JP2009005997A - Indwelling needle assembly - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide an indwelling needle assembly, in which a needle tip is not exposed outward, but is protected when an inner needle is removed, force necessary for protecting the tip is small, and operation by one hand is easy. <P>SOLUTION: The indwelling needle assembly 1 comprises the inner needle 2, an inner needle hub 3, an outer needle 4, an outer needle hub 5, and a protector 6 axially slidably disposed around the inner needle for protecting the tip of the inner needle 2. The protector 6 comprises a protection member 61 in which the tip of the inner needle 2 can be housed, and a closing member 62 slidably disposed around the protection member. A displaceable side wall 63 is provided to be displaceable inward for closing a tip side opening 612 of the protection member 61. The displaceable side wall 63 is displaced inward as the closing member 62 is disposed around a tip part of the protection member. The protector 6 is engaged and fixed inside the outer needle hub 5 before the tip of the inner needle 2 is protected. The protector 6 becomes releasable from the outer needle hub 5 only after the tip is protected. <P>COPYRIGHT: (C)2009,JPO&INPIT

Description

  The present invention relates to an indwelling needle assembly that is punctured and placed in a blood vessel during infusion or blood collection.

  When performing infusion or blood collection on a patient, a metallic needle (inner needle) for puncturing the patient's skin and a resin needle (outer needle) for placement in the patient's blood vessel on the outer periphery thereof ) May be used. The inner needle of the indwelling needle has a sharp needle tip. When the inner needle is removed from the outer needle to place only the outer needle in the patient after use, an accidental puncture accident occurs due to the needle tip of the inner needle. There is a risk.

To discard the inner needle after use, insert the inner needle again into the packaging material that had been stored before use, or reinsert the needle tip of the inner needle into the cap that covered the needle tip before use. Measures such as insertion have been taken. However, even in these operations, it is necessary to pay close attention so that an accidental puncture accident caused by the needle tip does not occur, and it cannot be said that it is a measure for reducing the risk of an erroneous puncture accident.
Therefore, from the viewpoint of reducing such erroneous puncture accidents, in recent years, when removing the inner needle from the outer needle, an erroneous puncture prevention mechanism for protecting the sharp needle tip of the inner needle without exposing it to the outside is provided. Indwelling needle assemblies are beginning to become popular.

  As the erroneous puncture prevention mechanism, for example, a protector that is arranged on the inner needle so as to be slidable in the axial direction of the needle and accommodates the needle tip therein is used. And as an example of use of such a protector, an indwelling needle assembly (for example, refer to patent documents 1) provided with a cylindrical protector which has a plurality of fingers urged inward at the tip, front, back An indwelling needle assembly (see, for example, Patent Document 2 or 3) including a protector made of an elastic spring clip having a wall is well known.

  The protectors used in these indwelling needle assemblies have openings through which needles are inserted at least at two locations, the needle tip side (tip side) and the needle base side (base end side). It is engaged and fixed inside the outer needle hub. After puncturing the patient with the indwelling needle, when the inner needle is removed from the proximal end of the outer needle, the protector remains fixed in the outer needle hub. It passes through the opening on the distal end side and is housed and protected in the protector. Thereafter, the protector and the outer needle hub are unfixed, and the protector is completely removed from the outer needle together with the inner needle. When removing the inner needle, as soon as the needle tip passes through the opening on the tip side, the opening is closed, and the tip of the protector is attached inward to prevent the needle tip from being exposed to the outside from the tip of the protector again. It has a biased part. Therefore, in the state before the inner needle is removed, the tip of the protector is always in pressure contact with the outer peripheral surface of the inner needle, which increases the sliding resistance of the protector that moves on the inner needle, and prevents the needle tip from being protected. The necessary force is increased.

