Hemostatic Injection Device

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

[Technical field]

[0001] The present invention relates to a hemostatic agent injection device. [Background technology]

[0002] Conventionally, there has been known a procedure in which various medical elongated objects (e.g., introducers) are introduced into a blood vessel through a puncture site formed in a blood vessel of a patient's limb, such as an arm, to perform treatment or therapy on a lesion site. When performing such a procedure, the surgeon or the like performs hemostasis at the puncture site when removing the medical elongated object from the puncture site. As one method of hemostasis, a compression hemostasis method is known in which a compressive force is applied to the puncture site of the blood vessel and the surrounding subcutaneous tissue from the surface side of the patient's body.

[0003] When a compression hemostasis method is adopted, if excessive compression, which results in excessively large compression force, is performed for a long period of time, blood vessel blockage may occur. Therefore, it is required to appropriately adjust the compression force. In relation to such a problem, the following Patent Document 1 discloses a hemostasis device that enables non-compressive hemostasis. The hemostasis device of Patent Document 1 includes a sheath that can be inserted into a living body, and a cartridge that is charged with a hemostatic agent and is held inside the sheath. In a procedure using the hemostasis device of Patent Document 1, an operator introduces the distal end opening of the sheath to the vicinity of the puncture site of the blood vessel, and ejects the hemostatic agent through the distal end opening. The operator can block the puncture site by placing the hemostatic agent ejected from the sheath around the puncture site of the blood vessel. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] International Publication No. WO00 / 030553 Summary of the Invention [Problem to be solved by the invention]

[0005] The hemostatic device is provided with a stopper (locking member) that prevents the tip of the sheath from being inserted deeper than the depth of the puncture site of the blood vessel. The stopper is attached to the outer circumferential surface of the sheath, and when the sheath is inserted into the living body, it comes into contact with the surface of the patient's body to limit the insertion depth of the sheath.

[0006] The hemostatic device can prevent the sheath from being inserted into the blood vessel to a depth greater than the depth of the punctured site of the blood vessel. However, when using the hemostatic device, the surgeon cannot grasp the exact position of the punctured site of the blood vessel when starting to eject the hemostatic agent. Therefore, the surgeon must rely on the sense of touch of the finger to position the distal opening of the sheath at the punctured site of the blood vessel. Therefore, in a procedure using the hemostatic device, it is difficult to appropriately position the distal opening of the sheath relative to the punctured site of the blood vessel.

[0007] The present invention has been made to solve the above-mentioned problems, and aims to provide a hemostatic agent injection device that has a simple configuration and allows the ejection portion of a second member capable of ejecting a medicine to be appropriately positioned around the puncture site of a blood vessel. [Means for solving the problem]

[0008] The hemostatic agent injection device according to the present invention comprises a first member having a distal opening, a proximal opening, and a lumen communicating the distal opening and the proximal opening, and a second member connected to the first member and having a discharge part at its distal end capable of discharging a hemostatic agent, the first member having a first region located distal to the distal end of the second member. a second region located on the proximal side of the first region and fixed to the second member before being inserted into a blood vessel; The first region 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. When the inclined portion is disposed in a blood vessel, the first member causes blood to flow into the lumen through the distal end opening and causes the blood that has flowed into the lumen to leak out from the proximal end opening. do. Effect of the Invention

[0009] The hemostatic agent injection device according to the present invention includes a first region in which the first member is located distally of the distal end of the second member. The first region of the first member has an inclined portion inclined in a direction away from the second member. The inclined portion forms a distal opening of the first member into which blood can flow. The surgeon, etc. can confirm that blood has leaked from the base end opening of the first member by moving the first region including the distal opening of the first member toward the blood vessel through the subcutaneous tissue. By confirming that blood has leaked from the base end opening of the first member, the surgeon, etc. can easily grasp the situation of whether the distal opening of the first member is located inside the blood vessel wall (blood vessel) or outside the blood vessel wall (subcutaneous tissue). Therefore, the hemostatic agent injection device can appropriately position the discharge portion of the second member with respect to the periphery of the puncture site of the blood vessel with a simple configuration. [Brief description of the drawings]

