JP2024051577A - Hemostatic device - Google Patents

Abstract

To provide a hemostatic device capable of adjusting compression force to be applied to a puncture site formed on a patient with simple operation without using a dedicated instrument such as a syringe.SOLUTION: A hemostatic device 10 includes a support member 100 configured to cover a puncture site p formed on a patient, a balloon 210 connected to the support member and configured to compress the puncture site, a fixing member 300 extending from the support member and configured to fix the support member to the puncture part p, and a pair of clamping members 400 facing each other on both sides of the balloon. The pair of clamping members includes a first clamping member 410 and a second clamping member 420 facing the first holding member, with the balloon interposed therebetween. The first clamping member and the second clamping member are configured to be movable close to and away from each other such that a breadth of the balloon can be controlled by changing a distance between the first clamping member and the second clamping member.SELECTED DRAWING: Figure 1

Description

The present invention relates to a hemostatic device.

One known catheter technique is to puncture a blood vessel in a patient's limb, such as an arm or hand, and introduce various types of elongated medical objects into the blood vessel through the puncture site to diagnose or treat the lesion. For example, Patent Document 1 discloses a hemostatic device for stopping bleeding at a puncture site formed in a patient's arm.

The hemostatic device of Patent Document 1 includes a pressing member that applies a compressive force to the puncture site, and a band that fixes the pressing member to the patient's body. In the hemostatic device of Patent Document 1, the pressing member is composed of a balloon that can expand and contract as air or other fluids are injected and discharged. When expanding and contracting the pressing member, a doctor or nurse (hereinafter referred to as the "operator") connects a dedicated syringe to a connector portion (air injection port) attached to the hemostatic device, and operates the syringe to inject and discharge fluid into and from the pressing member.

JP 2017-202231 A

In the hemostasis method using the hemostasis device of Patent Document 1, the surgeon connects a dedicated syringe to the connector each time the surgeon adjusts the amount of expansion of the pressing member (adjusting the compression force applied by the pressing member). This forces the surgeon to carry a dedicated syringe. In addition, the surgeon needs to accurately control the adjustment of the amount of expansion of the pressing member based on the amount of movement of the plunger of the syringe. Therefore, the hemostasis device of Patent Document 1 requires a large workload for adjusting the amount of expansion.

For example, in order to eliminate the complexity involved in adjusting the expansion amount of the pressing member as described above, it is conceivable to configure the pressing member with a non-expandable structure. However, if the pressing member is configured with a non-expandable structure, it is not possible to easily adjust the compression force applied by the pressing member while the hemostatic device is attached to the patient's body and the hemostatic device is used to stop bleeding. Therefore, with a hemostatic device configured in this way, it is difficult to apply an appropriate compression force to the puncture site over time.

The present invention aims to provide a hemostatic device that can adjust the pressure applied to a puncture site created in a patient with a simple operation without using a dedicated device such as a syringe.

(1) The hemostatic device includes a support member configured to cover a puncture site formed in a patient, a pressing member connected to the support member and configured to press the puncture site, a fixing member extending from the support member and configured to fix the support member to the puncture site, and a pair of clamping members facing each other across the pressing member, the pair of clamping members including a first clamping member and a second clamping member facing the first clamping member across the pressing member, the first clamping member and the second clamping member being configured to be movable toward and away from each other so that the lateral width of the pressing member can be controlled by changing the distance between the first clamping member and the second clamping member.

(2) The hemostatic device described in (1) above, in which each of the first clamping member and the second clamping member has a knob portion protruding from the outer surface side of the support member, the outer surface side being located opposite the inner surface side on which the pressing member is arranged.

(3) The hemostatic device according to (2) above, in which the support member has a groove portion that slidably holds the first clamping member and the second clamping member, and a locking groove portion that extends along substantially the same direction as the groove portion, and the first clamping member and the second clamping member have an arm portion that is connected to the knob portion and inserted into the groove portion, and a locking portion that is configured to be able to be fitted into the locking groove portion and that limits the movement of the first clamping member and the second clamping member when fitted into the locking groove portion.

(4) The hemostatic device according to any one of (1) to (3) above, wherein the first clamping member and the second clamping member are configured to change the width and height of the pressing member based on the distance between the first clamping member and the second clamping member, and the first clamping member and the second clamping member compress the pressing member in the width direction so that the height of the pressing member is greater when the first clamping member and the second clamping member are at a first distance compared to when the first clamping member and the second clamping member are at a second distance longer than the first distance.

(5) A hemostatic device according to any one of (1) to (4) above, in which each of the first clamping member and the second clamping member has a suppressing portion that is arranged along the vertical width direction of the pressing member and presses the pressing member in the horizontal width direction as the first clamping member and the second clamping member approach each other, and the suppressing portion has a pressing surface that faces the pressing member.

(6) The hemostatic device according to (5) above, in which the pressing surface of the suppressing portion of the first clamping member and the pressing surface of the suppressing portion of the second clamping member are inclined so that the distance between them gradually decreases in the direction away from the support member.

(7) The hemostatic device described in (6) above, in which the pressing surface has a width of 70% or more of the vertical width of the pressing member when the suppressing portion is not compressing the pressing member in the lateral width direction.

(8) A hemostatic device according to any one of (1) to (7) above, in which, when the first clamping member and the second clamping member are in a state in which they are furthest apart, the distance between the support member and the lower end of the suppressing portion located on the side farther away from the support member is smaller than the first height of the pressing member.

(9) The hemostatic device according to any one of (1) to (8) above, wherein the suppressing portion of the first clamping member and the suppressing portion of the second clamping member are configured to form a gap between the inner surface of the support member on which the pressing member is disposed when the pressing member is not compressed in the width direction.

(10) A hemostatic device according to any one of (1) to (9) above, having a linking mechanism that links the action of moving the first clamping member toward and away from the second clamping member with the action of moving the second clamping member toward and away from the first clamping member.

(11) A hemostatic device according to any one of (1) to (10) above, in which the pair of clamping members are arranged to sandwich the pressing member therebetween in a vertical width direction intersecting with the horizontal width direction in which the clamping members approach and separate from each other, and which has a stopper portion that limits the maximum deformation amount of the pressing member in the vertical width direction when the pair of clamping members approach each other.

The hemostatic device of (1) above includes a first clamping member and a second clamping member that face each other with a pressing member between them. The surgeon can reduce the width of the pressing member by bringing the first clamping member and the second clamping member closer to each other to reduce the distance between the first clamping member and the second clamping member. When the width of the pressing member is reduced, the height of the pressing member increases. Therefore, in the above-mentioned hemostatic device, the pressing member applies a larger compressive force to the puncture site than before the width of the pressing member is reduced. In addition, the surgeon can increase the width of the pressing member by moving the first clamping member and the second clamping member away from each other to increase the distance between the first clamping member and the second clamping member. When the width of the pressing member is increased, the height of the pressing member decreases. Therefore, in the above-mentioned hemostatic device, the pressing member applies a smaller compressive force to the puncture site than before the width of the pressing member is increased. In this way, the hemostatic device described above can reversibly increase or decrease the compression force applied by the pressing member to the puncture site by the simple operation of changing the distance between the first clamping member and the second clamping member.

FIG. 2 is a diagram showing a hemostatic device according to an embodiment, and is a plan view seen from the outer surface side of a support member. FIG. 2 is a diagram showing a hemostatic device according to an embodiment, and is a plan view seen from the inner surface side of a support member. 1 is an enlarged plan view showing a portion of the hemostatic device as viewed from the outer surface side of the support member. FIG. 1 is an enlarged plan view showing a portion of the hemostatic device as viewed from the inner surface side of the support member. FIG. 5A is a cross-sectional view taken along line 5A-5A of FIG. 3, illustrating a state in which a second distance is provided between the first clamping member and the second clamping member. FIG. 5A is a cross-sectional view taken along line 5A-5A of FIG. 3, illustrating a state in which a first distance is provided between the first clamping member and the second clamping member. FIG. 7A is a cross-sectional view taken along line 7A-7A of FIG. 3, illustrating a state before the locking portion of the first clamping member is fitted into the locking groove portion of the support member. FIG. 7A is a cross-sectional view taken along line 7A-7A of FIG. 3, illustrating a state in which the locking portion of the first clamping member is fitted into the locking groove portion of the support member. FIG. 1A to 1C are diagrams illustrating a simplified example of a use of a hemostatic device according to an embodiment. 1A to 1C are diagrams illustrating a simplified example of a use of a hemostatic device according to an embodiment. 11A is a cross-sectional view taken along line 11A-11A of FIG. 10, illustrating a state in which a second distance is provided between the first clamping member and the second clamping member. 11A is a cross-sectional view taken along the line indicated by the arrows 11A-11A in FIG. 10, illustrating a state in which a first distance is provided between the first clamping member and the second clamping member. FIG. FIG. 11 is a cross-sectional view of a hemostatic device according to Modification 1. FIG. 11 is a cross-sectional view of a hemostatic device according to Modification 1. FIG. 11 is a plan view of a hemostatic device according to Modification 2, viewed from the outer surface side of a support member. FIG. 11 is a plan view of a hemostatic device according to Modification 2, viewed from the outer surface side of a support member. FIG. 13 is a cross-sectional view of a hemostatic device according to Modification 3. FIG. 13 is a plan view of a hemostatic device according to Modification 4, viewed from the inner surface side of a support member. FIG. 13 is a cross-sectional view of a hemostatic device according to Modification 5. FIG. 13 is a cross-sectional view of a hemostatic device according to Modification 5. FIG. 13 is a cross-sectional view of a hemostatic device according to Modification 6. FIG. 13 is a cross-sectional view of a hemostatic device according to Modification 6.

