third fixing part 173, and a fourth fixing part 174.

As shown in Figures 1 and 3, a first fixing portion 171 is disposed on the outer surface of the first band 140. A second fixing portion 172 is disposed on the outer surface of the second band 150.

As shown in Figures 2 and 4, a third fixing portion 173 is disposed on the inner surface of the second band 150. A fourth fixing portion 174 is disposed on the inner surface of the third band 160.

The "inner surface" of each band 140, 150, 160 is the surface that is positioned on the patient's body surface when the hemostatic device 100 is attached to the patient, and the "outer surface" of each band 140, 150, 160 is the surface that is located opposite the inner surface.

The first and second fastening parts 171 and 172 are configured on the male side of the hook-and-loop fastener. The third and fourth fastening parts 173 and 174 are configured on the female side of the hook-and-loop fastener. The hook-and-loop fastener in this specification is a fastener that can be attached and detached from the surface, such as Magic Tape (registered trademark) or Velcro (registered trademark).

The specific structure of each of the fixing parts 171, 172, 173, 174 is not limited as long as the support member 130 can be fixed to the patient's right hand H1 by connecting each of the bands 140, 150, 160 with each other while the hemostatic device 100 is placed on the patient's right hand H1. For example, the installation of some of the fixing parts can be omitted, or the positions of the fixing parts on each of the bands 140, 150, 160 can be changed as desired. In addition, when each of the fixing parts 171, 172, 173, 174 is configured with a hook-and-loop fastener, the male side and the female side of the hook-and-loop fastener may be reversed. In addition, each of the fixing parts 171, 172, 173, 174 may be configured with, for example, a snap, a button, a clip, or a connecting mechanism having a frame part with a hole or a protrusion formed therein and an engaged part with a hole that can engage with the frame part.

<Injection section>
As shown in FIGS. 1 and 2 , the hemostatic device 100 has an injection portion 191 for injecting a fluid into the expansion member 110 .

The injection part 191 is composed of a connector with a built-in check valve (not shown). A syringe (not shown) can be connected to the injection part 191.

A buffer member 192 having an expandable space is disposed between the injection section 191 and the expansion member 110. The buffer member 192 is made of a flexible bag-shaped member with an internal space. The buffer member 192 may be provided with an arrow-shaped marker indicating the direction in which the syringe is inserted into the injection section 191.

An injection part 191 is connected to one end of the buffer member 192. The inner cavity of the injection part 191 is connected to the space of the buffer member 192. However, while the check valve built into the injection part 191 is closed, communication between the inner cavity of the injection part 191 and the space of the buffer member 192 is blocked.

A flexible tube 193 is connected to the other end of the buffer member 192. The inner cavity of the tube 193 is connected to the space of the buffer member 192. The other end of the tube 193, opposite to the one end connected to the buffer member 192, is connected to the expansion member 110. The inner cavity of the tube 193 is connected to the inner cavity 113 of the expansion member 110.

When expanding the expansion member 110, the surgeon inserts the tip of a syringe (not shown) into the injection section 191 to open the check valve. With the check valve of the injection section 191 open, the surgeon presses the plunger of the syringe to inject air from within the syringe into the lumen 113 of the expansion member 110.

When air is injected into the inner cavity 113 of the expansion member 110, the expansion member 110 expands. When the expansion member 110 expands, the buffer member 192, which is in communication with the inner cavity 113 of the expansion member 110 via the tube 193, expands. By visually checking the expansion of the buffer member 192, the surgeon can easily determine that the expansion member 110 has expanded without any air leakage.

When contracting the expansion member 110, the surgeon inserts the tip of the syringe into the injection section 191 and pulls the plunger of the syringe. By performing the above operation, the surgeon can expel the air from the inner cavity 113 of the expansion member 110 into the syringe.

The injection section 191, the buffer member 192, and the tube 193 may be prepared and provided in a state where they are connected to the expansion member 110, or may be prepared and provided in a state where they are separate from the expansion member 110.

