JP6667234B2 - Hemostatic device - Google Patents

Description

  The present invention relates to a hemostasis device for pressing a punctured site to stop bleeding.

  In recent years, blood vessels such as the radial artery of the arm are punctured, an introducer sheath is introduced into the puncture site, and a catheter or the like is inserted through a lumen of the introducer sheath into a lesion such as a blood vessel to perform percutaneous treatment.・ Inspections are being conducted. When such a method is performed, it is necessary to stop the puncture site after removing the introducer sheath. In order to perform this hemostasis, a band for wrapping around the puncture site of the arm, a fixing portion for fixing the band around the puncture site, and having flexibility and expanding by injecting a fluid. Thus, there has been known a hemostatic device including an extension portion capable of pressing a puncture site (for example, see Patent Document 1). In this hemostatic device, the pressing force acting from the expansion portion is applied directly to the puncture site to stop the hemostasis.

JP-A-2004-154413

Ivo Bernat, MD et al. , "Efficacy and Safety of Transient Ulnar Artery Compression to Recanalize Act Radial Artery Occlusion After Translator, Journal of the United States of America, Amer. 1698-1701

  Incidentally, the radial artery and the ulnar artery branch off from the brachial artery near the elbow and are connected to each other at the palm. For this reason, if only the radial artery is pressed (compressed) for a long time, it becomes difficult for blood to flow to the radial artery, and the blood flow rate of the ulnar artery may excessively increase. As a result, the blood flow in the radial artery decreases, the blood vessels are occluded, and the amount of platelets and the like decreases, so that it takes a long time to stop the puncture site. For this reason, for example, it is known to press the ulnar artery in order to reopen the occluded radial artery after stopping the puncture site in the radial artery (for example, see Non-Patent Document 1).

  To cope with such a problem, for example, a pressing member for pressing the ulnar artery is further provided in the above-described hemostatic device, and when the radial artery is pressed, excessive blood flow flowing to the ulnar artery by pressing the ulnar artery is performed. It is considered that it is possible to prevent a significant increase and to suppress a decrease in blood flow in the radial artery.

  When the pressing member that presses the ulnar artery is provided as described above, the pressing position by the pressing member is defined based on the relationship with the position where the extension that presses the radial artery is provided. This is because the main purpose of using the hemostatic device is to apply a pressing force to the puncture site of the radial artery to perform compression hemostasis, so that the ulnar artery is positioned with the expansion part aligned with the puncture site. This is for positioning the pressing member.

  However, if the pressing position by the pressing member is uniquely defined by the position where the expansion portion is provided, the ulnar artery may be distorted due to differences in blood vessel running due to individual differences between patients or variations in puncturing positions for each treatment. As a result, the pressing member cannot be accurately positioned, and it becomes difficult to apply an appropriate pressing force to the ulnar artery. Conversely, after positioning the pressing member with respect to the ulnar artery and positioning the expansion portion with respect to the radial artery, applying an appropriate pressing force to the puncture site of the radial artery Becomes difficult.

  The present invention has been made in order to solve the above-described problem, and suppresses a decrease in the blood flow rate of the radial artery to enhance the hemostatic effect, and has an appropriate pressing force on both the radial artery and the ulnar artery. It is an object of the present invention to provide a hemostatic device in which a hemostatic effect can be provided and a hemostatic effect is further improved.

A hemostatic device that achieves the above object has a flexible band that can be wound around an arm on which a radial artery and an ulnar artery run, and a fixing unit that fixes the band in a state of being wound around the arm, Expanded by injecting a fluid connected to the band, an expanded portion capable of pressing a portion of the radial artery to be stopped, and can be arranged at a position different from the expanded portion in the longitudinal direction of the band. configured, and provided with a press member that presses the ulnar artery, the band body and the pressing member, have a holding portion for movably holding said pressing member in the longitudinal direction of the band body, The holding portion has a joining portion that detachably joins the pressing member to the band, the joining portion includes a first joining portion provided on an inner surface of the band, and a joining portion of the pressing member. And a second joint portion provided on the outer surface. The expansion unit has a marker for positioning the expansion unit to a site of the radial artery to stop bleeding, the band is the pressing member in a state held by the expansion unit and the holding unit. And a holding position confirmation marker different from the marker, wherein the holding position confirmation marker is located between the first joint site and the end of the extension on the first joint site side. A hemostatic device comprising a plurality of linear markers arranged at a predetermined distance from each other in the longitudinal direction of the band .

  According to the hemostatic device configured as described above, since the pressing member for pressing the ulnar artery is provided, it is possible to suppress a decrease in the blood flow in the radial artery and enhance the hemostatic effect. Furthermore, since the position of the pressing member can be changed along the longitudinal direction of the band by the holding portion, the expansion portion is positioned in alignment with the radial artery, and further, the pressing member is positioned in the ulnar artery. They can be arranged together. This makes it possible to apply an appropriate pressing force to both the radial artery and the ulnar artery when performing hemostasis, so that the hemostasis effect can be further improved.

It is the top view which looked at the hemostatic device concerning embodiment from the inner surface side. FIG. 2 is a sectional view taken along line AA of FIG. 1. It is a perspective view showing the state where the hemostatic device concerning an embodiment was attached. FIG. 4 is a sectional view taken along line BB of FIG. 3. FIG. 4 is a sectional view taken along the line CC of FIG. 3. FIG. 4 is a cross-sectional view taken along line DD of FIG. 3. It is the top view which looked at the hemostatic device concerning the modification 1 of embodiment from the inner surface side. It is the top view which looked at the hemostatic device concerning the modification 2 of embodiment from the inner surface side. It is the top view which looked at the hemostatic device concerning the modification 3 of embodiment from the inner surface side. FIG. 10 is a schematic sectional view of the hemostatic device along line 10A-10A shown in FIG. 9. It is sectional drawing of the hemostatic device which concerns on the modification 4 of embodiment.

  Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings. The following description does not limit the technical scope and the meaning of the terms described in the claims. In addition, the dimensional ratios in the drawings are exaggerated for convenience of description, and may be different from the actual ratios.

  As shown in FIG. 4, the hemostatic device 10 according to the embodiment of the present invention is formed in a radial artery 210 of a wrist 200 (corresponding to an arm) for the purpose of inserting a catheter or the like for performing treatment / examination into a blood vessel. After the introducer sheath indwelled at the puncture site 220 (corresponding to a site to stop bleeding) is removed, the puncture site 220 is used to stop bleeding.

