JP5200901B2 - Hemostatic device - Google Patents

Description

  The present invention relates to a hemostatic device that is wound around a portion of a limb that is to be hemostatically stopped.

  After removal of a catheter inserted into a blood vessel in a limb such as an arm or a leg or a relatively large diameter needle inserted into a blood vessel, it is necessary to stop hemorrhage at the invasive site by insertion of the catheter or needle insertion There is. In order to stop hemostasis of a relatively large invasive site, a hemostatic device is conventionally known as a device that reliably and easily compresses the invasive site.

  As a conventional hemostatic device, one in which a balloon is provided on a belt that can be wound around a limb is known (Patent Documents 1 and 2). The band is fixed in a state where it is wound around the limb by, for example, a hook-and-loop fastener. A balloon is provided inside the band. When air or the like is injected, the balloon is inflated inside the band to compress the portion to be hemostatic. By maintaining this compressed state, blood coagulation, adhesion of an invasive site, and the like occur at the site to be stopped, thereby completing the hemostasis.

  Further, in order to incline the direction of the force compressed by the balloon with respect to the surface of the limb, a configuration is further provided in which the curved plate is further provided in the aforementioned hemostatic device, and an auxiliary balloon is provided in the curved portion of the curved plate. (Patent Document 3).

JP 2008-119517 A JP 2005-218593 A JP 2007-75650 A

  However, in the conventional hemostatic devices as shown in Patent Documents 1 and 2, since the balloon is inflated not only on the limb side but also on the opposite side, the balloon bulge is dispersed and concentrated on the compression force on the limb body. do not do. Therefore, if a compression force is to be secured for reliable hemostasis, the balloon will be greatly inflated, and there is a problem that the balloon becomes unstable with respect to the limb.

  As disclosed in Patent Document 3, if a rigid body such as a curved plate is arranged on the opposite side of the limb from the balloon, the direction in which the balloon bulges can be controlled, and the balloon bulge is compressed against the limb. You can concentrate on your strength to some extent. However, the configuration shown in Patent Document 3 has a problem that the shape and size of the rigid body do not necessarily match the shape and size of the limb. For example, if the shape and size of a rigid body is matched to a limb with an average shape or size, it will not match a small limb or a large limb, and a hemostatic device is attached to a limb that deviates from the average shape or size. If the balloon is inflated, the balloon becomes unstable with respect to the limb. As a result, the balloon is displaced and blood leaks during hemostasis, or the balloon presses blood vessels and nerves other than the hemostatic site, resulting in numbness and poor blood circulation. Further, when the balloon becomes unstable, there is a problem that the wearing feeling is bad.

  Further, when the above-described hemostatic device is mounted on a small limb, the end of the rigid body protrudes outward from the limb, so that the band is bent sharply at the end of the rigid body. If it does so, it will become easy to rub a belt | band | zone intensively in the end of a rigid body, and the problem that damage and a fracture | rupture will arise easily will arise.

  Moreover, in the conventional hemostatic device as disclosed in Patent Documents 1, 2, and 3, those having a hook-and-loop fastener as a band are adopted, and after the band is wrapped around the limb, the band is formed by the hook-and-loop fastener. Fixed to the limb. However, since the band is only in pressure contact with the limb, if the friction of the band against the limb is reduced by sweat or the like from the limb, the band is likely to rotate with respect to the limb. In addition, the belt body may rotate with respect to the limb body during the work of fixing the surface fastener of the belt body. As a result, the compressed position of the balloon is displaced from the position where it was initially aligned, and as described above, blood leaks during hemostasis, and blood vessels and nerves other than the hemostatic site are compressed, causing numbness and poor circulation. It occurs.

  The present invention has been made in view of such problems, and an object of the present invention is to control the direction in which the balloon is inflated and to stably fix the balloon in accordance with various limbs having different shapes and sizes. It is to provide a hemostatic device.

  Another object of the present invention is to provide a hemostatic device in which the band is hardly damaged or broken.

  Another object of the present invention is to provide a hemostatic device that can be easily attached to a limb.

  (1) A hemostatic device according to the present invention includes a flexible flat band wound around and fixed to a site to be stopped in a limb, a flat plate fixed to a first surface of the flat band, and the flat plate A balloon fixed to a second surface opposite to the flat belt and inflated by injecting a fluid. In the flat plate, the first length along the first direction which is the longitudinal direction of the flat belt is longer than the second length along the first direction in the balloon (first length> second length). ) And a hinge portion extending in a direction intersecting the first direction, and the hinge portion can be bent with respect to the first direction.

  The hemostatic device is used by being wound around a portion of the limb that should be hemostatic (hereinafter also referred to as a “hemostatic site”). The limb is, for example, a human arm or leg. The flexible flat belt is wound around the limb with the first surface, which is one of the front and back surfaces, facing the limb. The flat belt is provided with an adhesive layer on the first surface side or a surface fastener, and the adhesive layer adheres to the limb or is pressed against the limb by making the flat belt into an annular shape by the surface fastener. By doing so, the flat belt is fixed to the limb.