<Examples of use of hemostatic devices>
Next, a first example of use of the hemostatic device 100 will be described with reference to FIGS.

In the first use example, the procedure for using the hemostatic device 100 to stop bleeding at the first puncture site p1 formed on the patient's right hand H1 shown in FIG. 11 will be described.

Figure 12 shows the state after the sheath tube of the introducer 200 has been inserted into the first puncture site p1 and various procedures have been performed.

When attaching the hemostatic device 100 to the patient's right hand H1, the surgeon places the support member 130 over the back of the patient's right hand H1, as shown in FIG. 12. At this time, the surgeon visually checks the position of the first marker portion 115 placed on the expansion member 110, while placing the first marker portion 115 at the first puncture site p1, thereby allowing the expansion member 110 to be appropriately positioned at the first puncture site p1.

In the hemostatic device 100, before the expansion member 110 is expanded, the first marker portion 115 projected onto the support member 130 overlaps with the second marker portion 125. Therefore, the surgeon can position the expansion member 110 at the first puncture site p1 more accurately by checking the relative positional relationship between the first marker portion 115 and the second marker portion 125 and using the first marker portion 115 and the second marker portion 125 as references.

After completing the procedure using the introducer 200, the surgeon may pull out a portion of the sheath tube of the introducer 200 from the first puncture site p1 before attaching the hemostatic device 100 to the patient's right hand H1. For example, with the sheath tube of the introducer 200 left in place in blood vessel B (see Figures 15 and 16), the surgeon can pull out the sheath tube about 2 to 3 cm toward the surgeon's hand and then begin the attachment of the hemostatic device 100.

As shown in Figures 12 and 13, the surgeon wraps the first band 140 and the second band 150 around the circumference of the patient's right hand H1. The surgeon can connect the first band 140 and the second band 150 via the respective fixing parts 171, 173 by contacting the first fixing part 171 (see Figure 1) located on the outer surface of the first band 140 with the third fixing part 173 (see Figure 2) located on the inner surface of the second band 150.

When wrapping the first band 140 and the second band 150 around the outer circumference of the patient's right hand H1, the surgeon can rotate the first band 140 and the second band 150 around the rotation axis R located in the first region 131 of the support member 130. By rotating the first band 140 and the second band 150, the surgeon can adjust the wrapping position of each band 140, 150 with respect to the patient's right hand H1.

As shown in FIG. 14, the surgeon places a part of the third band 160 on the palm side of the patient's right hand H1 while passing the third band 160 through the inter-finger area fb located between the thumb and index finger of the patient's right hand H1. At this time, the surgeon can connect the second band 150 and the third band 160 via the fixing parts 172, 174 by contacting the second fixing part 172 (see FIG. 1) located on the outer surface of the second band 150 with the fourth fixing part 174 (see FIG. 2) located on the inner surface of the third band 160.

With a syringe connected to the injection section 191, the surgeon injects air into the expansion member 110 to expand the expansion member 110. As shown in Figures 15 and 16, when the expansion member 110 expands, the expansion member 110 applies a compressive force to the first puncture site p1 of the patient's right hand H1.

A first curved portion 134a is formed near each of the first holes 133a, 133b of the support member 130 (see Figures 9 and 10). Therefore, when the patient twists the wrist to move the right hand H1 up and down or left and right while the hemostatic device 100 is attached to the patient's right hand H1 as shown in Figure 16, each of the first curved portions 134a prevents the peripheral portion of the support member 130 from contacting the patient's right hand H1.

In addition, second curved portions 134b are formed near each of the second holes 133c, 133d of the support member 130 (see Figures 9 and 10). Therefore, when the expansion member 110 expands while the hemostatic device 100 is attached to the patient's right hand H1 as shown in Figure 15, each second curved portion 134b presses the expansion member 110 along a portion of the outer periphery of the patient's right hand H1. This allows the hemostatic device 100 to prevent the expansion member 110 from lifting up from the patient's right hand H1.

