Hemostatic device

Abstract

Provided is a hemostatic device capable of performing a decompression operation of an expansion member and a re-injection operation of fluid to the expansion member with simple operations without using a separate dedicated device relative to the hemostatic device. A hemostatic device (100) includes an expansion member (30) configured to compress a puncture site of a patient; a belt (10) and a hook-and-loop fastener (20) functioning as a fixing member configured to fix the expansion member (30) to the puncture site of the patient; and an injection member (50) configured to be able to inject gas (fluid) into a lumen of the expansion member (30), the injection member (50) including a connector portion (first protruding portion (71g)) for injecting the gas, a main body portion including a tube (60) connecting the connector portion and the lumen of the expansion member (30), and a control portion (70) controlling the flow of the gas passing through the lumen of the injection member (50), the control portion (70) including a first valve member (71), a second valve member (72) located on the expansion member (30) side compared to the first valve member (71), and a fluid storage portion (73) located between the first valve member (71) and the second valve member (72).

Description

Technical Field

[0001] This invention relates to a hemostatic device for applying pressure to a patient's puncture site to stop bleeding. Background Technology

[0002] In recent years, percutaneous treatments / examinations have involved puncturing blood vessels in the arm or leg, inserting a guiding sheath into the puncture site, and then delivering a catheter or other medical device to the lesion through the lumen of the guiding sheath. During such treatments / examinations, the practitioner (hereinafter referred to as "the practitioner") sometimes needs to stop bleeding at the puncture site after the guiding sheath is removed. To achieve this hemostasis, a hemostatic device is known, comprising a band for wrapping around a limb such as the arm or leg, a fixing unit for securing the band while wrapped around the limb, and an expansion component connected to the band and expanded by injecting fluid to compress the puncture site.

[0003] In such hemostatic devices, if the dilating component continuously and forcefully compresses the puncture site and surrounding blood vessels or nerves over a prolonged period, there is a possibility of causing numbness or pain, or even vascular blockage. To prevent vascular blockage, the practitioner typically performs a decompression procedure after dilating the component, periodically connecting a syringe or other specialized instrument to the hemostatic device and draining the fluid from the dilating component according to a prescribed decompression protocol. This reduces the pressure applied to the puncture site over time.

[0004] However, the need to periodically connect specialized instruments such as syringes to hemostatic devices in such procedures may increase the practitioner's workload and time. Furthermore, during decompression procedures, there is a possibility that if the specialized instrument is lost, the decompression of the dilator cannot be performed.

[0005] Patent Document 1 discloses a hemostatic device that, during decompression operations of an expansion member, includes a pressure adjustment unit connected to the expansion member to facilitate decompression adjustment without the use of specialized instruments such as syringes. The pressure adjustment unit comprises a main container having multiple fluid passage holes connected to and communicating with the expansion member for drawing out a portion of the fluid contained within the expansion member. Furthermore, the pressure adjustment unit includes a sliding member mounted on the main container and moving along the main container from a state of blocking the fluid passage holes to opening them in multiple stages, and a movable body moving within the main container and sequentially blocking air passage holes opened through the sliding member in multiple stages. In the hemostatic device of Patent Document 1, when compressing the site of hemostasis on a limb, the practitioner can easily adjust the pressure on any site requiring hemostasis according to the patient's condition, reducing the practitioner's effort and time in adjusting the pressure.

[0006] Existing technical documents

[0007] Patent documents

[0008] Patent Document 1: International Publication No. 2015 / 199024 Summary of the Invention

[0009] The problem that the invention aims to solve

[0010] The hemostatic device described in Patent Document 1 has a pressure adjustment section for adjusting the decompression of the dilator, so the decompression amount can be adjusted according to the patient's condition even without using a special device such as a syringe. However, the pressure adjustment section is composed of other components that branch off from the injection section which communicates with the dilator, so there is a possibility that it may become an obstacle when operating the hemostatic device.

[0011] Furthermore, the hemostatic device described in Patent Document 1 also performs a re-injection of fluid based on the hemostatic status of the puncture site during decompression. However, in the hemostatic device of Patent Document 1, a special instrument such as a syringe must be used to re-inject the fluid. As mentioned above, considering the operator's operability, the hemostatic device of Patent Document 1 has room for improvement in its construction regarding the decompression operation of the dilation component and the re-injection of fluid.

[0012] At least one embodiment of the present invention was made in view of the above-mentioned problems, and its object is to provide a hemostatic device that does not require a special device separate from the hemostatic device, can perform decompression operation of the dilator and re-injection of fluid into the dilator with simple operation, and can reduce the labor and time of the operator in decompression operation and re-injection operation.

[0013] Solution for solving the problem

[0014] The hemostatic device of this embodiment includes: an expansion member configured to compress the patient's puncture site; a fixing member configured to fix the expansion member to the patient's puncture site; and an injection member configured to inject fluid into the cavity of the expansion member. The injection member includes a connector portion for injecting the fluid, a main body portion connecting the connector portion to the cavity of the expansion member, and a control portion for controlling the flow of the fluid passing through the cavity of the injection member. The control portion includes a first valve member, a second valve member located on the expansion member side compared to the first valve member, and a fluid receiving portion located between the first valve member and the second valve member.

[0015] Invention Effects

[0016] According to at least one embodiment of the present invention, after the operator injects fluid into the dilator, the operator can easily perform decompression and re-injection operations on the dilator, thus reducing the labor and time required for these operations. The injection component of the hemostatic device includes a control unit with a first valve component, a second valve component, and a fluid receiving portion located between the first and second valve components. By operating the first and second valve components, the control unit can receive a predetermined amount of fluid in the fluid receiving portion and re-inject gas contained in the fluid receiving portion into the dilator. That is, by receiving a predetermined amount of gas in the fluid receiving portion, the control unit can either release a predetermined amount of gas from the dilator or re-inject a predetermined amount of gas into the dilator. Therefore, by operating the opening and closing states of the first and second valve components during decompression of the dilator, the operator can cause a portion of the fluid contained in the dilator to flow into the fluid receiving portion, thereby allowing fluid to be discharged from the dilator. Furthermore, when the practitioner re-injects fluid into the dilator, they operate the opening and closing states of the first and second valve components to allow a predetermined amount of fluid contained in the fluid receiving section to flow into the dilator, thereby enabling fluid injection into the dilator. In this way, the hemostatic device of the present invention does not require a separate, specialized instrument for hemostasis, and allows for simple operation of decompression of the dilator and re-injection of fluid. Therefore, the hemostatic device of the present invention reduces the labor and time required for the practitioner in the operation of draining and re-injecting the dilator. Attached Figure Description

[0017] Figure 1 This is a plan view showing the structure of the hemostatic device according to this embodiment.

[0018] Figure 2 It is along Figure 1 A rough cross-sectional view of the XX line.

[0019] Figure 3 This is a magnified partial cross-sectional view of the periphery of the injection component in the hemostatic device of this embodiment.

[0020] Figure 4A This diagram shows the state in which the first valve core (third valve core) and the second valve core (fourth valve core) of the first valve component (second valve component) constituting the hemostatic device of this embodiment are separated.

[0021] Figure 4B This is a conceptual diagram showing the state in which the first valve core (third valve core) and the second valve core (fourth valve core) of the first valve component (second valve component) constituting the hemostatic device of this embodiment are in close contact.

[0022] Figure 5AThis is one embodiment of the fluid receiving section of the hemostatic device, and the diagram shows the state before the fluid receiving section is extended.

[0023] Figure 5B This is one embodiment of the fluid receiving section of the hemostatic device, and the diagram shows the state after the fluid receiving section has been extended.

[0024] Figure 6A This is another embodiment of the fluid receiving portion of the hemostatic device, and is a diagram showing the state before the fluid receiving portion is extended.

[0025] Figure 6B This is another embodiment of the fluid receiving portion of the hemostatic device, and the diagram shows the state after the fluid receiving portion has been extended.

[0026] Figure 7A This diagram shows the state of the first fixing and retaining member of the hemostatic device of this embodiment before it is engaged.

[0027] Figure 7B This diagram shows the state of the first retaining member of the hemostatic device of this embodiment during engagement.

[0028] Figure 7C This diagram shows the state of the first fixing and retaining component of the hemostatic device according to this embodiment after it is engaged.

[0029] Figure 8A This diagram shows the state of the second retaining component of the hemostatic device of this embodiment before it is engaged.

[0030] Figure 8B This diagram shows the state of the second retaining member of the hemostatic device in this embodiment during engagement.

[0031] Figure 8C This diagram shows the locked state of the second retaining component of the hemostatic device according to this embodiment.

[0032] Figure 9 This is a perspective view showing the state of the hemostatic device of this embodiment being fitted.

[0033] Figure 10A This diagram shows the sequence of injection operations of the hemostatic device according to this embodiment, and shows the first valve component and the second valve component in the closed state.

[0034] Figure 10B This diagram shows the sequence of injection operations of the hemostatic device according to this embodiment, and it shows the first valve component in the open state.

[0035] Figure 10CThis diagram shows the sequence of injection operations of the hemostatic device according to this embodiment, and it shows the second valve component in the open state.

[0036] Figure 10D This diagram illustrates the sequence of injection operations of the hemostatic device according to this embodiment, and is a diagram of the state during the fluid injection process based on the injection device (syringe).

[0037] Figure 10E This diagram shows the sequence of injection operations of the hemostatic device according to this embodiment, and it shows the second valve component in a closed state.

[0038] Figure 10F This diagram shows the sequence of injection operations of the hemostatic device according to this embodiment, and it shows the first valve component in a closed state.

[0039] Figure 11A This diagram shows the sequence of degassing operations of the hemostatic device according to this embodiment, and it shows the second valve component in the open state.

[0040] Figure 11B This diagram shows the sequence of degassing operations of the hemostatic device according to this embodiment, and this diagram shows the state of fluid flow in the fluid receiving section.

[0041] Figure 11C This diagram shows the sequence of degassing operations of the hemostatic device according to this embodiment, and it shows the second valve component in a closed state.

[0042] Figure 11D This diagram shows the sequence of degassing operations of the hemostatic device according to this embodiment, and it shows the first valve component in the open state.

[0043] Figure 11E This diagram shows the sequence of degassing operations of the hemostatic device according to this embodiment, and this diagram shows the state in which fluid has been discharged from the fluid receiving section.

[0044] Figure 12A This diagram shows the sequence of re-injection operations of the hemostatic device according to this embodiment, and it shows the second valve component in the open state.

[0045] Figure 12B This diagram shows the sequence of re-injection operations of the hemostatic device according to this embodiment, and also shows the state in which the first valve component is brought close to the second valve component (the state during the re-injection operation).

[0046] Figure 12C This diagram shows the sequence of re-injection operations of the hemostatic device according to this embodiment, and also shows the state in which the first valve component is brought close to the second valve component to allow fluid to be re-injected.

[0047] Figure 13AThis diagram shows the sequence of forced degassing operations of the hemostatic device according to this embodiment, and it shows the second valve component in the open state.

[0048] Figure 13B This diagram shows the sequence of forced degassing operations of the hemostatic device according to this embodiment, and also shows the state in which the first valve component is separated from the second valve component and fluid is discharged from the expansion component.

