JP4510508B2 - Hemostatic device - Google Patents

Description

  The present invention relates to a hemostatic device.

  When a catheter or the like is percutaneously inserted into the blood vessel from the lumen of the introducer sheath to perform treatment or examination, it is necessary to stop the puncture site after removing the introducer sheath. In order to perform this hemostasis, a belt for wrapping around a portion of the puncture site of the arm or leg, a fixing means for fixing the belt in a state of being wound around the puncture site, and expanding by injecting fluid, the puncture site There is known a hemostatic device including a balloon that compresses the blood pressure (see, for example, Patent Document 1).

  When such a hemostatic device is wrapped around the wrist, the balloon presses the puncture site to stop the hemostasis, but the reaction force acts on the belt, near the bean bone located on the opposite side of the wrist from the hemostasis site Squeeze. If the compression near the bean bone continues for a long time, numbness or pain may occur.

Utility model registration No. 3031486

  The purpose of the present invention is to prevent poor blood circulation by relieving the compression force acting on parts other than the hemostatic part, and in particular, by reducing the compression force on the bean bone of the worn wrist, The object is to provide a hemostatic device that can be prevented or alleviated.

Such an object is achieved by the present invention of the following (1) to ( 11 ).
(1) a flexible band wound around a portion of the wrist to be hemostatic;
Fixing means for fixing the belt in a state of being wound around the wrist;
A hemostatic device connected to the band and comprising a balloon that expands by injecting fluid;
The band body, the portion corresponding to Mamejo bone when wound around the wrist, have a opening,
After the hemostatic device is attached to the wrist and the balloon is expanded, the compression force by the balloon is configured to decrease over time,
The hemostatic device according to claim 1, wherein the time-dependent decrease in the compression force by the balloon is caused by the band body extending over time .

(2) a flexible band wound around a portion of the wrist to be hemostatic;
Fixing means for fixing the belt in a state of being wound around the wrist;
A hemostatic device connected to the band and comprising a balloon that expands by injecting fluid;
The band body, the portion corresponding to Mamejo bone when wound around the wrist, have a plurality of slits,
After the hemostatic device is attached to the wrist and the balloon is expanded, the compression force by the balloon is configured to decrease over time,
The hemostatic device according to claim 1, wherein the time-dependent decrease in the compression force by the balloon is caused by the band body extending over time .

(3) The opening area of the opening is 0.5 to 8 cm. ² The hemostatic device according to (1) above.

(4) The hemostatic device according to (2), wherein each of the slits is disposed obliquely and parallel to the longitudinal direction of the band.

(5) The hemostatic device according to (2), wherein each of the slits is arranged radially at a substantially equal interval from a central portion of a portion corresponding to the bean-like bone.

(6) The balloon, after expansion, the internal pressure is decreased over time, the internal pressure after the lapse of 60 minutes after the expansion, the above (1) that is configured to be 20 to 70% of the initial internal pressure ( The hemostatic device according to any one of 5) .

( 7 ) The hemostatic device according to any one of (1) to (6), wherein the belt has a tensile elastic modulus of 10 gf / mm ² or less.

( 8 ) The hemostatic device according to any one of (1) to (7) , wherein an elongation rate of the band after 180 minutes from the balloon expansion is 1 to 7%.

( 9 ) The hemostatic device according to any one of (1) to (8), wherein the hemostatic device is provided so as to overlap with the balloon, and at least a part thereof is curved toward the inner peripheral side. .

( 10 ) The hemostatic device according to (9) , further comprising a pressing member that is installed between the curved plate and the balloon so that at least a part thereof overlaps the balloon and presses the balloon.

( 11 ) The hemostatic device according to (10) , wherein the pressing member includes an auxiliary balloon that presses the balloon with the pressure of a fluid filled therein.

  According to the present invention, an excellent hemostatic effect can be obtained, and the compression force acting on a site other than the hemostatic site can be relieved to prevent poor circulation. In particular, numbness and pain can be prevented or alleviated by reducing the pressing force of the wrist equipped with the hemostatic device near the bean-like bone.

  In addition, when configured so that the compression force by the balloon decreases with time, numbness, pain, poor circulation, and the like can be more effectively prevented.

  In particular, in a configuration in which the compression force (internal pressure) of the balloon naturally decreases, there is no need for the doctor or nurse to perform an operation to relieve the compression force, such as removing the air from the balloon. Can be omitted (the complexity is avoided), and erroneous operation is also prevented.

  Further, when the curved plate is provided, particularly when the balloon is arranged at a position offset to one end side in the longitudinal direction of the curved plate, and further, the curved plate is arranged at the center portion on the side where the balloon is offset. In the case where a portion having a smaller radius of curvature is provided, a superior hemostatic effect can be obtained.

Hereinafter, the hemostatic device of the present invention will be described in detail based on preferred embodiments shown in the accompanying drawings.
<First Embodiment>
FIG. 1 is a bottom view showing a first embodiment of the hemostatic device of the present invention (a state in which the inner surface side can be seen when worn on the wrist), and FIG. 2 is a cross-sectional view showing a use state of the hemostatic device shown in FIG. FIG.