By following the above procedure, the surgeon can use the hemostatic device 100 to stop bleeding at the first puncture site p1 created in the patient's right hand H1.

The surgeon can check the position of the fixing member 120 (support member 130) relative to the patient's right hand H1 by attaching the hemostatic device 100 to the patient and checking the relative positional relationship between the first marker portion 115 and the second marker portion 125 when the expansion member 110 is expanded to apply a compressive force to the first puncture site p1. Specifically, the following procedure can be used to check.

The surgeon visually checks the expansion member 110 and the support member 130 from the outer surface 130b side of the support member 130. When the surgeon visually checks the expansion member 110 and the support member 130, if the first marker portion 115 and the second marker portion 125 projected onto the support member 130 overlap as shown in FIG. 17, the surgeon can confirm that there is no misalignment in the support member 130 or that there is no misalignment in the fixed positions of the bands 140, 150, and 160. In addition, by checking that the first marker portion 115 and the second marker portion 125 projected onto the support member 130 overlap, the surgeon can confirm that the expansion member 110 connected to the support member 130 is pressed toward the first puncture site p1 as shown in FIG. 15 and FIG. 16, and that the expansion member 110 applies a compressive force in the appropriate direction to the first puncture site p1.

For example, as shown in FIG. 18, if the fixed positions of the bands 140, 150, and 160 are shifted and the support member 130 is tilted in an unintended direction, the expansion member 110 connected to the support member 130 applies a compressive force in a direction shifted from the first puncture site p1. In such a state, when the surgeon visually checks the expansion member 110 and the support member 130 from the outer surface 130b side of the support member 130, as shown in FIG. 19, the first marker portion 115 located on the expansion member 110 side and the second marker portion 125 located on the support member 130 side do not overlap on the support member 130. Therefore, the surgeon can confirm that the expansion member 110 and the support member 130 are not positioned in an appropriate direction or posture. In such a case, the surgeon can adjust the attachment position of the hemostatic device 100 with respect to the patient's right hand H1 so that the direction and posture of the expansion member 110 and the support member 130 are appropriately positioned while checking the relative positional relationship between the first marker portion 115 and the second marker portion 125.

Figure 20 shows a second example of use of the hemostatic device 100. The second example of use is an example of use of the hemostatic device 100 when stopping bleeding at a second puncture site p2 formed on the patient's right hand H1.

As shown in FIG. 20, when the surgeon performs hemostasis at the second puncture site p2 formed in the patient's right hand H1, the surgeon attaches the hemostasis device 100 to the patient's right hand H1.

The second puncture site p2 formed on the patient's right hand H1 is located distal to the first puncture site p1 (see FIG. 11). When wrapping each band 140, 150 around the patient's right hand H1, the surgeon rotates each band 140, 150 around the rotation axis R. For example, the surgeon rotates each band 140, 150 so that each band 140, 150 is wrapped around the patient's right hand H1 at a position closer to the forearm A (proximal) than the first puncture site p1. By wrapping each band 140, 150 around a proximal position of the patient's right hand H1, the surgeon can prevent the distal portion of the patient's right hand H1 from being restrained by each band 140, 150.

As described above, the hemostatic device 100 according to this embodiment includes an expansion member 110 configured to compress the first puncture site p1, a fixing member 120 configured to fix the expansion member 110 to the first puncture site p1, a first marker portion 115 located on the expansion member 110 and configured to align the expansion member 110 to the first puncture site p1, and a second marker portion 125 located on the fixing member 120 and having at least one of a shape, size, and color different from that of the first marker portion 115. The second marker portion 125 has an outer shape larger than that of the first marker portion 115. The first marker portion 115 is located at a position overlapping with the second marker portion 125 when projected onto the fixing member 120 (support member 130) before the expansion member 110 is expanded.

