hemostatic instruments

Abstract

To provide a hemostatic device capable of adjusting a pressing position on a surface of a living body and improving stability of the pressing position of the surface of the living body.SOLUTION: A hemostatic device according to the present disclosure includes: a support member configured to cover a puncture site formed in a patient; a fixation member extending from the support member and configured to be fixable to the patient in a way such that the support member covers the puncture site; and an expansion member supported by the support member and configured to be expandable by fluid. The support member includes: a frame member surrounding the expansion member; and a plate member configured to selectively close an area surrounded by the frame member so as to inhibit expansion of a portion of the expansion member toward the living body surface side.SELECTED DRAWING: Figure 3A

Description

Technical Field

[0001] The present disclosure relates to a hemostatic device.

Background Art

[0002] In recent years, various forms of examinations and treatments have been performed using a slender, hollow tubular medical device called a catheter. As an example of a method for performing this type of examination and treatment, a conventional radial approach (hereinafter referred to as "cRA") in which a catheter is inserted percutaneously through a puncture site formed in the wrist to a vascular lesion is known. Also, as another example, a distal radial approach (hereinafter referred to as "dRA") in which a catheter is inserted percutaneously through a puncture site formed in the anatomical snuffbox of the hand to a vascular lesion is known.

[0003] After performing the above-described examinations and treatments, it is necessary to remove the catheter from the puncture site and stop the bleeding at the puncture site. Patent Document 1 discloses a hemostatic device for stopping bleeding at a puncture site formed in the wrist by cRA. Also, Patent Document 2 discloses a hemostatic device for stopping bleeding at a puncture site formed in the anatomical snuffbox by dRA.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Patent Document 2

Summary of the Invention

Problems to be Solved by the Invention

[0005] The hemostatic device described in Patent Document 2 has a different configuration for the right-handed version. Furthermore, the hemostatic device described in Patent Document 2 does not allow adjustment of the position of the compression member within the hemostatic device, and therefore does not allow adjustment of the compression position on the biological surface. For this reason, the hemostatic device described in Patent Document 2 cannot be used on a puncture site on the left hand for the right-handed version, and the hemostatic device can not be used on a puncture site on the right hand for the left-handed version.

[0006] In contrast, the hemostatic device described in Patent Document 1 allows for adjustment of the compression position on the biological surface by moving the position of the balloon relative to the curved plate. However, even with the hemostatic device described in Patent Document 1, there is still room for improvement in terms of the stability of the compression position on the biological surface by the hemostatic device.

[0007] This disclosure aims to provide a hemostatic device that allows for adjustment of the compression position on the biological surface and improves the stability of the compression position on the biological surface. [Means for solving the problem]

[0008] A hemostatic device according to a first aspect of the present disclosure comprises a support member configured to cover a puncture site formed on a patient; a fixing member extending from the support member and configured to be fixed to the patient in such a way that the support member covers the puncture site; and an expansion member supported by the support member and configured to be expandable by fluid, wherein the support member comprises a frame member surrounding the expansion member and a plate member configured to selectively close a region surrounded by the frame member so as to prevent a portion of the expansion member from expanding toward the biological surface.

[0009] In one embodiment of the present disclosure, the support member comprises a main body member that covers the region surrounded by the frame member from the side opposite to the biological surface, and the plate member is configured to selectively close the region surrounded by the frame member by covering the region surrounded by the frame member from the side opposite to the biological surface.

[0010] In one embodiment of the present disclosure, the expansion member is located only within the region surrounded by the frame member when in the contracted state.

[0011] In one embodiment of the present disclosure, the fixing member comprises a first strip protruding from one end of the support member, a second strip protruding from the other end of the support member opposite to the one end, and a third strip protruding from a position different from the one end and the other end of the support member, wherein the extension member is arranged across both sides of a center line passing through the center position in the width direction of the third strip in the region enclosed by the frame member.

[0012] In one embodiment of the present disclosure, the plate member is configured to be displaceable between a first position in which one side of the region surrounded by the frame member, which straddles the center line of the third strip, is open, and a second position in which the other side of the region surrounded by the frame member, which straddles the center line of the third strip, is open.

[0013] In one embodiment of the present disclosure, the plate member is attached to the frame member such that it is displaceable between the first position and the second position by rotating with respect to the frame member about a pivot axis.

[0014] In one embodiment of the present disclosure, the region enclosed by the frame member includes a closed region that is closed by the plate member at the first and second positions, respectively, and an open region that is not closed by the plate member at the first and second positions, wherein the expansion member is configured such that the maximum expansion length in the thickness direction of the plate member at the boundary between the closed region and the open region is smaller than the maximum expansion length in the thickness direction in the closed region and the open region.

[0015] In one embodiment of the hemostatic device of the present disclosure, marker portions are provided on both sides of the plate member in the thickness direction, configured to have lower light transmittance than the surrounding area and to be mutually identifiable.

[0016] As one embodiment of the present disclosure, the extension member includes an injection port into which the fluid is injected on the third belt side.

[0017] As one embodiment of the present disclosure, the injection port of the extension member is disposed at a position overlapping the center line of the third belt.

[0018] As one embodiment of the present disclosure, the injection port of the extension member opens in a direction along the plate member.

[0019] As one embodiment of the present disclosure, the support member includes an adjustment portion capable of adjusting the amount of extension protrusion on the biological surface side of the extension member.

Advantages of the Invention

[0020] According to the present disclosure, it is possible to provide a hemostatic device capable of adjusting the compression position on the biological surface and improving the stability of the compression position on the biological surface.