  A flat plate is fixed to a first surface which is an inner surface facing the limb in the flat belt wound around the limb. In this flat plate, a balloon is fixed to a second surface which is an inner surface facing the limb body, in other words, a second surface opposite to the flat belt body. This balloon is thinly deflated before use, and is inflated by injecting a fluid such as air.

  When a fluid such as air is injected, the balloon is inflated between the flat plate and the limb. Since the deformation of the balloon is suppressed by the flat plate on the outer flat plate side, the balloon bulges mainly to the inner limb side. Therefore, the balloon bulge is mainly directed toward the limb, and the balloon bulge acts as a compression force on the hemostatic site of the limb.

  The flat plate has a first length along the first direction longer than a second length along the first direction of the balloon (first length> second length). Accordingly, both ends of the flat plate in the first direction protrude in the first direction outside the inflated balloon, but the flat portion of the flat plate is bent with respect to the first direction due to the hinge portion being bent by the expansion of the balloon. Accordingly, both ends of the flat plate protruding outward in the first direction from the balloon are inclined along the balloon bulge and directed toward the limb. Since the bulge of the balloon matches the size and shape of the limb, the bending angle of the flat plate in the first direction of the hinge portion is displaced according to the size and shape of the limb. That is, the flat plate is appropriately bent with respect to the first direction according to the size and shape of the limb.

  (2) The hinge portion may be provided in at least two places on the flat plate, which are different positions with respect to the first direction.

  For example, by providing hinge portions at two locations on the flat plate, the flat plate is divided into three portions that can be bent at two locations with respect to the first direction. If these three parts are the central part and both end parts, the balloon is inflated as described above, so that the central part is substantially parallel to the surface of the limb and the balloon is inflated toward the limb. The deformation is suppressed, and both end portions extend toward the limb on both sides in the first direction of the balloon. As described above, the angle at which the both end portions bend with respect to the central portion depends on the size and shape of the limb, so that the flat plate matches the shape and size of the limb while suppressing deformation of the balloon. Bend in one direction.

  (3) The flat plate may be elastically deformable so as to bend in the first direction along the balloon when the balloon is inflated in a state where the flat plate is attached to the limb.

  For example, as described above, when two hinge portions are provided on the flat plate, the central portion thereof is elastically deformed along the shape in which the balloon is inflated. The elastically deformed central portion is directed toward the limb by deformation of the balloon due to its elastic restoring force, and the central portion follows the shape of the balloon bulging along the surface of the limb. Therefore, the wearing feeling of the hemostatic device is improved without significantly impairing the compression force due to the balloon bulge.

  (4) The hinge part may be a thin part or a cut formed in the flat plate.

  Thereby, the flat plate which has a hinge part can be integrally molded with a synthetic resin etc.

  (5) The flat belt may have an adhesive layer on the first surface side.

  Thereby, since the flat strip is directly bonded to the limb on the first surface side, the flat strip is prevented from being displaced with respect to the limb.

  According to the hemostasis device according to the present invention, the flat plate is provided on the outer side of the balloon, so that the direction in which the balloon is inflated is controlled. Since the flat plate is appropriately bent in the first direction, a hemostatic device in which the balloon is stable with respect to the limb is realized. In addition, since both ends in the first direction of the flat plate are directed toward the limbs in accordance with limbs having different shapes and sizes, the flat band is not rubbed intensively at both ends of the flat plate, and the flat band is not damaged or broken. A hemostatic device that is unlikely to occur is realized.

  Hereinafter, preferred embodiments of the present invention will be described. In addition, this embodiment is only one embodiment of this invention, and it cannot be overemphasized that an embodiment can be changed in the range which does not change the summary of this invention.

[Explanation of drawings]
FIG. 1 is a front view showing an external configuration of a hemostatic device 10 according to the first embodiment of the present invention. FIG. 2 is a plan view of the hemostatic device 10. FIG. 3 is a bottom view of the hemostatic device 10. FIG. 4 is a right side view of the hemostatic device 10. FIG. 5 is a partial cross-sectional view showing a cross-sectional structure taken along the line VV in FIG. 6A is a bottom view of the flat plate 12, and FIG. 6B is a partial cross-sectional view showing a cross-sectional structure taken along the line VI-VI. FIG. 7 is a schematic diagram showing a method of attaching the hemostatic device 10 to the arm 90. FIG. 8 is a schematic view showing a state in which the hemostatic device 10 is attached to the arm 90 and the balloon 13 is inflated. FIG. 9 is a front view showing an external configuration of the hemostatic device 30 according to the second embodiment of the present invention. FIG. 10 is a plan view of the hemostatic device 30. FIG. 11 is a bottom view of the hemostatic device 30. FIG. 12 is a right side view of the hemostatic device 30. 13 is a partial cross-sectional view showing a cross-sectional structure taken along the line XIII-XIII in FIG. FIG. 14 is a bottom view of the flat plate 32. FIG. 15 is a schematic diagram showing a method for attaching the hemostatic device 30 to the arm 90. FIG. 16 is a schematic view showing a state where the hemostatic device 10 is attached to the arm 90 and the balloon 33 is inflated. FIG. 17 is a schematic diagram showing a state where the hemostatic device 30 is attached to the arm 92 and the balloon 33 is inflated.