When the surgeon applies pressure to the first puncture site p1 by attaching the hemostatic device 100 to the patient's right hand H1, the surgeon can visually check the overlapping state of the first marker portion 115 projected onto the fixing member 120 (supporting member 130) and the second marker portion 125 arranged on the fixing member 120 to check the arrangement state of the fixing member 120 relative to the patient's right hand H1 (whether it is tilted, etc.). Based on the arrangement state of the fixing member 120, the surgeon can check the direction of the compressive force applied by the expansion member 110 to the first puncture site p1. In addition, since the second marker portion 125 has an outer shape larger than the outer shape of the first marker portion 115, it is not necessary to form the first marker portion 115 excessively large in order to align the expansion member 110 with the first puncture site p1. Therefore, the hemostatic device 100 can form the first marker portion 115 small. This allows the surgeon to use the first marker portion 115 as a reference when aligning the expansion member 110 with the first puncture site p1, thereby allowing the surgeon to position the expansion member 110 more accurately with respect to the first puncture site p1.

The expansion member 110 is composed of a single balloon with an inner cavity 113 partitioned by a membrane material. When the expansion member 110 is in an expanded state and projected onto the fixing member 120 (support member 130), the first marker portion 115 is positioned so as to overlap with the second marker portion 125 with the inner cavity 113 sandwiched therebetween.

According to the hemostatic device 100 configured as described above, the expansion member 110 is composed of one balloon, and when the expansion member 110 is expanded, the first marker portion 115 projected onto the support member 130 is arranged so as to overlap with the second marker portion 125. That is, when the hemostatic device 100 is not attached to the patient's right hand H1 and the expansion member 110 is expanded, the first marker portion 115 projected onto the support member 130 is arranged so as to overlap with the second marker portion 125. Therefore, compared to the modified example 4 (see Figures 26 and 27) described later, the hemostatic device 100 can stabilize the positional relationship between the first marker portion 115 and the second marker portion 125 before and after the expansion member 110 is expanded. Therefore, when placing the expansion member 110 and when the expansion member 110 is expanded, the surgeon can visually confirm the direction of the compression force applied by the expansion member 110 to the first puncture site p1 more accurately. This allows the surgeon to easily visually check the direction of the compression force that the expansion member 110 applies to the first puncture site p1 when the expansion member 110 is in an expanded state or when the expanded expansion member 110 is depressurized.

The fixing member 120 also includes a support member 130 and a number of bands 140, 150, 160 extending from the support member 130 and configured to be wrapped around the patient's right hand H1. The support member 130 is made of a material harder than the expansion member 110, and the second marker portion 125 is disposed on the support member 130.

According to the hemostatic device 100 configured as described above, since the second marker portion 125 is disposed on the support member 130 made of a material harder than the expansion member 110, when the expansion member 110 expands, the position of the second marker portion 125 can be prevented from being displaced due to the expansion of the expansion member 110. Therefore, when the expansion member 110 expands, the hemostatic device 100 can accurately grasp the positional state of the support member 130 based on the relative positional relationship between the first marker portion 115 and the second marker portion 125.

The band includes a first band 140 extending from the support member 130 in a first direction, and a second band 150 extending from the support member 130 in a second direction different from the first direction. The support member 130 has a first region 131 in which the expansion member 110 is disposed, and a second region 132 located outside the first region 131 and configured to allow the first band 140 and the second band 150 to be connected. When connected to the second region 132, the first band 140 and the second band 150 have a rotation axis R in the first region 131, and can rotate around the expansion member 110 in the second region 132 around the rotation axis R. The rotation axis R is positioned to pass through the second marker portion 125.

According to the hemostatic device 100 configured as above, when attaching the hemostatic device 100 to the patient's right hand H1, the surgeon can adjust the fixed position of each of the bands 140, 150 relative to the patient's right hand H1 by rotating each of the bands 140, 150. As a result, the hemostatic device 100 can position each of the bands 140, 150 on the patient's right hand H1 so that the movement of the patient's right hand H1 is not restricted. In addition, in the hemostatic device 100 described above, since the rotation axis R of each of the bands 140, 150 is positioned so as to pass through the second marker portion 125, when the surgeon attaches the hemostatic device 100 to the patient's right hand H1, the position of the rotation axis R can be confirmed by visually confirming the position of the second marker portion 125. Since the surgeon can grasp the position of the rotation axis R, the surgeon can easily adjust the fixed position of each of the bands 140, 150 relative to the patient's right hand H1.

