JP7411673B2 - hemostasis device - Google Patents

Description

The present invention relates to a hemostasis device for stopping bleeding at a puncture site.

Conventionally, techniques have been known in which various medical elongated bodies (e.g., introducers) are introduced into blood vessels through puncture sites formed in blood vessels of limbs such as patient's arms to treat or treat diseased areas. It is being When performing such a procedure, the operator or the like stops the bleeding at the puncture site when removing the medical elongated body from the puncture site.

A hemostasis device used to stop bleeding at a puncture site includes a band to be wrapped around the limb and a balloon connected to the band and expanded by injecting fluid to compress the puncture site. has been proposed (see Patent Document 1).

Japanese Patent Application Publication No. 2010-131296

In the hemostasis method using the hemostatic device disclosed in Patent Document 1, an expandable balloon is used to apply pressure around the puncture site. In such a hemostasis method, if overpressurized compression in which the compression force becomes excessively large is performed for a long time, blood vessel occlusion may occur, so it is required to appropriately adjust the compression force. In addition, in hemostasis methods using balloons, gels, etc., the pressure range is wide, so it is not possible to apply pressure locally to the puncture site, and it is difficult to enhance the hemostasis effect.

The present invention has been made to solve the above-mentioned problems, and aims to provide a hemostasis device that can effectively stop bleeding at a puncture site without causing excessive pressure on a blood vessel. purpose.

A hemostatic device that achieves the above object includes a hemostatic member disposed at a puncture site formed in a limb, and the hemostatic member includes a first rotating body and a second rotating body having a smaller external shape than the first rotating body. and the first rotating body is rotatable in a first direction, and the second rotating body is interlocked with the rotation of the first rotating body and rotates in a second direction different from the first direction. The first rotating body and the second rotating body are rotatable, and the puncture site is located between the first rotating body and the second rotating body with the hemostatic member disposed on the limb. It can be rotated so as to sandwich the periphery.

According to the hemostatic device configured as described above, the hemostatic member rotates so as to sandwich the area around the puncture site located between the first rotating body and the second rotating body, thereby removing the skin, etc. around the puncture site. The living tissue can be pulled up in the rotational direction of the first rotating body and the second rotating body, the wound formed at the puncture site can be closed, and bleeding at the puncture site can be stopped. Therefore, the hemostatic device can effectively stop the bleeding at the puncture site without causing excessive pressure on the blood vessel. Further, the first rotating body has a larger external shape than the second rotating body. Therefore, when the hemostasis member is placed at the puncture site, the first rotating body is placed so as to protrude further toward the blood vessel than the second rotating body. As a result, the first rotating body of the hemostasis member compresses the blood vessel to the extent that vascular occlusion does not occur, causing the inner wall of the blood vessel to protrude toward the blood vessel. Therefore, the hemostasis member can increase the shear stress generated on the inner wall of the blood vessel of the limb around the wound on the blood vessel side of the puncture site. The hemostasis member can promote hemostasis of blood clots in the blood vessel by increasing the shear stress using the first rotary body to promote platelet adhesion and aggregation reactions around the wound on the blood vessel side of the puncture site. Therefore, the hemostatic device described above can further enhance the hemostasis effect at the puncture site.

FIG. 1 is a plan view of a hemostatic device according to an embodiment. It is a perspective view which expands and shows a part of hemostasis device concerning an embodiment. It is a top view which expands and shows a part of hemostatic device based on embodiment. It is a sectional view showing the rotation regulation mechanism of the hemostasis instrument concerning an embodiment. FIG. 2 is a plan view showing a limb of a patient wearing a hemostatic device according to an embodiment. 1 is a cross-sectional view schematically showing a limb of a patient wearing a hemostasis device according to an embodiment. FIG. 7 is a perspective view showing a hemostasis member according to Modification 1. FIG. 7 is a perspective view showing a hemostasis member according to a second modification. FIG. 7 is a perspective view showing a hemostasis member according to modification 3. FIG. 7 is an enlarged plan view of a part of a hemostasis device according to modification 3; FIG. 7 is a plan view showing a limb of a patient wearing a hemostasis device according to modification 3; FIG. 7 is a cross-sectional view schematically showing a limb of a patient wearing a hemostatic device according to modification 3. 7 is a perspective view showing a fixing member and a connecting portion according to Modification 1. FIG. FIG. 7 is a perspective view showing a fixing member and a connecting portion according to Modification 2. FIG. FIG. 7 is a perspective view showing a fixing member and a connecting portion according to Modification 3.

Embodiments of the present invention will be described below with reference to the attached drawings. Note that the following description does not limit the technical scope or meaning of terms described in the claims. Further, the dimensional ratios in the drawings are exaggerated for convenience of explanation and may differ from the actual ratios.

