JPWO2007049563A1 - Indwelling needle assembly - Google Patents

Abstract

The indwelling needle assembly includes an inner needle having a sharp needle tip, an inner needle hub fixed to the proximal end portion of the inner needle, a hollow outer needle through which the inner needle is inserted, and a proximal end of the outer needle. An outer needle hub that is fixed to the head, an opening provided at the proximal end or side of the outer needle hub so as to communicate with the lumen of the outer needle, and an outer needle hub through which the inner needle is inserted. A possible hole or slit is formed, and a seal member that closes the hole or slit when the inserted inner needle is removed is provided. In this indwelling needle assembly, the inner surface of the hole or slit and / or the outer surface of the inner needle is subjected to a friction reducing process for reducing the frictional resistance therebetween.

Description

  The present invention relates to an indwelling needle assembly that punctures a blood vessel, for example, during infusion.

  When an infusion is performed on a patient, an indwelling needle connected to the infusion line is punctured into the patient's blood vessel, and the indwelling needle is placed in place.

  Such an indwelling needle includes a hollow outer needle, an outer needle hub fixed to the proximal end of the outer needle, an inner needle inserted into the outer needle and having a sharp needle tip, and a base of the inner needle. It is comprised with the inner needle hub fixed to the end (for example, refer Unexamined-Japanese-Patent No. 10-179734).

  When this indwelling needle is punctured into a patient's blood vessel, the puncture operation is performed in an assembled state in which the inner needle is inserted into the outer needle and the tip of the inner needle protrudes from the tip of the outer needle. In this assembled state, an infusion line connector is usually connected to the outer needle hub.

  When the needle tip of the inner needle reaches the blood vessel, the blood flowing in from the opening of the needle tip passes through the lumen of the inner needle and flows into the transparent inner needle hub (flashback). Thereby, it can confirm (visually recognize) that the inner needle secured the blood vessel.

  When this flashback is confirmed, the outer needle is advanced using the inner needle as a guide, and the outer needle is inserted (punctured) into the blood vessel.

  Next, the inner needle is removed from the outer needle while holding the outer needle by hand. Then, an infusion solution is administered through the connected infusion line and the outer needle.

  Now, the outer needle hub is provided (fixed) with a seal member (plug). This seal member can be punctured by the inner needle, and has a self-occlusion property when the punctured inner needle is removed.

  When the outer needle is advanced using the inner needle as a guide, a frictional resistance is generated between the seal member and the inner needle. For this reason, it becomes difficult for the outer needle to move (advance) smoothly, that is, the operability during the puncturing operation of the indwelling needle assembly may be inferior.

  An object of the present invention is to provide an indwelling needle assembly that is excellent in operability during a puncture operation.

In order to achieve the above object, the present invention provides:
An inner needle having a sharp needle tip at the tip;
An inner needle hub fixed to the proximal end of the inner needle;
A hollow outer needle through which the inner needle is inserted;
An outer needle hub fixed to a proximal end portion of the outer needle;
An opening provided in a proximal end portion or a side portion of the outer needle hub so as to communicate with a lumen of the outer needle;
A hole or slit provided in the outer needle hub, through which the inner needle can be inserted, and a seal member that closes the hole or the slit when the inserted inner needle is removed;
In the indwelling needle assembly, the inner surface of the hole or the slit and / or the outer surface of the inner needle is subjected to a friction reducing process for reducing a frictional resistance therebetween.

  According to the present invention as described above, the operability during the puncturing operation is excellent.

  In the indwelling needle assembly of the present invention, it is preferable that a tube is connected to the opening.

  Thereby, a liquid can be supplied to an outer needle through a tube.

  In the indwelling needle assembly of the present invention, it is preferable that the tube is inserted through the inner needle hub.

  This prevents the tube from interfering with the operation of the indwelling needle assembly.

  Moreover, in the indwelling needle assembly of this invention, it is preferable that the said friction reduction process is a process which provides a lubricant to the inner surface of the said hole or the said slit, and / or the outer surface of the said inner needle.

  Thereby, when the outer needle is advanced using the inner needle as a guide, the frictional resistance between the inner needle and the seal member can be reliably reduced. As a result, the outer needle moves smoothly, that is, the indwelling needle assembly has excellent operability during the puncturing operation.

  In the indwelling needle assembly of the present invention, it is preferable that the lubricant is mainly composed of silicone.

  Thereby, since the said silicone remains in the part which provided the silicone for a long time, a friction reduction effect can be continued.

  Moreover, in the indwelling needle assembly of this invention, it is preferable that the said friction reduction process is forming the layer comprised with the low friction material in the inner surface of the said hole or the said slit.

  Thereby, when the outer needle is advanced using the inner needle as a guide, the frictional resistance between the inner needle and the seal member can be reliably reduced. As a result, the outer needle moves smoothly, that is, the indwelling needle assembly has excellent operability during the puncturing operation.

  In the indwelling needle assembly of the present invention, it is preferable that the low friction material is mainly made of a fluororesin or an acrylic polymer.

  Thereby, when the outer needle is advanced using the inner needle as a guide, the frictional resistance between the inner needle and the seal member can be reliably reduced. As a result, the outer needle moves smoothly, that is, the indwelling needle assembly has excellent operability during the puncturing operation.

Moreover, in the indwelling needle assembly of the present invention, the inner needle has a portion whose outer diameter is different,
In a state where the inner needle is inserted into the outer needle, it is preferable that a portion having the smallest outer diameter of the inner needle is inserted into the hole or the slit of the seal member.

  Thereby, the frictional resistance between the outer periphery of the part with the smallest outer diameter of the inner needle and the inner periphery of the hole or slit can be reduced.

  The indwelling needle assembly of the present invention preferably includes a protector that covers at least the tip of the inner needle when the inner needle is removed from the outer needle.

  This prevents an accident that the operator or the like accidentally stabs a finger or the like with the needle tip during disposal of the inner needle after use, and is highly safe.

  In the indwelling needle assembly of the present invention, it is preferable that the indwelling needle assembly further includes a drop prevention means for preventing the protector covering the needle tip from dropping from the needle tip.

  As a result, it is possible to reliably maintain the state where the protector has covered the needle tip, thus preventing accidents such as accidental piercing of the finger by the needle tip when the inner needle is disposed of, etc. And high safety.

