JP2019058498A - Tourniquet instrument - Google Patents

Abstract

To provide a tourniquet device capable of reducing discomfort of a patient without increasing workload of an operator or inhibiting medical practice performed at the periphery.SOLUTION: A tourniquet device 10 includes: a belt body 21 to be wound around a puncture site P of a wrist W; a fixing member 30 for fixing, with the belt body wound around the wrist; an expansion member 40 disposed at an inner peripheral surface side of the belt body, with the belt body wound around the limb; a film-like valve member 60 disposed at the expansion member and including a communication passage 63 for communicating an inner space of the expansion member with the outside; and an injection member 70 capable of introducing fluid via the communication passage to the inner space of the expansion member. A communication passage 63a outside the expansion member is formed shorter than a communication passage 63b of the inner space of the expansion member. In a state where the expansion member is expanded and the injection member is removed from the film-like valve member, the film-like valve member is deformed in a direction of closing the communication passage located at the inner space of the expansion member by an internal pressure T of the expansion member.SELECTED DRAWING: Figure 5A

Description

  The present invention relates to a hemostatic device for compressing a hemorrhage at a punctured site.

  In recent years, blood vessels such as arms and legs are punctured, an introducer sheath is introduced to the puncture site, and a medical device such as a catheter is delivered to the lesion through the lumen of the introducer sheath, and the lesion is percutaneously Diagnosis, treatment, etc. are performed. When such diagnosis and treatment are performed, the operator needs to stop the bleeding at the puncture site after removing the introducer sheath. In order to perform this hemostasis, a band for winding around an limb such as an arm or a leg, a fixing member for fixing the band in a wound state around the limb, and a fluid which is disposed on the inner circumferential surface side of the band Hemostatic devices are known that include an expansion member that expands by injecting a pill to compress the puncture site, and an injection member that is connected to the expansion member and introduces fluid to the expansion member (eg, The following Patent Document 1).

  In the hemostatic device described in Patent Document 1 below, the injection member is connected to the elongated tube connected to the expansion member, the bag body connected to the tube, the bag body and the check valve. And a built-in connector. In addition, the hemostatic device described in Patent Document 1 below is provided with injection member fixing means for fixing the injection member to the band.

  The operator connects a fluid source such as a syringe to the connector, and injects the fluid into the expansion member through the injection member. After the dilation member is expanded, the operator removes the fluid source from the injection member. By removing the fluid supply from the injection member, the non-return valve built into the connector of the injection member is closed to prevent the fluid in the expansion member from flowing out. After removing the fluid source, the operator can ensure that the injection member does not interfere with the medical procedures performed around the hemostatic device and that the injection member does not touch the patient's limbs and the patient feels uncomfortable. The injection member fixing means fix the injection member to the band.

JP, 2012-40114, A

  However, in the hemostatic device described in Patent Document 1, after the operator removes the fluid supply source, it is further necessary to perform an operation of fixing the injection member to the band. Therefore, the workload of the operator increases.

  The present invention has been made to solve the above-mentioned problems, and it is possible to reduce the patient's discomfort without inhibiting the medical practice performed in the vicinity without increasing the workload of the operator. It aims at providing a hemostatic device.

  A hemostatic device for achieving the above object comprises: a band for winding around a portion of the limb where hemostasis is to be performed, a fixing member for fixing the band in a state of being wound around the limb, and the band being wound around the limb An expansion member disposed on the inner peripheral surface side of the band, and a film-like valve member provided in the expansion member, the film-like valve member including a communication passage disposed in the expansion member and communicating the inside space of the expansion member with the outside; And an injection member capable of introducing a fluid into the expansion member of the expansion member via the communication passage, the communication passage outside the expansion member being the communication passage empty of the expansion member. The film-like valve member is formed by the internal pressure of the expansion member in a state in which the expansion member is expanded and the injection member is removed from the film-like valve member. Of the communication passage located in the interior of the Jill deformed in the direction.

  According to the hemostatic device configured as described above, the film-like valve member is expanded by the internal pressure of the expansion member with the expansion member expanded and the injection member removed from the film-like valve member. It deforms in the direction to close the empty communication passage. Therefore, in a state where the injection member is removed from the film-like valve member, the film-like valve member can suppress the leakage of the fluid in the expansion member to the outside, and the expansion member can maintain the expanded state. As described above, since the injection member is removed from the film-like valve member, the injection member does not disturb the medical procedures performed in the vicinity, and does not touch the patient's limb, thereby reducing the patient's discomfort. Further, the film-like valve member is configured such that the communication passage on the outside of the expansion member is shorter than the communication passage on the inner side of the expansion member. Therefore, the film-like valve member has a relatively short portion exposed to the outside of the expansion member. Therefore, the film-like valve member does not inhibit the medical practice performed in the vicinity, and it is difficult to touch the patient's limbs, and the patient's discomfort can be reduced. As described above, the hemostatic device according to the present invention prevents medical operations performed in the vicinity without increasing the workload of the operator by the simple operation that the operator removes the injection member from the film-like valve member. And, the discomfort of the patient can be reduced.