The hemostatic device 100 according to this embodiment can be used to stop bleeding at the puncture site P1, as shown in FIGS. 5 and 6. For example, an operator or the like inserts the sheath tube 210 of the introducer 200 into a blood vessel B (e.g., radial artery) of a limb S (e.g., wrist) for the purpose of inserting a catheter or the like for treatment or examination into the blood vessel. , forming a puncture site P1.

The hemostatic device 100 will be outlined with reference to FIGS. 1, 2, 4, and 6. The hemostasis device 100 includes a hemostatic member 110 that is placed at a puncture site P1 formed in the limb S. The hemostasis member 110 includes a first rotating body 120 and a second rotating body 130 having a smaller external shape than the first rotating body 120 . The first rotating body 120 is rotatable in a first direction (arrow r1 direction in FIG. 6), and the second rotating body 130 is rotated in a second direction different from the first direction in conjunction with the rotation of the first rotating body 120. (direction of arrow r2 in FIG. 6). The first rotating body 120 and the second rotating body 130 are arranged around the puncture site A (see FIG. ) can be rotated to sandwich it.

As shown in FIGS. 1 and 2, the hemostasis member 110 has a first rotating shaft 123 that is the rotating shaft of the first rotating body 120 and a second rotating shaft 133 that is the rotating shaft of the second rotating body 130. , a connecting portion 160 that connects the first rotating shaft body 123 and the second rotating shaft body 133. The connecting portion 160 is connected to a fixing member 140 that fixes the hemostatic device 100 to the limb S.

The fixing member 140 includes a first fixing member 141 and a second fixing member 142 that can be wrapped around the limb S. The first fixing member 141 and the second fixing member 142 can be formed of, for example, band-shaped members having a predetermined width and length.

As shown in FIGS. 2 and 3, the connecting portion 160 includes a first connecting portion 161 connected to one longitudinal end 141a of the first fixing member 141, and one longitudinal end 142a of the second fixing member 142. and a second connecting portion 162 connected to the second connecting portion 162 . Each connecting portion 161, 162 can be fixed to the outer surface of each fixing member 141, 142 using an adhesive, for example. In this specification, when each fixing member 141, 142 is wrapped around the limb S, the surface of each fixing member 141, 142 on the side facing the body surface of the limb S is referred to as the "inner surface", and the opposite side is referred to as the "outer surface". It is defined as

As shown in FIG. 1, a first fixing portion 151 is arranged on the inner surface of the other longitudinal end portion 141b of the first fixing member 141. As shown in FIG. A second fixing portion 152 is disposed on the outer surface of the other end 142b of the second fixing member 142 in the longitudinal direction. The first fixing part 151 can be configured, for example, on the male side (or female side) of a hook-and-loop fastener. The second fixing portion 152 can be configured, for example, on the female side (or male side) of a hook-and-loop fastener.

When placing the hemostasis device 100 on the limb S, the operator or the like wraps the fixing members 141 and 142 around the limb S, as shown in FIG. The operator or the like can fix the hemostatic device 100 to the patient's limb S by bringing the first fixing part 151 and the second fixing part 152 into contact with each fixing member 141, 142 wrapped around the limb S. can. As shown in FIGS. 5 and 6, each rotating body 120, 130 is configured to be rotatable while the hemostatic device 100 is fixed to the limb S by the fixing member 140. FIG. 6 is a diagram schematically showing a cross section of the patient's limb S along the arrow 6A-6A shown in FIG.

The material constituting the fixing member 140 (the first fixing member 141 and the second fixing member 142) is not particularly limited, but may be made of a flexible resin material, for example.

As shown in FIGS. 1 and 6, the first rotating body 120 and the second rotating body 130 are such that the first rotating body 120 is rotatable in a first direction, and the second rotating body 130 is rotatable in a second direction. They are rotatably in contact with each other. In this embodiment, a portion of the outer circumferential surface of the first rotating body 120 and a portion of the outer circumferential surface of the second rotating body 130 are constantly pressed against each other.

As shown in FIG. 2, the first rotating body 120 has a recess 121 that is recessed from the outer peripheral surface of the first rotating body 120 toward the rotation center side of the first rotating body 120 (first rotating shaft body 123 side). . The recess 121 is formed approximately at the center of the first rotating body 120 in the longitudinal direction. The recess 121 is formed only in a part of the outer peripheral surface of the first rotating body 120 along the rotation direction of the first rotating body 120. The range in which the recess 121 is formed on the outer peripheral surface of the first rotating body 120 is not particularly limited. The recess 121 can be formed, for example, over half the circumferential area of the outer circumferential surface of the first rotating body 120.

As shown in FIGS. 2 and 3, a gap g is formed between the recess 121 of the first rotating body 120 and the second rotating body 130, into which the sheath tube 210 of the introducer 200 can be inserted. A portion of the first rotating body 120 in which the recess 121 is not formed contacts the second rotating body 130 .