Brief Description of the Drawings

[0021] [Figure 1] It is a diagram showing a hemostatic device as one embodiment of the present disclosure. [Figure 2] It is a diagram showing an assembled state of a support member and an extension member, in which the support member and the extension member shown in FIG. 1 are assembled to each other. [Figure 3A] It is a diagram showing a state in which a first region in a region surrounded by a frame member of the plate member shown in FIG. 1 is closed. [Figure 3B] It is a diagram showing a state in which a second region in a region surrounded by a frame member of the plate member shown in FIG. 1 is closed. [Figure 4A] It is a diagram showing a fixing method for fixing the hemostatic device shown in FIG. 1 to the left hand. [Figure 4B] It is a diagram showing a fixing method for fixing the hemostatic device shown in FIG. 1 to the right hand. [Figure 5] It is a diagram showing details of the frame member and the plate member shown in FIG. 1. [Figure 6] This figure shows modified examples of the frame member and plate member shown in Figure 5. [Figure 7A] This figure shows the details of the area near the injection port of the expansion member shown in Figure 1. [Figure 7B] This figure shows a modified example of the configuration near the inlet shown in Figure 7A. [Figure 7C] This figure shows a modified example of the configuration near the inlet shown in Figure 7A. [Figure 7D] This figure shows a modified example of the configuration near the inlet shown in Figure 7A. [Figure 8A] This figure shows a modified version of the main body component shown in Figure 1, illustrating the state in which the second lid completely closes the second opening. [Figure 8B] Figure 8A shows the main body component, illustrating a state where the second lid partially closes a portion of the second opening, leaving a portion of the second opening open. [Figure 9A] This figure shows a modified example of the plate member shown in Figure 1, where the plate member is closing off the first region of the area surrounded by the frame member. [Figure 9B] This figure shows a modified example of the plate member shown in Figure 1, where the plate member closes off the second region of the area enclosed by the frame member. [Modes for carrying out the invention]

[0022] Hereinafter, embodiments of the hemostatic device relating to this disclosure will be illustrated with reference to the drawings. In each figure, identical components are denoted by the same reference numerals.

[0023] Figure 1 shows a hemostatic device 100 as one embodiment of the hemostatic device according to the present disclosure. Figure 1 shows the hemostatic device 100 in a partially disassembled state. The hemostatic device 100 of this embodiment is configured to stop bleeding at a puncture site formed in an anatomical snuffbox using dRA.

[0024] As shown in Figure 1, the hemostatic device 100 comprises a support member 10, a fixing member 20, and an expansion member 30.

[0025] The support member 10 is configured to cover the puncture site formed on the patient. The fixing member 20 extends from the support member 10. The fixing member 20 is configured to be fixed to the patient in a state where the support member 10 covers the patient's puncture site. For the sake of explanation, the state in which the support member 10 covers the patient's puncture site and the fixing member 20 is fixed to the patient will be simply referred to as the "fixed state" of the hemostatic device 100. The expansion member 30 is supported by the support member 10. The expansion member 30 is configured to be expandable by a fluid such as air. In the fixed state of the hemostatic device 100, the expansion member 30 can compress the patient's puncture site by expanding with a fluid.

[0026] As shown in Figure 1, the support member 10 of this embodiment comprises a frame member 11, a plate member 12, and a main body member 13. For the sake of explanation, the support member 10 shown in Figure 1 is shown with the main body member 13 separated from the frame member 11 and the plate member 12. Also, Figure 1 is a view of the hemostatic device 100 in a fixed state, from the side facing the biological surface. Furthermore, Figure 1 shows the hemostatic device 100 in an unfolded state before it is fixed to the patient, rather than in a fixed state. Figure 2 is a diagram showing the assembly state of the support member 10 and the expansion member 30, which are assembled together with the support member 10 and the expansion member 30 shown in Figure 1.

[0027] As shown in Figure 2, the frame member 11 is positioned to surround the expansion member 30. The plate member 12 is configured to selectively close the region SA surrounded by the frame member 11. In this way, the plate member 12 is configured to selectively close region SA, thereby preventing a portion of the expansion member 30 from expanding toward the biological surface in the fixed state of the hemostatic device 100.

[0028] Referring to Figures 2 to 3B, the principle by which the plate member 12 of this embodiment inhibits the partial expansion of the expansion member 30 will be explained. As shown in the upper right and lower right figures of Figure 2, the plate member 12 of this embodiment is configured to divide the region SA surrounded by the frame member 11 into two regions, a first region SA1 and a second region SA2, and to selectively close the first region SA1 and the second region SA2. Figure 3A shows the state in which the plate member 12 of this embodiment is closing the first region SA1 of the region SA surrounded by the frame member 11. Figure 3B shows the state in which the plate member 12 of this embodiment is closing the second region SA2 of the region SA surrounded by the frame member 11. Furthermore, the left figures of Figures 3A and 3B show the contracted state of the expansion member 30. In addition, the right figures of Figures 3A and 3B show the expanded state of the expansion member 30. As shown in Figures 2 to 3B, in this embodiment, in the region SA that is closed by the plate member 12 (the first region SA1 in the upper right of Figure 2 and Figure 3A, and the second region SA2 in the lower right of Figure 2 and Figure 3B), the expansion of the expansion member 30 toward the biological surface BS (see Figures 3A and 3B) is obstructed by abutting against the plate member 12. This inhibits the expansion of the expansion member 30. On the other hand, in this embodiment, in the region SA that is not closed by the plate member 12 (the second region SA2 in the upper right of Figure 2 and Figure 3A, and the first region SA1 in the lower right of Figure 2 and Figure 3B), the expansion of the expansion member 30 toward the biological surface BS is not obstructed by the plate member 12. In other words, the expansion of the expansion member 30 toward the biological surface BS is not obstructed, and the patient's puncture site can be compressed.

[0029] Thus, because the plate member 12 is configured to selectively close region SA, the compression position of the biological surface BS can be adjusted. Furthermore, by changing the closure position of region SA with the plate member 12 without moving the expansion member 30, displacement of the expansion member 30 relative to the support member 10 can be suppressed. Therefore, the compression position of the biological surface BS by the expansion member 30 can be stabilized. In other words, a hemostatic device 100 can be realized that allows for adjustment of the compression position of the biological surface BS and improves the stability of the compression position of the biological surface BS.

[0030] The plate member 12 of this embodiment can selectively close the first region SA1 and the second region SA2 of the region SA surrounded by the frame member 11, but is not limited to this configuration. As will be described in detail later, the hemostatic device 100 of this embodiment is configured to be usable regardless of whether the puncture site formed in the anatomical snuffbox by dRA is formed on the left or right hand. For this reason, the region SA surrounded by the frame member 11 is divided into two regions, the first region SA1 and the second region SA2, but is not limited to a configuration that can be used on both the left and right hands. Even if it is configured to be dedicated to one hand, there may be cases where the compression position needs to be adjusted due to various circumstances, such as the patient's body type and amount of fat. For this reason, the plate member 12 may be configured to selectively close the region SA surrounded by the frame member 11 in three or more regions. In other words, the number and position of regions that can be selectively closed by the plate member 12 are not limited to the number and position of the regions of this embodiment.