The following describes an embodiment of the present invention with reference to the attached drawings. The following description does not limit the technical scope or the meaning of the terms described in the claims. Also, the dimensional proportions in the drawings have been exaggerated for the convenience of explanation and may differ from the actual proportions.

(Embodiment)
1 to 8 are diagrams for explaining a hemostatic device 10 according to the present embodiment. Figs. 9 to 12 are diagrams for explaining an example of use of the hemostatic device 10.

As shown in Figures 9 and 10, for example, the hemostatic device 10 can be used to stop bleeding at a puncture site p (hereinafter also simply referred to as "puncture site p") formed in a hand H located distal (toward the fingers) of a patient's forearm A when removing a sheath tube 510 of an introducer 500 that has been placed at the puncture site p.

In this embodiment, the target of hemostasis by the hemostatic device 10 is, for example, a puncture site p formed in artery B (hereinafter also referred to as "blood vessel B"; see Figures 11 and 12) located in the snuff box of the palmar artery running along the back side of the right hand Hr located distal to the patient's forearm A. The snuff box is a cavity in the hand located near the radius when the patient spreads the thumb of the hand H.

<Hemostatic instrument 10>
Generally speaking, as shown in Figures 1, 2, 9, 10, 11, and 12, the hemostatic device 10 comprises a support member 100 configured to cover the puncture site p, a pressing member 200 connected to the support member 100 and configured to compress the puncture site p, a fixing member 300 extending from the support member 100 and configured to fix the support member 100 to the puncture site p, and a pair of clamping members 400 facing each other with the pressing member 200 in between.

<Support member 100>
As shown in FIGS. 3, 4, 5 and 6, the support member 100 is configured as a plate-like member to which a pressing member 200 is connected.

The support member 100 has multiple grooves 111, 112 and multiple locking grooves 121a, 121b, 122a, 122b.

As shown in Figures 5 and 6, the support member 100 has a support portion 105 located between groove portions 111 and 112. A pressing member 200 is connected to the inner surface of the support portion 105 (inner surface 100a of the support member 100). The inner surface 100a of the support member 100 is the surface that is placed on the body surface side of the patient's right hand Hr when the hemostatic device 10 is attached to the patient's right hand Hr (see Figures 11 and 12). The outer surface 100b of the support member 100 is the surface that is located opposite the inner surface 100a.

Each groove 111, 112 extends linearly with a constant width. Groove 111 and groove 112 are disposed approximately symmetrically in the left-right direction of the support member 100 in a plan view, with the pressing member 200 sandwiched between them.

The first clamping member 410 is connected to the support member 100 so that it can slide along a linear path along the groove portion 111.

The second clamping member 420 is connected to the support member 100 so as to be slidable along a linear path along the groove portion 112.

As shown in Figures 3 and 4, each locking groove 121a, 121b extends in substantially the same direction as groove 111.

As shown in Figures 7 and 8, the locking groove 121a is configured so that the locking portion 417a of the first clamping member 410 can be fitted into it. The locking groove 121b is configured so that the locking portion 417b of the first clamping member 410 can be fitted into it.

The tip of each locking portion 417a, 417b (the end located on the side of each locking groove portion 121a, 121b) can be formed, for example, in a tapered shape that tapers toward each locking groove portion 121a, 121b.

The locking grooves 121a and 121b are arranged approximately symmetrically in the up-down direction in a plan view of the support member 100, with the groove 111 sandwiched between them. Each of the locking grooves 121a and 121b extends approximately parallel to the groove 111.

As shown in Figures 3 and 4, each locking groove 122a, 122b extends in substantially the same direction as groove 112.

As shown in Figures 7 and 8, the locking groove 122a is configured to be able to fit the locking portion 427a of the second clamping member 420. The locking groove 122b is configured to be able to fit the locking portion 427b of the second clamping member 420. Note that in this specification, illustrations of the state in which the locking portion 427a is fitted into the locking groove 122a and the state in which the locking portion 427b is fitted into the locking groove 122b are omitted.

The tip of each locking portion 427a, 427b located on the side of each locking groove 122a, 122b can be formed, for example, in a tapered shape that tapers toward each locking groove 122a, 122b.

The locking grooves 122a and 122b are arranged approximately symmetrically in the up-down direction in a plan view of the support member 100, with the groove 112 sandwiched between them. Each of the locking grooves 122a and 122b extends approximately parallel to the groove 112.

3 and 4, the planar shape of the support member 100 can be formed into a substantially elliptical shape with its maximum length in the width direction of the balloon 210. However, the support member 100 is not particularly limited as long as it can be positioned to cover the puncture site p when the hemostatic device 10 is attached to the patient's right hand Hr (see FIG. 10).

The grooves 111, 112 of the support member 100 are not limited to a shape that extends linearly with a constant width. For example, the grooves 111, 112 can be configured to have narrower and wider portions in each portion in the direction in which the grooves 111, 112 extend. When the grooves 111, 112 are configured in this manner, the positions of the clamping members 410, 420 can be maintained at the narrower portions. Therefore, the hemostatic device 10 can easily adjust the movement distance of the clamping members 410, 420 in stages when moving the clamping members 410, 420 closer to or farther apart.

The support member 100 can be made of, for example, a material having a predetermined hardness. Examples of materials that can be used to make the support member 100 include acrylic resin, polyvinyl chloride (particularly hard polyvinyl chloride), polyolefins such as polyethylene, polypropylene, and polybutadiene, polystyrene, poly-(4-methylpentene-1), polycarbonate, ABS resin, polymethyl methacrylate (PMMA), polyacetal, polyacrylate, polyacrylonitrile, polyvinylidene fluoride, ionomer, acrylonitrile-butadiene-styrene copolymer, and polyethylene terephthalate (PET).

<Pressing member 200>
5 and 6, the pressing member 200 can be configured with a balloon 210 configured to be filled with a predetermined filler 220. In this embodiment, an example in which the pressing member 200 is configured with the balloon 210 will be described.

The balloon 210 has an internal space 215 that can be filled with a filling material 220.

As shown in Figures 5 and 6, a portion of the upper surface 210a of the balloon 210 is connected to the support portion 105 of the support member 100. The method of connecting the balloon 210 to the support member 100 is not particularly limited, but for example, adhesion or fusion can be used.

As shown in Figures 1 and 2, the balloon 210 can be configured to have a substantially elliptical planar shape in a state where no compressive deformation in the width direction occurs due to the proximity of the pair of clamping members 400 (hereinafter also referred to as the "uncompressed state"). Also, as shown in Figure 5, the balloon 210 can be configured to have a substantially elliptical cross-sectional shape in an uncompressed state. In the following description, the state where the balloon 210 is compressed and deformed in the width direction due to the proximity of the pair of clamping members 400 is also referred to as the "compressed state".

There are no particular limitations on the planar shape and cross-sectional shape of the balloon 210 in the uncompressed and compressed states, and any shape can be used.

The balloon 210 can be made, for example, of a flexible membrane-like material.

The filling material 220 to be filled into the internal space 215 of the balloon 210 may be, for example, air, saline, or other fluid. However, the filling material 220 is not particularly limited as long as it is possible to control the width of the balloon 210 by moving the pair of clamping members 400 closer to or farther from each other. For example, gel or fine granular solids may be used as the filling material 220.

The filling material 220 can be pre-filled into the balloon 210 before starting hemostasis using the hemostatic device 10. However, the filling material 220 may be filled into the balloon 210 when starting hemostasis using the hemostatic device 10. When filling the balloon 210 with the filling material 220 when starting hemostasis, the hemostatic device 10 can be provided with a structure for filling the interior of the balloon 210 with the filling material 220. When using a fluid as the filling material 220, the hemostatic device 10 can be provided with an injection mechanism consisting of a tube connected to the internal space 215 of the balloon 210 and a connector with a check valve connected to the tube.

