JP2014068711A - Indwelling needle - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an indwelling needle, even when a protector for covering the needle is made of resin, capable of retaining high dimension accuracy of the protector with respect to the needle.SOLUTION: An indwelling needle 1 includes: a hollow resin needle 14; a resin needle hub 16 provided at a proximal end of the resin needle 14 and having an internal space 54 in communication with the resin needle 14; a metal needle 10 inserted into the resin needle 14; a protector 18 coveringly molded in contact with a part of the metal needle 10 by insertion molding of a nonbonding resin with respect to the metal needle 10, being movable relative to the metal needle 10, capable of including a needle tip 20 of the metal needle 10, and capable of being contained in the internal space 54; and a locking part 22 that is constituted of a bondable resin with respect to the metal needle 10, bonded to a part of the metal needle 10 to be coveringly molded, has such a dimension as entering the resin needle 14 and the internal space 54, and locks the protector 18.

Description

  The present invention relates to an indwelling needle that is inserted into a blood vessel during infusion or blood collection.

  An indwelling needle is used when performing treatment such as infusion or blood collection on a patient. The indwelling needle has a hollow outer needle hub in which a hollow outer needle extends from the tip, and an inner needle hub that is inserted into the outer needle and has a sharp needle tip extending from the tip. doing. An example of such an indwelling needle is disclosed in Patent Document 1.

  The indwelling needle is used as follows. First, the inner needle and the outer needle are both punctured into the patient's blood vessel. Next, the inner needle is pulled out from the blood vessel and also from the outer needle. As a result, only the outer needle is placed in the blood vessel. By placing the hollow outer needle in the blood vessel, blood can be collected from the patient's blood vessel via the outer needle, or liquid can be injected into the patient's blood vessel via the outer needle.

  By the way, if the inner needle pulled out from the outer needle remains exposed, there is a possibility that a doctor, a nurse, or the like may accidentally pierce a finger or the like with the needle tip of the inner needle. When the accident occurs, there is a risk that the blood adhering to the needle tip of the inner needle may infect a doctor or a nurse with a virus. Therefore, an indwelling needle is proposed in which a protector that covers and protects the inner needle so that the tip of the inner needle is not exposed when the inner needle is pulled out of the outer needle is attached. . An example of such an indwelling needle is disclosed in Patent Document 2.

JP 11-332991 A JP 2010-88521 A

  The indwelling needle disclosed in Patent Document 2 changes its posture between a posture in which the inner needle is exposed and a posture in which the inner needle is covered with a protector. In order to appropriately execute such a posture change, the indwelling needle disclosed in Patent Document 2 is configured such that the protector and the inner needle can move relative to each other and can move integrally. And in order to implement | achieve the said structure, the indwelling needle disclosed by patent document 2 is specifically comprised as follows.

  That is, the protector is formed with an insertion hole, and the inner needle is inserted through the insertion hole. An engaging portion is formed in the vicinity of the needle tip of the inner needle. The engaging part is formed by increasing the diameter of the vicinity of the needle tip of the inner needle as compared with other parts. The engagement portion having a larger diameter has a larger diameter than the insertion hole formed in the protector and cannot pass through the insertion hole. As described above, in the indwelling needle disclosed in Patent Document 2, the protector and the inner needle can be relatively moved in a state where the engaging portion is separated from the insertion hole. On the other hand, when the engaging portion presses the protector in a state where the engaging portion is in contact with the insertion hole, the protector and the inner needle can be integrally moved.

  Here, in the indwelling needle disclosed in Patent Document 2, the engagement portion abuts the insertion hole, and in order to ensure the posture in which the needle tip of the inner needle is covered by the protector, the inner needle and the insertion hole It is necessary to manage the difference in diameter with high accuracy. For this reason, protectors that require high dimensional accuracy are usually made of a metal such as stainless steel.

  However, while the metal protector has high dimensional accuracy, an expensive press die is required because the sheet metal process becomes complicated. In addition, in the configuration of the indwelling needle described above, it is necessary to pass the inner needle through the insertion hole of the protector, and the assembly process is complicated.

  The present invention has been made in view of the above problems, and its purpose is to make the protector that covers the needle a resin, while avoiding complication of the sheet metal process and the assembly process, and the dimensional accuracy of the protector with respect to the needle. It is to provide an indwelling needle that can maintain high.

  (1) a hollow resin needle, a hub provided at a base end portion of the resin needle and having an internal space communicating with the internal space of the resin needle, a metal needle inserted through the resin needle, It is molded so as to cover a part of the surface of the metal needle by insert molding a non-bonding resin with respect to the metal needle, and is movable in the axial direction of the metal needle with respect to the metal needle. There is an internal space that can contain the needle tip of the metal needle, and is provided between a protector having a size that can be accommodated in the internal space of the hub, and the needle tip of the metal needle and the protector, The resin needle and the hub have a size capable of entering the internal space of the hub, and a locking portion that locks the protector.

  According to this structure, the protector is comprised with resin. Therefore, in this structure, the complicated sheet metal process like the case where a protector is comprised with the metal is not required.

  Moreover, according to this structure, a protector is insert-molded with respect to a metal needle. Thereby, a protector can be easily shape | molded so that it may be in the state which contact | abutted with the metal needle and the metal needle was penetrated. That is, according to this structure, the complicated assembly | attachment process of letting a metal needle pass to a protector becomes unnecessary. Further, by forming the protector as described above, the difference between the diameter of the hole through which the metal needle is inserted in the protector and the diameter of the metal needle can be made substantially the same. That is, the dimensional accuracy of the hole of the protector with respect to the diameter of the metal needle can be maintained high.

  (2) The protector defines a base end side of the metal needle in the inner space of the protector, is longer than a diameter of a cross section of the metal needle along an orthogonal plane orthogonal to the axial direction, and the A base plate in which an opening having an inner diameter shorter than the distance between the center in the cross section of the locking portion along the orthogonal plane and the edge farthest from the center is formed, and the opening in the base plate is sandwiched A side plate extending from a position toward the needle tip side of the metal needle, wherein a gap between the metal needles on the needle tip side is a first width through which the metal needle can pass, and the gap Includes a side plate that is narrower than the first width and changes its posture to a second posture that is a second width through which the metal needle cannot pass. The side plate is in the first posture in a state where the metal needle is inserted into the gap, and when the needle tip of the metal needle passes through the gap and enters the internal space of the protector from the outside of the protector, The posture changes from the first posture to the second posture.