[0031] Furthermore, as shown in Figures 3A and 3B, in this embodiment, the plate member 12 is located on the biological surface BS side relative to the expansion member 30 in the fixed state of the hemostatic device 100, but the configuration is not limited to this. In other words, in this embodiment, a part of the expansion member 30 abuts against the plate member 12, thereby inhibiting expansion toward the biological surface BS side, but the configuration is not limited to this. The plate member 12 may be located on the opposite side from the biological surface BS side relative to the expansion member 30 in the fixed state of the hemostatic device 100. In this case, the support member 10 does not need to include the main body member 13. In this case, a part of the expansion member 30 does not abut against the plate member 12, thereby inhibiting expansion toward the biological surface BS side. The principle of inhibiting the expansion of the expansion member 30 toward the biological surface BS side in this manner is the same as that of the adjustment unit 40 described later, so the explanation is omitted here.

[0032] Furthermore, as shown in Figure 1, the fixing member 20 of this embodiment comprises a first band 21, a second band 22, and a third band 23, but is not limited to this configuration. The fixing member 20 may be configured as appropriate depending on the location of the patient's puncture site. However, in the case of a hemostatic device 100 that can stop bleeding at a puncture site formed in an anatomical snuffbox by dRA, as in this embodiment, it is preferable that the fixing member 20 comprises a first band 21, a second band 22, and a third band 23. Details of the fixing member 20 of this embodiment will be described later.

[0033] Furthermore, as shown in Figure 1, the expansion member 30 in this embodiment is a bag-shaped balloon placed in the region SA surrounded by the frame member 11, but it is not limited to this configuration. The expansion member 30 may be, for example, a membrane body whose outer edge is fixed to the main body member 13 of the support member 10. Also, the expansion member 30 may have any other configuration as long as its expansion toward the biological surface BS is partially inhibited by the plate member 12 that selectively closes the region SA surrounded by the frame member 11.

[0034] Further details of the hemostatic device 100 of this embodiment will be described below with reference to Figures 1 to 9B.

[0035] Figure 4A shows a method for fixing the hemostatic device 100 of this embodiment to the left hand. Figure 4B shows a method for fixing the hemostatic device 100 of this embodiment to the right hand. Figure 5 shows details of the frame member 11 and plate member 12 of the support member 10 of this embodiment. Figure 6 shows a modified example of the frame member 11 and plate member 12 shown in Figure 5. Figure 7A shows details of the vicinity of the injection port 34 of the expansion member 30 of this embodiment. Figures 7B to 7D show modified examples of the configuration near the injection port 34 shown in Figure 7A. Figures 8A and 8B show modified examples of the main body member 13 of the support member 10. Figures 9A and 9B show a modified example of the plate member 12.

[0036] As described above, the support member 10 of this embodiment comprises a frame member 11, a plate member 12, and a main body member 13. As shown in Figures 1 and 5, the frame member 11 of this embodiment has a polygonal cylindrical outer shape that surrounds the extension member 30. More specifically, the outer shape of the frame member 11 of this embodiment is hexagonal. However, the outer shape of the frame member 11 may be, for example, a square cylindrical shape (see Figure 6), a cylindrical shape, an oval cylindrical shape, etc. Furthermore, the hexagonal cylindrical frame member 11 of this embodiment has a flat outer shape with a thin thickness in the frame axis direction (the direction perpendicular to the plane of the paper in Figure 5) that extends through the inside of the frame member 11. Hereinafter, for the sake of convenience in explanation, the frame axis direction of the frame member 11 will be referred to as the "frame thickness direction" of the frame member 11, and the direction perpendicular to the frame axis direction of the frame member 11 will be referred to as the "frame surface direction" of the frame member 11.

[0037] As shown in Figures 3A and 3B, the thickness T1 of the frame member 11 in this embodiment is greater than the thickness T2 of the contracted expansion member 30 in the same direction. The range of region SA in the frame thickness direction in this embodiment is the same as the thickness T1 of the frame member 11. Furthermore, the thickness T2 of the frame member 11 in the frame thickness direction of the contracted expansion member 30 represents the maximum thickness of the contracted expansion member 30 in the same direction. In other words, in the contracted state, the expansion member 30 of this embodiment is located only within region SA surrounded by the frame member 11. To put it another way, in the contracted state, the expansion member 30 of this embodiment does not have any portion that protrudes beyond the plate member 12. Therefore, in the fixed hemostatic device 100, the contracted expansion member 30 before expansion is less likely to come into contact with the patient's biological surface BS. As a result, even if the contracted expansion member 30 has an edge portion (for example, a bent portion formed when a three-dimensional balloon is folded), this edge portion is less likely to come into contact with the biological surface BS, thereby reducing the patient's discomfort.

[0038] As shown in Figure 5, the frame member 11 of this embodiment is provided with two bearing recesses 11a capable of accommodating the two shaft portions 12b of the plate member 12, which will be described later. The frame member 11 of this embodiment is also provided with locking recesses 11b into which the locking projections 12c of the plate member 12, which will be described later, can be fitted. The number and position of the locking recesses 11b may be appropriately set according to the number and position of the locking projections 12c of the plate member 12.

[0039] As shown in Figures 3A and 3B, the plate member 12 of this embodiment is configured to cover the region SA surrounded by the frame member 11 from the biological surface BS side in the fixed hemostatic device 100. In this way, the plate member 12 of this embodiment can selectively close the first region SA1 and the second region SA2 of the region SA surrounded by the frame member 11.

[0040] As shown in Figures 2 and 5, the plate member 12 of this embodiment is attached to the frame member 11 so as to rotate relative to the frame member 11 around a pivot axis O1. More specifically, as shown in Figure 5, the plate member 12 comprises a plate body portion 12a and two shaft portions 12b protruding from the plate body portion 12a. The two shaft portions 12b protrude in opposite directions from opposing positions on the outer edge of the plate body portion 12a. The central axes of the two shaft portions 12b are substantially coincidental. The two shaft portions 12b are configured to fit into two bearing recesses 11a of the frame member 11. By fitting the shaft portions 12b into the bearing recesses 11a, the plate body portion 12a can rotate relative to the frame member 11 around the central axis of the shaft portions 12b, which serves as the pivot axis O1. Thus, the plate member 12 of this embodiment is attached to the frame member 11 so as to rotate relative to the frame member 11 around a pivot axis O1.