The balloon 210 has a marker portion 218 for aligning the balloon 210 with the puncture site p when attaching the hemostatic device 10 to the patient's right hand Hr.

As shown in Figures 5 and 6, the marker portion 218 can be formed, for example, on the underside 210b of the balloon 210. The marker portion 218 can be disposed, for example, at a position where, in a plan view of the balloon 210, an imaginary line passing through the center of the balloon 210 in the vertical width direction intersects with an imaginary line passing through the center of the balloon 210 in the horizontal width direction. The marker portion 218 can be configured, for example, by printing a predetermined shape and color on the underside 210b of the balloon 210.

The position of the balloon 210 that overlaps in plan view with the position where the marker portion 218 is formed can be made transparent or semi-transparent. Also, the position of the support portion 105 of the support member 100 that overlaps in plan view with the position where the marker portion 218 is formed can be made transparent or semi-transparent. By making the predetermined positions of the balloon 210 and the predetermined positions of the support portion 105 of the support member 100 transparent or semi-transparent as described above, it becomes possible for the surgeon to easily confirm the position of the marker portion 218 when visually inspecting the marker portion 218 from the outer surface 100b side of the support member 100.

As shown in Figures 4 and 5, the balloon 210 in an uncompressed state has a predetermined width W1 and a predetermined length W2. The width W1 of the balloon 210 is the dimension along the direction in which the pair of clamping members 400 approach and move away from each other (the left-right direction in Figures 4 and 5). The length W2 of the balloon 210 is the dimension along the direction perpendicular to the width W1 (the up-down direction in Figure 4).

As shown in FIG. 5, the balloon 210 in an uncompressed state has a predetermined first height H1. The first height H1 is the maximum dimension of the balloon 210 in the vertical direction of the cross-sectional view shown in FIG. 5. In the present embodiment, when the balloon 210 has a flat upper surface 210a and a flat lower surface 210b, the first height H1 of the balloon 210 can be defined as the linear distance between the upper surface 210a and the lower surface 210b.

As shown in Figures 5 and 6, the balloon 210 can be composed of a single bag-shaped member with an internal space 215 defined inside. There are no particular limitations on the specific structure of the balloon 210. For example, the balloon 210 may have a structure in which two sheet-shaped members are joined together and the internal space 215 is defined between the two sheet-shaped members.

The material of the membrane-like member that constitutes the balloon 210 is not particularly limited, but examples of materials that can be used 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), various thermoplastic elastomers such as polyvinylidene chloride, silicone, polyurethane, polyamide elastomer, polyurethane elastomer, and polyester elastomer, nylon, nylon elastomer, or any combination of these (blend resins, polymer alloys, laminates, etc.).

<Fixing member 300>
As shown in FIGS. 1, 2, 9 and 10, the fixing member 300 has a first band 310 connected to the support member 100, a second band 320 and a third band 330.

The first band 310 has one end located on the support member 100 side and connected to the outer surface 100b of the support member 100. As shown in FIG. 2, a first fixing portion 351 is located on the inner surface of the first band 310.

As shown in Figures 9 and 10, the first band 310 can be placed in the interdigital region fb between the thumb and index finger of the patient's right hand Hr.

The second band 320 has one end located on the support member 100 side connected to the outer surface 100b of the support member 100. The second band 320 extends in a direction different from the direction in which the first band 310 extends from the support member 100. As shown in FIG. 1, a second fixing portion 352 is arranged on the outer surface of the second band 320. As shown in FIG. 2, a third fixing portion 353 is arranged on the inner surface of the second band 320.

The third band 330 has one end located on the support member 100 side, which is connected to the outer surface 100b of the support member 100. The third band 330 extends from the support member 100 in a direction different from the direction in which the first band 310 and the second band 320 each extend. As shown in FIG. 1, a fourth fixing portion 354 is disposed on the outer surface of the third band 330.

As shown in Figures 9 and 10, the second band 320 and the third band 330 can be positioned to be wrapped around the outer circumference of the patient's right hand Hr.

The third fixing portion 353 arranged on the inner surface of the second band 320 can be connected to the fourth fixing portion 354 arranged on the outer surface of the third band 330. As shown in Figures 9 and 10, the surgeon can fix the second band 320 and the third band 330 to the patient's right hand Hr by connecting the third fixing portion 353 and the fourth fixing portion 354 while wrapping the second band 320 and the third band 330 around the patient's right hand Hr.

The first fixing portion 351 arranged on the inner surface of the first band 310 can be connected to the second fixing portion 352 arranged on the outer surface of the second band 320. As shown in FIG. 10, the surgeon can fix the first band 310 together with the second band 320 and the third band 330 to the patient's right hand Hr by connecting the first fixing portion 351 arranged on the inner surface of the first band 310 arranged in the inter-finger portion fb to the second fixing portion 352 arranged on the outer surface of the second band 320.

The material of each of the bands 310, 320, and 330 is not particularly limited, but may be made of, for example, polyvinyl chloride resin, polyurethane resin, polyester resin, etc.

Each of the fixing parts 351, 352, 353, 354 can be configured, for example, as the male side or male side of a hook-and-loop fastener. The hook-and-loop fastener referred to here is a fastener that can be attached and detached on the surface, such as Magic Tape (registered trademark) or Velcro (registered trademark). The specific structure of each of the fixing parts 351, 352, 353, 354 is not limited as long as the bands 310, 320, 330 can be connected together with the hemostatic device 10 placed on the patient's right hand Hr, thereby fixing the support member 100 in a state where it is placed over the puncture site p.

(Pair of clamping members 400)
As shown in FIGS. 1, 2, 3 and 4, the pair of clamping members 400 includes a first clamping member 410 and a second clamping member 420 that faces the first clamping member 410 with the balloon 210 sandwiched therebetween.

As shown in Figures 5 and 6, the first clamping member 410 and the second clamping member 420 are configured to be movable toward or away from each other so that the distance between the first clamping member 410 and the second clamping member 420 can be changed to control the lateral width of the balloon 210.

The first clamping member 410 and the second clamping member 420 can change the width and height of the balloon 210 based on the distance between the first clamping member 410 and the second clamping member 420.

Figure 5 shows a state in which a second distance L2 is formed between the first clamping member 410 and the second clamping member 420. Figure 6 shows a state in which a first distance L1 is formed between the first clamping member 410 and the second clamping member 420.

The first clamping member 410 and the second clamping member 420 are configured to compress the balloon 210 in the width direction so that the height of the balloon 210 is greater when the distance between the first clamping member 410 and the second clamping member 420 is the first distance L1 shown in FIG. 6 compared to when the distance is the second distance L2 shown in FIG. 5, which is longer than the first distance L1.

As shown in FIG. 5, when the second distance L2 is formed between the first clamping member 410 and the second clamping member 420, the first clamping member 410 and the second clamping member 420 do not compress the balloon 210 in the width direction. Therefore, the balloon 210 is in an uncompressed state. In the uncompressed state, the balloon 210 has a predetermined width W1 and a predetermined first height H1.

As shown in FIG. 6, when the first clamping member 410 and the second clamping member 420 approach each other and a first distance L1 is formed between the first clamping member 410 and the second clamping member 420, the first clamping member 410 and the second clamping member 420 clamp the balloon 210 and compress the balloon 210 in the width direction. The width of the balloon 210 changes to a width W1' smaller than the width W1 in the uncompressed state as the balloon 210 is compressed in the width direction. In addition, the height of the balloon 210 changes to a first height H1' larger than the first height H1 in the uncompressed state as the balloon 210 is compressed in the width direction.

When the hemostatic device 10 is deformed so that the height of the balloon 210 is increased, the balloon 210 is pressed against the body surface of the right hand Hr with a stronger force than before the balloon 210 was deformed so that the height of the balloon 210 was increased (see FIG. 12). Therefore, the hemostatic device 10 can increase the compressive force that the balloon 210 applies to the puncture site p compared to before the balloon 210 was deformed so that the height of the balloon 210 was increased.

When the surgeon wishes to reduce the compressive force applied by the balloon 210 to the puncture site p, the surgeon separates the first clamping member 410 and the second clamping member 420 from each other. By separating the first clamping member 410 and the second clamping member 420 from each other, the surgeon reduces the force with which the first clamping member 410 and the second clamping member 420 press against the balloon 210, thereby reducing the amount of compressive deformation in the width direction of the balloon 210. By performing the above operation, the surgeon can reduce the compressive force applied by the balloon 210 to the puncture site p. In this way, in the hemostasis method using the hemostasis device 10, the compressive force applied by the balloon 210 to the puncture site p can be adjusted by a simple operation of changing the distance between the first clamping member 410 and the second clamping member 420.