It is the top view which looked at the hemostatic tool which concerns on embodiment from the inner surface side. FIG. 2 is a cross-sectional view taken along line 2-2 of FIG. It is an expansion perspective view showing a film-like valve member of a hemostatic device concerning an embodiment. It is a perspective view which shows the state which wears | wears the wrist with the hemostatic tool which concerns on embodiment, and inject | pours a fluid into an expansion member. It is sectional drawing in alignment with the 5A-5A line of FIG. It is a figure which shows the state which stopped injection | pouring of the fluid from the state of FIG. 5A. It is a figure which shows the state which removed the injection | pouring member from the film-like valve member from the state of FIG. 5B. It is sectional drawing in alignment with line 6-6 in FIG. It is a figure where it uses for description of the dimension of the injection | pouring member. It is a figure which shows the hemostatic tool which concerns on the modification 1, Comprising: It is a figure corresponding to FIG. 5A of embodiment. It is a figure which shows the state which removed the injection | pouring member from the film-like valve member from the state of FIG. 8A. It is a figure which shows the hemostatic tool which concerns on the modification 2, Comprising: It is a figure corresponding to FIG. 7 of embodiment. It is a figure which shows the state which removed the injection | pouring member from the film-like valve member from the state of FIG. 9A.

  A hemostatic device according to an embodiment of the present invention and a modification thereof will be described below with reference to the attached drawings. The following description does not limit the technical scope or the meaning of terms described in the claims. Also, the dimensional proportions of the drawings are exaggerated for the convenience of the description, and may differ from the actual proportions.

  FIG. 1 and FIG. 2 are diagrams for explaining the overall configuration of the hemostatic device 10 according to the embodiment. 3 to 7 are diagrams for describing the configuration of each part of the hemostatic device 10. The hemostatic device 10 according to the embodiment will be described below.

  The hemostatic device 10 is, as shown in FIG. 6, a radial artery R of a wrist W (corresponding to “limb”) by introducing a catheter from a radial artery R to perform diagnosis and treatment (TRI: Trans Radial Intervention) It is used for hemostasis at the puncture site P (corresponding to "the site to be controlled for hemostasis) formed in R.

  The hemostatic device 10 is, as generally described, shown in FIG. 1, a band 21 for winding around the wrist W, a support plate 22 formed of a material harder than the band 21, and the band 21 on the wrist W In order to align the expansion member 40 and the expansion member 40 with the puncture site P, the expansion member 40 which expands by injecting the gas (corresponding to “fluid”) and fixes the fixing member 30 fixed in a wound state, and the expansion member 40. A film-like valve member 60 provided with a communication passage 63 communicating the inner space of the expansion member 40 with the outside, and an injection member 70 for introducing a gas into the expansion member 40 via the communication passage 63; Have.

  Hereinafter, each part of the hemostatic device 10 will be described. In the present specification, when the band 21 is wound around the wrist W, the side (mounting surface side) of the band 21 facing the body surface of the wrist W is referred to as the “inner side” and the opposite side is It is called "outside side". Further, as shown in FIG. 1, the extending direction of the film-like valve member 60 is referred to as “longitudinal direction Y”. Further, in the longitudinal direction Y, the expansion member 40 side is referred to as “distal end side Y1”, and the opposite side is referred to as “proximal side Y2”.

(Obi)
The band 21 is constituted by a flexible belt-like member.

  The band 21 is wound so as to go around the outer circumference of the wrist W substantially as shown in FIG. A support plate holding portion 21 a for holding a support plate 22 described later is formed at a central portion of the band 21. In the support plate holding portion 21a, separate strip-like members are fused (heat fusion, high frequency fusion, ultrasonic fusion, etc.) or adhesion (adhesion or adhesion by solvent) on the outer surface side (or inner surface side) Bonding by a method holds the support plate 22 which is doubled and inserted in these gaps. However, the method in which the band 21 holds the support plate 22 is not particularly limited. For example, the band 21 may hold the support plate 22 by bonding the support plate 22 to a substantially central portion of the band 21. Also, for example, the band 21 may hold the support plate 22 by attaching the end of the band 21 to each of both ends of the support plate 22.

  The constituent material of the band 21 is not particularly limited as long as it has flexibility. Such materials are not particularly limited, and examples thereof include polyvinyl chloride, polyethylene, polypropylene, polybutadiene, polyolefin such as ethylene-vinyl acetate copolymer (EVA), polyethylene terephthalate (PET), and polybutylene terephthalate (PBT). ), Polyesters such as polyvinylidene chloride, silicones, polyurethanes, polyamide elastomers, polyurethane elastomers, polyester elastomers, etc., or combinations of any of these (blend resins, polymer alloys, laminates etc.) Be

  The portion of the band 21 at least overlapping with the expanding member 40 is preferably substantially transparent, but is not limited to being transparent, and may be translucent or colored and transparent. As a result, the operator (corresponding to a “user”) can visually recognize the puncture site P from the outer surface side in a state where the band 21 is wound around the patient's wrist W, and the marker 50 can be easily attached to the puncture site P Can be aligned.