[0049] Figure 13C This diagram illustrates the sequence of forced degassing operations of the hemostatic device according to this embodiment, with the second valve component in a closed state and the first valve component in an open state.

[0050] Figure 14A This diagram shows the state of the first fixing and retaining member of the hemostatic device of this embodiment before it is engaged.

[0051] Figure 14B This diagram shows the state of the first retaining component of the hemostatic device in Modified Example 1 during engagement.

[0052] Figure 14C This is a diagram showing the engaged state of the first retaining component of the hemostatic device in Modified Example 1.

[0053] Figure 15A This diagram shows the state of the second retaining component of the hemostatic device in Modified Example 1 before it is engaged.

[0054] Figure 15B This diagram shows the state of the second retaining component of the hemostatic device in Modified Example 1 during engagement.

[0055] Figure 15C This is a diagram showing the engaged state of the second retaining component of the hemostatic device in Modified Example 1.

[0056] Figure 16A This is a diagram showing the structure of the first valve component with a first fixing and retaining member in the hemostatic device of Modification Example 2.

[0057] Figure 16B This is a diagram showing the structure of the second valve component with a second fixing and retaining member in the hemostatic device of Modification 2.

[0058] Figure 17A This is a diagram showing the state of the third retaining component in the hemostatic device of Modified Example 3 before it is engaged.

[0059] Figure 17B This is a diagram showing the engaged state of the third retaining component in the hemostatic device of Modified Example 3. Detailed Implementation

[0060] Hereinafter, the method of carrying out the present invention will be described with reference to the appendix. Figure 1 The following is a detailed description. The embodiments shown herein are illustrative of the technical concept of the present invention and are not intended to limit the present invention. Furthermore, all other feasible methods, embodiments, and techniques that can be conceived by those skilled in the art without departing from the spirit of the present invention are included within the scope and spirit of the present invention, and are included in the technical solutions described in the claims and their equivalents.

[0061] Furthermore, regarding the accompanying drawings added to this specification, in order to facilitate easy understanding of the illustrations, there are instances where the scale, aspect ratio, shape, etc., are appropriately altered relative to the actual object for schematic representation. However, this is merely an example and does not limit the interpretation of the present invention.

[0062] Furthermore, the use of ordinal numbers such as "the 1st" and "the 2nd" in this instruction manual is for convenience only and does not specify any order unless otherwise stated.

[0063] A hemostatic device 100 according to one embodiment of the present invention, such as Figure 9 As shown, when a catheter or similar device is inserted into a blood vessel for treatment / examination, the guiding sheath or similar device placed at the puncture site formed on the radial artery R of the patient's wrist W is removed, and then used to stop bleeding at the puncture site. Furthermore, the specific surgical procedures and sequence of actions using the hemostatic device 100 according to one embodiment of the present invention are only representative examples and do not represent the present invention in a particularly specific manner.

[0064] <Structure>

[0065] First, appropriate reference Figure 1 Figure 8 illustrates the hemostatic device 100 of this embodiment. Figure 1 or Figure 2 As shown, in summary, the hemostatic device 100 includes a band 10 for wrapping around the wrist W, a hook and loop fastener 20 for securing the band 10 in the wrapped-around state, an expansion member 30 for expanding by injecting fluid to compress the puncture site, a mark 40 for aligning the expansion member 30 with the puncture site, and an injection member 50 for 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 securing the expansion member 30 to the puncture site.

[0066] Furthermore, the fluid injected into the expansion member 30 is not particularly limited as long as it is a gas such as air, a liquid such as purified water or saline solution that can be injected / discharged relative to the expansion member 30. In this embodiment, the fluid is set to a gas (air) that is simpler to inject / discharge and easier to handle compared to a liquid.

[0067] Furthermore, in this specification, when the strap 10 is wrapped around the wrist W, the side of the strap 10 facing the wrist W (the wearing side) is referred to as the "inner surface side", and the opposite side is referred to as the "outer surface side".

[0068] The belt 10 includes a strip 11 made of flexible strip-shaped components and a support plate 12 with a higher hardness than the strip 11.

[0069] Strip 11 Figure 9 As shown, the band wraps approximately around the outer periphery of the wrist W. A support plate retaining portion 11a is formed in the center of the band 11 to hold the support plate 12. The support plate retaining portion 11a is doubled by attaching other band-shaped components to its outer surface side (or inner surface side) using methods such as welding (thermal welding, high-frequency welding, ultrasonic welding, etc.) or bonding (adhesive or solvent-based bonding), thus holding the support plate 12 inserted between them.

[0070] In strip 11 Figure 1 On the outer surface of the portion near the left end of the strip 11, a hook and loop fastener 20, commonly referred to as a Magic Tape (registered trademark), is provided on the male (or female) side 21. Figure 1 On the inner surface of the portion near the right end of the middle, a female (or male) side 22 of the hook and loop fastener 20 is provided. For example... Figure 9 As shown, the strap 10 is worn on the wrist W by wrapping the strap 11 around the wrist W and joining the male side 21 and the female side 22. Furthermore, the means of securing the strap 10 in the state of wrapping around the wrist W is not limited to the hook and loop fastener 20, but may also be, for example, a snap fastener, a button, a clip, or a frame component through which the ends of the strap 11 pass.

[0071] The constituent material of strip 11 is not particularly limited as long as it is flexible. Examples of such materials include polyvinyl chloride, polyethylene, polypropylene, polybutadiene, polyolefins such as ethylene-vinyl acetate copolymer (EVA), polyesters such as polyethylene terephthalate (PET) and polybutylene terephthalate (PBT), polyvinylidene chloride, silicone resin, polyurethane, polyamide elastomer, polyurethane elastomer, polyester elastomer, and other thermoplastic elastomers, or materials obtained by any combination of them (mixed resins, polymer alloys, laminates, etc.).

[0072] Furthermore, the portion of strip 11 that overlaps at least with the expansion member 30 is preferably substantially transparent, but is not limited to being transparent; it may also be translucent or colored transparent. This allows for visual confirmation of the puncture site from the outer surface side, and makes it easy to align the mark 40 with the puncture site.

[0073] Support plate 12 as Figure 2 As shown, the support plate 12 is held in place by being inserted between the double-formed support plate holding portions 11a of the strip 11. The support plate 12 has a plate shape in which at least a portion of it is bent toward the inner surface side (wearing surface side). The support plate 12 is made of a material that is harder than the strip 11 and maintains a generally fixed shape.

[0074] The support plate 12 is elongated along the length of the strip 11. The central portion 12a of the support plate 12 is substantially flat and not curved. On both sides of this central portion 12a, first curved portions 12b are formed, curving towards the inner surface and along the length of the strip 11 (circumferential direction of the wrist W). Figure 2 (left side) and the second bend 12c ( Figure 2 (Right side).

[0075] The supporting plate 12 may be composed of materials such as acrylic resin, polyvinyl chloride (especially rigid polyvinyl chloride), polyethylene, polypropylene, polyolefins such as polybutadiene, polystyrene, poly-(4-methyl-1-pentene), polycarbonate, ABS resin, polymethyl methacrylate (PMMA), polyacetal, polyacrylate, polyacrylonitrile, polyvinylidene fluoride, ionomer, acrylonitrile-butadiene-styrene terpolymer, polyesters such as polyethylene terephthalate (PET) and polybutylene terephthalate (PBT), butadiene-styrene copolymer, aromatic or aliphatic polyamide, polytetrafluoroethylene and other fluorinated resins.

[0076] Similar to the strip 11, the portion of the support plate 12 that overlaps with the expansion member 30 is preferably substantially transparent, but not limited to transparent; it can also be translucent or colored transparent. This allows for precise visual identification of the puncture site from the outer surface side, and makes it easy to align the mark 40 with the puncture site. Furthermore, the support plate 12 may not have a flat portion like the central portion 12a, but rather a shape that curves along its entire length.

[0077] An expansion member 30 is connected to the band 10. The expansion member 30 expands by injecting fluid, compressing the puncture site of the wrist W.

[0078] Expansion component 30, such as Figure 2 As shown, on the inner surface side of the belt body 10, the expansion member 30 is positioned offset towards one end of the support plate 12 held along the length direction of the belt body 10 and overlaps with it. That is, in the structure shown, the expansion member 30 is positioned opposite the support plate 12. Figure 2The periphery of the first curved portion 12b and the central portion 12a on the left end side overlaps. 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 pressure of the expansion member 30 is concentrated on the wrist W side. Thus, the expansion member 30 can appropriately apply pressure to the puncture site.

[0079] Furthermore, when the expansion member 30 is positioned at one end of the support plate 12 and overlaps it, the first curved portion 12b located on both sides of the support plate 12 in the longitudinal direction is longer than the second curved portion 12c in the longitudinal direction. Therefore, when the hemostatic device 100 is worn on the wrist W and the expansion member 30 is expanded, the second curved portion 12c of the support plate 12 contacts the wrist W, which can suppress the risk of pain or other discomfort.

[0080] The material of the expansion member 30 is not particularly limited as long as it is a flexible material; for example, the same material as the aforementioned strip 11 can be used. Furthermore, the expansion member 30 is preferably made of the same or similar material as the strip 11. Therefore, the expansion member 30 can be easily joined to the strip 11 by welding.

[0081] Expansion component 30, for example Figure 2 As shown, the expansion member 30 is constructed by overlapping two sheets of material as described above and bonding or welding their edges together to form a bag-like component. This creates an expansion space 31 between the two sheets. Furthermore, the structure of the expansion member 30 is not particularly limited as long as it can expand by injecting fluid. For example, the expansion member 30 can also be constructed as a bag-like component obtained by folding a sheet and bonding or welding its edges together, or it can be constructed as a balloon-like component without edges. Additionally, the external shape of the expansion member 30 can be, for example, as shown... Figure 1 As shown, it can be configured to form a quadrilateral shape when viewed in a plane in its unexpanded state. In addition, the expansion member 30 can also have a circular, elliptical, or polygonal shape when viewed in a plane in its unexpanded state.

[0082] When the expansion member 30 is expanded, the front barrel of the syringe S, which serves as 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 core 71a, described later). The pressing member of the syringe S is then pushed to inject the gas inside the syringe S into the expansion member 30 via the injection member 50. Furthermore, the gas injection operation into the expansion member 30 will be described in detail later.

[0083] Furthermore, the expansion member 30, like the strip 11 and the support plate 12, is preferably substantially transparent, but not limited to transparent; it can also be translucent or colored transparent. This allows the operator to visually confirm the puncture site from the outer surface and easily align the mark 40 with the puncture site.

[0084] like Figure 1 and Figure 2 As shown, the mark 40 is located approximately at the center of the expansion member 30 on the side facing the band 10. By providing such a mark 40 on the expansion member 30, it is easy to align the expansion member 30 relative to the puncture site, thus preventing misalignment of the expansion member 30. Furthermore, since the mark 40 is located on the side of the expansion member 30 facing the band 10, the mark 40 does not directly contact the puncture site. Moreover, the position of the mark 40 is not particularly limited as long as it allows for alignment of the expansion member 30 with the puncture site. Therefore, the mark 40 can also be located on the side of the expansion member 30 facing the wrist W. In this case, the mark 40 is preferably located on the inner surface of the expansion member 30 in a manner that does not directly contact the puncture site.