[0010] [Figure 1] FIG. 1 is a perspective view showing a hemostatic agent injection device according to an embodiment. [Diagram 2] FIG. 2 is a perspective view of a hemostatic agent injection device according to an embodiment, illustrating a state in which a third region of a first member is being separated from a second member. [Diagram 3] FIG. 3 is a cross-sectional view taken along arrows 3A-3A shown in FIG. [Figure 4] FIG. 4 is a cross-sectional view taken along the arrows 4A-4A shown in FIG. [Diagram 5] FIG. 5 is a cross-sectional view taken along the arrows 5A-5A shown in FIG. [Figure 6] FIG. 6 is a cross-sectional view taken along the arrows 6A-6A shown in FIG. [Figure 7] 1A to 1C are schematic cross-sectional views for explaining an example of use of a hemostatic agent injection device according to an embodiment. [Figure 8] 1A to 1C are schematic cross-sectional views for explaining an example of use of a hemostatic agent injection device according to an embodiment. [Figure 9] 1A to 1C are schematic cross-sectional views for explaining an example of use of a hemostatic agent injection device according to an embodiment. [Figure 10]1A to 1C are schematic cross-sectional views for explaining an example of use of a hemostatic agent injection device according to an embodiment. [Figure 11] 1A to 1C are schematic cross-sectional views for explaining an example of use of a hemostatic agent injection device according to an embodiment. [Figure 12] 1A to 1C are schematic cross-sectional views for explaining an example of use of a hemostatic agent injection device according to an embodiment. [Figure 13] 1A to 1C are schematic cross-sectional views for explaining an example of use of a hemostatic agent injection device according to an embodiment. [Figure 14] FIG. 1 is a schematic cross-sectional view for explaining an example of use of a hemostatic agent injection device according to an embodiment, showing an enlarged view of a puncture site of a blood vessel. [Figure 15] FIG. 1 is a schematic cross-sectional view for explaining an example of use of a hemostatic agent injection device according to an embodiment, showing an enlarged view of a puncture site of a blood vessel. [Figure 16] FIG. 13 is a perspective view of the hemostatic agent injection device according to Modification 1, illustrating the state when the third region of the first member is being separated from the second member. [Figure 17] FIG. 13 is a perspective view of a hemostatic agent injection device according to Modification 2, illustrating the state when the third region of the first member is being separated from the second member. [Figure 18] FIG. 11 is a perspective view showing a hemostatic agent injection device according to Modification 3. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011] Hereinafter, a hemostatic agent injection device 10 according to this embodiment and a hemostatic method using the hemostatic agent injection device 10 will be described with reference to Figs.

[0012] 1 to 6 are diagrams illustrating the configuration of each part of a hemostatic agent injection device 10 according to an embodiment, and FIGS. 7 to 15 are diagrams illustrating an example of use of the hemostatic agent injection device 10 according to an embodiment.

[0013] In the description of this specification, the extension direction of the hemostatic agent injection device 10 (the vertical direction in Figs. 1, 2, and 3) is referred to as the axial direction. The side of the hemostatic agent injection device 10 that is introduced into the living body is referred to as the distal side (the lower end side in Figs. 1, 2, and 3), and the end side opposite the distal side (the upper end side in Figs. 1, 2, and 3) is referred to as the proximal side. In the description of this specification, the distal portion means a region including the distal end (the most distal end) and a predetermined range from the distal end toward the proximal end, and the proximal portion means a region including the proximal end (the most proximal end) and a predetermined range from the proximal end toward the distal end.

[0014] 1, 2, and 3, the hemostatic agent injection device 10 includes a first member 100 having a distal opening 101, a proximal opening 103, and a lumen 105 communicating the distal opening 101 and the proximal opening 103, and a second member 200 connected to the first member 100 and provided at its distal end with a discharge portion 201a capable of discharging a hemostatic agent 240. The first member 100 has a first region 101A located on the distal side of the distal end of the second member 200. The first region 101A has an inclined portion 101a inclined in a direction away from the second member 200. The inclined portion 101a forms the distal opening 101 of the first member 100.

[0015] The first member 100 is composed of a tubular member having a distal opening 101, a proximal opening 103, and a lumen 105.

[0016] The second member 200 has a first body member 210, a second body member 220, and a connecting member 230. The first body member 210 is configured as a tubular member having a proximal opening 213 and a lumen 215. The second body member 220 is configured as a tubular member having a proximal opening 223 and a lumen 225. As described later, each of the body members 210, 220 is provided with a partition section 203 and a sixth region 206A that divide a predetermined space within each of the lumens 215, 225.

[0017] In this embodiment, the lumen 215 of the first body member 210 is referred to as the "first lumen 215 of the second member 200," and the lumen 225 of the second 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, the second member may be provided with only one lumen. When the second member is composed of three or more tubular members, the second member may be provided with three or more lumens.

[0018] The connecting member 230 connects the first body member 210 and the second body member 220. An internal space 235 into which the first body member 210 and the second 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 each of the body members 210, 220. However, it is not necessary to provide a gap between the inner surface of the connecting member 230 and each of the body members 210, 220. For example, the gap can be filled by filling the gap between the connecting member 230 and each of the body members 210, 220 with a filler such as a resin material.

[0019] 4 and 5, the connection member 230 is fixed to each of the main body members 210, 220 in a state where it covers the outer circumferential surfaces of each of the main body members 210, 220. The connection member 230 and each of the main body members 210, 220 can be fixed to each other by, for example, adhesion or fusion.

[0020] Discharge portion 201a that discharges hemostatic agent 240 from second member 200 is formed by tip opening 201 of connecting member 230. When second member 200 is configured from a single tubular member (for example, see a modified example shown in FIG. 16 described later), discharge portion 201a can be formed by the tip opening of the single tubular member.

[0021] As shown in Figures 1, 2, and 3, the first member 100 has a second region 102A located on the base end side of the first region 101A and fixed to the second member 200, and a third region 103A located on the base end side of the second region 102A and including the base end of the first member 100.

[0022] The third region 103A is configured to be separable from the second member 200. A state in which the third region 103A is being separated from the second member 200 is simply shown in FIG.

[0023] The inclined portion 101a formed in the first region 101A is inclined in a direction away from the second member 200. The inclination angle of the inclined portion 101a (the inclination angle with respect to the axis of the first member 100 before the third region 103A is separated from the second member 200) is not particularly limited.

[0024] The hemostatic agent injection device 10 has a tip opening 101 formed by an inclined portion 101a. Therefore, when the tip opening 101 of the hemostatic agent injection device 10 is disposed in the blood vessel Bv, the tip opening 101 is disposed so as to face the direction of blood flow, whereby blood B can easily flow into the lumen 105 of the first member 100 (see Figs. 9 and 10).

