WO2021177217A1

WO2021177217A1 - Hemostatic agent injection device

Info

Publication number: WO2021177217A1
Application number: PCT/JP2021/007654
Authority: WO
Inventors: 雄一日置; 浩平渡邉
Original assignee: テルモ株式会社
Priority date: 2020-03-03
Filing date: 2021-03-01
Publication date: 2021-09-10
Also published as: JPWO2021177217A1

Abstract

[Problem] To provide a hemostatic agent injection device which is so configured that an ejection part in a second member through which a hemostatic agent is ejected can be positioned properly at a puncture site on a blood vessel. [Solution] The hemostatic agent injection device 10 is provided with a first member 100 which has a tip-end opening 101, a base-end opening 103 and a rumen 105 that can communicate the tip-end opening with the base-end opening and a second member 200 which is connected to the first member and has, arranged at a tip part thereof, an ejection part 201a through which a hemostatic agent 240 can be ejected, in which the first member has a first region 101A that is located on the tip end side relative to the tip of the second member, the first region has a tilted part 101a that is tilted toward a direction away from the second member, and the tilted part forms the tip-end opening of the first member.

Description

Hemostatic infusion device

The present invention relates to a hemostatic agent injection device.

Conventionally, it has been known that various medical long bodies (for example, an introducer) are introduced into a blood vessel through a puncture site formed in a blood vessel of a limb such as a patient's arm to treat or treat the lesion site. Has been done. When such a procedure is performed, the surgeon or the like stops bleeding at the puncture site when removing the medical long body from the puncture site. As one of the hemostasis methods, a compression hemostasis method is known in which a compression force is applied to the puncture site of a blood vessel and the subcutaneous tissue around the puncture site from the surface layer side of the living body of the patient.

When the compression hemostasis method is adopted, if overpressure compression in which the compression force becomes excessively large is performed for a long time, vascular occlusion may occur. Therefore, it is required to adjust the compression force appropriately. In relation to such a problem, Patent Document 1 below discloses a hemostasis device that enables non-compression hemostasis. The hemostatic device of Patent Document 1 includes a sheath that can be inserted into a living body and a cartridge charged with a hemostatic agent held inside the sheath. In the procedure using the hemostatic device of Patent Document 1, the operator or the like introduces the tip opening of the sheath to the vicinity of the puncture site of the blood vessel, and discharges the hemostatic agent through the tip opening. The surgeon or the like can close the puncture site by arranging the hemostatic agent discharged from the sheath around the puncture site of the blood vessel.

International release WO00 / 030553

The hemostatic device is provided with a stopper (locking member) that prevents the tip of the sheath from being inserted beyond the depth of the puncture site of the blood vessel. The stopper is attached to the outer peripheral surface of the sheath, and when the sheath is inserted into the living body, it comes into contact with the surface layer of the patient's living body to limit the insertion length of the sheath.

According to the above hemostatic device, it is possible to prevent the sheath from being excessively inserted into the blood vessel beyond the depth of the puncture site of the blood vessel. However, when the hemostatic device is used, the operator or the like cannot grasp the exact position of the puncture site of the blood vessel when starting the discharge of the hemostatic agent. Therefore, the surgeon or the like has no choice but to place the tip opening of the sheath at the puncture site of the blood vessel, depending on the sensation of the hand or the like. Therefore, in the procedure using the hemostatic device, it is difficult to properly position the tip opening of the sheath with respect to the puncture site of the blood vessel.

The present invention has been made to solve the above-mentioned problems, and it is possible to appropriately arrange a discharge portion of a second member having a simple structure and capable of discharging a drug around a puncture site of a blood vessel. It is an object of the present invention to provide a hemostatic agent infusion device capable.

The hemostatic agent injection device according to the present invention is connected to a first member having a tip opening, a proximal end opening, and a lumen that communicates the distal end opening with the proximal end opening, and is connected to the first member to discharge a hemostatic agent. A possible discharge portion includes a second member provided at the tip portion, and the first member has a first region located on the tip side of the tip of the second member, and the first region is The inclined portion has an inclined portion inclined in a direction away from the second member, and the inclined portion forms the tip opening of the first member.

The hemostatic agent injection device according to the present invention includes a first region in which the first member is located on the tip side of the tip of the second member. Further, the first region of the first member has an inclined portion that is inclined toward a direction away from the second member. The inclined portion forms a tip opening of the first member through which blood can flow. The surgeon or the like can confirm that blood has leaked from the proximal opening of the first member by moving the first region including the distal opening of the first member to the blood vessel side through the subcutaneous tissue. By confirming that blood has leaked from the base end opening of the first member, the surgeon or the like determines whether the tip opening of the first member is located inside the blood vessel wall (blood vessel) or outside the blood vessel wall (subcutaneous tissue). ) Can be easily grasped. Therefore, the hemostatic agent injection device can appropriately arrange the position of the discharge portion of the second member with respect to the periphery of the puncture site of the blood vessel with a simple configuration.