  In the indwelling needle assembly of the present invention, the central axis of the outer needle and the central axis of the distal end portion of the tube are substantially parallel with the inner needle inserted through the outer needle. Is preferred.

  Thereby, when puncturing the outer needle and the inner needle, the tube does not get in the way and the operability is excellent.

  In the indwelling needle assembly of the present invention, it is preferable that the tube is mainly composed of polybutadiene.

  As a result, the tube has excellent flexibility, chemical resistance, and chemical adsorption prevention.

  In the indwelling needle assembly of the present invention, it is preferable that the slit has a single letter shape.

  Thereby, the slit in the closed state can be easily opened, so that the inner needle can smoothly pass through the slit.

  Moreover, in the indwelling needle assembly of this invention, it is preferable that the said slit has a self-occlusion property.

  Thereby, when the inner needle is removed, liquid leakage from the proximal end of the outer needle hub can be prevented, and sterility within the outer needle hub can be maintained.

  In the indwelling needle assembly of the present invention, it is preferable that at least a part of the inner needle is solid.

  Thereby, when the inner needle is discarded after the operation is finished, there is no risk that blood remains in the inner needle or the blood flows out, and the safety is high.

  Moreover, in the indwelling needle assembly of this invention, it is preferable that the groove | channel is formed in the at least front-end | tip part of the said inner needle along the longitudinal direction of this inner needle.

  Thus, the groove functions as a blood flow path when the blood vessel is punctured, for example, with the inner needle inserted through the outer needle. Thereby, the flashback of blood can be confirmed reliably.

  Moreover, in the indwelling needle assembly of this invention, it is preferable that the said inner needle is comprised with the metal material.

  Thereby, the slidability of the inner needle with respect to the seal member is improved, that is, the frictional resistance between the seal member and the inner needle can be more reliably reduced. As a result, the outer needle moves more smoothly, that is, the indwelling needle assembly is more excellent in operability during the puncturing operation.

  Moreover, in the indwelling needle assembly of this invention, it is preferable that the said drop-off prevention means is comprised with the connection member which connects the said protector and the said inner needle hub.

  As a result, it is possible to reliably maintain the state where the protector has covered the needle tip, thus preventing accidents such as accidental piercing of the finger by the needle tip when the inner needle is disposed of, etc. And high safety.

  Further, in the indwelling needle assembly of the present invention, the connecting member is extendable and contracts in a state where the inner needle is inserted into the outer needle, and in a state where the inner needle is removed from the outer needle. Elongation is preferred.

  Accordingly, the connecting member does not get in the way during the puncturing operation, and the operability of the indwelling needle assembly is improved.

  Moreover, in the indwelling needle assembly of this invention, it is preferable that the said inner needle has penetrated the said connection member.

  Thereby, the inner needle functions as a guide for the connecting member when the connecting member expands and contracts.

FIG. 1 is a perspective view showing a first embodiment of an indwelling needle assembly of the present invention. FIG. 2 is a cross-sectional view taken along line AA in FIG. FIG. 3 is an enlarged view of a region [B] in FIG. FIG. 4 is a cross-sectional view taken along line AA in FIG. FIG. 5 is a cross-sectional view taken along line AA in FIG. FIG. 6 is a cross-sectional view taken along line AA in FIG. FIG. 7 is a perspective view corresponding to FIG. 6 of the indwelling needle assembly shown in FIG. FIG. 8 is a perspective view showing a state where the tube is removed from the inner needle hub in the indwelling needle assembly shown in FIG. FIG. 9 is a perspective view of a seal member included in the indwelling needle assembly shown in FIG. FIG. 10 is a perspective view of a seal member included in the indwelling needle assembly (second embodiment) of the present invention. FIG. 11 is a perspective view of a seal member and a compression member included in the indwelling needle assembly (third embodiment) of the present invention.

  Hereinafter, the indwelling needle assembly of the present invention will be described in detail based on a preferred embodiment shown in the accompanying drawings.

<First Embodiment>
1 is a perspective view showing a first embodiment of an indwelling needle assembly of the present invention, FIG. 2 is a cross-sectional view taken along the line AA in FIG. 1, and FIG. 3 is a region in FIG. The enlarged view of [B], FIGS. 4 to 6 are sectional views taken along the line AA in FIG. 1, and FIG. 7 corresponds to FIG. 6 of the indwelling needle assembly shown in FIG. FIG. 8 is a perspective view showing a state where the tube is removed from the inner needle hub in the indwelling needle assembly shown in FIG. 1, and FIG. 9 is shown in the indwelling needle assembly shown in FIG. It is a perspective view of a sealing member.

  In the following, the right side in FIG. 1, FIG. 7 and FIG. 8 is the “proximal end”, the left side is the “distal end”, and the upper side in FIGS. The lower side will be described as the “tip”. Further, in FIGS. 2 and 4 to 6, the dropping prevention means included in the indwelling needle assembly of the present invention is omitted.

  The indwelling needle assembly 1 shown in each figure includes a hollow outer needle 2, an outer needle hub 3 fixed to the proximal end portion of the outer needle 2, an inner needle 4 inserted into the outer needle 2, and an inner needle. The inner needle hub 5 fixed to the proximal end portion of the outer needle hub 4 and the proximal end portion (or the side portion) of the outer needle hub 3 are connected so as to communicate with the inner lumen 21 of the outer needle 2. Tube 7. Hereinafter, the configuration of each unit will be described.

  As the outer needle 2, one having a certain degree of flexibility is preferably used. The constituent material of the outer needle 2 is preferably a resin material, in particular, a soft resin material. Specific examples thereof include fluorine resins such as PTFE, ETFE, and PFA, olefin resins such as polyethylene and polypropylene, and these. And mixtures of polyurethane, polyester, polyamide, polyether nylon resin, a mixture of the olefin resin and ethylene-vinyl acetate copolymer, and the like.

  Such an outer needle 2 may be entirely or partially visible inside. Further, in the constituent material of the outer needle 2, for example, an X-ray contrast agent such as barium sulfate, barium carbonate, bismuth carbonate, and tungstic acid can be blended to have a contrast function.

