Hemostatic instrument and hemostatic instrument set

Abstract

[Problem] To provide a hemostatic instrument and a hemostatic instrument set capable of preventing a deterioration in the sealability of a connector part caused by foreign matter intruding into a lumen of the connector part. [Solution] An injection member 200 of a hemostatic instrument 10 includes: a connector part 210; and a coupling part 220 for coupling a lumen of the connector part and a lumen 170a of an expansion member 170. A check valve member 300 of the connector part 210 includes an outer member 310, an inner member 320 positioned in a lumen 316 of the outer member, and a spring member 390 connected to the inner member. The inner member has a body part 330 configured such that the spring member comes into contact with an inner protrusion 315 in a natural state, and a tip protrusion 340 protruding from a tip of the body part to a tip opening 311 side. An upper end 350 of the tip protrusion has a recess 353 recessed toward the body part side. A side wall 360 of the tip protrusion has a slit 361 continuous with the recess and extending in a longitudinal direction of the inner member. The recess has a trap part 355 in which a width W1 becomes narrower from a center position O1 of the upper end toward an outer edge 351 of the upper end in a plan view.

Description

Hemostatic instruments and hemostatic instrument sets

[0001] The present invention relates to a hemostatic device and a hemostatic device set.

[0002] One known catheterization procedure involves puncturing a blood vessel in a patient's limb, such as an arm or a hand, to form a puncture site, and introducing various types of elongated medical objects into the blood vessel to perform diagnosis or treatment of a lesion. For example, Patent Document 1 discloses a hemostatic device that stops bleeding at a puncture site formed to enable access to a blood vessel running through the hand (including the distal radial artery).

[0003] The hemostatic device of Patent Document 1 comprises an expansion member that applies pressure to a puncture site formed on the patient's hand, a cover member for fixing the expansion member to the patient's hand, a connector portion (port portion) configured to allow injection of a fluid to expand the expansion member, and a connecting portion (tube portion) that connects the connector portion to the inner cavity of the expansion member.

[0004] US Patent Application Publication No. 2019 / 0133602

[0005] When a surgeon such as a doctor (hereinafter referred to as "the surgeon") uses the hemostatic device of Patent Document 1 to stop bleeding at a puncture site formed on a patient's hand, the surgeon fixes the hemostatic device to the patient's hand with the expansion member positioned at the puncture site formed on the patient's hand. By expanding the expansion member with the hemostatic device fixed to the patient's hand, the surgeon can apply a compressive force from the expansion member to the puncture site formed on the patient's hand to stop bleeding.

[0006] When expanding the expansion member, the surgeon connects a fluid injection instrument, such as a syringe, to the connector portion for injecting fluid. The connector portion of the hemostatic device includes a check valve (valve element) disposed therein for blocking fluid communication between the lumen of the expansion member and the outside of the connector portion, for example, when the fluid injection instrument is not connected. The surgeon connects the fluid injection instrument to the connector portion and pushes the check valve disposed inside the connector portion with the fluid injection instrument, thereby moving the check valve from a predetermined closed position to a predetermined open position. By moving the check valve to the predetermined open position, the surgeon can establish fluid communication between the fluid holding portion (outer tubular portion) of the fluid injection instrument and the lumen of the expansion member via the connecting portion (front tubular portion) of the fluid injection instrument. With the fluid holding portion of the fluid injection instrument fluidically connected to the lumen of the expansion member, the surgeon can operate the fluid injection instrument to inject fluid into the lumen of the expansion member, thereby expanding the expansion member.

[0007] After expanding the expansion member, the surgeon withdraws the fluid injection tool from the connector portion. When the surgeon withdraws the fluid injection tool from the connector portion, the check valve disposed inside the connector portion moves to a closed position within the connector portion. When the check valve moves to the closed position within the connector portion, the hemostatic tool again blocks fluid communication between the lumen of the expansion member and the outside of the connector portion.

[0008] The connector portion of the hemostatic device disclosed in Patent Document 1 can be configured to allow a portion of a fluid injection device to be inserted into the connector portion, as described above. Furthermore, when the connector portion is used, the hemostatic device can be provided with a connection opening for maintaining the connection between the connector portion and the fluid injection device. When such a connector portion and connection opening structure is employed in the hemostatic device, a portion of the interior of the connector portion is exposed to the outside of the connector portion through the connection opening when the fluid injection device is not connected to the connector portion. When a portion of the interior of the connector portion is exposed to the outside of the connector portion through the connection opening, foreign matter may enter the inside of the connector portion through the connection opening. Therefore, when the connector portion and connection opening structure described above are employed in the hemostatic device, if the check valve is moved from the open position to the closed position while a foreign matter has entered the inside of the connector portion, there is a risk that the foreign matter may become trapped between the check valve moved to the closed position and the inner wall of the connector portion. Therefore, when the above-mentioned hemostatic device employs the above-described connector portion and connection opening structure, if a foreign object becomes trapped between the check valve that has moved to the closed position and the inner wall of the connector portion, the sealing (airtightness) of the check valve is reduced, and fluid injected into the lumen of the expansion member may leak to the outside through the check valve and the connector portion. If fluid injected into the lumen of the expansion member leaks to the outside of the connector portion, the compression force applied by the expansion member to the puncture site formed on the patient's hand may be reduced. Therefore, the hemostatic device of Patent Document 1 may not be able to exert a sufficient hemostatic effect due to the influence of foreign object that has entered the connector portion.

[0009] The present invention has been made in light of the above-mentioned problems, and aims to provide a hemostatic device and a hemostatic device set that can prevent a deterioration in the sealing performance of the connector part due to foreign matter entering the inner cavity of the connector part.

[0010] The present invention is achieved by any one of the following means (1) to (13).

[0011] (1) A device comprising: a cover member configured to cover a puncture site formed in a patient; an expansion member connected to the cover member and configured to compress the puncture site; and an injection member connected to the expansion member and configured to be able to inject a fluid into the expansion member, wherein the injection member has a connector portion and a connecting portion that connects an inner cavity of the connector portion and an inner cavity of the expansion member, the connector portion has a check valve member configured to be able to control communication between the inner cavity of the connector portion and the outside, and a connecting member that connects the check valve member and the connecting portion, the check valve member has an outer member, an inner member located in the inner cavity of the outer member, and a spring member connected to the inner member, the outer member has a tip opening configured to expose a part of the inner member to the outside, and a tip opening that connects the inner cavity of the outer member and the inner cavity of the connecting member and an inner protrusion configured to prevent movement of the inner member toward the tip opening side, wherein the spring member is located between the base opening and the inner protrusion so as to maintain contact between an outer surface of the inner member and the inner protrusion in a natural state, the inner member has a main body configured to contact the inner protrusion in a natural state, and a tip protrusion protruding from the tip of the main body toward the tip opening side, the tip protrusion having an upper end and a side wall connecting the upper end and the main body, the upper end having a recess recessed toward the main body, the side wall having a slit portion continuous with the recess and extending in the longitudinal direction of the inner member, and the recess having a trap portion whose width narrows from the center position of the upper end toward the outer edge of the upper end in a plan view.

[0012] (2) The hemostatic device according to (1) above, wherein the recess is connected to the slit portion via the trap portion.

[0013] (3) The hemostatic device according to (1) or (2) above, wherein the upper end portion has a first protrusion formed on the outer edge of the upper end portion.

[0014] (4) The hemostatic device according to (3) above, wherein the upper end portion has a plurality of upper surface portions positioned on the same plane.

[0015] (5) The hemostatic device according to (4) above, wherein the upper surface portion has a second convex portion formed on the inner edge portion of the upper surface portion.

[0016] (6) A hemostatic device according to any one of (1) to (5) above, wherein the outer diameter of the upper end is larger than the inner diameter of the tip opening.

[0017] (7) A hemostatic device described in any one of (1) to (6) above, wherein in a natural state, the spring member holds the end of the slit portion located on the main body side at a position closer to the tip opening than the inner protrusion, and when a pushing force is applied to the spring member in a direction toward the base opening, the spring member moves the end of the slit portion to a position closer to the base opening than the inner protrusion.

[0018] (8) A hemostatic device described in any one of (1) to (7) above, wherein the recess has a notch connecting the center position of the upper end and the side surface of the upper end, and the width of the notch gradually narrows toward the main body portion.

[0019] (9) The hemostatic device described in (8) above, wherein the four cutout portions are arranged at equal intervals around the circumference of the upper end portion, based on the center position of the upper end portion.

[0020] (10) A hemostatic device described in any one of (1) to (9) above, wherein the slit portion has a predetermined depth along a direction from the side wall portion toward the center position of the upper end portion.

[0021] (11) The hemostatic device according to any one of (1) to (10) above, wherein the slit portion extends with a substantially constant width along the longitudinal direction of the side wall portion.

[0022] (12) A hemostatic device described in any one of (1) to (11) above, wherein the upper end portion comprises a first region having an upper surface portion and a second region forming the bottom of the recess, and the end portion located on the main body portion side of the slit portion is located closer to the main body portion than the second region.

[0023] (13) A hemostatic device set comprising the hemostatic device according to any one of (1) to (12) above and a fluid injection device having a tip tube portion that abuts against the upper end portion, wherein the upper surface portion of the upper end against which the tip tube portion abuts has an outer diameter larger than that of the tip tube portion in a plan view.

[0024] The hemostatic device (1) described above includes a check valve member disposed in the lumen of the connector portion. The spring member of the check valve member maintains contact between the inner member and an inner protrusion formed on the outer member in a natural state, thereby forming a seal within the connector portion and preventing fluid communication between the lumen of the expansion member and the outside of the connector portion via the connector portion. In the hemostatic device described above, the inner member has a main body portion configured to contact the inner protrusion of the outer member and a distal protrusion portion protruding from the distal end of the main body portion toward the distal opening. The distal protrusion portion has an upper end and a side wall portion connecting the upper end and the main body portion. The upper end has a recess recessed toward the main body portion, and the recess has a trap portion whose width narrows from the center of the upper end toward the outer edge of the upper end in a plan view. The hemostatic device described above can capture foreign matter that has entered the lumen of the outer member through the distal opening using the trap portion provided in the recess located closer to the distal opening than the main body portion of the inner member. Furthermore, in the hemostatic device, when a foreign object has entered the connector portion and fluid is delivered to the injection portion via the connector portion, the trap can capture the foreign object migrated toward the main body portion by the injected fluid. Therefore, the hemostatic device can prevent foreign objects that have entered the lumen of the outer member from migrating to the main body portion of the inner member. Therefore, even if a foreign object has entered the lumen of the outer member, the hemostatic device can prevent the foreign object from becoming trapped between the outer surface of the main body portion of the inner member and the inner protrusion of the outer member when the spring member is in its natural state. Therefore, the hemostatic device can prevent a decrease in the sealing performance of the seal portion due to a foreign object that has entered the lumen of the outer member. Therefore, the hemostatic device can prevent a decrease in the compressive force applied by the expansion member to the puncture site formed in the patient due to a foreign object that has entered the lumen of the outer member. Furthermore, in the hemostatic device, the side wall portion of the distal protrusion has a slit that is continuous with the recess and extends in the longitudinal direction of the inner member. In the above-mentioned hemostatic device, when fluid is injected into the inner cavity of the expansion member, a pushing force is applied to the spring member in a direction away from the tip opening via a fluid injection device inserted into the inner cavity of the outer member, causing the spring member to compress along the longitudinal direction of the connector portion.In the hemostatic device described above, when the spring member is compressed, the inner member moves toward the proximal end as the spring member is compressed. When the inner member moves toward the proximal end as the spring member is compressed, the outer surface of the main body portion of the inner member and the inner protrusion of the outer member are released from contact. When fluid is injected into the lumen of the outer member via a fluid injection device while the outer surface of the main body portion of the inner member and the inner protrusion of the outer member are released from contact, the injected fluid can be smoothly transported from the distal protrusion side toward the main body side through a slit formed in the side wall portion connecting the upper end and the main body portion. Therefore, when the expansion member is expanded using a fluid injection device, the hemostatic device described above can smoothly deliver fluid to the lumen of the expansion member via the connector portion and the connecting portion.

