Hemostatic device and hemostatic device set

Abstract

To provide a hemostatic device and a hemostatic device set, capable of preventing lowering of sealing property of a connector part due to foreign matters invaded into a lumen of the connector part.SOLUTION: An injection member 200 of a hemostatic device has a connector part 210 and a connection part 220. A check valve member 300 included in the connection part has an outer member 310, an inner member 320, and a spring member 390. The inner member has: a body part configured so as to come into contact with an inner projection part in a natural state of the spring member; and a tip protrusion part. An upper end part included in the tip protrusion part has a recessed part recessed toward the body part side. A side wall part included in the tip protrusion part has a slit part extending in the longitudinal direction of the inner member. The upper end part includes a first region forming an upper surface part, and a second region forming a bottom part of the recessed part. The recessed part is configured so as to position the second region on a side closer to the body part side than to the slit part.SELECTED DRAWING: Figure 8

Description

[Technical field]

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

[0002] As one of the catheter procedures, a procedure is known in which a blood vessel in a patient's limb such as an arm or a hand is punctured to form a puncture site, and various medical elongated objects are introduced into the blood vessel through the puncture site to diagnose or treat the lesion site. For example, Patent Document 1 discloses a hemostatic device that stops bleeding at a puncture site formed to enable access to a blood vessel (including the distal radial artery) running through the hand.

[0003] The hemostatic device of Patent Document 1 comprises an expansion member that applies a compressive force 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. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] US Patent Application Publication No. 2019 / 0133602 Summary of the Invention [Problem to be solved by the invention]

[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 placed 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 for injecting a fluid to the connector part. Inside the connector part of the hemostatic instrument, for example, in a state where the fluid injection instrument is not connected, a check valve (valve body) is arranged to block fluid communication between the inner cavity of the expansion member and the outside of the connector part. The surgeon connects the fluid injection instrument to the connector part and pushes the check valve arranged inside the connector part with the fluid injection instrument, thereby moving the check valve from a predetermined closed position to a predetermined open position of the connector part. By moving the check valve to the predetermined open position, the surgeon can fluidically communicate the fluid holding part (outer tube part) of the fluid injection instrument and the inner cavity of the expansion member via the connection part (front tube part) of the fluid injection instrument. In a state where the fluid holding part of the fluid injection instrument and the inner cavity of the expansion member are fluidically connected, the surgeon can inject a fluid into the inner cavity of the expansion member by operating the fluid injection instrument, 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 inside the connector portion. When the check valve moves to the closed position inside 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 part of the hemostatic device of Patent Document 1 can adopt a configuration in which a part of the fluid injection device can be inserted into the connector part as described above. In addition, when the above connector part is adopted, the hemostatic device can be provided with a connection opening for maintaining the connection state between the connector part and the fluid injection device. When such a structure of the connector part and the connection opening part is adopted in the hemostatic device, when the fluid injection device is not connected to the connector part, a part of the inside of the connector part is exposed to the outside of the connector part through the connection opening part. When a part of the inside of the connector part is exposed to the outside of the connector part through the connection opening part in this way, a foreign object may enter the inside of the connector part through the connection opening part. Therefore, when the above-mentioned structure of the connector part and the connection opening part is adopted in the hemostatic device, if an operation is performed to move the check valve from the open position to the closed position with a foreign object entering the inside of the connector part, there is a risk that the foreign object may be pinched between the check valve that has moved to the closed position and the inner wall of the connector part. In the above hemostatic device, if a foreign object is caught between the check valve that has moved to the closed position and the inner wall of the connector, the sealing (airtightness) provided by the check valve is reduced, and the fluid injected into the lumen of the expansion member may leak to the outside through the check valve and the connector. In the above hemostatic device, if the fluid injected into the lumen of the expansion member leaks to the outside of the connector in this way, the compressive force applied by the expansion member to the puncture site formed on the patient's hand is reduced. Therefore, the hemostatic device of Patent Document 1 may not be able to exert a sufficient hemostatic effect due to the influence of the foreign object that has entered the inside of the connector.

[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 decrease in the sealing property of the connector part due to foreign matter entering the inner cavity of the connector part. [Means for solving the problem]

[0010] The present invention can be achieved by any one of the following means (1) to (12).

[0011] (1) A catheter 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, 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, the check valve member having an outer member, an inner member located inside the outer member, and a spring member connected to the inner member, the outer member having a tip opening configured to expose a part of the inner member to the outside, a base opening communicating between the inner cavity of the outer member and the inner cavity of the connecting member, and a front opening. 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 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 has 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 a front 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 extending in a longitudinal direction of the inner member, the upper end having a first region forming an upper surface portion and a second region forming a bottom of the recess, and the recess is configured such that the second region is located on the main body portion side relative to the slit portion.

[0012] (2) The hemostatic device according to (1) above, wherein the first region is located closer to the main body portion than the tip of the side wall portion located on the tip opening side.

[0013] (3) The hemostatic device described in (2) above, wherein the side wall portion has a convex portion located closer to the tip opening side than the upper end portion, and the convex portion has the slit portion.

[0014] (4) The hemostatic device according to (3) above, wherein the upper end portion has a groove portion formed between the second region and the convex portion.

[0015] (5) The hemostatic device according to (1) above, wherein the first region is located at the tip of the side wall portion located on the tip opening side.

[0016] (6) The hemostatic device according to (5) above, wherein the recess is connected to the slit portion.

[0017] (7) The hemostatic device described in (6) above, wherein the upper end portion has a third region located between the first region and the second region, and the recess is connected to the slit portion via the third region.

[0018] (8) The hemostatic device according to (6) above, wherein the recess has a trap portion whose width narrows from the center position of the upper end portion toward the edge portion of the upper end portion in a plan view.

[0019] (9) The hemostatic device according to (8) above, wherein the recess is connected to the slit portion via the trap portion.

[0020] (10) The hemostatic device according to (8) or (9) above, wherein the upper end portion has a first protrusion formed on an outer edge portion of the upper end portion.

[0021] (11) The hemostatic device according to any one of (1) to (10) above, wherein an outer diameter of the tip of the tip protrusion is larger than an inner diameter of the tip opening.

[0022] (12) A hemostatic device set comprising: a hemostatic device according to any one of (1) to (11) above; and a fluid injection device having a tip tube portion that abuts against the upper end portion, wherein the upper end portion has a larger outer diameter than the tip tube portion when viewed in a plane. Effect of the Invention

[0023] The hemostatic device of (1) above includes a check valve member disposed in the inner cavity of the connector portion. The spring member of the check valve member maintains contact between the inner member and the inner protrusion formed on the outer member in a natural state to form a seal inside the connector portion, thereby preventing the inner cavity of the expansion member from fluidly communicating with 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 tip protrusion protruding from the tip of the main body portion toward the tip opening side. The tip protrusion has an upper end portion and a side wall portion connecting the upper end portion and the main body portion. The upper end portion has a recessed portion recessed toward the main body portion side, and the side wall portion has a slit portion extending in the longitudinal direction of the inner member. The recessed portion has a first region forming an upper surface portion and a second region forming a bottom portion of the recess, and is configured so that the second region is located closer to the main body portion than the slit portion. In this way, the tip protrusion has a structure in which the side wall extends in the longitudinal direction so as to surround the bottom of the recess, since the second region forming the bottom of the recess is located closer to the main body than the slit. The hemostatic device described above can capture a foreign object that has entered the inner cavity of the outer member through the tip opening in a recess that is located closer to the tip opening than the main body of the inner member and is surrounded by the side wall. Therefore, the hemostatic device described above can suppress the foreign object that has entered the inner cavity of the outer member from moving to the main body of the inner member. As a result, even if a foreign object has entered the inner cavity of the outer member, the hemostatic device described above can prevent the foreign object from being pinched between the outer surface of the main body 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 described above can prevent the sealability of the inner cavity of the connector from being reduced due to the influence of the foreign object that has entered the inner cavity of the outer member. The distal end of the inner member is provided with a proximal end that protrudes from the distal end of the inner member and proximal end of the distal end of the inner member.In the above hemostatic device, when fluid is injected into the lumen of the expansion member, a pushing force in a direction away from the tip opening is applied to the spring member via a fluid injection device inserted into the lumen of the outer member, whereby the spring member is compressed along the longitudinal direction of the connector portion. When the spring member is compressed, the above hemostatic device moves the inner member toward the base end side as the spring member is compressed. When the inner member moves toward the base end side as the spring member is compressed, the contact between the outer surface of the main body portion of the inner member and the inner protrusion of the outer member is released. When fluid is injected into the lumen of the outer member via the fluid injection device with the contact between the outer surface of the main body portion of the inner member and the inner protrusion of the outer member released, the above hemostatic device can smoothly move the injected fluid from the tip protrusion side toward the main body side through a slit portion formed in a side wall portion connecting the upper end portion and the main body portion. Therefore, when the expansion member is expanded using a fluid injection device, the above-mentioned hemostatic device can smoothly deliver fluid into the inner cavity of the expansion member via the connector portion and the connecting portion. [Brief description of the drawings]