[First Embodiment]
The hemostatic device 10 according to the first embodiment will be described below.

[Hemostatic device 10]
The hemostatic device 10 is wound around a site to be stopped in a human arm, leg, or the like, so as to squeeze the site to be stopped (hemostatic site). The hemostatic device 10 is used, for example, for hemostasis after removal of a catheter or a needle inserted into a human blood vessel for the purpose of treatment or examination. As a more specific example, it is used for hemostasis after removing a sheath introducer placed near the wrist of an arm for the purpose of inserting a catheter.

  As shown in FIGS. 1 to 4, the hemostatic device 10 mainly includes a flat belt body 11 that can be wound around a limb such as an arm, a flat plate 12 provided inside the flat belt body 11, It is comprised from the balloon 13 provided inside.

[Flat belt 11]
As shown in FIG. 2, the flat belt 11 is a thin belt-shaped sheet long enough to be wrapped around a limb such as an arm, and has flexibility to deform along the limb. In each figure, the direction indicated by the arrow 101 is the longitudinal direction of the flat strip 11 and corresponds to the first direction in the present invention. In the present embodiment, the width of the flat strip 11 is expanded to the same extent as the width of the flat plate 12 in the vicinity where the flat plate 12 is disposed, but the planar shape of the flat strip 11 may be changed as appropriate. Good.

  The flat belt 11 is made of cloth, non-woven fabric, paper, synthetic resin, or a laminate of these as long as it has a flexible sheet shape. The wearing feeling of 10 is improved.

  As shown in FIG. 5, in the state where the hemostatic device 10 is attached to the limb, an adhesive layer 16 is laminated on the inner surface 18 of the flat belt body 11 on the limb body side. The adhesive layer 16 is mainly composed of, for example, an acrylic or silicone adhesive. The adhesive layer 16 is laminated on the entire inner surface 18 of the flat strip 11. The inner surface 18 of the flat band 11 is a surface (surface on the side shown in FIG. 3) that faces the limb when the hemostatic device 10 is attached to the limb, and this inner surface 18 is the first surface in the present invention. It corresponds to. On the other hand, the surface on the side shown in FIG. 2 is referred to as the outer surface of the flat strip 11. A known medical adhesive tape or the like is used as the flat belt 11 having such an adhesive layer 16. The flat band 11 is directly bonded to the limb such as an arm on the inner surface 18 side by the adhesive layer 16, so that the flat band 11 is not easily displaced with respect to the limb. The adhesive layer 16 is covered with the release sheets 14 and 15 and the sheet 19 before use.

  As shown in FIG. 3, two release sheets 14, 15 are arranged on both ends in the first direction (arrow 101) with respect to one flat belt 11 to adhere the flat belt 11. Covers layer 16. The adhesive layer 16 is also covered with the sheet 19 between the two release sheets 14 and 15, but the sheet 19 may not be peelable from the adhesive layer 16. The pressure-sensitive adhesive layer 16 covered with the sheet 19 is not bonded to the arm 30 or the like in use.

  As shown in FIG. 2, the flat strip 11 has a window 17 formed by cutting a part of the center in the width direction in the thickness direction. The window 17 corresponds to the arrangement of the flat plate 12 and the balloon 13, and the flat plate 12 is visually recognized from the outer surface side of the flat strip 11 through the window 17. As will be described later, when the flat plate 12 is made of a translucent member, the balloon disposed inside the flat plate 12 through the window 17 becomes visible. Furthermore, since the balloon 13 is made of a translucent member, a hemostatic site in the limb can be visually recognized from the outside of the flat band 11 through the window 17, the flat plate 12 and the balloon 13.

[Flat plate 12]
As shown in FIG. 3, the flat plate 12 is disposed and fixed on the inner surface 18 side of the flat strip 11. In the place where the flat plate 12 is disposed, the release sheets 14 and 15 and the sheet 19 are not provided and the adhesive layer 16 is exposed. Therefore, the flat plate 12 is bonded and fixed to the inner surface 18 side of the flat strip 11 by the adhesive layer 16. The flat plate 12 is arranged offset from the center in the first direction (arrow 101) to one end side (left side in FIG. 3) in the flat strip body 11, and the flat strip body 11 fixes the flat plate 12 to the limb body. If it is a position which can do, the arrangement | positioning of the flat plate 12 will not be specifically limited.

  As shown in FIG. 3 and FIG. 6A, the flat plate 12 is orthogonal to the first direction so as to partition a part of both ends in the direction along the first direction (arrow 101) in the plan view. Hinge portions 21 and 22 extending in the direction to be provided are provided. By the hinge portions 21 and 22, the flat plate 12 is roughly classified into three sections including a central portion 23 and end portions 24 and 25.