  The outer needle hub 3 is fixed (fixed) to the proximal end portion of the outer needle 2 in a liquid-tight manner by, for example, caulking, fusing (thermal fusing, high frequency fusing, etc.), bonding with an adhesive, or the like. Yes.

  The outer needle hub 3 is configured by a substantially cylindrical member, and an inner portion 31 of the outer needle hub 3 communicates with the lumen 21 of the outer needle 2.

  A flow path 32 having one end opened to the inside 31 of the outer needle hub 3 is formed in the right side wall portion of the outer needle hub 3 in FIG. 2 (also in FIGS. 3 to 6). The flow path 32 is substantially L-shaped, and the other end is opened by a concave portion 33 that is recessed at the proximal end of the outer needle hub 3, and an opening 321 is formed. Further, a ring-shaped convex portion (connecting portion) 34 is formed on the distal end surface (bottom surface) of the concave portion 33 so as to surround the opening 321 so as to protrude in the proximal direction.

  This convex portion 34 is inserted into the lumen 71 at the distal end portion of the tube 7, and one end portion (the distal end portion) of the tube 7 is connected to the outer needle hub 3. Thereby, liquid, such as a chemical | medical solution, can be supplied to the outer needle 2 (outer needle hub 3) via the tube 7. FIG.

  Further, a pair of wings 6 a and 6 b are formed integrally with the outer needle hub 3 on the left and right sides of the outer needle hub 3 in FIG. 2 (also in FIGS. 3 to 6). Each of the wings 6a and 6b has flexibility, and is configured to be openable and closable by bending or bending the vicinity of the joint of the wings 6a and 6b with the outer needle hub 3.

  When the outer needle 2 and the inner needle 4 are punctured into a blood vessel or the like, the wings 6a and 6b can be picked up and closed with fingers to perform the puncturing operation. Further, without picking the wings 6a and 6b, the inner needle hub 5 is picked and punctured with the thumb and the middle finger, and when the tip of the outer needle 2 enters the blood vessel, the outer needle hub 3 is pushed forward with the index finger and only the outer needle 2 is moved. It can also be advanced into the blood vessel. When the outer needle 2 is indwelled, the wings 6a and 6b are opened, and the wings 6a and 6b are fixed to the skin with an adhesive tape or the like.

  An inner needle 4 having a sharp needle tip 41 at the tip is inserted into the outer needle 2. In the indwelling needle assembly 1, the inner needle 4 is inserted into the outer needle 2, and an inner needle hub 5 and an outer needle hub 3 described later are brought into contact with each other, that is, in the state shown in FIGS. 1 and 2. used. Hereinafter, this state is referred to as an “assembled state”.

  The length of the inner needle 4 is set to such a length that at least the needle tip 41 protrudes from the distal end opening 22 of the outer needle 2 when in the assembled state.

  The inner needle 4 may be a hollow needle, but is preferably a solid needle. By making the inner needle 4 a solid needle, it is possible to ensure a sufficient strength while reducing the outer diameter. In addition, by making the inner needle 4 a solid needle, when the inner needle 4 is discarded after the operation is completed, there is no risk that blood will remain inside the inner needle 4 or that the blood will flow out. Is expensive.

  Further, when the inner needle 4 is a hollow needle, when the inner needle 4 punctures a blood vessel, blood flows into the hollow portion of the inner needle 4 to confirm the flashback of the blood. By using a solid needle, blood flows into the gap between the inner needle 4 and the outer needle 2, and the flashback of blood can be confirmed earlier.

  The inner needle 4 has both a hollow portion and a solid portion (for example, by filling a part of the lumen of the hollow needle, the distal end side is hollow and the proximal end side is solid. However, the cost of the inner needle 4 can be reduced by configuring the entirety with one member.

  Further, the inner needle 4 has a plurality (three in the present embodiment) of different outer diameters. That is, the inner needle 4 has a maximum outer diameter portion 4a having the largest outer diameter on the distal end side (tip portion), a minimum outer diameter portion 4c having the smallest outer diameter on the proximal end side, and a maximum outer diameter portion therebetween. And an intermediate outer diameter portion 4b having an outer diameter between 4a and the minimum outer diameter portion 4c.

  Further, the inner needle 4 includes a first outer diameter changing portion 42 whose outer diameter continuously changes at a boundary portion between the maximum outer diameter portion 4a and the intermediate outer diameter portion 4b, and the intermediate outer diameter portion 4b and the minimum outer diameter portion 4b. A second outer diameter changing portion 43 that continuously changes is formed between the diameter portion 4c.

  In each of the outer diameter changing portions 42 and 43, the outer diameter of the inner needle 4 may change stepwise, but by continuously changing (tapering), the outer needle 2 is changed to the inner needle. To prevent the outer diameter changing portions 42 and 43 from being caught on the leading edge of a slit 81 of the seal member 8 to be described later, the leading edge of the inner needle passage 911 of the protector body 91, etc. Thus, the operation of removing the inner needle 4 from the outer needle 2 can be performed more smoothly and reliably.

  Each of the outer diameter changing portions 42 and 43 may be formed when the inner needle 4 is manufactured, and a step that is inevitably formed when a groove 44 described later is formed. It may be.

  Further, the maximum outer diameter portion 4 a is set to have an outer diameter substantially equal to the inner diameter of the outer needle 2, and is in close contact with the inner surface of the outer needle 2 with the inner needle 4 being inserted through the outer needle 2. A groove (flow path) 44 is formed to be recessed along the longitudinal direction of the inner needle 4 on the outer peripheral portion of the maximum outer diameter portion 4a (tip portion). With the groove 44, the distal end opening 22 of the outer needle 2 and the inside 31 of the outer needle hub 3 communicate with each other with the inner needle 4 inserted through the outer needle 2. The groove 44 functions as a blood (body fluid) flow path, for example, when a blood vessel is punctured. Thereby, the flashback of blood can be confirmed reliably.

  Examples of the constituent material of the inner needle 4 include a metal material such as stainless steel, aluminum or an aluminum alloy, titanium, or a titanium alloy.

  An inner needle hub 5 is fixed (fixed) to the proximal end portion of the inner needle 4. The inner needle hub 5 includes a fixing portion 51 that fixes the inner needle 4 and a cover portion 52 that is provided on the outer peripheral side of the fixing portion 51. The fixing part 51 and the cover part 52 are preferably formed integrally.