[0041] Furthermore, the plate member 12 in this embodiment is attached to the frame member 11 so as to be displaceable between a first position and a second position by rotating around the pivot axis O1 relative to the frame member 11. The "first position" refers to the position of the plate member 12 that opens one side of the region SA enclosed by the frame member 11, which straddles the center line O2 of the third strip 23 of the fixing member 20 (see Figures 7A and 7B). In this embodiment, the position of the plate member 12 that closes the first region SA1 and opens the second region SA2 (see Figure 3A) is defined as the "first position". The "second position" refers to the position of the plate member 12 that opens the other side of the region SA enclosed by the frame member 11, which straddles the center line O2 of the third strip 23. In this embodiment, the position of the plate member 12 that closes the second region SA2 and opens the first region SA1 (see Figure 3B) is defined as the "second position".

[0042] Furthermore, as shown in Figure 5, the plate member 12 of this embodiment is provided with a plurality of locking projections 12c that protrude from a position on the outer edge of the plate body 12a different from the position where the shaft portion 12b protrudes. The locking projections 12c are configured to be fitted into the locking recesses 11b of the frame member 11. The locking projections 12c are fitted into the locking recesses 11b so as to be sandwiched between the inner surfaces of the locking recesses 11b. Therefore, when the locking projections 12c are fitted into the locking recesses 11b, the locking projections 12c are locked into the locking recesses 11b by frictional force with the inner surface of the locking recesses 11b, etc. By locking the locking projections 12c into the locking recesses 11b, the rotation of the plate member 12 around the rotation axis O1 relative to the frame member 11 is restricted. In this way, the plate member 12 of this embodiment is lockable to the frame member 11 so as not to rotate around the rotation axis O1 relative to the frame member 11. The frame member 11 is provided with a locking recess 11b that locks the locking projection 12c of the plate member 12 when the plate member 12 is in the first position (see Figure 3A) and the second position (see Figure 3B) described above. Therefore, the plate member 12 in this embodiment can be locked to the frame member 11 in the first position (see Figure 3A) and the second position (see Figure 3B).

[0043] As shown in Figure 6, the plate member 12 may be attached to the frame member 11 so as to be slidable relative to the frame member 11 in the direction of the frame surface. In other words, the plate member 12 may selectively close the region SA surrounded by the frame member 11 by sliding relative to the frame member 11 in the direction of the frame surface. In other words, the plate member 12 may be displaceable between a first position (see Figure 3A) and a second position (see Figure 3B) by sliding relative to the frame member 11 in the direction of the frame surface. Furthermore, the plate member 12 may be configured to be attachable to different positions on the frame member 11. In other words, the plate member 12 may selectively close the region SA surrounded by the frame member 11 by being attached to different positions on the frame member 11. In other words, the plate member 12 may be displaceable between a first position (see Figure 3A) and a second position (see Figure 3B) by being attached to different positions on the frame member 11. However, as in this embodiment, it is preferable that the plate member 12 is attached to the frame member 11 so as to be rotatable around the pivot axis O1. This improves the operability of the plate member 12 and the design freedom of the shapes of the frame member 11 and the plate member 12. For example, the shapes of the frame member 11 and the plate member 12 shown in Figure 5 cannot be realized with a plate member 12 that is slidable relative to the frame member 11 in the direction of the frame surface.

[0044] Furthermore, as shown in Figures 9A and 9B, marker portions 12d1 and 12d2 may be provided on both sides of the plate member 12 in the thickness direction, respectively, configured to have lower light transmittance than the surrounding area and to be mutually distinguishable. As will be described in detail later, the hemostatic device 100 of this embodiment is configured to be usable regardless of whether the puncture site formed in the anatomical snuffbox by dRA is formed on the left or right hand. For this reason, the plate member 12 shown in Figure 9A includes a marker portion 12d1 that indicates that the plate member 12 is in a first position (see Figure 3A) that closes the first region SA1 and is ready for use with the left hand. As shown in Figure 9A, the marker portion 12d1 is provided on the side of the plate member 12 opposite to the biological surface BS (see Figure 3A, etc.) side of the plate member 12 in the first position that closes the first region SA1. The marker portion 12d1 shown in Figure 9A may include, for example, an "L" mark indicating "left". Furthermore, the plate member 12 shown in Figure 9B includes a marker portion 12d2 that indicates the position of the plate member 12 is in a second position (see Figure 3B) that closes the second region SA2 and is ready for use with the right hand. As shown in Figure 9B, the marker portion 12d2 is provided on the side of the plate member 12 opposite to the biological surface BS side when it is in the second position that closes the second region SA2. The marker portion 12d2 shown in Figure 9B may include, for example, an "R" mark indicating "right". The support member 10 and the expansion member 30 of this embodiment are made of a transparent resin that is light-transmitting. Therefore, it is preferable that the marker portions 12d1 and 12d2 are made of, for example, a paint with low light transmittance. By doing so, the marker portions 12d1 and 12d2 have lower light transmittance than the surrounding area, making them easier for medical personnel such as doctors using the hemostatic device 100 to identify through the main body member 13 of the support member 10 (not shown in Figures 9A and 9B) and the expansion member 30. In this way, by providing marker portions 12d1 and 12d2 on both sides of the plate member 12 in the thickness direction, medical professionals such as doctors using the hemostatic device 100 can easily recognize whether or not the plate member 12 is in the desired position.

[0045] Furthermore, in the examples shown in Figures 9A and 9B, the marker portions 12d1 and 12d2 of the plate member 12 are configured to overlap with the positioning markers 31a and 32a of the expansion member 30, which will be described later. Specifically, in Figure 9A, the marker portion 12d1, located on the side of the plate member 12 opposite to the biological surface BS (see Figure 3A, etc.) at the first position that closes the first region SA1, is positioned to overlap with one of the positioning markers 31a of the expansion member 30. Therefore, medical professionals can more easily recognize the other positioning marker 32a, which is used for actual positioning, than the other positioning marker 31a. In other words, by reducing the visibility of the positioning marker 31a that is not actually used when using the hemostatic device 100, it is possible to suppress medical professionals from mistakenly using the positioning marker 31a to position the hemostatic device 100 on the biological surface BS. In Figure 9B, the marker portion 12d2 on the side of the plate member 12 at the second position closing the second region SA2, opposite to the biological surface BS, is positioned to overlap with the other positioning marker 32a of the expansion member 30. Therefore, medical personnel can more easily recognize the positioning marker 31a used for actual positioning than the other positioning marker 32a. In other words, by reducing the visibility of the positioning marker 32a that is not actually used when using the hemostatic device 100, it is possible to prevent medical personnel from mistakenly using the positioning marker 32a to position the hemostatic device 100 on the biological surface BS.