  As shown in FIG. 3, in the flat plate 12, the first length L <b> 1 along the first direction (arrow 101) is longer than the second length L <b> 2 along the first direction in the balloon 13. (First length L1> second length L2). The width W1 of the flat plate 12 is slightly wider than the width W2 of the balloon 13.

  Since each hinge part 21 and 22 is equivalent shape except for the position in the flat plate 12, a detailed structure is demonstrated to the hinge part 22 as an example. As shown in FIG. 6B, the hinge portion 22 is configured by a thin portion in which the thickness of the flat plate 12 is reduced. The thin portion has a constant cross-sectional shape and is formed across both edges along the first direction of the flat plate 12. By reducing the thickness of the flat plate 12 in the hinge portion 22, desired rigidity is maintained in the central portion 23 and the end portion 25, and the central portion 23 and the end portion 25 are bent at an arbitrary angle in the hinge portion 22. It becomes possible. The angle that can be formed by the central portion 23 and the end portion 25 varies depending on the shape, thickness, width, and the like of the hinge portion 22. As long as the end portion 25 can be bent, the end portion 25 is on the inner surface 26 side of the flat plate 12 (the front side in FIGS. 3 and 6A, the lower side in FIG. 6B). However, it is needless to say that it can be bent more greatly, or it can be bent to both the inner surface 26 side and the outer surface side of the flat plate 12. The hinge portion 21 is not described in detail, but the central portion 23 and the end portion 24 can be bent at an arbitrary angle by the hinge portion 21 having the same configuration as the hinge portion 22.

  The flat plate 12 is formed, for example, as a molded body of a synthetic resin having translucency. Although the thin part which comprises the hinge parts 21 and 22 can be integrally formed when shape | molding the flat plate 12, after the flat plate 12 of fixed thickness is shape | molded, the location equivalent to the hinge parts 21 and 22 is thickness direction. The hinge parts 21 and 22 may be formed by being cut out. Moreover, it replaces with a thin part and the hinge parts 21 and 22 may be formed by forming the notch in the flat plate 12. FIG.

  The flat plate 12 can be elastically deformed so as to bend in the first direction along the balloon 13 by the expansion of the balloon 13 described later (see FIG. 8). Since the balloon 13 is mainly disposed at the central portion 23 of the flat plate 12, the central portion 23 can be elastically deformed so as to bend along the balloon 13 in the first direction. Such elastic deformation is realized by the material and thickness of the flat plate 12. The degree of elastic deformation is not particularly limited, but when the hemostatic device 10 is attached to an arm or the like and the balloon 13 is inflated as described later, the flat band 11 is broken or the balloon 13 is ruptured. The flat plate 12 may be elastically deformed without causing strong pain in the arm or the like.

[Balloon 13]
The balloon 13 has a generally bag shape and is inflated when a fluid such as air or liquid is injected. Such a balloon 13 is formed into a bag shape by, for example, stacking two films of the same shape and fixing the peripheral edges of the two films to each other by welding or adhesion. Although the film which comprises the balloon 13 is not specifically limited, if it has translucency, a hemostatic site | part can be visually observed through the flat plate 12 and the balloon 13 from the window 17 of the flat strip 11 as mentioned above. Therefore, it is preferable.

  As shown in FIG. 3, the balloon 13 has a substantially square sheet shape, and the portion that expands when the fluid is injected (the region indicated by the dotted line in FIG. 3) is in the first direction (arrow 101). A long rectangle in the direction perpendicular to The inflated portion having the rectangular shape swells in a pillow shape with the thickest center when the fluid is injected (see FIG. 8). This does not compress the hemostatic site with a point like a spherical balloon, but compresses the hemostatic site with a wider surface, so that a compression force is reliably applied to the hemostatic site and reliable hemostasis is realized. .

  The balloon 13 is fixed to the inner surface 26 of the flat plate 12, that is, the surface opposite to the flat strip 11. The inner surface 26 corresponds to the second surface in the present invention. As described above, the balloon 13 is mainly disposed in the central portion 23 of the flat plate 12, and a part of the balloon 13 is also disposed in the end portion 25. The arrangement of the balloon 13 is such that the thickest portion of the inflated balloon 13 corresponds to the hemostatic site in consideration of the hemostatic site (blood vessel) in the limb and the nerve to be compressed, and does not excessively compress the nerve. Is set as follows.

  The balloon 13 is provided with a tube 27 and a connector 28 for injecting fluid into the bag-shaped internal space. A port communicating with the bag-shaped internal space is formed in a part of the periphery of the balloon 13 (lower side in FIG. 3), and a tube 27 is connected to the port so that fluid can be injected. A connector 28 is provided at the end of the tube 27. The connector 28 is connected to a device such as a syringe for injecting fluid, but in order to prevent erroneous connection with a medical device such as a sheath introducer, one having a smaller diameter than the connector used for these medical devices. used. Although not shown in each figure, the connector 28 is provided with a valve capable of injecting fluid into the balloon 13 and preventing reverse flow of the fluid from the balloon 13.

