Hemostatic device

Abstract

To provide a hemostatic device that can effectively impart a compression force to a puncture site.SOLUTION: A hemostatic device 100 has: an expansion member 130 configured to press a site p1 of a patient's body to stop bleeding; a support member 140 with the expansion member fixed thereto; and fixing member 120 (belt bodies 150, 160, 170) configured to be connectable with the support member, and configured so as to fix the support member to a patient. The expansion member includes an expansion part 230 configured expandable by the injection of fluid, and a protrusion 231 protruding from the circumference of the expansion part. The support member includes a central area 241 positioned in the center of the support member, and a curvature area 242 curving in the direction apart from the expansion part of the expansion member from the central area toward the edge of the support member. The expansion member is configured such that only the protrusion is fixed to the curvature area in the position where the expansion part is overlapped with the central area.SELECTED DRAWING: Figure 1

Description

Technical Field

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

Background Art

[0002] As one of catheter procedures, a procedure is known in which various medical elongate bodies are introduced into a blood vessel through a puncture site formed by puncturing a blood vessel in a patient's arm or hand, and treatment or therapy for a lesion site is performed. For example, Patent Document 1 discloses a hemostatic device for stopping bleeding at a puncture site formed to enable access to a blood vessel (including the distal radial artery) that runs through the hand.

[0003] The hemostatic device of Patent Document 1 includes a balloon that applies a compressive force to a puncture site formed in a patient's hand, a plate to which the balloon is fixed, and a plurality of bands for fixing the plate to the patient's hand. Further, the plurality of bands include a winding band arranged to wind along the outer periphery of the hand and a finger-hooking band arranged at an interdigital part located between adjacent fingers of the hand.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0005] When an operator such as a doctor (hereinafter referred to as "operator") uses the hemostatic device of Patent Document 1 to stop bleeding at a puncture site formed on a patient's hand, the balloon and the plate are arranged so as to overlap the puncture site. The operator wraps a band for winding along the outer periphery of the hand, and further arranges a band for hooking between the thumb and the index finger at the interdigital part. The operator can prevent the balloon from shifting from the puncture site formed on the patient's hand by fixing the hemostatic device using each band with the balloon arranged at the puncture site formed on the patient's hand and its peripheral part.

[0006] In the hemostatic device described in Patent Document 1, the balloon is fixed to the plate by an adhesive or the like. However, the balloon of Patent Document 1 fixes the entire surface of the side of the balloon surface facing the plate to the plate by an adhesive or the like. Therefore, when the balloon of the hemostatic device of Patent Document 1 is expanded, it depends on the fixing position of the plate and the balloon, and the plate affects the expansion direction of the balloon. For example, when the plate has a region curved toward the side away from the balloon and the entire surface of the side of the balloon surface facing the plate is fixed to the curved region, when the balloon of the hemostatic device of Patent Document 1 is expanded, the balloon may expand laterally with respect to the direction toward the puncture site. As a result, the compressive force on the puncture site is dispersed, and the compressive force cannot be effectively applied to the puncture site.

[0007] In view of the above problems, an object of the present invention is to provide a hemostatic device capable of effectively applying a compressive force to a puncture site.

Means for Solving the Problems

[0008] The hemostatic device according to the present invention includes an expansion member configured to compress a site to be hemostatic on a patient's limb, a support member to which the expansion member is fixed, and a fixing member configured to be connectable to the support member and fix the support member to the patient. The expansion member includes an expansion part configured to be expandable by injection of a fluid, and a protruding part protruding from around the expansion part. The support member includes a central region located at the center of the support member, and a curved region that curves in a direction away from the expansion part of the expansion member from the central region toward an edge of the support member. The expansion member is such that only the protruding part is at least at positions facing each other with the extension part in between fixed to the curved region.

Effects of the Invention

[0009] In the hemostatic device of the present invention, in a state where the expansion part of the expansion member is located at a position overlapping the central region of the support member, only the protruding part of the expansion member is fixed to the curved region of the support member. Further, the support member curves in a direction away from the expansion part of the expansion member from the central region toward an edge of the support member. Therefore, in the hemostatic device, since only the protruding part of the expansion member is fixed to the curved region of the support member, a space is formed between the edge of the expansion part and the curved region of the support member in a state where the expansion part of the expansion member is expanded. Accordingly, the hemostatic device can suppress the expansion part of the expansion member from spreading laterally with respect to the direction toward the puncture site when the expansion part of the expansion member is expanded. As a result, it is possible to prevent the compression force on the puncture site by the expansion member from being dispersed, and effectively apply a compression force to the puncture site. Furthermore, the expansion part of the expansion member and the central region of the support member only overlap and are not fixed via an adhesive or the like. For this reason, the visibility through the expansion member and the support member does not decrease.

Brief Description of the Drawings

[0010]

Figure 1

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Figure 21

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Embodiments for Carrying Out the Invention

[0011] Hereinafter, embodiments of the present invention will be described with reference to the attached drawings. The following description does not limit the technical scope or the meaning of terms described in the claims. Also, the dimensional ratios in the drawings are exaggerated for convenience of explanation and may be different from the actual ratios.

[0012] FIGS. 1 to 16 are diagrams for explaining the hemostatic device 100 according to the present embodiment, FIGS. 17 to 20 are diagrams for explaining modifications, and FIGS. 21 to 27 are diagrams for explaining usage examples of the hemostatic device 100.

[0013] The hemostatic device 100 can be used to stop bleeding at a puncture site (for example, each of the puncture sites p1 and p2 described later) formed on the hand H located on the distal side (finger side) of the patient's forearm A when removing the sheath tube 201 of the introducer 200 that was placed at the puncture site, as shown in FIGS. 21 and 24 to 26 for example.

[0014] The specific position of the puncture site to be stopped bleeding by the hemostatic device 100 is not particularly limited, but in this embodiment, the following first puncture site p1 and second puncture site p2 are exemplified. In this specification, mainly through an example of using the hemostatic device 100 to stop bleeding at the first puncture site p1, the structure of each part of the hemostatic device 100 will be described.

[0015] As shown in FIGS. 21 and 24, the first puncture site p1 is a puncture site formed on an artery B (hereinafter, also referred to as "blood vessel B") located in the snuffbox of the palmar artery that runs along the back Hb side of the right hand H1 (hand H) located on the distal side of the patient's forearm A. The snuffbox is a cavity of the hand located near the radius when the patient spreads the thumb of the hand H.

[0016] As shown in FIGS. 21 and 27, the second puncture site p2 is a puncture site formed on the distal radial artery located on the distal side of the snuffbox of the palmar artery that runs along the back Hb side of the patient's right hand H1. The second puncture site p2 is located on the distal side of the right hand H1 from the first puncture site p1 with reference to the extensor tendon t1 of the long thumb located on the back Hb of the patient's right hand H1.

[0017] Hereinafter, the hemostatic device 100 will be described in detail.

[0018] Generally speaking, as shown in FIGS. 1, 2, 24, 25, and 26, the hemostatic device 100 includes an expansion member 130 configured to compress a site to be stopped bleeding on the patient's limb (for example, the first puncture site p1 formed on the patient's right hand H1), a support member 140 to which the expansion member 130 is fixed, and a fixing member 120 configured to be connectable to the support member 140 and to be fixed to the patient.

[0019] As shown in FIGS. 1, 2, 3, and 4, the fixing member 120 includes a first belt body 150 (corresponding to the first belt portion) configured to be connectable to the support member 140, a second belt body 160 (corresponding to the second belt portion) configured to be connectable to the support member 140, and a third belt body 170 (corresponding to the third belt portion) configured to be connectable to the support member 140. The first belt body 150 extends in the first direction from the support member 140. The second belt body 160 extends in a second direction different from the first direction from the support member. The third belt body 170 extends in a third direction different from the first and second directions from the support member. For example, in FIG. 1, the first and second directions are the left-right direction, and the third direction is the up-down direction.

[0020] In the hemostatic instrument 100, as will be described later, among the three belt bodies of the first belt body 150, the second belt body 160, and the third belt body 170, the two belt bodies of the first belt body 150 and the second belt body 160 are configured to be rotatable about the rotation axis R of the support member 140 (see FIG. 8).

[0021] As shown in FIG. 24, the third belt body 170 can be arranged to be hooked on the finger space fb located between two adjacent fingers (for example, the thumb and the index finger) when the hemostatic instrument 100 is worn on the right hand H1 of the patient.

[0022] As shown in FIGS. 22, 23, and 24, the first belt body 150 and the second belt body 160 can be arranged to be wound along the outer periphery of the right hand H1 when the hemostatic instrument 100 is worn on the right hand H1 of the patient.

[0023] <Expansion member> As shown in FIGS. 6 and 7, the expansion portion 230 of the expansion member 130 includes, for example, a lumen 133 into which a fluid such as air can flow. FIGS. 6 and 7 show cross-sectional views of the expansion portion 230 of the expansion member 130 in an expanded state. Also, FIGS. 6 and 7 show partial cross-sectional views in which the cross-sections along the arrows 6A-6A and 7A-7A shown in FIG. 5 are inverted vertically.