It is a perspective view which shows the hemostatic agent injection device which concerns on embodiment. It is a perspective view which shows the hemostatic agent injection device which concerns on embodiment, and is the figure which shows the state when the 3rd region of the 1st member is separated from the 2nd member. It is sectional drawing which follows the arrow 3A-3A shown in FIG. It is sectional drawing which follows the arrow 4A-4A shown in FIG. It is sectional drawing which follows the arrow 5A-5A shown in FIG. It is sectional drawing which follows the arrow 6A-6A shown in FIG. It is a schematic cross-sectional view for demonstrating the use example of the hemostatic agent injection device which concerns on embodiment. It is a schematic cross-sectional view for demonstrating the use example of the hemostatic agent injection device which concerns on embodiment. It is a schematic cross-sectional view for demonstrating the use example of the hemostatic agent injection device which concerns on embodiment. It is a schematic cross-sectional view for demonstrating the use example of the hemostatic agent injection device which concerns on embodiment. It is a schematic cross-sectional view for demonstrating the use example of the hemostatic agent injection device which concerns on embodiment. It is a schematic cross-sectional view for demonstrating the use example of the hemostatic agent injection device which concerns on embodiment. It is a schematic cross-sectional view for demonstrating the use example of the hemostatic agent injection device which concerns on embodiment. It is a schematic cross-sectional view for demonstrating the use example of the hemostatic agent injection device which concerns on embodiment, and is the figure which enlarges and shows the puncture site of a blood vessel. It is a schematic cross-sectional view for demonstrating the use example of the hemostatic agent injection device which concerns on embodiment, and is the figure which enlarges and shows the puncture site of a blood vessel. It is a perspective view which shows the hemostatic agent injection device which concerns on the modification 1, and is the figure which shows the state when the 3rd region of the 1st member is separated from the 2nd member. It is a perspective view which shows the hemostatic agent injection device which concerns on the modification 2, and is the figure which shows the state when the 3rd region of the 1st member is separated from the 2nd member. It is a perspective view which shows the hemostatic agent injection device which concerns on modification 3.

Hereinafter, a hemostatic method using the hemostatic agent injection device 10 and the hemostatic agent injection device 10 according to the present embodiment will be described with reference to FIGS. 1 to 15.

1 to 6 are diagrams for explaining the configuration of each part of the hemostatic agent injection device 10 according to the embodiment, and FIGS. 7 to 15 are for explaining a usage example of the hemostatic agent injection device 10 according to the embodiment. It is a figure to serve.

In the description of the present specification, the extending direction (vertical direction of FIGS. 1, 2 and 3) of the hemostatic agent injection device 10 is referred to as an axial direction. Further, the side of the hemostatic agent injection device 10 introduced into the living body is referred to as the tip side (lower end side of FIGS. 1, 2, and 3), and the end side opposite to the tip side (FIGS. 1, 2, and 3). The upper end side of 3) is referred to as the base end side. Further, in the description of the present specification, the tip end portion means a tip end (tip end) and a region including a predetermined range from the tip end to the base end side, and the base end portion is a base end (most base end). And a region including a predetermined range from the proximal end to the distal end side.

Generally, the hemostatic agent injection device 10 includes a tip opening 101, a proximal opening 103, and a lumen 105 that communicates the distal opening 101 and the proximal opening 103, as shown in FIGS. 1, 2, and 3. It includes one member 100 and a second member 200 connected to the first member 100 and provided with a discharge portion 201a connected to the first member 100 and capable of discharging the hemostatic agent 240 at the tip portion. The first member 100 has a first region 101A located on the tip side of the tip of the second member 200. The first region 101A has an inclined portion 101a that is inclined toward a direction away from the second member 200. The inclined portion 101a forms a tip opening 101 of the first member 100.

The first member 100 is composed of a tubular member having a tip opening 101, a base end opening 103, and a lumen 105.

The second member 200 has a first main body member 210, a second main body member 220, and a connecting member 230. The first main body member 210 is composed of a tubular member having a base end opening 213 and a lumen 215. The second main body member 220 is composed of a tubular member having a base end opening 223 and a lumen 225 formed therein. As will be described later, each of the

main body members

210 and 220 is provided with a partition portion 203 and a sixth region 206A that partition a predetermined space within the

lumens

215 and 225.

In the present embodiment, the lumen 215 of the first main body member 210 is referred to as "the first lumen 215 of the second member 200", and the lumen 225 of the second main body member 220 is referred to as "the second lumen 225 of the second member 200". .. When the second member is composed of one tubular member, only one lumen can be provided on the second member. Further, when the second member is composed of three or more tubular members, the second member may be provided with three or more lumens.

The connecting member 230 connects the first main body member 210 and the second main body member 220. An internal space 235 into which the first main body member 210 and the second main body member 220 can be inserted is formed inside the connecting member 230 (see FIGS. 4 and 5). A gap is formed between the inner surface of the connecting member 230 and the

main body members

210 and 220. However, it is not necessary to provide a gap between the inner surface of the connecting member 230 and the

main body members

210 and 220. For example, the gap can be filled by filling a filler such as a resin material between the connecting member 230 and the

main body members

210 and 220.

As shown in FIGS. 4 and 5, the connecting member 230 is fixed to the

main body members

210 and 220 while covering the outer peripheral surfaces of the

main body members

210 and 220. As a method of fixing the connecting member 230 and the

main body members

210 and 220, for example, adhesion or fusion can be adopted.

The discharge portion 201a for discharging the hemostatic agent 240 from the second member 200 is formed by the tip opening 201 of the connection member 230. When the second member 200 is composed of one tubular member (for example, see a modified example shown in FIG. 16 described later), the discharge portion 201a can be formed by opening the tip of one tubular member.

As shown in FIGS. 1, 2, and 3, the first member 100 is located on the proximal end side of the first region 101A, and is fixed to the second member 200 in the second region 102A and the second region 102A. It is located closer to the proximal end and has a third region 103A including the proximal end of the first member 100.

The third region 103A is configured to be separable from the second member 200. FIG. 2 briefly shows the state when the third region 103A is separated from the second member 200.

The inclined portion 101a formed in the first region 101A is inclined in a direction away from the second member 200. The tilt angle of the tilted portion 101a (the tilt angle of the first member 100 with respect to the axis before the third region 103A is separated from the second member 200) is not particularly limited.

In the hemostatic agent injection device 10, the tip opening 101 is formed by the inclined portion 101a. Therefore, when arranging the tip opening 101 in the blood vessel Bv, the hemostatic agent injection device 10 arranges the tip opening 101 so as to face the blood flow direction, so that the blood B enters the lumen 105 of the first member 100. Can be easily flowed in (see FIGS. 9 and 10).