  As shown in FIGS. 1 and 2, the hemostatic device 10 includes a band 20 for winding around the wrist 200, a hook-and-loop fastener 30 (corresponding to a fixing portion) for fixing the band 20 around the wrist 200, A curved plate 40 (corresponding to a supporting plate), a first extended portion 50 (corresponding to an extended portion), a second extended portion 60 (corresponding to a pressing member), a connection holding portion 170 (corresponding to a holding portion), a marker 70, a first injection unit 80, and a second injection unit 81.

  In this specification, when the band 20 is wound around the wrist 200, the side of the band 20 facing the body surface of the wrist 200 (the mounting surface side) is referred to as the “inner side”, and the opposite side is referred to as the “inner side”. It is referred to as "outer surface side".

  In the figure, the longitudinal direction of the band 20 is indicated by an arrow X, and the direction orthogonal to the longitudinal direction of the band 20 is indicated by an arrow Y.

  The band body 20 is a flexible band-shaped member. As shown in FIG. 4, the band 20 is wound around the outer circumference of the wrist 200 substantially completely. As shown in FIG. 2, a curved plate holding portion 21 that holds the curved plate 40 is formed at a central portion of the band body 20. In the curved plate holding portion 21, a separate band-shaped member is formed on the outer surface side (or the inner surface side) by fusion (heat fusion, high frequency fusion, ultrasonic fusion, or the like) or adhesion (adhesion with an adhesive or a solvent). By being joined by the method, it is doubled and holds the curved plate 40 inserted in these gaps.

  A male side (or female side) 31 of a hook-and-loop fastener 30 generally called a Velcro (registered trademark) or the like is arranged on an outer surface side of a portion near the left end in FIG. The female side (or male side) 32 of the hook-and-loop fastener 30 is arranged on the inner surface side of the portion near the right end in FIG. As shown in FIG. 3 and FIG. 4, the band 20 is attached to the wrist 200 by winding the band 20 around the wrist 200 and joining the male side 31 and the female side 32. The means for fixing the band 20 in a state wound around the wrist 200 is not limited to the hook-and-loop fastener 30, but may be, for example, a snap, a button, a clip, or a frame member through which the end of the band 20 passes.

  The constituent material of the band body 20 is not particularly limited as long as it is a material having flexibility. For example, polyvinyl chloride, polyethylene, polypropylene, polybutadiene, polyolefin such as ethylene-vinyl acetate copolymer (EVA), polyethylene Various thermoplastic elastomers such as polyesters such as terephthalate (PET) and polybutylene terephthalate (PBT), polyvinylidene chloride, silicone, polyurethane, polyamide elastomers, polyurethane elastomers, polyester elastomers and the like, or any combination thereof (blended resin) , Polymer alloys, laminates, etc.).

  The band 20 is preferably substantially transparent, but is not limited to being transparent, and may be translucent or colored and transparent. Thereby, the puncture site 220 can be visually recognized from the outer surface side, and the marker 70 described later can be easily aligned with the puncture site 220.

  As shown in FIG. 2, the curved plate 40 is held by the band 20 by being inserted between the double-shaped curved plate holding portions 21 of the band 20. The curved plate 40 is made of a material harder than the belt 20, and keeps a substantially constant shape.

  The curved plate 40 has a shape that is long in the longitudinal direction (the direction of the arrow X) of the band 20. The central portion 41 of the curved plate 40 in the longitudinal direction is substantially flat and has a flat plate shape. On both sides of the central portion 41, the longitudinal direction of the band 20 is A first curved portion 42 (the left side in FIG. 2) and a second curved portion 43 (the right side in FIG. 2) curved along the direction (the circumferential direction of the wrist 200) are formed.

  The constituent material of the curved plate 40 is not particularly limited as long as the puncture site 220 can be visually recognized. For example, acrylic resin, polyvinyl chloride (especially hard polyvinyl chloride), polyethylene, polypropylene, polyolefin such as polybutadiene, and polystyrene , Poly- (4-methylpentene-1), polycarbonate, ABS resin, polymethyl methacrylate (PMMA), polyacetal, polyacrylate, polyacrylonitrile, polyvinylidene fluoride, ionomer, acrylonitrile-butadiene-styrene copolymer, polyethylene terephthalate ( PET), polyesters such as polybutylene terephthalate (PBT), butadiene-styrene copolymers, aromatic or aliphatic polyamides, fluorine resins such as polytetrafluoroethylene, etc. And the like.

  The curved plate 40 is preferably substantially transparent, like the band 20, but is not limited to transparent, and may be translucent or colored and transparent. Thereby, the puncture site 220 can be reliably viewed from the outer surface side, and the marker 70 described later can be easily aligned with the puncture site 220. Note that the curved plate 40 may not have a non-curved portion such as the central portion 41, that is, may be curved over its entire length.

  The first expansion part 50 and the second expansion part 60 included in the hemostatic device 10 expand by injecting a fluid (a gas or a liquid such as air). The first extension part 50 presses the puncture site 220 located in the radial artery 210 of the wrist 200. The second extension part 60 presses the ulnar artery 230 by pressing the body surface of the wrist 200.

  As shown in FIG. 2, the first extension portion 50 is positioned so as to overlap the vicinity of the curved plate 40 between the first curved portion 42 on the left end side in FIG. 2 and the central portion 41.

  The constituent material of the first extension portion 50 is not particularly limited as long as the material has flexibility, and for example, the same material as the constituent material of the band body 20 described above can be used. Further, the first extension portion 50 is preferably made of the same or the same material as the belt 20.

  The first extension 50 is preferably substantially transparent, like the band 20 and the curved plate 40. Thereby, the puncture site 220 can be visually recognized from the outer surface side, and the marker 70 described later can be easily aligned with the puncture site 220.

  For example, as shown in FIG. 2, the structure of the first extension portion 50 is such that two sheet materials made of the above-described materials are overlapped, and the edges are joined by a method such as fusion or adhesion to form a bag. It can be formed. As shown in FIG. 1, the outer shape of the first extension part 50 is a quadrangle when not expanded.