The first rotating body 120 has a cylindrical shape with a portion corresponding to the recess 121 removed. The first rotating body 120 has a circular shape in a side view. The second rotating body 130 has a cylindrical shape. Like the first rotating body 120, the second rotating body 130 has a circular shape when viewed from the side. The diameter of the side surface of the first rotating body 120 is larger than the diameter of the side surface of the second rotating body 130. Therefore, when the hemostasis device 100 is attached to the patient's limb S, the hemostasis member 110 has a lowermost point of the first rotating body 120 than a lowermost point of the second rotating body 130, as shown in FIG. It is pushed into the limb S so that it is placed close to B.

The materials constituting the first rotary body 120 and the second rotary body 130 are not particularly limited, but may be made of, for example, an elastic resin material. The first rotary body 120 and the second rotary body 130 may be made of, for example, a hard resin material or a metal material coated with an elastic resin material.

As shown in FIG. 2, the hemostasis device 100 includes a level 170 disposed on the second connecting portion 162. As shown in FIG. With the hemostasis member 110 (first rotating body 120 and second rotating body 130) placed on the limb S, the operator or the like can check the levelness of the second connecting portion 162 using the level instrument 170. By checking the horizontality of the second connecting portion 162, the operator can determine whether the first rotating shaft 123 and the second rotating shaft 133 are arranged parallel to the body surface of the limb S. It can be confirmed. The level 170 can be constructed of a known type including, for example, a bubble tube. The leveler 170 may be arranged, for example, at the first connecting part 161, or at the first connecting part 161 and the second connecting part 162.

As shown in FIG. 4, the first rotating body 120 has a rotation regulating mechanism 180 for regulating the rotation direction of the first rotating body 120 to only one direction. FIG. 4 shows a cross-sectional view of the first rotating body 120 along arrow 4A-4A shown in FIG.

The rotation regulating mechanism 180 is arranged inside the first rotating body 120. The rotation regulating mechanism 180 has a groove portion 181 and a pawl portion 183 formed on the inner surface of the first rotating body 120 . The pawl portion 183 has a connecting portion 183a connected to the first rotating shaft body 123, and a claw portion 183b formed at the tip of the pawl portion 183.

The groove portion 181 stands obliquely toward the rotation direction opposite to the first direction (direction of arrow r1 in the figure), which is the rotation direction of the first rotating body 120. Therefore, when the claw portion 183b attempts to rotate along the groove portion 181 in the rotation direction opposite to the first direction, the claw portion 183b is caught in the groove portion 181. The claw portion 183b allows the first rotating body 120 to rotate in the first direction while being in contact with the groove portion 181, while allowing the first rotating body 120 to rotate in the rotation direction opposite to the first direction. regulate what to do.

Next, an example of how the hemostasis device 100 is used will be described.

The operator or the like places the hemostatic device 100 on the limb S of the patient. The operator or the like places the first rotating body 120 on the upper limb side of the patient's body, and places the second rotating body 130 on the fingertip side (distal side) of the patient's hand. The operator or the like fixes the hemostatic device 100 to the limb S using the first fixing part 151 disposed on the first fixing member 141 and the second fixing part 152 disposed on the second fixing member 142. The operator or the like can press the rotating bodies 120 and 130 against the limb S by fixing the hemostasis device 100 to the limb S using the fixing members 141 and 142. The operator or the like can suppress movement of the blood vessel B to be punctured. By suppressing the movement of the blood vessel B with each of the rotary bodies 120 and 130, the operator etc. can move the hemostatic device 100 to the patient's limb S as desired through the gap g, as described later. The puncture site P1 can be formed accurately by the position of.

The operator or the like inserts a puncture tool (not shown) into the gap g formed between the first rotating body 120 and the second rotating body 130. The operator or the like forms a puncture site P1 in the blood vessel B by puncturing the blood vessel B with a puncture tool from the body surface side of the limb S. The operator or the like performs puncture with the puncture tool through the gap g formed by the recess 121, so that the wound on the skin surface at the time of puncturing is located between the first rotating body 120 and the second rotating body 130. A puncture site P1 can be formed at.

The operator or the like inserts the sheath tube 210 of the introducer 200 into the puncture site P1, as shown in FIGS. 5 and 6. A surgeon or the like delivers various medical devices to a patient's treatment target site via the introducer 200 to perform treatment or diagnosis.