[0025] The third region 103A can be connected to the outer surface of the connection member 230 of the second member 200 by, for example, fusion or adhesion. The connection force that maintains the connection between the third region 103A and the connection member 230 can be set to a magnitude that allows the third region 103A to be separated from the second member 200 when an operator or the like pulls the first member 100 in a direction that relatively separates them from the second member 200 with the force of the operator's fingers. Note that the specific magnitude of the connection force that connects the third region 103A and the second member 200 is not particularly limited. In addition, when the connection member 230 is not provided on the second member 200 (for example, see the modified examples shown in FIG. 16 and FIG. 18 described later), the third region 103A can be connected to the first main body member 210 and / or the second main body member 220 in a detachable manner.

[0026] 1, 2 and 3, the second member 200 has a fourth region 204A including a discharge portion 201a, a fifth region 205A located on the proximal side of the fourth region 204A and holding a hemostatic agent 240, and a partition portion 203 disposed between the fourth region 204A and the fifth region 205A and separating the fourth region 204A from the fifth region 205A. The partition portion 203 can communicate the fourth region 204A with the fifth region 205A by the internal pressure of the fifth region 205A when the fifth region 205A is compressed.

[0027] As shown in FIG. 3, the partition portion 203 has a first partition member 203a that seals the tip of the first main body member 210 when the fifth region 205A is not compressed, and a second partition member 203b that seals the tip of the second main body member 220 when the fifth region 205A is not compressed.

[0028] The fifth region 205A is composed of a specified space within the first lumen 215 partitioned by the first partition member 203a and the first blocking member 206a described later, and a specified space within the second lumen 225 partitioned by the second partition member 203b and the second blocking member 206b described later.

[0029] The first partition member 203a can be formed, for example, of 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 formed, for example, of a resin film-like member provided so as to close the tip opening of the second main body member 220.

[0030] In addition, the specific configuration of the partitioning part 203 is not particularly limited as long as it can prevent each of the drugs 240a and 240b held in the fifth region 205A from moving to the fourth region 204A in a state where a compressive force of a predetermined magnitude or more is not applied to the fifth region 205A. For example, the partitioning part 203 may be configured as a fusion part in which the tip of the first body member 210 and the tip of the second body member 220 are fused together. When such a fusion part is provided in the second member 200 as the partitioning part 203, the magnitude of the compressive force required to break the fusion part can be adjusted by adjusting the fusion amount of the first body member 210 and the second body member 220. In addition, the partitioning part 203 may be configured as a valve (e.g., a one-way valve) that communicates the fourth region 204A and the fifth region 205A depending on the magnitude of the compressive force applied to the fifth region 205A.

[0031] As shown in Figures 1, 2, 3 and 5, the fifth region 205A has a first lumen 215 that holds a first drug 240a, a second lumen 225 that holds a second drug 240b that forms a hemostatic agent 240 when mixed with the first drug 240a, and a wall portion 204 (see Figure 3) that separates the first lumen 215 and the second lumen 225.

[0032] 3, the wall portion 204 is formed by the tubular wall of the first body member 210 and the tubular wall of the second body member 220. The wall portion 204 separates the first drug 240a held in the first lumen 215 and the second drug 240b held in the second lumen 225.

[0033] The second member 200 is configured such that, when the fifth region 205A is pressed, communication between the fourth region 204A and the fifth region 205A occurs more easily than breakage of the wall portion 204. In other words, the partition portion 203 is configured to break more easily than the wall portion 204. Therefore, when an operator or the like presses the fifth region 205A, it is possible to prevent the wall portion 204 from breaking unintentionally, causing the first drug 240a and the second drug 240b to mix together in the fourth region 204A.

[0034] As shown in FIGS. 1, 2, 3, and 4, second member 200 has sixth region 206A that is located closer to the proximal end than fifth region 205A and blocks first lumen 215 and second lumen 225 of second member 200.

[0035] As shown in FIG. 3, the sixth region 206A is composed of a first occlusion member 206a arranged on the base end side of the portion of the first lumen 215 that forms the fifth region 205A, and a second occlusion member 206b arranged on the base end side of the portion of the second lumen 225 that forms the fifth region 205A.

[0036] The portion of the first lumen 215 where the fifth region 205A is formed is partitioned by the first partition member 203a arranged on the distal side of the portion and the first occluding member 206a arranged on the proximal side of the portion when the fifth region 205A is not compressed. Also, the portion of the second lumen 225 where the fifth region 205A is formed is partitioned by the second partition member 203b arranged on the distal side of the portion and the second occluding member 206b arranged on the proximal side of the portion when the fifth region 205A is not compressed. Therefore, the hemostatic agent injection device 10 can prevent each of the drugs 240a, 240b from moving to the distal side or the proximal side of the fifth region 205A when the fifth region 205A is not compressed.

[0037] The second member 200 is configured such that, when the fifth region 205A is compressed, the wall portion 204 is more likely to break than the sixth region 206A. Therefore, the hemostatic agent injection device 10 can prevent the sixth region 206A from breaking before the wall portion 204 breaks when the fifth region 205A is compressed.

[0038] Each of the blocking members 206a, 206b can be made of, for example, a resin material or the like having a predetermined thickness that can prevent breakage even when the fifth region 205A is compressed.