  And the tube 7 is arrange | positioned between the fixing | fixed part 51 and the cover part 52 in the assembly state. That is, the tube 7 is inserted through the inner needle hub 5 in the assembled state. As a result, the tube 7 can be prevented from interfering with the operation of the indwelling needle assembly 1.

Further, the cover portion 52 is provided with a pair of guides 523 and 523 for guiding the tube 7 (see FIG. 1). The guide 523 constitutes a side wall (side portion) of the cover portion 52, and the central axis O ₂ at the distal end portion of the tube 7 is substantially parallel to the longitudinal direction of the inner needle hub 5 (the central axis O ₁ of the outer needle 2). It guides you to become.

  Further, when the inner needle 4 is removed from the outer needle 2, the tube 7 can be removed from the inner needle hub 5 through the space between the guides 523 (gap 521).

  Examples of the method for fixing the inner needle 4 to the inner needle hub 5 (fixing portion 51) include a method such as fitting, caulking, fusing, adhesion using an adhesive, or a method using these in combination. When the inner needle 4 is hollow, for example, it is necessary to seal so that blood that flows backward when puncturing a blood vessel does not jump out from the proximal end of the inner needle 4.

  Further, as shown in FIG. 1 (the same applies to FIGS. 2, 7 and 8), a flange 522 may be formed on the outer periphery of the tip of the inner needle hub 5. By providing the flange 522, for example, when the inner needle 4 is removed from the outer needle 2, a finger can be hooked on the flange 522 and this operation can be performed more easily and reliably.

  Each of the inner needle hub 5 and the outer needle hub 3 described above is preferably made of a transparent (colorless and transparent), colored transparent or translucent resin to ensure internal visibility. Thereby, when the outer needle 2 secures the blood vessel, the flashback of the blood flowing in through the groove 44 of the inner needle 4 described above can be visually confirmed. Further, if the inner needle 4 is solid, for example, all the blood that is flashed back by the pressure inside the blood vessel flows back through the groove 44, so that the visibility is better.

  The constituent materials of the outer needle hub 3, the inner needle hub 5 and the blades 6a and 6b are not particularly limited. For example, polyolefins such as polyethylene, polypropylene, and ethylene-vinyl acetate copolymer, polyurethane, polyamide, polyester, Various resin materials such as polycarbonate, polybutadiene, and polyvinyl chloride are listed.

  The tube 7 has flexibility, and one end thereof is connected to the proximal end portion of the outer needle hub 3 as described above. A connector 72 is attached to the other end (base end) of the tube 7. The connector 72 is connected to, for example, a connector attached to an end of an infusion line that supplies an infusion solution (medical solution) to be administered, a mouth portion (tip end) of a syringe that stores the medicinal solution, and the like.

  In addition, although it does not specifically limit as a constituent material of the tube 7, For example, polyolefin, such as polyethylene, a polypropylene, an ethylene-vinyl acetate copolymer, polyvinyl chloride, polybutadiene, polyamide, polyester, etc. are mentioned, Among these, In particular, it is preferable to use polybutadiene. When polybutadiene is used as the constituent material of the tube 7, it is excellent in moderate flexibility, chemical resistance, and chemical adsorption prevention.

  The indwelling needle assembly 1 has a cylindrical (block-shaped) seal member 8 in the inside 31 of the outer needle hub 3 (see FIG. 9). A slit 81 penetrating along the longitudinal direction is formed at substantially the center of the seal member 8. Here, the “slit” refers to the one that is closed in a natural state. The “natural state” refers to a state in which no external force is applied to the seal member 8.

  As shown in FIG. 9, the slit 81 has a single character shape. Thereby, the slit 81 in the closed state can be easily opened. Therefore, the inner needle 4 can smoothly pass through the seal member 8 (slit 81), that is, when the outer needle 2 is advanced using the inner needle 4 as a guide as described later, the inner needle 4 (minimum outer diameter portion 4c). ) Between the outer surface 45 and the inner surface 811 of the slit 81 can be reduced. For this reason, the operativity at the time of puncture operation of the indwelling needle assembly 1 improves more.

  When the inner needle 4 is inserted into the slit 81 and the inserted inner needle 4 is removed in the assembled state, the seal member 8 is self-blocking in which the slit 81 is closed by its own elastic force. It has sex. Thereby, when the inner needle 4 is removed, liquid leakage from the proximal end of the outer needle hub 3 can be prevented, and sterility within the outer needle hub 3 can be maintained.

  Further, as shown in FIGS. 2 and 3, the minimum outer diameter portion 4c of the inner needle 4 is located in the slit 81 in the assembled state. Thereby, the contact area of the outer surface 45 of the minimum outer diameter part 4c and the inner surface 811 of the slit 81 becomes small, and therefore the frictional resistance between them can be reduced. Moreover, it can prevent that the sealing member 8 (slit 81) is wrinkled, and the sealing performance falls.

  Examples of the constituent material of the seal member 8 include various rubber materials such as natural rubber, isoprene rubber, butyl rubber, butadiene rubber, styrene-butadiene rubber, urethane rubber, nitrile rubber, acrylic rubber, fluorine rubber, and silicone rubber. (Especially those that have been vulcanized), various thermoplastic materials such as urethane-based, polyester-based, polyamide-based, olefin-based, and styrene-based materials, or mixtures thereof.

  Further, a flow path 82 is formed in the seal member 8 at a location different from the slit 81. The flow path 82 is open at the front end face and the side face of the seal member 8 and is substantially L-shaped.

  Then, the seal member 8 is inserted into the outer needle hub 3, and the opening opened on the side surface of the seal member 8 of the flow path 82 matches the opening opened to the inside 31 of the outer needle hub 3 of the flow path 32 described above. By doing so, a relay flow path having a crank shape is formed (completed). The lumen 21 of the outer needle 2 and the lumen 71 of the tube 7 communicate with each other through this relay channel. With such a configuration, the length of the relay flow path can be made relatively short, and the outer needle hub 3 can be prevented from being enlarged.

  Now, the indwelling needle assembly 1 is subjected to a friction reducing process for reducing the frictional resistance between the inner surface 811 of the slit 81 and the outer surface 45 of the inner needle 4.

