Hemostatic devices

Abstract

To provide a hemostatic device capable of preventing a gas from remaining in a balloon when a liquid is injected into the balloon.SOLUTION: A hemostatic device 10 comprises a balloon 40, a belt 21 (equivalent to "a belt body"), and a discharge part 70. The balloon has a lumen 40a to inject a liquid therein, is configured to compress a puncture site P formed at a patient, and is expandable and contractable. The balloon is fixed to the wrist W with the belt. The discharge part is disposed at the balloon to discharge a gas in the balloon to the outside of the balloon with injection of the liquid into a lumen.SELECTED DRAWING: Figure 4

Description

Technical Field

[0001] The present invention relates to a hemostatic device for compressing a punctured site to stop bleeding.

Background Art

[0002] In recent years, percutaneous treatments and examinations have been performed, such as puncturing blood vessels in the arms or legs, introducing an introducer sheath into the punctured site, and delivering medical devices such as catheters to the lesion through the lumen of the introducer sheath. When performing such treatments and examinations, the operator needs to stop bleeding at the punctured site after removing the introducer sheath. To stop bleeding, there is known a hemostatic device including a band for winding around a limb such as an arm or a leg, a fixing means for fixing the band in a state of being wound around the limb, and a balloon which is connected to the band and expands by injecting a fluid to compress the punctured site.

[0003] In such a hemostatic device, if the expanded balloon continuously compresses the punctured site and the surrounding blood vessels and nerves for a long time, it may cause numbness or pain, or occlude the blood vessels. To prevent blood vessel occlusion and the like, generally, after expanding the balloon, a doctor or a nurse regularly connects a dedicated instrument such as a syringe to the hemostatic device, discharges the fluid in the balloon, and performs a decompression operation to reduce the internal pressure of the balloon, thereby reducing the compressive force acting on the punctured site over time.

[0004] On the other hand, the hemostatic device according to Patent Document 1 below discloses expanding the balloon with a liquid (such as water) having ultrasonic characteristics and disposing a liquid (such as water) having ultrasonic characteristics in the balloon. For this reason, it is configured to transmit ultrasonic waves irradiated from an ultrasonic probe to living tissue and allow the ultrasonic waves to pass through. Thereby, an ultrasonic image of the blood vessel puncture site can be generated.

Prior Art Documents

Patent Documents

[0005] [Patent Document 1] U.S. Patent Application Publication No. 2019 / 0274692 [Overview of the project] [Problems that the invention aims to solve]

[0006] The propagation of ultrasound is greatly influenced by the difference in acoustic impedance (density × speed of sound) between the propagation mediums. When liquid is injected into a balloon, gas remains in the balloon. Because gas has a significantly different acoustic impedance from the soft tissues in the body, the ultrasound is almost entirely reflected at the interface and does not propagate further. Therefore, there is a risk that an ultrasound image of the vascular puncture site may not be obtainable.

[0007] Patent Document 1 does not disclose a solution to the problems that arise when liquid is injected into a balloon.

[0008] The present invention was made to solve the above problems and aims to provide a hemostatic device that can prevent gas from remaining inside a balloon when liquid is injected into the balloon. [Means for solving the problem]

[0009] Hemostatic device according to the present invention One aspect The device comprises an expandable and deflated balloon having a lumen into which a liquid is injected and configured to compress a puncture site formed in the patient, a band for securing the balloon to a part of the patient's body, and the balloon Distributed to It is provided with a discharge section that discharges the gas inside the balloon to the outside of the balloon as the liquid is injected into the lumen. The discharge portion is composed of a porous member that constitutes at least a part of one side of the balloon that is located on the side that is in contact with the body and the other side that is located on the opposite side, and the porous member is composed of a member that allows the passage of the gas and restricts the passage of the liquid. Another embodiment of the hemostatic device according to the present invention comprises an expandable and contractible balloon having a lumen into which a liquid is injected and configured to compress a puncture site formed in a patient; a band for securing the balloon to a part of the patient's body; and a discharge section positioned on the balloon for discharging gas from the balloon to the outside of the balloon as the liquid is injected into the lumen. The band is made of a material less elastic than the balloon and is connected to the balloon at a position where one surface of the balloon that is in contact with the body and the other surface that is opposite to the one surface extend, in which case the discharge section is positioned in a region of the balloon that does not overlap with the band. A further embodiment of the hemostatic device according to the present invention comprises an expandable and contractible balloon having a lumen into which a liquid is injected and configured to compress a puncture site formed in a patient; a band for securing the balloon to a part of the patient's body; and a discharge portion disposed on the balloon for discharging gas from the balloon to the outside of the balloon as the liquid is injected into the lumen. The hemostatic device further comprises a support plate made of a material harder than the balloon and disposed on the other side of the balloon opposite to one side that is in contact with the body, the band being connected to the support plate, the balloon being connected to the support plate on the other side, the support plate having a window that exposes a part of the other side of the balloon, and the discharge portion being positioned to overlap the window in the plane direction of the balloon in which the one side and the other side expand. [Effects of the Invention]

[0010] According to the hemostatic device of the present invention, a balloon is fixed to a part of the patient's body by a band, and when liquid is injected into the lumen of the balloon, the expanded balloon compresses the puncture site. As liquid is injected into the lumen of the balloon, the gas inside the balloon is discharged to the outside of the balloon by a discharge port. Therefore, when liquid is injected into the balloon, it is possible to prevent gas from remaining inside the balloon. Since no gas remains inside the balloon, for example, even when ultrasound is irradiated from an ultrasound probe toward the puncture site to confirm an ultrasound image, attenuation of the propagating ultrasound is less likely to occur. Therefore, the ultrasound image can be confirmed favorably, and based on the obtained ultrasound image, the occlusion state of the blood vessel located at the puncture site can be accurately confirmed. [Brief explanation of the drawing]