[How to use the hemostatic device 10]
The hemostatic device 10 is obtained by inserting a catheter or inserting a needle after removing a catheter inserted into a blood vessel in a limb such as a human arm or leg, or a relatively large needle inserted through the blood vessel. Used for hemostasis of an invasive site. In the present embodiment, as an example, it is assumed that a sheath introducer for inserting a catheter is inserted into a human arm. Since the structure and insertion method of the sheath introducer itself are not directly related to the present invention, the description and illustration thereof are omitted.

  In the hemostatic device 10 before mounting, the balloon 13 is in a deflated state, and the adhesive layer 16 of the flat belt 11 is entirely covered with release sheets 14 and 15. Since the adhesive layer 16 is covered with the release sheets 14 and 15, when the hemostatic device 10 is attached to the arm, the flat band 11 is not erroneously adhered to a portion other than a desired portion.

  When the hemostatic device 10 is mounted, the center of the balloon 13 is first checked while the hemostatic site 91 (see FIG. 8) of the arm 90 is confirmed from the outer surface side of the flat belt 11 through the window 17, the flat plate 12 and the balloon 13. And the hemostatic site 91 are aligned. And the peeling sheets 14 and 15 are peeled, the adhesive layer 16 of the flat strip 11 is exposed, and both ends of the flat strip 11 are wound around the arms 90 and bonded. Thereby, as shown in FIG. 7, the flat belt 11 is wound around the arm 90 and fixedly adhered thereto. By fixing the flat band 11, the flat plate 12 and the balloon 13 are fixed at a position corresponding to the hemostatic site 91, that is, outside the hemostatic site 91.

  Subsequently, as shown in FIG. 7, a syringe 29 is connected to the connector 28, and air is injected into the internal space of the balloon 13 through the tube 27. When air is injected, the balloon 13 is inflated between the flat plate 12 and the hemostatic site 91 of the arm 90 as shown in FIG. The balloon 13 tries to inflate so that the center thereof is the thickest, but the rigidity of the flat plate 12 outside the balloon 13 prevents the balloon 13 from inflating outside. It bulges to the hemostatic site 91 which is the inside. Therefore, the bulge of the balloon 13 is mainly directed to the hemostatic site 91, and the bulge of the balloon 13 acts as a pressing force to the hemostatic site 91. The sheath introducer placed at the hemostatic site 91 is extracted from the blood vessel after the balloon 13 is inflated.

  Further, as shown in FIG. 8, the central portion 23 of the flat plate 12 is elastically deformed so as to bend outward as the balloon 13 bulges. The elastically deformed central portion 23 is directed toward the hemostatic site 91 by the elastic restoring force, and the central portion 23 follows the shape of the balloon 13 that is inflated in accordance with the size and shape of the arm 90. Therefore, the feeling of wearing the hemostatic device 10 is improved without significantly impairing the pressing force on the hemostatic site 91 due to the bulging of the balloon 13.

  Further, as shown in FIG. 8, the end portions 24 and 25 of the flat plate 12 protrude outward in the first direction (arrow 101) with respect to the balloon 13. When the hinges 21 and 22 are bent by the bulging, the arm 90 is directed to the arm 90 side. Since the bulge of the balloon 13 matches the size and shape of the arm 90, the bending angle of the flat plate 12 in the first direction of the hinge portions 21 and 22 is displaced according to the size and shape of the arm 90. That is, the flat plate 12 is appropriately bent with respect to the first direction in accordance with the size and shape of the arm 90.

[Operational effects of this embodiment]
As described above, according to the hemostatic device 10, the flat plate 12 is provided outside the balloon 13, whereby the direction in which the balloon 13 is inflated is controlled, and the flat portions 12 are provided with the hinge portions 21 and 22. Since the end portions 24 and 25 are appropriately bent with respect to the arms 90 having different shapes and sizes, the balloon 13 is stabilized with respect to the various arms 90. Further, since the end portions 24 and 25 are directed toward the arm 90 in accordance with the size and shape of the arm 90, the flat band 11 is not rubbed intensively at both ends of the flat plate 12, and damage to the flat band 11 or It is difficult to break.

  In addition, the adhesive layer 16 is not exposed around the flat plate 12 where the release sheets 14 and 15 are not disposed, so that the flat strip 11 around the flat plate 12 is not bonded to the arm 90. As a result, the balloon 13 is inflated, so that it is possible to reduce the peeling of the flat band 11 from the arm 90 around the flat plate 12 and the application of excessive stress to the arm 90, and the skin caused by the adhesive layer 16. Obstacles are reduced.

  In the present embodiment, the hinges 21 and 22 are provided at two positions on the flat plate 12 that are different from each other in the first direction (arrow 101). However, the number and arrangement of the hinges are appropriately changed. May be.

  In addition, the hinge portions 21 and 22 form thin portions and cuts in the flat plate 12, for example, a flexible tape that connects the central portion 23 and the end portions 24 and 25 of the flat plate 12 as separate members. Or a film.

  In the present embodiment, the balloon 13 is inflated into a rectangular pillow shape. However, even when a spherical balloon or the like is employed, the same effect as that of the present embodiment is achieved.