  The friction reduction process in the present embodiment is a process for applying a lubricant to at least one of the inner surface 811 of the slit 81 and the outer surface 45 of the inner needle 4.

  The method of applying the lubricant is not particularly limited. For example, the lubricant is applied to the inner surface 811 of the slit 81 and the outer surface 45 of the inner needle 4, or the seal member 8 and the inner needle 4 are immersed in the lubricant. The method of doing is mentioned.

  The lubricant is not particularly limited, but for example, silicone, particularly reactive silicone is preferably used. The reactive silicone is a silicone that is cured by heat or radiation, and by using this, the silicone remains on the inner surface 811 of the slit 81 (or hole) of the seal member 8 or the surface (outer surface 45) of the inner needle 4 for a long time. Since it remains, the friction reduction effect can be maintained.

  By such a friction reduction process, when the outer needle 2 is advanced using the inner needle 4 as a guide, the frictional resistance between the inner needle 4 and the seal member 8 can be reliably reduced. Thereby, the outer needle 2 moves smoothly, that is, the indwelling needle assembly 1 is excellent in operability during the puncturing operation.

  When the inner needle 4 is made of a metal material as described above, the slidability of the inner needle 4 with respect to the seal member 8 is improved by the lubricant, that is, the seal member 8 and the inner needle 4 The frictional resistance between the two can be reduced more reliably. Thereby, the outer needle 2 moves more smoothly, that is, the indwelling needle assembly 1 is more excellent in operability during the puncturing operation.

  Furthermore, the indwelling needle assembly 1 has a protector 9 that covers at least the needle tip 41 of the inner needle 4 when the inner needle 4 is removed from the outer needle 2. Hereinafter, the protector 9 will be described.

  As shown in FIG. 2 (the same applies to FIGS. 4 to 6), the protector 9 includes a protector main body 91 whose outer shape is substantially a rectangular parallelepiped, and shutter means 92 provided in the protector main body 91. ing.

  An inner needle passage 911 through which the inner needle 4 is inserted is formed at substantially the center of the protector main body 91 so as to penetrate along the longitudinal direction of the protector main body 91.

  The cross-sectional shape of the inner needle passage 911 is substantially circular, and the inner diameter thereof is set to be equal to or slightly larger than the outer diameter of the maximum outer diameter portion 4 a of the inner needle 4.

  Further, a concave portion 912 is formed on the inner wall (the surface facing the inner needle passage 911) on the distal end side of the protector main body 91.

  In this recess 912, shutter means 92 is accommodated. The shutter means 92 includes a block-shaped shutter member 921 and a coil spring (biasing means) 922 that biases the shutter member 921 toward the inner needle passage 911 side.

  Most of the shutter means 92 is retracted into the recess 912, and a first posture (the posture shown in FIG. 2) in which the inner needle 4 can be inserted into the inner needle passage 911, and a part of the shutter member 921 are The inner needle passage 911 can be displaced into a second posture (posture shown in FIG. 4) that prevents the inner needle 4 from passing the needle tip 41.

  According to such a protector 9, the needle tip 41 of the inner needle 4 after use can be covered quickly and safely with a simple operation, and the needle tip 41 once covered by the action of the shutter means 92. However, it does not protrude from the tip of the protector 9 (protector body 91). For this reason, when the inner needle 4 or the like is disposed of, an accident that the operator or the like accidentally stabs a finger or the like with the needle tip 41 is prevented, and safety is high.

  Further, almost all of the protector 9 is covered with both the outer needle hub 3 and the inner needle hub 5 in the assembled state. Thereby, when the outer needle 2 and the inner needle 4 are punctured, the protector 9 does not get in the way, so that the operation can be performed more reliably. Note that almost all of the protector 9 may be covered with either the outer needle hub 3 or the inner needle hub 5.

  Further, the protector 9 is configured to be positioned on the proximal end side with respect to the seal member 8 in the assembled state. Thereby, when removing the inner needle 4 from the outer needle 2, it is not necessary to pass the protector 9 through the slit 81 of the seal member 8, and therefore, the operation can be performed more easily and reliably. Moreover, since the total length of the inner needle 4 can be set shorter with such a configuration, there is an advantage that the portion of the indwelling needle assembly 1 excluding the tube 7 can be downsized.

  As shown in FIGS. 7 and 8, the indwelling needle assembly 1 is connected to the protector 9 as a drop-off preventing means for preventing the protector 9 from dropping from the needle tip 41 when the protector 9 covers the needle tip 41. A member 20 is provided.

  The connecting member 20 is configured to connect the protector 9 and the inner needle hub 5. Thus, the protector 9 is reliably prevented from falling off the inner needle hub 5 (needle tip 41), and thus the state in which the protector 9 covers the needle tip 41 can be reliably maintained. For this reason, when the inner needle 4 or the like is disposed of, an accident that the operator or the like accidentally stabs a finger or the like with the needle tip 41 is surely prevented, and safety is high.

  Further, the connecting member 20 has a bellows shape, and is thus extendable. Such a connecting member 20 contracts in an assembled state, that is, is folded, and expands in a state where the inner needle 4 is removed from the outer needle 2 (the state shown in FIGS. 7 and 8), that is, expands. .

  Such a connecting member 20 contracts in an assembled state and is accommodated in the inner needle hub 5 in the contracted state. Thereby, the connection member 20 does not get in the way during the puncturing operation, and the operability of the indwelling needle assembly 1 is improved. There is also an advantage that the indwelling needle assembly 1 can be reduced in size.

  Further, the inner needle 4 penetrates the connecting member 20 in a state where the connecting member 20 is contracted and extended. Thereby, the inner needle 4 functions as a guide for the connecting member 20 when the connecting member 20 expands and contracts. Therefore, for example, when the indwelling needle assembly 1 is put into an assembled state (manufactured), the connecting member 20 is reliably prevented from contracting, that is, contracted without being stored in the inner needle hub 5. can do.

  Further, such an indwelling needle assembly 1 has a fixing means for fixing the protector 9 to the outer needle hub 3 in the assembled state, and the protector 9 covers at least the needle tip 41 of the inner needle 4. Further, when the inner needle 4 and the protector 9 are engaged with each other, an engaging means (movement restricting means) for restricting the movement of the inner needle 4 with respect to the protector 9 in the direction opposite to the needle tip 41 is provided. Hereinafter, each of these fixing means and engaging means will be described in detail.