JP-A-9-99073 JP-T-2001-514943 JP 2002-248168 A

The removal of the inner needle is usually performed by a medical worker with one hand, and it is preferable that the tip of the inner needle is protected simultaneously with or just before the inner needle is removed from the outer needle. However, if the force required to protect the needle tip increases, the needle tip protection operation cannot be performed with one hand, so the needle tip cannot be protected immediately after removal or the protector is completely moved to the position where the needle tip is protected. The needle tip may damage the patient's blood vessels and skin when the inner needle is removed.
Accordingly, the present invention provides an indwelling needle assembly in which the needle tip is protected without being exposed to the outside when the inner needle is removed, and the force required for the needle tip protection operation is smaller than in the prior art and is easy to operate with one hand. The purpose is to provide a solid.

  As a result of intensive studies, the present inventors have divided the protector into two members, a protective member and a closing member, so that the inward biasing force of the protector tip is not applied to the outer peripheral surface of the needle before the inner needle is removed. As a result, the inventors have found that the above-described problems can be solved and have reached the present invention.

That is, the present invention
(1) An inner needle having a sharp needle tip at the tip and an engaging portion in the vicinity of the tip, an inner needle hub provided at the proximal end of the inner needle, and an outer needle disposed on the outer periphery of the inner needle An indwelling needle assembly comprising: an outer needle hub provided at a proximal end portion of the outer needle; and a protector for protecting the needle tip of the inner needle that is slidably disposed in the axial direction on the outer periphery of the inner needle. In
The protector is provided with an internal space that can accommodate the needle tip of the inner needle, and a protective member that can slide in the axial direction on the inner needle, and is slidably disposed on the outer periphery of the protective member from the proximal end to the distal end. A closure member,
The protection member is provided with a distal end side opening through which the inner needle can be inserted and a proximal end opening through which the inner needle body can be inserted but the engagement portion cannot pass. A displacement side wall is provided that can be displaced inward to close the opening on the front end side when accommodated in a space, and the displacement side wall is inward by disposing the closing member on the outer periphery of the front end of the protective member. Is displaced to
The closure member is disposed on the outer periphery of the base end portion where the displacement side wall of the protection member is not provided before the needle tip is accommodated in the internal space of the protection member, and the needle tip is accommodated in the internal space of the protection member. When the outer periphery of the protection member is slid to the tip side when it is done, it is arranged on the outer periphery of the tip portion provided with a displacement side wall of the protection member,
The protector is disposed in the outer needle hub before the needle tip of the inner needle is accommodated in the inner space of the protection member, and the inner peripheral surface of the outer needle hub and the closing member are engaged and fixed, In the engagement, the inner needle is withdrawn from the outer needle to the proximal end side, and the engaging portion of the inner needle engages with the proximal end opening of the protecting member, so that the protective member and the inner needle are in the proximal end. The locking member is maintained until the closing member slides and is arranged on the outer periphery of the distal end portion of the protective member, and the engagement is provided with the locking member provided at the distal end portion of the protective member. An indwelling needle assembly that is released by being locked by the outer needle hub and that can be detached from the outer needle hub;
(2) The protector of the protector includes a proximal wall having a proximal opening, a distal wall having a distal opening, and a side wall extending in the axial direction of a needle provided integrally with the proximal wall and the distal wall. The indwelling needle assembly according to (1), wherein the displacement side wall is provided on a part of the side wall,
(3) The indwelling needle assembly according to (2), wherein the protective member of the protector has a pair of opposing side walls, and one tip of the side wall is a displacement side wall.
(4) The protector of the protector has four side walls that surround the needle tip from four directions, and a pair of displacement side walls are provided at a pair of tip portions opposed to the side walls. Indwelling needle assembly,
(5) The closing member of the protector includes an opening having an inner diameter slightly smaller than an inner diameter necessary for inserting the proximal end of the protective member, and is biased inwardly in the state of the protective member. The indwelling needle assembly according to any one of (1) to (4), which is disposed on the outer periphery of the base end portion,
(6) The indwelling needle assembly according to (5), wherein the closing member of the protector is an annular body partly cut.
(7) The indwelling needle assembly according to (5), wherein the closing member of the protector is an annular body formed of an elastic material.
(8) The locking means provided at the distal end portion of the protection member is at least one groove portion in which the closing member can be contracted and fitted by an urging force, according to any one of (5) to (7). Indwelling needle assembly,
(9) The closing member of the protector is an annular body that includes an opening having an inner diameter through which the base end of the protection member can be inserted, and is disposed on the outer periphery of the base end portion of the protection member in a natural state (1 ) To (4), the indwelling needle assembly according to any one of
(10) The locking means provided at the distal end portion of the protection member are a claw portion projecting outward toward the proximal end side and a claw portion projecting outward toward the distal end side. (9) The indwelling needle assembly according to
(11) The engagement fixing between the inner peripheral surface of the outer needle hub and the closing member before the needle tip of the inner needle is accommodated in the inner space of the protection member is performed by the closing member being the inner peripheral surface of the outer needle hub. The indwelling needle assembly according to any one of (1) to (10), which is made by fitting into an annular recess formed in
(12) The engagement fixing between the inner peripheral surface of the outer needle hub and the closing member before the needle tip of the inner needle is accommodated in the inner space of the protective member is performed by the closing member being the inner peripheral surface of the outer needle hub. The present invention relates to the indwelling needle assembly according to any one of (1) to (10), wherein the indwelling needle assembly is engaged with an annular protrusion formed on the base end side of the closing member.