  According to this configuration, when the needle tip of the metal needle passes through the gap between the side plates and enters the internal space of the protector, the side plate changes its posture from the first posture to the second posture. This makes it impossible for the needle tip of the metal needle to pass through the gap from the interior space of the protector and be exposed to the outside of the protector. As a result, it is possible to maintain a state in which the needle tip of the metal needle is accommodated in the internal space of the protector. That is, the metal needle can be prevented from being exposed to the outside.

  (3) The locking portion is formed so as to cover a part of the surface of the metal needle, and is an adhesive resin with respect to the metal needle.

  According to this configuration, even if the locking portion is resin, the locking portion is joined to the metal needle. Therefore, the latching | locking part can latch the protector which moves relatively with respect to a metal needle.

  (4) The metal needle has a rough surface formed by etching the surface. The protector is made of a resin that is non-bonding to the rough surface. The locking portion is made of a resin that is bondable to the rough surface.

  According to this configuration, for example, the metal needle and the locking portion are joined by the resin constituting the locking portion entering the rough concave portion formed on the surface of the metal needle. That is, the metal needle and the locking portion are physically joined. For this reason, according to this structure, while joining of a metal needle and a latching | locking part can be strengthened, the time-dependent deterioration of the said joint can be decreased.

  Further, since the protector is made of a resin that is non-bonding to the rough surface, the protector can be configured to be movable relative to the metal needle.

  (5) The indwelling needle of the present invention is formed so as to cover a part of the metal needle on the proximal end side of the metal needle with respect to the protector, and is made of a resin that is non-bonding to the rough surface. And a cover member that can be moved relative to the metal needle in the axial direction to cover the protector and can be fitted to the hub while being accommodated in the internal space of the hub. Yes. The side plate is elastically changed to the first posture and the second posture, and is biased toward the first posture. The covering member includes the resin needle, the hub provided on the resin needle, and the covering member fitted to the hub against the protector abutted on the metal needle and the locking portion. When the metal plate is moved relative to the needle tip side, the side plate is pressed from the outside to change the posture from the first posture to the second posture.

  According to this structure, a side plate maintains a 2nd attitude | position by being pressed by the coating | coated member. Therefore, according to this configuration, it is possible to prevent the side plate in the second posture from being erroneously changed to the first posture.

  (6) The needle tip portion of the metal needle is formed as a smooth surface by being not etched.

  When the surface of the needle tip portion of the metal needle is etched to become a rough surface, the pain felt by the patient having the needle tip punctured becomes large. Therefore, in this configuration, the needle tip portion of the metal needle is formed on the smooth surface by being not etched. As a result, the pain felt by the patient who has been punctured with the needle tip can be reduced.

  (7) The metal needle and the protector are integrally formed.

  As in this configuration, the metal needle and the protector are integrally formed by a suitable means for forming the protector as described in the above (1), in other words, forming the protector in contact with the metal needle. is there.

  (8) The indwelling needle of the present invention can be inserted with the metal needle, and a sealing member disposed in the internal space so as to seal the internal space of the hub in a state where the metal needle is inserted. The sealing member is made of a material that liquid-tightly closes the internal space of the hub in a state where the metal needle is removed.

  According to this configuration, the internal space of the hub is closed while the metal needle is removed from the sealing member. That is, according to this configuration, the indwelling needle can be sealed. When the indwelling needle is hermetically sealed, it is possible to prevent blood collected from the blood vessel through the resin needle from leaking outside through the internal space of the hub.

  ADVANTAGE OF THE INVENTION According to this invention, the difference of the diameter of the hole in which the metal needle in the protector comprised with resin is penetrated, and the diameter of a metal needle can be made substantially the same. That is, even when the protector that covers the metal needle is made of resin, the dimensional accuracy of the protector with respect to the metal needle can be maintained high.

FIG. 1 is a side view of the indwelling needle 1. FIG. 2 is a longitudinal sectional view of the indwelling needle 1. FIG. 3 is a side view of the indwelling needle with the metal needle 10 removed from the resin needle 14. FIG. 4 is a longitudinal sectional view of the indwelling needle 1 with the metal needle 10 removed from the resin needle 14. FIG. 5 is an external perspective view schematically showing the metal needle 10, the metal needle hub 12, the locking portion 22, the protector 18, and the covering member 60. FIG. 6 is a side view of the metal needle 10, the locking portion 22, the protector 18, and the stomach member 60, and (A) shows a state where the pair of side plates 82 and 83 are in the first posture, (B) shows a state in which the locking portion 22 is in contact with the opening 64 of the base end plate 81, and (C) shows a state in which the pair of side plates 82 and 83 are in the second posture. . FIG. 7 is an enlarged view of the surface of the metal needle 10 by 50,000 times.

[Overall configuration of indwelling needle 1]
As shown in FIG. 1, the indwelling needle 1 of the present embodiment includes a metal needle 10, a metal needle hub 12 that fixes a proximal end portion of the metal needle 10, a resin needle 14 that is extrapolated to the metal needle 10, A resin needle hub 16 (an example of the hub of the present invention) that fixes the base end portion of the resin needle 14 and a protector 18 (FIGS. 2, 4, and 4) housed in an internal space 54 (see FIG. 4) of the resin needle hub 16 And a sealing member 28 (see FIGS. 2 and 4).

  In the present specification, when the indwelling needle 1 is used to puncture a patient, the side far from the practitioner and close to the patient is referred to as the distal end side. Further, the indwelling needle 1 and the protector 18 positioned on the distal end side, or the end portions of the respective members constituting the indwelling needle 1 and the protector 18 are referred to as the distal end portion. The side closer to the practitioner and far from the patient is referred to as the proximal side. The end portion on the base end side is referred to as a base end portion. Moreover, in this specification, an axial direction is an axial direction of the metal needle 10 and the resin needle 14 in the state mounted in the indwelling needle 1, for example, is the left-right direction in FIG.