[0024] [Figure 1] FIG. 2 is a plan view showing the hemostatic device according to the embodiment, as viewed from the outer surface side of each band portion. [Diagram 2] FIG. 2 is a diagram showing a hemostatic device according to an embodiment, and is a plan view seen from the inner surface side of each band portion. [Diagram 3] 13 is an enlarged view of a portion of the hemostatic device as viewed from the outer surface side of the main body of the cover member. FIG. [Figure 4] 13 is an enlarged view of a portion of the hemostatic device as viewed from the inner surface side of the main body of the cover member. FIG. [Diagram 5] 13 is an enlarged view of a portion of the hemostatic device as viewed from the outer surface side of the main body of the cover member. FIG. [Figure 6] 6A is a partial cross-sectional view of the hemostatic device taken along arrows 6A-6A in FIG. 5, illustrating the state when the expansion member is expanded. [Figure 7] 7A is a partial cross-sectional view of the hemostatic device taken along arrows 7A-7A in FIG. 5, illustrating the state when the expansion member is expanded. [Figure 8]FIG. 4 is an enlarged perspective view of a portion of the injection member. [Figure 9] 9A is a cross-sectional view of the check valve member taken along arrows 9A-9A shown in FIG. 8. [Figure 10] FIG. 4 is a cross-sectional view of a check valve member. [Figure 11] FIG. 4 is a cross-sectional view of a check valve member. [Figure 12] 12A is an enlarged view of the portion 12A shown in FIG. 11 together with a partial cross-sectional view of the inner member. [Figure 13] FIG. [Figure 14] FIG. 4 is a plan view of the inner member as viewed from the tip side. [Figure 15] FIG. 4 is a perspective view showing a tip protrusion of the inner member. [Figure 16] 1A is a perspective cross-sectional view of a tip protruding portion of an inner member, and FIG. 1B is a view showing a tip tube portion of a fluid injection device. [Figure 17] FIG. 4 is a plan view of the connector portion as viewed from the tip side. [Figure 18] FIG. 1 shows a patient's hand (right hand) on which a hemostatic device is to be used. [Figure 19] 1A to 1C are diagrams illustrating a simplified example of how a hemostatic device is used. [Figure 20] 1A to 1C are diagrams illustrating a simplified example of how a hemostatic device is used. [Figure 21] 1A to 1C are diagrams illustrating a simplified example of how a hemostatic device is used. [Figure 22] 22A is a partial cross-sectional view taken along the arrows 22A-22A shown in FIG. 21. [Figure 23] 23A is a partial cross-sectional view taken along the arrows 23A-23A shown in FIG. 21. [Figure 24] FIG. 11 is a side view of an inner member according to the first modified example. [Diagram 25] 13 is a plan view of an inner member according to Modification 1, as viewed from the tip side. FIG. [Figure 26] 13 is a perspective view showing a tip protrusion of an inner member according to Modification 1. FIG. [Figure 27] 13 is a perspective cross-sectional view of a tip protrusion of an inner member according to Modification 1. FIG. [Figure 28] 11 is a side view of an inner member according to Modification 2. FIG. [Figure 29] 11 is a plan view of an inner member according to Modification 2, as viewed from the tip side. FIG. [Diagram 30] 13 is a perspective view showing a tip protrusion of an inner member according to Modification 2. FIG. [Diagram 31] 11 is a perspective cross-sectional view of a tip protrusion of an inner member according to Modification 2. FIG. [Diagram 32] FIG. 11 is a side view of an inner member according to Modification 3. [Diagram 33] 13 is a plan view of an inner member according to Modification 3, as viewed from the tip side. FIG. [Diagram 34] FIG. 11 is a perspective view showing a tip protrusion of an inner member according to Modification 3. [Diagram 35] 13 is a perspective cross-sectional view of a tip protrusion of an inner member according to Modification 3. FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0025] Hereinafter, an embodiment 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. In addition, the dimensional ratios of the drawings are exaggerated for the convenience of explanation and may differ from the actual ratios.

[0026] Figures 1 to 17 are views for explaining a hemostatic device 10 according to an embodiment. Figures 18 to 23 are views for explaining an example of use of the hemostatic device 10 according to an embodiment.

[0027] The hemostatic device 10 can be used, for example, to stop bleeding at a first puncture site p1 (hereinafter also simply referred to as the "first puncture site") formed in a patient's hand H located distal (toward the fingertip) from the forearm Ar, when removing a sheath tube 810 of an introducer 800 that has been placed at the first puncture site p1.

[0028] The specific location of the puncture site that is the target of hemostasis by the hemostatic device 10 is not particularly limited, but in this specification, a first puncture site p1 and a second puncture site p2 are given as examples.

[0029] As shown in Figures 18, 21, 22, and 23, 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 snuff box Sb of the palmar artery running on the back side of the right hand H1 located distal to the forearm Ar of the patient. The first puncture site p1 is located between the metacarpal bone B1 of the index finger and the metacarpal bone B2 of the thumb, and is located at a predetermined position avoiding the metacarpal bone B1 of the index finger and the metacarpal bone B2 of the thumb. The snuff box Sb is a cavity in the hand located near the radius when the patient spreads the thumb of the hand H.

[0030] The second puncture site p2 is a puncture site formed in an artery V2 located at a snuff box Sb of a palmar artery running on the back side of a right hand H1, as shown in Fig. 18. The second puncture site p2 is located closer to the patient's forearm Ar (proximal side) 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 located at a predetermined position avoiding the positions of the metacarpal bone B1 of the index finger and the metacarpal bone B2 of the thumb.

[0031] 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.

[0032] The hemostatic device 10 will now be described in more detail.

[0033] (Hemostasis device 10) Generally speaking, as shown in Figures 1, 2, 8, 21, 22, and 23, 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.

[0034] In this specification, the directions of the cover member 100 and the support member 500 included in 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 defined as the "distal side" and the side of the forearm Ar is defined as the "base side".

[0035] (Expansion member 170) 6 and 7, the expansion member 170 includes a lumen 170a into which a fluid can be injected. The expansion member 170 is configured to expand in response to the injection of a fluid into the lumen 170a and to contract in response to the discharge of the fluid injected into the lumen 170a.

[0036] 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.

[0037] 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.

[0038] The extension member 170 can be formed, for example, of a film-like member (sheet material) connected to the sheet material 120 constituting the cover body 110 of the cover member 100, as shown in FIGS.

[0039] The sheet material constituting the expansion member 170 can be connected to the cover member 100 so that a fluid-injectable lumen 170a 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 constituting the cover body 110 of the cover member 100.

[0040] 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 or adhesive.

[0041] 6, an edge 172 located at a 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 at an 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 overlapping with the lower surface 500a of the support member 500 in the planar direction.

[0042] The film-like member constituting the expansion member 170 can be made of, for example, a resin material having a predetermined thickness.

[0043] The material of the membrane-like member constituting the expansion member 170 is not particularly limited, but examples thereof 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 elastomers (nylon elastomers), polyurethane elastomers, and polyester elastomers, or any combination of these (blend resins, polymer alloys, laminates, etc.).

[0044] The extension member 170 is disposed on the inner surface 110a side of the cover body 110 of the cover member 100, as shown in FIGS.

[0045] In this embodiment, the inner surface 110a of the cover body 110 is configured as a surface that is placed on the body surface side of the right hand H1 in the lower surface region 132 of the holding part 130 (see Figs. 22 and 23). The outer surface 110b of the cover body 110 is configured as a surface that is placed facing the outside in the upper surface region 131 of the holding part 130.

[0046] As shown in FIGS. 19, 20, and 21, the expansion member 170 has a marker portion 175 for aligning the expansion member 170 with the first puncture site p1.

[0047] As shown in Figs. 4, 6 and 7, the marker portion 175 can be composed of a transparent central portion surrounding the central position of the expansion member 170 and a colored circular frame portion surrounding the central portion.

[0048] 6 and 7, the marker portion 175 is disposed on the outer surface of the expansion member 170. The marker portion 175 may be disposed on the inner surface of the expansion member 170 facing the lumen 170a.

[0049] There are no particular limitations on the specific shape, color, position in the planar direction of the extension member 170, formation method, etc., of the marker portion 175. The marker portion 175 can be configured as, for example, a circular marker that is entirely colored, a marker that is composed of a transparent center portion and a rectangular frame portion, a rectangular marker that is entirely colored, or the like.

[0050] 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.

[0051] In addition, there is no particular limitation on the specific configuration of the expansion member 170. The expansion member 170 may be formed, for example, by joining an edge of one sheet-like member to the other sheet-like member in a state in which a cavity 170a is formed between two sheet-like members. 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 constituting the cover body 110 of the cover member 100. In addition, the expansion member 170 can be configured, for example, by a single bag-like member shaped to have a cavity 170a on the inside. When the expansion member 170 is configured in this manner, the expansion member 170 can be configured to connect a part of the surface of the bag-like member to the sheet material 120 constituting the cover body 110 of the cover member 100.

[0052] (Cover member 100) As shown in Figures 3, 4, 5, and 21, 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 positioned 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.

[0053] 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.

[0054] 6 and 7, the cover body 110 has a two-layer structure. The cover body 110 having a two-layer structure includes a holding portion 130 that holds the support member 500.

[0055] 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).

[0056] The curved region 133 is formed by folding back a portion of the sheet material 120 constituting the cover body 110 toward the first band portion 610. In this embodiment, a portion of the sheet material 120 constituting 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 sheet material 120 thus folded back. The portion of the sheet material 120 where the insertion portion 135 is formed constitutes the holding portion 130 for holding the support member 500.

