hemostatic instruments

Abstract

[Problem] To provide a hemostatic instrument which can perform, with a simple operation, an operation for depressurizing an extension member and an operation for re-injecting a fluid into the extension member without using a dedicated instrument other than the hemostatic instrument. [Solution] This hemostatic instrument 100 comprises: an extension member 30 configured to press a stimulus portion of a patient; a band body 10 and a surface fastener 20 which function as a fixing member configured to fix the extension member 30 to the stimulus portion of the patient; and an injection member 50 configured to inject a gas (fluid) into an inner cavity of the extension member 30. The injection member 50 comprises: a connector part (first protruding part 71g) for injecting a gas; a main body part including a tube 60 which connects the connector part and the inner cavity of the extension member 30; and a control unit 70 which controls the flow of the gas passing through an inner cavity of the injection member 50. The control unit 70 comprises: a first valve member 71; a second valve member 72 positioned further toward the extension member 30 side than the first valve member 71; and a fluid accommodation part 73 positioned between the first valve member 71 and the second valve member 72.

Description

Technical Field

[0001] The present invention relates to a hemostatic device for compressing a puncture site of a patient to stop bleeding.

Background Art

[0002] In recent years, percutaneous treatments and examinations have been performed, such as puncturing blood vessels in the arm or leg, introducing an introducer sheath into the puncture site, and delivering a medical device such as a catheter to the lesion through the lumen of the introducer sheath. When performing such treatments and examinations, an operator such as a doctor (hereinafter simply referred to as "operator") needs to stop bleeding at the puncture site after removing the introducer sheath. To perform this hemostasis, there is known a hemostatic device including a belt-like body for winding around a limb such as an arm or a leg, fixing means for fixing the belt-like body in a state of being wound around the limb, and an expansion member that is connected to the belt-like body and expands by injecting a fluid to compress the puncture site.

[0003] In such a hemostatic device, if the expanded expansion member continuously compresses the puncture site and the surrounding blood vessels and nerves strongly for a long time, it may cause numbness and pain or occlude the blood vessels. To prevent blood vessel occlusion and the like, generally, after expanding the expansion member, the operator regularly connects a dedicated instrument such as a syringe to the hemostatic device and performs a decompression operation of discharging the fluid in the expansion member according to a predetermined decompression protocol to reduce the internal pressure of the expansion member, thereby reducing the compressive force acting on the puncture site over time.

[0004] However, in such a hemostatic device, an operation of regularly connecting a dedicated instrument such as a syringe to the hemostatic device is required, which may increase the labor of the operator. Also, during the decompression operation, if the dedicated instrument is lost, a situation may occur where the decompression operation of the expansion member cannot be performed.

[0005] Patent Document 1 discloses a hemostatic device equipped with a pressure adjustment unit connected to an expansion member, which allows for pressure adjustment of the expansion member without using a dedicated instrument such as a syringe during the depressurization operation of the expansion member. The pressure adjustment unit is connected to the expansion member and includes a main container section having a plurality of fluid passage holes for draining a portion of the fluid contained within the expansion member. The pressure adjustment unit also includes a slide member attached to the main container section that moves along the main container section from a state where the fluid passage holes are blocked to open the fluid passage holes in multiple stages, and a movable body that moves within the main container section to sequentially block the air passage holes opened by the slide member in multiple stages. In the hemostatic device of Patent Document 1, when compressing the area of ​​the limb to be hemostatic, the operator can easily adjust the compression force on the area to be hemostatic according to the patient's condition, thereby reducing the effort required for the operator to adjust the compression force. [Prior art documents] [Patent Documents]

[0006] [Patent Document 1] International Publication No. 2015 / 199024 [Overview of the project] [Problems that the invention aims to solve]

[0007] The hemostatic device described in Patent Document 1 is equipped with a pressure adjustment unit for adjusting the pressure reduction of the expansion member, so the amount of pressure reduction can be adjusted according to the patient's condition without using a dedicated instrument such as a syringe. However, since the pressure adjustment unit is composed of a separate component that is further branched and connected from the injection unit which communicates with the expansion member, it can sometimes get in the way when operating the hemostatic device.

[0008] Furthermore, the hemostatic device described in Patent Document 1 also allows for the reinjection of fluid depending on the hemostatic state at the puncture site when decompression is performed. However, with the hemostatic device of Patent Document 1, when reinjecting fluid, a dedicated instrument such as a syringe must be used to reinject the fluid. As described above, considering the ease of operation for the surgeon, there was room for improvement in the structure of the hemostatic device of Patent Document 1 for performing decompression of the expansion member and reinjection of fluid.

[0009] At least one embodiment of the present invention has been made in view of the above problems, and aims to provide a hemostatic device that allows for depressurization of the expansion member and reinjection of fluid into the expansion member with simple operation without using a separate dedicated device from the hemostatic device, thereby reducing the effort required for the operator to perform depressurization and reinjection operations. [Means for solving the problem]

[0010] The hemostatic device according to this embodiment comprises an expansion member configured to compress the puncture site of a patient, a fixing member configured to fix the expansion member to the puncture site of the patient, and an injection member configured to inject fluid into the lumen of the expansion member, wherein the injection member comprises a connector portion for connecting a fluid injection device, a main body portion connecting the connector portion and the lumen of the expansion member, and a control unit connected between the connector portion and the main body portion without branching from the main body portion and controlling the flow of the fluid through the lumen of the injection member, wherein the control unit comprises a first valve member, a second valve member located on the expansion member side of the first valve member, and a fluid storage portion located between the first valve member and the second valve member, and the fluid storage portion is By being compressed in the longitudinal direction, The system is configured to allow fluid to flow between the expansion member and the expansion member, and to be reinjected into the expansion member. [Effects of the Invention]

[0011] According to at least one embodiment of the present invention, after the surgeon injects fluid into the expansion member, the surgeon can perform a depressurization operation and a fluid reinjection operation on the expansion member with simple operations, thereby reducing the effort required for the surgeon to perform the depressurization and reinjection operations. The injection member of the hemostatic device includes a control unit having a first valve member, a second valve member, and a fluid reservoir located between the first valve member and the second valve member. The control unit can store a predetermined amount of fluid in the fluid reservoir and reinject the gas stored in the fluid reservoir into the expansion member by operating the first valve member and the second valve member. In other words, the control unit can degas a predetermined amount of gas from the expansion member or reinject a predetermined amount of gas into the expansion member by storing a predetermined amount of gas in the fluid reservoir. Therefore, when depressurizing the expansion member, the surgeon can operate the open and closed states of the first valve member and the second valve member to allow a portion of the fluid stored in the expansion member to flow into the fluid reservoir, thereby discharging fluid from the expansion member. Furthermore, when reinjecting fluid into the expansion member, the surgeon can inject fluid into the expansion member by operating the open and closed states of the first valve member and the second valve member, thereby allowing a predetermined amount of fluid contained in the fluid reservoir to flow into the expansion member. In this way, the hemostatic device of the present invention allows for depressurization and fluid reinjection operations on the expansion member with simple operation, without the need to use a separate, dedicated device. Therefore, the hemostatic device of the present invention can reduce the effort required for the surgeon to perform drainage and reinjection operations on the expansion member. [Brief explanation of the drawing]

[0012] [Figure 1] This is a plan view showing the configuration of the hemostatic device according to this embodiment. [Figure 2] This is a schematic cross-sectional view along line XX in Figure 1. [Figure 3] This is an enlarged partial cross-sectional view of the area around the injection member in the hemostatic device according to this embodiment. [Figure 4A] This figure shows the state in which the first valve body (third valve body) and the second valve body (fourth valve body) constituting the first valve member (second valve member) of the hemostatic device according to this embodiment are separated. [Figure 4B]It is a conceptual diagram showing a state where the first valve body (third valve body) and the second valve body (fourth valve body) constituting the first valve member (second valve member) of the hemostatic device according to this embodiment are in close contact with each other. [Figure 5A] It is a view showing a state before extending the fluid storage part, which is one form of the fluid storage part of the hemostatic device according to this embodiment. [Figure 5B] It is a view showing a state after extending the fluid storage part, which is one form of the fluid storage part of the hemostatic device according to this embodiment. [Figure 6A] It is a view showing a state before extending the fluid storage part, which is another form of the fluid storage part of the hemostatic device according to this embodiment. [Figure 6B] It is a view showing a state after extending the fluid storage part, which is another form of the fluid storage part of the hemostatic device according to this embodiment. [Figure 7A] It is a view showing a state before engagement of the first fixed holding member of the hemostatic device according to this embodiment. [Figure 7B] It is a view showing a state during engagement of the first fixed holding member of the hemostatic device according to this embodiment. [Figure 7C] It is a view showing a state after engagement of the first fixed holding member of the hemostatic device according to this embodiment. [Figure 8A] It is a view showing a state before engagement of the second fixed holding member of the hemostatic device according to this embodiment. [Figure 8B] It is a view showing a state during engagement of the second fixed holding member of the hemostatic device according to this embodiment. [Figure 8C] It is a view showing a state after engagement of the second fixed holding member of the hemostatic device according to this embodiment. [Figure 9] It is a perspective view showing a state where the hemostatic device according to this embodiment is worn. [Figure 10A] It is a view showing the procedure of the injection operation of the hemostatic device according to this embodiment, and it is a view where the first valve member and the second valve member are in a closed state. [Figure 10B] It is a view showing the procedure of the injection operation of the hemostatic device according to this embodiment, and it is a view where the first valve member is in an open state. [Figure 10C]It is a diagram showing the procedure of the injection operation of the hemostatic device according to this embodiment, and is a diagram showing the second valve member in an open state. [Figure 10D] It is a diagram showing the procedure of the injection operation of the hemostatic device according to this embodiment, and is a diagram showing the state during fluid injection by an injection device (syringe). [Figure 10E] It is a diagram showing the procedure of the injection operation of the hemostatic device according to this embodiment, and is a diagram showing the second valve member in a closed state. [Figure 10F] It is a diagram showing the procedure of the injection operation of the hemostatic device according to this embodiment, and is a diagram showing the first valve member in a closed state. [Figure 11A] It is a diagram showing the procedure of the degassing operation of the hemostatic device according to this embodiment, and is a diagram showing the second valve member in an open state. [Figure 11B] It is a diagram showing the procedure of the degassing operation of the hemostatic device according to this embodiment, and is a diagram showing the state where fluid is flowing in the fluid storage part. [Figure 11C] It is a diagram showing the procedure of the degassing operation of the hemostatic device according to this embodiment, and is a diagram showing the second valve member in a closed state. [Figure 11D] It is a diagram showing the procedure of the degassing operation of the hemostatic device according to this embodiment, and is a diagram showing the first valve member in an open state. [Figure 11E] It is a diagram showing the procedure of the degassing operation of the hemostatic device according to this embodiment, and is a diagram showing the state where fluid is exhausted from the fluid storage part. [Figure 12A] It is a diagram showing the procedure of the reinjection operation of the hemostatic device according to this embodiment, and is a diagram showing the second valve member in an open state. [Figure 12B] It is a diagram showing the procedure of the reinjection operation of the hemostatic device according to this embodiment, and is a diagram showing the state where the first valve member is close to the second valve member (the state during the reinjection operation). [Figure 12C] It is a diagram showing the procedure of the reinjection operation of the hemostatic device according to this embodiment, and is a diagram showing the state where the first valve member is close to the second valve member and fluid is reinjected. [Figure 13A] It is a diagram showing the procedure of the forced degassing operation of the hemostatic device according to this embodiment, and is a diagram showing the second valve member in an open state. [Figure 13B]This figure shows the procedure for forced degassing of the hemostatic device according to this embodiment, and illustrates the state in which the first valve member is separated from the second valve member and fluid is discharged from the expansion member. [Figure 13C] This diagram shows the procedure for forced degassing of the hemostatic device according to this embodiment, with the second valve member in the closed state and the first valve member in the open state. [Figure 14A] This figure shows the state of the first fixing and holding member of the hemostatic device according to this embodiment before engagement. [Figure 14B] This diagram shows the state of the first fixing and holding member of the hemostatic device in the process of engagement according to Modification 1. [Figure 14C] This figure shows the state of the first fixing and holding member of the hemostatic device according to Modification 1 after engagement. [Figure 15A] This figure shows the state of the second fixing and holding member of the hemostatic device according to Modification 1 before engagement. [Figure 15B] This figure shows the state of the second fixing and holding member of the hemostatic device according to Modification 1 during the engagement process. [Figure 15C] This figure shows the state of the second fixing and holding member of the hemostatic device according to Modification 1 after engagement. [Figure 16A] This figure shows the configuration of the first valve member equipped with a first fixing and holding member in a hemostatic device according to modified example 2. [Figure 16B] This figure shows the configuration of the second valve member equipped with a second fixing and holding member in a hemostatic device according to modified example 2. [Figure 17A] This figure shows the state of the third fixing and holding member in the hemostatic device according to Modification 3 before engagement. [Figure 17B] This figure shows the state of the third fixing and holding member after engagement in the hemostatic device according to Modification 3. [Modes for carrying out the invention]