[0039] In the hemostatic agent injection device 10, the ease with which each part breaks or communicates when a compressive force is applied to the fifth region 205A can be set, for example, as follows.

[0040] First compression force (compression force for releasing the partition formed by partition portion 203) applied to fifth region 205A to connect fourth region 204A and fifth region 205A < second compression force applied to fifth region 205A when wall portion 204 breaks < third compression force applied to fifth region 205A when sixth region 206A breaks.

[0041] By setting "first compression force<third compression force" as described above, the first drug 240a and the second drug 240b can be reliably mixed in the fourth region 204A and can be ejected from the distal end opening 201. Also, by setting "first compression force<second compression force" as described above, it is possible to prevent the drugs 240a and 240b from being mixed in the fifth region 205A before the drugs 240a and 240b move from the fifth region 205A to the fourth region 204A. Also, by setting "second compression force<third compression force" as described above, it is possible to prevent the drugs 240a and 240b from moving toward the base end side beyond the fifth region 205A, and to eject the hemostatic agent 240 from the fourth region 204A through the distal end opening 201 even when the wall portion 204 is broken in a state in which the partition portion 203 is broken. Therefore, the hemostatic agent injection device 10 can preferably prevent a situation in which the sixth region 206A breaks before the wall portion 204, causing the hemostatic agent 240 to leak toward the base end and not be ejected toward the tip end.

[0042] 3, the seventh region 207A is formed on the base end side of the sixth region 206A. A part of the third region 103A is detachably connected to a part of the outer circumferential surface of the seventh region 207A (a part of the outer circumferential surface of the connection member 230).

[0043] 3, a mixing space 208 for mixing the drugs 240a, 240b held in the fifth region 205A is formed inside the fourth region 204A (a portion located distal to the tip of the first body member 210 and the tip of the second body member 220 in the internal space 235 of the connecting member 230). When the fifth region 205A is compressed and the partition members 203a, 203b are broken, the hemostatic agent injection device 10 moves the drugs 240a, 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 drugs 240a, 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 part 201 a located on the tip side of the mixing space 208 .

[0044] A part of the second region 102A is fixed to the fourth region 204A. Also, the fifth region 205A has a longer length along the axial direction of the second member 200 than the fourth region 204A, as shown in Fig. 1 and Fig. 3. Since the fourth region 204A is short as described above, the surgeon can efficiently discharge the hemostatic agent 240 formed in the mixing space 208 of the fifth region 205A from the discharge portion 201a.

[0045] The first member 100 can be formed to have a total axial length of, for example, 100 mm to 500 mm. When forming the total length of the first member 100 as described above, the first region 101A can be formed to have a length of, for example, 1 mm to 2 mm, the second region 102A can be formed to have a length of, for example, 1 mm to 2 mm, and the third region 103A can be formed to have a length of, for example, 96 mm to 498 mm.

[0046] The second member 200 can be formed to have an overall length along the axial direction of, for example, 99 mm to 499 mm. When forming the overall length of the second member 200 as described above, the fourth region 204A can be formed to have a length of, for example, 1 mm to 2 mm, the fifth region 205A can be formed to have a length of, for example, 30 mm to 150 mm, the sixth region 206A can be formed to have a length of, for example, 0.1 mm to 0.5 mm, and the seventh region 207A can be formed to have a length of, for example, 67.9 mm to 467.9 mm.

[0047] As shown in FIGS. 1 and 2, the first member 100 has a recognition portion 110 that enables the relative positional relationship between the first member 100 and the second member 200 in the circumferential direction of the hemostatic agent injection device 10 to be grasped.

[0048] The recognition unit 110 can be configured, for example, by a colored portion, a figure, a symbol, a pattern, a concave-convex shape, or the like, attached to the outer peripheral surface of the first member 100. The specific configuration of the recognition unit 110 is not limited as long as the surgeon or the like 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 vision, touch, or the like. 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, it is preferable that the appearance, shape, etc. of the recognition unit 110 provided on the first member 100 and the recognition unit 110 provided on the second member 200 are different. By providing the recognition portion 110 on the first member 100 and the second member 200 in this manner, the surgeon can easily grasp the circumferential position of the hemostatic agent injection device 10 when ejecting the hemostatic agent 240 from the hemostatic agent injection device 10.

[0049] For example, when a liquid tissue adhesive is used as the hemostatic agent 240, the hemostatic agent injection device 10 can use a fibrinogen solution as the first drug 240a and a thrombin solution as the second drug 240b. However, the type of hemostatic agent 240 (types of each drug 240a, 240b) is not particularly limited as long as it is possible to stop bleeding at the puncture site P2 of the blood vessel Bv.

[0050] The first member 100 and the second member 200 (the first main body member 210, the second main body member 220, and the connecting member 230) may be made of a resin material such as polyamide elastomer. However, the specific type of material for the members 100 and 200 is not particularly limited.

[0051] Next, a method for stopping bleeding using the hemostatic agent injection device 10 will be described with reference to FIGS.

[0052] FIG. 7 shows a state where the introducer 300 is inserted into the blood vessel Bv from the skin of the patient. In the procedure described in this embodiment, the introducer 300 is inserted in a direction opposite to the direction of blood flow (from the right side to the left side in FIG. 7) in the blood vessel Bv. The surgeon can deliver various medical devices to a treatment target site of the patient through the introducer 300 and perform treatment or diagnosis. Prior to the procedure using the introducer 300, the surgeon 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 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, the radial artery running through the wrist of the patient. However, the blood vessel Bv can be arbitrarily selected according to the contents of the procedure and the like, and is not particularly limited.

