Indwelling needle

The indwelling needle design with an elastic member and guide portion addresses stagnation issues by ensuring smooth fluid flow and stable assembly, reducing thrombus formation and improving procedural safety.

JP7715147B2Active Publication Date: 2025-07-30NIPRO CORP
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Patent Information

Application Number
JP2022512577
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Priority Date
2020-03-30
Filing Date
2021-03-30
Publication Date
2025-07-30
Estimated Expiration
2041-03-30

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Abstract

Provided is an indwelling needle that is less likely to cause blood stagnation in the vicinity of an elastic member. The present invention provides an indwelling needle comprising: an inner needle that punctures a living body; an outer needle that is inserted into the living body together with the inner needle as the inner needle penetrates the outer needle and punctures the living body; a main body that is disposed along the axis of the inner needle; and a branch part that branches from the main body. The indwelling needle is provided with: an outer needle hub that has a passage in communication with the interior of the outer needle; an elastic member that is disposed within the outer needle hub, is penetrated by the inner needle, and has a flexible solid part that blocks fluid flow to the proximal end side of the main body when the inner body is removed; and a holder that is attached to the proximal end of the elastic member. The elastic member forms at least part of the passage that allows communication between the interior of the outer needle and the branch part, and has an end surface inclined relative to the axial direction. The outer needle hub has a guide part that is engaged with the elastic member or the holder and guides the rotation direction of the elastic member around the axis to a certain direction.
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Description

Technical Field

[0001] The present invention relates to an indwelling needle provided with an outer needle that is punctured and indwelled in a living body.

Background Art

[0002] As a medical device used for infusion such as intravenous drip, an indwelling needle has been developed. The indwelling needle includes an inner needle that is punctured into a patient's blood vessel, and an outer needle that is penetrated by the inner needle and inserted into the patient's blood vessel together with the inner needle when the inner needle punctures the living body. Then, the outer needle is indwelled in the patient's blood vessel, and blood collection or intravenous drip is performed on the patient through the outer needle. As such an indwelling needle, as disclosed in Patent Document 1, an indwelling needle is disclosed in which a tube is provided on the side of the outer needle hub and a rubber stopper (also referred to as an elastic member) is provided at the proximal end of the outer needle hub.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] In the indwelling needle as described above, since there is a space between the rubber stopper and the tube inside the outer needle hub, stagnation may occur near the rubber stopper. Therefore, for example, when used in a procedure in which a liquid (blood) having a coagulation component such as hemodialysis is flowed over a long period of time, a thrombus may form near the rubber stopper.

[0005] Therefore, an object of the present invention is to provide an indwelling needle in which stagnation hardly occurs near the elastic member.

Means for Solving the Problems

[0006] In order to solve the above-described problems, the present invention employs the following configuration.

[0007] That is, the indwelling needle according to one aspect of the present invention is an inner needle to be punctured into a living body, an outer needle that is penetrated by the inner needle and inserted into the living body together with the inner needle when the inner needle is punctured into the living body, including a main body portion arranged along the axis of the inner needle and a branch portion branching from the main body portion, and an outer needle hub having a flow path communicating with the inside of the outer needle, an elastic member disposed inside the outer needle hub, having a flexible solid portion that penetrates the inner needle and seals the flow of fluid to the proximal end side of the main body portion when the inner needle is removed, and a holder attached to the proximal end of the elastic member, the elastic member forms at least a part of the flow path communicating the inside of the outer needle and the branch portion, and has an end face inclined with respect to the axial direction, the outer needle hub is characterized by having a guide portion that engages with the elastic member or the holder to guide the axial rotation direction of the elastic member in a certain direction.

[0008] In this way, the elastic member can be positioned in the axial rotation direction such that the inclined surface faces the branch portion side by the guide portion. By the inclined surface of the elastic member, the flow path from the tip of the outer needle hub to the branch portion can be made smoother than before. As a result, the fluidity of the liquid in the outer needle hub is improved, and the situation where stagnation occurs in the vicinity of the elastic member is reduced.

[0009] Further, in the present invention, the elastic member has a central portion formed with the inclined end face and an outer peripheral portion formed on the outer peripheral side of the central portion. The outer needle hub has a peripheral wall portion having a base end face facing the tip end face of the outer peripheral portion formed on the inner surface, and at least a part of the central portion is located inside the peripheral wall portion. In this way, a step is less likely to occur between the elastic member and the peripheral wall portion, and the formation of a space that causes stagnation can be suppressed.

[0010] The guided portion that engages with the guiding portion of the present invention may be the inclined surface of the tip end surface of the elastic member, or may be a concave portion or a convex portion formed on the outer surface of the elastic member. Further, the guided portion may be formed on the tip end surface of the holder, or may be a concave portion or a convex portion formed on the outer surface of the holder. That is, the guiding portion may be a peripheral wall portion, or may be a convex portion or a concave portion extending in the axial direction. Further, it may be a screw portion that defines the axial rotation direction in a fixed direction. Further, the guiding portion is not limited to the inner surface of the outer needle hub, and may be provided on the outer surface of the outer needle hub, or a guided portion extending on the outer surface of the outer needle hub may be formed on the holder. Further, inclined surfaces having different inclined surface directions from the inclined surface of the elastic member may be formed on the inner surface of the hub and the elastic member or the holder, and the axial rotation direction of the elastic member may be set as a predetermined direction by overlapping the surfaces with each other.

[0011] Further, in the present invention, the end surface of the central portion of the elastic member and the end surface of the peripheral wall portion are formed so as to have a major axis and a minor axis. By doing so, it becomes easy to position the central portion within the peripheral wall portion of the outer needle hub, and it becomes possible to easily define the elastic member in a predetermined axial rotation direction.

[0012] Further, in the present invention, the major axis of the central portion of the elastic member is along the axial direction of the branch portion. By doing so, it is possible to make it difficult for liquid to stay when moving from the branch portion to the outer needle or from the outer needle to the branch portion.

[0013] Further, in the present invention, the step between the central portion and the outer peripheral portion of the elastic member is inclined. By doing so, it is possible to easily position the central portion within the peripheral wall portion and improve the fixing force by increasing the contact area with the peripheral wall portion.

[0014] Further, in the present invention, the slit formed in the central portion of the elastic member is a single character along the major axis direction of the central portion of the elastic member.

[0015] In the present invention, the proximal end of the elastic member is inserted into the holder. By doing so, when the elastic member is assembled to the outer needle hub, the elastic member is less likely to escape, and stable assembly can be achieved. Note that a part of the proximal end surface of the elastic member is a plane perpendicular to the axial direction, and if a surface that engages with a part of the proximal end surface of the elastic member is provided on the distal end surface of the holder, deformation of the elastic member is less likely to occur when the elastic member is moved through the holder, which is preferable.

[0016] In the present invention, a part of the proximal end surface of the elastic member is an inclined surface that is inclined with respect to the axial direction, and the holder has an inclined surface that engages with the inclined surface. By doing so, relative rotation between the elastic member and the holder can be suppressed.

[0017] In the present invention, a concave portion or a convex portion may be provided on a part of the proximal end surface of the elastic member, and a convex portion or a concave portion may be provided on the distal end surface of the holder to suppress relative rotation between the elastic member and the holder. By doing so, relative rotation between the elastic member and the holder can be suppressed.

[0018] In the present invention, the guide portion is a proximal end surface formed on the peripheral wall portion and inclined with respect to the axial direction, and the outer peripheral portion has a distal end surface that engages with the proximal end surface of the peripheral wall portion.

[0019] By doing so, since the deformation of the elastic member in the proximal end direction is restricted by the holder, when the elastic member is pushed into the outer needle hub, a guiding action in the axial rotation direction occurs on the elastic member when the outer peripheral portion and the peripheral wall portion come into contact. Since the guiding action occurs until the outer peripheral portion and the peripheral wall portion engage, the elastic member is defined in a predetermined axial rotation direction.

[0020] In the present invention, the guide portion is an anti-rotation mechanism that prevents rotation of the elastic member about its axis.

[0021] In the present invention, the holder has a locking portion that restricts axial relative movement with respect to the outer needle hub. As means for restricting the axial relative movement of the holder with respect to the outer needle hub, not limited to the locking portion, the holder and the outer needle hub may be fixed with an adhesive or the like.

[0022] Also, in the present invention, the elastic member is compressed radially inward. By compressing in this way, liquid leakage from the slit is prevented. Note that the compression may be performed by the outer needle hub or by the holder.

[0023] Also, in the present invention, the central portion is compressed inward by the peripheral wall portion.

[0024] Also, in the present invention, the holder has an annular stepped portion adjacent to the central portion of the elastic member. In this way, it is possible to make it difficult for the central portion of the elastic member that directly receives pressure from the liquid to deform toward the proximal end side, and it is possible to make it difficult to generate a retention space on the distal end side of the elastic member.

[0025] Also, in the present invention, the elastic member has a cylindrical portion extending from the outer peripheral portion toward the proximal end, and the holder has a small-diameter portion inserted into the cylindrical portion and a large-diameter portion that abuts against the proximal end of the cylindrical portion. If this is the case, the elastic member can be stably assembled to the holder. In addition, the wall thickness of the holder can be reduced, and the necessary external force when pulling out the inner needle can be reduced.

[0026] Also, in the present invention, the peripheral wall portion and the distal end portion of the holder face each other to axially compress the elastic member.

[0027] Also, in the present invention, the holder has a mounted portion on which the elastic member is mounted, the elastic member is a cylindrical portion supported on the inner diameter side by the mounted portion on the proximal end side of the solid portion, and in a state before being assembled to the outer needle hub, the cylindrical portion has a radial thickness larger than the interval between the mounted portion and the surface of the outer needle hub facing the mounted portion in the radial direction.

[0028] In this way, since the gap between the elastic member and the surface of the outer needle hub on which the elastic member is disposed is sealed by the cylindrical portion compressed between the mounted portion of the holder and the surface of the outer needle hub, it is possible to prevent fluid from flowing to the proximal end side of the main body portion through the gap between the elastic member and the surface of the outer needle hub on which the elastic member is disposed. The radial thickness of the cylindrical portion is not limited to the case where it is constant in the axial direction, and at least a part of the cylindrical portion in the axial direction may be made such that the radial thickness is larger than the distance between the mounted portion and the surface of the outer needle hub facing the mounted portion in the radial direction.

[0029] That is, the indwelling needle according to one aspect of the present invention an inner needle to be punctured into a living body, an outer needle that penetrates the inner needle and is inserted into the living body together with the inner needle when the inner needle is punctured into the living body, a main body portion disposed along the axis of the inner needle, and a branch portion branching from the main body portion, and an outer needle hub having a flow path communicating with the inside of the outer needle, an elastic member disposed inside the outer needle hub, having a flexible solid portion that penetrates the inner needle and seals the flow of fluid to the proximal end side of the main body portion when the inner needle is removed, The elastic member forms at least a part of the flow path communicating the inside of the outer needle and the branch portion, and has an end face inclined with respect to the axial direction, The outer needle hub is characterized by having a guide portion that engages with the elastic member and guides the elastic member in a fixed direction around the axis.

[0030] In this way, the elastic member can be positioned in the circumferential direction around the axis by the guide portion so that the inclined surface faces the branch portion side. The inclined surface of the elastic member can make the flow path from the tip of the outer needle hub to the branch portion smoother than before. As a result, the fluidity of the liquid in the outer needle hub is improved, and the situation of stagnation occurring near the elastic member is reduced.

[0031] That is, the indwelling needle according to one aspect of the present invention an inner needle to be punctured into a living body, An outer needle that is inserted into a living body together with the inner needle when the inner needle penetrates and the inner needle is punctured into the living body, An outer needle hub including a main body portion disposed along the axis of the inner needle and a branch portion branching from the main body portion, and having a flow path communicating with the inside of the outer needle; An elastic member disposed inside the outer needle hub, having a flexible solid portion that penetrates the inner needle and seals the flow of fluid to the proximal end side of the main body portion when the inner needle is removed; The elastic member has a central portion and an outer peripheral portion, the central portion forming at least a part of the flow path communicating the inside of the outer needle and the branch portion, and having an end face inclined with respect to the axial direction; The outer needle hub is characterized in that a peripheral wall portion having a base end face facing the tip end face of the outer peripheral portion is formed on the inner surface, and at least a part of the central portion is located on the inner surface of the peripheral wall portion.

