Hemostatic device

JP2025027571APending Publication Date: 2025-02-28TERUMO KK
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Patent Information

Application Number
JP2023132433
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Filing Date
2023-08-16
Publication Date
2025-02-28

AI Technical Summary

Benefits of technology

【0029】 上記(14)に記載の止血器具は、固定部材の本体部がコネクタ部とチューブ部とを接続した状態において、本体部と爪部の間にカバー部材が挿入されることにより、コネクタ部をカバー部材に固定することができる。また、上記の止血器具において、爪部は本体部側に向かって突出する凸部を有し、本体部は平面視で凸部と重なる位置に凹部を有する。上記の止血器具は、本体部と爪部の間に挿入されたカバー部材を凸部に引っ掛けるように配置することができる。また、本体部と爪部の間に挿入されカバー部材は、本体部と爪部の間において凸部と凹部に沿って蛇行した状態で配置される。そのため、上記の止血器具は、本体部と爪部の間からカバー部材が抜け出ることを効果的に防止できる。また、上記の止血器具は、術者が本体部と爪部の間にカバー部材を挿入する際、カバー部材の一部を凹部内に逃がしつつ、凸部に沿って移動させることができる。そのため、術者は、凸部が設けられた爪部と凹部が設けられた本体部の間にカバー部材を簡単かつ円滑に挿入することができる。また、上記の止血器具は、本体部と爪部の間にカバー部材の一部が挿入されることで、固定部材をカバー部材に固定させることができる。そのため、上記の止血器具は、固定部材がカバー部材に固定される際、患者の肢体(手等)の体表面に向けて押し付ける方向の不要な力が止血器具に対して加えられることを防止できる。したがって、上記の止血器具は、固定部材がカバー部材に固定される際、患者の肢体に装着した止血器具が位置ずれしたり、拡張部材が位置ずれしたりすることを防止できる。

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Abstract

To provide a hemostatic device capable of easily fixing a connector part to a cover member in a state where connection between a tube part for injecting fluid into an expansion member and the connector part is maintained, and capable of preventing an occurrence of positional deviations, etc. in the hemostatic device and the expansion member when fixing the connector part to the cover member.SOLUTION: An injection member 200 of a hemostatic device 10 includes: a connector part 210; a tube part 220 connected to an expansion member 150; and a fixing member 230 for connecting the connector part to the tube part and fixing the connector part to a cover member 100. The fixing member includes: a body part 240 for connecting the connector part to the tube part; a pawl part 250 extending to an expansion member side while facing the body part; and a connection part 260 configured to have the cover member 100 inserted between the body part and the pawl part and to connect the body part and the pawl part. The body part includes a convex part 245 protruding toward a pawl part side. The pawl part includes a recessed part 255 recessed to a side separated from the body part at a position overlapping with the convex part in a plane view.SELECTED DRAWING: Figure 12
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Description

[Technical field]

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

[0002] As one of the catheter procedures, a procedure is known in which a blood vessel in a patient's limb such as an arm or a hand is punctured to form a puncture site, and various medical elongated objects are introduced into the blood vessel through the puncture site to diagnose or treat the lesion site. For example, Patent Document 1 discloses a hemostatic device that stops bleeding at a puncture site formed to enable access to a blood vessel (including the distal radial artery) running through the hand.

[0003] The hemostatic device of Patent Document 1 comprises an expansion member that applies a compressive force to a puncture site formed on the patient's hand, a cover member for fixing the expansion member to the patient's hand, an injection member having a connector portion (port) configured to be able to inject a fluid to expand the expansion member and a tube portion connecting the connector portion and the inner cavity of the expansion member, and a tube fixing portion located on the cover member and configured to be able to fix the tube portion. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] International Publication No. 2019 / 090104 Summary of the Invention [Problem to be solved by the invention]

[0005] When a surgeon such as a doctor (hereinafter referred to as "the surgeon") uses the hemostatic device of Patent Document 1 to stop bleeding at a puncture site formed on a patient's hand, the surgeon fixes the hemostatic device to the patient's hand with the expansion member positioned at the puncture site formed on the patient's hand, thereby preventing the expansion member from shifting from the puncture site formed on the patient's hand. In addition, by fixing the tube portion to the tube fixing portion, the surgeon can prevent the tube portion from moving in accordance with the movement of the patient's hand while the expansion member is applying a compressive force to the puncture site.

[0006] However, the hemostatic device described in Patent Document 1 may have the following problems.

[0007] The tube fixing part of the hemostatic device of Patent Document 1 has a groove for fixing the tube part. When attaching or detaching the tube part from the tube fixing part, the surgeon applies an external force to the tube part, thereby deforming (e.g., elastically deforming) the tube fixing part in a direction to widen the groove part. The force required to deform the tube fixing part in a direction to widen the groove part when attaching or detaching the tube part from the tube fixing part is determined by the mechanical configuration of the tube fixing part. However, the tube fixing part may not be designed with the surgeon's operability or convenience in mind.

[0008] For example, if a greater force is required for the operator to attach or detach the tube part from the tube fixing part, when the operator applies an external force to the tube fixing part, the external force may be transmitted to the expansion member via the cover member on which the tube fixing part is disposed. As a result, the operator may unintentionally apply an external force to the puncture site and its surrounding area when attaching or detaching the tube part from the tube fixing part. In addition, if the external force applied by the operator to the tube fixing part is transmitted to the expansion member as described above, the expansion member may become displaced from the puncture site.

[0009] In relation to the above-mentioned problems, Patent Document 1 discloses a hemostatic device having a configuration in which a port that enables injection of a fluid is directly connected to an expansion member. In this hemostatic device, since the port is directly connected to the expansion member, the fluid can be injected into the expansion member without going through a tube part. Therefore, it is possible to prevent the occurrence of the above-mentioned problems that may occur when the tube part is attached to and detached from the tube fixing part arranged in the cover member.

[0010] However, the above-mentioned hemostatic device has the following concerns.

[0011] The port directly connected to the expansion member is arranged to protrude outward from the outer surface side located opposite the body surface of the cover member. Therefore, when the surgeon connects a fluid supplying instrument such as a syringe to the port when expanding the expansion member, the pushing force at the time of connection is transmitted to the entire hemostatic instrument, which may cause the hemostatic instrument to shift in position or be tilted. If the hemostatic instrument shifts in position or is tilted as described above, the expansion member may shift in position or the direction of the compression force applied from the expansion member to the puncture site may change to an unintended direction.

[0012] The present invention has been made in light of the above-mentioned problems, and aims to provide a hemostatic device that can easily fix the connector portion to a cover member while maintaining the connection between the tube portion for injecting fluid into the expansion member and the connector portion, and that can prevent the hemostatic device and the expansion member from becoming misaligned when the connector portion is fixed to the cover member. [Means for solving the problem]

[0013] The present invention can be achieved by any one of the following means (1) to (14).

[0014] (1) A surgical instrument comprising: a cover member configured to cover a puncture site formed in a patient; an expansion member connected to the cover member and configured to compress the puncture site; and an injection member connected to the expansion member and configured to be capable of injecting a fluid into the expansion member, wherein the injection member has a connector portion, a tube portion connected to the expansion member, and a fixing member connecting the connector portion and the tube portion and configured to be capable of fixing the connector portion to the cover member, wherein the fixing member has a main body portion connecting the connector portion and the tube portion, a claw portion facing the main body portion and extending toward the expansion member side, and a connecting portion configured to allow the cover member to be inserted between the main body portion and the claw portion and connecting the main body portion and the claw portion, wherein the main body portion has a convex portion protruding toward the claw portion, and the claw portion has a recessed portion recessed on the side away from the main body portion at a position overlapping the convex portion in a planar view.

[0015] (2) A hemostatic device as described in (1) above, wherein the convex portion has a tip portion located on the tube portion side in the longitudinal direction of the main body portion, and the tip portion of the convex portion is inclined toward the tube portion side.

[0016] (3) A hemostatic device as described in (1) or (2) above, wherein the width of the recessed portion in the longitudinal direction of the main body portion is longer than the width of the protruding portion in the longitudinal direction of the main body portion.

[0017] (4) A hemostatic device described in any one of (1) to (3) above, wherein the width of the recessed portion in a direction perpendicular to the longitudinal direction of the main body portion is longer than the width of the protruding portion in a direction perpendicular to the longitudinal direction of the main body portion.

[0018] (5) The hemostatic device described in (4) above, wherein the depression has, in a planar view, a shape that is rotationally symmetrical with respect to an intersection point that passes through the center position of the depression in the longitudinal direction of the main body portion and the center position of the depression in a direction perpendicular to the longitudinal direction of the main body portion, and the protrusion has a shape that is symmetrical in the longitudinal direction of the main body portion with respect to a straight line that passes through the intersection point and runs along a direction perpendicular to the longitudinal direction of the main body portion.

[0019] (6) A hemostatic device described in any one of (1) to (5) above, wherein the claw portion has an inner surface located on the main body portion side and an outer surface located opposite the inner surface, and the maximum protruding position of the convex portion is located on the outer surface side of the claw portion relative to a plane parallel to the inner surface of the claw portion.

[0020] (7) A hemostatic device described in any one of (1) to (6) above, wherein the main body portion is located on the tube portion side in the longitudinal direction of the main body portion and has a curved portion that is inclined toward the tube portion side, and the claw portion has a tip portion located on the tube portion side in the longitudinal direction of the main body portion, and the tip portion of the claw portion is located in a position that overlaps with the curved portion in a planar view.

[0021] (8) A hemostatic device as described in (7) above, wherein the tip portion of the claw portion has a protrusion that protrudes toward the main body portion, and the protrusion is located at the end portion on the base end side of the curved portion when viewed in a plane.

[0022] (9) A hemostatic device described in any one of (1) to (8) above, wherein the convex portion has an upper surface portion located on the claw portion side, and the upper surface portion has a plurality of protrusions protruding toward the claw portion side.

[0023] (10) A hemostatic device described in any one of (1) to (9) above, wherein the width of the connecting portion in a direction perpendicular to the longitudinal direction of the main body portion is smaller than the width of the recessed portion in a direction perpendicular to the longitudinal direction of the main body portion.

[0024] (11) A hemostatic device according to any one of (1) to (10) above, wherein the main body portion has a convex portion formed in a predetermined pattern surrounding a portion of the outer surface of the main body portion, and a space portion partitioned inside the convex portion.

[0025] (12) A hemostatic device described in any one of (1) to (11) above, wherein the main body portion has a plurality of the convex portions arranged at a predetermined interval in the longitudinal direction of the main body portion, and the claw portion has a plurality of the concave portions arranged at positions overlapping with each of the plurality of the convex portions in a planar view.

[0026] (13) A hemostatic device described in any one of (1) to (12) above, wherein an inner edge of the recessed portion located at the rear side of the claw portion in the insertion direction in which the cover member is inserted has an inclined portion inclined toward the main body portion.

[0027] (14) A hemostatic device comprising: a cover member configured to cover a puncture site formed in a patient; an expansion member connected to the cover member and configured to compress the puncture site; and an injection member connected to the expansion member and configured to be capable of injecting a fluid into the expansion member, wherein the injection member has a connector portion, a tube portion connected to the expansion member, and a fixing member connecting the connector portion to the tube portion and configured to be capable of fixing the connector portion to the cover member, wherein the fixing member has a main body portion connecting the connector portion to the tube portion, a claw portion facing the main body portion and extending toward the expansion member, and a connecting portion configured to allow the cover member to be inserted between the main body portion and the claw portion and connecting the main body portion to the claw portion, wherein the claw portion has a convex portion protruding toward the main body portion, and the main body portion has a concave portion at a position overlapping the convex portion in a planar view.