The expansion member 110 also has a fixed region 117 that is fixed to the support member 130. The peripheral portion of the fixed region 117 surrounds the second marker portion 125 when projected onto the support member 130.

According to the hemostatic device 100 configured as described above, the hemostatic device 100 has a fixing region 117 in which the expansion member 110 is fixed to the support member 130, so that the expansion member 110 is unlikely to shift position from the support member 130. In addition, since the second marker portion 125 of the hemostatic device 100 is disposed at a position surrounded by the peripheral portion of the fixing region 117, even if the expansion member 110 is inadvertently deformed when attaching the hemostatic device 100 to the patient's right hand H1, the second marker portion 125 remains inside the peripheral portion of the fixing region 117. Therefore, the surgeon can more accurately position the expansion member 110 at the first puncture site p1 using the first marker portion 115 and the second marker portion 125 as references.

Next, modified examples of the hemostatic device according to the present invention will be described. In the description of the modified examples, the explanation of the components and the procedure for using the hemostatic device that have already been described in the description of the above-mentioned embodiment will be omitted as appropriate. Furthermore, the contents not specifically described in each modified example can be the same as those in the above-mentioned embodiment.

<Modification 1>
21 and 22 show enlarged views of a portion of the hemostatic device 100A according to Modification 1. Fig. 21 is a plan view of the hemostatic device 100A as viewed from the outer surface side of the support member 130, and Fig. 22 is a plan view of the hemostatic device 100A as viewed from the inner surface side of the support member 130.

The hemostatic device 100A of the first modification example differs from the hemostatic device 100 of the above-described embodiment in the configuration of the first marker portion 115A and the second marker portion 125A.

As shown in Figures 21 and 22, the hemostatic device 100A generally comprises an expansion member 110 configured to compress the first puncture site p1, a fixing member 120 configured to fix the expansion member 110 to the first puncture site p1, a first marker portion 115A located on the expansion member 110 and configured to align the expansion member 110 with the first puncture site p1, and a second marker portion 125A located on the fixing member 120 and having a different shape from the first marker portion 115A.

The first marker portion 115A is positioned on the outer surface of the expansion member 110 opposite the side on which the support member 130 is positioned (see Figures 6 and 7).

As shown in Figures 21 and 22, the first marker portion 115A is formed of two or more linear portions 115a and 115b that intersect to form an intersection point 115c. The intersection point 115c is located approximately at the center position of the surface of the expansion member 110.

When the expansion member 110 is in a pre-expansion state and projected onto the support member 130, the intersection point 115c overlaps with the second marker portion 125A.

The second marker portion 125A has a ring shape with a blank space on the inside.

The second marker portion 125A is disposed on the outer surface 130b of the support member 130 (see Figures 6 and 7).

The center of the second marker portion 125A is located at approximately the center of the expansion member 110. Therefore, the center of the second marker portion 125A and the intersection 115c of the first marker portion 115A projected onto the support member 130 overlap. In addition, the center of the second marker portion 125A and the intersection 115c of the first marker portion 115A overlap with the rotation axis R of each band 140, 150.

The specific shape of the first marker portion 115A is not limited as long as it has two or more linear portions 115a, 115b that form an intersection 115c. For example, the first marker portion 115A may be formed of three or more linear portions that form one intersection. There are also no particular limitations on the thickness, color, length, etc. of each linear portion 115a, 115b. The specific shape of the second marker portion 125A is not limited as long as it has a shape different from that of the first marker portion 115A.

The expansion member 110 of the hemostatic device 100A is composed of a single balloon with an inner cavity 113 defined by a membrane material (see Figures 6 and 7).

