JP2012135574A - Introducer assembly - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an introducer assembly formed by previously integrating an introducer sheath with a dilator together, maintaining the blood stop performance of a blood stop valve over a long period of time and causing no hindrance to the original function of a dilator tube.SOLUTION: The introducer assembly is configured to insert the dilator tube 450 through an insertion part 441 of a blood stop valve 440, and to previously integrate the introducer sheath 411 with the dilator 413 together. A deformation member 490 arranged between a sheath hub 430 and the blood stop valve is moved in a direction to cross with the axial direction of the sheath hub, so as to press the blood stop valve. Thus, compression force in a direction to clog the insertion part is imparted to the blood stop valve.

Description

  The present invention relates to an introducer assembly.

  2. Description of the Related Art In recent years, various forms of treatments and examinations have been performed in medicine using an elongated hollow tubular medical device called a catheter. Such treatment methods include the method of administering a drug directly to the affected area using the length of the catheter, and the use of a catheter attached to the tip of a balloon that expands by pressurization to push the stenotic part in the body cavity. There are a method of opening, a method of scraping and opening the affected part using a catheter with a cutter attached to the tip, and a method of closing the aneurysm, bleeding site or feeding blood vessel using a catheter. In addition, there is a treatment method in which a tube-shaped stent having a meshed side surface is implanted into a body cavity using a catheter in order to maintain the stenosis in the body cavity in an open state. Furthermore, there is an aspiration of a liquid that is excessive for the body.

  When performing treatment / inspection using a catheter, the introducer sheath is generally introduced into the puncture site formed on the arm or leg using a catheter introducer, and the lumen of the introducer sheath is removed. A catheter or the like is percutaneously inserted into a lesion such as a blood vessel.

  Patent Document 1 discloses an introducer assembly in which an introducer sheath and a dilator are integrated in advance so as to reduce the complexity of assembling them at the site where treatment and inspection are performed. . When the introducer sheath and the dilator are integrated in advance, the state in which the dilator tube is inserted through the hemostasis valve provided in the introducer sheath is continued until it is used. In this case, the compressive force accompanying the insertion of the dilator tube acts on the hemostasis valve for a long time. For this reason, the so-called “sagging” occurs in the hemostasis valve due to secular change, and when the dilator tube is pulled out, the hemostasis valve may not exhibit sufficient hemostasis performance. Therefore, in the introducer assembly of Patent Document 1, the outer diameter of the portion that remains in contact with the hemostasis valve in the longitudinal direction of the dilator tube is formed to be smaller than the outer diameter of other portions. It is. As a result, the compressive force acting on the hemostasis valve over a long period of time is reduced, and the decrease in hemostasis performance when the dilator tube is extracted is suppressed.

Japanese Patent Laid-Open No. 08-168532

  However, when the diameter of a part of the dilator tube in the longitudinal direction is reduced, the stress acting on the dilator tube is concentrated on the portion where the diameter changes, and the dilator tube is easily broken. For this reason, the function as a core material of a sheath tube which is the original function of a dilator tube cannot be fully exhibited.

  The present invention has been made to solve the problems associated with the above-described prior art, and is an introducer assembly in which an introducer sheath and a dilator are integrated in advance, and maintains the hemostatic performance of the hemostasis valve over a long period of time. Furthermore, an object of the present invention is to provide an introducer assembly that does not hinder the original function of the dilator tube.

In order to achieve the above object, an introducer assembly of the present invention comprises a sheath tube, a sheath hub attached to the proximal end side of the sheath tube, and an insertion portion attached to the proximal end side of the sheath hub for inserting a catheter. An introducer sheath with a provided hemostasis valve;
A dilator comprising a dilator tube, and a dilator hub attached to the proximal end side of the dilator tube;
The hemostatic valve is disposed between the sheath hub and the hemostasis valve, moves in a direction crossing the axial direction of the sheath hub and presses the hemostasis valve, thereby applying a compressive force in a direction in which the insertion portion is closed. A deformable member applied to the valve;
A locking member that locks the deformable member with respect to the sheath hub and holds the state where the hemostatic valve is pressed. Then, the introducer sheath and the dilator are integrated in advance in a state before the dilator tube is inserted into the through hole of the cap and the insertion portion of the hemostasis valve, and the compressive force is applied. It is.