[0028] In the hemostatic device described in (1) above, when the main body of the fixing member connects the connector and the tube, the cover member is inserted between the main body and the claw, thereby fixing the connector to the cover. In the hemostatic device described above, the main body has a protrusion protruding toward the claw, and the claw has a recessed portion recessed on the side away from the main body at a position overlapping the protrusion of the main body in a plan view. In the hemostatic device described above, the cover member inserted between the main body and the claw can be arranged so as to be hooked on the protrusion. In addition, the cover member inserted between the main body and the claw is arranged in a meandering state along the protrusion and the recess between the main body and the claw. Therefore, the hemostatic device described above can effectively prevent the cover member from slipping out from between the main body and the claw. In addition, in the hemostatic device described above, when the surgeon inserts the cover member between the main body and the claw, the surgeon can move the cover member along the protrusion while releasing a part of the cover member into the recess. Therefore, the surgeon can easily and smoothly insert the cover member between the main body portion provided with the convex portion and the claw portion provided with the concave portion. Furthermore, the above-mentioned hemostatic device can fix the fixing member to the cover member by inserting a part of the cover member between the main body portion and the claw portion. Therefore, when the fixing member is fixed to the cover member, the above-mentioned hemostatic device can prevent unnecessary force from being applied to the hemostatic device in a direction pressing it against the body surface of the patient's limb (hand, etc.). Therefore, when the fixing member is fixed to the cover member, the hemostatic device can prevent the hemostatic device attached to the patient's limb from shifting in position and the expansion member from shifting in position.

[0029] In the hemostatic device described in (14) above, when the main body of the fixing member connects the connector and the tube, the cover member is inserted between the main body and the claw, thereby fixing the connector to the cover. In the hemostatic device described above, the claw has a convex portion protruding toward the main body, and the main body has a concave portion at a position overlapping the convex portion in a plan view. In the hemostatic device described above, the cover member inserted between the main body and the claw is arranged so as to be hooked on the convex portion. In addition, the cover member inserted between the main body and the claw is arranged in a meandering state along the convex portion and the concave portion between the main body and the claw. Therefore, the hemostatic device described above can effectively prevent the cover member from slipping out from between the main body and the claw. In addition, in the hemostatic device described above, when the surgeon inserts the cover member between the main body and the claw, the surgeon can move the cover member along the convex portion while releasing a part of the cover member into the concave portion. Therefore, the surgeon can easily and smoothly insert the cover member between the claw provided with the convex portion and the main body provided with the concave portion. Furthermore, in the above hemostatic device, the fixing member can be fixed to the cover member by inserting a part of the cover member between the main body portion and the claw portion. Therefore, when the fixing member is fixed to the cover member, the above hemostatic device can prevent unnecessary force from being applied to the hemostatic device in a direction pressing it against the body surface of the patient's limb (hand, etc.). Therefore, when the fixing member is fixed to the cover member, the above hemostatic device can prevent the hemostatic device attached to the patient's limb from shifting in position and the expansion member from shifting in position. [Brief description of the drawings]

[0030] [Figure 1] FIG. 2 is a diagram showing the hemostatic device according to the first embodiment, and is a plan view seen from the outer surface side of each band portion. [Diagram 2] FIG. 2 is a diagram showing the hemostatic device according to the first embodiment, and is a plan view seen from the inner surface side of each band portion. [Diagram 3] 13 is an enlarged view of a portion of the hemostatic device as viewed from the outer surface side of the main body of the cover member. FIG. [Figure 4] 13 is an enlarged view of a portion of the hemostatic device as viewed from the inner surface side of the main body of the cover member. FIG. [Diagram 5] 5A is a partial cross-sectional view of the hemostatic device taken along arrows 5A-5A in FIG. 3, illustrating the state when the expansion member is expanded. [Figure 6] 6A is a partial cross-sectional view of the hemostatic device taken along arrows 6A-6A in FIG. 3, illustrating the state when the expansion member is expanded. [Figure 7] FIG. [Figure 8] 8A is a partial cross-sectional view of the injection member taken along arrows 8A-8A shown in FIG. 7. [Figure 9] 8 is a partial cross-sectional view of the injection member as viewed from the direction of arrow 9A shown in FIG. 7. [Figure 10] 8 is a partial cross-sectional view of the injection member as viewed from the direction of arrow 10A shown in FIG. 7. [Figure 11] 11 is a partial cross-sectional view seen from the side, showing a state in which a cover member is inserted between a main body portion and a claw portion of a fixing member. FIG. [Figure 12] 11 is a partial cross-sectional view seen from the side, showing a state in which a cover member is inserted between a main body portion and a claw portion of a fixing member. FIG. [Figure 13] 11 is a partial cross-sectional view seen from the front side, showing a state in which a cover member is inserted between a main body portion and a claw portion of a fixing member. FIG. [Figure 14] 11A and 11B are diagrams for explaining the function and effect of a fixing member. [Figure 15] 11A and 11B are diagrams for explaining the function and effect of a fixing member. [Figure 16] 11A and 11B are diagrams for explaining the function and effect of a fixing member. [Figure 17] FIG. 1 is a diagram showing a patient's hand (right hand) on which the hemostatic device according to the first embodiment is to be used. [Figure 18] FIG. 2 is a diagram showing a simplified example of use of the hemostatic device according to the first embodiment. [Figure 19] FIG. 2 is a diagram showing a simplified example of use of the hemostatic device according to the first embodiment. [Figure 20] FIG. 2 is a diagram showing a simplified example of use of the hemostatic device according to the first embodiment. [Figure 21] 21A is a partial cross-sectional view taken along the arrows 21A-21A shown in FIG. 20. [Figure 22] 22A is a partial cross-sectional view taken along the arrows 22A-22A shown in FIG. 20. [Diagram 23] FIG. 11 is a perspective view of an injection member according to a first modified example. [Figure 24] 11 is a partial cross-sectional view of the injection member according to the first modified example, viewed from the side. FIG. [Diagram 25] 11 is a partial cross-sectional view of the injection member according to Modification 2, as viewed from the side. FIG. [Figure 26] 13 is a partial cross-sectional view of the injection member according to Modification 3, as viewed from the side. FIG. [Figure 27] 13 is a partial cross-sectional view of the injection member according to Modification 4, as viewed from the side. FIG. [Figure 28] 11 is a partial cross-sectional view of a side surface of an injection member according to a second embodiment. FIG. [Figure 29] FIG. 11 is a perspective view showing an example of use of the hemostatic device according to the third embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0031] Hereinafter, an embodiment of the present invention will be described with reference to the accompanying drawings. The following description does not limit the technical scope or meaning of terms described in the claims. In addition, the dimensional ratios of the drawings are exaggerated for the convenience of explanation and may differ from the actual ratios. First Embodiment 1 to 16 are diagrams illustrating the structure of each part of a hemostatic device 10 according to this embodiment. FIGs. 17 to 22 are diagrams illustrating a hemostatic method using the hemostatic device 10.

[0032] The hemostatic device 10 can be used, for example, to stop bleeding at a first puncture site p1 (hereinafter also simply referred to as "first puncture site p1") when removing a sheath tube 610 of an introducer 600 that has been placed at a first puncture site p1 formed in a hand H located distal (toward the fingertip) of a patient's forearm Ar, as shown in Figures 17, 19, 20, 21, and 22.

[0033] The specific positions of the puncture sites that are targets of hemostasis by the hemostatic device 10 are not particularly limited, but in this embodiment, a first puncture site p1 and a second puncture site p2 are exemplified.

[0034] As shown in Figures 17, 20, 21, and 22, the first puncture site p1 is a puncture site formed in the distal radial artery (hereinafter also referred to as "blood vessel V1") located distal to the snuff box Sb of the palmar artery running on the back side of the right hand H1 located distal to the forearm Ar of the patient. The first puncture site p1 is located between the metacarpal bone B1 of the index finger and the metacarpal bone B2 of the thumb, and is located at a predetermined position avoiding the metacarpal bone B1 of the index finger and the metacarpal bone B2 of the thumb. The snuff box Sb is a hollow part of the hand located near the radius when the patient spreads the thumb of the hand H.

[0035] The second puncture site p2 is a puncture site formed in an artery V2 located at a snuff box Sb of a palmar artery running on the back side of a right hand H1, as shown in Fig. 17. The second puncture site p2 is located closer to the patient's forearm Ar (proximal side) than the first puncture site p1, and is located between the extensor pollicis longus tendon T1 and the extensor pollicis brevis tendon T2 located on the back of the patient's right hand H1. The second puncture site p2 is located at a predetermined position avoiding the positions of the metacarpal bone B1 of the index finger and the metacarpal bone B2 of the thumb.

[0036] In addition, the hemostatic device 10 can also be used to stop bleeding at a puncture site formed on a patient's left hand at a position corresponding to the first puncture site p1 exemplified by the patient's right hand H1, or at a puncture site formed on a patient's left hand at a position corresponding to the second puncture site p2 exemplified by the patient's right hand H1.

[0037] The hemostatic device 10 will now be described in more detail.

[0038] (Hemostasis device 10) Generally speaking, as shown in Figures 1, 2, 7, 20, 21, and 22, the hemostatic device 10 comprises a cover member 100 configured to cover the first puncture site p1, an expansion member 150 connected to the cover member 100 and configured to compress the first puncture site p1, and an injection member 200 connected to the expansion member 150 and configured to be able to inject a fluid into the expansion member 150.

[0039] (Expansion member 150) The expansion member 150 has an internal cavity 150a into which a fluid can be injected, as shown in Figures 5 and 6. Figure 5 shows a cross-sectional view of the expansion member 150 in an expanded state taken along the line of arrows 5A-5A shown in Figure 3. Figure 6 shows a cross-sectional view of the expansion member 150 in an expanded state taken along the line of arrows 6A-6A shown in Figure 3.

[0040] The expansion member 150 is configured to expand in response to the injection of a fluid into the internal cavity 150a, and to contract in response to the discharge of the fluid injected into the internal cavity 150a. The fluid used to expand the expansion member 150 is, for example, a gas such as air.

[0041] A tube portion 220 (see FIGS. 3 and 4) is connected to the inner cavity 150a of the expansion member 150.

[0042] The extension member 150 can be formed, for example, of a film-like member (sheet material) connected to the sheet material 120 constituting the cover body 110 of the cover member 100, as shown in FIGS.

[0043] The expansion member 150 can be positioned to form a lumen 150a between itself and the underside region 132 of the retention portion 130 defined by the sheet material 120 .

[0044] The outer peripheral edge of the membrane-like member that constitutes the expansion member 150 constitutes an edge portion 151 of the expansion member 150. The edge portion 151 of the expansion member 150 can be connected to the sheet material 120 by, for example, fusion or an adhesive.

[0045] The film-like member constituting the expansion member 150 can be made of, for example, a resin material having a predetermined thickness.

[0046] The material of the membrane-like member constituting the expansion member 150 is not particularly limited, but may be, for example, polyvinyl chloride, ethylene-vinyl acetate copolymer (EVA), polyvinylidene chloride, silicone, polyamide (nylon), polyurethane, polyolefins such as polyethylene, polypropylene, and polybutadiene, polyesters such as polyethylene terephthalate (PET) and polybutylene terephthalate (PBT), various thermoplastic elastomers such as polyamide elastomer (nylon elastomer), polyurethane elastomer, and polyester elastomer, or any combination of these (blend resin, polymer alloy, laminate, etc.). The cover member 100 (sheet material 120) described later may be made of, for example, the same materials as those exemplified above.