After finishing the procedure using the medical device, the surgeon or the like removes the sheath tube 210 of the introducer 200 from the puncture site P1. The operator or the like rotates at least one of the first rotating body 120 and the second rotating body 130. When the operator or the like rotates the first rotating body 120 in the first direction, the second rotating body 130 rotates in the second direction in conjunction with the rotation of the first rotating body 120. The operator or the like uses the first rotating body 120 and the second rotating body 130 to pull up the living tissue such as the skin around the puncture site A in the rotation direction of the first rotating body 120 and the second rotating body 130, and The area around the puncture site A can be pinched to close the wound formed on the skin side. Thereby, the operator or the like can start hemostasis at the puncture site P1. The operator or the like rotates the rotating bodies 120 and 130 in accordance with the withdrawal of the sheath tube 210 of the introducer 200, thereby removing the living tissue such as the skin around the puncture site A from the first rotating body 120 and the second rotating body. It can be pulled up in the rotational direction of 130. Therefore, the operator or the like can appropriately stop the bleeding at the puncture site P1 by gradually increasing the force to close the wound formed on the skin side of the puncture site P1 while removing the sheath tube 210 from the limb S. .

Further, the first rotating body 120 has a larger external shape than the second rotating body 130. Therefore, as shown in FIG. 6, when the hemostasis device 100 is fixed to the patient's limb S, the first rotating body 120 is placed so as to protrude further toward the blood vessel B than the second rotating body 130. The first rotating body 120 applies a pressing force (arrow F1 in the figure) to the vicinity A of the puncture site to the extent that the blood vessel B is not occluded. When the first rotary body 120 applies the above-mentioned pressing force, the shear stress of the blood flow (arrow F2 in the figure) increases near the puncture site P1 on the blood vessel inner wall Bw. Therefore, the hemostasis device 100 increases the shear stress using the first rotary body 120 to promote platelet adhesion and aggregation reactions around the wound on the blood vessel side of the puncture site P1, and causes platelets to condense in the wound at the puncture site P1. It can be made easier. Thereby, the operator or the like can promote hemostasis of the blood clot at the puncture site P1. The operator or the like removes the hemostatic device 100 from the limb S after hemostasis is completed.

In the above-described usage example of the hemostatic device 100, the hemostasis device 100 is placed on the limb S of the patient before the operator or the like punctures the blood vessel. However, after finishing a procedure using a medical device, a surgeon or the like inserts the sheath tube 210 of the introducer 200 into the gap g formed between the first rotating body 120 and the second rotating body 130 of the hemostasis device 100. The hemostatic device 100 is attached to the limb S of the patient so that the wound on the skin surface of the puncture site P1 is located between the first rotating body 120 and the second rotating body 130, and the bleeding at the puncture site P1 is stopped. You can.

As described above, the hemostasis device 100 according to the present embodiment includes the hemostatic member 110 disposed at the puncture site P1 formed in the limb S. The hemostasis member 110 includes a first rotating body 120 and a second rotating body 130 having a smaller external shape than the first rotating body 120 . The first rotating body 120 is rotatable in a first direction, and the second rotating body 130 is rotatable in a second direction different from the first direction in conjunction with the rotation of the first rotating body 120. The first rotating body 120 and the second rotating body 130 sandwich the puncture site periphery A located between the first rotating body 120 and the second rotating body 130 when the hemostatic member 110 is placed on the limb S. It can be rotated to

According to the hemostatic device 100, the hemostasis member 110 rotates to sandwich the puncture site periphery A located between the first rotating body 120 and the second rotating body 130, thereby removing the skin, etc. around the puncture site A. The living tissue is pulled up in the rotation direction of the first rotating body 120 and the second rotating body 130, the wound formed at the puncture site P1 is closed, and bleeding at the puncture site P1 can be stopped. Therefore, the hemostasis device 100 can effectively stop the bleeding at the puncture site P1 without applying excessive pressure to the blood vessel B. Further, the first rotating body 120 has a larger external shape than the second rotating body 130. Therefore, when the hemostasis member 110 is placed at the puncture site P1, the first rotating body 120 is placed so as to protrude further toward the blood vessel B than the second rotating body 130. As a result, the first rotating body 120 of the hemostasis member 110 compresses the blood vessel B to the extent that no blood vessel occlusion occurs, and causes the blood vessel inner wall Bw to protrude toward the blood vessel side. Therefore, the hemostasis member 110 can increase the shear stress generated on the blood vessel inner wall Bw of the limb S around the wound on the blood vessel side of the puncture site P1. The hemostasis member 110 can promote thrombosis hemostasis in the blood vessel B by increasing the shear stress using the first rotating body 120 and promoting platelet adhesion and aggregation reactions around the wound on the blood vessel side of the puncture site P1. can. Therefore, the hemostatic device 100 can further enhance the hemostatic effect at the puncture site P1.

The first rotating body 120 and the second rotating body 130 are in contact with each other in a state where the first rotating body 120 is rotatable in a first direction and the second rotating body 130 is rotatable in a second direction. . By rotating one of the rotating bodies with the first rotating body 120 and the second rotating body 130 in contact with each other, the operator can easily rotate the other rotating body in conjunction with the rotation of one rotating body. can be done. Therefore, the operator or the like can stop the bleeding at the puncture site P1 with a simple operation.