The third region 103A can be connected to the outer surface of the connecting member 230 of the second member 200, for example, by fusion or adhesion. The connecting force for maintaining the connection between the third region 103A and the connecting member 230 is obtained when the operator or the like pulls the first member 100 from the second member 200 in a direction relatively separated by the force of a finger or the like. The size of the third region 103A can be set so as to be separable from the second member 200. The specific magnitude of the connecting force that connects the third region 103A and the second member 200 is not particularly limited. Further, when the connecting member 230 is not provided in the second member 200 (for example, see the modified examples shown in FIGS. 16 and 18 described later), the third region 103A is the first main body member 210 and / or the second. It can be separably connected to the main body member 220.

As shown in FIGS. 1, 2, and 3, the second member 200 is located on the proximal end side of the fourth region 204A including the discharge portion 201a and the fourth region 204A, and holds the hemostatic agent 240. It has a partition portion 203 that is arranged between the 5 region 205A and the 4th region 204A and the 5th region 205A and partitions the 4th region 204A and the 5th region 205A. The partition portion 203 can communicate the fourth region 204A and the fifth region 205A by the internal pressure of the fifth region 205A in a state where the fifth region 205A is compressed.

As shown in FIG. 3, in the partition portion 203, the first partition member 203a that seals the tip of the first main body member 210 and the fifth region 205A are compressed in a state where the fifth region 205A is not compressed. It has a second partition member 203b that seals the tip of the second main body member 220 in the absence state.

The fifth region 205A is composed of a predetermined space in the first lumen 215 partitioned by the first partition member 203a and the first closing member 206a described later, and the second partition member 203b and the second closing member 206b described later. It is composed of a predetermined space in the partitioned second lumen 225.

The first partition member 203a can be composed of, for example, a resin film-like member provided so as to close the tip opening of the first main body member 210. The second partition member 203b can be composed of, for example, a resin film-like member provided so as to close the tip opening of the second main body member 220.

In the partition portion 203, the

agents

240a and 240b held in the fifth region 205A move to the fourth region 204A in a state where a pressing force of a predetermined size or more is not applied to the fifth region 205A. As long as this can be prevented, the specific configuration is not particularly limited. For example, the partition portion 203 may be composed of a fused portion in which the tip of the first main body member 210 and the tip of the second main body member 220 are fused. When such a fused portion is provided on the second member 200 as a partition portion 203, it is necessary to break the fused portion by adjusting the amount of fusion between the first main body member 210 and the second main body member 220. The amount of compression force can be adjusted. Further, the partition portion 203 is composed of, for example, a valve (for example, a one-sided valve) that communicates the fourth region 204A and the fifth region 205A according to the magnitude of the pressing force applied to the fifth region 205A. You may.

As shown in FIGS. 1, 2, 3, and 5, the fifth region 205A forms a hemostatic agent 240 by being mixed with the first lumen 215 holding the first drug 240a and the first drug 240a. It has a second lumen 225 holding the second agent 240b and a wall portion 204 (see FIG. 3) that separates the first lumen 215 and the second lumen 225.

As shown in FIG. 3, the wall portion 204 is composed of a pipe wall of the first main body member 210 and a pipe wall of the second main body member 220. The wall 204 separates the first agent 240a held in the first lumen 215 and the second agent 240b held in the second lumen 225.

The second member 200 is configured so that when the fifth region 205A is compressed, communication between the fourth region 204A and the fifth region 205A is more likely to occur than the breakage of the wall portion 204. That is, the partition portion 203 is configured to be more easily broken than the wall portion 204. Therefore, when the operator or the like presses the fifth region 205A, it is possible to prevent the wall portion 204 from being unintentionally broken and the first agent 240a and the second agent 240b from being mixed in the fourth region 204A. ..

As shown in FIGS. 1, 2, 3, and 4, the second member 200 is located on the proximal end side of the fifth region 205A, and has the first lumen 215 and the second lumen 225 of the second member 200. It has a sixth region 206A to be occluded.

As shown in FIG. 3, the sixth region 206A includes a first closing member 206a arranged on the proximal end side of the portion forming the fifth region 205A in the first lumen 215 and a fifth region in the second lumen 225. It is composed of a second closing member 206b arranged on the proximal end side of the portion forming the 205A.

The portion of the first lumen 215 on which the fifth region 205A is formed is the first partition member 203a arranged on the distal end side of the portion and the proximal end of the portion when the fifth region 205A is not compressed. It is partitioned by a first closing member 206a arranged on the side. Further, the portion of the second lumen 225 on which the fifth region 205A is formed is larger than the second partition member 203b arranged on the tip side of the portion and the portion of the second lumen 205A in a state where the fifth region 205A is not compressed. It is partitioned by a second closing member 206b arranged on the base end side. Therefore, the hemostatic agent injection device 10 prevents the

agents

240a and 240b from moving to the distal end side or the proximal end side from the fifth region 205A in a state where the fifth region 205A is not compressed. Can be prevented.

The second member 200 is configured so that the wall portion 204 is more likely to break than the sixth region 206A when the fifth region 205A is compressed. Therefore, the hemostatic agent injection device 10 can prevent the sixth region 206A from breaking before the wall portion 204 when the fifth region 205A is compressed.

Each of the

closing members

206a and 206b can be made of, for example, a resin material having a predetermined thickness that can prevent breakage even when the fifth region 205A is pressed.

In the hemostatic agent injection device 10, the ease of breaking and the ease of communication of each part when a pressing force is applied to the fifth region 205A can be set as follows, for example.

First compression force applied to the fifth region 205A to communicate the fourth region 204A and the fifth region 205A (compression force for releasing the partition by the partition portion 203) <No. 1 when the wall portion 204 breaks. Second compression force applied to the fifth region 205A <Third compression force applied to the fifth region 205A when the sixth region 206A breaks.