[0032] In this way, it is possible to suppress the formation of a space where stagnation occurs on the distal end side of the elastic member, and to provide an indwelling needle in which stagnation is unlikely to occur in the vicinity of the elastic member.

[0033] Further, in the present invention, There is a holder attached to the proximal end of the elastic member and having a portion to be attached to which the elastic member is attached, The elastic member is a cylindrical portion supported on the inner diameter side by the portion to be attached at the proximal end side of the solid portion, and has a radial thickness larger than the distance between the portion to be attached and the surface of the outer needle hub facing the portion to be attached in the radial direction before being assembled to the outer needle hub.

[0034] In this way, since the gap between the elastic member and the surface of the outer needle hub on which the elastic member is disposed is sealed by the cylindrical portion compressed between the portion to be attached of the holder and the surface of the outer needle hub, it is possible to prevent fluid from flowing to the proximal end side of the main body portion through the gap between the elastic member and the surface of the outer needle hub on which the elastic member is disposed. The radial thickness of the cylindrical portion is not limited to being constant in the axial direction, and at least a part of the cylindrical portion in the axial direction may have a radial thickness larger than the distance between the mounted portion and the surface of the outer needle hub facing the mounted portion in the radial direction.

Advantages of the Invention

[0035] According to the present invention, it is possible to provide an indwelling needle in which stagnation hardly occurs in the vicinity of the elastic member.

Brief Description of the Drawings

[0036]

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Embodiments for Carrying Out the Invention

[0037] Hereinafter, with reference to the drawings, embodiments for carrying out the present invention will be illustratively and in detail described based on examples. However, the dimensions, materials, shapes, relative arrangements, etc. of the components described in this embodiment should be appropriately changed according to the configuration of the device to which the invention is applied and various conditions. That is, the scope of the present invention is not intended to be limited to the following embodiments.

[0038] (Example 1) <Overview of the indwelling needle> FIG. 1 shows a side view of the indwelling needle 1 according to an embodiment of the present invention. FIG. 2 shows a cross-sectional view of the indwelling needle 1 in the A-A direction in FIG. 1. FIG. 3 shows a cross-sectional view of the indwelling needle 1 shown in FIG. 1 in the B-B direction in FIG. 2.

[0039] First, the outline of the indwelling needle 1 will be described with reference to FIG. 1. As shown in FIG. 1, the indwelling needle 1 includes a hollow inner needle 2 and a cylindrical outer needle 3 provided so as to cover the outer surface of the inner needle 2. The inner needle 2 protrudes from the opening at the tip of the outer needle 3 and is inserted into the blood vessel of the patient (living body) to be punctured. In the following, also in the indwelling needle 1, the end portion (side / direction) where the inner needle 2 protrudes is referred to as the tip (side / direction), and the opposite end portion is referred to as the rear end (side / direction) or the proximal end (side / direction). Also, the direction in which the inner needle 2 protrudes is also referred to as the puncture direction.

[0040] At the rear end of the outer needle 3, an outer needle hub 4 is connected. Inside this outer needle hub 4, a hollow portion communicating with the hollow portion 31 of the outer needle 3 is provided (see Fig. 4). As shown in Fig. 1, the outer needle hub 4 includes a main body portion 40 that linearly extends along the puncture direction, that is, the direction of the axis L1 of the inner needle 2 to be described later, and a substantially cylindrical branch portion 41 that branches in a Y shape from the main body portion 40 in the direction opposite to the puncture direction, that is, in a direction inclined with respect to the axis L1 direction of the inner needle 2 (the axis L2 of the branch portion 41 is shown in Fig. 4). Inside the main body portion 40, a hollow portion 400 and a hollow portion 405 are provided (see Fig. 4). Also, inside the branch portion 41, a hollow portion 410 is provided (see Fig. 4). The hollow portion 31 of the outer needle, the hollow portions 400 and 405 of the main body portion 40, and the hollow portion 410 of the branch portion 41 communicate with each other. When the inner needle 2 is removed from the outer needle 3, a flow path is formed that connects the hollow portion 31 of the outer needle 3, the hollow portion 400 of the main body portion 40, and the hollow portion 410 of the branch portion 41, and the second end face 63 of the hemostatic valve 6 to be described later forms a part of this flow path. The outer needle hub 4 can be formed of a resin such as polypropylene, and is not particularly limited as long as it is a material generally used for medical devices. Note that the outer needle hub 4 may be formed of a single member or a plurality of members. Also, a flexible soft tube may be disposed between the tip and the base end of the outer needle hub 4. Also, the outer needle hub 4 is not limited to a Y shape, and may be, for example, an L shape. Also, the branch portion 41 may extend in the left - right direction instead of on the top - surface side.

[0041] At the rear end of the branch portion 41 in the indwelling needle 1, for example, an extension tube through which blood supplied from an external device such as an artificial dialysis device passes is connected. Note that an extension tube may not be provided, and a connector may be provided at the port end. Here, blood corresponds to the fluid of the present invention.

[0042] At the rear end of the main body portion 40 in the indwelling needle 1, a hemostatic valve holder 5 that supports the hemostatic valve 6 to be described later and an inner needle hub 21 that holds the rear end of the inner needle 2 are connected. Here, the hemostatic valve 6 and the hemostatic valve holder 5 respectively correspond to the elastic member and the support member of the present invention.

[0043] On the outer periphery of the distal end side of the main body portion 40 of the indwelling needle, a pair of wing portions 7 are provided so as to sandwich the main body portion 40. The wing portion 7 has a cylindrical sleeve 70 that fits and is attached to the outer periphery of the distal end side of the main body portion 40, and a plate-like portion 71 that protrudes in a direction orthogonal to the axial direction (the front side and the back side of the paper surface) from the side surface of the sleeve 70. The sleeve 70 is fixed so as not to move in the axial direction or the circumferential direction around the axis with respect to the main body portion. The wing portion 7 functions as a gripping portion for an operator to grip when using the indwelling needle 1, and also functions as a fixing portion for fixing the indwelling needle 1 to the body with tape or the like. Note that the wing portion extends in a direction intersecting the extending direction of the branching portion, but may extend in a direction parallel to the branching portion. Also, the sleeve 70 may be provided so as to be relatively rotatable around the axis with respect to the main body portion. In that case, the user can position the wing portion at a suitable position. Also, the wing portion may not be provided.

[0044] <Internal Structure of Indwelling Needle> Next, the details inside the indwelling needle 1 will be described with reference to FIGS. 2 and 3. As shown in FIG. 2, on the distal end side of the main body portion 40 of the outer needle hub 4, an outer needle holding portion 401 that holds the proximal end side of the outer needle 3 is provided. And at the tip of the outer needle holding portion 401, a tip opening 402 that opens in the puncture direction is provided. The outer needle 3 is held by the outer needle holding portion 401 such that its tip protrudes from the tip opening 402. The proximal end side of the outer needle 3 is fixed by a caulking pin 403 that caulks between the outer needle 3 and the outer needle hub 4.

[0045] Also, a hemostatic valve 6 is attached to the tip of the hemostatic valve holder 5. And an inner needle hub 21 is connected to the rear end side of the hemostatic valve holder 5. The inner needle hub 21 holds the proximal end side of the inner needle 2 on the distal end side. Also, a protector 8 for protecting the needle tip 2a of the inner needle 2 is attached to the distal end side of the inner needle hub 21. The protector 8 has a protector body 80 and a protector holder 81.

[0046] The protector body 80 is configured to cover and protect the needle tip 2a of the inner needle 2, and is made of various metal materials such as stainless steel, aluminum, aluminum alloy, titanium alloy, copper, copper alloy, and copper-based alloy, for example. The protector body 80 can be configured as a substantially quadrangular prism-shaped member formed by bending and deforming a thin plate of the above-mentioned metal material, for example. As shown in FIG. 3, the protector body 80 mainly includes a substantially square bottom plate portion 80a, and flexible protection pieces 80b and 80c extending from two opposite sides of the bottom plate portion 80a toward the tip. The inner needle 2 is inserted through a hole formed in the center of the bottom plate portion 80a, and the protector body 80 is supported so as to be movable in the axial direction of the inner needle 2. The protection pieces 80b and 80c are substantially rectangular plate-like members and face each other with the inner needle 2 interposed therebetween. The protection piece 80b and the protection piece 80c are bent in a direction away from each other (the outer diameter direction of the inner needle 2) from the bottom plate portion 80a toward the tip side, and then bent in a direction approaching each other (the inner diameter direction of the inner needle 2), and form a substantially J-shaped configuration in which they approach each other toward the rear end side at the tip side. The protection piece 80b is formed longer than the protection piece 80c, and the tip portion of the protection piece 80b is located on the tip side of the tip portion of the protection piece 80c.

[0047] The protector holder 81 is a substantially cylindrical member made of synthetic resin. The protector holder 81 has a cylindrical portion 81a on the tip side, a housing portion 81b on the rear end side, and a ring portion 81c at the rear end portion of the housing portion 81b. The cylindrical portion 81a is formed in a substantially cylindrical shape, is inserted through the opening on the rear end side of the hemostatic valve holder 5, is housed in the hollow portion of the hemostatic valve holder 5, and is locked to the hemostatic valve holder 5 by engaging means such as unevenness (not shown). The housing portion 81b is formed in a substantially square tube shape with a substantially square cross section, and the tip side is integrally formed with the rear end of the cylindrical portion 81a. Substantially rectangular openings are formed in a pair of opposing side walls (the two side walls in the vertical direction in FIG. 3) of the housing portion 81b. These openings are provided on the side opposite to the inner needle 2 with respect to the protection pieces 80b and 80c, and these openings allow the protection pieces 80b and 80c to deform in a direction away from each other.

[0048] Further, the ring portion 81c is formed in an annular shape with a square cross-section composed of four side walls. The dimensions of the inner peripheral portion of the ring portion 81c are formed to substantially match the outer dimensions of the bottom plate portion 80a of the protector main body 80. Thus, when the protector main body 80 is moved so as to be pulled out from the ring portion 81c and the protection pieces 80b and 80c of the protector main body 80 are passed through the ring portion 81c, the protection pieces 80b and 80c are pushed inward by the ring portion 81c. By being pushed inward, the protection pieces 80b and 80c are elastically deformed so as to approach each other, the opposing protection pieces 80b and 80c come into contact with each other, and the gap therebetween is closed. At this time, the deformed portions of the protection pieces 80b and 80c protrude from the opening of the accommodating portion 81b. In this way, since the protection pieces 80b and 80c cannot move in a direction to approach each other any further, the movement of the protector main body 80 is restricted by the rear end side portions of the protection pieces 80b and 80c, and the protector main body 80 cannot be pulled out from the protector holder 81. In this way, by moving the protector main body 80 in a direction to pull it out from the protector holder 81, the needle tip 2a of the inner needle 2 is covered and protected by the protector main body 80, and since the protector main body 80 cannot move relative to the protector holder 81, the protected state is maintained.

[0049] When the outer needle 3 is indwelled in the body and the inner needle hub 21 is pulled out from the outer needle hub 4, at least a part of the outer diameter of the engaging portion provided on the tip side of the inner needle 2 is set larger than the inner diameter of the hole formed in the bottom plate portion 80a of the protector main body 80. When the engaging portion and the bottom plate portion 80a are engaged and an attempt is made to further pull out the inner needle hub 21, the protector main body 80 including the bottom plate portion 80a engaged with the inner needle 2 moves toward the rear end side. Further, when the inner needle hub 21 is pulled out, as described above, since the protector main body 80 moves relative to the protector holder 81 toward the rear end side, the protection pieces 80b and 80c that are in contact with each other can cover and protect the needle tip 2a of the inner needle 2.

[0050] <Configuration of the main part> Figure 4 is a view showing an enlarged main part of the cross-sectional view shown in Figure 3. Figure 5 is a cross-sectional view taken along the line D-D of Figure 1. Figure 6 is an exploded perspective view of the outer needle hub 4, the hemostatic valve 6, and the hemostatic valve holder 5. The axis L1 is a line indicating the axial direction of the main body 40 of the outer needle hub 4, and in the state where the inner needle 2 is inserted into the outer needle 3, it coincides with the axis of the inner needle 2. As shown in Figure 4, the outer needle hub 4 is provided with a hollow portion 400 communicating with the hollow portion 31 of the outer needle 3. A hollow portion 405 on the rear end side in the direction of the axis L1 from the hollow portion 400 and a hollow portion 410 inclined with respect to the direction of the axis L1 from the hollow portion 400 communicate with each other through the hollow portion 400.