[0046] As shown in Figures 3A and 3B, in this embodiment, the main body member 13 covers the region SA surrounded by the frame member 11 in the fixed hemostatic device 100 from the side opposite to the biological surface BS. More specifically, the main body member 13 in this embodiment covers the entire region SA from the side opposite to the biological surface BS. In other words, the main body member 13 in this embodiment covers region SA by spanning both the first region SA1 and the second region SA2. Therefore, as shown in Figures 3A and 3B, in the region SA that is not closed by the plate member 12 (the second region SA2 in Figure 3A and the first region SA1 in Figure 3B), the expansion member 30 expands toward the biological surface BS and is sandwiched between the main body member 13 and the biological surface BS, thereby compressing the puncture site on the biological surface BS. On the other hand, as shown in Figures 3A and 3B, in the regions of region SA that are closed off by the plate member 12 (the first region SA1 in Figure 3A and the second region SA2 in Figure 3B), the expansion member 30 is sandwiched between the plate member 12 and the main body member 13 and cannot expand, thus not compressing the biological surface BS.

[0047] The main body member 13 of this embodiment has a hexagonal plate shape, but is not limited to this shape. The main body member 13 is not particularly limited in its configuration as long as it covers the area SA surrounded by the frame member 11 from a direction opposite to the biological surface BS side when the hemostatic device 100 is fixed. However, it is preferable that the main body member 13 is flattened. By doing so, the protrusion height of the hemostatic device 100 from the biological surface BS can be flattened when the hemostatic device 100 is fixed. Therefore, it is possible to suppress the main body member 13 from interfering with the patient's body movement when the hemostatic device 100 is fixed.

[0048] As shown in Figures 2 to 3B, the main body member 13 of this embodiment constantly covers the entire area SA surrounded by the frame member 11, but the configuration is not limited to this. As shown in Figures 8A and 8B, the main body member 13 may have an opening 13a that leads to the area SA surrounded by the frame member 11. Also, as shown in Figures 8A and 8B, multiple openings 13a may be formed. In the example shown in Figures 8A and 8B, a first opening 13a1 is provided at a position corresponding to the first area SA1 of the area SA surrounded by the frame member 11. Also, in the example shown in Figures 8A and 8B, a second opening 13a2 is provided at a position corresponding to the second area SA2 of the area SA surrounded by the frame member 11. Furthermore, the support member 10 shown in Figures 8A and 8B further includes a cover 14 that can adjust the opening area of ​​the opening 13a of the main body member 13. More specifically, in the example shown in Figures 8A and 8B, a first cover 14a is provided that can adjust the opening area of ​​the first opening 13a1. Furthermore, in the example shown in Figures 8A and 8B, a second cover 14b is provided that allows adjustment of the opening area of ​​the second opening 13a2. Hereafter, when the first opening 13a1 and the second opening 13a2 are not distinguished, they will simply be referred to as "opening 13a". Similarly, when the first cover 14a and the second cover 14b are not distinguished, they will simply be referred to as "cover 14".

[0049] The lid 14 shown in Figures 8A and 8B is attached to the main body member 13 so as to be slidable relative to the main body member 13. Furthermore, the lid 14 shown in Figures 8A and 8B is configured to allow stepless adjustment of the opening area from a state in which the opening 13a is completely closed to a state in which it is not closed at all. However, the lid 14 may be configured to be detachable from the main body member 13, for example. Also, the lid 14 may be configured to be rotatable relative to the main body member 13, for example. Moreover, the lid 14 may be configured to selectively close the opening 13a.

[0050] Thus, the support member 10, in addition to the plate member 12, is equipped with a lid 14 that can adjust the opening area of ​​the opening 13a of the main body member 13, thereby allowing adjustment of the amount of expansion and protrusion of the expansion member 30 toward the biological surface BS. This allows medical professionals such as doctors to adjust the amount of expansion and protrusion of the expansion member 30 toward the biological surface BS and adjust the compressive force on the biological surface BS. In Figures 8A and 8B, the plate member 12 closes the second region SA2 of the region SA surrounded by the frame member 11. Therefore, in the fixed state of the hemostatic device 100, the expansion member 30 can expand toward the biological surface BS in the first region SA1 of the region SA surrounded by the frame member 11. In this case, in the example shown in Figures 8A and 8B, the opening area of ​​the second opening 13a2 is adjusted by the second lid 14b. Figure 8A shows the state in which the second lid 14b completely closes the second opening 13a2. Figure 8B shows a state in which the second lid 14b partially closes a portion of the second opening 13a2, leaving a portion of the second opening 13a2 open. As shown in Figure 8B, when the second opening 13a2 is open, a portion of the expanded member 30 in the expanded state can enter the second opening 13a2. This makes it possible to reduce the amount of expansion and protrusion of the expanded member 30 toward the biological surface BS in the first region SA1 compared to the state shown in Figure 8A.

[0051] Furthermore, although only the opening area of ​​the second opening 13a2 is adjusted in Figures 8A and 8B, the configuration is not limited to this. In the state shown in Figure 8B, the opening area of ​​the first opening 13a1 may also be adjusted by the first lid 14a. Alternatively, in the state shown in Figure 8B, the second opening 13a2 may be completely closed, and only the opening area of ​​the first opening 13a1 may be adjusted. In this way, by adjusting the opening area of ​​at least one of the first opening 13a1 and the second opening 13a2, the amount of expansion protrusion of the expansion member 30 toward the biological surface BS can be adjusted. However, as shown in Figure 8B, a configuration in which only the opening (second opening 13a2 in Figure 8B) corresponding to the region (second region SA2 in Figure 8B) that is closed by the plate member 12 within the region SA surrounded by the frame member 11 is open is preferred. By doing so, the shape stability of the expansion member 30 when it is expanded in the first region SA1 can be increased, and the compression position of the biological surface BS can be further stabilized.

[0052] Unlike the examples shown in Figures 8A and 8B, the same applies when the plate member 12 closes the first region SA1 of the region SA surrounded by the frame member 11. In other words, for the same reasons as above, it is preferable that only the first opening 13a1 corresponding to the first region SA1 is open.