  In the indwelling needle assembly of the present invention, the protector is composed of two members, that is, a protective member and a closing member, so that the inward biasing force is not directly applied to the outer peripheral surface of the needle unlike the conventional protector. Therefore, the sliding resistance of the protector that slides on the inner needle when the inner needle is removed is lowered, and the operation can be easily performed with one hand. Also, when the protector is placed on the inner needle before use, the protector's inward biasing force is not directly applied to the outer peripheral surface of the needle, so it is necessary to insert the inner needle through the protector's opening while resisting the biasing force. There is no smooth arrangement.

Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the drawings, but the present invention is not limited thereto.
FIG. 1 is a longitudinal sectional view showing a state before an inner needle is removed in an embodiment of the indwelling needle assembly of the present invention, and FIG. 2 is an enlarged longitudinal sectional view of a protector portion of the indwelling needle assembly shown in FIG. is there. 3 is a perspective view showing a state of the protector in the indwelling needle assembly according to an embodiment of the present invention before accommodation of the needle tip, and FIG. 4 is a perspective view showing a state of the protector shown in FIG. 3 after accommodation of the needle tip. It is. 5 to 7 are perspective views showing other embodiments of the protector in the indwelling needle assembly of the present invention. FIG. 8 is an explanatory view showing a state in which the tip of the inner needle is accommodated in the protector when the inner needle is removed in the indwelling needle assembly shown in FIG.

  As shown in FIG. 1, an indwelling needle assembly 1 of the present invention includes an inner needle 2 having a sharp needle tip 21 at a distal end, an inner needle hub 3 provided at a proximal end portion of the inner needle 2, and an inner needle. 2, an outer needle 4 disposed on the outer periphery of the outer needle 4, an outer needle hub 5 provided at the proximal end of the outer needle 4, and a protector 6 disposed on the outer periphery of the inner needle 2. In the indwelling needle assembly 1 of the present invention, the distal end side is the needle tip 21 side (left side in the figure) punctured by the patient, and the proximal end side is a needle proximal side (right side in the figure) connected to a syringe, a tube, or the like. ).

  The inner needle 2 is a hollow needle, and examples of the material thereof include stainless steel, aluminum or aluminum alloy, titanium or titanium alloy, and it is preferable to use stainless steel in view of easy processability and cost. Further, a sharp needle tip 21 is formed at the tip of the inner needle 2, but the shape is not particularly limited as long as it reduces puncture resistance to the patient.