[0013] Hereinafter, embodiments for carrying out the present invention will be described in detail with reference to the drawings. The embodiments shown herein are illustrative examples for embodying the technical idea of ​​the present invention and do not limit the present invention. Furthermore, all other implementable forms, examples, and operational techniques that can be conceived by those skilled in the art without departing from the spirit of the present invention are included in the scope and spirit of the present invention, as well as in the claims and their equivalents.

[0014] Furthermore, the drawings attached to this specification may be schematically represented with changes to scale, aspect ratio, shape, etc., from the actual object for the sake of illustration and ease of understanding, but these are merely examples and do not limit the interpretation of the present invention.

[0015] In this specification, ordinal numbers such as "the first" and "the second" are used for explanation, but unless otherwise specified, they are used for convenience and do not prescribe any particular order.

[0016] As shown in Figure 9, the hemostatic device 100 according to one embodiment of the present invention is used to stop bleeding at a puncture site after removing a device such as an introducer sheath that was placed at a puncture site formed in the radial artery R at the patient's wrist W, for the purpose of inserting a catheter or the like into a blood vessel for treatment, examination, etc. Note that the specific procedures and treatment steps described for using the hemostatic device 100 according to one embodiment of the present invention are representative examples and do not specify the present invention.

[0017] <Structure> First, the hemostatic device 100 according to this embodiment will be described with reference to Figures 1 to 8 as appropriate. As shown in Figure 1 or Figure 2, the hemostatic device 100 generally comprises a band 10 for wrapping around the wrist W, a hook-and-loop fastener 20 for fixing the band 10 in place while wrapped around the wrist W, an expansion member 30 for expanding by injecting fluid to compress the puncture site, a marker 40 for aligning the expansion member 30 with the puncture site, and an injection member 50 capable of injecting fluid into the expansion member 30. In the hemostatic device 100, the band 10 and the hook-and-loop fastener 20 function as "fixing members" for fixing the expansion member 30 to the puncture site.

[0018] Furthermore, the fluid injected into the expansion member 30 is not particularly limited as long as it can be injected into and discharged from the expansion member 30, such as a gas like air, or a liquid like purified water or physiological saline solution. In this embodiment, the fluid is a gas (air) which is easier to handle and more convenient to inject and discharge compared to a liquid.

[0019] In this specification, when the band 10 is wrapped around the wrist W, the side of the band 10 facing the body surface of the wrist W (the attachment side) is referred to as the "inner side," and the opposite side is referred to as the "outer side."

[0020] The band 10 comprises a belt 11 made of a flexible, strip-shaped member, and a support plate 12 that is harder than the belt 11.

[0021] As shown in Figure 9, the belt 11 is wrapped around the outer circumference of the wrist W in approximately one complete circle. A support plate holder portion 11a is formed in the center of the belt 11 to hold the support plate 12. The support plate holder portion 11a is double-layered, with a separate strip-shaped member joined to the outer surface (or inner surface) by methods such as fusion (thermal fusion, high-frequency fusion, ultrasonic fusion, etc.) or adhesion (adhesion with adhesive or solvent), and holds the support plate 12 inserted into the gap between them.

[0022] On the outer surface of the belt 11 near the left end in Figure 1, the male (or female) side 21 of a hook-and-loop fastener 20, commonly known as Velcro (registered trademark), is positioned, and on the inner surface of the belt 11 near the right end in Figure 1, the female (or male) side 22 of the hook-and-loop fastener 20 is positioned. As shown in Figure 9, the belt 11 is wrapped around the wrist W, and the male side 21 and female side 22 are joined together to attach the band 10 to the wrist W. Note that the means for securing the band 10 while wrapped around the wrist W is not limited to the hook-and-loop fastener 20; for example, a snap, button, clip, or a frame member through which the end of the belt 11 passes may also be used.

[0023] The constituent materials of the belt 11 are not particularly limited as long as they are flexible. Examples of such materials include polyolefins such as polyvinyl chloride, polyethylene, polypropylene, polybutadiene, and ethylene-vinyl acetate copolymer (EVA), polyesters such as polyethylene terephthalate (PET) and polybutylene terephthalate (PBT), polyvinylidene chloride, silicone, polyurethane, polyamide elastomer, polyurethane elastomer, polyester elastomer, or any combination thereof (blended resin, polymer alloy, laminate, etc.).

[0024] Furthermore, while it is preferable that at least the portion of the belt 11 that overlaps with the expansion member 30 be substantially transparent, it is not limited to being transparent and may be semi-transparent or colored transparent. This allows the puncture site to be visible from the outside and the marker 40 to be easily positioned at the puncture site.

[0025] As shown in Figure 2, the support plate 12 is held by the belt 11 by being inserted between the double-layered support plate holding portions 11a of the belt 11. The support plate 12 has a plate shape in which at least a portion is curved toward the inner side (mounting surface side). The support plate 12 is made of a harder material than the belt 11 and is designed to maintain a nearly constant shape.

[0026] The support plate 12 has a shape that is elongated in the longitudinal direction of the belt 11. The central portion 12a of the support plate 12 in the longitudinal direction is almost flat with no curvature, and on both sides of this central portion 12a, there are first curved portions 12b (left side in Figure 2) and second curved portions 12c (right side in Figure 2), respectively, which are curved toward the inner surface and along the longitudinal direction of the belt 11 (circumferential direction of the wrist W).

[0027] Examples of materials that make up the support plate 12 include acrylic resin, polyvinyl chloride (especially rigid polyvinyl chloride), polyethylene, polypropylene, polyolefins such as polybutadiene, polystyrene, poly-(4-methylpentene-1), polycarbonate, ABS resin, polymethyl methacrylate (PMMA), polyacetal, polyacrylate, polyacrylonitrile, polyvinylidene fluoride, ionomer, acrylonitrile-butadiene-styrene copolymer, polyester such as polyethylene terephthalate (PET) and polybutylene terephthalate (PBT), butadiene-styrene copolymer, aromatic or aliphatic polyamide, and fluororesins such as polytetrafluoroethylene.

[0028] The support plate 12, like the belt 11, is preferably substantially transparent in the portion that overlaps with the expansion member 30, but is not limited to being transparent; it may be semi-transparent or colored transparent. This allows the puncture site to be clearly visible from the outside, and the marker 40 to be easily positioned at the puncture site. The support plate 12 may not have a flat portion like the central part 12a, but may have a curved shape along its entire length.

[0029] An expansion member 30 is connected to the band 10. The expansion member 30 expands by injecting fluid and compresses the puncture site on the wrist W.

[0030] As shown in Figure 2, the expansion member 30 is positioned on the inner surface of the band 10, overlapping with one end of the support plate 12 held by the band 10 in the longitudinal direction. That is, in the illustrated configuration, the expansion member 30 is positioned to overlap with the vicinity between the first curved portion 12b and the central portion 12a on the left end of the support plate 12 in Figure 2. Therefore, when the expansion space 31 is expanded, the expansion member 30 is prevented from expanding away from the body surface of the wrist W by the support plate 12, and the compressive force of the expansion member 30 is concentrated on the wrist W side. As a result, the expansion member 30 can suitably apply compressive force to the puncture site.

[0031] Furthermore, when the expansion member 30 is positioned to overlap one end of the support plate 12 in the longitudinal direction, the first curved portion 12b located on both sides of the support plate 12 in the longitudinal direction is longer in the longitudinal direction than the second curved portion 12c. This reduces the risk of pain, such as soreness, occurring when the hemostatic device 100 is attached to the wrist W and the expansion member 30 is expanded, as the second curved portion 12c of the support plate 12 comes into contact with the wrist W.

[0032] The constituent material of the expansion member 30 is not particularly limited as long as it is a flexible material, and for example, the same material as the constituent material of the belt 11 described above can be used. Furthermore, it is preferable that the expansion member 30 is made of the same material or of the same type as the belt 11. This allows the expansion member 30 to be easily joined to the belt 11 by fusion.

[0033] The expansion member 30 is constructed as a bag-shaped member formed by overlapping two sheets made of the aforementioned material and bonding or fusing their edges, as shown in Figure 2. This creates an expansion space 31 between the two sheets. The configuration of the expansion member 30 is not particularly limited as long as it can be expanded by injecting fluid. For example, the expansion member 30 may be constructed as a bag-shaped member formed by folding a single sheet and bonding or fusing its edges, or as a balloon-shaped member without edges. Furthermore, the external shape of the expansion member 30 can be configured to form a rectangle when viewed from above in its unexpanded state, as shown in Figure 1. However, the expansion member 30 may have an external shape such as a circle, ellipse, or polygon when viewed from above in its unexpanded state.

[0034] When expanding (inflating) the expansion member 30, the tip of a syringe S, which is a fluid injection device, is inserted into the connector portion of the injection member 50 (for example, the first protrusion 71g of the first valve body 71a, which will be described later), and the plunger of the syringe S is pushed to inject the gas inside the syringe S into the expansion member 30 via the injection member 50. The operation of injecting gas into the expansion member 30 will be described in detail later.

[0035] The expansion member 30 is preferably substantially transparent, similar to the belt 11 and support plate 12, but is not limited to transparent; it may be semi-transparent or colored transparent. This allows the surgeon to visually confirm the puncture site from the outside and easily align the marker 40 with the puncture site.

[0036] As shown in Figures 1 and 2, the marker 40 is provided approximately in the center of the side of the expansion member 30 facing the band 10. By providing such a marker 40 on the expansion member 30, the expansion member 30 can be easily aligned with the puncture site, thereby suppressing misalignment of the expansion member 30. Furthermore, since the marker 40 is provided on the side of the expansion member 30 facing the band 10, the marker 40 does not directly contact the puncture site. The position of the marker 40 is not particularly limited as long as the expansion member 30 can be aligned with the puncture site. Therefore, the marker 40 may be provided on the side of the expansion member 30 facing the wrist W. In this case, it is preferable that the marker 40 be provided on the inner surface of the expansion member 30 so as not to directly contact the puncture site.

