Hemostatic device and manufacturing method of expansion member

Abstract

To provide a hemostatic device capable of preventing generation of discomfort when the hemostatic device is attached.SOLUTION: In an expansion member 40 of a hemostatic device 10, in a state where the expansion member is not expanded, a plane is set as a reference, the plane passing a boundary line 40L between a first sheet and a second sheet in a fusion part 40M in which an edge portion 41A of the first sheet 41 and an edge portion 42A of the second sheet 42 are fused, one side and the other side arranged in a patient body have an asymmetrical structure, and the other side of the expansion member is thinner than the one side of the expansion member.SELECTED DRAWING: Figure 4

Description

[Technical field]

[0001] The present invention relates to a hemostatic device for compressing a punctured site to stop bleeding. [Background technology]

[0002] In recent years, percutaneous treatment and examination have been performed in which a blood vessel in an arm, leg, etc. is punctured, an introducer sheath is inserted into the puncture site, and a medical instrument such as a catheter is delivered to the affected area through the lumen of the introducer sheath.

[0003] When such treatment or examination is performed, the surgeon needs to stop the bleeding at the puncture site after removing the introducer sheath. To stop the bleeding, a hemostatic device is known that includes a band for wrapping around a limb such as an arm or a leg, a fixing means for fixing the band in the wrapped state around the limb, and an expansion member connected to the band and expands by injecting a fluid to compress the puncture site (see, for example, Patent Document 1 below). In general, the expansion member has a structure in which an inner cavity is formed between the first sheet and the second sheet by fusing the edge of a first sheet made of resin and the edge of a second sheet made of resin that are superimposed on each other. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Japanese Patent Application Publication No. 05-277125 Summary of the Invention [Problem to be solved by the invention]

[0005] In the hemostatic device disclosed in Patent Document 1, when the expansion member is expanded, the fused portion where the edge of the first sheet and the edge of the second sheet are fused may deform toward the patient's body. Such deformation of the fused portion toward the patient's body may cause discomfort when the device is worn.

[0006] The present invention has been made to solve the above-mentioned problems, and aims to provide a method for manufacturing a hemostatic device and an expansion member that can prevent discomfort when wearing the hemostatic device. [Means for solving the problem]

[0007] A hemostatic device that achieves the above object includes an expandable and contractible expansion member having an inner cavity into which a fluid is injected and configured to compress a puncture site formed in a patient, and a band for fixing the expansion member to a part of the patient's body. The expansion member has a structure in which the inner cavity is formed between a first resin sheet and a second resin sheet that are superimposed on each other by fusing an edge of the first sheet and an edge of a second resin sheet. When the expansion member is in an unexpanded state, the expansion member has an asymmetric structure in which one side that is placed on the patient's body and the other side that is located opposite to the one side are asymmetric with respect to a plane that passes through the boundary line between the first sheet and the second sheet at the fusion part where the edge of the first sheet and the edge of the second sheet are fused, and the other side of the expansion member is thinner than the one side of the expansion member.

[0008] Furthermore, a method for manufacturing an expansion member that achieves the above-mentioned object is a method for manufacturing an expandable and contractible expansion member configured to compress a puncture site formed in a patient, in which an expansion member having an inner cavity into which a fluid can be injected between the first sheet and the second sheet is manufactured by superimposing a first sheet made of resin and a second sheet made of resin, and fusing an edge of the first sheet to an edge of the second sheet while the first sheet and the second sheet are overlapped, and the expansion member is manufactured so that, by the fusing, when the expansion member is in an unexpanded state, one side that is placed on the patient's body and the other side that is located on the opposite side are asymmetrical with respect to a plane that passes through the boundary line between the first sheet and the second sheet at the fused portion where the edge of the first sheet and the edge of the second sheet are fused, and the other side is thinner than the one side. Effect of the Invention

[0009] According to the hemostatic device configured as described above and the hemostatic device including the expansion member manufactured by the manufacturing method of the expansion member, the one side placed on the patient's body and the other side have an asymmetric structure based on a plane passing through the boundary between the first sheet and the second sheet at the fusion part where the edge of the first sheet and the edge of the second sheet are fused, and since the other side of the expansion member is thinner than the one side of the expansion member, when the expansion member is expanded, the fusion part deforms to the opposite side to the body side, which prevents discomfort from occurring when wearing the hemostatic device. [Brief description of the drawings]