[0085] The shape of the mark 40 is not particularly limited, and can be exemplified by polygons such as circles, triangles, and quadrilaterals. In this embodiment, it is a quadrilateral.

[0086] The size of the mark 40 is not particularly limited. For example, if the mark 40 is quadrilateral, 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 mark 40 becomes larger relative to the size of the puncture site, making it difficult to align the center of the expansion member 30 with the puncture site.

[0087] The material marked 40 is not particularly limited, and examples include oil-based colorants such as inks and resins mixed with pigments.

[0088] The color of the mark 40 is not particularly limited as long as it allows the expansion member 30 to be aligned with the puncture site, but it is preferably green. By using a green color, the mark 40 can be easily visually identified on the blood and skin, making it easier to align the expansion member 30 with the puncture site.

[0089] Furthermore, the mark 40 is preferably semi-transparent or colored transparent. This allows the puncture site to be visually identified from the outer surface of the mark 40.

[0090] There is no particular limitation on the method of setting the mark 40 on the expansion member 30. Examples include printing the mark 40 on the expansion member 30, applying adhesive to one side of the mark 40 and pasting it to the expansion member 30, etc.

[0091] The injection component 50 is the part used to inject gas into the expansion component 30, such as... Figure 1 As shown, it is connected to the expansion component 30.

[0092] The injection component 50 has a flexible tube 60 whose inner cavity communicates with the inner cavity of the expansion component 30, and a control portion 70 that communicates with the inner cavity of the tube 60 and is disposed at the base end of the tube 60. In this embodiment, the control portion 70 is as follows: Figure 3 As shown, the expansion member 30 has a connector section capable of connecting a fluid injection device (syringe S) for injecting gas into the expansion member 30. Furthermore, the connector section can also be configured by connecting other components capable of connecting the fluid injection device (syringe S) to the first protrusion 71g of the control member 70. In the injection member 50, "front end (front end side)" refers to the side where the fluid faces the expansion member 30 (i.e., the tube 60 side), and "base end (base end side)" refers to the side where the fluid is discharged from the expansion member 30 (i.e., the side of the first protrusion 71g of the first valve core 71a). Additionally, in the injection member 50, "long axis direction" is the direction of the axis extending along the length of the injection member 50 (from the base end side towards the front end side).

[0093] The tube 60 constitutes the main body of the injection member 50. The tube 60 connects to the inner cavity of the expansion member 30, allowing the inner cavity of the expansion member 30 to communicate with the outside. Thus, gas injected from the connector can flow through the control unit 70 and the tube 60 into the expansion space 31 of the expansion member 30. Furthermore, gas contained in the expansion space 31 can be discharged to the outside through the tube 60 and the control unit 70.

[0094] The front end of the tube 60 is connected to the expansion member 30, and the base end is connected to the control unit 70. There is no particular limitation on the connection position of the tube 60 relative to the expansion member 30, as long as the inner cavity of the tube 60 is in communication with the expansion space 31 of the expansion member 30.

[0095] The control unit 70 controls the flow of gas through the inner cavity of the injection member 50. One end of the control unit 70 forms a connector portion, or is connected to a connector portion, and the other end is connected to the tube 60. In this embodiment, the control unit 70 is as follows: Figure 3 As shown, the control unit 70 has a first protrusion 71g that functions as a connector. Therefore, the portion of the control unit 70 other than the first protrusion 71g that functions as a connector is located between the connector (first protrusion 71g) and the expansion member 30, and the control unit 70 is connected to the tube 60 in a manner that communicates with the inner cavity of the tube 60.

[0096] The control unit 70 includes a first valve component 71, a second valve component 72 located at the front end side (expansion member 30 side) compared to the first valve component 71, and a fluid receiving portion 73 located between the first valve component 71 and the second valve component 72. In addition, the first valve component 71 and the second valve component 72 are provided with fixing and retaining members 80 (first fixing and retaining member 81 and second fixing and retaining member 82) for maintaining the closed state of each valve component 71, 72.

[0097] The first valve component 71 includes a first valve core 71a located at the base end of the injection component 50, and a second valve core 71b opposite to the first valve core 71a and disposed at the front end of the injection component 50 in the long axis direction. The first valve core 71a and the second valve core 71b are connected by a first connecting member 71c in a manner that allows them to move relative to each other (approaching and separating) along the long axis direction of the injection component 50. The first valve component 71 can switch between an open state (a state in which gas can flow) and a closed state (a state in which gas flow is cut off) according to the approaching or separating movement of the first valve core 71a and the second valve core 71b. In addition, the first valve component 71 includes a first retaining member 81 that holds the first valve core 71a and the second valve core 71b in a state of close contact.

[0098] The first valve core 71a is made of a plate having a first hole 71d that extends through the thickness direction to allow gas flow. Furthermore, the first valve core 71a is disc-shaped, and has a first protrusion 71g on its base-end side in the thickness direction. The first protrusion 71g, for example, is a cylindrical shape with an inner cavity, extending towards the base-end side in the long axis direction of the injection member 50. In this embodiment, as described above, the first protrusion 71g functions as a "connector" for injecting gas, serving as the front end of a gas injection device such as a syringe S.

[0099] The second valve core 71b is made of a plate having a second hole 71e that extends through the thickness direction to allow gas to pass through. In this embodiment, the second valve core 71b, like the first valve core 71a, is disc-shaped. The second hole 71e connects the first flow space 71f formed by the first connecting member 71c to the inner cavity of the fluid receiving portion 73.

[0100] Furthermore, the shapes of the first valve core 71a and the second valve core 71b are not limited to a disc shape; their shapes, when viewed from the long axis direction, can also be polygons such as triangles or quadrilaterals.

[0101] Figure 4 shows an example of the configuration of the first hole 71d in the first valve core 71a and the second hole 71e in the second valve core 71b. For example... Figure 4AAs shown, the first hole 71d is positioned to match the first protrusion 71g, allowing communication with the inner cavity of the first protrusion 71g. The second hole 71e is positioned in a position not connected in series with the first hole 71d. Figure 4A In this state, the first valve component 71 can supply gas flow. For example... Figure 4B As shown, when the end face of the first valve core 71a coincides with the end face of the second valve core 71b (i.e., when the first valve core 71a is projected onto the second valve core 71b), the first hole 71d and the second hole 71e are positioned at different locations. Therefore, if the first valve core 71a and the second valve core 71b are fixed by the first retaining member 81 in a state of close contact, the first hole 71d is blocked by the end face of the second valve core 71b, and the second hole 71e is blocked by the end face of the first valve core 71a, thus cutting off the flow of gas. In other words, in Figure 4B In this state, the first valve component 71 becomes a non-flowing state for gas. In this way, the first valve component 71 brings the first valve core 71a and the second valve core 71b close together or separates, thereby blocking or opening the first orifice 71d and the second orifice 71e, thus controlling the flow of gas. Therefore, the first valve component 71 can easily switch between open and closed states with a simple structure. Furthermore, the first orifice 71d and the second orifice 71e only need to be blocked or opened at least when the first valve core 71a and the second valve core 71b are in close contact; the number and shape of the orifices are not limited to the manner shown in FIG. 4.

[0102] The first connecting member 71c is made of a flexible membrane material and connects the first valve core 71a and the second valve core 71b in a manner that allows them to move relative to each other along the long axis of the injection member 50. When engaged with the first valve core 71a and the second valve core 71b, the first connecting member 71c forms a first flow space 71f, which is a sealed space allowing gas to flow between the first valve core 71a and the second valve core 71b. Therefore, when gas flows between the first valve core 71a and the second valve core 71b, leakage of gas from the first flow space 71f to the outside is prevented.

[0103] Furthermore, in this embodiment, the membrane material constituting the first connecting member 71c is, for example, such as Figure 3 As shown, the connection is near the outer peripheral end of the base end of the first valve core 71a and near the outer peripheral end of the front end of the second valve core 71b. However, the connection position of the membrane material constituting the first connecting member 71c is not particularly limited as long as it is engaged with the outer peripheral surfaces of the first valve core 71a and the second valve core 71b.

[0104] The second valve component 72 includes a third valve core 72a located at the front end of the injection component 50, and a fourth valve core 72b opposite to the third valve core 72a and disposed at the base end of the injection component 50 in the long axis direction. The third valve core 72a and the fourth valve core 72b are connected by a second connecting member 72c in a manner that allows them to move relative to each other (approaching and separating) along the long axis direction of the injection component 50. The second valve component 72 can switch between an open state and a closed state according to the approaching or separating movement of the third valve core 72a and the fourth valve core 72b. In addition, the second valve component 72 includes a second retaining member 82 that holds the third valve core 72a and the fourth valve core 72b in a close contact state.

[0105] The third valve core 72a is made of a plate having a third hole 72d for gas flow. Furthermore, the third valve core 72a is disc-shaped, and has a second protrusion 72g on its front end face in the thickness direction. The second protrusion 72g, for example, is a cylindrical shape with an inner cavity, extending towards the front end of the injection member 50 in the long axis direction. The second protrusion 72g is connected to the tube 60. Thus, the control unit 70 can be connected to the expansion member 30 via the tube 60.

[0106] The fourth valve core 72b is made of a plate having a fourth hole 72e for gas flow. In this embodiment, the fourth valve core 72b, like the third valve core 72a, is disc-shaped. The fourth hole 72e connects the second flow space 72f formed by the second connecting member 72c to the inner cavity of the fluid receiving portion 73.

[0107] Furthermore, the shapes of the third valve core 72a and the fourth valve core 72b are similar to those of the first valve core 71a and the second valve core 71b, and are not limited to a disc shape. The shapes observed from the long axis direction can also be polygons such as triangles or quadrilaterals.

[0108] In addition, such as Figure 4A As shown, the third hole 72d is positioned to match the second protrusion 72g, allowing communication with the inner cavity of the second protrusion 72g. Furthermore, the fourth hole 72e is positioned in a position not connected in series with the third hole 72d. Figure 4A In this state, the second valve component 72 can supply gas flow. For example... Figure 4BAs shown, when the end face of the third valve core 72a coincides with the end face of the fourth valve core 72b (i.e., when the third valve core 72a is projected onto the fourth valve core 72b), the third hole 72d and the fourth hole 72e are positioned at different locations. Therefore, similarly to the first valve core 71a and the second valve core 71b, if the third valve core 72a and the fourth valve core 72b are fixed by the second retaining member 82 in a state of close contact, the third hole 72d is blocked by the end face of the fourth valve core 72b, and the fourth hole 72e is blocked by the end face of the third valve core 72a, thus cutting off gas flow. In other words, in Figure 4B In this state, the second valve component 72 becomes a non-flowing state for gas. In this way, the second valve component 72 brings the third valve core 72a and the fourth valve core 72b closer together or separates them, thereby blocking or opening the third orifice 72d and the fourth orifice 72e, thus controlling the flow of gas. Therefore, like the first valve component 71, the second valve component 72 can easily switch between open and closed states with a simple structure. Furthermore, the third orifice 72d and the fourth orifice 72e only need to be blocked or opened at least when the third valve core 72a and the fourth valve core 72b are in close contact; the number and shape of the orifices are not limited to those shown in FIG. 4.