  The hemostatic device 1 shown in FIG. 1 and FIG. 2 is used after removing a catheter or the like inserted percutaneously into a blood vessel (artery) from a puncture hole formed in the wrist 500 (limb) for the purpose of treatment, examination, diagnosis, etc. The band 2 to be wound around the wrist 500, the hook-and-loop fastener 3 as a fixing means for fixing the band 2 around the wrist 500, and the curved plate 4. , A balloon 5 and an auxiliary balloon 6 are provided.

  The band 2 is a band-shaped member having flexibility. As shown in FIG. 2, the band 2 is wound around the wrist 500 so as to make a round, and is attached to the wrist 500 so that portions near both ends thereof are overlapped with each other. Then, the band 2 is fixed (joined) at the overlapping portion by a surface fastener 3 described later.

  In the band 2, an opening 22 is formed at a predetermined site. The portion where the opening 22 is formed is a portion corresponding to the bean-like bone 530 of the wrist 500 in a state where the band 2 is wound around the wrist 500 and mounted (hereinafter referred to as “mounted state”). Specifically, as shown in FIG. 2, when the belt body 2 is attached, it is a place opposite to the balloon 5 via the center portion 520 of the wrist 500.

  The shape of the opening 22 is not limited to the circular shape as illustrated, and may be any shape such as an elliptical shape, a quadrangular shape, a pentagonal shape, a hexagonal shape, a polygonal shape such as an octagonal shape, or the like.

  By providing such an opening 22 in the band 2, when the band 2 is attached, a part other than the part to be hemostatic (puncture part 510), in particular, the bean bone 530 and its vicinity are compressed by the band 2. Power can be reduced. That is, as shown in FIG. 2, the vicinity of the protruding bean-like bone 530 enters the opening 22 to relieve an increase in the tension of the band 2 and reduce the compression force. As a result of the reduction of the compression force, adverse effects such as numbness, pain and poor circulation can be prevented or alleviated.

Opening area of the opening 22 is not particularly limited, preferably about 0.5～8Cm ^2, about 2～6Cm ² is more preferable. If the opening area is too small, the effect of reducing the compression force near the bean bone may be reduced. If the opening area is too large, the strength of the band 2 is reduced, and the band 2 is elongated in the vicinity of the opening 22. There is a risk that the compression force will rapidly decrease.

  The constituent material (sheet material) of the band 2 is not particularly limited. For example, polyvinyl chloride, polyethylene, polypropylene, polybutadiene, polyolefin such as ethylene-vinyl acetate copolymer (EVA), polyethylene terephthalate (PET) , Polyesters such as polybutylene terephthalate (PBT), polyvinylidene chloride, silicones, polyurethanes, polyamide elastomers, polyurethane elastomers, polyester elastomers and other thermoplastic elastomers, or any combination thereof (blend resins, polymer alloys, Laminates and the like).

  Moreover, it is preferable that the band 2 is substantially transparent. Thereby, the part which wound the belt | band | zone 2 around the wrist, especially the affected part can be visually recognized from the outside.

  The thickness of the sheet material constituting the band 2 is not particularly limited, but is preferably about 0.1 to 0.7 mm, considering the tensile elastic modulus and elongation of the band 2 described later, About 0.5 mm is more preferable.

  A curved plate holding portion 21 that holds a curved plate 4 to be described later is formed at the center of the band 2. In the curved plate holding portion 21, a separate belt-like member is fused (thermal fusion, high frequency fusion, ultrasonic fusion, etc.) or adhesion (adhesion with an adhesive or a solvent) on the outer surface side (or inner surface side). By joining by the method, it becomes double and holds the curved plate 4 inserted in the gap between them.

  A male side (or female side) 31 of a hook-and-loop fastener 3 generally called Velcro (registered trademark) or the like is installed on the inner surface side (the front side of the paper surface of FIG. 1) of the band 2 near the left end in FIG. A female side (or male side) 32 of the hook-and-loop fastener 3 is installed (fixed) on the outer surface side (the back side of the paper surface of FIG. 1) of the band 2 near the right end in FIG. Has been. As shown in FIG. 2, the band 2 is attached to the wrist 500 by joining the male side 31 and the female side 32 of the hook-and-loop fastener 3. In addition to the advantage that the hook-and-loop fastener 3 is easy to attach and detach, the fixing position can be finely adjusted according to the thickness of the wrist 500, and the belt 2 can be attached in an appropriate state regardless of the thickness of the wrist 500. There is an advantage that it can be attached.

  The fixing means for fixing the belt 2 in a state of being wound around the wrist 500 is not limited to the hook-and-loop fastener 3, but includes, for example, a snap, a button, a clip, a hook, an adhesive tape, and a frame member that passes the end of the belt 2. Any configuration may be used.

  The curved plate 4 is held by the belt 2 by being inserted between the double curved plate holding portions 21 of the belt 2.

