Adhesive material injection device

Abstract

[Problem] To retain an adhesive member at an appropriate position relative to a puncture site formed in a lumen of a living body. [Solution] An adhesive member injection device comprises a tube member (10) having a plurality of lumens, and an adhesive member (200) that is held by the lumens of the tube member (10). The tube member (10) is provided with a first lumen (11) that extends between a first tip opening (11a) and a first base opening (11b), and a second lumen (12) that extends between a second tip opening (12a) and a second base opening (32), at a different position than the first lumen (11). The first tip opening (11a) is positioned nearer the tip-side than the second tip opening (12a) in the long axis direction of the tube member (10). The adhesive member (200) is held by the first lumen (11) between the first tip opening (11a) and the first base opening (11b).

Description

Technical Field

[0001] The present invention relates to an adhesive member injection device.

Background Art

[0002] Conventionally, a technique of introducing various medical elongate bodies (for example, an introducer sheath) into a blood vessel through a puncture site formed in a blood vessel of a limb such as a patient's arm and performing treatment or therapy on a lesion site is known. When performing such a technique, when the operator removes the medical elongate body from the puncture site, the operator stops bleeding at the puncture site.

[0003] As one of the hemostasis methods, a compression hemostasis method of applying a compressive force to the puncture site of a blood vessel and the surrounding subcutaneous tissue from the surface layer side of a patient's living body is known. However, when the compression hemostasis method is adopted, if overpressure compression in which the compressive force becomes excessively large is carried out for a long time, there is a possibility that blood vessel occlusion may occur. Therefore, the operator is required to appropriately adjust the compressive force.

[0004] In relation to such problems, Patent Document 1 below discloses a hemostasis device that enables non-compression hemostasis. The hemostasis 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 technique using the hemostasis device of Patent Document 1, the operator introduces the distal opening of the sheath to the periphery of the puncture site of the blood vessel and discharges the hemostatic agent through the distal opening. The operator can block the puncture site by arranging the hemostatic agent discharged from the sheath around the puncture site of the blood vessel.

Prior Art Documents

Patent Documents

[0005]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0006] The above hemostatic device is equipped with a stopper (locking member) that prevents the tip of the sheath from being inserted beyond the depth of the puncture site in the blood vessel. The stopper is attached to the outer surface of the sheath and, when the sheath is inserted into the body, comes into contact with the surface of the patient's body to limit the insertion length of the sheath.

[0007] The above-described hemostatic device prevents the sheath from being inserted too far into the blood vessel beyond the depth of the puncture site. However, when using the above-described hemostatic device, the operator cannot determine the exact location of the puncture site before starting to dispense the hemostatic agent. Therefore, the operator is forced to rely on their sense of touch to position the tip opening of the sheath at the puncture site. Consequently, in procedures using the above-described hemostatic device, it is difficult to properly position the tip opening of the sheath relative to the puncture site.

[0008] The present invention has been made in view of the above problems, and specifically aims to provide an adhesive member injection device that can place an adhesive member at an appropriate position on a puncture site formed in a biological lumen. [Means for solving the problem]

[0009] The adhesive member injection device according to the present invention comprises a tube member having a plurality of lumens, and an adhesive member held in the lumens of the tube member, wherein the tube member comprises a first lumen extending between a first tip opening and a first base opening, and a second lumen extending between a second tip opening and a second base opening at a different position from the first lumen, wherein the first tip opening is located on the tip side of the long axis of the tube member than the second tip opening, and the adhesive member is held in the first lumen between the first tip opening and the first base opening. The tube member comprises a first region and a second region located closer to the base end than the first region, the first lumen extending only in the first region, the second lumen being longer than the first lumen and extending across both the first and second regions, and the first base end opening located between the second tip opening and the second base end opening. . [Effects of the Invention]

[0010] According to the present invention, the tube member has a first tip opening and a second tip opening located on the proximal end side of the first tip opening. The adhesive member is held in a first lumen extending between the first tip opening and the first proximal end opening. Furthermore, the adhesive member injection device has a first tip opening from which the adhesive member can be discharged located tipward of the second tip opening from which blood can flow. The perforation formed in the patient's puncture site to introduce a medical length is formed at an acute angle from the skin tissue to the blood vessel. Therefore, in order to configure the adhesive member injection device so that the first tip opening and the second tip opening are positioned outside the perforation formed in the blood vessel at the same time, with the second tip opening located distal to the blood vessel than the first tip opening, it is necessary to position the first tip opening tipward of the second tip opening. With an adhesive injection device having such a configuration, the surgeon can introduce the adhesive injection device into the blood vessel through the patient's puncture site, position the first and second tip openings of the tube member inside the blood vessel, and then retract the adhesive injection device towards the proximal end, thereby confirming the position of the second tip opening while checking for blood leakage from the second proximal opening. Therefore, by confirming that blood has leaked from the second proximal opening of the tube member, the surgeon can easily determine whether the first tip opening of the tube member is located inside the blood vessel wall (blood vessel) or outside the blood vessel wall (subcutaneous tissue). Consequently, the surgeon can accurately determine the discharge position of the adhesive member around the perforation of the blood vessel, and thus be able to place the adhesive member in the appropriate position for the perforation formed in the blood vessel. [Brief explanation of the drawing]

[0011] [Figure 1] This is a schematic diagram of the medical device according to this embodiment. [Figure 2] This is a schematic diagram showing a medical device according to this embodiment, in which an adhesive member injection device is attached to an introducer sheath. [Figure 3] This is a schematic cross-sectional view of the adhesive member injection device according to this embodiment. [Figure 4A]This is a partially enlarged cross-sectional view of the vicinity of the tip of an adhesive member injection device, which has a configuration in which no inclined portion is formed at the second tip opening, when it is withdrawn from a blood vessel. [Figure 4B] This is a partially enlarged cross-sectional view of the vicinity of the tip of an adhesive member injection device, which has a slanted portion formed at the second tip opening, when it is withdrawn from a blood vessel. [Figure 5A] This is an end view along the line indicated by arrow II-II in Figure 3. [Figure 5B] This is an end view along the line indicated by arrow III-III in Figure 3. [Figure 6A] This figure shows an example of the configuration of the first marker portion provided in the adhesive member injection device according to this embodiment. [Figure 6B] This figure shows an example of the configuration of the second marker portion provided on the extruded member according to this embodiment. [Figure 7A] This is a schematic cross-sectional view illustrating an example of the use of the adhesive member injection device according to this embodiment. [Figure 7B] This is a schematic cross-sectional view illustrating an example of the use of the adhesive member injection device according to this embodiment. [Figure 7C] This is a schematic cross-sectional view illustrating an example of the use of the adhesive member injection device according to this embodiment. [Figure 7D] This is a schematic cross-sectional view illustrating an example of the use of the adhesive member injection device according to this embodiment. [Figure 7E] This is a schematic cross-sectional view illustrating an example of the use of the adhesive member injection device according to this embodiment. [Figure 7F] This is a schematic cross-sectional view illustrating an example of the use of the adhesive member injection device according to this embodiment. [Figure 7G] This is a schematic cross-sectional view illustrating an example of the use of the adhesive member injection device according to this embodiment. [Figure 7H] This is a schematic cross-sectional view illustrating an example of the use of the adhesive member injection device according to this embodiment, and shows a magnified view of the puncture site of a blood vessel. [Figure 8] This is a schematic diagram showing an adhesive member injection device according to Modification 1.

Best Mode for Carrying Out the Invention

[0012] Hereinafter, embodiments for carrying out the present invention will be described in detail with reference to the drawings. The embodiments shown here are examples for embodying the technical idea of the present invention and do not limit the present invention. Further, other possible embodiments, examples, and operation techniques that can be considered by those skilled in the art without departing from the gist of the present invention are all included in the scope and gist of the present invention, and are included in the invention described in the claims and the equivalent scope thereof.