[0025] 11A-11C are plan views of a hemostatic device according to an embodiment, as viewed from the outer surface side of each band portion; FIG. 11B are plan views of a hemostatic device according to an embodiment, as viewed from the inner surface side of each band portion; FIG. 11C are enlarged views of a portion of the hemostatic device as viewed from the outer surface side of the main body portion of the cover member; FIG. 11B are enlarged views of a portion of the hemostatic device as viewed from the inner surface side of the main body portion of the cover member; FIG. 11C are enlarged views of a portion of the hemostatic device as viewed from the outer surface side of the main body portion of the cover member; FIG. 11C are partial cross-sectional views of the hemostatic device taken along arrows 6A-6A in FIG. 5, showing the state when the expansion member is expanded; FIG. 11C are partial cross-sectional views of the hemostatic device taken along arrows 7A-7A in FIG. 5, showing the state when the expansion member is expanded; FIG. 11D are partial cross-sectional views of the check valve member taken along arrows 9A-9A in FIG. 8; FIG. 11C are cross-sectional views of the check valve member; FIG. 11D are partial cross-sectional views of the inner member, as viewed from the inner surface side of the main body portion of the cover member; FIG. 11E are partial cross-sectional views of the inner member; FIG. 11F are partial cross-sectional views of the inner member; FIG. 11F are partial cross-sectional views of the tip protrusion of the inner member; FIG. 11F are partial cross-sectional views ... tip protrusion of the inner member; 22A-22A. FIG. 22B is a plan view of the inner member as viewed from the distal end side. FIG. 23A is a view showing a side wall portion of the inner member. FIG. 23B is a plan view of the connector portion as viewed from the distal end side. FIG. 23C is a perspective view showing the state when the front tube portion of the fluid injection instrument is pressed against the upper end of the inner member. FIG. 23D is a view showing the hand (right hand) of a patient on whom the hemostatic instrument is to be used. FIG. 23D is a view showing a simplified example of how the hemostatic instrument is used. FIG. 23E is a view showing a simplified example of how the hemostatic instrument is used. FIG. 23F is a view showing a simplified example of how the hemostatic instrument is used. FIG. 23F is a partial cross-sectional view taken along arrows 23A-23A shown in FIG. 22A. FIG. 23F is a partial cross-sectional view taken along arrows 24A-24A shown in FIG. 22A. FIG. 23C is a view showing a side wall portion of the inner member according to Modification 1. FIG. 23D is a plan view of the inner member according to Modification 2 as viewed from the distal end side. FIG. 23E is a side view of the inner member according to Modification 2. FIG. 23F is a perspective view showing the front protruding portion of the inner member according to Modification 2. FIG. 23F is a partial cross-sectional view of the front protruding portion of the inner member according to Modification 2. FIG. 23F is a perspective view showing the front protruding portion of the inner member according to Modification 3. FIG. 23F is a plan view of the inner member according to Modification 4 as viewed from the distal end side. FIG. 23F is a side view of the inner member according to Modification 4. Fig. 10 is a perspective view showing a tip protrusion of an inner member according to Modification 4. Fig. 11 is a partial cross-sectional view of the tip protrusion of the inner member according to Modification 4. Fig. 12 is a plan view of the inner member according to Modification 5 as viewed from the tip side. Fig. 13 is a side view of the inner member according to Modification 5. Fig. 14 is a perspective view showing the tip protrusion of the inner member according to Modification 5.FIG. 13 is a partial cross-sectional view of a tip protrusion of an inner member according to Modification 5.

[0026] Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings. The following description does not limit the technical scope or meaning of terms described in the claims. Furthermore, the dimensional proportions in the drawings are exaggerated for the convenience of explanation and may differ from the actual proportions.

[0027] 1 to 18 are diagrams illustrating a hemostatic device 10 according to an embodiment. Figures 19 to 24 are diagrams illustrating an example of use of the hemostatic device 10 according to an embodiment.

[0028] As shown in Figures 19, 22, 23, and 24, the hemostatic device 10 can be used to stop bleeding at a first puncture site p1 (hereinafter also simply referred to as the "first puncture site") formed in a hand H located distal to (toward the fingertips of) a patient's forearm Ar when removing a sheath tube 810 of an introducer 800 that has been placed at the first puncture site p1.

[0029] The specific locations of the puncture sites that are the targets of hemostasis by the hemostatic device 10 are not particularly limited, but in this specification, a first puncture site p1 and a second puncture site p2 are given as examples.

[0030] As shown in Figures 19, 22, 23, and 24, the first puncture site p1 is a puncture site formed in the distal radial artery (hereinafter also referred to as "blood vessel V1") located distal to the snuffbox Sb of the palmar artery running on the back side of the patient's right hand H1 located distal to the forearm Ar. The first puncture site p1 is located between the metacarpal B1 of the index finger and the metacarpal B2 of the thumb, at a predetermined position that avoids the metacarpal B1 of the index finger and the metacarpal B2 of the thumb. The snuffbox Sb is a cavity in the hand that is located near the radius when the patient spreads the thumb of the hand H.

[0031] 19, the second puncture site p2 is a puncture site formed in the artery V2 located at the snuffbox Sb of the palmar artery running along the back of the right hand H1. The second puncture site p2 is located closer to the patient's forearm Ar (proximal) than the first puncture site p1, and is located between the extensor pollicis longus tendon T1 and the extensor pollicis brevis tendon T2 located on the back of the patient's right hand H1. The second puncture site p2 is also located at a predetermined position that avoids the positions of the metacarpal bone B1 of the index finger and the metacarpal bone B2 of the thumb.

[0032] In addition, the hemostatic device 10 can also be used to stop bleeding at a puncture site formed on the patient's left hand at a position corresponding to the first puncture site p1 exemplified by the patient's right hand H1, or at a puncture site formed on the patient's left hand at a position corresponding to the second puncture site p2 exemplified by the patient's right hand H1.

[0033] The hemostatic device 10 will now be described in detail.

[0034] (Hemostatic device 10) In general, as shown in Figures 1, 2, 8, 22, 23, and 24, the hemostatic device 10 has a cover member 100 configured to cover the first puncture site p1, an expansion member 170 connected to the cover member 100 and configured to compress the first puncture site p1, and an injection member 200 connected to the expansion member 170 and configured to be able to inject a fluid into the expansion member 170.

[0035] In this specification, the directions of the cover member 100 and the support member 500 of the hemostatic device 10 are defined as follows: When the hemostatic device 10 is attached to the patient's right hand H1, the side of the fingertips is the "distal side," and the side of the forearm Ar is the "proximal side."

[0036] 6 and 7, the expansion member 170 has an inner cavity 170a into which a fluid can be injected. The expansion member 170 is configured to expand as a fluid is injected into the inner cavity 170a, and to contract as the fluid injected into the inner cavity 170a is discharged.

[0037] The fluid used to expand the expansion member 170 is, for example, a gas such as air. Figures 6 and 7 show cross-sectional views of the expansion member 170 in an expanded state.

[0038] A connecting portion 220 (see FIGS. 1 and 2), which will be described later, is connected to the inner cavity 170a of the expansion member 170. Note that the connecting portion 220 is not shown in the cross-sectional views of FIGS. 6, 7, 23, and 24.

[0039] As shown in FIGS. 6 and 7, the extension member 170 can be made up of, for example, a film-like member (sheet material) connected to the sheet material 120 that constitutes the cover body 110 of the cover member 100.

[0040] The sheet material constituting the expansion member 170 can be connected to the cover member 100 so that an inner cavity 170a into which a fluid can be injected is defined between the sheet material 120 constituting the cover body 110 of the cover member 100 and the underside region 132 of the retaining portion 130 formed by the sheet material 120.

[0041] The outer periphery of the membrane-like member that constitutes the expansion member 170 constitutes the edge of the expansion member 170. The edge of the expansion member 170 can be connected to the sheet material 120 by, for example, fusion bonding or adhesive.

[0042] As shown in Fig. 6, an edge 172 located at the lower end 502 of the support member 500 in the sheet material constituting the extension member 170 can be connected to the curved region 133 formed by the cover member 100. Also, as shown in Fig. 6, an edge 171 located on the upper end 501 side of the support member 500 in the sheet material constituting the extension member 170 can be fixed to the sheet material 120 at a predetermined position that overlaps with the lower surface 500a of the support member 500 in the planar direction.

[0043] The film-like member that constitutes the expansion member 170 can be made of, for example, a resin material having a predetermined thickness.

[0044] The material of the membrane-like member that constitutes the expansion member 170 is not particularly limited, but examples include polyvinyl chloride, ethylene-vinyl acetate copolymer (EVA), polyvinylidene chloride, silicone, polyamide (nylon), polyurethane, polyolefins such as polyethylene, polypropylene, and polybutadiene, polyesters such as polyethylene terephthalate (PET) and polybutylene terephthalate (PBT), various thermoplastic elastomers such as polyamide elastomer (nylon elastomer), polyurethane elastomer, and polyester elastomer, or any combination of these (blend resin, polymer alloy, laminate, etc.).

[0045] As shown in FIGS. 6 and 7, the extension member 170 is disposed on the inner surface 110 a side of the cover body 110 of the cover member 100 .

[0046] In this embodiment, the inner surface 110a of the cover body 110 is configured as a surface that is positioned on the body surface side of the right hand H1 in the lower surface region 132 of the holding part 130 (see FIGS. 23 and 24). The outer surface 110b of the cover body 110 is configured as a surface that is positioned facing the outside in the upper surface region 131 of the holding part 130.

[0047] As shown in FIGS. 20, 21, and 22, the expansion member 170 has a marker portion 175 for aligning the expansion member 170 with the first puncture site p1.

[0048] As shown in FIGS. 4, 6, and 7, the marker portion 175 can be configured with a transparent central portion surrounding the central position of the expansion member 170 and a colored circular frame portion surrounding the central portion.

[0049] 6 and 7, the marker portion 175 is disposed on the outer surface of the expansion member 170. Note that the marker portion 175 may also be disposed on the inner surface of the expansion member 170 that faces the lumen 170a.

[0050] There are no particular limitations on the specific shape, color, position in the surface direction of the extension member 170, formation method, etc. of the marker portion 175. The marker portion 175 can also be configured as, for example, a circular marker that is entirely colored, a marker that is composed of a transparent center and a rectangular frame, or a rectangular marker that is entirely colored.

[0051] There are no particular limitations on the planar shape of the expansion member 170 in the planar view shown in Figures 6 and 7. The expansion member 170 can be configured to have a planar shape such as a circle, an ellipse, a rectangle, etc. When the expansion member 170 is configured to have a planar shape such as a circle, an ellipse, a rectangle, etc., the center of the expansion member 170 can be defined as the center position of the outer shape in the planar view.

[0052] Furthermore, there are no particular limitations on the specific configuration of the expansion member 170. For example, the expansion member 170 may be formed by joining an edge of one sheet-like member to two sheet-like members with a cavity 170a formed between the other sheet-like member. When the expansion member 170 is configured in this manner, the surface of one sheet-like member can be connected to the sheet material 120 that constitutes the cover body 110 of the cover member 100. The expansion member 170 can also be configured, for example, by a single bag-like member shaped to have a cavity 170a inside. When the expansion member 170 is configured in this manner, the expansion member 170 can be connected to a portion of the surface of the bag-like member to the sheet material 120 that constitutes the cover body 110 of the cover member 100.

[0053] (Cover member 100) As shown in Figures 3, 4, 5, and 22, the cover member 100 comprises a cover body 110 in which the extension member 170 is located, a first band portion 610 configured to be placed between the patient's fingers and extending from the cover body 110 in a first direction, a second band portion 620 extending from the cover body 110 in a second direction different from the first direction, and a third band portion 630 facing the second band portion 620 across the extension member 170 and extending from the cover body 110 in a third direction different from the first and second directions.

[0054] The area of ​​the cover member 100 where the extension member 170 is arranged (the area overlapping with the extension member 170 in the plan views shown in FIGS. 3, 4, and 5) constitutes the cover main body 110.

[0055] 6 and 7, the cover body 110 has a two-layer structure. The cover body 110 has a two-layer structure and includes a holding portion 130 that holds the support member 500.

[0056] As shown in Figures 6 and 7, the holding portion 130 has an upper surface region 131 located on the upper surface 500b side of the support member 500, a lower surface region 132 located on the lower surface 500a side of the support member 500 and facing the upper surface region 131 across the support member 500, and a curved region 133 connecting the upper surface region 131 and the lower surface region 132 on the base end side of the support member 500 (the lower end portion 502 side of the support member 500).

[0057] The curved region 133 is formed by folding back a portion of the sheet material 120 that constitutes the cover body 110 toward the first band portion 610. In this embodiment, a portion of the sheet material 120 that constitutes the cover body 110 is folded back from the base end side to the tip end side of the cover body 110. An insertion portion 135 in which the support member 500 can be placed is formed between the upper surface region 131 and the lower surface region 132 of the folded back sheet material 120. The portion of the sheet material 120 where the insertion portion 135 is formed constitutes the holding portion 130 that holds the support member 500.