[Second Embodiment]
The second embodiment of the present invention will be described below.

[Hemostatic device 30]
The application of the hemostatic device 30 is the same as the hemostatic device 10 described above. As shown in FIG. 9 to FIG. 12, the hemostatic device 30 mainly includes a flat strip 31 that can be wound around a limb such as an arm, a flat plate 32 provided inside the flat strip 31, It is comprised from the balloon 33 provided inside.

[Flat belt 31]
As shown in FIG. 9 to FIG. 12, the flat belt 31 is a thin belt-shaped sheet that is long enough to be wound around a limb such as an arm, and has flexibility to deform along the limb. . In each figure, the direction indicated by the arrow 101 is the longitudinal direction of the flat strip 31 and corresponds to the first direction in the present invention. In the present embodiment, a flat band 31 having a constant width is shown. However, as in the first embodiment, the width of the flat band 31 is increased in the vicinity where the flat plate 13 is disposed. The planar shape of 31 may be changed as appropriate. The material of the flat strip 31 is selected in the same manner as the flat strip 11 described above.

  As shown in FIG. 13, the adhesive layer 36 is laminated on the entire inner surface 38 of the flat belt body 31 on the limb body side when the hemostatic device 30 is attached to the limb body. The inner surface 38 corresponds to the first surface in the present invention. On the other hand, the surface on the side shown in FIG. 10 is referred to as the outer surface of the flat strip 31. The adhesive layer 36 is covered with release sheets 34 and 35 before use.

  As shown in FIG. 11, two release sheets 34, 35 are arranged so as to be aligned in the first direction (arrow 101) with respect to one flat belt 31, and the adhesive layer of the flat belt 31. 36 is covered. The release sheet 34 covers the periphery of the flat plate 32 in the adhesive layer 36, and the release sheet 35 covers one end side of the adhesive layer 36 away from the periphery of the flat plate 32.

  As shown in FIG. 12, the width W3 of the flat strip 31 in the direction orthogonal to the first direction (arrow 101) is wider than the width W4 of the flat plate 32 (width W3> width W4). Therefore, the adhesive layer 36 exists outside the flat plate 32 disposed on the inner surface of the flat strip 31 in the width direction (the direction orthogonal to the arrow 101), and includes the portion corresponding to the adhesive layer 36 with respect to the flat plate 32. A part of the adhesive layer 36 on both sides in the first direction is covered with one release sheet 34. The release sheet 34 can be peeled from the adhesive layer 36 of the flat strip 31 independently of the release sheet 35 described above.

  As shown in FIG. 10, the flat strip 31 has a window 37 formed by cutting out a part in the center in the width direction in the thickness direction. The window 37 corresponds to the arrangement of the flat plate 32 and the balloon 33, and the flat plate 32 is visually recognized from the outer surface side of the flat strip 31 through the window 37.

[Plate 32]
As shown in FIG. 11, a flat plate 32 is disposed and fixed on the inner surface 18 side of the flat strip 31. In the place where the flat plate 32 is disposed, the release sheets 34 and 35 are not provided and the adhesive layer 36 is exposed. Therefore, the flat plate 32 is bonded and fixed to the inner surface 18 side of the flat strip 31 by the adhesive layer 36. The flat plate 32 is arranged offset from the center of the first direction (arrow 101) to one end side (left side in FIG. 11) in the flat strip 31. The flat strip 31 fixes the flat plate 32 to the limb. If it is a position which can do, the arrangement | positioning of the flat plate 32 will not be specifically limited. Moreover, one edge (lower edge in FIG. 11) along the first direction in the flat plate 32 and one edge (lower edge in FIG. 11) along the first direction in the flat strip 31 are formed. However, the arrangement of the flat plate 32 with respect to the width direction of the flat strip 31 (the direction orthogonal to the arrow 101) is not particularly limited.

  As shown in FIG. 11 and FIG. 14, the flat plate 32 has an oblong shape with the first direction (arrow 101) as the longitudinal direction, and both ends in the first direction have a semicircular shape. Hinge portions 41 and 42 extending in a direction orthogonal to the first direction are provided so as to partition the semicircular shapes at both ends. By the hinge portions 41 and 42, the flat plate 32 is roughly classified into three sections of a central portion 43 and end portions 44 and 45.

  As shown in FIG. 11, in the flat plate 32, the third length L3 along the first direction (arrow 101) is longer than the fourth length L4 along the first direction in the balloon 33. (3rd length L3> 4th length L4). The width W4 of the flat plate 32 is substantially equal to the width of the balloon 33. In the present embodiment, the outer shape of the central portion 43 of the flat plate 32 and the outer shape of the balloon 33 are substantially equal. However, in the present invention, these do not need to be equal. The third length L3 described above corresponds to the first length in the present invention, and the fourth length L4 corresponds to the second length in the present invention.

  Since the hinge portions 41 and 42 are the same as the hinge portions 21 and 22 in the flat plate 12 described above, a detailed description thereof is omitted. However, the hinge portions 41 and 42 have a central portion 43 and end portions 44 and 45. It can be bent at any angle.