The first rotating body 120 has a recess 121 that is depressed from the outer peripheral surface of the first rotating body 120 toward the rotation center of the first rotating body 120 . The operator or the like can form the puncture site P1 through the gap g with the hemostatic device 100 attached to the limb S. The operator or the like can start hemostasis using the hemostasis device 100 with a portion of the introducer 200 placed in the gap g. Therefore, in a procedure using the hemostasis device 100, the operator or the like can smoothly proceed with various tasks included in the procedure without removing the hemostasis device 100 from the limb S. Furthermore, the operator or the like can start hemostasis using the hemostasis device 100 while the introducer 200 is placed in the puncture site P1 through the gap g. Therefore, the operator or the like can stop the bleeding at the puncture site P1 while suppressing the bleeding that occurs when the introducer 200 is removed.

The first rotating body 120 has a recess 121 formed approximately at the center in the longitudinal direction of the first rotating body 120 . The recess 121 is formed in the first rotating body 120 having a larger external shape than the second rotating body 130 . Therefore, the operator or the like can easily visually confirm the desired position for forming the puncture site P1 or the puncture site P1 through the gap g formed by the recess 121, so that the hemostasis device 100 can be easily attached to the patient's limb S. Can be installed. In addition, in the hemostatic device 100, since the recess 121 is formed at approximately the center position in the longitudinal direction of the first rotating body 120, the puncture site P1 is located approximately at the center of the hemostatic member 110, and the first rotating body 120 and the first rotating body The two-rotating body 130 can suitably perform hemostasis at the puncture site P1. In addition, the operator or the like can form the puncture site P1 through the gap g formed between the first rotating body 120 and the second rotating body 130 by the recess 121. Therefore, the operator or the like can form the puncture site P1 at a desired position using the approximate longitudinal center position of the first rotating body 120 as a guide.

The recess 121 of the first rotating body 120 is formed only in a part of the outer peripheral surface of the first rotating body 120 along the rotation direction of the first rotating body 120. Since the recess 121 is formed only in a part of the outer peripheral surface of the first rotating body 120, while the first rotating body 120 is rotating, the first rotating body 120 and the limb S The contact state can be maintained more reliably. Therefore, by the rotation of the first rotating body 120 and the second rotating body 130, the hemostatic member 110 reliably moves the living tissue such as the skin around the puncture site A in the rotational direction of the first rotating body 120 and the second rotating body 130. The needle can be pulled up to stop the bleeding at the puncture site P1. In addition, the first rotating body 120 of the hemostasis member 110 compresses the blood vessel B to the extent that vascular occlusion does not occur, and causes the blood vessel inner wall Bw to protrude toward the blood vessel side, thereby reliably increasing the shear stress generated on the blood vessel inner wall Bw. Can be done.

The hemostasis device 100 has a fixing member 140 that fixes the hemostatic member 110 to the limb S. The first rotating body 120 and the second rotating body 130 are rotatable while the hemostatic member 110 is fixed to the limb S by the fixing member 140. The operator or the like can suitably fix the hemostatic member 110 to the patient's limb S using the fixing member 140. Therefore, the operator or the like fixes the positions of the first rotating body 120 and the second rotating body 130 by rotating the first rotating body 120 and the second rotating body 130 with the hemostatic member 110 fixed to the limb S. In this state, the vicinity A of the puncture site can be reliably sandwiched between the first rotating body 120 and the second rotating body 130.

The hemostasis member 110 has a first rotating shaft 123 that is the rotating shaft of the first rotating body 120, a second rotating shaft 133 that is the rotating shaft of the second rotating body 130, and a first rotating shaft 123 and a second rotating shaft. It has a connecting part 160 that connects the rotating shaft body 133. The connecting portion 160 is connected to the fixing member 140. In the hemostatic device 100, the hemostatic member 110 is disposed on the fixed member 140 in such a manner that the rotation of the rotating shaft bodies 123, 133 of the rotating bodies 120, 130 is not inhibited. Therefore, the operator or the like can suitably rotate each rotating body 120, 130 while the hemostasis device 100 is fixed to the limb S by the fixing member 140.

The hemostasis device 100 includes a level 170 that is disposed on the connecting portion 160 and indicates the levelness of the connecting portion 160 when the hemostasis member 110 is placed on the limb S. The operator or the like confirms the levelness of the connecting part 160 using the level 170, so that the first rotating shaft 123 of the first rotating body 120 and the second rotating shaft 133 of the second rotating body 130 are aligned with the limb S. It is possible to check whether the position is parallel to the body surface. The operator or the like aligns the first rotating shaft 123 of the first rotating body 120 and the second rotating shaft 133 of the second rotating body 130 parallel to the body surface of the limb S based on the levelness indicated by the level 170. By arranging the rotating bodies 120 and 130, when the rotating bodies 120 and 130 are rotated, the vicinity A of the puncture site can be more reliably sandwiched between the rotating bodies 120 and 130.