[0024] The expansion member 130 can be configured, for example, as a resin balloon. A tube 193, which will be described later, is connected to the inner cavity 133 of the expansion part 230 of the expansion member 130.

[0025] The material constituting the expansion member 130 is not particularly limited. For example, polyolefins such as polyvinyl chloride, polyethylene, polypropylene, polybutadiene, and ethylene-vinyl acetate copolymer (EVA), polyesters such as polyethylene terephthalate (PET) and polybutylene terephthalate (PBT), polyvinylidene chloride, silicone, polyurethane, various thermoplastic elastomers such as polyamide elastomer, polyurethane elastomer, and polyester elastomer, nylon, nylon elastomer, or any combination thereof (blend resin, polymer alloy, laminate, etc.) can be used.

[0026] As shown in FIGS. 6, 7, 25, and 26, the expansion member 130 is disposed on one surface 140a side of the support member 140. One surface 140a of the support member 140 is the surface that is disposed on the body surface side of the patient's hand H when the hemostatic instrument 100 is attached to the patient's hand H. The other surface 140b of the support member 140 is the surface located on the opposite side of the one surface 140a.

[0027] As shown in FIGS. 6 and 7, the expansion member 130 can be connected to one surface 140a of the support member 140.

[0028] As shown in FIGS. 12, 14, 15(A), 15(B), and 15(C), the expansion member 130 can include an expansion part 230 configured to be expandable by fluid injection, and a protruding part 231 protruding from the periphery of the expansion part 230. The protruding part 231 is disposed over the entire circumference of the expansion part 230. The direction in which the expansion part 230 expands is, for example, a direction perpendicular to the plane of the paper in FIG. 12. The direction in which the protruding part 231 protrudes from the periphery of the expansion part 230 is, for example, the direction of the plane of the paper in FIG. 12.

[0029] The protruding portion 231 has a flange portion 232 located around the expanding portion 230 and a convex portion 233 protruding from the flange portion 232. The convex portion 233 further protrudes outward from the edge of the flange portion 232. Four convex portions 233 of the embodiment are arranged.

[0030] The expanding portion 230 of the expanding member 130 has a circular shape in a plan view shown in FIGS. 1 to 5, FIG. 12, and FIG. 14. Similarly, the flange portion 232 of the protruding portion 231 has a circular shape. The convex portion 233 of the protruding portion 231 has a tongue-like shape.

[0031] However, the shapes in the plan view of the expanding portion 230 and the protruding portion 231 (flange portion 232 and convex portion 233) in the expanding member 130 are not limited to the illustrated circular and tongue shapes. Also, there are no particular restrictions on the cross-sectional shape before and after expansion of the expanding portion 230, the constituent material of the expanding member 130, the specific structure of the expanding member 130, etc.

[0032] The fixing structure between the support member 140 and the expanding member 130 will be described later.

[0033] As shown in FIGS. 4, 5, 6, 7, 25, and 26, a marker 135 for aligning the expanding member 130 with the first puncture site p1 is arranged on the expanding member 130.

[0034] The marker 135 is arranged on the outer surface of the surface of the expanding member 130 opposite to the surface on which the support member 140 is arranged (the surface arranged on the body surface side of the patient's hand H when the hemostatic instrument 100 is attached to the patient's hand H).

[0035] As long as the marker 135 is arranged on the expanding member 130, there are no particular restrictions on the specific arrangement location. The marker 135 may be arranged, for example, on the inner surface of the surface of the expanding member 130 opposite to the surface on which the support member 140 is arranged (the surface arranged on the body surface side of the patient's hand H when the hemostatic instrument 100 is attached to the patient's hand H).

[0036] As shown in FIGS. 5, 12, and 14, the marker 135 is disposed at a substantially central position in the plane direction of the expansion portion 230 in the expansion member 130. Further, the marker 135 is disposed so as to overlap with the substantially central position in the plane direction of the support member 140.

[0037] The marker 135 can be formed, for example, as a rectangular marker entirely formed in a colored manner. Note that the specific shape, color, forming method, position, etc. of the marker 135 are not particularly limited. For example, the marker 135 may be composed of a transparent central portion and a colored linear frame portion surrounding the central portion. Further, for example, the marker 135 may be provided on the support member 140.

[0038] <Support member> As shown in FIGS. 3, 5, 6, and 7, the support member 140 has a first region 141 where the expansion portion 230 of the expansion member 130 is disposed, and a second region 142 that is located outside the first region 141 and is configured such that the third belt body 170, the first belt body 150, and the second belt body 160 can be connected.

[0039] The support member 140 has a circular shape in a plan view shown in FIG. 5.

[0040] The first region 141 is a region where the expansion portion 230 of the expansion member 130 overlaps in a plan view shown in FIG. 5. The second region 142 is a region located outside the first region 141 in a plan view shown in FIG. 5.

[0041] Note that the first region 141 can be arbitrarily defined based on the outer shape and size of the expansion portion 230 of the expansion member 130 disposed on the support member 140. Further, the second region 142 can be defined based on the relative positional relationship with the first region 141. Therefore, the first region 141 and the second region 142 can be appropriately changed according to the outer shape and size of the expansion member 130 disposed on the support member 140.

[0042] As shown in FIGS. 5, 6, 7, and 8, a rotation axis R serving as the rotation center of the first belt body 150 and the second belt body 160 is provided in the first region 141.

[0043] As shown in FIGS. 5, 6, 7, 9, and 10, in the second region 142, a pair of first hole portions 145a and 145b that face each other with the expansion portion 230 of the expansion member 130 interposed therebetween, and a pair of second hole portions 147a and 147b that face each other with the expansion portion 230 of the expansion member 130 interposed therebetween at a position different from the pair of first hole portions 145a and 145b are formed.

[0044] In the description of this specification, the first hole portion 145a is also referred to as "one first hole portion 145a". Further, the first hole portion 145b is also referred to as "the other first hole portion 145b". Further, the second hole portion 147a is also referred to as "one second hole portion 147a". Further, the second hole portion 147b is also referred to as "the other second hole portion 147b".

[0045] As shown in FIG. 5, the one first hole portion 145a and the other first hole portion 145b are arranged on the distal side (fingertip side) of the hand H or the proximal side (forearm portion A side) of the hand H with the expansion portion 230 of the expansion member 130 interposed therebetween. In the present embodiment, when the hemostatic device 100 is attached to the right hand H1 of the patient, the one first hole portion 145a is arranged on the distal side of the hand H with respect to the expansion portion 230 of the expansion member 130, and the other first hole portion 145b is arranged on the proximal side of the hand H with respect to the expansion portion 230 of the expansion member 130 (see FIG. 24).

[0046] Note that when changing the attachment position of the hemostatic device 100 to the hand H of the patient, the one first hole portion 145a and the other first hole portion 145b can be arranged by interchanging their positional relationship with respect to the expansion portion 230 of the expansion member 130. That is, the one first hole portion 145a may be arranged on the proximal side of the hand H with respect to the expansion portion 230 of the expansion member 130, and the other first hole portion 145b may be arranged on the distal side of the hand H with respect to the expansion portion 230 of the expansion member 130.

[0047] As shown in FIGS. 3, 4, and 5, one first hole portion 145a and the other first hole portion 145b are arranged in a circular shape along the outer shape of the support member 140. In the present embodiment, the support member 140 has a circular shape in the plan view shown in FIG. 5. Therefore, one first hole portion 145a and the other first hole portion 145b are arranged along the circumferential direction of the second region 142 located outside the support member 140 than the first region 141.

[0048] The above-mentioned "arranged in a circular shape" assumes a case where holes continuous in the circumferential direction of the second region 142 of the support member 140 are formed, and one first hole portion 145a and the other first hole portion 145b are arranged at arbitrary positions occupying a part of the holes with a gap therebetween. The positional relationship of the one second hole portion 147a and the other second hole portion 147b arranged in a circular shape, which will be described later, is the same as the above.

[0049] As shown in FIGS. 3, 4, 5, and 7, the third belt body 170 can be connected to one first hole portion 145a.

[0050] In the present embodiment, the width (the width in the direction orthogonal to the extending direction of the third belt body 170) W3 of the third end portion 171 of the third belt body 170 is substantially the same as the hole length L1 of one first hole portion 145a (see FIG. 5). Therefore, the third belt body 170 is restricted from rotating about the rotation axis R of the support member 140 in a state where the third belt body 170 is connected to the support member 140 via one first hole portion 145a.

[0051] Note that the hole length of each of the hole portions 145a, 145b, 147a, and 147b in the present specification means the linear distance between the end portions located in the circumferential direction of the support member 140 of each of the hole portions 145a, 145b, 147a, and 147b.

[0052] The width W3 of one first hole portion 145a is formed to be substantially the same as the hole length L2 of the other first hole portion 145b (see FIG. 5). Therefore, the third belt body 170 is restricted from rotating about the rotation axis R of the support member 140 when the third belt body 170 is connected to the support member 140 via the other first hole portion 145b.

[0053] As shown in FIGS. 3, 4, and 5, one second hole portion 147a and the other second hole portion 147b are arranged with the expansion portion 230 of the expansion member 130 interposed therebetween in a direction intersecting a straight line (virtual line C shown in FIG. 5) connecting one first hole portion 145a and the other first hole portion 145b.