[0057] As shown in FIG. 6, an edge 121 (hereinafter referred to as "edge 121 of lower surface region 132") located at the tip side of the folded-back portion of sheet material 120 constituting cover body 110 is fixed to sheet material 120 at a position tip side of upper end portion 501 of support member 500 via each fixing region 150A, 150B described later.

[0058] In the curved region 133, a base end portion 122 of the cover member 100 formed from a part of the sheet material 120 constituting the cover body 110 is located.

[0059] As shown in FIGS. 5 and 6, the insertion portion 135 of the holding portion 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.

[0060] 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. As shown in FIG.

[0061] 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.

[0062] The first fixed region 150A and the second fixed region 150B can be disposed so as to face each other with the non-fixed region 160 interposed therebetween in the plan view shown in FIG. 4 and FIG.

[0063] The first fixing region 150A and the second fixing region 150B can be configured to have a symmetrical shape with respect to the center line C (see FIG. 4) of the first band portion 610. Each fixing region 150A, 150B can be configured by, for example, an adhesive part or a fused part that fixes the lower surface region 132 to the sheet material 120.

[0064] Each of the fixing regions 150A, 150B can be disposed 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 disposed so as to surround each edge portion on the tip side of the support member 500 in the plan view shown in Figs. 4 and 5.

[0065] Each of the fixing regions 150A, 150B can be disposed such 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.

[0066] 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 arbitrarily.

[0067] (First band 610, second band 620, third band 630) As shown in FIGS. 3 and 4, the first band portion 610 is connected to the cover body 110 at a position facing the curved region 133 with the support member 500 interposed therebetween.

[0068] The second band portion 620 and the third band portion 630 are integrally formed with the cover body 110 .

[0069] Similarly to the first band portion 610, the second band portion 620 and the third band portion 630 may be formed of separate members from the cover body 110 and connected to the cover body 110. Similarly to the second band portion 620 and the third band portion 630, the first band portion 610 may be formed integrally with the cover body 110.

[0070] 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.

[0071] 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 adhesion.

[0072] 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.

[0073] As shown in FIG. 6, the slit 615 penetrates the inner surface 610a and the outer surface 610b of the first band portion 610.

[0074] 3 and 4, the connecting portion 220 of the injection member 200 passes between the fixing regions 150A, 150B formed in the cover body 110, and is inserted from the inner surface 610a side of the first band portion 610 to the outer surface 610b side of the first band portion 610 via the slit 615. Therefore, as shown in FIGS. 1 and 2, the connector portion 210 connected to the connecting portion 220 is disposed on the outer surface 610b side of the first band portion 610 together with a part of the connecting portion 220.

[0075] 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.

[0076] As shown in FIG. 21, the first band portion 610 can be positioned so that it is hooked onto the inter-finger area fb located between the thumb and index finger of the patient's right hand H1 with the expansion member 170 positioned at the first puncture site p1.

[0077] 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.

[0078] The second direction in which the second band portion 620 extends is not particularly limited, so long as it is a direction different from the first direction in which the first band portion 610 extends.

[0079] 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.

[0080] The third direction in which the third band portion 630 extends is not particularly limited, so long as it is 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.

[0081] As shown in Figures 20 and 21, when the hemostatic device 10 is worn on a 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.

[0082] The second band section 620 has a flexible section 625 located closer to the first band section 610 than the end of the first fixing region 150A located on the curved region 133 side in the plan view shown in Fig. 5. The third band section 630 has a flexible section 635 located closer to the first band section 610 than the end of the second fixing region 150B located on the curved region 133 side in the plan view shown in Fig. 5.

[0083] 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 a tensile force is applied from the outside, it easily stretches in the direction in which the tensile force is applied, compared to a portion of each of the band portions 620, 630 where each of the flexible portions 625, 635 is not formed.

[0084] 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.

[0085] Each of the band portions 610, 620, 630 has four fastening portions, a first fastening portion 710, a second fastening portion 720, a third fastening portion 730, and a fourth fastening portion 740, arranged thereon to enable the cover member 100 to be fixed to the right hand H1.

[0086] As shown in FIG. 1, a first fastening portion 710 is disposed on the outer surface of the middle portion 623 of the second band portion 620 .

[0087] As shown in FIG. 1, a second fastening portion 720 is disposed on the outer surface of the middle portion 633 of the third band portion 630 .

[0088] As shown in FIG. 2, a third fastening portion 730 is disposed on the inner surface of the middle portion 633 of the third band portion 630 .

[0089] As shown in FIG. 2, a fourth fastening portion 740 is disposed on the inner surface of the middle portion 613 of the first band portion 610 .

[0090] The first fastening portion 710 and the second fastening portion 720 may be, for example, the male side of a hook-and-loop fastener. The third fastening portion 730 and the fourth fastening portion 740 may be, for example, 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 on a surface, such as Magic Tape (registered trademark) or Velcro (registered trademark).

[0091] The second band unit 620 and the third band unit 630 are configured to be detachable via a first fastening portion 710 located on the outer surface of the middle portion 623 of the second band unit 620 and a third fastening portion 730 located on the inner surface of the middle portion 633 of the third band unit 630. The first band unit 610 and the third band unit 630 are also configured to be detachable via a fourth fastening portion 740 located on the inner surface of the middle portion 613 of the first band unit 610 and a second fastening portion 720 located on the outer surface of the middle portion 633 of the third band unit 630.

[0092] The specific structure of each of the fixing parts 710, 720, 730, 740 is not limited as long as the cover member 100 can be fixed to the right hand H1 by connecting the band parts 610, 620, 630 to each other in a state where the hemostatic device 10 is placed on the right hand H1. For example, the installation of some of the fixing parts can be omitted, or the positions of the fixing parts in the band parts 610, 620, 630 can be changed as desired. In addition, when each of the fixing parts 710, 720, 730, 740 is configured with a hook-and-loop fastener, the male side and the female side of the hook-and-loop fastener may be interchanged. In addition, each of the fixing parts 710, 720, 730, 740 may be configured with, for example, a snap, a button, a clip, or a connecting mechanism having a frame part with a protrusion and an engaged part with a hole part that can engage with the frame part.

[0093] (Support member 500) The support member 500 can be placed in the insertion portion 135 of the holding portion 130, as shown in FIGS.

[0094] 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.

[0095] 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 attached to the patient's right hand H1. The lower end 502 of the support member 500 can be positioned on the forearm Ar side (base end side) when the hemostatic device 10 is attached to 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 "base end" of the support member 500.

[0096] Each of an upper end portion 501 of the support member 500 and a lower end portion 502 of the support member 500 can be configured to include a flat portion that extends in a substantially straight line in the plan view shown in FIG.

[0097] 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 (to the left and right direction in FIG. 7).

[0098] 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 vertical direction in FIG. 5), for example.

[0099] 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 and right sides in FIG. 7) as shown in FIG. 7. Therefore, the lower surface 500a of the support member 500 is curved in a convex shape in a direction away from the extension member 170 as shown in FIG.

[0100] 6, the support member 500 can be configured so that the thickness of each of the side surface portions 503, 504 connecting the upper end portion 501 and the lower end portion 502 becomes thinner from the upper end portion 501 toward the lower end portion 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 portion 501 toward the lower end portion 502 in the cross-sectional view shown in FIG. 6 and the cross-sectional view shown in FIG. 23.

[0101] 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.

[0102] 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 overlapping 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 overlapping with the marker portion 175 are formed transparently. When the members 100, 170, and 500 are configured in this manner, 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 when attaching the hemostatic device 10 to the right hand H1 of the patient as shown in Figs. 19, 20, and 21. Note that the term "transparent" in this specification includes colored transparent, colorless transparent, and translucent.

[0103] When the expansion member 170 is made of the materials mentioned above, the constituent materials of the support member 500 may be, for example, acrylic resin, polyvinyl chloride (especially rigid polyvinyl chloride), polyolefins such as polyethylene, polypropylene, 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.

[0104] (Injection member 200) Fig. 8 is a perspective view showing injection member 200. Figs. 9 to 11 are partial cross-sectional views of check valve member 300 taken along the line of arrows 9A-9A shown in Fig. 8, and Fig. 12 is an enlarged view of dashed dotted line portion 12A in Fig. 11 together with a cross-sectional view of inner member 320. Figs. 13 to 17 are views for explaining inner member 320 provided in check valve member 300.

[0105] As shown in Figures 1, 2, and 8, the injection member 200 has a connector portion 210 and a connecting portion 220 that connects an inner cavity of the connector portion 210 (an inner cavity 410a of the connecting member 400 and an inner cavity 316 of the outer member 310 described later) to an inner cavity 170a of the expansion member 170.

[0106] The connecting portion 220 is made up of a tube with an inner cavity.

[0107] 5, one end 221 of the coupling part 220 is coupled to the inner cavity 170a of the expansion member 170. The other end 222 of the coupling part 220 is coupled to the inner cavity of the connector part 210, as shown in FIG.

[0108] The tube constituting the connecting portion 220 can be made of, for example, polyvinyl chloride (particularly soft polyvinyl chloride), polybutadiene, polyurethane, silicone, or the like.

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

[0110] As shown in Figures 8 and 9, 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 and the connecting portion 220.