[0053] As shown in FIG. 8, after completing a procedure using various medical devices, the surgeon inserts the hemostatic agent injection device 10 into the living body via the sheath tube 310 of the introducer 300.

[0054] The surgeon places the first region 101A of the first member 100 in the blood vessel Bv through the distal end opening 311 of the sheath tube 310. With the first region 101A placed at the distal end of the sheath tube 310 placed in the blood vessel Bv, the surgeon moves (retreats) the introducer 300 toward the base end as shown by arrow b1. This allows the surgeon to protrude the first region 101A from the distal end opening 311 of the sheath tube 310. The surgeon can remove the introducer 300 from the living body by further moving the introducer 300 toward the base end along the hemostatic agent injection device 10, as shown in FIG. 9.

[0055] When placing the first region 101A in the blood vessel Bv, the surgeon can confirm the relative positional relationship between the first member 100 and the second member 200 in the outer circumferential direction of the hemostatic agent injection device 10 based on the position of the recognition unit 110. The surgeon can easily cause blood B flowing through the blood vessel Bv to flow into the lumen 105 of the first member 100 by placing the hemostatic agent injection device 10 so that the distal end opening 101 of the first member 100 faces the upstream side of the blood vessel Bv in the blood flow direction (the right side in FIG. 9 ).

[0056] Furthermore, when the surgeon or the like protrudes the first region 101A from the distal opening 311 of the sheath tube 310 (when the surgeon or the like protrudes the first region 101A of the first member 100 into the blood vessel Bv), as shown in Fig. 10, blood B flows into the lumen 105 of the first member 100 through the distal 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 causes the blood B to leak from the proximal opening 103. By confirming that the blood B has leaked from the proximal opening 103, the surgeon or the like can recognize that the first region 101A is disposed in the blood vessel Bv.

[0057] If blood B does not leak from the base end opening 103 of the first member 100 even after a predetermined time has elapsed after the surgeon etc. has caused the distal opening 101 of the first member 100 to protrude from the distal opening 311 of the sheath tube 310, the surgeon etc. may advance the hemostatic agent injection device 10 toward the blood vessel Bv. The surgeon etc. can cause blood B to flow into the lumen 105 via the distal opening 101 by advancing the hemostatic agent injection device 10 and moving the distal opening 101 of the first member 100 into the blood vessel Bv.

[0058] After confirming that blood B has leaked from the base end opening 103 of the first member 100, the surgeon moves the hemostatic agent injection device 10 toward the base end side. When blood B is leaking from the base end opening 103 of the first member 100, the surgeon can know that the first region 101A is disposed within the blood vessel Bv. In addition, when blood B stops leaking from the base end opening 103 of the first member 100 or the amount of blood B leaking from the base end opening 103 is significantly reduced when the surgeon moves the hemostatic agent injection device 10 toward the base end side, the surgeon can know that the distal end opening 101 of the first member 100 has moved to the outside of the blood vessel wall Bw (to the subcutaneous tissue S side of the blood vessel wall Bw).

[0059] The surgeon may advance and retract the hemostatic agent injection device 10 multiple times. By reciprocating the distal end opening 101 of the first member 100 inside and outside the blood vessel Bv, the surgeon can grasp the position of the distal end opening 101 of the first member 100 more reliably.

[0060] Next, the surgeon etc. separates the third region 103A from the second member 200 as shown in Fig. 12. With the third region 103A separated from the second member 200, the surgeon etc. presses the fifth region 205A as shown in Fig. 13. The surgeon etc. can use, for example, a pressing member 250 capable of applying a gripping force (clamping force) to the fifth region 205A. Note that, as the pressing member 250, for example, a known tool such as a clip can be used.

[0061] The surgeon can apply a compressive force to the fifth region 205A by moving the compressing member 250 attached to the outer surface of the fifth region 205A toward the distal end along the axial direction of the second member 200. When applying a compressive force to the fifth region 205A, the surgeon simultaneously applies a compressive force to the portion of the first body member 210 that forms the fifth region 205A and the portion of the second body member 220 that forms the fifth region 205A. At this time, the surgeon can apply a compressive force to the fifth region 205A in a state in which the first region 101A is separated from the second member 200. Therefore, the surgeon can prevent the lumen 105 of the first member 100 from being crushed due to the application of a compressive force to the first member 100, or the blood B that has flowed into the lumen 105 of the first member 100 from being pushed back into the blood vessel Bv.

[0062] The surgeon etc. can apply a compressive force to the fifth region 205A to increase the internal pressure of the fifth region 205A, thereby breaking the partition portion 203 (see Figs. 1 and 3) provided in the second member 200. After breaking the partition portion 203, the surgeon etc. can apply a compressive force to the fifth region 205A toward the tip side along the axial direction of the second member 200, thereby discharging the hemostatic agent 240 toward the tip side of the second member 200 through the discharge portion 201a provided in the fourth region 204A.

[0063] 14, the surgeon can place (fill) the hemostatic agent 240 in a predetermined range in the depth direction of the perforation P1 in the subcutaneous tissue S by discharging the hemostatic agent 240 from the discharge portion 201a of the second member 200 while moving the hemostatic agent injection device 10 toward the base end side as shown by arrow b2. The surgeon can block the puncture site P2 of the blood vessel Bv with the hemostatic agent 240.