(Support plate)
The support plate 22 has a long shape in the longitudinal direction of the band 21 as shown in FIG. The central portion 22 a in the longitudinal direction of the support plate 22 is flat and hardly curved. On both sides of the central portion 22a, first curved portions 22b (left side in FIG. 2) and a second curved toward the inner surface and along the longitudinal direction of the band 21 (the circumferential direction of the wrist W) A curved portion 22c (right side in FIG. 2) is formed. The support plate 22 is made of a material harder than the band 21 and is designed to maintain a substantially constant shape. The support plate 22 only needs to have a shape in which at least a portion thereof curves toward the inner peripheral side, and does not have a flat plate-like portion like the central portion 22a, and is curved over the entire length It may be

  The constituent material of the support plate 22 is not particularly limited as long as the material is harder than the band 21. Such materials are not particularly limited, and, for example, acrylic resin, polyvinyl chloride (especially hard polyvinyl chloride), polyethylene, polypropylene, polyolefin such as polybutadiene, polystyrene, poly- (4-methylpentene-1) , Polycarbonate, ABS resin, polymethyl methacrylate (PMMA), polyacetal, polyacrylate, polyacrylonitrile, polyvinylidene fluoride, ionomer, acrylonitrile-butadiene-styrene copolymer, polyethylene terephthalate (PET), polybutylene terephthalate (PBT), etc. Polyesters, butadiene-styrene copolymers, aromatic or aliphatic polyamides, fluorocarbon resins such as polytetrafluoroethylene, and the like.

  The support plate 22 is preferably substantially transparent in the portion overlapping with the expansion member 40 like the band 21, but is not limited to transparent and may be translucent or colored transparent. Thereby, in a state where the band 21 is wound around the wrist W, the operator can reliably visually recognize the puncture site P from the outer surface side, and the marker 50 can be easily aligned with the puncture site P.

(Fixing member)
In the present embodiment, the fixing member 30 is configured by a surface fastener (for example, a hook and loop fastener known as a general product such as VELCRO (registered trademark) or Velcro (registered trademark) in Japan).

  The fixing member 30 has a male side (or a female side) 31 of the surface fastener attached to the outer surface side of a portion near the left end in FIG. 1 of the band 21 and a portion near the right end in FIG. The female side (or male side) 32 of the surface fastener attached to the inner side. As shown in FIG. 6, the operator can attach the hemostatic device 10 to the wrist W by winding the band 21 around the patient's wrist W and joining the male side 31 and the female side 32. The configuration of the fixing member 30 is not particularly limited as long as it can be fixed in a state in which the band 21 is wound around the wrist W. The fixing member 30 may be constituted by, for example, a snap, a button, a clip, or a frame member through which the end of the band 21 passes.

(Expansion member)
As shown in FIG. 2 and FIG. 6, the expansion member 40 is expanded by the injection of a gas to compress the puncture site P, the first expansion member 41, the first expansion member 41 and the band 21. And a second expansion member 42 for adjusting the direction of the compression force F1 applied to the wrist W by the first expansion member 41. Hereinafter, each part of the expansion member 40 will be described.

  First, the first expansion member 41 will be described.

  In the present embodiment, the first expansion member 41 is configured by a bag body in which two flexible sheet materials are stacked and the peripheral portions of the two sheet materials are joined by a method such as fusion or adhesion. doing. An inner space 41a into which a gas is injected is formed between the two sheet materials. However, the first expansion member 41 is not particularly limited as long as it can be expanded by the injection of a gas, and for example, one flexible sheet is folded back to fuse or bond the edges to each other. You may comprise by the bag body joined by methods, such as one. Further, as shown in FIG. 1, in the present embodiment, the first expansion member 41 has a substantially rectangular outer shape when viewed in a plan view in a non-expanded state. However, the external shape of the first expandable member 41 in the non-expanded state is not particularly limited, and may be, for example, a circular shape, an elliptical shape, or a polygonal shape.

  Each of the two sheet members constituting the first expansion member 41 has a projecting portion 41 b in which a part of the peripheral edge protrudes outward in a plan view. As shown in FIG. 3, a film-like valve member 60 is disposed between the projecting portions 41 b of the two sheet members. Each of the protrusions 41 b is airtightly joined to the outer surface of the film-like valve member 60 by a method such as fusion or adhesion. Thus, the gas injected into the first expansion member 41 can be prevented from leaking from between the first expansion member 41 and the film-like valve member 60 to the outside. In addition, the 1st expansion member 41 does not need to be equipped with the protrusion part 41b.

  As shown in FIG. 2, the first expansion member 41 is positioned to overlap with the vicinity between the first curved portion 22 b and the central portion 22 a. The first expansion member 41 is connected to the band 21 by bonding one side 41c of its peripheral portion to the band 21 by a method such as fusion bonding or adhesion.

  The constituent material of the first expansion member 41 is not particularly limited as long as it is a material having flexibility, and, for example, the same constituent material as that of the band 21 described above can be used. The first expansion member 41 is preferably made of the same or the same material as the band 21. Thereby, joining of the band body 21 and the 1st expansion member 41 by fusion | fusion can be performed easily, and the hemostatic tool 10 can be manufactured easily.

  The first expanding member 41 is preferably substantially transparent, but is not limited to being transparent, and may be translucent or colored and transparent. Thereby, the operator can visually recognize the puncture site P from the outer surface side in the state where the band 21 is wound around the wrist W, and the marker 50 can be easily aligned with the puncture site P.

  Next, the second expansion member 42 will be described.

  Similar to the first expansion member 41, the second expansion member 42 is constituted by a flexible bag. The bag body is formed with an inner space 42a into which a gas can be injected. As shown in FIG. 1, in the present embodiment, the second expansion member 42 has a rectangular outer shape when viewed in plan in an unexpanded state. However, the external shape of the second expandable member 42 in the non-expanded state is not particularly limited, and may be, for example, a round shape, an elliptical shape, or a polygonal shape.