  The curved plate 4 has a shape in which at least a part thereof is curved toward the inner peripheral side. The curved plate 4 is made of a material that is harder than the band 2 and maintains a substantially constant shape.

As shown in FIG. 1, in the present embodiment, the curved plate 4 has a shape that is long in the longitudinal direction of the band 2. As shown in FIG. 2, the central portion 41 in the longitudinal direction of the curved plate 4 has a flat plate shape with almost no curvature, and on both sides of the central portion 41, respectively, toward the inner peripheral side, And the curved part 42 curved along the longitudinal direction (circumferential direction of the wrist 500) of the strip | belt body 2 is formed. That is, the radius of curvature _{R 2} of the curved portion 42, the curvature of the central portion 41 radius _{R 1} (in the illustrated configuration, _{R 1} is nearly infinite) smaller.

  The constituent material of the curved plate 4 is not particularly limited, and examples thereof include acrylic resins, polyvinyl chloride (particularly hard polyvinyl chloride), polyolefins such as polyethylene, polypropylene, and polybutadiene, polystyrene, and poly- (4-methylpentene- 1) Polycarbonate, ABS resin, polymethyl methacrylate (PMMA), polyacetal, polyarylate, polyacrylonitrile, polyvinylidene fluoride, ionomer, acrylonitrile-butadiene-styrene copolymer, polyethylene terephthalate (PET), polybutylene terephthalate (PBT) And fluorinated resins such as polyester, butadiene-styrene copolymer, aromatic or aliphatic polyamide, and polytetrafluoroethylene.

  Moreover, it is preferable that the curved plate 4 is substantially transparent. Thereby, the affected part can be visually recognized from the outside (through the curved plate 4).

  Note that the curved plate 4 may be one that does not have an uncurved portion like the central portion 41, that is, one that is curved over its entire length.

  Moreover, the method of installing the curved plate 4 on the band 2 is not limited to the configuration shown in the figure. For example, the curved plate 4 may be bonded to the inner surface side or the outer surface side of the band member 2 by a method such as fusion or adhesion. Further, the band 2 does not have to go around the wrist 500, and may be one connected to both ends of the curved plate 4, for example. That is, the band 2 does not have to exist in the portion overlapping the curved plate 4.

  Inside the curved plate 4, a balloon 5 made of a flexible material is installed. The balloon 5 is expanded by injecting a fluid (a gas such as air or a liquid) and compresses the puncture site 510 of the wrist 500.

  The balloon 5 is positioned so as to be offset toward one end in the longitudinal direction of the curved plate 4. That is, in the illustrated configuration, the balloon 5 is positioned so as to overlap with the substantially right half side of the curved plate 4 in FIG.

  The constituent material of the balloon 5 is not particularly limited, and for example, the same constituent material as that of the band 2 described above can be used. The balloon 5 is preferably made of the same or the same kind of material as that of the band 2. Thereby, joining with the strip | belt body 2 by melt | fusion can be performed easily, and it can manufacture easily.

  The balloon 5 is preferably substantially transparent. Thereby, the affected part can be visually recognized from the outside (through the balloon 5).

  The thickness of the sheet material constituting the balloon 5 is not particularly limited, but is preferably about 0.1 to 0.5 mm, and preferably about 0.2 to 0.3 mm in consideration of the tensile elastic modulus and elongation of the balloon. More preferred.

  The structure of the balloon 5 can be formed into a bag shape by sealing the edge of a sheet material made of the above-described material by a method such as fusion or adhesion. In the illustrated configuration, the balloon 5 is substantially square when not expanded.

  Such a balloon 5 is connected to the belt body 2 through a connecting part 11 having flexibility. In the present embodiment, the side of the balloon 5 that is offset from the curved plate 4, that is, the right side in FIG. As for this connection part 11, the substantial length is made comparatively short, and, thereby, the balloon 5 is tethered in the position offset with respect to the curved board 4. FIG. The connecting portion 11 is preferably made of the same material as the balloon 5.

  In the present embodiment, since the balloon 5 is connected to the band 2 only on one side by the connecting portion 11, the balloon 5 assumes a slightly inclined posture in the state shown in FIG. 2, and as a result, the puncture site 510 is pushed. The pressure F acts in an inclined direction and exhibits an excellent hemostatic effect.

  As shown in FIG. 1, the balloon 5 is connected to an injection portion 7 that injects a fluid into the balloon 5. The injection portion 7 has a flexible tube 71 whose base end portion is connected to the balloon 5 and whose lumen communicates with the inside of the balloon 5, a bag body 72 installed at the distal end portion of the tube 71, It is comprised with the tubular connector 73 joined to the bag body 72. FIG.

  When the balloon 5 is expanded (expanded), a distal end protruding portion of a syringe (not shown) is inserted into the connector 73, and a pusher of the syringe is pushed, so that the fluid in the syringe is passed through the injecting portion 7. Inject into. After injecting the fluid into the balloon 5, when the distal end protruding portion of the syringe is removed from the connector 73, the check valve built in the connector 73 is closed to prevent fluid leakage. This prevents the balloon 5 from rapidly contracting.