  When the deformable member arranged between the sheath hub and the hemostasis valve moves in a direction crossing the axial direction of the sheath hub and presses the hemostasis valve, a compressive force is applied to the hemostasis valve in a direction in which the insertion portion is closed. Therefore, even if the hemostatic valve is opened before use and the dilator tube is inserted, the burden on the hemostatic valve is small, and the hemostatic valve exhibits sufficient hemostatic performance even after the dilator tube is removed during use. To do. In addition, since it is not necessary to reduce the diameter of a portion of the dilator tube in the longitudinal direction, the function as the core material of the sheath tube, which is the original function of the dilator tube, is sufficiently exhibited. Therefore, according to the present invention, an introducer assembly in which an introducer sheath and a dilator are integrated in advance can maintain the hemostatic performance of the hemostasis valve over a long period of time. It is possible to provide an introducer assembly that does not impair the function.

FIG. 1A is a view showing an introducer assembly according to an embodiment of the present invention, and is a plan view showing a state of being packaged in a packaging film. FIG. 1B is a view showing FIG. It is an expanded sectional view of the part shown by broken line part 1B. It is a top view which decomposes | disassembles and shows the introducer sheath of a introducer assembly, and a dilator. FIG. 3A is a plan view showing the hemostasis valve in a state before the compression force is applied together with the sheath hub, and FIG. 3B is a perspective view showing the hemostasis valve in a state before the compression force is applied. is there. FIG. 4A is a plan view showing the hemostasis valve in a state where a compressive force is applied together with the sheath hub, and FIG. 4B is a perspective view showing the hemostasis valve in a state where the compressive force is applied. It is a schematic sectional drawing used for description of an effect | action of an introducer assembly, Comprising: It is a schematic sectional drawing which shows the state before an introducer sheath and a dilator are integrated. It is a schematic sectional drawing with which explanation of an operation of an introducer assembly is provided, and is a schematic sectional view showing the state where a dilator was temporarily fixed to an introducer sheath. It is a schematic sectional drawing which shows the state which pushed the dilator hub toward the sheath hub from the state shown by FIG. It is a schematic sectional drawing which shows the introducer sheath after extracting the dilator from the state shown by FIG. 9A is an enlarged view of a portion indicated by a broken line portion 9A in FIG. 6, and FIG. 9B is an enlarged view of a portion indicated by a broken line portion 9B in FIG. It is a schematic sectional drawing with which it uses for description of the modification of a holding member and a connection member.

  Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings. In the description of the drawings, the same elements are denoted by the same reference numerals, and redundant description is omitted. In addition, the dimensional ratios in the drawings are exaggerated for convenience of explanation, and may be different from the actual ratios.

  The introducer assembly 410 is a device for securing an access route into the body cavity. In the following description, the hand operation unit side of the device is referred to as “proximal end side”, and the side inserted into the body cavity is referred to as “distal end side”.

  Referring to FIGS. 1, 2, and 7, the introducer assembly 410 is outlined. The introducer assembly 410 includes an introducer sheath 411 and a dilator 413. In the introducer assembly 410 of the present embodiment, the introducer sheath 411 and the dilator 413 are integrated in advance and packaged in a packaging film (corresponding to a packaging member) 120. The introducer sheath 411 includes a hemostasis valve 440 provided with a sheath tube 420, a sheath hub 430 attached to the proximal end side of the sheath tube 420, and an insertion portion 441 for attaching the catheter attached to the proximal end side of the sheath hub 430. I have. The dilator 413 includes a dilator tube 450 and a dilator hub 460 attached to the base end side of the dilator tube 450.

  The introducer assembly 410 further includes a deformable member 490 and a locking member 480 (see also FIGS. 3 and 4). The deformable member 490 is disposed between the sheath hub 430 and the hemostasis valve 440, moves in a direction intersecting with the axial direction of the sheath hub 430 (indicated by an arrow in FIGS. 4 and 7), and presses the hemostasis valve 440. The compression force in the direction in which the insertion portion 441 is closed is applied to the hemostasis valve 440. The insertion portion 441 is a portion that can pass through the dilator tube 450 and the like and can be opened and closed. The locking member 480 holds the deformed member 490 with respect to the sheath hub 430 and presses the hemostasis valve 440.

  And the introducer assembly 410 inserted the dilator tube 450 in the insertion part 441 of the hemostatic valve 440, and integrated the introducer sheath 411 and the dilator 413 in the state before giving compressive force. It is hermetically sealed (see also FIG. 6). Hereinafter, the introducer assembly 410 will be described in detail.