[0051] The hemostatic valve 6 and the hemostatic valve holder 5 are attached to the hollow portion 405. And, an inner needle hub 21 with a protector 8 attached is attached to the rear end side of the hemostatic valve holder 5. At this time, the inner needle 2 pushes open the slit 64 of the hemostatic valve 6 and is inserted into the hollow portion 31 of the outer needle 3. The hemostatic valve 6 is formed of, for example, synthetic rubber such as polyisoprene or a thermoplastic elastomer. The hemostatic valve holder 5 can be formed of, for example, a resin such as polypropylene and is not particularly limited as long as it is a material generally used for medical devices.

[0052] As shown in FIG. 6, the hemostatic valve 6 is formed in a generally bottomed cylindrical shape. The end portion on the tip side of the hemostatic valve 6 is formed as an inclined surface that is inclined with respect to the axis L1 direction. Specifically, the hemostatic valve 6 includes a cylindrical portion 60, an annular first end surface 61 connected to the edge on the tip side of the cylindrical portion 60, an annular stepped portion 62 connected to the inner diameter side of the first end surface 61 and extending in the axis L1 direction, and a disk-shaped second end surface 63 connected to the inner diameter side of the stepped portion 62. The first end surface 61 and the second end surface 63 of the hemostatic valve 6 are configured to be substantially parallel and are similarly inclined with respect to the axis L1 direction. And a linear slit 64 that penetrates the flexible solid portion 631 from the tip side to the rear end side is provided at the center of the second end surface 63. In addition, the shape of the slit can be a cross shape, a Y shape, or the like. Also, the central base end surface 66, which is the surface on the rear end side of the first end surface 61 and the second end surface 63 of the hemostatic valve 6, is formed as a single surface parallel to the first end surface 61. The shape of the second end surface 63 of the hemostatic valve 6 is not limited to a flat surface, and may be formed as a curved surface that follows the cylindrical surface shape of the peripheral wall of the hollow portion 410 of the branch portion 41. Also, it can be said that the second end surface 63 is also the central portion of the hemostatic valve 6, and the first end surface 61 is the outer peripheral portion formed on the outer periphery of this central portion. Also, the hemostatic valve 6 may be shaped such that the second end surface 63 and the stepped portion 62 have a major axis along the straight line La and a minor axis along the straight line Sa shown by the dotted line in FIG. 4. In this case, the opening 404 of the outer needle hub 4 also has a shape with a major axis and a minor axis. By having a major axis and a minor axis in the central portion of the hemostatic valve 6 and the opening 404 of the outer needle hub 4, it functions as an outer peripheral portion and a guided portion, and it is possible to easily position the hemostatic valve 6 in a predetermined direction around the axis. Also, when the second end surface 63 and the stepped portion 62 are shaped with a major axis and a minor axis in this way, it is desirable to set the major axis in the direction along the axis L2 of the branch portion 41 from the viewpoint of miniaturization. Also, when the second end surface 63 is shaped with a major axis and a minor axis in this way, it is desirable to form the linear slit along the major axis direction. The stepped portion 62 formed between the first end surface 61 and the second end surface 63 is inclined with respect to the axis L1 direction, and is made easy to insert when inserting the central portion of the hemostatic valve 6 into the opening 404 of the outer needle hub 4. Also, the rear end side of the hemostatic valve 6 is open in a cylindrical shape, with the center being thinner than the outer peripheral portion, reducing the resistance during inner needle withdrawal.The end face 65 on the rear end side of the hemostatic valve 6 forms a plane orthogonal to the direction of the axis L1 and abuts against the stepped portion 52a of the hemostatic valve holder 5. By doing so, it is possible to reduce the unintentional deformation of the elastic valve body when the hemostatic valve 6 is relatively moved within the outer needle hub.

[0053] The hemostatic valve holder 5 is formed in a substantially cylindrical shape. The hemostatic valve holder 5 includes a small-diameter portion 51, a diameter-expanded portion 52, a large-diameter portion 53, and a flange portion 54 in order from the tip side. At the end on the tip side of the small-diameter portion 51, an annular first end face 51a that is connected to the inner diameter side of the edge of the small-diameter portion 51 and is inclined with respect to the direction of the axis L1 is formed. An annular stepped portion 51b that extends in the direction of the axis L1 is connected to the inner diameter side of the first end face 51a. Further, a second end face 51c that is inclined with respect to the direction of the axis L1 is formed by connecting to the inner diameter side of the stepped portion. The first end face 51a and the second end face 51c of the hemostatic valve holder 5 are configured to be substantially parallel and are inclined in the same manner with respect to the direction of the axis L1. Also, the first end face 51a and the second end face 51c of the hemostatic valve holder 5 are configured to be parallel to the first end face 61 and the second end face 63 of the hemostatic valve 6, respectively, and are inclined in the same manner with respect to the direction of the axis L1. Here, the annular stepped portion 51b may be provided to be inclined with respect to the direction of the axis L1 in order to increase the contact area with the hemostatic valve 6. Further, it is desirable that the tip of the second end face 51c is formed in an R shape.

[0054] In the hemostatic valve holder 5, the rear end side of the small diameter portion 51 is connected to an enlarged diameter portion 52 that expands toward the rear end side via a stepped portion 52a extending in the outer diameter side direction, that is, in a direction orthogonal to the axis L1. The rear end side of the enlarged diameter portion 52 is connected to a large diameter portion 53. Further, an annular flange portion 54 protruding to the outer diameter side is formed on the rear end side of the large diameter portion 53. And on the side surface of the large diameter portion 53, protrusions 55a and 55b (see FIG. 5) that gradually protrude to the outer diameter side from the front end side toward the rear end side are formed. The protrusion 55a and the protrusion 55b are provided at positions symmetric with respect to the axis L1. Also, on the side surface of the large diameter portion 53, a rib 56 that protrudes to the outer diameter side and extends in the direction of the axis L1 from the front end side to the rear end side is formed, and the rear end side of the rib 56 is connected to the flange portion 54. The rib 56 is provided between the protrusion 55a and the protrusion 55b, and in relation to the outer needle hub 4, it is provided at a position on the opposite side of the branch portion 41 with respect to the direction of the axis L1.

[0055] The outer diameter dimension of the small-diameter portion 51 of the hemostatic valve holder 5 is set to be slightly smaller than the inner diameter dimension of the cylindrical portion 60 of the hemostatic valve 6. When the small-diameter portion 51 of the hemostatic valve holder 5 is inserted into the inner circumference of the cylindrical portion 60 of the hemostatic valve 6 from the tip side, a frictional force acts between the inner circumferential surface of the cylindrical portion 60 of the hemostatic valve 6 and the outer circumferential surface of the small-diameter portion 51 of the hemostatic valve holder 5 due to the elastic deformation of the cylindrical portion 60 of the hemostatic valve 6 that tries to reduce its diameter by slightly expanding on the outer diameter side. Since the first end face 51a, which is the tip end face of the hemostatic valve holder 5, is inclined with respect to the axial direction in the same way as the central base end face 66 of the hemostatic valve 6, it restricts the displacement of the hemostatic valve 6 with respect to the hemostatic valve holder 5 in the direction of the axis L1 and the rotational direction around the axis L1. Also, it functions as a guide when assembling the hemostatic valve 6 and the hemostatic valve holder 5 in a predetermined circumferential direction around the axis. With the first end face 51a of the small-diameter portion 51 of the hemostatic valve holder 5 in contact with the rear end side of the first end face 61 and the second end face 63 of the hemostatic valve 6, the dimensions in the direction of the axis L1 of the cylindrical portion 60 of the hemostatic valve 6 and the small-diameter portion 51 of the hemostatic valve holder 5 are set so that the end face 65 on the rear end side of the cylindrical portion 60 of the hemostatic valve 6 contacts the stepped portion 52a of the hemostatic valve holder 5. When the small-diameter portion 51 of the hemostatic valve holder 5 is pushed into the hemostatic valve 6 up to the position where the end face on the rear end side of the cylindrical portion 60 of the hemostatic valve 6 contacts the stepped portion 52a of the hemostatic valve holder 5, the stepped portion 51b and the second end face 51c of the small-diameter portion 51 of the hemostatic valve holder 5 slightly bite into the rear end side of the second end face 63 of the hemostatic valve 6. Since both the hollow portion of the hemostatic valve 6 and the small-diameter portion 51 of the hemostatic valve holder 5 are configured in a shape that is rotationally asymmetric with respect to the axis L1, the rotation of the hemostatic valve 6 around the axis L1 with respect to the hemostatic valve holder 5 is restricted in the state where the hemostatic valve 6 is attached to a predetermined position of the small-diameter portion 51 of the hemostatic valve holder 5. By having such a rotation prevention mechanism that restricts the relative rotation between the hemostatic valve holder 5 and the hemostatic valve 6, it is possible to reduce the situation where the hemostatic valve is displaced during assembly. Note that the shape of the small-diameter portion of the hemostatic valve holder 5 is not limited to a cylindrical shape.

[0056] FIG. 4 shows a state where the hemostatic valve 6 and the hemostatic valve holder 5 are properly positioned with respect to the outer needle hub 4. An opening 404 is provided at the tip side of the hollow portion 405 of the main body portion 40 of the outer needle hub 4 via a stepped portion 406. The inner diameter in the direction orthogonal to the axis L1 of the opening 404 is set smaller than the inner diameter of the hollow portion 405. The inner diameter of the hollow portion 405 is set such that the outer peripheral surface of the hemostatic valve holder 5 with the hemostatic valve 6 attached is in pressure contact with the inner peripheral surface of the hollow portion 405, and the liquid such as blood flowing through the outer peripheral side of the hemostatic valve 6 and the hemostatic valve holder 5 between the hollow portion 400 and the hollow portion 405 is sealed. For this reason, the inner peripheral surface on the tip side of the hollow portion 405 is formed in a cylindrical shape corresponding to the cylindrical portion 60 of the hemostatic valve 6, and the rear end side is formed in a tapered shape that expands toward the outer diameter side toward the rear end side corresponding to the enlarged diameter portion 52 of the hemostatic valve holder 5, and the further rear end side is formed in a cylindrical shape corresponding to the large diameter portion 53 of the hemostatic valve holder 5. Note that the portion including the stepped portion 406 and the opening 404 of the outer needle hub 4 may be formed as a separate member from the other portions of the outer needle hub 4, or may be integrated by fixing the separate member to the outer needle hub 4.

[0057] As shown in Fig. 4, when the hemostatic valve 6 and the hemostatic valve holder 5 are properly positioned with respect to the outer needle hub 4, the first end face 61 and the stepped portion 62 of the hemostatic valve 6 are respectively in contact with the stepped portion 406 of the outer needle hub 4 and the inner peripheral surface of the opening 404. The hemostatic valve 6 is compression-fixed in the direction of the axis L1 between the stepped portion 406 of the outer needle hub 4 facing each other and the first end face 51a of the hemostatic valve holder 5. And the second end face 63 of the hemostatic valve 6 is exposed toward the hollow portion 400 side. The second end face 63 of the hemostatic valve 6 is set to be substantially at the same height as the portion adjacent to the opening 404 among the inner peripheral surfaces of the hollow portion 410 of the branch portion 41. In this way, the outer peripheral portion of the hemostatic valve 6 is firmly fixed, the central portion fills the gap in the outer needle hub 4, and in the hollow portion 410 branching from the hollow portion 400, at the portion of the second end face 63 of the hemostatic valve 6 that constitutes a part of the inner peripheral surface of the hollow portion 410, a sudden shape change does not occur. Therefore, in the hollow portion 31 of the outer needle 3, the hollow portion 400 of the main body portion 40 of the outer needle hub 4, and the hollow portion 410 of the branch portion 41, liquids such as blood flow smoothly, and no retention that causes blood clot formation occurs. The stepped portion 406 and the opening 404 of the outer needle hub 4 function as a peripheral wall portion with respect to the second end face 63 which is the central portion on the tip side of the hemostatic valve 6, and the stepped portion 406 constitutes the base end face of the peripheral wall portion that engages with the first end face. The stepped portion 406 inclined in the direction of the axis L1 constitutes a guide portion, and the tip face of the hemostatic valve 6 constitutes a guided portion. Also, when the hemostatic valve 6 is properly positioned with respect to the outer needle hub 4, the interval between the opposing portions 62a and 62b sandwiching the slit 64 of the stepped portion 62 of the hemostatic valve 6 is set to be slightly larger than the inner diameter of the corresponding portion of the opening 404. The portion of the hemostatic valve 6 including these portions 62a and 62b is press-fitted into the opening 404. By setting it in this way, a force that compresses the slit 64 of the hemostatic valve 6 in the closing direction acts on the opening 404 of the outer needle hub 4. Therefore, the elastic restoring force of the slit 64 when the inner needle 2 is removed and after removal is increased, and the sealing performance of the hemostatic valve 6 can be ensured. In addition, in the above-described embodiment, the hemostatic valve 6 is compressed toward the inner diameter side as described above by the inner circumference of the opening 404, but the compression mode is not limited to the above-described one. For example, the thickness of the hemostatic valve 6 may be increased so that the central base end surface 66 of the hemostatic valve 6 is perpendicular to the axial direction, and the sealing property of the hemostatic valve 6 can be ensured by applying compression radially inward from the outer needle hub 4. Further, the thickness of the hemostatic valve 6 can be further increased to ensure the sealing property of the hemostatic valve 6 without applying compression. Further, an inclined surface inclined in the axial direction is provided at the contact portion of the hemostatic valve holder 5 with the outer needle hub 4, and an inclined surface engaging with the inclined surface is provided on the inner surface of the outer needle hub 4, thereby constituting a guide portion and a guided portion, and the circumferential direction around the axis of the outer needle hub 4 and the hemostatic valve holder 5 may be set as a specified direction.