[0011] [Figure 1] This is a plan view of the hemostatic device according to the first embodiment, as seen from the inner side. [Figure 2] Figure 2(A) is a cross-sectional view illustrating the balloon configuration of the hemostatic device according to the first embodiment. Figure 2(A) is a cross-sectional view showing the state before liquid is injected into the balloon, and Figure 2(B) is a cross-sectional view showing the state after liquid has been injected into the balloon. [Figure 3] This is a perspective view showing the hemostatic device according to the first embodiment being worn on the wrist. [Figure 4] This is a cross-sectional view showing the balloon of the hemostatic device according to the first embodiment in an expanded state, and is a cross-sectional view along line 4-4 in Figure 3. [Figure 5] This is a plan view of the hemostatic device according to the second embodiment, seen from the inner side. [Figure 6] Figure 6(A) is a cross-sectional view illustrating the configuration of the balloon of the hemostatic device according to the second embodiment. Figure 6(A) is a cross-sectional view showing the state before liquid is injected into the balloon, and Figure 6(B) is a cross-sectional view showing the state after liquid has been injected into the balloon. [Figure 7] This is a perspective view showing the hemostatic device according to the second embodiment being worn on the wrist. [Figure 8]It is a cross-sectional view showing the state where the balloon of the hemostatic device according to the second embodiment is expanded, and is a cross-sectional view taken along line 8-8 of FIG. 7. [Figure 9] It is a plan view of the balloon and the support plate of the hemostatic device according to the second embodiment as viewed from the outer surface side. [Figure 10] It is a plan view of the balloon and the support plate of the hemostatic device according to Modification 1 of the second embodiment as viewed from the outer surface side, and is a plan view showing a state where the long axis of the ultrasonic probe is pressed against the balloon along the longitudinal direction of the support plate. [Figure 11] It is a plan view of the balloon and the support plate of the hemostatic device according to Modification 1 of the second embodiment as viewed from the outer surface side, and is a plan view showing a state where the long axis of the ultrasonic probe is pressed against the balloon along the width direction of the support plate. [Figure 12] It is a plan view of the balloon and the support plate of the hemostatic device according to Modification 2 of the second embodiment as viewed from the outer surface side, and is a plan view showing a state where the long axis of the ultrasonic probe is pressed against the balloon along the longitudinal direction of the support plate. [Figure 13] It is a plan view of the balloon and the support plate of the hemostatic device according to Modification 2 of the second embodiment as viewed from the outer surface side, and is a plan view showing a state where the long axis of the ultrasonic probe is pressed against the balloon along the width direction of the support plate. [Figure 14] It is a plan view of the balloon and the support plate of the hemostatic device according to Modification 3 of the second embodiment as viewed from the outer surface side. [Figure 15] It is a plan view of the balloon and the support plate of the hemostatic device according to Modification 4 of the second embodiment as viewed from the outer surface side. [Figure 16] It is a cross-sectional view for explaining the configuration of the balloon of the hemostatic device according to Modification 5 of the second embodiment, and is a cross-sectional view showing the state when liquid is injected into the balloon. [Figure 17] It is a cross-sectional view showing the hemostatic device according to Modification 5 of the second embodiment, and is a cross-sectional view of the main part showing an enlarged view of part A in FIG. 16. [Figure 18] It is a plan view of the balloon and the support plate of the hemostatic device according to Modification 5 of the second embodiment as viewed from the outer surface side.

Best Mode for Carrying Out the Invention

[0012] Hereinafter, embodiments of the present invention and modifications thereof will be described with reference to the attached drawings. Note that the following description does not limit the technical scope or the meaning of terms described in the claims. Also, the dimensional ratios in the drawings are exaggerated for convenience of explanation and may differ from the actual ratios.

[0013] <First Embodiment> Referring to FIGS. 1 to 4, a first embodiment of the present invention will be described.

[0014] FIGS. 1 and 2 are diagrams for explaining the configuration of each part of the hemostatic device 10 according to the first embodiment. FIGS. 3 and 4 are diagrams schematically showing an example of use of the hemostatic device 10.

[0015] As shown in FIGS. 3 and 4, the hemostatic device 10 according to the first embodiment is used to stop bleeding at the puncture site P formed in the radial artery R of the wrist W (corresponding to "a part of the patient's body") after removing the introducer sheath that had been placed at the puncture site P for the purpose of inserting a catheter or the like for performing treatment, examination, etc. into the blood vessel. Further, the hemostatic device 10 is configured to be able to obtain an ultrasonic image by the ultrasonic probe 80 (see FIG. 4). Based on the obtained ultrasonic image, the occlusion state (such as the blood vessel diameter) of the blood vessel located at the puncture site P can be confirmed.

[0016] As shown in FIGS. 1 and 2, the hemostatic device 10 includes a balloon 40, a belt 21 (corresponding to a "band"), and a discharge part 70. The balloon 40 has a lumen 40a into which a liquid is injected, is configured to compress the puncture site P formed in the patient, and is expandable and contractible. The balloon 40 is fixed to the wrist W by the belt 21. The discharge part 70 is disposed on the balloon 40 and discharges the gas in the balloon 40 to the outside of the balloon 40 as the liquid is injected into the lumen 40a.

[0017] The hemostatic device 10 further includes a hook-and-loop fastener 30 for securing the belt 21 to the wrist W, a marker 40c for aligning the balloon 40 to the puncture site P, and an injection section 60 for injecting liquid into the balloon 40.

[0018] In this specification, when the belt 21 is wrapped around the wrist W, the side of the wrist W facing the body surface (the attachment surface) is referred to as the "inner surface," and the opposite side is referred to as the "outer surface." Also, when the belt 21 is wrapped around the wrist W, the circumferential direction of the wrist W is referred to as the "longitudinal direction," and the direction intersecting the longitudinal direction is referred to as the "width direction."

[0019] As shown in Figures 1 and 4, belt 21 has a first belt 23 connected to one longitudinal end of balloon 40 (the left end in Figure 1) and a second belt 24 connected to the other longitudinal end of balloon 40 (the right end in Figure 1). Unless otherwise specified, the first belt 23 and the second belt 24 are collectively referred to as belt 21.

[0020] The belt 21 is made of a flexible, strip-shaped member. As shown in Figures 1, 3, and 4, the belt 21 is connected to the balloon 40 and wrapped around the outer circumference of the wrist W. The ends of the belt 21 are joined to the ends of the balloon 40 by methods such as fusion (heat fusion, high-frequency fusion, ultrasonic fusion, etc.) or adhesion (adhesion with adhesive or solvent) on the inner side.

[0021] On the outer surface of the first belt 23 near the left end in Figure 1, the male (or female) side 31 of the hook-and-loop fastener 30 is positioned, and on the inner surface of the second belt 24 near the right end in Figure 1, the female (or male) side 32 of the hook-and-loop fastener 30 is positioned. The hook-and-loop fastener 30 is a hook-and-loop fastener that is commonly known in Japan as a product such as VELCRO® or Velcro®. As shown in Figure 4, the belt 21 is wrapped around the wrist W, and the male side 31 and female side 32 are joined together to attach the belt 21 to the wrist W. Note that the means for fixing the belt 21 while it is wrapped around the wrist W is not limited to the hook-and-loop fastener 30; for example, a snap, button, clip, or a fixing member such as a frame member through which the end of the belt 21 passes may also be used.

[0022] The belt 21 is made of a material that is less elastic than the balloon 40. Furthermore, as shown in Figure 1, the belt 21 is connected to the balloon 40 at a position where it does not overlap with at least a portion of the balloon 40 in the planar direction. The discharge section 70 is located in the area of ​​the balloon 40 where the belt 21 does not overlap.