By setting "first compression force <third compression force" as described above, the first agent 240a and the second agent 240b are surely mixed in the fourth region 204A and discharged from the tip opening 201. be able to. Further, by setting "first compression force <second compression force" as described above, the

respective agents

240a and 240b are before the

respective agents

240a and 240b move from the fifth region 205A to the fourth region 204A. Can be prevented from being mixed in the fifth region 205A. Further, by setting "second compression force <third compression force" as described above, the partition portion is prevented from moving the

respective agents

240a and 240b to the proximal end side from the fifth region 205A. Even when the wall portion 204 is broken while the 203 is broken, the hemostatic agent 240 can be discharged from the fourth region 204A through the tip opening 201. Therefore, the hemostatic agent injection device 10 preferably prevents the sixth region 206A from breaking before the wall portion 204, causing the hemostatic agent 240 to leak to the proximal end side and not be discharged to the distal end side. Can be done.

As shown in FIG. 3, a seventh region 207A is formed on the proximal end side of the sixth region 206A. A part of the third region 103A is separably connected to a part of the outer peripheral surface of the seventh region 207A (a part of the outer peripheral surface of the connecting member 230).

As shown in FIG. 3, the inside of the fourth region 204A (the portion of the internal space 235 of the connecting member 230 located closer to the tip of the first main body member 210 and the tip of the second main body member 220) is A mixing space 208 for mixing the

respective drugs

240a and 240b held in the 5 region 205A is formed. When the fifth region 205A is compressed and the

partition members

203a and 203b are broken, the hemostatic agent injection device 10 moves the

agents

240a and 240b held in the fifth region 205A to the mixing space 208. The hemostatic agent injection device 10 forms the hemostatic agent 240 by mixing the

agents

240a and 240b in the mixing space 208. The hemostatic agent injection device 10 can discharge the hemostatic agent 240 formed in the mixing space 208 to the tip side of the second member 200 via the discharge portion 201a located on the tip side of the mixing space 208.

A part of the second region 102A is fixed to the fourth region 204A. Further, as shown in FIGS. 1 and 3, the fifth region 205A has a longer length along the axial direction of the second member 200 than the fourth region 204A. Since the fourth region 204A is short as described above, the operator can efficiently discharge the hemostatic agent 240 formed in the mixed space 208 of the fifth region 205A from the discharge portion 201a.

The first member 100 can be formed, for example, with a total length of 100 mm to 500 mm along the axial direction. When forming the total length of the first member 100 as described above, the first region 101A can be formed to, for example, 1 mm to 2 mm, and the second region 102A can be formed to, for example, 1 mm to 2 mm. , The third region 103A can be formed to, for example, 96 mm to 498 mm.

The second member 200 can be formed, for example, with a total length of 99 mm to 499 mm along the axial direction. When forming the total length of the second member 200 as described above, the fourth region 204A can be formed to, for example, 1 mm to 2 mm, and the fifth region 205A can be formed to, for example, 30 mm to 150 mm. The sixth region 206A can be formed, for example, from 0.1 mm to 0.5 mm, and the seventh region 207A can be formed, for example, from 67.9 mm to 467.9 mm.

As shown in FIGS. 1 and 2, the first member 100 has a recognition unit 110 that makes it possible to grasp the relative positional relationship between the first member 100 and the second member 200 in the outer peripheral direction of the hemostatic agent injection device 10. ..

The recognition unit 110 can be composed of, for example, a colored portion, a figure, a symbol, a pattern, an uneven shape, etc. attached to the outer peripheral surface of the first member 100. The recognition unit 110 can grasp the relative positional relationship between the first member 100 and the second member 200 in the outer peripheral direction of the hemostatic agent injection device 10 by the operator or the like by sight, touch, or the like. The specific configuration is not limited. Further, the recognition unit 110 may be provided only on the second member 200, or may be provided on the first member 100 and the second member 200. However, when the recognition unit 110 is provided on the first member 100 and the second member 200, the appearance and shape of the recognition unit 110 provided on the first member 100 and the recognition unit 110 provided on the second member 200 may be different. preferable. By providing the recognition unit 110 on the first member 100 and the second member 200 in this way, when the hemostatic agent 240 is discharged from the hemostatic agent injection device 10, the operator can easily position the hemostatic agent injection device 10 in the outer peripheral direction. Can be grasped.

In the hemostatic agent injection device 10, for example, when a liquid tissue adhesive is used as the hemostatic agent 240, a fibrinogen solution can be used as the first agent 240a, and a thrombin solution can be used as the second agent 240b. However, the type of hemostatic agent 240 (types of each

agent

240a and 240b) is not particularly limited as long as it is possible to stop bleeding at the puncture site P2 of the blood vessel Bv.

As the material constituting the first member 100 and the second member 200 (first main body member 210, second main body member 220, connecting member 230), for example, a resin material such as a polyamide elastomer can be used. However, the specific type of the material constituting each

member

100, 200 is not particularly limited.

Next, a hemostatic method using the hemostatic agent injection device 10 will be described with reference to FIGS. 7 to 15.

FIG. 7 shows a state in which the introducer 300 is inserted into the blood vessel Bv from the patient's skin. In the procedure described in this embodiment, the introducer 300 is inserted in a direction facing the blood flow direction (direction from the right side to the left side in FIG. 7) flowing in the blood vessel Bv. The surgeon or the like can deliver various medical devices to the treatment target site of the patient via the introducer 300 to perform treatment or diagnosis. Prior to the procedure using the introducer 300, the surgeon or the like forms a perforation P1 in the subcutaneous tissue S that reaches the blood vessel wall Bw in order to introduce the sheath tube 310 of the introducer 300 into the blood vessel Bv. In addition, the surgeon or the like forms a puncture site P2 (perforation P2 penetrating the blood vessel wall Bw) of the blood vessel Bv in the subcutaneous tissue S. The blood vessel Bv is, for example, a radial artery running on the wrist of a patient. However, the blood vessel Bv can be arbitrarily selected according to the content of the procedure and the like, and is not particularly limited.