[0053] As described above, the support member 10 may be equipped with an adjustment section 40 that can adjust the amount of expansion protrusion of the expansion member 30 on the biological surface BS side. In Figures 8A and 8B, the adjustment section 40 is composed of an opening 13a and a cover 14 of the main body member 13, but the configuration is not limited to this. The adjustment section 40 may have a different configuration that can adjust the amount of expansion protrusion of the expansion member 30 on the biological surface BS side. However, as shown in Figures 8A and 8B, when the adjustment section 40 is composed of an opening 13a and a cover 14 of the main body member 13, the adjustment section 40 is easier to operate from the medical professional's side, and the operability of the adjustment section 40 can be improved in the fixed state of the hemostatic device 100.

[0054] Furthermore, the support member 10 shown in Figures 8A and 8B includes a lid 14 in addition to the plate member 12, but it may also be configured to include only the lid 14 and not the plate member 12. In other words, the lid 14 may be used to configure a "plate member capable of selectively closing the region SA surrounded by the frame member 11 so as to inhibit the expansion of a portion of the expansion member 30 toward the biological surface BS." The lid 14 inhibits the expansion of a portion of the expansion member 30 toward the biological surface BS by adjusting the amount of expansion protrusion of the expansion member 30. In other words, the plate member 12 in this embodiment is configured to cover the region SA from the biological surface BS side in the fixed hemostatic device 100, but it may also be configured to cover the region SA from the opposite side of the biological surface BS side.

[0055] As described above, in the support member 10 of this embodiment, the first region SA1 and the second region SA2 of the region SA surrounded by the frame member 11 are selectively closed by the plate member 12, thereby selectively changing the compression position of the biological surface BS. Therefore, with the hemostatic device 100 of this embodiment, the compression position of the biological surface BS by the expansion member 30 can be adjusted.

[0056] As shown in Figures 1, 4A, and 4B, the fixing member 20 of this embodiment comprises a first strip 21, a second strip 22, and a third strip 23. The first strip 21, the second strip 22, and the third strip 23 are flexible. The first strip 21 protrudes from one end of the support member 10. More specifically, the first strip 21 of this embodiment protrudes from a part of the outer edge of the main body member 13, which is one end of the support member 10. The second strip 22 protrudes from the other end of the support member 10, opposite to the aforementioned one end. More specifically, the second strip 22 of this embodiment protrudes from the part of the outer edge of the main body member 13, which is the other end of the support member 10, opposite to the part from which the first strip 21 protrudes. In other words, the first strip 21 and the second strip 22 protrude in opposite directions from opposing positions on the outer edge of the support member 10. In this embodiment, the first band 21 protrudes outward from the support member 10 on the side of the second region SA2 of the region SA surrounded by the frame member 11. Similarly, the second band 22 in this embodiment protrudes outward from the support member 10 on the side of the first region SA1 of the region SA surrounded by the frame member 11. As shown in Figures 4A and 4B, in this embodiment, the hemostatic device 100 has the first band 21 and the second band 22 of the fixing member 20 wrapped around the patient's wrist. The first band 21 and the second band 22 are then connected to each other by a connecting part such as a hook-and-loop fastener while wrapped around the wrist. This allows the first band 21 and the second band 22 to remain wrapped around the wrist.

[0057] The third band 23 protrudes from a position different from the one end of the support member 10 from which the first band 21 protrudes, and the other end from which the second band 22 protrudes. The third band 23 is wrapped around the patient so as to pass between the patient's thumb and index finger, and its tip is connected to the first band 21 or the second band 22. This prevents the first band 21 or the second band 22, which is wrapped around the wrist, from shifting along the forearm. In this way, the hemostatic device 100 of this embodiment can be fixed to the patient in a state in which the support member 10 covers the puncture site formed by dRA in an anatomical snuffbox by using the first band 21, the second band 22, and the third band 23 of the fixing member 20.

[0058] As shown in Figures 4A and 4B, the length L1 of the first band 21 in the extending direction in this embodiment is longer than the length L2 of the second band 22 in the extending direction, but the configuration is not limited to this. The length L1 of the first band 21 in the extending direction may be shorter than the length L2 of the second band 22 in the extending direction. Also, the length L1 of the first band 21 in the extending direction may be approximately equal to the length L2 of the second band 22 in the extending direction. The first band 21 and the second band 22 can be wrapped around the entire circumference of the patient's wrist either by themselves or with an extension band that can be connected to the first band 21 or the second band 22 attached, and their lengths are not particularly limited.

[0059] As shown in Figures 1 to 3B, the expansion member 30 of this embodiment is a bag-shaped balloon that can be expanded by fluid. A part of the expansion member 30 of this embodiment may be joined to the main body member 13 of the support member 10 by welding, adhesive, or the like. As described above, in the contracted state, the expansion member 30 of this embodiment is positioned in the region SA surrounded by the frame member 11 of the support member 10.

[0060] Furthermore, as shown in Figure 7A, the extension member 30 of this embodiment is positioned across both sides of the center line O2 passing through the center position in the width direction of the third strip 23 of the fixing member 20 in the region SA enclosed by the frame member 11. In addition, the extension member 30 of this embodiment is positioned across the first region SA1 and the second region SA2 in the region SA enclosed by the frame member 11.

[0061] As described above, the plate member 12 of this embodiment is displaceable between a first position (see Figure 3A) that closes the first region SA1 and opens the second region SA2, and a second position (see Figure 3B) that closes the second region SA2 and opens the first region SA1. For the sake of explanation, the regions SA enclosed by the frame member 11 that are closed by the plate member 12 at the first and second positions will be referred to as "closed regions." The regions SA enclosed by the frame member 11 that are not closed by the plate member 12 at the first and second positions will be referred to as "open regions." In this case, as shown in Figures 3A and 3B, the expansion member 30 of this embodiment is configured such that, when the expansion member 30 is expanded, the maximum expansion length L3 of the plate member 12 in the thickness direction (the same direction as the frame thickness direction of the frame member 11) at the boundary BL between the closed and open regions is smaller than the maximum expansion lengths L4 and L5 of the plate member 12 in the thickness direction in the closed and open regions. In this way, when the expansion member 30 is expanded, it is possible to suppress the expansion member 30 from coming into contact with the outer edge of the plate member 12, which is the boundary BL between the closed region and the open region. Therefore, it is possible to suppress localized stress on the expansion member 30, and thus prevent damage to and rupture of the balloon as an expansion member 30.