[0047] The extension member 150 is disposed on the inner surface 110a side of the cover body 110 of the cover member 100, as shown in FIGS.

[0048] In this embodiment, the inner surface 110a of the cover body 110 is configured as a surface that is disposed on the body surface side of the right hand H1 in the lower surface region 132 of the holding portion 130 formed by the cover member 100 (see Figs. 21 and 22). The outer surface 110b of the cover body 110 is configured as a surface that is disposed facing the outside in the upper surface region 131 of the holding portion 130 formed by the cover member 100.

[0049] As shown in FIGS. 18, 19, and 20, the expansion member 150 has a marker portion 160 for aligning the expansion member 150 with the first puncture site p1.

[0050] As shown in Figs. 4 and 5, the marker portion 160 can be composed of a transparent central portion and a colored circular frame portion surrounding the central portion.

[0051] 5 and 6, the marker portion 160 is disposed on the outer surface of the expansion member 150. Note that the marker portion 160 may be disposed on the inner surface of the expansion member 150 facing the lumen 150a.

[0052] There are no particular limitations on the specific shape, color, formation method, etc. of the marker portion 160. The marker portion 160 may be, for example, a circular marker that is entirely colored, a marker that is composed of a transparent center and a rectangular frame, or a rectangular marker that is entirely colored.

[0053] The expansion member 150 can be configured to have, for example, an oval shape in the plan view shown in Figures 3 and 4. However, there are no particular limitations on the planar shape of the expansion member 150 in the planar view. The expansion member 150 may be configured to have, for example, a circular, elliptical, rectangular, or other planar shape.

[0054] In addition, there is no particular limitation on the specific configuration of the expansion member 150 included in the hemostatic device 10. The expansion member 150 may be formed, for example, by joining an edge of one sheet-like member to the other sheet-like member in a state in which a lumen 150a is formed between two sheet-like members. When the expansion member 150 is configured in this manner, the surface of one sheet-like member can be connected to the sheet material 120 constituting the cover body 110 of the cover member 100. In addition, the expansion member 150 can be configured, for example, by a single bag-like member shaped to have a lumen 150a on the inside. When the expansion member 150 is configured in this manner, the expansion member 150 can be configured by connecting a part of the surface of the bag-like member to the sheet material 120 constituting the cover body 110 of the cover member 100.

[0055] (Cover member 100) As shown in Figures 4, 5, and 6, the cover member 100 comprises a cover body 110 in which the extension member 150 is located, a first band portion 410 configured to be positioned between the patient's fingers and extending from the cover body 110 in a first direction, a second band portion 420 extending from the cover body 110 in a second direction different from the first direction, and a third band portion 430 facing the second band portion 420 across the extension member 150 and extending from the cover body 110 in a third direction different from the first and second directions.

[0056] The cover body 110 includes a support member 300 formed of a material harder than the extension member 150. The support member 300 is disposed so as to overlap the extension member 150 in the plan view shown in Figs.

[0057] 5 and 6, the cover body 110 has a two-layer structure. The cover body 110 has a two-layer structure and includes a holding portion 130 that holds the support member 300.

[0058] As shown in FIG. 6, the holding portion 130 has an upper surface region 131 located on the outer surface 300b side of the support member 300, a lower surface region 132 located on the inner surface 300a side of the support member 300 and facing the upper surface region 131 across the support member 300, and a curved region 133 connecting the upper surface region 131 and the lower surface region 132 on the base end side of the support member 300 (the lower end portion 302 side of the support member 300).

[0059] The curved region 133 is formed by folding back a portion of the cover body 110 toward the first band portion 410. In this embodiment, a portion of the sheet material 120 constituting the cover body 110 is folded back from the base end side to the tip end side of the cover body 110 to form the holding portion 130 having the gap portion g in which the support member 300 can be disposed.

[0060] The first end 121 located at the tip side of the folded-back portion of the sheet material 120 can be connected to the sheet material 120 at a position further tip than the upper end 301 of the support member 300, as shown in FIG. 6.

[0061] As shown in Fig. 5, the retaining portion 130 has the gap g closed in the vertical width direction of the expansion member 150 (the up-down direction in Fig. 4). Also, as shown in Fig. 6, the retaining portion 130 has the gap g communicated with the outside on the second band portion 420 side and the third band portion 430 side in the horizontal width direction of the expansion member 150 (the left-right direction in Fig. 4).

[0062] 4, each of the band parts 410, 420, 430 can be connected to any part of the area surrounding the periphery of the holding part 130 in the cover body 110. Also, each of the band parts 410, 420, 430 can be connected to, for example, the surface of the cover body 110 that is placed on the body surface side of the right hand H1. Each of the band parts 410, 420, 430 can be connected to the cover body 110 by, for example, fusion or adhesion. Also, each of the band parts 410, 420, 430 may be configured integrally with the cover body 110.

[0063] As shown in Figures 1, 2, 3, and 4, the first band portion 410 has one end 411 connected to the cover body 110 of the cover member 100, the other end 412 located opposite the one end 411, and a main body portion 413 extending between the one end 411 and the other end 412.

[0064] As shown in FIG. 20, the first band portion 410 can be positioned so that it is hooked onto the inter-finger portion fb located between the thumb and index finger of the patient's right hand H1 when the expansion member 150 is placed at the first puncture site p1.

[0065] As shown in Figures 1, 2, 3, and 4, the second band portion 420 has one end 421 connected to the cover body 110 of the cover member 100, the other end 422 located opposite the one end 421, and a main body portion 423 extending between the one end 421 and the other end 422.

[0066] As shown in Figures 1, 2, 3, and 4, the third band portion 430 has one end 431 connected to the cover body 110 of the cover member 100, the other end 432 located opposite the one end 431, and a main body portion 433 extending between the one end 431 and the other end 432.

[0067] As shown in FIG. 20, when the hemostatic device 10 is worn on a patient's right hand H1, the second band portion 420 and the third band portion 430 can be arranged so as to be wrapped around the outer circumference of the right hand H1.

[0068] The constituent material of each of the band parts 410, 420, 430 is not particularly limited, but may be, for example, vinyl chloride resin, polyurethane resin, polyester resin, etc. Furthermore, there are no particular limitations on the shape, length, thickness, etc. of each of the band parts 410, 420, 430.

[0069] Each band portion 410, 420, 430 is provided with four fastening portions, a first fastening portion 510, a second fastening portion 520, a third fastening portion 530, and a fourth fastening portion 540, which enable the cover member 100 to be fixed to the right hand H1.

[0070] As shown in FIG. 1, a first fastening portion 510 may be disposed on the outer surface of the body portion 423 of the second band portion 420 .

[0071] As shown in FIG. 1, a second fastening portion 520 may be disposed on the outer surface of the body portion 433 of the third band portion 430 .

[0072] As shown in FIG. 2, a third fastening portion 530 may be disposed on the inner surface of the body portion 423 of the second band portion 420 .

[0073] As shown in FIG. 2, a fourth fastening portion 540 may be disposed on the inner surface of the body portion 413 of the first band portion 410 .

[0074] The first fastening portion 510 and the second fastening portion 520 are configured on the male side of a hook-and-loop fastener. The third fastening portion 530 and the fourth fastening portion 540 are configured on the female side of a hook-and-loop fastener. The hook-and-loop fastener in this specification is a fastener that can be attached and detached on a surface, such as Magic Tape (registered trademark) or Velcro (registered trademark).

[0075] The second band unit 420 and the third band unit 430 are configured to be detachable via a third fastening portion 530 arranged on the inner surface of the second band unit 420 and a second fastening portion 520 arranged on the outer surface of the third band unit 430. The first band unit 410 and the second band unit 420 are configured to be detachable via a fourth fastening portion 540 arranged on the inner surface of the first band unit 410 and a first fastening portion 510 arranged on the outer surface of the second band unit 420.

[0076] The specific structure of each of the fixing sites 510, 520, 530, 540 is not particularly limited as long as the band parts 410, 420, 430 can be connected to each other with the hemostatic device 10 placed on the right hand H1 to fix the cover member 100 to the right hand H1. For example, the installation of some of the fixing sites can be omitted, or the positions of the fixing sites on the band parts 410, 420, 430 can be changed as desired. In addition, when each of the fixing sites 510, 520, 530, 540 is configured with a hook-and-loop fastener, the male side and the female side of the hook-and-loop fastener may be interchanged. In addition, each of the fixing sites 510, 520, 530, 540 may be configured with, for example, a snap, a button, a clip, or a connecting mechanism having a frame part with a protrusion and an engaged part with a hole part that can engage with the frame part.

[0077] (Support member 300) The support member 300 can be disposed in the gap g of the holding portion 130, as shown in FIGS.

[0078] As shown in Figures 4, 5, and 6, the support member 300 is located on the first band portion 410 side and has an upper end portion 301 that forms the end of the support member 300, a lower end portion 302 that forms the end opposite the upper end portion 301, and a pair of side portions 303, 304 that connect the upper end portion 301 and the lower end portion 302.

[0079] The upper end 301 of the support member 300 can be positioned on the fingertip side (distal end side) when the hemostatic device 10 is attached to the patient's right hand H1. The lower end 302 of the support member 300 can be positioned on the forearm Ar side (base end side) when the hemostatic device 10 is attached to the patient's right hand H1. The upper end 301 forms the "distal end" of the support member 300, and the lower end 302 forms the "base end" of the support member 300.

[0080] Each of the upper end 301 of the support member 300 and the lower end 302 of the support member 300 can be configured to include a flat portion that extends in a substantially straight line in the plan view shown in FIG.

[0081] As shown in FIG. 6, the outer surface 300b of the support member 300 is curved towards the second band portion 420 and the third band portion 430 (to the left and right direction in FIG. 6).

[0082] The radius of curvature of the outer surface 300b of the support member 300 can be formed to be approximately constant at each portion in the vertical direction of the support member 300 (the vertical direction in FIG. 4), for example.

[0083] 6, the inner surface 300a of the support member 300 is curved toward the second band portion 420 and the third band portion 430 (the left and right sides in FIG. 6). Therefore, the inner surface 300a of the support member 300 is curved in a convex shape in a direction away from the expansion member 150, as shown in FIG.

[0084] The radius of curvature of the inner surface 300a near the upper end 301 of the support member 300 can be formed to be smaller than the radius of curvature of the inner surface 300a near the lower end 302 of the support member 300, for example.

[0085] The support member 300 can be configured so that the thickness of each of the side portions 303, 304 connecting the upper end portion 301 and the lower end portion 302 becomes thinner from the upper end portion 301 toward the lower end portion 302. In other words, the support member 300 can be configured to have a cross-sectional shape that is inclined so that the distance between the outer surface 300b and the inner surface 300a becomes smaller from the upper end portion 301 toward the lower end portion 302 in the cross-sectional views shown in Fig. 5 and Fig. 21.

[0086] In the plan view shown in FIG. 4, each of the four corners of the support member 300 can be formed in a rounded curved shape.