[0023] Since the elasticity of the belt 21 is lower than that of the balloon 40, the balloon 40 can be pressed against the outer circumference of the wrist W without creating any gaps. Therefore, an air layer is less likely to form between the balloon 40 and the outer circumference of the wrist W, and attenuation of ultrasound waves emitted from the ultrasound probe 80 is less likely to occur when generating ultrasound images. Furthermore, in positions where the balloon 40 does not overlap with the belt 21, there are no other members covering its outer surface. Therefore, the ultrasound probe 80 can be pressed directly against the outer surface of the balloon 40, and attenuation of ultrasound waves emitted from the ultrasound probe 80 is less likely to occur. The discharge section 70 is not covered on its outer surface by the belt 21. Therefore, the gas inside the balloon 40 is not left inside the balloon 40 but is discharged to the outside of the balloon 40 through the discharge section 70. Thus, by configuring it as described above, attenuation of ultrasound waves due to the presence of air or boundaries with other members is less likely to occur. Therefore, based on the obtained ultrasound image, the occlusion state of the blood vessel located at the puncture site P can be confirmed more accurately.

[0024] The constituent material of the belt 21 is not particularly limited as long as it is a flexible material. Examples of such materials include polyolefins such as polyvinyl chloride, polyethylene, polypropylene, polybutadiene, and ethylene-vinyl acetate copolymer (EVA), polyesters such as polyethylene terephthalate (PET) and polybutylene terephthalate (PBT), polyvinylidene chloride, silicone, polyurethane, polyamide elastomer, polyurethane elastomer, polyester elastomer, or any combination thereof (blended resin, polymer alloy, laminate, etc.).

[0025] The balloon 40 expands by injecting liquid, providing compression to the puncture site P. The balloon 40 also has a discharge section 70 that expels the gas inside the balloon 40 to the outside as liquid is injected into the lumen 40a. The liquid injected into the balloon 40 is not particularly limited as long as it can expand the balloon 40, but for example, water, saline solution, etc., can be used.

[0026] The temperature of the liquid injected into balloon 40 can be kept relatively cold. This helps to alleviate pain near the puncture site P.

[0027] As shown in Figures 1, 2(A)(B), and 4, the balloon 40 is constructed from a bag-like member made by overlapping two roughly rectangular sheets and bonding or heat-sealing (ultrasonic or laser) the edges. This forms a lumen 40a between the two sheets. In Figures 2(A)(B), the sheet shown on the upper side and located on the outer surface of the balloon 40 is referred to as the first sheet 47. In Figures 2(A)(B), the sheet shown on the lower side and located on the inner surface of the balloon 40 is referred to as the second sheet 48. In Figures 2(A)(B), reference numeral 49 indicates the joint where the first sheet 47 and the second sheet 48 are joined. In Figure 2(B), reference numeral 51 indicates the bubbles contained in the liquid inside the lumen 40a of the balloon 40, and reference numeral 52 indicates the gas discharged to the outside of the balloon 40 by the discharge section 70.

[0028] The discharge section 70 is composed of a porous member 71 that constitutes at least a portion of one side of the balloon 40 that is in contact with the body ("inner surface") and the other side that is opposite to it ("outer surface"). The porous member 71 is composed of a material that allows the passage of gas (e.g., air) and restricts the passage of liquid.

[0029] As liquid is injected into the lumen 40a of the balloon 40, the gas inside the balloon 40 is expelled to the outside of the balloon 40 by passing through the porous member 71. Furthermore, the passage of liquid inside the balloon 40 through the porous member 71 is restricted. Therefore, the compressive force on the puncture site P by the balloon 40 is not reduced, and gas is prevented from remaining inside the balloon 40. As a result, the occlusion state of the blood vessel located at the puncture site P can be more accurately confirmed based on the obtained ultrasound image without compromising hemostatic function.

[0030] In the first embodiment, the entire first sheet 47 is made of a porous member 71. The joint portion 49 of the first sheet 47 loses its function of allowing gas to pass through due to the processing (adhesion, heat fusion, etc.) that forms the joint portion 49. The balloon 40 is connected to the belt 21 at the end where the joint portion 49 is formed. Therefore, as shown in Figures 1 and 4, the discharge portion 70 is not covered on its outer surface by the belt 21.

[0031] The constituent materials of the porous member 71 are, for example, polyethylene, polyester, fluororesin (PTFE), etc.

[0032] The constituent material of the second sheet 48 in the balloon 40 is not particularly limited as long as it is a flexible material, and for example, the same material as the constituent material of the belt 21, such as polyvinyl chloride, can be used. Polyvinyl chloride is suitable for use as a constituent material of the second sheet 48 because its acoustic impedance is relatively close to that of biological tissue.

[0033] Preferably, at least a portion of the balloon 40 other than the portion made of the porous member 71 is made of a material with lower elasticity than the porous member 71.

[0034] In the first embodiment, the second sheet 48 in the balloon 40 is made of a material with lower elasticity than the porous member 71, such as polyvinyl chloride. In the balloon 40, the elongation of the discharge section 70, which is made of the porous member 71, is suppressed by the other parts. Therefore, the deterioration of the function of the porous member 71 due to elongation can be suppressed.

[0035] The discharge section 70 can be configured to discharge gas from the maximum expansion section 72, which is located at the position furthest from the patient's body on the balloon 40 when the balloon 40 is expanded.

[0036] Here, "the maximum expansion portion 72 located furthest from the patient's body" refers to the part that becomes the apex of the balloon 40 when it is expanded. With this configuration, any gas remaining in the balloon 40 accumulates in the maximum expansion portion 72, so the discharge portion 70 can discharge the gas from the balloon 40 most effectively from the maximum expansion portion 72 to the outside of the balloon 40. However, when using the hemostatic device 10, depending on how the wrist W is tilted, the maximum expansion portion 72 may not coincide with the apex of the balloon 40 in that position. However, the wrist W moves to some extent even during hemostasis. Furthermore, when checking the ultrasound image, the ultrasound probe 80 is moved. Therefore, as the wrist W moves and the ultrasound probe 80 is operated, any gas remaining in the balloon 40 accumulates in the maximum expansion portion 72, allowing the gas from the balloon 40 to be discharged to the outside of the balloon 40.

[0037] The external shape of the balloon 40 is not particularly limited. For example, when viewed from above, the balloon 40 may have an external shape such as a circle, an ellipse, or a polygon when not expanded.

[0038] The balloon 40 is preferably substantially transparent, but is not limited to transparent; it may be semi-transparent or colored transparent. This allows the puncture site P to be visible from the outside, and the marker 40c, described later, can be easily positioned at the puncture site P.

[0039] As shown in Figure 4, the marker 40c is provided approximately in the center of the outer surface of the balloon 40. By providing such a marker 40c on the balloon 40, the balloon 40 can be easily aligned with the puncture site P, thereby suppressing displacement of the balloon 40. The marker 40c may also be provided on the side of the balloon 40 facing the wrist W. In this case, it is preferable that the marker 40c be provided on the inner surface inside the balloon 40 so as not to come into direct contact with the puncture site P.