[0109] The second connecting member 72c is made of a flexible membrane material and connects the third valve core 72a and the fourth valve core 72b in a manner that allows them to move relative to each other along the long axis of the injection member 50. When engaged with the third valve core 72a and the fourth valve core 72b, the second connecting member 72c forms a second flow space 72f, a sealed space allowing gas to flow between the third valve core 72a and the fourth valve core 72b. Therefore, when gas flows between the third valve core 72a and the fourth valve core 72b, gas leakage from the second flow space 72f to the outside is prevented.

[0110] Furthermore, in this embodiment, the membrane material constituting the second connecting member 72c is, for example, such as Figure 3 As shown, the membrane material is joined near the outer peripheral end of the front end side of the third valve core 72a and near the outer peripheral end of the base end side of the fourth valve core 72b. However, the joining position of the membrane 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 core 72a and the fourth valve core 72b.

[0111] The fluid containment section 73, located between the first valve component 71 and the second valve component 72, is a sealable space that contains gas flowing from the expansion component 30. Gas contained in the expansion component 30 flows into the fluid containment section 73 under the pressure difference created by the pressure difference between the internal pressure of the expansion space 31 of the expansion component 30 and the internal pressure within the fluid containment section 73, resulting from a predetermined operation via the second valve component 72. The fluid containment section 73 has a volume capable of containing the amount of gas (discharged fluid) released according to a predetermined pressure reduction procedure. The volume of the fluid containment section 73 can be appropriately set according to the pressure reduction procedure.

[0112] The fluid containment section 73 only needs to have a structure capable of containing a predetermined amount of gas. Therefore, the fluid containment section 73 can be, for example, a balloon type made of an expandable membrane 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, the fluid containment section 73 is preferably a balloon type whose shape can expand according to the amount of fluid held, as illustrated in the structure. This is because when the fluid containment section 73 is made of an expandable balloon type, its shape expands according to the amount of fluid held, thus allowing more gas to be contained in a smaller space compared to a tube type. By making the fluid containment section 73 an expandable balloon type, the size of the injection component 50 is miniaturized, improving operability without hindering the operator's operation. In addition, by configuring the fluid containment section 73 to be expandable, the amount of gas that can be degassed at one time (i.e., the gas capacity) can be increased, thus reducing the number of degaussing operations. Furthermore, by appropriately setting the composition or thickness of the material used, the fluid containment section 73 made of expandable material can adjust the degree of expansion (volume increase) before and after expansion.

[0113] Furthermore, the fluid receiving section 73, being constructed of a flexible, expandable material, allows the distance between the first valve component 71 and the second valve component 72 to be extended along the long axis of the injection component 50, thereby increasing the accommodating volume. Figure 5 shows the fluid receiving section 73 before and after its extension. Figure 5A As shown, the fluid receiving section 73, before its extension, is in a contracted state between the first valve member 71 and the second valve member 72. Figure 5B As shown, if the practitioner moves the first valve component 71 in a direction separating it from the second valve component 72, the fluid receiving portion 73 extends by a predetermined length along the long axis of the injection component 50, and the distance between the first valve component 71 and the second valve component 72 increases. Furthermore, the fluid receiving portion 73, before its extension, is not limited to... Figure 5A The structure that contracts as shown can also be configured to maintain a predetermined distance between the first valve component 71 and the second valve component 72.

[0114] Additionally, as shown in FIG6, the fluid receiving portion 73 can also be corrugated as another way to extend 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 interval between the first valve member 71 and the second valve member 72). Figure 6A As shown, the fluid receiving section 73, before being extended, is folded between the first valve member 71 and the second valve member 72. Figure 6B As shown, if the practitioner moves the first valve component 71 in a direction that separates it from the second valve component 72, the fluid receiving part 73 will unfold the folded portion and extend by a predetermined length along the long axis of the injection component 50.

[0115] As shown in Figures 5 and 6, the fluid receiving section 73 has a structure that extends the distance between the first valve member 71 and the second valve member 72, thereby increasing the volume that can be contained in the fluid receiving section 73. The hemostatic device 100 typically degasses a predetermined amount of gas at predetermined intervals according to a decompression procedure. If degassing is continuous, the internal pressure within the expansion member 30 may gradually decrease, and the predetermined amount of gas may cease to flow. Because the fluid receiving section 73 has the aforementioned structure that extends the distance between the first valve member 71 and the second valve member 72, even if the flow rate (degassing amount) of the expansion member 30 decreases, the distance between the first valve member 71 and the second valve member 72 can be extended, creating a negative pressure within the fluid receiving section 73. Therefore, the hemostatic device 100 can forcibly degas (suction) a predetermined amount of gas from the expansion member 30, thus enabling degassing operations in accordance with the decompression procedure. Furthermore, since the fluid receiving section 73 has the structure 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 the fluid receiving section 73 can accommodate. Thus, the fluid receiving section 73 can adjust the amount of gas that can be degassed in one go according to the distance (separation distance) between the first valve member 71 and the second valve member 72. Therefore, by adjusting the amount of degassed contained in the fluid receiving section 73 to increase the amount of degassed beyond the amount specified in the depressurization procedure, the operator can reduce the number of degassed operations.

[0116] Furthermore, the fluid receiving section 73 can also be appropriately combined with the structures shown in FIG5 and FIG6. That is, the fluid receiving section 73 can also be configured as a corrugated structure made of a flexible and expandable material.

[0117] The first valve component 71 includes a first retaining member 81 that maintains the first valve core 71a and the second valve core 71b in close contact. Additionally, the second valve component 72 includes a second retaining member 82 that maintains the third valve core 72a and the fourth valve core 72b in close contact.

[0118] The first retaining member 81 holds the first valve core 71a and the second valve core 71b in close contact. The first retaining member 81, as shown... Figures 7A to 7C As shown, it is composed of a first engaging portion 81a provided at the outer peripheral end of the front end side of the first valve core 71a and a second engaging portion 81b provided at the outer peripheral end of the base end side of the second valve core 71b.

[0119] The first engaging portion 81a, as an example, consists of a base 811a protruding from the outer peripheral end of the front end of the first valve core 71a toward the second valve core 71b, and a claw portion 812a formed into a hook shape by bending the front end of the base 811a in a direction orthogonal to the long axis of the injection member 50. The second engaging portion 81b, as an example, consists of a recess 811b provided at the outer peripheral end of the base end of the second valve core 71b and engaging with the claw portion 812a.

[0120] like Figure 7A As shown, the first valve core 71a and the second valve core 71b are separated when, for example, the gas contained in the fluid containment section 73 is displaced to the outside. After the gas is displaced, when the first valve core 71a and the second valve core 71b are brought into close contact again, as illustrated... Figure 7B As shown, the first valve core 71a is brought close to the second valve core 71b. At this time, the end face of the first valve core 71a is in close contact with the end face of the second valve core 71b, but the first engaging portion 81a and the second engaging portion 81b are not yet engaged. Then, as... Figure 7C As shown, the first valve core 71a (or the second valve core 71b) is moved relative to the second valve core 71b (or the first valve core 71a) in a direction orthogonal to the long axis of the injection member 50, thereby engaging the first engaging portion 81a with the second engaging portion 81b. Figure 7C As shown, when the first engaging portion 81a and the second engaging portion 81b engage, the claw portion 812a is engaged with the recess 811b. Thus, the first valve core 71a and the second valve core 71b maintain close contact.

[0121] Furthermore, the first retaining member 81 only needs to be able to hold (fix) the first valve core 71a and the second valve core 71b in a tight contact state, so the structure of the first engaging portion 81a and the second engaging portion 81b can be replaced. Additionally, the first valve core 71a and the second valve core 71b in their state before the first engaging portion 81a and the second engaging portion 81b engage, such as... Figure 7A As shown, a portion of the first engaging portion 81a abuts against a portion of the second engaging portion 81b, but it can also be configured such that a portion of the first engaging portion 81a does not abut against a portion of the second engaging portion 81b.

[0122] The second retaining member 82 holds the third valve core 72a and the fourth valve core 72b in close contact. The second retaining member 82, as shown... Figures 8A to 8C As shown, it is composed of a third engaging portion 82a provided at the outer peripheral end of the base end side of the third valve core 72a and a fourth engaging portion 82b provided at the outer peripheral end of the front end side of the fourth valve core 72b.

[0123] The third engaging portion 82a, as an example, consists of a base 821a protruding from the outer peripheral end of the base end of the third valve core 72a toward the fourth valve core 72b, and a claw portion 822a formed by bending the front end of the base 821a in a direction orthogonal to the long axis of the injection member 50. The fourth engaging portion 82b, as an example, consists of a recess 821b provided at the outer peripheral end of the front end of the fourth valve core 72b and engaging with the claw portion 822a.

[0124] like Figure 8A As shown, the third valve core 72a and the fourth valve core 72b are separated as illustrated when, for example, gas is released from the expansion member 30. After a predetermined amount of gas flows into the fluid receiving section 73, when the third valve core 72a and the fourth valve core 72b are brought into close contact again, as shown... Figure 8B As shown, the third valve core 72a is brought close to the fourth valve core 72b. At this time, the end face of the third valve core 72a is in close contact with the end face of the fourth valve core 72b, but the third engaging portion 82a and the fourth engaging portion 82b are not yet engaged. Then, as... Figure 8C As shown, the third valve core 72a (or the fourth valve core 72b) is moved relative to the fourth valve core 72b (or the third valve core 72a) in a direction orthogonal to the long axis of the injection member 50, thereby engaging the third engaging portion 82a with the fourth engaging portion 82b. Figure 8C As shown, when the third engaging portion 82a and the fourth engaging portion 82b engage, the claw portion 822a is engaged with the recess 821b. Thus, the third valve core 72a and the fourth valve core 72b remain in close contact.

[0125] Furthermore, the second retaining member 82 only needs to be able to hold (fix) the third valve core 72a and the fourth valve core 72b in a tight contact state, so the structure of the third engaging portion 82a and the fourth engaging portion 82b can be replaced. Additionally, the third valve core 72a and the fourth valve core 72b in their state before the third engaging portion 82a and the fourth engaging portion 82b engage, such as... Figure 8A As shown, a portion of the third engaging portion 82a abuts against a portion of the fourth engaging portion 82b, but it can also be configured such that a portion of the third engaging portion 82a does not abut against a portion of the fourth engaging portion 82b.

[0126] As described above, the first retaining member 81 is held in a state where the first valve core 71a and the second valve core 71b are in close contact, maintaining the first valve member 71 in a closed state to cut off the flow of gas. Similarly, the second retaining member 82 is held in a state where the third valve core 72a and the fourth valve core 72b are in close contact, maintaining the second valve member 72 in a closed state to cut off the flow of gas.