[0013] Furthermore, the drawings attached to this specification may be changed from the actual objects and schematically represented in terms of scale, vertical and horizontal dimension ratios, shape, etc. for the convenience of illustration and easier understanding, but this is merely an example and does not limit the interpretation of the present invention.

[0014] In this specification, ordinal numbers such as "first" and "second" are used for explanation, but unless otherwise specified, they are used for convenience and do not define any order.

[0015] In the description of this specification, the extending direction of the adhesive member injection device 100 (for example, the vertical direction in FIGS. 1, 2, and 3) is referred to as the "long axis direction". Also, the side of the adhesive member injection device 100 that is introduced into the living body is referred to as the "tip" (the lower end side in FIGS. 1, 2, and 3), and the end side opposite to the tip (the upper end side in FIGS. 1, 2, and 3) is referred to as the "base end". Further, the "tip portion" and "tip side" mean a region including the tip (the foremost end) and a predetermined range extending from the tip toward the base end side, and the "base end portion" and "base end side" mean a region including the base end (the most base end) and a predetermined range extending from the base end toward the tip side.

[0016] The adhesive member injection device 100 according to one embodiment of the present invention is used to stop bleeding at a puncture site after removing a device such as an introducer sheath (introducer sheath 400) that has been placed in a puncture site formed in a blood vessel Bv (e.g., radial artery) of a patient's limb, such as the arm, which is a biological lumen. The specific procedures and treatment steps for using the adhesive member injection device 100 according to one embodiment of the present invention are representative examples and do not specify the present invention.

[0017] [composition] First, the configuration of the medical device 1 according to this embodiment will be described. As shown in Figures 1 and 2, the medical device 1 is generally composed of an adhesive member injection device 100 and an introducer sheath 400. The adhesive member injection device 100 has multiple lumens and holds the adhesive member 200 in the lumens. The adhesive member injection device 100 also has an extrusion member 300 for discharging the adhesive member 200 held in the lumens from the lumens. Each component will be described in detail below.

[0018] <Adhesive material injection device> The adhesive injection device 100 comprises a tube member 10, a hub portion 20, and a stopcock 30. The tube member 10 also has a first lumen 11, a second lumen 12, and a first marker portion 13. The adhesive injection device 100 is inserted into an introduction sheath (introducer sheath 400) introduced into the blood vessel Bv and then introduced into the blood vessel Bv (see Figures 2 and 7B).

[0019] <Tube component> As shown in Figure 3, the tube member 10 is a tubular member comprising a first lumen 11 and a second lumen 12. The first lumen 11 and the second lumen 12 extend independently along the long axis of the tube member 10. The adhesive member injection device 100 according to this embodiment has a configuration having two lumens, the first lumen 11 and the second lumen 12. Note that the tube member 10 may be configured to have three or more lumens, for example, when using a mixture of multiple adhesive members 200.

[0020] The outer diameter and length of the tube member 10 are set to match the size of the introducer sheath 400 used (the size of the lumen (French (Fr) size) and the total length of the lumen). Specifically, the outer diameter of the tube member 10 may be set to a size specific to the Fr size of the introducer sheath 400 used (for example, specifically for 5Fr size or 6Fr size). Alternatively, the outer diameter of the tube member 10 may be set to the smallest Fr size of the introducer sheath 400 that can be used, thereby encompassing a certain range of Fr sizes of the introducer sheath 400. For example, if it is designated as "for 5Fr-6Fr," the outer diameter of the tube member 10 is set to match the 5Fr size introducer sheath, and if it is designated as "for 7Fr-8Fr," the outer diameter of the tube member 10 is set to match the 7Fr size introducer sheath. Furthermore, the tube member 10 is set so that its tip protrudes from the tip of the sheath body 410 of the introducer sheath 400. Therefore, the length of the tube member 10 is set to be longer than the total length of the introducer sheath 400. By setting the total length of the tube member 10 to a size that exceeds the maximum total length of the introducer sheath 400 that can be used, the length of the tube member 10 can be set to encompass introducer sheaths 400 with different total lengths to some extent. For example, if it is designated as "for 7cm to 15cm", the total length of the tube member 10 is set to exceed 15cm, which is the maximum total length of the tube member 10 that can be used, and if it is designated as "for 15cm to 25cm", the total length of the tube member 10 is set to exceed 25cm, which is the maximum total length of the tube member 10 that can be used.

[0021] The constituent material of the tube member 10 can be, for example, a resin material such as polypropylene, polyamide, polystyrene, or polyimide. The tube member 10 is made of a resin material that has appropriate rigidity and flexibility so that, after being introduced into the blood vessel Bv, it can deform along the blood vessel Bv while maintaining the lumen of the first lumen 11 and the second lumen 12. However, the specific type of material constituting the tube member 10 is not particularly limited.

[0022] <First Lumen> The first lumen 11 extends between a first tip opening 11a provided on the tip side of the tube member 10 and a first base end opening 11b provided on the base end side of the tube member 10. The first lumen 11 is loaded with adhesive member 200 and functions as an adhesive member discharge lumen for discharging the adhesive member 200 into the hole P1.

[0023] The tube member 10 comprises a first region A1 and a second region A2 located closer to the proximal end than the first region A1. As shown in Figure 3, the first region A1 is the region where the first lumen 11 and the second lumen 12 exist in a cross section perpendicular to the longitudinal direction of the tube member 10. Furthermore, the first region A1 is located closer to the tip of the introducer sheath 400 (i.e., a portion not covered by the introducer sheath 400) when the adhesive member injection device 100 is mounted on the introducer sheath 400.

[0024] As shown in Figure 3, the first lumen 11 is formed only in the first region A1 along the long axis of the tube member 10. The first region A1 is a region extending a predetermined distance from the tip to the base end of the tube member 10. In other words, the first lumen 11 is located in a region extending a predetermined distance from the tip to the base end of the tube member 10. Furthermore, the first base end opening 11b of the first lumen 11 is located on the tip side of the introducer sheath 400 (i.e., a portion not covered by the introducer sheath 400) when the adhesive member injection device 100 is mounted on the introducer sheath 400.

[0025] As shown in Figures 4A and 4B, the first tip opening 11a is located distal to the second tip opening 12a of the second lumen 12, which will be described later, in the longitudinal direction of the tube member 10. That is, the first tip opening 11a is positioned offset distally to the second tip opening 12a. Figure 4A shows the state in which the tip of the tube member 10, which does not have the inclined portion 12c described later formed on the second tip opening 12a, is positioned outside the blood vessel wall Bw. Figure 4B shows the state in which the tip of the tube member 10, which has the inclined portion 12c formed on the second tip opening 12a, is positioned outside the blood vessel wall Bw. Here, the introducer sheath 400 is inserted into the blood vessel Bv at an angle of 20 to 60 degrees to the patient's body surface (skin). That is, the perforation P1 formed at the patient's puncture site to introduce the introducer sheath 400 is formed at an angle of 20 to 60 degrees to the blood vessel Bv from the skin tissue. Therefore, when the surgeon withdraws the adhesive member injection device 100 from the blood vessel Bv, it is preferable that the first tip opening 11a is positioned 2 mm to 5 mm further forward than the second tip opening 12a, so that the first tip opening 11a and the second tip opening 12a are positioned outside the perforation P1 formed in the blood vessel Bv at the same time. That is, in the case of the tube member 10 shown in Figure 4A, it is preferable that the length of distance L1 in the figure (the distance from the position of the opening end of the second tip opening 12a to the position of the opening end of the first tip opening 11a) be 2 mm to 5 mm. Also, in the case of the tube member 10 shown in Figure 4B, it is preferable that the length of distance L2 in the figure (the distance from the position of the base end of the inclined portion 12c to the position of the opening end of the first tip opening 11a) be 2 mm to 5 mm. Furthermore, the center of the first tip opening 11a is located at a position off-center from the axis of the tube member 10 (an eccentric position).