As shown in FIG. 8, the surgeon or the like inserts the hemostatic agent injection device 10 into the living body via the sheath tube 310 of the introducer 300 after completing the procedure using various medical devices.

The surgeon or the like arranges the first region 101A of the first member 100 in the blood vessel Bv via the tip opening 311 of the sheath tube 310. The surgeon or the like moves (retracts) the introducer 300 toward the proximal end side as shown by the arrow b1 in a state where the first region 101A is arranged at the tip of the sheath tube 310 arranged in the blood vessel Bv. As a result, the operator or the like can project the first region 101A from the tip opening 311 of the sheath tube 310. The operator or the like can remove the introducer 300 from the living body as shown in FIG. 9 by further moving the introducer 300 toward the proximal end side along the hemostatic agent injection device 10.

When the operator or the like arranges the first region 101A in the blood vessel Bv, the surgeon or the like has a relative positional relationship between the first member 100 and the second member 200 in the outer peripheral direction of the hemostatic agent injection device 10 based on the position of the recognition unit 110. Can be confirmed. The surgeon or the like arranges the hemostatic agent injection device 10 so that the tip opening 101 of the first member 100 faces the upstream side (right side in FIG. 9) of the blood vessel Bv in the blood flow direction, so that the blood B flowing through the blood vessel Bv Can be easily flowed into the lumen 105 of the first member 100.

Further, when the operator or the like projects the first region 101A from the tip opening 311 of the sheath tube 310 (when the operator or the like projects the first region 101A of the first member 100 into the blood vessel Bv), as shown in FIG. Blood B flows into the lumen 105 of the first member 100 through the tip opening 101 formed in the first region 101A. When the blood B moves through the lumen 105 of the first member 100 and reaches the proximal opening 103, the hemostatic agent injection device 10 leaks the blood B from the proximal opening 103. By confirming that blood B has leaked from the proximal opening 103, the surgeon or the like can grasp that the first region 101A is arranged in the blood vessel Bv.

After the tip opening 101 of the first member 100 is projected from the tip opening 311 of the sheath tube 310, the surgeon or the like causes blood B to flow from the proximal opening 103 of the first member 100 even after a predetermined time has elapsed. If there is no leakage, the hemostatic agent infusion device 10 may be advanced toward the blood vessel Bv side. By advancing the hemostatic agent injection device 10 and moving the tip opening 101 of the first member 100 into the blood vessel Bv, the surgeon or the like can allow blood B to flow into the lumen 105 through the tip opening 101. can.

After confirming that blood B has leaked from the proximal end opening 103 of the first member 100, the operator or the like moves the hemostatic agent injection device 10 toward the proximal end side. When the blood B is leaking from the proximal opening 103 of the first member 100, the surgeon or the like can grasp that the first region 101A is arranged in the blood vessel Bv. Further, when the operator or the like moves the hemostatic agent injection device 10 toward the proximal end side, when blood B does not leak from the proximal end opening 103 of the first member 100, or when blood leaks from the proximal end opening 103, the surgeon or the like When the amount of B is significantly reduced, it can be grasped that the tip opening 101 of the first member 100 has moved to the outside of the blood vessel wall Bw (on the subcutaneous tissue S side of the blood vessel wall Bw).

The operator or the like may move the hemostatic agent injection device 10 forward and backward a plurality of times. By reciprocating the tip opening 101 of the first member 100 into and out of the blood vessel Bv, the surgeon or the like can more reliably grasp the position of the tip opening 101 of the first member 100.

Next, as shown in FIG. 12, the operator or the like separates the third region 103A from the second member 200. The operator or the like presses the fifth region 205A as shown in FIG. 13 in a state where the third region 103A is separated from the second member 200. The surgeon or the like can use, for example, a compression member 250 capable of imparting a gripping force (holding force) to the fifth region 205A. As the compression member 250, for example, a known instrument such as a clip can be used.

The surgeon or the like applies a compression force to the fifth region 205A by moving the compression member 250 mounted on the outer surface of the fifth region 205A toward the tip side along the axial direction of the second member 200. can do. When the surgeon or the like applies a pressing force to the fifth region 205A, the surgeon or the like applies the compression force to the portion forming the fifth region 205A of the first main body member 210 and the portion forming the fifth region 205A of the second main body member 220. At the same time, it gives a pressing force. At this time, the surgeon or the like can apply a pressing force to the fifth region 205A in a state where the first region 101A is separated from the second member 200. Therefore, the surgeon or the like exerts a pressing force on the first member 100 to crush the lumen 105 of the first member 100, or the blood B that has flowed into the lumen 105 of the first member 100 enters the blood vessel Bv. It can be prevented from being pushed back.

The surgeon or the like applies a pressing force to the fifth region 205A to increase the internal pressure of the fifth region 205A, thereby increasing the partition portion 203 provided in the second member 200 (see FIGS. 1 and 3). ) Can be broken. Further, the surgeon or the like applies a pressing force to the fifth region 205A toward the tip end side along the axial direction of the second member 200 after breaking the partition portion 203, thereby applying a pressing force to the fourth region 204A. The hemostatic agent 240 can be discharged toward the tip end side of the second member 200 via the discharge portion 201a provided in the second member 200.

As shown in FIG. 14, the operator or the like moves the hemostatic agent injection device 10 toward the proximal end side as shown by the arrow b2 while discharging the hemostatic agent 240 from the discharge portion 201a of the second member 200. The hemostatic agent 240 can be placed (filled) in a predetermined range in the depth direction of the perforation P1 of the subcutaneous tissue S. The surgeon or the like can block the puncture site P2 of the blood vessel Bv with the hemostatic agent 240.

As shown in FIG. 15, the surgeon and the like remove the hemostatic agent injection device 10 from the living body, place the hemostatic agent 240 in the perforation P1 of the subcutaneous tissue S, and then perform the finger F from the surface layer side of the living body to the vicinity of the perforation P1. You may press with. The surgeon or the like can promote the adhesion of the perforation P1 formed in the subcutaneous tissue S by pressing the vicinity of the perforation P1 from the surface layer side of the living body with the finger F.