[0087] In the hemostatic device 10, it is preferable that the portion of the expansion member 150 where the marker portion 160 is provided, the portion of the cover member 100 that overlaps with the marker portion 160 (the upper surface region 131 and the lower surface region 132 of the holding portion 130), and the portion of the support member 300 that overlaps with the marker portion 160 are formed transparently. When the members 100, 150, and 300 are configured in this manner, when the surgeon wears the hemostatic device 10 on the right hand H1 of the patient as shown in Figures 18, 19, and 20, the surgeon can easily visually confirm the position of the marker portion 160 and / or the first puncture site p1 arranged on the expansion member 150 through the transparent portions of the members 100, 150, and 300. In this specification, transparent includes colored transparent, colorless transparent, and translucent.

[0088] When the expansion member 150 is made of the materials mentioned above, the constituent materials of the support member 300 may be, for example, acrylic resin, polyvinyl chloride (especially rigid polyvinyl chloride), polyolefins such as polyethylene, polypropylene, 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.

[0089] (Injection member 200) Fig. 7 is a perspective view showing the overall configuration of injection member 200. Fig. 8 is a partial cross-sectional view taken along line 8A-8A in Fig. 7. Fig. 9 is a side view (partial cross-sectional view) seen from the direction of arrow 9A in Fig. 7. Fig. 10 is a bottom view (partial cross-sectional view) seen from the direction of arrow 10A in Fig. 7. Note that tube portion 220 is omitted from Figs. 9 and 10.

[0090] As shown in Figures 1, 2, and 7, the injection member 200 has a connector portion 210, a tube portion 220 connected to the expansion member 150, and a fixing member 230 that connects the connector portion 210 and the tube portion 220 and is configured to be able to fix the connector portion 210 to the cover member 100.

[0091] 7, the connector portion 210 has a port portion 211 extending from a base end portion 242 of the main body portion 240 of the fixing member 230 to the outside, and a valve portion 213 disposed in the internal space 240a of the main body portion 240 of the fixing member 230. The valve portion 213 is simply illustrated in FIG 7, and is not illustrated in the other drawings.

[0092] A fluid supply tool for supplying fluid to the lumen 150a of the expansion member 150 can be connected to the connector portion 210. For example, a syringe (not shown in the specification) can be used as the fluid supply tool.

[0093] The valve portion 213 can be configured, for example, by a check valve. The valve portion 213 maintains a closed state when the front cylinder portion of the syringe is not inserted into the connector portion 210. When the valve portion 213 is in a closed state, the valve portion 213 blocks communication between the inner cavity 223 (see FIG. 8) of the tube portion 220 and the outside of the connector portion 210. When the front cylinder portion of the syringe is inserted into the connector portion 210, the valve portion 213 opens. When the valve portion 213 opens, the inner cavity 223 of the tube portion 220 communicates with the inside of the front cylinder portion of the syringe via the internal space 240a of the main body portion 240 in which the valve portion 213 is located.

[0094] One end 221 of the tube portion 220 is connected to the expansion member 150, as shown in Figures 3 and 4. The other end 222 of the tube portion 220 is connected to the main body portion 240 of the fixing member 230, as shown in Figure 7. In addition, the other end 222 of the tube portion 220 is located in the internal space 240a of the main body portion 240 of the fixing member 230.

[0095] The inner cavity 223 of the tube portion 220 communicates with the internal space 240a of the main body portion 240 via the other end portion 222 of the tube portion 220. The inner cavity 150a of the expansion member 150 communicates with the internal space 240a of the main body portion 240 of the fixing member 230 via the inner cavity 223 of the tube portion 220.

[0096] When expanding the expansion member 150, the surgeon inserts the tip of a syringe (not shown) into the connector portion 210 to open the valve portion 213. With the valve portion 213 open, the surgeon can inject air from within the syringe into the inner cavity 150a of the expansion member 150 by pressing the plunger of the syringe. When air is injected into the inner cavity 150a, the expansion member 150 expands.

[0097] When contracting the expansion member 150, the surgeon inserts the tip of a syringe into the connector portion 210 and pulls the plunger of the syringe. By performing the above operation, the surgeon can discharge the air in the lumen 150a of the expansion member 150 into the syringe.

[0098] (Fixing member 230) As shown in FIG. 7, the fixing member 230 has a main body portion 240 that connects the connector portion 210 and the tube portion 220, a claw portion 250 that faces the main body portion 240 and extends toward the expansion member 150, and a connecting portion 260 that is configured to allow the cover member 100 to be inserted between the main body portion 240 and the claw portion 250 and connects the main body portion 240 and the claw portion 250.

[0099] In this specification, the side of the fixing member 230 to which the other end 222 of the tube portion 220 is connected is referred to as the "tip side (side indicated by arrow X1)", and the side of the fixing member 230 to which the port portion 211 is arranged is referred to as the "base side (side indicated by arrow X2)". The longitudinal direction of the main body portion 240 of the fixing member 230 is the direction from the tip side toward the base side (or from the base side to the tip side). The arrows X1-X2 in each drawing indicate the longitudinal direction of the main body portion 240, the arrows Y1-Y2 indicate the direction perpendicular to the longitudinal direction of the main body portion 240, and the arrows Z1-Z2 indicate the height direction of the main body portion 240.

[0100] 11 and 12 , a space defined between the main body 240 and the claw 250 at a position on the distal side of the connecting portion 260 forms an insertion portion I into which a part of the cover member 100 can be inserted. The insertion depth of the cover member 100 into the insertion portion I is determined according to the position of the connecting portion 260 disposed near the base end 252 of the claw 250.

[0101] As shown in FIGS. 7 and 9, the main body 240 has a protrusion 245 that protrudes toward the claw 250 side.

[0102] As shown in FIG. 9, the protruding portion 245 has a tip portion 245a located on the tube portion 220 side in the longitudinal direction of the main body portion 240.

[0103] Tip 245a of protrusion 245 is inclined toward tube portion 220. That is, tip 245a of protrusion 245 has a shape that is inclined toward the tip side of main body portion 240 and approaching the outer surface of main body portion 240 in the side view shown in FIG.

[0104] The tip end 245a of the convex portion 245 can be formed to have a curved shape that is rounded toward the tip end side, for example, as shown in Fig. 9. Note that the base end 245b of the convex portion 245 can be formed to have a curved shape that is rounded toward the base end side, similar to the tip end 245a of the convex portion 245.

[0105] 10, the protrusion 245 can be formed in a rectangular shape in plan view with a long side of a predetermined length arranged along the longitudinal direction of the main body 240. Each vertex of the protrusion 245 in the plan view shown in FIG. 10 can be formed in a curved shape.

[0106] 9, the protrusion 245 has an upper surface portion 246 located on the claw portion 250 side. The upper surface portion 246 has a plurality of protrusions 247 protruding toward the claw portion 250 side.

[0107] In this embodiment, each of the multiple protrusions 247 is formed in a curved shape with a rounded end located on the claw portion 250 side. As shown in Fig. 10, five protrusions 247 can be provided at predetermined intervals from each other in the longitudinal direction of the upper surface portion 246.

[0108] As shown in FIG. 10, each of the multiple protrusions 247 can be configured to have a predetermined length along a direction perpendicular to the longitudinal direction of the main body 240 in a plan view.

[0109] There are no particular limitations on the shape, size, number, or distance between adjacent protrusions 247 in the longitudinal direction of the protrusions 247.

[0110] As shown in FIGS. 7 and 10, the claw portion 250 has a recessed portion 255 recessed on the side away from the main body portion 240 at a position overlapping the protrusion portion 245 in a plan view.

[0111] The above "position overlapping with convex portion 245 in plan view" means that in a plan view (the bottom view shown in FIG. 10, or the top view of main body portion 240 seen from the top side), at least a portion of recess portion 255 is in a position overlapping with at least a portion of convex portion 245.

[0112] As shown in Figures 11 and 12, in this embodiment, the recess portion 255 is composed of a hole portion 256 that penetrates between an inner surface 250a of the claw portion 250 located on the main body portion 240 side and an outer surface 250b of the claw portion 250 located opposite the inner surface 250a.

[0113] Note that recessed portion 255 may have at least a cross-sectional shape that is recessed in a concave shape toward the side (arrow Z2 side) away from main body portion 240. For example, recessed portion 255 may be configured in the form of a recess that does not penetrate claw portion 250 in the height direction.

[0114] In addition, it is preferable that the recessed portion 255 is configured with a hole portion 256, because when the surgeon inserts the cover member 100 between the main body portion 240 and the claw portion 250, the cover member 100 can be inserted more easily and smoothly between the main body portion 240 having the convex portion 245 and the claw portion 250 having the recessed portion 255.

[0115] As shown in FIG. 10, the hole 256 can be formed in the shape of an elongated hole having a length in the longitudinal direction of the main body 240 in a plan view.

[0116] 10, a width W11 of the hole 256 in the longitudinal direction of the main body 240 is larger than a width W21 of the protrusion 245 in the longitudinal direction of the main body 240. Therefore, a tip end 245a and a base end 245b of the protrusion 245 are located between an inner edge 256a on the tip side of the hole 256 and an inner edge 256b on the base side of the hole 256.

[0117] 10, the width W12 of the hole 256 in the direction perpendicular to the longitudinal direction of the main body 240 is larger than the width W22 of the protrusion 245 in the direction perpendicular to the longitudinal direction of the main body 240. Therefore, each end of the protrusion 245 in the direction perpendicular to the longitudinal direction of the main body 240 is located between each inner edge of the hole 256 in the direction perpendicular to the longitudinal direction of the main body 240.

[0118] As described above, in this embodiment, the width W11 of the hole 256 of the main body 240 is larger than the width W21 of the convex portion 245, and the width W12 of the hole 256 is larger than the width W22 of the convex portion 245. Therefore, as shown in Fig. 10, the convex portion 245 is disposed so as to be contained inside the hole 256 in the longitudinal direction of the main body 240 and in the direction perpendicular to the longitudinal direction of the main body 240 in a plan view.

[0119] 10, in a plan view, recessed portion 255 has a shape that is rotationally symmetrical with respect to an intersection point O that passes through the center position of recessed portion 255 in the longitudinal direction of main body portion 240 (the position that passes through straight line C1 in the figure) and the center position of recessed portion 255 in a direction perpendicular to the longitudinal direction of main body portion 240 (the position that passes through straight line C2 in the figure). For example, recessed portion 255 has a shape that is two-dimensionally symmetrical with intersection point O as the axis of rotation, as shown in FIG.

[0120] As shown in Figure 10, the convex portion 245 has a shape that is symmetrical in the longitudinal direction of the main body portion 240 with respect to a straight line (synonymous with the straight line C1 in this embodiment) that passes through the intersection point O and runs perpendicular to the longitudinal direction of the main body portion 240.

[0121] Specifically, the protruding portion 245 has a planar shape such that a tip end 245a of the protruding portion 245 overlaps with a base end 245b of the protruding portion 245 when the protruding portion 245 is folded back toward the tip end or base end in the longitudinal direction of the main body portion 240 with respect to the straight line C1. In other words, the protruding portion 245 has a shape that is symmetrical in the left-right direction with respect to the straight line C1 in the plan view of FIG.

[0122] 10, an example of the above-mentioned "shape symmetrical in the longitudinal direction of the main body portion 240 with respect to the straight line C1" can be an elongated hole shape having a predetermined length in the longitudinal direction of the main body portion 240. Also, examples of shapes other than the above-mentioned elongated hole shape can include a rectangle whose long side is aligned along the longitudinal direction of the main body portion 240 and an ellipse whose long axis is aligned along the longitudinal direction of the main body portion 240.

[0123] As shown in Figures 7, 11, and 12, the maximum protruding position of the convex portion 245 can be located at approximately the same position as the plane PL (see Figure 7) parallel to the inner surface 250a of the claw portion 250, or on the outer surface 250b side of the plane PL parallel to the inner surface 250a of the claw portion 250.