[0062] More specifically, the balloon as the expansion member 30 of this embodiment comprises a first expansion portion 31 that can be expanded and contracted in a first region SA1, a second expansion portion 32 that can be expanded and contracted in a second region SA2, and a connecting portion 33 that connects the first expansion portion 31 and the second expansion portion 32. The connecting portion 33 of this embodiment is the part of the expansion member 30 that is positioned at the boundary BL between the closed region and the open region. The expansion member 30 partitions the containment space into which a fluid such as air is supplied. The containment space of this expansion member 30 is integrally formed over the interior of the first expansion portion 31, the interior of the second expansion portion 32, and the interior of the connecting portion 33. As shown in Figure 1, the expansion member 30 of this embodiment is configured to form two peaks when expanded without any external force acting on it. More specifically, when the expansion member 30 of this embodiment is expanded without any external force acting on it, the first expansion portion 31 and the second expansion portion 32 expand significantly, while the connecting portion 33 does not expand more than the first expansion portion 31 and the second expansion portion 32. Therefore, the expansion member 30 of this embodiment expands such that two tops are formed by the first expansion portion 31 and the second expansion portion 32.

[0063] Here, the maximum expansion length L3 of this embodiment described above is the maximum expansion length of the connecting portion 33, which is the part of the expansion member 30 corresponding to the position of the boundary BL between the closed region and the open region. It is preferable that this maximum expansion length L3 is smaller than the thickness T1 in the frame thickness direction of the frame member 11. Furthermore, it is even more preferable that the maximum expansion length L3 is smaller than the maximum expansion length of the expansion member 30 in the closed region (the length of L4 in Figure 3A and the length of L5 in Figure 3B). By doing so, it is possible to further suppress the expansion member 30 from biting into the outer edge of the plate member 12 which is the boundary BL between the closed region and the open region.

[0064] As shown in Figure 4A, when the hemostatic device 100 of this embodiment is worn on the left hand, only the first region SA1 of the region SA surrounded by the frame member 11 is closed by the plate member 12. Therefore, the second expansion portion 32 of the expansion member 30 located in the second region SA2 expands to protrude toward the biological surface BS (see Figure 3A, etc.). In contrast, as shown in Figure 4B, when the hemostatic device 100 of this embodiment is worn on the right hand, only the second region SA2 of the region SA surrounded by the frame member 11 is closed by the plate member 12. Therefore, the first expansion portion 31 of the expansion member 30 located in the first region SA1 expands to protrude toward the biological surface BS. Thus, with the hemostatic device 100 of this embodiment, regardless of whether the puncture site formed in the anatomical snuffbox by dRA is formed on the left or right hand, the expansion member 30 can compress a desired position on the biological surface BS.

[0065] Furthermore, as shown in Figures 1 and 2, positioning markers 31a and 32a are provided at the top of the first and second expansion portions 31 and 32 in this embodiment, respectively, at positions that can be aligned with a desired compression position on the biological surface BS. The support member 10 and the expansion member 30 are made of a light-transmitting transparent material. Therefore, when a physician or other medical professional fixes the hemostatic device 100 to a patient, they can visually see the positioning markers 31a and 32a of the expansion member 30 and the patient's puncture site from the side opposite to the patient's biological surface BS. This allows the medical professional to fix the hemostatic device 100 to the patient while aligning the positioning markers 31a and 32a of the expansion member 30 to the desired compression position.

[0066] Furthermore, as shown in Figure 7A, the expansion member 30 is equipped with an inlet 34 into which fluid is injected from a fluid supply member. In Figure 7A, the dimensional ratio of the inlet 34 is shown enlarged for ease of explanation. The actual dimensional ratio of the inlet 34 may differ from the dimensional ratio shown in Figure 7A. As shown in Figure 7A, the inlet 34 is connected to one end of the tubular body 35. A connector 36 to which a fluid supply member can be connected is provided at the other end of the tubular body 35. In this way, fluid is injected into the expansion member 30 of this embodiment from a fluid supply member such as a syringe connected to the connector 36 through the tubular body 35. As a result, the expansion member 30 of this embodiment can be expanded from a contracted state to an expanded state. Conversely, by using a fluid supply member such as a syringe to aspirate the fluid inside the expansion member 30, the expansion member 30 can be contracted from an expanded state to a contracted state. The hemostatic device 100 of this embodiment is equipped with a connector 36 to which a fluid supply member can be attached and detached, and does not have a fluid supply member, but is not limited to this configuration. The hemostatic device 100 may be configured to include, for example, a fluid supply member, such as an air balloon, connected to the tubular body 35.

[0067] Furthermore, as shown in Figure 7A, the injection port 34 of the expansion member 30 in this embodiment is provided on the third band 23 side. This allows the hemostatic device 100 to be fixed to the patient's hand so that the tube 35 connected to the fluid supply member protrudes toward the patient's fingers. This improves the operability of medical personnel, such as adjusting the amount of fluid injected from the fluid supply member.

[0068] In particular, as shown in Figure 7A, it is preferable that the injection port 34 of the expansion member 30 in this embodiment be positioned to coincide with the center line O2 of the third band 23 of the fixing member 20. In Figure 7A, the position of the third band 23 of the fixing member 20 is indicated by a dashed line. This makes it easier to position the injection port 34 near the connecting portion 33. As a result, the fluid injected from the injection port 34 is easily supplied to both the first expansion portion 31 and the second expansion portion 32. Consequently, regardless of whether the position of the plate member 12 is the first position or the second position, the expansion deformation of the expansion member 30 toward the biological surface BS (see Figure 3A, etc.) can be made uniform. In addition, regardless of whether the position of the plate member 12 is the first position or the second position, the fluid injection resistance can be made uniform. That is, regardless of whether the hemostatic device 100 is used on the patient's left hand (see Figure 4A) or on the patient's right hand (see Figure 4B), the operability of the hemostatic device 100 can be improved.

[0069] Furthermore, as shown in Figure 7A, the inlet 34 of the expansion member 30 in this embodiment opens in a direction along the plate member 12. More specifically, the inlet 34 in this embodiment opens in the direction of the frame surface of the frame member 11. Therefore, it is possible to suppress the fluid injected from the inlet 34 from being blown toward the plate member 12. This prevents the plate member 12 from being unintentionally displaced relative to the frame member 11.