[0058] As shown in Figure 6, an edge 121 (hereinafter referred to as the "edge 121 of the lower surface region 132") located at the tip side of the folded portion of the sheet material 120 constituting the cover body 110 is fixed to the sheet material 120 at a position tip side of the upper end portion 501 of the support member 500 via each fixing region 150A, 150B described later.

[0059] The base end portion 122 of the cover member 100 , which is made up of a part of the sheet material 120 that constitutes the cover body 110 , is located in the curved region 133 .

[0060] As shown in FIGS. 5 and 6, the insertion portion 135 of the holder 130 is closed at a position on the upper end portion 501 side of the support member 500 except for a non-fixed region 160, which will be described later.

[0061] As shown in FIGS. 5 and 6, the insertion portion 135 of the holding portion 130 is closed by a curved region 133 at the side of the lower end portion 502 of the support member 500 .

[0062] As shown in Figures 4 and 5, the edge 121 of the lower surface region 132 has a first fixed region 150A and a second fixed region 150B fixed to the upper surface region 131, and a non-fixed region 160 adjacent to each fixed region 150A, 150B and not fixed to the upper surface region 131.

[0063] The first fixed region 150A and the second fixed region 150B can be arranged to face each other with the non-fixed region 160 sandwiched between them in the plan view shown in FIGS. 4 and 5, for example.

[0064] The first and second fixing regions 150A, 150B may be configured to have symmetrical shapes with respect to the center line C (see FIG. 4 ) of the first band portion 610. Each fixing region 150A, 150B may be configured by, for example, an adhesive or fused portion that fixes the lower surface region 132 to the sheet material 120.

[0065] Each of the fixing regions 150A, 150B can be arranged so that at least a portion of each of the fixing regions 150A, 150B is located on the tip side of the support member 500. Furthermore, each of the fixing regions 150A, 150B can be arranged so as to surround each edge portion on the tip side of the support member 500 in the plan view shown in Figures 4 and 5.

[0066] Each of the fixing regions 150A, 150B can be arranged so that at least a portion of each of the fixing regions 150A, 150B extends from the upper end portion 501 side of the support member 500 to each of the side portions 503, 504 side of the support member 500.

[0067] There are no particular limitations on the specific shape and position of each of the fixed regions 150A and 150B, and they can be changed as desired.

[0068] (First band portion 610, second band portion 620, third band portion 630) As shown in Figures 3 and 4, the first band portion 610 is connected to the cover body 110 at a position opposite the curved region 133 with the support member 500 in between.

[0069] The second band portion 620 and the third band portion 630 are integrally formed with the cover body 110 .

[0070] Similar to the first band 610, the second band 620 and the third band 630 may be formed as separate members from the cover body 110 and connected to the cover body 110. Similarly to the second band 620 and the third band 630, the first band 610 may be formed integrally with the cover body 110.

[0071] As shown in Figures 1, 2, 3, and 4, the first band portion 610 has a first end 611 connected to the cover body 110 of the cover member 100, a second end 612 located opposite the first end 611, and an intermediate portion 613 extending between the first end 611 and the second end 612.

[0072] 6, a first end 611 of the first band portion 610 is connected to the cover body 110 of the cover member 100. The first end 611 of the first band portion 610 can be connected to the cover body 110 by, for example, fusion or adhesive bonding.

[0073] As shown in FIGS. 3 and 4, the first band portion 610 has a slit 615 extending in the longitudinal direction of the first band portion 610 .

[0074] As shown in FIG. 6, the slit 615 penetrates the inner surface 610a and the outer surface 610b of the first band portion 610.

[0075] 3 and 4, connecting portion 220 of injection member 200 passes between fixing regions 150A, 150B formed on cover body 110 and is inserted through slit 615 from the inner surface 610a side of first band portion 610 to the outer surface 610b side of first band portion 610. Therefore, as shown in FIGS. 1 and 2, connector portion 210 connected to connecting portion 220 is disposed on the outer surface 610b side of first band portion 610.

[0076] The slit 615 can be configured, for example, to extend a predetermined length from the first end 611 of the first band portion 610 along the longitudinal direction of the first band portion 610 .

[0077] As shown in Figure 22, the first band portion 610 can be positioned so that it is hooked onto the inter-finger portion fb located between the thumb and index finger of the patient's right hand H1, with the expansion member 170 positioned at the first puncture site p1.

[0078] As shown in Figures 1, 2, 3, and 4, the second band portion 620 has a first end 621 that is integrally connected to the cover body 110 of the cover member 100, a second end 622 that is located opposite the first end 621, and an intermediate portion 623 that extends between the first end 621 and the second end 622.

[0079] The second direction in which the second band portion 620 extends is not particularly limited as long as it is a direction different from the first direction in which the first band portion 610 extends.

[0080] As shown in Figures 1, 2, 3, and 4, the third band portion 630 has a first end 631 that is integrally connected to the cover body 110 of the cover member 100, a second end 632 that is located opposite the first end 631, and an intermediate portion 633 that extends between the first end 631 and the second end 632.

[0081] The third direction in which the third band portion 630 extends is not particularly limited as long as it is a direction different from the first direction in which the first band portion 610 extends and the second direction in which the second band portion 620 extends.

[0082] As shown in Figures 21 and 22, when the hemostatic device 10 is worn on the patient's right hand H1, the second band portion 620 and the third band portion 630 can be positioned so as to be wrapped around the outer circumference of the right hand H1.

[0083] 5, the second band portion 620 has a flexible portion 625 that is located closer to the first band portion 610 than the end of the first fixing region 150A that is located on the curved region 133 side. In addition, the third band portion 630 has a flexible portion 635 that is located closer to the first band portion 610 than the end of the second fixing region 150B that is located on the curved region 133 side.

[0084] Each of the flexible portions 625, 635 is formed by a portion where the material constituting each of the band portions 620, 630 is curved so as to undulate in the thickness direction of each of the band portions 620, 630. Each of the flexible portions 625, 635 is configured so that when an external pulling force is applied, it easily stretches in the direction of the applied pulling force, compared to a portion of each of the band portions 620, 630 where no flexible portion 625, 635 is formed.

[0085] The constituent material of each of the band portions 610, 620, 630 is not particularly limited, but may be, for example, vinyl chloride resin, polyurethane resin, polyester resin, etc. Furthermore, there are no particular limitations on the shape, length, thickness, etc. of each of the band portions 610, 620, 630.

[0086] Each band portion 610, 620, 630 has four fixing portions, namely, a first fixing portion 710, a second fixing portion 720, a third fixing portion 730, and a fourth fixing portion 740, which enable the cover member 100 to be fixed to the right hand H1.

[0087] As shown in FIG. 1 , a first fixing portion 710 is disposed on the outer surface of the middle portion 623 of the second band portion 620 .

[0088] As shown in FIG. 1 , a second fixing portion 720 is disposed on the outer surface of the middle portion 633 of the third band portion 630 .

[0089] As shown in FIG. 2 , a third fixing portion 730 is disposed on the inner surface of the middle portion 633 of the third band portion 630 .

[0090] As shown in FIG. 2 , a fourth fixing portion 740 is disposed on the inner surface of the middle portion 613 of the first band portion 610 .

[0091] The first and second fastening portions 710 and 720 may be formed, for example, by the male side of a hook-and-loop fastener. The third and fourth fastening portions 730 and 740 may be formed, for example, by the female side of a 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).

[0092] The second band portion 620 and the third band portion 630 are configured to be detachable via a first fastening portion 710 located on the outer surface of the intermediate portion 623 of the second band portion 620 and a third fastening portion 730 located on the inner surface of the intermediate portion 633 of the third band portion 630. The first band portion 610 and the third band portion 630 are also configured to be detachable via a fourth fastening portion 740 located on the inner surface of the intermediate portion 613 of the first band portion 610 and a second fastening portion 720 located on the outer surface of the intermediate portion 633 of the third band portion 630.

[0093] The specific structure of each of the fixing portions 710, 720, 730, and 740 is not limited as long as the band portions 610, 620, and 630 can be connected together to fix the cover member 100 to the right hand H1 while the hemostatic device 10 is placed on the right hand H1. For example, some of the fixing portions may be omitted, or the positions of the fixing portions on the band portions 610, 620, and 630 may be changed as desired. Furthermore, when each of the fixing portions 710, 720, 730, and 740 is configured using a hook-and-loop fastener, the male and female sides of the hook-and-loop fastener may be reversed. Furthermore, each of the fixing portions 710, 720, 730, and 740 may be configured using, for example, a snap, a button, a clip, or a connecting mechanism including a frame portion with a protrusion and an engaged portion with a hole that can engage with the frame portion.

[0094] (Supporting Member 500) As shown in Figs. 6 and 7, the supporting member 500 can be disposed in the inserting portion 135 of the holding portion 130.

[0095] As shown in Figures 5, 6, and 7, the support member 500 is located on the first band portion 610 side and has an upper end portion 501 that forms the end of the support member 500, a lower end portion 502 that forms the end opposite the upper end portion 501, and a pair of side portions 503, 504 that connect the upper end portion 501 and the lower end portion 502.

[0096] The upper end 501 of the support member 500 can be positioned on the fingertip side (distal end side) when the hemostatic device 10 is worn on the patient's right hand H1. The lower end 502 of the support member 500 can be positioned on the forearm Ar side (proximal end side) when the hemostatic device 10 is worn on the patient's right hand H1. The upper end 501 forms the "distal end" of the support member 500, and the lower end 502 forms the "proximal end" of the support member 500.

[0097] Each of the upper end portion 501 and the lower end portion 502 of the support member 500 can be configured to include a flat portion that extends substantially linearly in the plan view shown in FIG.

[0098] As shown in FIG. 7, the upper surface 500b of the support member 500 is curved toward the second band portion 620 and the third band portion 630 (toward the left and right in FIG. 7).

[0099] The radius of curvature of the upper surface 500b of the support member 500 can be formed to be approximately constant at each portion in the vertical direction of the support member 500 (the up-and-down direction in FIG. 5), for example.

[0100] As shown in Fig. 7, the lower surface 500a of the support member 500 is curved toward the second band portion 620 and the third band portion 630 (the left-right direction in Fig. 7). Therefore, as shown in Fig. 7, the lower surface 500a of the support member 500 is curved convexly in a direction away from the expansion member 170.

[0101] 6, the support member 500 can be configured so that the thickness of each side surface 503, 504 connecting the upper end 501 and the lower end 502 becomes thinner from the upper end 501 to the lower end 502. In other words, the support member 500 can be configured to have a cross-sectional shape that is inclined so that the distance between the upper surface 500b and the lower surface 500a becomes smaller from the upper end 501 to the lower end 502 in the cross-sectional view shown in FIG.

[0102] In the plan view shown in FIG. 5, the edge portions located at the four corners of the support member 500 can be formed in a rounded curved shape.

[0103] In the hemostatic device 10, it is preferable that the portion of the expansion member 170 where the marker portion 175 is provided, the portion of the cover member 100 that overlaps with the marker portion 175 (the upper surface region 131 and the lower surface region 132 of the holding portion 130), and the portion of the support member 500 that overlaps with the marker portion 175 are formed transparently. When the members 100, 170, and 500 are configured in this manner, when the surgeon attaches the hemostatic device 10 to the patient's right hand H1 as shown in Figures 20, 21, and 22, the surgeon can easily visually confirm the position of the marker portion 175 and / or the first puncture site p1 arranged on the expansion member 170 through the transparent portions of the members 100, 170, and 500. Note that, in this specification, "transparent" includes colored transparent, colorless transparent, and translucent.

[0104] When the expansion member 170 is made of the materials mentioned above, the support member 500 can be made of materials such as acrylic resin, polyvinyl chloride (particularly rigid polyvinyl chloride), polyethylene, polypropylene, polyolefins such as 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.

[0105] (Injection member 200) Figure 8 is a perspective view showing the overall configuration of injection member 200. Figures 9 to 11 are partial cross-sectional views of check valve member 300 taken along the line of arrow 9A-9A shown in Figure 8, and Figure 12 is an enlarged view of dashed-dotted line portion 12A in Figure 11 together with a cross-sectional view of inner member 320. Figures 13 to 18 are diagrams for explaining inner member 320 provided in check valve member 300.

[0106] As shown in Figures 1, 2, and 8, the injection member 200 has a connector portion 210 and a connecting portion 220 that connects the inner cavity of the connector portion 210 (the inner cavity 410a of the connecting member 400 and the inner cavity 316 of the outer member 310, which will be described later) to the inner cavity 170a of the expansion member 170.

[0107] The connecting portion 220 is made of a tube with an inner cavity. The tube that constitutes the connecting portion 220 can be made of, for example, polyvinyl chloride (particularly, soft polyvinyl chloride), polybutadiene, polyurethane, silicone, or the like.