[0111] The connecting member 400 has a accommodating portion 410 with an inner cavity 410a that accommodates the check valve member 300, a claw portion 420 that faces the accommodating portion 410 and extends toward the expansion member 170 (the other end 222 side of the connecting portion 220), and a connecting portion 430 that connects the accommodating portion 410 and the claw portion 420.

[0112] 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. The surgeon can fix the connector portion 210 and the coupling portion 220 to the cover member 100 by inserting the cover member 100 into the gap 440 (see FIG. 22).

[0113] A fixing protrusion 415 for increasing the fixing force for the cover member 100 inserted into the gap 440 can be provided at a portion of the accommodation portion 410 facing the claw portion 420. In addition, a hole portion 416 can be provided at a position facing the fixing protrusion 415 on the claw portion 420. 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 part of the cover member 100 along the fixing protrusion 415 and moving it to escape to the hole portion 416 side. In addition, in the state where the cover member 100 is inserted into the gap 440, the hemostatic device 10 can hold a part of the cover member 100 in a meandering state between the fixing protrusion 415 and the hole portion 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 tip of outer member 310 where insertion opening 313 is located protrudes from the tip of 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 connection member 400 and the lumen 316 of the outer member 310 via the insertion port 313 of the outer member 310. In addition, as shown in FIG. 11 , the surgeon can push the front tube portion 910 to a position on the base end side of the tip opening 311 of the outer member 310 by moving the front tube portion 910 further toward the base end side in a state in which the front tube portion 910 of the fluid injection instrument 900 is inserted into the lumen 316 of the outer member 310 via the insertion port 313.

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

[0117] As shown in FIG. 9, the outer member 310 includes a tip opening 311 configured to expose a portion of the inner member 320 to the outside, an insertion opening 313 located distal to the tip opening 311 and enabling movement of the tip tube portion 910 into and out of the inner cavity 316 of the outer member 310, a base opening 312 communicating between the inner cavity 316 of the outer member 310 and the inner cavity 410a of the connecting member 400, and an inner protrusion 315 configured to prevent movement of the inner member 320 toward the tip opening 311.

[0118] In the plan view shown in Figure 17 (plan view of connector portion 210 from the tip side), a portion of tip protrusion 340 of inner member 320 is exposed to the outside of connector portion 210 through tip opening 311 and insertion port 313 (see Figure 9) of 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 further distal than the first portion 316a and having a smaller inner diameter than the first portion 316a, and a third portion 316c located further distal than 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, the spring member 390 is located between the base end 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.

[0122] The above-mentioned "natural state" refers to a state in which no force is applied to the spring member 390 in a compressive direction (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 tip end 390a of the spring member 390 is connected to a base end 335 of the inner member 320. In addition, a base end 390b of the spring member 390 is fixed to the inner wall of the base end of the outer member 310.

[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 towards the tip opening portion 311.

[0125] The inner member 320 has a base end 335 located on the base end side of the main body portion 330. The base end 335 has an outer shape smaller than that of the main body portion 330. The base end 335 is inserted into a space defined inside the spring member 390.

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

[0127] 9 and 10 , in a natural state, the spring member 390 forms a seal portion 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 portion S in the lumen 316 of the outer member 310, the connector portion 210 prevents fluid communication between the lumen 170a of the expansion member 170 and the outside of the connector portion 210 via the coupling portion 220 and the connector portion 210.

[0128] 11 , when the inner member 320 is pushed toward the base end by the front tube portion 910 of the fluid injection instrument 900 inserted into the lumen 316 of the outer member 310, the spring member 390 separates the outer surface of the seal forming portion 338 of the main body portion 330 from the inner protruding portion 315. When the outer surface of the seal forming portion 338 of the main body portion 330 separates from the inner protruding portion 315, the lumen 316 of the outer member 310 enters an unsealed state in which the seal portion S is not formed. When the lumen 316 of the outer member 310 enters an unsealed state, the hemostatic instrument 10 fluidly communicates the lumen 170a of the expansion member 170 and the lumen 911 of the front tube portion 910. The surgeon can inject fluid into the lumen 170a of the expansion member 170 by operating the fluid injection instrument 900 while the lumen 170a of the expansion member 170 and the lumen 911 of the front tube portion 910 are in fluid communication with each other. When releasing the fluid communication between the lumen 170a of the expansion member 170 and the lumen 911 of the front tube portion 910, the surgeon pulls out the front tube portion 910 from the connector portion 210 (the outer member 310 and the connection member 400). When the front tube portion 910 is pulled out from the connector portion 210, the spring member 390 of the hemostatic device 10 returns to its natural state. The spring member 390 that 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 protruding portion 315, thereby forming the seal portion S again near the inner protruding portion 315.

[0129] As shown in FIGS. 13 to 15, the tip protrusion 340 has an upper end 350 and a side wall portion 360 that connects the upper end 350 and the main body portion 330.

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

[0131] The tip protrusion 340 has an outer shape smaller than that of the main body 330. In this embodiment, the main body 330 (a portion of the main body 330 excluding the seal forming portion 338) 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] As shown in FIG. 13, the side wall portion 360 extends in a substantially straight line between the main body portion 330 and the upper end portion 350 in a side view.

[0133] As shown in FIG. 15, the upper end portion 350 has a recess 353 recessed toward the main body portion 330 side (proximal end side).

[0134] As shown in FIG. 15, the side wall portion 360 has a slit portion 361 extending in the longitudinal direction of the inner member 320 .

[0135] The upper end 350 includes a first region 381 that forms the upper surface 375 and a second region 382 that forms the bottom 353 a of the recess 353 .

[0136] The upper surface portion 375 is located at a position that is a predetermined distance away from the main body portion 330 than the bottom portion 353a of the recessed portion 353. In addition, the upper surface portion 375 is located closer to the tip end of the tip protruding portion 340 (the side of the insertion opening 313 of the outer member 310) than the bottom portion 353a of the recessed portion 353.

[0137] Two top surface portions 375 are formed on the upper end portion 350. The top surface portions 375 are disposed to face each other with the center position O1 (the center position in the plan view of FIG. 14) of the upper end portion 350 in between. The bottom portion 353a is located at a position sandwiched between the two top surface portions 375 in the plan view shown in FIG.

[0138] Each of the upper surface portions 375 has a flat surface shape that is located on the same plane and extends generally parallel to a direction perpendicular to the extension direction of the upper end portion 350. The bottom portion 353a has a flat surface shape that extends generally parallel to the upper surface portion 375.

[0139] When the surgeon uses the fluid injection tool 900 to inject fluid into the inner cavity 170a of the expansion member 170, the surgeon can position the tip surface of the tip tube portion 910 of the fluid injection tool 900 so that it is in surface contact with each upper surface portion 375 (see FIG. 18).

[0140] 15 and 16, the recess 353 is configured such that the second region 382 is located closer to the main body 330 than the slit portion 361. The other end 361b located closest to the main body 330 (base end side) in the slit portion 361 is located closer to the tip of the tip protruding portion 340 (the side of the insertion opening 313 of the outer member 310) than the bottom portion 353a.

[0141] Since the second region 382 of the recess 353 is located closer to the main body 330 than the slit portion 361, the bottom 353a of the recess 353 and the second region 382 forming the bottom 353a are surrounded by the sidewall portion 360 extending so as to protrude from the main body 330 side toward the tip side, as shown in Fig. 15. Therefore, in the side view shown in Fig. 13, the bottom 353a is not exposed to the outside through the slit portion 361.

[0142] Two slits 361 are formed in the side wall 360. Each of the slits 361 is formed at a position corresponding to both ends in the extending direction of the bottom 353a (both ends in the left-right direction in FIG. 14).

[0143] As described above, the second region 382 forming the bottom 353a of the recess 353 is surrounded by the side wall 360. Therefore, the hemostatic device 10 can capture a foreign object that has entered the inner cavity of the connector portion 210 (the inner cavity 316 of the outer member 310 located in the inner cavity 410a of the connection member 400) near the bottom 353a of the recess 353. Even if a foreign object enters the inner cavity of the connector portion 210, the hemostatic device 10 can capture the foreign object by the recess 353 at a position on the distal side of the inner protrusion 315 forming the seal portion S (the side where the insertion opening 313 and the distal end opening 311, which are the path for the foreign object to enter, are located as viewed from the inner protrusion 315). Therefore, the hemostatic device 10 can prevent the foreign object that has entered the inner cavity of the connector portion 210 from moving to the position where the inner protrusion 315 is located in the inner cavity 316 of the outer member 310. As a result, even if a foreign object enters the inner cavity 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 protruding portion 315. As a result, the hemostatic device 10 can prevent a decrease in the sealing property of the seal portion S formed in the inner cavity 316 of the outer member 310 due to the influence of the foreign object that has entered the inner cavity of the connector portion 210. Note that the type, shape, size, etc. of the foreign object to be captured by the recess 353 are not particularly limited, and examples of the foreign object include pieces of hook-and-loop fasteners used in the fixing portions 710, 720, 730, and 740 of the hemostatic device 10.