  As shown in FIG. 2, the first extension portion 50 is connected to the belt 20 via a first holding portion 51 having flexibility. Note that the first holding portion 51 is preferably provided on the first bending portion 42 side of the bending plate 40. Further, it is preferable that the first holding portion 51 is formed of the same material as the first extension portion 50. Thereby, it is possible to easily perform the joining with the band body 20 by fusion, and it is possible to manufacture easily.

  As shown in FIG. 2, the second extended portion 60 is located at a position different from the first extended portion 50 in the longitudinal direction of the band body 20 and overlaps the vicinity between the second curved portion 43 and the central portion 41. Be placed.

  The constituent material of the second expanded portion 60 is preferably a material having flexibility, like the first expanded portion 50. For example, the same material as the constituent material of the above-described band 20 can be used. . The second extension 60 is preferably substantially transparent, like the band 20, the curved plate 40, and the first extension 50.

  The structure of the second expanded portion 60 is the same as that of the first expanded portion 50, in which two sheets made of the above-described material are overlapped, and the edges are joined by a method such as fusion or adhesion to form a bag. It can be formed. As shown in FIG. 1, the outer shape of the second extension part 60 is a quadrangle when not expanded. In the present embodiment, as the pressing member that presses the ulnar artery 230, a member (the second expanding portion 60) that expands by injecting a fluid is illustrated, but the pressing member is limited to one configured in this manner. Not done. The pressing member that presses the ulnar artery 230 may be, for example, a hard member such as plastic or metal, or a sponge-like material, an elastic material, an aggregate of fibers such as cotton, or a combination thereof. An elastic member may be used.

  As shown in FIG. 2, a marker 70 is provided on the outer surface side of the first extension 50, that is, on the surface of the first extension 50 that does not face the body surface of the wrist 200. By providing such a marker 70 on the first extension portion 50, the first extension portion 50 can be easily positioned with respect to the puncture site 220, so that the positional displacement of the first extension portion 50 is suppressed. .

  The shape of the marker 70 is not particularly limited, and includes, for example, a circle, a triangle, a square, and the like. In the present embodiment, the marker 70 has a square shape.

  Although the size of the marker 70 is not particularly limited, for example, when the shape of the marker 70 is a square, the length of one side is preferably in a range of 1 to 4 mm. If the length of one side is 5 mm or more, the size of the marker 70 becomes larger than the size of the puncture site 220, so that it is difficult to align the center of the first extension 50 with the puncture site 220.

  The material of the marker 70 is not particularly limited, and examples thereof include an oily colorant such as an ink and a resin in which a dye is kneaded.

  The color of the marker 70 is not particularly limited as long as the color can align the first extension portion 50 with the puncture site 220, but is preferably green. By using a greenish color, the marker 70 can be easily visually recognized on blood or skin, so that it is easier to align the first extension portion 50 with the puncture site 220.

  The marker 70 is preferably translucent or colored and transparent. Thereby, the puncture site 220 can be visually recognized from the outer surface side of the marker 70.

  The method of providing the marker 70 on the first extension 50 is not particularly limited, but includes, for example, a method of printing the marker 70 on the first extension 50, a method of fusing the marker 70 to the first extension 50, and a method of forming the marker 70 on one surface of the marker 70. For example, a method of applying an adhesive and attaching the adhesive to the first extension 50 may be used.

  Note that the marker 70 may be provided on the inner surface side of the first extension 50. At this time, it is preferable that the marker 70 is provided on an inner surface or the like in the first extension portion 50 so as not to directly contact the puncture site 220.

  The first injection part 80 and the second injection part 81 are parts for injecting a fluid into the first expansion part 50 and the second expansion part 60, respectively, and as shown in FIG. And the second extension unit 60.

  The first injection portion 80 has a flexible first tube 82 having a proximal end connected to the first expansion portion 50 and having a lumen communicating with the inside of the first expansion portion 50, and a first tube 82. A first bag 84 disposed at the distal end of the first tube 82 so as to communicate with the inner cavity of the first tube 82; and a tubular first connector 86 connected to the first bag 84, respectively. The first connector 86 has a built-in check valve (not shown).

  The second injection portion 81 has a flexible second tube 83 whose base end is connected to the second expansion portion 60 and whose inner cavity communicates with the inside of the second expansion portion 60, and a second tube 83. A second bag body 85 disposed at the distal end of the second tube 83 so as to communicate with the inner cavity of the second tube 83, and a tubular second connector 87 connected to the second bag body 85, respectively. The second connector 87 has a built-in check valve (not shown).

  When expanding (expanding) the first expansion portion 50, the front end of a syringe (not shown) is inserted into the first connector 86 to open the check valve, and the pusher of this syringe is pushed to push the inside of the syringe. Is injected into the first expansion section 50 through the first injection section 80. When the first expansion part 50 expands, the first bag body 84 communicating with the first expansion part 50 via the first tube 82 also expands, and the first expansion part 50 can be pressurized without leaking fluid. Can be confirmed visually. After injecting the fluid into the first extension portion 50, when the leading end portion of the syringe is removed from the first connector 86, the check valve built in the first connector 86 closes to prevent leakage of the fluid, and The state where the expansion part 50 is expanded is maintained.

  If the same operation is performed on the second injection section 81 connected to the second extension section 60, the state where the second extension section 60 is expanded is maintained. Thereby, as shown in FIGS. 4 to 6, the first extension unit 50 and the second extension unit 60 are extended. The second tube 83 is preferably arranged on the same side of the band 20 as the side on which the first tube 82 is arranged. Thus, fluid can be injected into the first tube 82 and the second tube 83 from the same side. Therefore, when the same syringe is used for the first tube 82 and the second tube 83, the operation of inserting and removing the syringe can be easily performed.

  As shown in FIGS. 1 and 2, the connection holding unit 170 movably holds the second expansion unit 60 in the longitudinal direction (X direction) of the band 20.

  The connection holding section 170 has a joining section 180 that is provided on the surface of the band body 20 and the surface of the second extension section 60 and that detachably joins the second extension section 60. The second extension 60 can be connected to the band 20 via the joint 180, and can be separated from the band 20 by releasing the holding by the joint 180.