[0108] 5, one end 221 of the coupling portion 220 is coupled to the inner cavity 170a of the expansion member 170. The other end 222 of the coupling portion 220 is coupled to the inner cavity of the connector portion 210, as shown in FIG.

[0109] In this specification, the directions related to the connector portion 210 are defined as follows: the side of the connector portion 210 where the insertion port 313 of the outer member 310 is disposed is referred to as the "tip side (side indicated by arrow X1)," and the side of the connector portion 210 where the other end 222 of the coupling portion 220 is coupled is referred to as the "base side (side indicated by arrow X2)." Additionally, the arrows X1-X2 in each drawing indicate the longitudinal direction of the connector portion 210, the arrows Y1-Y2 indicate the width direction perpendicular to the longitudinal direction of the connector portion 210, and the arrows Z1-Z2 indicate the height direction of the connector portion 210.

[0110] As shown in Figures 8 and 9, the connector portion 210 has a check valve member 300 that is configured to be able to control the communication between the inner cavity of the connector portion 210 and the outside, and a connecting member 400 that connects the check valve member 300 and the connecting portion 220.

[0111] The connecting member 400 has a storage section 410 with an inner cavity 410a that accommodates the check valve member 300, a claw section 420 that faces the storage section 410 and extends toward the expansion member 170 side (the other end side of the connecting section 220), and a connecting section 430 that connects the storage section 410 and the claw section 420.

[0112] As shown in Fig. 8 , a gap 440 into which the cover member 100 can be inserted is provided between the storage portion 410 and the claw portion 420. As shown in Fig. 22 , the surgeon can fix the connector portion 210 and the connecting portion 220 to the cover member 100 by inserting the cover member 100 into the gap 440.

[0113] As shown in FIG. 8 , a fixing protrusion 415 can be provided on the portion of the accommodation portion 410 facing the claw portion 420 to increase the fixing force for the cover member 100 inserted into the gap 440. Furthermore, a hole 416 can be provided on the claw portion 420 at a position facing the fixing protrusion 415. When placing the cover member 100 in the gap 440, the surgeon can smoothly insert the cover member 100 into the gap 440 by bending a portion of the cover member 100 along the fixing protrusion 415 and moving it toward the hole 416. Furthermore, when the cover member 100 is inserted into the gap 440, the hemostatic device 10 can hold a portion of the cover member 100 in a serpentine state between the fixing protrusion 415 and the hole 416. This allows the hemostatic device 10 to increase the fixing force of the connector portion 210 to the cover member 100.

[0114] As shown in FIGS. 8 and 17, a part of the end of the housing portion 410 where the insertion opening 313 of the outer member 310 is located protrudes from the end of the housing portion 410.

[0115] When expanding the expansion member 170, the surgeon inserts the front tube portion 910 of the fluid injection instrument 900 into the lumen 410a of the connecting member 400 and the lumen 316 of the outer member 310 via the insertion port 313 of the outer member 310. Furthermore, as shown in Figures 10 and 11 , with the front tube portion 910 inserted into the lumen 316 of the outer member 310 via the insertion port 313, the surgeon can push the front tube portion 910 to a position closer to the base end than the distal opening 311 of the outer member 310 by further moving the front tube portion 910 toward the base end.

[0116] As shown in FIGS. 8 and 9, the check valve member 300 has an outer member 310, an inner member 320 located in the inner cavity 316 of the outer member 310, and a spring member 390 connected to the inner member 320.

[0117] As shown in Figure 9, the outer member 310 has a tip opening 311 configured to expose a portion of the inner member 320 to the outside, a base opening 312 that connects the inner cavity 316 of the outer member 310 with the inner cavity 410a of the connecting member 400, and an inner protrusion 315 configured to prevent the inner member 320 from moving toward the tip opening 311.

[0118] In the plan view shown in Figure 17 (plan view of the connector portion 210 from the base end side), a portion of the tip protrusion 340 of the inner member 320 is exposed to the outside of the connector portion 210 through the tip opening 311 and insertion port 313 (see Figure 9) of the outer member 310.

[0119] As shown in FIG. 9, the inner cavity 316 of the outer member 310 is formed with a first portion 316a in which the main body portion 330 of the inner member 320 is disposed, a second portion 316b located distally of the first portion 316a and having a smaller inner diameter than the first portion 316a, and a third portion 316c located distally of the second portion 316b and having a smaller inner diameter than the second portion 316b.

[0120] The inner protrusion 315 is located at the tip of the first portion 316a. The tip of the first portion 316a has a tapered shape in which the inner diameter gradually decreases toward the second portion 316b (tip side).

[0121] As shown in FIGS. 9 and 10, in a natural state, the spring member 390 is positioned between the proximal opening 312 and the inner protrusion 315 so as to maintain contact between the outer surface of the inner member 320 and the inner protrusion 315 .

[0122] The above-mentioned "natural state" refers to a state in which no compressive force is applied to the spring member 390 (a state in which the front tube portion 910 of the fluid injection instrument 900 is not pressed against the inner member 320).

[0123] A base end 390a of the spring member 390 is fixed to the inner wall of the base end of the outer member 310. A tip end 390b of the spring member 390 is connected to the base end 335 of the inner member 320.

[0124] The inner member 320 has a main body portion 330 configured to contact the inner protrusion portion 315 in a natural state, and a tip protrusion portion 340 that protrudes from the tip of the main body portion 330 toward the tip opening 311.

[0125] The inner member 320 has a base end portion 335 that is located closer to the base end than the main body portion 330. The base end portion 335 has a smaller outer diameter than the main body portion 330. The base end portion 335 is inserted into a space that extends inside the spring member 390.

[0126] The tip of the main body 330 has a tapered shape in which the outer shape gradually decreases toward the tip protrusion 340. The tip of the main body 330 forms a seal forming portion 338 that maintains contact with the inner protrusion 315 when the spring member 390 is in its natural state.

[0127] 9 and 10 , in a natural state, the spring member 390 forms a seal S near the inner protrusion 315 by bringing the outer surface of the seal-forming portion 338 of the main body portion 330 into contact with the inner protrusion 315. By forming the seal S in the lumen 316 of the outer member 310, the connector portion 210 prevents fluid communication between the lumen 170 a of the expansion member 170 and the outside of the connector portion 210 via the connecting portion 220 and the connector portion 210.

[0128] 11 , when the inner member 320 is pushed toward the base end by the tip tubular portion 910 of the fluid injection instrument 900 inserted into the lumen 316 of the outer member 310, the spring member 390 moves the outer surface of the seal forming portion 338 of the main body portion 330 away from the inner protrusion 315. When the outer surface of the seal forming portion 338 of the main body portion 330 moves away from the inner protrusion 315, the lumen 316 of the outer member 310 enters an unsealed state in which no seal portion S is formed. With the lumen 316 of the outer member 310 in an unsealed state, the hemostatic instrument 10 can establish fluid communication between the lumen 170a of the expansion member 170 and the lumen 911 of the tip tubular portion 910. With the lumen 170a of the expansion member 170 and the lumen 911 of the tip tubular portion 910 in fluid communication, the surgeon can inject fluid into the lumen 170a of the expansion member 170 by operating the fluid injection instrument 900. When the surgeon releases the fluid communication between the lumen 170a of the expansion member 170 and the lumen 911 of the tip tubular portion 910, he or she pulls the tip tubular portion 910 out of the connector portion 210 (the outer member 310 and the connecting member 400). When the tip tubular portion 910 is pulled out of the connector portion 210, the spring member 390 of the hemostatic device 10 returns to its natural state. The spring member 390, which has returned to its natural state, brings the outer surface of the seal forming portion 338 of the main body portion 330 into contact with the inner protrusion 315, thereby again forming the seal portion S near the inner protrusion 315.

[0129] As shown in FIGS. 13 and 14 , the tip protrusion 340 has an upper end 350 and a side wall 360 that connects the upper end 350 to the main body 330 .

[0130] The upper end 350 is an end of the tip protruding portion 340 that is located on the tip side (the insertion opening 313 side of the outer member 310 ).

[0131] The tip protrusion 340 has an outer diameter smaller than that of the main body 330. In this embodiment, the main body 330 has a substantially cylindrical outer shape, and the tip protrusion 340 also has a substantially cylindrical outer shape. Therefore, the tip protrusion 340 is configured to have a smaller outer diameter than the main body 330.

[0132] The side wall portion 360 extends in a substantially straight line between the main body portion 330 and the upper end portion 350 in the side view shown in FIG.

[0133] As shown in FIGS. 13 and 14, the upper end portion 350 has a recess 353 recessed toward the main body portion 330 side (proximal end side).

[0134] As shown in FIGS. 13, 14, and 16, the side wall portion 360 has a slit portion 361 that is continuous with the recessed portion 353 and extends in the longitudinal direction of the inner member 320.

[0135] The recess 353 has a trap portion 355 whose width W1 narrows from the center position O1 of the upper end portion 350 toward the outer edge portion 351 of the upper end portion 350 in the plan view shown in FIG.

[0136] In this embodiment, in the plan view shown in Figure 15, a recess 353 is formed in the upper end 350, extending in an approximately symmetrical shape in the vertical direction (in the direction of arrows Z1-Z2) and the horizontal direction (in the direction of arrows Y1-Y2) with respect to the center position O1 of the upper end 350.

[0137] 15, trap portions 355 having a width W1 narrower than the portion located at the center position O1 of the recess 353 are formed at four positions near the upper end, lower end, left end, and right end of the recess 353 extending in a notched shape. In this embodiment, the "center position O1 of the recess 353" means the same position as the "center position O1 of the upper end 350."

[0138] 14 , the recess 353 is connected to the slit portion 361 via the trap portion 355. That is, the recess 353 communicates with the outer surface side of the side wall portion 360 from the center position O1 of the upper end portion 350 via the trap portion 355 and the slit portion 361.

[0139] In the hemostatic device 10, four trap portions 355 are formed in the recess 353. The slit portions 361 are formed one at a time (four in total) at positions substantially identical to the circumferential positions of the trap portions 355, so as to correspond to the number and positions of the trap portions 355.

[0140] The hemostatic device 10 can capture foreign matter that has entered the lumen of the connector portion 210 (the lumen 316 of the outer member 310 located in the lumen 410a of the connecting member 400) by using the trap portion 355 formed on the upper end portion 350 of the inner member 320. There are no particular limitations on the foreign matter that can be captured by the trap portion 355, and examples of such foreign matter include fragments of hook-and-loop fasteners used in the fixing sites 710, 720, 730, and 740 of the hemostatic device 10. Even if a foreign matter enters the lumen of the connector portion 210, the hemostatic device 10 can capture the foreign matter by the trap portion 355 at a position distal to the inner protrusion 315 that forms the seal portion S (on the side of the inner protrusion 315 where the insertion opening 313 and the distal opening 311, which serve as a route for the foreign matter to enter, are located). Therefore, the hemostatic device 10 can prevent a foreign object that has entered the lumen of the connector portion 210 from moving to the position of the inner protrusion 315 in the lumen 316 of the outer member 310. As a result, even if a foreign object enters the lumen of the connector portion 210, the hemostatic device 10 can prevent the foreign object from being pinched between the outer surface of the main body portion 330 of the inner member 320 and the inner protrusion 315. As a result, the hemostatic device 10 can prevent a deterioration in the sealing ability of the seal portion S formed in the lumen 316 of the outer member 310 due to the influence of the foreign object that has entered the lumen of the connector portion 210.

[0141] 11 and 12 , when fluid is injected into the lumen of the connector portion 210 via the tip tube portion 910 of the fluid injection instrument 900 while the seal-forming portion 338 of the main body portion 330 is in an unsealed state with the seal-forming portion 338 spaced apart from the inner protrusion 315, the injected fluid can be smoothly moved from the distal end to the proximal end of the connector portion 210 via the recess 353 and the slit portion 361 connected to the recess 353. Therefore, when the surgeon operates the fluid injection instrument 900 to inject fluid into the lumen 170a of the expansion member 170, the resistance felt by the surgeon (difficulty in pushing) can be reduced. This allows the surgeon to smoothly proceed with hemostasis at the first puncture site p1 using the hemostatic instrument 10.

[0142] As shown in FIG. 16, the slit portion 361 extends along the longitudinal direction of the side wall portion 360 with a substantially constant width W3.

[0143] As shown in FIGS. 13 and 14 , the upper end portion 350 has a first protrusion 371 formed on the outer edge portion 351 of the upper end portion 350 .