<Fixing means>
First, the fixing means will be described.

  A through hole 913 is formed in the inner wall of the protector main body 91 on the base end side of the concave portion 912, and a convex portion 914 protruding inward is formed at the left end of the through hole 913 in FIG. .

  A fixing pin 10 having a flange portion 11 at the right end in FIG. 2 is inserted into the through-hole 913 in a state where the coil spring 12 is housed. In this state, the coil spring 12 has its left end in contact with the convex portion 914 and its right end in contact with the flange portion 11 in FIG.

  Further, a through hole 35 into which the fixing pin 10 can be inserted is formed at the base end portion of the left side wall portion of the outer needle hub 3 in FIG.

  In a state where the inner needle 4 is inserted (penetrated) into the inner needle passage 911, the right surface of the fixing pin 10 comes into contact with the outer peripheral surface (outer surface 45) of the inner needle 4, and the left end portion of the fixing pin 10 has a through-hole. It protrudes from 913 and is inserted into the through hole 35. Thereby, the protector 9 is fixed with respect to the outer needle hub 3 (refer FIG. 2 and FIG. 4).

  On the other hand, when the inner needle 4 is removed from the inner needle passage 911, the fixing pin 10 is pressed by the coil spring 12 and moves to the right in FIG. 5, and the left end portion of the fixing pin 10 comes out of the through hole 35. Thereby, the fixing of the protector 9 to the outer needle hub 3 is released (see FIG. 5).

  Thus, in this embodiment, the fixing means for fixing the protector 9 to the outer needle hub 3 is mainly constituted by the through hole 913, the fixing pin 10, the coil spring 12, and the inner needle 4.

  As shown in FIG. 4, in this embodiment, the fixing means is activated after the shutter means 92 is activated. That is, the fixing of the protector 9 to the outer needle hub 3 by the fixing means is maintained in a state where the shutter means 92 is activated. With such a configuration, in a state where the protector 9 is fixed to the outer needle hub 3, the shutter means 92 is surely operated. Therefore, when the inner needle 4 or the like is disposed of, the operator or the like An accident in which a finger or the like is accidentally stabbed with the needle tip 41 can be prevented more reliably.

<Engagement means>
Next, the engaging means will be described.

  A diameter-reduced portion 915 formed by reducing the diameter of the inner needle passage 911 is formed at the proximal end portion of the protector main body 91. The inner diameter of the reduced diameter portion 915 is set to be larger than the outer diameter of the intermediate outer diameter portion 4b and the minimum outer diameter portion 4c of the inner needle 4 and smaller than the outer diameter of the maximum outer diameter portion 4a.

  Thus, when the inner needle 4 is removed from the outer needle 2, the minimum outer diameter portion 4c, the second outer diameter changing portion 43, and the intermediate outer diameter portion 4b can pass through the reduced diameter portion 915. The outer diameter changing portion 42 cannot pass through the reduced diameter portion 915 and engages with the reduced diameter portion 915 (see FIG. 5).

  In other words, in the present embodiment, the first outer diameter changing portion 42 and the reduced diameter portion 915 constitute an engaging means for engaging the inner needle 4 and the protector 9.

  By providing such an engaging means, the inner needle 4 can be engaged with the protector 9 and the protector 9 can be detached from the outer needle hub 3 in a series of operations for removing the inner needle 4 from the outer needle 2. (Refer to FIG. 5 and FIG. 6) Therefore, the operation is very simple. Further, the inner needle 4 is prevented from coming off from the protector 9 in a state where the needle tip 41 is covered.

  Further, since the first outer diameter changing portion 42 and the reduced diameter portion 915 are formed on the inner needle 4 and the protector 9, respectively, the configuration is simple, the number of parts is not increased, and the size and the diameter are reduced. Contributes to

In the indwelling needle assembly 1 as described above, as shown in FIGS. 1 and 2, the tube 7 is connected to the proximal end portion of the outer needle hub 3, and the central axis O of the outer needle 2 in the assembled state. ₁ and the central axis O ₂ at the tip of the tube 7 are configured to be substantially parallel. That is, the tube 7 protrudes from the proximal end of the outer needle hub 3 in the proximal direction.

  Here, if the tube 7 protrudes to the side of the outer needle hub 3, when the outer needle 2 and the inner needle 4 are punctured, the outer needle hub 3 is pulled laterally by the tube 7, and the balance is maintained. The operation may be difficult.

  If the tube 7 protrudes above the outer needle hub 3, the tube 7 is bent when the outer needle hub 3 is fixed to the patient when the outer needle 2 is placed in the patient's blood vessel or the like ( There is a risk of kinking).

  Further, when the tube 7 protrudes to the side or upward of the outer needle hub 3, the tube 7 is not sandwiched when the outer needle 2 is advanced into the blood vessel after the outer needle 2 enters the blood vessel. 7, it is necessary to grip the inner needle hub 5 and the operation becomes complicated.

  On the other hand, in the indwelling needle assembly 1 of the present invention, the tube 7 protrudes in the proximal direction of the outer needle hub 3 and is covered with the inner needle hub 5, so that the inconvenience described above occurs. No operability and excellent operability.

  Next, an example of how to use the indwelling needle assembly 1 (when puncturing a blood vessel) will be described in detail.

  [1] The indwelling needle assembly 1 is brought into an assembled state, and a connector previously attached to the end of the infusion line is connected to the connector 72 so that the infusion from the infusion line can be supplied.

  At this time, a predetermined location on the tube 7 or the infusion line is sandwiched by, for example, a clamp (an example of a channel opening / closing means), and the lumen is closed.

  [2] Next, the block of the tube 7 or the infusion line by the clamp or the like is released, and the infusion from the infusion line is introduced into the outer needle hub 3 through the tube 7.

  The transfusion introduced into the outer needle hub 3 fills the space on the distal end side with respect to the flow path 32, the flow path 82, and the seal member 8 inside the outer needle hub 3, and is introduced into the lumen 21 of the outer needle 2. Thereby, the lumen 21 of the outer needle 2 is primed by infusion. At this time, a part of the infusion flows out from the distal end opening 22 of the outer needle 2.