  The second expansion member 42 is located between the band 21 and the first expansion member 41 so as to overlap the first curved portion 22 b of the support plate 22 as shown in FIG. 2. As shown in FIG. 5A, the second expandable member 42 is joined to the first expandable member 41 by a method such as fusion or adhesion. A communication passage 42b is provided at the junction of the second expansion member 42 and the first expansion member 41. The communication path 42b communicates the internal space 41a of the first expansion member 41 and the internal space 42a of the second expansion member 42. Therefore, part of the gas injected into the inner space 41a of the first expansion member 41 is directed to the inner space 42a of the second expansion member 42 (in the figure, the flow of the gas is indicated by a broken arrow), and the first expansion is performed. The second expanding member 42 is also expanded along with the member 41. The expanded second expansion member 42 applies a pressing force F2 to the first expansion member 41 as shown in FIG. 6, and the direction of the compression force F1 applied to the wrist W by the first expansion member 41 is the puncture site P Adjust in the direction towards

  The constituent material of the second expansion member 42 is not particularly limited as long as it is a material having flexibility, like the first expansion member 41, and for example, the same constituent material as the above-described band 21 is used Can. It is preferable that the second expansion member 42 use the same material as the first expansion member 41. Thereby, joining of the 1st expansion member 41 and the 2nd expansion member 42 by fusion | fusion can be performed easily, and the hemostatic device 10 can be manufactured easily.

(marker)
As shown in FIG. 2, the marker 50 is provided at substantially the center of the outer surface of the first expansion member 41 on the side facing the band 21. The operator can suppress the positional deviation of the first expansion member 41 with respect to the puncture site P by aligning the marker 50 with the puncture site P. In addition, since the marker 50 is provided on the side of the first expansion member 41 facing the band 21 in the present embodiment, the marker 50 does not directly contact the puncture site P. The position where the marker 50 is provided is not particularly limited as long as the first expansion member 41 can be aligned with the puncture site P. For example, the marker 50 may be provided substantially at the center of the inner surface of the first expansion member 41 on the side disposed on the wrist W side. Also, for example, the marker 50 may be provided at the end of the outer surface of the second expansion member 42 closer to the center of the first expansion member 41.

  The shape of the marker 50 is not particularly limited, and may be, for example, a circle, a triangle, a square or the like, and in the present embodiment, it is a square.

  Although the size of the marker 50 is not particularly limited, for example, when the shape of the marker 50 is a quadrangle, it is preferable that the length of one side is in the range of 1 to 4 mm. When the length of one side is 5 mm or more, the size of the marker 50 is larger than the size of the puncture site P, so that it is difficult to align the central portion of the first expansion member 41 with the puncture site P.

  The material of the marker 50 is not particularly limited, and examples thereof include an oil-based colorant such as ink, and a resin obtained by kneading a pigment.

  The color of the marker 50 is not particularly limited as long as the expansion member 40 can be aligned with the puncture site P, but a green color is preferable. By making it green, the operator can easily visually recognize the marker 50 on blood and skin, and it becomes easier to align the first expansion member 41 with the puncture site P.

  Moreover, it is preferable that the marker 50 is semitransparent or colored transparent. Thereby, the operator can visually recognize the puncture site P from the outer surface side of the marker 50.

  Although the method of providing the marker 50 on the expansion member 40 is not particularly limited, for example, a method of printing the marker 50 on the expansion member 40, a method of applying an adhesive on one side of the marker 50 and attaching it to the expansion member 40 may be mentioned. .

(Film-like valve member)
As shown in FIG. 3, in the present embodiment, the film-like valve member 60 is a stack of two rectangular film members 61 and 62 (sheet members having flexibility), and two sheets The film members 61 and 62 are formed by joining a part of two edges extending in the longitudinal direction Y of the film members 61 and 62. The edges of the two film members 61 and 62 in the direction intersecting the longitudinal direction Y are not joined, and openings 60 a and 60 b are formed between the edges in the direction intersecting the longitudinal direction Y. ing. Further, between the two film members 61 and 62, a communication passage 63 is formed, which communicates one opening 60a with the other opening 60b. As described above, since the film-like valve member 60 is configured by stacking the two film members 61 and 62, as shown in FIG. 5B and FIG. 5C, the internal pressure T of the expanded expansion member 40 It easily deforms in the direction in which the communication path 63 is closed (the direction in which the two film members 61 and 62 approach each other) and adheres to each other. In addition, the film-like valve member 60 is not what laminated | stacked the film members 61 and 62 of 2 sheets, but folded the film member of 1 sheet, and joined the edge parts of the longitudinal direction Y of 1 film member which folded back It may be configured by ones.

  As shown in FIG. 3, in the film-like valve member 60, one opening 60 a is disposed in the inner space 41 a of the first expansion member 41, and the other opening 60 b is disposed outside the first expansion member 41. As shown, a portion thereof is inserted into the inner space 41 a of the first expansion member 41. Therefore, the communication passage 63 communicates the inside air 41 a of the first expansion member 41 with the outside.

  As shown in FIG. 5A, the communication passage 63 is a communication passage 63a located outside the first expansion member 41 (hereinafter simply referred to as "the communication passage 63a outside the expansion member 40"), and the first expansion member 41. And a communication passage 63b (hereinafter simply referred to as "the communication passage 63b in the expansion member 40") located inside the The length L1 of the communication passage 63a outside the expansion member 40 is shorter than the length L2 of the hollow communication passage 63b inside the expansion member 40. Therefore, the length along the longitudinal direction Y of the portion of the film-like valve member 60 exposed from the expansion member 40 is relatively short. Therefore, as shown in FIG. 5C, the film-like valve member 60 does not inhibit the medical practice performed in the vicinity, and it is difficult to contact the patient's wrist W, which can reduce the patient's discomfort.