  As shown in FIG. 2, an auxiliary balloon 6 made of a flexible material is installed between the curved plate 4 and the balloon 5 so that all or part of the auxiliary balloon 6 overlaps the balloon 5. Yes. The auxiliary balloon 6 functions as a pressing member that presses the balloon 5.

  The auxiliary balloon 6 presses the expanded balloon 5 almost in the direction toward the center portion 520 of the wrist 500 as indicated by an arrow f in FIG. 2 due to the pressure of the fluid filled therein. By receiving such a pressing force from the auxiliary balloon 6, the balloon 5 moves the puncture site 510 in a vertical direction from the top to the bottom (perpendicular to the surface of the wrist 500) as shown by an arrow F in FIG. 2. It is pressed (compressed) in an inclined direction (a direction toward the central portion 520 of the wrist 500), not in the direction). Thereby, in the hemostatic device 1 of this embodiment, compared with the case where the puncture site 510 is pressed (pressed) in a vertical direction from top to bottom, a superior hemostatic effect can be obtained, and hemostasis can be performed more reliably. .

  In the configuration shown in FIG. 2, the balloon 5 is not in contact with the curved plate 4 (via the band 2) in the state shown in FIG. Contact).

  The constituent material of the auxiliary balloon 6 is not particularly limited, and for example, the same constituent materials as those of the band 2 and the balloon 5 described above can be used. The auxiliary balloon 6 is preferably substantially transparent. Thereby, an affected part can be visually recognized from the outside. The thickness of the sheet material constituting the auxiliary balloon 6 can be the same as that of the balloon 5, and the structure of the auxiliary balloon 6 can be the same as that of the balloon 5.

  In the present embodiment, the auxiliary balloon 6 is set to have a width smaller than that of the balloon 5 in the longitudinal direction of the band 2, so that the size of the auxiliary balloon 6 is smaller than that of the balloon 5. Press on. Thereby, the direction of the pressing force F from the balloon 5 to the puncture site 510 can be inclined more reliably.

  In the present embodiment, the auxiliary balloon 6 is positioned near the right end in FIG. 2 in the longitudinal direction of the curved plate 4. Thereby, the direction of the pressing force f from the auxiliary balloon 6 to the balloon 5 can be more surely directed to the central portion 520 of the wrist 500, and as a result, the pressing force from the balloon 5 to the puncture site 510 is achieved. The direction of F can be inclined more reliably.

  Furthermore, in this embodiment, as described above, the curved plate 4 has the curved portion 42 having a smaller radius of curvature than the central portion 41 on the side where the balloon 5 is offset (the right side in FIG. 2). . Then, the auxiliary balloon 6 contacts the curved portion 42 of the curved plate 4 or a portion on the right side in FIG. 2 (via the belt 2). Thereby, the direction of the force that the auxiliary balloon 6 receives from the curved plate 4, in other words, the normal direction of the curved plate 4 where the auxiliary balloon 6 contacts (via the band 2) is the center of the wrist 500. It will be inclined in a direction toward 520. As a result, the direction of the pressing force f and the pressing force F can be tilted more reliably.

  In this embodiment, a part of the balloon 5 and a part of the auxiliary balloon 6 are joined to each other by a method such as fusion or adhesion. A communication portion (opening portion) 12 that connects the inside of the balloon 5 and the inside of the auxiliary balloon 6 is formed at the joint portion. Thereby, when the fluid is injected into the balloon 5 as described above, a part of the injected fluid flows into the auxiliary balloon 6 through the communication portion 12, and the auxiliary balloon 6 is expanded as the balloon 5 is expanded. To do. Thereby, both can be expanded by one operation, it is excellent in operativity, and the internal pressure of both the balloons 5 and 6 is also automatically adjusted equally, and a moderate compression force is obtained.

  The auxiliary balloon 6 may be further joined to the balloon 5 at a portion close to the connecting portion 11 (right end portion in FIG. 2) in addition to the portion near the communication portion 12. Thereby, since the balloon 5 can be pressed more reliably and the force for pushing up the curved plate 4 becomes stronger, the curved plate 4 is more easily separated from the wrist 500.

  The auxiliary balloon 6 may be configured to be expanded by injecting a fluid separately from the balloon 5.

  Although not shown, the auxiliary balloon 6 may be fixed (connected) to the belt body 2 via a flexible connecting portion (fixed portion). In this case, the connecting portion may be any member such as one installed separately from the connecting portion 11 or one extending from the end or midway of the connecting portion 11.

  Further, the auxiliary balloon 6 is not limited to being expanded by injecting a fluid at the time of use as in the present embodiment, but may be one that is filled and expanded from the beginning.

  The pressing member that presses the balloon 5 is not limited to the auxiliary balloon 6, and has, for example, a sponge-like substance (porous material), an elastic material, an aggregate of fibers such as cotton (cotton), and other stretchability. It may be a member such as a pad constituted by a member or a combination thereof.