  The joining portion 180 includes a first joining portion 181 provided on an inner surface (a surface facing the wrist 200) of the band body 20 and an outer surface (a surface facing the band body 20) of the second expanding portion 60. ) Provided at the second joint portion 182. The first joint part 181 is constituted by the female side of the hook-and-loop fastener, and the second joint part 182 is constituted by the male side of the hook-and-loop fastener. The joint 180 is not limited to the hook-and-loop fastener, and may be, for example, a snap, a button, a clip, or a structure in which one joint is inserted into the other joint to maintain the joined state.

  As shown in FIGS. 1 and 2, the length L1 of the first joint portion 181 (the length along the longitudinal direction of the band 20) is the length L2 of the first joint portion 181 (the length of the band 20 in the longitudinal direction). (Length along the length). Therefore, the joining position of the second joining portion 182 can be adjusted within the range where the first joining portion 181 is provided. In addition, by adjusting the joining position of the second joining portion 182 with respect to the first joining portion 181, it is possible to adjust the holding position where the second extension portion 60 is held on the band body 20.

  In addition, in this specification, "the connection holding part (holding part) movably holds the second expansion part (pressing member)" means that the second expansion part 60 is held by the band 20. In the state where the second extension portion 60 is movable and the holding position of the second extension portion 60 with respect to the band 20 is changed in a state where the second extension 60 is separated from the band 20, This means that the second extension unit 60 has both functions of being movable to different positions, or that it has at least one of the two functions. In the present embodiment in which the connection holding portion 170 is formed of a hook-and-loop fastener, the holding position of the second extension portion 60 with respect to the band 20 is changed in a state where the second expansion portion 60 is separated from the band 20, The second extension part 60 can be moved to a position different from the above.

  The position where the connection holding portion 170 (joining portion 180) is provided is not particularly limited as long as the position where the second expansion portion 60 can be held with respect to the band body 20 is provided. However, when the curved plate 40 that supports the second extended portion 60 is provided as in the hemostatic device 10 according to the present embodiment, the second extended portion 50 is held within a range where the curved plate 40 is arranged. It is preferable to set the position where the connection holding section 170 is provided so that the connection holding section 170 is provided. This is for the following reasons.

  As will be described later, the curved plate 40 has a function of supporting the second expanded portion 60 in an expanded state and adjusting the expansion direction (direction of applying a pressing force) of the second expanded portion 60. For this reason, the connection and holding are performed such that the second extended portion 60 is held at a position outside the position where the curved plate 40 is provided, that is, at a position outside the range where the curved plate 40 is arranged in the longitudinal direction of the band 20. When the portion 170 is configured, it is difficult to appropriately adjust the direction of expansion of the second expansion portion 50 by the curved plate 40. In the present embodiment, when the second joint part 182 is joined to an arbitrary position of the first joint part 181, the second extension part 60 is positioned within the range where the curved plate 40 is arranged. Thus, the hemostatic device 10 is configured. Specifically, as shown in FIGS. 1 and 2, the first joint portion 181 of the joint portion 180 is formed over a predetermined range near the second curved portion 43 of the curved plate 40, and further, the joint portion is formed. The second joining portion 182 of the second member 180 is formed near the end of the second extended portion 60 (the end disposed on the second curved portion 43 side of the curved plate 40).

  As shown in FIG. 1, the band body 20 has a holding position confirmation marker 190 indicating a distance between the first extension portion 50 and the second extension portion 60 held by the connection holding portion 170.

  The holding position confirmation marker 190 is constituted by a plurality of linear markers 191 arranged at a predetermined distance from each other along the longitudinal direction (X direction) of the band 20. Each linear marker 191 has a shape extending along a width direction (Y direction) orthogonal to the longitudinal direction of the band body 20. When attaching the second extension portion 60 to the belt 20, the end of the second extension portion 60 (short side arranged on the first extension portion 50 side in plan view) is aligned with each linear marker 191. This makes it possible to visually confirm the holding position of the second extension portion 60. That is, by using the holding position confirmation marker 190, it is possible to arrange the second extended portion 60 at a desired position of the band 20 based on the position of the first extended portion 50.

  The holding position confirmation marker 190 can be formed, for example, of the same material as the marker 70. Further, for example, it can be formed on the outer surface of the band body 20 (the surface on the side facing the curved plate 40) by the same method as the marker 70. Further, the holding position confirmation marker 190 can be colored, for example, similarly to the marker 70. However, when using the hemostatic device 10, it is preferable to use a different color from the marker 70 when adding a color so that the user does not mistake the marker 70.

  The thickness (dimension along the X direction), the length (dimension along the Y direction), the number of each linear marker 191 provided in the holding position confirmation marker 190, the number, the interval between the linear markers 191 and the like are not particularly limited. For example, for example, the size can be changed as appropriate according to the size of the entire hemostatic device 10 and the sizes of the expansion portions 50 and 60. Further, the shape of the holding position confirmation marker 190 may be any shape as long as the holding position can be visually confirmed, and is not limited to a linear shape as illustrated. For example, the holding position confirmation marker 190 may be formed of a round shape, a rectangular shape, a star shape, the same shape with different colors, a scale with a distance indicating the distance from the first extension 50, or the like. . Further, the holding position confirmation marker 190 can be formed on the curved plate 40, for example, or can be formed on both the band body 20 and the curved plate 40. Even when the holding position confirmation marker 190 is formed on the curved plate 40, the specific configuration and the like are not particularly limited, and for example, the markers in the above-described various forms can be appropriately used.

  Next, a method of using the hemostatic device 10 according to the present embodiment will be described.

  Before attaching the hemostatic device 10 to the wrist 200, the first extension portion 50 and the second extension portion 60 are in an unexpanded state. When puncturing wrist 200, puncturing site 220 to radial artery 210 is usually located at a position offset toward the thumb of right wrist 200. Usually, an introducer sheath is placed at the puncture site 220. The band 20 is wrapped around the wrist 200 in a state where the introducer sheath is left in place, and the first extension 50 and the band 20 are wound so that the marker 70 provided on the first extension 50 overlaps the puncture site 220. Are aligned, the male side 31 and the female side 32 of the hook-and-loop fastener 30 are brought into contact and joined, and the belt 20 is mounted on the wrist 200.