[0040] The shape of the marker 40c is not particularly limited and can be a circle, triangle, quadrilateral, etc., and in this embodiment it is a quadrilateral.

[0041] The size of the marker 40c is not particularly limited, but for example, if the shape of the marker 40c is rectangular, it is preferable that the length of one side is in the range of 1 to 4 mm. If the length of one side is 5 mm or more, the size of the marker 40c becomes large relative to the size of the puncture site P, making it difficult to align the center of the balloon 40 with the puncture site P.

[0042] The material of marker 40c is not particularly limited and includes, for example, oil-based colorants such as ink, resins mixed with pigments, etc.

[0043] The color of the marker 40c is not particularly limited as long as it is a color that allows the balloon 40 to be positioned at the puncture site P, but a green color is preferred. By using a green color, the marker 40c can be easily seen on the blood or skin, making it easier to position the balloon 40 at the puncture site P.

[0044] Furthermore, the marker 40c is preferably semi-transparent or colored transparent. This allows the puncture site P to be visible from the outer surface of the marker 40c.

[0045] The method for attaching the marker 40c to the balloon 40 is not particularly limited, but examples include printing the marker 40c onto the balloon 40, fusing the marker 40c to the balloon 40, or applying adhesive to one side of the marker 40c and attaching it to the balloon 40.

[0046] The injection section 60 is a part for injecting liquid into the balloon 40, and is connected to the balloon 40 as shown in Figure 1.

[0047] The injection section 60 includes a flexible tube 61 that communicates with the lumen 40a of the balloon 40, a tubular connector 63 connected to the tube 61 and containing a check valve (not shown), and a syringe 64 that can be connected to the connector 63. The syringe 64 is filled with liquid to be injected into the balloon 40. The position in the balloon 40 where the tube 61 is connected is not particularly limited, as long as the tube 61 communicates with the lumen 40a of the balloon 40.

[0048] To inflate (expand) the balloon 40, the tip of the syringe 64 is inserted into the connector 63 to open the check valve, and the plunger of the syringe 64 is pushed to inject the liquid inside the syringe 64 into the balloon 40 via the injection port 60. After the liquid has been injected into the balloon 40, when the tip of the syringe 64 is removed from the connector 63, the check valve built into the connector 63 closes, preventing liquid leakage.

[0049] Next, the method of using the hemostatic device 10 according to this embodiment will be described.

[0050] Before attaching the hemostatic device 10 to the wrist W, the balloon 40 is in a deflated state (see Figure 2(A)). An ultrasound-transmitting gel or similar material is applied between the inner surface of the balloon 40 and the wrist W. As shown in Figures 3 and 4, when puncturing the radial artery R in the right wrist W, the puncture site P is located off-center towards the thumb. Normally, an introducer sheath is placed at the puncture site P. The belt 21 is wrapped around the wrist W with the introducer sheath still in place, and the balloon 40 and belt 21 are aligned so that the marker 40c on the balloon 40 overlaps the puncture site P. The male side 31 and female side 32 of the hook-and-loop fastener 30 are brought into contact and joined, and the belt 21 is attached to the wrist W.

[0051] In this case, the hemostatic device 10 is attached to the wrist W such that the injection part 60 faces downstream (palmar side) of the blood flow in the radial artery R. This allows the injection part 60 to be operated without interference with procedures upstream of the wrist W or with instruments located upstream (e.g., blood pressure monitor). Furthermore, by attaching the hemostatic device 10 to the right wrist W with the injection part 60 facing downstream, the balloon 40 is positioned in the radial artery R, ​​which is located off-center towards the thumb side of the wrist W. In the case of arteries, the upstream side of a blood vessel refers to the direction of the blood vessel towards the heart, and the downstream side refers to the direction of the blood vessel away from the heart.

[0052] The hemostatic device 10 may also be used when puncturing the radial artery R in the left wrist W. In this case, the injection part 60 is attached to the left wrist W so as to face upstream of the blood flow in the radial artery R.

[0053] After attaching the hemostatic device 10 to the wrist W, a syringe 64 is connected to the connector 63 of the injection section 60, and the liquid is injected into the balloon 40 as described above, thereby expanding the balloon 40.

[0054] As shown in Figures 2(A) and 2(B), the discharge section 70 discharges the gas inside the balloon 40 to the outside of the balloon 40 as liquid is injected into the lumen 40a of the balloon 40. The gas inside the lumen 40a rises through the liquid as bubbles 51. The porous member 71 constituting the discharge section 70 has the function of allowing the passage of gas and restricting the passage of liquid. The gas inside the lumen 40a passes through the porous member 71 and is discharged to the outside. The gas 52 discharged to the outside diffuses into the atmosphere. Therefore, the lumen 40a of the balloon 40 is filled with liquid and no air is present.

[0055] An ultrasound-transmitting gel or similar material is applied to the outer surface of the balloon 40 and the ultrasound probe 80. As shown in Figure 4, the ultrasound probe 80 is pressed against the outer surface of the balloon 40, and ultrasound waves are irradiated from the ultrasound probe 80 toward the puncture site P.

[0056] The ultrasound probe 80 is in close contact with the first sheet 47 of the balloon 40, the lumen 40a of the balloon 40 is empty of air, and the second sheet 48 of the balloon 40 is in close contact with the wrist W. Therefore, the ultrasound emitted from the ultrasound probe 80 propagates through the first sheet 47, the liquid inside the balloon 40, the second sheet 48, and the biological tissue. The difference in acoustic impedance between the propagation media plays a significant role in the propagation of ultrasound. The hemostatic device 10 minimizes the interface between the propagation media as much as possible, making it difficult for the propagating ultrasound to attenuate. As a result, the ultrasound image can be viewed clearly, and based on the obtained ultrasound image, the occlusion state of the blood vessel located at the puncture site P can be accurately confirmed.

[0057] Because the occlusion of the blood vessel can be accurately confirmed based on ultrasound images, the degree of balloon 40 expansion, i.e., the compressive force acting on the puncture site P, can be easily and accurately adjusted according to the case. For example, if too much fluid is injected into the balloon 40 and it becomes over-expanded, the excess fluid can be drained from the balloon 40 using the syringe 64.

[0058] After inflating balloon 40, detach syringe 64 from connector 63. Then remove introducer sheath from puncture site P.

[0059] At appropriate intervals, the vascular condition based on the ultrasound images described above is checked. If, for example, hemostasis is not sufficiently achieved based on the vascular condition based on the ultrasound images, fluid is injected into balloon 40 to increase the internal pressure of balloon 40.