  In the present invention, a hemostatic device that does not have a pressing member represented by the auxiliary balloon 6 may be used.

  Such a hemostatic device 1 is preferably configured such that when the balloon 5 is expanded in the mounted state and starts hemostasis, the compression force of the balloon 5 decreases with time. In this case, the temporal decrease in the compression force by the balloon 5 is caused by the deformation of the band 2 and / or the balloon 5 over time. In the present embodiment, this is done by decreasing (gradually decreasing) the internal pressure of the balloon 5 over time.

  The degree of the internal pressure of the balloon 5 that decreases with time is preferably as described below. That is, the balloon 5 is preferably 30 so that its internal pressure decreases with time after expansion (from the completion of expansion), and the internal pressure after 60 minutes after expansion is 20 to 70% of the initial internal pressure. It is configured to be ˜60%. Here, the “initial internal pressure” refers to a pressure at the time when 10 seconds have elapsed after the balloon 5 is expanded to such an extent that a compression force suitable for hemostasis is obtained.

  With such a configuration, the compression force by the balloon 5 is moderated (over and short) moderately over time, and coupled with the effect of the opening 22 described above, adverse effects caused by the continued high compression force, such as puncture sites and It is possible to effectively prevent numbness, pain, poor circulation (blood vessel obstruction), and the like on the peripheral side. In particular, the decrease in the internal pressure of the balloon 5 occurs naturally without a doctor or nurse or the like performing any operation (for example, a decompression operation such as loosening a valve or an evacuation operation). Therefore, the trouble (complexity) by performing such operation is avoided.

  If the internal pressure after 60 minutes after balloon expansion is more than 70% of the initial internal pressure, the rate of decrease of the internal pressure of the balloon 5 is small, and the compression force (internal pressure) when expanded is maintained as it is. There is little effect to avoid the harmful effects of maintaining high pressure.

  Further, if the internal pressure after 60 minutes has passed after balloon expansion is less than 20% of the initial internal pressure, the rate of decrease of the internal pressure of the balloon 5 is too large, and the compression force of the balloon 5 decreases before the hemostasis is sufficiently achieved. There is a risk of blood leaking from the puncture site 510.

  Specific examples of the configuration for obtaining a decrease in the internal pressure of the balloon 5 over time include the following examples (A to F).

  A. As the material for the band 2 and / or the balloon 5, a material that is flexible and can be easily deformed (elongated) is used.

  Due to the internal pressure and repulsive force of the expanded balloon 5, all or a part of the band 2 and / or the balloon 5 is gradually deformed so as to conform to the shape of the puncture site 510 and the bean-like bone 530. The internal pressure is reduced, and the pressing force on the puncture site 510 is relieved. That is, the degree of reduction of the compression force to the puncture site is controlled by the physical properties (tensile elastic modulus, thickness, elongation rate, etc.) of the constituent material of the band 2 and / or the balloon 5.

Specifically, the tensile modulus of the band member 2, preferably 10 gf / mm ² or less, more preferably 2~9gf / mm ^2.

  Further, the elongation rate of the band 2 after 180 minutes has passed after the balloon expansion is preferably 1 to 7%, more preferably 3 to 6%.

  In the vicinity of the opening 22 of the band 2, the width of the band 2 is substantially reduced and the strength is reduced. Therefore, the elongation rate is further increased in this portion. Therefore, the compression force with respect to the periphery of the bean-like bone 530 (near the outer peripheral portion of the opening 22) is further relaxed.

  B. The gas permeability of the balloon 5 is controlled. As a result, the gas in the balloon 5 permeates the sheet material of the balloon 5 and is gradually dissipated to the outside, the internal pressure of the balloon 5 gradually decreases, and the pressing force on the puncture site is alleviated.

  C. The gas permeability of the auxiliary balloon 6 communicating with the balloon 5 is controlled. Thereby, the gas in the auxiliary balloon 6 permeates through the sheet material of the auxiliary balloon 6 and is gradually dissipated to the outside, and the internal pressure of the auxiliary balloon 6 and the balloon 5 communicating with the auxiliary balloon 6 gradually decreases, thereby compressing the puncture site. Power is eased.

  D. The gas permeability of the tube 71 and / or the bag body 72 communicating with the balloon 5 is controlled. Thereby, the gas in the balloon 5 permeates the tube 71 and / or the bag body 72 and is gradually dissipated to the outside, the internal pressure of the balloon 5 is gradually reduced, and the compression force on the puncture site is alleviated.

E. The check valve incorporated in the connector 73 is not completely effective in preventing the gas backflow, and a small amount of gas leaks from the check valve. Thereby, a small amount of gas in the balloon 5 is discharged to the outside through the check valve built in the connector 73, the internal pressure of the balloon 5 is gradually reduced, and the pressure on the puncture site is alleviated.
F. Any two or more combinations of A to E.

  According to the methods A to F as described above, there is an advantage that control (decrease with time) of the internal pressure of the balloon 5 can be achieved with a simple configuration. In particular, according to the method A, it is possible to easily control the internal pressure of the balloon 5 by appropriately setting various conditions (for example, the shape and the opening area of the opening 22) such as the constituent materials and dimensions of the band 2 and the balloon 5. Is possible.