[0058] Rectangular openings 42a and 42b are formed on the side surface of the rear end side of the main body portion 40 of the outer needle hub 4. The openings 42a and 42b are provided at positions symmetric with respect to the axis L1. Further, a notch 43 with the rear end side being open is formed on the rear end side of the main body portion 40 of the outer needle hub 4. The notch 43 is provided between the opening 42a and the opening 42b, and is provided at a position on the opposite side of the branch portion 41 with respect to the axis L1.

[0059] When the hemostatic valve holder 5 with the hemostatic valve 6 attached is press-fitted into the outer needle hub 4 from the opening at the rear end side and attached to the outer needle hub 4, the protrusions 55a, 55b, and rib 56 of the hemostatic valve holder 5 are held in a posture corresponding to the opening 42a, the opening 42b, and the notch 43 of the outer needle hub 4. Then, the hemostatic valve holder 5 is advanced in the direction of the axis L1 with respect to the outer needle hub 4, press-fitted from the opening at the rear end side, and the protrusions 55a, 55b, and rib 56 are fitted into the opening 42a, the opening 42b, and the notch 43, respectively. At this time, since the notch 43 and the rib 56 extend in the direction of the axis L1, the hemostatic valve holder 5 is guided in the direction of the axis L1 with respect to the outer needle hub 4 by the notch 43 and the rib 56. In this way, when attaching the hemostatic valve 6 and the hemostatic valve holder 5 to the outer needle hub 4, the circumferential direction around the axis L1 of the hemostatic valve 6 and the hemostatic valve holder 5 with respect to the outer needle hub 4 can be set to a predetermined direction. That is, the circumferential direction around the axis L1 of the hemostatic valve 6 and the hemostatic valve holder can be guided in a fixed direction, and thereby, the direction around the axis L1 of the hemostatic valve 6 attached to the hemostatic valve holder 5 can be defined. By providing the anti-rotation mechanism such as the protrusions 55a, 55b, the rib 56, the openings 42a, 42b, and the notch 43 as described above, rotation of the hemostatic valve 6 and the hemostatic valve holder 5 around the axis L1 with respect to the outer needle hub 4 can be prevented. Note that the anti-rotation mechanism may be constituted only by the rib 56 and the notch 43. Further, the protrusions 55a and 55b of the hemostatic valve holder 5 constitute a locking portion that restricts relative movement in the axial direction L1 with respect to the outer needle hub 4 by fitting with the openings 42a and 42b of the outer needle hub 4.

[0060] <Modification Example 1> In the above-described embodiment, an example in which the anti-rotation mechanism when attaching the hemostatic valve 6 and the hemostatic valve holder 5 to the outer needle hub 4 is provided in the hemostatic valve holder 5 and the outer needle hub 4 has been described. Here, the hemostatic valve holder 5 is provided with the protrusions 55a and 55b and the rib 56, and the outer needle hub 4 is provided with the openings 42a and 42b and the notch 43. In contrast, the hemostatic valve holder 5 may be provided with an opening, a notch, or a recess, and the inner peripheral surface of the hollow portion 405 of the outer needle hub 4 may be provided with a protrusion or a rib.

[0061] <Modification Example 2> In a modification of the above-described embodiment, the central base end surface 66 of the hemostatic valve 6 and the first end surface 51a at the tip of the hemostatic valve holder 5 are inclined, restricting the relative rotation of the hemostatic valve 6 and the hemostatic valve holder 5. However, the central base end surface 66 of the hemostatic valve 6 and the first end surface 51a at the tip of the hemostatic valve holder 5 do not necessarily have to be inclined. By providing notches, recesses, protrusions, etc. on the hemostatic valve and providing protrusions, etc. that engage with the notches, recesses, protrusions, etc. on the hemostatic valve holder, the relative rotation may be restricted. Further, by roughening either one or both of the inner peripheral surface of the cylindrical portion 60 of the hemostatic valve 6 or the outer peripheral surface of the small-diameter portion 51 of the hemostatic valve holder 5, a frictional force may act between the hemostatic valve 6 and the small-diameter portion 51 of the hemostatic valve holder 5. Further, the hemostatic valve 6 and the small-diameter portion 51 of the hemostatic valve holder 5 may be formed of materials that generate frictional force with each other. A member that generates a frictional force may be interposed between the hemostatic valve 6 and the small-diameter portion 51 of the hemostatic valve holder 5. They may be fixed with an adhesive. Note that the cause of the frictional force between the hemostatic valve 6 and the small-diameter portion 51 of the hemostatic valve holder 5 is not limited to the intermolecular force.

[0062] <Modification Example 3> With reference to FIGS. 7 and 8, the outer needle hub 4 and the hemostatic valve holder 15 according to Modification Example 3, which is a modification of Example 1, will be described. Since the hemostatic valve 6 and the other configurations of the indwelling needle are the same as those in the above-described embodiment, detailed descriptions thereof will be omitted. The same reference numerals are used for the same configurations as in Example 1.

[0063] FIG. 7(A) is a side view of the outer needle hub 4 to which the hemostatic valve holder 15 is assembled, and FIG. 7(B) is an end view of the outer needle hub 4 to which the hemostatic valve holder 15 is assembled, as viewed from the proximal end side along the axis L1 direction. FIG. 7(C) is a cross-sectional view of the outer needle hub 4 to which the hemostatic valve holder 15 is assembled in the A-A direction, and FIG. 7(D) is a cross-sectional view of the outer needle hub 4 to which the hemostatic valve holder 15 is assembled in the B-B direction. Further, FIG. 8 is a side view of the hemostatic valve holder 15.

[0064] As shown in FIG. 8, the hemostatic valve holder 15 has a small-diameter portion 51, a diameter-expanded portion 52, and a large-diameter portion 53, similar to those in the first embodiment. In the third modification, as shown in FIGS. 7(C) and 7(D), on the rear end side of the large-diameter portion 53, there are provided a flange-like end portion 151 protruding to the outer diameter side, and a substantially cylindrical outer insertion portion 152 extending in parallel with the large-diameter portion 53 and covering the outer peripheral side of the large-diameter portion 53 from the edge portion on the outer diameter side of the end portion 151 toward the front end side. On the outer insertion portion 152, claws 153a and 153b are provided at positions symmetric with respect to the axis L1. The substantially rectangular claws 153a and 153b are joined to the outer insertion portion 152 on the rear end side, and are provided so as to be elastically deformable in the radial direction with the rear end side as a fulcrum. On the inner diameter side of the claws 153a and 153b, there are provided inclined surfaces 1541a and 1541b protruding toward the inner diameter side from the front end side to the rear end side, and protrusions 154a and 154b having a triangular cross-section with end surfaces 1542a and 1542b on the rear end side orthogonal to the axis L1 direction.

[0065] As shown in FIGS. 7(A) and 7(D), similar to the embodiment, rectangular openings 42a and 42b are provided on the rear end side of the main body portion 40 of the outer needle hub 4. A cylindrical gap 155 is formed between the outer insertion portion 152 and the large-diameter portion 53 of the hemostatic valve holder 5. When the hemostatic valve holder 15 is press-fitted into the opening at the rear end of the outer needle hub 4 from the small-diameter portion 51, the main body portion 40 of the outer needle hub 4 fits into the gap 155 from the rear end side. At this time, when the inclined surfaces 1541a and 1541b contact the main body portion 40 of the outer needle hub 4, the claws 153a and 153b are elastically deformed to the outer diameter side, and the protrusions 154a and 154b rub against the outer surface of the main body portion 40 of the outer needle hub 4. Then, when the protrusions 154a and 154b reach the positions of the openings 42a and 42b, due to the elastic return of the claws 153a and 153b, the protrusions 154a and 154b fit into the openings 42a and 42b, respectively.

[0066] In this way, by fitting the protrusions 154a and 154b of the hemostatic valve holder 5 into the openings 42a and 42b of the outer needle hub 4 from the outer diameter side, the direction around the axis L1 of the hemostatic valve holder 5 can be guided in a fixed direction. Therefore, the direction around the axis L1 of the hemostatic valve 6 attached to the hemostatic valve holder 5 can be defined. Accordingly, the blood flowing from the outer needle 3 into the outer needle hub 4 can be smoothly moved to the branch portion 41, and the retention near the hemostatic valve 6 can be prevented. Here, the openings 42a and 42b of the outer needle hub 4 constitute a guide portion. The protrusions 154a and 154b constitute a guided portion, and the openings 42a and 42b of the outer needle hub 4 and the protrusions 154a and 154b of the hemostatic valve holder 5 constitute an anti-rotation mechanism. Further, the protrusions 154a and 154b of the hemostatic valve holder 15 constitute a lock portion that restricts the relative movement in the direction of the axis L1 with respect to the outer needle hub 4 by fitting with the openings 42a and 42b of the outer needle hub 4. Note that the openings 42a and 42b may be recesses formed on the outer surface of the outer needle hub 4.

[0067] In Modification 3, the openings 42a and 42b are provided in the outer needle hub 4, and the protrusions 154a and 154b are provided in the hemostatic valve holder 15. However, protrusions may be provided in the outer needle hub 4 and openings may be provided in the hemostatic valve holder 15. By fitting the protrusion of the outer needle hub 4 and the opening of the hemostatic valve holder 5, the direction around the axis L1 of the hemostatic valve holder 5 can be guided in a fixed direction. Thereby, the direction around the axis L1 of the hemostatic valve 6 attached to the hemostatic valve holder 5 can be defined. Accordingly, the blood flowing from the outer needle 3 into the outer needle hub 4 can be smoothly moved to the branch portion 41, and the retention near the hemostatic valve 6 can be prevented.

[0068] <Modification 4> With reference to FIGS. 9 and 10, the outer needle hub 4 and the hemostatic valve holder 25 according to Modification 4 will be described. Since the hemostatic valve 6 and the other configurations of the indwelling needle are the same as those in the above-described embodiment, detailed description thereof will be omitted. The same reference numerals are used for the same configurations as those in the above-described embodiment.

[0069] FIG. 9(A) is a side view of the outer needle hub 4 with the hemostatic valve holder 25 assembled thereto, and FIG. 9(B) is an end view of the outer needle hub 4 with the hemostatic valve holder 25 assembled thereto, as viewed from the proximal end side along the axis L1. FIG. 9(C) is a cross-sectional view of the outer needle hub 4 with the hemostatic valve holder 25 assembled thereto taken along the line A-A, and FIG. 9(D) is a cross-sectional view of the outer needle hub 4 with the hemostatic valve holder 25 assembled thereto taken along the line B-B. Further, FIG. 10(A) is a side view of the hemostatic valve holder 25, and FIG. 10(B) is an end view of the hemostatic valve holder 25 as viewed from the proximal end side.