As shown in Figures 5, 6, 7, and 8, the first clamping member 410 and the second clamping member 420 each have a knob portion 411, 421 that protrudes toward the outer surface 100b of the support member 100, which is located opposite the inner surface 100a on which the balloon 210 is arranged.

When changing the distance between the first clamping member 410 and the second clamping member 420, the surgeon can move the first clamping member 410 and the second clamping member 420 closer to or farther away from each other by grasping the knob portions 411, 421 protruding toward the outer surface 100b of the support member 100 with the fingers and manipulating the knob portions 411, 421 to move them closer to or farther away from each other.

As shown in Figures 5, 6, 7, and 8, the first clamping member 410 has an arm portion 413 connected to the knob portion 411 and inserted into the groove portion 111 of the support member 100, and locking portions 417a and 417b that are configured to be able to fit into the locking groove portions 121a and 121b of the support member 100 and limit the movement of the first clamping member 410 when fitted into the locking groove portions 121a and 121b.

As shown in FIG. 7, each locking portion 417a, 417b is configured as a protrusion that can be pushed into each locking groove portion 121a, 121b. The first clamping member 410 has each locking portion 417a, 417b inserted into each locking groove portion 121a, 121b from the outer surface 100b side of the support member 100. The first clamping member 410 is held against the support member 100 by being positioned so that each locking portion 417a, 417b is hooked onto each locking groove portion 121a, 121b.

Figure 7 shows the state before the locking portions 417a, 417b are fitted into the locking grooves 121a, 121b of the support member 100 (hereinafter also referred to as the "unlocked state"). In the unlocked state, the locking portions 417a, 417b of the first clamping member 410 can move along the locking grooves 121a, 121b. In addition, the arm portion 413 connected to the locking portions 417a, 417b can move along the groove 111 in the unlocked state. Therefore, the first clamping member 410 including the arm portion 413 and the locking portions 417a, 417b can move along the groove 111 in the unlocked state.

Figure 8 shows the state in which the locking portions 417a, 417b are fitted into the locking grooves 121a, 121b of the support member 100 (hereinafter also referred to as the "locked state"). In the locked state, the movement of the locking portions 417a, 417b of the first clamping member 410 along the locking grooves 121a, 121b is restricted. In addition, in the locked state, the movement of the arm portion 413 connected to the locking portions 417a, 417b along the groove 111 is restricted. Therefore, in the locked state, the movement of the first clamping member 410 including the arm portion 413 and the locking portions 417a, 417b along the groove 111 is restricted.

As shown in FIG. 8, when the locking portions 417a, 417b of the first clamping member 410 are pushed into the locking grooves 121a, 121b to a predetermined depth or more, the movement is restricted by the frictional force generated between the locking portions 417a, 417b and the inner surfaces of the locking grooves 121a, 121b. Since the tip of each of the locking portions 417a, 417b of the hemostatic device 10 has a tapered shape, each of the locking portions 417a, 417b can be easily pushed into each of the locking grooves 121a, 121b.

When the hemostatic device 10 is in the locked state shown in FIG. 8, it can be switched to the unlocked state shown in FIG. 7 by lifting each of the locking portions 417a, 417b from the locking grooves 121a, 121b to release the state in which each of the locking portions 417a, 417b is fitted into each of the locking grooves 121a, 121b.

As shown in Figures 3, 4, 5, and 6, the second clamping member 420 has an arm portion 423 connected to the knob portion 421 and inserted into the groove portion 111 of the support member 100, and locking portions 427a and 427b that are configured to be able to fit into the locking groove portions 122a and 122b of the support member 100 and limit the movement of the second clamping member 420 when fitted into the locking groove portions 122a and 122b.

The arm portion 423 of the second clamping member 420 has substantially the same configuration as the arm portion 413 of the first clamping member 410. In addition, each locking portion 427a, 427b of the second clamping member 420 has substantially the same configuration as each locking portion 417a, 417b of the first clamping member 410. Therefore, detailed description of the arm portion 423 and each locking portion 417a, 417b of the second clamping member 420 will be omitted.

The surgeon can switch between the locked and unlocked states of the second clamping member 420 by engaging and releasing the locking portions 427a, 427b of the second clamping member 420 into the locking grooves 122a, 122b in the same manner as when switching between the locked and unlocked states of the first clamping member 410.

As shown in Figures 4, 5, and 6, the first clamping member 410 is arranged along the vertical width direction of the balloon 210 and has a suppressing portion 415 that presses the balloon 210 in the horizontal width direction as the first clamping member 410 and the second clamping member 420 approach each other.

As shown in Figures 4, 5, and 6, the second clamping member 420 is arranged along the vertical width direction of the balloon 210 and has a suppressing portion 425 that presses the balloon 210 in the horizontal width direction as the first clamping member 410 and the second clamping member 420 approach each other.

The suppressing portion 415 of the first clamping member 410 has a pressing surface 415a that faces the balloon 210. The suppressing portion 425 of the second clamping member 420 has a pressing surface 425a that faces the balloon 210.

When the first clamping member 410 moves closer to the second clamping member 420, the pressing surface 415a of the suppressing portion 415 comes into surface contact with the side surface of the balloon 210. When the second clamping member 420 moves closer to the first clamping member 410, the pressing surface 425a of the suppressing portion 425 comes into surface contact with the side surface of the balloon 210. When the first clamping member 410 and the second clamping member 420 come closer to each other, the hemostatic device 10 presses the balloon 210 from both sides in the width direction of the balloon 210 with the pressing surfaces 415a, 425a in surface contact with the balloon 210, thereby deforming the balloon 210 from an uncompressed state to a compressed state.

As shown in FIG. 4, the pressing surface 415a of the suppressing portion 415 of the first clamping member 410 has a width W3 of 70% or more of the vertical width W2 of the balloon 210 in an uncompressed state where the suppressing portion 415 does not compress the balloon 210. The pressing surface 425a of the suppressing portion 425 of the second clamping member 420 has a width W4 of 70% or more of the vertical width W2 of the balloon 210 in an uncompressed state where the suppressing portion 425 does not compress the balloon 210. The widths W3 and W4 of the pressing surfaces 415a and 415b are dimensions in a direction perpendicular to the horizontal width direction of the balloon 210 in the plan view shown in FIG. 4 (the vertical direction in FIG. 4).

The first and second clamping members 410 and 420 are formed such that the widths W3 and W4 of the pressing surfaces 415a and 425a are 70% or more of the vertical width W2 of the balloon 210. Therefore, when the first and second clamping members 410 and 420 press the balloon 210, the pressing surfaces 415a and 425b come into contact over a relatively long range in the vertical width direction of the balloon 210. Therefore, when the first and second clamping members 410 and 420 press the balloon 210 in the horizontal width direction with the pressing surfaces 415a and 425a, the portions near both ends of the balloon 210 in the vertical width direction (portions near both ends on the upper and lower sides shown in FIG. 4) protrude from between the pressing surfaces 415a and 425a, and the balloon 210 is prevented from being deformed into a gourd-like shape in a plan view. This allows the hemostatic device 10 to compress the balloon 210 toward the center of the balloon 210 in the vertical width direction. Therefore, the balloon 210 deforms so that the center of the balloon 210 in the vertical width direction protrudes in the height direction of the balloon 210. As a result, the hemostatic device 10 can increase the compression force that the balloon 210 applies to the puncture site p.

As shown in FIG. 5, when the first clamping member 410 and the second clamping member 420 are at their farthest apart state, the distance L3 between the support member 100 and the lower ends 416, 426 of the suppressing portions 415, 425 located on the side farther from the support member 100 is smaller than the first height H1 of the balloon 210.

Because the distance L3 is smaller than the first height H1 of the balloon 210, the hemostatic device 10 can prevent the lower ends 416, 426 of the suppressing portions 415, 425 from coming into contact with the body surface of the patient's right hand Hr when the balloon 210 is placed at the puncture site p as shown in FIG. 11. Therefore, when the balloon 210 is in an uncompressed state, the hemostatic device 10 can place the balloon 210 at the puncture site p without being hindered by the suppressing portions 415, 425. Therefore, when the surgeon gradually transitions the balloon 210 from a compressed state to a non-compressed state in order to reduce the compression force on the puncture site p, the hemostatic device 10 can maintain the compression force of the balloon 210 on the puncture site p without being hindered by the suppressing portions 415, 425. Similarly, in the hemostatic device 10, since the distance L3 is smaller than the first height H1 of the balloon 210, as shown in FIG. 12, when the balloon 210 applies a compressive force to the puncture site p, the lower ends 416, 426 of the suppressing portions 415, 425 can be prevented from coming into contact with the body surface of the patient's right hand Hr. Therefore, when the balloon 210 is in a compressed state, the hemostatic device 10 can place the balloon 210 at the puncture site p without being hindered by the suppressing portions 415, 425. In addition, when the balloon 210 is in a compressed state, the hemostatic device 10 can suitably apply a compressive force from the balloon 210 to the puncture site p without being hindered by the suppressing portions 415, 425.