Next, an example of the action (usage method) of the hemostatic device 1 will be described.
[1] Before the hemostatic device 1 is attached to the wrist 500, the balloon 5 and the auxiliary balloon 6 are not expanded. In the case of the wrist 500, the puncture site 510 to the artery is usually at a position offset toward the thumb side inside the wrist 500 (the side where the tendon is present). In addition, a bean-like bone 530 is located at a position almost opposite to the puncture site 510 via the center portion 520 of the wrist 500.

  The band 2 is wrapped around the wrist 500 so that the balloon 5 is positioned on the puncture site 510 while pressing the puncture site (hemostatic site) 510 with a finger or the like, and the vicinity of both ends of the band 2 is wound around the hook-and-loop fastener 3. To fix (join). In this state, the protruding portion of the bean-like bone 530 is located in the vicinity of the opening 22 or in the opening 22.

  [2] When the hemostatic device 1 is attached to the wrist 500, a syringe (not shown) is connected to the connector 73 of the injection unit 7, and the fluid is injected into the balloon 5 and the auxiliary balloon 6 as described above. And the auxiliary balloon 6 is expanded. In the hemostatic device 1 of the present embodiment, the degree of expansion of the balloon 5 and the auxiliary balloon 6, that is, the compression force on the puncture site 510 is easily and appropriately adjusted according to the case and the like by the amount of fluid injected at this time. It can be used and has excellent operability.

  [3] When the balloon 5 and the auxiliary balloon 6 are expanded, the syringe is detached from the connector 73. Due to the effect of the check valve of the connector 73, the sudden leakage of fluid is prevented, whereby the balloon 5 and the auxiliary balloon 6 are maintained in the expanded state as much as necessary, and the compressed state to the puncture site 510 is maintained. (See FIG. 2). In this state, the balloon 5 locally presses the puncture site 510 (and its surroundings), and due to the expansion of the balloon 5 and the auxiliary balloon 6, the curved plate 4 is separated from the surface of the wrist 500 and applied to the wrist 500. It becomes difficult to touch. As a result, the puncture site 510 (and its surroundings) concentrates and receives a compressive force, so that the hemostasis effect is high and it is possible to avoid pressing other blood vessels or nerves that do not require hemostasis. It is possible to effectively prevent numbness or poor circulation.

  As the balloon 5 and the auxiliary balloon 6 are expanded, the tension acting on the band 2 gradually increases, and the inner surface of the band 2 opposite to the balloon 5 is in close contact with the outer surface of the wrist 500. At this time, the protruding portion of the bean-like bone 530 is inserted into the opening 22. Thereby, the compression force near the bean-like bone 530 is relieved, and numbness, pain, poor circulation and the like are effectively prevented.

  [4] The internal pressure of the balloon 5 gradually decreases from the time when the expansion is completed. For example, the internal pressure after 60 minutes from the expansion is about 20 to 70% of the initial internal pressure. Thereby, the compression force near the puncture site 510 and the bean-like bone 530 is relieved with time, and various adverse effects due to the persistence of the high compression force, such as numbness, pain, and poor blood circulation, can be prevented.

  The hemostatic device 1 is removed from the wrist 500 when it is determined that the hemostasis has been sufficiently achieved. The time from the completion of the expansion of the balloon 5 to the removal of the hemostatic device 1 (the hemostatic device mounting time) is not particularly limited, and can be, for example, about 150 to 360 minutes. The hemostatic device wearing time can be appropriately selected according to patient cases, individual differences, and the like.

<Second Embodiment>
FIG. 3 is a bottom view showing a second embodiment of the hemostasis device of the present invention (a state in which the inner surface side can be seen when worn on the wrist).

  Hereinafter, the second embodiment of the hemostatic device of the present invention will be described with reference to this figure, but the description will focus on the differences from the first embodiment described above, and the description of the same matters will be omitted.

  In the hemostatic device 1 of the first embodiment, the opening 22 is provided in a portion corresponding to the bean bone 530 of the band 2 in the mounted state. However, in the hemostatic device 1 of the second embodiment, the opening is provided in the portion. Instead of 22, a plurality of slits 23 are provided, and other configurations are the same as in the first embodiment.

  As shown in FIG. 3, the slits 23 are arranged obliquely, in parallel, and at substantially equal intervals with respect to the longitudinal direction of the band 2. In the configuration of FIG. 3, the region 230 in which the slits 23 are formed in the band 2 is substantially rectangular (rectangular), but the shape of the region 230 is a polygon such as a circle, an ellipse, a hexagon, and an octagon. Any shape may be used. Further, the number of slits 23 is not particularly limited.