[0054] As shown in FIGS. 3 and 4, one second hole portion 147a and the other second hole portion 147b are arranged circularly along the outer shape of the support member 140.

[0055] As shown in FIG. 22, when the hemostatic instrument 100 arranges one first hole portion 145a on the distal side of the patient's right hand H1 with respect to the expansion portion 230 of the expansion member 130 and arranges the other first hole portion 145b on the proximal side of the patient's right hand H1 with respect to the expansion portion 230 of the expansion member 130, one second hole portion 147a can be arranged on the inner side in the circumferential direction of the patient's right hand H1 (the side where the patient's body is arranged), and the other second hole portion 147b can be arranged on the outer side in the circumferential direction of the patient's right hand H1.

[0056] The hole length L3 of one second hole portion 147a is longer than the hole lengths L1 and L2 of the respective first hole portions 145a and 145b (see FIG. 5). Similarly, the hole length L4 of the other second hole portion 147b is longer than the hole lengths L1 and L2 of the respective first hole portions 145a and 145b. The hole length L3 of one second hole portion 147a and the hole length L4 of the other second hole portion 147b are formed to have substantially the same length.

[0057] As shown in FIGS. 3, 4, 5, and 7, a first belt body 150 is connected to one second hole portion 147a.

[0058] The width W1 of the first end portion 151 of the first belt body 150 (the width in a direction orthogonal to the extending direction of the first belt body 150) is shorter than the hole length L3 of one second hole portion 147a (see FIG. 5). Therefore, as shown in FIG. 8, the first belt body 150 can rotate within a range of a predetermined rotation angle θ1 around the rotation axis R of the support member 140 in a state where the first belt body 150 is connected to the support member 140 via one second hole portion 147a.

[0059] The rotation angle θ1 of the first belt body 150 can be arbitrarily defined by the width W1 of the first end portion 151 of the first belt body 150 and the hole length L3 of one of the second hole portions 147a. The rotation angle θ1 of the first belt body 150 is not particularly limited, but can be set, for example, within the range of 1° to 75°.

[0060] As shown in FIGS. 3, 4, 5, and 7, the second belt body 160 is connected to the other second hole portion 147b.

[0061] The width W2 of the second end portion 161 of the second belt body 160 (the width in the direction orthogonal to the extending direction of the second belt body 160) is shorter than the hole length L4 of the other second hole portion 147b (see FIG. 5). Therefore, as shown in FIG. 8, the second belt body 160 can rotate within a predetermined rotation angle θ2 range around the rotation axis R of the support member 140 in a state where the second belt body 160 is connected to the other second hole portion 147b.

[0062] The rotation angle θ2 of the second belt body 160 can be arbitrarily defined by the width W2 of the second end portion 161 of the second belt body 160 and the hole length L4 of the other second hole portion 147b. The rotation angle θ2 of the second belt body 160 is not particularly limited, but can be set, for example, within the range of 1° to 75°.

[0063] In addition, as shown in FIG. 5, each of the first hole portions 145a, 145b and each of the second hole portions 147a, 147b can be arranged concentrically around the rotation axis R of the support member 140. However, each of the first hole portions 145a, 145b and each of the second hole portions 147a, 147b do not necessarily have to be arranged concentrically.

[0064] Also, one of the first hole portions 145a and the other first hole portion 145b may have different shapes and hole lengths. Also, one of the second hole portions 147a and the other second hole portion 147b may have different shapes and hole lengths.

[0065] Also, the hole length L1 of one first hole portion 145a and / or the hole length L2 of the other first hole portion 145b may be formed to be larger than the width W3 of the third end portion 171 of the third belt body 170. When configured in this way, the third belt body 170 can rotate about the rotation axis R of the support member 140 in a state where the third belt body 170 is connected to the support member 140 via one first hole portion 145a or the other first hole portion 145b.

[0066] As shown in FIGS. 7, 9, 10, and 26, in the portion of the second region 142 of the support member 140 where the pair of first hole portions 145a and 145b are arranged, a first curved region 148a that is convexly curved toward the side away from the extension portion 230 of the extension member 130 arranged on one surface 140a of the support member 140 is formed.

[0067] The above-mentioned "side away from the extension portion 230 of the extension member 130" is the side away from the body surface of the patient's hand H (the upper side in FIG. 26) when the hemostatic instrument 100 is attached to the patient's hand H, as shown in FIG. 26.

[0068] As shown in FIGS. 6, 9, 10, and 25, in the portion of the second region 142 of the support member 140 where the pair of second hole portions 147a and 147b are arranged, a second curved region 148b that is convexly curved toward the side of the extension portion 230 of the extension member 130 arranged on one surface 140a of the support member 140 is formed.

[0069] The above-mentioned "side of the extension portion 230 of the extension member 130" is the side close to the body surface of the patient's hand H (the lower side in FIG. 25) when the hemostatic instrument 100 is attached to the patient's hand H, as shown in FIG. 25.

[0070] The support member 140 is preferably made of a material having a predetermined hardness. When the support member 140 is configured to have a predetermined hardness, as shown in FIGS. 25 and 26, when the expansion portion 230 of the expansion member 130 applies a compressive force to the first puncture site p1 formed on the right hand H1 of the patient, the support member 140 can press the expansion portion 230 of the expansion member 130 against the right hand H1 of the patient. Thereby, it is possible to prevent the expansion portion 230 of the expansion member 130 from lifting off the right hand H1 of the patient.

[0071] As the constituent material of the support member 140 having the hardness as described above, for example, acrylic resin, polyvinyl chloride (especially rigid polyvinyl chloride), polyethylene, polypropylene, polyolefins such as polybutadiene, polystyrene, poly-(4-methylpentene-1), polycarbonate, ABS resin, polymethyl methacrylate (PMMA), polyacetal, polyacrylate, polyacrylonitrile, polyvinylidene fluoride, ionomer, acrylonitrile-butadiene-styrene copolymer, polyethylene terephthalate (PET), etc. can be used.

[0072] In each of the expansion member 130 and the support member 140, the portions overlapping each other in the plan view shown in FIGS. 4 and 5 can be formed to be transparent. When the expansion member 130 and the support member 140 are configured in this way, as shown in FIGS. 22 and 23, when the hemostatic instrument 100 is attached to the right hand H1 of the patient, it becomes possible for the operator to more easily visually confirm the position of the marker 135 and / or the first puncture site p1 through the expansion member 130 and the support member 140. Note that the above “transparent” includes colored transparent, colorless transparent, and translucent.

[0073] <Fixing structure between support member and expansion member> As shown in FIGS. 7, 9, 10, 11, and 13, the support member 140 includes a central region 241 located at the center of the support member 140 and a curved region 242 that curves in a direction away from the expansion portion 230 of the expansion member 130 from the central region 241 toward the edge of the support member 140. The central region 241 is a region that includes the center of the support member 140 when the support member 140 is viewed in plan. The central region 241 is formed from a plane or a curved surface. The curved region 242 is a region that includes the aforementioned first curved region 148a formed in the second region 142.

[0074] As shown in FIGS. 9, 10, and 11, the support member 140 is convexly curved toward the side away from the expansion portion 230 of the expansion member 130 disposed on one surface 140a of the support member 140. The central region 241 is a region of the support member 140 that includes the apex of its convex shape.

[0075] The above-mentioned "direction away from the expansion portion 230 of the expansion member 130" is, as shown in FIG. 26, the direction away from the body surface of the patient's hand H (upward in FIG. 26) when the hemostatic device 100 is attached to the patient's hand H.

[0076] As shown in FIGS. 12, 14, 15(A), 15(B), and 15(C), the protruding portion 231 of the expansion member 130 has a through-hole 233a formed in the convex portion 233. As shown in FIGS. 11 and 13, the support member 140 has a mounting hole 242a formed in the curved region 242. As shown in FIGS. 15(A), 15(B), and 15(C), the caulking pin 234 is inserted through the through-hole 233a and the mounting hole 242a and caulked. As a result, the expansion member 130 is fixed such that only the protruding portion 231 is fixed to the curved region 242 of the support member 140 at a position where the expansion portion 230 overlaps the central region 241 of the support member 140. The inside of the circle indicated by reference numeral 235 in FIG. 12 schematically shows the position where the expansion portion 230 of the expansion member 130 and the central region 241 of the support member 140 overlap. The expansion portion 230 and the central region 241 only overlap. The expansion portion 230 and the central region 241 are not fixed via an adhesive or the like.

[0077] As shown in FIGS. 15(B) and 15(C), the expansion member 130 forms a space S between the edge 230a of the expansion part 230 and the curved region 242 of the support member 140 in a state where the expansion part 230 is expanded. The ring-shaped part surrounded by the reference numeral 236 in FIG. 12 schematically shows the space S formed between the edge 230a of the expansion part 230 and the curved region 242.

[0078] FIGS. 16(A), 16(B), and 16(C) schematically show the operation of the structure of the proportional example in which the expansion member 130 is fixed to the support member 140.