  The introducer sheath 411 is placed in a body cavity, and a catheter, a guide wire, an embolus, etc. are inserted through the introducer sheath 411 and introduced into the body cavity.

  The sheath tube 420 is introduced percutaneously into the body cavity.

  Examples of the constituent material of the sheath tube 420 include polyolefin (for example, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more thereof), polyolefin elastomer, Polyolefin cross-linked products, polyvinyl chloride, polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane, polyurethane elastomer, fluororesin, polycarbonate, polystyrene, polyacetal, polyimide, polyetherimide, and other polymer materials or mixtures thereof are used. be able to.

  In the sheath hub 430, the side port 14 communicating with the inside of the sheath tube 420 is formed. One end of a flexible tube 15 made of polyvinyl chloride, for example, is liquid-tightly connected to the side port 14. For example, a three-way cock 16 is attached to the other end of the tube 15. A priming process is performed by injecting a liquid such as physiological saline from the port of the three-way cock 16 into the introducer sheath 411 through the tube 15.

  Referring to FIG. 5, the sheath hub 430 includes a sheath hub main body 431, a center hole 432 formed in the sheath hub main body 431, a storage portion 433 that is provided on the proximal end side of the center hole 432 and stores the hemostasis valve 440. have. The storage portion 433 has a support surface 436 against which the outer peripheral edge 449 of the back surface 448 of the hemostasis valve 440 is brought into contact.

  A clamping member 438 that clamps the hemostasis valve 440 with the support surface 436 of the sheath hub 430 is attached to the sheath hub 430. The sandwiching member 438 has a frame-like outer shape in which a central hole is formed, and is disposed in contact with the outer peripheral edge 447 of the surface 446 of the hemostasis valve 440. The clamping member 438 is fixed to the sheath hub 430 in a state where the hemostasis valve 440 is sandwiched between the clamping surface 436 and the support surface 436. For example, welding can be employed as the fixing method.

  A first protrusion 511 is provided on the outer wall surface of the clamping member 438. On the outer wall surface of the sheath hub main body 431, a second protrusion 512 is provided at a position located on the distal end side of the first protrusion 511 of the clamping member 438. The first protrusion 511 and the second protrusion 512 are used in combination with the first recess 516 and the second recess 517 provided on the inner wall surface of the dilator hub 460, and the introducer sheath 411, the dilator 413, and the like. It functions as a connection member 530 for connecting (see FIGS. 7 and 9B).

  The constituent material of the sheath hub 430 and the sandwiching member 438 is not particularly limited, but a hard material such as a hard resin is suitable. Specific examples of the hard resin include polyolefin such as polyethylene and polypropylene, polyamide, polycarbonate, polystyrene, and the like.

  Referring to FIGS. 3 and 4, hemostasis valve 440 is formed of an elastic member having a rectangular plate shape, and is liquid-tightly fixed to sheath hub 430. Of both faces of the hemostatic valve 440, the end face on the side facing the sheath tube 420 is referred to as “back face” 448, and the end face on the opposite side is referred to as “front face” 446. The surface 446 of the hemostasis valve 440 is shown on the upper side in FIGS.

  A groove 442 is provided on the surface 446 of the hemostatic valve 440. The groove 442 extends in a direction orthogonal to the direction in which the deformable member 490 moves (short direction of the hemostasis valve 440), and has a concave cross section along the moving direction of the deformable member 490 (longitudinal direction of the hemostasis valve 440). ing. The hemostasis valve 440 further includes a small hole 445 that is opened before the dilator tube 450 is inserted through the insertion portion 441 and before the hemostasis valve 440 is pressed by the deformable member 490.

  When the dilator tube 450 is inserted, the insertion portion 441 of the hemostatic valve 440 is expanded by the dilator tube 450 and deformed (see FIG. 6). Since the insertion portion 441 includes the opened small hole 445, the amount of deformation when the dilator tube 450 is inserted is smaller than that of the insertion portion having a configuration that does not include the opened small hole. Further, since the groove 442 is also provided, the deformation amount when the dilator tube 450 is inserted is small from this point. Therefore, for example, when the state where the compressive force is applied is released after holding the state where the compressive force is applied to the hemostasis valve 440, the insertion portion 441 returns to the initial shape by the elastic restoring force.