  When the bean bone 530 comes into contact with the region 230 where such a slit 23 is formed in the state where the hemostatic device 1 is mounted, the slit 23 opens (the narrow portion between the slits 23 extends and separates), and the region 230 easily deforms to follow the protruding shape of the bean-like bone 530. That is, the region 230 has a raised shape. Therefore, similarly to the opening 22 described above, an increase in the tension of the band body 2 is alleviated and the compression force is reduced. As a result, numbness, pain, poor circulation, and the like can be prevented or alleviated.

<Third Embodiment>
FIG. 4 is a bottom view showing a third embodiment of the hemostatic device of the present invention (a state in which the inner surface side can be seen when worn on the wrist).

  Hereinafter, the third embodiment of the hemostatic device of the present invention will be described with reference to this figure, but the description will focus on the differences from the first embodiment described above, and description of similar matters will be omitted.

  In the hemostatic device 1 of the first embodiment, the opening 22 is provided in a portion corresponding to the bean bone 530 of the band 2 in the mounted state. However, in the hemostatic device 1 of the third embodiment, the opening is provided in the portion. Instead of 22, a plurality of slits 24 are provided, and other configurations are the same as those of the first embodiment.

  As shown in FIG. 4, the slits 24 are arranged radially from the central portion at substantially equal angular intervals. In the configuration of FIG. 4, the region 240 in which the slit 24 is formed in the band 2 is substantially circular, but the shape of the region 230 may be any shape such as an ellipse, a quadrangle, a hexagon, an octagon, or the like. Shape may be sufficient. Further, the number of slits 24 is not particularly limited.

  When the bean bone 530 comes into contact with the region 240 where the slit 24 is formed in the state where the hemostatic device 1 is mounted, the slit 24 opens (the wedge-shaped portion between the slits 24 is deformed and separated so as to be turned up). ), The region 240 is easily deformed to follow the protruding shape of the bean-like bone 530. That is, the region 240 has a raised shape. Therefore, similarly to the opening 22 described above, an increase in the tension of the band body 2 is alleviated and the compression force is reduced. As a result, numbness, pain, poor circulation, and the like can be prevented or alleviated.

<Fourth embodiment>
FIG. 5 is a bottom view showing the fourth embodiment of the hemostatic device of the present invention (a state in which the inner surface side can be seen when worn on the wrist), and FIG. 7 is an enlarged perspective view showing the structure in the vicinity of the pad of the hemostatic device shown in FIG. FIG.

  Hereinafter, the fourth embodiment of the hemostatic device of the present invention will be described with reference to these drawings. However, the difference from the first embodiment described above will be mainly described, and the description of the same matters will be omitted.

  In the hemostatic device 1 of the fourth embodiment, a ring-shaped pad 8 is provided (fixed) at a site corresponding to the bean-like bone 530 of the band 2 in the mounted state.

  The pad 8 has a cushioning function (cushion function), and examples of the constituent material thereof include polyvinyl chloride, polyethylene, polypropylene, polybutadiene, polyolefin such as ethylene-vinyl acetate copolymer (EVA), polyethylene, and the like. Various thermoplastic elastomers such as polyesters such as terephthalate (PET) and polybutylene terephthalate (PBT), polyvinylidene chloride, silicone, polyurethane, polyamide elastomer, polyurethane elastomer, polyester elastomer, or any combination thereof (blend resin) , Polymer alloys, laminates, etc.).

  When the hemostatic device 1 is attached, the bean bone 530 is inserted into the internal space 81 of the pad 8, that is, the pad 8 is used so as to surround the bean bone 530. As a result, the bean-like bone 530 is not directly crimped to the band body 2 or has a smaller crimping force even if it is crimped. Therefore, the compression force is reduced, and numbness, pain, poor blood circulation, and the like are prevented. Or it can be relaxed.

<Fifth Embodiment>
FIG. 6 is a bottom view showing the fifth embodiment of the hemostatic device of the present invention (a state in which the inner surface side can be seen when worn on the wrist), and FIG. 8 is an enlarged perspective view showing the structure in the vicinity of the pad of the hemostatic device shown in FIG. FIG.

  Hereinafter, the fifth embodiment of the hemostatic device of the present invention will be described with reference to these drawings. However, the difference from the first embodiment described above will be mainly described, and the description of the same matters will be omitted.

  In the hemostatic device 1 according to the fifth embodiment, a pair of pads 9 arranged substantially in parallel is provided (fixed) at a portion corresponding to the bean-like bone 530 of the band 2 in the mounted state.

  The pad 9 has a buffer function (cushion function), and can be made of the same material as the pad 8.

  In the mounted state of the hemostatic device 1, the bean bone 530 is inserted into the gap 91 between the pads 9, that is, used to surround (pinch) the bean bone 530 with both pads 9. As a result, the bean-like bone 530 is not directly crimped to the band body 2 or has a smaller crimping force even if it is crimped. Therefore, the compression force is reduced, and numbness, pain, poor blood circulation, and the like are prevented. Or it can be relaxed.

  The shape of the pad is not limited to that shown in FIGS. 7 and 8. For example, a U-shaped pad 93 as shown in FIG. 9 or a plate shape as shown in FIG. The pad 94 may be of any shape.