[0144] The above-mentioned "outer edge 351 of upper end 350" means any position on a line drawn by connecting an imaginary line within an area including the notched portion where trap portion 355 is formed, when upper end 350 is viewed in plan view as shown in Fig. 15. In this embodiment, the planar shape of outer edge 351 of upper end 350 is represented by an imaginary circle centered at center position O1 of upper end 350.

[0145] 14, the first protrusion 371 protrudes toward the side (tip side) opposite to the side where the main body 330 is located. The end of the first protrusion 371 located in the protruding direction can be configured to have a curved shape that is rounded toward the tip side.

[0146] As shown in FIGS. 13 and 15, the upper end portion 350 has a plurality of upper surface portions 375 that are located in the same plane.

[0147] Four upper surface portions 375 are formed at different positions in the circumferential direction relative to the center position O1 of the upper end portion 350. In the plan view shown in Figure 15, trap portions 355 are located between adjacent upper surface portions 375 in the circumferential direction of the upper end portion 350.

[0148] The upper surface portions 375 are located at a position that is a predetermined distance away from the main body portion 330 than the bottom portions 353a of the recessed portions 353. Each of the upper surface portions 375 has a flat surface shape that extends substantially parallel to a direction perpendicular to the extension direction of the upper end portions 350. The first convex portions 371 are located on the outer edge portions 351 of the upper end portions 350 that are located on the outer edge side of the upper surface portions 375 (the side away from the center position O1 in the plan view shown in FIG. 15 ). The upper surface portions 375 are located closer to the main body portion 330 than the ends (tip portions) of the first convex portions 371 that are located in the protruding direction.

[0149] When the surgeon uses the fluid injection device 900 to inject fluid into the lumen 170a of the expansion member 170, the surgeon can position the tip surface of the tip tube portion 910 of the fluid injection device 900 so that it comes into contact with a wider area of ​​each of the upper surface portions 375, which have a flat surface shape extending approximately parallel along a direction perpendicular to the extension direction of the upper end portion 350 (see Figure 18).

[0150] As shown in FIG. 9, the outer diameter D1 of the upper end portion 350 can be configured to be larger than the inner diameter D2 of the tip opening 311 of the outer member 310.

[0151] In the hemostatic device 10, the outer diameter D1 of the upper end portion 350 is larger than the inner diameter D2 of the distal end opening 311 of the outer member 310. Therefore, as shown in Fig. 9 , when the inner member 320 is placed in the lumen 316 of the outer member 310, a certain range from the outer edge portion 351 of the upper end portion 350 toward the center position O1 overlaps with the distal end portion of the outer member 310 (the portion located distal to the distal end opening 311). Therefore, as shown in the plan view of Fig. 17 , when the lumen 316 of the outer member 310 is viewed from the distal end side of the outer member 310 (the distal end side of the connecting member 400), the range (portion) of the inner member 320 exposed through the insertion port 313 of the outer member 310 is limited to a certain range that includes the center position O1 of the distal end protrusion 340 and the upper surface portion 375.

[0152] In the natural state shown in FIGS. 9 and 10, the spring member 390 holds the other end 361b of the slit portion 361 located on the main body portion 330 side at a position closer to the tip opening portion 311 than the inner protrusion portion 315.

[0153] The other end 361b of the slit portion 361 is the end of the slit portion 361 that is located closest to the main body portion 330. The one end 361a of the slit portion 361 is the end that is located opposite (on the tip side of) the other end 361b.

[0154] 11 and 12, the spring member 390 is configured to move the other end 361b of the slit portion 361 to a position closer to the base end opening 312 than the inner protrusion 315 when a pushing force is applied to the spring member 390 in a direction toward the base end opening 312. Note that the length, amount of expansion / contraction deformation, elastic modulus, etc. of the spring member 390 in its natural state can be set arbitrarily so that the other end 361b of the slit portion 361 can be positioned at each of the positions shown in FIGS.

[0155] As shown in FIGS. 13, 14, and 15, the recess 353 has a notch 355a that connects the center position O1 of the upper end 350 to the side surface (outer periphery) of the upper end 350.

[0156] The notch 355a of the recess 353 is configured as a notched space formed in the longitudinal direction of the tip protrusion 340. The recess 353 is connected (communicates) with the center position O1 of the upper end 350 and the side surface of the upper end 350 via the notch 355a located between the center position O1 of the upper end 350 and the side surface of the upper end 350 facing the outside. The trap portion 355 is configured as a part of the notch 355a located near the outer edge 351 of the upper end 350.

[0157] As shown in FIG. 14, the width W2 of the notch 355a gradually narrows toward the main body 330 (downward in the drawing).

[0158] 13 and 15, four cutouts 355a can be arranged at equal intervals around the circumference of the upper end 350, with the center position O1 of the upper end 350 as the reference point. The angular difference between the cutouts 355a in the circumference is approximately 90°.

[0159] 13 , the slit 361 has a predetermined depth L1 along a direction from the side wall 360 toward the center position O1 of the upper end 350. The depth L1 of the slit 361 is preferably, for example, 0.25 mm or more and 0.35 mm or less. The outer diameter of the tip protrusion 340 is preferably, for example, 3.25 mm or more and 3.35 mm or less.

[0160] As shown in FIG. 14, the upper end 350 includes a first region 381 that includes the upper surface 375 and a second region 382 that forms the bottom 353 a of the recess 353 .

[0161] As shown in FIG. 14 , the other end 361 b of the slit 361 located on the main body 330 side is located closer to the main body 330 than the second region 382 .

[0162] In this embodiment, the hemostatic device 10 and a fluid injection device 900 (see Figure 18) having a tip tube portion 910 that abuts against the upper end portion 350 of the inner member 320 (in this embodiment, the upper surface portion 375 of the upper end portion 350 of the inner member 320) can constitute a hemostatic device assembly (corresponding to a "hemostatic device set") used to stop bleeding at the first puncture site p1 formed in the patient's right hand H1.

[0163] The fluid injection device 900 can be configured, for example, as a syringe for supplying fluids, which is well known in the medical field.

[0164] When a hemostatic device assembly is formed from the hemostatic device 10 and the fluid injection device 900 as described above, the upper surface portion 375, with which the tip tubular portion 910 of the fluid injection device 900 abuts at the upper end portion 350 of the inner member 320, can be configured to have a larger outer diameter in plan view than the tip tubular portion 910. In other words, the outer diameter D3 of the upper surface portion 375 shown in Fig. 15 can be larger than the outer diameter D4 (outer diameter of the most distal end) of the tip tubular portion 910 shown in Fig. 18.

[0165] The above-mentioned "outer diameter D3 of upper surface portion 375" means the outer diameter of an imaginary circle represented by connecting the outer periphery of upper surface portion 375, including the cutout-shaped portion where trap portion 355 is formed, with an imaginary line when upper end portion 350 is viewed in a plan view as shown in Figure 15.

[0166] It is preferable that the inner diameter D5 of the injection port 912 of the front tube portion 910 is smaller than the outer diameter D6 of the inner periphery of the recess 353 (inner diameter D5<outer diameter D6) (see FIG. 18).

[0167] The above-mentioned "outer diameter D6 of the inner periphery of the recess 353" can be defined as the outer diameter of an imaginary circle connecting the ends of each upper surface portion 375 located at a position closest to the center position O1 of the upper end portion 350.

[0168] For example, if the inner diameter D5 of the injection port 912 is larger than the outer diameter D6 of the inner periphery of the recess 353, when a fluid is injected through the injection port 912 while foreign matter is present on the upper surface 375, the fluid may be sprayed onto the foreign matter present on the upper surface 375. This may cause the foreign matter to move from the upper surface 375 toward the main body 330 via the slit 361 or the like, potentially resulting in a deterioration in the sealing performance of the seal portion S. If the inner diameter D5 of the injection port 912 provided in the front tube portion 910 is equal to or smaller than the outer diameter D6 of the inner periphery of the recess 353, the fluid injected through the injection port 912 can be prevented from being directly sprayed onto the foreign matter present on the upper surface 375. This may prevent the deterioration in the sealing performance of the seal portion S due to the influence of the foreign matter as described above.

[0169] The connecting member 400 and the outer member 310 can be made of, for example, ABS resin, polypropylene resin, or the like.

[0170] The inner member 320 can be made of an elastic member that can provide a predetermined sealing property when the outer surface of the main body 330 comes into contact with the inner protrusion 315 when the spring member 390 is in its natural state. Silicone rubber, ethylene propylene diene rubber, or the like can be used as a constituent material of the inner member 320 that provides the above-described function. It is preferable that the inner member 320 be colored green or the like so that it is easy to visually check if any foreign matter has adhered to or been placed on the inner member 320.

[0171] 20 to 24, a description will be given of an example of how to use the hemostatic device 10. The following describes the procedure for using the hemostatic device 10 to stop bleeding at the first puncture site p1 formed on the patient's right hand H1 shown in FIG.

[0172] FIG. 20 shows a state in which various procedures using the sheath tube 810 of the introducer 800 inserted into the first puncture site p1 have been completed.

[0173] When attaching the hemostatic device 10 to the patient's right hand H1, the surgeon positions the expansion member 170 and the support member 500 so that they overlap at the first puncture site p1, as shown in Fig. 20. At this time, the surgeon visually checks the position of the marker portion 175 placed on the expansion member 170, and positions the marker portion 175 at the first puncture site p1, thereby enabling the expansion member 170 and the support member 500 to be properly aligned with the first puncture site p1.

[0174] When attaching the hemostatic device 10 to the patient's right hand H1, the surgeon can position the support member 500 so that it overlaps at least a portion of the metacarpal bone B1 of the index finger and at least a portion of the metacarpal bone B2 of the thumb. For example, as shown in Fig. 19 , when hemostasis at the first puncture site p1, the surgeon can position the support member 500 at a predetermined position P1 located on an extension of the metacarpal bones B1 and B2. Furthermore, when hemostasis at the second puncture site p2, the surgeon can position the support member 500 at a predetermined position P2 located on an extension of the metacarpal bones B1 and B2 and closer to the forearm Ar than the predetermined position P1.

[0175] As shown in FIG. 21, the surgeon wraps the second band portion 620 and the third band portion 630 around the outer circumference of the patient's right hand H1.

[0176] The surgeon can connect the second band portion 620 and the third band portion 630 via the fixing portions 710, 730 by bringing the third fixing portion 730 (see FIG. 2 ), which is located on the inner surface of the third band portion 630, into contact with the first fixing portion 710 (see FIG. 1 ), which is located on the outer surface of the second band portion 620. The surgeon can connect the band portions 620, 630 together while overlapping the support member 500 over at least a portion of the metacarpal bone B1 of the index finger and at least a portion of the metacarpal bone B2 of the thumb, thereby tightly wrapping the band portions 620, 630 around the outer circumference of the right hand H1.

[0177] The upper surface 500b of the support member 500 is curved toward the second band portion 620 (side surface 503) and the third band portion 630 (side surface 504) (see FIG. 7). Therefore, by wrapping the second band portion 620 and the third band portion 630 around the outer periphery of the patient's right hand H1 as shown in FIG. 21, the surgeon can press the support member 500 against the right hand H1 from the upper surface 500b side along the outer periphery of the right hand H1 as shown in FIG. 24. Therefore, the hemostatic device 10 can increase the fixing force of the support member 500 and the expansion member 170 to the patient's right hand H1.

[0178] 22 , the surgeon places a portion of the first band portion 610 on the palm side of the patient's right hand H1 while passing the first band portion 610 through the interdigital portion fb located between the thumb and index finger of the patient's right hand H1. At this time, the surgeon can connect the first band portion 610 and the third band portion 630 via the fixing portions 720, 740 by bringing the fourth fixing portion 740 (see FIG. 2 ), which is located on the inner surface of the first band portion 610, into contact with the second fixing portion 720 (see FIG. 1 ), which is located on the outer surface of the third band portion 630.

[0179] Various portions of the patient's right hand H1 (e.g., around the snuff box Sb) have inclined portions. Furthermore, the shape of the inclined portions of the right hand H1 varies depending on the individual patient. For example, if the lower surface 500a of the support member 500 is flat, it is difficult to position the support member 500 so that it aligns with the inclined portions of the right hand H1. In the hemostatic device 10 of this embodiment, the lower surface 500a of the support member 500 is convexly curved in a direction away from the expansion member 170 (see FIGS. 7 and 24 ). Therefore, when the lower surface 500a of the support member 500 is positioned so that it overlaps the inclined portions of the patient's right hand H1, the lower surface 500a of the support member 500 can be positioned along the patient's right hand H1. This allows the hemostatic device 10 to position the support member 500 over the first puncture site p1, regardless of the individual differences between the patient's right hand H1 and left hand or the surgeon's positioning. Therefore, the hemostatic device 10 can appropriately position the support member 500 at a desired position near the first puncture site p1.