  In the film-like valve member 60, in the present embodiment, as shown in FIG. 3, two film members 61 and 62 are joined to the area of the tip end side Y1 of the two edges extending in the longitudinal direction Y The joint portions 60c and 60d are provided, and non-joint portions 60e and 60f in which the two film members 61 and 62 are not joined are provided in the region of the proximal end side Y2. Therefore, the portions on the base end side Y2 of the two film members 61 and 62 can be deformed in directions away from each other, and the opening 60b on the base end side Y2 can be opened. Therefore, the injection member 70 is easily inserted from the opening 60 b of the proximal end side Y 2 of the film-like valve member 60. The film-like valve member 60 may not include the non-joining portions 60e and 60f, and the edge extending in the longitudinal direction Y may be joined along the entire length. When the edges of the two film members 61 and 62 in the longitudinal direction Y are joined along the entire length, the film-like valve member 60 has the opening 60b on the proximal end Y2 at the proximal end Y2 of the protrusion 41b. All of which may be disposed within the first expanding member 41 so as to overlap the edges of the. That is, the length L1 of the communication passage 63a outside the expansion member 40 may be zero.

  The film members 61 and 62 are not particularly limited, and for example, flexible plastic sheets such as vinyl chloride, polyethylene, polystyrene, ethylene-vinyl acetate copolymer and the like can be used.

(Injection member)
The injection member 70 is attached to the tube 71 disposed in the communication passage 63 of the film-like valve member 60 and the proximal end Y2 of the tube 71 as shown in FIG. And the hollow connector 72 which can be connected. The injection member 70 will be described below. In the state where the injection member 70 is removed from the hemostatic device 10, the injection member 70 refers to the connector 72 side as the “proximal end side”, and on the opposite side (from the end of the tube 71, The side not attached is referred to as "tip side".

  First, the tube 71 will be described.

  As shown in FIG. 3, the tube 71 has a cylindrical main body portion 71a having a substantially constant outer diameter, and a cylindrical tapered portion 71b which is continuous with the tip end of the main body portion 71a and which tapers toward the tip end side Y1. Have. As described above, since the tube 71 includes the tapered portion 71 b, the tube 71 can be easily inserted into the film-like valve member 60. The tube 71 may not have the tapered portion 71 b and may have a substantially constant outer diameter over the entire length thereof.

  The outer diameter R1 of the main body portion 71a is not particularly limited as long as it can be disposed in the communication passage 63. However, the outer diameter R1 of the main body 71a is, as shown in FIG. 7, from the viewpoint of suppressing the leakage of the gas in the expansion member 40 to the outside from the gap between the tube 71 and the film-like valve member 60. When the portion forming the communication passage 63 of the film-like valve member 60 is deformed into a substantially circular shape, the length may be substantially the same as the radial length R2 of the inner surface of the film-like valve member 60. Is preferred.

  As shown in FIG. 1, the tube 71 is disposed in the communication passage 63 in a state where the expansion member 40 is not expanded. That is, at the stage of providing the hemostatic device 10 to the operator, the tube 71 is disposed in the communication passage 63. Therefore, when the operator starts using the hemostatic device 10, there is no need to arrange the tube 71 in the communication passage 63 (insert the tube 71 into the film-like valve member 60). Therefore, the hemostatic device 10 can reduce the work load on the operator.

  As shown in FIG. 5A, in the state where the tip of the tube 71 is disposed at the position Y2 on the base end side Y2 of the tip of the communication path 63 (the opening 60a on the tip side Y1), The valve member 60 is fixed. Thereby, as shown in FIG. 5B, at the time when the expanding member 40 is expanded and the operator stops injecting the gas by the syringe S, the distal end side Y1 of the film-like valve member 60 is the expanding member 40. The internal communication passage 63b of the expansion member 40 is deformed in the closing direction by the internal pressure T. Therefore, the operator need not adjust the position of the distal end of the tube 71 in the communication passage 63 when injecting the gas into the expansion member 40. Further, the tip of the tube 71 protrudes from the tip of the film-like valve member 60 to the tip side Y1 (the tip of the tube 71 protrudes from the opening 60a of the tip side Y1) between the film-like valve member 60 and the tube 71 The gas in the expansion member 40 can be prevented from leaking to the outside from the gap of

  The fixing portion 71 c releases the fixed state of the injection member 70 and the film-like valve member as the operator pulls the injection member 70 to the proximal end Y2. The configuration of the fixing portion 71 c is not particularly limited. For example, the fixing portion 71 c may be configured by a joint portion in which the tube 71 and the film-like valve member 60 are adhered or fused. You may comprise by the mechanical connection part. The tube 71 does not have to be fixed to the film-like valve member 60, and the operator may insert the tube 71 into the film-like valve member 60 when the use of the hemostatic device 10 is started. Moreover, when fixing the tube 71 to the film-like valve member 60, the position of the tip of the tube 71 is not particularly limited. For example, the tip of the tube 71 may be disposed closer to the tip Y 1 than the tip of the film-like valve member 60.

  Next, the connector 72 will be described.

