Hemostatic device

Abstract

To provide a hemostatic device capable of correctly and easily discharging a desired amount of fluid, every time of decompression, even when performing decompression of fluid from an expansion part over multiple times.SOLUTION: A hemostatic device 100 comprises: an expansion part 130 expanding by injection of fluid; one or more tubes 160 connected to the expansion part; injection parts 170 provided on the tubes and injecting fluid into the expansion part through the tubes; multiple container parts 180 connected to the expansion part through the tubes, and allowing fluid injected into the expansion part to move into outside of the expansion part; and a channel switching part 190 connected to the tubes, and capable of being switched reversibly between a communication state and a non-communication state of the expansion part and the container parts, wherein at least one of the multiple container parts is provided between the injection part and the expansion part, and the channel switching part is provided between the expansion part and the respective container parts.SELECTED DRAWING: Figure 1

Description

Technical Field

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

Background Art

[0002] In recent years, a blood vessel such as the radial artery of the arm is punctured, an introducer sheath is introduced into the puncture site, and a catheter or the like is inserted into a lesion such as a blood vessel through the lumen of the introducer sheath, and percutaneous treatment, examination, etc. are performed. When such a method is carried out, it is necessary to stop bleeding at the puncture site after removing the introducer sheath.

[0003] As a medical device for performing the above-mentioned hemostasis, there is known a hemostatic device including a band for winding around a puncture site of the arm, a fixing portion for fixing the band in a state of being wound around the puncture site, and an expansion portion configured to expand by injecting a fluid and compress the puncture site.

[0004] In the hemostasis method using the above-mentioned hemostatic device, in order to avoid complications such as blood vessel occlusion due to compression of the puncture site over a long period of time, a decompression operation is sometimes performed in which the compressive force applied by the expansion portion to the puncture site is gradually decreased in multiple steps according to a predetermined decompression protocol during hemostasis.

[0005] In relation to the above-mentioned hemostasis method, for example, Patent Document 1 discloses a hemostatic device including an injection portion with a check valve for preventing leakage of the fluid injected into the expansion portion. When a doctor or a nurse (hereinafter referred to as "operator") contracts the expansion portion to reduce the compressive force, an injection device such as a syringe is connected to the injection portion and the check valve is opened. The operator can discharge the fluid from the expansion portion by operating the pusher of the injection device with the check valve open.

Prior Art Documents

Patent Documents

[0006]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0007] When performing hemostasis using the hemostatic device of Patent Document 1, each time the operator performs a decompression operation to discharge fluid from the expansion part, it is necessary to connect an injection device to the injection part. In addition, in order to achieve the discharge of a desired amount of fluid, the operator must pay careful attention to accurately adjusting the movement amount of the pusher of the injection device each time the decompression operation is performed. Therefore, in the hemostasis method using the hemostatic device of Patent Document 1, when performing the decompression operation multiple times according to the decompression protocol as described above, not only does the burden on the operator become excessive, but it also leads to a decrease in the efficiency of clinical services in the medical field.

[0008] The present invention has been made to solve the above-described problems, and an object thereof is to provide a hemostatic device that can easily and appropriately discharge a desired amount of fluid each time a decompression operation is performed even when decompressing fluid from the expansion part multiple times.

Means for Solving the Problems

[0009] The above object of the present invention is achieved by the following means.

[0010] (1) A flexible band that can be wound around a part of a limb to be hemostatic, A fixing part that fixes the band in a state where it is wound around the limb, An expansion part that is connected to the band and expands by injecting fluid, One or more tubes connected to the expansion part, An injection part provided in the tube for injecting fluid into the inside of the expansion part through the tube, A plurality of container parts that are connected to the expansion part through the tube and allow the fluid injected into the inside of the expansion part to move to the outside of the expansion part, It is connected to the tube and has a flow path switching unit that can reversibly switch between the communicating state and the non-communicating state of the expansion unit and the container unit. At least one of the plurality of container units is provided between the injection unit and the expansion unit. The hemostatic device is characterized in that the flow path switching unit is provided between the expansion unit and each of the container units.

[0011] (2) The tube has an injection tube to which the injection unit is connected, at least one branch portion, a branch tube extending from the branch portion, and the container unit and the flow path switching unit each connected to at least one of the injection tube and the branch tube. The hemostatic device according to (1) above.

[0012] (3) The container unit is composed of a flexible member having a lumen capable of holding a fluid. The hemostatic device according to (1) or (2) above.

[0013] (4) The internal volumes of the plurality of container units are all equal. The hemostatic device according to any one of (1) to (3) above.

[0014] (5) The total volume of the plurality of container units is smaller than the internal volume of the expansion unit. The hemostatic device according to any one of (1) to (4) above.

[0015] (6) Two or more branch portions are provided in the tube, a plurality of branch tubes are provided corresponding to the number of the branch portions, and at least one container unit and at least one flow path switching unit are connected to each of the plurality of branch tubes. The hemostatic device according to (2) above.