[0037] The shape of the marker 40 is not particularly limited and can be a circle, a triangle, a quadrilateral, or any other polygon; in this embodiment, it is a quadrilateral.

[0038] The size of the marker 40 is not particularly limited, but for example, if the shape of the marker 40 is rectangular, it is preferable that the length of one side is in the range of 1 to 4 mm. If the length of one side is 5 mm or more, the size of the marker 40 becomes large relative to the size of the puncture site, making it difficult to align the center of the expansion member 30 with the puncture site.

[0039] The material of the marker 40 is not particularly limited and may include, for example, oil-based colorants such as ink, or resins mixed with pigments.

[0040] The color of the marker 40 is not particularly limited as long as it is a color that allows the expansion member 30 to be positioned at the puncture site, but a green color is preferred. By using a green color, the marker 40 can be easily seen on the blood or skin, making it easier to position the expansion member 30 at the puncture site.

[0041] Furthermore, the marker 40 is preferably semi-transparent or colored transparent. This allows the puncture site to be visible from the outer surface of the marker 40.

[0042] The method for providing the marker 40 on the extension member 30 is not particularly limited, but examples include printing the marker 40 on the extension member 30, or applying adhesive to one side of the marker 40 and attaching it to the extension member 30.

[0043] The injection member 50 is a part for injecting gas into the expansion member 30, and is connected to the expansion member 30 as shown in Figure 1.

[0044] The injection member 50 comprises a flexible tube 60 whose lumen communicates with the lumen of the expansion member 30, and a control unit 70 which communicates with the lumen of the tube 60 and is located at the base end of the tube 60. In this embodiment, as shown in Figure 3, the control unit 70 has a connector portion to which a fluid injection device (syringe S) can be connected in order to inject gas into the expansion member 30. The connector portion may be configured by connecting a separate member to the first protrusion 71g of the control unit 70, to which a fluid injection device (syringe S) can be connected. In the injection member 50, "tip (tip side)" refers to the side toward which the fluid is directed towards the expansion member 30 (i.e., the tube 60 side), and "base (base side)" refers to the side toward which the fluid is discharged from the expansion member 30 (i.e., the first protrusion 71g side of the first valve body 71a). Furthermore, in the injection member 50, "long axis direction" refers to the direction of the axis extending in the longitudinal direction of the injection member 50 (the direction from the base end to the tip end).

[0045] The tube 60 constitutes the main body of the injection member 50. The tube 60 connects to the lumen of the expansion member 30, creating communication between the lumen of the expansion member 30 and the outside. As a result, the gas injected from the connector can flow into the expansion space 31 of the expansion member 30 via the control unit 70 and the tube 60. Furthermore, the gas contained in the expansion space 31 can be discharged to the outside by passing through the tube 60 and the control unit 70.

[0046] The tip of the tube 60 is connected to the expansion member 30, and the base end is connected to the control unit 70. The connection position of the tube 60 to the expansion member 30 is not particularly limited, as long as the lumen of the tube 60 is in communication with the expansion space 31 of the expansion member 30.

[0047] The control unit 70 controls the flow of gas through the lumen of the injection member 50. The control unit 70 has one end forming a connector or connected to a connector, and the other end connected to the tube 60. In this embodiment, as shown in Figure 3, the control unit 70 has a first protrusion 71g that functions as a connector. Therefore, the part of the control unit 70 other than the first protrusion 71g that forms the connector is located between the connector (first protrusion 71g) and the expansion member 30, and is connected to the tube 60 so as to communicate with the lumen of the tube 60.

[0048] The control unit 70 includes a first valve member 71, a second valve member 72 located on the tip side (towards the expansion member 30) of the first valve member 71, and a fluid storage section 73 located between the first valve member 71 and the second valve member 72. The first valve member 71 and the second valve member 72 are also provided with fixing and holding members 80 (first fixing and holding member 81, second fixing and holding member 82) for maintaining the closed state of each valve member 71, 72.

[0049] The first valve member 71 comprises a first valve body 71a located on the base end side of the injection member 50, and a second valve body 71b positioned opposite the first valve body 71a on the tip side in the longitudinal direction of the injection member 50. The first valve body 71a and the second valve body 71b are connected by a first connecting member 71c so that they can move relative to each other (towards and away from each other) along the longitudinal direction of the injection member 50. The first valve member 71 can be switched between an open state (a state in which gas can flow) and a closed state (a state in which the flow of gas is blocked) by the movement of the first valve body 71a and the second valve body 71b toward or away from each other. The first valve member 71 also includes a first fixed holding member 81 that holds the first valve body 71a and the second valve body 71b in close contact.

[0050] The first valve body 71a is made of a plate material with a first hole 71d that penetrates in the thickness direction and through which gas can flow. The first valve body 71a is disc-shaped and has a first projection 71g on its base end face in the thickness direction. The first projection 71g is, for example, cylindrical in shape with a lumen and extends towards the base end in the long axis direction of the injection member 50. In this embodiment, as described above, the first projection 71g is attached to the tip of a dedicated gas injection device such as a syringe S and functions as a "connector part" for injecting gas.

[0051] The second valve body 71b is made of a plate material having a second hole 71e that penetrates in the thickness direction and through which gas can flow. In this embodiment, the second valve body 71b is disc-shaped, similar to the first valve body 71a. The second hole 71e connects the first flow space 71f formed by the first connecting member 71c with the lumen of the fluid containment section 73.

[0052] Furthermore, the shapes of the first valve body 71a and the second valve body 71b are not limited to a disc shape; their shapes, when viewed from the long axis side, may be polygonal, such as a triangle or a quadrilateral.

[0053] Figure 4 shows an example of the arrangement of the first hole 71d provided in the first valve body 71a and the second hole 71e provided in the second valve body 71b. As shown in Figure 4A, the first hole 71d is positioned to communicate with the lumen of the first projection 71g, and is aligned with the position of the first projection 71g. The second hole 71e is positioned so as not to be in series with the first hole 71d. In the state shown in Figure 4A, the first valve member 71 is capable of allowing gas to flow. As shown in Figure 4B, when the end face of the first valve body 71a and the end face of the second valve body 71b are superimposed (i.e., when the first valve body 71a is projected onto the second valve body 71b), the first hole 71d and the second hole 71e are positioned at different locations. Therefore, when the first valve body 71a and the second valve body 71b are fixed together by the first fixing member 81 in a tightly packed state, the first hole 71d is blocked by the end face of the second valve body 71b, and the second hole 71e is blocked by the end face of the first valve body 71a, thereby blocking the flow of gas. In other words, in the state shown in Figure 4B, the first valve member 71 is in a state where gas cannot flow. In this way, the first valve member 71 allows control of gas flow by closing or opening the first hole 71d and the second hole 71e by bringing the first valve body 71a and the second valve body 71b closer together or further apart. Therefore, the first valve member 71 can easily switch between open and closed states with a simple configuration. Furthermore, the first hole 71d and the second hole 71e only need to be closed or open when at least the first valve body 71a and the second valve body 71b are in close contact, and the number of holes and the shape of the holes are not limited to the configuration shown in Figure 4.

[0054] The first connecting member 71c is made of a flexible film material and connects the first valve body 71a and the second valve body 71b so that they can move relative to each other along the long axis of the injection member 50. When the first connecting member 71c is joined to the first valve body 71a and the second valve body 71b, it forms a first flow space 71f between the first valve body 71a and the second valve body 71b, which is a sealed space through which gas can flow. Therefore, when gas flows between the first valve body 71a and the second valve body 71b, leakage from the first flow space 71f to the outside is prevented.

[0055] In this embodiment, the film material constituting the first connecting member 71c is joined to the vicinity of the outer peripheral end on the base side of the first valve body 71a and the vicinity of the outer peripheral end on the tip side of the second valve body 71b, as shown in Figure 3, for example. However, the joining position of the film material constituting the first connecting member 71c is not particularly limited as long as it is joined to the outer peripheral surfaces of the first valve body 71a and the second valve body 71b.

[0056] The second valve member 72 comprises a third valve body 72a located on the tip side of the injection member 50, and a fourth valve body 72b positioned opposite the third valve body 72a and on the base side in the longitudinal direction of the injection member 50. The third valve body 72a and the fourth valve body 72b are connected by a second connecting member 72c so as to be able to move relative to each other (towards and away from each other) along the longitudinal direction of the injection member 50. The second valve member 72 can be switched between an open state and a closed state by the movement of the third valve body 72a and the fourth valve body 72b towards or away from each other. The second valve member 72 also includes a second fixing and holding member 82 that holds the third valve body 72a and the fourth valve body 72b in close contact.

[0057] The third valve body 72a is made of a plate material with a third hole 72d through which gas can flow. The third valve body 72a is disc-shaped and has a second projection 72g on its end face at the tip in the thickness direction. The second projection 72g is, for example, cylindrical with a lumen and extends towards the tip in the long axis direction of the injection member 50. A tube 60 is connected to the second projection 72g. As a result, the control unit 70 is connected to the expansion member 30 via the tube 60 so that it can communicate with it.

[0058] The fourth valve body 72b is made of a plate material with a fourth hole 72e through which gas can flow. In this embodiment, the fourth valve body 72b is disc-shaped, similar to the third valve body 72a. The fourth hole 72e connects the second flow space 72f formed by the second connecting member 72c to the lumen of the fluid containment section 73.

[0059] Furthermore, the shapes of the third valve body 72a and the fourth valve body 72b are not limited to a disc shape, similar to the first valve body 71a and the second valve body 71b, and may be polygonal, such as a triangle or quadrilateral, when viewed from the long axis side.

[0060] Furthermore, as shown in Figure 4A, the third hole 72d is positioned to communicate with the lumen of the second projection 72g, and is aligned with the position of the second projection 72g. The fourth hole 72e is positioned so as not to be in series with the third hole 72d. In the state shown in Figure 4A, the second valve member 72 is capable of allowing gas to flow. As shown in Figure 4B, when the end face of the third valve body 72a and the end face of the fourth valve body 72b are superimposed (i.e., when the third valve body 72a is projected onto the fourth valve body 72b), the third hole 72d and the fourth hole 72e are positioned at different locations. Therefore, when the third valve body 72a and the fourth valve body 72b are fixed together by the second fixing member 82 in the same way as the first valve body 71a and the second valve body 71b, the third hole 72d is blocked by the end face of the fourth valve body 72b, and the fourth hole 72e is blocked by the end face of the third valve body 72a, thereby blocking the flow of gas. In other words, in the state shown in Figure 4B, the second valve member 72 is in a state where gas cannot flow. Thus, the second valve member 72 can control the flow of gas by closing or opening the third hole 72d and the fourth hole 72e by bringing the third valve body 72a and the fourth valve body 72b closer together or further apart. Therefore, the second valve member 72, like the first valve member 71, can easily switch between open and closed states with a simple configuration. Furthermore, the third hole 72d and the fourth hole 72e only need to be closed or open when at least the third valve body 72a and the fourth valve body 72b are in close contact, and the number of holes and the shape of the holes are not limited to the form shown in Figure 4.