[0144] 11 and 12, when the seal forming portion 338 of the main body portion 330 is in an unsealed state with the seal forming portion 338 separated from the inner protruding portion 315, the hemostatic device 10 injects a fluid into the lumen of the connector portion 210 through the front tube portion 910 of the fluid injection device 900, and the injected fluid is guided from the inside of the side wall portion 360 to the outer surface side of the side wall portion 360 through the slit portion 361 formed in the side wall portion 360. The hemostatic device can smoothly move the fluid guided to the outer surface side of the side wall portion 360 from the front protruding portion 340 side toward the main body portion 330 side (from the front end side of the connector portion 210 to the base end side) while guiding the fluid along the outer surface of the side wall portion 360. Therefore, when the operator operates the fluid injection device 900 to inject a fluid into the lumen 170a of the expansion member 170, the resistance felt by the operator at the hand (difficulty in pushing the hand operation portion of the fluid injection device 900) can be reduced. This allows the surgeon to smoothly proceed with hemostasis at the first puncture site p1 using the hemostasis instrument .

[0145] 15 and 16, the first region 381 is located closer to the main body portion 330 (proximal end side) than the tip portion 360a of the side wall portion 360 located on the tip opening 311 side (tip side). In other words, the tip portion 360a of the side wall portion 360 is located closer to the tip side than the first region 381.

[0146] 15 and 16, the side wall 360 has a protrusion 365 located closer to the tip opening 311 (tip side) than the upper end 350. The protrusion 365 is configured as a portion of the side wall 360 that protrudes beyond the upper end 350.

[0147] As shown in FIGS. 13 and 15, the convex portion 365 has a slit portion 361 .

[0148] One end 361a of the slit portion 361 is located at the tip portion 360a of the side wall portion 360, and the other end 361b of the slit portion 361 is located at a predetermined position on the base end side of the tip portion 360a of the side wall portion 360 (a position on the tip side of the first region 381). In other words, the slit portion 361 is formed along the longitudinal direction of the convex portion 365 (the direction along the arrow X1-X2).

[0149] As shown in FIG. 13, the slit portion 361 can be configured so that the width W1 gradually narrows from one end portion 361a located on the tip portion 360a side to the other end portion 361b located on the main body portion 330 side, for example.

[0150] As shown in FIGS. 15 and 16, the upper end portion 350 has a groove portion 358 formed between the second region 382 and the protrusion 365.

[0151] 14, groove portion 358 extends so as to surround bottom portion 353a and each top surface portion 375. The bottom surface of groove portion 358 located on the main body portion 330 side can be disposed closer to main body portion 330 than bottom portion 353a (first region 381).

[0152] 9, the outer diameter D1 of the tip of the tip protrusion 340 can be configured to be larger than the inner diameter D2 of the tip opening 311 of the outer member 310. In this embodiment, the outer diameter D1 of the tip of the tip protrusion 340 means the outer diameter D1 of the convex portion 365 (see FIG. 14).

[0153] In the hemostatic device 10, the outer diameter D1 of the tip of the tip protruding portion 340 is larger than the inner diameter D2 of the tip opening 311 of the outer member 310, and therefore, when the inner member 320 is placed in the lumen 316 of the outer member 310, as shown in Fig. 9, the part located on the inner circumferential side of the convex portion 365 (the inner circumferential side of the tip portion 360a of the side wall portion 360) is arranged to overlap with the tip portion of the outer member 310 (the part located on the tip side of the tip opening 311). Therefore, as shown in the plan view of Fig. 17, when the lumen 316 of the outer member 310 is visually observed from the tip side of the outer member 310 (the tip side of the connection member 400), the convex portion 365 (the tip portion 360a of the side wall portion 360) is arranged in a state covered by the outer member 310 (in a state not exposed from the opening 451).

[0154] In this embodiment, the hemostatic device 10 and a fluid injection device 900 (see FIG. 16) including a tip tube portion 910 abutting against 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 a first puncture site p1 formed in a patient's right hand H1. The fluid injection device 900 can be constituted, for example, by a syringe for supplying fluid that is known in the medical field.

[0155] In the above-described hemostatic device assembly, the upper end portion 350 can be configured to have a larger outer diameter in plan view than the front tube portion 910. That is, the outer diameter D3 of the upper end portion 350 shown in Fig. 14 and Fig. 16 can be larger than the outer diameter D4 (outer diameter of the most distal end portion) of the front tube portion 910 shown in Fig. 16.

[0156] The above-mentioned "outer diameter D3 of upper end portion 350" means the outer diameter of a virtual circle represented by connecting the outer periphery of groove portion 358 with a virtual line (arc) when upper end portion 350 is viewed in a plan view as shown in Figure 14.

[0157] It is preferable that the inner diameter D5 of the injection port 912 of the front tube part 910 is smaller than the width W2 (the dimension in the vertical direction shown in FIG. 14) of the bottom part 353a (inner diameter D5<width W2). For example, if the inner diameter D5 of the injection port 912 is larger than the width W2 of the bottom part 353a, when a fluid is injected through the injection port 912 in a state in which a foreign object exists on the upper surface part 375, the fluid may be directly sprayed onto the foreign object present on the upper surface part 375. As a result, there is a concern that the foreign object may move from the upper surface part 375 to the main body part 330 side through the slit part 361 or the like, resulting in a decrease in the sealing property of the seal part S. If the inner diameter D5 of the injection port 912 of the front tube part 910 is smaller than the width W2 of the bottom part 353a, the fluid injected from the injection port 912 may be prevented from being directly sprayed onto the foreign object present on the upper surface part 375. This can prevent deterioration of the sealing performance of the seal portion S due to the influence of foreign matter as described above.

[0158] The connecting member 400 and the outer member 310 may be made of, for example, ABS resin or polypropylene.

[0159] The inner member 320 can be made of an elastic member that can exert a predetermined sealing property by contacting the outer surface of the main body 330 with the inner protruding portion 315 when the spring member 390 is in a natural state. For example, silicone rubber, ethylene propylene diene rubber, etc. can be used as a constituent material of the inner member 320 that exerts the above-mentioned function. Note that the inner member 320 is preferably colored green or the like so that it is easy to visually check if a foreign object is attached to or placed on the inner member 320.

[0160] (Example of use of hemostatic devices) Next, an example of how to use the hemostatic device 10 will be described with reference to Figures 19 to 23. Below, a procedure for using the hemostatic device 10 when stopping bleeding at the first puncture site p1 formed on the patient's right hand H1 shown in Figure 18 will be described.

[0161] FIG. 19 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.

[0162] 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. 19. 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 appropriately positioned at the first puncture site p1.

[0163] When the surgeon attaches the hemostatic device 10 to the patient's right hand H1, the surgeon can arrange the support member 500 so as to overlap at least a part of the metacarpal bone B1 of the index finger and at least a part of the metacarpal bone B2 of the thumb. For example, as shown in Fig. 18, when stopping bleeding at the first puncture site p1, the support member 500 can be arranged at a predetermined position P1 located on an extension of the metacarpal bones B1 and B2. Also, as shown in Fig. 18, when stopping bleeding at the second puncture site p2, the support member 500 can be arranged 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.

[0164] As shown in FIG. 22, 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.

[0165] The surgeon can connect the second band portion 620 and the third band portion 630 via the fixing portions 710, 730 by contacting the first fixing portion 710 (see FIG. 1) arranged on the outer surface of the second band portion 620 with the third fixing portion 730 (see FIG. 2) arranged on the inner surface of the third band portion 630. The surgeon can connect the band portions 620, 630 together while overlapping the support member 500 with at least a part of the metacarpal bone B1 of the index finger and at least a part of the metacarpal bone B2 of the thumb, thereby firmly wrapping the band portions 620, 630 around the outer circumference of the right hand H1.

[0166] The upper surface 500b of the support member 500 is curved toward the second band portion 620 side (side surface portion 503 side) and the third band portion 630 side (side surface portion 504 side) (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, 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. 23. 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.

[0167] As shown in Fig. 21, the surgeon places a part of the first band part 610 on the palm side of the patient's right hand H1 while passing the first band part 610 through the inter-finger part 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 part 610 and the third band part 630 via the fixing parts 720, 740 by contacting the second fixing part 720 (see Fig. 1) located on the outer surface of the third band part 630 with the fourth fixing part 740 (see Fig. 2) located on the inner surface of the first band part 610.

[0168] Each part of the patient's right hand H1 (for example, around the snuff box Sb) has an inclined portion. The shape of the inclined portion of the right hand H1 depends on the individual differences of the patient. For example, if the lower surface 500a of the support member 500 is formed in a flat shape, it is difficult to arrange the support member 500 so as to follow the inclined portion of the right hand H1. In the hemostatic device 10 of this embodiment, the lower surface 500a of the support member 500 is curved in a convex shape in a direction away from the expansion member 170 (see Figs. 7 and 23). Therefore, when the lower surface 500a of the support member 500 is arranged so as to overlap the inclined portion of the patient's right hand H1, the lower surface 500a of the support member 500 can be arranged along the patient's right hand H1. As a result, the hemostatic device 10 can arrange the support member 500 so as to overlap the first puncture site p1, regardless of the individual differences of the patient's right hand H1 and left hand and the way the surgeon places it. Therefore, the hemostatic device 10 can appropriately position the support member 500 at a desired position near the first puncture site p1.

[0169] Furthermore, when the surgeon wraps the second band portion 620 and the third band portion 630 around the patient's right hand H1, the lower surface 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 of the side portions 503 and 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. 23). 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. As a result, when the hemostatic device 10 is attached to the patient's right hand H1, the support member 500 and the expansion member 170 are less likely to become displaced even when an external impact or the like is applied thereto.