  [3] When priming is completed as described above, the tube 7 or the infusion line is closed again with a clamp or the like, and the blades 6a and 6b are gripped and closed, and the blades 6a and 6b are gripped (operating unit). ) The integrated outer needle 2 and inner needle 4 are punctured into the blood vessel (vein or artery) of the patient.

  In this manner, by performing the puncture operation to the blood vessel by grasping the wings 6a and 6b, the puncture angle becomes smaller than the case of performing the puncture operation by directly grasping the outer needle hub 3, that is, the outer needle 2 And the inner needle 4 comes closer to the blood vessel more parallel. Therefore, the puncture operation is easy and the burden on the patient's blood vessel is reduced.

  When a blood vessel is secured by the outer needle 2, the blood flows back through the lumen 21 of the outer needle 2 through the groove 44 of the inner needle 4 due to the inner pressure (blood pressure) of the blood vessel. This can be confirmed in at least one of the outer needle 2, the outer needle hub 3, the inner needle hub 5 and the tube 7.

  Then, after confirming this, the outer needle 2 is further advanced toward the distal end by a minute distance using the inner needle 4 as a guide, that is, along the inner needle 4. As described above, the outer needle 45 can move smoothly because the outer surface 45 of the inner needle 4 and the inner surface 811 of the slit 81 are provided with a friction reducing process, that is, a lubricant.

  Further, when such a blood vessel is punctured, since the lumen 21 of the outer needle 2 is primed by infusion, it is possible to reliably prevent bubbles from entering the blood vessel by mistake, and the safety is extremely high.

Further, as described above, in the indwelling needle assembly 1 of the present invention, the tube 7 is connected to the proximal end portion of the outer needle hub 3, and in the assembled state, the central axis O ₁ of the outer needle 2 and the distal end portion of the tube 7. so that the substantially parallel and the central axis O ₂ at. For this reason, when the outer needle 2 and the inner needle 4 are punctured, the tube 7 does not get in the way and the operability is excellent.

  [4] When a blood vessel is secured by the outer needle 2, the outer needle 2 or the outer needle hub 3 is fixed with one hand, the inner needle hub 5 is grasped with the other hand, and pulled toward the proximal end. Is removed from the outer needle 2.

  [5] Further, when the inner needle 4 moves in the proximal direction and the needle tip 41 passes through the slit 81, the self-closing sealing member 8 closes the slit 81 by its own elastic force. As a result, liquid leakage does not occur through the slit 81, and sterility of the outer needle hub 3 and the infusion line is ensured.

  [6] Furthermore, when the inner needle 4 moves in the proximal direction and the needle tip 41 passes near the recess 912 of the inner needle passage 911, the shutter member 921 moves to the inner needle passage 911 side by the pressing of the coil spring 922, The right surface of the shutter member 921 is in contact with the surface of the inner needle passage 911 that faces the recess 912. That is, the shutter means 92 changes from the first posture (see FIG. 2) to the second posture (see FIG. 4).

  As described above, when the shutter unit 92 is in the second posture, the shutter member 921 closes the inner needle passage 911. Therefore, even if the needle tip 41 tries to move back toward the distal end, the needle tip 41 remains in the shutter member. It abuts on 921 and cannot return.

  [7] Further, when the inner needle 4 moves in the proximal direction and the needle tip 41 passes through the vicinity of the through hole 913 of the inner needle passage 911, the fixing pin 10 moves toward the inner needle passage 911 by the pressing of the coil spring 12. The right surface of the fixing pin 10 comes into contact with the surface of the inner needle passage 911 facing the through hole 913. At this time, the left end portion of the fixing pin 10 is detached from the through hole 35 of the outer needle hub 3. Thereby, the fixing of the protector 9 to the outer needle hub 3 is released (see FIG. 5).

  Thus, in a state where the protector 9 is fixed to the outer needle hub 3, the shutter means 92 operates reliably, so that when the inner needle 4 or the like is disposed of, the operator or the like mistakenly An accident of piercing a finger or the like at the tip 41 can be prevented more reliably.

  [8] Further, when the inner needle 4 moves in the proximal direction, the first outer diameter changing portion 32 cannot pass through the reduced diameter portion 915 and engages with the reduced diameter portion 915 (the inner needle 4 is protected by the protector 9). To engage).

  When the inner needle hub 5 is further pulled in the proximal direction in this state, the protector 9 engaged with the inner needle 4 moves in the proximal direction together with the inner needle 4 and is separated from the outer needle hub 3 (FIG. 6). And FIG. 7). At this time, the connecting member 20 prevents the protector 9 from being detached from the inner needle hub 5.

Even when the series of operations in the steps [5] to [9] is performed, the central axis O ₁ of the outer needle 2 and the central axis on the distal end side of the tube 7 are guided by the guide 523 of the inner needle hub 5. Since they are substantially parallel, these operations can be performed smoothly and reliably.

  [9] Next, the tube 7 inserted through the inner needle hub 5 is removed through the gap 521 (see FIG. 8).

  After the inner needle 4 is removed from the outer needle 2 in this manner, the inner needle 4 and the inner needle hub 5 become unnecessary, and are therefore disposed of.

  Since the needle tip 41 of the inner needle 4 is covered with the protector 9, in particular, the needle tip 41 moves beyond the shutter means 92 to the tip side, and does not protrude from the tip of the protector 9. Accidents such as a person who performs the disposal process accidentally pricks a finger or the like with the needle tip 41 are prevented.

  [10] Next, the wings 6a and 6b are opened and fixed to the skin with an adhesive tape or the like, and the blockage of the tube 7 or the infusion line by the clamp is released, and the supply of the infusion is started.

  The infusion supplied from the infusion line is injected into the blood vessel of the patient through the lumens of the connector 72, the tube 7, the outer needle hub 3 and the outer needle 2.

Second Embodiment
FIG. 10 is a perspective view of a seal member included in the indwelling needle assembly (second embodiment) of the present invention.

  Hereinafter, the second embodiment of the indwelling needle assembly of the present invention will be described with reference to this figure. However, the difference from the above-described embodiment will be mainly described, and the description of the same matters will be omitted.

This embodiment is the same as the first embodiment except that the configuration of the seal member is different.
As shown in FIG. 10, in the sealing member 8A, a low friction layer 83 is formed on each of the opposing inner surfaces 811 of the slit 81. Each low friction layer 83 is made of a low friction material.