[0010] [Figure 1] 1 is a plan view of a hemostasis device according to an embodiment, viewed from the inner surface side. [Diagram 2] FIG. 2 is a cross-sectional view taken along line 2-2 in FIG. [Diagram 3] FIG. 2 is a schematic cross-sectional view showing a state before a first sheet and a second sheet are fused together. [Figure 4] FIG. 4 is a schematic cross-sectional view showing the state after the first sheet and the second sheet have been fused. [Diagram 5] FIG. 13 is a perspective view showing an expanded state of an expansion member according to a comparative example. [Figure 6] FIG. 2 is a perspective view showing an expanded state of the expansion member according to the embodiment. [Figure 7] 1 is a schematic cross-sectional view showing a state of an expansion member according to Modification 1 before a first sheet and a second sheet are fused together. FIG. [Figure 8] 10 is a schematic cross-sectional view showing the state of the expansion member according to Modification 1 after the first sheet and the second sheet have been fused. FIG. [Figure 9] FIG. 11 is a plan view showing a part of an expansion member according to Modification 2. [Figure 10] FIG. 11 is a perspective view showing a state in which the expansion member according to Modification 2 is expanded. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011] Hereinafter, an embodiment of the present invention and its modified examples will be described with reference to the attached drawings. Note that the following description does not limit the technical scope or meaning of the terms described in the claims. Also, the dimensional ratios in the drawings are exaggerated for the convenience of explanation and may differ from the actual ratios.

[0012] The hemostatic device 10 of the embodiment is used to stop bleeding at a puncture site formed in the radial artery in the wrist after removing an introducer sheath that has been placed at the puncture site for the purpose of inserting a catheter or the like into a blood vessel for treatment, examination, etc.

[0013] As shown in Figures 1 and 2, the hemostatic device 10 has a band 20 for wrapping around the wrist, a hook-and-loop fastener 30 for fixing the band 20 in place while wrapped around the wrist, an expansion member 40 that expands when gas is injected into it and compresses the puncture site, and an injection section 60 that can inject gas into the expansion member 40.

[0014] In this specification, when band 20 is wrapped around the wrist, the side of band 20 that faces the body surface of the wrist (the wearing side, inner side) is referred to as "one side," and the opposite side (the outer side) is referred to as "the other side."

[0015] As shown in FIG. 2, the band 20 includes a belt 21 made of a flexible band-shaped member, and a support plate 22 having a harderness than that of the belt 21.

[0016] The belt 21 is wrapped around the wrist so as to go around the circumference of the wrist. As shown in Fig. 2, a support plate holding part 21a that holds the support plate 22 is formed in the center of the belt 21. The support plate holding part 21a is double-layered by joining a separate belt-shaped member to the other side (or one side) by a method such as fusion (thermal fusion, high-frequency fusion, ultrasonic fusion, etc.) or adhesion (adhesive or solvent adhesion), and holds the support plate 22 inserted in the gap between them.

[0017] A male side (or female side) 31 of a hook-and-loop fastener 30, generally called a Velcro (registered trademark) or the like, is disposed on the other side of the portion of the belt 21 near the left end in FIG. 1, and a female side (or male side) 32 of the hook-and-loop fastener 30 is disposed on one side of the portion of the belt 21 near the right end in FIG. 1. The belt 21 is wrapped around the wrist and the male side 31 and the female side 32 are joined together, so that the band 20 is worn on the wrist. The means for fastening the band 20 in a wrapped state around the wrist is not limited to the hook-and-loop fastener 30, and may be, for example, a snap, a button, a clip, or a frame member through which the end of the belt 21 passes.

[0018] The material for the belt 21 is not particularly limited, but may be a thermoplastic resin such as polyvinyl chloride, polyethylene, polypropylene, or polyvinylidene chloride, or various thermoplastic elastomers such as an olefin-based thermoplastic elastomer or a styrene-based thermoplastic elastomer.

[0019] In addition, at least the portion of the belt 21 that overlaps with the expansion member 40 is preferably substantially transparent, but is not limited to being transparent, and may be semi-transparent or colored transparent.

[0020] 2, the support plate 22 is inserted between the double support plate holding portion 21a of the belt 21 and is thereby held by the belt 21. The support plate 22 has a plate shape with at least a part of it curved toward one side (the mounting surface side). The support plate 22 is made of a material harder than the belt 21 and is designed to maintain an almost constant shape.