[0127] The hemostatic device 100 includes a first retaining member 81 that maintains the first valve component 71 in a closed state and a second retaining member 82 that maintains the second valve component 72 in a closed state. Therefore, when the hemostatic device 100 maintains the close contact between the first valve core 71a and the second valve core 71b (the third valve core 72a and the fourth valve core 72b), the operator does not need to maintain the close contact between the first valve core 71a and the second valve core 71b (the third valve core 72a and the fourth valve core 72b) by hand, or use clamps or other components to maintain the close contact between the first valve core 71a and the second valve core 71b (the third valve core 72a and the fourth valve core 72b). Therefore, the hemostatic device 100, with its simple construction, can reliably maintain the closed state of the first valve component 71 and the second valve component 72. Even if it comes into contact with other surrounding components (table, bed, interior walls, etc.), the closed state of the first valve component 71 and the second valve component 72 will not be released under the action of the first retaining component 81 and the second retaining component 82. Thus, the hemostatic device 100 will not cause unintentional degassing operations, and can properly maintain the pressure of the dilation component 30 on the puncture site.

[0128] <Action>

[0129] Next, refer to Figures 9-1 3. An example of using the hemostatic device 100 is explained. Furthermore, the order of the examples described below is merely illustrative; any substitutions may be made as long as they do not impede operation.

[0130] The following hemostatic instruments number 100 Figure 9 As shown, the hemostatic device 100 is used when the strap 10 is wrapped around the wrist W and worn. Additionally, the hemostatic device 100 is used in… Figure 9 In the wearing state shown, perform the "injection operation" as appropriate (refer to...). Figures 10A to 10F "Degassing operation (refer to...") Figures 11A to 11E "Re-injection operation (refer to)" Figures 12A-12C ")" and "Forced degassing operation (refer to Figures 13A-13C )".

[0131] <Injection Operation>

[0132] The injection operation is an operation used to inject a predetermined amount of gas into the dilation component 30. During the injection operation, the hemostatic device 100 is used as an example according to... Figures 10A to 10F Perform the operations in the order shown.

[0133] like Figure 10A As shown, before the injection operation, the hemostatic device 100 is in a state where the first valve component 71 and the second valve component 72 are blocked.

[0134] like Figure 10B As shown, the practitioner first releases the tight contact between the first valve core 71a and the second valve core 71b of the first valve component 71, thus separating them. This opens the first valve component 71, allowing gas to flow. Next, as... Figure 10C As shown, the practitioner releases the tight contact between the third valve core 72a and the fourth valve core 72b of the second valve component 72, thus separating them. As a result, the second valve component 72 becomes open, allowing gas to flow.

[0135] like Figure 10D As shown, the operator attaches the syringe S to the first protrusion 71g, which functions as a connector, and operates the pressing element of the syringe S to inject an amount of gas corresponding to the volume of the expansion member 30. The injected gas flows into the expansion member 30 in the order of the first valve member 71, the fluid receiving part 73, the second valve member 72, and the tube 60.

[0136] If the injection of gas relative to the expansion member 30 ends, such as Figure 10E As shown, the practitioner brings the third valve core 72a and the fourth valve core 72b into close contact, thereby sealing the second valve component 72. As a result, the second valve component 72 becomes closed, and the gas injected into the expansion component 30 will not flow out through the injection component 50.

[0137] Then, the caster, as Figure 10F As shown, after the first valve core 71a and the second valve core 71b are brought into close contact to close the first valve component 71, the syringe S is disengaged from the first protrusion 71g to end the injection operation. Consequently, the patient's puncture site is compressed by the dilation component 30 to begin hemostasis.

[0138] Furthermore, before the hemostatic device 100 is fitted onto the wrist W, the first valve component 71 and the second valve component 72 can also be in the open state. In this case, the practitioner, such as Figure 9 As shown, after the hemostatic device 100 is fitted onto the patient, the operation of setting the first valve component 71 and the second valve component 72 to the open state is omitted, such as... Figure 10DAs shown, the operator can attach the syringe S to the first protrusion 71g, which functions as a connector, and operate the pressing part of the syringe S to inject an amount of gas corresponding to the volume of the expansion member 30.

[0139] <Degassing operation (fluid discharge operation)>

[0140] The degassing operation is an operation used to remove a specified amount of gas from the expansion member 30 at specified intervals according to the prescribed decompression procedure. During the degassing operation, the hemostatic device 100 is used as an example... Figures 11A to 11E Perform the operations in the order shown.

[0141] like Figure 11A As shown, the practitioner separates the third valve core 72a from the fourth valve core 72b, setting the second valve component 72 to the open state. As a result, the gas contained in the expansion member 30 flows into the fluid containing part 73 due to the pressure difference between the internal pressure in the expansion member 30 and the internal pressure in the fluid containing part 73.

[0142] like Figure 11B As shown, the practitioner confirms that a prescribed amount of gas flows from the expansion member 30 to the fluid containment section 73, which expands to fill with gas. Then, as... Figure 11C As shown, the third valve core 72a and the fourth valve core 72b are brought into close contact, thereby closing the second valve component 72. This cuts off the flow of gas from the expansion member 30 relative to the fluid receiving portion 73.

[0143] Then, the caster, as Figure 11D As shown, separating the first valve core 71a from the second valve core 71b puts the first valve component 71 in the open state, allowing the gas contained in the fluid containment section 73 to escape to the outside, thereby ending the degassing operation. The operator, as... Figure 11E As shown, after the degassing operation is completed, the first valve core 71a and the second valve core 71b are brought into close contact to close the first valve component 71.

[0144] <Re-injection operation>

[0145] The re-injection operation is used when, based on the hemostasis status at the puncture site, it is determined that a large amount of gas has detached from the dilator 30, causing the gas temporarily contained in the fluid containment section 73 to return to the dilator 30. During the re-injection operation, the hemostatic device 100 is used as an example... Figures 12A-12C Perform the operations in the order shown.

[0146] like Figure 12A As shown, the operator separates the third valve core 72a from the fourth valve core 72b, setting the second valve component 72 to the open state, allowing gas to be contained in the fluid containment section 73. This process is similar to... Figure 11A , Figure 11B The degassing procedure is the same as shown. At this point, if the operator determines that the patient's hemostasis is poor and requires re-injection of gas, such as... Figure 12B As shown, the first valve component 71 is brought close to the second valve component 72, and the gas contained in the fluid containment section 73 is re-injected.

[0147] Then, the caster, as Figure 12C As shown, the first valve component 71 is brought closer to the second valve component 72, and after the gas contained in the fluid containment section 73 is injected, the third valve core 72a and the fourth valve core 72b are brought into close contact, thus closing the second valve component 72 and ending the re-injection operation. As a result, the gas contained in the fluid containment section 73 is re-injected into the expansion member 30, and the internal pressure (expansion degree) of the expansion member 30 returns to the state before the re-injection operation.

[0148] Forced degassing operation (forced fluid discharge operation)

[0149] Forced degassing is an operation used to forcibly degas the gas within the dilation member 30 when it is determined that the amount of gas detached from the dilation member 30 is less than a specified amount. During forced degassing, the hemostatic device 100 is used as an example... Figures 13A-13C Perform the operations in the order shown.

[0150] like Figure 13A As shown, the expansion member 30 experiences a decrease in internal pressure due to repeated degassing operations, resulting in a smaller pressure difference between the internal pressure of the expansion member 30 and the internal pressure of the fluid containment section 73, and consequently, a decrease in the flow rate of gas into the fluid containment section 73. If the operator determines that the flow rate from the expansion member 30 is lower than the prescribed amount, such as... Figure 13B As shown, the third valve core 72a and the fourth valve core 72b are separated to form the open state of the second valve component 72. In this state, the first valve component 71 is further separated from the second valve component 72, causing the fluid receiving portion 73 to extend in the long axis direction. As a result, a negative pressure is generated inside the fluid receiving portion 73, which forces a predetermined amount of gas to escape from the expansion member 30.

[0151] Then, the caster, as Figure 13C As shown, after the third valve core 72a and the fourth valve core 72b are brought into close contact to close the second valve component 72, the first valve core 71a and the second valve core 71b are separated to open the first valve component 71, allowing the gas contained in the fluid containment section 73 to escape to the outside, thus ending the forced degassing operation.

[0152] [Variation Example]

[0153] Next, variations of the hemostatic device 100 of the present invention will be described. In the following descriptions of variations 1 to 3, the same reference numerals are used for technical features having the same function as the aforementioned embodiments, and detailed descriptions are omitted. Structures, components, and methods of use not specifically mentioned can be assumed to be the same as the aforementioned embodiments. Furthermore, the structures of this embodiment and the structures of variations 1 to 3 can be arbitrarily combined and implemented without departing from the spirit of the present invention.

[0154] In the following modified examples 1 to 3, a modified example of a fixed retaining member 80 for maintaining the closed state of the first valve member 71 and the second valve member 72 is shown.

[0155] <Variation Example 1>

[0156] Referring to Figures 14 and 15, a modification 1 of the hemostatic device 100 will be described. In the modification 1, the engagement method of the first retaining member 83 and the second retaining member 84 differs from that of the first retaining member 81 and the second retaining member 82 in the aforementioned embodiment. Furthermore, Figure 14 shows a modification of the structure of the first retaining member 81, showing the first retaining member 83, and Figure 15 shows a modification of the structure of the second retaining member 82, showing the second retaining member 84.

[0157] In the hemostatic device 100 of Modified Example 1, the first valve component 71 is as follows: Figures 14A-14C As shown, a first retaining member 83 is provided to maintain a tight contact between the first valve core 71a and the second valve core 71b. Additionally, the second valve member 72 is as follows... Figures 15A-15C As shown, a second fixed retaining member 84 is provided to maintain the third valve core 72a and the fourth valve core 72b in close contact.

[0158] The first retaining member 83 holds the first valve core 71a and the second valve core 71b in a tight contact state. The first retaining member 83, as shown... Figures 14A-14C As shown, it is composed of a first engaging portion 83a provided at the outer peripheral end of the front end side of the first valve core 71a and a second engaging portion 83b provided at the outer peripheral end of the base end side of the second valve core 71b.

[0159] The first engaging portion 83a engages with the second engaging portion 83b. The first engaging portion 83a, as an example, is composed of a base 831a that protrudes from the outer peripheral end of the front end of the first valve core 71a toward the second valve core 71b, and a claw portion 832a that is bent into a hook shape by bending the front end of the base 831a in a direction orthogonal to the long axis of the injection member 50.

[0160] The second engaging portion 83b engages with the first engaging portion 83a. As an example, the second engaging portion 83b is formed by a groove provided along the outer peripheral end of the base end side of the second valve core 71b. This groove includes a first groove portion 831b that engages with the base portion 831a when engaged with the first engaging portion 83a, and a second groove portion 832b that is deeper than the first groove portion 831b and engages with the claw portion 832a when engaged with the first engaging portion 83a. The second groove portion 832b has an insertion portion 833b for inserting the claw portion 832a. Furthermore, the second groove portion 832b includes a guide portion 834b, which guides the movement of the claw portion 832a when the first valve core 71a moves relative to the second valve core 71b (rotational movement along the circumferential direction) while the claw portion 832a is inserted into the insertion portion 833b. The insertion portion 833b extends in the thickness direction within the second valve core 71b, and the guide portion 834b extends a predetermined length from the end portion (end portion) of the insertion portion 833b along the outer periphery of the second valve core 71b.