In this embodiment, in the locked state shown in FIG. 6, the distance L3' formed between the inner surface 100a of the support member 100 and each lower end 416, 426 is configured to be smaller than the first height H1' of the balloon 210 in the compressed state. Therefore, even when the clamping members 410, 420 are in the locked state and the balloon 210 is in the compressed state, the balloon 210 arranged between the suppressing portions 415, 425 of the hemostatic device 10 can preferably apply a compressive force to the puncture site p.

As shown in Figures 5, 6, 7, and 8, the lower end portions 416, 426 of each suppression portion 415, 425 can be formed with a cross-sectional shape that is curved downward (away from the support member 100). By having the lower end portions 416, 426 of each suppression portion 415, 425 have a curved cross-sectional shape, it is possible to prevent the patient from experiencing pain even when the lower end portions 416, 426 of each suppression portion 415, 425 come into contact with the body surface of the patient's right hand Hr.

The pressing surfaces 415a, 415b of each suppressing portion 415, 425 can be configured to have a linear shape in the vertical direction of the cross section shown in Figures 5 and 6. By forming the cross-sectional shape of each pressing surface 415a, 415b in this manner, the contact area when each pressing surface 415a, 415b contacts the balloon 210 can be increased. This allows each pressing surface 415a, 415b to effectively apply a pressing force to the balloon 210.

<Examples of use of hemostatic devices>
Next, a usage example of the hemostatic device 10 will be described with reference to Figures 9 to 12. In the usage example, a procedure for using the hemostatic device 10 when stopping bleeding at a puncture site p formed on a patient's right hand Hr as shown in Figure 9 will be described.

Figure 9 shows the state after the sheath tube 510 of the introducer 500 has been inserted into the puncture site p created on the patient's right hand Hr and various procedures have been performed.

When stopping bleeding at the puncture site p, the surgeon positions the support member 100 so as to cover the puncture site p. At this time, the surgeon visually checks the position of the marker portion 218 placed on the balloon 210 while placing the marker portion 218 at the puncture site p, thereby allowing the balloon 210 to be appropriately positioned at the puncture site p.

The surgeon secures the first strap 310, the second strap 320, and the third strap 330 to the patient's right hand Hr, as shown in Figure 10.

When attaching the hemostatic device 10 to the patient's right hand Hr, the surgeon may prepare the balloon 210 in an uncompressed state or in a compressed state. In this example of use, as shown in FIG. 12, the balloon 210 is prepared in a compressed state when attaching the hemostatic device 10 to the patient's right hand Hr, and then the pressure in the balloon 210 is reduced over time by separating the clamping members 410, 420 according to the hemostatic state of the puncture site p. As shown in FIG. 12, when the surgeon fixes the bands 310, 320, 330 with the balloon 210 positioned at the puncture site p, the balloon 210 applies a compressive force to the puncture site p.

When the surgeon wants to maintain the compressed balloon 210 exerting a compressive force on the puncture site p, the surgeon switches to the locked state by fitting each locking portion 417a, 417b, 427a, 427b into each locking groove portion 121a, 121b, 122a, 122b. By switching to the locked state, the surgeon restricts the movement of each clamping member 410, 420. By switching to the locked state, the surgeon can prevent the amount of compressive deformation of the balloon 210 in the width direction from changing inadvertently.

When the surgeon wishes to reduce the compressive force applied by the balloon 210 to the puncture site p, he releases the locks of the locking sections 417a, 417b, 427a, and 427b. With the locks released, the surgeon separates the first clamping member 410 and the second clamping member 420 from each other. As shown in FIG. 11, when the first clamping member 410 and the second clamping member 420 are separated from each other and the distance between the first clamping member 410 and the second clamping member 420 increases, the amount of compressive deformation of the balloon 210 in the width direction decreases. The balloon 210 deforms so that the height of the balloon 210 decreases as the amount of compressive deformation of the balloon 210 in the width direction decreases. As a result, the balloon 210 reduces the compressive force applied to the puncture site p compared to before the distance between the first clamping member 410 and the second clamping member 420 increases.

When moving the first clamping member 410 and the second clamping member 420 toward or away from each other, the surgeon can grasp the knobs 411, 421 protruding toward the outer surface 100b of the support member 100 with his/her fingers. By moving the knobs 411, 421 toward or away from each other while grasping the knobs 411, 421 with his/her fingers, the surgeon can move the first clamping member 410 and the second clamping member 420 toward or away from each other together with the knobs 411, 421. In the hemostatic device 10, the knobs 411, 421 are arranged to protrude toward the outer surface 100b of the support member 100, so that the surgeon can easily grasp and operate the knobs 411, 421.

As described above, the hemostatic device 10 according to this embodiment includes a support member 100 configured to cover a puncture site p formed in a patient, a balloon 210 connected to the support member 100 and configured to compress the puncture site p, a fixing member 300 extending from the support member 100 and configured to fix the support member 100 to the puncture site p, and a pair of clamping members 400 facing each other across the balloon 210. The pair of clamping members 400 includes a first clamping member 410 and a second clamping member 420 facing the first clamping member 410 across the balloon 210. The first clamping member 410 and the second clamping member 420 are configured to be movable toward and away from each other so that the distance between the first clamping member 410 and the second clamping member 420 can be changed to control the width of the balloon 210.

The hemostatic device 10 includes a first clamping member 410 and a second clamping member 420 that face each other with the balloon 210 in between. The surgeon can reduce the width of the balloon 210 by bringing the first clamping member 410 and the second clamping member 420 close to each other and reducing the distance between the first clamping member 410 and the second clamping member 420. When the width of the balloon 210 is reduced, the height of the balloon 210 increases. Therefore, in the above-mentioned hemostatic device 10, the compression force applied by the balloon 210 to the puncture site p is greater than before the width of the balloon 210 is reduced. In addition, the surgeon can increase the width of the balloon 210 by moving the first clamping member 410 and the second clamping member 420 away from each other and increasing the distance between the first clamping member 410 and the second clamping member 420. When the width of the balloon 210 is increased, the height of the balloon 210 is reduced. Therefore, in the hemostatic device 10 described above, the compressive force applied by the balloon 210 to the puncture site p is smaller than before the width of the balloon 210 was increased. In this way, the hemostatic device 10 can reversibly increase or decrease the compressive force applied by the balloon 210 to the puncture site p by the simple operation of changing the distance between the first clamping member 410 and the second clamping member 420.

The first clamping member 410 and the second clamping member 420 each have a knob portion 411, 421 that protrudes toward the outer surface 100b of the support member 100, which is located opposite the inner surface 100a on which the balloon 210 is arranged.

When the surgeon changes the distance between the first clamping member 410 and the second clamping member 420, the hemostatic device 10 configured as described above can move the knobs 411, 421 closer to or farther from each other while grasping the knobs 411, 421 protruding from the outer surface 100b of the support member 100 with the fingers. Since the hemostatic device 10 has the knobs 411, 421 protruding from the outer surface 100b of the support member 100, the surgeon can easily grasp and operate the knobs 411, 421.

The support member 100 also has grooves 111 and 112 that slidably hold the first clamping member 410 and the second clamping member 420, and locking grooves 121a, 121b, 122a, and 122b that extend in substantially the same direction as the grooves 111 and 112. The first clamping member 410 and the second clamping member 420 have arm portions 413 and 423 that are connected to the knob portions 411 and 421 and inserted into the grooves 111 and 112, and locking portions 417a, 417b, 427a, and 427b that are configured to be able to be fitted into the locking grooves 121a, 121b, 122a, and 122b and that limit the movement of the first clamping member 410 and the second clamping member 420 when fitted into the locking grooves 121a, 121b, 122a, and 122b.

The hemostatic device 10 configured as described above can be switched to a locked state in which the movement of each clamping member 410, 420 is restricted by a simple operation of fitting the locking portions 417a, 417b, 427a, 427b into the locking grooves 121a, 121b, 122a, 122b. The hemostatic device 10 can also be switched to an unlocked state in which the clamping members 410, 420 are movable by a simple operation of releasing the fitting of the locking portions 417a, 417b, 427a, 427b into the locking grooves 121a, 121b, 122a, 122b.

The first clamping member 410 and the second clamping member 420 are configured to change the width and height of the balloon 210 based on the distance between the first clamping member 410 and the second clamping member 420. The first clamping member 410 and the second clamping member 420 compress the balloon 210 in the width direction so that the height of the balloon 210 is larger when the distance between the first clamping member 410 and the second clamping member 420 is a first distance L1 compared to when the distance is a second distance L2 that is longer than the first distance L1.