[0026] In addition, the first tip opening 11a is located more distal to the second tip opening 12a in the longitudinal direction of the tube member 10. Therefore, as shown in Figure 7D, the adhesive injection device 100 is inserted obliquely into the blood vessel Bv, and with the second tip opening 12a located distal to the blood vessel Bv than the first tip opening 11a, the first tip opening 11a and the second tip opening 12a are located in an overlapping position in the axial direction of the blood vessel Bv around the puncture site. Consequently, when the operator retracts the adhesive injection device 100 towards the proximal end, the first tip opening 11a and the second tip opening 12a are located outside the blood vessel wall Bw at the same time from the perforation P1. This allows the surgeon to introduce the adhesive injection device 100 into the blood vessel Bv through the patient's puncture site, position the first tip opening 11a and the second tip opening 12a of the tube member 10 inside the blood vessel Bv, and then retract the adhesive injection device 100 towards the proximal end, thereby confirming the position of the second tip opening 12a while checking for leakage of blood B from the second proximal opening 12b. This allows the surgeon to easily determine whether the first tip opening 11a of the tube member 10 is located inside the blood vessel wall Bw (blood vessel Bv) or outside the blood vessel wall Bw (subcutaneous tissue S) by confirming that blood B has leaked from the second proximal opening 12b of the tube member 10. Therefore, the surgeon can accurately determine the discharge position of the adhesive member 200 around the perforation P1 in the blood vessel Bv, and thus place the adhesive member 200 in an appropriate position relative to the perforation P1 formed in the blood vessel Bv. The introducer sheath 400 is inserted obliquely into blood vessel Bv to create an access route for introducing the treatment device into blood vessel Bv from outside the body. Therefore, the perforations P1 and P2 formed at the patient's puncture site are formed at an acute angle from the skin tissue to blood vessel Bv. The distal side of blood vessel Bv is the direction in which blood B flows.

[0027] The first proximal end opening 11b is located between the second tip opening 12a and the second proximal end opening 12b in the longitudinal direction of the tube member 10. The first proximal end opening 11b is located in the first region A1 and is provided on the side wall of the tube member 10. Therefore, when the adhesive member injection device 100 is attached to the introducer sheath 400, the first proximal end opening 11b is located on the tip side of the introducer sheath 400 (i.e., in a location not covered by the introducer sheath 400). Thus, the surgeon can insert the extrusion member 300 into the first proximal end opening 11b with the adhesive member injection device 100 attached to the introducer sheath 400.

[0028] Furthermore, the first proximal opening 11b is configured to be exposed outside the body when the first distal opening 11a is positioned on the outer surface of the perforation P1 of the blood vessel Bv (outside the blood vessel wall Bw). Therefore, by simultaneously moving (retracting) the adhesive member injection device 100 and the introducer sheath 400 towards the proximal end, the first proximal opening 11b is exposed outside the body before the first distal opening 11a is positioned outside the blood vessel wall Bw. The operator can then insert the extrusion member 300 into the first proximal opening 11b that is exposed outside the body, thereby discharging the adhesive member 200 to the outside of the blood vessel wall Bw through the first distal opening 11a.

[0029] As shown in Figure 3, the first lumen 11 is configured to be shorter than the second lumen 12. Therefore, the adhesive injection device 100 can be configured such that the length of the extrusion member 300 inserted into the first lumen 11 is shorter than the total length of the tube member 10. For example, if the tube member 10 has the first base end opening 11b and the second base end opening 12b at the same position on the base end side of the tube member 10, the device length of the first lumen 11 and the extrusion member 300 must be corresponding to the length of the introducer sheath 400. As the length of the extrusion member 300 increases, its operability decreases, and the dispensing operation can become complicated. In contrast, since the adhesive injection device 100 can be configured such that the length of the extrusion member 300 inserted into the first lumen 11 is shorter, the operator can efficiently transmit the pushing force to the adhesive member 200 when pushing it out through the first tip opening 11a.

[0030] Furthermore, as shown in Figure 3, the first proximal end opening 11b is located between the second tip opening 12a and the second proximal end opening 12b of the tube member 10, and opens on the side of the tube member 10. In addition, the first proximal end opening 11b is configured to be located on the tip side of the introducer sheath 400 when the adhesive member injection device 100 is attached to the introducer sheath 400. Therefore, the length of the extrusion member 300 can be set regardless of the length of the introducer sheath 400. Also, since the first proximal end opening 11b is located between the second tip opening 12a and the second proximal end opening 12b, the operator can discharge the adhesive member 200 through the first tip opening 11a while confirming the leakage of blood B from the second proximal end opening 12b.

[0031] The tube member 10 includes a curved region 11c that forms part of the first lumen 11 connecting the first tip opening 11a and the first base opening 11b. Therefore, the first lumen 11 is curved in the direction of the side surface of the tube member 10 between the first tip opening 11a and the first base opening 11b, and at a position closer to the base end than where the adhesive member 200 is placed. The curved region 11c supports part of the extrusion member 300 when the operator inserts the extrusion member 300 into the first lumen 11 and pushes out the adhesive member 200. Therefore, the operator can easily transmit the pressing force when pushing out the adhesive member 200 with the extrusion member 300 to the extrusion member 300, and the adhesive member 200 can be reliably discharged.

[0032] In Figure 3, the curved region 11c forms a lumen that curves with a predetermined curvature from the first base opening 11b toward the first tip opening 11a. However, the curved region 11c may also form a lumen that extends diagonally in a straight line toward the inside of the tube member 10 from the first base opening 11b and then bends at a predetermined angle.

[0033] <Second Lumen> The second lumen 12 extends between the second tip opening 12a, which is provided on the tip side of the tube member 10, and the second proximal opening 12b, which is provided on the proximal side of the tube member 10. The second lumen 12 functions as a backflow confirmation lumen to confirm leakage of blood B, which has flowed in from the second tip opening 12a, from the second proximal opening 12b when introduced into the blood vessel Bv.

[0034] As shown in Figure 3, the second lumen 12 is formed in the first region A1 and the second region A2 along the longitudinal axis of the tube member 10. The second lumen 12 extends across the first region A1 and the second region A2 and is longer than the first lumen 11. Here, the second region A2 is located on the base end side of the first region A1 in the longitudinal direction of the tube member 10. That is, the second region A2 is located on the base end side of the first base end opening 11b in the longitudinal direction of the tube member 10. Therefore, the second lumen 12 extends from a predetermined position in the first region A1 to a position on the base end side of the first base end opening 11b in the longitudinal direction of the tube member 10. For example, as shown in Figure 3, the second lumen 12 extends from the second tip opening 12a located in the first region A1 to the base end of the tube member 10.

[0035] The second tip opening 12a is located closer to the base end than the first tip opening 11a in the longitudinal direction of the tube member 10. The center of the second tip opening 12a is located at an eccentric position, away from the axial center of the tube member 10, similar to the first tip opening 11a.

[0036] As shown in Figure 3, it is preferable that the second tip opening 12a forms an inclined portion 12c that slopes toward the tip side of the first lumen 11 (first tip opening 11a). When the second tip opening 12a forms an inclined portion 12c, the adhesive member injection device 100 has a shape in which the outer diameter decreases from the base end to the tip of the inclined portion 12c and does not have corners that protrude in the outer circumference direction. Therefore, when the adhesive member injection device 100 is removed from the body, it is possible to prevent damage to the biological tissue around the second tip opening 12a and reduce sliding resistance caused by catching on the subcutaneous tissue S.