Advantages of the Invention

[0016] (1) The hemostatic device described in (1) has an expansion part that expands by injecting fluid, a plurality of container parts connected to the expansion part, and a flow path switching part provided between the expansion part and each container part, which can reversibly switch between a communication state and a non-communication state between the expansion part and the container part. When the operator performs a decompression operation on the expansion part during hemostasis using the above hemostatic device, by switching to open the flow path switching part, a desired amount of fluid can be easily moved (discharged) from the expansion part to an arbitrary container part. Further, when the operator discharges a desired amount of fluid from the expansion part multiple times according to a predetermined decompression protocol during hemostasis, by switching to open an arbitrary flow path switching part each time a decompression operation is performed, fluid can be discharged from the expansion part in an amount corresponding to the number of container parts. Therefore, when the operator performs a decompression operation on the expansion part multiple times, a desired amount of fluid can be easily and appropriately discharged each time the decompression operation is performed. Accordingly, the above hemostatic device can significantly reduce the burden on the operator associated with the decompression operation and can improve the efficiency of clinical services in the medical field.

Brief Description of the Drawings

[0017]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

Figure 10

Mode for Carrying Out the Invention

[0018] Hereinafter, with reference to FIGS. 1 to 5, a hemostatic device 100 according to an embodiment of the present invention will be described. FIG. 1 is a plan view showing the overall configuration of the hemostatic device 100 (a plan view seen from the outer surface side of the belt body 110), FIG. 2 is a cross-sectional view taken along the arrow 2A-2A shown in FIG. 1, FIG. 3 is a perspective view showing a usage example of the hemostatic device 100, and FIG. 4 is a schematic cross-sectional view showing a usage example of the hemostatic device 100 (a cross-sectional view of the limb A in a state where the expansion part 130 is expanded to compress the part p to be hemostatic). Note that the dimensional ratios in each drawing are exaggerated for convenience of explanation and may be different from the actual ratios.

[0019] As shown in FIGS. 3 and 4, the hemostatic device 100 is a medical device used to stop bleeding at the part p to be hemostatic, such as a puncture site formed on the patient's limb A (for example, the wrist or forearm) after removing the introducer sheath that had been placed at the part p to be hemostatic for the purpose of inserting a catheter or the like for performing treatment, examination, etc. into the blood vessel.

[0020] As shown in FIGS. 1 to 4, generally speaking, the hemostatic device 100 includes a flexible belt 110 that can be wound around a site p to be hemostatic on a limb A, a fixing portion 120 that fixes the belt 110 in a state where it is wound around the limb A, an expansion portion 130 that is connected to the belt 110 and expands by injecting a fluid, one or more tubes 160 connected to the expansion portion 130, an injection portion 170 provided on the tube 160 for injecting a fluid into the interior of the expansion portion 130 via the tube 160, a plurality of container portions 180 connected to the expansion portion 130 via the tube 160 and enabling the fluid injected into the interior of the expansion portion 130 to move to the outside of the expansion portion 130, and a flow path switching portion 190 connected to the tube 160 and capable of reversibly switching the communication state and non-communication state between the expansion portion 130 and the container portions 180. At least one of the plurality of container portions 180 is provided between the injection portion 170 and the expansion portion 130, and the flow path switching portion 190 is provided between the expansion portion 130 and each of the container portions 180.

[0021] <belt 110> As shown in FIGS. 1 and 3, the belt 110 has a predetermined length that can be wound around a patient's limb A where the site p to be hemostatic is formed. In FIGS. 1 and 2, the longitudinal direction of the belt 110 is indicated by the arrow X1-X2. In this embodiment, the end of the belt 110 located on the X1 side of the arrow is referred to as the "one end", and the end of the belt 110 located on the X2 side of the arrow is referred to as the "other end".

[0022] As shown in FIG. 2, the belt 110 has a main body portion 111 and a cover portion 112 disposed so as to cover a part of the main body portion 111.

[0023] A predetermined holding portion (holding space) 113 is formed between the main body portion 111 and the cover portion 112. A support plate 115 made of a material harder than the main body portion 111 and the cover portion 112 can be disposed in the holding portion 113.

[0024] The support plate 115 has a curved cross-sectional shape as shown in FIG. 2. When the hemostatic device 100 applies a compressive force to the site p to be hemostatic, since the support plate 115 is disposed on the belt 110, the expanded expansion part 130 is pressed against the limb A side, thereby preventing the compressive force applied from the expansion part 130 to the site p to be hemostatic from decreasing (see FIG. 4).

[0025] As shown in FIG. 2, the expansion part 130 is connected to the inner surface 110a (the inner surface of the main body part 111) of the belt 110. The expansion part 130 is disposed at a position shifted to the other end side rather than the central part in the longitudinal direction of the belt 110.

[0026] As materials for constituting the main body part 111 and the cover part 112 of the belt 110, for example, resin materials such as polyvinyl chloride, polyethylene, polypropylene, polybutadiene, polyolefins such as ethylene-vinyl acetate copolymer (EVA), polyethylene terephthalate (PET), and polybutylene terephthalate (PBT) can be used.

[0027] When each part 111, 112 of the belt 110 is made of the above materials, as the material of the support plate 115, for example, acrylic resin, polyvinyl chloride (especially rigid polyvinyl chloride), polyethylene, polypropylene, etc. can be used.

[0028] Preferably, the portion of the belt 110 and the support plate 115 where the expansion part 130 is disposed is configured to be transparent (including translucent and colored transparent). By configuring in this way, when the expansion part 130 is disposed overlapping the site p to be hemostatic as shown in FIG. 3, the operator can easily visually confirm the position and state of the site p to be hemostatic through the belt 110 and the support plate 115.

[0029] (Fixing part 120) As shown in FIGS. 1 and 2, the fixing part 120 can be constituted by, for example, a first fixing member 121 disposed near one end of the belt 110 and a second fixing member 122 disposed near the other end of the belt 110.