[0070] Figure 7B shows a modified example of the inlet 34. As shown in Figure 7B, the inlet 34 may be branched into a first inlet 34a that opens towards the first expansion section 31 and a second inlet 34b that opens towards the second expansion section 32. In Figure 7B, the dimensional ratio of the inlet 34 is shown enlarged for ease of explanation. The actual dimensional ratio of the inlet 34 may differ from the dimensional ratio shown in Figure 7B.

[0071] Furthermore, as shown in Figure 7A, the pipe 35 connected to the inlet 34 of the expansion member 30 in this embodiment extends both inside and outside the frame member 11 through a slit 11c formed in the frame member 11, but the configuration is not limited to this. As shown in the modified examples in Figures 7C and 7D, the pipe 35 connected to the inlet 34 may extend both inside and outside the frame member 11 through a through hole in the main body member 13. Also, as shown in Figure 7D, the inlet 34 may be branched into a first inlet 34a opening towards the first expansion portion 31 and a second inlet 34b opening towards the second expansion portion 32, similar to the configuration shown in Figure 7B.

[0072] The hemostatic device relating to this disclosure is not limited to the specific configurations shown in the embodiments and modifications described above, and various modifications, changes, and combinations are possible as long as they do not deviate from the scope of the claims. For example, the hemostatic device 100 described above is configured to stop bleeding at a puncture site formed in an anatomical snuffbox by dRA, but by changing the region SA surrounded by the frame member 11 that is selectively closed by the plate member 12, and the configuration of the fixing member 20, it may be configured to stop bleeding at a puncture site formed at a different location on the patient. [Industrial applicability]

[0073] This disclosure relates to hemostatic devices. [Explanation of symbols]

[0074] 10: Support member 11: Frame member 11a: Bearing recess 11b: Locking recess 11c: Slit 12: Plate component 12a: Plate body 12b: Shaft 12c: Locking convex part 12d1, 12d2: Marker section 13: Main body components 13a: Opening (an example of a component of the adjustment part) 13a1: 1st opening 13a2: 2nd opening 14: Cover (an example of a component of the adjustment part) 14a: First lid 14b: Second lid 20: Fixing member 21: First body 22: Second body 23: Third body 30: Expansion member 31: First Expansion Section 31a: Positioning marker 32: Second Expansion Section 32a: Positioning marker 33:Connection part 34: Inlet 34a: 1st injection port 34b: 2nd injection port 35: Body 36: Connector 40: Adjustment section 100: Hemostatic device BL: Boundary between closed and open regions BS: Biological surface L1: Length in the extension direction of the first band L2: Length in the extension direction of the second band L3: Maximum extension length of the expansion member at the boundary between the closed and open regions. L4, L5: Maximum extension length of the extension member in the closed and open regions. O1: Rotation axis of the plate member O2: Centerline of the third zone SA: Area enclosed by frame members SA1: 1st area SA2:Second area T1: Thickness of the frame member in the frame thickness direction T2: Thickness of the expanded member in the frame thickness direction of the frame member when contracted.

Claims

1. A support member configured to cover the puncture site formed on the patient, A fixing member extending from the support member and configured to be fixed to the patient in such a way that the support member covers the puncture site, The system comprises an expansion member supported by the aforementioned support member and configured to be expandable by fluid, The aforementioned support member is A cylindrical frame member, The region enclosed by the frame member is covered by a single plate member, either from one end of the frame member in the frame thickness direction, which is the side facing the biological surface, or from the other end of the frame member in the frame thickness direction, which is the side opposite to the side facing the biological surface. The aforementioned extension member is arranged in the aforementioned region, The region includes a closed region covered by the one plate member and an open region not covered by the one plate member, at different positions in the frame surface direction perpendicular to the frame thickness direction. A hemostatic device wherein the position covering the area is variable in the direction of the frame surface, such that the positions of the closed region and the open region in the direction of the frame surface vary to other positions of the closed region and the open region in the direction of the frame surface.

2. The support member comprises a main body member that covers the area surrounded by the frame member from the side opposite to the biological surface, The hemostatic device according to claim 1, wherein the one plate member covers the area surrounded by the frame member from the biological surface side.

3. The hemostatic device according to claim 1 or 2, wherein the expansion member is located only within the region surrounded by the frame member when in a contracted state.

4. The aforementioned fixing member is A first strip protruding from one end of the support member, A second strip protruding from the other end of the support member opposite to the one end, The support member comprises a third strip protruding from a position different from that of the one end and the other end of the support member, The hemostatic device according to any one of claims 1 to 3, wherein the expansion member is arranged across both sides of a center line passing through the center position in the width direction of the third band in the region surrounded by the frame member.

5. The aforementioned one plate member is A first position in which, within the region enclosed by the frame member, one side of the third strip body that straddles the center line is left open to form the open region, and the other side is closed to form the closed region, The hemostatic device according to claim 4, wherein the region enclosed by the frame member is configured to be displaceable between a second position in which the other side of the third band, straddling the center line, is left open to form the open region, and the other side is closed to form the closed region.

6. The hemostatic device according to claim 5, wherein the one plate member is attached to the frame member so as to be displaceable between the first position and the second position by rotating with respect to the frame member about a pivot axis.

7. The hemostatic device according to claim 5 or 6, wherein the expansion member is configured such that the maximum expansion length in the frame thickness direction at the boundary between the closed region and the open region is smaller than the maximum expansion length in the frame thickness direction in the closed region and the open region.

8. The hemostatic device according to any one of claims 4 to 7, wherein a marker portion is provided on each of the two sides of the one plate member in the frame thickness direction, configured to have lower light transmittance than the surrounding area and to be mutually distinguishable.

9. The hemostatic device according to any one of claims 4 to 8, wherein the expansion member is provided with an injection port on the third band side into which the fluid is injected.

10. The hemostatic device according to claim 9, wherein the injection port of the expansion member is positioned to coincide with the center line of the third band.

11. The hemostatic device according to claim 9 or 10, wherein the injection port of the expansion member is open toward the frame surface.

12. The hemostatic device according to any one of claims 1 to 11, wherein the support member is provided with an adjustment part that can adjust the amount of expansion protrusion of the expansion member on the biological surface side.

Images