[0037] The tube member 10 comprises a first lumen 11 and a second lumen 12 in the first region A1. As shown in Figure 5A, in the first region A1, the surface area of ​​the second lumen 12 is smaller than the surface area of ​​the first lumen 11 in a cross section perpendicular to the longitudinal direction of the tube member 10. That is, the proportion of the cross section perpendicular to the longitudinal direction of the tube member 10 occupied by the second lumen 12 is smaller than the proportion of the cross section perpendicular to the longitudinal direction of the tube member 10 occupied by the first lumen 11. Therefore, when the tube member 10 deforms, the second lumen 12 is less affected by the deformation of the tube member 10 than the first lumen 11. Consequently, when the tube member 10 deforms, the second lumen 12 is less likely to collapse than the first lumen 11. As a result, the adhesive member injection device 100 can suppress the collapse of the second lumen 12 in the first region A1, even if the tube member 10 deforms when the operator inserts the adhesive member injection device 100 into the blood vessel Bv. Therefore, the operator can reliably confirm the leakage of blood B through the second lumen 12 of the tube member 10.

[0038] As shown in Figure 5A, it is preferable that the cross-sectional area X2 of the second lumen 12 is smaller than the cross-sectional area X1 of the first lumen 11 in the first region A1, but the cross-sectional area X2 of the second lumen 12 may be larger than the cross-sectional area X1 of the first lumen 11 in the first region A1.

[0039] Furthermore, the tube member 10 includes a second lumen 12 in the second region A2. As shown in Figure 5B, the surface area of ​​the second lumen 12 in the second region A2 is the same as the surface area of ​​the second lumen 12 in the first region A1 in a cross-section perpendicular to the longitudinal direction of the tube member 10. Thus, from the viewpoint of ease of manufacturing the tube member 10, it is preferable that the second lumen 12 has the same cross-sectional area in the first region A1 and the second region A2. However, the cross-sectional area of ​​the second lumen 12 in the second region A2 may be different from the cross-sectional area of ​​the second lumen 12 in the first region A1.

[0040] As shown in Figure 6A, the tube member 10 has a first marker portion 13 that indicates the distance from the first tip opening 11a to a predetermined position in the first lumen 11. The first marker portion 13 is provided on the outer surface of the tube member 10 so that it can be visually confirmed by the operator. For example, the first marker portion 13 is provided on the outer circumferential surface near the tip of the tube member 10 and is composed of a colored portion, a figure, a symbol, a pattern, or an uneven shape. The specific configuration of the first marker portion 13 is not limited as long as the operator can grasp the distance from the first tip opening 11a and the orientation of the first base end opening 11b in the outer circumferential direction of the adhesive member injection device 100 by sight or touch. The operator can confirm the distance to the tip of the tube member 10 (first tip opening 11a) by confirming the position of the first marker portion 13 of the tube member 10 exposed outside the body. Therefore, when the surgeon retracts the adhesive injection device 100 to find the discharge position of the adhesive member 200, they can easily determine the exact discharge position of the adhesive member 200 by checking the first marker portion 13. In addition, when the surgeon retracts the adhesive injection device 100 proximal to the vessel Bv, they can determine how much further the tube member 10 is inserted into the body by checking the first marker portion 13 that is exposed outside the body.

[0041] <Hub section> The hub portion 20 includes a base portion 21 attached to the outer circumference of the tube member 10, and a first engaging portion 22 on the outer surface of the base portion 21 that can be connected to the second engaging portion 421 of the sheath hub portion 420. The hub portion 20 is located in the second region A2 of the tube member 10 and is provided between the first base end opening 11b and the second base end opening 12b. In this embodiment, the first engaging portion 22 is composed of a claw member having a hook-shaped portion at its tip and fits into the second engaging portion 421 of the sheath hub portion 420. The form of the first engaging portion 22 is not limited to a claw member, and any form that is complementary to the second engaging portion 421 is acceptable.

[0042] The hub portion 20 can be connected to the sheath hub portion 420 of the introducer sheath 400 by the first engaging portion 22. Therefore, the adhesive injection device 100 can be connected to the introducer sheath 400 via the hub portion 20 while the tube member 10 is inserted into the sheath membrane 411 of the introducer sheath 400. This allows the surgeon to move the adhesive injection device 100 and the introducer sheath 400 simultaneously by connecting the hub portion 20 and the sheath hub portion 420 when adjusting the position of the first tip opening 11a of the adhesive injection device 100. For example, when removing the adhesive injection device 100, the procedure can be easily removed simultaneously with the introducer sheath 400, thus simplifying the procedure. It is preferable that the extrusion member 300 can be inserted into the first base end opening 11b while the hub portion 20 and the sheath hub portion 420 are connected. Therefore, the first base end opening 11b of the adhesive member injection device 100 is located on the tip side of the tip of the introducer sheath 400 when the hub portion 20 is connected to the sheath hub portion 420.

[0043] <Stopcock> The stopcock 30 comprises an operating lever 31, a first port 32, and a second port 33. The stopcock 30 is connected to the base end of the tube member 10. The lumen of the stopcock 30 communicates with the second lumen 12 of the tube member 10 via a second base opening 12b. The stopcock 30 can control the communication between the first port 32 and the second lumen 12, and the communication between the second port 33 and the second lumen 12, by rotating the operating lever 31. Therefore, the stopcock 30 can control the flow of blood B through the second lumen 12 of the tube member 10 and control the outflow of blood B from the adhesive member injection device 100 via the second base opening 12b. Instead of a three-way stopcock as shown in Figure 1, a multi-way stopcock with four or more ports may be provided.

[0044] Inside the stopcock 30, a valve (not shown) is provided to switch between communication between the first port 32 or the second port 33 and the second lumen 12 in conjunction with the rotation of the operating lever 31 in a predetermined direction. When the operating lever 31 is rotated in a predetermined direction, the valve moves, and the first port 32 and the second lumen 12 are in communication (ON state). At this time, the second port 33 is not in communication with the second lumen 12. Alternatively, when the operating lever 31 is rotated in a predetermined direction, the valve moves, and the second port 33 and the second lumen 12 are in communication (ON state). At this time, the first port 32 is not in communication with the second lumen 12. When the first port 32 and the second lumen 12 are in communication, blood B flows in through the second tip opening 12a, passes through the second lumen 12, and leaks out of the body through the first port 32.

[0045] A priming syringe or the like can be connected to the second port 33 of the stopcock 30 to prime the second lumen 12. This allows the surgeon to prime the second lumen 12 with saline solution or the like before inserting the adhesive material injection device 100 into the introducer sheath 400.

[0046] The stopcock 30 may also be configured as a two-way stopcock that handles the functions of the first port 32 and the second port 33 with a single port, and allows switching between communication and non-communication between the port and the second lumen 12 by operating an operating lever.

[0047] <Adhesive material> The adhesive member 200 is a member that can bond the perforation P1 of the blood vessel Bv, and is placed in the first lumen 11 of the tube member 10. For example, as shown in Figure 3, the adhesive member 200 is pre-held in the first lumen 11. This eliminates the need for the surgeon to load the adhesive member 200 during the procedure, thereby simplifying the procedure.

[0048] Furthermore, it is preferable that the adhesive member 200 be positioned near the first tip opening 11a. This shortens the distance over which the operator presses the adhesive member 200 with the extrusion member 300, allowing the operator to dispense the adhesive member 200 to the placement position with relatively little force using the extrusion member 300. Therefore, when the operator places the adhesive member 200 at the desired position, the displacement of the adhesive member injection device 100 caused by applying excessive force to the extrusion member 300 can be reduced, allowing the adhesive member 200 to be easily dispensed at the desired position.