The first rotating body 120 has a rotation regulating mechanism 180 that restricts the rotation direction of the first rotating body 120 to only one direction. When rotating the first rotating body 120, the operator or the like can restrict the first rotating body 120 from rotating in the opposite direction to the first direction. The operator or the like can easily control the rotational direction of the first rotating body 120 only in the first direction.

The hemostasis method according to the present embodiment using a hemostasis device includes the steps of arranging a hemostatic member on a limb in which a puncture site has been formed, and in a state in which the hemostasis member is placed on the limb, a first rotating body of the hemostasis member is and rotating a second rotating body of the hemostasis member having a smaller external shape than the first rotating body in a second direction different from the first direction in conjunction with the rotation of the first rotating body. , the first rotating body and the second rotating body sandwich the area around the puncture site located between the first rotating body and the second rotating body.

According to the above-mentioned hemostasis method, the operator or the like rotates the area around the puncture site located between the first rotating body and the second rotating body so as to sandwich the area between the rotating bodies, thereby removing the skin, etc. around the puncturing site. The living tissue can be pulled up in the rotational direction of the first rotating body and the second rotating body, the wound formed at the puncture site can be closed, and bleeding at the puncture site can be stopped. Therefore, the operator or the like can efficiently stop the bleeding at the puncture site using the hemostasis device without applying excessive pressure to the blood vessel. Further, the first rotating body has a larger external shape than the second rotating body. Therefore, when applying compressive force to the puncture site with the hemostasis member, the operator or the like can place the first rotating body in such a manner that it protrudes more toward the blood vessel than the second rotating body. Thereby, the operator or the like can increase the shear stress generated on the inner wall of the blood vessel of the limb. By increasing the shear stress, the operator or the like can promote hemostasis of the blood clot in the wound on the blood vessel side of the blood vessel puncture site. Therefore, the operator or the like can further enhance the hemostasis effect at the puncture site.

The hemostasis method according to the present embodiment uses a hemostatic device having a concave portion recessed from the outer circumferential surface of at least one of the first and second rotating bodies toward the rotation center (rotating shaft side). a step of forming a puncture site through a gap formed between the first rotary body and the second rotary body by the recess with the hemostasis device placed on the patient's limb; and a step of rotating the first rotary body and the second rotary body with the introducer disposed at the puncture site through a gap.

According to the above-mentioned hemostasis method, the operator or the like forms a puncture site through the gap formed by the recess between the first rotating body and the second rotating body while the hemostasis device is placed on the limb. Can be done. Further, the operator or the like can start hemostasis using the hemostasis instrument by rotating the first rotating body and the second rotating body while placing a portion of the introducer in the gap. Therefore, in a procedure using a hemostatic device, the operator or the like can smoothly perform various tasks required for the procedure without removing the hemostatic device from the limb.

Next, a modification of the hemostatic member will be described. Descriptions of the configuration and function of each member, the procedure for using the hemostasis device, etc. that have already been described in the above-described embodiments will be omitted as appropriate.

As described in the following modification, the recess can be provided in at least one of the first rotating body and the second rotating body. The recess may be provided on a part of the outer circumferential surface of at least one of the rotating bodies, or may be provided only on a part of the outer circumferential surface of at least one of the rotating bodies. The recess may not be provided in the first rotating body and the second rotating body.

<Modification 1 of hemostasis member>
FIG. 7 shows a hemostasis member 110A according to modification 1. In the hemostasis member 110A according to the first modification, the first rotating body 120A is different from the first rotating body 120 of the embodiment described above. In the first rotating body 120A, a recess 121 is formed along the entire circumference of the outer peripheral surface of the first rotating body 120A.

<Modification 2 of hemostasis member>
FIG. 8 shows a hemostatic member 110B according to a second modification. In the hemostatic member 110B according to the second modification, the second rotating body 130B is different from the second rotating body 130 of the embodiment described above. A recess 131 is formed in the second rotating body 130B. The recess 131 is formed along the entire circumference of the outer peripheral surface of the second rotating body 130B.

<Modification 3 of hemostasis member>
9 and 10 show a hemostatic member 110C according to a third modification. In the hemostasis member 110C according to the third modification, the first rotating body 120C and the second rotating body 130 have no recessed portions.

FIG. 11 and FIG. 12 show how a hemostatic member 110C according to modification 3 is used to stop bleeding. FIG. 11 is a plan view showing how a hemostatic device including a hemostasis member 110C is placed on a limb S. FIG. 12 is a diagram schematically showing a cross section of the patient's limb S along the arrow 12A-12A shown in FIG.