  The connector 72 is connected to the tip of the syringe S, as shown in FIG. The method of connecting the connector 72 to the tip of the syringe S is not particularly limited, but the inner diameter of the connector 72 and the outer diameter of the tip of the syringe S are set to substantially the same length, and the connector 72 is used as the tip of the syringe S Use a method of fitting, a method of providing a female screw on the inner peripheral surface of the connector 72, providing a male screw on the outer peripheral surface of the distal end of the syringe S, and screwing the connector 72 to the distal end of the syringe S it can. Preferably, the connector 72 is attachable to and detachable from the tip of the syringe S. Also, the fluid source used in combination with the hemostatic device 10 need not be the syringe S, but may be, for example, a cuff.

(how to use)
Next, a usage example of the hemostatic device 10 according to the present embodiment will be described.

  Before attaching the hemostatic device 10 to the wrist W, as shown in FIG. 2, the expansion member 40 is in a non-expanded state. At this time, the injection member 70 is disposed in the communication passage 63 as shown in FIG. Therefore, the operator does not have to insert the injection member 70 into the film-like valve member 60 when starting use of the hemostatic device 10. Therefore, the hemostatic device 10 can reduce the work load on the operator.

  As shown in FIG. 4, when the radial artery R of the wrist W of the right hand is punctured, the puncture site P is at a position offset to the thumb side. Usually, an introducer sheath (not shown) is placed at the puncture site P. The band 21 is wound around the wrist W with the introducer sheath left in place, and the expansion member 40 and the band 21 are aligned so that the markers 50 provided on the expansion member 40 overlap the puncture site P. Then, the male side 31 and the female side 32 of the surface fastener are brought into contact and joined, and the band 21 is attached to the wrist W.

  At this time, the hemostatic device 10 is attached to the wrist W such that the injection member 70 faces the downstream side (palm side) of the blood flow of the radial artery R. Thereby, the operation of the injection member 70 and the syringe S can be performed without interfering with the procedure on the upstream side of the wrist W or a device (for example, a sphygmomanometer or the like) located on the upstream side. Also, by mounting the hemostatic device 10 on the wrist W of the right hand so that the injection member 70 faces downstream, the first expansion member 41 is positioned in the radial artery R located on the thumb side of the wrist W . In the case of an artery, the upstream side of a blood vessel means a direction in which the blood vessel approaches the heart. Further, the downstream side of the blood vessel means a direction of moving away from the heart of the blood vessel. The hemostatic device 10 may be used when puncturing the radial artery in the wrist of the left hand. In this case, the injection member 70 is attached to the wrist of the left hand so as to face the blood flow of the radial artery upstream.

  Next, the operator connects the syringe S to the connector 72 of the injection member 70. The operator may connect the syringe S to the connector 72 of the injection member 70 before attaching the hemostatic device 10 to the wrist W.

  Next, as shown in FIG. 5A, the operator pushes the pusher of the syringe S to inject gas into the expanding member 40 to expand the expanding member 40. The operator expands the expanding member 40 to such an extent that bleeding from the puncture site P can be prevented, and then removes the introducer sheath from the puncture site P.

  Next, the operator pushes the pusher of the syringe S and further injects a gas into the expansion member 40 to expand the expansion member 40 to such an extent that the puncture site P can be compressed and stopped. As a result, as shown in FIG. 5B, the film-like valve member 60 is deformed in the direction to close the communication passage 63b in the expansion member 40 by the internal pressure T of the expansion member 40 (in the present embodiment, two sheets of The portion on the tip side Y1 of the film members 61 and 62 is in close contact). The operator can easily adjust the expansion degree of the expansion member 40, that is, the magnitude of the compression force F1 acting on the puncture site P, by adjusting the gas injection amount according to the case. . For example, if the operator excessively injects gas into the expansion member 40 and the expansion member 40 is overexpanded, the syringe S may be used to discharge excess gas from the inside of the expansion member 40.

  Next, the operator removes the injection member 70 from the film-like valve member 60 as shown in FIG. 5C. Since the film-like valve member 60 is deformed in the direction to close the communication passage 63 b in the expansion member 40, the expansion state of the expansion member 40 can be maintained. As described above, since the injection member 70 is removed from the film-like valve member 60, the injection member 70 does not disturb the medical practice performed in the vicinity, and does not touch the patient's wrist W, so Pleasure can be reduced. Further, in the film-like valve member 60, the communication passage 63 a outside the expansion member 40 is configured to be shorter than the communication passage 63 b empty inside the expansion member 40. Therefore, the film-like valve member 60 does not inhibit the medical practice performed in the vicinity, and it is difficult to touch the patient's wrist W, and the patient's discomfort can be reduced. Further, since the operator only needs to remove the injection member 70, the workload on the operator does not increase.

  Next, the operator inserts the injection member 70 to which the syringe S is connected into the film-like valve member 60 in stages, and exhausts the gas in the expansion member 40 to the outside (decompression operation). Thereby, for example, the dilation member 40 can continue to compress the puncture site P and the blood vessels and nerves around the puncture site P for a long time to prevent the patient from feeling numbness or pain or occluding the blood vessels. .

  If hemostasis is not sufficiently performed, the operator inserts the injection member 70 to which the syringe S is connected into the film-like valve member 60, injects a gas into the expansion member 40, and the expansion member 40. Internal pressure may be increased.

  After the predetermined time has passed and the hemostasis at the puncture site P is completed, the operator removes the hemostatic device 10 from the wrist W of the patient. The hemostatic device 10 is removed from the wrist W by peeling the male side 31 and the female side 32 of the surface fastener.