[0049] The adhesive member 200 is extruded from the first tip opening 11a by the extrusion member 300 inserted from the first proximal opening 11b. Specifically, the surgeon brings the tip of the extrusion member 300 into contact with the adhesive member 200, and while fixing the position of the extrusion member 300, moves the adhesive member injection device 100 toward the proximal end. This prevents the movement of the adhesive member 200 with the tip of the extrusion member 300, allowing the adhesive member 200 to be discharged from the first tip opening 11a. Therefore, when discharging the adhesive member 200 from the first tip opening 11a, the surgeon moves the adhesive member injection device 100 toward the proximal end while fixing the position of the extrusion member 300, eliminating the need for the tip of the extrusion member 300 to push the adhesive member 200 toward the tip of the tube member 10. Consequently, the surgeon can accurately position the adhesive member 200 in the perforation P1 formed in the blood vessel Bv while preventing the adhesive member 200 from being discharged into the blood vessel Bv.

[0050] The adhesive member 200 can be made of a material that can be placed outside the blood vessel wall Bw to stop hemostasis of the perforation P1. The adhesive member 200 can be, for example, an adhesive member composition (liquid) such as cyanoacrylate, but is not particularly limited as long as it is a material that can be placed outside the blood vessel wall Bw to stop hemostasis of the perforation P1. Furthermore, the adhesive member 200 has a structure that prevents leakage from the first lumen 11 until the operator performs the dispensing operation. For example, the adhesive member injection device 100 can form a sealed space in the first lumen 11 with two membrane-like sealing members and hold the liquid adhesive member 200 in that sealed space. Alternatively, the adhesive member injection device 100 can load the adhesive member 200 contained in a bioabsorbable or biodegradable capsule into the first lumen 11.

[0051] <Extruded material> The extrusion member 300 is made up of a rod-shaped member and has an outer diameter that allows it to be inserted into the first lumen 11. The extrusion member 300 is inserted into the first lumen 11 and is configured to extrude the adhesive member 200 that is held in the first lumen 11. For example, as shown in Figure 7G, the surgeon can use the extrusion member 300 to place it on the outside of the vascular wall Bw of the blood vessel Bv.

[0052] As shown in Figure 6B, the extruded member 300 has a second marker portion 310 for determining the insertion amount when inserted from the first base end opening 11b. The second marker portion 310 is provided on the outer surface of the extruded member 300 so that the operator can visually confirm it. For example, it is provided on the outer circumferential surface of the extruded member 300 and can be composed of a colored portion, a figure, a symbol, a pattern, or an uneven shape. The specific configuration of the second marker portion 310 is not limited as long as the operator can determine the insertion amount of the extruded member 300 into the first lumen 11 by sight or touch. By providing the second marker portion 310 on the extruded member 300, the operator can determine the insertion amount of the extruded member 300 into the first lumen 11 and thus insert the extruded member 300 appropriately.

[0053] <Introducer Sheath> The introducer sheath 400 is a hollow tubular member that is placed at a puncture site formed in a blood vessel Bv of a patient's limb, such as the arm, for the purpose of inserting guidewires, catheters, etc., into the blood vessel Bv for treatment, examination, etc. The adhesive member injection device 100 is introduced into the blood vessel Bv via the introducer sheath 400, as shown in Figure 7B.

[0054] The introducer sheath 400 comprises a sheath body 410 having a lumen extending in the axial direction, and a sheath hub portion 420 connected to the proximal end of the sheath body 410. The sheath body 410 is the portion that is introduced percutaneously into the blood vessel Bv when the introducer sheath 400 is placed at the puncture site. The sheath body 410 is formed from a substantially cylindrical tubular member, and a see-through membrane 411 is formed in its lumen. The see-through membrane 411 is a lumen that extends from the tip to the proximal end of the sheath body 410. The sheath hub portion 420 is configured to be connectable to the hub portion 20 of the adhesive member injection device 100. The sheath hub portion 420 communicates with the see-through membrane 411 internally.

[0055] The outer circumferential surface of the sheath hub portion 420 is provided with a second engaging portion 421 that can be connected to the first engaging portion 22 of the hub portion 20. In this embodiment, the second engaging portion 421 is composed of a groove provided along the outer circumferential surface of the sheath hub portion 420, into which the tip (hook-shaped portion) of the first engaging portion 22 of the hub portion 20 fits. Note that the shape of the second engaging portion 421 is not limited to a groove, and any shape that is complementary to the first engaging portion 22 is acceptable.

[0056] As shown in Figure 3, a hemostatic valve 422 is installed inside the sheath hub portion 420. The hemostatic valve 422 can be a substantially elliptical membrane-like (disc-shaped) valve body made of, for example, an elastic material such as silicone rubber, latex rubber, butyl rubber, or isoprene rubber, but the shape and material of the valve are not particularly limited.

[0057] [Treatment Method] Next, a treatment method using the adhesive member injection device 100 according to this embodiment will be described with reference to Figures 7A to 7H. Note that the following description illustrates a series of steps in the treatment method, but is not limited to the specific order presented.

[0058] Figure 7A shows the introducer sheath 400 introduced into the blood vessel Bv through the patient's skin. In the procedure described in this embodiment, the introducer sheath 400 is inserted in a direction opposite to the direction of blood flow within the blood vessel Bv. The operator can deliver various medical devices to the treatment site of the patient via the introducer sheath 400 to perform treatment or diagnosis. Prior to the procedure using the introducer sheath 400, the operator creates a perforation P2 in the subcutaneous tissue S that reaches the blood vessel wall Bw, which will serve as the puncture site, in order to introduce the sheath body 410 of the introducer sheath 400 into the blood vessel Bv. The operator also creates a perforation P1 in the blood vessel Bv in the subcutaneous tissue S, which will serve as the puncture site. The perforations P1 and P2 formed at the patient's puncture site are formed at an acute angle from the skin tissue to the blood vessel Bv. The blood vessel Bv is, for example, the radial artery running through the patient's wrist. However, the blood vessel Bv can be selected arbitrarily depending on the nature of the procedure, and is not particularly limited.

[0059] The surgeon prepares an adhesive injection device 100 in which the adhesive member 200, as shown in Figure 1, is pre-held in the first lumen 11. This eliminates the need to load the adhesive member 200 during the procedure, thus simplifying the procedure. If the adhesive member 200 is not held in the first lumen 11 of the adhesive injection device 100, the surgeon places the adhesive member 200 in the first lumen 11.

[0060] As shown in Figure 7B, after completing procedures using various medical devices, the surgeon inserts the adhesive injection device 100 into the body through the sheath body 410 of the introducer sheath 400, positioning the first tip opening 11a, the first proximal opening 11b, and the second tip opening 12a within the blood vessel Bv. Before inserting the adhesive injection device 100 into the introducer sheath 400, the surgeon primes the second lumen 12 with saline solution or the like to prevent air from entering the blood vessel Bv. With the adhesive injection device 100 inserted into the introducer sheath 400, the surgeon engages the first engaging portion 22 of the hub portion 20 with the second engaging portion 421 of the sheath hub portion 420. This attaches the adhesive injection device 100 to the introducer sheath 400. Furthermore, when the adhesive member injection device 100 and the introducer sheath 400 are attached, the first region A1 of the tube member 10 is located more towards the tip than the introducer sheath 400. Therefore, the first tip opening 11a, the first proximal opening 11b, and the second tip opening 12a are located within the blood vessel Bv.