[0180] Furthermore, when the surgeon wraps the second band portion 620 and the third band portion 630 around the patient's right hand H1, the underside 500a of the support member 500 is positioned along the body surface of the right hand H1, so that the second band portion 620 and the third band portion 630 extending from each side portion 503, 504 of the support member 500 can be positioned close to or in close contact with the body surface of the patient's right hand H1 (see FIG. 24 ). This increases the fixing force of the support member 500 and the expansion member 170 to the patient's right hand H1. As a result, when the hemostatic device 10 is worn on the patient's right hand H1, the support member 500 and the expansion member 170 are less likely to become displaced, even if an external impact or the like is applied.

[0181] The surgeon connects the band portions 610, 620, 630 to each other and secures the hemostatic device 10 to the patient's right hand H1, and then connects the fluid injection device 900 to the connector portion 210. By connecting the fluid injection device 900 to the connector portion 210, the surgeon moves the inner member 320, which is disposed in the lumen 316 of the outer member 310, toward the proximal end, thereby releasing the sealed state formed by the seal portion S formed by the seal-forming portion 338 of the inner member 320 and the inner protrusion 315 of the outer member 310, and setting it to an unsealed state (see FIGS. 11 and 12 ). After setting the lumen of the connector portion 210 (lumen 316 of the outer member 310) to an unsealed state, the surgeon operates the fluid injection device 900 to inject fluid into the lumen of the connector portion 210. When the surgeon injects fluid into the lumen of the connector portion 210, the injected fluid is injected into the lumen 170a of the expansion member 170 via the connector portion 210 and the connecting portion 220. In the hemostatic device 10, the expansion member 170 is expanded by injecting fluid into the lumen 170a of the expansion member 170.

[0182] As shown in FIGS. 23 and 24, when the expansion member 170 expands in the hemostatic device 10, the expansion member 170 applies a compressive force to the first puncture site p1.

[0183] After the surgeon expands the expansion member 170 to the desired expansion amount, the surgeon removes the fluid injection tool 900 from the connector portion 210. When the surgeon removes the fluid injection tool 900 from the connector portion 210, the spring member 390 disposed in the lumen 316 of the outer member 310 returns to its natural state (see FIGS. 9 and 10 ). When the spring member 390 returns to its natural state, the outer surface of the seal-forming portion 338 of the inner member 320 comes into contact with the inner protrusion 315 of the outer member 310, and a seal portion S is formed in the lumen 316 of the outer member 310. By forming the seal portion S in the lumen 316 of the outer member 310, the hemostatic device 10 can maintain the sealing of the lumen of the connector portion 210. Therefore, after the fluid injection device 900 is removed from the connector portion 210, the hemostatic device 10 can prevent the fluid injected into the inner cavity 170a of the expansion member 170 from leaking out of the connector portion 210 through the connecting portion 220 and the inner cavity of the connector portion 210.

[0184] When the expansion member 170 expands while the hemostatic device 10 is attached to the patient's right hand H1, the support member 500 presses the expansion member 170 against the patient's right hand H1, thereby preventing the hemostatic device 10 from lifting up from the patient's right hand H1.

[0185] When using a hemostatic device to stop bleeding, the surgeon can, for example, tightly tighten the first band portion located in the interdigital region fb to increase the fixing force of the support member to the patient's right hand H1. By tightly tightening the first band portion, the surgeon can firmly fix the support member to the patient's right hand H1, even if the support member is positioned unstable on the patient's right hand H1. However, tightening the first band portion too tightly may cause the patient to feel pain. Therefore, if the first band portion cannot be tightened too tightly due to pain or other reasons, the hemostatic device may be positioned with the lower surface of the support member tilted relative to the body surface of the patient's right hand H1. Specifically, the upper end of the support member where the first band portion is located is raised to a position farther away from the body surface of the patient's right hand H1 than the lower end located opposite the upper end. As a result, the hemostatic device is positioned with the support member tilted so that the distance between the lower surface of the support member and the body surface of the patient's right hand H1 gradually narrows from the upper end to the lower end of the support member.

[0186] The hemostatic device 10 is configured so that the thickness of the side portions 503, 504 of the support member 500 decreases from the upper end 501 toward the lower end 502 (see FIG. 6 ). In addition, the first band portion 610, which is configured to be placed in the interdigital region fb located between the patient's fingers, extends from the upper end 501 side of the support member 500 and is configured to press the upper end 501 side of the support member 500 against the patient's right hand H1. In the hemostatic device 10 configured in this manner, when the support member 500 and the expansion member 170 are fixed to the patient's right hand H1 and the expansion member 170 begins to expand, the expansion member 170 applies force to the vicinity of the upper end 501 of the support member 500. The force applied by the expansion member 170 presses the upper end 501 side of the support member 500 against the right hand H1, while lifting the lower end 502 side. As a result, when the expansion member 170 is in an expanded state, the underside 500a of the support member 500 is positioned approximately parallel to the body surface of the patient's right hand H1, as shown in Fig. 23. Therefore, when the expansion member 170 is expanded, the hemostatic device 10 can apply a compressive force in the vertical direction to the first puncture site p1.

[0187] After expanding the expansion member 170, the surgeon removes the sheath tube 810 of the introducer 800 from the first puncture site p1 as shown in Figure 22. The surgeon confirms that there is no bleeding from the first puncture site p1 while using the hemostatic device 10 to stop bleeding. If there is bleeding from the first puncture site p1, the surgeon can appropriately adjust the amount of fluid injected into the expansion member 170.

[0188] With the expansion member 170 expanded, the surgeon can fix the connector portion 210 and the linking portion 220 connected to the connector portion 210 to the cover member 100 via the connecting member 400 (see FIG. 8 ), as shown in Fig. 22. By fixing the connector portion 210 and the linking portion 220 to the cover body 110, the surgeon can prevent the linking portion 220 from inadvertently moving in response to the movement of the patient's right hand H1 while the expansion member 170 is applying a compressive force to the first puncture site p1.

[0189] The surgeon can secure the connector portion 210 to the cover member 100 by inserting a portion of the cover member 100 into a gap 440 (see FIG. 8 ) extending between the receiving portion 410 and the claw portion 420, which extend in the longitudinal direction of the connector portion 210. Therefore, when securing the connector portion 210 to the cover member 100, the hemostatic device 10 can prevent unnecessary force from being applied to the hemostatic device 10 in a direction pressing it against the body surface of the patient's right hand H1. Therefore, when securing the connector portion 210 to the cover member 100, the hemostatic device 10 can prevent displacement of the hemostatic device 10 attached to the patient's right hand H1 and displacement of the expansion member 170.

[0190] The surgeon can fix the connector portion 210 at any position where a space (gap) is formed between the cover member 100 and the body surface of the right hand H1 in which the claw portion 420 can be placed when the expansion member 170 is expanded. An example of such a position is the fixed portion 110C (see FIG. 22 ) located between the first band portion 610 and the second band portion 620 on the cover main body 110. However, the position at which the connector portion 210 is fixed on the cover member 100 is not limited to the fixed portion 110C. For example, the connector portion 210 can also be fixed to the periphery of the first end 621 of the second band portion 620 on the cover main body 110, any position on the first band portion 610, any position on the second band portion 620, or the like.

[0191] The effects of the hemostatic device 10 according to this embodiment will be described below.

[0192] The hemostatic device 10 includes a cover member 100 configured to cover a first puncture site p1 formed in a patient, an expansion member 170 connected to the cover member 100 and configured to compress the first puncture site p1, and an injection member 200 connected to the expansion member 170 and configured to be able to inject a fluid into the expansion member 170. The injection member 200 has a connector portion 210 and a connecting portion 220 that connects an inner cavity of the connector portion 210 to an inner cavity 170a of the expansion member 170. The connector portion 210 has a check valve member 300 configured to be able to control communication between the inner cavity of the connector portion 210 and the outside, and a connecting member 400 that connects the check valve member 300 to the connecting portion 220. The check valve member 300 has an outer member 310, an inner member 320 located in an inner cavity 316 of the outer member 310, and a spring member 390 connected to the inner member 320. The outer member 310 includes a distal opening 311 configured to expose a portion of the inner member 320 to the outside, a proximal opening 312 that connects a lumen 316 of the outer member 310 with a lumen 410a of the connecting member 400, and an inner protrusion 315 configured to prevent movement of the inner member 320 toward the distal opening 311. The spring member 390 is located between the proximal opening 312 and the inner protrusion 315 so as to maintain contact between the outer surface of the inner member 320 and the inner protrusion 315 in a natural state. The inner member 320 includes a main body portion 330 configured to contact the inner protrusion 315 in a natural state, and a distal protrusion 340 that protrudes from the distal end of the main body portion 330 toward the distal opening 311. The distal protrusion 340 includes an upper end portion 350 and a side wall portion 360 that connects the upper end portion 350 and the main body portion 330. The upper end portion 350 has a recess 353 recessed toward the main body portion 330, and the side wall portion 360 has a slit portion 361 that is continuous with the recess 353 and extends in the longitudinal direction of the inner member 320. The recess 353 has a trap portion 355 whose width W1 narrows from a center position O1 of the upper end portion 350 toward an outer edge portion 351 of the upper end portion 350 in a plan view.

[0193] The hemostatic device 10 described above includes a check valve member 300 disposed in the lumen of the connector portion 210. In a natural state, the spring member 390 of the check valve member 300 maintains contact between the inner member 320 and an inner protrusion 315 formed on the outer member 310, thereby forming a seal S inside the connector portion 210 and preventing fluid communication between the lumen 170a of the expansion member 170 and the outside of the connector portion 210 via the connector portion 210. In addition, in the hemostatic device 10 described above, the inner member 320 includes a main body portion 330 configured to contact the inner protrusion 315 of the outer member 310, and a distal protrusion portion 340 protruding from the distal end of the main body portion 330 toward the distal opening 311. The distal protrusion portion 340 includes an upper end portion 350 and a side wall portion 360 connecting the upper end portion 350 and the main body portion 330. The upper end 350 has a recess 353 recessed toward the main body 330, and the recess 353 has a trap portion 355 whose width W1 narrows from a center position O1 of the upper end 350 toward an outer edge 351 of the upper end 350 in a plan view. The hemostatic device 10 described above can capture foreign matter that has entered the lumen 316 of the outer member 310 through the distal end opening 311 using the trap portion 355 provided in the recess 353, which is located closer to the distal end opening 311 than the main body 330 of the inner member 320. Furthermore, when a fluid is delivered to the injection member 200 through the connector 210 with foreign matter having entered the connector 210, the hemostatic device 10 can capture the foreign matter that is moved toward the main body 330 by the injected fluid using the trap portion 355. Therefore, the hemostatic device 10 described above can prevent foreign matter that has entered the lumen 316 of the outer member 310 from moving toward the main body 330 of the inner member 320. As a result, even if a foreign object enters the lumen 316 of the outer member 310, the hemostatic device 10 can prevent the foreign object from being pinched between the outer surface of the main body 330 of the inner member 320 and the inner protrusion 315 of the outer member 310 when the spring member 390 is in its natural state. Therefore, the hemostatic device 10 can prevent a decrease in the sealing ability of the seal portion S due to the influence of the foreign object that has entered the lumen 316 of the outer member 310.As a result, the hemostatic device 10 can prevent a decrease in the compressive force applied by the expansion member 170 to the first puncture site p1 formed in the patient due to the influence of foreign matter that has entered the lumen 316 of the outer member 310. Furthermore, in the hemostatic device 10, the side wall portion 360 of the distal protruding portion 340 has a slit portion 361 that is continuous with the recess 353 and extends in the longitudinal direction of the inner member 320. When injecting fluid into the lumen 170a of the expansion member 170, the fluid injection device 900 inserted into the lumen 316 of the outer member 310 applies a pushing force to the spring member 390 in a direction away from the distal opening 311, compressing the spring member 390 along the longitudinal direction of the connector portion 210. In the hemostatic device 10, when the spring member 390 compresses, the inner member 320 is moved toward the proximal end in response to the compression of the spring member 390. When the inner member 320 moves toward the base end as the spring member 390 is compressed, the outer surface of the main body portion 330 of the inner member 320 is released from contact with the inner protrusion 315 of the outer member 310. In the hemostatic device 10 described above, when fluid is injected into the lumen 316 of the outer member 310 via the fluid injection device 900 in a state in which the outer surface of the main body portion 330 of the inner member 320 is released from contact with the inner protrusion 315 of the outer member 310, the injected fluid can be smoothly transferred from the distal protrusion 340 side toward the main body portion 330 side via the slit portion 361 formed in the side wall portion 360 connecting the upper end portion 350 and the main body portion 330. Therefore, in the hemostatic device 10 described above, when the expansion member 170 is expanded using the fluid injection device 900, the fluid can be smoothly delivered to the lumen 170a of the expansion member 170 via the connector portion 210 and the connecting portion 220.