[0021] The support plate 22 has a long shape in the longitudinal direction of the belt 21. A central portion 22a in the longitudinal direction of the support plate 22 is flat with almost no curvature, and on both sides of the central portion 22a, a first curved portion 22b (left side in FIG. 2) and a second curved portion 22c (right side in FIG. 2) are formed, each curved toward one side along the longitudinal direction of the belt 21 (circumferential direction of the wrist).

[0022] Examples of materials constituting the support plate 22 include acrylic resin, polyvinyl chloride (particularly rigid polyvinyl chloride), polyolefins such as polyethylene, polypropylene, and polybutadiene, polystyrene, poly-(4-methylpentene-1), polycarbonate, ABS resin, polymethyl methacrylate (PMMA), polyacetal, polyacrylate, polyacrylonitrile, polyvinylidene fluoride, ionomer, polyesters such as acrylonitrile-butadiene-styrene copolymer, polyethylene terephthalate (PET), and polybutylene terephthalate (PBT), butadiene-styrene copolymer, aromatic or aliphatic polyamide, and fluorine-based resins such as polytetrafluoroethylene.

[0023] Like the belt 21, the support plate 22 is preferably substantially transparent in the portion overlapping with the expansion member 40, but is not limited to being transparent and may be semi-transparent or colored transparent. Note that the support plate 22 may not have a flat portion such as the central portion 22a and may be curved over its entire length.

[0024] 2 to 4, the expansion member 40 has an internal cavity 40R into which a fluid is injected, and is configured to compress a puncture site formed in a patient. The expansion member 40 is configured to be expandable and contractable by an injection section 60. The fluid to be injected into the expansion member 40 is not particularly limited as long as it is capable of expanding the expansion member 40, and air, for example, can be used.

[0025] As shown in Figs. 2 to 4, the expansion member 40 is constructed by overlapping a first sheet 41 and a second sheet 42 into a bag shape. Specifically, the expansion member 40 has a structure in which an edge portion 41A of the overlapping resin first sheet 41 and an edge portion 42A of the resin second sheet 42 are fused together to form an inner cavity 40R between the first sheet 41 and the second sheet 42. The first sheet 41 and the second sheet 42 have similar shapes, and the second sheet 42 has a smaller outer shape than the first sheet 41. In addition, the edge portion 42A of the second sheet 42 is thinner than the edge portion 41A of the first sheet 41, as shown in Fig. 4.

[0026] The first sheet 41 and the second sheet 42 have an outer shape that is substantially rectangular in a plan view. The outer shapes of the first sheet 41 and the second sheet 42 are not particularly limited to the above shapes, and may be, for example, circular, elliptical, or polygonal. The first sheet 41 constitutes one side of the expansion member 40. The second sheet 42 constitutes the other side of the expansion member.

[0027] The first sheet 41 has a relatively thick edge portion 41A and an inner portion 41B that is provided inside the edge portion 41A and is thinner than the edge portion 41A. As shown in Fig. 4, the edge portion 41A of the first sheet 41 is thicker than the edge portion 42A of the second sheet 42. With this configuration, by fusing the first sheet 41 and the second sheet 42, it is possible to manufacture a structure in which one side placed on the patient's body and the other side are asymmetrical with respect to the boundary line 40L between the first sheet 41 and the second sheet 42, and the other side of the expansion member 40 is thinner than the one side of the expansion member 40.

[0028] The second sheet 42 has a substantially uniform thickness along the longitudinal direction.

[0029] 4, when the expansion member 40 is in an unexpanded state, the expansion member 40 has an asymmetric structure with one side placed on the patient's body and the other side being based on a boundary line 40L between the first sheet 41 and the second sheet 42 at a fused portion 40M where an edge portion 41A of the first sheet 41 and an edge portion 42A of the second sheet 42 are fused. The other side of the expansion member 40 is thinner than the one side of the expansion member 40.

[0030] Here, for example, in the case of a hemostatic device 900 having a structure in which one side and the other side are symmetrical with respect to the boundary line 40L between the first sheet 41 and the second sheet 42, or a structure in which the other side is thicker than the one side with respect to the boundary line 40L between the first sheet 41 and the second sheet 42, as shown in Fig. 5, when the expansion member is expanded, the fused portion where the edge of the first sheet and the edge of the second sheet are fused may deform toward the patient's body side as shown in Fig. 5. Such deformation of the fused portion toward the patient's body side may cause discomfort or pain when worn.