  As described above, the hemostatic device 10 includes the band 21 for winding around the puncture site P of the wrist W, the fixing member 30 for fixing the band 21 in the state of being wound around the wrist W, and the band 21 In the state of being wound around W, the expansion member 40 disposed on the inner peripheral surface side of the band 21 and the communication passage 63 disposed on the expansion member 40 and communicating the inner spaces 41 a and 42 a of the expansion member 40 with the outside. And an injection member 70 capable of introducing a gas into the inner spaces 41 a and 42 a of the expansion member 40 via the communication passage 63. The communication passage 63 a on the outside of the expansion member 40 is shorter than the communication passage 63 b on the inner side of the expansion member 40. With the expansion member 40 expanded and the injection member 70 removed from the film-like valve member 60, the film-like valve member 60 is driven by the internal pressure T of the expansion member 40 and the communication passage 63 b in the hollow of the expansion member 40. Transform in the closing direction.

  According to the hemostatic device 10 configured as described above, the internal pressure of the film-like valve member 60 is expanded with the expansion member 40 expanded and the injection member 70 removed from the film-like valve member 60. By T, the inner empty communication passage 63b of the expansion member 40 is deformed in the closing direction. Therefore, in a state where the injection member 70 is removed from the film-like valve member 60, the film-like valve member 60 can suppress the gas inside the expansion member 40 from leaking to the outside, and the expansion member 40 can maintain the expanded state. . As described above, since the injection member 70 is removed from the film-like valve member 60, it does not inhibit the medical practice performed in the vicinity, and the patient's discomfort can be reduced because the patient's limbs are not touched. In addition, the film-like valve member 60 is configured such that the communication passage 63 a outside the expansion member 40 is shorter than the communication passage 63 b empty inside the expansion member 40. Therefore, the film-like valve member 60 has a relatively short portion exposed to the outside of the expansion member 40. Therefore, the film-like valve member 60 does not inhibit the medical practice performed in the vicinity, and it is difficult to touch the patient's limbs, and the patient's discomfort can be reduced. As described above, the hemostatic device 10 does not cause an increase in the operation load of the operator by the simple operation that the operator withdraws the injection member 70 from the film-like valve member 60, so that the hemostatic device 10 And the patient's discomfort can be reduced.

  The injection member 70 is disposed in the communication passage 63 in a state where the expansion member 40 is not expanded. That is, at the stage of providing the hemostatic device 10 to the operator, the injection member 70 is disposed in the communication passage 63. Therefore, the operator does not have to perform the operation of arranging the injection member 70 in the communication passage 63 when the use of the hemostatic device 10 is started. Therefore, the hemostatic device 10 can reduce the work load on the operator.

  Further, the injection member 70 is fixed to the film-like valve member 60 in a state in which the front end of the injection member 70 is disposed at the position Y2 on the proximal end side of the front end of the communication passage 63. Therefore, when the expansion of the expansion member 40 is completed and the operator stops injecting the gas by the syringe S, the distal end side Y1 of the film-like valve member 60 is expanded by the internal pressure T of the expansion member 40. It deform | transforms in the direction to close the communication path 63b of 40 inside. Therefore, when the operator injects the gas into the expansion member 40, the tip of the injection member 70 protrudes to the tip side more than the tip of the film-like valve member 60, and from the gap between the film-like valve member 60 and the injection member 70 It is possible to prevent the gas in the expansion member 40 from leaking to the outside.

  In addition, the injection member 70 is provided with a connector 72 to which a syringe S for supplying gas to the injection member 70 can be connected to the proximal end Y2. Therefore, the injection member 70 can be easily connected to the syringe S.

  In addition, the injection member 70 is provided with a tapered portion 71b that is tapered toward the front end side of the injection member 70 at a portion on the front end side Y1. Therefore, the injection member 70 can be easily disposed in the communication passage 63.

(Modification 1)
8A and 8B are views showing a hemostatic device 110 according to the first modification. Hereinafter, the same components as those in the above-described embodiment are denoted by the same reference numerals, and the description thereof will be omitted.

  When the film-like valve member 60 is deformed in the direction to close the communication passage 63b of the expansion member 40 due to the internal pressure T of the expansion member 40, the hemostatic device 110 according to the first modification The hemostatic device according to the embodiment is different from the hemostatic device according to the above-described embodiment in that the pressure reducing mechanism 180 is provided in communication with the outside to gradually discharge the gas in the expansion member 40 to the outside.

  The pressure reducing mechanism 180 is configured of an open-cell foam that extends from the distal end of the communication passage 63 toward the proximal end. Therefore, when the film-like valve member 60 is deformed in the direction to close the communication passage 63b in the expansion member 40, the gas in the expansion member 40 is gradually discharged to the outside through the open cells (voids) of the decompression mechanism 180. (The flow of gas is indicated by a broken arrow in the figure). Thus, the gas within the expansion member 40 is automatically discharged to the outside even if the operator does not perform the decompression operation, so the hemostatic device 110 can further reduce the workload of the operator.

  The pressure reducing mechanism 180 is joined to one of the two film members 61 and 62 that constitute the film-like valve member 60.

  The constituent material of the pressure reducing mechanism 180 is not particularly limited as long as it is an open-cell foam, but, for example, an open-cell polyurethane foam, polystyrene foam, polyolefin foam or the like can be used.