[0124] The above-mentioned "maximum protruding position of the convex portion 245" can be defined as the maximum protruding position of the multiple protruding portions 247 when the convex portion 245 has multiple protruding portions 247 as in this embodiment. Also, for example, when the convex portion 245 has an upper surface portion 246 configured with a flat surface as in this embodiment, the upper surface portion 246 can be disposed at a position substantially identical to a plane PL parallel to the inner surface 250a of the claw portion 250. Also, when the convex portion 245 has multiple protruding portions 247 protruding from the upper surface portion 246 toward the claw portion 250 as in this embodiment, the multiple protruding portions 247 can be disposed at a position on the outer surface 250b side of the claw portion 250 from the plane PL parallel to the inner surface 250a of the claw portion 250 (for example, any position within the recessed portion 255).

[0125] When the convex portion 245 does not include a plurality of protrusions 247, the maximum protruding position of the convex portion 245 can be defined as the maximum protruding position of the convex portion 245 itself. In this case, when the convex portion 245 includes an upper surface portion 246 configured with a flat surface, the maximum protruding position of the convex portion 245 can be defined as any position of the upper surface portion 246.

[0126] In the hemostatic device 10, if the maximum protruding position of the convex portion 245 is farther toward the main body portion 240 than the plane PL parallel to the inner surface 250a of the claw portion 250, the distance between the convex portion 245 and the claw portion 250 becomes large. Therefore, in the hemostatic device 10, it becomes possible to smoothly insert the cover member 100 into the insertion portion I. However, if the distance between the convex portion 245 and the claw portion 250 becomes excessively large, the fixing force of the fixing member 230 to the cover member 100 becomes smaller in a state in which the cover member 100 is inserted into the insertion portion I, and the cover member 100 becomes more likely to come out of the insertion portion I. In order to prevent such a decrease in the fixing force, the hemostatic device 10 can be configured, as described in this embodiment and the modified example described later (see Figure 25), so that the maximum protruding position of the convex portion 245 (the maximum protruding position of the multiple protrusions 247) is located on the outer surface 250b side of the plane PL parallel to the inner surface 250a of the claw portion 250, or at approximately the same position as the plane PL parallel to the inner surface 250a of the claw portion 250 (see Figure 7).

[0127] As shown in FIGS. 7 and 9, the main body portion 240 has a curved surface portion 243 that is located on the tube portion 220 side (tip side) in the longitudinal direction of the main body portion 240 and is inclined toward the tube portion 220 side.

[0128] 7, main body portion 240 has a trunk portion 244 located on the base end side of curved surface portion 243. Trunk portion 244 has a cylindrical shape with a constant outer diameter. Trunk portion 244 extends in a substantially straight line along the longitudinal direction of main body portion 240 in the side view shown in FIG.

[0129] The curved surface portion 243 constitutes a tapered portion in which the outer diameter of the main body portion 240 gradually decreases toward the tip side. A tip portion 241 extending with a substantially constant outer diameter is located on the tip side of the curved surface portion 243. An end portion 243a whose shape changes from a curved shape to a linear shape is located between the curved surface portion 243 and the body portion 244.

[0130] 10, tip portion 251 of claw portion 250 is located at a position overlapping curved portion 243 in a plan view. The above "position overlapping curved portion 243 in a plan view" means any position between end portion 243a located at the base end of curved portion 243 and the tip of curved portion 243 (the boundary with tip portion 251).

[0131] As shown in Figures 7, 9, and 14, the main body portion 240 has a convex portion 248a formed in a predetermined pattern surrounding a portion of the outer surface 240b of the main body portion 240, and a space portion 248b partitioned inside the convex portion 248a.

[0132] As shown in FIG. 7, the convex portion 248a and the space portion 248b are arranged on the outer surface 240b of the main body portion 240 in pairs on both sides in a direction perpendicular to the longitudinal direction of the main body portion 240.

[0133] The convex portion 248a may be formed in an elliptical pattern with its major axis aligned along the longitudinal direction of the main body 240, as shown in Fig. 7 and Fig. 9. However, the pattern in which the convex portion 248a is arranged is not limited to an elliptical pattern. The convex portion 248a may be formed in a rectangular, circular, square, or other pattern.

[0134] The cross-sectional shape of the convex portion 248a (see FIG. 14) is preferably a rounded shape so that the surgeon does not feel pain when gripping it with the fingers f, etc. Also, the pattern of the convex portion 248a is preferably a shape without corners, such as an ellipse shown in FIG.

[0135] 15, the width W3 of the connecting portion 260 in a direction perpendicular to the longitudinal direction of the main body portion 240 is smaller than the width W12 of the hole portion 256 in a direction perpendicular to the longitudinal direction of the main body portion 240. Note that in FIG. 15, the claw portion 250 and the connecting portion 260 are shown in a simplified manner in order to explain the relationship in size between the width W3 of the connecting portion 260 and the width W12 of the hole portion 256.

[0136] The constituent material of the fixing member 230 (main body portion 240, claw portion 250, and connecting portion 260) is not particularly limited, but examples thereof include relatively hard materials such as hard resins such as ABS resin and polycarbonate resin, and metals.

[0137] (Example of use of hemostatic devices) Next, an example of use of the hemostatic device 10 and the function and effect of the fixing member 230 will be described with reference to Figs.

[0138] The following describes the procedure for using the hemostatic device 10 when stopping bleeding at the first puncture site p1 formed on the patient's right hand H1 shown in FIG.

[0139] FIG. 18 shows a state in which various procedures performed using the sheath tube 610 of the introducer 600 inserted into the first puncture site p1 have been completed.

[0140] When attaching the hemostatic device 10 to the patient's right hand H1, the surgeon positions the expansion member 150 and the support member 300 so that they overlap at the first puncture site p1, as shown in Fig. 18. At this time, the surgeon visually checks the position of the marker portion 160 placed on the expansion member 150, while placing the marker portion 160 at the first puncture site p1, thereby enabling the expansion member 150 and the support member 300 to be appropriately positioned at the first puncture site p1.

[0141] The surgeon wraps the second band portion 420 and the third band portion 430 around the outer circumference of the patient's right hand H1 as shown in Fig. 19. The surgeon can connect the second band portion 420 and the third band portion 430 via the respective fixing portions 520, 530 by bringing the second fixing portion 520 (see Fig. 1) arranged on the outer surface of the third band portion 430 into contact with the third fixing portion 530 (see Fig. 2) arranged on the inner surface of the second band portion 420.

[0142] The outer surface 300b of the support member 300 is curved toward the second band portion 420 side (side surface portion 303 side) and the third band portion 430 side (side surface portion 304 side) (see FIG. 6). Therefore, by wrapping the second band portion 420 and the third band portion 430 around the patient's right hand H1 as shown in FIG. 19, the surgeon can press the support member 300 from the outer surface 300b side against the right hand H1 so as to fit along the outer circumference of the right hand H1 as shown in FIG. 22. Therefore, the hemostatic device 10 can increase the fixing force of the support member 300 and the expansion member 150 to the patient's right hand H1.

[0143] As shown in Fig. 20, the surgeon places a part of the first band part 410 on the palm side of the patient's right hand H1 while passing the first band part 410 through the inter-finger part fb located between the thumb and index finger of the patient's right hand H1. At this time, the surgeon can connect the first band part 410 and the second band part 420 via the fixing parts 510, 540 by contacting the first fixing part 510 (see Fig. 1) located on the outer surface of the second band part 420 with the fourth fixing part 540 (see Fig. 2) located on the inner surface of the first band part 410.

[0144] Each part of the patient's right hand H1 (for example, around the snuff box Sb) has an inclined portion (see FIG. 17). The shape of the inclined portion of the right hand H1 depends on the individual differences of the patient. For example, if the inner surface of the support member is formed in a flat shape, it is difficult to arrange the support member so as to fit along the inclined portion of the right hand H1. In the hemostatic device 10 of this embodiment, the inner surface 300a of the support member 300 is curved convexly in a direction away from the expansion member 150 (see FIGS. 6 and 22). Therefore, by arranging the inner surface 300a of the support member 300 so as to overlap the inclined portion of the patient's right hand H1, the inner surface 300a of the support member 300 can be arranged so as to fit along the patient's right hand H1. As a result, the hemostatic device 10 can be arranged so that the support member 300 overlaps the first puncture site p1, regardless of the patient's dominant hand or the way the surgeon places the hemostatic device 10. Therefore, in the hemostatic device 10, the support member 300 can be suitably disposed at a desired position near the first puncture site p1.

[0145] With the hemostatic device 10 attached to the patient's right hand H1 in the above-described procedure, the surgeon connects a syringe to the port portion 211 (see FIG. 7). The surgeon operates the syringe to inject air into the expansion member 150, thereby expanding the expansion member 150. As shown in FIGS. 21 and 22, when the expansion member 150 expands, the hemostatic device 10 applies a compressive force to the first puncture site p1.

[0146] The support member 300 is made of a harder material than the expansion member 150. Therefore, when the expansion member 150 expands while the hemostatic device 10 is attached to the patient's right hand H1, the support member 300 presses the expansion member 150 against the patient's right hand H1. This allows the hemostatic device 10 to prevent the expansion member 150 from lifting up from the patient's right hand H1.

[0147] When performing hemostasis using a hemostatic instrument, the surgeon can, for example, strongly tighten the first band portion disposed in the interdigital portion fb in order to increase the fixing force of the support member to the patient's right hand H1. By strongly tightening the first band portion, the surgeon can firmly fix the support member to the patient's right hand H1 even if the support member is placed in an unstable state on the patient's right hand H1. However, if the first band portion is strongly tightened, the patient may feel pain. Therefore, if the first band portion cannot be tightened strongly due to pain felt by the patient, the hemostatic instrument may be placed with the inner surface of the support member inclined relative to the body surface of the patient's right hand H1. Specifically, the upper end of the support member where the first band portion is disposed is raised to a position excessively farther from the body surface of the patient's right hand H1 than the lower end located opposite the upper end. As a result, the hemostatic device is positioned with the support member tilted so that the distance between the inner surface of the support member and the body surface of the patient's right hand H1 gradually narrows from the upper end to the lower end of the support member.

[0148] The hemostatic device 10 is configured such that the thickness of the side portions 303, 304 of the support member 300 becomes thinner from the upper end portion 301 toward the lower end portion 302 (see Figs. 5 and 21). The first band portion 410, which is disposed in the interdigital portion fb between the patient's fingers, extends from the upper end portion 301 side of the support member 300 and is configured to press the upper end portion 301 side of the support member 300 against the patient's right hand H1. In the hemostatic device 10 having the support member 300 and the first band portion 410 configured in this manner, when the expansion member 150 starts to expand in a state in which the support member 300 and the expansion member 150 are fixed to the patient's right hand H1, the expansion member 150 applies force to the vicinity of the upper end portion 301 of the support member 300. The upper end portion 301 side of the support member 300 is lifted by the force applied by the expansion member 150. As a result, when the expansion member 150 is in an expanded state, the inner surface 300a of the support member 300 is disposed approximately parallel to the body surface of the patient's right hand H1, as shown in Fig. 21. Therefore, when the expansion member 150 is expanded, the hemostatic device 10 can apply a compressive force in the vertical direction to the first puncture site p1.