[Metal needle 10]
As shown in FIG. 5, the metal needle 10 is a needle tip 20 having a predetermined length and a sharp tip. In the present embodiment, the metal needle 10 is made of stainless steel. The metal needle 10 may be made of a metal other than stainless steel, for example, an aluminum alloy, titanium, a titanium alloy, or the like, as long as the metal needle 10 is made of a material capable of forming a plurality of recesses by an etching process described later.

  In the present embodiment, the metal needle 10 is hollow. An opening 11 is formed in the metal needle 10. Thus, as will be described later, when the metal needle 10 is inserted into the blood vessel of the patient in a state where the metal needle 10 is inserted through the resin needle 14, the patient's blood enters the inside from the tip of the metal needle 10 and opens. 11 flows between the metal needle 10 and the resin needle 14. Here, as will be described later, when the resin needle 14 has transparency, it is possible to visually recognize the blood flowing between the metal needle 10 and the resin needle 14 from the outside.

[Metal needle hub 12]
As shown in FIGS. 3 and 5, the metal needle hub 12 is composed of a substantially cylindrical main body 12A and a handle 12B integrally attached to the main body 12A. The metal needle hub 12 is made of synthetic resin. In this embodiment, the metal hub 12 is made of polyphenylene sulfide resin (PPS) or polybutylene terephthalate resin (PBT), but flows into a dent described later formed in the metal needle 10 and can be directly joined to the metal. Any resin having high fluidity may be used. A hole 33 extending in the axial direction is formed in the distal end portion 32 of the metal needle hub 12. The hole 33 is joined in a state in which the proximal end portion of the metal needle 10 is inserted.

  In the present embodiment, the metal needle hub 12 is molded so as to be joined to the metal needle 10 by the procedure described below. That is, PPS or PBT softened by heating is poured into a metal mold having the shape of the metal needle hub 12 covering at least the periphery of the base end portion of the metal needle 10. Here, the surface of the metal needle 10 is formed into a rough surface by an etching process described later. PPS or PBT is a resin that is bondable to the rough surface. Therefore, the PPS or PBT poured into the mold is joined to the metal needle 10. The metal needle hub 12 may be bonded to the metal needle 10 with an adhesive.

  An annular step surface 34 is formed on the proximal end side of the distal end portion 32 of the metal needle hub 12. The diameter of the tip 32 of the metal needle hub 12 is substantially the same as the inner diameter of an internal space 54 (see FIG. 4) of the resin needle hub 16 described later. Accordingly, the distal end portion 32 of the metal needle hub 12 is inserted into the internal space 54 of the resin needle hub 16 from the proximal end side opening portion 52 (see FIG. 4) which is an opening formed on the proximal end side of the resin needle hub 16. Then, as shown in FIGS. 1 and 2, the resin needle hub 16 is attached. That is, the metal needle hub 12 can be attached to and detached from the resin needle hub 16.

[Resin needle 14]
The length of the resin needle 14 shown in FIGS. 3 and 4 is shorter than that of the metal needle 10. The resin needle 14 is composed of a thin tube that can be externally inserted into the metal needle 10. That is, the resin needle 14 is hollow, and the metal needle 10 is inserted through the resin needle 14.

  The material of the resin needle 14 is not limited at all. However, it is desirable that the material of the resin needle 14 has an appropriate flexibility so as not to damage the blood vessel wall or the like when placed in the patient's blood vessel. For example, as a material for forming the resin needle 14, various soft resins such as ethylene-tetrafluoroethylene copolymer, polyurethane, polyether nylon, and polypropylene are used. The resin needle 14 preferably has transparency so that the flow of the liquid flowing through the inside can be grasped after being placed in the blood vessel of the patient.

[Resin needle hub 16]
As shown in FIGS. 3 and 4, the resin needle hub 16 has a substantially cylindrical shape. An internal space 54 is formed in the resin needle hub 16. The internal space 54 is opened on the base end side of the resin needle hub 16 through the base end side opening 52. As shown in FIG. 2, a protector 18, a covering member 60, and a sealing member 28, which will be described later, are accommodated in the internal space 54 of the resin needle hub 16 while being penetrated by the metal needle 10. The material of the resin needle hub 16 is preferably transparent so that the flow of the liquid flowing through the inside can be grasped in the same manner as the resin needle 14. For example, polyethylene terephthalate resin (PET) is used as a material for forming the resin needle hub 16.

  As shown in FIGS. 3 and 4, the distal end portion 50 of the resin needle hub 16 is provided with a through hole 56 extending in the axial direction. The base end portion of the resin needle 14 is inserted and fixed in the through hole 56. That is, the resin needle hub 16 is provided at the proximal end portion of the resin needle 14. A proximal end portion of the resin needle 14 fixed to the resin needle hub 16 protrudes from the distal end side of the resin needle hub 16 into the internal space 54. That is, the internal space 54 of the resin needle hub 16 communicates with the internal space of the resin needle 14, that is, the inner hole of the resin needle 14.

  As described above, when the metal needle 10 is inserted into the resin needle 14 (the state shown in FIG. 1), the needle tip 20 of the metal needle 10 is punctured into the blood vessel of the patient, and the metal needle 10 is pulled out from the resin needle 14 (FIG. 3), the tip of the resin needle 14 is placed in the blood vessel. Then, the blood flowing through the blood vessel is circulated to the internal space 54 through the inner hole of the resin needle 14 placed in the blood vessel.

  Further, as shown in FIGS. 3 and 4, a mounting portion 66 is formed on the side surface between the proximal end side and the distal end side of the resin needle hub 16. The mounting portion 66 is provided with an opening 67 that communicates with the internal space 54. An instrument 68 for injecting liquid into the blood vessel can be attached to the opening 67. Then, the liquid is circulated from the instrument 68 to the blood vessel through the inner space 54 and the inner hole of the resin needle 14. As will be described later, the internal space 54 is liquid-tightly closed by the sealing member 28 at the distal end side of the proximal end side opening 52, so that the blood and the liquid are proximal to the internal space 54. There is no leakage through the opening 52 to the outside.

  As a method for fixing the resin needle 14 to the distal end portion 50 of the resin needle hub 16, for example, a method similar to the conventional method using an adhesive, a caulking pin or the like is employed.