[0031] In contrast, the hemostatic device 10 according to this embodiment has an asymmetric structure between one side placed on the patient's body and the other side with respect to the boundary line 40L between the first sheet 41 and the second sheet 42, and the other side of the expansion member 40 is thinner than the one side of the expansion member 40, so that when the expansion member 40 is expanded, the fused part 40M deforms toward the side opposite the body side, as shown in Fig. 6. This makes it possible to prevent discomfort and pain when wearing the hemostatic device 10.

[0032] 4, the expansion member 40 in this embodiment has a first region 43 where part of the edge 41A of the first sheet 41 and part of the edge 42A of the second sheet 42 overlap, and a second region 44 that is located further away from the lumen 40R than the first region 43 and where only part of the edge 41A of the first sheet 41 is located. This configuration allows for a simple structure in which one side that is placed on the patient's body and the other side are asymmetrical with respect to the boundary line 40L between the first sheet 41 and the second sheet 42, and the other side of the expansion member 40 can be made thinner than the one side of the expansion member 40.

[0033] As shown in FIG. 4, the expansion member 40 has a recessed portion from the lumen 40R side toward the fused portion 40M side. It has a recess 45. With this configuration, when the expansion member 40 is expanded, the fused portion 40M can be deformed more suitably to the side opposite the patient.

[0034] The material constituting the first sheet 41 and the second sheet 42 is not particularly limited, but examples thereof include thermoplastic resins such as polyvinyl chloride, polyethylene, polypropylene, polyvinylidene chloride, etc., or various thermoplastic elastomers such as olefin-based thermoplastic elastomers, styrene-based thermoplastic elastomers, etc.

[0035] It is preferable that the expansion member 40 is substantially transparent, but is not limited to being transparent, and may be semi-transparent or colored transparent.

[0036] The injection section 60 is a section for injecting gas into the expansion member 40, and is connected to the expansion member 40 as shown in FIG.

[0037] The injection section 60 comprises a flexible tube 61 whose base end is connected to the expansion member 40 and whose inner cavity communicates with the interior of the expansion member 40, a bag body 62 which is arranged at the tip end of the tube 61 so as to communicate with the inner cavity of the tube 61 and which incorporates a check valve (not shown), and a tubular connector 63 connected to the bag body 62.

[0038] When expanding (inflating) the expansion member 40, the front tube part of a syringe (not shown) is inserted into the connector 63 to open the check valve, and the plunger of the syringe is pressed to inject the fluid in the syringe into the expansion member 40 via the injection part 60. When the expansion member 40 expands, the bag body 62 communicating with the expansion member 40 via the tube 61 also expands, and it can be visually confirmed that the expansion member 40 has been pressurized without any fluid leakage. After injecting the fluid into the expansion member 40, the front tube part of the syringe is removed from the connector 63, and the check valve built into the connector 63 closes to prevent gas leakage.

[0039] Next, a method of using the hemostatic device 10 according to this embodiment will be described.

[0040] Before the hemostatic device 10 is attached to the wrist, the expansion member 40 is in an unexpanded state as shown in Fig. 2. When puncturing the radial artery in the right wrist, the puncture site is located toward the thumb. Usually, an introducer sheath is placed at the puncture site. The band 20 is wrapped around the wrist with the introducer sheath still in place, and the male side 31 and the female side 32 of the hook-and-loop fastener 30 are brought into contact with each other and joined, and the band 20 is attached to the wrist.

[0041] At this time, the hemostatic device 10 is attached to the wrist so that the injection part 60 faces the downstream side (palm side) of the blood flow of the radial artery. This allows the injection part 60 to be operated without interfering with procedures upstream of the wrist or with instruments (e.g., a blood pressure monitor, etc.) located upstream. In addition, by attaching the hemostatic device 10 to the wrist of the right hand so that the injection part 60 faces downstream, the expansion member 40 is located in the radial artery located toward the thumb side of the wrist. In the case of an artery, the upstream side of the blood vessel refers to the direction of the blood vessel approaching the heart. In addition, the downstream side of the blood vessel refers to the direction of the blood vessel away from the heart.

[0042] After the hemostatic device 10 is attached to the wrist, a syringe (not shown) is connected to the connector 63 of the injection portion 60, and fluid is injected into the expansion member 40, causing the expansion member 40 to expand.