[0061] The second connecting member 72c is made of a flexible film material and connects the third valve body 72a and the fourth valve body 72b so that they can move relative to each other along the long axis of the injection member 50. When the second connecting member 72c is joined to the third valve body 72a and the fourth valve body 72b, it forms a second flow space 72f between the third valve body 72a and the fourth valve body 72b, which is a sealed space through which gas can flow. Therefore, when gas flows between the third valve body 72a and the fourth valve body 72b, leakage from the second flow space 72f to the outside is prevented.

[0062] In this embodiment, the film material constituting the second connecting member 72c is joined to the vicinity of the outer peripheral end on the tip side of the third valve body 72a and the vicinity of the outer peripheral end on the base side of the fourth valve body 72b, as shown in Figure 3, for example. However, the joining position of the film material constituting the second connecting member 72c is not particularly limited as long as it is joined to the outer peripheral surfaces of the third valve body 72a and the fourth valve body 72b.

[0063] The fluid containment section 73 is located between the first valve member 71 and the second valve member 72 and is a sealable space that contains the gas flowing from the expansion member 30. When the second valve member 72 is operated in a predetermined manner, the gas contained in the expansion member 30 flows into the fluid containment section 73 due to the pressure difference created between the internal pressure of the expansion space 31 of the expansion member 30 and the internal pressure of the fluid containment section 73. The fluid containment section 73 has a volume capable of accommodating the amount of gas (amount of fluid to be discharged) to be degassed according to a predetermined degassing protocol. The volume of the fluid containment section 73 may be set appropriately according to the degassing protocol.

[0064] The fluid storage section 73 only needs to have a configuration that can accommodate a predetermined amount of gas. For this reason, the fluid storage section 73 may be a balloon type made of an expandable film material that is more flexible than the material of the main body (tube 60), or a tube type made of a flexible but non-expandable material. However, considering the operator's operability, it is preferable that the fluid storage section 73 be a balloon type whose outer shape can be expanded depending on the amount of fluid to be held, among the exemplified configurations. This is because, when the fluid storage section 73 is an expandable balloon type, its outer shape expands depending on the amount of fluid to be held, so that more gas can be contained in a smaller space compared to the tube type. By making the fluid storage section 73 an expandable balloon type, the size of the injection member 50 can be reduced, improving operability without hindering the operator's operation. In addition, by making the fluid storage section 73 expandable, the amount of gas that can be degassed at once (i.e., the amount of gas to be contained) can be increased, thus reducing the number of degassing operations. Furthermore, the fluid containment section 73, which uses expandable material, allows for adjustment of the degree of expansion (volume increase) before and after expansion by appropriately setting the composition or thickness of the material used.

[0065] Furthermore, by constructing the fluid containment section 73 from a flexible, expandable material, the distance between the first valve member 71 and the second valve member 72 along the longitudinal axis of the injection member 50 can be extended, thereby increasing the volume that can be contained. Figure 5 shows the fluid containment section 73 before and after extension. As shown in Figure 5A, in the state before extension, the fluid containment section 73 is contracted between the first valve member 71 and the second valve member 72. As shown in Figure 5B, when the operator moves the first valve member 71 away from the second valve member 72, the fluid containment section 73 extends by a predetermined length along the longitudinal axis of the injection member 50, widening the distance between the first valve member 71 and the second valve member 72. Note that the fluid containment section 73 is not limited to the contracted state shown in Figure 5A in the state before extension, and may be configured to maintain a predetermined distance between the first valve member 71 and the second valve member 72.

[0066] Furthermore, as shown in Figure 6, the fluid containment section 73 may also adopt a bellows structure as another form for extending the distance between the first valve member 71 and the second valve member 72 along the long axis direction of the injection member 50 (extending the distance between the first valve member 71 and the second valve member 72). As shown in Figure 6A, in its pre-extension state, the fluid containment section 73 is folded between the first valve member 71 and the second valve member 72. As shown in Figure 6B, when the operator moves the first valve member 71 away from the second valve member 72, the folded portion of the fluid containment section 73 unfolds and extends by a predetermined length along the long axis direction of the injection member 50.

[0067] As shown in Figures 5 and 6, the fluid containment section 73 has a configuration that allows the distance between the first valve member 71 and the second valve member 72 to be extended, thereby increasing the volume that can be contained in the fluid containment section 73. The hemostatic device 100 is generally degassed in predetermined amounts at predetermined intervals according to a decompression protocol. However, as the degassing operation continues, the internal pressure in the expansion member 30 may gradually decrease, and the predetermined amount of gas may no longer flow. Since the fluid containment section 73 has a configuration that allows the distance between the first valve member 71 and the second valve member 72 to be extended as described above, even if the amount of flow (degassing amount) in the expansion member 30 decreases, the distance between the first valve member 71 and the second valve member 72 can be extended to generate negative pressure in the fluid containment section 73. As a result, the hemostatic device 100 can forcibly degass (suction) a predetermined amount of gas from the expansion member 30, making it possible to perform degassing operations according to the decompression protocol. Furthermore, since the fluid storage section 73 has the configuration shown in Figures 5 and 6, it can be easily extended until the distance between the first valve member 71 and the second valve member 72 reaches a predetermined length. Therefore, it also has the function of increasing the volume that can be stored in the fluid storage section 73. As a result, the amount of gas that can be degassed at once in the fluid storage section 73 can be adjusted according to the distance (separation distance) between the first valve member 71 and the second valve member 72. Consequently, the operator can reduce the number of degassing operations by adjusting the amount of degassed stored in the fluid storage section 73 to exceed the amount of degassed specified by the decompression protocol.

[0068] Furthermore, the fluid containment section 73 can be constructed by combining the configurations shown in Figures 5 and 6 as appropriate. In other words, the fluid containment section 73 can be a bellows structure made of a flexible and expandable material.

[0069] The first valve member 71 includes a first fixed retaining member 81 that maintains a state in which the first valve body 71a and the second valve body 71b are in close contact. The second valve member 72 also includes a second fixed retaining member 82 that maintains a state in which the third valve body 72a and the fourth valve body 72b are in close contact.

[0070] The first fixing and holding member 81 holds the first valve body 71a and the second valve body 71b in close contact. As shown in Figures 7A to 7C, the first fixing and holding member 81 consists of a first engaging portion 81a provided on the outer peripheral end on the tip side of the first valve body 71a and a second engaging portion 81b provided on the outer peripheral end on the base side of the second valve body 71b.

[0071] The first engaging portion 81a is composed of, for example, a base portion 811a that protrudes toward the second valve body 71b from the outer peripheral end on the tip side of the first valve body 71a, and a claw portion 812a formed by bending the tip side of the base portion 811a in a direction perpendicular to the long axis direction of the injection member 50 to form a hook shape. The second engaging portion 81b is composed of, for example, a recess 811b provided on the outer peripheral end on the base side of the second valve body 71b that engages with the claw portion 812a.

[0072] As shown in Figure 7A, the first valve body 71a and the second valve body 71b are separated as shown when, for example, degassing gas contained in the fluid containment section 73 to the outside. After degassing the gas, when bringing the first valve body 71a and the second valve body 71b into close contact again, the first valve body 71a is brought close to the second valve body 71b, as shown in Figure 7B. At this time, the end faces of the first valve body 71a and the second valve body 71b are in close contact, but the first engaging portion 81a and the second engaging portion 81b are not yet engaged. Then, as shown in Figure 7C, the first valve body 71a (or the second valve body 71b) is moved relative to the second valve body 71b (or the first valve body 71a) in a direction perpendicular to the long axis of the injection member 50, thereby engaging the first engaging portion 81a and the second engaging portion 81b. As shown in Figure 7C, when the first engaging portion 81a and the second engaging portion 81b engage, the claw portion 812a becomes fitted with the recess 811b. As a result, the first valve body 71a and the second valve body 71b maintain a tight seal.

[0073] Furthermore, since the first fixing member 81 only needs to hold (fix) the first valve body 71a and the second valve body 71b in close contact, the structures of the first engaging portion 81a and the second engaging portion 81b may be swapped. Also, in the state before the first engaging portion 81a and the second engaging portion 81b engage, as shown in Figure 7A, a part of the first engaging portion 81a is in contact with a part of the second engaging portion 81b, but the first engaging portion 81a may be arranged so that a part of the first engaging portion 81a is not in contact with a part of the second engaging portion 81b.

[0074] The second fixing and holding member 82 holds the third valve body 72a and the fourth valve body 72b in close contact. As shown in Figures 8A to 8C, the second fixing and holding member 82 consists of a third engaging portion 82a provided on the outer peripheral end on the base end side of the third valve body 72a and a fourth engaging portion 82b provided on the outer peripheral end on the tip side of the fourth valve body 72b.

[0075] The third engaging portion 82a is composed of, for example, a base portion 821a that protrudes toward the fourth valve body 72b from the outer peripheral end on the base side of the third valve body 72a, and a claw portion 822a formed by bending the tip side of the base portion 821a in a direction perpendicular to the long axis direction of the injection member 50 to form a hook shape. The fourth engaging portion 82b is composed of, for example, a recess 821b provided on the outer peripheral end on the tip side of the fourth valve body 72b that engages with the claw portion 822a.

[0076] As shown in Figure 8A, when degassing gas from within the expansion member 30, for example, the third valve body 72a and the fourth valve body 72b are separated as shown. After a predetermined amount of gas has flowed into the fluid containment section 73, when bringing the third valve body 72a and the fourth valve body 72b into close contact again, the third valve body 72a is brought close to the fourth valve body 72b, as shown in Figure 8B. At this time, the end faces of the third valve body 72a and the fourth valve body 72b are in close contact, but the third engaging portion 82a and the fourth engaging portion 82b are not yet engaged. Then, as shown in Figure 8C, the third valve body 72a (or the fourth valve body 72b) is moved relative to the fourth valve body 72b (or the third valve body 72a) in a direction perpendicular to the long axis of the injection member 50, thereby engaging the third engaging portion 82a and the fourth engaging portion 82b. As shown in Figure 8C, when the third engaging portion 82a and the fourth engaging portion 82b engage, the claw portion 822a becomes fitted with the recess 821b. As a result, the third valve body 72a and the fourth valve body 72b maintain a tight seal.

[0077] Furthermore, since the second fixing member 82 only needs to hold (fix) the third valve body 72a and the fourth valve body 72b in close contact, the structures of the third engaging portion 82a and the fourth engaging portion 82b may be swapped. Also, in the state before the third engaging portion 82a and the fourth engaging portion 82b engage, as shown in Figure 8A, a part of the third engaging portion 82a is in contact with a part of the fourth engaging portion 82b, but the third engaging portion 82a may be arranged so that a part of the third engaging portion 82a is not in contact with a part of the fourth engaging portion 82b.

[0078] As described above, the first fixed holding member 81 holds the first valve body 71a and the second valve body 71b in close contact, maintaining the closed state of the first valve member 71 so as to block the flow of gas. The second fixed holding member 82 holds the third valve body 72a and the fourth valve body 72b in close contact, maintaining the closed state of the second valve member 72 so as to block the flow of gas.