When the expansion member 110 is in an expanded state, the intersection 115c of the first marker portion 115A is located at a position that overlaps with the second marker portion 125 with the lumen 113 sandwiched therebetween when projected onto the fixing member 120.

When attaching the hemostatic device 100A to the patient's right hand H1, the surgeon can appropriately position the expansion member 110 at the first puncture site p1 by aligning the intersection 115c of the first marker portion 115A located on the expansion member 110 with the first puncture site p1. In addition, when the surgeon expands the expansion member 110 to compress and stop the bleeding at the first puncture site p1 while the hemostatic device 100A is attached to the patient's right hand H1, the surgeon can check the positioning state of the support member 130 by checking the overlapping state of the intersection 115c of the first marker portion 115A projected onto the support member 130 and the second marker portion 125A. By checking the positioning state of the support member 130, the surgeon can easily check whether the expansion member 110 connected to the support member 130 is appropriately applying a compressive force toward the first puncture site p1.

According to the hemostatic device 100A of the first modification, when the surgeon applies pressure to the first puncture site p1 by attaching the hemostatic device 100A to the patient's right hand H1, the surgeon can visually check the overlapping state of the intersection 115c of the first marker portion 115A projected onto the fixing member 120 (supporting member 130) and the second marker portion 125 arranged on the fixing member 120 to check the arrangement state of the fixing member 120 relative to the patient's right hand H1 (presence or absence of inclination, etc.). Based on the arrangement state of the fixing member 120, the surgeon can check the direction of the compressive force applied by the expansion member 110 to the first puncture site p1. In addition, the first marker portion 115A has a reference portion for aligning the expansion member 110 with the first puncture site p1, which is composed of the intersection of two or more linear portions 115a and 115b. Therefore, when aligning the expansion member 110 with the first puncture site p1, the surgeon can position the expansion member 110 more accurately with respect to the first puncture site p1 by placing the intersection point 115c at the first puncture site p1.

The expansion member 110 of the hemostatic device 100A is composed of a single balloon with an inner cavity 113 partitioned by a membrane material. When the expansion member 110 is in an expanded state and projected onto the fixing member 120, the intersection 115c of the first marker portion 115A is located at a position that overlaps with the second marker portion 125 with the inner cavity 113 sandwiched therebetween.

According to the hemostatic device 100A configured as described above, the expansion member 110 is composed of one balloon, and when the expansion member 110 is in an expanded state, the intersection 115c of the first marker portion 115A projected onto the support member 130 is arranged so as to overlap with the second marker portion 125. Therefore, the hemostatic device 100A can stabilize the positional relationship between the first marker portion 115A and the second marker portion 125A before and after the expansion member 110 is expanded, similar to the hemostatic device 100 according to the above-mentioned embodiment (see Figures 6 and 7). Therefore, when placing the expansion member 110 and when the expansion member 110 is in an expanded state, the surgeon can visually confirm more accurately the direction of the compression force applied by the expansion member 110 to the first puncture site p1. This allows the surgeon to easily visually confirm the direction of the compression force applied by the expansion member 110 to the first puncture site p1 when the expansion member 110 is in an expanded state or when the expanded expansion member 110 is decompressed.

<Modification 2>
23 shows a partial cross-sectional view of a hemostatic device according to Modification 2. FIG 23 is a cross-sectional view corresponding to FIG 6 .

In the hemostatic device of the second modification, the structure of the connection member 180A differs from that of the hemostatic device 100 of the above-described embodiment (see FIG. 6). The connection member 180A has a frame shape with a hole formed in the central portion in the planar direction. As shown in FIG. 23, the fixing region 117 of the expansion member 110 is positioned along the outer shape of the connecting member 180A. The peripheral portion of the fixing region 117 is arranged to surround the second marker portion 125.

As described above, there are no particular limitations on the shape of the connecting member 180A or the shape and position of the fixing region 117 of the expansion member 110, and these can be changed as appropriate.