[0161] Furthermore, the first valve core 71a and the second valve core 71b are preferably configured such that, before the first engaging portion 83a and the second engaging portion 83b engage, a portion of the first engaging portion 83a and a portion of the second engaging portion 83b remain in contact. Thus, when the operator engages the first engaging portion 83a and the second engaging portion 83b, the claw portion 832a can be easily inserted relative to the insertion portion 833b of the second groove portion 832b.

[0162] Furthermore, in Modified Example 1, the membrane material constituting the fluid containment portion 73 is, for example, Figure 14A As shown, it is preferably engaged near the outer peripheral end of the base end side of the first valve core 71a and near the outer peripheral end of the front end side of the second valve core 71b. Thus, when the first retaining member 83 is engaged, the membrane material will not hinder the relative movement of the first valve core 71a and the second valve core 71b, and engagement can be performed smoothly.

[0163] like Figure 14A As shown, the first valve core 71a and the second valve core 71b are separated when, for example, the gas contained in the fluid containment section 73 is released to the outside. When the gas is released and the first valve core 71a and the second valve core 71b are brought into close contact again, as illustrated... Figure 14B As shown, the first valve core 71a is brought close to the second valve core 71b. At this time, the end face of the first valve core 71a is in close contact with the end face of the second valve core 71b, 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. Figure 14B In this state, the first engaging part 83a and the second engaging part 83b are not yet engaged. Then, as... Figure 14CAs shown, the first valve core 71a is rotated relative to the second valve core 71b, causing the first engaging portion 83a to engage with the second engaging portion 83b. Figure 14C As shown, when the first engaging portion 83a and the second engaging portion 83b engage, the claw portion 832a engages with the guide portion 834b of the second groove portion 832b. Thus, the first valve core 71a and the second valve core 71b engage and maintain a tight contact.

[0164] Furthermore, the first retaining member 83 only needs to be able to hold (fix) the first valve core 71a and the second valve core 71b in a tight contact state, so the structure of the first engaging portion 83a and the second engaging portion 83b can be replaced. Additionally, in the state before the first engaging portion 83a and the second engaging portion 83b engage, as shown in FIG14, a portion of the first engaging portion 83a abuts against a portion of the second engaging portion 83b, but it can also be configured such that a portion of the first engaging portion 83a does not abut against a portion of the second engaging portion 83b. Moreover, the engagement position of the membrane material constituting the fluid receiving portion 73 relative to the first valve core 71a and the second valve core 71b is not limited to the vicinity of the outer peripheral end on the base end side of the first valve core 71a and the outer peripheral end on the front end side of the second valve core 71b, as long as it is on the outer peripheral surface of the first valve core 71a and the second valve core 71b.

[0165] The second retaining member 84 holds the third valve core 72a and the fourth valve core 72b in close contact. The second retaining member 84, as shown... Figures 15A-15C As shown, it is composed of a third engaging portion 84a located at the outer peripheral end of the front end side of the first valve core 71a and a fourth engaging portion 84b located at the outer peripheral end of the base end side of the second valve core 71b.

[0166] The third engaging portion 84a engages with the fourth engaging portion 84b. As an example, the third engaging portion 84a is composed of a base 841a that protrudes from the outer peripheral end of the base end of the third valve core 72a toward the fourth valve core 72b, and a claw portion 842a that is bent into a hook shape by bending the front end of the base 841a toward a direction orthogonal to the long axis of the injection member 50.

[0167] The fourth engaging portion 84b engages with the third engaging portion 84a. As an example, the fourth engaging portion 84b is formed by a groove provided along the outer peripheral end of the front end side of the fourth valve core 72b. This groove includes a third groove portion 841b that engages with the base portion 841a when engaged with the third engaging portion 84a, and a fourth groove portion 842b that is deeper than the third groove portion 841b and engages with the claw portion 842a when engaged with the third engaging portion 84a. Furthermore, the fourth groove portion 842b has an insertion portion 843b for inserting the claw portion 842a. Additionally, the fourth groove portion 842b has a guide portion 844b, which guides the movement of the claw portion 842a when the third valve core 72a moves relative to the fourth valve core 72b (rotational movement along the circumferential direction) while the claw portion 842a is inserted into the insertion portion 843b. The insertion portion 843b extends in the thickness direction within the fourth valve core 72b, and the guide portion 844b extends a predetermined length from the end portion (end portion) of the insertion portion 843b along the outer periphery of the fourth valve core 72b.

[0168] Furthermore, the third valve core 72a and the fourth valve core 72b are preferably configured such that, before the third engaging portion 84a and the fourth engaging portion 84b engage, the front end of the claw portion 842a of the third engaging portion 84a abuts against a portion of the fourth engaging portion 84b. Thus, when the operator engages the third engaging portion 84a and the fourth engaging portion 84b, the claw portion 842a can be smoothly inserted relative to the insertion portion 843b of the fourth groove portion 842b.

[0169] Furthermore, in Modified Example 1, the membrane material constituting the fluid containment portion 73 is, for example, Figure 15A As shown, it is preferably engaged near the outer peripheral end of the front end side of the third valve core 72a and near the outer peripheral end of the base end side of the fourth valve core 72b. Therefore, when the second retaining member 84 is engaged, the membrane material will not impede the relative movement of the third valve core 72a and the fourth valve core 72b, allowing for smooth engagement.

[0170] like Figure 15A As shown, the third valve core 72a and the fourth valve core 72b are separated when, for example, the gas inside the expansion member 30 is detached. After a predetermined amount of gas flows into the fluid receiving section 73, the third valve core 72a and the fourth valve core 72b are brought into close contact again, as illustrated. Figure 15B As shown, the third valve core 72a is brought close to the fourth valve core 72b. At this time, the end face of the third valve core 72a is in close contact with the end face of the fourth valve core 72b, 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. Figure 15B In this state, the third engaging part 84a and the fourth engaging part 84b are not yet engaged. Then, as... Figure 15CAs shown, the third valve core 72a is rotated relative to the fourth valve core 72b, causing the third engaging portion 84a to engage with the fourth engaging portion 84b. Figure 15C As shown, when the third engaging portion 84a and the fourth engaging portion 84b engage, the claw portion 842a engages with the guide portion 844b of the fourth groove portion 842b. Thus, the third valve core 72a and the fourth valve core 72b engage and maintain a tight contact.

[0171] Furthermore, the second retaining member 84 only needs to be able to hold (fix) the third valve core 72a and the fourth valve core 72b in a tight contact state, so the structure of the third engaging portion 84a and the fourth engaging portion 84b can be replaced. Additionally, in the state before the third engaging portion 84a and the fourth engaging portion 84b engage, as shown in FIG15, a portion of the third engaging portion 84a abuts against a portion of the fourth engaging portion 84b, but it can also be configured such that a portion of the third engaging portion 84a does not abut against a portion of the fourth engaging portion 84b. Moreover, the engagement position of the membrane material constituting the fluid receiving portion 73 relative to the third valve core 72a and the fourth valve core 72b is not limited to the vicinity of the outer peripheral end on the front end side of the third valve core 72a and the outer peripheral end on the base end side of the fourth valve core 72b, as long as it is the outer peripheral surface of the third valve core 72a and the fourth valve core 72b.

[0172] The hemostatic device 100 of Modification 1 has a structure in which the first engaging portion 83a provided on the first valve core 71a and the second engaging portion 83b provided on the second valve core 71b are engaged by the relative rotational movement of the first valve core 71a and the second valve core 71b. Furthermore, the hemostatic device 100 of Modification 1 has a structure in which the third engaging portion 84a provided on the third valve core 72a and the fourth engaging portion 84b provided on the fourth valve core 72b are engaged by the relative rotational movement of the third valve core 72a and the fourth valve core 72b. Therefore, the hemostatic device 100 of Modification 1 reliably maintains the first valve component 71 and the second valve component 72 in a closed state, and even if it comes into contact with other surrounding components (table, bed, interior wall, etc.), the closed state of the first valve component 71 and the second valve component 72 will not be released under the action of the first retaining member 83 and the second retaining member 84. Therefore, the hemostatic device 100 of Modified Example 1 will not cause unintentional degassing operations, and can properly maintain the pressure of the dilation component 30 on the puncture site.

[0173] <Variation Example 2>

[0174] Next, with reference to FIG16, a modification 2 of the hemostatic device 100 will be described. In the modification 2, the first retaining member 85 and the second retaining member 86 of the hemostatic device 100 are not physically engaged like the first retaining member 81 and the second retaining member 82 in the aforementioned embodiment and the first retaining member 83 and the second retaining member 84 in the modification 1, but are engaged by magnetic force.

[0175] In the hemostatic device 100 of Modification 2, the first fixing and retaining member 85 has a structure that uses magnetic force to maintain the first valve core 71a and the second valve core 71b in close contact. Furthermore, the second fixing and retaining member 86 has a structure that uses magnetic force to maintain the third valve core 72a and the fourth valve core 72b in close contact.

[0176] Detailed description, the first fixed retaining component 85, as shown Figure 16A As shown, the valve core 71a has a first engaging portion 85a located on the end face of the front end of the first valve core 71a, and a second engaging portion 85b located on the end face of the base end of the second valve core 71b at a position opposite to the first engaging portion 85a.

[0177] The first engaging portion 85a and the second engaging portion 85b are, as examples, made of a magnetic material capable of magnetic connection, such as a magnetic body or a magnet. The material of the first engaging portion 85a can be appropriately selected depending on the shape of the second engaging portion 85b. That is, if the first engaging portion 85a is made of a magnetic body when the second engaging portion 85b is made of a magnetic body, it can be made of a magnet to be able to connect with the second engaging portion 85b. Alternatively, if the first engaging portion 85a is made of a magnet when the second engaging portion 85b is made of a magnet, it can be made of a magnetic body or a magnet with a different magnetic pole than the second engaging portion 85b to be able to connect with the second engaging portion 85b. Furthermore, as long as the first engaging portion 85a and the second engaging portion 85b can be magnetically connected to each other, their number and shape are not particularly limited.

[0178] Second fixing and retaining component 86, as shown Figure 16B As shown, the valve core 72a has a third engaging portion 86a located on the end face of the base end side of the third valve core 72a, and a fourth engaging portion 86b located on the end face of the front end side of the fourth valve core 72b at a position opposite to the third engaging portion 86a.

[0179] The third engaging portion 86a and the fourth engaging portion 86b, as examples, are made of a magnetic material capable of magnetic connection, such as a magnetic body or a magnet. The material of the third engaging portion 86a can be appropriately selected based on the shape of the fourth engaging portion 86b. That is, if the fourth engaging portion 86b is a magnetic body, the third engaging portion 86a can be made of a magnet to connect with the fourth engaging portion 86b. Furthermore, if the fourth engaging portion 86b is a magnet, the third engaging portion 86a can be made of a magnetic body or a magnet with poles different from those of the fourth engaging portion 86b to connect with it. Moreover, as long as the third engaging portion 86a and the fourth engaging portion 86b can be magnetically connected to each other, their number and shape are not particularly limited.