[0194] In the hemostatic device 10, the recess 353 is connected to the slit portion 361 via the trap portion 355 (see FIG. 13).

[0195] In the hemostatic device 10 configured as described above, even if a fluid is injected into the inner cavity 316 of the outer member 310 while a foreign object is present in the recess 353 and the injected fluid causes the foreign object to move toward the main body portion 330, the foreign object is captured by the trap portion 355 connected to the slit portion 361 before it reaches the slit portion 361. Therefore, even if a foreign object enters the inner cavity of the connector portion 210, the hemostatic device 10 can more reliably prevent the foreign object from moving to the inner protrusion 315 of the main body portion 330.

[0196] Furthermore, in the hemostatic device 10, the upper end portion 350 has a first protrusion 371 formed on the outer edge portion 351 of the upper end portion 350 (see FIGS. 13 and 14).

[0197] In the hemostatic device 10, the first convex portion 371 formed on the outer edge portion 351 of the upper end portion 350 extends from the upper end portion 350 toward the tip side, so that if a foreign object enters the upper end portion 350 of the outer member 310, or if a fluid is injected with a foreign object in the upper end portion 350 of the outer member 310, the foreign object can be prevented from passing through the outer edge portion 351 of the upper end portion 350 and moving toward the main body portion 330.

[0198] Furthermore, in the hemostatic device 10, the upper end portion 350 has a plurality of upper surface portions 375 positioned on the same plane (see FIGS. 13 and 15).

[0199] In the hemostatic device 10 configured as described above, when the tip tubular portion 910 of the fluid injection instrument 900 is inserted into the lumen of the connector portion 210 to inject fluid into the expansion member 170, the distal end surface of the tip tubular portion 910 can come into contact with the multiple upper surfaces 375 of the upper end portion 350 over a wider area. The surgeon can apply a firm pushing force to the inner member 320 by pushing the fluid injection instrument 900 while the distal end surface of the tip tubular portion 910 is in contact with the multiple upper surfaces 375 over a wider area. This allows the surgeon to easily move the inner member 320 toward the proximal end. Therefore, the surgeon can unseal the lumen of the connector portion 210 with the simple operation of inserting the tip tubular portion 910 of the fluid injection instrument 900 into the lumen of the connector portion 210.

[0200] In addition, in the hemostatic device 10, the outer diameter D1 of the upper end portion 350 is larger than the inner diameter D2 of the tip opening 311 (see FIG. 9).

[0201] 17 , in a plan view seen from the distal end of the connector portion 210, the hemostatic device 10 configured as described above has a projection surface of the upper end portion 350 projected onto the outer member 310 that is larger than the projection surface of the distal opening 311 of the outer member 310. Therefore, when the spring member 390 is in its natural state, the hemostatic device 10 can prevent an excessive gap (a space that allows the passage of foreign matter) from being formed between the inner periphery (inner wall) of the outer member 310 and the outer periphery of the upper end portion 350 when the outer member 310 is viewed from the distal end of the connector portion 210. Therefore, even if a foreign matter enters the lumen 316 of the outer member 310, the hemostatic device 10 can effectively prevent the foreign matter from passing through the gap between the inner periphery of the outer member 310 and the outer periphery of the upper end portion 350 and reaching the main body portion 330.

[0202] In addition, in the hemostatic device 10, the spring member 390, in its natural state, holds the end (other end) 361b of the slit portion 361 located on the main body portion 330 side at a position closer to the tip opening 311 than the inner protrusion 315, and the spring member 390 is configured to move the other end 361b of the slit portion 361 to a position closer to the base opening 312 than the inner protrusion 315 when a pushing force is applied to the spring member 390 in a direction toward the base opening 312 (see Figures 9, 10, and 11).

[0203] In the hemostatic device 10 configured as described above, when the spring member 390 is in its natural state, the other end 361b of the slit portion 361 located on the main body portion 330 side is held at a position closer to the distal opening 311 than the inner protrusion 315, thereby more reliably preventing foreign matter from moving to the main body portion 330 through the slit portion 361 when the seal portion S is formed. Furthermore, in the hemostatic device 10 configured as described above, when a pushing force is applied to the spring member 390 in a direction toward the proximal opening 312 to put the spring member 390 in an unsealed state, the other end 361b of the slit portion 361 is located closer to the proximal opening 312 than the inner protrusion 315. Therefore, the hemostatic device 10 can more reliably move fluid injected from the distal side of the outer member 310 from the one end 361a side of the slit portion 361 located distally of the inner protrusion 315 toward the other end 361b side located proximal to the inner protrusion 315. This allows the hemostatic device 10 to smoothly deliver fluid into the lumen 170a of the expansion member 170 in the unsealed state.

[0204] Furthermore, in the hemostatic device 10, the recess 353 has a notch 355a that connects the center position O1 of the upper end 350 to the side surface of the upper end 350. The width W2 of the notch 355a gradually narrows toward the main body 330 (see FIG. 14).

[0205] In the hemostatic device 10 configured as described above, when a foreign object reaches the recess 353 and moves toward the main body 330, the foreign object can be captured by the notch 355a before reaching the slit 361. Furthermore, because the width W2 of the notch 355a gradually narrows toward the main body 330, when the foreign object reaches the recess 353 and moves from the tip side of the upper end 350 toward the main body 330, the foreign object can be more reliably captured by the portion of the notch 355a where the width W2 is smaller. Therefore, even if a foreign object enters the lumen of the connector 210, the hemostatic device 10 can more reliably prevent the foreign object from moving to the main body 330.

[0206] Furthermore, in the hemostatic device 10, four notches 355a are arranged at equal intervals around the circumference of the upper end 350, with the center position O1 of the upper end 350 as the reference point (see FIG. 15).

[0207] In the hemostatic device 10 configured as described above, when the tip tube portion 910 of the fluid injection device 900 is brought into contact with the distal end protrusion 340 to inject fluid, the fluid can be moved from the upper end portion 350 toward the side wall portion 360 via the four notches 355a. Furthermore, because the notches 355a are arranged at equal intervals around the circumference of the upper end portion 350, the fluid can be moved radially from the center position O1 of the upper end portion 350 in each of the four directions in which the notches 355a extend. Therefore, the hemostatic device 10 can smoothly deliver fluid into the lumen 170a of the expansion member 170. Furthermore, the hemostatic device 10 has four notches 355a at the upper end 350 spaced at equal intervals around the recess 353, thereby realizing smooth fluid movement as described above while preventing the rigidity of the upper end 350 from being excessively reduced due to the provision of the notches 355a.

[0208] In addition, in the hemostatic device 10, the slit portion 361 has a predetermined depth L1 along the direction from the side wall portion 360 toward the center position O1 of the upper end portion 350 (see FIG. 13).

[0209] In the hemostatic device 10 configured as described above, the slit portion 361 has a predetermined depth L1 along the direction from the side wall portion 360 toward the center position O1 of the upper end portion 350, and therefore, even if a foreign object passes through the trap portion 355, the foreign object can be captured by the slit portion 361 connected to the trap portion 355. Therefore, the hemostatic device 10 can more reliably prevent a foreign object that has entered the lumen of the connector portion 210 from moving to the main body portion 330.

[0210] In the hemostatic device 10, the slit portion 361 extends along the longitudinal direction of the side wall portion 360 with a substantially constant width W3 (see FIG. 16).

[0211] In the hemostatic device 10 configured as described above, when fluid is injected into the lumen 170a of the expansion member 170 from the distal end protruding portion 340 side, the fluid is smoothly guided toward the main body portion 330 side along the slit portion 361 having a substantially constant width W3. Therefore, the hemostatic device 10 can effectively reduce the resistance felt by the surgeon at his / her hand when the surgeon operates the fluid injection device 900 to inject fluid into the lumen 170a of the expansion member 170.

[0212] In addition, the hemostatic device 10 has a first region 381 in which the upper end portion 350 has an upper surface portion 375 and a second region 382 that forms the bottom portion 353a of the recess 353, and the end portion (other end portion 361b) located on the main body portion 330 side of the slit portion 361 is located on the main body portion 330 side rather than the second region 382 (see Figure 14).

[0213] In the hemostatic device 10 configured as described above, the other end 361b of the slit portion 361 located on the main body portion 330 side is located closer to the main body portion 330 than the second region 382, ​​so that when fluid is injected into the lumen 170a of the expansion member 170 from the tip protruding portion 340 side, the fluid moves smoothly toward the main body portion 330 side via the other end 361b of the slit portion 361. Therefore, the hemostatic device 10 can effectively reduce the resistance felt by the surgeon at his / her hand when the surgeon operates the fluid injection device 900 to inject fluid into the lumen 170a of the expansion member 170.

[0214] Furthermore, this embodiment can provide a hemostatic device assembly including the hemostatic device 10 and a fluid injection device 900 having a tip tubular portion 910 that abuts against the upper end portion 350. In such a hemostatic device assembly, the upper surface portion 375, with which the tip tubular portion 910 abuts at the upper end portion 350, has an outer diameter D3 that is larger than that of the tip tubular portion 910 in plan view (see FIGS. 15 and 18 ).

[0215] The hemostatic device assembly configured as described above allows the upper surface portion 375 and the tip tubular portion 910 to come into contact over a wider area when the tip tubular portion 910 is abutted against the upper surface portion 375 of the upper end portion 350, while preventing the tip tubular portion 910 from protruding outward from the outer edge of the upper surface portion 375. Therefore, when the tip tubular portion 910 of the fluid injection device 900 is inserted into the lumen of the connector portion 210 and the inner member 320 is pushed in, the hemostatic device 10 can apply a stronger pushing force to the inner member 320. This allows the hemostatic device 10 to more smoothly deliver fluid into the lumen 170a of the expansion member 170 when expanding the expansion member 170.

[0216] Next, a modified example of the above-described embodiment will be described. In the description of the modified example, the description of the components already described and the procedure for using the hemostatic device will be omitted as appropriate. Furthermore, the content of the modified example that is not specifically described can be the same as the above-described embodiment.

[0217] <Modification 1> Fig. 25 shows an inner member according to Modification 1. Fig. 25 is a drawing corresponding to Fig. 16 of the embodiment described above.

[0218] As shown in FIG. 25, the slit portion 361 can be configured so that the width W3 gradually narrows toward the main body portion 330 side, for example.

[0219] <Modification 2> Figures 26 to 29 show an inner member 320A according to Modification 2. Figure 26 is a plan view of the inner member 320A according to Modification 2 as seen from the tip side, Figure 27 is a side view of the inner member 320A according to Modification 2, Figure 28 is a perspective view showing an upper end portion 350 and a side wall portion 360 of the inner member 320A according to Modification 2, and Figure 29 is a partial cross-sectional view of the upper end portion 350 and a side wall portion 360 of the inner member 320A according to Modification 2.

[0220] As shown in Figure 29, the inner member 320A of variant example 2 has the other end 361b located on the main body 330 side of the slit portion 361 located at approximately the same position in the height direction of the tip protrusion 340 as the second region 382 that forms the bottom 353a of the recess 353.

[0221] In the hemostatic device according to Modification 2, in the plan view shown in Fig. 26 , there is no portion where the width W3 of each slit portion 361 widens, and the minimum portion of the width W1 of the trap portion 355 and the width W3 of the slit portion 361 are substantially constant (in the hemostatic device 10 of the above-described embodiment, the width W3 of each slit portion 361 widens to be larger than the width W1 of the trap portion 355 in the plan view shown in Fig. 15 ), making it easier to capture foreign matter in each slit portion 361. However, in the hemostatic device according to Modification 2, the width W3 of the slit portion 361 is the same as the width W2 (minimum width) of the cutout portion 355a (in the hemostatic device 10 of the above-described embodiment, the width W3 of the slit portion 361 is greater than the width W2 of the cutout portion 355a), which narrows the gap (space) between the inner periphery of the outer member 310 and the outer periphery of the inner member 320, increasing the resistance to fluid injection. Therefore, when reducing the resistance to fluid injection, it is preferable that the hemostatic device employs the structure of the hemostatic device 10 according to the above-described embodiment.

[0222] <Modification 3> FIG. 30 shows a perspective view of a tip protrusion 340A of an inner member according to Modification 3. In FIG.

[0223] The upper end portion 350 of the tip protrusion 340A of the inner member according to the third modification has a second convex portion 372 formed on the inner edge portion 352 of the upper end portion 350 .