[0030] The first fixing member 121 can be disposed on the inner surface 110a of the belt 110. The first fixing member 121 can be constituted by, for example, the male side (or female side) of a hook-and-loop fastener.

[0031] The second fixing member 122 can be disposed on the outer surface 110b (the outer surface of the main body portion 111) of the belt 110. The second fixing member 122 can be constituted by, for example, the female side (or male side) of a hook-and-loop fastener that is detachable from the first fixing member 121.

[0032] The hook-and-loop fastener in this specification is a fastener that can be detachably attached in a planar manner, and is, for example, Magic Tape (registered trademark) or Velcro (registered trademark).

[0033] As shown in FIG. 3, when the belt 110 is wound around the limb A of the patient, the operator can fix the hemostatic instrument 100 to the limb A of the patient by connecting the fixing members 121 and 122 to each other.

[0034] Note that the fixing portion 120 (the first fixing member 121 and the second fixing member 122) is not limited to a specific structure as long as it can fix the belt 110 in a state where it is wound around the limb A. For example, a configuration can be adopted in which the male side and the female side of the hook-and-loop fastener are interchanged between the fixing members 121 and 122. Further, the fixing portion 120 can also be constituted by, for example, a connecting mechanism including a snap, a button, a clip, a frame portion formed with a protrusion, and an engaged portion formed with a hole portion that can be engaged with the frame portion.

[0035] (Expansion portion 130) As shown in FIGS. 2 and 3, the expansion portion 130 can be constituted by, for example, a balloon that is expanded by injecting a fluid. In the present embodiment, the expansion portion 130 is constituted by two balloons, a first balloon 140 and a second balloon 150 having a volume smaller than that of the first balloon 140.

[0036] As shown in FIG. 4, the first balloon 140 includes a lumen 141 into which fluid can be injected. The first balloon 140 expands when fluid is injected into the lumen 141 and contracts when fluid is discharged from the lumen 141.

[0037] As shown in FIG. 4, the second balloon 150 includes a lumen 151 into which fluid can be injected. The second balloon 150 expands when fluid is injected into the lumen 151 and contracts when fluid is discharged from the lumen 151.

[0038] The lumen 141 of the first balloon 140 and the lumen 151 of the second balloon 150 are communicated via a communication hole 142 formed in the first balloon 140 and a communication hole 152 formed in the second balloon 150.

[0039] The first balloon 140 can be connected to the second balloon 150 by fusion, an adhesive, or the like around each of the communication holes 142 and 152. The second balloon 150 can be connected to the inner surface 110a of the belt body 110 by fusion, an adhesive, or the like.

[0040] In the present embodiment, a tube 160 that enables fluid to move in and out of the expansion part 130 is connected to the second balloon 150. When an operator injects fluid into the second balloon 150 through the tube 160, the fluid flows into the lumen 141 of the first balloon 140 through the lumen 151, the communication hole 152, and the communication hole 142 of the second balloon 150. Note that the tube 160 may be connected to the first balloon 140, or may be connected to both balloons of the first balloon 140 and the second balloon 150 as shown in a modification example described later (see FIGS. 9 and 10).

[0041] The first balloon 140 can be formed by joining the outer peripheral edges of two sheet-like members with a lumen 141 formed therebetween, for example, in a substantially rectangular shape. The second balloon 150 can also be composed of two sheet-like members in the same manner as described above. The sheet-like members constituting the first balloon 140 and the second balloon 150 can be made of the same material as the constituent material of the aforementioned belt-like body 110 (main body portion 111 and cover portion 112) and the exemplified materials.

[0042] Note that the first balloon 140 and the second balloon 150 are not particularly limited in terms of specific shape and structure as long as they are configured to be expandable and contractible with the injection and discharge of fluid. For example, each balloon 140, 150 can also be constituted by a single bag-like member formed to have a lumen inside. Further, for example, the first balloon 140 and / or the second balloon 150 can be provided with a marker portion or the like used as a guide when aligning the expansion portion 130 with the site p to be hemostatic.

[0043] Also, the hemostatic instrument 100 may not include the second balloon 150. When the expansion portion 130 is composed of only a single balloon (a balloon corresponding to the first balloon 140), the tube 160 can be connected to the single balloon.

[0044] As shown in FIG. 4, when the expansion portion 130 is expanded with the hemostatic instrument 100 attached to the patient's limb A, the first balloon 140 applies a compressive force to the site p to be hemostatic. At this time, the second balloon 150 adjusts the direction of the compressive force applied by the first balloon 140 to the site p to be hemostatic in the direction toward the site p to be hemostatic. Thereby, the hemostatic instrument 100 can effectively apply a compressive force from the expansion portion 130 to the site p to be hemostatic.

[0045] (Tube 160, Container portion 180, Flow path switching portion 190) As shown in FIG. 1, at least one of the plurality of container portions 180 is provided between the injection portion 170 and the expansion portion 130. Further, the flow path switching portion 190 is provided between the expansion portion 130 and each of the container portions 180. By providing at least one of the plurality of container portions 180 between the injection portion 170 and the expansion portion 130, it becomes possible to reduce the number of tubes for connecting to the decompression container, and the work load during the operation by the operator can be reduced.

[0046] The tube 160 has an injection tube 161 to which the injection portion 170 is connected, at least one branch portion 163, a branch tube 164 extending from the branch portion 163, and a flow path switching portion 190 and a container portion 180 each connected to at least one of the injection tube 161 and the branch tube 164.