[0079] In the case of the proportional example, the expansion member 130 and the support member 140 are fixed as follows. The entire surface of the outer peripheral surface of the expansion member 130 on the side facing the curved support member 140 is fixed to the support member 140 with an adhesive or the like. When the expansion member 130 is expanded, there is a risk that the expansion member 130 will also expand in the lateral direction with respect to the direction toward the puncture site p1. As a result, the compressive force of the expansion member 130 on the puncture site p1 is dispersed, and the compressive force cannot be effectively applied to the puncture site p1.

[0080] FIGS. 15(A), 15(B), and 15(C) schematically show the operation of the structure of the embodiment in which the expansion member 130 is fixed to the support member 140.

[0081] In the case of the embodiment, the extension member 130 is fixed such that only the protruding portion 231 is fixed to the curved region 242 of the support member 140 at a position where the extension portion 230 overlaps with the central region 241 of the support member 140. Then, with the extension member 130 in a state where the extension portion 230 is extended, a space S is formed between the edge portion 230a of the extension portion 230 and the curved region 242 of the support member 140. By fixing the extension member 130 and the support member 140 such that a space S is formed between the extension member 130 and the curved support member 140, when the extension portion 230 of the extension member 130 is extended, it is possible to suppress the lateral expansion of the extension portion 230 of the extension member 130 with respect to the direction toward the puncture site p1. As a result, it is possible to prevent the compressive force on the puncture site p1 by the extension member 130 from being dispersed, and an effective compressive force can be applied to the puncture site p1. Further, the extension portion 230 and the central region 241 only overlap and are not fixed via an adhesive or the like. Therefore, the visibility of the marker 135 is not reduced.

[0082] As shown in FIGS. 12 and 14, the protruding portion 231 of the extension member 130 has a flange portion 232 located around the extension portion 230 and a convex portion 233 protruding from the flange portion 232. Then, the extension member 130 is fixed to the curved region 242 via the convex portion 233.

[0083] Since the extension member 130 is fixed to the support member 140 via the convex portion 233, a predetermined distance can be ensured between the extension portion 230 and the convex portion 233 by the flange portion 232 located between the extension portion 230 and the convex portion 233. Therefore, the extension member 130 can more reliably form a space S between the edge portion 230a of the extension portion 230 and the curved region 242 of the support member 140 with the extension portion 230 extended by the flange portion 232 and the convex portion 233 of the protruding portion 231. Thereby, the hemostatic instrument 100 can suppress the lateral expansion of the extension portion 230 of the extension member 130 with respect to the direction toward the puncture site p1 when the extension portion 230 is extended. As a result, it is possible to further prevent the compressive force on the puncture site p1 by the extension member 130 from being dispersed, and an effective compressive force can be further applied to the puncture site p1.

[0084] As shown in FIGS. 4, 5, and 8, the mounting holes 242a (see FIGS. 9, 10, 11, and 13) of the support member 140 do not overlap with the pair of second hole portions 147a and 147b in a direction orthogonal to the longitudinal direction (vertical direction in the figure) of the third belt body 170 (left - right direction in the figure). Therefore, the extension member 130 is fixed to the bending region 242 at a position that does not overlap with the movable ranges of the first belt body 150 and the second belt body 160 in a direction orthogonal to the longitudinal direction of the third belt body 170.

[0085] Since the first belt body 150 and the second belt body 160 are fixed to the support member 140 at positions where the extension member 130 does not overlap with their movable ranges, when the operator moves the first belt body 150 and the second belt body 160, they do not contact the caulking pin 234 (the fixing portion between the support member 140 and the extension member 130). For this reason, the mobility of the first belt body 150 and the second belt body 160 is not inhibited, and the operator can wind the first belt body 150 and the second belt body 160 around the patient's hand H without any hindrance. In addition, since the extension member 130 is not fixed between the pair of second hole portions 147a and 147b in a direction orthogonal to the longitudinal direction of the third belt body 170, a wide area for arranging the extension portion 230 of the extension member 130 on the support member 140 can also be secured.

[0086] As shown in FIGS. 6, 9, 10, 11, and 25, the support member 140 curves from the central region 241 toward the edge of the support member 140 and toward the extension portion 230 side of the extension member 130 in a direction orthogonal to the longitudinal direction of the third belt body 170 (see the second bending region 148b). Also, as shown in FIGS. 11, 12, and 13, the bending region 242 of the support member 140 forms an inclined portion 243 from the axial center (major axis C) in the longitudinal direction of the third belt body 170 toward the first belt body 150 side and the second belt body 160 side. The mounting hole 242a is formed in the inclined portion 243. Therefore, the protruding portion 231 of the extension member 130 is fixed to the inclined portion 243.

[0087] As shown in Fig. 25, the "side of the expansion member 130 on the expansion part 230 side" is the side (the lower side in Fig. 25) close to the body surface of the patient's hand H when the hemostatic device 100 is attached to the patient's hand H.

[0088] The expansion member 130 is configured such that the expansion part 230 of the expansion member 130 is suppressed from expanding laterally with respect to the direction toward the puncture site p1 by the space S, and further, by the second bending region 148b of the support member 140, the expansion in the direction orthogonal to the longitudinal direction of the third belt body 170 is suppressed. As a result, it is possible to further prevent the compressive force on the puncture site p1 by the expansion member from being dispersed, and it is possible to apply a compressive force more effectively to the puncture site p1.

[0089] The protruding portion 231 of the expansion member 130 is fixed to the bending region 242 at a position symmetric with respect to the longitudinal axis (major axis C) of the third belt body 170.

[0090] The hemostatic device can form a space S between the edge 230a of the expansion part 230 and the bending region 242 of the support member 140 when the expansion part 230 of the expansion member 130 is expanded. Since the protruding portion 231 of the expansion member 130 is fixed at a position symmetric with respect to the longitudinal axis of the third belt body 170, this space S is symmetric with respect to the major axis C of the third belt body 170. Therefore, regardless of whether the support member 140 is disposed on the patient's right hand H1 or left hand, it is possible to prevent the compressive force on the puncture site p1 from being dispersed, and it is possible to effectively apply a compressive force to the puncture site p1.

[0091] At least one of the support member 140 or the expansion part 230 of the expansion member 130 is located in the central region 241 of the support member 140 and includes a marker 135 for aligning with the site to be hemostatic on the patient. As shown in Fig. 12, the protruding portion 231 of the expansion member 130 is fixed to the bending region 242 of the support member 140 by four fixing portions. The intersection of two straight lines 237 passing through two fixing portions facing each other with the expansion part 230 interposed therebetween is located at the marker 135. In the embodiment, the four fixing portions are constituted by caulking pins 234.

[0092] Marker 135 is located in the central region 241 of the support member 140, and the intersection of the two straight lines 237 is located at marker 135. Therefore, when the operator fixes the expansion part 230 of the expansion member 130 to the puncture site p1 through marker 135 and expands the expansion part 230 of the expansion member 130, the space S formed between the edge 230a of the expansion part 230 and the curved region 242 of the support member 140 is symmetric with respect to the major axis C of the third belt body 170 passing through marker 135. Accordingly, the hemostatic instrument 100 has a structure that compresses the vicinity of the center of the expansion part 230 where marker 135 is located in the central region 241 of the support member 140, and even when the support member 140 is arranged on either the patient's right hand H1 or left hand, the compression force on the puncture site p1 by the expansion member 130 is prevented from being dispersed, and an effective compression force can be applied to the puncture site p1.

[0093] <Fixing member> As shown in FIGS. 1, 2, 3, and 4, the fixing member 120 includes a first belt body 150, a second belt body 160, and a third belt body 170. The first belt body 150 and the second belt body 160 are connected to the support member 140 and have a rotation axis R in the central region 241 of the support member 140, and are configured to be rotatable around the rotation axis R around the expansion part 230. The third belt body 170 is configured to be arranged between the patient's fingers in a state of being connected to the support member 140.

[0094] As shown in FIGS. 1, 2, 3, and 4, the third belt body 170 has a third main body part 175, a third one end part 171 configured to be connectable to one first hole part 145a of the support member 140, and a free third other end part 173.

[0095] In addition, the "free other end part" in this specification means that there is no direct or articulated connection relationship with other members in the non-mounted state of the hemostatic instrument 100 (the state where the hemostatic instrument is not mounted on the patient).

[0096] As shown in FIGS. 1 and 2, the third main body part 175 extends along the longitudinal direction of the third belt body 170.

[0097] As shown in FIG. 7, the third one end portion 171 of the third belt body 170 can be arranged so as to be inserted into and wound around one first hole portion 145a of the support member 140. The third belt body 170 is connected to the support member 140 via the third one end portion 171 and one first hole portion 145a.

[0098] As described above, in the present embodiment, the width W3 of the third one end portion 171 of the third belt body 170 is formed to be substantially the same as the hole length L1 of one first hole portion 145a (see FIG. 5). Therefore, the third belt body 170 is restricted from rotating about the rotation axis R of the support member 140 in a state where the third belt body 170 is connected to the support member 140.