The hemostatic device 10 configured as described above can compress the balloon 210 in the width direction so that the height of the balloon 210 increases by bringing the first clamping member 410 and the second clamping member 420 closer to each other so that the distance between the first clamping member 410 and the second clamping member 420 decreases. The hemostatic device 10 can adjust the compression force applied by the balloon 210 to the puncture site p to be greater than before the height of the balloon 210 increases by compressing the balloon 210 in the width direction while expanding in the height direction as the first clamping member 410 and the second clamping member 420 approach each other.

The first clamping member 410 and the second clamping member 420 each have a suppressing portion 415, 425 that is arranged along the vertical width direction of the balloon 210 and presses the balloon 210 in the horizontal width direction as the first clamping member 410 and the second clamping member 420 approach each other. Each suppressing portion 415, 425 has a pressing surface 415a, 425a that faces the balloon 210.

When the first clamping member 410 and the second clamping member 420 are brought close to each other, the hemostatic device 10 configured as described above compresses the balloon 210 in the width direction while the pressing surface 415a of the suppressing portion 415 and the pressing surface 425a of the suppressing portion 425 come into surface contact with the balloon 210. Therefore, by bringing the first clamping member 410 and the second clamping member 420 close to each other, the balloon 210 can be efficiently compressed in the width direction.

In addition, the pressing surfaces 415a, 425a have a width that is 70% or more of the vertical width of the balloon 210 when the suppressing sections 415, 425 are not compressing the balloon 210 in the horizontal width direction.

In the hemostatic device 10 configured as described above, the width of the pressing surfaces 415a and 425a is formed to be 70% or more of the vertical width of the balloon 210, so that the pressing surfaces 415a and 425a can compress the balloon 210 along the horizontal width direction over a relatively long range in the vertical width direction of the balloon 210. As a result, when the pressing surfaces 415a and 425a of the first clamping member 410 and the second clamping member 420 contact the balloon 210, the portions near both ends in the vertical width direction of the balloon 210 protrude from between the pressing surfaces 415a and 425a, and the balloon 210 can be prevented from being deformed into a gourd-like shape. As a result, the hemostatic device 10 can compress the balloon 210 toward the center of the vertical width direction of the balloon 210. The balloon 210 deforms so that the center of the vertical width direction of the balloon 210 protrudes in the height direction. Therefore, the hemostatic device 10 can increase the compression force that the balloon 210 applies to the puncture site p.

In addition, when the first clamping member 410 and the second clamping member 420 are at their farthest apart state, the distance L3 between the support member 100 and the lower ends 416, 426 of the suppressing portions 415, 425 located on the side farther from the support member 100 is smaller than the first height H1 of the balloon 210.

The hemostatic device 10 configured as described above can prevent the lower ends 416, 426 of the suppressing portions 415, 425 from contacting the body surface of the patient's right hand Hr when the balloon 210 is placed at the puncture site p because the distance L3 is smaller than the first height H1 of the balloon 210. Therefore, the hemostatic device 10 can place the balloon 210 at the puncture site p without being hindered by the suppressing portions 415, 425 when the balloon 210 is in an uncompressed state. Similarly, the hemostatic device 10 can prevent the lower ends 416, 426 of the suppressing portions 415, 425 from contacting the body surface of the patient's right hand Hr when the balloon 210 applies a compressive force to the puncture site p because the distance L3 is smaller than the first height H1 of the balloon 210. Therefore, the hemostatic device 10 can preferably apply a compressive force to the puncture site p from the balloon 210 placed between the suppressing portions 415, 425.

Next, modified examples of the hemostatic device according to the present invention will be described. In the description of the modified examples, the explanation of the components and the procedure for using the hemostatic device that have already been described in the description of the above-mentioned embodiment will be omitted as appropriate. Furthermore, the contents not specifically described in each modified example can be the same as those in the above-mentioned embodiment.

(Variation 1)
Figures 13 and 14 are cross-sectional views of a hemostatic device according to Modification 1. Figures 13 and 14 are cross-sectional views corresponding to Figures 5 and 6 of the above-mentioned embodiment. Figure 13 shows the balloon 210A in an uncompressed state, and Figure 14 shows the balloon 210A in a compressed state.

As shown in FIG. 13, the hemostatic device according to the first modification has a "drop-shaped" cross section in which the cross-sectional area of the balloon 210A gradually increases from the upper surface 210a side toward the lower surface 210b side in an uncompressed state, and gradually decreases from approximately the center in the height direction toward the lower surface 210b. Because the balloon 210A has a drop-shaped cross section as described above, when the filling material 220 is filled in the balloon 210A, the lower surface 210b side of the balloon 210A deforms so as to droop. As a result, the cross-sectional area of the portion of the balloon 210A located near the upper surface 210a becomes even smaller than the cross-sectional area of the portion of the balloon 210A located near the lower surface 210b, and the vicinity of the upper surface 210a presents a narrowed cross section.

14, when the first clamping member 410 and the second clamping member 420 approach each other, the pressing surfaces 415a, 425a of the suppressing portions 415, 425 contact only a portion located on the upper surface 210a side of the balloon 210A having a small cross-sectional area. In the hemostatic device according to the first modification, the pressing surfaces 415a, 425a contact only a portion located on the upper surface 210a side of the balloon 210A having a small cross-sectional area, so that when the first clamping member 410 and the second clamping member 420 approach each other, the balloon 210A can be prevented from being pinched between the inner surface 100a of the support member 100 (the inner surface of the support portion 105) and each clamping member 410, 420. Therefore, when the first clamping member 410 and the second clamping member 420 approach each other, the surgeon can smoothly move the first clamping member 410 and the second clamping member 420. As a result, the hemostatic device of variant 1 can prevent the surgeon from feeling stressed when the surgeon changes the positions of the clamping members 410, 420 by having the balloon 210A pinched between the clamping members 410, 420.

When the balloon 210A is deformed to the compressed state shown in FIG. 14, the portion (lowermost portion) located near the lower surface 210b of the balloon 210A has a smaller cross-sectional area than the portion located near the center of the balloon 210A in the height direction. Therefore, the balloon 210A can locally apply a compressive force to the puncture site p from near the lower surface 210b. This allows the balloon 210A to effectively increase the compressive force applied to the puncture site p. Furthermore, since the balloon 210A is formed in a drop shape, when the balloon 210A is deformed to the compressed state, the area of the lower surface 210b side of the balloon 210 becomes larger than the upper surface 210a, so the balloon 210 is more likely to rise on the lower surface 210b side, and the balloon 210A can apply a stronger compressive force to the puncture site p.

(Variation 2)
Figures 15 and 16 are plan views of a hemostatic device according to Modification 2. Figures 15 and 16 are cross-sectional views corresponding to Figure 3 of the above-mentioned embodiment. Figures 15 and 16 are plan views of a support member 100 as viewed from the outer surface 100b side.

The hemostatic device of the second modification has an interlocking mechanism 430 that interlocks the action of moving the first clamping member 410 toward and away from the second clamping member 420 with the action of moving the second clamping member 420 toward and away from the first clamping member 410.

The interlocking mechanism 430 has a rotation drive unit 440, a first drive unit 451 connected to the first clamping member 410, and a second drive unit 452 connected to the second clamping member 420.

The rotation drive unit 440 is disposed on the support portion 105 of the support member 100. The rotation drive unit 440 is configured to be rotatable clockwise and counterclockwise as indicated by the arrows R-R' in FIG. 15. A gear portion 441 is provided on the outer periphery of the rotation drive unit 440.

The first drive unit 451 has a gear portion 451a that meshes with the gear portion 441 of the rotation drive unit 440. The second drive unit 452 has a gear portion 452a that meshes with the gear portion 441 of the rotation drive unit 440.

16, when the surgeon rotates the rotation drive unit 440 clockwise as indicated by the arrow R, the first drive unit 451 and the second drive unit 452 move in a direction approaching each other in conjunction with the rotation of the rotation drive unit 440. When the first drive unit 451 and the second drive unit 452 move in a direction approaching each other, the first clamping member 410 connected to the first drive unit 451 and the second clamping member 420 connected to the second drive unit 452 move in a direction approaching each other. The surgeon can deform the balloon 210 into a compressed state by bringing the first clamping member 410 and the second clamping member 420 in close proximity to each other. When the surgeon moves the first clamping member 410 and the second clamping member 420 away from each other, the surgeon rotates the rotation drive unit 440 counterclockwise. When the surgeon rotates the rotation drive unit 440 counterclockwise, the first drive unit 451 and the second drive unit 452 move away from each other. When the first drive unit 451 and the second drive unit 452 move away from each other, the first clamping member 410 and the second clamping member 420 move away from each other. This operation allows the surgeon to change the balloon 210 from a compressed state to an uncompressed state.