  Before attaching band 20 to wrist 200, the distance between radial artery 210 and ulnar artery 230 is measured. Then, based on this distance, the position where the second extension 60 is held with respect to the band 20 is determined, and then the band 20 is held by the band 20 via the connection holding portion 170. The holding position of the second expansion portion 60 is appropriately adjusted so that the second expansion portion 60 is positioned with respect to the ulnar artery 230 when the belt 20 is mounted on the wrist 200. When the band 20 holds the second extension 60, the user can proceed with the operation while checking the holding position confirmation marker 190, so that the second extension 60 can be easily and quickly arranged at a desired position. .

  In addition, before performing the treatment using the hemostatic device 10, the second expansion unit 60 may be prepared in a state of being held by the band 20, or may be prepared in a state of being separated from the band 20. Is also good.

  When the band 20 is attached to the wrist 200 while the band 20 holds the second extension 60, for example, the second extension 60 is placed at an unintended position (for example, at a position away from the ulnar artery 230). In such a case, the hemostatic device 10 can be once removed from the wrist 200 to adjust the position of the second extension portion 60. In the hemostatic device 10, since the connection holding portion 170 (joining portion 180) is formed of a hook-and-loop fastener, the operation of attaching and detaching the second extension portion 60 to and from the band 20 can be easily performed.

  In addition, before the expansion of the first extension portion 50 progresses to some extent, if it is possible to move the second extension portion 60 with the hemostatic device 10 attached to the wrist 200, the hemostatic device 10 is moved to the wrist. It is also possible to adjust the position of the second extension portion 60 while the device is mounted.

  The hemostatic device 10 is attached to the wrist 200 so that the first injection unit 80 and the second injection unit 81 face downstream of the blood flow in the radial artery 210. Accordingly, the first injection unit 80 and the second injection unit 81 can be operated without performing a procedure on the upstream side of the wrist or interfering with a device (for example, a sphygmomanometer or the like) located on the upstream side. . Also, by attaching the hemostatic device 10 to the wrist 200 of the right hand so that the first injection portion 80 and the second injection portion 81 face downstream, the first extension portion 50 is shifted to the thumb side of the wrist 200. The second dilation part 60 is located around the ulnar artery 230, which is located at the located radial artery 210. In the case of an artery, the upstream side of a blood vessel refers to a direction in which the blood vessel approaches the heart. Further, the downstream side of the blood vessel refers to a direction of the blood vessel moving away from the heart.

  After attaching the hemostatic device 10 to the wrist 200, a syringe (not shown) is connected to the first connector 86 of the first injection unit 80, and the fluid is injected into the first expansion unit 50 as described above. As shown in FIGS. 4 and 5, the first extension section 50 is expanded to press the puncture site 220. At this time, the degree of expansion of the first expansion portion 50, that is, the pressing force on the puncture site 220 located in the radial artery 210, can be easily adjusted depending on the case by the injection amount of the fluid.

  After the first extension section 50 is expanded, the syringe is detached from the first connector 86. Then, the introducer sheath is removed from the puncture site 220. As a result, the first expansion section 50 maintains the expanded state, and the pressed state against the puncture site 220 is maintained.

  Next, when a syringe is connected to the second connector 87 of the second injection part 81 and a fluid is injected into the second expansion part 60 as described above, expansion of the second expansion part 60 starts. At this time, the pressing force of the second expanding portion 60 on the ulnar artery 230 can be easily adjusted by the amount of the fluid injected.

  When the first extension part 50 and the second extension part 60 expand, the curved plate 40 separates from the body surface of the wrist 200 and becomes difficult to contact the wrist 200. In addition, when the first extension portion 50 and the second extension portion 60 are expanded after the hemostatic device 10 is mounted, the curved plate 40 causes the first extension portion 50 and the second extension portion 60 to move from the body surface of the wrist 200. Expansion in the direction away is suppressed, and the pressing force of the first expansion part 50 and the second expansion part 60 concentrates on the wrist 200 side. For this reason, the pressing force from the first expanding portion 50 acts intensively around the puncture site 220, so that the hemostatic effect can be improved.

  In addition, when the first expansion section 50 presses the radial artery 210, the blood flow flowing to the ulnar artery 230 is prevented from being excessively increased by pressing the ulnar artery 230, and the decrease in the blood flow of the radial artery 210 is suppressed. can do. This prevents occlusion of a blood vessel and suppresses a decrease in the amount of platelets and the like, so that hemostasis at the puncture site 220 can be performed in a relatively short time.

  When the hemostasis is completed, the pressing force of the first expansion portion 50 on the puncture site 220 and the pressing force of the second expansion portion 60 on the ulnar artery 230 are reduced, and the hemostatic device 10 is removed. At this time, the syringe is connected to the first connector 86 of the first injection part 80, and the fluid injected into the first expansion part 50 is discharged. Similarly, the syringe is connected to the second connector 87 of the second injection part 81, and the fluid injected into the second expansion part 60 is discharged.

  When removing the hemostatic device 10 after the hemostasis of the puncture site 220 is completed, the first and second expansion portions 50 and 60 are contracted, and then the male and female sides 31 and 32 of the hook-and-loop fastener 30 are peeled off. The device 10 is removed from the wrist 200. When removing the hemostatic device 10, the first expansion portion 50 and the second expansion portion 60 do not have to be contracted.

  As described above, the hemostatic device 10 according to the present embodiment has the flexible band 20 that can be wound around the wrist 200 on which the radial artery 210 and the ulnar artery 230 run, and the band 20 is attached to the wrist 200. A hook-and-loop fastener 30 that is fixed in a wound state, a first expansion portion 50 that is connected to the band 20 and expands by injecting a fluid to press a portion of the radial artery 210 to stop bleeding; A second expansion part 60 configured to be able to be arranged at a position different from the first expansion part 50 in the longitudinal direction, and capable of pressing the ulnar artery 230, wherein the band 20 and the second expansion part 60 are 20 has a connection holding portion 170 that movably holds the second extension portion 60 in the longitudinal direction.

  According to the hemostatic device 10 configured as described above, by providing the second expansion portion 60 for pressing the ulnar artery 230, it is possible to suppress a decrease in the blood flow rate of the radial artery 210 and enhance the hemostatic effect. Can be. Furthermore, since the position of the second expansion part 60 can be changed along the longitudinal direction of the band 20 by the connection holding part 170, the first expansion part 50 is positioned and arranged on the radial artery 210. In addition, the second dilation 60 can be positioned in alignment with the ulnar artery 230. Accordingly, when performing hemostasis, it is possible to apply an appropriate pressing force to both the radial artery 210 and the ulnar artery 230, so that the hemostasis effect can be further improved.