[0149] Furthermore, the inner surface 300a of the support member 300 is curved toward the second band portion 420 side and the third band portion 430 side (see Fig. 6 and Fig. 22). As shown in Fig. 22, the hemostatic device 10 is disposed such that the inner surface 300a of the support member 300 is along the body surface of the patient's right hand H1 when the expansion member 150 is in an expanded state. When the expansion member 150 expands, the hemostatic device 10 presses the expansion member 150 by the inner surface 300a of the support member 300 so that the expansion member 150 is along the body surface of the patient's right hand H1. As a result, when the expansion member 150 expands, the expansion member 150 applies a compressive force in a direction toward the first puncture site p1 from each of the side portions 303, 304 located near the center in the width direction of the inner surface 300a of the support member 300 and at both ends in the width direction of the inner surface 300a of the support member 300. Therefore, in the hemostatic device 10, the compression force applied by the expansion member 150 to the first puncture site p1 can be effectively increased compared to when the inner surface 300a of the support member 300 is formed in a flat surface shape.

[0150] After expanding the expansion member 150, the surgeon removes the sheath tube 610 of the introducer 600 from the first puncture site p1 as shown in Fig. 20. The surgeon checks that there is no bleeding from the first puncture site p1 while performing hemostasis using the hemostatic instrument 10. If there is bleeding from the first puncture site p1, the surgeon can adjust the amount of air injected into the expansion member 150.

[0151] By following the above procedure, the surgeon can use the hemostatic instrument 10 to stop bleeding at the first puncture site p1 formed in the patient's right hand H1.

[0152] With the expansion member 150 in an expanded state, the surgeon can fix the fixing member 230 to the cover member 100 as shown in FIG.

[0153] The fixing member 230 can be fixed at any position where a gap is formed between the cover member 100 and the body surface of the right hand H1 where the claw portion 250 can be placed when the expansion member 150 is expanded. An example of such a position is the fixed portion 110C (see Figs. 3 and 20) located between the first band portion 410 and the second band portion 420 in the cover main body 110. Other fixing positions of the cover member 100 can include, for example, a peripheral portion of a position where one end portion 421 of the second band portion 420 is connected, any position of the first band portion 410, any position of the second band portion 420, etc.

[0154] The surgeon can fix the fixing member 230 to the cover member 100 in the following procedure.

[0155] The surgeon inserts a part of the cover member 100 into the insertion portion I formed between the main body portion 240 and the claw portion 250, as shown in FIG.

[0156] The hole portion 256 (recess portion 255) of the claw portion 250 is located at a position overlapping with the protrusion portion 245 in a plan view. Therefore, when the surgeon inserts a part of the cover member 100 into the insertion portion I, the surgeon can push the cover member 100 to the base end side of the insertion portion I while allowing a part of the cover member 100 to escape into the hole portion 256.

[0157] 12, the hemostatic device 10 holds a part of the cover member 100 inserted into the insertion portion I in a serpentine state so as to be aligned with the convex portion 245 and the hole portion 256. Therefore, the hemostatic device 10 can prevent the part of the cover member 100 inserted into the insertion portion I from accidentally slipping out of the insertion portion I.

[0158] The surgeon can fix the fixing member 230 to the cover member 100 by inserting a part of the cover member 100 toward the insertion portion I defined between the main body portion 240 and the claw portion 250 as described above. Therefore, when the fixing member 230 is fixed to the cover member 100, the hemostatic device 10 can prevent unnecessary force from being applied in a direction pressing the hemostatic device 10 toward the body surface of the patient's right hand H1. Therefore, when the fixing member 230 is fixed to the cover member 100, the hemostatic device 10 can prevent the hemostatic device 10 worn on the patient's right hand H1 and the expansion member 150 from shifting in position.

[0159] Furthermore, in the hemostatic device 10, the protrusion 245 has a tip 245a located on the tube portion 220 side in the longitudinal direction of the main body portion 240. The tip 245a of the protrusion 245 is inclined toward the tube portion 220 side. Therefore, as shown in FIG. 11 , when inserting a part of the cover member 100 into the insertion portion I, the surgeon can smoothly guide the part of the cover member 100 between the protrusion 245 and the hole 256 while aligning the part along the tip 245a of the protrusion 245.

[0160] Furthermore, in the hemostatic device 10, the width W11 of the hole 256 in the longitudinal direction of the main body 240 is longer than the width W21 of the protrusion 245 in the longitudinal direction of the main body 240 (see FIG. 10). Therefore, as shown in FIGS. 11 and 12, when a part of the cover member 100 is inserted into the insertion part I from the distal end side of the main body 240, the hemostatic device 10 can prevent the inserted part of the cover member 100 from contacting the protrusion 245 at a position distal to the inner edge 256a on the distal side of the hole 256. This allows the hemostatic device 10 to move the cover member 100 more smoothly toward the base end side of the insertion part I by bringing a part of the cover member 100 into contact with the protrusion 245 to guide the moving direction of the cover member 100.

[0161] In the hemostatic device 10, the width W12 of the hole 256 in a direction perpendicular to the longitudinal direction of the main body 240 is longer than the width W22 of the protruding portion 245 in a direction perpendicular to the longitudinal direction of the main body 240. That is, in the hemostatic device 10, the width W11 of the hole 256 of the main body 240 is larger than the width W21 of the protruding portion 245, and the width W12 of the hole 256 is larger than the width W22 of the protruding portion 245. Therefore, as shown in Fig. 10, the protruding portion 245 is disposed to be accommodated inside the hole 256 in the width direction of the main body 240 and in the direction perpendicular to the width direction of the main body 240 in a plan view. Therefore, in the hemostatic device 10, a part of the cover member 100 is inserted between the protruding portion 245 and the hole 256 over the entire circumference surrounding the periphery of the protruding portion 245 in a plan view. Thereby, the hemostatic device 10 can sandwich the cover member 100 between the convex portion 245 and the hole portion 256 over the entire circumference surrounding the periphery of the convex portion 245. Therefore, the hemostatic device 10 can increase the fixing force of the fixing member 230 to the cover member 100 inserted into the insertion portion I.

[0162] In the hemostatic device 10, the recess 255 has a shape that is rotationally symmetrical in plan view with respect to an intersection O that passes through the center position of the recess 255 in the longitudinal direction of the main body 240 and the center position of the recess 255 in a direction perpendicular to the longitudinal direction of the main body 240, and the protrusion 245 has a shape that is symmetrical in the longitudinal direction of the main body 240 with respect to a straight line that passes through the intersection O and runs in a direction perpendicular to the longitudinal direction of the main body 240. Therefore, in the plan view shown in FIG. 10, the hemostatic device 10 can make the distance between the tip of the protrusion 245 located in the longitudinal direction of the main body 240 and the inner edge 256a located on the tip side of the hole 256 approximately equal to the distance between the base end of the protrusion 245 located in the longitudinal direction of the main body 240 and the inner edge 256b located on the base side of the hole 256. As a result, in the hemostatic device 10, when a part of the cover member 100 is inserted into the insertion portion I, the fixing force generated by pinching the cover member 100 between the tip end 245a of the convex portion 245 and the vicinity of the inner edge 256a located on the tip side of the claw portion 250 is substantially the same as the fixing force generated by pinching the cover member 100 between the base end 245b of the convex portion 245 and the vicinity of the inner edge 256b located on the base end side of the claw portion 250. Therefore, the hemostatic device 10 can prevent the fixing force fixing the cover member 100 on the tip end 245a side and the base end 245b side of the convex portion 245 from being biased. As a result, the hemostatic device 10 can more effectively prevent the cover member 100 inserted into the insertion portion I from accidentally coming out of the insertion portion I.

[0163] 10, in this embodiment, the convex portion 245 has a shape that is symmetrical also in a direction perpendicular to the longitudinal direction of the main body portion 240 with respect to a straight line (straight line C2) that passes through the intersection O and runs along the longitudinal direction of the main body portion 240. Therefore, the hemostatic device 10 can prevent bias in the fixing force that fixes the cover member 100 even on both end sides of the convex portion 245 that are positioned in the direction perpendicular to the main body portion 240. This allows the hemostatic device 10 to more effectively prevent the cover member 100 inserted into the insertion portion I from accidentally slipping out of the insertion portion I.

[0164] Furthermore, in the hemostatic device 10, the main body portion 240 has a curved surface portion 243 that is located on the tube portion 220 side in the longitudinal direction of the main body portion 240 and is inclined toward the tube portion 220 side. The claw portion 250 has a tip portion 251 that is located on the tube portion 220 side in the longitudinal direction of the main body portion 240. The tip portion 251 of the claw portion 250 is located at a position that overlaps with the curved surface portion 243 in a plan view. Therefore, when inserting a part of the cover member 100 into the insertion portion I as shown in FIG. 11, the surgeon can move the cover member 100 toward the claw portion 250 by moving the cover member 100 along the curved surface portion 243. In the hemostatic device 10, the cover member 100 moves along the curved surface portion 243, and after a part of the cover member 100 moves to the tip portion 251 of the claw portion 250 located at a position overlapping the curved surface portion 243 in a plan view, the cover member 100 can be smoothly moved as it is toward the base end side of the insertion portion I. This allows the surgeon to insert the cover member 100 into the insertion portion I more easily and smoothly.

[0165] Moreover, in the hemostatic device 10, the convex portion 245 has an upper surface portion 246 located on the claw portion 250 side. The upper surface portion 246 has a plurality of projections 247 projecting toward the claw portion 250 side. Therefore, as shown in Figs. 12 and 13, in the hemostatic device 10, when a part of the cover member 100 is inserted into the insertion portion I, the plurality of projections 247 can contact the cover member 100. As a result, in the hemostatic device 10, when the cover member 100 is inserted into the insertion portion I, the plurality of projections 247 can prevent the cover member 100 from slipping. Therefore, in the hemostatic device 10, the cover member 100 inserted into the insertion portion I can be prevented from slipping out of the insertion portion I.

[0166] In the hemostatic device 10, the width W3 of the connecting portion 260 in the direction perpendicular to the longitudinal direction of the main body portion 240 is smaller than the width W12 of the hole portion 256 in the direction perpendicular to the longitudinal direction of the main body portion 240 (see FIG. 15). As shown in FIG. 16, if the width W3 of the connecting portion 260 is larger than the width W12 of the hole portion 256, and the cover member 100 is arranged in an obliquely inclined state when a part of the cover member 100 is inserted to a position where it contacts the connecting portion 260 located at the back side in the insertion direction of the insertion portion I, the area of ​​the cover member 100 sandwiched between the protrusion portion 245 and the claw portion 250 is reduced. Therefore, the fixing force of the cover member 100 by the sandwiching between the protrusion portion 245 and the claw portion 250 is reduced. On the other hand, as shown in Fig. 15, if the width W3 of the connecting portion 260 is smaller than the width W12 of the hole 256, even when the cover member 100 is arranged in an obliquely inclined state in the insertion portion I, it is possible to prevent a decrease in the area of ​​the cover member 100 sandwiched between the convex portion 245 and the claw portion 250. Therefore, it is possible to prevent a decrease in the fixing force of the cover member 100 caused by the sandwiching between the convex portion 245 and the claw portion 250. In this embodiment, as shown in Figs. 3, 4, and 15, the fixed portion 110C located between the first band portion 410 and the second band portion 420 of the cover member 100 is configured in a curved planar shape. In the case where the width W3 of the connecting portion 260 is smaller than the width W12 of the hole 256, when the fixed portion 110C having the above-described shape is inserted into the insertion portion I and positioned so that the fixed portion 110C contacts the connecting portion 260, the fixed portion 110C is positioned so as to be hooked onto the connecting portion 260. Therefore, the hemostatic device 10 can further effectively increase the fixing force of the fixing member 230 to the cover member 100.