  The flat plate 32 can be elastically deformed so as to bend with respect to the first direction along the balloon 33 by the expansion of the balloon 33 described later (see FIG. 16). Since the balloon 33 is disposed at the central portion 43 of the flat plate 32, the central portion 43 can be elastically deformed so as to bend along the balloon 33 in the first direction. Such elastic deformation is realized by the material and thickness of the flat plate 32.

[Balloon 33]
The balloon 33 is the same as the balloon 13 described above except that its shape is different. As shown in FIG. 11, in the deflated state, the balloon 33 is in the form of a rectangular sheet that is long in the first direction (arrow 101), and when the fluid is injected, the central portion swells into the thickest pillow shape. (See FIG. 16).

  The balloon 33 is fixed to the inner surface 46 of the flat plate 32, that is, the surface opposite to the flat strip 31. The inner surface 46 corresponds to the second surface in the present invention. As described above, the balloon 33 is disposed so as to overlap almost the entire region of the central portion 23 of the flat plate 32.

  The balloon 33 is provided with a tube 47 and a connector 48 for injecting fluid into the bag-shaped internal space. Since the tube 47 and the connector 48 are the same as the tube 27 and the connector 28 described above, detailed description is omitted.

[How to use the hemostatic device 30]
The hemostatic device 30 is used to stop hemostasis in the human limb, similar to the hemostatic device 10 described above.

  In the hemostatic device 30 before mounting, the balloon 33 is in a deflated state, and the adhesive layer 36 of the flat belt 31 is entirely covered with release sheets 34 and 35. Since the adhesive layer 36 is covered with the release sheets 34 and 35, when the hemostatic device 30 is attached to the arm, the flat belt body 31 is not erroneously adhered to a portion other than a desired location.

  As shown in FIG. 15, when the hemostatic device 30 is mounted, first, the release sheet 34 covering the adhesive layer 36 around the flat plate 32 is peeled off, and the adhesive layer 36 around the flat plate 32 is exposed. Is done. Then, while the hemostatic site 91 of the arm 90 is confirmed through the window 37, the flat plate 32, and the balloon 33 from the outer surface side of the flat band 31, the center of the balloon 33 and the hemostatic site 91 are aligned, as shown in FIG. Further, the adhesive layer 36 around the flat plate 32 is adhered to the skin of the arm 90. Although not shown in FIG. 15, at this time, a sheath introducer is placed in the hemostatic site 91.

  As shown in FIG. 15, the adhesive layer 36 at the end (the right side in FIG. 15) on the side far from the flat plate 32 in the flat strip 31 is covered with the release sheet 35. Therefore, as described above, when the balloon 33 is positioned and the flat band body 31 is adhered to the arm 90 by the adhesive layer 36 around the flat plate 32, the above-described end portion is erroneously adhered to a portion other than the desired portion. There is nothing to do. After the positioning of the balloon 33 is completed as described above, the release sheet 35 is peeled off, and the end portion of the flat strip 31 is also wound around the arm 90 and bonded thereto. As a result, the flat belt 31 is wound around the arm 90 and fixed thereto. By fixing the flat band 31, the flat plate 32 and the balloon 33 are fixed at a position corresponding to the hemostatic site 91, that is, outside the hemostatic site 91.

  Subsequently, a syringe or the like is connected to the connector 48, and air is injected into the internal space of the balloon 33 through the tube 47. When air is injected, the balloon 33 is inflated between the flat plate 32 and the hemostatic site 91 of the arm 90 as shown in FIG. The balloon 33 tries to inflate so that the center of the balloon 33 is the thickest, but the rigidity of the flat plate 32 outside the balloon 33 prevents the balloon 33 from inflating outside. It bulges to the hemostatic site 91 which is the inside. Therefore, the bulge of the balloon 33 is mainly directed to the hemostatic site 91, and the bulge of the balloon 33 acts as a pressing force to the hemostatic site 91. The sheath introducer placed at the hemostatic site 91 is extracted from the blood vessel after the balloon 33 is inflated.

  Further, as shown in FIG. 16, due to the balloon 33 bulging, the central portion 43 of the flat plate 32 is elastically deformed so as to curve outward. The elastically deformed central portion 43 is deformed by the elastic restoring force so that the deformation of the balloon 33 is directed to the hemostatic site 91, and the central portion 43 follows the shape of the balloon 33 that is inflated according to the size and shape of the arm 90. Therefore, the feeling of wearing the hemostatic device 30 is improved without significantly impairing the pressing force on the hemostatic site 91 due to the balloon 33 bulging.

  As shown in FIG. 16, the end portions 44 and 45 of the flat plate 32 protrude outward in the first direction (arrow 101) with respect to the balloon 33. The hinge portions 41 and 42 are bent by the bulging, so that the arm 90 is directed to the arm 90 side. Since the expansion of the balloon 33 matches the size and shape of the arm 90, the bending angle of the flat plate 32 in the first direction of the hinge portions 41 and 42 is displaced according to the size and shape of the arm 90. That is, the flat plate 32 is appropriately bent with respect to the first direction in accordance with the size and shape of the arm 90.