[0064] 15, the surgeon may 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 press the vicinity of the perforation P1 from the surface layer side of the living body with a finger F. By pressing the vicinity of the perforation P1 from the surface layer side of the living body with a finger F, the surgeon can promote adhesion of the perforation P1 formed in the subcutaneous tissue S.

[0065] As described above, the hemostatic agent injection device 10 according to this embodiment includes the first member 100 having the distal opening 101, the proximal opening 103, and the lumen 105 communicating the distal opening 101 and the proximal opening 103, and the second member 200 connected to the first member 100 and provided at its distal end with the discharge portion 201a capable of discharging the hemostatic agent 240. The first member 100 has a first region 101A located on the distal side of the distal end of the second member 200. The first region 101A has an inclined portion 101a inclined in a direction away from the second member 200. The inclined portion 101a forms the distal opening 101 of the first member 100.

[0066] In the hemostatic agent injection device 10 configured as described above, the first member 100 includes a first region 101A located on the distal side of the distal end of the second member 200. The first region 101A has an inclined portion 101a inclined in a direction away from the second member 200. The inclined portion 101a forms the distal opening 101 of the first member 100 through which blood can flow. The surgeon, etc. can confirm that blood B has leaked from the base end opening 103 of the first member 100 by moving the first region 101A including the distal opening 101 of the first member 100 toward the blood vessel Bv through the subcutaneous tissue S. By confirming that blood B has leaked from the base end opening 103 of the first member 100, the surgeon, etc. can easily grasp the situation of whether the distal opening 101 of the first member 100 is located inside the blood vessel wall Bw (blood vessel Bv) or outside the blood vessel wall Bw (subcutaneous tissue S). Therefore, the hemostatic agent injection device 10 can appropriately position the discharge portion 201a of the second member 200 with respect to the periphery of the puncture site P2 of the blood vessel Bv with a simple configuration.

[0067] In the hemostatic agent injection device 10, the first member 100 has a second region 102A located on the proximal side of the first region 101A and fixed to the second member 200, and a third region 103A located on the proximal side of the second region 102A and 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 surgeon can separate the third region 103A from the second member 200 in a state in which the first region 101A is inserted into a living body. By separating the third region 103A from the second member 200, the surgeon can easily apply a compressive force to the second member 200 to eject the hemostatic agent 240 while avoiding the application of a compressive force to the first member 100 and maintaining the state in which the hemostatic agent injection device 10 is inserted into a living body.

[0068] In the hemostatic agent injection device 10, the second member 200 has a fourth region 204A including the discharge portion 201a, a fifth region 205A located on the proximal side of the fourth region 204A and holding the hemostatic agent 240, and a partition portion 203 disposed between the fourth region 204A and the fifth region 205A and separating the fourth region 204A from the fifth region 205A. When the fifth region 205A is compressed, the partition portion 203 can communicate the fourth region 204A with the fifth region 205A by the internal pressure of the fifth region 205A. According to the hemostatic agent injection device 10 configured as described above, before the operator or the like compresses the fifth region 205A, the hemostatic agent 240 can be reliably held in the fifth region 205A. Moreover, by the operator pressing the fifth region 205A, the state in which the fourth region 204A and the fifth region 205A are separated by the partitioning portion 203 can be released. As a result, when the operator presses the fifth region 205A, the operator can break the partitioning portion 203 and smoothly move each of the drugs 240a and 240b held in the fifth region 205A to the fourth region 204A. Therefore, the operator can appropriately place 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.

[0069] The fifth region 205A has a first lumen 215 that holds the first drug 240a, a second lumen 225 that holds the second drug 240b that forms the hemostatic agent 240 by mixing with the first drug 240a, and a wall 204 that separates the first lumen 215 and 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 breakage of the wall 204. According to the hemostatic agent injection device 10 configured as described above, the surgeon or the like can prevent the first drug 240a held in the first lumen 215 and the second drug 240b held in the second lumen 225 from being unintentionally mixed by the wall 204 provided in the second member 200. Moreover, the operator can break the partition 203 while preventing the wall 204 from breaking by pressing the fifth region 205A. This allows the first drug 240a held in the first lumen 215 and the second drug 240b held in the second lumen 225 to join in the fourth region 204A to form the hemostatic agent 240. Therefore, the operator can appropriately place the hemostatic agent 240 formed in the fourth region 204A at the puncture site P2 of the blood vessel Bv via the discharge portion 201a included in the fourth region 204A. Furthermore, by separating the first drug 240a and the second drug 240b until immediately before use, a biological material (e.g., fibrinogen) that initiates a hardening reaction when mixed can be used as the hemostatic agent 240. Furthermore, by mixing the first drug 240a and the second drug 240b immediately before use, each drug 240a, 240b can be prevented from hardening within the hemostatic agent injection device 10, while allowing the drugs to exhibit high adhesive strength in the subcutaneous tissue S.