[0047] In the present embodiment, each of the container portions 181, 182, 183 described later is collectively referred to as the "container portion 180", each of the flow path switching portions 191, 192, 193 described later is collectively referred to as the "flow path switching portion 190", each of the branch portions 163a, 163b described later is collectively referred to as the "branch portion 163", and each of the branch tubes 164a, 164b described later is collectively referred to as the "branch tube 164". In FIG. 1, in order to clearly show the relationship between the respective constituent members, the reference numerals 180, 190, 163, and 164 are also shown together.

[0048] As shown in FIGS. 1 and 3, in the present embodiment, the tube 160 is configured to have one injection tube 161 and two branch tubes 164a, 164b.

[0049] The tube 160 is connected to the second balloon 150 as described above. The tube 160 has a first branch portion 163a that forms a branch between the injection tube 161 side and the branch tube 164 side when viewed from the expansion portion 130 side (upstream side in the fluid discharge direction), and a second branch portion 163b provided at a location farther from the expansion portion 130 side than the first branch portion 163a (downstream side in the fluid discharge direction).

[0050] The injection tube 161 is connected to one flow path switching section 190 and one container section 180. In the present embodiment, the container section 180 connected to the injection tube 161 is referred to as the "first container section 181", and the flow path switching section 190 connected to the injection tube 161 is referred to as the "first flow path switching section 191".

[0051] The first flow path switching section 191 is disposed between the expansion section 130 (the second balloon 150) and the first container section 181 on the injection tube 161.

[0052] A part of the tube 160 branched at the first branch section 163a further branches via the second branch section 163b.

[0053] One flow path switching section 190 and one container section 180 are connected to the first branch tube 164a branched from the second branch section 163b to one side. In the present embodiment, the container section 180 connected to the first branch tube 164a is referred to as the "second container section 182", and the flow path switching section 190 connected to the first branch tube 164a is referred to as the "second flow path switching section 192".

[0054] The second flow path switching section 192 is disposed between the expansion section 130 (the second balloon 150) and the second container section 182 on the first branch tube 164a.

[0055] One flow path switching section 190 and one container section 180 are connected to the second branch tube 164b branched from the second branch section 163b to the other side. In the present embodiment, the container section 180 connected to the second branch tube 164b is referred to as the "third container section 183", and the flow path switching section 190 connected to the second branch tube 164b is referred to as the "third flow path switching section 193".

[0056] The second flow path switching section 192 is disposed between the expansion section 130 (the second balloon 150) and the third container section 183 on the second branch tube 164b.

[0057] As the tube 160 (injection tube 161, branch tube 164), a tube made of a resin material having a lumen through which a fluid can flow can be used.

[0058] The tube 160 can be manufactured, for example, by the following procedure. Prepare a tube forming the injection tube 161, and connect a first branch tube 164a to a portion forming the first branch portion 163a of this tube by welding or the like. Further, connect a second branch tube 164b to a portion forming the second branch portion 163b of the first branch tube 164a extending from the first branch portion 163a by welding or the like. By the above operations, a tube 160 including one injection tube 161, two branch portions 163a and 163b, and two branch tubes 164a and 164b can be easily manufactured.

[0059] Each of the container portions 181, 182, and 183 can be formed of a flexible member having a lumen 180a capable of holding a liquid. As the material constituting each of the container portions 181, 182, and 183, for example, the same materials as those exemplified as the material constituting the expansion portion 130 (the same as the material constituting the belt 110) can be used. The number of container portions 180 in the hemostatic device 100 is not limited to three, and may be less than or more than three as long as it can correspond to the number of decompression times specified in a predetermined decompression protocol.

[0060] In the present embodiment, the internal volumes (the volumes of the lumens 180a) of the container portions 181, 182, and 183 are all equal.

[0061] Also, in the present liquid, the total volume of the plurality of container portions 181, 182, and 183 is smaller than the internal volume of the expansion portion 130 (the total volume of the lumen 141 of the first balloon 140 and the lumen 151 of the second balloon 150).

[0062] When the total volume of each of the container parts 181, 182, and 183 is configured such that the maximum internal volume of the expansion part 130 is 15 ml to 25 ml, for example, it is preferably set to 4.5 ml to 7.5 ml. In clinical practice, the amount of fluid injected into the expansion part 130 does not exceed 20 ml. However, considering the amount of air remaining in the container part 180 before use, it is preferable to set the internal volume of the expansion part 130 within the above range. Further, when the total volume of each of the container parts 181, 182, and 183 is set as described above, the internal volume of each of the container parts 181, 182, and 183 is preferably, for example, 1.5 ml to 2.5 ml. Note that the internal volume of each of the container parts 181, 182, and 183 is not particularly limited as long as bleeding does not occur from the site p to be hemostatic during the decompression operation based on a predetermined decompression protocol, and more preferably, it is 2 ml.

[0063] Each of the flow path switching parts 191, 192, and 193 can be configured by, for example, a known valve mechanism for controlling fluid. As an example, a flow path switching part 190 having a clamp mechanism capable of opening and closing the inner cavity (flow path) of the tube 160 along with a simple opening and closing operation can be used. By providing the flow path switching part 190 with a clamp mechanism, it becomes possible to completely switch the communication state and non-communication state of the inner cavity of the tube 160. As a result, the amount of fluid moving from the expansion part 130 becomes clear, and a more quantitative decompression operation becomes possible rather than allowing the fluid to flow out over time. Further, since the inner cavity of the tube 160 can be opened and closed by a simple opening and closing operation, it becomes possible to move the fluid bidirectionally between the expansion part 130 and the container part 180 at an arbitrary timing.