[Sealing member 28]
In the present embodiment, as shown in FIGS. 2 and 4, the sealing member 28 is disposed in the internal space 54 of the resin needle hub 16. The indwelling needle 1 may not include the sealing member 28. The sealing member 28 is a substantially columnar member extending along the axial direction in a state where the sealing member 28 is disposed in the internal space 54 of the resin needle hub 16. The sealing member 28 is formed with a slit along the axial direction from the center of the bottom surface on the distal end side to the center portion of the bottom surface on the proximal end side.

  The sealing member 28 is press-contacted or fixed to the inner surface that defines the internal space 54 of the resin needle hub 16. Thereby, the internal space 54 is divided by the sealing member 28 into the distal end side internal space 54A and the proximal end side internal space 54B.

  The metal needle 10 is inserted into the slit of the sealing member 28. This will be described in detail below. The distal end portion of the metal needle 10 is inserted from the proximal end side opening portion 52 of the resin needle hub 16 into the proximal end side internal space 54B. When the metal needle 10 is further inserted on the distal end side, the distal end portion of the metal needle 10 is inserted into the sealing member 28. When the metal needle 10 is further inserted into the distal end side, the distal end portion of the metal needle 10 is inserted into the distal end side internal space 54 </ b> A of the resin needle hub 16. When the metal needle 10 is further inserted on the distal end side, the distal end portion of the metal needle 10 is inserted into the inner hole of the resin needle 14. When the metal needle 10 is further inserted on the distal end side, since the length of the metal needle 10 is longer than that of the resin needle 14, the distal end portion of the metal needle 10 protrudes from the distal end of the resin needle 14 (FIG. 1 and FIG. (See FIG. 2).

  In this embodiment, the material of the sealing member 28 is a soft material that liquid-tightly closes the proximal end side of the internal space 54 of the resin needle hub 16 even when the metal needle 10 is removed from the sealing member 28. It consists of Examples of such a material include silicon rubber that can close a slit formed in the sealing member 28 by elasticity in a state where the metal needle 10 is removed from the sealing member 28. As described above, the sealing member 28 liquid-tightly closes between the distal end side internal space 54A and the proximal end side internal space 54B of the resin needle hub 16 regardless of whether or not the metal needle 10 is inserted.

  The position of the sealing member 28 disposed in the resin needle hub 16 in the axial direction is closer to the proximal end than the mounting portion 66. Thereby, the blood flowing through the blood vessel passes through the inner hole of the resin needle 14 placed in the blood vessel, the inner space 54A on the distal end side, and the opening 67 of the mounting portion 66 and into the instrument 68 attached to the opening 67. The

[Locking part 22]
As shown in FIGS. 4 and 5, a locking portion 22 is formed in the vicinity of the needle tip 20 of the metal needle 10, that is, between the needle tip 20 of the metal needle 10 and a protector 18 described later. The locking portion 22 is formed so as to cover the surface of the metal needle 10. Specifically, the locking portion 22 is provided so as to cover the surface of the metal needle 10 at a part or the entire circumference in the circumferential direction at a position near the needle tip 20 of the metal needle 10. As a result, the apparent diameter of the metal needle 10 is made larger at the position where the locking portion 22 is formed than at other positions.

  The material of the locking part 22 is a synthetic resin. In detail, the latching | locking part 22 is comprised with the material joined to the metal needle 10 in which the etching process mentioned later was given. In the present embodiment, the locking portion 22 is made of polyphenylene sulfide resin (PPS) or polybutylene terephthalate resin (PBT).

  In the present embodiment, the locking portion 22 is shaped to be joined to the metal needle 10 in the same manner as the metal needle hub 12. That is, PPS or PBT softened by heating is poured into a mold that covers at least the periphery of the needle tip 20 of the metal needle 10. Here, the surface of the metal needle 10 is formed into a rough surface by an etching process described later. PPS or PBT is a resin that is bondable to the rough surface. Therefore, the PPS or PBT poured into the mold is joined to the metal needle 10. In addition, when the latching | locking part 22 and the metal needle hub 12 are the same materials, shaping | molding of the latching | locking part 22 and the metal needle hub 12 may be performed simultaneously by using a common metal mold | die.

  The maximum length of the locking portion 22 in the orthogonal plane orthogonal to the axial direction (hereinafter also referred to as the maximum diameter of the locking portion 22) is the minimum of the internal space 54 of the resin needle hub 16 in the plane orthogonal to the axial direction. Shorter than the length of. That is, the locking portion 22 has a size that can enter the internal space 54 of the resin needle hub 16.

  Further, the maximum diameter of the locking portion 22 is slightly longer than the diameter of the inner hole of the resin needle 14. However, since the resin needle 14 is made of a soft material, the locking portion 22 can enter the resin needle 14. Further, since the sealing member 28 is also made of a soft material, the locking portion 22 can be inserted into the slit of the sealing member 28.

  Further, the maximum diameter of the locking portion 22 is longer than the diameter of an opening 64 formed in the protector 18 described later that moves relative to the metal needle 10. As a result, the locking portion 22 contacts the protector 18 that moves relative to the metal needle 10 to lock the protector 18.

[Protector 18]
As shown in FIGS. 2, 4, and 5, the protector 18 is formed on the base end side of the locking portion 22 in the metal needle 10. The protector 18 is formed so as to cover a part of the surface of the metal needle 10.

  The maximum length of the protector 18 in the plane orthogonal to the axial direction is shorter than the minimum length of the inner diameter of the proximal end side internal space 54 </ b> B of the resin needle hub 16. Thereby, the protector 18 can be accommodated in the proximal end side internal space 54 </ b> B of the resin needle hub 16. That is, the protector 18 is sized to be accommodated in the internal space 54 of the resin needle hub 16.

  The material of the protector 18 is a synthetic resin. In detail, the protector 18 is comprised with the material which is not joined to the metal needle 10 in which the etching process mentioned later was given. In the present embodiment, the protector 18 is made of polypropylene resin (PP) or polyethylene resin (PE).