  Further, the band 20 has the curved plate 40 formed of a material harder than the band 20, and the connection holding unit 170 moves the second expansion unit 60 within the range where the curved plate 40 is arranged. It is configured to hold as possible. Thus, even when the holding position of the second expansion portion 60 with respect to the band 20 is changed, the expansion direction of the second expansion portion 60 is adjusted by the curved plate 40 in the direction toward the ulnar artery 230. For this reason, it is possible to intensively apply the pressing force to the ulnar artery 230 and its periphery.

  Further, the connection holding section 170 has a joining section 180 provided on the surface of the band body 20 and the surface of the second extension section 60 to detachably join the second extension section 60. By using the joining portion 180, it is possible to easily switch between holding the second expansion portion 60 with respect to the band body 20 and releasing the holding. Therefore, the convenience of the hemostatic device 10 is improved.

  Further, the band body 20 has a holding position confirmation marker 190 that indicates a distance between the first extension portion 50 and the second extension portion 60 held by the connection holding portion 170. For this reason, when the belt 20 holds the second extension 60, the user can proceed with the operation while checking the holding position confirmation marker 190, so that the second extension 60 can be easily and quickly arranged at a desired position. Will be possible.

  Next, a modified example of the connection holding unit 170 described in the above embodiment will be described. In the description of the modification, those having substantially the same functions as the members already described will not be described. In addition, configurations that are not particularly mentioned in the description of the modification can be configured in the same manner as the above-described embodiment.

  The above-described connection holding portion 170 includes a joining portion 180 (surface fastener) constituted by a first joining portion 181 provided on the band body 20 and a second joining portion 182 provided on the second expanded portion 60 (pressing member). It is configured as something. However, the configuration of the connection holding portion is not particularly limited as long as the pressing member can movably hold the pressing member in the longitudinal direction of the band, and for example, as shown in Modifications 1 to 4 described below. May be configured.

(Modification 1)
FIG. 7 illustrates the hemostatic device 10 including the connection holding unit 310 according to the first modification.

  The connection holding section 310 includes a joining section 311 formed on the inner surface side of the band body 20. The joining portion 311 can be formed of an adhesive layer (adhesive surface) made of a known material such as a rubber, acrylic, or silicone. In addition, it is also possible to attach an adhesive tape or the like on which an adhesive layer is formed to the band body 20 and use it as the joint 311.

  When the joining portion 311 is formed of an adhesive layer, a release paper 315 can be provided so as to cover the joining portion 311 so that the joining portion 311 is not inadvertently brought into contact with another member and joined. . The material and size of the release paper 315 can be appropriately selected according to the size and material of the joint 311.

  The adhesive layer is preferably formed to be transparent or translucent so that, for example, when the hemostatic device 10 is mounted on the wrist, the wrist can be viewed through the joint 311.

  When holding the second extended portion 60 to the band 20, the release paper 315 is removed from the joint portion 311 and the second extended portion 60 is brought into contact with the joint portion 311. By such a simple operation, the second extension portion 60 can be held on the belt 20. When removing the second extended portion 60 from the band 20, an operation of applying a tensile force to the extent that the holding is released to one of the band 20 and / or the second extended portion 60 is performed. Even after the holding is once released, the holding of the second expanded portion 60 by the bonding portion 311 can be repeated while the bonding force of the adhesive layer remains.

  As shown in the present modification, even when the joint 311 provided in the connection holding section 310 is provided only on the side of the band 20, the second extension section 60 is provided in the longitudinal direction of the band 20 via the connection holding section 310. Can be held movably. Further, since the joints 311 are provided only on the band body 20 side, the holding position of the second extension 60 can be adjusted relatively freely within the range where the joints 311 are provided. Therefore, as compared with the case where the joining portion is also provided on the second extension portion 60 side, the holding position of the second extension portion 60 can be given a degree of freedom, so that the usability of the hemostatic device 10 is improved. Becomes

  In addition, since the joining portion 311 is formed of the adhesive layer, the second extended portion 60 is detachably held to the band body 20 by a simple operation of bringing the second extended portion 60 into contact with the adhesive layer. Can be.

  In the first modification, the band 20 is provided with the connection holding portion 310. However, for example, the band 20 is not provided with the connection holding portion 310, and the second extended portion 60 is provided with the connection holding portion 310. It is also possible to adopt a configuration.

(Modification 2)
FIG. 8 illustrates the hemostatic device 10 including the connection holding unit 320 according to the second modification.

  The connection holding section 320 includes a bag section (pocket) 321 provided in the band body 20. The bag portion 321 is configured to be able to house the pressing member 60a therein. By inserting the pressing member 60 a into the bag portion 321, the pressing member 60 a is held by the belt 20.

  The bag portion 321 can be formed of, for example, a flexible material. As a material having flexibility, for example, a material similar to that of the first extended portion 50 or the band body 20 can be used. The bag portion 321 attaches the sheet material made of the above-described material to the band body 20 by fusing or bonding, for example, so that an accommodation space is defined between the sheet material and the band body 20. Can be configured.

  The bag portion 321 is preferably formed to be transparent or translucent, for example, in order to make the wrist visible through the bag portion 321 when the hemostatic device 10 is mounted on the wrist.

  For example, a plurality of the bag portions 321 can be provided on one belt body 20. In this modified example, three bag portions 321a, 21b, 321c are installed at different positions in the longitudinal direction of the band body 20. When the pressing member 60a is inserted, by selecting an arbitrary bag portion 321 from the bag portions 321a, 321b, and 321c, the holding position of the pressing member 60a with respect to the band 20 can be changed. In order to change the holding position of the pressing member 60 a in the longitudinal direction of the band 20, for example, two or more bag portions 321 can be provided on one band 20.

  The pressing member 60a is not a member (expanded portion) configured to be expandable by injecting a fluid, but a member having hardness enough to apply a pressing force to the ulnar artery 230. Similarly to the pressing member 60 (second expanding portion) shown in the above-described embodiment and Modification 1, the pressing member 60a can be formed of an expandable member, but each of the bag portions 321a, 321b, and 321c. In consideration of the work of inserting the pressing member 60a, it is preferable that the pressing member 60a be configured to have a certain degree of hardness.