  In the case of the plate-like (flat plate-like) pad 94 shown in FIG. 10, the thickness may be uniform, but the thickness of the central portion 95 is thinner than that of the outer peripheral portion, that is, It is preferable that the central portion 95 has a recessed shape. As a result, the pad 94 abuts so as to wrap the bean-like bone 530 and can more uniformly disperse the pressure-bonding force to the bean-like bone 530, so that numbness, pain, poor circulation, etc. can be more effectively prevented or Can be relaxed.

  The hemostatic device of the present invention has been described above with respect to each illustrated embodiment. However, the present invention is not limited to these embodiments, and each component constituting the hemostatic device has any configuration that can exhibit the same function. Can be substituted for Moreover, arbitrary components may be added.

  Moreover, the hemostatic device of the present invention is applied to a hemostatic device that is used by being worn on a wrist, as well as being worn on a part other than the wrist, such as an arm and a leg (collectively referred to as “limbs”). can do.

It is a bottom view which shows 1st Embodiment of the hemostatic device of this invention (state which can see the inner surface side when it mounts | wears with a wrist). It is sectional drawing which shows the use condition of the hemostatic device shown in FIG. It is a bottom view which shows 2nd Embodiment of the hemostatic device of this invention (state which can see the inner surface side when it mounts | wears with a wrist). It is a bottom view which shows 3rd Embodiment of the hemostatic device of this invention (state which can see the inner surface side when mounted | worn on a wrist). It is a bottom view (state which can see the inner surface side when wearing on a wrist) which shows a 4th embodiment of a hemostatic device of the present invention. It is a bottom view which shows 5th Embodiment of the hemostatic device of this invention (state which can see the inner surface side when mounted | worn on a wrist). It is an expansion perspective view which shows the structure of the pad vicinity of the hemostatic device shown in FIG. It is an expansion perspective view which shows the structure of the pad vicinity of the hemostatic device shown in FIG. It is an expansion perspective view which shows the other structure of the pad in the hemostatic device of this invention. It is an expansion perspective view which shows the other structure of the pad in the hemostatic device of this invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Hemostatic instrument 11 Connection part 12 Communication part 2 Band 21 Curved board holding part 22 Opening 23 Slit 230 Area 24 Slit 240 Area 3 Surface fastener 31 Male side 32 Female side 4 Curved plate 41 Central part 42 Curved part 5 Balloon 6 Auxiliary balloon 7 Injection portion 71 Tube 72 Bag body 73 Connector 8 Pad 81 Internal space 9 Pad 91 Gap 93 Pad 94 Pad 95 Central portion 500 Wrist 510 Puncture site 520 Center portion 530 Bean bone

Claims (11)

A flexible band that wraps around the wrist to be hemostatic,
Fixing means for fixing the belt in a state of being wound around the wrist;
A hemostatic device connected to the band and comprising a balloon that expands by injecting fluid;
The band body, the portion corresponding to Mamejo bone when wound around the wrist, have a opening,
After the hemostatic device is attached to the wrist and the balloon is expanded, the compression force by the balloon is configured to decrease over time,
The hemostatic device according to claim 1, wherein the time-dependent decrease in the compression force by the balloon is caused by the band body extending over time . A flexible band that wraps around the wrist to be hemostatic,
Fixing means for fixing the belt in a state of being wound around the wrist;
A hemostatic device connected to the band and comprising a balloon that expands by injecting fluid;
The band body, the portion corresponding to Mamejo bone when wound around the wrist, have a plurality of slits,
After the hemostatic device is attached to the wrist and the balloon is expanded, the compression force by the balloon is configured to decrease over time,
The hemostatic device according to claim 1, wherein the time-dependent decrease in the compression force by the balloon is caused by the band body extending over time .   The opening area of the opening is 0.5 to 8 cm. ² The hemostatic device according to claim 1.   The hemostatic device according to claim 2, wherein each of the slits is disposed obliquely and parallel to the longitudinal direction of the band.   The hemostatic device according to claim 2, wherein each of the slits is radially arranged from a central portion of a portion corresponding to the bean-like bone at substantially equal angular intervals. The balloon, after expansion, the internal pressure is decreased over time, the internal pressure after the lapse of 60 minutes after expansion, claims 1 and is configured to be 20 to 70% of the initial internal pressure in any of 5 The described hemostatic device. The hemostatic device according to any one of claims 1 to 6, wherein a tensile elastic modulus of the band is 10 gf / mm ² or less. The hemostatic device according to any one of claims 1 to 7 , wherein an elongation rate of the band after 180 minutes from the balloon expansion is 1 to 7%. The hemostatic device according to any one of claims 1 to 8, further comprising a curved plate that is installed so as to overlap with the balloon and at least a part of which is curved toward the inner peripheral side. The hemostatic device according to claim 9 , further comprising a pressing member that is installed between the curved plate and the balloon so that at least a part thereof overlaps the balloon and presses the balloon. The hemostatic device according to claim 10 , wherein the pressing member includes an auxiliary balloon that presses the balloon by the pressure of a fluid filled therein.

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