[0070] As shown in FIG. 10(A), the hemostatic valve holder 25 has a small-diameter portion 51 and a large-diameter portion 52, similar to those in the first embodiment. In the fourth modification, as shown in FIG. 10(A), on the rear end side of the large-diameter portion 52, claws 251a and 251b are provided at positions symmetric with respect to the axis L1. The claws 251a and 251b extend in the direction of the axis L1 from the rear end portion of the large-diameter portion 52. The claws 251a and 251b each have a base portion 2511a and a base portion 2511b having a partial cylindrical shape following the shape of the rear end portion of the large-diameter portion 52 and connected to the rear end portion of the large-diameter portion 52, and projections 2512a and 2512b protruding outward in the diameter direction on the rear end side of the base portions 2511a and 2511b, respectively. The projection 2512a has a triangular cross-section having an inclined surface 25121a protruding outward in the diameter direction from the front end side to the rear end side and an end surface 25122a connected to the rear end side of the inclined surface 25121a and orthogonal to the direction of the axis L1. Similarly, the projection 2512b has a triangular cross-section having an inclined surface 25121b and an end surface 25122b. In the hemostatic valve holder 25, partial cylindrical portions 252a and 252b that are connected to the rear end portion of the large-diameter portion 52 and follow the shape of the rear end portion are provided at positions symmetric with respect to the axis L1, being sandwiched by the claws 251a and 251b in the circumferential direction. A gap is formed in the circumferential direction between each of the claws 251a and 251b and the partial cylindrical portions 252a and 252b.

[0071] As shown in FIGS. 9(A) and 9(D), similar to the embodiment, rectangular openings 42a and 42b are provided on the rear end side of the main body portion 40 of the outer needle hub 4. When the hemostatic valve holder 5 is press-fitted into the opening at the rear end of the outer needle hub 4 from the small diameter portion 51, the rear end portion of the outer needle hub 4 rubs against the slopes 25121a of the protrusions 2512a provided on the claws 251a and 251b and the slopes 25121b of the protrusions 2512b. When the tops of the protrusions 2512a and 2512b contact the inner peripheral surface of the outer needle hub 4, the claws 251a and 251b are pressed toward the inner diameter side and elastically deformed toward the inner diameter side with the base as the fulcrum. When the hemostatic valve holder 25 is further pushed into the outer needle hub 4 toward the tip side and the protrusions 2512a and 2512b reach the positions of the openings 42a and 42b of the outer needle hub 4, due to the elastic return of the claws 251a and 251b, the protrusions 2512a and 2512b are respectively fitted into the openings 42a and 42b from the inner diameter side.

[0072] In this way, by fitting the protrusions 2512a and 2512b of the hemostatic valve holder 25 into the openings 42a and 42b of the outer needle hub 4 from the inner diameter side, the direction around the axis L1 of the hemostatic valve holder 25 can be guided in a certain direction. Therefore, the direction around the axis L1 of the hemostatic valve 6 attached to the hemostatic valve holder 25 can be defined. Thus, the blood flowing from the outer needle 3 into the outer needle hub 4 can be smoothly moved to the branch portion 41, and stagnation near the hemostatic valve 6 can be prevented. Here, the openings 42a and 42b of the outer needle hub 4 constitute a guide portion. The protrusions 2512a and 2512b constitute a guided portion, and the openings 42a and 42b of the outer needle hub 4 and the protrusions 2512a and 2512b of the hemostatic valve holder 5 constitute a rotation prevention mechanism. Further, the protrusions 2512a and 2512b of the hemostatic valve holder 25 constitute a locking portion that restricts the relative movement in the direction of the axis L1 with respect to the outer needle hub 4 by fitting with the openings 42a and 42b of the outer needle hub 4.

[0073] In Modification 4, although the protrusions 2512a and 2512b are provided on the claws 251a and 251b provided at positions symmetric with respect to the axis L1, a cylindrical large-diameter portion may be provided on the rear end side of the enlarged-diameter portion 52 of the hemostatic valve holder 25, and a flange having a triangular cross section protruding in the outer diameter direction over the entire circumference may be provided on the outer peripheral surface of this large-diameter portion. In this case, a part of the flange is fitted into the opening 42a and the opening 42b of the outer needle hub 4, respectively.

[0074] (Example 2) Hereinafter, the indwelling needle according to Example 2 of the present invention will be described. For the same configurations as those in Example 1, the same reference numerals will be used and the detailed description will be omitted.

[0075] FIG. 11 is an exploded perspective view of the outer needle hub 34, the hemostatic valve holder 35, and the hemostatic valve 6 according to Example 2. FIG. 12(A) is a side view showing a state in which the hemostatic valve 6 and the hemostatic valve holder 35 are assembled to the outer needle hub 34 according to Example 2, and FIG. 12(B) is an end view of the outer needle hub 34 to which the hemostatic valve 6 and the hemostatic valve holder 35 are assembled, viewed from the proximal end side along the axis L1 direction. FIG. 12(C) is a cross-sectional view of the outer needle hub 34 to which the hemostatic valve 6 and the hemostatic valve holder 35 are assembled in the C-C direction, and FIG. 12(D) is a cross-sectional view of the outer needle hub 34 to which the hemostatic valve 6 and the hemostatic valve holder 35 are assembled in the D-D direction. FIG. 12(E) is a cross-sectional view of the outer needle hub 34 to which the hemostatic valve 6 and the hemostatic valve holder 35 are assembled in the A-A direction.

[0076] As shown in FIG. 11, on the rear end side of the main body portion 40 of the outer needle hub 34 according to the second embodiment, a substantially rectangular opening 342a and an opening 342b are provided. The opening 342a and the opening 342b are provided at symmetric positions with respect to the axis L1. Further, a substantially rectangular parallelepiped protrusion 343 that protrudes in the direction of the axis L1 from the end face 407 on the rear end side of the main body portion 40 of the outer needle hub 34 is provided. The protrusion 343 is provided between the opening 342a and the opening 342b, and is provided at a position on the side where the branch portion 41 branches with respect to the axis L1. Substantially rectangular claws 344a and 344b are respectively provided on the opening 342a and the opening 342b of the outer needle hub 34 so as to be elastically deformable. The claws 344a and 344b are formed in a shape in which the tip side is bent toward the inner diameter side, and are connected to the main body portion 40 on the rear end side.

[0077] Also, as shown in FIGS. 12(C) and 12(D), inside the outer needle hub 4, a hollow portion 3405 is provided on the rear end side of the hollow portion 400. The inner diameter of the hollow portion 3405 is substantially constant in the direction of the axis L1. On the rear end side of the hollow portion 3405, a hollow portion 3407 having an inner diameter larger than that of the hollow portion 3405 is provided via a hollow portion 3406 that expands in the outer diameter side. The opening 342a and the opening 342b are provided so as to penetrate the outer needle hub 34 in the outer diameter direction from the hollow portion 3406 to the hollow portion 3407.

[0078] As shown in FIG. 11, in the hemostatic valve holder 35 according to the second embodiment, a cylindrical middle diameter portion 352 having a diameter larger than that of the small diameter portion 51 and having a constant diameter in the direction of the axis L1 is connected to the rear end side of the small diameter portion 51 of the same type as in the first embodiment via an end face 352a in a direction orthogonal to the direction of the axis L1. A cylindrical second middle diameter portion 354 having substantially the same diameter as the middle diameter portion 352 is connected to the rear end side of the middle diameter portion 352 via a flange portion 353 having a first diameter-expanded portion 3531 that expands in diameter toward the rear end side and an end face 3532 in a direction orthogonal to the direction of the axis L1 over the entire circumference. A second diameter-expanded portion 355 that expands in diameter toward the rear end side is provided over the entire circumference on the rear end side of the second middle diameter portion 354, and a large diameter portion 356 having a cylindrical shape with a diameter larger than those of the middle diameter portion 352 and the second middle diameter portion 354 and substantially the same diameter as the flange portion 353 is provided continuously with the second diameter-expanded portion 355. An annular flange portion 357 that protrudes outward in diameter is formed at the rear end portion of the large diameter portion 356. A recessed portion 3571 that is recessed from a part of the end face 357a on the tip side toward the rear end side is provided on the tip side of the flange portion 357. The recessed portion 3571 opens from the end face 357a on the tip side of the flange portion 357 to the outer peripheral surface 357b. The recessed portion 3571 is provided at a position opposite to the side where the inclined first end face 51a of the small diameter portion 51 protrudes more toward the tip side with respect to the axis L1.

[0079] The hemostatic valve holder 35 with the hemostatic valve 6 attached is press-fitted into the opening at the rear end of the outer needle hub 34 and attached to the outer needle hub 34. When the hemostatic valve holder 35 is press-fitted into the outer needle hub 34, the tip portions 3441a and 3441b of the claws 344a and 344b are pressed to the outer diameter side and elastically deformed by coming into contact with the first enlarged diameter portion 3531 of the flange portion 353 of the hemostatic valve holder 35. When the hemostatic valve holder 35 is further pushed into the outer needle hub 34 toward the tip side, the tip portions 3441a and 3441b of the claws 344a and 344b slide on the first enlarged diameter portion 3531 of the flange portion 353 of the hemostatic valve holder 35. Then, when the hemostatic valve holder 35 is properly positioned within the outer needle hub 34, the tip portions 3441a and 3441b of the claws 344a and 344b cross over the first enlarged diameter portion 3531 of the flange portion 353 of the hemostatic valve holder 35. As shown in FIG. 12(D), since the second medium diameter portion 354 is provided in contact with the end face 3532 on the rear end side of the flange portion 353, the claws 344a and 344b that have been pressed to the outer diameter side elastically return to the inner diameter side, and the tip portions 3441a and 3441b come into contact with the second medium diameter portion 354. At this time, the portion on the rear end side of the tip portions 3441a and 3441b of the claws 344a and 344b may be brought into contact with the second enlarged diameter portion 355. Inside the portion sandwiched in the circumferential direction between the opening 342a and the opening 342b of the outer needle hub 34, the first enlarged diameter portion 3531 of the flange portion 353 of the hemostatic valve holder 35 abuts against the inner peripheral surface of the hollow portion 3406 of the outer needle hub 34. And at this time, the large diameter portion 356 of the hemostatic valve holder 35 abuts against the hollow portion 3407 of the outer needle hub 34. Also, when the hemostatic valve holder 35 is properly positioned within the outer needle hub 34, the protrusion 343 of the outer needle hub fits into the recess 3571 of the collar portion 357 of the hemostatic valve holder 35.

[0080] In this way, the claws 344a and 344b of the outer needle hub 34 are fitted into the recess formed by the flange portion 353, the second middle diameter portion 354, and the second enlarged diameter portion 355 of the hemostatic valve holder 5, and the protrusion 343 of the outer needle hub 34 is fitted into the recess 3571 in the direction of the axis L1, so that the direction of the hemostatic valve holder 35 around the axis L1 can be guided in a certain direction. Therefore, the direction of the hemostatic valve 6 mounted on the hemostatic valve holder 35 around the axis L1 can be defined. Accordingly, the blood flowing from the outer needle 3 into the outer needle hub 4 can be smoothly moved to the branch portion 41, and the retention near the hemostatic valve 6 can be prevented. Here, the claws 344a and 344b of the outer needle hub 34 and the flange portion 353 of the hemostatic valve holder 35 define the axial relative position of the hemostatic valve and the hemostatic valve holder with respect to the outer needle hub. And the protrusion 343 and the recess 3571 define the relative position around the axis of the hemostatic valve and the hemostatic valve holder with respect to the outer needle hub. That is, the protrusion 343 constitutes a guide portion and a lock portion, the recess 3571 constitutes a guided portion, and both constitute a rotation prevention mechanism.

[0081] <Modification 5> With reference to FIGS. 13(A) to 13(D), the outer needle hub 74 and the hemostatic valve holder 75 according to Modification 5, which is a modification of Example 2, will be described. Since the hemostatic valve 6 and the other configurations of the indwelling needle are the same as those in the above-described examples, detailed descriptions thereof will be omitted. The same reference numerals are used for the same configurations as in Example 2 and Example 1. FIG. 13(A) is a plan view showing a state in which the hemostatic valve 6 and the hemostatic valve holder 75 are assembled to the outer needle hub 74 according to Modification 5, and FIG. 13(B) is a cross-sectional view of the outer needle hub 74 to which the hemostatic valve 6 and the hemostatic valve holder 75 are assembled taken along the A-A direction. FIG. 13(C) is a side view showing a state in which the hemostatic valve 6 and the hemostatic valve holder 75 are assembled to the outer needle hub 74 in the indwelling needle according to Modification 5, and FIG. 13(B) is a cross-sectional view of the outer needle hub 74 to which the hemostatic valve 6 and the hemostatic valve holder 75 are assembled taken along the B-B direction.