  In the present embodiment, the protector 18 is integrally formed with the metal needle 10. That is, the protector 18 is molded so as to contact the metal needle 10. The protector 18 and the metal needle 10 are in contact with each other at the edge of the opening 64 described later. Hereinafter, molding of the protector 18 will be described in detail. PP or PE softened by heating is poured into a mold having a shape of the protector 18 covering at least the periphery of the proximal end side of the locking portion 22 in the metal needle 10. Here, the surface of the metal needle 10 is formed into a rough surface by an etching process described later. However, PP and PE are non-bonding resins with respect to the rough surface. Therefore, PP or PE poured into the mold covers the metal needle 10 and comes into contact with the opening 64 described later, but is not joined to the metal needle 10. Therefore, the protector 18 can move relative to the metal needle 10 in the axial direction while covering the metal needle 10.

  An inner space 84 is formed in the protector 18. The protector 18 includes a base end plate 81 and a pair of side plates 82 and 83, and the base end plate 81 and the pair of side ends 82 and 83 each define the internal space 84. In the present embodiment, the pair of side plates is a pair, but the side plates do not have to be a pair as long as the needle tip 20 of the metal needle 10 can be included as described below.

  The base end plate 81 is a plate-like member along a plane intersecting the axial direction, and constitutes a base end side surface of the internal space 84. That is, the base end plate 81 defines the base end side of the metal needle 10 in the internal space 84 of the protector 18.

  An opening 64 is formed in the central portion of the base end plate 81. The metal needle 10 is inserted through the opening 64. The protector 18 is in contact with the metal needle 10 at the edge of the opening 64 through which the metal needle 10 is inserted. That is, the inner diameter of the opening 64 formed in the base end plate 81 and the diameter of the metal needle 10 are substantially the same length. Specifically, the inner diameter of the opening 64 formed in the base end plate 81 is slightly longer than the diameter of the metal needle 10.

  Further, the inner diameter of the opening 64 is shorter than the maximum length of the locking portion 22 in the orthogonal plane orthogonal to the axial direction, that is, the maximum diameter of the locking portion 22. That is, the inner diameter of the opening 64 is shorter than the distance between the center in the cross section of the locking portion 22 along the orthogonal plane and the edge farthest from the center.

  The pair of side plates 82 and 83 are plate-like members along the axial direction, and constitute a peripheral surface along the axial direction of the internal space 84. The pair of side plates 82 and 83 extend from the edge portion of the base end plate 81 toward the distal end side, that is, toward the needle tip 20 side of the metal needle 10 along the axial direction. That is, the pair of side plates 82 and 83 are extended so as to sandwich the opening formed in the central portion of the base end plate 81.

  The pair of side plates 82, 83 are a first inclined plate 86 that is inclined away from the metal needle 10 as it goes from the proximal end portion toward the distal end side, and a metal as it goes from the distal end portion of the first inclined plate 86 toward the distal end side. And a second inclined plate 87 inclined so as to approach the needle 10. Due to the second inclined plate 87, the gap between the pair of side plates 82 and 83 is narrowed on the tip side.

  The pair of side plates 82 and 83 has a base end side connected to the base end plate 81 and a tip end side not connected to any member. As a result, the pair of side plates 82 and 83 are moved in the direction of the arrow 85 (see FIGS. 2 and 6C) around the connecting portion with the base end plate 81 by the elastic force of the side plates 82 and 83 themselves. It can be rotated. That is, the pair of side plates 82 and 83 are elastically changed in posture between the first posture shown in FIG. 2 and the second posture shown in FIG. 4 by rotating.

  The first posture shown in FIG. 2 is the posture of the pair of side plates 82 and 83 in a state where no force is applied to the pair of side plates 82 and 83 from the outside. The mutual gap between the tip portions of the pair of side plates 82 and 83 in the first posture, that is, the mutual gap between the second inclined plates 87 is the first width. The length of the first width is longer than the diameter of the metal needle 10. Therefore, in a state where the pair of side plates 82 and 83 are in the first posture, the metal needle 10 can pass through the tip portions of the pair of side plates 82 and 83.

  The second posture shown in FIG. 4 is a pair of side plates 82 and 83 in a state in which a force in a direction approaching the metal needle 10 is applied to the pair of side plates 82 and 83 from the outside (a covering member 60 described later in the present embodiment). Is the attitude. That is, in the present embodiment, the pair of side plates 82 and 83 are biased toward the first posture side. The gap between the tip portions of the pair of side plates 82 and 83 in the second posture, that is, the gap between the second inclined plates 87 has the second width. The length of the second width is shorter than the diameter of the metal needle 10. Specifically, in the present embodiment, as shown in FIG. 4, the pair of second inclined plates 87 are in a state of overlapping in the axial direction, and therefore there is no gap. Therefore, in a state where the pair of side plates 82 and 83 are in the second posture, the metal needle 10 cannot pass through the tip portions of the pair of side plates 82 and 83.

  The gap between the pair of side plates 82 and 83 other than the tip portions is larger than the diameter of the metal needle 10 regardless of the posture of the pair of side plates 82 and 83. As a result, the internal space 84 can contain the needle tip 20 of the metal needle 10.

  Further, a detent portion 88 is formed on the pair of side plates 82 and 83 of the protector 18. The function of the detent unit 88 will be described later.

[Coating member 60]
As shown in FIGS. 4 and 5, a covering member 60 is formed on the proximal side of the protector 18 in the metal needle 10. The covering member 60 is formed so as to cover the surface of the metal needle 10.

  The maximum length of the covering member 60 on the surface orthogonal to the axial direction is substantially the same as the minimum length of the proximal end side internal space 54B of the resin needle hub 16 on the surface orthogonal to the axial direction. Thereby, the covering member 60 can be accommodated so as to be fitted into the proximal end side internal space 54 </ b> B of the resin needle hub 16. That is, at least a part of the covering member 60 has a size that can be accommodated in the proximal end side internal space 54 </ b> B of the resin needle hub 16.

  The material of the covering member 60 is a synthetic resin. Specifically, the covering member 60 is made of a material that is not joined to the metal needle 10 that has been subjected to an etching process, which will be described later, like the protector 18. Specifically, in this embodiment, the covering member 60 is made of polypropylene resin (PP) or polyethylene resin (PE).