  The pressing member 60a may be, for example, a hard member such as plastic or metal, a sponge-like material, an elastic material, an aggregate of fibers such as cotton, or an elastic member formed by combining these. You may. The shape of the pressing member 60a is not particularly limited, but may be, for example, a columnar shape extending along the direction of insertion into the bag portion 321.

  When holding the pressing member 60a with respect to the belt 20, the pressing member 60a is inserted into each of the bag portions 321a, 321b, 321c. By such a simple operation, the pressing member 60a can be held on the belt 20. When removing the pressing member 60a from the band 20, an operation of pulling out the pressing member 60a from each of the bag portions 321a, 321b, 321c is performed. After the pressing member 60a is pulled out from the bag portions 321a, 321b, and 321c, the pressing member 60a is inserted into the respective bag portions 321a, 321b, and 321c again, so that the pressing member 60a can be repeatedly held.

  For example, the volume and outer shape of each of the bag portions 321a, 321b, and 321c are not particularly limited as long as at least a part of the pressing member 60a can be accommodated, and are appropriately changed according to the size (outer size) of the pressing member 60a. It is possible to In the case where a plurality of bag portions 321 are provided, it is possible to change the shape or size of each bag portion 321.

  When the bag 321 is made of a flexible material, the bag 321 is wound around the wrist 200 and the pressing member 60a is not inserted into the bag 321. The portion 321 deforms so as to bend along the outer peripheral surface of the wrist 200. For this reason, in a case where the state in which the pressing force is applied to the ulnar artery 230 is released and the pressing force is applied only to the radial artery 210, the bag portion 321 moves between the wrist 200 and the band 20. It is possible to suitably prevent interference and decrease in the pressing force applied to the radial artery 210 due to the interference.

  As shown in this modification, the connection holding section 320 can be configured to include a bag section 321 that houses and holds the pressing member 60a. Even in the case of such a configuration, the hemostatic device 10 can movably hold the pressing member 60 a in the longitudinal direction of the band 20 via the connection holding portion 320. Furthermore, the pressing member 60a can be detachably held to the belt 20 by a simple operation of inserting the pressing member 60a into the bag portion 321.

(Modification 3)
9 and 10 show the hemostatic device 10 including the connection holding section 330 according to the third modification. FIG. 10 is a simplified view of a cross section taken along line 10A-10A shown in FIG.

  The connection holding section 330 includes an engagement member 331 provided on the second extension section 60. The engagement member 331 is configured to be able to engage with the belt 20.

  As shown in FIG. 10, the engagement member 331 has a clip structure that is engaged with the band body 20 by applying a holding force. In this modification, the engaged portion 335 is attached to the band 20 so that the engagement member 331 can be easily and reliably engaged with the band 20. Since the holding force of the second extended portion 60 with respect to the band body 20 is increased by sandwiching the engaged portion 335 with the engaging member 331 having a clip structure, it is possible to prevent the second extended portion 60 from being displaced. It becomes possible.

  The operation of engaging the engaging member 331 with the engaged portion 335 is performed by a simple operation of sliding the engaging member 331 along the engaged portion 335 as shown by an arrow in FIG. Can be. When removing the second extension portion 60 from the band 20, the engaging member 331 is slid in the direction opposite to the direction in which the engaging operation is performed. After the engagement by the engagement member 331 is released, the engagement of the engagement member 331 with the engaged portion 335 again allows the second extension portion 60 to be held on the belt 20 repeatedly.

  The engagement member 331 is attached to a surface of the second expansion portion 60 on a side facing the inner surface of the band 20. The engaged portion 335 is attached to the inner surface of the band 20. Further, in order to be able to hold the second expanded portion 60 at different positions in the longitudinal direction of the band 20, a plurality of engaged portions 335 are provided at different positions in the longitudinal direction of the band 20. The number of the engaged portions 335 provided on one band 20 is not particularly limited, but two or more are provided to enable the holding position of the second expanded portion 60 to be changed in the longitudinal direction of the band 20. Is preferred.

  As shown in the present modification, the connection holding portion 330 can be configured to include an engagement member 331 configured to be able to engage with the band 20. Even in the case of such a configuration, the hemostatic device 10 can movably hold the second expansion portion 60 in the longitudinal direction of the band 20 via the connection holding portion 330. Furthermore, the second expanding portion 60 can be detachably held to the band 20 by a simple operation of engaging the engaging member 331 with the band 20.

  In the third modification, the band body 20 is provided with the engaged portion 335. However, for example, the band body 20 is not provided with the engaged portion 335, and the engagement member provided on the second extended portion 60 is not provided. 331 may be configured to directly hold the second extension 60 with respect to the band 20. In this case, the engagement member 331 can be configured by, for example, an openable and closable clip to which an elastic force is applied in a closing direction for applying a clamping force. In the third modification, the pressing member is configured to be expandable by injecting a fluid. However, similarly to the second modification, the pressing member can apply a pressing force to the ulnar artery 230. Any member may be used, and the configuration is not particularly limited.

(Modification 4)
FIG. 11 shows a cross section of the hemostatic device 10 including the connection holding portion 340 according to the fourth modification.

  The connection holding portion 340 includes a first guide member 341 extending along the longitudinal direction (X direction) of the band body 20 and a second guide member 342 in which an insertion hole 342a through which the first guide member 341 is inserted is formed. And

  The first guide member 341 is provided on the inner surface of the belt 20. The first guide member 341 can be formed of, for example, a material having flexibility. As a material having flexibility, for example, a material similar to that of the first extended portion 50 or the band body 20 can be used.

  As shown in FIG. 11, the first guide member 341 is attached to the band 20 such that a predetermined gap 345 is formed between the first guide member 341 and the band 20. The first guide portion 341 is formed, for example, by bonding a sheet material made of a flexible material by fusing or bonding such that a gap 345 is formed between the sheet material and the band member 20. 20 can be attached.

  The second guide member 342 is provided on the outer surface of the second extension part 60 (the surface on the side facing the band body 20). As shown in FIG. 11, the second guide member 342 is held by the band 20 by inserting the first guide member 341 into an insertion hole 342a penetrating along the longitudinal direction of the band 20. You. The second extension part 60 is held movably along the longitudinal direction of the band body 20 via the second guide member 342.