[0180] like Figure 16A As shown, if the first valve component 71 brings the first valve core 71a and the second valve core 71b close together, the magnetic force acts, and the first engaging portion 85a and the second engaging portion 85b connect and remain in a closed state. Conversely, if the first valve component 71 resists the magnetic force and separates the first valve core 71a and the second valve core 71b, the first orifice 71d and the second orifice 71e open together, and the first valve component 71 becomes open. Figure 16B As shown, if the third valve core 72a and the fourth valve core 72b are brought close together by the second valve component 72, the magnetic force will act, and the third engaging portion 86a and the fourth engaging portion 86b will connect and remain in a closed state. Alternatively, if the second valve component 72 resists the magnetic force and separates the third valve core 72a and the fourth valve core 72b, the third hole 72d and the fourth hole 72e will open together, and the second valve component 72 will be in an open state.

[0181] Modification 2 of the hemostatic device 100 has a structure in which the first engaging portion 85a and the second engaging portion 85b constituting the first fixing and retaining member 85 are magnetically connected to maintain the first valve member 71 in a closed state, and the third engaging portion 86a and the fourth engaging portion 86b constituting the second fixing and retaining member 86 are magnetically connected to maintain the second valve member 72 in a closed state. Therefore, the structure of the first fixing and retaining member 85 and the second fixing and retaining member 86 for maintaining the connection state is simple and not complicated, and the switching of the open and closed states of the first valve member 71 and the second valve member 72 is also simple, consisting only of a simple approach / separation operation. Furthermore, in Modification 2, the hemostatic device 100 reliably maintains the first valve component 71 and the second valve component 72 in a closed state via the first retaining member 85 and the second retaining member 86. Therefore, even if it comes into contact with other surrounding components (table, bed, interior walls, etc.), the closed state of the first valve component 71 and the second valve component 72 will not be released under the action of the first retaining member 85 and the second retaining member 86. As a result, the hemostatic device 100 in Modification 2 will not cause unintentional degassing operations, and can properly maintain the pressure of the dilation member 30 on the puncture site.

[0182] <Variation Example 3>

[0183] Next, a variation 3 of the hemostatic device 100 will be described with reference to FIG17. In order to maintain the first valve member 71 and the second valve member 72 in a closed state, the hemostatic device 100 of variation 3 includes a third retaining member 87 as illustrated in FIG17. Furthermore, FIG17 shows a configuration in which multiple third retaining members 87 (two in the figure) are provided relative to the first valve member 71.

[0184] The retaining components 80 (first retaining components 81, 83, and 85, and second retaining components 82, 84, and 86) shown in the aforementioned embodiments, modifications 1, and modifications 2 are composed of mutually engaging components that engage with the two valve cores constituting the first valve component 71 (or the second valve component 72) for different shapes or properties. In contrast, the third retaining component 87 shown in modification 3 is a structure that uses a single component to retain the two valve cores constituting the first valve component 71 (or the second valve component 72).

[0185] like Figure 17A and Figure 17B As shown, the third retaining member 87 is rotatably disposed relative to the outer peripheral surface of the second valve core 71b, with a support shaft 87a in a direction orthogonal to the long axis of the injection member 50 as its center. The third retaining member 87 includes a base 87b rotatably supported relative to the support shaft 87a, and a hook-shaped claw 87c provided at the front end of the base 87b and abutting against the end face of the base end of the first valve core 71a.

[0186] Multiple (two) third retaining members 87 are provided relative to the outer peripheral surface of the second valve core 71b. By providing multiple third retaining members 87, multiple portions of the end face of the first valve core 71a are fixed, thus enabling the first valve component 71 to be stably maintained in a closed state.

[0187] The third retaining member 87, by rotating about the pivot 87a, can bring the claw 87c closer to or further away from the first valve member 71. When the first valve core 71a and the second valve core 71b are in the open state, as... Figure 17A As shown, the base 87b is rotated to separate the claw portion 87c from the first valve core 71a, thus releasing the locking state. As a result, the first valve core 71a is not restricted in its movement by the third retaining member 87, and can therefore approach / separate relative to the second valve core 71b.

[0188] While keeping the first valve core 71a and the second valve core 71b in the closed state, such as Figure 17BAs shown, the base 87b is rotated so that the claw 87c approaches the first valve core 71a, causing the claw 87c to engage with the end face of the base end side of the first valve core 71a. The engagement of the claw 87c with the end face restricts the movement of the first valve core 71a, thus maintaining a close contact between the first valve core 71a and the second valve core 71b.

[0189] Furthermore, in the embodiment shown in FIG17, the third retaining member 87 is rotatably mounted on the second valve core 71b, but it can also be rotatably supported relative to the first valve core 71a. Additionally, the embodiment shown in FIG17 has a structure in which multiple third retaining members 87 are provided relative to the first valve component 71, but even a single third retaining member 87 can perform its function. Moreover, when multiple third retaining members 87 are provided, it is preferable to add them equally to the end face of the first valve core 71a, and to arrange them at equal intervals circumferentially relative to the first valve component 71. This ensures that the fixed positions of the third retaining members 87 are arranged without imbalance relative to the circumferential direction of the first valve core 71a, thus maintaining the first valve component 71 in a more stable closed state.

[0190] Additionally, although not shown, the third retaining member 87 can also be provided on the second valve member 72. By providing the third retaining member 87 on the fourth valve core 72b (or the third valve core 72a), the second valve member 72 can be kept in a closed state, similar to the first valve member 71.

[0191] The hemostatic device 100 of Modification 3 has a structure that includes a third retaining member 87 to maintain the first valve member 71 and the second valve member 72 in a closed state. The third retaining member 87 is rotatably supported for the first valve member 71 and the second valve member 72 relative to a support shaft 87a in a direction orthogonal to the long axis of the injection member 50. Therefore, when switching the open and closed states of the first valve member 71 and the second valve member 72, the third retaining member 87 can be rotated in a predetermined direction to engage or disengage the claw portion 87c, simplifying the switching operation. Furthermore, the hemostatic device 100 of Modification 3 reliably maintains the first valve member 71 and the second valve member 72 in a closed state via the third retaining member 87. Therefore, even if contact occurs with other surrounding components (tables, beds, interior walls, etc.), the closed state of the first valve member 71 and the second valve member 72 will not be released under the action of the third retaining member 87. Therefore, the hemostatic device 100 of Modified Example 3 will not cause unintentional degassing operations, and can properly maintain the pressure of the dilation component 30 on the puncture site.

[0192] [Effects]

[0193] As described above, the hemostatic device 100 of this embodiment includes: an expansion member 30 configured to compress the patient's puncture site; a band 10 and a hook and loop fastener 20 functioning 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 cavity of the expansion member 30. Furthermore, the injection member 50 includes a connector portion (first protrusion 71g) for injecting gas, a tube 60 connecting the connector portion to the cavity of the expansion member 30, and a control portion 70 for controlling the flow of gas passing through the cavity of the injection member 50. The control portion 70 includes a first valve member 71, a second valve member 72 located on the expansion member 30 side compared to the first valve member 71, and a fluid receiving portion 73 located between the first valve member 71 and the second valve member 72.

[0194] The hemostatic device 100 includes an injection unit 50 comprising a control unit 70, which has a first valve component 71, a second valve component 72, and a fluid receiving portion 73 located between the first valve component 71 and the second valve component 72. By operating the first valve component 71 and the second valve component 72, the control unit 70 can receive a predetermined amount of gas into the fluid receiving portion 73 and re-inject the gas received in the fluid receiving portion 73 into the dilator 30. In other words, the control unit 70 has the same function as a dedicated device such as a syringe S used for degassing and re-injecting gas into the dilator 30. Therefore, when depressurizing the dilator 30, the operator can operate the opening and closing states of the first valve component 71 and the second valve component 72 to cause a portion of the fluid received in the dilator 30 to flow into the fluid receiving portion 73, thereby allowing the fluid to be discharged from the dilator 30. Furthermore, when the practitioner re-injects fluid into the dilator 30, by operating the opening and closing states of the first valve component 71 and the second valve component 72, a predetermined amount of fluid contained in the fluid receiving section 73 flows into the dilator 30, thereby enabling the injection of fluid into the dilator 30. In this way, the hemostatic device 100 does not require a separate dedicated instrument, allowing for simple operation of depressurization of the dilator 30 and re-injection of fluid. Therefore, the hemostatic device 100 reduces the labor and time required for the practitioner in degassing and re-injecting the dilator 30.

[0195] Furthermore, in the hemostatic device 100 of this embodiment, the following structure is suitable. That is, it can also be configured such that the fluid receiving portion 73 is made of a material that is softer than the material of the tube 60, and the fluid receiving portion 73 can expand its shape when holding fluid in the fluid receiving portion 73.

[0196] The fluid receiving section 73 only needs to be able to hold a predetermined amount of fluid, so a tube-type structure made of a material that does not have an expansion function can be used. However, with such a tube-type structure, a certain size (length, inner diameter) is required to hold the predetermined amount of gas, and the injection member 50 becomes longer in the length direction, which may hinder the degassing operation. In this regard, the fluid receiving section 73 of the hemostatic device 100 is configured to expand, so the length of the injection member 50 in the length direction can be shortened and the predetermined amount of gas can be held in a small space, without hindering the degassing operation, thus improving operability. In addition, the fluid receiving section 73 can adjust the amount of gas that can be degassed at one time by expanding, thus reducing the number of degassing operations. Moreover, since the fluid receiving 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 contained in the fluid receiving section 73 can be temporarily increased by widening the gap between the first valve member 71 and the second valve member 72. Thus, the fluid receiving section 73 can adjust the amount of gas that can be degassed at one time, thus reducing the number of degassing operations.

[0197] In addition, the hemostatic device 100 of this embodiment is also suitable to have the following structure. That is, the fluid receiving part 73 may have a corrugated structure that allows the first valve member 71 and the second valve member 72 to extend at intervals along the length direction (long axis direction) of the control part 70.

[0198] Because the fluid containment section 73 has a corrugated structure, it can be easily extended by pulling the first valve component 71 or the second valve component 72 along the length of the control section 70 until the distance between the first valve component 71 and the second valve component 72 reaches a predetermined length. Therefore, when the operator performs a degassing operation on the dilator 30, the operator can easily adjust the amount of gas contained in the fluid containment section 73. In addition, when the flow from the dilator 30 decreases, the fluid containment section 73 expands its corrugated structure to extend the distance between the first valve component 71 and the second valve component 72, thereby generating a negative pressure within the fluid containment section 73. Therefore, since the hemostatic device 100 can forcibly release a predetermined amount of gas from the dilator 30, it can continue to discharge a predetermined amount of gas from the dilator 30 according to the depressurization procedure, without being affected by the internal pressure of the dilator 30.

[0199] Alternatively, the hemostatic device 100 of this embodiment may also have the following structure: The first valve component 71 may include: a first valve core 71a having a first hole 71d; a second valve core 71b having a second hole 71e and disposed opposite to the first valve core 71a; and a deformable first connecting member 71c connecting the first valve core 71a and the second valve core 71b. Furthermore, the second valve component 72 may include: a third valve core 72a having a third hole 72d; a fourth valve core 72b having a fourth hole 72e and disposed opposite to the third valve core 72a; and a deformable second connecting member 72c connecting the third valve core 72a and the fourth valve core 72b. Alternatively, when the end face of the first valve core 71a is projected onto the end face of the second valve core 71b, the first hole 71d may be positioned at a different location than the second hole 71e, and when the end face of the third valve core 72a is projected onto the end face of the fourth valve core 72b, the third hole 72d may be positioned at a different location than the fourth hole 72e.