Recesses are not formed in each of the rotating bodies 120C and 130C according to Modification 3. Therefore, no gap is formed between the first rotating body 120C and the second rotating body 130C in which the sheath tube 210 of the introducer 200 can be placed. The operator or the like places the hemostasis device according to Modification 3 on the limb S when starting to remove the introducer 200 after completing treatment or diagnosis using the medical device. When the surgeon or the like uses the hemostasis device according to the third modification to stop the bleeding at the puncture site P1, as shown in FIG. Each rotating body 120C, 130C is placed so as to press against the limb S from above the surface layer of the living body S. At this time, the operator or the like places the hemostatic instrument so that the wound on the skin side of the puncture site P1 is located between the first rotating body 120C and the second rotating body 130C. When the sheath tube 210 of the introducer 200 is removed, the surgeon rotates the rotating bodies 120 and 130 to remove the living tissue such as the skin around the puncture site A from the first rotating body 120C and the second rotating body 120C. The body 130C is pulled up in the rotational direction to close the wound formed at the puncture site P1 and stop bleeding at the puncture site.

Next, modified examples of the fixing member and the connecting portion will be described. Descriptions of the configuration and function of each member, the procedure for using the hemostasis device, etc. that have already been described in the above-described embodiments will be omitted as appropriate.

As explained in the following modification, the form of connecting the fixing member and the connecting portion is not particularly limited as long as it is possible to maintain the connected state of the fixing member and the connecting portion.

<Modification 1 of fixing member and connecting part>
FIG. 13 shows a fixing member 140D and a connecting portion 160D according to Modification 1.

The fixing member 140D according to the first modification differs from the fixing member 140 of the embodiment described above in the structure of one end portion 142a connected to the connecting portion 160D. A space 143 into which a part of the connecting portion 160D is inserted is formed in one end 142a of the fixing member 140D. The fixing member 140D is connected to the connecting portion 160D by inserting the connecting portion 160D into the space 143.

The connecting portion 160D according to the first modification is configured integrally with each rotating shaft body 123, 133. An intermediate portion 162a is formed between the first rotating shaft body 123 and the second rotating shaft body 133. The intermediate portion 162a is inserted into a space 143 formed in one end portion 142a of the fixing member 140D.

<Modification example 2 of fixing member and connecting part>
FIG. 14 shows a fixing member 140E and a connecting portion 160E according to a second modification.

The connecting portion 160E according to the second modification has an insertion portion 163 into which one end portion 142a of the fixing member 140E can be inserted. The fixing member 140E is connected to the connecting portion 160E by inserting one end 142a of the fixing member 140E into the insertion portion 163 of the connecting portion 160E. An adhesive may be placed on the insertion portion 163 in order to increase the fixing force of the insertion portion 163 to the connecting portion 160E.

<Modification example 3 of fixing member and connecting part>
FIG. 15 shows a fixing member 140F and a connecting portion 160F according to Modification 3.

The connecting portion 160F according to the third modification has the same configuration as the connecting portion 160D according to the first modification. The fixing member 140F according to the third modification is configured integrally with the first band member 145 disposed in a position close to the first rotating shaft body 123, which is configured integrally with the connecting portion 160F, and the connecting portion 160F. and a second band member 146 disposed close to the second rotating shaft body 133. One end 145a of the first band 145 in the longitudinal direction is connected to the connecting portion 160F. One end 146a in the longitudinal direction of the second band 146 is connected to a connecting portion 160F. Although not shown, a second fixing portion 152 (see FIG. 1) is disposed at the other longitudinal end of each band 145, 146. When fixing the hemostasis device including the fixing member 140F and the connecting part 160F according to the third modification to the limb S, the operator etc. should adjust the fixing force (tightening force) of each of the first band 145 and the second band 146. Can be adjusted individually. For example, the operator or the like can prevent the first rotating body 120, which has a larger external shape than the second rotating body 130, from lifting off from the limb S by tightening the first band 145 more tightly than the second band 146. It can be suppressed. Although not shown, a structure similar to that of the fixing member 140F and the coupling portion 160F is also provided on the first fixing member side (first coupling portion side) of the fixing member 140F.

Although the hemostasis device according to the present invention has been described above through the embodiments and modified examples, the present invention is not limited to each configuration described, and can be modified as appropriate based on the description of the claims. It is. For example, each part constituting the hemostasis device can be replaced with any part that can perform the same function. Moreover, arbitrary components may be added.

The configuration described in the embodiment and the configuration described in each modification can be arbitrarily combined as long as the effects of the hemostasis device according to the present invention can be exhibited.

The external shape, cross-sectional shape, size, etc. of each rotating body are not particularly limited as long as the puncture site can be compressed to stop bleeding. Each rotating body can have an outer shape such as a spherical shape, an elliptical shape, a polygonal shape, or the like.