[0082] As shown in FIGS. 13(B) and 13(D), in Modification 5, a flange portion is not provided on the rear end side of the large-diameter portion 756 of the hemostatic valve holder 75, and the large-diameter portion 756 is provided up to the rear end. Further, the outer needle hub 74 according to Modification 5 has substantially the same configuration as that of Example 2, but the rear end side of the main body portion 40 extends along the direction of the axis L1, and the main body portion 40 extends to a position further rearward than the rear end of the appropriately positioned hemostatic valve holder 75. Furthermore, in Modification 5, the protrusion 343 is not provided on the outer needle hub 74. Note that the configuration of the hemostatic valve 6 according to Modification 6 is the same as that of Example 2 and Example 1.

[0083] In this way, by fitting the claws 344a and 344b of the outer needle hub 74 into the recess formed by the flange portion 353, the second medium-diameter portion 354, and the second enlarged-diameter portion 355 of the hemostatic valve holder 75, the axial positions of the hemostatic valve 6 and the hemostatic valve holder 75 can be defined. Also, the direction around the axis L1 of the hemostatic valve holder 75 can be guided in a certain direction by the hemostatic valve 6 and the peripheral wall portion of the outer needle hub 74.

[0084] <Modification 6> With reference to FIGS. 14 and 15, the outer needle hub 84 and the hemostatic valve holder 85 according to Modification 6, which is a modification of Example 2, will be described. Since the hemostatic valve 6 and the other configurations of the indwelling needle are the same as those in the above-described embodiments, detailed descriptions thereof will be omitted. The same reference numerals are used for the same configurations as those in the above-described embodiments.

[0085] FIG. 14(A) is a side view of the outer needle hub 84 with the hemostatic valve holder 85 assembled thereto, and FIG. 14(B) is an end view of the outer needle hub 84 with the hemostatic valve holder 85 assembled thereto, viewed from the proximal end side along the axis L1. FIG. 14(C) is a cross-sectional view of the outer needle hub 84 with the hemostatic valve holder 85 assembled thereto taken along the line A-A, and FIG. 14(D) is a cross-sectional view of the outer needle hub 84 with the hemostatic valve holder 85 assembled thereto taken along the line B-B. Also, FIG. 15(A) is a side view of the hemostatic valve holder 85, and FIG. 15(B) is an end view of the hemostatic valve holder 85, viewed from the proximal end side.

[0086] As shown in FIGS. 14(A) and 14(D), similar to Example 2, in the outer needle hub 84 according to Modification 6, substantially rectangular openings 342a and 342b are formed, and substantially rectangular claws 344a and 344b are provided in the openings 342a and 342b so as to be elastically deformable. Note that the outer needle hub 84 according to Modification 6 is not provided with the protrusion 343.

[0087] As shown in FIG. 15(A), in the hemostatic valve holder 85, a cylindrical middle diameter portion 352 is provided on the rear end side of the small diameter portion 51, a diameter-expanded portion 853 that expands in diameter toward the rear end side, a large diameter portion 854, and a flange portion 856 that protrudes to the outer diameter side are provided. On the front end side of the large diameter portion 854, a recess 855a and a recess 855b are provided adjacent to the diameter-expanded portion 253. The recess 855a has, at the front end side, an end surface 8551a that extends from the outer surface of the large diameter portion 854 toward the inner diameter side, a bottom portion 8552a that is continuous with the end portion on the inner diameter side of the end surface 8551a, side surfaces 8553a and 8554a that are continuous from both circumferential end portions of the end surface 8551a, respectively, and a slope portion 8555a that slopes toward the outer diameter side from the bottom portion 8552a toward the rear end side and is continuous with the outer surface of the large diameter portion. Similarly, the recess 855b has an end surface 8551b, a bottom portion 8552b, side surfaces 8553b and 8554b, and a slope portion 8555b. The recesses 855a and 855b are provided at positions symmetric with respect to the axis L1.

[0088] When the hemostatic valve holder 85 is press-fitted into the opening on the rear end side of the outer needle hub 84 from the small diameter portion 51, the tip portions 3441a and 3441b of the claws 344a and 344b of the outer needle hub 84 are pressed to the outer diameter side by the diameter-expanded portion 853 of the hemostatic valve holder 85 and elastically deformed. When the hemostatic valve holder 85 is further pushed toward the front end side of the outer needle hub 84 and the claws 344a and 344b reach the recesses 855a and 855b, respectively, the claws 344a and 344b elastically return and bend toward the inner diameter side, and the tip portions 3441a and 3441b of the claws 344a and 344b abut against the bottom portions 8552a and 8552b. Thereby, the claws 344a and 344b of the outer needle hub 84 are fitted into the recesses 855a and 855b of the hemostatic valve holder 85.

[0089] In this way, by fitting the claws 344a and 344b of the outer needle hub 84 into the recesses 855a and 855b of the hemostatic valve holder 85, the direction around the axis L1 of the hemostatic valve holder 85 can be guided in a fixed direction. Therefore, the direction around the axis L1 of the hemostatic valve 6 attached to the hemostatic valve holder 85 can be defined. Accordingly, the blood flowing from the outer needle 3 into the outer needle hub 84 can be smoothly moved to the branch portion 41, and the retention near the hemostatic valve 6 can be prevented. Here, the claws 344a and 344b of the outer needle hub 84 constitute a guide portion. And the recesses 855a and 855b constitute a guided portion, and the claws 344a and 344b of the outer needle hub 84 and the recesses 855a and 855b of the hemostatic valve holder 85 constitute an anti-rotation mechanism. Further, the recesses 855a and 855b of the hemostatic valve holder 85 constitute a lock portion that restricts the relative movement in the axis L1 direction with respect to the outer needle hub 4 by fitting with the claws 344a and 344b of the outer needle hub 4.

[0090] <Modification Example 7> Hereinafter, Modification Example 7, which is a modification of Example 1 and Example 2, will be described. The same components as those in Example 1 and Example 2 will be denoted by the same reference numerals, and detailed descriptions thereof will be omitted. FIG. 16 is a plan view of an outer needle hub 94 to which the hemostatic valve 6 according to Modification Example 7 is attached. FIG. 17 is a cross-sectional view of the outer needle hub 94 to which the hemostatic valve 6 according to Modification Example 7 is attached, taken along the line C-C. As described in Example 1 and Example 2, instead of attaching the hemostatic valve holder 5 to which the hemostatic valve 6 is attached to the outer needle hub 4, as shown in FIG. 17, first, a case where only the hemostatic valve 6 is attached to the outer needle hub 94 can also be considered. In this case, as shown in FIGS. 18(A) to 18(C), an anti-rotation mechanism can also be provided for the hemostatic valve 6. FIGS. 18(A) to 18(C) show the hemostatic valve 6 and the outer needle hub 94 in the cross-section taken along the line E-E of FIG. 17. In this way, the hemostatic valve 6 can be attached to the outer needle hub 94, and then the hemostatic valve holder 5 can be press-fitted and assembled to the outer needle hub 94, or the hemostatic valve 6 can be made thicker and the hemostatic valve holder 5 can be omitted.

[0091] In FIG. 18(A), ribs 60a, 60b, and 60c in the axial direction of the axis L1 are provided at three circumferential positions of the cylindrical portion 60 of the hemostatic valve 6, and grooves 405a, 405b, and 405c in the axial direction of the axis L1 are provided at positions corresponding to the ribs 60a, 60b, and 60c on the inner peripheral surface of the hollow portion 405 of the main body portion 40 of the outer needle hub 94. When the hemostatic valve 6 is press-fitted into the hollow portion 405 of the main body portion 40 of the outer needle hub 94, the ribs 60a, 60b, and 60c of the hemostatic valve 6 are respectively fitted into the grooves 405a, 405b, and 405c on the inner peripheral surface of the hollow portion 405, and the hemostatic valve 6 is moved in the axial direction of the axis L1, whereby the hemostatic valve 6 can be attached to the outer needle hub 94 without rotating around the axis L1. That is, the grooves 405a, 405b, and 405c on the inner peripheral surface of the hollow portion 405 of the outer needle hub 94 can guide the direction of the hemostatic valve 6 around the axis L1 in a certain direction. For this reason, the direction of the hemostatic valve 6 around the axis L1 can be defined. Therefore, the blood flowing from the outer needle 3 into the outer needle hub 94 can be smoothly moved to the branch portion 41, and the retention near the hemostatic valve 6 can be prevented. Here, the grooves 405a, 405b, and 405c on the inner peripheral surface of the hollow portion 405 of the outer needle hub 94 constitute a guide portion. And the ribs 60a, 60b, and 60c of the hemostatic valve 6 constitute a guided portion, and the ribs 60a, 60b, and 60c and the grooves 405a, 405b, and 405c on the inner peripheral surface of the hollow portion 405 constitute a rotation prevention mechanism. Note that the positions of the ribs 60a, 60b, and 60c of the hemostatic valve 6 are not limited to the case where they are arranged at equal intervals in the circumferential direction of the cylindrical portion 60, and they may be arranged at different intervals in the circumferential direction of the cylindrical portion 60. In this case, the grooves 405a, 405b, and 405c on the inner peripheral surface of the main body portion 40 of the outer needle hub 94 are also provided at positions corresponding to the ribs 60a, 60b, and 60c of the hemostatic valve 6. Also, the guide portion may extend to the proximal end of the outer needle hub 94.

[0092] In Fig. 18(B), grooves 60d, 60e, and 60f in the axial direction of axis L1 are provided at three circumferential positions of the cylindrical portion 60 of the hemostatic valve 6, and ribs 405d, 405e, and 405f in the axial direction of axis L1 are provided at positions on the inner peripheral surface of the hollow portion 405 of the main body portion 40 of the outer needle hub 94 corresponding to the grooves 60d, 60e, and 60f. When the hemostatic valve 6 is press-fitted into the hollow portion 405 of the main body portion 40 of the outer needle hub 4, the hemostatic valve 6 can be attached to the outer needle hub 94 without rotating the hemostatic valve 6 around the axis L1 by moving the hemostatic valve 6 in the axial direction of axis L1 while fitting the grooves 60d, 60e, and 60f of the hemostatic valve 6 to the ribs 405d, 405e, and 405f on the inner peripheral surface of the hollow portion 405, respectively. That is, the ribs 405d, 405e, and 405f on the inner peripheral surface of the hollow portion 405 of the outer needle hub 94 can guide the direction of the hemostatic valve 6 around the axis L1 in a certain direction. For this reason, the direction of the hemostatic valve 6 around the axis L1 can be defined. Therefore, the blood flowing from the outer needle 3 into the outer needle hub 94 can be smoothly moved to the branch portion 41, and the retention near the hemostatic valve 6 can be prevented. Here, the ribs 405d, 405e, and 405f on the inner peripheral surface of the hollow portion 405 of the outer needle hub 94 constitute a guide portion. Further, the grooves 60d, 60e, and 60f of the hemostatic valve 6 constitute a guided portion, and the grooves 60d, 60e, and 60f and the ribs 405d, 405e, and 405f on the inner peripheral surface of the hollow portion 405 constitute an anti-rotation mechanism. Note that the positions of the grooves 60d, 60e, and 60f of the hemostatic valve 6 are not limited to the case where they are arranged at equal intervals in the circumferential direction of the cylindrical portion 60, and they may be arranged at different intervals in the circumferential direction of the cylindrical portion 60. In this case, the ribs 405d, 405e, and 405f on the inner peripheral surface of the main body portion 40 of the outer needle hub 94 are also provided at positions corresponding to the grooves 60d, 60e, and 60f of the hemostatic valve 6. Further, the guide portion may extend to the proximal end of the outer needle hub 94.