[0224] The above-mentioned "inner edge 352 of upper end portion 350" refers to the portion of upper end portion 350 that is closest to center position O1 of upper surface portion 375. When multiple upper surface portions 375 are formed on upper end portion 350 as shown in this modification, inner edge 352 of upper surface portion 375 can be defined as the edge of each upper surface portion 375 that is located on the side of center position O1 of upper end portion 350.

[0225] The inner member according to the third modification has a first protrusion 371 formed on an outer edge 351 of an upper end 350 and a second protrusion 372 formed on an inner edge 352 of the upper end 350. An upper surface 375 having a flat surface shape has a concave shape surrounded on all sides by the first protrusion 371 and the second protrusion 372.

[0226] The inner member according to Modification 3, with its concave upper surface portion 375 configured as described above, can more reliably capture foreign matter that has entered the lumen of the connector portion 210. However, with the inner member according to Modification 3, when the fluid injection instrument 900 is pressed against the upper end portion 350, the tip tubular portion 910 of the fluid injection instrument 900 cannot contact the upper surface portion 375, and the contact area of ​​the tip tubular portion 910 is limited to the upper end of the second protrusion portion 372. As a result, the surgeon may not be able to transmit a sufficient pushing force to the inner member via the tip tubular portion 910 of the fluid injection instrument 900. Therefore, when it is possible to transmit a sufficient pushing force to the inner member as described above, it is preferable to employ a configuration in which the second protrusion portion 372 is not provided on the inner edge portion 352 of the upper end portion 350 (see FIG. 13 ), as shown in the embodiment described above.

[0227] <Modification 4> Figures 31 to 34 show an inner member 320B according to Modification 4. Figure 31 is a plan view of the inner member 320B according to Modification 4 as seen from the tip side, Figure 32 is a side view of the inner member 320B according to Modification 4, Figure 33 is a perspective view showing an upper end portion 350 and a side wall portion 360 of the inner member 320B according to Modification 4, and Figure 34 is a partial cross-sectional view of the upper end portion 350 and a side wall portion 360 of the inner member 320B according to Modification 4.

[0228] An inner member 320B according to the fourth modification differs from the inner member 320 of the above-described embodiment in the shape of the recess 353 in a plan view.

[0229] The recess 353 of the inner member 320B has a generally rectangular shape with its long sides extending in the left-right direction (the direction of the arrows Y1-Y2) in the plan view shown in Figure 31. Two upper surface portions 375 are formed so as to sandwich the recess 353 therebetween.

[0230] As shown in Figures 31 and 34, the trap portion 355 is formed in a portion extending from near both ends of the recess 353 in the long side direction toward the slit portion 361. Furthermore, the cutout portion 355a of the recess 353 is located between the trap portion 355 and the slit portion 361 in the plan view shown in Figure 31. The slit portion 361 is provided at a position corresponding to the positions where the trap portion 355 and the cutout portion 355a are formed. Two slit portions 361 are formed so as to sandwich the recess 353 therebetween.

[0231] When using the fluid injection tool 900 to inject fluid into the lumen 170a of the expansion member 170, the surgeon abuts the front tube portion 910 of the fluid injection tool 900 against the two upper surface portions 375. When the surgeon operates the fluid injection tool 900 with the front tube portion 910 of the fluid injection tool 900 abutting against the upper surface portion 375 of the inner member 320B, a larger amount of fluid can be delivered via the recess 353, which extends over a relatively wide range in the left-right direction including the center position O1 of the upper end portion 350, thereby allowing the fluid to move more smoothly toward the main body portion 330. However, because the recess 353 of the inner member 320B according to the fourth modification forms a space that extends over a relatively wide range in the left-right direction of the upper end portion 350, it is less effective at capturing foreign matter than the inner member 320 (see FIG. 15 ) that includes the recess 353 formed in the shape of a cross cutout shown in the embodiment described above. Therefore, when the hemostatic device is configured to more fully exhibit the effect of capturing foreign matter, it is preferable to employ a configuration similar to that of the inner member 320 of the above-described embodiment.

[0232] <Modification 5> Figures 35 to 38 show an inner member 320C according to Modification 5. Figure 35 is a plan view of the inner member 320C according to Modification 5 as seen from the tip side, Figure 36 is a side view of the inner member 320C according to Modification 5, Figure 37 is a perspective view showing an upper end portion 350 and a side wall portion 360 of the inner member 320C according to Modification 5, and Figure 38 is a partial cross-sectional view of the upper end portion 350 and a side wall portion 360 of the inner member 320C according to Modification 5.

[0233] Like the inner member 320B described in the fourth modification, the inner member 320C according to the fifth modification differs from the inner member 320 of the above-described embodiment in the shape of the recess 353 in a plan view.

[0234] The recess 353 of the inner member 320C extends a predetermined length in the left-right direction (the direction of arrows Y1-Y2) in the plan view shown in Figure 35. Two upper surface portions 375 are formed so as to sandwich the recess 353 therebetween.

[0235] As shown in Figures 35 and 37, a plurality of trap portions 355 are formed at predetermined intervals along the extension direction of the recess 353. Therefore, the recess 353 has a wave-like shape in the plan view shown in Figure 35. The cutout portions 355a are located near both ends of the recess 353 in the left-right direction in the plan view shown in Figure 35. The slit portions 361 are provided at positions corresponding to the positions where the cutout portions 355a are formed. Two slit portions 361 are formed so as to sandwich the recess 353 therebetween.

[0236] When using the fluid injection tool 900 to inject fluid into the lumen 170a of the expansion member 170, the surgeon abuts the front tubular portion 910 of the fluid injection tool 900 against the two upper surface portions 375. When the surgeon operates the fluid injection tool 900 with the front tubular portion 910 of the fluid injection tool 900 abutting against the upper surface portion 375 of the inner member 320C, a larger amount of fluid can be delivered via the recess 353, which extends over a relatively wide range in the left-right direction including the center position O1 of the upper end portion 350, thereby allowing the fluid to move more smoothly toward the main body portion 330. However, like the recess of the inner member 320B according to Variation 4, the recess 353 of the inner member 320C according to Variation 5 forms a space that extends over a relatively wide range in the left-right direction of the upper end portion 350. Therefore, it is less effective at capturing foreign matter than the inner member 320 (see FIG. 15 ) that includes the recess 353 formed in the shape of a cross cutout shown in the embodiment described above. Therefore, when the hemostatic device is configured to more fully exhibit the effect of capturing foreign matter, it is preferable to employ a configuration similar to that of the inner member 320 of the above-described embodiment.

[0237] The hemostatic device according to the present invention has been described above through embodiments and modified examples, but the present invention is not limited to the content described in the specification and can be modified as appropriate based on the description of the claims.

[0238] The shape and dimensions of each part of the hemostatic device are not particularly limited and can be changed as appropriate as long as the expansion member placed at the puncture site can compress and stop bleeding.

[0239] The specific shapes of the expansion member and the support member are not limited to the shapes shown in the embodiments.

[0240] The hemostatic device can also be configured to stop bleeding at a puncture site other than a puncture site formed on the hand. For example, the hemostatic device can be configured to use the expansion member of the embodiment to stop bleeding at a puncture site formed on a patient's arm, leg, or the like.

[0241] This application is based on Japanese Patent Application No. 2023-170329, filed on September 29, 2023, the disclosure of which is incorporated herein by reference in its entirety.

[0242] 10 Hemostatic device 100 Cover member 120 Sheet material 170 Expansion member 170a Inner cavity of expansion member 200 Injection member 210 Connector portion 220 Connection portion 300 Check valve member 310 Outer member 311 Distal opening 312 Base opening 313 Insertion port 315 Inner protrusion 316 Inner cavity of outer member 320 Inner member 320A Inner member 320B Inner member 320C Inner member 330 Main body portion 338 Seal forming portion 340 Distal protrusion 340A Distal protrusion 350 Upper end portion 351 Outer edge portion 352 Inner edge portion 353 Recess 353a Bottom portion 355 Trap portion 355a Notch portion 360 Side wall portion 361 Slit portion 361a One end of slit portion 361b Other end (end) of slit portion 371 First convex portion 372 Second convex portion 375 Upper surface portion 381 First region 382 Second region 390 Spring member 400 Connecting member 410a Inner cavity of connecting member 500 Support member 610 First band portion 620 Second band portion 630 Third band portion 800 Introducer 900 Fluid injection device 910 Front tubular portion 912 Inlet O1 Center position of upper end S Sealing portion D1 Outer diameter of upper end D2 Inner diameter of tip opening D3 Outer diameter of upper surface portion D4 Outer diameter of front tubular portion D5 Inner diameter of inlet D6 Outer diameter of inner periphery of recess L1 Depth of slit portion W1 Width of trap portion W2 Width of notch portion W3 Width of the slit H Hand H1 Right hand Ar Forearm fb Interdigital region Sb Snuff box B1 Metacarpal bone of index finger B2 Metacarpal bone of thumb T1 Extensor pollicis longus tendon T2 Extensor pollicis brevis tendon V1 Blood vessel (distal radial artery) V2 Artery located in the snuff box p1 First puncture site (puncture site) p2 Second puncture site (puncture site)

Claims

1. A device comprising: a cover member configured to cover a puncture site formed in a patient; an expansion member connected to the cover member and configured to compress the puncture site; and an injection member connected to the expansion member and configured to be capable of injecting a fluid into the expansion member, wherein the injection member has a connector portion and a connecting portion connecting an inner cavity of the connector portion and an inner cavity of the expansion member, wherein the connector portion has a check valve member configured to be capable of controlling communication between the inner cavity of the connector portion and the outside, and a connecting member connecting the check valve member and the connecting portion, wherein the check valve member has an outer member, an inner member located in the inner cavity of the outer member, and a spring member connected to the inner member, wherein the outer member has a tip opening configured to expose a part of the inner member to the outside, a base opening communicating the inner cavity of the outer member and the inner cavity of the connecting member, and an inner protrusion configured to prevent the inner member from moving towards the tip opening, a hemostatic device comprising: a spring member positioned between the base end opening and the inner protrusion so as to maintain contact between an outer surface of the inner member and the inner protrusion in a natural state; the inner member having a main body portion configured to contact the inner protrusion in a natural state; and a tip protrusion protruding from a tip of the main body portion toward the tip opening side; the tip protrusion having an upper end and a side wall portion connecting the upper end and the main body portion; the upper end having a recess that is recessed toward the main body portion side; the side wall portion having a slit portion that is continuous with the recess and extends in the longitudinal direction of the inner member; and the recess having a trap portion that narrows in width from the center position of the upper end toward the outer edge of the upper end in a planar view.

2. The hemostatic device according to claim 1, wherein the recess is connected to the slit portion via the trap portion.

3. The hemostatic device according to claim 1, wherein said upper end portion has a first protrusion formed on an outer edge of said upper end portion.

4. The hemostatic device according to claim 3, wherein said upper end portion has a plurality of upper surface portions located in the same plane.

5. The hemostatic device according to claim 4, wherein the upper surface portion has a second protrusion formed on an inner edge portion of the upper surface portion.

6. The hemostatic device of claim 1, wherein the outer diameter of said upper end is greater than the inner diameter of said tip opening.

7. A hemostatic device as described in claim 1, wherein in a natural state, the spring member holds the end of the slit portion located on the main body side at a position closer to the tip opening than the inner protrusion, and when a pushing force is applied to the spring member in a direction toward the base opening, the spring member moves the end of the slit portion to a position closer to the base opening than the inner protrusion.

8. A hemostatic device as described in claim 1, wherein the recess has a notch connecting the center position of the upper end portion and the side surface of the upper end portion, and the width of the notch gradually narrows toward the main body portion.

9. The hemostatic device according to claim 8, wherein the four cutouts are arranged at equal intervals in the circumferential direction of the upper end portion with respect to the center position of the upper end portion.

10. The hemostatic device according to claim 1, wherein said slit portion has a predetermined depth along a direction from said side wall portion toward a center position of said upper end portion.

11. The hemostatic device according to claim 1, wherein said slit portion extends with a substantially constant width along the longitudinal direction of said side wall portion.

12. A hemostatic device as described in claim 1, wherein the upper end portion comprises a first region having an upper surface portion and a second region forming the bottom of the recess, and the end portion of the slit portion located on the main body portion side is located closer to the main body portion than the second region.

13. A hemostatic instrument set comprising: a hemostatic instrument according to any one of claims 1 to 12; and a fluid injection instrument having a leading tubular portion that abuts against the upper end portion, wherein an upper surface portion of the upper end against which the leading tubular portion abuts has an outer diameter larger than that of the leading tubular portion in a plan view.

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