[0060] Once the prescribed time has elapsed and hemostasis at the puncture site P is complete, the hemostatic device 10 is removed from the wrist W. The hemostatic device 10 is removed from the wrist W by peeling off the male side 31 and female side 32 of the hook-and-loop fastener 30.

[0061] (Effects and Benefits) As described above, the hemostatic device 10 of the first embodiment includes a balloon 40, a belt 21, and a discharge unit 70. The balloon 40 has a lumen 40a into which liquid is injected, is configured to compress a puncture site P formed on the patient, and is expandable and deflated. The belt 21 secures the balloon 40 to a part of the patient's body. The discharge unit 70 is positioned on the balloon 40 and discharges the gas inside the balloon 40 to the outside of the balloon 40 as liquid is injected into the lumen 40a.

[0062] With the hemostatic device 10 configured as described above, the balloon 40 is fixed to a part of the patient's body by the belt 21, and when liquid is injected into the lumen 40a of the balloon 40, the expanded balloon 40 compresses the puncture site P. As liquid is injected into the lumen 40a of the balloon 40, the gas inside the balloon 40 is discharged to the outside of the balloon 40 by the discharge section 70. Therefore, when liquid is injected into the balloon 40, it is possible to prevent gas from remaining inside the balloon 40. Since no gas remains inside the balloon 40, even when ultrasound is irradiated from the ultrasound probe 80 toward the puncture site P to confirm the ultrasound image, attenuation of the propagating ultrasound is less likely to occur. Therefore, the ultrasound image can be confirmed favorably, and based on the obtained ultrasound image, the occlusion state of the blood vessel located at the puncture site P can be accurately confirmed.

[0063] Furthermore, the belt 21 is made of a material with lower elasticity than the balloon 40. In addition, it is connected to the balloon 40 at a position that does not overlap with at least a portion of the balloon 40 in the planar direction. The discharge section 70 is positioned in the area of ​​the balloon 40 where the belt 21 does not overlap. With this configuration, since the elasticity of the belt 21 is lower than that of the balloon 40, the balloon 40 can be pressed against the outer circumference of the wrist W without creating any gaps. Furthermore, in the position where the balloon 40 does not overlap with the belt 21, there are no other members covering its outer surface. The discharge section 70's outer surface is not covered by the belt 21. Therefore, attenuation of ultrasound due to the presence of air or boundaries with other members is less likely to occur. As a result, the occlusion state of the blood vessel located at the puncture site P can be confirmed more accurately based on the obtained ultrasound image.

[0064] Furthermore, the discharge section 70 is composed of a porous member 71 that constitutes at least a portion of one side of the balloon 40 that is located on the side that contacts the body and another side that is located on the opposite side. The porous member 71 is composed of a material that allows the passage of gas and restricts the passage of liquid. With this configuration, when liquid is injected into the lumen 40a of the balloon 40, the gas inside the balloon 40 is discharged to the outside of the balloon 40 by passing through the porous member 71. Also, the passage of liquid inside the balloon 40 is restricted from passing through the porous member 71. As a result, the compressive force of the balloon 40 on the puncture site P is not reduced, and gas does not remain inside the balloon 40. Therefore, the occlusion state of the blood vessel located at the puncture site P can be more accurately confirmed based on the obtained ultrasound image without reducing the hemostatic function.

[0065] Furthermore, at least a portion of the balloon 40 other than the part made of the porous member 71 is made of a material with lower elasticity than the porous member 71. With this configuration, the expansion of the discharge section 70 made of the porous member 71 is suppressed by the other parts of the balloon 40. Therefore, the deterioration of the function of the porous member 71 due to expansion can be suppressed.

[0066] Furthermore, the discharge unit 70 is configured to discharge gas from the maximum expansion portion 72, which is located at the position furthest from the patient's body on the balloon 40 when the balloon 40 is expanded. With this configuration, any gas remaining in the balloon 40 accumulates in the maximum expansion portion 72, so the discharge unit 70 can discharge the gas from the balloon 40 to the outside of the balloon 40 from the maximum expansion portion 72.

[0067] <Second Embodiment> Next, a second embodiment of the present invention will be described with reference to Figures 5 to 9. In the following description, redundant explanations of content already described will be omitted. Furthermore, content not specifically mentioned in the following description may be the same as that of the first embodiment.

[0068] The hemostatic device 10A according to the second embodiment differs from the first embodiment in that it has a support plate 90.

[0069] As shown in Figures 5 and 6, the hemostatic device 10A, similar to the first embodiment, includes a balloon 40, a belt 21, and a discharge section 70A.

[0070] The hemostatic device 10A further includes a support plate 90, as shown in Figures 5 to 9. The support plate 90 is made of a harder material than the balloon 40 and is positioned on the other side ("outer surface") of the balloon 40 opposite to the side ("inner surface") that is in contact with the body. The belt 21 is connected to the support plate 90. The balloon 40 is connected to the support plate 90 on the other side ("outer surface"). The support plate 90 has a window portion 91 that exposes a portion of the other side ("outer surface") of the balloon 40. The discharge portion 70A is positioned so as to overlap with the window portion 91 in the planar direction of the balloon 40.

[0071] The support plate 90 is harder than the balloon 40, positioned on the outer side of the balloon 40, and connected to the outer surface of the balloon 40. The belt 21 is connected to this support plate 90. As a result, the balloon 40 can be pressed against the outer circumference of the wrist W without any gaps. Therefore, an air layer is less likely to form between the balloon 40 and the outer circumference of the wrist W, and attenuation of the ultrasound waves emitted from the ultrasound probe 80 is less likely to occur when generating an ultrasound image. Furthermore, the support plate 90 has a window portion 91 that exposes a part of the outer surface of the balloon 40. As a result, at the position of the window portion 91 of the support plate 90, there are no other members covering the outer surface of the balloon 40. Therefore, the ultrasound probe 80 can be pressed directly against the outer surface of the balloon 40, and attenuation of the ultrasound waves emitted from the ultrasound probe 80 is less likely to occur. The discharge portion 70A is positioned to overlap with the window portion 91, and its outer surface is not covered by the support plate 90. Therefore, the gas inside the balloon 40 is not left inside the balloon 40 but is discharged to the outside of the balloon 40 through the discharge portion 70A. Therefore, by configuring the device as described above, attenuation of ultrasound due to the presence of air or boundaries with other components is less likely to occur. As a result, the occlusion state of the blood vessel located at the puncture site P can be confirmed more accurately based on the obtained ultrasound image. In addition, the gas discharged through the discharge section 70A does not accumulate between the outer surface of the balloon 40 and the inner surface of the support plate 90.

[0072] As shown in Figures 5, 8, and 9, the support plate 90 includes a first support plate 93 connected to one end of the balloon 40 in the longitudinal direction (the left end in Figure 5) and a second support plate 94 connected to the other end of the balloon 40 in the longitudinal direction (the right end in Figure 5). Unless otherwise specified, the first support plate 93 and the second support plate 94 are collectively referred to as the support plate 90.