[0200] By configuring the first valve component 71 such that when the first valve core 71a and the second valve core 71b are in close contact, the first orifice 71d and the second orifice 71e are blocked, resulting in a closed state; and when the first valve core 71a and the second valve core 71b are separated, the first orifice 71d and the second orifice 71e are opened, resulting in an open state. Similarly, when the second valve component 72 is in close contact with the third valve core 72a and the fourth valve core 72b, the third orifice 72d and the fourth orifice 72e are blocked, resulting in a closed state; and when the third valve core 72a and the fourth valve core 72b are separated, the third orifice 72d and the fourth orifice 72e are opened, resulting in an open state. Therefore, the operator can switch the open and closed states of the first valve component 71 and the second valve component 72 with a simple operation without performing complex procedures. Therefore, the hemostatic device 100 can further reduce the labor and time required for the operator to perform the degassing operation of the dilator 30 and the re-injection operation.

[0201] Alternatively, the hemostatic device 100 of this embodiment may also be suitably structured as follows: that is, the first valve component 71 may have a first fixing and retaining component 81, 83 or 85 that keeps the first valve core 71a and the second valve core 71b in close contact, and the second valve component 72 may have a second fixing and retaining component 82, 84 or 86 or 84 that keeps the third valve core 72a and the fourth valve core 72b in close contact.

[0202] The first valve component 71 has a first retaining component 81, and the second valve component 72 has a second retaining component 82, thus enabling the first valve component 71 and the second valve component 72 to be kept in a closed state. Therefore, when the hemostatic device 100 keeps the first valve component 71 and the second valve component 72 in a closed state, the operator does not need to maintain the close contact between the first valve core 71a and the second valve core 71b (the third valve core 72a and the fourth valve core 72b) by hand, or maintain the close contact between the first valve core 71a and the second valve core 71b (the third valve core 72a and the fourth valve core 72b) by clamps or other components. Therefore, the hemostatic device 100 can reliably maintain the closed state of the first valve component 71 and the second valve component 72 with a simple structure. Even if it comes into contact with other surrounding components (table, bed, room walls, etc.), the closed state of the first valve component 71 and the second valve component 72 will not be released under the action of the first fixing and holding component 81 and the second fixing and holding component 82. As a result, the hemostatic device 100 will not cause unintentional degassing operations, and can properly maintain the pressure of the dilation component 30 on the puncture site.

[0203] Alternatively, the hemostatic device 100 of this embodiment may also have the following structure: The first fixing and retaining member 81 (or 83) may also include a first engaging portion 81a (or 83a) located at the end of the first valve core 71a opposite to the second valve core 71b, and a second engaging portion 81b (or 83b) located at the end of the second valve core 71b opposite to the first valve core 71a and engaging with the first engaging portion 81a (or 83a). Furthermore, the second fixing and retaining member 82 (or 84) may also include a third engaging portion 82a (or 84a) located at the end of the third valve core 72a opposite to the fourth valve core 72b, and a fourth engaging portion 82b (or 84b) located at the end of the fourth valve core 72b opposite to the third valve core 72a and engaging with the third engaging portion 82a (or 84a). It can also be configured such that the first engaging portion 81a (or 83a) and the second engaging portion 81b (or 83b) engage by relative movement of the first valve core 71a and the second valve core 71b while the first valve core 71a and the second valve core 71b are in close contact, and the third engaging portion 82a (or 84a) and the fourth engaging portion 82b (or 84b) engage by relative movement of the third valve core 72a and the fourth valve core 72b while the third valve core 72a and the fourth valve core 72b are in close contact.

[0204] To maintain the closed state of the first valve component 71, the hemostatic device 100 includes a first engaging portion 81a (or 83a) and a second engaging portion 81b (or 83b) that engage when the first valve core 71a and the second valve core 71b are in close contact and move relative to each other. Similarly, to maintain the closed state of the second valve component 72, the hemostatic device 100 includes a third engaging portion 82a (or 84a) and a fourth engaging portion 82b (or 84b) that engage when the third valve core 72a and the fourth valve core 72b are in close contact and move relative to each other. Therefore, the operator can reliably maintain the closed state of either the first valve component 71 or the second valve component 72 by simply moving the first valve core 71a relative to the second valve core 71b, or by moving the third valve core 72a relative to the fourth valve core 72b. Therefore, even if the hemostatic device 100 comes into contact with other surrounding components (table, bed, interior walls, etc.), the closed state of the first valve component 71 and the second valve component 72 will not be released under the action of the first retaining component 81 (or 83) and the second retaining component 82 (or 84). Thus, the hemostatic device 100 will not cause unintentional degassing operations, and can appropriately maintain the pressure of the dilation component 30 on the puncture site.

[0205] Alternatively, the hemostatic device 100 of this embodiment may also have the following structure: The first fixing and retaining member 85 may also include: a first engaging portion 85a made of magnetic material, disposed on the end face of the first valve core 71a opposite to the second valve core 71b; and a second engaging portion 85b made of magnetic material, disposed on the end face of the second valve core 71b opposite to the first valve core 71a and magnetically connected to the first engaging portion 85a. Furthermore, the second fixing and retaining member 86 may also include: a third engaging portion 86a made of magnetic material, disposed on the end face of the third valve core 72a opposite to the fourth valve core 72b; and a fourth engaging portion 86b made of magnetic material, disposed on the end face of the fourth valve core 72b opposite to the third valve core 72a and magnetically connected to the third engaging portion 86a.

[0206] In the hemostatic device 100, the first valve component 71 includes a first retaining member 85 composed of a first engaging portion 85a and a second engaging portion 85b that can be magnetically connected, and the second valve component 72 includes a second retaining member 86 composed of a third engaging portion 86a and a fourth engaging portion 86b that can be magnetically connected. Therefore, when switching between the open and closed states of the first valve component 71 and the second valve component 72, the first valve component 71 will remain closed by simply performing an approach / separation operation on the first valve core 71a and the second valve core 71b, and the second valve component 72 will remain closed by simply performing an approach / separation operation on the third valve core 72a and the fourth valve core 72b. Thus, the hemostatic device 100 can control the flow of gas with a simple structure. Furthermore, because the hemostatic device 100 is equipped with the first retaining member 85 and the second retaining member 86, even if it comes into contact with other surrounding components (table, bed, room walls, etc.), the closed state of the first valve member 71 and the second valve member 72 will not be released under the action of the first retaining member 85 and the second retaining member 86. Therefore, the hemostatic device 100 will not cause unintentional degassing operations, and can appropriately maintain the pressure of the dilation member 30 on the puncture site.

[0207] This application is based on Japanese Patent Application No. 2020-178745, filed on October 26, 2020, the disclosure of which is incorporated herein by reference in its entirety.

[0208] Explanation of reference numerals in the attached figures

[0209] 10 bands,

[0210] 11 stripes,

[0211] 12 Support plates,

[0212] 20 Hook and loop fasteners (21 male side, 22 female side),

[0213] 30 Expansion components,

[0214] 31. Expanding space,

[0215] Mark 40

[0216] 50 Injection components,

[0217] 60 tubes

[0218] 70 Control Department

[0219] 71 First valve component (71a First valve core, 71b Second valve core, 71c First connecting component, 71d First bore, 71e Second bore, 71f First flow space, 71g First protrusion)

[0220] 72 Second valve component (72a Third valve core, 72b Fourth valve core, 72c Second connecting component, 72d Third hole, 72e Fourth hole, 72f Second flow space, 72g Second protrusion)

[0221] 73. Fluid containment section,

[0222] 80 Fixed retaining components,

[0223] 81, 83, 85 First retaining components (81a, 83a, 85a first engaging part, 81b, 83b, 85b second engaging part),

[0224] 82, 84, 86, second retaining components (82a, 84a, 86a, third engaging part; 82b, 84b, 86b, fourth engaging part),

[0225] 87. Third fixed retaining component.

[0226] 100 hemostatic instruments,

[0227] R radial artery,

[0228] S syringe,

[0229] W refers to the wrist.

Claims

1. A hemostatic device, comprising: The dilation component is configured to compress the patient's puncture site; A fixation component configured to fix the dilation component to the puncture site of the patient; and An injection component is configured to inject fluid into the cavity of the expansion component. The injection component includes a connector portion for injecting the fluid, a main body portion connecting the connector portion to the inner cavity of the expansion component, and a control portion for controlling the flow of the fluid passing through the inner cavity of the injection component. The control unit includes a first valve component, a second valve component located on the expansion component side compared to the first valve component, and a fluid receiving portion located between the first valve component and the second valve component. The first valve component includes: a first valve core having a first hole; a second valve core having a second hole and disposed opposite to the first valve core; and a deformable first connecting member connecting the first valve core and the second valve core. The second valve component includes: a third valve core having a third hole; a fourth valve core having a fourth hole and disposed opposite to the third valve core; and a deformable second connecting component connecting the third valve core and the fourth valve core. When the end face of the first valve core is projected onto the end face of the second valve core, the first hole is positioned at a different location than the second hole. When the end face of the third valve core is projected onto the end face of the fourth valve core, the third hole is positioned at a different location than the fourth hole.

2. The hemostatic device according to claim 1, wherein, The fluid containment section is made of a material that is softer than the material of the main body. When the fluid is held in the fluid, the fluid receiving part can expand its shape.

3. The hemostatic device according to claim 1 or 2, wherein, The fluid receiving portion has a corrugated structure that allows the first valve component and the second valve component to extend at a distance along the length of the control portion.

4. The hemostatic device according to claim 1 or 2, wherein, The first valve component includes a first retaining member that maintains the first valve core and the second valve core in close contact. The second valve component includes a second retaining component that maintains the third valve core and the fourth valve core in close contact.

5. The hemostatic device according to claim 4, wherein, Composed of, The first retaining member includes: a first engaging portion disposed at the end of the first valve core opposite to the second valve core; and a second engaging portion disposed at the end of the second valve core opposite to the first valve core, and engaging with the first engaging portion. The second retaining member includes: a third engaging portion disposed at the end of the third valve core opposite to the fourth valve core; and a fourth engaging portion disposed at the end of the fourth valve core opposite to the third valve core, and engaging with the third engaging portion. The first engaging portion and the second engaging portion engage through the relative movement of the first valve core and the second valve core while the first valve core and the second valve core are in close contact. The third and fourth engaging portions engage through relative movement of the third and fourth valve cores while the third and fourth valve cores are in close contact.

6. The hemostatic device according to claim 4, wherein, The first retaining component includes: a first engaging portion made of magnetic material, disposed on the end face of the first valve core opposite to the second valve core; and a second engaging portion made of magnetic material, disposed on the end face of the second valve core opposite to the first valve core, and magnetically connected to the first engaging portion. The second retaining component includes: a third engaging portion made of magnetic material, which is disposed on the end face of the third valve core opposite to the fourth valve core; and a fourth engaging portion made of magnetic material, which is disposed on the end face of the fourth valve core opposite to the third valve core and is magnetically connected to the third engaging portion.

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