As described above, the hemostatic agent injection device 10 according to the present embodiment includes a first member 100 including a tip opening 101, a proximal opening 103, and a lumen 105 communicating the distal opening 101 and the proximal opening 103, and a first member. A second member 200 is provided at the tip thereof with a discharge portion 201a connected to the member 100 and capable of discharging the hemostatic agent 240. The first member 100 has a first region 101A located on the tip side of the tip of the second member 200. The first region 101A has an inclined portion 101a that is inclined toward a direction away from the second member 200. The inclined portion 101a forms a tip opening 101 of the first member 100.

The hemostatic agent injection device 10 configured as described above includes a first region 101A in which the first member 100 is located on the tip side of the tip of the second member 200. Further, the first region 101A has an inclined portion 101a that is inclined toward a direction away from the second member 200. The inclined portion 101a forms a tip opening 101 of the first member 100 that allows blood to flow in. The surgeon or the like has determined that blood B has leaked from the proximal opening 103 of the first member 100 by moving the first region 101A including the distal opening 101 of the first member 100 to the blood vessel Bv side through the subcutaneous tissue S. You can check. By confirming that blood B has leaked from the proximal end opening 103 of the first member 100, the surgeon or the like determines whether the tip opening 101 of the first member 100 is located inside the blood vessel wall Bw (blood vessel Bv). It is possible to easily grasp the situation such as whether it is located outside the blood vessel wall Bw (subcutaneous tissue S). Therefore, the hemostatic agent injection device 10 can appropriately arrange the position of the discharge portion 201a of the second member 200 with respect to the vicinity of the puncture site P2 of the blood vessel Bv with a simple configuration.

Further, in the hemostatic agent injection device 10, the first member 100 is located on the proximal end side of the first region 101A, and is fixed to the second member 200 at the proximal end of the second region 102A and the second region 102A. It is located on the side and has a third region 103A including the proximal end of the first member 100. The third region 103A is separable from the second member 200. According to the hemostatic agent injection device 10 configured as described above, the operator or the like can separate the third region 103A from the second member 200 in a state where the first region 101A is inserted into the living body. By separating the third region 103A from the second member 200, the operator or the like applies a compressive force to the first member 100 while maintaining the state in which the hemostatic agent injection device 10 is inserted into the living body. While avoiding this, it is possible to easily apply a pressing force for discharging the hemostatic agent 240 to the second member 200.

Further, in the hemostatic agent injection device 10, the second member 200 includes a fourth region 204A including the discharge portion 201a and a fifth region 205A located on the proximal end side of the fourth region 204A and holding the hemostatic agent 240. , A partition portion 203 arranged between the fourth region 204A and the fifth region 205A and partitioning the fourth region 204A and the fifth region 205A. The partition portion 203 can communicate the fourth region 204A and the fifth region 205A by the internal pressure of the fifth region 205A in a state where the fifth region 205A is compressed. According to the hemostatic agent injection device 10 configured as described above, the hemostatic agent 240 can be reliably held in the fifth region 205A before the operator or the like presses the fifth region 205A. can. Further, when the operator or the like presses the fifth region 205A, the state in which the fourth region 204A and the fifth region 205A are separated by the partition portion 203 can be released. As a result, when the operator or the like presses the fifth region 205A, the partition portion 203 can be broken and the

respective agents

240a and 240b held in the fifth region 205A can be smoothly moved to the fourth region 204A. can. Therefore, the surgeon or the like can appropriately arrange the hemostatic agent 240 at the puncture site P2 of the blood vessel Bv via the discharge portion 201a included in the fourth region 204A.

Further, the fifth region 205A has a first lumen 215 holding the first drug 240a, a second lumen 225 holding the second lumen 240b which forms a hemostatic agent 240 by being mixed with the first drug 240a, and a second. It has a wall portion 204 that separates one lumen 215 and a second lumen 225. The second member 200 is configured so that when the fifth region 205A is compressed, communication between the fourth region 204A and the fifth region 205A is more likely to occur than the breakage of the wall portion 204. According to the hemostatic agent injection device 10 configured as described above, the surgeon or the like can hold the first agent 240a and the second lumen 225 held in the first lumen 215 by the wall portion 204 provided in the second member 200. It is possible to prevent the second drug 240b held in the above from being unintentionally mixed. Further, the operator or the like can break the partition portion 203 while preventing the wall portion 204 from breaking by pressing the fifth region 205A. Thereby, the first drug 240a held in the first lumen 215 and the second drug 240b held in the second lumen 225 can be merged in the fourth region 204A to form the hemostatic agent 240. Therefore, the surgeon or the like can appropriately arrange the hemostatic agent 240 formed in the fourth region 204A via the discharge portion 201a included in the fourth region 204A at the puncture site P2 of the blood vessel Bv. Further, by separating the first drug 240a and the second drug 240b until just before use, a biological substance (for example, fibrinogen) whose curing reaction starts by mixing can be used as the hemostatic agent 240. Further, by mixing the first drug 240a and the second drug 240b immediately before use, the drug exerts a high adhesive force in the subcutaneous tissue S while preventing the

drugs

240a and 240b from hardening in the hemostatic agent injection device 10. Can be expressed.

Further, the second member 200 is located on the proximal end side of the fifth region 205A and has a sixth region 206A that closes the first lumen 215 and the second lumen 225. The second member 200 is configured so that the wall portion 204 is more likely to break than the sixth region 206A when the fifth region 205A is compressed. According to the hemostatic agent injection device 10 configured as described above, the operator or the like has the first agent 240a and the second lumen held in the first lumen 215 by the sixth region 206A provided in the second member 200. It is possible to prevent the second drug 240b held on the 225 from moving to the proximal end side of the second member 200. Further, the hemostatic agent injection device 10 prevents the

agents

240a and 240b from moving toward the proximal end side of the fifth region 205A, and even when the wall portion 204 is broken while the partition portion 203 is broken. , The hemostatic agent 240 can be discharged from the fourth region 204A through the tip opening 201. Therefore, the hemostatic agent injection device 10 preferably prevents the sixth region 206A from breaking before the wall portion 204, causing the hemostatic agent 240 to leak to the proximal end side and not be discharged to the distal end side. Can be done.