  The low friction material constituting each low friction layer 83 is not particularly limited, and examples thereof include fluorine resins such as polytetrafluoroethylene, and acrylic polymers.

  By providing such a low friction layer 83, when the outer needle 2 is advanced using the inner needle 4 as a guide, the frictional resistance between the inner needle 4 and the seal member 8 can be reliably reduced. Thereby, the outer needle 2 moves smoothly, that is, the indwelling needle assembly 1 is excellent in operability during the puncturing operation.

  Thus, in the present embodiment, the low friction layer 83 is formed as the friction reducing process.

<Third Embodiment>
FIG. 11 is a perspective view of a seal member and a compression member included in the indwelling needle assembly (third embodiment) of the present invention.

  Hereinafter, the third embodiment of the indwelling needle assembly of the present invention will be described with reference to this drawing. However, the difference from the above-described embodiment will be mainly described, and the description of the same matters will be omitted.

  This embodiment is the same as the first embodiment except that the configuration of the slit of the seal member is different.

  The seal member 8B shown in FIG. 11 (a) has a hole 81B that is open in a natural state. Here, the “natural state” refers to a state in which no external force is applied to the seal member 8B.

  In the indwelling needle assembly 1 of the present embodiment, the seal member 8B is press-fitted into the compression member 30 formed of a tubular body, and is installed in the outer needle hub 3 in this state (see FIG. 11 (b)). .

  When the sealing member 8B is press-fitted into the compression member 30, the hole 81B compressed in the radial direction is closed.

The outer diameter d ₁ of the seal member 8 is set slightly larger than the inner diameter d ₂ of the compression member 30. Thereby, the sealing member 8 is reliably compressed in the radial direction, and thus the hole 81B is reliably closed.

  The indwelling needle assembly according to the present invention has been described above with reference to the illustrated embodiment. However, the present invention is not limited to this, and each part constituting the indwelling needle assembly may be any unit that can exhibit the same function. It can be replaced with the configuration of Moreover, arbitrary components may be added.

  In addition, the indwelling needle assembly of the present invention is not limited to those used by being inserted into blood vessels, and is applied to those used by being inserted into the abdominal cavity, thoracic cavity, lymphatic vessel, spinal canal, etc. You can also

  The shape of the slit of the seal member is not limited to a single letter shape, and may be, for example, a cross shape, a Y shape, a T shape (a G shape), or an H shape.

  In addition, after removing the inner needle from the outer needle, a cap to be attached to the proximal end portion of the outer needle hub may be provided. Thereby, the liquid leak from the base end of an outer needle hub can be prevented more reliably. The cap may be formed integrally with the outer needle hub, or may be a separate body from the outer needle hub. Further, the method of fixing the cap to the outer needle hub may be any method such as a method using friction and a method using hooking.

  Further, the protector is not limited to the illustrated configuration, and for example, has a configuration that can be rotated (displaceable) between a position that covers at least the needle tip of the inner needle and a position that is separated from the inner needle. There may be.

  Moreover, it does not specifically limit as a connector provided in the edge part of a tube, For example, the needleless connector described in Unexamined-Japanese-Patent No. 2005-261931, a three-way cock, etc. are mentioned.

  Moreover, what is provided in the edge part of a tube is not limited to the said connector, For example, a cap, an air filter, etc. may be sufficient.

  Moreover, in the indwelling needle assembly of this invention, these connectors, a cap, and an air filter can be suitably changed to the edge part of a tube.

  The indwelling needle assembly of the present invention includes an inner needle having a sharp needle tip at a tip, an inner needle hub fixed to a proximal end portion of the inner needle, a hollow outer needle through which the inner needle is inserted, An outer needle hub fixed to a proximal end portion of the outer needle, an opening provided in a proximal end portion or a side portion of the outer needle hub so as to communicate with a lumen of the outer needle, and the outer needle A hole or a slit provided in the hub, through which the inner needle can be inserted, and a seal member that closes the hole or the slit when the inserted inner needle is removed; The inner surface of the slit and / or the outer surface of the inner needle is subjected to a friction reducing process for reducing the frictional resistance therebetween. Therefore, during the puncturing operation, the frictional resistance between the seal member and the inner needle can be reliably reduced, so that the operability is excellent and the line for infusion or the like can be secured easily and reliably. Therefore, the puncture device of the present invention has industrial applicability.

Claims (10)

An inner needle having a sharp needle tip at the tip;
An inner needle hub fixed to the proximal end of the inner needle;
A hollow outer needle through which the inner needle is inserted;
An outer needle hub fixed to a proximal end portion of the outer needle;
An opening provided in a proximal end portion or a side portion of the outer needle hub so as to communicate with a lumen of the outer needle;
A hole or slit provided in the outer needle hub, through which the inner needle can be inserted, and a seal member that closes the hole or the slit when the inserted inner needle is removed;
An indwelling needle assembly, wherein an inner surface of the hole or the slit and / or an outer surface of the inner needle is subjected to a friction reducing process for reducing a frictional resistance therebetween. The indwelling needle assembly according to claim 1, wherein a tube is connected to the opening. The indwelling needle assembly according to claim 2, wherein the tube is inserted through the inner needle hub. The indwelling needle assembly according to claim 1, wherein the friction reducing process is a process of applying a lubricant to the inner surface of the hole or the slit and / or the outer surface of the inner needle. The indwelling needle assembly according to claim 4, wherein the lubricant is mainly composed of silicone. The indwelling needle assembly according to claim 1, wherein the friction reducing process is to form a layer made of a low friction material on an inner surface of the hole or the slit. The indwelling needle assembly according to claim 6, wherein the low friction material is mainly made of a fluorine resin or an acrylic polymer. The inner needle has a portion whose outer diameter is different,
The indwelling needle assembly according to claim 1, wherein a portion having the smallest outer diameter of the inner needle is inserted into the hole or the slit of the seal member in a state where the inner needle is inserted into the outer needle. . The indwelling needle assembly according to claim 1, further comprising a protector that covers at least a needle tip of the inner needle when the inner needle is removed from the outer needle. The indwelling needle assembly according to claim 9, further comprising a drop prevention means for preventing the protector covering the needle tip from falling off the needle tip.

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