  FIGS. 3B and 4B show a simplified view of the hemostatic valve 440 in a state before and after the shape is changed by pressing by the deformable member 490. When the hemostatic valve 440 is pressed from the outer peripheral side surface by the deformable member 490, the hemostatic valve 440 is bent starting from the concave groove 442, and is deformed into a convex shape so that the entire shape of the hemostatic valve 440 is directed toward the back surface 448 side. Thereby, at least on the surface 446 side, the small hole 445 that has been opened is closed, and the insertion portion 441 is closed. The groove 442 functions as a guide surface for guiding the distal end of the dilator tube 450 and the like when the dilator tube 450 and the catheter are inserted, while serving as a starting point of bending and easily closing the hemostasis valve 440. And reduce the resistance when inserting.

  The constituent material of the hemostatic valve 440 is not particularly limited, and examples thereof include silicone rubber, latex rubber, butyl rubber, and isoprene rubber which are elastic members.

  For example, the hemostatic valve 440 processed in a circular or elliptical shape can be used, but when a rectangular processed material is used, the sheet material that is the material of the hemostatic valve is rectangular. Since each cut piece can be cut out and used as the hemostasis valve 440, the sheet material can be used without waste as compared with the case where a circular or oval hemostasis valve is used, and the yield can be improved.

  The deformable member 490 includes a first pressing member 491 and a second pressing member 492 that are disposed in pairs with the hemostasis valve 440 interposed therebetween. Each of the first pressing member 491 and the second pressing member 492 includes a pressing piece 493 disposed in the sheath hub 430, and a pressing unit provided integrally with the pressing piece 493 and having an end disposed outside the sheath hub 430. Member 494.

  The locking member 480 includes a locking groove 481 provided in the sheath hub 430 and a locking protrusion 482 provided in the deformable member 490 and detachable from the locking groove 481. The locking protrusion 482 is formed integrally with the pushing member 494 of the deformation member 490.

  When the first pressing member 491 and the second pressing member 492 move closer to each other, the outer peripheral side surface of the hemostasis valve 440 is pressed, and a compressive force in a direction in which the insertion portion 441 is closed is applied to the hemostasis valve 440. The As the first pressing member 491 and the second pressing member 492 move closer to each other, the locking projection 482 is fitted into the locking groove 482, and the first pressing member 491 and the second pressing member 492 are respectively attached to the sheath hub 430. It is locked against.

  The constituent materials of the first pressing member 491 and the second pressing member 492 are not particularly limited, but a hard material such as a hard resin is suitable. Specific examples of the hard resin include polyolefin such as polyethylene and polypropylene, polyamide, polycarbonate, polystyrene, and the like.

  The locking protrusion 482 may be formed integrally with the first pressing member 491 and the second pressing member 492 by resin molding, for example, or may be formed by retrofitting a bead or ring that functions as the locking protrusion. Is possible. In the embodiment, from the viewpoint of simplifying the manufacturing work, a method of integrally forming the pressing members 491 and 492 by molding is adopted.

  The dilator 413 is used to prevent the sheath tube 420 from being broken or to enlarge the skin perforation when the introducer sheath 411 is inserted into the blood vessel.

  The dilator tube 450 is inserted into the sheath tube 420. As shown in FIG. 1, the tip portion 451 of the dilator tube 450 is exposed from the tip of the sheath tube 420. Note that the distal end portion 451 of the dilator tube 450 may not be exposed from the distal end of the sheath tube 420 until a compression force is applied to the hemostatic valve 440.

  The dilator tube 450 has a hole 452 for allowing the fluid supplied to the introducer sheath 411 to flow into the dilator tube 450 in a state where the introducer sheath 411 and the dilator 413 are integrated. (See FIG. 1B). In the state where the introducer sheath 411 and the dilator 413 are integrated, there is a slight clearance (gap) between the sheath hub 430 and the dilator tube 450 and between the sheath tube 420 and the dilator tube 450. Is formed. For this reason, the physiological saline for the priming process and the EOG for the sterilization process supplied to the introducer sheath 411 pass through the sheath hub 430, pass through the hole 452 formed in the dilator tube 450, and the dilator tube 450. Flows in. Therefore, even if the introducer sheath 411 and the dilator 413 are integrated in advance, the priming process and the sterilization process in the dilator tube 450 can be performed without hindrance.

  The number of holes 452 for allowing fluid to flow into the dilator tube 450 is not particularly limited, but at least two holes 452 may be provided to facilitate smooth circulation of the fluid. desirable. Moreover, there is no restriction | limiting in particular also about a dimension or a shape.