  As described above, when the film-like valve member 60 is deformed by the internal pressure T of the expansion member 40 in the direction to close the communication passage 63 b located inside the expansion member 40, the hemostatic device 110 according to the first modification The pressure reducing mechanism 180 is further provided, which communicates the inside air of the expansion member 40 with the outside, and gradually discharges the gas in the expansion member 40 to the outside. Thus, the gas within the expansion member 40 is automatically discharged to the outside even if the operator does not perform the decompression operation, so the hemostatic device 110 can further reduce the workload of the operator.

  The decompression mechanism 180 also includes an open-cell foam member disposed in the communication passage 63. Therefore, the gas in the expansion member 40 can be gradually discharged to the outside through the open cells of the foam member.

(Modification 2)
9A and 9B show a hemostatic device 210 according to a second modification. Hereinafter, the same components as those in the above-described embodiment are denoted by the same reference numerals, and the description thereof will be omitted.

  The hemostatic device 210 according to the second modification is different from the decompression device 180 of the hemostatic device 110 of the first modification in the configuration of the decompression mechanism 280.

  The pressure reducing mechanism 280 is constituted by grooves 281 and 282 provided on the inner surfaces of the two film members 61 and 62 constituting the film-like valve member 60. The grooves 281 and 282 extend from the tip end of the film members 61 and 62 toward the base end. The decompression mechanism 280 may have at least one groove, and for example, the groove may be one or three or more.

  As shown in FIG. 9B, after the operator expands the expansion member 40, the operator removes the injection member 70 from the film-like valve member 60. As a result, the film-like valve member 60 is deformed in the closing direction of the communication passage 63 by the internal pressure T of the expansion member 40. The gas in the expanding member 40 is gradually discharged to the outside of the expanding member 40 through the grooves 281, 282. Since the gas in the expansion member 40 is automatically exhausted to the outside even if the operator does not perform the decompression operation, the hemostatic device 210 can further reduce the operator's work load.

  As described above, in the hemostatic device 210 according to the second modification, the pressure reducing mechanism 280 includes the groove portions 281 and 282 formed along the communication passage 63 on the inner surface of the film-like valve member 60. Therefore, the gas in the expansion member 40 can be gradually discharged through the grooves 281 and 282.

  Although the hemostatic device according to the present invention has been described above through the embodiment and the modification, the present invention is not limited to only the described configurations, and can be appropriately modified based on the description of the claims. It is.

  For example, each part which comprises a hemostatic tool can be substituted by the thing of arbitrary structures which can exhibit the same function. Also, any component may be added.

  Further, the present invention is not limited to the hemostatic device used by being attached to the wrist, and can be applied to the hemostatic device by being attached to and using a leg or the like.

  Also, the film-like valve member may be disposed not on the first expansion member but on the second expansion member.

  In addition, the expansion member may not include the second expansion member. Moreover, the expansion member may be equipped with a pressing member that pushes the first expansion member without expanding instead of the second expansion member.

10, 110, 210 Hemostatic devices,
21 bands,
30 fixed members,
40 expansion members,
60 film-like valve members,
63 communication channels,
63a communication passage outside the extension member,
63b communication passage inside the expansion member,
70 injection members,
71b taper part,
71c fixed part,
72 connectors,
180, 280 decompression mechanism,
281, 282 grooves,
P puncture site (site to be controlled),
T internal pressure of the expansion member,
W Wrist (limb).

Claims (8)

A band for winding around the area of the limb where hemostasis is to be performed,
A fixing member for fixing the band in a state of being wound around the limb;
An expanding member disposed on an inner circumferential surface side of the band in a state where the band is wound around the limb;
A film-like valve member disposed in the expansion member, the film-like valve member including a communication passage communicating the inside space of the expansion member with the outside;
An injection member capable of introducing a fluid into the interior of the expansion member via the communication passage;
The communication passage outside the expansion member is formed shorter than the communication passage empty in the expansion member,
With the expansion member expanded and the injection member removed from the film-like valve member, the film-like valve member is positioned in the hollow of the expansion member by the internal pressure of the expansion member. A hemostatic device that deforms in the direction of closing the communication passage.   The hemostatic device according to claim 1, wherein the injection member is disposed in the communication passage when the expansion member is not expanded. And a fixing portion configured to fix the injection member to the film-like valve member in a state where the front end of the injection member is disposed at a position proximal to the front end of the communication passage,
The hemostatic device according to claim 2, wherein the fixing portion releases the fixed state of the injection member and the film-like valve member in accordance with an operation of the user pulling the injection member.   The hemostatic device according to any one of claims 1 to 3, wherein the injection member comprises, at a proximal portion thereof, a connector to which a fluid source for supplying a fluid to the injection member can be connected.   The hemostatic device according to any one of claims 1 to 4, wherein the injection member is provided with a tapered portion which is tapered toward the distal end side of the injection member at a distal end portion thereof.   When the film-like valve member is deformed in a direction to close the communication passage located in the hollow of the expansion member by the internal pressure of the expansion member, the inside and the outside of the expansion member communicate with each other. The hemostatic device according to any one of claims 1 to 5, further comprising a decompression mechanism that gradually discharges the fluid in the expansion member to the outside.   The hemostatic device according to claim 6, wherein the decompression mechanism comprises an open-cell foam disposed in the communication passage.   The hemostatic device according to claim 6, wherein the decompression mechanism comprises a groove formed along the communication passage on an inner surface of the film-like valve member.