[0061] Next, as shown in Figure 7C, the surgeon moves the adhesive injection device 100 towards the proximal end so that the first proximal opening 11b is exposed outside the body. At this time, the adhesive injection device 100 is connected to the introducer sheath 400 via the hub portion 20. Therefore, as shown in Figure 7C, the surgeon can simultaneously move (retract) the adhesive injection device 100 and the introducer sheath 400 towards the proximal end, exposing the first proximal opening 11b outside the body. This allows the surgeon to insert the extrusion member 300 into the first proximal opening 11b that is exposed outside the body. Also, as shown in Figure 7C, although the introducer sheath 400 moves outside the body, the first tip opening 11a and the second tip opening 12a of the tube member 10 remain located inside the blood vessel Bv.

[0062] Next, as shown in Figure 7D, the surgeon inserts the extrusion member 300 into the first proximal end opening 11b that is exposed outside the body. After inserting the extrusion member 300 into the first lumen 11, the surgeon moves the extrusion member 300 so that its tip is located near the proximal end of the adhesive member 200. At this time, the surgeon advances the extrusion member 300 in the direction of the first proximal end opening 11a until its tip contacts the proximal end of the adhesive member 200.

[0063] Next, as shown in Figure 7E, the surgeon confirms the leakage of blood B from the second proximal opening 12b through the second lumen 12. At this time, the surgeon rotates the operating lever 31 of the stopcock 30 to connect the second lumen 12 and the first port 32. As a result, when the second tip opening 12a is located in the blood vessel Bv, the blood B that has flowed from the blood vessel Bv into the second tip opening 12a leaks out of the body through the first port 32 of the stopcock 30. Therefore, the surgeon can confirm the position of the second tip opening 12a by confirming that blood B has leaked from the first port 32 of the stopcock 30.

[0064] Furthermore, if the second lumen 12 and the first port 32 are in communication and no blood B leaks from the first port 32, the surgeon may advance the adhesive injection device 100 toward the blood vessel Bv so that the second tip opening 12a is positioned toward the blood vessel Bv. By advancing the adhesive injection device 100 and moving the second tip opening 12a into the blood vessel Bv, the surgeon can allow blood B to flow into the second lumen 12.

[0065] Next, as shown in Figure 7F, the operator moves (retracts) the adhesive injection device 100 towards the proximal end until the leakage of blood B from the second proximal opening 12b stops, while confirming the blood B leaking from the second proximal opening 12b via the first port 32. At this time, the introducer sheath 400 moves towards the proximal end simultaneously with the adhesive injection device 100 because it is connected to the adhesive injection device 100 via the hub portion 20. When the adhesive injection device 100 is positioned where the leakage of blood B from the second proximal opening 12b stops, the second tip opening 12a is located outside the blood vessel wall Bw. When the second tip opening 12a of the adhesive injection device 100 is located outside the blood vessel wall Bw, the leakage of blood B from the second proximal opening 12b via the first port 32 stops or the amount of leakage is significantly reduced. This allows the surgeon to confirm that the second tip opening 12a is positioned outside the blood vessel wall Bw by observing the blood B leaking from the second proximal opening 12b via the first port 32. Furthermore, when the second tip opening 12a is positioned outside the blood vessel wall Bw, the first tip opening 11a of the adhesive material injection device 100 is also positioned outside the blood vessel wall Bw. Therefore, the surgeon can position the first tip opening 11a outside the blood vessel wall Bw by retracting the adhesive material injection device 100 towards the proximal end until the leakage of blood B from the second proximal opening 12b stops, while observing the blood B leaking from the second proximal opening 12b via the first port 32.

[0066] The operator may also advance and retract the adhesive injection device 100 while confirming the leakage of blood B from the second proximal opening 12b via the first port 32. By moving the second tip opening 12a between the inside and outside of the blood vessel Bv, the operator can reliably determine whether the second tip opening 12a has moved to the outside of the blood vessel wall Bw.

[0067] Next, as shown in Figure 7G, the surgeon fixes the position of the extrusion member 300 so that it does not move together with the adhesive injection device 100, and moves (retracts) the adhesive injection device 100 towards the proximal end. For example, the surgeon fixes the position of the extrusion member 300 with their right hand while moving the adhesive injection device 100 towards the proximal end with their left hand. As a result, the adhesive member 200 is compressed by the tip of the extrusion member 300 and pushed out from the first tip opening 11a. Therefore, when the surgeon retracts the adhesive injection device 100 towards the proximal end, the adhesive member 200 is placed in the perforation P1, which is the puncture site formed in the blood vessel Bv. Note that the introducer sheath 400 is connected to the adhesive injection device 100 via the hub portion 20, and therefore moves towards the proximal end simultaneously with the adhesive injection device 100. When the adhesive member 200 is extruded from the first tip opening 11a of the first lumen 11, it is placed (filled) within a predetermined range in the depth direction of the perforation P2 in the subcutaneous tissue S from the outside of the blood vessel wall Bw. This allows the operator to easily control the starting position from which the adhesive member 200 is extruded from the first tip opening 11a into the perforation P1, and to reliably place the adhesive member 200 on the outside of the blood vessel wall Bw, thereby safely sealing the perforation P1 in the blood vessel Bv with the adhesive member 200.

[0068] As shown in Figures 7A to 7G, the adhesive injection device 100 can be introduced into the blood vessel Bv via the introducer sheath 400, allowing for hemostasis at the puncture site with simple operation. Therefore, the adhesive injection device 100 can be used at various puncture sites on different limbs using the introducer sheath 400. Consequently, the operator does not need to learn different hemostasis methods or how to use the device for various puncture sites on different limbs, and can still achieve hemostasis at the puncture site. Furthermore, even if the placement position of the adhesive member 200 shifts from the appropriate position, the adhesive member 200 can be repositioned by reloading it into the first lumen 11.

[0069] As shown in Figure 7H, the surgeon removes the adhesive injection device 100 from the body and applies pressure to the area near the puncture site from the surface of the body. For example, the surgeon removes the adhesive injection device 100, which is connected to the introducer sheath 400, from the body and applies pressure to the area near the perforation P2 from the surface of the body with their fingers F. By applying pressure to the area near the perforation P2 from the surface of the body with their fingers F, the surgeon can promote adhesion of the perforation P2 formed in the subcutaneous tissue S. This allows the surgeon to stop bleeding at the perforations P1 and P2, which are the puncture sites.

[0070] [Effects and Effects] As described above, the adhesive member injection device 100 according to this embodiment includes a tube member 10 having a plurality of lumens, and an adhesive member 200 held in the lumens of the tube member 10. The tube member 10 includes a first lumen 11 extending between a first tip opening 11a and a first base opening 11b, and a second lumen 12 extending between a second tip opening 12a and a second base opening 12b at a different position from the first lumen 11. The first tip opening 11a is located on the tip side of the tube member 10 in the longitudinal direction, compared to the second tip opening 12a. The adhesive member 200 is held in the first lumen 11 between the first tip opening 11a and the first base opening 11b.