<Modification 3>
24 shows a partial cross-sectional view of a hemostatic device according to Modification 3. FIG 24 is a cross-sectional view corresponding to FIG 6 .

The support member 130A in the third modification has a flat surface portion 139 formed in the first region 131. The second marker portion 125 is disposed on the flat surface portion 139.

When attaching the hemostatic device of Modification 3 to the patient's right hand H1, the surgeon can easily visually check the first marker portion 115 by looking into the first marker portion 115 through the flat portion 139 from the outer surface 130b side of the support member 130. In this way, the surgeon can easily check the position of the first marker portion 115 through the support member 130, compared to when the first region 131 is formed in a curved shape. In addition, when performing compression hemostasis using the hemostatic device, the surgeon can easily check the overlapping state of the first marker portion 115 and the second marker portion 125 because the position of the first marker portion 115 can be easily checked through the flat portion 139.

<Modification 4>
Figures 25 to 28 show a hemostatic device 100B according to Modification 4. Figure 25 is a plan view of hemostatic device 100B, Figures 26 and 27 are cross-sectional views taken along arrows 26A-26A shown in Figure 25, and Figure 28 is a view showing the hemostatic device 100B attached to the forearm A of a patient.

As shown in FIG. 28, the hemostatic device 100B according to the fourth modification is configured to be attachable to the forearm A of a patient. The expansion member 110B included in the hemostatic device 100B is configured to be capable of applying a compressive force to a puncture site p3 formed in the forearm A of the patient. The puncture site p3 can be formed in the forearm A of the patient, for example, to ensure an access path for introducing an introducer or the like into the radial artery running through the forearm A.

As shown in FIG. 25, the hemostatic device 100B has an expansion member 110B and a fixing member 120.

As shown in Figures 26 and 27, the expansion member 110B is composed of two expansion members, a first expansion member 110C and a second expansion member 110D. Each expansion member 110C, 110D has an inner cavity 113. An injection section 191 for supplying and discharging fluid, a buffer member 192, and a tube 193 are connected to the first expansion member 110C.

The first expansion member 110C and the second expansion member 110D are connected via a connecting member 119 as shown in Figures 26 and 27. The connecting member 119 can be composed of, for example, a tube having an internal cavity.

The fixing member 120B has a band 140B that can be wrapped around the patient's forearm A. At each end of the band 140B in the extending direction, fixing portions 171B and 172B are provided for fixing the band 140B to the patient's forearm A.

As shown in Figures 26 and 27, the first marker portion 115 is positioned on the outer surface of the surface opposite the surface of the second expansion member 110D that faces the first expansion member 110C.

The second marker portion 125 is positioned on the outer surface of the band 140B.

Figure 26 shows the state before each expansion member 110C, 110D is expanded and before the hemostatic device 100B is attached to the patient's forearm A. In this state, the first marker portion 115 projected onto the fixing member 120B (band 140B) does not overlap with the second marker portion 125.

Figure 27 shows the state before the expansion members 110C, 110D are expanded, when the hemostatic device 100B is attached to the patient's forearm A. As shown in Figure 27, when the expansion members 110C, 110D are arranged adjacent to each other, the first marker portion 115 projected onto the fixing member 120B (band 140B) overlaps with the second marker portion 125.

As described above, the hemostatic device of the present invention only needs to be arranged so that the first marker portion 115 and the second marker portion 125 overlap at least before the expansion member 110B is expanded, and the first marker portion 115 and the second marker portion 125 projected onto the fixing member 120 may or may not overlap before and after the hemostatic device 100B is attached to the patient's limb (forearm A or hand H).

A support member (curved plate) 130B having a predetermined hardness similar to that of the support member 130 of the hemostatic device 100 according to the above-described embodiment can be disposed on the band 140B of the hemostatic device 100B. The support member 130B can be accommodated in a space partitioned between a predetermined covering member 190 and the band 140B.