  In the present embodiment, the covering member 60 is formed around the metal needle 10. This will be described in detail below. PP or PE softened by heating is poured into a mold having a shape of a covering member 60 to be described later that covers at least the periphery of the proximal end side of the protector 18 in the metal needle 10. Here, the surface of the metal needle 10 is formed into a rough surface by an etching process described later. However, PP or PE is a resin that is non-bonding to the rough surface. Therefore, PP or PE poured into the mold does not join over the metal needle 10. Therefore, the covering member 60 can move relative to the metal needle 10 in the axial direction while covering the metal needle 10.

  The covering member 60 has a generally cylindrical shape extending along the axial direction. The base end portion 61 of the covering member 60 has a shorter inner diameter than other portions. Specifically, the inner diameter of the covering member 60 is the maximum distance between the pair of side plates 82, 83 at the base end portion 61, that is, the pair of side plates 82 at the boundary between the first inclined plate 86 and the second inclined plate 87, It is shorter than the interval 83 and longer than the maximum length in the plane perpendicular to the axial direction of the base end plate 81. Further, the inner diameter of the covering member 60 is longer than the maximum interval except for the base end portion 61. Thereby, the covering member 60 can cover the protector 18.

[Instrument 68 for injecting fluid into the blood vessel]
As shown in FIGS. 1 and 2, in this embodiment, the instrument 68 is provided with three connection portions, that is, a first connection portion 71, a second connection portion 72, and a third connection portion 73. . The three connection portions 71, 72, 73 are connected inside the instrument 68. The first connection portion 71 is connected to the opening 67 of the mounting portion 66 provided on the resin needle hub 16 via the tube 74. The 2nd connection part 72 and the 3rd connection part 73 can be connected with a liquid bag (not shown) etc. via a tube (not shown), respectively. A liquid bag storing different types of liquid is connected to each of the second connection part 72 and the third connection part 73 via a tube, so that the instrument 68, the resin needle hub 16, and Two types of liquid can be injected into the patient via the resin needle 14.

[Insertion and removal of metal needle 10 with respect to resin needle 14]
Hereinafter, operations of the protector 18 and the covering member 60 when the metal needle 10 is inserted through the resin needle 14 will be described.

  The distal end of the metal needle 10 is inserted from the proximal end side opening 52 of the resin needle hub 16 into the proximal end side internal space 54B (see FIG. 4). Thereafter, the distal end of the metal needle 10 passes through the proximal end side internal space 54B, penetrates the sealing member 28, and passes through the distal end side internal space 54A. Next, the tip of the metal needle 10 is inserted through the inner hole of the resin needle 14. Thereby, the front-end | tip of the metal needle 10 protrudes from the front-end | tip of the resin needle 14 (refer FIG. 1).

  When the metal needle 10 is inserted into the resin needle hub 16, the protector 18 and the covering member 60 are in a state where the protector 18 is covered with the covering member 60 (the state shown in FIG. 2). It is accommodated in the end side internal space 54B. Further, the metal needle hub 12 is attached to the resin needle hub 16 in a state where the tip of the metal needle 10 protrudes from the tip of the resin needle 14. That is, as shown in FIG. 2, the protector 18 and the covering member 60 are accommodated in the internal space 54 of the resin needle hub 16 while being sandwiched between the resin needle hub 16 and the metal needle hub 12. Further, the covering member 60 is fitted to the resin needle hub 16 while being accommodated in the internal space 54 of the resin needle hub 16.

  Below, operation | movement of the protector 18 and the coating | coated member 60 when the metal needle 10 is extracted from the resin needle 14 is demonstrated.

  In a state where the metal needle 10 is inserted through the resin needle 14 (see FIGS. 1 and 2), the metal needle 10 is moved relative to the resin needle 14 toward the proximal end side. Pulled out of. When the metal needle 10 moves relative to the resin needle 14 toward the base end side, the metal needle hub 12 and the locking portion 22 fixed to the metal needle 10 also move relative to the resin needle 14 toward the base end side. Moving. Here, the protector 18 and the covering member 60 that can move relative to the metal needle 10 do not move relative to the resin needle 14 because the covering member 60 is fitted to the resin needle hub 16. At this time, the protector 18 is in the first posture in the normal state (see FIGS. 2 and 6A).

  The locking portion 22 that moves relative to the resin needle 14 toward the base end side enters the internal space 84 of the protector 18 from the gap between the pair of side plates 82 and 83 of the protector 18 in the first posture. Next, the needle tip 20 of the metal needle 10 enters the internal space 84 of the protector 18 from the gap. And if the latching | locking part 22 moves further toward the base end side, the latching | locking part 22 will contact | abut with the base end plate 81 of the protector 18 (refer FIG. 6 (B)). When the locking portion 22 comes into contact with the proximal end plate 81, the protector 18 is pushed by the locking portion 22 and moves relative to the resin needle 14 toward the proximal end side. As a result, the first inclined plate 86 of the protector 18 presses the proximal end portion 61 of the covering member 60. However, since the covering member 60 is accommodated so as to be fitted in the internal space 54 of the resin needle hub 16, it does not move relatively. Thereby, the protector 18 moves so as to be pushed into the internal space of the base end portion 61 of the covering member 60, and the second posture (see FIGS. 4 and 6) from the first posture (see FIGS. 2 and 6A). 6 (C)). As a result, the needle tip 20 of the metal needle 10 cannot go out from the internal space 84 of the protector 18 through the gap between the pair of side plates 82 and 83. That is, the state in which the needle tip 20 of the metal needle 10 is accommodated in the internal space 84 of the protector 18 is maintained.

  In other words, the covering member 60 presses the pair of side plates 82 and 83 from the outside by moving the covering member 60 relative to the protector 18 toward the needle tip 20 side of the metal needle 10. To change the posture from the first posture to the second posture.

  When the protector 18 is further moved relative to the covering member 60 and the detent portion 88 is located on the base end side with respect to the covering member 60, as shown in FIG. 4 and FIG. The portion 88 is no longer pressed by the base end portion 61 of the covering member 60 and is opened outward. Thereby, the protector 18 is prevented from moving relative to the front end side with respect to the covering member 60.