  For example, as shown in FIG. 17, when the hemostatic device 30 is attached to a relatively small arm 92, the end portions 44 and 45 of the flat plate 32 are bent largely at the hinge portions 41 and 42 toward the arm 92 side. . On the other hand, since the balloon 33 swells between the flat plate 32 and the hemostatic site 93 of the arm 92, the bulge of the balloon 33 acts as a pressing force on the hemostatic site 93. As described above, the bending angle of the hinge portions 41 and 42 in the first direction of the flat plate 32 is appropriately displaced depending on the size and shape of the arms 90 and 92, and the end portions 44 and 45 are appropriately directed toward the arms 90 and 92. Bends.

[Operational effects of this embodiment]
As described above, according to the hemostatic device 30, the flat plate 32 is provided outside the balloon 33, whereby the direction in which the balloon 33 is inflated is controlled, and the flat plate 32 is provided with the hinge portions 41 and 42. Since the end portions 44 and 45 are appropriately bent with respect to the arms 90 and 92 having different shapes and sizes, the balloon 33 is stabilized with respect to the various arms 90 and 92. In addition, since the end portions 44 and 45 are directed toward the arms 90 and 92 in accordance with the size and shape of the arms 90 and 92, the flat belt body 31 is not rubbed intensively at both ends of the flat plate 32, and the flat belt body. 31 damage and breakage are unlikely to occur.

  Further, by peeling the release sheet 34, the adhesive layer 36 around the flat plate 32 is exposed, and the exposed adhesive layer 36 can be immediately bonded to the arms 90 and 92. Therefore, the release sheet 34 is peeled off. Then, the operation from the positioning of the balloon 33 to the bonding of the flat band 31 to the arms 90 and 92 is simplified, and the hemostatic device 30 that is easy to attach to the arms 90 and 92 is realized.

FIG. 1 is a front view showing an external configuration of a hemostatic device 10 according to the first embodiment of the present invention. FIG. 2 is a plan view of the hemostatic device 10. FIG. 3 is a bottom view of the hemostatic device 10. FIG. 4 is a right side view of the hemostatic device 10. FIG. 5 is a partial cross-sectional view showing a cross-sectional structure taken along the line V-V in FIG. 6A is a bottom view of the flat plate 12, and FIG. 6B is a partial cross-sectional view showing a cross-sectional structure taken along the line VI-VI. FIG. 7 is a schematic diagram showing a method of attaching the hemostatic device 10 to the arm 90. FIG. 8 is a schematic view showing a state in which the hemostatic device 10 is attached to the arm 90 and the balloon 13 is inflated. FIG. 9 is a front view showing an external configuration of the hemostatic device 30 according to the second embodiment of the present invention. FIG. 10 is a plan view of the hemostatic device 30. FIG. 11 is a bottom view of the hemostatic device 30. FIG. 12 is a right side view of the hemostatic device 30. 13 is a partial cross-sectional view showing a cross-sectional structure taken along the line XIII-XIII in FIG. FIG. 14 is a bottom view of the flat plate 32. FIG. 15 is a schematic diagram showing a method for attaching the hemostatic device 30 to the arm 90. FIG. 16 is a schematic view showing a state where the hemostatic device 10 is attached to the arm 90 and the balloon 33 is inflated. FIG. 17 is a schematic diagram showing a state where the hemostatic device 30 is attached to the arm 92 and the balloon 33 is inflated.

Explanation of symbols

10, 30 ... hemostatic device 11, 31 ... flat band 12, 32 ... flat plate 13, 33 ... balloon 14, 15, 34, 35 ... release sheet 16, 36 ... adhesive Layers 21, 22, 41, 42 ... hinge portions 26, 46 ... inner surface (second surface)
90, 92 ... arms (limbs)
91, 93 ... hemostatic site

Claims (5)

A flexible flat band that is wrapped around and fixed to a portion of the limb that is to be hemostatic,
A flat plate fixed to the first surface of the flat belt,
A balloon that is fixed to the second surface on the opposite side of the flat strip in the flat plate and inflates when fluid is injected;
In the flat plate, the first length along the first direction which is the longitudinal direction of the flat belt is longer than the second length along the first direction of the balloon (first length> second length). ) And a hemostatic device having a hinge portion extending in a direction intersecting with the first direction, and capable of being bent with respect to the first direction by the hinge portion.   The hemostatic device according to claim 1, wherein the hinge portion is provided in at least two places on the flat plate that are at different positions with respect to the first direction.   The said flat plate is elastically deformable so that it may curve with respect to the said 1st direction along the said balloon, when the said balloon is inflated in the state with which the said limb body was mounted | worn. Hemostatic device.   The hemostatic device according to any one of claims 1 to 3, wherein the hinge portion is a thin portion or a cut formed in the flat plate.   The hemostatic device according to any one of claims 1 to 4, wherein the flat band has an adhesive layer on a first surface side thereof.

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