[0079] The hemostatic device 100 includes a first fixing and holding member 81 that maintains the closed state of the first valve member 71, and a second fixing and holding member 82 that maintains the closed state of the second valve member 72. Therefore, when the hemostatic device 100 maintains the tight seal between the first valve body 71a and the second valve body 71b (the third valve body 72a and the fourth valve body 72b), the operator does not need to manually maintain the tight seal between the first valve body 71a and the second valve body 71b (the third valve body 72a and the fourth valve body 72b), nor does it need to maintain the tight seal between the first valve body 71a and the second valve body 71b (the third valve body 72a and the fourth valve body 72b) with a separate device such as a clip. Therefore, the hemostatic device 100 has a simple structure that ensures the closed state of the first valve member 71 and the second valve member 72 is reliably maintained, and even if it comes into contact with other surrounding objects (desk, bed, room wall, etc.), the closed state of the first valve member 71 and the second valve member 72 is not released due to the action of the first fixing member 81 and the second fixing member 82. Thus, the hemostatic device 100 can maintain an appropriate compressive force on the puncture site by the expansion member 30 without unintended degassing operations.

[0080] <Operation> Next, with reference to Figures 9 to 13, examples of the use of the hemostatic device 100 will be explained. Note that the following examples of use are merely illustrative and the order may be changed as appropriate, provided that it does not hinder the operation.

[0081] The hemostatic device 100 shown below is used with the band 10 wrapped around the wrist W, as shown in Figure 9. In addition, with the hemostatic device 100 in the attached state shown in Figure 9, the following operations are performed as appropriate: "injection operation (see Figures 10A to 10F)", "degassing operation (see Figures 11A to 11E)", "re-injection operation (see Figures 12A to 12C)", and "forced degassing operation (see Figures 13A to 13C)".

[0082] <Injection operation> The injection operation is an operation to inject a predetermined amount of gas into the expansion member 30. During the injection operation, the hemostatic device 100 is operated according to the procedure shown in Figures 10A to 10F as an example.

[0083] As shown in Figure 10A, in the state before the injection operation, the first valve member 71 and the second valve member 72 of the hemostatic device 100 are in a closed state.

[0084] As shown in Figure 10B, the operator first releases the tight seal between the first valve body 71a and the second valve body 71b of the first valve member 71, separating them. This causes the first valve member 71 to open, allowing gas to flow. Next, as shown in Figure 10C, the operator releases the tight seal between the third valve body 72a and the fourth valve body 72b of the second valve member 72, separating them. This causes the second valve member 72 to open, allowing gas to flow.

[0085] As shown in Figure 10D, the surgeon attaches a syringe S to the first protrusion 71g, which functions as a connector, and operates the plunger of the syringe S to inject an amount of gas corresponding to the volume of the expansion member 30. The injected gas flows through the first valve member 71, the fluid reservoir 73, the second valve member 72, and the tube 60 in that order, into the expansion member 30.

[0086] Once the gas injection into the expansion member 30 is complete, as shown in Figure 10E, the operator closes the third valve body 72a and the fourth valve body 72b to close the second valve member 72. As a result, the second valve member 72 is closed, and the gas injected into the expansion member 30 does not flow out to the outside through the injection member 50.

[0087] Subsequently, as shown in Figure 10F, the operator closes the first valve member 71 by bringing the first valve body 71a and the second valve body 71b into close contact, and then detaches the syringe S from the first protrusion 71g to complete the injection operation. As a result, the patient's puncture site is compressed by the expansion member 30, and hemostasis is initiated.

[0088] In addition, the hemostatic device 100 may have the first valve member 71 and the second valve member 72 in the open state before attaching the band 10 to the wrist W. In that case, as shown in Figure 9, the surgeon can omit the step of opening the first valve member 71 and the second valve member 72 after attaching the hemostatic device 100 to the patient, and as shown in Figure 10D, the surgeon can attach the syringe S to the first protrusion 71g which functions as a connector, and inject an amount of gas corresponding to the volume of the expansion member 30 by operating the plunger of the syringe S.

[0089] <Degassing operation (fluid discharge operation)> The degassing operation is an operation to degas a predetermined amount of gas from the expansion member 30 at predetermined intervals according to a predetermined decompression protocol. During the degassing operation, the hemostatic device 100 is operated according to the procedure shown in Figures 11A to 11E as an example.

[0090] As shown in Figure 11A, the operator separates the third valve body 72a and the fourth valve body 72b to open the second valve member 72. As a result, the gas contained in the expansion member 30 flows into the fluid containment section 73 due to the pressure difference between the internal pressure in the expansion member 30 and the internal pressure in the fluid containment section 73.

[0091] As shown in Figure 11B, the operator confirms that a predetermined amount of gas flows from the expansion member 30 into the fluid reservoir 73, causing the fluid reservoir 73 to expand and fill with gas. Then, as shown in Figure 11C, the third valve body 72a and the fourth valve body 72b are brought into close contact to close the second valve member 72. This blocks the flow of gas from the expansion member 30 to the fluid reservoir 73.

[0092] Subsequently, as shown in Figure 11D, the operator separates the first valve body 71a and the second valve body 71b to open the first valve member 71, thereby degassing the gas contained in the fluid reservoir 73 to the outside and completing the degassing operation. After the degassing operation is completed, as shown in Figure 11E, the operator brings the first valve body 71a and the second valve body 71b into close contact to close the first valve member 71.

[0093] <Re-injection operation> The re-injection operation is performed when it is determined that there is a large amount of gas to be released from the expansion member 30 based on the hemostatic state of the puncture site, and the gas temporarily stored in the fluid storage section 73 is returned to the expansion member 30. During the re-injection operation, the hemostatic device 100 is operated according to the procedure shown in Figures 12A to 12C as an example.

[0094] As shown in Figure 12A, the surgeon separates the third valve body 72a and the fourth valve body 72b to open the second valve member 72 and allow gas to be contained in the fluid containment section 73. This process is the same as the degassing operation shown in Figures 11A and 11B. At this point, if the surgeon determines that the patient's hemostasis is not satisfactory and that gas needs to be injected again, as shown in Figure 12B, the surgeon brings the first valve member 71 close to the second valve member 72 and begins reinjecting the gas contained in the fluid containment section 73.

[0095] Subsequently, as shown in Figure 12C, the operator brings the first valve member 71 closer to the second valve member 72 and injects the gas contained in the fluid reservoir 73. Then, the third valve body 72a and the fourth valve body 72b are brought into close contact to close the second valve member 72, thus ending the re-injection operation. As a result, the gas contained in the fluid reservoir 73 is injected again into the expansion member 30, and the internal pressure (degree of expansion) of the expansion member 30 returns to the state before the re-injection operation.

[0096] <Forced degassing operation (forced discharge operation of fluid)> The forced degassing operation is performed when it is determined that the amount of gas to be degassed from the expansion member 30 is less than the specified amount, in order to forcibly degass the gas inside the expansion member 30. During the forced degassing operation, the hemostatic device 100 is operated according to the procedure shown in Figures 13A to 13C as an example.

[0097] As shown in Figure 13A, repeated degassing operations can reduce the internal pressure of the expansion member 30, decreasing the pressure difference between the expansion member 30 and the fluid reservoir 73, which can reduce the amount of gas flowing into the fluid reservoir 73. If the operator determines that the amount of gas flowing from the expansion member 30 has fallen below a specified amount, as shown in Figure 13B, the operator separates the third valve body 72a and the fourth valve body 72b to open the second valve member 72, and in this state, further separates the first valve member 71 from the second valve member 72, extending the fluid reservoir 73 in the longitudinal direction. This generates negative pressure inside the fluid reservoir 73, allowing a predetermined amount of gas to be forcibly degassed from the expansion member 30.

[0098] Subsequently, as shown in Figure 13C, the operator closes the second valve member 72 by bringing the third valve body 72a and the fourth valve body 72b into close contact, then opens the first valve member 71 by separating the first valve body 71a and the second valve body 71b, thereby degassing the gas contained in the fluid reservoir 73 to the outside and ending the forced degassing operation.

[0099] [Differentiation] Next, modified examples of the hemostatic device 100 according to the present invention will be described. In Modified Examples 1 to 3 described below, the same reference numerals are used for constituent elements having the same function as in the previously described embodiment, and detailed descriptions are omitted. Configurations, members, and methods of use that are not specifically mentioned may be the same as in the previously described embodiment. Furthermore, the configuration of this embodiment and the configurations of Modified Examples 1 to 3 can be arbitrarily combined and implemented without departing from the spirit of the present invention.

[0100] Modifications 1 to 3 described below all show modified versions of the fixing and holding member 80 for maintaining the closed state of the first valve member 71 and the second valve member 72.

[0101] <Example 1> A modified example 1 of the hemostatic device 100 will be described with reference to Figures 14 and 15. In the hemostatic device 100 of Modified Example 1, the engagement configuration of the first fixing member 83 and the second fixing member 84 differs from that of the first fixing member 81 and the second fixing member 82 in the previously described embodiment. Figure 14 shows the first fixing member 83, which is a modified example of the configuration of the first fixing member 81, and Figure 15 shows the second fixing member 84, which is a modified example of the second fixing member 82.

[0102] In the hemostatic device 100 of the modified example 1, the first valve member 71 is equipped with a first fixing and holding member 83 that maintains a state in which the first valve body 71a and the second valve body 71b are in close contact, as shown in Figures 14A to 14C. The second valve member 72 is equipped with a second fixing and holding member 84 that maintains a state in which the third valve body 72a and the fourth valve body 72b are in close contact, as shown in Figures 15A to 15C.

[0103] The first fixing and holding member 83 holds the first valve body 71a and the second valve body 71b in close contact. As shown in Figures 14A to 14C, the first fixing and holding member 83 consists of a first engaging portion 83a provided on the outer peripheral end on the tip side of the first valve body 71a and a second engaging portion 83b provided on the outer peripheral end on the base side of the second valve body 71b.

[0104] The first engaging portion 83a engages with the second engaging portion 83b. The first engaging portion 83a is composed of, for example, a base portion 831a that protrudes toward the second valve body 71b from the outer peripheral end on the tip side of the first valve body 71a, and a claw portion 832a formed by bending the tip side of the base portion 831a in a direction perpendicular to the long axis direction of the injection member 50 to create a hook shape.

[0105] The second engaging portion 83b engages with the first engaging portion 83a. The second engaging portion 83b is provided, for example, along the outer peripheral end on the base end side of the second valve body 71b and is composed of a recessed groove comprising a first groove 831b that engages with the base portion 831a when engaged with the first engaging portion 83a, and a second groove 832b whose groove depth is deeper than that of the first groove 831b and engages with the claw portion 832a when engaged with the first engaging portion 83a. The second groove 832b has an insertion portion 833b into which the claw portion 832a is inserted. The second groove 832b also has a guide portion 834b that guides the movement of the claw portion 832a when the first valve body 71a is moved relative to the second valve body 71b (rotational movement along the circumferential direction) with respect to the second valve body 71b while the claw portion 832a is inserted into the insertion portion 833b. The insertion portion 833b extends in the thickness direction on the second valve body 71b, and the guide portion 834b extends for a predetermined length from the end portion (butt portion) of the insertion portion 833b along the outer circumference of the second valve body 71b.

[0106] Furthermore, it is preferable that the first valve body 71a and the second valve body 71b are arranged such that, before the first engaging portion 83a and the second engaging portion 83b engage, a state is maintained in which a part of the first engaging portion 83a abuts against a part of the second engaging portion 83b. This allows the operator to easily insert the claw portion 832a into the insertion portion 833b of the second groove portion 832b when engaging the first engaging portion 83a and the second engaging portion 83b.