Further, the second region 102A is fixed to the fourth region 204A. The fifth region 205A has a longer length along the axial direction of the second member 200 than the fourth region 204A. According to the hemostatic agent injection device 10 configured as described above, since the second region 102A is fixed to the fourth region 204A, when the third region 103A is separated from the second member 200, the second region 102A Can be prevented from separating from the second member 200. Therefore, the surgeon or the like can easily separate the third region 103A from the second member 200 while maintaining the state in which the second region 102A is inserted into the living body. Further, in the hemostatic agent injection device 10, since the fifth region 205A has a longer length along the axial direction of the second member 200 than the fourth region 204A, a desired amount of the hemostatic agent 240 (first agent) is provided in the fifth region 205A. 240a, second agent 240b) can be retained. Therefore, the hemostatic agent injection device 10 can prevent the hemostatic agent 240 from becoming insufficient when stopping the bleeding at the puncture site P2 of the blood vessel Bv.

Further, the first member 100 has a recognition unit 110 that makes it possible to grasp the relative positional relationship between the first member 100 and the second member 200 in the outer peripheral direction of the hemostatic agent injection device 10. When the operator or the like inserts the hemostatic agent injection device 10 into the living body, the operator or the like confirms the recognition unit 110 so that the relative positions of the first member 100 and the second member 200 in the outer peripheral direction of the hemostatic agent injection device 10 The relationship can be easily grasped. For example, the surgeon or the like adjusts the direction of the tip opening 101 of the first member 100 so as to face the upstream side in the blood flow direction of the blood vessel Bv so that the blood B flowing through the blood vessel Bv is inside the lumen 105 of the first member 100. Can be easily flowed into. Therefore, the surgeon or the like can easily and surely confirm that the blood B has leaked from the proximal end opening 103 of the first member 100.

Next, the hemostatic agent injection device according to the modified example will be described. In the modified example, duplicate explanations about the contents already explained will be omitted. Further, the contents not particularly explained in the modified example can be the same as those in the above-described embodiment.

<Modification example 1>
FIG. 16 shows a perspective view of the hemostatic agent injection device 20 according to the first modification.

In the hemostatic agent injection device 20, for example, the second member 200 can be composed of one member. In this modification, the second member 200 is composed of the first main body member 210 described in the above-described embodiment. The second member 200 may be composed of the second main body member 220, or may be composed of other members having lumens. As the hemostatic agent 240, one that exhibits a hemostatic effect with one kind of agent can be used. As the hemostatic agent 240, for example, an adhesive composition such as cyanoacrylate can be used. Since the other configurations of the hemostatic agent injection device 20 are substantially the same as those of the hemostatic agent injection device 10 (see FIG. 2) according to the above-described embodiment, detailed description thereof will be omitted.

According to the hemostatic agent injection device 20 according to this modification, the structure is simple because the second member 200 is composed of one member. Further, since the hemostatic agent 240 can be composed of one kind of drug, the plurality of drugs are not properly mixed with each other before the hemostatic agent 240 is arranged at the puncture site P2 of the blood vessel Bv. It is possible to prevent problems such as a decrease in the hemostatic effect from occurring.

<Modification 2>
FIG. 17 shows a perspective view of the hemostatic agent injection device 30 according to the second modification.

The structure of the discharge portion 201b of the second member 200 of the hemostatic agent injection device 30 is different from that of the hemostatic agent injection device 10 (see FIG. 2) according to the above-described embodiment. The discharge portion 201b of the second member 200 is composed of a plurality of holes formed in the fourth region 204A of the second member 200. The plurality of holes are provided in the first main body member 210 and the second main body member 220. Each hole provided in the second main body member 220 penetrates the lumen 215 of the first main body member 210 and the side surface of the first main body member 210. Further, each hole provided in the second main body member 220 penetrates the lumen 225 of the second main body member 220 and the side surface of the second main body member 220. The tip of the second member 200 is closed so that the hemostatic agent 240 is not discharged from the tip. Since the other configurations of the hemostatic agent injection device 30 are substantially the same as those of the hemostatic agent injection device 10 (see FIG. 2) according to the above-described embodiment, detailed description thereof will be omitted.

The surgeon or the like presses the fifth region 205A when arranging the hemostatic agent 240 at the puncture site P2 of the blood vessel Bv using the hemostatic agent injection device 30. When the operator or the like presses the fifth region 205A, the hemostatic agent injection device 30 moves the

agents

240a and 240b held in the fifth region 205A to the fourth region 204A. The hemostatic agent injection device 30 forms the hemostatic agent 240 by mixing the first agent 240a and the second agent 240b in the mixing space 208 of the fourth region 204A. The hemostatic agent injection device 30 discharges the hemostatic agent 240 from the discharge unit 201b included in the fourth region 204A. The hemostatic agent injection device 30 can discharge the hemostatic agent 240 from the side surface of the second member 200 over a wide range in the outer peripheral direction of the second member 200 by the discharge portion 201b composed of a plurality of holes. Therefore, the hemostatic agent injection device 30 can reliably fill the hemostatic agent 240 with the puncture site P2 of the blood vessel Bv.