At least one of the first rotating body and the second rotating body can be provided with an operating section for assisting rotational operation of the rotating body. The operating section can be configured with a protrusion that allows the operator or the like to easily operate the rotation of the rotating body with fingers. The protrusion can be provided on the outer peripheral surface of the rotating body or on the side surface of the rotating body.

At least one of the first rotating body and the second rotating body may be provided with a locking mechanism that restricts rotation of the rotating body. While stopping the bleeding using a hemostatic device, the operator restricts the rotation of each rotating body using the lock mechanism, so that the first rotating body and the second rotating body can protect against living tissue such as the skin around the puncture site. By keeping the needle pulled up in the rotational direction and keeping the wound formed at the puncture site closed, it is possible to stop bleeding at the puncture site.

The first rotary body and the second rotary body may be provided with gear structures that mesh with each other on part of the outer surfaces of the first rotary body and the second rotary body. Thereby, when an operator or the like rotates either the first rotating body or the second rotating body, the two rotating bodies can reliably move in conjunction with each other due to the gear structure.

The rotation regulating mechanism may be provided on the first rotating body and the second rotating body, or may be provided only on the second rotating body. As long as the rotation regulating mechanism can restrict the rotational direction of the rotating body to only one direction, there is no restriction on the specific configuration or the position provided on the rotating body.

The specific configuration of the fixing member is not limited as long as the hemostasis member can be fixed to the limb. For example, the hemostatic device may not include a fixation member. If the hemostatic device does not include a fixing member, the hemostatic device may be fixed to the limb using a known tape or the like having an adhesive layer. When configured in this way, the hemostasis device can be provided with wings on the connecting portion for pasting the tape.

The hemostasis device is not limited to being used by being attached to the wrist, but can also be used by being attached to any part of the limb such as the arm or leg.

This application is based on Japanese Patent Application No. 2019-178737 filed on September 30, 2019, the disclosure content of which is incorporated by reference in its entirety.

100 Hemostasis instruments 110, 110A, 110B, 110C Hemostasis members 120, 120A, 120C First rotating body 121 Recess 123 First rotating shaft 130, 130B, 130C Second rotating body 131 Recess 133 Second rotating shaft 140, 140D, 140E, 140F Fixed member 141 First fixed member 142 Second fixed member 151 First fixed part 152 Second fixed part 160, 160D, 160E, 160F Connection part 161 First connection part 162 Second connection part 170 Level 180 Rotation regulation Mechanism 200 Introducer 210 Sheath tube A Surrounding puncture site B Blood vessel Bw Inner wall of blood vessel P1 Puncture site S Limb g Gap

Claims (9)

having a hemostasis member placed at a puncture site formed on the limb;
The hemostasis member includes a first rotating body and a second rotating body having a smaller external shape than the first rotating body,
The first rotating body is rotatable in a first direction,
The second rotating body is rotatable in a second direction different from the first direction in conjunction with the rotation of the first rotating body,
The first rotating body and the second rotating body are configured to sandwich the vicinity of the puncture site located between the first rotating body and the second rotating body with the hemostatic member disposed on the limb. A hemostatic device that is rotatable. The first rotating body and the second rotating body are in contact with each other in a state where the first rotating body is rotatable in the first direction and the second rotating body is rotatable in the second direction. The hemostatic device according to claim 1. According to claim 2, at least one of the first rotating body and the second rotating body has a recess that is depressed from an outer peripheral surface of the one rotating body toward a rotation center of the one rotating body. Hemostasis device as described. The hemostasis device according to claim 3, wherein the first rotating body has the recess formed at a substantially central position in the longitudinal direction of the first rotating body. The hemostasis device according to claim 4, wherein the recessed portion of the first rotating body is formed only in a part of the outer peripheral surface of the first rotating body along the rotation direction of the first rotating body. a fixing member for fixing the hemostasis member to the limb;
The hemostatic device according to any one of claims 1 to 5, wherein the first rotating body and the second rotating body are rotatable with the hemostatic member being fixed to the limb by the fixing member. . The hemostatic member includes a first rotating shaft that is a rotating shaft of the first rotating body, a second rotating shaft that is a rotating shaft of the second rotating body, and a first rotating shaft that is a rotating shaft of the first rotating body and a second rotating shaft that is a rotating shaft of the first rotating body. It has a connecting part that connects the shaft body,
The hemostatic device according to claim 6, wherein the connecting portion is connected to the fixing member. The hemostatic device according to claim 7, further comprising a level that is disposed at the connecting portion and indicates the levelness of the connecting portion when the hemostasis member is placed on the limb. According to any one of claims 1 to 8, at least one of the first rotating body and the second rotating body has a rotation regulating mechanism that restricts the rotation direction of the one rotating body to only one direction. Hemostasis device as described.