[0099] Note that the structure for connecting the third one end portion 171 of the third belt body 170 and the support member 140 is not particularly limited. For example, a fixing member (for example, a hook-and-loop fastener) capable of holding and releasing the state of being wound around one first hole portion 145a can be arranged at the third one end portion 171 of the third belt body 170. When the third belt body 170 is configured in this way, the third belt body 170 can be connected and separated from the support member 140.

[0100] As shown in FIGS. 1, 2, 3, and 4, the first belt body 150 has a first main body portion 155, a first one end portion 151 configured to be connectable to one second hole portion 147a of the support member 140, and a free first other end portion 153.

[0101] As shown in FIGS. 1 and 2, the first main body portion 155 extends along the longitudinal direction of the first belt body 150.

[0102] As shown in FIG. 6, the first one end portion 151 of the first belt body 150 can be arranged so as to be inserted into and wound around one second hole portion 147a of the support member 140. The first belt body 150 is connected to the support member 140 via the first one end portion 151 and one second hole portion 147a.

[0103] As described above, the width W1 of the first end portion 151 of the first belt body 150 is shorter than the hole length L3 of one of the second hole portions 147a (see FIG. 5). Therefore, the first belt body 150 is rotatable about the rotation axis R of the support member 140 in a state where the first belt body 150 is connected to the support member 140 (see FIG. 8).

[0104] Note that the structure for connecting the first end portion 151 of the first belt body 150 and the support member 140 is not particularly limited. For example, a fixing member (for example, a hook-and-loop fastener) capable of holding and releasing a state of being wound around one of the second hole portions 147a can be disposed at the first end portion 151 of the first belt body 150. When the first belt body 150 is configured in this way, the first belt body 150 can be connected and separated from the support member 140.

[0105] As shown in FIGS. 1, 2, 3, and 4, the second belt body 160 has a second main body portion 165, a second first end portion 161 configured to be connectable to another second hole portion 147b of the support member 140, and a free second other end portion 163.

[0106] As shown in FIGS. 1 and 2, the second main body portion 165 extends along the longitudinal direction of the second belt body 160.

[0107] As shown in FIG. 6, the second first end portion 161 of the second belt body 160 can be disposed so as to be inserted through and wound around another second hole portion 147b of the support member 140. The second belt body 160 is connected to the support member 140 via the second first end portion 161 and another second hole portion 147b.

[0108] As described above, the width W2 of the second first end portion 161 of the second belt body 160 is shorter than the hole length L4 of another second hole portion 147b (see FIG. 5). Therefore, the second belt body 160 is rotatable about the rotation axis R of the support member 140 in a state where the second belt body 160 is connected to the support member 140 (see FIG. 8).

[0109] Note that the structure for connecting the second one - end portion 161 of the second belt body 160 and the support member 140 is not particularly limited. For example, a fixing member (e.g., a hook - and - loop fastener) capable of holding and releasing the state of being wound around another second hole portion 147b can be arranged at the second one - end portion 161 of the second belt body 160. When the second belt body 160 is configured in this way, the second belt body 160 can be connected to and separated from the support member 140.

[0110] Also, on the side of each one - end portion 151, 161, 171 of each belt body 150, 160, 170, a symbol M (including a figure and characters) for making each belt body 150, 160, 170 distinguishable is provided. In the present embodiment, the number "1" is provided on the side of the one - end portion 151 of the first belt body 150, the number "2" is provided on the side of the one - end portion 161 of the second belt body 160, and the number "3" is provided on the side of the one - end portion 171 of the third belt body 170. The numbers provided on each belt body 150, 160, 170 correspond to the order in which each belt body 150, 160, 170 is wound when the operator attaches the hemostatic instrument 100 to the patient's right hand H1. Therefore, by visually recognizing the symbol M, the operator can attach each belt body 150, 160, 170 to the patient's right hand H1 in the correct order. Note that the size, color, forming method, position, etc. of the symbol M are not particularly limited. For example, the forming method of the symbol M can be formed not only by printing but also by making holes in the belt body. When forming the symbol M by making holes, it is desirable that at least the periphery of the holes is single - colored. This is because it is difficult to see the symbol if the holes are made in multiple colors. Of course, the whole belt body may be single - colored.

[0111] The constituent materials of each belt body 150, 160, 170 are not particularly limited. For example, they can be made of vinyl chloride resin, polyamide resin, polyamide elastomer resin, polyurethane resin, polyester resin, etc. Also, there are no particular restrictions on the shape, length, thickness, etc. of each belt body 150, 160, 170.

[0112] <Fixing part> As shown in FIGS. 1, 2, 3, and 4, the hemostatic instrument 100 includes four fixing parts: a first fixing part 181, a second fixing part 182, a fourth fixing part 184, and a fifth fixing part 185.

[0113] As shown in FIGS. 1 and 3, a first fixing portion 181 is disposed on the outer surface of the first band 150. A second fixing portion 182 is disposed on the outer surface of the second band 160.

[0114] Also, as shown in FIGS. 2 and 4, a third fixing portion 183 is disposed on the inner surface of the first band 150. A fourth fixing portion 184 is disposed on the inner surface of the second band 160. A fifth fixing portion 185 is disposed on the inner surface of the third band 170. The third fixing portion 183 of the first band 150 is used when fixing the first band 150 to the support member 140. The third fixing portion 183 of the first band 150 is not used for winding the first band 150 around the wrist.

[0115] Note that the inner surfaces of the bands 150, 160, and 170 are the surfaces that are disposed on the patient's body surface side when the hemostatic device 100 is worn on the patient, and the outer surfaces of the bands 150, 160, and 170 are the surfaces located on the opposite side of the inner surfaces.

[0116] The first fixing portion 181 and the second fixing portion 182 are configured by the male side of the hook-and-loop fastener. The third fixing portion 183, the fourth fixing portion 184, and the fifth fixing portion 185 are configured by the female side of the hook-and-loop fastener. The hook-and-loop fastener in this specification is a fastener that can be detachably attached in a planar manner, and for example, it is Magic Tape (registered trademark) or Velcro (registered trademark).

[0117] Note that as long as the expansion member 130 can be fixed to the right hand H1 by connecting the bands 150, 160, and 170 to each other with the hemostatic device 100 disposed on the patient's right hand H1, the specific structure of each fixing portion 181, 182, 183, 184, and 185 is not limited. For example, the installation of some fixing portions can be omitted, or the positions where the fixing portions are disposed on the bands 150, 160, and 170 can be changed arbitrarily. Also, when each fixing portion 181, 182, 184, and 185 is configured by a hook-and-loop fastener, a configuration in which the male side and the female side of the hook-and-loop fastener are interchanged may be used. Further, each fixing portion 181, 182, 184, and 185 may be, for example, a snap, a button, a clip, a frame member formed with a hole portion, or the like.

[0118] <Injection part> As shown in FIGS. 1 and 2, the hemostatic device 100 has an injection part 191 for injecting fluid into the expansion part 230 of the expansion member 130.

[0119] The injection part 191 is composed of a connector incorporating a check valve (not shown). A syringe (not shown) can be connected to the injection part 191.

[0120] A buffer member 192 having an expandable space is disposed between the injection part 191 and the expansion member 130. The buffer member 192 is composed of a flexible bag-shaped member having a space formed therein. Note that the buffer member 192 may be provided with an arrow-shaped marker indicating the insertion direction of the syringe into the injection part 191.

[0121] One end side of the buffer member 192 is connected to the injection part 191. The inner cavity of the injection part 191 communicates with the space of the buffer member 192. However, while the check valve incorporated in the injection part 191 is closed, the communication between the inner cavity of the injection part 191 and the space of the buffer member 192 is blocked.

[0122] A flexible tube 193 is connected to the other end side of the buffer member 192. The inner cavity of the tube 193 communicates with the space of the buffer member 192. Also, the other end of the tube 193 opposite to the one end connected to the buffer member 192 is connected to the expansion part 230 of the expansion member 130. The inner cavity of the tube 193 communicates with the inner cavity 133 of the expansion part 230 of the expansion member 130.

[0123] When the operator expands the expansion part 230 of the expansion member 130, the operator inserts the tip cylinder part of a syringe (not shown) into the injection part 191 to open the check valve. With the check valve of the injection part 191 open, the operator presses the plunger of the syringe to inject the air in the syringe into the inner cavity 133 of the expansion part 230 of the expansion member 130.

[0124] When air is injected into the inner cavity 133 of the expansion part 230 of the expansion member 130, the expansion part 230 of the expansion member 130 expands. When the expansion part 230 of the expansion member 130 expands, the buffer member 192 communicating with the inner cavity 133 of the expansion part 230 of the expansion member 130 through the tube 193 expands. By visually confirming the expansion of the buffer member 192, the operator can easily grasp that the expansion part 230 of the expansion member 130 has expanded without air leakage.

[0125] When the operator contracts the expansion part 230 of the expansion member 130, the operator inserts the tip cylinder part of the syringe into the injection part 191 and pulls the plunger of the syringe. By performing the above operation, the operator can discharge the air in the inner cavity 133 of the expansion part 230 of the expansion member 130 into the syringe.

[0126] <Usage example of the hemostatic instrument> Next, with reference to FIGS. 22 to 26, a first usage example of the hemostatic instrument 100 will be described.