[0043] At this time, the fused portion 40M where the edge 41A of the first sheet 41 and the edge 42A of the second sheet 42 are fused has an asymmetric structure with respect to a plane passing through the boundary line 40L between the first sheet 41 and the second sheet 42, and since the other side of the expansion member 40 is thinner than the one side of the expansion member 40, when the expansion member 40 is expanded, the fused portion 40M deforms toward the opposite side to the body side (the upper side in FIG. 6) as shown in FIG. 6. This makes it possible to prevent discomfort when wearing the hemostatic device 10.

[0044] After expanding the expansion member 40, the syringe is detached from the connector 63. Then, the introducer sheath is removed from the puncture site.

[0045] After a predetermined time has elapsed and hemostasis at the puncture site has been completed, the hemostasis device 10 is removed from the wrist by peeling off the male side 31 and the female side 32 of the hook-and-loop fastener 30.

[0046] As described above, the hemostatic device 10 according to the present embodiment includes an expandable and contractible expansion member 40 having a lumen 40R into which a fluid is injected and configured to compress a puncture site formed in a patient, and a band 20 for fixing the expansion member 40 to a part of the patient's body. The expansion member 40 has a structure in which an inner lumen 40R is formed between a first sheet 41 made of resin and an edge portion 42A of a second sheet 42 made of resin, which are superimposed, by fusing the edge portion 41A of the first sheet 41 and the edge portion 42A of the second sheet 42. When the expansion member 40 is in an unexpanded state, the expansion member 40 has an asymmetric structure in which one side placed on the patient's body and the other side located opposite to the one side are asymmetric with respect to a plane passing through a boundary line 40L between the first sheet 41 and the second sheet 42 at a fusion portion 40M where the edge portion 41A of the first sheet 41 and the edge portion 42A of the second sheet 42 are fused, and the other side of the expansion member 40 is thinner than the one side of the expansion member 40. According to the hemostatic device 10 configured in this manner, the fused portion 40M where the edge 41A of the first sheet 41 and the edge 42A of the second sheet 42 are fused has an asymmetric structure with respect to a plane passing through the boundary line 40L between the first sheet 41 and the second sheet 42, and since the other side of the expansion member 40 is thinner than the one side of the expansion member 40, when the expansion member 40 is expanded, the fused portion 40M deforms to the side opposite the body side. This makes it possible to prevent discomfort when wearing the hemostatic device 10.

[0047] Moreover, the first sheet 41 constitutes one side of the expansion member 40, and the second sheet 42 constitutes the other side of the expansion member 40, with the edge 41A of the first sheet 41 being thicker than the edge 42A of the second sheet 42. According to the hemostatic device 10 configured in this manner, by fusing the first sheet 41 and the second sheet 42, it is possible to manufacture a structure in which the one side placed on the patient's body and the other side are asymmetrical with respect to the boundary line 40L between the first sheet 41 and the second sheet 42, and the other side of the expansion member 40 is thinner than one side of the expansion member 40.

[0048] The expansion member 40 has a first region 43 where part of the edge 41A of the first sheet 41 and part of the edge 42A of the second sheet 42 overlap, and a second region 44 where only part of the edge 41A of the first sheet 41 is located and is located further away from the inner cavity 40R than the first region 43. The hemostatic device 10 configured in this manner has a simple structure in which one side placed on the patient's body and the other side are asymmetrical with respect to the boundary line 40L between the first sheet 41 and the second sheet 42, and a structure can be adopted in which the other side of the expansion member 40 is thinner than the one side of the expansion member 40.

[0049] Moreover, the expansion member 40 has a recess 45 recessed from the inner cavity 40R side toward the fused portion 40M side. According to the hemostatic device 10 configured in this manner, when the expansion member 40 is expanded, the fused portion 40M can be more suitably deformed to the side opposite the patient.

[0050] <Expansion Member According to Modification Example 1> Hereinafter, the configuration of the extension member 140 according to the first modification will be described with reference to FIGS.

[0051] 7 and 8, the expansion member 140 is configured by overlapping a first sheet 141 and a second sheet 142 into a bag shape. Specifically, the expansion member 140 has a structure in which an inner cavity 140R is formed between the first sheet 141 and the second sheet 142 by fusing an edge portion 141A of the overlapping resin first sheet 141 and an edge portion 142A of the resin second sheet 142.