  Examples of the constituent material of the dilator tube 450 include polyolefin (for example, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more thereof), polyolefin elastomer, and the like. , Polyolefin cross-linked products, polyvinyl chloride, polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane, polyurethane elastomer, fluororesin, polycarbonate, polystyrene, polyacetal, polyimide, polyetherimide and other polymer materials or mixtures thereof Can be used.

  Referring to FIG. 6, the dilator hub 460 includes a dilator hub main body 461, a center hole 462 formed in the dilator hub main body 461, and a first recess provided in the inner wall surface of the dilator hub main body 461. 516 and a second recess 517 provided on the tip side of the first recess 516.

  The constituent material of the dilator hub 460 is not particularly limited, but a hard material such as a hard resin is suitable. Specific examples of the hard resin include polyolefin such as polyethylene and polypropylene, polyamide, polycarbonate, polystyrene, and the like.

  The introducer assembly 410 allows the introducer sheath 411 and the dilator 413 to be integrated in a state before compression force is applied by temporarily fixing the dilator hub 460 to the sheath hub 430. The holding member 510 is provided. The holding member 510 does not cause compression deformation of the hemostasis valve 440 until the introducer assembly 410 is used, and can be distributed as a product in an integrated state. The holding member 510 includes a first protrusion 511 provided on the holding member 438 attached to the sheath hub 430 and a second recess 517 provided on the dilator hub 460 (see FIG. 9A). . By fitting the first protrusion 511 into the second recess 517, the sheath hub 430 and the dilator hub 460 are connected and temporarily fixed.

  The introducer assembly 410 has a connection member 530 that removably connects the dilator hub 460 to the sheath hub 430 as the dilator hub 460 moves relative to the sheath hub 430 (FIGS. 7 and 9B). )). The connection member 530 of the present embodiment includes first and second protrusions 511 and 512 provided on the sheath hub 430 and first and second recesses 516 and 517 provided on the dilator hub 460. The first protrusion 511 and the second protrusion 512 are formed in substantially the same shape, and the first recess 516 and the second recess 517 are also formed in substantially the same shape. Therefore, from the state where the introducer sheath 411 and the dilator 413 are temporarily fixed by the first protrusion 511 and the second recess 517, the dilator hub 460 is further moved to the distal end side, and the first protrusion 511 is moved to the first position. The dilator hub 460 can be connected to the sheath hub 430 by fitting into the recess 516 and further fitting the second protrusion 512 into the second recess 517. Further, when the dilator hub 460 is moved with respect to the sheath hub 430, the pushing member 494 disposed outside the sheath hub 430 is pushed toward the inside of the sheath hub 430. Therefore, the first pressing member 491 and the second pressing member 491 are pushed. The members 492 move closer to each other, and a compressive force is applied to the hemostatic valve 440. At this time, the first pressing member 491 and the second pressing member 492 are locked to the sheath hub 430 by the locking member 480.

  The shape of the first and second protrusions 511 and 512 and the shape of the first and second recesses 516 and 517 are not particularly limited as long as the sheath hub 430 and the dilator hub 460 can be connected and the connection state can be maintained. However, it is preferably provided in a form in which connection and separation operations can be smoothly performed, for example, with the relative movement of the dilator hub 460 with respect to the sheath hub 430. For this reason, in the embodiment, the connection member 530 is configured by the recess and the rib-shaped protrusion that can be easily fitted into and removed from the recess.

  A guide surface 513 that is inclined at substantially the same inclination angle as the inclined surface formed on the first and second protrusions 511 and 512 and the inclined surface formed on the pushing member 494 is provided at the tip of the dilator hub 460. (See FIG. 9). When the dilator hub 460 is connected, the dilator hub 460 can be slid relative to the sheath hub 430 to perform the connection work, and the push-in member 494 can be smoothly moved into the sheath hub 430 as the slide moves. This is because it can be pushed in.

  Next, the operation of the introducer assembly 410 will be described.

  Referring to FIG. 5, prior to applying compressive force in the direction in which insertion portion 441 is closed to hemostatic valve 440, dilator hub 460 is temporarily fixed to sheath hub 430. The dilator 413 is moved closer to the introducer sheath 411 and the dilator tube 450 is inserted through the insertion portion 441 of the hemostasis valve 440. At this time, since the groove 442 of the hemostasis valve 440 guides the insertion of the dilator tube 450, the operation can be performed smoothly.