[0093] In FIG. 18(C), the shape of the cylindrical portion 60 of the hemostatic valve 6 is a triangular cylinder shape with rounded corners, and the shape of the hollow portion 405 of the main body portion 40 of the outer needle hub 94 is a triangular prism shape with rounded corners. The hemostatic valve 6 having such a shape is configured such that a portion where the distance from the axis L1 to the outer peripheral surface of the cylindrical portion 60 is long and a portion where the distance is short appear at different positions in the circumferential direction. When the hemostatic valve 6 is press-fitted into the hollow portion 405 of the main body portion 40 of the outer needle hub 94, while the outer shape of the cylindrical portion 60 of the hemostatic valve 6 is made to conform to the inner peripheral shape of the hollow portion 405, the hemostatic valve 6 is moved in the direction of the axis L1, whereby the hemostatic valve 6 can be attached to the outer needle hub 94 without rotating around the axis L1. That is, the inner peripheral shape of the hollow portion 405 of the outer needle hub 94 can guide the direction around the axis L1 of the hemostatic valve 6 in a fixed direction. For this reason, the direction around the axis L1 of the hemostatic valve 6 can be defined. Therefore, the blood that has flowed from the outer needle 3 into the outer needle hub 94 can be smoothly moved to the branch portion 41, and retention near the hemostatic valve 6 can be prevented. Here, the inner peripheral shape of the hollow portion 405 constitutes a guide portion. And the outer shape of the cylindrical portion 60 of the hemostatic valve 6 constitutes a guided portion, and the outer shape of the cylindrical portion 60 and the inner peripheral shape of the hollow portion 405 constitute an anti-rotation mechanism. Note that the shape of the cylindrical portion 60 of the hemostatic valve 6 is not limited to the above-described shape, and a shape in which a portion where the distance from the axis L1 to the outer peripheral surface of the cylindrical portion 60 is long and a portion where the distance is short appear at unequal intervals in the circumferential direction, respectively, or a shape in which the length of the distance from the axis L1 to the outer peripheral surface of the cylindrical portion 60 is different in the circumferential direction may also be used. It is also possible to provide the guided portion described in FIGS. 18(A) to 18(C) on the hemostatic valve holder.

[0094] <Modification Example 8> Hereinafter, Modification Example 8, which is a modification example for Example 1 and Example 2, will be described. The same components as those in Example 1 and Example 2 will be denoted by the same reference numerals, and detailed description thereof will be omitted. FIG. 19 is an exploded perspective view of an outer needle hub 104, a hemostatic valve 6, and a hemostatic valve holder 105 according to Modification Example 8. As shown in FIG. 19, a display 45 for aligning the relative positional relationship in the rotational direction around the axis L1 is provided on the outer peripheral surface of the rear end side of the main body portion 40 of the outer needle hub 104. Displays for aligning the relative positional relationship in the rotational direction around the axis L1 are also provided at corresponding positions on the outer peripheral surfaces of the enlarged diameter portion 52 and the large diameter portion 53 of the hemostatic valve holder 105. When attaching the hemostatic valve holder 105 with the hemostatic valve 6 attached to the outer needle hub 104, referring to these displays 45 and 57 so that the direction of the display 45 of the outer needle hub 104 coincides with the direction of the display 57 of the hemostatic valve holder 105, while maintaining the posture of the hemostatic valve holder 105 with respect to the outer needle hub 104, the hemostatic valve holder 105 is press-fitted from the opening at the rear end side of the outer needle hub 104, thereby preventing the rotation of the hemostatic valve 6 and the hemostatic valve holder 105 around the axis L1. That is, the display 45 of the outer needle hub 104 can guide the direction of the hemostatic valve holder 105 around the axis L1 in a fixed direction. For this reason, the direction of the hemostatic valve 6 around the axis L1 can be defined. Therefore, the blood flowing into the outer needle hub 104 from the outer needle 3 can be smoothly moved to the branch portion 41, and stagnation near the hemostatic valve 6 can be prevented. Here, the display 45 of the outer needle hub 104 constitutes a guide portion. And the display 57 of the hemostatic valve holder 105 constitutes a guided portion. The display 45 of the outer needle hub 104 and the display 57 of the hemostatic valve holder 105 constitute a rotation prevention mechanism. The display for aligning with the display of the outer needle hub 104 may be provided on the outer peripheral surface of the cylindrical portion 60 of the hemostatic valve 6, or may be provided on the outer peripheral surfaces of both the hemostatic valve 6 and the hemostatic valve holder 105. Also, the content of the display can use characters, symbols, figures, etc., and the form is not limited as long as it can be recognized by the operator. Also, the display is not limited to being two-dimensionally represented by printing or the like, and may be three-dimensionally represented.

[0095] (Example 3) Hereinafter, the indwelling needle according to Example 3 of the present invention will be described. Regarding the same configurations as in Examples 1 and 2, the description will be omitted using the same reference numerals. Regarding the inner needle 2 and the inner needle hub 21 of the indwelling needle, since they are the same as in Example 1, the description will be omitted.

[0096] The outer needle hub 34 according to Example 3 is the same as that of Example 2 shown in FIG. 11, but the hemostatic valve 16 and the hemostatic valve holder 115 are different from those of Example 1 and Example 2. FIG. 20(A) shows a plan view of the outer needle hub 34 with the hemostatic valve 16 and the hemostatic valve holder 115 of Example 3 assembled thereto, and FIG. 20(B) shows a cross-sectional view taken along line A-A thereof. FIG. 21(A) shows a side view of the outer needle hub 34 with the hemostatic valve 16 and the hemostatic valve holder 115 of Example 3 assembled thereto, and FIG. 21(B) shows a cross-sectional view taken along line B-B thereof. FIG. 22(A) shows a perspective view of the hemostatic valve 16 of Example 3, and FIG. 22(B) shows a cross-sectional view taken along line A-A thereof. FIG. 23(A) shows a side view of the hemostatic valve holder 115 of Example 3, and FIG. 23(B) shows a side view of the hemostatic valve holder 125 of the reference example. FIG. 24(A) shows a cross-sectional view taken along line A-A of the outer needle hub 34 with the hemostatic valve 26 and the hemostatic valve holder 125 of the reference example assembled thereto, and FIG. 24(B) shows a cross-sectional view taken along line B-B thereof.

[0097] As shown in Fig. 22(A), similar to those in the first and second embodiments, the hemostatic valve 16 has a first end face 61, a stepped portion 62, and a second end face 63 on the tip side. The slit 164 of the hemostatic valve 16 is provided in a direction perpendicular to the plane including the axis L1 and the axis L2, and the direction of this slit 64 is perpendicular to the direction of the slit 64 of the hemostatic valve 6 in the first embodiment. Since the central base end face 66 of the hemostatic valve 6 according to the first and second embodiments was formed to be inclined in the direction of the axis L1 parallel to the first end face 61 and the second end face 63, the flexible solid portion 631 sandwiched between the first end face 61 and the second end face 63 and the central base end face 66 was thin. In contrast, as shown in Fig. 22(B), in the hemostatic valve 16, the central base end face 166 is not parallel to the first end face 61 and the second end face 63, but is formed perpendicular to the direction of the axis L1. Therefore, in the hemostatic valve 16, the flexible solid portion 1631 sandwiched between the first end face 61 and the second end face 63 and the central base end face 166 is formed thick. Here, among the first end face 61 of the hemostatic valve 16, the portion that is connected to the cylindrical portion 160 at the most proximal end side is called the end point 61a of the first end face 61. A position that is symmetric with respect to the axis L1 with respect to this end point of the first end face 61 and is connected to the cylindrical portion 160 at the most distal end side is called the starting point 61b of the first end face 61. In the hemostatic valve 16, the cylindrical portion 160 has a first cylindrical portion 1601 having a solid portion 1631 on the inner diameter side and a second cylindrical portion 1602 that extends from the first cylindrical portion 1601 along the axis L1 direction toward the proximal end side and has a hollow inner diameter side. Here, the second cylindrical portion 1602 corresponds to the cylindrical portion of the present invention. Also, in the hemostatic valve 16, among the cylindrical portion 160, the length in the axis L1 direction of the portion extending from the end point 61a of the first end face 61 toward the proximal end side (which corresponds to the second cylindrical portion 1602 here) is set to be longer than the length in the axis L1 direction of the portion extending from the end point 61a of the first end face 61 toward the proximal end side among the cylindrical portions 60 according to the first and second embodiments. The portion extending from the end point 61a of the first end face 61 toward the proximal end side has a length of 1 mm or more in the axis L1 direction from the end point 61a of the first end face 61, preferably a length of 2 mm or more. Further, in the second cylindrical portion 1602 of the hemostatic valve 16, a thick portion 1602a with an increased radial wall thickness is provided on the proximal end side along the axis L1 direction with respect to the end point of the first end face 61.As the thick portion 1602a, a large-diameter portion having a rectangular cross-section and convex on the outer diameter side is formed over the entire circumference around the axis L1. The thick portion 1602a is provided on the rear end side of the second cylindrical portion 1602. The outer diameter of the thick portion 1602a is set to be larger than the inner diameter of the portion of the hollow portion 3405 of the outer needle hub 34 that faces the thick portion 1602a when the hemostatic valve 16 is properly positioned on the outer needle hub 34. Also, the radial thickness of the thick portion 1602a is such that when the hemostatic valve 16 and the hemostatic valve holder 115 are properly positioned on the outer needle hub 34, it is larger than the distance between the small-diameter portion 1151 of the hemostatic valve holder 115 that supports the second cylindrical portion 1602 from the inner diameter side and the inner peripheral surface of the hollow portion 3405 of the outer needle hub 34 that faces the small-diameter portion 1151 through the second cylindrical portion 1602. The configuration is not limited to one in which the wall thickness in the direction of the axis L1 is constant like the cross-sectional shape of the thick portion 1602a, and an appropriate shape can be adopted. Among the second cylindrical portion 1602, the region where the thick portion 1602a is formed is not limited to the rear end side region, and can be provided in an appropriate region of a part or all of the region from the end point 61a of the first end face 61 to the rear end side end face 165. Also, among the second cylindrical portion 1602, the region where the thick portion 1602a is formed is not limited to the entire circumference around the axis L1, and can be provided in a part of the circumferential direction including the region from the end point 61a of the first end face 61 to the rear end side end face 165, that is, the region in the direction in which the branch portion 41 branches.

[0098] In accordance with the configuration of the flexible solid portion 1631 and the central base end face 166 of the hemostatic valve 16 as described above, as shown in FIG. 23(A), the small-diameter portion 1151 of the hemostatic valve holder 115 has a cylindrical shape, and a substantially annular end face 1151a is formed in a direction perpendicular to the axis L1 at the end on the tip side of the small-diameter portion 1151. A protrusion 1151b protruding in the direction of the axis L1 is formed on the end face 1151a. The protrusion 1151b is provided on the side opposite to the recess 3571 with respect to the axis L1. The shape of the protrusion 1151b is not limited, but it is desirable that the tip portion has an R shape. An annular protrusion 1151c protruding in the direction of the axis L1 is provided on the end face 1151a in the same manner as the protrusion 1151b. The annular protrusion 1151c is formed over the entire outer peripheral edge of the end face 1151a. In addition to the shape of the end on the tip side of the small-diameter portion 1151 of the hemostatic valve holder 115 being different from that of the hemostatic valve holder 35, the length of the small-diameter portion 1151 in the direction of the axis L1 is set to be longer than the small-diameter portion 51 of the hemostatic valve holder 35. Here, the small-diameter portion 1151 corresponds to the mounted portion of the present invention. From the end face 1152a provided on the base end side of the small-diameter portion 1151 of the hemostatic valve holder 115 to the base end side, it is configured in the same manner as the hemostatic valve holder 35, except that the length of the large-diameter portion 1152 in the direction of the axis L1 is shorter than that of the hemostatic valve holder 35.