[0170] The surgeon connects the fluid injection instrument 900 to the connector portion 210 in a state where the band portions 610, 620, 630 are connected to each other and the hemostatic instrument 10 is fixed to the right hand H1 of the patient. By connecting the fluid injection instrument 900 to the connector portion 210, the surgeon moves the inner member 320 arranged in the inner cavity 316 of the outer member 310 toward the base end side, and releases the sealed state formed by the seal portion S formed by the seal forming portion 338 of the inner member 320 and the inner protruding portion 315 of the outer member 310 to an unsealed state (see Figs. 11 and 12). After the inner cavity of the connector portion 210 (the inner cavity 316 of the outer member 310) is unsealed, the surgeon operates the fluid injection instrument 900 to inject a fluid into the inner cavity of the connector portion 210. When the surgeon injects a fluid into the inner cavity of the connector portion 210, the injected fluid is injected into the inner cavity 170a of the expansion member 170 via the connector portion 210 and the coupling portion 220. In the hemostatic device 10, the fluid is injected into the inner cavity 170a of the expansion member 170, thereby expanding the expansion member 170.

[0171] As shown in FIGS. 22 and 23, when the expansion member 170 of the hemostatic device 10 expands, the expansion member 170 applies a compressive force to the first puncture site p1.

[0172] After the surgeon expands the expansion member 170 to a desired expansion amount, the surgeon removes the fluid injection instrument 900 from the connector portion 210. When the surgeon removes the fluid injection instrument 900 from the connector portion 210, the spring member 390 arranged in the inner cavity 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 protruding portion 315 of the outer member 310, and a seal portion S is formed in the inner cavity 316 of the outer member 310. By forming the seal portion S in the inner cavity 316 of the outer member 310, the hemostatic instrument 10 can maintain the sealing of the inner cavity 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 via the connecting portion 220 and the inner cavity of the connector portion 210.

[0173] 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. This enables the hemostatic device 10 to prevent the expansion member 170 from lifting up from the patient's right hand H1.

[0174] When performing hemostasis using a hemostatic instrument, the surgeon can, for example, strongly tighten the first band portion disposed in the interdigital portion fb in order to increase the fixing force of the support member to the patient's right hand H1. By strongly 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 placed in an unstable state on the patient's right hand H1. However, if the first band portion is strongly tightened, the patient may feel pain. Therefore, if the first band portion cannot be tightened strongly due to pain felt by the patient, the hemostatic instrument may be placed with the lower surface of the support member inclined 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 disposed is raised to a position excessively farther 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 decreases from the upper end to the lower end of the support member.

[0175] The hemostatic device 10 is configured such that the thickness of the side portions 503, 504 of the support member 500 becomes thinner from the upper end 501 toward the lower end 502 (see FIG. 6). In addition, the first band portion 610 configured to be placed in the interdigital portion 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 starts to expand, the expansion member 170 applies force to the vicinity of the upper end 501 of the support member 500. The upper end 501 side of the support member 500 is pressed against the right hand H1 by the force applied by the expansion member 170, while the lower end 502 side is lifted. As a result, when the expansion member 170 is in an expanded state, the lower surface 500a of the support member 500 is disposed approximately parallel to the body surface of the patient's right hand H1, as shown in Fig. 22. 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.

[0176] 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 Fig. 21. The surgeon checks that there is no bleeding from the first puncture site p1 while performing hemostasis using the hemostatic instrument 10. 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.

[0177] With the expansion member 170 expanded, the surgeon can fix the connector portion 210 and the connecting portion 220 connected to the connector portion 210 to the cover member 100 via the connecting member 400 (see Figure 8), as shown in Figure 21.

[0178] The surgeon can fix the connector part 210 to the cover member 100 by inserting a part of the cover member 100 into a gap part 440 (see FIG. 8 ) extending between the accommodation part 410 and the claw part 420 extending in the longitudinal direction of the connector part 210. When fixing the connector part 210 to the cover member 100, the surgeon 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 fixing the connector part 210 to the cover member 100, the surgeon can prevent the hemostatic device 10 attached to the patient's right hand H1 from shifting in position and the expansion member 170 from shifting in position.

[0179] By fixing the connector portion 210 and the connecting portion 220 to the cover body 110, the surgeon can prevent the connecting 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.

[0180] The surgeon can fix the connector part 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 part 420 can be placed when the expansion member 170 is expanded. An example of such a position is the fixed part 110C (see FIG. 21) located between the first band part 610 and the second band part 620 in the cover main body 110. However, the position where the connector part 210 is fixed in the cover member 100 is not limited to the fixed part 110C. For example, the connector part 210 can be fixed to the periphery of the first end part 621 of the second band part 620 in the cover main body 110, any position of the first band part 610, any position of the second band part 620, etc.

[0181] The effects of the hemostatic device 10 according to this embodiment will be described below.

[0182] 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 and 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 and 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 end opening 311 configured to expose a part of the inner member 320 to the outside, a proximal end opening 312 that communicates with an inner cavity 316 of the outer member 310 and an inner cavity 410a of the connection member 400, and an inner protrusion 315 configured to prevent the inner member 320 from moving toward the distal end opening 311. The spring member 390 is located between the proximal end 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, and the inner member 320 includes a main body portion 330 configured to contact the inner protrusion 315 in a natural state, and a distal end protrusion 340 that protrudes from the distal end of the main body portion 330 toward the distal end opening 311. The distal end 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 350 has a recess 353 recessed toward the main body 330, and the side wall 360 has a slit 361 extending in the longitudinal direction of the inner member 320. The upper end 350 includes a first region 381 forming the upper surface 375, and a second region 382 forming the bottom 353a of the recess 353. The recess 353 is configured such that the second region 382 is located closer to the main body 330 than the slit 361.

[0183] The hemostatic device 10 includes a check valve member 300 disposed in the inner cavity 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 the inner protrusion 315 formed on the outer member 310 to form a seal portion S inside the connector portion 210, thereby preventing the inner cavity 170a of the expansion member 170 from fluidly communicating with the outside of the connector portion 210 via the connector portion 210. In the hemostatic device 10, the inner member 320 includes a main body portion 330 configured to contact the inner protrusion 315 of the outer member 310, and a tip protrusion portion 340 protruding from the tip of the main body portion 330 toward the tip opening 311. The tip 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 side wall 360 has a slit 361 extending in the longitudinal direction of the inner member 320. The recess 353 has a first region 381 forming the upper surface 375 and a second region 382 forming the bottom 353a of the recess 353, and is configured so that the second region 382 is located closer to the main body 330 than the slit 361. In this way, the recess 353 has a structure in which the side wall 360 extends in the longitudinal direction so as to surround the bottom 353a, since the second region 382 forming the bottom 353a of the recess 353 is located closer to the main body 330 than the first region 381 forming the upper surface 375. The hemostatic device 10 can capture a foreign object that has entered the inner cavity 316 of the outer member 310 through the tip opening 311 in the recess 353 that is located closer to the tip opening 311 than the main body 330 of the inner member 320 and is surrounded by the side wall 360. Therefore, the hemostatic device 10 can suppress the foreign object that has entered the inner cavity 316 of the outer member 310 from moving to the main body 330 of the inner member 320. As a result, even if a foreign object has entered the inner cavity 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 performance of the inner cavity of the connector portion 210 due to the influence of the foreign object that has entered the inner cavity 316 of the outer member 310.Thereby, 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 a foreign object that has entered the inner cavity 316 of the outer member 310. In the hemostatic device 10, the side wall portion 360 of the distal end protruding portion 340 has a slit portion 361 extending in the longitudinal direction of the inner member 320. When a pushing force is applied to the spring member 390 in a direction away from the distal end opening 311 via the fluid injection device 900 inserted in the inner cavity 316 of the outer member 310 during injection of a fluid into the inner cavity 170a of the expansion member 170, the spring member 390 is compressed along the longitudinal direction of the connector portion 210. When the spring member 390 is compressed, the hemostatic device 10 moves the inner member 320 toward the base end side in accordance with the compression of the spring member 390. When the inner member 320 moves toward the base end side with the compression of the spring member 390, the contact between the outer surface of the main body portion 330 of the inner member 320 and the inner protruding portion 315 of the outer member 310 is released. When a fluid is injected into the lumen 316 of the outer member 310 via the fluid injection instrument 900 in a state in which the contact between the outer surface of the main body portion 330 of the inner member 320 and the inner protruding portion 315 of the outer member 310 is released, the injected fluid can be smoothly moved from the tip protruding portion 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, when the expansion member 170 is expanded using the fluid injection instrument 900, the above-mentioned hemostatic instrument 10 can smoothly send the fluid into the lumen 170a of the expansion member 170 via the connector portion 210 and the connecting portion 220.

[0184] Furthermore, in the hemostatic device 10, the first region 381 is located closer to the main body portion 330 than the tip portion 360a of the side wall portion 360 located on the tip opening 311 side (see FIGS. 15 and 16).

[0185] In the hemostatic device 10 configured as described above, the first region 381 is located closer to the main body portion 330 than the tip portion 360a of the side wall portion 360 located on the tip opening 311 side, and therefore foreign matter can be captured by the bottom portion 353a formed by the second region 382 and the top surface portion 375 formed by the first region 381. Therefore, the hemostatic device 10 can capture foreign matter more reliably by the recess 353 including the bottom portion 353a and the top surface portion 375.