  Referring to FIG. 6, dilator hub 450 is temporarily fixed to sheath hub 430 by holding member 510 (first protrusion 511 and second recess 517). It becomes possible to distribute the introducer sheath 411 and the dilator 413 as a product in a state in which the introducer sheath 411 and the dilator 413 are integrated in advance.

  In the temporarily fixed state, the first pressing member 491 and the second pressing member 492 as the deforming member 490 do not press the hemostasis valve 440, and the insertion portion 441 is in the closed state in the hemostasis valve 440. The compressive force in the direction is not applied.

  Referring to FIG. 7, when the dilator 413 is moved downward from the state shown in FIG. 6, the connection member 530 (first and second protrusions 511 and 512, and first and second) The sheath hub 430 and the dilator hub 460 are connected by the recesses 516 and 517).

  As the dilator hub 460 moves, the pushing member 494 disposed outside the sheath hub 430 is pushed toward the inside of the sheath hub 430. As a result, the first pressing member 491 and the second pressing member 492 move closer to each other in the direction intersecting the axial direction of the sheath hub 430, and press the hemostatic valve 440 in the direction toward the central axis of the sheath hub 440. A compressive force in a direction in which the insertion portion 441 is closed is applied to the hemostasis valve 440.

  The locking member 480 locks the first pressing member 491 and the second pressing member 492 with respect to the sheath hub 430 and maintains the state where the hemostatic valve 440 is pressed.

  Referring to FIG. 8, dilator tube 450 is extracted from insertion portion 441 of hemostasis valve 440. Even after the dilator tube 450 is extracted, the locking member 480 maintains a state in which a compressive force in a direction in which the insertion portion 441 is closed is applied to the hemostatic valve 440. The insertion portion 441 is closed, and the hemostasis valve 440 prevents leakage of liquid such as blood from the proximal end of the dilator hub 460.

  Since the hemostasis valve 440 is easily deformed by the groove 442, the small hole 445 provided in the hemostasis valve 440 can be more reliably closed.

  Since the outer peripheral edge portion 447 of the surface 446 of the hemostatic valve 440 and the outer peripheral edge portion 449 of the back surface 448 are sandwiched between the holding member 438 and the support surface 436 of the sheath hub 460, the hemostasis valve 440 faces the back surface 448 side. Thus, the deformed state is maintained. It is possible to prevent the hemostasis valve 440 from being deformed in a convex shape toward the surface 446 side or the hemostasis valve 440 from being displaced.

  The catheter insertion operation using the introducer sheath 411 will be briefly described below.

  First, a perforation is made at a predetermined position on the skin using an introduction needle or the like, and a guide wire is inserted into the blood vessel through the perforation, for example. Then, the guide wire is inserted into the lumen from the tip of the introducer sheath 411, and the introducer sheath 411 is inserted into the blood vessel along the guide wire. At the time of this insertion, the tip portion 451 of the dilator tube 450 expands the skin perforation. Thereby, the distal end side of the introducer sheath 411 can be inserted into the blood vessel. After the introducer sheath 411 is inserted into the blood vessel, the guide wire and the dilator 413 are removed to leave only the introducer sheath 411. Thereby, the introducer sheath 411 functions as a passage connecting the outside of the body and the inside of the blood vessel, and an instrument such as a catheter can be inserted into the blood vessel through this sheath.

  As described above, according to the present embodiment, the deformable member 490 disposed between the sheath hub 430 and the hemostasis valve 440 moves in a direction crossing the axial direction of the sheath hub 430 to press the hemostasis valve 440. Thus, the compression force in the direction in which the insertion portion 441 is closed is applied to the hemostasis valve 440. Therefore, even before the hemostasis valve 440 is opened and the dilator tube 450 is inserted before use, the load on the hemostasis valve 440 is reduced. The hemostasis valve 440 exhibits sufficient hemostasis performance even after the dilator tube 450 is pulled out during use. In addition, since it is not necessary to reduce the diameter of a part of the dilator tube 450 in the longitudinal direction, the function as the core material of the sheath tube 420 which is the original function of the dilator tube 450 is sufficiently exhibited. Therefore, the introducer assembly 410 in which the introducer sheath 411 and the dilator 413 are integrated in advance can maintain the hemostatic performance of the hemostatic valve 440 over a long period of time, and further, the original function of the dilator tube 450 It is possible to provide an introducer assembly 410 that does not interfere with the above.