[0052] The first sheet 141 and the second sheet 142 have substantially the same planar shape. The edge 141A of the first sheet 141 has a flat portion 141B located at the outermost periphery and an inclined portion 141C whose thickness gradually decreases from the flat portion 141B toward the inner cavity 140R. The edge 142A of the second sheet 142 is thinner than the flat portion 141B.

[0053] The extension member 140 of variant example 1 is manufactured by overlapping the edge portion 142A of the second sheet 142 on the flat portion 141B of the first sheet 141 and fusing the flat portion 141B of the first sheet 141 and the edge portion 142A of the second sheet 142.

[0054] The expansion member 140 according to the first modification thus manufactured has a fused region (corresponding to a fused portion) 140M in which a part of the edge portion 141A of the first sheet 141 and a part of the edge portion 142A of the second sheet 142 are fused to each other, and a non-fused region 140N located closer to the lumen 140R of the expansion member 140 than the fused region 140M and having a thickness thinner on the first sheet 141 side toward the lumen 140R side. In the expansion member 140 thus configured, the other side of the expansion member 140 is thinner than one side of the expansion member 140, so that when the expansion member 140 is expanded, the fused region 140M deforms to the opposite side to the body side. This makes it possible to prevent discomfort from occurring when the hemostatic device 110 is worn.

[0055] 7 and 8, the expansion member 140 according to the first modification has a recess 145 recessed from the inner cavity 140R side toward the fused part 140M side. According to the expansion member 140 configured in this manner, when the expansion member 140 is expanded, the fused part 140M is more suitably deformed toward the side opposite to the body side.

[0056] <Expansion Member 240 According to Modification Example 2> The configuration of the extension member 240 according to the second modification will be described below with reference to FIGS.

[0057] 9 and 10, the expansion member 240 is configured by overlapping a first sheet 241 and a second sheet 242 into a bag shape. Specifically, the expansion member 240 has a structure in which an inner cavity 240R is formed between the first sheet 241 and the second sheet 242 by fusing an edge of the overlapping resin first sheet 241 and an edge of the resin second sheet 242 to form a fused portion 240M.

[0058] The fusion portion 240M has a first fusion portion 241M that fuses the edge of the first sheet 241 and the edge of the second sheet 242, a second fusion portion 242M that fuses the first sheet 241 and the second sheet 242 at a position closer to the inner cavity 240R than the first fusion portion 241M, and a cut portion 245 that is provided at a position corresponding to the position where the second fusion portion 242M is formed on the edge of the first sheet 241 and the edge of the second sheet 242, and is formed so that the width gradually decreases from the edge of the first sheet 241 and the edge of the second sheet 242 toward the inner cavity 240R.

[0059] 9, the extension member 240 according to the second modification has a polygonal (e.g., quadrangular) planar shape, and the second fusion parts 242M and the cut parts 245 are disposed on the sides of the polygon. Furthermore, the cut parts 245 have their outermost edges chamfered.

[0060] According to the expansion member 240 of the second modification configured in this manner, as shown in FIG. 10, it is possible to suppress wrinkles (see the outer periphery in FIG. 6) that occur when the expansion member 240 is expanded.

[0061] The above describes the hemostatic device of the present invention through embodiments and modified examples, but the present invention is not limited to the described configurations and can be modified as appropriate based on the description of the claims.

[0062] For example, the hemostatic device may be configured to include an auxiliary compression portion between the expansion member 40 and the band 20, as disclosed in Figure 7 of WO2017 / 164242.

[0063] Furthermore, each part constituting the hemostatic device may be replaced with any other part capable of exerting the same function. Also, any other component may be added.

[0064] Furthermore, the present invention is not limited to a hemostatic device worn on the wrist, but can also be applied to a hemostatic device worn on the leg or the like.

[0065] In the hemostatic device of the present invention, the band and the expansion portion are connected by fusion, but this does not mean that other components (e.g., the first sheet and the second sheet, the expansion portion and the injection portion, etc.) may be bonded together by adhesive. [Explanation of symbols]

[0066] 10, 110, 210 Hemostatic devices, 20 belts, 40, 140, 240 extension members, 40L border, 40M, 140M, 240M fused part, 140N non-fused area, 40R, 140R, 240R lumen, 41, 141, 241 1st sheet, 41A, 141A Edge of first sheet, 141B flat area, 141C slope, 42, 142, 242 2nd sheet, 42A, 142A Edge of second sheet; 43 Part 1, 44 Part 2, 45, 145 recesses, 241M 1st fusion part, 242M 2nd fusion part, 245 Cutout, 60 Injection part.