  When the metal needle 10 is moved relative to the proximal end side with a stronger force than before, the fitting between the covering member 60 and the resin needle hub 16 is released. Accordingly, the covering member 60 is pushed by the protector 18 and moves relative to the resin needle 14 toward the proximal end side integrally with the protector 18. As a result, the metal needle 10 is removed from the resin needle 14 (see FIGS. 3 and 4). That is, the metal needle 10, the protector 18, the covering member 60, and the metal needle hub 12 are separated from the resin needle 14 and the resin needle hub 16. At this time, the needle tip 20 of the metal needle 10 is covered with the protector 18 (see FIG. 4).

[Etching process]
As described above, in the present embodiment, the metal needle 10 is made of stainless steel. The surface of the metal needle 10 is formed into a rough surface.

  Here, the rough surface is a surface having a large number of dents that can be physically bonded to a resin such as PBT, and the dents are formed by performing an etching process described in detail below. In addition, in this embodiment, although the diameter of each dent is 20-300 nm, the diameter of each dent is not restricted to the said diameter. FIG. 7 is a diagram in which the surface of the metal needle 10 made of stainless steel is enlarged 50,000 times. In FIG. 7, the portion shown as a black shadow is the above-described dent.

  The etching process in this application means the process which forms the minute dent for making it join directly with resin with high fluidity | liquidity on a metal surface. Below, the etching process performed to the metal needle 10 is demonstrated. In addition, the etching process demonstrated below is an example, The process process, the kind of solution in which the metal needle 10 is immersed, etc. may differ.

  The etching process includes a water washing process and a dipping process. In the water washing treatment, a stainless steel degreasing agent, iron degreasing agent, or a commercially available neutral detergent is prepared, and the prepared detergent is dissolved in water to obtain an aqueous solution having a concentration of about several percent. And the temperature of this aqueous solution shall be about 40-70 degreeC, and the metal needle 10 is immersed for 5 to 10 minutes. Thereby, the metal needle 10 is washed with water and degreased.

  In the immersion treatment, the metal needle 10 is immersed in a sulfuric acid aqueous solution for several minutes. Here, examples of the aqueous sulfuric acid solution include aqueous solutions of hydrohalic acid such as hydrochloric acid, sulfurous acid, sulfuric acid, and metal halide salts that corrode stainless steel. Moreover, the density | concentration of sulfuric acid aqueous solution is about 10 to 15%, for example. Moreover, the temperature of sulfuric acid aqueous solution is 60-70 degreeC, for example. When the metal needle 10 is immersed in the sulfuric acid aqueous solution described above, the above-described recess is formed on the surface of the metal needle 10. In addition, it is preferable that the metal needle 10 is sufficiently washed with water after the immersion treatment.

  The metal needle 10 that has been subjected to the above processing steps is insert-molded to form the metal needle 10, the metal needle hub 12, and the locking portion 22, and is strong against the metal needle 10, the metal needle hub 12, and the locking portion 22. A needle having a bonding force can be easily produced.

[Effect of the embodiment]
According to this embodiment, the protector 18 is comprised with resin. Therefore, in this embodiment, a complicated sheet metal process as in the case where the protector 18 is made of metal is not required.

  Further, according to the present embodiment, the protector 18 is insert-molded with respect to the metal needle 10. Thereby, the protector 18 can be easily shape | molded so that it may contact | abut with the metal needle 10 and the metal needle 10 may be penetrated. That is, according to the present embodiment, a complicated assembly process for passing the metal needle 10 through the protector 18 is not required. Further, by forming the protector 18 as described above, the difference between the diameter of the hole through which the metal needle 10 is inserted in the protector 18 and the diameter of the metal needle 10 can be made substantially the same. That is, the dimensional accuracy of the hole of the protector 18 with respect to the diameter of the metal needle 10 can be maintained high. That is, even when the protector 18 covering the metal needle 10 is made of resin instead of metal, the dimensional accuracy of the protector 18 with respect to the metal needle 10 can be kept high.

  Moreover, according to this embodiment, even if the latching | locking part 22 is resin, the said latching | locking part 22 is joined to the metal needle 10. FIG. Therefore, the locking portion 22 can lock the protector 18 that moves relative to the metal needle 10.

  Moreover, according to this embodiment, the metal needle 10 and the latching | locking part 22 are joined by the resin which comprises the latching | locking part 22 entering the rough surface recessed part formed in the surface of the metal needle | hook 10, for example. The That is, the metal needle 10 and the locking part 22 are physically joined. For this reason, according to this embodiment, while joining the metal needle 10 and the latching | locking part 22 strong, deterioration with time of the said joint can be decreased.

  In addition, according to the present embodiment, the protector 18 is made of a resin that is non-bonding to the rough surface, and thus the protector 18 can be configured to be movable relative to the metal needle 10.

  In addition, according to the present embodiment, the pair of side plates 82 and 83 maintain the second posture by being pressed by the covering member 60. Therefore, according to the present embodiment, it is possible to prevent the pair of side plates 82 and 83 in the second posture from being erroneously changed to the first posture.

  Further, as in the present embodiment, integrally forming the metal needle 10 and the protector 18 is a suitable means for forming the protector 18 in a state of being in contact with the metal needle 10.

  Further, according to the present embodiment, since the sealing member 28 is made of a material such as silicon rubber, the internal space 54 of the resin needle hub 16 is closed in a state where the metal needle 10 is removed from the sealing member 28. The That is, according to the present embodiment, the indwelling needle 1 can be sealed. When the indwelling needle 1 is a sealed type, it is possible to prevent blood collected from the resin needle 14 from leaking to the outside through the proximal end side internal space 54B of the resin needle hub 16.

[Modification 1]
In the above-described embodiment, the posture of the pair of side plates 82 and 83 is changed from the first posture to the second posture when the covering member 60 presses the pair of side plates 82 and 83 from the outside. However, the pair of side plates 82 and 83 may change the posture from the first posture to the second posture without being pressed by the covering member 60.

  For example, the pair of side plates 82 and 83 are in the second posture in a state where no force is applied from the outside, and in a state where the metal needle 10 is inserted into the gap between the tip portions of the pair of side plates 82 and 83, The first posture may be maintained by being pressed inward by the metal needle 10. In this case, when the metal needle 10 is pulled out of the resin needle 14, the needle tip 20 of the metal needle 10 passes through the gap between the tip portions of the pair of side plates 82 and 83, and the internal space 84 of the protector 18 from the outside of the protector 18. When entering the position, the pair of side plates 82 and 83 change their posture from the first posture to the second posture due to their urging force.