[0167] In the hemostatic device 10, the main body 240 has a convex portion 248a formed in a predetermined pattern surrounding a part of the outer surface 240b of the main body 240, and a space portion 248b defined inside the convex portion 248a. When an operator fixes the fixing member 230 to the cover member 100, as shown in FIG. 14, the convex portion 248a functions as a slip prevention member when the operator grips the outer surface 240b of the main body 240 with fingers f or the like. Therefore, the hemostatic device 10 can prevent the main body 240 from slipping off the operator's fingers f when fixing the fixing member 230 to the cover member 100 or when removing the cover member 100 from the fixing member 230. This allows the operator to more smoothly fix the fixing member 230 to the cover member 100 or more smoothly remove the cover member 100 from the fixing member 230.

[0168] As described above, the hemostatic device 10 according to this embodiment includes a cover member 100 configured to cover a first puncture site p1 formed in a patient, an expansion member 150 connected to the cover member 100 and configured to compress the first puncture site p1, and an injection member 200 connected to the expansion member 150 and configured to be able to inject a fluid into the expansion member 150. The injection member 200 has a connector portion 210, a tube portion 220 connected to the expansion member 150, and a fixing member 230 configured to connect the connector portion 210 and the tube portion 220 and to be able to fix the connector portion 210 to the cover member 100. The fixing member 230 has a main body portion 240 that connects the connector portion 210 and the tube portion 220, a claw portion 250 that faces the main body portion 240 and extends toward the expansion member 150, and a connecting portion 260 that connects the main body portion 240 and the claw portion 250 and is configured so that the cover member 100 can be inserted between the main body portion 240 and the claw portion 250. The main body portion 240 has a protrusion 245 that protrudes toward the claw portion 250 side, and the claw portion 250 has a recessed portion 255 that is recessed on the side away from the main body portion 240 at a position that overlaps with the protrusion 245 in a plan view.

[0169] In the hemostatic device 10 configured as described above, in a state in which the main body 240 of the fixing member 230 connects the connector 210 and the tube 220, the cover member 100 is inserted between the main body 240 and the claw 250, thereby fixing the connector 210 to the cover member 100. In the hemostatic device 10, the main body 240 has a convex portion 245 protruding toward the claw 250, and the claw 250 has a recessed portion 255 recessed on the side away from the main body 240 at a position overlapping with the convex portion 245 of the main body 240 in a plan view. In the hemostatic device 10, the cover member 100 inserted between the main body 240 and the claw 250 can be arranged so as to be hooked on the convex portion 245. In addition, the cover member 100 inserted between the main body 240 and the claw 250 is arranged in a meandering state along the convex portion 245 and the recessed portion 255 between the main body 240 and the claw 250. Therefore, the hemostatic device 10 can effectively prevent the cover member 100 from slipping out from between the main body portion 240 and the claw portion 250. Furthermore, when the surgeon inserts the cover member 100 between the main body portion 240 and the claw portion 250, the hemostatic device 10 can move the cover member 100 along the convex portion 245 while releasing a part of the cover member 100 into the recessed portion 255. Therefore, the surgeon can easily and smoothly insert the cover member 100 between the main body portion 240 provided with the convex portion 245 and the claw portion 250 provided with the recessed portion 255. Furthermore, the hemostatic device 10 can fix the fixing member 230 to the cover member 100 by inserting a part of the cover member 100 between the main body portion 240 and the claw portion 250. Therefore, when the fixing member 230 is fixed to the cover member 100, the hemostatic device 10 can prevent unnecessary force from being applied to the hemostatic device 10 in a direction pressing the cover member 100 against the body surface of the limb such as the patient's right hand H1. Therefore, when the fixing member 230 is fixed to the cover member 100, the hemostatic device 10 can be prevented from shifting in position when worn on the patient's right hand H1, and the expansion member 150 can be prevented from shifting in position.

[0170] Next, a modified example of the first embodiment described above will be described. In the description of the modified example, the description of the members already described in the first embodiment and the procedure for using the hemostatic device will be omitted as appropriate. Furthermore, the contents not specifically described in the modified example can be the same as those in the first embodiment.

[0171] <Variation 1> Fig. 23 is a perspective view of injection member 200A according to Modification 1. Fig. 24 is a partial cross-sectional view of injection member 200A according to Modification 1 as viewed from the side.

[0172] As shown in FIGS. 23 and 24, tip portion 251 of claw portion 250 has protrusion 257 that protrudes toward main body portion 240 side.

[0173] The protruding portion 257 is located at the end portion 243a on the base end side of the curved portion 243 in a plan view.

[0174] The protruding portion 257 protrudes from the inner surface 250a of the claw portion 250. An end portion of the protruding portion 257 located in the protruding direction can be formed in a shape that is curved convexly toward the main body portion 240 side, for example.

[0175] A width W4 of the protrusion 257 in a direction perpendicular to the longitudinal direction of the main body 240 can be configured to be larger than a width W12 of the hole 256 in a direction perpendicular to the longitudinal direction of the main body 240 (see FIG. 10).

[0176] As shown in FIG. 24, in the state where a part of cover member 100 is inserted into insertion portion I, injection member 200A according to modification 1 has protrusion 257 disposed at tip 251 of claw portion 250, which pinches a part of cover member 100 between itself and main body portion 240. Therefore, injection member 200A according to modification 1 can increase the fixing force of fixing member 230 to cover member 100. In particular, in injection member 200A according to modification 1, protrusion 257 is located at end 243a on the base end side of curved surface portion 243 in a plan view, so that protrusion 257 comes into contact with cover member 100 at a position where the distance between main body portion 240 and claw portion 250 near end 243a on the base end side of curved surface portion 243 is relatively small. Therefore, injection member 200A according to modification 1 can more effectively increase the fixing force of fixing member 230 to cover member 100.

[0177] <Variation 2> FIG. 25 is a partial cross-sectional view of the injection member according to the second modification, as viewed from the side.

[0178] As shown in FIG. 25, the claw portion 250 has an inner surface 250a located on the main body portion 240 side, and an outer surface 250b located on the opposite side to the inner surface 250a.

[0179] An upper surface 246 of the protrusion 245 and a plurality of protrusions 247 provided on the protrusion 245 are located on the outer surface 250b side of the claw portion 250 relative to a plane PL parallel to the inner surface 250a of the claw portion 250.

[0180] In this embodiment, the upper surface 246 of the convex portion 245 and the maximum protruding position of the convex portion 245 (the maximum protruding position of the multiple protrusions 247) are located within the hole 256. Also, the convex portion 245 is disposed such that a predetermined range from the maximum protruding position of the convex portion 245 to the main body portion 240 side is contained within the hole 256 in each of the longitudinal direction of the main body portion 240 and the direction perpendicular to the longitudinal direction of the main body portion 240.

[0181] 25, the injection member according to the second modification can be arranged so that, with a portion of the cover member 100 inserted into the insertion portion I, the cover member 100 is hooked onto the convex portion 245 and the multiple protrusions 247 located in the hole 256. By being hooked onto the convex portion 245 and the multiple protrusions 247 located in the hole 256, the cover member 100 is arranged in the insertion portion I in a state in which it meanders more greatly in the up-down direction (the direction of the arrows Z1-Z2). Therefore, the injection member according to the second modification can more reliably prevent the cover member 100 from slipping out of the insertion portion I.

[0182] <Modification 3> FIG. 26 is a partial cross-sectional view of the injection member according to the third modification, as viewed from the side.

[0183] As shown in FIG. 26, in the injection member of variant example 3, the claw portion 250 has an inner edge 256b of the hole portion 256 located at the rear side (the base end portion 122 side of the main body portion 240) in the insertion direction in which the cover member 100 is inserted, and has an inclined portion 256c inclined toward the main body portion 240.

[0184] The inclined portion 256c is inclined in a substantially linear manner toward the connecting portion 260. The inclined portion 256c may have a curved shape. Furthermore, the inner edge 256b of the hole 256 may be entirely composed of the inclined portion.

[0185] When a portion of cover member 100 is inserted up to inclined portion 256c, the injection member according to Modification 2 can move cover member 100 along inclined portion 256c from hole portion 256 toward main body portion 240. Therefore, the injection member according to Modification 2 can make the operation of inserting cover member 100 into insertion portion I even smoother.

[0186] <Variation 4> FIG. 27 is a partial cross-sectional view of the injection member according to the fourth modification, as viewed from the side.

[0187] In the injection member according to the fourth modification, main body portion 240 has multiple protrusions 245A, 245B arranged at a predetermined interval in the longitudinal direction of main body portion 240. The protrusion arranged on the tip side of main body portion 240 is referred to as a "first protrusion 245A," and the protrusion arranged on the base end side of main body portion 240 is referred to as a "second protrusion 245B."

[0188] In addition, in the injection member according to the fourth modification, claw portion 250 has a plurality of holes (depressions) 256A, 256B arranged at positions overlapping with a plurality of protrusions 245A, 245B in a plan view. The hole arranged on the tip side of main body portion 240 is referred to as a "first hole portion 256A," and the hole arranged on the base end side of main body portion 240 is referred to as a "second hole portion 256B."

[0189] 27, when a portion of cover member 100 is inserted into insertion portion I, injection member 200 according to modification 4 is arranged in a state in which it meanders multiple times along multiple protrusions 245A, 245B and multiple holes 256A, 256B. Therefore, injection member 200 according to modification 4 can more effectively prevent cover member 100 from slipping out of insertion portion I.

[0190] In the injection member according to the fourth modification, an example has been described in which two convex portions and two hole portions (recess portions) are provided, but the number of convex portions and hole portions is not particularly limited and may be, for example, three or more. In addition, when a plurality of convex portions and hole portions are provided as in the injection member according to the fourth modification, there is no particular limit to the distance between each convex portion and each hole portion. In addition, when a plurality of convex portions and hole portions are provided as in the injection member according to the fourth modification, each convex portion may or may not have the same configuration. Similarly, each hole portion may or may not have the same configuration.

[0191] <Second embodiment> Fig. 28 is a diagram showing an injection member included in a hemostatic device according to a second embodiment, and is a partial cross-sectional view of the injection member as viewed from the side.

[0192] The hemostatic device according to the second embodiment has a common configuration to the hemostatic device 10 according to the first embodiment described above, except for the fixing member 230A.

[0193] Specifically, the hemostatic device 10 according to the first embodiment is configured such that the main body 240 has a protrusion 245, and the claw 250 has a recess 255 (hole 256). On the other hand, the hemostatic device according to the second embodiment is configured such that the claw 250 has a protrusion 270 protruding toward the main body 240, and the main body 240 has a recess 280 at a position overlapping the protrusion 270 in a plan view, as shown in Fig. 28.

[0194] The convex portion 270 can be configured to have a plurality of protrusions 277, as in the first embodiment. The maximum protruding position of the upper surface portion of the convex portion 270 (the upper surface portion of the claw portion 250) can be, for example, the same position as an imaginary plane PL1 extending on the same plane as a straight line passing through the lowest end portion of the main body portion 240 (the most protruding position toward the claw portion 250 side of the trunk portion 244 in the cross-sectional view shown in FIG. 28), or can be located at a position inside the concave portion 280 (the position on the arrow Z1 side) relative to the imaginary plane PL1.