[0064] (Injection part 170) The injection part 170 can be configured by, for example, a connector made of a rigid resin in which a check valve 171 is disposed inside. The check valve 171 can be configured by a known check valve that maintains a closed state when no external force is applied and has a slit that opens when a member such as the nozzle of an injection instrument is inserted therethrough.

[0065] In the injection part 170, an injection device (such as a syringe) for injecting fluid into the inner cavities of the expansion part 130 (the inner cavities 141 and 151 of each balloon 140 and 150) can be connected. The operator can open the check valve 171 by inserting the nozzle (tip cylinder part) of the injection device into the injection part 170. Also, the operator can close the check valve 171 by removing the nozzle of the injection device inserted into the injection part 170.

[0066] <Usage example of the hemostatic device 100> Next, a usage example of the hemostatic device 100 will be described.

[0067] As shown in FIGS. 3 and 4, when hemostasis is performed on the site p to be hemostatic, the user wraps the belt body 110 around the patient's limb A. The user fixes the belt body 110 to the patient's limb A using the fixing part 120 in the state where the belt body 110 is wrapped around the patient's limb A, and attaches the hemostatic device 100 to the patient.

[0068] When attaching the hemostatic device 100 to the limb A as described above, if a medical device such as an introducer is inserted at the site p to be hemostatic, the operator can arrange the expansion part 130 (the first balloon 140 and the second balloon 150) so as to cover the site p in the state where the introducer is inserted at the site p to be hemostatic.

[0069] The operator expands the expansion part 130 in the state where the expansion part 130 is arranged so as to overlap the site p to be hemostatic. Prior to expanding the expansion part 130, the operator opens the first flow path switching part 191 and closes the second flow path switching part 192 and the third flow path switching part 193. The operator connects an injection device (not shown) to the injection part 170 in the state where each flow path switching part 191, 192, 193 is switched as described above, and further operates the injection device to inject fluid into the expansion part 130 via the first container part 181 and the injection tube 161. The fluid used for expanding the expansion part 130 is a gas such as air, for example.

[0070] When fluid is injected, the expansion part 130 expands as shown in FIG. 4 and applies a compressive force to the site p to be hemostatic. Note that the site p to be hemostatic shown in this embodiment is, for example, a puncture site formed between a blood vessel such as the radial artery V and the skin surface (body surface).

[0071] When expanding the expansion part 130 as described above, by closing the second flow path switching part 192 and the third flow path switching part 193, it is possible to prevent the fluid injected through the injection part 170 from being injected into the second container part 182 and the third container part 183. Therefore, the operator can quickly inject a predetermined amount of fluid into the expansion part 130 and prevent the time required to expand the expansion part 130 from becoming too long.

[0072] The first container part 181 is connected to the expansion part 130 via the injection tube 161. Therefore, after injecting a predetermined amount of fluid into the expansion part 130 and the expansion part 130 expands, if the injection of the fluid is continued, the first container part 181 expands following the expansion part 130. The operator can easily grasp that the expansion part 130 has expanded until it reaches a predetermined expansion amount by visually confirming the expansion of the first container part 181.

[0073] The operator injects a predetermined amount of fluid into the expansion part 130 and starts compression hemostasis by the expansion part 130. When injecting the fluid, the operator can confirm that a predetermined internal pressure is applied to the expansion part 130 by touching with a fingertip or the like to confirm that the first container part 181 is sufficiently expanded by the fluid. Then, the first container part 181 is crushed with a finger to completely extrude the fluid existing in the inner cavity 180a to the expansion part 130 side, and then the first flow path switching part 191 is closed. By removing the fluid from the inner cavity 180a before closing the first flow path switching part 191, the operator can use the first container part 181 not only for confirming the internal pressure of the expansion part 130 but also as a container for discharging fluid during the decompression operation. In addition, by closing the first flow path switching part 191, the operator can maintain the expanded state of the expansion part 130 and preferably maintain a state in which a predetermined compressive force is applied to the site p to be hemostatic from the expansion part 130. After expanding the expansion part 130, the operator appropriately removes the introducer from the site p to be hemostatic.

[0074] When the operator starts the decompression operation of the expansion part 130 according to a predetermined decompression protocol, the operator switches from the state where any one of the plurality of flow path switching parts 191, 192, 193 is closed to the open state. At the stage of performing the decompression operation of the expansion part 130, the internal pressure of the expansion part 130 is of a magnitude sufficient to apply a sufficient compressive force to the site p to be hemostatic (for example, an internal pressure corresponding to an internal volume of 4 ml to 25 ml of the expansion part 130). Therefore, when switching from the state where the flow path switching part 190 is closed to the open state as described above, the fluid is automatically discharged from the expansion part 130 to the container part 180.

[0075] Each time the operator opens one flow path switching section 190, the expansion section 130 and one container section 180 are in fluid communication, so that an amount of fluid corresponding to the volume of the inner cavity 180a of the one container section 180 can be discharged from the expansion section 130. Therefore, the operator can quantitatively discharge a predetermined volume of fluid corresponding to the volume of the inner cavity 180a of the one container section 180 from the expansion section 130 by a simple operation of opening the flow path switching section 190. Further, the operator can reduce the pressing force applied by the expansion section 130 to the site p to be hemostatic according to the volume of the discharged fluid.