[0071] In the adhesive member injection device 100 configured in this way, the tube member 10 has a first tip opening 11a and a second tip opening 12a located on the proximal end side of the first tip opening 11a. The adhesive member 200 is held in a first lumen 11 extending between the first tip opening 11a and the first proximal end opening 11b. Furthermore, the adhesive member injection device 100 has the first tip opening 11a, from which the adhesive member 200 can be discharged, located on the tip side of the second tip opening 12a, from which blood B can flow. Perforations P1 and P2 formed in the patient's puncture site to introduce the introducer sheath 400 are formed at an acute angle from the skin tissue to the blood vessel Bv. Therefore, in order to configure the adhesive member injection device 100 so that the first tip opening 11a and the second tip opening 12a are positioned outside the perforation P1 formed in the blood vessel Bv at the same time, with the second tip opening 12a positioned distal to the blood vessel Bv than the first tip opening 11a, it is necessary to position the first tip opening 11a distal to the second tip opening 12a. With an adhesive member injection device 100 having such a configuration, the operator can introduce the adhesive member injection device 100 into the blood vessel Bv through the patient's puncture site, position the first tip opening 11a and the second tip opening 12a of the tube member 10 inside the blood vessel Bv, and then retract the adhesive member injection device 100 toward the proximal end, thereby confirming the position of the second tip opening 12a while checking for leakage of blood B from the second proximal end opening 12b. Therefore, by confirming that blood B has leaked from the second proximal end opening 12b of the tube member 10, the surgeon can easily determine whether the first tip opening 11a of the tube member 10 is located inside the blood vessel wall Bw (blood vessel Bv) or outside the blood vessel wall Bw (subcutaneous tissue S). Consequently, the surgeon can accurately determine the discharge position of the adhesive member 200 around the perforation P1 of the blood vessel Bv, and thus can place the adhesive member 200 in an appropriate position relative to the perforation P1 formed in the blood vessel Bv.

[0072] Furthermore, in the adhesive member injection device 100, the tube member 10 may be configured to include a first region A1 and a second region A2 located closer to the base end than the first region A1, with the first lumen 11 extending only in the first region A1, the second lumen 12 being longer than the first lumen 11 and extending across both the first region A1 and the second region A2, and the first base end opening 11b being located between the second tip opening 12a and the second base end opening 12b.

[0073] With the adhesive injection device 100 configured in this way, the first lumen 11 is configured to be shorter than the second lumen 12. Also, the first base end opening 11b is located between the first tip opening 11a and the second base end opening 12b in the longitudinal direction of the tube member 10. Therefore, the adhesive injection device 100 can hold the adhesive member 200 in the region between the second tip opening 12a and the first base end opening 11b of the tube member 10 while configuring the distance of the first lumen 11 to be short. In addition, when the operator pushes the adhesive member 200 through the first tip opening 11a, the adhesive injection device 100 can shorten the distance the operator moves the adhesive member 200 in the first lumen 11. Furthermore, because the distance of the first lumen 11 is short, the length of the extrusion member 300 can also be configured to be short. Therefore, when the surgeon pushes out the adhesive member 200 through the first tip opening 11a, they can use the extrusion member 300 to efficiently transmit the pressing force to the adhesive member 200. This improves the surgeon's operability.

[0074] Furthermore, in the adhesive member injection device 100, the cross-sectional area X2 of the second lumen 12 may be configured to be smaller than the cross-sectional area X1 of the first lumen 11 in the first region A1.

[0075] With the adhesive member injection device 100 configured in this way, the tube member 10 has a first lumen 11 and a second lumen 12 in the first region A1. In addition, the cross-sectional area X2 of the second lumen 12 is smaller than the cross-sectional area X1 of the first lumen 11 in the first region A1. That is, in the first region A1, the surface area of ​​the second lumen 12 is smaller than the surface area of ​​the first lumen 11 in a cross section perpendicular to the longitudinal direction of the tube member 10. Therefore, when the tube member 10 deforms, the second lumen 12 is less affected by the deformation of the tube member 10 than the first lumen 11. As a result, even when the tube member 10 is deformed, the operator can reliably confirm the leakage of blood B through the second lumen 12 of the tube member 10 while pushing out the adhesive member 200 through the first lumen 11.

[0076] Furthermore, in the adhesive member injection device 100, the first base end opening 11b may be provided on the side wall of the tube member 10, and the tube member 10 may be configured to include a curved region 11c that forms part of the first lumen 11.

[0077] With the adhesive member injection device 100 configured in this way, the tube member 10 has a curved region 11c that forms part of the first lumen 11. Therefore, when the operator inserts the extrusion member 300 from the first proximal opening 11b toward the first tip opening 11a and pushes out the adhesive member 200 with the extrusion member 300, the curved region 11c supports part of the extrusion member 300 while changing the orientation of the tip of the extrusion member 300. Thus, the operator can easily transmit the pressing force when pushing out the adhesive member 200 with the extrusion member 300 to the extrusion member 300, and the adhesive member 200 can be reliably dispensed.

[0078] Furthermore, in the adhesive member injection device 100, the second tip opening 12a may have an inclined portion 12c that slopes toward the first lumen 11.

[0079] With the adhesive injection device 100 configured in this way, the second tip opening 12a forms an inclined portion 12c that slopes toward the first lumen 11. As a result, the outer diameter of the tube member 10 decreases from the base end to the tip of the inclined portion 12c. Therefore, when the adhesive injection device 100 is removed from the body, it is possible to prevent damage to the biological tissue around the second tip opening 12a while reducing sliding resistance caused by snagging on the subcutaneous tissue S.

[0080] Furthermore, in the adhesive member injection device 100, the tube member 10 may be configured to include a first marker portion 13 between the first tip opening 11a and the first base opening 11b, which indicates the distance to the first tip opening 11a.

[0081] With the adhesive member injection device 100 configured in this way, the tube member 10 has a first marker portion 13 that indicates the position up to the first tip opening 11a. Therefore, the surgeon can confirm the distance to the tip of the tube member 10 (first tip opening 11a) by confirming the position of the first marker portion 13 of the tube member 10 exposed outside the body. Thus, the surgeon can easily grasp the position of the first tip opening 11a and place the adhesive member 200 in the appropriate position.

[0082] Furthermore, in the adhesive member injection device 100, the tube member 10 may be configured to have a hub portion 20 between the first base end opening 11b and the second base end opening 12b.

[0083] With the adhesive injection device 100 configured in this way, the hub portion 20 is located between the first base end opening 11b and the second base end opening 12b. Therefore, the adhesive injection device 100 can be operated integrally with the introducer sheath 400 by connecting it to the introducer sheath 400 via the hub portion 20. Thus, the operator can move the adhesive injection device 100 and the introducer sheath 400 simultaneously, simplifying the procedure. Furthermore, the hub portion 20 is located between the first base end opening 11b and the second base end opening 12b in the longitudinal direction of the tube member 10. Therefore, when the adhesive injection device 100 is connected to the introducer sheath 400 via the hub portion 20, it can be configured so that the first base end opening 11b is exposed from the tip of the sheath body 410.

[0084] Furthermore, the adhesive member injection device 100 may be configured to include an extrusion member 300 that is inserted from the first base end opening 11b of the first lumen 11 and discharged from the first tip opening 11a.

[0085] The adhesive injection device 100 configured in this way has a dedicated extrusion member 300 that can be inserted into the first base end opening 11b and extrude the adhesive member 200 from the first lumen 11. Therefore, when the operator uses the adhesive injection device 100, the effort required to extrude the adhesive member 200 is reduced.

[0086] Furthermore, in the adhesive member injection device 100, the extrusion member 300 may be configured to include a second marker portion 310 that indicates the amount of insertion of the extrusion member 300 into the first lumen 11.

[0087] With the adhesive member injection device 100 configured in this way, the extruder member 300 is equipped with a second marker portion 310 that indicates the amount of insertion of the extruder member 300 into the first base end opening 11b. Therefore, the operator can easily grasp the amount of insertion of the extruder member 300 into the first lumen 11 via the second marker portion 310.

[0088] The medical device 1 according to this embodiment includes the adhesive member injection device 100 described above, and an introducer sheath 400 having a lumen (see-through lumen 411) into which the adhesive member injection device 100 can be inserted. The introducer sheath 400 includes a sheath hub portion 420 that can be connected to the hub portion 20. The adhesive member injection device 100 is configured such that, with the hub portion 20 connected to the sheath hub portion 420, the first base end opening 11b of the adhesive member injection device 100 is located on the tip side of the introducer sheath 400.