  According to the first modification, when the needle tip 20 of the metal needle 10 passes through the gap between the tips of the pair of side plates 82 and 83 and enters the internal space 84 of the protector 18, the pair of side plates 82 and 83 is in the first posture. The posture changes from 1 to the second posture. This makes it impossible for the needle tip 20 of the metal needle 10 to be exposed from the internal space 84 of the protector 18 through the gap to the outside of the protector 18. As a result, the state where the needle tip 20 of the metal needle 10 is accommodated in the internal space 84 of the protector 18 can be maintained. That is, the metal needle 10 can be prevented from being exposed to the outside.

[Modification 2]
In the above-described embodiment, the entire surface of the metal needle 10 is etched, but only a part of the surface of the metal needle 10 may be etched. For example, the needle tip 20 of the metal needle 10 may be configured to be a surface on which no dent is formed by being not etched, that is, a smooth surface.

  As described above, in the case where the needle tip 20 of the metal needle 10 is not subjected to the etching treatment, the pretreatment step and the main treatment step of the etching treatment are performed with the needle tip 20 of the metal needle 10 covered with a member such as rubber. It only has to be executed.

  When the surface of the needle tip 20 of the metal needle 10 is etched to become a rough surface, the pain felt by the patient who has been punctured with the needle tip 20 increases. Therefore, in the second modification, the needle tip 20 of the metal needle 10 is configured as a smooth surface by not being etched. As a result, the pain felt by the patient with the needle tip 20 punctured can be reduced.

[Modification 3]
In the above-described embodiment, the metal needle 10 is etched, and a resin that is bonded to the rough surface is poured into the rough surface formed on the surface of the metal needle 10 by the etching process. And the non-bonding resin with respect to the rough surface is poured, so that the resin and the metal needle 10 can be moved relative to each other.

  However, the present invention only needs to include the protector 18 formed by insert molding a non-bonding resin with respect to the metal needle 10. Therefore, the rough surface may not be formed on the surface of the metal needle 10. Moreover, the structure for joining resin, such as the metal needle hub 12 and the latching | locking part 22, and the metal needle 10, is not restricted to the said structure. For example, the metal needle 10 and the locking part 22 may be joined by an adhesive, or the locking part 22 may be made of an adhesive resin with respect to the metal needle 10. As an adhesive resin, Modic (Mitsubishi Chemical) may be considered.

[Modification 4]
In the above-described embodiment, the locking portion 22 is made of resin, but the locking portion 22 may not be made of resin. For example, the locking portion 22 may be formed by squeezing a part of the metal needle 10 so that the part has a larger diameter than the other part.

DESCRIPTION OF SYMBOLS 1 ... Indwelling needle 10 ... Metal needle 14 ... Resin needle 16 ... Resin needle hub 18 ... Protector 22 ... Locking part 28 ... Sealing member 54 ... Internal space 60 ... Cover member 81 ... Base end plate 82 ... Side plate 83 ... Side plate 84 ... Internal space

Claims (8)

A hollow resin needle,
A hub provided at a base end portion of the resin needle, and having an internal space communicated with an internal space of the resin needle;
A metal needle inserted through the resin needle;
It is molded so as to cover a part of the surface of the metal needle by insert molding a non-bonding resin with respect to the metal needle, and is movable in the axial direction of the metal needle with respect to the metal needle. A protector having an internal space that can contain the needle tip of the metal needle, and having a size that can be accommodated in the internal space of the hub;
A locking portion that is provided between the tip of the metal needle and the protector, is large enough to enter the internal space of the resin needle and the hub, and locks the protector. Indwelling needle. The protector is
The base end side of the metal needle in the interior space of the protector is partitioned, the diameter is longer than the diameter of the cross section of the metal needle along the orthogonal plane orthogonal to the axial direction, and the engagement along the orthogonal plane is A base plate in which an opening having an inner diameter shorter than the distance between the center in the cross section of the stopper and the edge farthest from the center is formed;
A side plate extending from a position of the base end plate across the opening to a needle tip side of the metal needle, wherein a mutual gap on the needle tip side of the metal needle is a first through which the metal needle can pass. A first posture which is a width, and a side plate whose posture is changed to a second posture which is a second width which is narrower than the first width and cannot pass through the metal needle,
The side plate
When the metal needle is inserted into the gap, the first posture is established. When the needle tip of the metal needle passes through the gap and enters the internal space of the protector from the outside of the protector, the first posture is resumed. The indwelling needle according to claim 1, wherein the posture is changed to the second posture.   The indwelling needle according to claim 1 or 2, wherein the locking portion is formed so as to cover a part of the surface of the metal needle and is an adhesive resin with respect to the metal needle. The metal needle has a rough surface formed by being etched on the surface,
The protector is made of a resin that is non-bonding to the rough surface,
The indwelling needle according to claim 1, wherein the locking portion is made of a resin that is bondable to the rough surface. It is formed so as to cover a part of the metal needle on the base end side of the metal needle from the protector, and is made of a resin that is non-bonding to the rough surface. The protector can be covered by relative movement in the axial direction, and further includes a covering member that can be fitted to the hub while being accommodated in the internal space of the hub,
The side plate
The posture is elastically changed to the first posture and the second posture, and is biased toward the first posture;
The covering member is
The resin needle, the hub provided on the resin needle, and the covering member fitted to the hub are disposed on the metal needle and the protector in contact with the locking portion. The indwelling needle according to claim 4, wherein the side plate is pressed from outside to change its posture from the first posture to the second posture by being relatively moved toward the needle tip side.   The indwelling needle according to claim 4 or 5, wherein the needle tip portion of the metal needle is formed on a smooth surface by being not etched.   The indwelling needle according to any one of claims 1 to 6, wherein the metal needle and the protector are integrally formed. The metal needle is insertable, and includes a sealing member disposed in the internal space so as to seal the internal space of the hub in a state where the metal needle is inserted,
The indwelling needle according to any one of claims 1 to 7, wherein the sealing member is made of a material that liquid-tightly closes the internal space of the hub in a state where the metal needle is removed.

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