[0127] In the first usage example, the usage procedure of the hemostatic instrument 100 when hemostatizing the first puncture site p1 formed on the right hand H1 of the patient will be described.

[0128] FIG. 22 shows a state where the sheath tube 201 of the introducer 200 has been inserted into the first puncture site p1 and various procedures have been completed.

[0129] As shown in FIG. 22, the operator arranges the support member 140 so as to overlap the back Hb of the patient's right hand H1. At this time, while visually confirming the position of the marker 135 arranged on the expansion part 230 of the expansion member 130, the operator can appropriately position the support member 140 at the first puncture site p1 by arranging the marker 135 at the first puncture site p1.

[0130] After the operator finishes the procedure using the introducer 200, before attaching the hemostatic device 100 to the patient's right hand H1, the operator may pull out a part of the sheath tube of the introducer 200 from the first puncture site p1 formed on the patient's right hand H1. For example, with the sheath tube 201 of the introducer 200 indwelling in the blood vessel B, the operator can start the attachment operation of the hemostatic device 100 after pulling out the sheath tube 201 about 2 - 3 cm toward the operator's side.

[0131] As shown in FIGS. 22 and 23, the operator wraps the first band 150 and the second band 160 along the outer periphery of the patient's right hand H1. The operator can fix the first band 150 and the second band 160 via the respective fixing parts 181, 184 by bringing the fourth fixing part 184 (see FIG. 2) arranged on the inner surface of the second band 160 into contact with the first fixing part 181 (see FIG. 1) arranged on the outer surface of the first band 150.

[0132] When the operator wraps the first band 150 and the second band 160 along the outer periphery of the patient's right hand H1, the operator can rotate the first band 150 or the second band 160 around the rotation axis R of the first region 141 of the support member 140. By rotating the first band 150 and the second band 160, the operator can adjust the positions where the respective bands 150, 160 are wrapped around the patient's right hand H1. For example, the operator can rotate the respective bands 150, 160 within the range of the rotation angles θ1, θ2 (see FIG. 8) so that the respective bands 150, 160 are wrapped around the patient's right hand H1 at positions on the forearm A side (proximal side) from the first puncture site p1.

[0133] As shown in FIG. 24, the operator passes the third band 170 through the interdigital part fb located between the thumb and index finger of the patient's right hand H1, and arranges a part of the third band 170 on the palmar side of the patient's right hand H1. At this time, the operator can fix the third band 170 and the second band 160 through the respective fixing parts 182 and 185 by bringing the fifth fixing part 185 (see FIG. 2) arranged on the inner surface of the third band 170 into contact with the second fixing part 182 (see FIG. 1) arranged on the outer surface of the second band 160.

[0134] As described above, the operator arranges the first band 150 and the second band 160 so as to wrap around the outer periphery of the patient's right hand H1, and further hooks and arranges a part of the third band 170 in the interdigital part fb between the thumb and index finger of the patient's right hand H1, thereby effectively preventing the hemostatic device 100 from being displaced from the patient's right hand H1.

[0135] With a syringe connected to the injection part 191, the operator injects air into the expansion part 230 of the expansion member 130 to expand the expansion part 230 of the expansion member 130. As shown in FIGS. 25 and 26, when the expansion part 230 of the expansion member 130 expands, the hemostatic device 100 applies a compressive force to the first puncture site p1 of the patient's right hand H1.

[0136] As shown in FIGS. 24 and 26, when the operator attaches the hemostatic instrument 100 to the patient's hand H, the operator can place the first bending region 148a formed near one first hole 145a at a position on the distal side of the patient's right hand H1. Also, the operator can place the first bending region 148a formed near the other first hole 145b at a position on the proximal side of the patient's right hand H1. By arranging the hemostatic instrument 100 in this way, when the patient twists the wrist and moves the right hand H1 in the vertical or horizontal direction with the hemostatic instrument 100 attached to the patient's right hand H1, the first bending region 148a prevents the peripheral edge of the support member 140 from contacting the patient's right hand H1. Similarly, when the patient moves the right hand H1 as described above, the hemostatic instrument 100 prevents the first bending region 148a formed near the other first hole 145b from allowing the peripheral edge of the support member 140 to contact the patient's right hand H1. Thereby, while the hemostatic instrument 100 is stopping the bleeding at the first puncture site p1 formed in the patient's right hand H1, it can prevent the peripheral edge of the support member 140 from contacting or digging into the patient's right hand H1, which could cause the patient to feel discomfort or pain.

[0137] Also, as shown in FIGS. 24 and 25, when the operator attaches the hemostatic instrument 100 to the patient's hand H, the operator can fix the expansion part 230 of the expansion member 130 to the patient's right hand H1 so that the second bending region 148b formed in the support member 140 is arranged along a part of the outer periphery of the patient's right hand H1. When the expansion part 230 of the expansion member 130 expands with the hemostatic instrument 100 attached to the patient's right hand H1 in this way, the second bending region 148b of the support member 140 presses against the expansion part 230 of the expansion member 130 along a part of the outer periphery of the patient's right hand H1. Thereby, the hemostatic instrument 100 can prevent the expansion part 230 of the expansion member 130 from lifting off the patient's right hand H1. Therefore, the hemostatic instrument 100 can effectively apply a compressive force to the first puncture site p1 by the expansion part 230 of the expansion member 130.

[0138] After the operator expands the expansion part 230 of the expansion member 130, as shown in FIG. 24, the operator removes the sheath tube 201 of the introducer 200 from the first puncture site p1 formed in the patient's right hand H1. While the operator is using the hemostatic instrument 100 to stop bleeding, the operator confirms that there is no bleeding from the first puncture site p1 formed in the patient's right hand H1. If there is bleeding from the first puncture site p1 formed in the patient's right hand H1, the operator adjusts the amount of air injected into the expansion part 230 of the expansion member 130.

[0139] By the above procedure, the operator can use the hemostatic instrument 100 to stop bleeding at the first puncture site p1 formed in the patient's right hand H1.

[0140] FIG. 27 shows a second usage example of the hemostatic instrument 100. The second usage example is an example of using the hemostatic instrument 100 when stopping bleeding at the second puncture site p2 formed in the patient's right hand H1.

[0141] As shown in FIG. 27, when the operator stops bleeding at the second puncture site p2 formed in the patient's right hand H1, the operator attaches the hemostatic instrument 100 to the patient's right hand H1. The second puncture site p2 formed in the patient's right hand H1 is located more distally on the patient's right hand H1 than the aforementioned first puncture site p1 (see FIG. 21). When the operator wraps the belts 150 and 160 around the patient's right hand H1, the operator rotates the belts 150 and 160 about the rotation axis R of the first region 141 of the support member 140. For example, the operator rotates the belts 150 and 160 so that the belts 150 and 160 are wrapped around the patient's right hand H1 at a position on the forearm A side (proximal side) of the first puncture site p1. By wrapping the belts 150 and 160 around the proximal position of the patient's right hand H1, the operator can prevent the distal portion of the patient's right hand H1 from being restrained by the belts 150 and 160.

[0142] Although not shown, the hemostatic device 100 can also be used when hemostasis is performed on a puncture site formed on the patient's left hand. The puncture site formed on the left hand is, for example, a puncture site formed on an artery located in the snuffbox of the palmar artery running along the back of the patient's left hand, or a puncture site formed on the distal radial artery located more distally than the snuffbox of the palmar artery running along the back of the patient's left hand. The latter puncture site is located more distally on the left hand than the former puncture site with reference to the extensor tendon of the long thumb located on the back of the patient's left hand.

[0143] Even when hemostasis is performed on the puncture site of the left hand, the hemostatic device 100 can be attached to the patient's left hand in the same procedure as in the first and second usage examples described above. The operator can adjust the position where each belt 150, 160 is wound around the left hand by rotating each belt 150, 160 about the rotation axis R of the first region 141 of the support member 140 according to the position of each puncture site on the patient's left hand. By adjusting the position where each belt 150, 160 is wound around the left hand, the operator can prevent the distal portion of the patient's left hand from being restrained by each belt 150, 160 when hemostasis is performed on each puncture site.

[0144] As described through each usage example, the hemostatic device 100 can be attached to either the patient's right hand H1 or left hand. Also, when the hemostatic device 100 is used for hemostasis of each puncture site p1, p2 formed at different positions on the patient's right hand H1, and when it is used for hemostasis of each puncture site formed at different positions on the patient's left hand, it can be attached to the patient's hand H so that the distal portion of the patient's hand H is not restrained by each belt 150, 160.

[0145] As described above, the hemostatic device 100 according to the present embodiment includes an expansion member 130 configured to compress a site p1 to be hemostatic on a patient's limb, a support member 140 to which the expansion member 130 is fixed, and a fixing member 120 configured to be connectable to the support member 140 and to be fixable to the patient. The expansion member 130 includes an expansion portion 230 configured to be expandable by injection of a fluid, and a protruding portion 231 protruding from around the expansion portion 230. The support member 140 includes a central region 241 located at the center of the support member 140, and a curved region 242 that curves in a direction away from the expansion portion of the expansion member 130 from the central region 241 toward the edge of the support member 140. The expansion member 130 is fixed such that only the protruding portion 231 is fixed to the curved region 242 at a position where the expansion portion 230 overlaps the central region 241. As a result, the expansion member 130 forms a space S between the edge 230a of the expansion portion 230 and the curved region 242 of the support member 140 in a state where the expansion portion 230 is expanded.