[0073] As shown in Figures 5 to 9, the first support plate 93 and the second support plate 94 are spaced apart along their longitudinal direction. The space between the first support plate 93 and the second support plate 94 can be configured as a window portion 91. The form of the window portion 91 of the support plate 90 is not limited to this case. Modifications of the form of the window portion 91 will be described later (see Modification 3 in Figure 14 and Modification 4 in Figure 15).

[0074] As shown in Figure 8, the support plate 90 has a plate shape in which at least a portion is curved toward the inner side (mounting surface side). The support plate 90 is made of a harder material than the balloon 40 and is designed to maintain a nearly constant shape.

[0075] In Figure 8, the right end of the first support plate 93 has a first curved portion 93a that curves inward. The second support plate 94 has a long shape in the longitudinal direction. The central portion 94a of the second support plate 94 in the longitudinal direction is almost flat and not curved. In Figure 8, the left end of the second support plate 94 has a second curved portion 94b that curves inward. Note that the support plate 90 may not have a non-curved portion like the central portion 94a, that is, it may be curved along its entire length.

[0076] Examples of materials that make up the support plate 90 include acrylic resin, polyvinyl chloride (especially rigid polyvinyl chloride), polyethylene, polypropylene, polyolefins such as polybutadiene, polystyrene, poly-(4-methylpentene-1), polycarbonate, ABS resin, polymethyl methacrylate (PMMA), polyacetal, polyacrylate, polyacrylonitrile, polyvinylidene fluoride, ionomer, acrylonitrile-butadiene-styrene copolymer, polyester such as polyethylene terephthalate (PET) and polybutylene terephthalate (PBT), butadiene-styrene copolymer, aromatic or aliphatic polyamide, and fluororesins such as polytetrafluoroethylene.

[0077] The discharge section 70A, as in the first embodiment, is composed of a porous member 71 that constitutes at least a portion of one side of the balloon 40 that is in contact with the body ("inner surface") and the other side that is opposite to it ("outer surface"). The porous member 71 is composed of a material that allows the passage of gas (e.g., air) and restricts the passage of liquid.

[0078] As shown in Figures 6(A) and 6(B), in the second embodiment, the discharge section 70A is positioned to overlap with the window section 91. For this reason, a portion of the first sheet 47 is made of the porous material 71. The other portion of the first sheet 47 is made of, for example, polyvinyl chloride, similar to the second sheet 48. The balloon 40 is connected to the support plate 90 at the end where the joint 49 is formed and in areas where the discharge section 70A is not present. Therefore, as shown in Figures 5, 8, and 9, the outer surface of the discharge section 70A is not covered by the support plate 90. Region 92 in Figure 9 indicates the connection point between the balloon 40 and the support plate 90.

[0079] As shown in Figure 9, the area of ​​the discharge section 70A is larger than the contact area of ​​the ultrasonic probe 80. Therefore, when the ultrasonic probe 80 is pressed against the balloon 40, the ultrasonic probe 80 does not cover the entire area of ​​the discharge section 70A. A portion of the discharge section 70A remains exposed to the outside. Therefore, even when the ultrasonic probe 80 is pressed against the balloon 40, the gas inside the balloon 40 is discharged to the outside of the balloon 40 through the discharge section 70A.

[0080] As shown in Figures 5, 8, and 9, belt 21 includes a first belt 23 connected to the longitudinal end of the first support plate 93 (the left end in Figure 5) and a second belt 24 connected to the longitudinal end of the second support plate 94 (the right end in Figure 5). Unless otherwise specified, the first belt 23 and the second belt 24 are collectively referred to as belt 21.

[0081] The belt 21 is made of a flexible, strip-shaped member. As shown in Figures 5 to 9, the belt 21 is connected to the balloon 40 and wrapped around the outer circumference of the wrist W. The ends of the belt 21 are joined to the ends of the support plate 90 by methods such as fusion (heat fusion, high-frequency fusion, ultrasonic fusion, etc.) or adhesion (adhesion with adhesive or solvent) on the inner side.

[0082] The balloon 40 is positioned to overlap the first support plate 93 and the second support plate 94. As a result, as shown in Figure 8, when the balloon 40 is expanded, the support plate 90 prevents the balloon 40 from expanding away from the body surface of the wrist W, and the compressive force of the balloon 40 is concentrated on the wrist W side. Therefore, the puncture site P can be effectively compressed.

[0083] (Effects and Benefits) As described above, the hemostatic device 10A of the second embodiment, like the hemostatic device 10 of the first embodiment, includes a balloon 40, a belt 21, and a discharge section 70A. The hemostatic device 10A further includes a support plate 90. The support plate 90 is made of a material harder than the balloon 40 and is positioned on the other side ("outer surface") of the balloon 40 that is opposite to one side ("inner surface") that is in contact with the body. The belt 21 is connected to the support plate 90. The balloon 40 is connected to the support plate 90 on the other side ("outer surface"). The support plate 90 has a window 91 that exposes a part of the other side ("outer surface") of the balloon 40. The discharge section 70A is positioned so as to overlap with the window 91 in the planar direction of the balloon 40.

[0084] With the hemostatic device 10A configured as described above, the balloon 40 is fixed to a part of the patient's body by the support plate 90 and belt 21, and when liquid is injected into the lumen 40a of the balloon 40, the expanded balloon 40 compresses the puncture site P. As liquid is injected into the lumen 40a of the balloon 40, the gas inside the balloon 40 is discharged to the outside of the balloon 40 by the discharge part 70A facing the window 91 of the support plate 90. Therefore, when liquid is injected into the balloon 40, it is possible to prevent gas from remaining inside the balloon 40. Since no gas remains inside the balloon 40, for example, even if ultrasound is irradiated from the ultrasound probe 80 toward the puncture site P to confirm an ultrasound image, attenuation of the propagating ultrasound is less likely to occur. Therefore, the ultrasound image can be confirmed favorably, and based on the obtained ultrasound image, the occlusion state of the blood vessel located at the puncture site P can be accurately confirmed.

[0085] The support plate 90 is rigider than the balloon 40, positioned on the outer side of the balloon 40, and connected to the outer surface of the balloon 40. The belt 21 is connected to this support plate 90. Furthermore, the support plate 90 has a window portion 91 that exposes a part of the outer surface of the balloon 40. The discharge portion 70A is positioned to overlap with the window portion 91, and its outer surface is not covered by the support plate 90. Therefore, attenuation of ultrasound due to the presence of air or the boundary with other components is less likely to occur. As a result, the occlusion state of the blood vessel located at the puncture site P can be confirmed more accurately based on the obtained ultrasound image. In addition, the gas discharged through the discharge portion 70A does not accumulate between the outer surface of the balloon 40 and the inner surface of the support plate 90.