[0195] The recess 280 is configured by adding a specific shape forming a recess to the main body 240. As described above, the valve portion 213 is disposed in the internal space 240a of the main body 240 (see FIG. 7). Therefore, unlike the recess 255 formed in the main body 240 of the first embodiment, the recess 280 cannot be configured in the form of a hole penetrating the main body 240. Note that there are no particular limitations on the cross-sectional shape, size, etc. of the recess 280 as long as it is not in the form of a hole.

[0196] As described above, the hemostatic device according to the second embodiment includes cover member 100 configured to cover first puncture site p1 (see FIG. 17) formed in a patient, expansion member 150 connected to cover member 100 and configured to compress first puncture site p1, and injection member 200 connected to expansion member 150 and configured to be able to inject a fluid into expansion member 150. Injection member 200 has connector portion 210, tube portion 220 connected to expansion member 150, and fixing member 230A configured to connect connector portion 210 and tube portion 220 and to be able to fix connector portion 210 to cover member 100 (see FIGS. 1, 2, 7, 20, 28, etc.). Fixing member 230A has a main body portion 240 that connects connector portion 210 and tube portion 220, a claw portion 250 that faces main body portion 240 and extends toward expansion member 150, and a connecting portion 260 that is configured so that cover member 100 can be inserted between main body portion 240 and claw portion 250 and connects main body portion 240 and claw portion 250. Claw portion 250 has a convex portion 270 that protrudes toward main body portion 240, and main body portion 240 has a concave portion 280 at a position that overlaps with convex portion 270 in a plan view.

[0197] In the hemostatic device configured as described above, when the main body 240 of the fixing member 230A connects the connector 210 and the tube 220, the cover member 100 is inserted between the main body 240 and the claw 250, thereby fixing the connector 210 to the cover member 100. In the hemostatic device described above, the claw 250 has a convex portion 270 protruding toward the main body 240, and the main body 240 has a concave portion 280 at a position overlapping the convex portion 270 in a plan view. In the hemostatic device described above, the cover member 100 inserted between the main body 240 and the claw 250 can be arranged so as to be hooked on the convex portion 270. In addition, the cover member 100 inserted between the main body 240 and the claw 250 is arranged in a meandering state along the convex portion 270 and the concave portion 280 between the main body 240 and the claw 250. Therefore, the hemostatic device can effectively prevent the cover member 100 from slipping out from between the main body portion 240 and the claw portion 250. Moreover, when the surgeon inserts the cover member 100 between the main body portion 240 and the claw portion 250, the surgeon can move the cover member 100 along the convex portion 270 while releasing a part of the cover member 100 into the concave portion 280. Therefore, the surgeon can easily and smoothly insert the cover member 100 between the claw portion 250 provided with the convex portion 270 and the main body portion 240 provided with the concave portion 280. Moreover, the hemostatic device can fix the fixing member 230A to the cover member 100 by inserting a part of the cover member 100 between the main body portion 240 and the claw portion 250. Therefore, the hemostatic device can prevent unnecessary force from being applied to the hemostatic device in a direction pressing the cover member 100 against the body surface of the limb such as the patient's right hand H1 when the fixing member 230A is fixed to the cover member 100. Therefore, when the fixing member 230A is fixed to the cover member 100, the hemostatic device described above can prevent the hemostatic device attached to the patient's right hand H1 and the expansion member 150 from shifting out of position.

[0198] <Third embodiment> As shown in FIG. 29, the injection member 200 can also be applied to a hemostatic device 10A that is configured so as to be wearable on a patient's arm, for example.

[0199] The hemostatic device 10A is configured as a hemostatic device for stopping bleeding at a puncture site p3 formed in the radial artery R running through the forearm Ar of a patient.

[0200] The hemostatic device 10A includes a band-shaped cover member 700 configured to be fixed in a state where it is wrapped around the patient's arm, and an expansion member 750 disposed on the cover member 700. A tube portion 220 is connected to the expansion member 750. The tube portion 220 is connected to a main body portion 240 of a fixing member 230.

[0201] When performing hemostasis using the hemostatic device 10A, for example, as shown in Fig. 29, by inserting the cover member 700 into the insertion portion I (see Fig. 12, etc.), it is possible to fix the fixing member 230 at a predetermined position of the cover member 700. Note that the specific position at which the fixing member 230 is fixed to the cover member 100 is not limited to only the position shown in Fig. 29.

[0202] The hemostatic device of the present invention has been described above through multiple embodiments and modified examples, but the present invention is not limited to the contents described in the specification and can be modified as appropriate based on the description of the claims.

[0203] The shape, dimensions, etc. of each part of the hemostatic device are not particularly limited as long as the expansion member placed at the puncture site can compress and stop bleeding, and can be changed as appropriate.

[0204] The specific shapes (planar shape and cross-sectional shape) of the expansion member and the support member are not limited to the shapes shown in the figures in the embodiments. [Explanation of symbols]

[0205] 10 Hemostatic devices 10A Hemostatic devices 100 Cover member 700 Cover material 110 Cover body 110C Fixed part 150 Extension member 750 Extension member 150a: Lumen of expansion member 200 Injection material 200A Injection Parts 210 Connector part 211 Port section 213 Valve section 220 Tube section 221 One end of the tube 222 Other end of tube 230 Fixing member 230A Fixing member 240 Main body of fixing member 240a Internal space of the main body 240b Outer surface of main body 241 Tip of main body 242 Base end of main body 243 Curved surface part 243a End of curved surface 245 Convex 245A Convex part (first convex part) 245B convex part (second convex part) 245a Tip of protrusion 245b Base end of protrusion 246 Upper surface of convex part 247 Multiple protrusions 248a Convex part 248b Space section 250 Claw 250a Inner surface of the claw 250b Outer surface of claw 251 Tip of claw 252 Base end of claw 255 Depression 256 Hole 256A Hole (1st hole) 256B Hole (2nd hole) 256a Inner edge of the tip of the hole 256b Inner edge of the base end of the hole 256c Slope 257 Protrusion 260 Connection section 270 Convex 277 Multiple protrusions 280 Recess 300 Support member 410 First Belt Body 420 Second Belt Body 430 Third Belt Body 510 1st fixation site 520 Second fixation site 530 Third fixation site 540 4th fixation site 600 Introducer 610 Sheath tube p1 1st puncture site (puncture site) p2 2nd puncture site (puncture site) p3 puncture site C1 Center position of the recess in the longitudinal direction of the main body C2 Center position of the recess in the direction perpendicular to the longitudinal direction of the main body O intersection I Insertion section PL: Plane parallel to the inner surface of the claw PL1 Virtual Surface W11 Width of hole in the longitudinal direction of the body W12 Width of the hole in the direction perpendicular to the longitudinal direction of the main body W21 Width of the protruding part in the longitudinal direction of the main body W22 Width of the protrusion in the direction perpendicular to the longitudinal direction of the main body W3 Width of joint H hand H1 right hand Ar Forearm fb between fingers Sb snuff box B1 Metacarpal bone of index finger B2 Thumb metacarpal T1 extensor pollicis longus tendon T2 extensor pollicis brevis tendon V1 vessel (distal radial artery) V2 Artery located in snuffbox R radial artery

Claims

1. a cover member configured to cover a puncture site formed in a patient; an expansion member connected to the cover member and configured to compress the puncture site; an injection member connected to the expansion member and configured to be able to inject a fluid into the expansion member; the injection member has a connector portion, a tube portion connected to the expansion member, and a fixing member configured to connect the connector portion and the tube portion and to be capable of fixing the connector portion to the cover member, The fixing member has a main body portion that connects the connector portion and the tube portion, a claw portion that faces the main body portion and extends toward the expansion member side, and a connecting portion that connects the main body portion and the claw portion and is configured so that the cover member can be inserted between the main body portion and the claw portion, The main body portion has a protrusion protruding toward the claw portion, The claw portion has a recessed portion that is recessed on a side away from the main body portion at a position that overlaps with the protrusion in a plan view.

2. the protrusion has a tip portion located on the tube portion side in a longitudinal direction of the main body, The hemostatic device according to claim 1 , wherein the tip of the protrusion is inclined toward the tube portion.

3. The hemostatic device according to claim 1 , wherein a width of the recess in the longitudinal direction of the main body portion is greater than a width of the protrusion in the longitudinal direction of the main body portion.

4. The hemostatic device according to claim 3 , wherein a width of the recessed portion in a direction perpendicular to a longitudinal direction of the main body portion is greater than a width of the protruding portion in a direction perpendicular to the longitudinal direction of the main body portion.

5. the recess has a shape that is rotationally symmetrical with respect to an intersection point passing through a center position of the recess in a longitudinal direction of the main body and a center position of the recess in a direction perpendicular to the longitudinal direction of the main body, in a plan view; The hemostatic device according to claim 4 , wherein the convex portion has a shape that is symmetrical in the longitudinal direction of the main body portion with respect to a straight line that passes through the intersection point and is aligned in a direction perpendicular to the longitudinal direction of the main body portion.

6. The claw portion has an inner surface located on the main body side and an outer surface located opposite the inner surface, The hemostatic device according to claim 1 , wherein a maximum protruding position of the convex portion is located on an outer surface side of the claw portion relative to a plane parallel to an inner surface of the claw portion.

7. the main body portion has a curved surface portion that is located on the tube portion side in the longitudinal direction of the main body portion and is inclined toward the tube portion side, The claw portion has a tip portion located on the tube portion side in the longitudinal direction of the main body portion, The hemostatic device according to claim 1 , wherein the tip portions of the claw portions are positioned so as to overlap the curved surface portion in a plan view.

8. The tip of the claw portion has a protrusion that protrudes toward the main body portion, The hemostatic device according to claim 7 , wherein the protruding portion is located at an end portion on a proximal end side of the curved portion in a plan view.

9. The protrusion has an upper surface portion located on the claw portion side, The hemostatic device according to claim 1 , wherein the upper surface portion has a plurality of protrusions protruding toward the claw portion.

10. The hemostatic device according to claim 1 , wherein a lateral width of the connecting portion in a direction perpendicular to a longitudinal direction of the main body portion is smaller than a width of the recessed portion in the direction perpendicular to the longitudinal direction of the main body portion.

11. The hemostatic device according to claim 1 , wherein the main body portion has a convex portion formed in a predetermined pattern surrounding a portion of an outer surface of the main body portion, and a space portion defined inside the convex portion.

12. The main body portion has a plurality of the protruding portions arranged at predetermined intervals in a longitudinal direction of the main body portion, The hemostatic device according to claim 1 , wherein the claw portion has a plurality of the recessed portions disposed at positions overlapping with the plurality of the protruding portions in a plan view.

13. The hemostatic device according to claim 1 , wherein an inner edge of the recess located on the far side of the claw portion in an insertion direction in which the cover member is inserted has an inclined portion inclined toward the main body portion.

14. a cover member configured to cover a puncture site formed in a patient; an expansion member connected to the cover member and configured to compress the puncture site; an injection member connected to the expansion member and configured to be able to inject a fluid into the expansion member; the injection member has a connector portion, a tube portion connected to the expansion member, and a fixing member configured to connect the connector portion and the tube portion and to be capable of fixing the connector portion to the cover member, The fixing member has a main body portion that connects the connector portion and the tube portion, a claw portion that faces the main body portion and extends toward the expansion member side, and a connecting portion that connects the main body portion and the claw portion and is configured so that the cover member can be inserted between the main body portion and the claw portion, The claw portion has a protrusion protruding toward the main body portion, The main body portion has a recess at a position overlapping with the protrusion in a plan view.

Citation Information

Patent Citations

  • Hemostasis devices and methods of use

    WO2019090104A2