[0099] The outer dimensions of the small-diameter portion 1151 of the hemostatic valve holder 115 are set to be slightly smaller than the inner diameter dimensions of the cylindrical portion 160 of the hemostatic valve 16. When the small-diameter portion 51 of the hemostatic valve holder 115 is inserted into the inside of the cylindrical portion 160 of the hemostatic valve 16 from the tip side, due to the elastic deformation of the cylindrical portion 160 of the hemostatic valve 16 that tends to reduce its diameter while slightly expanding on the outer diameter side, a frictional force acts between the inner peripheral surface of the cylindrical portion 160 of the hemostatic valve 16 and the outer peripheral surface of the small-diameter portion 1151 of the hemostatic valve holder 115. Until the end face 165 on the rear end side of the cylindrical portion 160 of the hemostatic valve 16 abuts against the end face 1151a which is the front end face of the hemostatic valve holder 115, when the hemostatic valve holder 115 is inserted into the hemostatic valve 16, the end face 1151a of the hemostatic valve holder 115 abuts against the central base end face 166 of the hemostatic valve 16, and the protrusion 1151b of the hemostatic valve holder 115 presses the central base end face 166. When the protrusion 1151b properly assembles the hemostatic valve 16 to the hemostatic valve holder 115, it coincides with the direction in which the first end face 61 and the second end face 63 of the hemostatic valve 16 are located on the most tip side around the axis L1. Therefore, the protrusion 1151b functions as a guide when assembling the hemostatic valve 16 to the hemostatic valve holder 115 in a predetermined direction around the axis L1. Also, since the protrusion 1151b presses and slightly deforms the central base end face 166 of the hemostatic valve 16, it constitutes a rotation prevention mechanism that restricts the relative rotation around the axis L1 between the hemostatic valve holder 115 and the hemostatic valve 16. Also, since the annular protrusion 1151c also presses and slightly deforms the central base end face 166 of the hemostatic valve 16, it can prevent the displacement between the hemostatic valve holder 115 and the hemostatic valve 16, and suppress the generation of a gap that causes liquid leakage between the hemostatic valve 16 and the outer needle hub 34.

[0100] Also, as shown in FIG. 22(B), in the hemostatic valve 16, the central base end surface 166 is located in the vicinity of the proximal side of the end point 61a of the first end surface 61 along the direction of the axis L1, and the end surface 1151a of the hemostatic valve holder 115 is fitted into this position. Therefore, when the hemostatic valve 16 is properly attached to the hemostatic valve holder 115, the small-diameter portion 1151 of the hemostatic valve holder 115 is disposed on the inner diameter side of the second cylindrical portion 1602 of the hemostatic valve 16, and the second cylindrical portion 1602 is supported by the small-diameter portion 1151 from the inner diameter side. As described above, the radial thickness of the thick portion 1602a is set to be larger than the distance between the small-diameter portion 1151 of the hemostatic valve holder 115 that supports the second cylindrical portion 1602 from the inner diameter side and the inner peripheral surface of the hollow portion 3405 of the outer needle hub 34 that faces the small-diameter portion 1151 via the second cylindrical portion 1602 when the hemostatic valve 16 and the hemostatic valve holder 115 are properly positioned on the outer needle hub 34. For this reason, as shown in FIGS. 20(B) and 21(B), when the hemostatic valve holder 115 to which the hemostatic valve 16 is attached is properly positioned with respect to the outer needle hub 34, the thick portion 1602a is compressed between the hemostatic valve holder 115 and the inner peripheral surface of the hollow portion 3405 of the outer needle hub 34. When the thick portion 1602a of the hemostatic valve 16 is compressed in the radial direction, due to the elastic force, the thick portion 1602a is pressed against the inner peripheral surface of the hollow portion 3405 of the outer needle hub 34, so that the gap between the cylindrical portion 160 of the hemostatic valve 16 and the hollow portion 3405 of the outer needle hub 34 is sealed. Therefore, even if a gap occurs due to play, misalignment, or deformation of the hemostatic valve 16 between the step portion 62 and the first end surface 61 of the hemostatic valve 16 and the opening 404 and the step portion 406 of the outer needle hub 34, and further between the cylindrical portion 160 of the hemostatic valve 16 and the inner peripheral surface of the hollow portion 3405 of the outer needle hub 34, it is possible to suppress the fluid flowing through the hollow portion 400 and the hollow portion 410 from leaking to the proximal side beyond the thick portion 1602a of the hemostatic valve 16.

[0101] FIG. 23(B) shows a side view of the hemostatic valve holder 125 of the reference example. And FIG. 24(A) shows an A-A cross-sectional view (see FIG. 20(A)) of a state where the hemostatic valve holder 125 to which the hemostatic valve 26 of the reference example is attached is properly assembled to the outer needle hub 34, and FIG. 24(B) shows the same B-B cross-sectional view (see FIG. 21(B)). The same reference numerals are used for the same configurations as in the first to third embodiments.

[0102] Similar to the hemostatic valve 16, the central base end face 266 of the hemostatic valve 26 is formed in a direction perpendicular to the direction of the axis L1. Correspondingly, the end face 151a on the tip side of the small-diameter portion 1251 of the hemostatic valve holder 125 is also formed in a direction perpendicular to the direction of the axis L1. Further, a protrusion 1251b protruding in the direction of the axis L1 is formed on the end face 1251a of the hemostatic valve holder 125. The shape and function of the protrusion 1251b are the same as those of the protrusion 1151b. In the hemostatic valve 26, the axial length of the first cylindrical portion 2601 of the cylindrical portion 260 is the same as the axial length of the first cylindrical portion 1601 of the hemostatic valve 16 in the direction of the axis L1, but the axial length of the second cylindrical portion 2602 in the direction of the axis L1 is set to be shorter than the axial length of the second cylindrical portion 1602 of the hemostatic valve 16 in the direction of the axis L1. Correspondingly, the axial length of the small-diameter portion 1251 of the hemostatic valve holder 125 is shorter than that of the small-diameter portion 1151 of the hemostatic valve holder 115, and the axial length of the large-diameter portion 1252 of the hemostatic valve holder 125 is set to be longer than that of the large-diameter portion 1152 of the hemostatic valve holder 115.

[0103] As in the hemostatic valve 26 of the reference example, when the length from the end point 61a of the first end face 61 to the end face 265 on the rear end side in the cylindrical portion 260 is short, for example, less than 1 mm, between the stepped portion 62 and the first end face 61 of the hemostatic valve 26, and the opening 404 and the stepped portion 406 of the outer needle hub 34, and further between the cylindrical portion 260 of the hemostatic valve 26 and the inner peripheral surface of the hollow portion 3405 of the outer needle hub 34, if a gap is generated due to looseness of components, misalignment, deformation of the hemostatic valve 16, etc., the fluid flowing through the hollow portion 400 and the hollow portion 410 may leak to the proximal end side beyond the second cylindrical portion 2602 of the hemostatic valve 26.

[0104] The hemostatic valve 16 and the hemostatic valve holder 115 of Example 3 solve the problems caused by the hemostatic valve 26 of the reference example by setting the length of the second cylindrical portion 1602 extending from the end point 61a of the first end face 61 to the proximal end side to be 1 mm or more, preferably 2 mm or more.

[0105] <Modification Example 10> In Example 3, the central base end face 166 of the hemostatic valve 26 is formed in a direction perpendicular to the axis L1 direction. However, it can also be applied when the central base end face 66 of the hemostatic valve 6 in Example 1, Example 2, and their modified examples is inclined with respect to the axis L1 direction and is formed parallel to the first end face 61 and the second end face 63. Regarding the hemostatic valve 6, the entire inner diameter side of the cylindrical portion 60 extending from the solid portion 631 to the base end side in the axis L1 direction is hollow. Among the cylindrical portion 60, the portion on the tip side of the end point 61a of the first end face 61 is defined as the first cylindrical portion, and the portion extending from the end point 61a to the base end side is defined as the second cylindrical portion. The length of the second cylindrical portion of the hemostatic valve 6 defined in this way is set to 1 mm or more, preferably 2 mm or more, and a thick portion is provided in the second cylindrical portion. In this case, the length of the small diameter portion 51 of the hemostatic valve holders 5, 15, 25, 35, 75, 85, 105 in the axis L1 direction is also set to correspond to the length of the second cylindrical portion in the axis L1 direction. Thereby, even if a gap is generated between the stepped portion 62 and the first end face 61 of the hemostatic valve 6 and the opening 404 and the stepped portion 406 of the outer needle hub 34, and further between the cylindrical portion 60 of the hemostatic valve 6 and the inner peripheral surface of the hollow portion 3405 of the outer needle hub 34 due to looseness, misalignment, or deformation of the hemostatic valve 6 of the components, it is possible to suppress the fluid flowing through the hollow portion 400 and the hollow portion 410 from leaking to the base end side beyond the thick portion 1602a of the hemostatic valve 6. Here too, the second cylindrical portion defined as described above corresponds to the cylindrical portion of the present invention.

[0106] The embodiments and modified examples disclosed above can be combined with each other.

Explanation of reference numerals

[0107] 1... Indwelling needle 2... Inner needle 3... Outer needle 4, 34, 74, 84... Outer needle hub 5, 15, 25, 35, 75, 85... Hemostatic valve holder 6... Hemostatic valve 40... Body portion 41... Branch portion 42a, 42b, 342a, 342b... Opening 43... Slit 44... Display 51 ··· Small diameter part 55a, 55b ··· Protrusions 56 ··· Rib 57 ··· Display 60a, 60b, 60c ··· Ribs 60d, 60e, 60f ··· Grooves 344a, 344b ··· Claws 344 ··· Protrusion 405a, 405b, 405c ··· Grooves 405d, 405e, 405f ··· Ribs

Claims

1. An inner needle to be punctured into a living body, an outer needle that is penetrated by the inner needle and inserted into the living body together with the inner needle when the inner needle punctures the living body, a main body portion arranged along the axis of the inner needle, and a branch portion branching from the main body portion, and an outer needle hub having a flow path communicating with the inside of the outer needle, an elastic member disposed inside the outer needle hub, having a flexible solid portion that seals the flow of fluid to the proximal end side of the main body portion when the inner needle penetrates and is removed, and a holder attached to the proximal end of the elastic member, the elastic member forms at least a part of the flow path communicating the inside of the outer needle and the branch portion, and has an end face inclined with respect to the axial direction, the outer needle hub has a guide portion that engages with the elastic member or the holder to guide the axial rotation direction of the elastic member in a fixed direction, the elastic member has the end face exposed to the flow path, the guide portion positions the elastic member in the axial rotation direction such that the end face faces the branch portion side. A retention needle characterized by this.

2. An inner needle to be punctured into a living body, an outer needle that is penetrated by the inner needle and inserted into the living body together with the inner needle when the inner needle punctures the living body, a main body portion arranged along the axis of the inner needle, and a branch portion branching from the main body portion, and an outer needle hub having a flow path communicating with the inside of the outer needle, an elastic member disposed inside the outer needle hub, having a flexible solid portion that seals the flow of fluid to the proximal end side of the main body portion when the inner needle penetrates and is removed, the elastic member forms at least a part of the flow path communicating the inside of the outer needle and the branch portion, and has an end face inclined with respect to the axial direction, the outer needle hub has a guide portion that engages with the elastic member to guide the axial rotation direction of the elastic member in a fixed direction, the elastic member has the end face exposed to the flow path, the guide portion positions the elastic member in the axial rotation direction such that the end face faces the branch portion side. A retention needle characterized by this.

3. An inner needle to be punctured into a living body, an outer needle that is penetrated by the inner needle and inserted into the living body together with the inner needle when the inner needle punctures the living body, a main body portion arranged along the axis of the inner needle, and a branch portion branching from the main body portion, and an outer needle hub having a flow path communicating with the inside of the outer needle, An elastic member disposed inside the outer needle hub, having a flexible solid part through which the inner needle penetrates and seals the flow of fluid to the proximal end side of the main body when the inner needle is removed. The tip of the elastic member has a central part and an outer peripheral part that project to the tip side and form at least a part of the flow path that communicates the inside of the outer needle and the branch part, and has an end face inclined with respect to the axial direction. The outer needle hub is characterized in that a peripheral wall part having a base end face facing the tip end face of the outer peripheral part is formed on the inner surface, and at least a part of the central part is located on the inner surface of the peripheral wall part.

4. The holder has a mounted part on which the elastic member is mounted. The elastic member is a cylindrical part supported on the inner diameter side by the mounted part on the proximal end side of the solid part, and has a radial thickness larger than the distance between the mounted part and the surface of the outer needle hub facing the mounted part in the radial direction in a state before being assembled to the outer needle hub. The indwelling needle according to claim 1, characterized by having a cylindrical part.

5. It has a holder mounted on the proximal end of the elastic member and having a mounted part on which the elastic member is mounted. The elastic member is a cylindrical part supported on the inner diameter side by the mounted part on the proximal end side of the solid part, and has a radial thickness larger than the distance between the mounted part and the surface of the outer needle hub facing the mounted part in the radial direction in a state before being assembled to the outer needle hub. The indwelling needle according to claim 2 or 3, characterized by having a cylindrical part.

Citation Information

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