[0086] In the balloon 40, at least a portion of the parts other than those made of the porous member 71 is made of a material with lower elasticity than the porous member 71. With this configuration, the expansion of the discharge section 70A made of the porous member 71 is suppressed by the other parts of the balloon 40. Therefore, the deterioration of the function of the porous member 71 due to expansion can be suppressed. Furthermore, the support plate 90 is connected to the balloon 40 at the other parts that have lower elasticity than the porous member 71. Therefore, expansion between the balloon 40 and the support plate 90 can be prevented.

[0087] Next, a modified version of the second embodiment will be described. In the following description, redundant explanations of content already described will be omitted. Also, content not specifically mentioned in the following description can be the same as in the second embodiment.

[0088] <Example 1> Figures 10 and 11 show plan views of the balloon 40 and support plate 90 as seen from the outside, according to Modification 1 of the second embodiment. Figure 10 shows the state in which the long axis of the ultrasonic probe 80 is pressed against the balloon 40 along the longitudinal direction of the support plate 90, and Figure 11 shows the state in which the long axis of the ultrasonic probe 80 is pressed against the balloon 40 along the width direction of the support plate 90.

[0089] As shown in Figures 10 and 11, the window portion 91 has a rectangular shape with a long side 91a located along the longitudinal direction of the support plate 90 and a short side 91b located along the width direction of the support plate 90. The porous member 71 constituting the discharge portion 70B has a central part 73a located at the center of the window portion 91 in the planar direction, a first protrusion 73b protruding from the central part 73a along the long side 91a, and a second protrusion 73c protruding from the central part 73a along the short side 91b.

[0090] The discharge section 70B has a roughly cross shape. The area along the long side 91a of the window section 91 in the discharge section 70B is larger than the contact area of ​​the ultrasound probe 80. The area along the short side 91b of the window section 91 in the discharge section 70B is larger than the contact area of ​​the ultrasound probe 80. Therefore, in both cases, when the long axis of the ultrasound probe 80 is pressed against the balloon 40 along the longitudinal direction of the support plate 90 (state in Figure 10) and when the long axis of the ultrasound probe 80 is pressed against the balloon 40 along the width direction of the support plate 90 (state in Figure 11), the ultrasound probe 80 does not cover the entire area of ​​the discharge section 70B. A part of the discharge section 70B remains exposed to the outside. When the ultrasound probe 80 is pressed against the balloon 40, the ultrasound probe 80 is not restricted in its orientation and can easily be aligned with the blood vessel by either its long or short axis. Therefore, the ultrasound probe 80 is easy to use. Furthermore, when the ultrasonic probe 80 is pressed against the balloon 40, the gas inside the balloon 40 can be discharged to the outside of the balloon 40 through the discharge section 70B.

[0091] <Modification 2> Figures 12 and 13 show plan views of the balloon 40 and support plate 90 as seen from the outside, according to Modification 2 of the second embodiment. Figure 12 shows the state in which the long axis of the ultrasonic probe 80 is pressed against the balloon 40 along the longitudinal direction of the support plate 90, and Figure 13 shows the state in which the long axis of the ultrasonic probe 80 is pressed against the balloon 40 along the width direction of the support plate 90.

[0092] As shown in Figures 12 and 13, the window portion 91 has a rectangular shape with a long side 91a located along the longitudinal direction of the support plate 90 and a short side 91b located along the width direction of the support plate 90. The porous members 71 constituting the discharge portion 70C have a rectangular shape and are arranged at the four corners of the window portion 91. In the balloon 40, the parts other than the discharge portion 70C are made of, for example, polyvinyl chloride, similar to the second sheet 48.

[0093] The parts other than the discharge portion 70C have a roughly cross shape. In the parts other than the discharge portion 70C, the area along the long side 91a of the window portion 91 is larger than the contact area of ​​the ultrasound probe 80. In the parts other than the discharge portion 70C, the area along the short side 91b of the window portion 91 is larger than the contact area of ​​the ultrasound probe 80. Therefore, in both cases, when the long axis of the ultrasound probe 80 is pressed against the balloon 40 along the longitudinal direction of the support plate 90 (state in Figure 12) and when the long axis of the ultrasound probe 80 is pressed against the balloon 40 along the width direction of the support plate 90 (state in Figure 13), the discharge portion 70C remains exposed on the outer surface. When the ultrasound probe 80 is pressed against the balloon 40, the ultrasound probe 80 is not restricted in its orientation and it is easy to align its long axis or short axis with the blood vessel. Therefore, the ultrasound probe 80 is easy to use. Furthermore, when the ultrasonic probe 80 is pressed against the balloon 40, the gas inside the balloon 40 can be discharged to the outside of the balloon 40 through the discharge section 70C.

[0094] <Variation 3> Figure 14 shows a plan view of the balloon 40 and support plate 90 as seen from the outside, according to a modified example 3 of the second embodiment.

[0095] As shown in Figure 14, the support plate 90 of the modified example 3 has a pair of girder sections 95 that extend along the longitudinal direction and connect the first support plate 93 and the second support plate 94. The girder sections 95 are located in the width direction of the window section 91. The window section 91 is formed by opening a part of the support plate 90.

[0096] With this configuration, the pair of girder sections 95 of the support plate 90 can hold down the ends of the balloon 40 in the width direction. Therefore, it is possible to suppress the balloon 40 from shifting in the width direction.

[0097] <Modification 4> Figure 15 shows a plan view of the balloon 40 and support plate 90 as seen from the outside, according to Modification 4 of the second embodiment.

[0098] As shown in Figure 15, the support plate 90 of the modified example 4 has a third support plate 96 and a fourth support plate 97 extending in the longitudinal direction. The third support plate 96 and the fourth support plate 97 are spaced apart along the width direction. The space between the third support plate 96 and the fourth support plate 97 can be configured as a window portion 91.

[0099] The balloon 40 is connected to the inner surface of the third support plate 96 at one end in the width direction (the upper end in Figure 15) and to the inner surface of the fourth support plate 97 at the other end in the width direction (the lower end in Figure 15).

[0100] The third support plate 96 and the fourth support plate 97 are connected to the inner surface of the first belt 23 at one end in the longitudinal direction (the right end in Figure 15) and to the inner surface of the second belt 24 at the other end in the longitudinal direction (the left end in Figure 15).

[0101] Even with this configuration, the support plates 90 (third support plate 96 and fourth support plate 97) are positioned on the outer surface side of the balloon 40 and connected to the outer surface of the balloon 40. The belt 21 is connected to these support plates 90. As a result, the balloon 40 can be pressed against the outer circumference of the wrist W without creating any gaps.