[0107] Furthermore, in the modified example 1, it is preferable that the film material constituting the fluid containment section 73 is joined to the vicinity of the outer peripheral end on the base side of the first valve body 71a and the vicinity of the outer peripheral end on the tip side of the second valve body 71b, as shown in Figure 14A. This allows the film material to not interfere with the relative movement of the first valve body 71a and the second valve body 71b when engaging the first fixing and holding member 83, enabling smooth engagement.

[0108] As shown in Figure 14A, the first valve body 71a and the second valve body 71b are separated as shown when, for example, degassing gas contained in the fluid reservoir 73 to the outside. When bringing the first valve body 71a and the second valve body 71b into close contact again after degassing the gas, the first valve body 71a is brought close to the second valve body 71b, as shown in Figure 14B. At this time, the end faces of the first valve body 71a and the second valve body 71b are in close contact, and the claw portion 832a of the first engaging portion 83a is inserted into the insertion portion 833b of the second groove portion 832b of the second engaging portion 83b. In the state shown in Figure 14B, the first engaging portion 83a and the second engaging portion 83b are not yet engaged. Then, as shown in Figure 14C, the first valve body 71a is rotated relative to the second valve body 71b to engage the first engaging portion 83a and the second engaging portion 83b. As shown in Figure 14C, when the first engaging portion 83a and the second engaging portion 83b are engaged, the claw portion 832a engages with the guide portion 834b of the second groove portion 832b. As a result, the first valve body 71a and the second valve body 71b are engaged and maintain a tight seal.

[0109] Furthermore, since the first fixing member 83 only needs to hold (fix) the first valve body 71a and the second valve body 71b in close contact, the structures of the first engaging portion 83a and the second engaging portion 83b may be swapped. Also, in the state before the first engaging portion 83a and the second engaging portion 83b engage, as shown in Figure 14, a part of the first engaging portion 83a is in contact with a part of the second engaging portion 83b, but the first engaging portion 83a may be arranged so that a part of the first engaging portion 83a is not in contact with a part of the second engaging portion 83b. Moreover, the joining position of the film material constituting the fluid containment portion 73 to the first valve body 71a and the second valve body 71b is not limited to the vicinity of the outer peripheral end on the base end side of the first valve body 71a and the vicinity of the outer peripheral end on the tip side of the second valve body 71b, but can be any outer peripheral surface of the first valve body 71a and the second valve body 71b.

[0110] The second fixing member 84 holds the third valve body 72a and the fourth valve body 72b in close contact. As shown in Figures 15A to 15C, the second fixing member 84 consists of a third engaging portion 84a provided on the outer peripheral end on the tip side of the first valve body 71a and a fourth engaging portion 84b provided on the outer peripheral end on the base side of the second valve body 71b.

[0111] The third engaging portion 84a engages with the fourth engaging portion 84b. The third engaging portion 84a is composed, for example, of a base portion 841a that protrudes toward the fourth valve body 72b from the outer peripheral end on the base end side of the third valve body 72a, and a claw portion 842a formed by bending the tip side of the base portion 841a in a direction perpendicular to the long axis direction of the injection member 50 to create a hook shape.

[0112] The fourth engaging portion 84b engages with the third engaging portion 84a. The fourth engaging portion 84b is provided, for example, along the outer peripheral end on the tip side of the fourth valve body 72b and is composed of a recessed groove comprising a third groove 841b that engages with the base portion 841a when engaged with the third engaging portion 84a, and a fourth groove 842b whose groove depth is deeper than that of the third groove 841b and engages with the claw portion 842a when engaged with the third engaging portion 84a. The fourth groove 842b also has an insertion portion 843b into which the claw portion 842a is inserted. The fourth groove 842b also has a guide portion 844b that guides the movement of the claw portion 842a when the third valve body 72a is moved relative to the fourth valve body 72b (rotational movement along the circumferential direction) with respect to the fourth valve body 72b while the claw portion 842a is inserted into the insertion portion 843b. The insertion portion 843b extends in the thickness direction on the fourth valve body 72b, and the guide portion 844b extends for a predetermined length from the end portion (butt portion) of the insertion portion 843b along the outer circumference of the fourth valve body 72b.

[0113] Furthermore, it is preferable that the third valve body 72a and the fourth valve body 72b are positioned such that, before the third engaging portion 84a and the fourth engaging portion 84b engage, the tip of the claw portion 842a of the third engaging portion 84a remains in contact with a part of the fourth engaging portion 84b. This allows the operator to smoothly insert the claw portion 842a into the insertion portion 843b of the fourth groove portion 842b when engaging the third engaging portion 84a and the fourth engaging portion 84b.

[0114] Furthermore, in the modified example 1, it is preferable that the film material constituting the fluid containment section 73 is joined to the vicinity of the outer peripheral end on the tip side of the third valve body 72a and the vicinity of the outer peripheral end on the base side of the fourth valve body 72b, as shown in Figure 15A. This allows the film material to not interfere with the relative movement of the third valve body 72a and the fourth valve body 72b when engaging the second fixing and holding member 84, enabling smooth engagement.

[0115] As shown in Figure 15A, when degassing gas from, for example, the expansion member 30, the third valve body 72a and the fourth valve body 72b are separated as shown. After a predetermined amount of gas has flowed into the fluid containment section 73, when the third valve body 72a and the fourth valve body 72b are brought into close contact again, the third valve body 72a is brought close to the fourth valve body 72b, as shown in Figure 15B. At this time, the end faces of the third valve body 72a and the fourth valve body 72b are in close contact, and the claw portion 842a of the third engaging portion 84a is inserted into the insertion portion 843b of the fourth groove portion 842b of the fourth engaging portion 84b. In the state shown in Figure 15B, the third engaging portion 84a and the fourth engaging portion 84b are not yet engaged. Then, as shown in Figure 15C, the third valve body 72a is rotated relative to the fourth valve body 72b to engage the third engaging portion 84a and the fourth engaging portion 84b. As shown in Figure 15C, when the third engaging portion 84a and the fourth engaging portion 84b are engaged, the claw portion 842a engages with the guide portion 844b of the fourth groove portion 842b. As a result, the third valve body 72a and the fourth valve body 72b are engaged and maintain a tight seal.

[0116] Furthermore, since the second fixing member 84 only needs to hold (fix) the third valve body 72a and the fourth valve body 72b in close contact, the configurations of the third engaging portion 84a and the fourth engaging portion 84b may be swapped. Also, in the state before the third engaging portion 84a and the fourth engaging portion 84b engage, as shown in Figure 15, a part of the third engaging portion 84a is in contact with a part of the fourth engaging portion 84b, but the third engaging portion 84a may be arranged so that a part of the third engaging portion 84a is not in contact with a part of the fourth engaging portion 84b. Moreover, the joining position of the film material constituting the fluid containment portion 73 to the third valve body 72a and the fourth valve body 72b is not limited to the vicinity of the outer peripheral end on the tip side of the third valve body 72a and the vicinity of the outer peripheral end on the base side of the fourth valve body 72b, but can be any outer peripheral surface of the third valve body 72a and the fourth valve body 72b.

[0117] The hemostatic device 100 of Modified Example 1 has a configuration in which a first engaging portion 83a provided on the first valve body 71a and a second engaging portion 83b provided on the second valve body 71b are engaged by the relative rotational movement of the first valve body 71a and the second valve body 71b. Furthermore, the hemostatic device 100 of Modified Example 1 has a configuration in which a third engaging portion 84a provided on the third valve body 72a and a fourth engaging portion 84b provided on the fourth valve body 72b are engaged by the relative rotational movement of the third valve body 72a and the fourth valve body 72b. Therefore, in the hemostatic device 100 of Modified Example 1, the closed state of the first valve member 71 and the second valve member 72 is reliably maintained, and even if it comes into contact with other surrounding materials (desk, bed, room wall, etc.), the closed state of the first valve member 71 and the second valve member 72 is not released by the action of the first fixing member 83 and the second fixing member 84. Thus, in the hemostatic device 100 of Modified Example 1, unintended degassing operations do not occur, and the compressive force on the puncture site by the expansion member 30 can be appropriately maintained.

[0118] <Variation 2> Next, a modified example 2 of the hemostatic device 100 will be described with reference to Figure 16. The first fixing member 85 and the second fixing member 86 of the hemostatic device 100 in modified example 2 do not have a physical engagement form like the first fixing member 81 and the second fixing member 82 in the embodiment described above, or the first fixing member 83 and the second fixing member 84 in modified example 1, but rather an engagement form that utilizes magnetic force.

[0119] In the hemostatic device 100 of the modified example 2, the first fixing and holding member 85 has a configuration that maintains the close contact between the first valve body 71a and the second valve body 71b by magnetic force. The second fixing and holding member 86 has a configuration that maintains the close contact between the third valve body 72a and the fourth valve body 72b by magnetic force.

[0120] More specifically, as shown in Figure 16A, the first fixed retaining member 85 includes a first engaging portion 85a provided on the tip end face of the first valve body 71a, and a second engaging portion 85b provided on the base end face of the second valve body 71b at a position opposite to the first engaging portion 85a.

[0121] The first engaging portion 85a and the second engaging portion 85b are composed of magnetically connectable magnetic materials, such as magnetic materials or magnets, as an example. The material of the first engaging portion 85a can be appropriately selected depending on the form of the second engaging portion 85b. That is, if the second engaging portion 85b is composed of a magnetic material, the first engaging portion 85a may be composed of a magnet so as to be connectable to the second engaging portion 85b. Also, if the second engaging portion 85b is composed of a magnet, the first engaging portion 85a may be composed of a magnetic material or a magnet with a different magnetic pole from the second engaging portion 85b so as to be connectable to the second engaging portion 85b. Note that the number and shape of the first engaging portion 85a and the second engaging portion 85b are not particularly limited, as they only need to be magnetically connectable to each other.

[0122] As shown in Figure 16B, the second fixed retaining member 86 includes a third engaging portion 86a provided on the base end face of the third valve body 72a, and a fourth engaging portion 86b provided on the tip end face of the fourth valve body 72b at a position opposite to the third engaging portion 86a.

[0123] The third engaging portion 86a and the fourth engaging portion 86b are, for example, made of magnetically connectable magnetic materials such as magnetic bodies or magnets. The material of the third engaging portion 86a can be appropriately selected depending on the form of the fourth engaging portion 86b. That is, if the fourth engaging portion 86b is made of a magnetic body, the third engaging portion 86a may be made of a magnet so as to be connectable to the fourth engaging portion 86b. Also, if the fourth engaging portion 86b is made of a magnet, the third engaging portion 86a may be made of a magnetic body or a magnet with a different magnetic pole from the fourth engaging portion 86b so as to be connectable to the fourth engaging portion 86b. Note that the number and shape of the third engaging portion 86a and the fourth engaging portion 86b are not particularly limited, as long as they can be magnetically connected to each other.

[0124] As shown in Figure 16A, when the first valve body 71a and the second valve body 71b of the first valve member 71 are brought close together, a magnetic force acts on them, connecting the first engaging portion 85a and the second engaging portion 85b, and maintaining the closed state. Conversely, when the first valve body 71a and the second valve body 71b of the first valve member 71 are separated against the magnetic force, both the first hole 71d and the second hole 71e open, and the first valve member 71 becomes open. As shown in Figure 16B, when the third valve body 72a and the fourth valve body 72b of the second valve member 72 are brought close together, a magnetic force acts on them, connecting the third engaging portion 86a and the fourth engaging portion 86b, and maintaining the closed state. Furthermore, when the second valve member 72 separates the third valve body 72a and the fourth valve body 72b against the magnetic force, the third hole 72d and the fourth hole 72e both open, causing the second valve member 72 to be in an open state.