[0186] Furthermore, in the hemostatic device 10, the side wall portion 360 has a protruding portion 365 located closer to the tip opening 311 than the upper end portion 350, and the protruding portion 365 has a slit portion 361 (see FIGS. 15 and 16).

[0187] In the hemostatic device 10 configured as above, the recess 353 is surrounded by the protruding portion 365, so that the foreign matter captured by the recess 353 can be prevented from moving toward the outer surface side of the side wall portion 360. This makes it possible for the hemostatic device 10 to more reliably prevent the foreign matter from moving toward the main body portion 330. Furthermore, in the hemostatic device 10 configured as above, the protruding portion 365 has the slit portion 361, so that when a fluid is injected into the recess 353, the fluid can be more smoothly moved toward the main body portion 330 via the slit portion 361 formed in the protruding portion 365 located on the tip side relative to the upper end portion 350.

[0188] Additionally, the upper end portion 350 of the hemostatic device 10 has a groove portion 358 formed between the second region 382 and the protruding portion 365 (see FIGS. 14 and 16).

[0189] The hemostatic device 10 configured as described above can capture foreign matter by the groove portion 358 formed between the bottom portion 353a defined by the second region 382 and the protruding portion 365. Therefore, the hemostatic device 10 can more reliably capture foreign matter that has entered the inner cavity of the connector portion 210 by the groove portion 358.

[0190] Furthermore, in the hemostatic device 10, the outer diameter D1 of the tip of the tip protruding portion 340 is larger than the inner diameter D2 of the tip opening 311 (see FIG. 9).

[0191] In the hemostatic device 10 configured as described above, in a plan view seen from the tip side of the connector section 210, the projection surface of the outer periphery of the tip of the tip protrusion 340 projected onto the outer member 310 is larger than the projection surface of the tip opening 311 of the outer member 310. Therefore, when the spring member 390 is in a natural state, the hemostatic device 10 can prevent an excessive gap (a space that allows the passage of a foreign object) from being formed between the inner periphery (inner wall) of the outer member 310 and the outer periphery of the tip of the tip protrusion 340 when the outer member 310 is seen from the tip side of the connector section 210. Therefore, even if a foreign object enters the lumen 316 of the outer member 310, the hemostatic device 10 can suitably prevent the foreign object from passing through the gap between the inner periphery of the outer member 310 and the outer periphery of the tip of the tip protrusion 340 and reaching the main body section 330.

[0192] Furthermore, in this embodiment, it is possible to provide a hemostatic device assembly having a hemostatic device 10 and a fluid injection device 900 including a tip tubular portion 910 that abuts against the upper end portion 350. In such a hemostatic device assembly, the upper end portion 350 has an outer diameter D3 larger than that of the tip tubular portion 910 in a plan view (see FIG. 16).

[0193] The hemostatic device assembly configured as described above can prevent the leading tube portion 910 from protruding outward from the outer periphery of the upper end portion 350 when the leading tube portion 910 is abutted against the upper surface portion 375 of the upper end portion 350, and can bring the leading tube portion 910 into contact with the upper surface portion 375 over a wider area. Therefore, when the leading tube portion 910 of the fluid injection device 900 is inserted into the inner cavity of the connector portion 210 to push the inner member 320, the hemostatic device 10 can apply a larger pushing force to the inner member 320. This allows the hemostatic device 10 to more smoothly send fluid into the inner cavity 170a of the expansion member 170 when expanding the expansion member 170.

[0194] Next, a modified example of the above-mentioned embodiment will be described. In the description of the modified example, the description of the already-described members and the procedure for using the hemostatic device will be omitted as appropriate. Furthermore, the contents not specifically described in the modified example can be the same as those in the above-mentioned embodiment.

[0195] <Variation 1> Figures 24 to 27 show an inner member 320A according to Modification 1. Figure 24 is a side view of the inner member 320A according to Modification 1, Figure 25 is a plan view of the inner member 320A according to Modification 1 seen from the tip side, Figure 26 is a perspective view of a tip protrusion 340 according to Modification 1, and Figure 27 is a perspective cross-sectional view of the inner member 320A according to Modification 1.

[0196] 26 and 27, in the inner member 320A, the first region 381 and the tip portion 360a of the side wall portion 360 located on the tip opening 311 side are positioned at substantially the same position in the longitudinal direction of the tip protrusion 340 (the protruding direction of the tip protrusion 340). Also, in the longitudinal direction of the tip protrusion 340, the upper surface portion 375 formed by the first region 381 and the tip portion 360a of the side wall portion 360 are positioned at substantially the same position.

[0197] As described above, the first region 381 of the inner member 320A is located at the same position as the tip 360a of the side wall 360 located on the tip opening 311 side in the longitudinal direction of the tip protruding portion 340, so that when injecting fluid into the expansion member 170 using the fluid injection tool 900, the tip surface of the tip tube 910 can be more reliably abutted against the upper surface 375 by inserting the tip tube 910 of the fluid injection tool 900 into the lumen 316 of the outer member 310. Also, as described above, the first region 381 of the inner member 320 is located at the same position as the tip 360a of the side wall 360 located on the tip opening 311 side in the longitudinal direction of the tip protruding portion 340, so that a relatively long distance can be provided between the upper surface 375 and the bottom 353a. Therefore, inner member 320 can more reliably prevent foreign matter captured at bottom portion 353a from moving to upper surface portion 375 and escaping from recess 353.

[0198] 26 and 27, the recess 353 provided in the upper end portion 350 is connected to the slit portion 361. In other words, the recess 353 communicates with the outside of the side wall portion 360 via the slit portion 361.

[0199] Since the recess 353 of the inner member 320A is connected to the slit portion 361 as described above, when a fluid is injected into the recess 353, the fluid can be moved from the recess 353 to the slit portion 361. The inner member 320A can move the fluid moved from the recess 353 to the slit portion 361 through the slit portion 361 and the outer surface side of the side wall portion 360 toward the main body portion 330. Therefore, when the hemostatic device expands the expansion member 170, the fluid can be sent to the inner cavity 170a of the expansion member 170 more smoothly.

[0200] 27, the upper end portion 350 has a third region 383 located between a first region 381 forming the upper surface portion 375 and a second region 382 forming the bottom portion 353a. The recess 353 is connected to the slit portion 361 via the third region 383.

[0201] As described above, the inner member 320A has the third region 383 located between the first region 381 and the second region 382, ​​and the recess 353 is connected to the slit portion 361 (the portion where the thickness of the tip protrusion 340 is thin) via the third region 383. Therefore, the strength (rigidity) of the inner member 320 can be increased compared to when the third region 383 does not exist (when a space is formed between the first region 381 and the second region 382).

[0202] 25 and 27, two bottoms 353a are formed in the recess 353. The recess 353 also has three protrusions 385 extending from the bottoms 353a toward the tip end.

[0203] The tip end of each protrusion 385 is located in the third region 383. The tip end of each protrusion 385 can be formed in a rounded curved shape toward the tip side. Since the tip end of each protrusion 385 of the inner member 320A has the above-mentioned shape, the inner member 320A can guide foreign matter that has reached the third region 383 from the tip end of each protrusion 385 toward the bottom 353a. Therefore, the inner member 320A can capture foreign matter more reliably at the bottom 353a.

[0204] 25, bottom portion 353a is disposed so as to be sandwiched between two adjacent protruding portions 385. Since each bottom portion 353a is sandwiched between two adjacent protruding portions 385, it is possible to more reliably prevent a foreign object that has entered bottom portion 353a from escaping from bottom portion 353a.

[0205] For example, when the inner diameter D5 of the injection port 912 of the fluid injection tool 900 is larger than the third region 383, the injected fluid is sprayed directly onto the third region 383. Also, when one of the three protrusions 385 is located at the center of the recess 353, the injected fluid hits the protrusion 385 located at the center and moves to the third region 383 on the slit portion 361 side before moving to the bottom 353a. This allows the inner member 320A to move the fluid to the slit portion 361 via the third region 383 before it reaches the bottom 353a when the fluid is injected into the recess 353. Therefore, even when the fluid is injected in a state where a foreign object is captured at the bottom 353a of the recess 353, the inner member 320A can more reliably keep the foreign object within the bottom 353a.

[0206] <Variation 2> Figures 28 to 31 show an inner member 320B according to Modification 2. Figure 28 is a side view of inner member 320B according to Modification 2, Figure 29 is a plan view of inner member 320B according to Modification 2 as viewed from the tip side, Figure 30 is a perspective view of tip protrusion 340 according to Modification 2, and Figure 31 is a perspective cross-sectional view of inner member 320B according to Modification 2.

[0207] Inner member 320B according to modification 2 differs from inner member 320A according to modification 1 in the configuration of protrusion 385 formed in third region 383. Other configurations and effects exerted by inner member 320 are substantially the same as those of inner member 320.

[0208] The third region 383 of the inner member 320B is provided with two protrusions 385 arranged near both ends in the width direction (the left-right direction in the plan view of FIG. 29) of the bottom portion 353a.