[0102] <Modification 5> Figures 16 and 17 show a modified example 5 of the second embodiment. Figure 16 is a cross-sectional view illustrating the configuration of the balloon 40 of the hemostatic device 10A according to modified example 5, showing the state when liquid is injected into the balloon 40. Figure 17 is a cross-sectional view showing the hemostatic device 10A according to modified example 5, showing an enlarged cross-section of the main part of part A in Figure 16. Figure 18 shows a plan view of the balloon 40 and support plate 90 of the hemostatic device 10A according to modified example 5, viewed from the outer side.

[0103] As shown in Figures 16 to 17, Modified Example 5 has, in addition to the discharge section 70A in which a part of the first sheet 47 of the balloon 40 is made of a porous member 71, the following discharge section 70D.

[0104] The discharge section 70D includes a tube 74 that connects the lumen 40a and the outside of the balloon 40, and a restricting section 75 configured to allow the discharge of gas through the tube 74 while restricting the discharge of liquid.

[0105] The limiting portion 75 is formed by filling the tube 74 with the porous material 71 described above.

[0106] A bag-shaped air pocket 76 communicating with the tube 74 is positioned on the outer surface of the balloon 40. The air pocket 76 is made of the same material as the balloon 40 and is deflated before the hemostatic device 10A is used. Note that if the limiting portion 75 is made of a porous material 71, the air pocket 76 is not an essential component.

[0107] As shown in Figure 18, the discharge section 70D is positioned so as not to interfere with the movement of the ultrasonic probe 80, and the tube 74 can be placed in the maximum expansion section 72.

[0108] As liquid is injected into the lumen 40a of the balloon 40, the gas inside the balloon 40 is discharged to the outside of the balloon 40 by passing through the porous member 71 of the discharge section 70. Furthermore, the gas inside the balloon 40 is discharged into the air pocket 76 by passing through the restricting section 75 of the discharge section 70D. In addition, the passage of liquid inside the balloon 40 is restricted to the porous member 71. As a result, the compressive force of the balloon 40 on the puncture site P is not reduced, and gas does not remain inside the balloon 40. Therefore, the occlusion state of the blood vessel located at the puncture site P can be more accurately confirmed based on the obtained ultrasound image without reducing the hemostatic function.

[0109] Alternatively, the discharge section 70A, which is made of porous material 71, can be omitted from the balloon 40, and only the discharge section 70D can be placed on the balloon 40. In this case, the first sheet 47 is made of, for example, polyvinyl chloride, similar to the second sheet 48. The tube 74 and the limiting section 75 are then placed on the first sheet 47.

[0110] Although the hemostatic device according to the present invention has been described above through embodiments and modifications, the present invention is not limited to the configurations described above and can be modified as appropriate based on the claims.

[0111] For example, each component of a hemostatic device can be replaced with any component capable of performing a similar function. Furthermore, any additional components may be added.

[0112] Furthermore, the present invention is not limited to hemostatic devices worn on the wrist, but can also be applied to hemostatic devices worn on the legs or other parts of the body. [Explanation of Symbols]

[0113] 10, 10A Hemostatic Devices 21. Belt (strap) 23. Belt 1 24. Belt 2 30 hook-and-loop fasteners 40 balloons 40a lumen 47 Sheet 1 48. Second seat 49 Joint 51 bubbles 52 Gases 60 Injection part 70, 70A, 70B, 70C, 70D Discharge section 71 Porous material 72 Maximum expansion section 73a center 73b 1st protrusion 73c 2nd protrusion 74 tubes 75 Restriction section 76 Air Pockets 80 Ultrasound probes 90 Support plate 91 Window section 91a Long side 91b Short side 93 1st support plate 94 Second support plate 95 digit part 96 Third support plate 97 4th support plate P puncture site R radial artery W wrist

Claims

1. An expandable and deflated balloon having a lumen into which a liquid is injected and configured to compress a puncture site formed in a patient, A band for securing the balloon to a part of the patient's body, The balloon has a discharge section that is arranged in the balloon and discharges the gas inside the balloon to the outside of the balloon when the liquid is injected into the lumen, The discharge portion is made of a porous material that constitutes at least a part of the other surface of the balloon that is located opposite to one surface that is located on the side that is in contact with the body. A hemostatic device wherein the porous member is composed of a member that allows the passage of the gas and restricts the passage of the liquid.

2. An expandable and deflated balloon having a lumen into which a liquid is injected and configured to compress a puncture site formed in a patient, A band for securing the balloon to a part of the patient's body, The balloon has a discharge section that is arranged in the balloon and discharges the gas inside the balloon to the outside of the balloon when the liquid is injected into the lumen, The band is made of a material that is less elastic than the balloon, and is connected to the balloon at a position where it does not overlap with at least a portion of the area in the planar direction of the balloon where one surface of the balloon that is in contact with the body and the other surface that is opposite to the one surface extend. The discharge portion is located in a region of the balloon where the band does not overlap, and is a hemostatic device.

3. An expandable and deflated balloon having a lumen into which a liquid is injected and configured to compress a puncture site formed in a patient, A band for securing the balloon to a part of the patient's body, The balloon has a discharge section that is arranged in the balloon and discharges the gas inside the balloon to the outside of the balloon when the liquid is injected into the lumen, The balloon further comprises a support plate made of a harder material than the balloon, and positioned on the side opposite to the side of the balloon that is in contact with the body. The strip is connected to the support plate, The balloon is connected to the support plate on the other side, The support plate has a window portion that exposes a part of the other surface of the balloon, A hemostatic device wherein the discharge portion is positioned in the balloon at a location that overlaps with the window portion in the plane direction of the balloon in which the one surface and the other surface expand.

4. The window portion has a rectangular shape with a long side located along the longitudinal direction of the support plate and a short side located along the width direction of the support plate. The hemostatic device according to claim 3, wherein the discharge portion has a central portion positioned at the center of the window portion in the plane direction, a first protrusion protruding from the central portion along the long side, and a second protrusion protruding from the central portion along the short side.

5. The discharge portion is made of a porous material that constitutes at least a part of the other surface of the balloon that is located opposite to one surface that is located on the side that is in contact with the body. The hemostatic device according to any one of claims 2 to 4, wherein the porous member is composed of a member that allows the passage of the gas and restricts the passage of the liquid.

6. The hemostatic device according to claim 1 or 5, wherein at least a portion of the balloon other than the portion made of the porous member is made of a material that is less elastic than the porous member.

7. The discharge section includes a tube connecting the lumen and the outside of the balloon, and a restricting section configured to allow the discharge of the gas through the tube and to restrict the discharge of the liquid. The hemostatic device according to claim 1, wherein the limiting portion is formed by filling the tube with the porous member.

8. The hemostatic device according to any one of claims 1 to 7, wherein the discharge portion is the portion that becomes the apex of the balloon when the balloon is expanded, and is configured to discharge the gas from the maximum expansion portion where the gas remaining inside the balloon accumulates.

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