[0125] The hemostatic device 100 of the modified example 2 has a configuration in which the first engaging portion 85a and the second engaging portion 85b constituting the first fixing and holding member 85 are magnetically connected to maintain the closed state of the first valve member 71, and the third engaging portion 86a and the fourth engaging portion 86b constituting the second fixing and holding member 86 are magnetically connected to maintain the closed state of the second valve member 72. As a result, the configuration for maintaining the connected state of the first fixing and holding member 85 and the second fixing and holding member 86 is simple and not complicated, and switching between the open and closed states of the first valve member 71 and the second valve member 72 is also simple, requiring only a simple proximity and separation operation. Furthermore, in the hemostatic device 100 of Modified Example 2, the closed state of the first valve member 71 and the second valve member 72 is reliably maintained by the first fixing member 85 and the second fixing member 86. Therefore, even if it comes into contact with other surrounding objects (such as a desk, bed, or room wall), the closed state of the first valve member 71 and the second fixing member 86 will not be released due to the action of the first fixing member 85 and the second fixing member 86. Thus, the hemostatic device 100 of Modified Example 2 can maintain appropriate compression force on the puncture site by the expansion member 30 without unintended degassing operations.

[0126] <Variation 3> Next, a third modification of the hemostatic device 100 will be described with reference to Figure 17. The hemostatic device 100 of the third modification includes a third fixing and holding member 87, as illustrated in Figure 17, to maintain the closed state of the first valve member 71 and the second valve member 72. Figure 17 shows a configuration in which multiple (two in the figure) third fixing and holding members 87 are provided for the first valve member 71.

[0127] The fixing and holding members 80 (first fixing and holding members 81, 83, and 85, and second fixing and holding members 82, 84, and 86) shown in the above-described embodiments, modified example 1, and modified example 2 are composed of members that engage with each other with different shapes or properties for each of the two valve bodies constituting the first valve member 71 (or second valve member 72). In contrast, the third fixing and holding member 87 shown in modified example 3 is configured to hold the two valve bodies constituting the first valve member 71 (or second valve member 72) with a single member.

[0128] As shown in Figures 17A and 17B, the third fixing and holding member 87 is rotatably mounted on the outer circumferential surface of the second valve body 71b around a support shaft 87a that is perpendicular to the long axis direction of the injection member 50. The third fixing and holding member 87 includes a base portion 87b that is rotatably supported with respect to the support shaft 87a, and a hook-shaped claw portion 87c provided on the tip side of the base portion 87b that abuts against the end face on the base end side of the first valve body 71a.

[0129] Multiple (two) third fixing and holding members 87 are provided on the outer circumferential surface of the second valve body 71b. Because multiple third fixing and holding members 87 are provided, multiple points on the end face of the first valve body 71a are fixed to the first valve member 71, allowing it to stably maintain a closed state.

[0130] The third fixing member 87 can move its claw portion 87c closer to or further away from the first valve member 71 by rotating around the pivot shaft 87a. When opening the first valve body 71a and the second valve body 71b, the base portion 87b is rotated so that the claw portion 87c is separated from the first valve body 71a, as shown in Figure 17A, to release the engagement. As a result, the first valve body 71a is not restricted in its movement by the third fixing member 87, and can therefore be moved closer to or further away from the second valve body 71b.

[0131] To maintain the closed state of the first valve body 71a and the second valve body 71b, as shown in Figure 17B, the base portion 87b is rotated so that the claw portion 87c is brought close to the first valve body 71a, and the claw portion 87c is hooked onto the end face on the base side of the first valve body 71a and engaged. Since the movement of the first valve body 71a is restricted by the engagement of the claw portion 87c with its end face, the tightly closed state of the first valve body 71a and the second valve body 71b is maintained.

[0132] In the embodiment shown in Figure 17, the third fixing member 87 is rotatably mounted on the second valve body 71b, but it may also be rotatably supported on the first valve body 71a. Furthermore, although the embodiment shown in Figure 17 has multiple third fixing members 87 mounted on the first valve member 71, it can perform its function with just one. Moreover, when multiple third fixing members 87 are provided, it is preferable to arrange them at equal intervals in the circumferential direction of the first valve member 71 so that they are applied evenly to the end face of the first valve body 71a. This ensures that the fixing positions of the third fixing members 87 are evenly distributed with respect to the circumferential direction of the first valve body 71a, and the closed state of the first valve member 71 can be held more stably.

[0133] Although not shown in the figures, the third fixing and holding member 87 can also be provided on the second valve member 72. By providing the third fixing and holding member 87 on the fourth valve body 72b (or the third valve body 72a), the closed state of the second valve member 72 can be maintained, similar to the first valve member 71.

[0134] The hemostatic device 100 of Modified Example 3 is equipped with a third fixing and holding member 87 that is rotatably supported on a pivot shaft 87a perpendicular to the longitudinal axis of the injection member 50, with respect to the first valve member 71 and the second valve member 72, and has a configuration that holds the first valve member 71 and the second valve member 72 in a closed state. Therefore, when switching between the open and closed states of the first valve member 71 and the second valve member 72, the third fixing and holding member 87 is rotated in a predetermined direction to engage or disengage the claw portion 87c, making the switching operation simple. Furthermore, in the hemostatic device 100 of Modified Example 3, since the closed state of the first valve member 71 and the second valve member 72 is reliably held by the third fixing and holding member 87, even if it comes into contact with other surrounding objects (desk, bed, room wall, etc.), the closed state of the first valve member 71 and the second valve member 72 will not be released due to the action of the third fixing and holding member 87. Therefore, the hemostatic device 100 of the modified example 3 can maintain appropriate compression force on the puncture site by the expansion member 30 without unintended degassing operations.

[0135] [Effects and Effects] As described above, the hemostatic device 100 according to this embodiment includes an expansion member 30 configured to compress the patient's puncture site, a band 10 and hook-and-loop fastener 20 that function as fixing members configured to fix the expansion member 30 to the patient's puncture site, and an injection member 50 configured to inject gas (fluid) into the lumen of the expansion member 30. The injection member 50 also includes a connector portion (first protrusion 71g) for injecting gas, a tube 60 connecting the connector portion and the lumen of the expansion member 30, and a control unit 70 that controls the flow of gas through the lumen of the injection member 50. The control unit 70 includes a first valve member 71, a second valve member 72 located on the expansion member 30 side of the first valve member 71, and a fluid storage portion 73 located between the first valve member 71 and the second valve member 72.

[0136] The hemostatic device 100 includes an injection member 50 which includes a control unit 70 having a first valve member 71, a second valve member 72, and a fluid reservoir 73 located between the first valve member 71 and the second valve member 72. The control unit 70 can operate the first valve member 71 and the second valve member 72 to store a predetermined amount of gas in the fluid reservoir 73 and to reinject the gas stored in the fluid reservoir 73 into the expansion member 30. In other words, the control unit 70 has the same function as a dedicated instrument such as a syringe S for degassing and reinjecting gas into the expansion member 30. Therefore, when the surgeon depressurizes the expansion member 30, they can operate the open and closed states of the first valve member 71 and the second valve member 72 to allow a portion of the fluid stored in the expansion member 30 to flow into the fluid reservoir 73, thereby discharging fluid from the expansion member 30. Furthermore, when reinjecting fluid into the expansion member 30, the surgeon can inject fluid into the expansion member 30 by operating the opening and closing states of the first valve member 71 and the second valve member 72, thereby allowing a predetermined amount of fluid contained in the fluid storage section 73 to flow into the expansion member 30. In this way, the hemostatic device 100 allows for depressurization and fluid reinjection operations on the expansion member 30 with simple operations, without the need to use a separate, dedicated device. Therefore, the hemostatic device 100 can reduce the effort required for the surgeon to perform degassing and reinjection operations on the expansion member 30.

[0137] Furthermore, in the hemostatic device 100 according to this embodiment, the following configuration may be preferred. That is, the fluid storage portion 73 may be made of a material that is more flexible than the material of the tube 60, and the fluid storage portion 73 may be configured so that its outer shape can be expanded when fluid is held in the fluid storage portion 73.

[0138] The fluid storage section 73 only needs to be able to accommodate a predetermined amount of fluid, so for example, a tube-type configuration made of a material that does not have expansion capabilities can be adopted. However, if such a tube-type configuration is adopted, a certain size (length, inner diameter) is required to accommodate a predetermined amount of gas, and the injection member 50 may become long in the longitudinal direction, which may hinder degassing operations. In contrast, since the hemostatic device 100 has an expandable fluid storage section 73, the longitudinal length of the injection member 50 can be shortened, allowing a predetermined amount of gas to be accommodated in a small space, which does not interfere with degassing operations and improves operability. In addition, since the amount of gas that can be degassed at once can be adjusted by expanding the fluid storage section 73, the number of degassing operations can be reduced. Furthermore, since the fluid storage section 73 is made of a material that is more flexible than the material of the tube 60, the amount of gas that can be accommodated in the fluid storage section 73 can be temporarily increased by widening the distance between the first valve member 71 and the second valve member 72. As a result, the amount of gas that can be degassed at once in the fluid containment section 73 can be adjusted, thus reducing the number of degassing operations required.

[0139] Furthermore, the hemostatic device 100 according to this embodiment may preferably have the following configuration. That is, the fluid containment section 73 may have a bellows structure that can extend the distance between the first valve member 71 and the second valve member 72 along the longitudinal direction (long axis direction) of the control unit 70.

[0140] Because the fluid containment section 73 has a bellows structure, the first valve member 71 or the second valve member 72 can be easily extended by pulling them along the longitudinal direction of the control unit 70 until the distance between the first valve member 71 and the second valve member 72 reaches a predetermined length. Therefore, when the surgeon performs a degassing operation on the expansion member 30, the amount of gas that can be contained in the fluid containment section 73 can be easily adjusted. In addition, when the amount of fluid flowing from the expansion member 30 decreases, the fluid containment section 73 can expand its bellows structure to increase the distance between the first valve member 71 and the second valve member 72, thereby generating negative pressure within the fluid containment section 73. Therefore, the hemostatic device 100 can forcibly degass a predetermined amount of gas from the expansion member 30, and can continuously discharge a predetermined amount of gas from the expansion member 30 according to a decompression protocol, without being affected by the internal pressure of the expansion member 30.

[0141] Furthermore, the hemostatic device 100 according to this embodiment may preferably have the following configuration. That is, the first valve member 71 may include a first valve body 71a having a first hole 71d, a second valve body 71b having a second hole 71e and positioned opposite to the first valve body 71a, and a deformable first connecting member 71c connecting the first valve body 71a and the second valve body 71b. Also, the second valve member 72 may include a third valve body 72a having a third hole 72d, a fourth valve body 72b having a fourth hole 72e and positioned opposite to the third valve body 72a, and a deformable second connecting member 72c connecting the third valve body 72a and the fourth valve body 72b. Furthermore, the first hole 71d may be positioned differently from the second hole 71e when the end face of the first valve body 71a is projected onto the end face of the second valve body 71b, and the third hole 72d may be positioned differently from the fourth hole 72e when the end face of the third valve body 72a is projected onto the end face of the fourth valve body 72b.