[0209] 30 and 31, the inner member 320B is located at the tip 360a of the side wall 360 where the first region 381 is located on the tip opening 311 side. That is, the inner member 320B is located at the same position as the tip 360a of the side wall 360 where the first region 381 is located on the tip opening 311 side.

[0210] As shown in FIGS. 30 and 31, the recess 353 provided in the upper end portion 350 is connected to the slit portion 361 .

[0211] 31, the upper end portion 350 has a third region 383 located between a first region 381 forming the upper surface portion 375 and a second region 382 forming the bottom portion 353a. The recess 353 is connected to the slit portion 361 via the third region 383.

[0212] An inner periphery 385a of the protruding portion 385 located in the third region 383 is located inside the recessed portion 353. Moreover, the inner periphery 385a of the protruding portion 385 has a curved shape. Therefore, the inner member 320B can guide the foreign matter that has reached the protruding portion 385 into the recessed portion 353 via the inner periphery 385a.

[0213] <Modification 3> Figures 32 to 35 show an inner member 320C according to Modification 3. Figure 32 is a side view of the inner member 320C according to Modification 3, Figure 33 is a plan view of the inner member 320C according to Modification 3 seen from the tip side, Figure 34 is a perspective view of a tip protrusion 340 according to Modification 3, and Figure 35 is a perspective cross-sectional view of the inner member 320C according to Modification 3.

[0214] In the inner member 320C, the recess 353 has a trap portion 355 whose width W3 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.

[0215] 34 and 35, the recess 353 is connected to the slit portion 361 via the trap portion 355. In other words, the recess 353 communicates with the outside of the upper end portion 350 on the side surface side of the upper end portion 350 from the center position O1 of the upper end portion 350 via the trap portion 355 and the slit portion 361.

[0216] In the hemostatic device 10, two trap portions 355 are formed in the recess 353. The slit portions 361 are formed one each at approximately the same circumferential positions as the trap portions 355 so as to correspond to the number and positions of the trap portions 355 (two in total).

[0217] The first protrusion 371 is located on the outer edge 351 of the upper end 350. Therefore, the upper surface portion 375 is located closer to the main body portion 330 than the end (tip) of the first protrusion 371 located in the protruding direction.

[0218] The above-mentioned "outer edge portion 351 of upper end portion 350" means the portion along a line represented by connecting an area including the cutout-shaped portion in which trap portion 355 is formed, with a virtual line, when upper end portion 350 is viewed in a plan view as shown in Figure 33.

[0219] As shown in FIG. 32, the slit portion 361 extends such that the width W1 narrows from one end portion 361a toward the other end portion 361b.

[0220] 34, first protrusion 371 protrudes toward the side opposite to the side where main body 330 is located (the tip side). Between the tip of first protrusion 371 and upper surface 375, a curved inclined surface that connects the tip of first protrusion 371 and upper surface 375 is formed.

[0221] The two upper surface portions 375 are formed so as to face each other with the center position O1 of the upper end portion 350 therebetween.

[0222] As shown in FIG. 35, the other end 361b of the slit portion 361 located on the main body portion 330 side is located closer to the upper surface portion 375 side (tip side) than the second region 382.

[0223] As described above, the inner member 320C according to the third modification has a trap portion 355 whose width W3 narrows from the center position O1 of the upper end portion 350 toward the outer edge portion 351 of the upper end portion 350 (see FIGS. 33 and 34).

[0224] Inner member 320C can capture foreign matter that has entered cavity 316 of outer member 310 by trap portion 355 provided in recess 353. In addition, trap portion 355 has width W3 that narrows from center position O1 of upper end portion 350 toward outer edge portion 351 of upper end portion 350, so that foreign matter can be more reliably prevented from passing through trap portion 355 and escaping recess 353.

[0225] Furthermore, in the inner member 320C, the recess 353 is connected to the slit portion 361 via the trap portion 355 (see FIGS. 34 and 35).

[0226] 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 moves the foreign object toward the main body portion 330, the inner member 320C can capture the foreign object 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 inward protruding portion 315 of the main body portion 330.

[0227] Additionally, the inner member 320C has an upper end 350 having a first protrusion 371 formed on an outer edge 351 of the upper end 350 (see FIGS. 34 and 35).

[0228] Since 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, when a foreign object enters the inner cavity 316 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. By preventing the foreign object from passing through the outer edge portion 351 of the upper end portion 350, the inner member 320C can prevent the foreign object from moving toward the main body portion 330 via the side surface of the upper end portion 350.

[0229] The hemostatic device and hemostatic device set according to the present invention have been described above through embodiments and modified examples. However, the present invention is not limited to the contents described in the specification, and can be modified as appropriate based on the description of the claims.

[0230] The shape, dimensions, etc. of each part of the hemostatic device are not particularly limited as long as the expansion member placed at the puncture site can compress and stop bleeding, and can be changed as appropriate.

[0231] The specific shapes of the expansion member and the support member are not limited to the shapes shown in the embodiments.

[0232] The hemostatic device may be configured to stop bleeding at a puncture site other than a puncture site formed on a hand. For example, the hemostatic device may be configured to stop bleeding at a puncture site formed on a patient's arm or leg using the expansion member of the embodiment. [Explanation of symbols]

[0233] 10 Hemostatic devices 100 Cover member 120 Sheet material 170 Extension member 170a: Lumen of expansion member 200 Injection material 210 Connector part 220 Connection section 300 Check valve member 310 Outer member 311 Tip opening 312 Proximal opening 313 Insertion port 315 Inner protrusion 316 Lumen of outer member 320 Inner member 320A Inner member 320B Inner member 320C Inner member 330 Main body 338 Seal forming part 340 Tip protrusion 350 Upper end 351 Outer edge 353 Recess 353a bottom 355 Trap section 358 Groove 360 Side wall 360a Tip of side wall 361 Slit section 361a One end of the slit 361b Other end of slit 365 Convex 371 First convex part 375 Top part 381 1st area 382 Second area 383 Third area 385 Protrusion 390 Spring parts 400 Connection parts 410a Lumen of connecting member 500 Support member 610 First Belt Body 620 Second Belt Body 630 Third Belt Body Part 800 Introducer 900 Fluid injection equipment 910 Tip tube part 912 Inlet O1 Center position of top end S Seal Part D1 Outer diameter of upper end D2 Inner diameter of tip opening D3 Outer diameter of upper surface D4 Outer diameter of the front tube D5 Inlet inner diameter W1 Width of slit W2 Bottom width W3 Width of trap H hand H1 right hand Ar Forearm fb between fingers Sb snuff box B1 Metacarpal bone of index finger B2 Thumb metacarpal T1 extensor pollicis longus tendon T2 extensor pollicis brevis tendon V1 vessel (distal radial artery) V2 Snuffbox artery p1 1st puncture site (puncture site) p2 2nd puncture site (puncture site)

Claims

1. 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; an injection member connected to the expansion member and configured to be able to inject a fluid into the expansion member; 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 includes a check valve member configured to be able to control communication between an inner cavity of the connector portion and the outside, and a connection member connecting the check valve member and the connecting portion, The check valve member includes an outer member, an inner member located inside the outer member, and a spring member connected to the inner member, the outer member includes a tip opening configured to expose a portion of the inner member to the outside, a base opening communicating an inner cavity of the outer member with an inner cavity of the connecting member, and an inner protrusion configured to prevent the inner member from moving toward the tip opening, the spring member is located 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 has a main body portion configured to contact the inner protrusion portion in a natural state, and a tip protrusion portion protruding from a tip of the main body portion toward a front tip opening side, The tip protrusion has an upper end and a side wall portion connecting the upper end and the main body portion, The upper end portion has a recess that is recessed toward the main body portion, The side wall portion has a slit portion extending in a longitudinal direction of the inner member, the upper end portion includes a first region forming a top surface portion and a second region forming a bottom portion of the recess, The recess is configured such that the second region is located closer to the main body portion than the slit portion.

2. The hemostatic device according to claim 1 , wherein the first region is located closer to the main body portion than a tip end of the side wall portion located on the tip opening side.

3. The side wall portion has a convex portion located closer to the tip opening than the upper end portion, The hemostatic device according to claim 2 , wherein the protrusion has the slit portion.

4. The hemostatic device according to claim 3 , wherein the upper end portion has a groove portion formed between the second region and the protrusion.

5. The hemostatic device according to claim 1 , wherein the first region is located at a distal end portion of the side wall portion located on the distal opening side.

6. The hemostatic device according to claim 5 , wherein the recess is connected to the slit portion.

7. the upper end portion has a third region located between the first region and the second region, The hemostatic device according to claim 6 , wherein the recess is connected to the slit portion via the third region.

8. The hemostatic device according to claim 5 , wherein the recess has a trap portion whose width narrows from a center position of the upper end portion toward an edge portion of the upper end portion in a plan view.

9. The hemostatic device according to claim 8 , wherein the recess is connected to the slit portion via the trap portion.

10. The hemostatic device according to claim 8 , wherein the upper end portion has a first protrusion formed on an outer edge of the upper end portion.

11. The hemostatic device according to claim 1 , wherein an outer diameter of the tip of the distal projection is larger than an inner diameter of the distal opening.

12. A hemostatic device according to any one of claims 1 to 11, a fluid injection instrument having a tip portion abutting against the upper end portion, The upper end portion has an outer diameter larger than that of the tip portion in a plan view.

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