Claims

1. an expandable and contractible expansion member having an internal lumen through which a fluid is injected and configured to compress a puncture site formed in the patient; a strap for securing the expansion member to a portion of the patient's body; The expansion member has a structure in which the inner cavity is formed between a first sheet and a second sheet made of resin by fusing an edge portion of the first sheet and an edge portion of the second sheet made of resin that are overlapped with each other, the expansion member has an asymmetric structure in which one side to be placed on the patient's body and another side located opposite to the one side are asymmetric with respect to a plane passing through a boundary line between the first sheet and the second sheet at a fusion portion where the edge of the first sheet and the edge of the second sheet are fused, when the expansion member is in an unexpanded state; A hemostatic device, wherein the other side of the expansion member is thinner than the one side of the expansion member.

2. the first sheet constitutes the one side of the expansion member, the second sheet constitutes the other side of the expansion member, The hemostatic device of claim 1 , wherein the edge of the first sheet is thicker than the edge of the second sheet.

3. The expansion member is a first region where a portion of the edge of the first sheet and a portion of the edge of the second sheet overlap; The hemostatic device according to claim 2 , further comprising: a second portion located at a position farther from the inner cavity than the first portion and in which only a portion of the edge of the first sheet is located.

4. The expansion member is 3. The hemostatic device according to claim 2, further comprising: a fused region located at the fused portion, in which a portion of the edge of the first sheet and a portion of the edge of the second sheet are fused; and a non-fused region located closer to the inner cavity of the expansion member than the fused region, in which the thickness of the first sheet side decreases toward the inner cavity side.

5. The hemostatic device according to claim 1 , wherein the expansion member has a recess recessed from the inner cavity side toward the fused portion side.

6. The fused portion is a first fusion portion that fuses the edge portion of the first sheet and the edge portion of the second sheet; A hemostatic device as described in any one of claims 1 to 5, comprising: a second fusion portion that fuses the first sheet and the second sheet at a position closer to the inner cavity than the first fusion portion; and a cut portion that is provided at a position corresponding to the position where the second fusion portion is formed at the edge portion of the first sheet and the edge portion of the second sheet, and is formed so that the width gradually decreases from the edge portion of the first sheet and the edge portion of the second sheet toward the inner cavity side.

7. The expansion member has a polygonal planar shape, The hemostatic device according to claim 6 , wherein the second fused portion and the cut portion are disposed on sides of the polygon.

8. The hemostatic device according to claim 6 or claim 7, wherein the outermost portion of the edge of the notch is chamfered.

9. 1. A method of manufacturing an expandable and contractible expansion member configured to compress a puncture site formed in a patient, comprising: a first resin sheet and a second resin sheet are superimposed on each other, and an edge of the first sheet is fused to an edge of the second sheet to produce the expansion member having an internal cavity into which a fluid can be injected between the first sheet and the second sheet; A method for manufacturing an expansion member, wherein the expansion member is manufactured such that, by the fusion, when the expansion member is in an unexpanded state, one side that is placed on the patient's body is asymmetrical to the other side that is located on the opposite side, based on a plane that passes through the boundary line between the first sheet and the second sheet at the fused portion where the edge of the first sheet and the edge of the second sheet are fused, and the other side is thinner than the one side.

10. the first sheet and the second sheet have similar shapes, the second sheet has a smaller outer profile than the first sheet; the edge of the second sheet is thinner than the edge of the first sheet; A method for manufacturing an expansion member as described in claim 9, wherein the edge portion of the second sheet is overlapped on the first sheet, and the edge portion of the second sheet is fused to the first sheet, thereby forming one side of the expansion member from the first sheet and forming the other side of the expansion member from the second sheet.

11. The first sheet and the second sheet have substantially the same planar shape, The edge portion of the first sheet has a flat portion located at the outermost periphery and an inclined portion whose thickness gradually decreases from the flat portion toward the inner cavity side, The edge portion of the second sheet is thinner than the flat portion, A method for manufacturing an expansion member as described in claim 9, wherein the edge portion of the second sheet is overlapped on the flat portion of the first sheet, and the flat portion of the first sheet and the edge portion of the second sheet are fused together to form one side of the expansion member from the first sheet and the other side of the expansion member from the second sheet.

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