[0076] After the operator performs a pressure reducing operation to discharge fluid from the expansion section 130 to one container section 180 (for example, the first container section 181), the operator closes the first flow path switching section 191. By closing the first flow path switching section 191, the operator can continue hemostasis with the hemostasis device 100 while the pressing force applied by the expansion section 130 to the site p to be hemostatic is reduced by the volume of the inner cavity 180a of the first container section 181.

[0077] As described above, when the operator performs a pressure reducing operation on the expansion section 130, there is no need to connect an injection device to the injection section 170. Therefore, the work of connecting an injection device to the injection section 170 can be omitted. Further, when performing a pressure reducing operation using an injection device, in order to accurately discharge a desired amount of fluid from the injection section 170, it is necessary to precisely and accurately operate the operation amount of the pusher or the like of the injection device. According to the hemostasis device 100, since a desired amount of fluid can be appropriately discharged from the expansion section 130 by a simple operation of opening and closing the flow path switching section 190, there is no need to perform the above-mentioned complicated work using an injection device.

[0078] In subsequent hemostasis procedures, when the operator performs a pressure reducing operation on the expansion section 130 again according to a predetermined pressure reducing protocol, the operator performs an operation of appropriately opening and closing the second flow path switching section 192 or the third flow path switching section 193 in the same manner as the above-described operation. By performing such an operation, the operator can stepwise reduce the internal pressure of the expansion section 130 multiple times.

[0079] In the above example, the procedure of opening the first flow path switching unit 191 to discharge the fluid into the first container unit 181 when performing the first pressure reduction operation was described. However, there are no particular restrictions on the order of the container units 180 used for the pressure reduction operation of the expansion unit 130 and the number of flow path switching units 190 to be opened. For example, it is also possible to use the second container unit 182 or the third container unit 183 to discharge the fluid in the expansion unit 130 before using the first container unit 181.

[0080] By performing the above procedure, the operator can easily and smoothly perform a hemostasis treatment according to a predetermined pressure reduction protocol.

[0081] As described above, the hemostasis device 100 according to the present embodiment includes a flexible belt body 110 that can be wound around a site p to be hemostatic on the limb A, a fixing portion 120 that fixes the belt body 110 in a state where it is wound around the limb A, an expansion portion 130 that is connected to the belt body 110 and expands by injecting fluid, one or more tubes 160 connected to the expansion portion 130, an injection portion 170 provided in the tube 160 for injecting fluid into the inside of the expansion portion 130 via the tube 160, a plurality of container portions 180 connected to the expansion portion 130 via the tube 160 and capable of moving the fluid injected into the inside of the expansion portion 130 to the outside of the expansion portion 130, and a flow path switching portion 190 connected to the tube 160 and capable of reversibly switching the communication state and the non-communication state between the expansion portion 130 and the container portions 180. At least one of the plurality of container portions 180 is provided between the injection portion 170 and the expansion portion 130, and the flow path switching portion 190 is provided between the expansion portion 130 and each of the container portions 180.

[0082] When the operator performs a decompression operation on the expansion part 130 while performing hemostasis using the hemostatic instrument 100 configured as described above, by switching the flow path switching part 190 to open, a desired amount of fluid can be easily moved (discharged) from the expansion part 130 to any container part 180. Also, when the operator discharges a desired amount of fluid from the expansion part 130 a plurality of times according to a predetermined decompression protocol during hemostasis, by switching the opening and closing of the flow path switching part 190 each time a decompression operation is performed, the fluid can be discharged from the expansion part 130 by an amount corresponding to the number of container parts 180. Therefore, when the operator performs a decompression operation a plurality of times, the operator can easily and appropriately discharge a desired amount of fluid from the expansion part 130 each time the decompression operation is performed. Accordingly, the hemostatic instrument 100 can significantly reduce the burden on the operator required for the decompression operation and can improve the efficiency of clinical services in the medical field.

[0083] In addition, in the present embodiment, the tube 160 includes an injection tube 161 to which the injection unit 170 is connected, at least one branch portion 163, a branch tube 164 extending from the branch portion 163, and a flow path switching unit 190 and a container unit 180 each connected to at least one of the injection tube 161 and the branch tube 164. As described above, the hemostatic device 100 includes the branch portion 163 and the branch tube 164 extending from the branch portion 163, so that while reducing the number of tubes 160 directly connected to the expansion portion 130 (the first balloon 140 and the second balloon 150), a configuration can be adopted in which the expansion portion 130 and a plurality of container portions 180 are connected. If the number of tubes 160 directly connected to the expansion portion 130 is increased, a manufacturing process for connecting the tube 160 to the expansion portion 130 while maintaining the airtightness of the expansion portion 130 is required, resulting in a complicated manufacturing operation. On the other hand, when a configuration is adopted in which the branch portion 163 is provided on the tube 160 side and the number of container portions 180 is increased as in the present embodiment, the number of container portions 180 can be increased without increasing the number of tubes 160 directly connected to the expansion portion 130, so that the manufacturing operation of the hemostatic device 100 can be simplified. Furthermore, in the present embodiment, by adopting a configuration in which the first container portion 181 is provided between the injection portion 170 and the expansion portion 130, the first container portion 181 can serve as a fluid discharge container when a predetermined decompression protocol is executed and as an internal pressure confirmation container for confirming whether the expansion portion 130 has reached a predetermined expansion amount. Therefore, since the number of container portions 180 in the hemostatic device 100 can be reduced, the manufacturing operation of the hemostatic device 100 can be simplified. At the same time, since the number of elements constituting the hemostatic device 100 is reduced, the overall weight is reduced, and the load on the patient's wrist can be reduced.