[0146] In the state where the expansion part 230 of the expansion member 130 is located at a position overlapping with the central region 241 of the support member 140, only the protruding part 231 of the expansion member 130 is fixed to the curved region 242 of the support member 140 in the hemostatic device 100 configured as described above. Further, the support member 140 is curved in a direction away from the expansion part 230 of the expansion member 130 from the central region 241 toward the edge of the support member 140. Therefore, in the hemostatic device 100, since only the protruding part 231 of the expansion member 130 is fixed to the curved region 242 of the support member 140, a space S is formed between the edge 230a of the expansion part 230 and the curved region 242 of the support member 140 in a state where the expansion part 230 of the expansion member 130 is expanded. Accordingly, when the expansion part 230 of the expansion member 130 is expanded, the hemostatic device 100 can suppress the expansion part 230 of the expansion member 130 from spreading laterally with respect to the direction toward the puncture site p1. As a result, it is possible to prevent the compressive force on the puncture site p1 by the expansion member 130 from being dispersed, and an effective compressive force can be applied to the puncture site p1. Further, the expansion part 230 of the expansion member 130 and the central region 241 of the support member 140 only overlap and are not fixed via an adhesive or the like. For this reason, the visibility through the expansion part 230 of the expansion member 130 and the support member 140 does not decrease.

[0147] The protruding part 231 has a flange part 232 located around the expansion part 230 and a convex part 233 protruding from the flange part 232, and the expansion member 130 is fixed to the curved region 242 via the convex part 233.

[0148] According to the hemostatic device 100 configured as described above, since the expansion member 130 is fixed to the support member 140 via the convex portion 233, a predetermined distance can be ensured between the expansion portion 230 and the convex portion 233 by the flange portion 232 located between the expansion portion 230 and the convex portion 233. Therefore, the expansion member 130 can more reliably form the space S between the edge portion 230a of the expansion portion 230 and the curved region 242 of the support member 140 in a state where the expansion portion 230 is expanded by the flange portion 232 and the convex portion 233 of the protruding portion 231. As a result, when the expansion portion 230 of the expansion member 130 is expanded, the hemostatic device 100 can suppress the expansion member 130 from spreading laterally with respect to the direction toward the puncture site p1. As a result, it is possible to further prevent the compression force on the puncture site p1 by the expansion member 130 from being dispersed, and it is possible to apply a compression force more effectively to the puncture site p1.

[0149] The fixing member 120 is configured to be connectable to the support member 140, and includes a first band 150 extending in a first direction from the support member 140, a second band 160 configured to be connectable to the support member 140 and extending in a second direction different from the first direction from the support member 140, and a third band 170 configured to be connectable to the support member 140 and extending in a third direction different from the first and second directions from the support member 140. The first band 150 and the second band 160 are configured to be rotatable around the periphery of the expansion portion 230 about the rotation axis R in a state of being connected to the support member 140 and having the rotation axis R in the central region 241. The third band 170 is configured to be disposed between the patient's fingers in a state of being connected to the support member 140. The expansion member 130 is fixed to the curved region 242 at a position that does not overlap with the movable ranges of the first band 150 and the second band 160 in a direction orthogonal to the longitudinal direction of the third band 170.

[0150] According to the hemostatic device 100 configured as described above, since the first band 150 and the second band 160 are fixed to the support member 140 at a position where the expansion member 130 does not overlap with the movable ranges of the first band 150 and the second band 160, when the operator moves the first band 150 and the second band 160, they do not contact the fixing part (for example, the caulking pin 234) between the support member 140 and the expansion member 130. For this reason, the movability of the first band 150 and the second band 160 is not hindered, and the first band 150 and the second band 160 can be wound around the hand H without any problem. Further, the first band 150 and the second band 160 can rotate about the rotation axis R located in the central region 241 of the support member 140 while being connected to the second region 142. Therefore, the hemostatic device 100 can adjust the rotational positions of the two bands with respect to the patient's hand H by rotating the two bands 150 and 160 with respect to the support member 140 while arranging the expansion part 230 of the expansion member 130 at the puncture site p1 formed on the patient's hand H. Further, since the expansion member 130 is not fixed between the pair of second holes 147a and 147b in the direction orthogonal to the longitudinal direction of the third band 170, a wide area for arranging the expansion part 230 of the expansion member 130 can also be secured on the support member 140.

[0151] The support member 140 curves toward the expansion part 230 side of the expansion member 130 from the central region 241 toward the edge of the support member 140 in the direction orthogonal to the longitudinal direction of the third band 170 (see the second curved region 148b). The curved region 242 of the support member 140 forms inclined portions 243 toward the first band 150 side and the second band 160 side from the axial center (major axis C) in the longitudinal direction of the third band 170. The protruding portion 231 of the expansion member 130 is fixed to the inclined portion 243.

[0152] According to the hemostatic device 100 configured as described above, when the expansion member 130 expands the expansion portion 230, the expansion portion 230 of the expansion member 130 is suppressed from spreading laterally with respect to the direction toward the puncture site p1 by the space S, and moreover, by the second bending region 148b of the support member 140, spreading in a direction orthogonal to the longitudinal direction of the third band 170 is suppressed. As a result, it is possible to further prevent the compressive force on the puncture site p1 by the expansion member 130 from being dispersed, and it is possible to apply a compressive force more effectively to the puncture site p1.

[0153] The protruding portion 231 of the expansion member 130 is fixed to the bending region 242 at a position symmetric with respect to the longitudinal axis (major axis C) of the third band 170.

[0154] According to the hemostatic device 100 configured as described above, when the expansion portion 230 of the expansion member 130 is expanded, a space S can be formed between the edge portion 230a of the expansion portion 230 and the bending region 242 of the support member 140. Since the protruding portion 231 of the expansion member 130 is fixed at a position symmetric with respect to the major axis C of the third band 170, the space S is symmetric with respect to the major axis C of the third band 170. Therefore, even when the support member 140 is disposed on either the right hand H1 or the left hand of the patient, it is possible to prevent the compressive force on the puncture site p1 by the expansion member 130 from being dispersed, and it is possible to effectively apply a compressive force to the puncture site p1.

[0155] At least one of the support member 140 or the expansion portion 230 of the expansion member 130 is located in the central region 241 of the support member 140 and includes a marker 135 for aligning with the site to be hemostatic of the patient. The protruding portion 231 of the expansion member 130 is fixed to the bending region 242 of the support member 140 by at least four fixing portions (for example, caulking pins 234), and the intersection of two straight lines 237 passing through two fixing portions facing each other with the expansion portion 230 interposed therebetween is located at the marker 135.

[0156] According to the hemostatic device 100 configured as described above, the marker 135 is located in the central region 241 of the support member 140, and the intersection of the two straight lines 237 is located at the marker 135. Therefore, when the operator fixes the expansion member 130 to the puncture site p1 via the marker 135 and expands the expansion part 230 of the expansion member 130, the space S formed between the edge 230a of the expansion part 230 and the curved region 242 of the support member 140 is symmetric with respect to the major axis C of the third band 170 passing through the marker 135. Accordingly, the hemostatic device 100 has a structure that compresses the vicinity of the center of the expansion part 230 where the marker 135 is located in the central region 241 of the support member 140, and even when the support member 140 is arranged on either the right hand H1 or the left hand of the patient, it is possible to prevent the compressive force on the puncture site p1 by the expansion member 130 from being dispersed, and effectively apply a compressive force to the puncture site p1.

[0157] <Modification example of the fixing structure between the support member and the expansion member> Figs. 17 to 20(A)(B)(C) show various modification examples of the structure for fixing the expansion member 130 to the support member 140.

[0158] In the embodiment, an example in which the support member 140 and the expansion member 130 are fixed at four locations using caulking pins 234 is shown, but the present invention is not limited to this case. The means for fixing, the location for fixing, the number of locations for fixing, etc. can be changed as appropriate.

[0159] In modification example 1, as shown in Fig. 17, the convex part 233 of the protruding part 231 is fixed to the curved region 242 of the support member 140 by fusion or adhesion. The circle 238 shown by the broken line in Fig. 7 schematically shows the range of fusion or adhesion between the convex part 233 and the curved region 242. In this case, the mounting hole 242a is not formed in the curved region 242. The location for fixing and the number of locations for fixing are the same as in the embodiment.

[0160] In Modification 2, as shown in FIG. 18, the size of the extension member 130 is smaller than the size of the extension member 130 in the embodiment. The convex portion 233 of the protruding portion 231 is fixed at four locations within the first region 141 of the support member 140. The fixing is by caulking pins 234, fusion, or adhesion.

[0161] In Modification 3, as shown in FIG. 19, similar to Modification 2, the size of the extension member 130 is smaller than the size of the extension member 130 in the embodiment. The convex portion 233 of the protruding portion 231 is fixed at two locations within the first region 141 of the support member 140. The fixing is by caulking pins 234, fusion, or adhesion.