[0070] The second member 200 also has a sixth region 206A located on the proximal side of the fifth region 205A and blocking the first lumen 215 and the second lumen 225. The second member 200 is configured such that when the fifth region 205A is compressed, the wall portion 204 is more likely to break than the sixth region 206A. According to the hemostatic agent injection device 10 configured as described above, the surgeon or the like can prevent the first drug 240a held in the first lumen 215 and the second drug 240b held in the second lumen 225 from moving toward the proximal side of the second member 200 by the sixth region 206A provided in the second member 200. Furthermore, the hemostatic agent injection device 10 can prevent each of the drugs 240a, 240b from moving further toward the base end than the fifth region 205A, and can eject the hemostatic agent 240 from the fourth region 204A through the distal opening 201 even when the wall portion 204 is broken with the partition portion 203 broken. Therefore, the hemostatic agent injection device 10 can suitably prevent a situation in which the sixth region 206A is broken before the wall portion 204, causing the hemostatic agent 240 to leak toward the base end and not be ejected toward the distal end.

[0071] Moreover, 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 being separated 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. Furthermore, since the fifth region 205A has a longer length along the axial direction of the second member 200 than the fourth region 204A, the hemostatic agent injection device 10 can hold a desired amount of the hemostatic agent 240 (the first drug 240a and the second drug 240b) in the fifth region 205A. Therefore, the hemostatic agent injection device 10 can prevent a shortage of the hemostatic agent 240 when stopping bleeding at the puncture site P2 of the blood vessel Bv.

[0072] Moreover, the first member 100 has a recognition unit 110 that allows the operator to grasp the relative positional relationship between the first member 100 and the second member 200 in the circumferential direction of the hemostatic agent injection device 10. When inserting the hemostatic agent injection device 10 into a living body, the operator can easily grasp the relative positional relationship between the first member 100 and the second member 200 in the circumferential direction of the hemostatic agent injection device 10 by checking the recognition unit 110. For example, the operator can easily cause the blood B flowing through the blood vessel Bv to flow into the lumen 105 of the first member 100 by adjusting the direction of the distal end opening 101 of the first member 100 so that it faces the upstream side of the blood flow direction of the blood vessel Bv. Therefore, the operator can easily and reliably confirm that the blood B has leaked from the proximal end opening 103 of the first member 100.

[0073] Next, a hemostatic agent injection device according to a modified example will be described. In the modified example, duplicated explanations of the contents already explained will be omitted. In addition, the contents not specifically explained in the modified example can be the same as those in the above-mentioned embodiment.

[0074] <Variation 1> FIG. 16 shows a perspective view of a hemostatic agent injection device 20 according to the first modification.

[0075] In the hemostatic agent injection device 20, for example, the second member 200 can be formed from a single member. In this modification, the second member 200 is formed from the first body member 210 described in the above embodiment. The second member 200 may be formed from the second body member 220, or may be formed from other members having a lumen. As the hemostatic agent 240, a single type of drug that exerts a hemostatic effect can be used. As the hemostatic agent 240, for example, an adhesive composition such as cyanoacrylate can be used. The other configurations of the hemostatic agent injection device 20 are substantially the same as those of the hemostatic agent injection device 10 according to the above embodiment (see FIG. 2), and therefore detailed description thereof will be omitted.

[0076] According to the hemostatic agent injection device 20 of this modification, the second member 200 is composed of a single member, and therefore the structure is simple. In addition, since the hemostatic agent 240 composed of a single type of drug can be used, it is possible to prevent problems such as a decrease in the hemostatic effect due to multiple drugs not being mixed properly before the hemostatic agent 240 is placed at the puncture site P2 of the blood vessel Bv.

[0077] <Variation 2> FIG. 17 shows a perspective view of a hemostatic agent injection device 30 according to the second modification.

[0078] The hemostatic agent injection device 30 differs from the hemostatic agent injection device 10 according to the above embodiment (see FIG. 2) in the structure of the discharge portion 201b of the second member 200. 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 body member 210 and the second body member 220. Each hole provided in the second body member 220 penetrates the lumen 215 of the first body member 210 and the side surface of the first body member 210. In addition, each hole provided in the second body member 220 penetrates the lumen 225 of the second body member 220 and the side surface of the second body member 220. The tip of the second member 200 is blocked so that the hemostatic agent 240 is not discharged from the tip. Other configurations of the hemostatic agent injection device 30 are substantially the same as those of the hemostatic agent injection device 10 according to the above-described embodiment (see FIG. 2), and therefore detailed description thereof will be omitted.

[0079] When the surgeon or the like uses the hemostatic agent injection device 30 to place the hemostatic agent 240 at the puncture site P2 of the blood vessel Bv, the surgeon or the like presses the fifth region 205A. When the surgeon or the like presses the fifth region 205A, the hemostatic agent injection device 30 moves each of the drugs 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 drug 240a and the second drug 240b in the mixing space 208 of the fourth region 204A. The hemostatic agent injection device 30 ejects the hemostatic agent 240 from the ejection portion 201b included in the fourth region 204A. The hemostatic agent injection device 30 can eject the hemostatic agent 240 from the side surface of the second member 200 over a wide range in the circumferential direction of the second member 200 by the ejection portion 201b consisting of a plurality of holes. Therefore, the hemostatic agent injection device 30 can more reliably fill the hemostatic agent 240 into the puncture site P2 of the blood vessel Bv.