[0084] In addition, in the present embodiment, each of the container portions 180 (the first container portion 181, the second container portion 182, and the third container portion 183) is constituted by a flexible member having a lumen capable of holding a fluid. Therefore, when the operator desires to increase the internal pressure of the expansion portion 130 by returning the fluid from the container portion 180 to the expansion portion 130 after discharging the fluid into the container portion 180, the flow path switching portion 190 provided corresponding to the first container portion 181, the second container portion 182, and the third container portion 183 is switched to an open state, and the container portion 180 is operated to be crushed with a finger or the like, so that the fluid can be returned from the container portion 180 to the expansion portion 130. Therefore, when readjusting to increase the compressive force of the expansion portion 130 after performing the decompression operation, it is not necessary to reconnect the injection instrument to the injection portion 170 again. Therefore, the usability of the hemostatic instrument 100 is further improved.

[0085] In addition, in the present embodiment, the internal volumes of the plurality of container portions 181, 182, and 183 are all equal. Therefore, when the operator performs the decompression operation of the expansion portion 130, any of the container portions 181, 182, and 183 can be used to quantitatively discharge a desired amount of fluid from the expansion portion 130. Therefore, the operator does not need to be careful not to make a mistake in selecting the container portion 180 used when performing the decompression operation or to prevent such mistakes from occurring. Therefore, even when the decompression operation of the expansion portion 130 is performed a plurality of times according to a predetermined decompression protocol, the hemostatic instrument 100 can effectively reduce the workload required for the decompression operation.

[0086] In addition, in the present embodiment, the total volume of the plurality of container portions 181, 182, and 183 is smaller than the internal volume of the expansion portion 130. Therefore, the internal pressure of the expansion portion 130 is always greater than the pressure obtained by summing the internal pressures of the respective container portions 181, 182, and 183. Therefore, when performing the decompression operation of the expansion portion 130, by opening the flow path switching portions 191, 192, and 193 corresponding to the respective container portions 181, 182, and 183, the fluid can be automatically discharged from the expansion portion 130 to the container portion 180, so that the labor required for the decompression operation can be significantly saved even when the decompression operation is performed a plurality of times.

[0087] Further, in the present embodiment, two or more branch portions 163 are provided in the tube 160, a plurality of branch tubes 164 are provided corresponding to the number of the branch portions 163, and at least one container portion 180 and at least one flow path switching portion 190 are connected to each of the plurality of branch tubes 164. By increasing the number of the branch portions 163 to two, three, etc. in this way and increasing the container portion 180 and the flow path switching portion 190 according to the number of the branch portions 163, a configuration including more container portions 180 (three in the embodiment) can be adopted. Further, when increasing the number of the container portions 180, by increasing the number of the branch portions 163 to correspond thereto, it is possible to prevent an increase in the number of the tubes 160 directly connected to the extension portion 130. Thereby, it is possible to preferably prevent the manufacturing operation of the hemostatic instrument 100 from being complicated.

[0088] Next, a modification of the above-described embodiment will be described. In the description of the modification, the description of the members already described and the usage procedures of the hemostatic instrument, etc. will be omitted as appropriate. Further, the content not particularly described in the modification can be the same as that of the above-described embodiment.

[0089] FIGS. 5 to 10 show arrangement examples of the tube, the container portion, and the flow path switching portion according to each modification. In these drawings, the illustration of the belt and the fixing portion described in the above-described embodiment is omitted, and only the arrangement relationship of each component member according to the modification is shown in a simplified manner.

[0090] In the description of each modification, for convenience of explanation, numeral classifiers are attached to the component members for explanation. However, these ordinal numbers are attached to identify the components, and do not specify the number, order, or structural differences of each member. Further, the numeral classifiers shown in each modification do not show a strict correspondence relationship with the component members shown in the above-described embodiment.

[0091] <Modification 1> FIG. 5 shows a partial configuration of the hemostatic instrument according to Modification 1.

[0092] The hemostatic device according to Modification Example 1 is configured to include two container portions 180, namely, a container portion 180 connected to the injection tube 161 and a container portion 180 connected to a first branch tube 164a extending from a branch portion 163. As shown in Modification Example 1, there is no particular limitation on the number of branch portions 163 provided in the tube 160. For example, as shown in FIG. 5, the number of branch portions 163 may be one.

[0093] <Modification Example 2> FIG. 6 shows a partial configuration of the hemostatic device according to Modification Example 2.

[0094] As shown in FIG. 6, when a plurality of branch portions 163a and 163b are provided in the tube 160, there is no particular limitation on the positions where the branch portions 163a and 163b are arranged. In the hemostatic device according to Modification Example 2, the first branch portion 163a and the second branch portion 163b are arranged on the side of the expansion portion 130 (the upstream side in the fluid discharge direction) rather than the first flow path switching portion 191 connected to the injection tube 161. Even in such a configuration, as in the above-described embodiment, it is possible to realize a decompression operation using each container portion 181, 182, 183 and each flow path switching portion 191, 192, 193 connected to the tube 160.

[0095] <Modification Example 3> FIG. 7 shows a partial configuration of the hemostatic device according to Modification Example 3.