As described above, the hemostatic device according to the second modification has an interlocking mechanism 430 that interlocks the operation of moving the first clamping member 410 close to and away from the second clamping member 420 and the operation of moving the second clamping member 420 close to and away from the first clamping member 410. The surgeon can interlock the approach and separation of the first clamping member 410 and the approach and separation of the second clamping member 420 by operating the interlocking mechanism 430. Therefore, the surgeon can perform the work of moving the first clamping member 410 and the second clamping member 420 close to and away from each other more simply and smoothly. In addition, since the approach and separation of the first clamping member 410 and the approach and separation of the second clamping member 420 are interlocked in the hemostatic device according to the second modification, it is also possible to prevent the balloon 210 from being displaced from the puncture site p due to erroneous operation or the like when moving the first clamping member 410 and the second clamping member 420.

The structure of the interlocking mechanism is not limited to the form shown in Fig. 15 and Fig. 16. For example, the interlocking mechanism may not include the rotation drive unit 440. When the interlocking mechanism is configured in this way, the interlocking mechanism can be configured to include a first drive unit that can move linearly, and a second drive unit that is connected to the first drive unit and can move in conjunction with the movement of the first drive unit. The first drive unit can be provided with a plurality of first uneven parts arranged along the approach/separation direction, and the second drive unit can be provided with a plurality of second uneven parts arranged along the approach/separation direction and engageable with the plurality of first uneven parts. In the hemostatic device configured in this way, when an operation is performed to move one of the first drive unit and the second drive unit toward or away from the other with the first uneven parts and the second uneven parts engaged, the other drive unit can be moved in the approach/separation direction in conjunction with the operation.

(Variation 3)
Fig. 17 shows a cross-sectional view of a hemostatic device according to Modification 3. Fig. 17 is a cross-sectional view corresponding to Fig. 6 of the above-mentioned embodiment. Fig. 17 shows a balloon 210 in a compressed state.

In the hemostatic device of the third modified example, the pressing surface 415b of the suppressing portion 415 of the first clamping member 410A and the pressing surface 425b of the suppressing portion 425 of the second clamping member 420A are inclined so that the distance between them gradually decreases in the direction away from the support member 100 (the inner surface 100a of the support member 100) (the direction toward the lower surface 210b of the balloon 210).

In the hemostatic device according to the third modification, when the first clamping member 410A and the second clamping member 420A approach each other, the pressing surfaces 415a, 415b compress the balloon 210A in the width direction toward the center side in the left-right direction of the cross-sectional view of FIG. 17. Therefore, in the compressed state, the balloon 210 deforms in a direction in which the vicinity of the center moves away from the support member 100 (downward in FIG. 17). This allows the balloon 210 to locally apply a compressive force to the puncture site p from the vicinity of the lower surface 210b of the balloon 210. Therefore, the balloon 210 can effectively increase the compressive force applied to the puncture site p.

As shown in FIG. 17, in the hemostatic device according to Modification 3, in the compressed state, the cross-sectional shape of the balloon 210 has a tapered shape in which the cross-sectional area gradually decreases from the upper surface 210a side toward the lower surface 210b side. In the hemostatic device according to Modification 3, the balloon 210 is formed with the cross-sectional shape described above, so that when the balloon 210 is deformed to the compressed state as shown in FIG. 17, the lower surface 210b of the balloon 210 comes into contact with the vicinity of the puncture site p over a narrow area. Therefore, in the hemostatic device according to Modification 3, the balloon 210 can locally apply a compressive force to the puncture site p. This makes it possible to effectively increase the compressive force that the balloon 210 applies to the puncture site p.

(Variation 4)
Fig. 18 shows a plan view of a hemostatic device according to Modification 4. Fig. 18 is a plan view corresponding to Fig. 4 of the above-mentioned embodiment. Fig. 18 is a plan view seen from the outer surface 100b side of the support member 100. Fig. 18 shows the balloon 210 in a compressed state.

As shown in FIG. 18, the hemostatic device according to the fourth modification is arranged with a balloon 210 sandwiched between a pair of clamping members 400 in a vertical width direction (up and down direction in the figure) that intersects with the horizontal width direction (left and right direction in the figure) in which the clamping members 400 approach and separate from each other, and has stopper portions 131, 132 that limit the maximum deformation of the balloon 210 in the vertical width direction when the pair of clamping members 400 approach each other.

The stopper portion 131 is disposed so as to face the stopper portion 132 across the balloon 210. Each of the stopper portions 131 and 132 is made of a material harder than the balloon 210.

The hemostatic device according to the fourth modification has the stopper portions 131 and 132, and thus can prevent the balloon 210 from deforming excessively in the vertical width direction when the balloon 210 is deformed to a compressed state. By preventing the balloon 210 from deforming excessively in the vertical width direction, the surgeon can guide the direction of deformation of the balloon 210 in the height direction of the balloon 210 (downward in FIG. 12) when the balloon 210 is deformed to a compressed state. Therefore, the hemostatic device according to the fourth modification can deform the balloon 210 so that it protrudes toward the puncture site p when the balloon 210 is deformed to a compressed state. As a result, the hemostatic device according to the fourth modification can effectively increase the compressive force applied by the balloon 210 to the puncture site p.

18, the hemostatic device according to the fourth modification is configured so that the pressing surfaces 415c, 425c of the suppressing portions 415, 425 of the clamping members 410B, 420B have a surface shape corresponding to the side surface located in the width direction of the balloon 210. In this modification, the pressing surfaces 415c, 425c of the suppressing portions 415, 425 have a concave surface shape along the curved side surface protruding toward the width direction of the balloon 210. As in the hemostatic device according to the fourth modification, the pressing surfaces 415c, 425c of the suppressing portions 415, 425 are formed in a surface shape corresponding to the side surface located in the width direction of the balloon 210, so that when the balloon 210 is deformed to a compressed state, the contact area between the side surface of the balloon 210 and the pressing surfaces 415c, 425c can be increased. Therefore, the hemostatic device according to the fourth modification can effectively compress the balloon 210 along the width direction.

(Variation 5)
Figures 19 and 20 are cross-sectional views of a hemostatic device according to Modification 5. Figures 19 and 20 are cross-sectional views corresponding to Figures 5 and 6 of the above-mentioned embodiment. Figure 19 shows the balloon 210 in an uncompressed state. Figure 20 shows the balloon 210 in a compressed state.

As shown in Figures 19 and 20, the hemostatic device of variant 5 is configured such that the suppressing portion 415 of the first clamping member 410C and the suppressing portion 425 of the second clamping member 420C form gaps g1 and g2 with the inner surface 100a (inner surface of the support portion 105) on which the balloon 210 of the support member 100 is arranged when the balloon 210 is not compressed.

As shown in FIG. 19, when the balloon 210 is in an uncompressed state, the pressing surface 415a of the suppressing portion 415 is disposed at a position spaced apart from the inner surface 100a of the support member 100 with a gap g1. Also, when the balloon 210 is in an uncompressed state, the pressing surface 425a of the suppressing portion 425 is disposed at a position spaced apart from the inner surface 100a of the support member 100 with a gap g2.

As shown in FIG. 20, when the first clamping member 410 and the second clamping member 420 are brought close to each other, the hemostatic device according to the fifth modification can compress the balloon 210 in the width direction by the suppressing portions 415, 425 while allowing a portion of the balloon 210 to escape into the gaps g1, g2. This can prevent the balloon 210 from being pinched between the inner surface 100a of the support member 100 (the inner surface of the support portion 105) and each of the clamping members 410C, 420C. Therefore, when the surgeon brings the first clamping member 410C and the second clamping member 420C close to each other, the surgeon can smoothly move the first clamping member 410C and the second clamping member 420C.

(Variation 6)
Figures 21 and 22 are cross-sectional views of a hemostatic device according to Modification 6. Figures 21 and 22 are cross-sectional views corresponding to Figures 5 and 6 of the above-mentioned embodiment. Figure 21 shows a balloon 210B in an uncompressed state. Figure 22 shows a balloon 210B in a compressed state.

As shown in Figures 21 and 22, the hemostatic device of variant 6 differs from the above-described embodiment in the configuration of the grooves 111 and 112 that hold the clamping members 410 and 420.

21 and 22, the support member 100 is configured with a cross-sectional shape that is convex downward from both ends of the support member 100 in the width direction (the ends in the left and right directions in FIGS. 21 and 22) toward the center of the support member 100 in the width direction. As a result, each groove 111A, 112A is inclined so that the height distance between the convex portion 219 located at the bottom end of the balloon 210 gradually decreases from the end side of the support member 100 in the width direction (the end side to which each band 320, 330 is connected) toward the center of the support member 100 in the width direction.