  The size of the gap 345 (the dimension along the thickness direction of the band body 20) is set to the second size in a state where the second expanded portion 60 is held by the band body 20 via the first guide member 341 and the second guide member 342. It is preferable that the extension part 60 be formed with a dimension that does not inadvertently rotate or swing with respect to the first guide member 341. By forming the gap 345 with such dimensions, while the second extension 60 is slid along the first guide 341, the second extension 60 is moved in a predetermined direction (for example, a belt body). 20 (normal direction to 20), it is possible to save the trouble of the operation of adjusting the direction of the second extension portion 60.

  Like the first guide member 341, the second guide member 342 can be formed of, for example, a material having flexibility. In addition, as the material having flexibility, for example, the same material as that of the first extended portion 50 and the belt 20 can be used.

  The first guide portion 341 and the second guide portion 342 are formed to be transparent or translucent, for example, so that the wrist can be visually recognized via the guide portions 341 and 342 when the hemostatic device 10 is mounted on the wrist. Is preferred.

  In the present modified example, the second guide member 342 is configured by attaching a member formed of a member separate from the second extended portion 60 to the second extended portion 60. However, the second guide member 342 can also be constituted by a part of the second guide member 342 by giving a part of the second expansion part 60 a structure similar to the structure shown in the drawing.

  When hemostasis is performed by the hemostatic device 10, the first guide member 341 is inserted into the insertion hole 342a of the second guide member 342, as shown in FIG. By assembling in this manner, the second expanding portion 60 can slide with respect to the first guide member 341. That is, the second extension part 60 is held movably along the longitudinal direction of the band body 20 via the first guide part 341 and the second guide part 342.

  The size of the first guide portion 341 (for example, the length along the longitudinal direction of the belt 20) and the size of the second guide member 342 (for example, the length of the belt 20 along the longitudinal direction) are the second expansion. It can be set as appropriate depending on conditions such as in what range the unit 60 is movably held, and there is no particular limitation.

  As shown in the present modification, the connection holding section 340 includes a first guide section 341 and a second guide section 342 that hold the second expansion section 60 slidably along the longitudinal direction of the band body 20. It is possible to configure. Even in the case of such a configuration, the hemostatic device 10 can movably hold the second expansion portion 60 in the longitudinal direction of the band 20 via the connection holding portion 340.

  In addition, since the second extension portion 60 is configured to be movable in a state where the second extension portion 60 is held with respect to the band 20, the second extension portion 60 can be moved without being separated from the band 20. The two extensions 60 can be aligned with the ulnar artery 230. Therefore, it is possible to prevent the second extended portion 60 from being accidentally dropped from the band body 20 or to be lost.

  In the fourth modification, the pressing member is configured to be expandable by injecting a fluid. However, similarly to the second modification, the pressing member can apply a pressing force to the ulnar artery 230. Any member may be used, and the configuration is not particularly limited.

  As described above, the hemostatic device according to the present invention has been described through the embodiments and the modified examples. However, the present invention is not limited to each configuration described above, and can be appropriately changed based on the description in the claims. It is.

  For example, each part configuring the hemostatic device can be replaced with an arbitrary configuration that can exhibit the same function. Further, an arbitrary component may be added. For example, the connection holding unit may be provided in one hemostatic device by arbitrarily combining the components described in the specification (the configurations according to the embodiment and the modified examples 1 to 4). .

  In addition, the present invention is not limited to a hemostatic device worn on the wrist and used, and can be applied to a hemostatic device worn and used on any part of the arm where the radial artery and the ulnar artery travel.

  In addition, in order to adjust the pressing direction of the first extension, an auxiliary compression unit that presses the first extension so as to overlap the first extension may be provided between the first extension and the band. The auxiliary compression part may be expanded by injecting a fluid, for example, similarly to the first expansion part, or may be made of a sponge-like substance, an elastic material, an aggregate of fibers such as cotton, or a combination thereof. It may be used.

  In addition, the outer shape of the first extended portion and the second extended portion is not limited to a quadrangle when not expanded, and may be, for example, a polygon such as a circle, an ellipse, and a pentagon.

  Further, instead of providing the marker on the first extension portion, the marker may be provided on the band, the curved plate, or the auxiliary compression portion. More preferably, the marker is provided so as to overlap the center of the first extension.

10, 11 hemostatic device,
20 belts,
30 surface fastener (fixed part),
40 curved plate (support plate),
50 first extension part (extension part),
60 a second expanded portion (pressing member);
60a pressing member,
70 markers,
170, 310, 320, 330, 340 connection holding section (holding section),
180, 311 joints,
190 holding position confirmation marker,
200 wrist (arm),
210 radial artery,
220 puncture site,
230 Ulnar artery.
321, 321a, 321b, 321c bag part,
331 engaging member,
341, a first guide member;
342 second guide member,
342a Insertion hole.

Claims (4)

A flexible body that can be wound around the arm on which the radial artery and the ulnar artery run,
A fixing portion for fixing the band body wound around the arm,
An expanded portion that is connected to the band to expand by injecting a fluid, and that can press a portion of the radial artery to stop bleeding,
A pressing member configured to be able to be arranged at a position different from the expanded portion in the longitudinal direction of the band, and capable of pressing the ulnar artery,
The band and the pressing member have a holding portion that movably holds the pressing member in a longitudinal direction of the band,
The holding portion has a joining portion that detachably joins the pressing member to the band body,
The joining portion has a first joining portion provided on an inner surface of the band, and a second joining portion provided on an outer surface of the pressing member,
The expansion unit has a marker for positioning the expansion unit at a site of the radial artery to stop bleeding,
The band body indicates a distance between the expanding portion and the pressing member in a state held by the holding portion, and has a holding position confirmation marker different from the marker,
The holding position confirmation markers are arranged at a predetermined distance from each other along the longitudinal direction of the band between the first joint portion and the end of the extension portion on the first joint portion side. A hemostatic device comprising a plurality of linear markers. The band has a support plate formed of a material harder than the band,
The hemostasis device according to claim 1, wherein the holding unit is configured to movably hold the pressing member within a range where the support plate is arranged.   The hemostatic device according to claim 1, wherein the holding portion includes a bag portion provided on the band body and configured to accommodate at least a part of the pressing member.   The hemostasis according to any one of claims 1 to 3, wherein the holding portion includes an engaging member provided on the pressing member and configured to be engageable with the band. Appliances.