[0089] With the medical device 1 configured in this way, the hub portion 20 of the adhesive material injection device 100 is configured to be connectable to the sheath hub portion 420 of the introducer sheath 400. Therefore, the surgeon can connect the hub portion 23 and the sheath hub portion 420 while the adhesive material injection device 100 is inserted into the introducer sheath 400 which has been placed in the blood vessel Bv. Thus, the surgeon can withdraw the adhesive material injection device 100 and the introducer sheath 400 simultaneously, thereby simplifying the procedure. Furthermore, the first proximal opening 11b is configured to be located on the tip side of the introducer sheath 400 when the adhesive material injection device 100 is attached to the introducer sheath 400. Therefore, the adhesive member injection device 100 is configured such that when the surgeon simultaneously retracts the adhesive member injection device 100 and the introducer sheath 400 towards the proximal end, the introducer sheath 400 can be removed from the body before the first proximal opening 11b of the tube member 10 is exposed outside the body. Thus, the surgeon can insert the extrusion member 300 through the first proximal opening 11b, which is exposed outside the body, without having to worry about the position of the introducer sheath 400. This allows the surgeon to extrude the adhesive member 200 to the outside of the blood vessel wall Bw through the first tip opening 11a.

[0090] Furthermore, in the medical device 1, the adhesive member injection device 100 may be configured to have an extrusion member 300 that is inserted from the first base end opening 11b of the first lumen 11 and discharged from the first tip opening 11a.

[0091] The medical device 1 configured in this way has a dedicated extrusion member 300 that can be inserted into the first base end opening 11b of the adhesive member injection device 100 and can extrude the adhesive member 200 from the first lumen 11. Therefore, when the surgeon uses the medical device 1, the effort required to extrude the adhesive member 200 is reduced by inserting the extrusion member 300 through the first base end opening 11b of the tube member 10 of the adhesive member injection device 100, which is exposed outside the body.

[0092] Furthermore, in the medical device 1, the extrusion member 300 may be configured to include a second marker portion 310 that indicates the amount of insertion of the extrusion member 300 into the first lumen 11.

[0093] With the medical device 1 configured in this way, the extrusion member 300 is equipped with a second marker portion 310 that indicates the amount of insertion of the extrusion member 300 into the first base end opening 11b, so the operator can easily grasp the amount of insertion of the extrusion member 300 into the first lumen 11 via the second marker portion 310.

[0094] [Other embodiments] Next, a modified adhesive member injection device 110 will be described. In the modified example, redundant explanations of content already described will be omitted. Furthermore, in the modified example, content not specifically described will have the same functions as the previously described embodiment and will produce the same effects.

[0095] <Example 1> Figure 8 shows a partial cross-sectional view of the adhesive member injection device 110 according to Modification 1. The adhesive member injection device 110 of Modification 1 differs from the adhesive member injection device 100 (see Figure 3) according to the above-described embodiment in the formation position of the first base end opening 11b relative to the tube member 10 and the structure of the first lumen 11.

[0096] The adhesive injection device 110 is configured such that the first lumen 11 extends substantially linearly along the long axis of the tube member 10, and the openings of the first tip opening 11a and the first base opening 11b are oriented toward the long axis. In other words, the adhesive injection device 110 does not have a curved region 11c that forms part of the first lumen 11 of the tube member 10. Similar to the adhesive injection device 100 described above, the first lumen 11 of the adhesive injection device 110 extends only to the first region A1, and the second lumen 12 extends across the first region A1 and the second region A2.

[0097] In the modified example 1, the adhesive injection device 110 has a first base end opening 11b that is aligned with the long axis of the tube member 10, making it easy to insert the extruder member 300 through the first base end opening 11b. Furthermore, when the adhesive injection device 110 is withdrawn towards the base end simultaneously with the introducer sheath 400, it can be withdrawn along the extruder member 300, allowing the adhesive member 200 to be smoothly discharged without the extruder member 300 getting stuck in the first lumen 11.

[0098] This application is based on Japanese Patent Application No. 2021-054840, filed on 29 March 2021, the disclosures of which are cited in their entirety by reference. [Explanation of Symbols]

[0099] 1. Medical devices, 10 Tube members, 11 First lumen (11a first tip aperture, 11b first base aperture, 11c curved region), 12 Second lumen (12a second tip opening, 12b second base opening, 12c inclined section), 13. First Marker Section 20 Hub section, 21 base, 22 First engagement portion, 30 stopcocks, 31 Operating lever, 32 Port 1, 33 Port 2, 100, 110, Adhesive material injection device, 200 adhesive members, 300 extruded members, 310 Second marker section, 400 Introducer Sheath, 410 Sheath body, 411 See-through mesh, 420 Sheath hub section, 421 Second engagement part, A1 1st area, A2 2nd area, B blood, Bv blood vessels, Bw blood vessel wall, F Finger, P1 Perforation of blood vessels, P2 Perforation, which is the site of puncture of the subcutaneous tissue. S Subcutaneous tissue.

Claims

1. A tube member having multiple lumens, The tube member comprises an adhesive member held in the lumen, The tube member comprises a first lumen extending between a first tip opening and a first base opening, and a second lumen extending between a second tip opening and a second base opening at a position different from that of the first lumen. The first tip opening is located on the tip side of the second tip opening in the longitudinal direction of the tube member, The adhesive member is held in the first lumen between the first tip opening and the first base opening. The tube member comprises a first region and a second region located closer to the proximal end than the first region. The first lumen extends only within the first region, The second lumen is longer than the first lumen and extends across the first and second regions. The first base end opening is located between the second tip end opening and the second base end opening in the adhesive member injection device.

2. The adhesive member injection device according to claim 1, wherein the cross-sectional area of ​​the second lumen is smaller than the cross-sectional area of ​​the first lumen in the first region.

3. The first base end opening is provided on the side wall of the tube member, The adhesive member injection device according to claim 1 or 2, wherein the tube member comprises a curved region that forms part of the first lumen.

4. The adhesive member injection device according to any one of claims 1 to 3, wherein the second tip opening has an inclined portion that slopes so as it approaches the tip side of the tube member, it approaches the first lumen side.

5. The adhesive member injection device according to any one of claims 1 to 4, wherein the tube member is provided with a first marker portion between the first tip opening and the first base opening, indicating the distance to the first tip opening.

6. The adhesive member injection device according to any one of claims 1 to 5, wherein the tube member has a hub portion between the first base end opening and the second base end opening that can be connected to a sheath hub portion formed in the introduction sheath.

7. An adhesive member injection device according to any one of claims 1 to 6, comprising an extrusion member for inserting into the first base end opening of the first lumen and for discharging the adhesive member from the first tip opening.

8. The adhesive member injection device according to claim 7, wherein the extruded member comprises a second marker portion indicating the amount of insertion of the extruded member into the first lumen.

9. The adhesive member injection device according to claim 6, It has an introduction sheath having a lumen into which the adhesive member injection device can be inserted, The introduction sheath comprises a sheath hub portion that can be connected to the hub portion, The adhesive member injection device is a medical device configured such that, with the hub portion connected to the sheath hub portion, the first base end opening of the adhesive member injection device is located on the tip side of the introduction sheath.

10. The medical device according to claim 9, wherein the adhesive member injection device has an extrusion member inserted from the first base end opening of the first lumen and for discharging the adhesive member from the first tip opening.

11. The medical device according to claim 10, wherein the extruded member is provided with a second marker portion indicating the amount of insertion of the extruded member into the first lumen.

Images