The hemostatic device according to the present invention has been described above through embodiments and modifications, but the present invention is not limited to the contents described in the specification, and can be modified as appropriate based on the claims.

In the description of the embodiment, a hemostatic device for stopping bleeding at a puncture site formed on the back of the right hand and a puncture site formed on the forearm has been exemplified. However, the hemostatic device may also be configured to stop bleeding at a puncture site formed on the back of the left hand, a puncture site formed on the palm of either the left or right hand, a puncture site formed on a patient's foot (e.g., the dorsum of the foot, the sole, etc.), etc.

The shape and dimensions of each part of the hemostatic device are not particularly limited and can be modified as appropriate, as long as the expansion member placed at the puncture site can be expanded to compress the puncture site to stop bleeding.

100, 100A, 100B Hemostatic device 110, 110B Expansion member 113 Inner cavity 115, 115A of expansion member First marker portion 115a, 115b Linear portion 115c Intersection 117 Fixation region 120, 120B Fixation member 125, 125A Second marker portion 130, 130A, 130B Support member 130a Inner surface 130b of support member Outer surface 131 of support member First region 132 Second region 133a, 133b First hole portion 133c, 133d Second hole portion 139 Planar portion 140 First band 150 Second band 160 Third band 180 Connection member 200 Introducer A Forearm portion B Blood vessel (artery)
H Hand H1 Right hand fb Finger space p1 First puncture site (puncture site)
p2 Second puncture site (puncture site)
p3 Puncture site R Rotation axis

Claims (8)

an expansion member configured to compress a puncture site formed in the patient;
a fixing member configured to fix the expansion member to the puncture site;
a first marker portion located on the expansion member and configured to align the expansion member with the puncture site on the patient;
A second marker portion is disposed on the fixing member and has at least one of a shape, a size, and a color different from that of the first marker portion,
The second marker portion has an outer shape larger than an outer shape of the first marker portion,
A hemostatic device, wherein the first marker portion is located at a position overlapping with the second marker portion when projected onto the fixing member in a state before the expansion member is expanded. an expansion member configured to compress a puncture site formed in the patient;
a fixing member configured to fix the expansion member to the puncture site;
a first marker portion located on the expansion member and configured to align the expansion member with the puncture site on the patient;
a second marker portion disposed on the fixing member and having a shape different from that of the first marker portion;
The first marker portion is formed of two or more linear portions intersecting to form an intersection point,
A hemostatic device in which the intersection is located at a position that overlaps with the second marker portion when projected onto the fixing member before the expansion member is expanded. The expansion member is composed of a balloon having an inner cavity defined by a membrane material,
The hemostatic device according to claim 1 , wherein the first marker portion is positioned so as to overlap with the second marker portion with the inner cavity therebetween when projected onto the fixing member in an expanded state of the expansion member. The expansion member is composed of a balloon having an inner cavity defined by a membrane material,
The hemostatic device according to claim 2 , wherein the intersection is located at a position overlapping with the second marker portion with the inner cavity therebetween when the expansion member is in an expanded state and projected onto the fixing member. The fixation member includes a support member and a strap extending from the support member and configured to be wrapped around a limb of the patient;
The support member is made of a material harder than the expansion member,
The hemostatic device according to claim 1 , wherein the second marker portion is disposed on the support member. The band includes a first band extending from the support member in a first direction and a second band extending from the support member in a second direction different from the first direction,
the support member has a first region in which the expansion member is disposed, and a second region located outside the first region and configured to be connectable to the first band and the second band,
The first band and the second band, when connected to the second region, have a rotation axis in the first region and are rotatable around the expansion member in the second region around the rotation axis,
The hemostatic device of claim 5 , wherein the axis of rotation passes through the second marker portion. The support member has a flat plane portion formed in the first region,
The hemostatic device according to claim 6 , wherein the second marker portion is disposed on the planar portion. The expansion member has a fixing region fixed to the support member,
The hemostatic device according to claim 5, wherein a peripheral portion of the fixing region surrounds the second marker portion when projected onto the support member.