[0096] As shown in FIG. 7, the tube 160 can also be composed of a single tube without a branch portion 163. When there is no branch portion 163 provided in the tube 160, in the case of realizing a depressurization operation using a plurality of container portions 180, for example, as shown in FIG. 7, from the side of the expansion portion 130 toward the side of the first container portion 181 to which the injection portion 170 is connected, a configuration can be adopted in which the flow path switching portion 190 and the container portions 180 are arranged in series in order. When configured in this way, when injecting fluid into the expansion portion 130, by keeping each of the flow path switching portions 191 and 192 open, the fluid can be injected into the expansion portion 130 via the tube 160. Also, when discharging the fluid from the expansion portion 130, the fluid can be discharged to the second container portion 182 with the first flow path switching portion 191 open and the second flow path switching portion 192 closed. Further, when performing a depressurization operation, by opening the first flow path switching portion 191 and the second flow path switching portion 192, the fluid can be discharged from the expansion portion 130 by an amount corresponding to the volume of each inner cavity 180a of the two container portions 181 and 182.

[0097] <Modification Example 4> FIG. 8 shows a partial configuration of the hemostatic instrument according to Modification Example 4.

[0098] In the arrangement example of the container portion 180 and the flow path switching portion 190 described in Modification Example 3, as shown in FIG. 8, by further increasing the number of the container portion 180 and the flow path switching portion 190, without providing a branch portion 163 in the tube 160, the number of container portions 180 used for discharging the fluid from the expansion portion 130 can be increased. By adopting such an arrangement, a depressurization operation using three or more container portions 180 can be realized.

[0099] <Modification Example 5> FIG. 9 shows a partial configuration of the hemostatic instrument according to Modification Example 5.

[0100] In the hemostatic device according to Modification Example 5 shown in FIG. 9, two tubes 161 and 165 are connected to the expansion part 130. In this example, the injection tube 161 is connected to the second balloon 150, and the auxiliary tube 165 is connected to the first balloon 140. When performing a decompression operation using the first container part 181 connected to the injection tube 161, the fluid injected into the expansion part 130 is discharged from the second balloon 150 side. Also, when performing a decompression operation using the second container part 182 connected to the auxiliary tube 165, the fluid injected into the expansion part 130 is discharged from the first balloon 140 side. Thus, the connection relationship of the tube 160, the container part 180, and the flow path switching part 190 can be arbitrarily changed as long as it is possible to realize the discharge of the fluid from the expansion part 130.

[0101] <Modification Example 6> FIG. 10 shows a partial configuration of the hemostatic device according to Modification Example 6.

[0102] In the arrangement example of the tube 160, the container part 180, and the flow path switching part 190 described in Modification Example 6, as shown in FIG. 10, by providing a branch part 163 in the auxiliary tube 165, the number of container parts 180 that can be used for the decompression operation can be increased. In this example, one branch part 163a is provided on the auxiliary tube 165 side. Note that it is also possible to provide two or more branch parts 163 on the auxiliary tube 165 side. Also, by providing a branch part 163 on the injection tube 161 side, it is also possible to further increase the number of container parts 180.

[0103] As described above, the hemostatic device according to the present invention has been described through the embodiments and modification examples. However, the present invention is not limited only to the content described in the specification, and can be appropriately changed based on the description in the claims.

[0104] For example, in the description in the specification, the hemostatic device is exemplified in a form that is worn and used on a limb such as the wrist. However, the hemostatic device may be worn on any part of the hand, arm, or leg (in this specification, these are collectively referred to as "limb").

Explanation of Reference Numerals

[0105] 100 Hemostatic device 110 Belt body 120 Fixing part 130 Expansion part 140 First balloon 141 Lumen of the first balloon 150 Second balloon 151 Lumen of the second balloon 152 Communication hole 160 Tube 161 Injection tube 163 Branch part 163a First branch part 163b Second branch part 164 Branch tube 164a First branch tube 164b Second branch tube 165 Auxiliary tube 170 Injection part 171 Check valve 180 Container part 180a Lumen of the container part 181 First container part 182 Second container part 183 Third container part 190 Flow path switching part 191 First flow path switching part 192 Second flow path switching part 193 Third flow path switching part A Limb p Site to be hemostatic

Claims

1. A flexible band that can be wrapped around the part of the limb where hemostasis is to be performed, A fixing part for fixing the band in a state where the band is wrapped around the limb, An expansion part connected to the band and expanding by injecting fluid, One or more tubes connected to the expansion part, An injection part provided on the tube for injecting fluid into the inside of the expansion part through the tube, A plurality of container parts connected to the expansion part through the tube and allowing the fluid injected into the inside of the expansion part to move outside the expansion part, A flow path switching part connected to the tube and capable of reversibly switching the communication state and non-communication state between the expansion part and the container part, and having, At least one of the plurality of container parts is provided between the injection part and the expansion part, The flow path switching part is provided between the expansion part and each of the container parts, A hemostatic device characterized by that.

2. The tube is, An injection tube to which the injection part is connected, At least one branch part, A branch tube extending from the branch part, The container part and the flow path switching part each connected to at least one of the injection tube and the branch tube, The hemostatic device according to claim 1.

3. The container part is constituted by a flexible member having a lumen capable of holding fluid, The hemostatic device according to claim 1.

4. The internal volumes of the plurality of container parts are all equal, The hemostatic device according to claim 1.

5. The total volume of the plurality of container parts is smaller than the internal volume of the expansion part, The hemostatic device according to claim 1.

6. Two or more branch parts are provided on the tube, A plurality of branch tubes are provided corresponding to the number of the branch parts, At least one of the container parts and at least one of the flow path switching parts are connected to each of the plurality of branch tubes, The hemostatic device according to claim 2.

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