[0162] In Modification 4, as shown in FIGS. 20(A), 20(B), and 20(C), the extension member 130 is provided with a bellows portion 239 on the protruding portion 231. When the expansion portion 230 expands, the extension member 130 can increase the length of the protruding portion 231 by providing the bellows portion 239, and can adjust the size of the space S formed between the edge portion 230a of the expansion portion 230 and the curved region 242 of the support member 140. Further, as shown in the illustrated example, the bellows portion 239 is provided only on the distal-side (finger-side) protruding portion 231, and the size of the space S formed on the distal side (finger side) can be made different from the size of the space S formed on the proximal side (forearm A side). Therefore, for example, when the expansion portion 230 is disposed at the second puncture site p2 (see FIG. 21) formed in the distal radial artery located more distally than the snuffbox of the palmar artery running on the back Hb side of the patient's right hand H1, the expansion direction of the expansion portion 230 of the extension member 130 becomes the proximal side (forearm A side), and the blood vessel at the puncture site is likely to hit the bone located more inside the body than the blood vessel. For this reason, the hemostatic effect can be enhanced.

[0163] As described above, the hemostatic device according to the present invention has been described through the embodiments. 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.

[0164] In the description of the embodiment, a configuration is exemplified in which the convex portions 233 of the protruding portions 231 in the extension member 130 are provided separately at partial (four locations) of the outer periphery of the flange portion 232. However, as long as the extension member 130 can form a space S between the edge portion 230a of the extension portion 230 and the curved region 242 of the support member 140 in a state where the extension portion 230 is extended, the convex portions 233 may be provided over the entire circumference of the flange portion 232 of the protruding portion 231 and may have a structure that is fixed to the curved region 242 through the entire circumference of the convex portions 233.

[0165] In the description of the embodiment, a hemostatic instrument is exemplified that includes a configuration in which the first belt body and the second belt body are rotatable about the rotation axis of the support member, and the third belt body cannot rotate about the rotation axis of the support member. However, the hemostatic instrument may also have a configuration in which the third belt body can rotate about the rotation axis of the support member.

[0166] In the description of the embodiment, a form is exemplified in which the support member 140 includes a total of four holes, namely, a pair of first hole portions 145a and 145b and a pair of second hole portions 147a and 147b. However, the specific number of the holes can be appropriately changed. For example, a form may be adopted in which the other first hole portion 145b among the pair of first hole portions 145a and 145b is not provided, and a total of three holes are provided.

[0167] In the description of the embodiment, each belt body was configured to be rotatable about the rotation axis of the support member in a state of being connected to each hole portion of the support member. However, the structure for connecting each belt body to the support member is not limited to the hole portions provided in the support member. The structure for connecting each belt body to the support member can also be configured, for example, by a convex portion provided on one of the support member and each belt body and a groove provided on the other of the support member and each belt body and configured to slidably hold the convex portion.

[0168] In the description of the embodiment, a hemostatic device for stopping bleeding at a puncture site formed on the back of the hand was exemplified. However, the hemostatic device can also be used to stop bleeding at a puncture site formed on the palm of the hand. Further, the arrangement of each belt when attaching the hemostatic device to the patient is not limited to the position described with reference to the drawings, and can be changed as appropriate. For example, the third belt can also be arranged at an interdigital part other than the interdigital part located between the thumb and the index finger. Also, the hemostatic device may be used on the foot, which has many moving parts such as fingers, similar to the hand. For example, the hemostatic device may be used to stop bleeding at a puncture site formed on the patient's foot (for example, the dorsal side of the foot, the sole of the foot, etc.).

[0169] The shape, dimensions, etc. of each part of the hemostatic device are not particularly limited as long as an expansion member can be arranged at the site to be hemostatic, and can be changed as appropriate.

Description of Reference Numerals

[0170] 100 Hemostatic device 120 Fixing member 130 Expansion member 133 Lumen 135 Marker 140 Support member 140a One surface of the support member 140b The other surface of the support member 141 First region of the support member 142 Second region of the support member 145a One first hole (a pair of first holes) 145b The other first hole (a pair of first holes) 147a One second hole (a pair of second holes) 147b The other second hole (a pair of second holes) 148a First curved region 148b Second curved region 150 First belt (fixing member, first belt portion) 151 One first end portion 153 The other first end portion 155 First main body portion 160 Second belt (fixing member, second belt portion) 161 Second one end 163 Second other end 165 Second main body 170 Third band (fixing member, third band part) 171 Third one end 173 Third other end 175 Third main body 230 Extension part 230a Edge of the extension part 231 Protrusion 232 Flange part 233 Convex part 233a Through hole 234 Caulking pin (fixing part) 239 Bellows 241 Central region 242 Curved region 242a Mounting hole 243 Tapered part A Forearm B Blood vessel (artery) H Hand H1 Right hand Hb Back of the hand L1 Hole length of one first hole part L2 Hole length of the other first hole part L3 Hole length of one second hole part L4 Hole length of the other second hole part fb Interdigital part p1 First puncture site (puncture site) p2 Second puncture site (puncture site) R Rotation axis S Space θ1, θ2 Rotation angle

Claims

1. An expansion member configured to compress a site on a patient's limb to be hemostatic; A support member to which the expansion member is fixed; A fixing member configured to be connectable to the support member and configured to fix the support member to the patient, having: The expansion member includes an expansion part configured to be expandable by injection of a fluid, and a protruding part protruding from around the expansion part; The support member includes a central region located at the center of the support member, and a curved region that curves in a direction away from the expansion part of the expansion member from the central region toward an edge of the support member; The expansion member is fixed to the curved region at a position where the expansion part overlaps the central region, and only the protruding part is fixed at a position facing at least across the expansion part. A hemostatic device.

2. The fixing member is configured to be connectable to the support member, and includes a first belt part extending in a first direction from the support member; A second belt part configured to be connectable to the support member and extending in a second direction different from the first direction from the support member; A third belt part configured to be connectable to the support member and extending in a third direction different from the first direction and the second direction from the support member; The first belt part and the second belt part are connected to the support member and have a rotation axis in the central region, and are configured to be rotatable around the rotation axis around the periphery of the expansion part; The third belt part is configured to be disposed between fingers of a patient in a state of being connected to the support member; The expansion member is fixed to the curved region at a position that does not overlap a movable range of the first belt part and the second belt part in a direction orthogonal to a longitudinal direction of the third belt part. The hemostatic device according to Claim 1.

3. An expansion member configured to compress a site on a patient's limb to be hemostatic; A support member to which the expansion member is fixed; A fixing member configured to be connectable to the support member and configured to fix the support member to the patient, having: The expansion member includes an expansion part configured to be expandable by injection of a fluid, and a protruding part protruding from around the expansion part; The support member includes a central region located at the center of the support member, and a curved region that curves in a direction away from the expansion part of the expansion member from the central region toward an edge of the support member; The expansion member is fixed to the curved region at a position where the expansion part overlaps the central region, and only the protruding part is fixed to the curved region. The fixing member is configured to be connectable to the support member, and includes a first belt portion extending in a first direction from the support member, a second belt portion configured to be connectable to the support member and extending in a second direction different from the first direction from the support member, and a third belt portion configured to be connectable to the support member and extending in a third direction different from the first direction and the second direction from the support member. The first belt portion and the second belt portion are configured to be rotatable around the periphery of the expansion portion with a rotation axis provided in the central region in a state of being connected to the support member. The third belt portion is configured to be disposed between the patient's fingers in a state of being connected to the support member. The expansion member is a hemostatic device fixed to the curved region at a position that does not overlap with the movable ranges of the first belt portion and the second belt portion in a direction orthogonal to the longitudinal direction of the third belt portion.

4. The protruding portion has a flange portion located around the expansion portion and a convex portion protruding from the flange portion. The expansion member is fixed to the curved region via the convex portion, and the hemostatic device according to any one of claims 1 to 3.

5. The support member is curved toward the expansion portion side of the expansion member from the central region toward the edge of the support member in a direction orthogonal to the longitudinal direction of the third belt portion. The curved region of the support member forms inclined portions toward the first belt portion side and the second belt portion side from the axis in the longitudinal direction of the third belt portion. The protruding portion of the expansion member is fixed to the inclined portion, and the hemostatic device according to claim 2 or claim 3.

6. The protruding portion of the expansion member is fixed to the curved region at a position symmetric with respect to the axis in the longitudinal direction of the third belt portion, and the hemostatic device according to any one of claims 2, 3, and 5.

7. At least one of the expansion portions of the support member or the expansion member is located in the central region of the support member and includes a marker for aligning with the site to be hemostatic of the patient. The protruding portion of the expansion member is fixed to the curved region of the support member by at least four fixing portions, and the intersection of two straight lines passing through the two fixing portions facing each other across the expansion portion is located at the marker, and the hemostatic device according to any one of claims 1 to 6.

8. The hemostatic instrument according to any one of claims 1 to 7, wherein the extension member includes a bellows portion at the protruding portion.

Images