[0142] With this configuration, when the first valve member 71 is brought into close contact with the first valve body 71a and the second valve body 71b, the first hole 71d and the second hole 71e are closed, resulting in a closed state. When the first valve body 71a and the second valve body 71b are separated, the first hole 71d and the second hole 71e are opened, resulting in an open state. Similarly, when the third valve body 72a and the fourth valve body 72b are brought into close contact with the second valve member 72, the third hole 72d and the fourth hole 72e are closed, resulting in a closed state. When the third valve body 72a and the fourth valve body 72b are separated, the third hole 72d and the fourth hole 72e are opened, resulting in an open state. Therefore, the operator does not need to perform complex operations and can switch the open and closed states of the first valve member 71 and the second valve member 72 with simple operations. Therefore, the hemostatic device 100 can further reduce the effort required of the surgeon to perform degassing and reinjection operations on the expansion member 30.

[0143] Furthermore, the hemostatic device 100 according to this embodiment may preferably have the following configuration. That is, the first valve member 71 may include a first fixing and holding member 81, 83, or 85 that maintains a state in which the first valve body 71a and the second valve body 71b are in close contact, and the second valve member 72 may include a second fixing and holding member 82, 84, 86, or 84 that maintains a state in which the third valve body 72a and the fourth valve body 72b are in close contact.

[0144] Since the first valve member 71 is equipped with a first fixing and holding member 81 and the second valve member 72 is equipped with a second fixing and holding member 82, the closed state of the first valve member 71 and the second valve member 72 can be maintained. Therefore, when the hemostatic device 100 maintains the closed state of the first valve member 71 and the second valve member 72, the operator does not need to manually maintain the tight seal between the first valve body 71a and the second valve body 71b (third valve body 72a and fourth valve body 72b), nor does it need to maintain the tight seal between the first valve body 71a and the second valve body 71b (third valve body 72a and fourth valve body 72b) with a separate device such as a clip. Therefore, the hemostatic device 100 has a simple structure that ensures the closed state of the first valve member 71 and the second valve member 72 is reliably maintained, and even if it comes into contact with other surrounding objects (desk, bed, room wall, etc.), the closed state of the first valve member 71 and the second valve member 72 is not released due to the action of the first fixing member 81 and the second fixing member 82. Thus, the hemostatic device 100 can maintain an appropriate compressive force on the puncture site by the expansion member 30 without unintended degassing operations.

[0145] Furthermore, the hemostatic device 100 according to this embodiment may preferably have the following configuration. That is, the first fixing and holding member 81 (or 83) may include a first engaging portion 81a (or 83a) provided at the end of the first valve body 71a facing the second valve body 71b, and a second engaging portion 81b (or 83b) provided at the end of the second valve body 71b facing the first valve body 71a and engaging with the first engaging portion 81a (or 83a). Also, the second fixing and holding member 82 (or 84) may include a third engaging portion 82a (or 84a) provided at the end of the third valve body 72a facing the fourth valve body 72b, and a fourth engaging portion 82b (or 84b) provided at the end of the fourth valve body 72b facing the third valve body 72a and engaging with the third engaging portion 82a (or 84a). Furthermore, the first engaging portion 81a (or 83a) and the second engaging portion 81b (or 83b) may be configured to engage by relative movement between the first valve body 71a and the second valve body 71b while the first valve body 71a and the second valve body 71b are in close contact, and the third engaging portion 82a (or 84a) and the fourth engaging portion 82b (or 84b) may be configured to engage by relative movement between the third valve body 72a and the fourth valve body 72b while the third valve body 72a and the fourth valve body 72b are in close contact.

[0146] The hemostatic device 100 includes a first engaging portion 81a (or 83a) and a second engaging portion 81b (or 83b) that engage the first valve body 71a and the second valve body 71b by moving them relative to each other while keeping them in close contact, in order to maintain the closed state of the first valve member 71. The hemostatic device 100 also includes a third engaging portion 82a (or 84a) and a fourth engaging portion 82b (or 84b) that engage the third valve body 72a and the fourth valve body 72b by moving them relative to each other while keeping them in close contact, in order to maintain the closed state of the second valve member 72. Therefore, the surgeon can reliably maintain the closed state of the first valve member 71 or the second valve member 72 with a simple operation of moving the first valve body 71a and the second valve body 71b relative to each other, or the third valve body 72a and the fourth valve body 72b relative to each other. Therefore, even if the hemostatic device 100 comes into contact with other surrounding materials (such as a desk, bed, or room wall), the action of the first fixing member 81 (or 83) and the second fixing member 82 (or 84) prevents the first valve member 71 and the second valve member 72 from being released. Thus, the hemostatic device 100 can maintain appropriate compression force on the puncture site by the expansion member 30 without unintended degassing operations.

[0147] Furthermore, the hemostatic device 100 according to this embodiment may preferably have the following configuration. That is, the first fixing and holding member 85 may include a first engaging portion 85a made of magnetic material provided on the end face of the first valve body 71a facing the second valve body 71b, and a second engaging portion 85b made of magnetic material provided on the end face of the second valve body 71b facing the first valve body 71a and magnetically connected to the first engaging portion 85a. Also, the second fixing and holding member 86 may include a third engaging portion 86a made of magnetic material provided on the end face of the third valve body 72a facing the fourth valve body 72b, and a fourth engaging portion 86b made of magnetic material provided on the end face of the fourth valve body 72b facing the third valve body 72a and magnetically connected to the third engaging portion 86a.

[0148] In the hemostatic device 100, the first valve member 71 is equipped with a first fixing and holding member 85 consisting of a magnetically connectable first engaging portion 85a and a second engaging portion 85b, and the second valve member 72 is equipped with a second fixing and holding member 86 consisting of a magnetically connectable third engaging portion 86a and a fourth engaging portion 86b. Therefore, when switching the open and closed states of the first valve member 71 and the second valve member 72 in the hemostatic device 100, the closed state of the first valve member 71 is maintained simply by moving the first valve body 71a and the second valve body 71b closer together and further apart, and the closed state of the second valve member 72 is maintained simply by moving the third valve body 72a and the fourth valve body 72b closer together and further apart. Thus, the hemostatic device 100 can control the flow of gas with a simple configuration. Furthermore, since the hemostatic device 100 is equipped with a first fixing member 85 and a second fixing member 86, even if it comes into contact with other surrounding objects (such as a desk, bed, or room wall), the first fixing member 85 and the second fixing member 86 will prevent the first valve member 71 and the second valve member 72 from being released from their closed state. Therefore, the hemostatic device 100 can maintain an appropriate compressive force on the puncture site by the expansion member 30 without unintended degassing operations.

[0149] This application is based on Japanese Patent Application No. 2020-178745, filed on 26 October 2020, the disclosures of which are cited in their entirety by reference. [Explanation of symbols]

[0150] 10. Bands, 11 belts, 12 support plate; 20 hook-and-loop fasteners (21 male side, 22 female side), 30 extension members, 31. Extended space, 40 markers, 50 injection members, 60 tubes, 70 Control unit, 71 First valve member (71a First valve body, 71b Second valve body, 71c First connecting member, 71d First hole, 71e Second hole, 71f First flow space, 71g First protrusion), 72 Second valve member (72a Third valve body, 72b Fourth valve body, 72c Second connecting member, 72d Third hole, 72e Fourth hole, 72f Second flow space, 72g Second protrusion), 73 Fluid containment section, 80 Fixing and holding member, 81, 83, 85 First fixing and holding members (81a, 83a, 85a First engaging portion, 81b, 83b, 85b Second engaging portion), 82, 84, 86 Second fixing and holding members (82a, 84a, 86a Third engaging portion, 82b, 84b, 86b Fourth engaging portion), 87 Third fixed holding member, 100 Hemostatic devices, R radial artery, S syringe, W wrist.

Claims

1. An expansion member configured to compress the patient's puncture site, A fixing member configured to fix the expansion member to the puncture site of the patient, The expansion member comprises an injection member configured to be able to inject fluid into the lumen of the expansion member, The injection member comprises a connector portion for connecting a fluid injection device, a main body portion connecting the connector portion and the lumen of the expansion member, and a control unit connected between the connector portion and the main body portion without branching from the main body portion, and controlling the flow of the fluid passing through the lumen of the injection member. The control unit comprises a first valve member, a second valve member located on the expansion member side of the first valve member, and a fluid storage portion located between the first valve member and the second valve member. A hemostatic device wherein the fluid receiving portion is compressed in the longitudinal direction, thereby allowing fluid to flow between it and the expansion member and to be reinjected into the expansion member.

2. The hemostatic device according to claim 1, wherein the fluid containment portion is further extended in the longitudinal direction to generate negative pressure inside, thereby forcibly discharging the fluid in the expanded member.

3. The hemostatic device according to claim 1 or 2, wherein the fluid reservoir is made of a material that is more flexible than the material of the main body, and the outer shape of the fluid reservoir can be expanded when the fluid is held in the fluid reservoir.

4. The hemostatic device according to any one of claims 1 to 3, wherein the fluid containment section has a bellows structure that allows the distance between the first valve member and the second valve member to be extended along the longitudinal direction of the control unit.

5. The first valve member comprises a first valve body having a first hole, a second valve body having a second hole and positioned opposite to the first valve body, and a deformable first connecting member connecting the first valve body and the second valve body. The second valve member comprises a third valve body having a third hole, a fourth valve body having a fourth hole and positioned opposite the third valve body, and a deformable second connecting member connecting the third valve body and the fourth valve body. The first hole is positioned differently from the second hole when the end face of the first valve body is projected onto the end face of the second valve body. The hemostatic device according to any one of claims 1 to 4, wherein the third hole is positioned differently from the fourth hole when the end face of the third valve body is projected onto the end face of the fourth valve body.

6. The first valve member includes a first fixed holding member that maintains the first valve body and the second valve body in a tightly closed state. The hemostatic device according to claim 5, wherein the second valve member comprises a second fixing and holding member that maintains the third valve body and the fourth valve body in close contact.

7. The first fixing and holding member comprises a first engaging portion provided at the end of the first valve body facing the second valve body, and a second engaging portion provided at the end of the second valve body facing the first valve body and engaging with the first engaging portion. The second fixing and holding member comprises a third engaging portion provided at the end of the third valve body facing the fourth valve body, and a fourth engaging portion provided at the end of the fourth valve body facing the third valve body and engaging with the third engaging portion. The first engaging portion and the second engaging portion engage by the relative movement of the first valve body and the second valve body while the first valve body and the second valve body are in close contact. The hemostatic device according to claim 6, wherein the third engaging portion and the fourth engaging portion are configured to engage by relative movement between the third valve body and the fourth valve body while the third valve body and the fourth valve body are in close contact.

8. The first fixed holding member comprises a first engaging portion made of magnetic material provided on the end face of the first valve body facing the second valve body, and a second engaging portion made of magnetic material provided on the end face of the second valve body facing the first valve body and magnetically connected to the first engaging portion. The hemostatic device according to claim 6, wherein the second fixing and holding member comprises a third engaging portion made of a magnetic material provided on the end face of the third valve body facing the fourth valve body, and a fourth engaging portion made of a magnetic material provided on the end face of the fourth valve body facing the third valve body and magnetically connected to the third engaging portion.

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