[0080] Furthermore, when performing hemostasis using the hemostatic agent injection device 30, the surgeon can place the hemostatic agent 240 in the perforation P1 of the subcutaneous tissue S without moving the second member 200 toward the base end side by applying a pressure force from the base end side to the tip end side of the fifth region 205A while maintaining the state in which the second member 200 is inserted into the living body. Therefore, the surgeon does not need to perform an operation of moving the hemostatic agent injection device 20 toward the base end side in order to place the hemostatic agent 240 discharged from the discharge portion 201b of the second member 200 in the perforation P1 of the subcutaneous tissue S, as in the hemostatic agent injection device 10 according to the above-mentioned embodiment (see FIG. 14). Therefore, the surgeon can perform hemostasis at the puncture site P2 of the blood vessel Bv more simply and smoothly by using the hemostatic agent injection device 20.

[0081] The discharge portion 201b according to this modification can also be provided in the hemostatic agent injection device 20 according to the first modification and the hemostatic agent injection device 40 according to the third modification.

[0082] <Modification 3> FIG. 18 shows a perspective view of a hemostatic agent injection device 40 according to the third modification.

[0083] The hemostatic agent injection device 40 differs from the hemostatic agent injection device 10 according to the above-described embodiment (see FIG. 2) in the structure of the second member 200. In the second member 200 according to this modification, no hemostatic agent or agent that forms the hemostatic agent is held in the lumen 215 prior to ejection of the hemostatic agent 240. Therefore, the hemostatic agent injection device 40 is not provided with the fifth region 205A, the partition section 203, the sixth region 206A, etc. for holding the hemostatic agent or agent that forms the hemostatic agent in advance.

[0084] When placing a hemostatic agent at the puncture site P2 of the blood vessel Bv using the hemostatic agent injection device 40, the surgeon can connect a member such as a hub to the base end 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, a tube, a syringe, or the like. The surgeon can place 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 a single tubular member such as the first main body member 210 or the second main body member 220, for example.

[0085] In the hemostatic agent injection device 40 according to this modification, a syringe or the like can be used to eject the hemostatic agent from the distal end opening 201 of the second member 200, so there is no need to apply a compressive force to the second member 200 when ejecting the hemostatic agent. 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 configured to be separable from the second member 200.

[0086] The above describes the hemostatic agent injection device of the present invention through embodiments and modified examples, but the present invention is not limited to the configurations described and can be modified as appropriate based on the description of the claims.

[0087] The structure of each part and the arrangement of components described in the specification may be modified as appropriate, and the use of additional components described in the figures may be omitted or other additional components may be used as appropriate.

[0088] This application is based on Japanese Patent Application No. 2020-036068 filed on March 3, 2020, the disclosure of which is incorporated by reference in its entirety. [Explanation of symbols]

[0089] 10, 20, 30, 40 Hemostatic agent injection device 100 First member 101 Tip opening 101a Slope 103 Proximal opening 105 lumens 101A 1st area 102A 2nd area 103A Third area 110 Recognition part 200 Second member 201 Tip opening 201a, 201b Discharge part 203 Partition 203a first partition member 203b Second partition member 204 Wall section 206a first closing member 206b second closing member 208 Mixed space 204A 4th area 205A 5th area 206A Area 6 207A Area 7 210 First body member 215 1st lumen 220 Second body member 225 2nd Lumen 230 Connection parts 240 Hemostatic Agent 240a First drug 240b Second drug 250 Pressing member 300 Introducer B blood Bv blood vessels Bw Blood vessel wall P1 Perforation of subcutaneous tissue P2 Vascular puncture site S subcutaneous tissue

Claims

1. a first member including a distal opening, a proximal opening, and a lumen communicating between the distal opening and the proximal opening; a second member connected to the first member and having a tip end provided with a discharge portion capable of discharging a hemostatic agent; the first member has a first region located distally of the distal end of the second member, and a second region located proximally of the first region and fixed to the second member before being inserted into a blood vessel; the first region has an inclined portion inclined in a direction away from the second member, the inclined portion defines the distal end opening of the first member, A hemostatic agent injection device characterized in that, when the inclined portion is placed in a blood vessel, the first member causes blood to flow into the lumen through the tip opening and causes the blood that has flowed into the lumen to leak out from the base opening.

2. The first member is a third region located on a proximal side of the second region and including a proximal end of the first member; The hemostatic agent injection device of claim 1 , wherein the third region is separable from the second member.

3. The second member is A fourth region including the ejection portion; a fifth region located proximal to the fourth region and configured to hold the hemostatic agent; a partition portion disposed between the fourth region and the fifth region and separating the fourth region from the fifth region, The hemostatic agent injection device according to claim 2, wherein the partition portion is capable of connecting the fourth region and the fifth region by the internal pressure of the fifth region when the fifth region is compressed.

4. The fifth region is a first lumen for holding a first agent; a second lumen for holding a second agent that is mixed with the first agent to form the hemostatic agent; a wall portion separating the first lumen and the second lumen, The hemostatic agent injection device of claim 3, characterized in that the second member is configured such that when the fifth region is compressed, communication between the fourth region and the fifth region is more likely to occur than rupture of the wall portion.

5. The second member is a sixth region located proximal to the fifth region and blocking the first lumen and the second lumen of the second member; The hemostatic agent injection device of claim 4, wherein the second member is configured such that when the fifth region is compressed, rupture of the wall portion occurs more easily than rupture of the sixth region.

6. the second region 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.

7. A hemostatic agent injection device as described in any one of claims 1 to 6, characterized in that at least one of the first member and the second member has a recognition portion that enables the relative positional relationship between the first member and the second member in the circumferential direction of the hemostatic agent injection device to be grasped.

Images