The hemostatic device according to the sixth modification is configured so that the end of the support member 100 in the width direction of each groove 111A, 112A forms a greater height distance between the protrusion 219 of the balloon 210 and the end of the support member 100 in the width direction of each groove 111A, 112A compared to the center position of the support member 100 in the width direction of each groove 111A, 112A. In other words, the support member 100 is curved in a direction away from the balloon 210 from the center of the support member 100 toward the periphery. Therefore, the lower end 416, 426 of each suppression portion 415, 425 can be prevented from contacting the body surface of the patient's right hand Hr. In particular, as shown in FIG. 21, when the balloon 210 is in an uncompressed state and the distance between the first clamping member 410 and the second clamping member 420 is the widest, the balloon 210B is not deformed into a shape that protrudes in the height direction, so that the lower end 416, 426 of each suppression portion 415, 425 is more likely to contact the body surface of the patient's right hand Hr. However, in the hemostatic device according to the sixth modification, the grooves 111A, 112A extend at an angle toward the center of the width of the support member 100 as described above, and therefore, when the first clamping member 410 and the second clamping member 420 are at their furthest apart, the lower ends 416, 426 of the suppressing portions 415, 425 can be prevented from contacting the body surface of the patient's right hand Hr. Similarly, even when the balloon 210B is in a compressed state, the hemostatic device can apply a compressive force from the balloon 210B to the puncture site p without being hindered by the suppressing portions 415, 425.

21 and 22, the balloon 210B of the hemostatic device according to the sixth modification has a convex portion 219 formed at approximately the center of the width of the balloon 210B. The convex portion 219 is disposed at a position farthest from the inner surface 100a of the support member 100 than other portions of the balloon 210B. In the hemostatic device according to the sixth modification, the balloon 210B is formed with a cross-sectional shape having the convex portion 219 as described above, so that when the balloon 210B is deformed to a compressed state as shown in FIG. 22, a compressive force can be applied locally from the convex portion 219 of the balloon 210B to the vicinity of the puncture site p. Therefore, the hemostatic device according to the sixth modification can increase the compressive force applied by the balloon 210B to the puncture site p.

(Other Modifications)
When the pressing member is a balloon, the thickness of the side of the balloon (the surface facing each clamping member) can be made thicker than other parts of the balloon. When the thickness of the side of the balloon is made thicker, the side of the balloon is less likely to deform than other parts of the balloon. When the balloon is configured in this way, it is possible to prevent the side of the balloon from deforming in such a way that it escapes in the width direction when the balloon is compressed. By preventing the side of the balloon from deforming in such a way that it escapes in the width direction, the hemostatic device can locally contact the lower surface or the lowest end of the balloon with the body surface of the patient's right hand Hr in a narrow range. Therefore, the compressive force applied by the balloon to the puncture site p can be effectively increased.

The hemostatic device according to the present invention has been described above through embodiments and modifications, but the present invention is not limited to the contents described in the specification, and can be modified as appropriate based on the claims.

In the embodiment and each modified example, an example in which the pressing member is configured with a balloon has been described. However, the specific structure of the pressing member is not limited as long as the width can be controlled by moving the pair of clamping members closer to each other and farther apart. The pressing member can be configured with, for example, an elastic member or the like that can deform to a smaller width when the pair of clamping members move closer to each other and can deform to a larger width when the pair of clamping members move farther apart.

In the embodiment, a hemostatic device for stopping bleeding at a puncture site formed on a right hand is exemplified. However, the hemostatic device can also be configured to stop bleeding at a puncture site formed on a left hand. In addition, the hemostatic device can also be used in a procedure to stop bleeding at a puncture site formed on a part of the patient other than the hand (for example, a puncture site formed on a limb including the wrist or lower leg).

The configurations described in the embodiment and each modified example can be combined in any way as long as it is possible to control the deformation in the width direction of the pressing member using a pair of clamping members.

10 Hemostatic device 100 Support member 100a Inner surface 100b of support member Outer surface 105 of support member Support portion 111 Groove portion 112 Groove portion 121a Locking groove portion 121b Locking groove portion 122a Locking groove portion 122b Locking groove portion 131 Stopper portion 132 Stopper portion 200 Pressing member 210 Balloon 210A Balloon 210B Balloon 210a Upper surface 210b of balloon Lower surface 215 of balloon Internal space 216 Lower end portion 218 Marker portion 219 Convex portion 220 Filler 300 Fixing member 310 First band 320 Second band 330 Third band 400 Pair of clamping members 410 First clamping member 410A First clamping member 410B First clamping member 410C First clamping member 411 Knob portion 413 Arm portion 415 Suppressing portion 415a Pressing surface 416 Lower end portion 417a of suppressing portion Locking portion 417b Locking portion 420 Second clamping member 420A Second clamping member 420B Second clamping member 420C Second clamping member 421 Knob portion 423 Arm portion 425 Suppressing portion 425a Pressing surface 426 Lower end portion 427a of suppressing portion Locking portion 427b Locking portion 430 Interlocking mechanism 440 Rotational drive unit 451 First drive unit 452 Second drive unit 500 Introducer 510 Sheath tube H1 First height H1' of pressing member in uncompressed state First height L1 of pressing member in compressed state First distance L2 Second distance L3 Distance L3' between support member and lower end portion of suppressing portion in uncompressed state Distance W1 between support member and lower end portion of suppressing portion in compressed state Horizontal width W1' of pressing member in uncompressed state Width W2 of the pressing member in a compressed state Length W3 of the pressing member in an uncompressed state Width W4 of the pressing surface Width g1 of the pressing surface Gap g2 Gap A Forearm B Artery (blood vessel)
H hand Hr right hand fb finger gap p puncture site

Claims (11)

a support member configured to cover a puncture site formed in a patient;
a pressing member connected to the support member and configured to press the puncture site;
a fixation member extending from the support member and configured to fix the support member at the puncture site;
a pair of clamping members opposed to each other with the pressing member in between,
The pair of clamping members includes a first clamping member and a second clamping member facing the first clamping member with the pressing member in between,
A hemostatic device, wherein the first clamping member and the second clamping member are configured to be movable toward and away from each other so that the distance between the first clamping member and the second clamping member can be changed to control the lateral width of the pressing member. The hemostatic device according to claim 1, wherein each of the first clamping member and the second clamping member has a knob portion protruding from the outer surface of the support member, the outer surface being located on the opposite side to the inner surface on which the pressing member is located. the support member has a groove portion that slidably holds the first clamping member and the second clamping member, and a locking groove portion that extends in substantially the same direction as the groove portion,
3. The hemostatic device according to claim 2, wherein the first clamping member and the second clamping member have an arm portion connected to the knob portion and inserted into the groove portion, and a locking portion configured to be able to be fitted into the locking groove portion and that limits movement of the first clamping member and the second clamping member when fitted into the locking groove portion. the first clamping member and the second clamping member are configured to change a width and a height of the pressing member based on a distance between the first clamping member and the second clamping member,
2. The hemostatic device according to claim 1, wherein the first clamping member and the second clamping member compress the pressing member in a width direction such that a height of the pressing member is greater when the first clamping member and the second clamping member are at a first distance compared to when the first clamping member and the second clamping member are at a second distance longer than the first distance. Each of the first clamping member and the second clamping member has a suppressing portion that is disposed along a vertical width direction of the pressing member and presses the pressing member in a horizontal width direction as the first clamping member and the second clamping member approach each other,
The hemostatic device according to claim 4 , wherein the suppressing portion has a pressing surface facing the pressing member. The hemostatic device according to claim 5, wherein the pressing surface of the suppressing portion of the first clamping member and the pressing surface of the suppressing portion of the second clamping member are inclined so that the distance between them gradually decreases in a direction away from the support member. The hemostatic device according to claim 5, wherein the pressing surface has a width of 70% or more of the vertical width of the pressing member when the suppressing portion is not compressing the pressing member in the horizontal width direction. The hemostatic device according to claim 5, wherein when the first clamping member and the second clamping member are in the most separated state, the distance between the support member and the lower end of the suppressing portion located on the side separated from the support member is smaller than the first height of the pressing member. The hemostatic device according to claim 5, wherein the suppressing portion of the first clamping member and the suppressing portion of the second clamping member are configured to form a gap between the inner surface of the support member on which the pressing member is disposed when the pressing member is not compressed in the width direction. The hemostatic device according to claim 1, further comprising an interlocking mechanism that interlocks the action of moving the first clamping member toward and away from the second clamping member with the action of moving the second clamping member toward and away from the first clamping member. The hemostatic device according to claim 1, in which the pair of clamping members are arranged to sandwich the pressing member in a vertical width direction intersecting with the horizontal width direction in which the clamping members approach and separate from each other, and which has a stopper portion that limits the maximum deformation amount of the pressing member in the vertical width direction when the pair of clamping members approach each other.