  Since the introducer sheath 411 and the dilator 413 are already integrated in advance at the time of shipment of the introducer assembly 410, it is possible to save time and labor for combining at the site of the procedure such as treatment.

  Since there is no work to combine at the procedure site, it is possible to fundamentally eliminate the possibility that the tip of the dilator 413 is broken or the hemostatic valve 440 is damaged when the dilator 413 is inserted. Since there is no bending of the tip or leakage from the hemostasis valve 440, the minimally invasiveness to the patient can be improved.

  An introducer assembly 410 in which an introducer sheath 411 and a dilator 413 are integrated in advance is packaged in the packaging film 120 (see FIG. 1). Compared to the case where the introducer sheath 411 and the dilator 413 are separately packaged in one packaging film, the tray for setting the introducer assembly 410 becomes smaller. By reducing the tray, it is possible to save space and resources, and to minimize energy loss for manufacturing factories, hospitals, and the earth. Moreover, since the integrated introducer assembly 410 is hermetically packaged by the packaging film 120, it is possible to suitably prevent contamination of the introducer assembly 410 during the distribution process before use.

  Further, the first and second pressing members 491 and 492 arranged in pairs with the hemostatic valve 440 interposed therebetween are moved closer to each other to press the outer peripheral side surface of the hemostatic valve 440, thereby stopping the hemostasis valve. Since the 440 is deformed toward the central axis of the sheath hub 440, the insertion portion 441 provided in the hemostasis valve 440 can be suitably closed.

  In addition, since the groove 442 provided on the surface 446 of the hemostasis valve 440 becomes a starting point of bending, the hemostasis valve 440 is easily deformed, so that the insertion portion 441 provided on the hemostasis valve 440 is more reliably blocked. be able to.

  Further, since the outer peripheral edge portion 447 of the surface 446 of the hemostatic valve 440 and the outer peripheral edge portion 449 of the back surface 448 are sandwiched between the holding member 438 and the sheath hub 430, the hemostatic valve 440 protrudes toward the surface 446 side. Can be prevented from being deformed into a shape or being displaced in the hemostasis valve 440. In the procedure using the dilator 413, it is possible to prevent an influence on the operation feeling at hand due to deformation or displacement of the hemostatic valve 440.

  Further, by a simple operation of moving the dilator hub 460 relative to the sheath hub 430, the connection work between the dilator hub 460 and the sheath hub 430 and the compression force applied to the hemostasis valve 440 can be performed. By improving the handleability of the introducer assembly 410, user convenience can be improved.

  In addition, since the physiological saline and EOG supplied to the introducer sheath 411 can be circulated in the dilator tube 450 through the hole 452 formed in the dilator tube 450, the introducer sheath 411 and the dilator. Even if 413 is integrated in advance, the priming process and the sterilization process in the dilator tube 450 can be performed without hindrance.

(Modification example of holding member and connecting member)
FIG. 10 is a schematic cross-sectional view for explaining a modified example of the holding member and the connecting member. In addition, the same code | symbol is attached | subjected to the member which is common in the member shown by FIGS. 1-9, and the description is abbreviate | omitted in part.

  In the previous embodiment, the first and second protrusions 511 are used as the holding member 510 for temporarily fixing the sheath hub 430 and the dilator hub 460, and the connecting member 530 that detachably connects the two members 430 and 460. 512 and a fitting type mechanism constituted by first and second recesses 516 and 517 are shown. However, in the present invention, the mechanism for temporarily fixing the sheath hub 430 and the dilator hub 460 and the mechanism for connecting both the members 430 and 460 are not limited to the fitting type, and FIG. It may be a screw-in type, such as the introducer assembly 560 shown.

  That is, in the modified example, the holding member 520 and the connection member 540 are provided with the first screw portion 541 provided on the inner wall surface on the distal end side of the dilator hub 460 and the first screw provided on the outer wall surface of the sheath hub 430. And a second screw portion 542 that meshes with the portion 541. In the state where the first screw portion 541 and the second screw portion 542 are firmly and firmly engaged with each other, the connection member 540 is separated from the screw portion in the region where the first and second screw portions 541 and 542 are engaged with each other. It is configured. Although not shown, the holding member 520 includes a lower end portion of the first screw portion 541 in the drawing and a second screw portion in a state where the first screw portion 541 and the second screw portion 542 are gently engaged with each other. It is comprised from the upper front-end | tip part in the figure among 542.