Further, when the operator or the like performs hemostasis using the hemostatic agent injection device 30, the second member 200 is applied to the living body by applying a pressing force from the proximal end side to the distal end side of the fifth region 205A. The hemostatic agent 240 can be placed in the perforation P1 of the subcutaneous tissue S without moving the second member 200 toward the proximal end side while maintaining the inserted state. Therefore, the surgeon or the like arranges the hemostatic agent 240 discharged from the discharge portion 201b of the second member 200 in the perforation P1 of the subcutaneous tissue S like the hemostatic agent injection device 10 according to the above-described embodiment. , It is not necessary to move the hemostatic agent injection device 20 toward the proximal end side (see FIG. 14). Therefore, the operator or the like can more easily and smoothly stop bleeding at the puncture site P2 of the blood vessel Bv by using the hemostatic agent injection device 20.

The discharge unit 201b according to the present modification can also be provided in the hemostatic agent injection device 20 according to the modification 1 or the hemostatic agent injection device 40 according to the modification 3.

<Modification example 3>
FIG. 18 shows a perspective view of the hemostatic agent injection device 40 according to the third modification.

The structure of the second member 200 of the hemostatic agent injection device 40 is different from that of the hemostatic agent injection device 10 (see FIG. 2) according to the above-described embodiment. In the second member 200 according to the present modification, the hemostatic agent and the agent forming the hemostatic agent are not held in the lumen 215 prior to the discharge of the hemostatic agent 240. Therefore, the hemostatic agent injection device 40 is not provided with the fifth region 205A, the partition portion 203, the sixth region 206A, and the like for holding the hemostatic agent and the agent forming the hemostatic agent in advance.

When the hemostatic agent is placed at the puncture site P2 of the blood vessel Bv by using the hemostatic agent injection device 40, the operator or the like can connect a member such as a hub to the base end portion of the second member 200. The surgeon can supply the hemostatic agent into the lumen 215 of the second member 200 using a hub, various connectors, tubes, syringes and the like. The surgeon or the like can dispose the hemostatic agent supplied to the lumen 215 of the second member 200 at the puncture site P2 of the blood vessel Bv via the discharge portion 201a of the second member 200. The second member 200 can be composed of one tubular member such as the first main body member 210 or the second main body member 220, for example.

Since the hemostatic agent injection device 40 according to this modification can discharge the hemostatic agent from the tip opening 201 of the second member 200 by using a syringe or the like, the hemostatic agent is discharged from the second member 200 when the hemostatic agent is discharged. There is no need to apply pressure. Therefore, the first member 100 is fixed to the second member 200 so as not to be separated from the second member 200. The first member 100 may be separably configured from the second member 200.

Although the hemostatic agent injection device according to the present invention has been described above through the embodiments and modifications, the present invention is not limited to each of the described configurations, and may be appropriately modified based on the description of the claims. Is possible.

The structure of each part and the arrangement of members described in the specification can be changed as appropriate, and the use of additional members described in the illustration can be omitted, and other additional members can be used as appropriate. obtain.

This application is based on Japanese Patent Application No. 2020-0360668 filed on March 3, 2020, the disclosure of which is cited as a whole by reference.

10, 20, 30, 40 Hemostatic agent injection device 100 First member 101 Tip opening 101a Inclined portion 103 Base end opening 105 Lumen

101A First region

102A Second region

103A Third region 110 Recognition unit 200 Second member 201

Tip opening

201a , 201b Discharge part 203 Partition part 203a First partition member 203b Second partition member 204 Wall part 206a First closing member 206b Second closing member 208 Mixed space

204A Fourth area

205A Fifth area

206A Sixth area

207A Seventh area 210 1st body member 215 1st body member 220 2nd body member 225 2nd lumen 230 Connection member 240 Hemostatic agent 240a 1st drug 240b 2nd drug 250 Pressing member 300 Introducer B Blood Bv Blood vessel Bw Blood vessel wall P1 Subcutaneous tissue puncture P2 Blood vessel puncture site S Subcutaneous tissue

Claims

A first member having a tip opening, a proximal opening, and a lumen that communicates the distal opening with the proximal opening.
A second member, which is connected to the first member and has a discharge portion capable of discharging a hemostatic agent at the tip thereof, is provided.
The first member has a first region located on the tip side of the tip of the second member.
The first region has an inclined portion that is inclined toward a direction away from the second member.
A hemostatic agent injection device, wherein the inclined portion forms the tip opening of the first member.
The first member is
A second region located on the proximal end side of the first region and fixed to the second member,
It is located on the proximal end side of the second region and has a third region including the proximal end of the first member.
The hemostatic agent injection device according to claim 1, wherein the third region is separable from the second member.
The second member is
The fourth region including the discharge portion and
A fifth region located closer to the proximal end than the fourth region and holding the hemostatic agent,
It is arranged between the fourth region and the fifth region, and has a partition portion for partitioning the fourth region and the fifth region.
The hemostasis according to claim 2, wherein the partition portion can communicate the fourth region and the fifth region by the internal pressure of the fifth region in a state where the fifth region is compressed. Agent infusion device.
The fifth region is
The first lumen holding the first drug and
A second lumen that holds the second agent that forms the hemostatic agent when mixed with the first agent,
It has a wall portion that separates the first lumen and the second lumen.
The second member is characterized in that, in a state where the fifth region is compressed, communication between the fourth region and the fifth region is more likely to occur than a breakage of the wall portion. The hemostatic agent infusion device according to claim 3.
The second member is
It is located on the proximal end side of the fifth region and has a sixth region that closes the first lumen and the second lumen of the second member.
The fourth aspect of the present invention is characterized in that the second member is configured so that the wall portion breaks more easily than the sixth region breaks when the fifth region is compressed. Hemostatic agent infusion device.
The second region is fixed to the fourth region, and is fixed to the fourth region.
The hemostatic agent injection device according to claim 5, wherein the fifth region has a longer length along the axial direction of the second member than the fourth region.
At least one of the first member and the second member has a recognition unit that makes it possible to grasp the relative positional relationship between the first member and the second member in the outer peripheral direction of the hemostatic agent injection device. The hemostatic agent injecting device according to any one of claims 1 to 6, characterized by this.