  The dilator hub 460 can be screwed into the sheath hub 430 by turning the dilator hub 460 in the direction of arrow A in FIG. 10 with the first screw portion 541 and the second screw portion 542 engaged with each other. In addition, the dilator hub 460 can be removed from the sheath hub 430 by turning the dilator hub 460 in the direction of arrow B in the reverse direction.

  Even when the screw-type mechanism shown in the modification is employed, the operation of connecting the dilator hub 460 and the sheath hub 430 and the hemostasis valve can be performed by screwing the dilator hub 460 into the sheath hub 430 and moving it. It is possible to apply a compressive force to 440.

(Other variations)
The application of the compressive force to the hemostasis valve 440 is not limited to the form performed in connection with the connection between the dilator hub 460 and the sheath hub 430 by the connection members 520 and 540. For example, when a person who performs a procedure uses the introducer assembly, it is possible to press the hemostasis valve by directly pushing the pushing member by hand and apply a compressive force.

  The pressing of the hemostasis valve 440 is not limited to the form performed by the movement of two members such as the first pressing member 491 and the second pressing member 492, but moves in a direction crossing the axial direction of the sheath hub. As long as a compressive force can be applied to the hemostatic valve 440, it can be appropriately changed. Therefore, it is possible to adopt a form in which pressing is performed using one deformable member, or a form in which pressing is performed using a plurality of pairs of pressing members arranged in pairs.

  Further, in the embodiment, the rectangular hemostatic valve 440 is shown, but the external shape of the hemostatic valve is not particularly limited, and for example, a circular or oval shape can be used. It is. It is also possible to improve the easiness of holding the dilator hub by forming the outer shape of the dilator hub into a rounded round shape in accordance with the outer shape of the hemostasis valve.

120 packaging film (packaging member),
410 Introducer assembly,
411 introducer sheath,
413 Dilator,
420 sheath tube,
430 sheath hub,
438 clamping member,
440 hemostatic valve,
441 insertion part,
442 groove,
445 small hole,
446 surface,
447 outer peripheral edge of the surface,
448 reverse side,
449 outer peripheral edge of the back surface,
450 Dilator tube,
452 holes,
460 Dilator Hub,
480 locking member,
490 deformation member,
491 a first pressing member,
492 second pressing member,
510 holding member,
530 connecting member.

Claims (7)

An introducer sheath comprising a sheath tube, a sheath hub attached to the proximal end side of the sheath tube, and a hemostasis valve attached to the proximal end side of the sheath hub and provided with an insertion portion for inserting a catheter;
A dilator comprising a dilator tube, and a dilator hub attached to the proximal end side of the dilator tube;
The hemostatic valve is disposed between the sheath hub and the hemostasis valve, moves in a direction crossing the axial direction of the sheath hub and presses the hemostasis valve, thereby applying a compressive force in a direction in which the insertion portion is closed. A deformable member applied to the valve;
A locking member that locks the deformable member with respect to the sheath hub and holds the state where the hemostasis valve is pressed, and
An introducer assembly in which the introducer sheath and the dilator are integrated in advance in a state before the dilator tube is inserted through the insertion portion of the hemostasis valve and the compression force is applied.   The deformable member includes first and second pressing members disposed in pairs with the hemostasis valve interposed therebetween, and the hemostasis valve is moved by moving the first and second pressing members closer to each other. The introducer assembly according to claim 1, wherein the introducer assembly is pressed.   A groove extending in a direction orthogonal to the moving direction of the deforming member and having a concave cross section along the moving direction of the deforming member is formed on the opposite surface of the both surfaces of the hemostasis valve to the side facing the sheath tube. An introducer assembly according to claim 1 or claim 2.   The introducer assembly according to claim 3, further comprising a clamping member that clamps outer peripheral portions of both front and back surfaces of the hemostasis valve with the sheath hub. A connecting member that detachably connects the dilator hub to the sheath hub as the dilator hub moves relative to the sheath hub;
The introducer assembly according to claim 1, wherein the deformable member presses the hemostasis valve in connection with the connection between the dilator hub and the sheath hub.   The said dilator tube has a hole for distribute | circulating the fluid supplied to the said introducer sheath in the said dilator tube in the state which integrated the said introducer sheath and the said dilator. The introducer assembly according to any one of the above.   The introducer assembly of any one of Claims 1-6 which has a packaging member which packages the said introducer assembly of the state which integrated the said introducer sheath and the said dilator previously.

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