  As shown in FIG. 8, an engaging portion 22 is formed near the tip of the inner needle 2. The engaging part 22 is a part in which a part of the outer peripheral surface of the inner needle 2 is enlarged in diameter, and has a diameter that cannot pass through the proximal end side opening 613 of the protective member 61 of the protector 6 described later. The engaging portion 22 may be an annular enlarged portion in which the outer peripheral surface of the inner needle 2 is expanded in the circumferential direction, or a protrusion provided in a part or a plurality of portions in the circumferential direction. May be. Further, the position where the engaging portion 22 is provided is that the needle tip 21 of the inner needle 2 is located when the engaging portion 22 is engaged with the proximal end wall 614 at the proximal end opening 613 portion of the protective member 61 of the protector 6 as described later. Is a position in which the internal space 611 of the protection member 61 is accommodated. Such an engaging portion 22 is formed by crimping the inner needle 2 or the like.

  The inner needle hub 3 provided at the proximal end portion of the inner needle 2 is a substantially cylindrical hollow member, and is fitted to the proximal end portion of the inner needle 2, caulked, fused or bonded by an adhesive, or these Fixed by a combination or the like. The inner needle hub 3 is made of a thermoplastic resin or the like and is formed by injection molding or the like. The inner needle hub 3 is preferably formed so as to be visible with a transparent, colored transparent or translucent resin so that blood flashback can be confirmed when the patient is punctured with the inner needle 2.

  It is preferable that an inner needle cap 7 having a ventilation filter 71 is connected to the proximal end side of the inner needle hub 3. The ventilation filter 71 has a property of allowing gas to permeate but not liquid, for example, a sintered porous material obtained by sintering a polymer material such as polyethylene and a material containing a hydrophilic, water-soluble or water-swellable polymer. Body, hydrophobic nonwoven fabric, and porous body. By using such a ventilation filter 71, it is possible to promote a flashback of blood when the patient is punctured with the inner needle 2, and it is possible to prevent blood flowing into the inner needle 2 due to the flashback from leaking to the outside. Since ventilation is blocked by the ventilation filter 71 coming into contact with blood, it is possible to prevent air from entering from the outside. Such a ventilation filter 71 may be provided directly inside the proximal end portion of the inner needle hub 3.

The outer needle 4 has a hollow shape and is formed of a material having flexibility to the extent that there is no possibility of damaging the blood vessel wall or the like when placed in a patient's blood vessel. As a material of the outer needle 4, for example, various soft resins such as ethylene-tetrafluoroethylene copolymer, polyurethane, polyether nylon resin, and polypropylene are preferable. Further, the outer needle 4 may be entirely or partially visible inside, and has a contrast function by blending an X-ray contrast agent such as barium sulfate or barium carbonate in the material. May be.
In order to reduce resistance when the patient's blood vessel is punctured with the inner needle 2 together with the inner needle 2, the outer needle 4 is preferably formed in a tapered shape whose outer diameter gradually decreases toward the distal end. In addition, one or a plurality of holes may be provided in the vicinity of the distal end portion of the outer needle 4 in order to efficiently enter and exit the fluid flowing inside.

  The outer needle hub 5 provided at the proximal end portion of the outer needle 4 is also a substantially cylindrical hollow member, like the inner needle hub 5, and is fitted, caulked, fused or bonded to the proximal end portion of the outer needle 4. It is fixed by bonding with an adhesive or a combination thereof. The material and molding method of the outer needle hub 5 are the same as those of the inner needle hub 5. An operation protrusion 51 may be formed on the outer peripheral surface of the outer needle hub 5 for facilitating the operation of piercing the patient's blood vessel with the inner needle 2 and the outer needle 4. Further, a female luer taper 52 and a flange 53 may be formed at the proximal end portion of the outer needle hub 5 in order to connect a medical device such as an arrangement of the inner needle hub 3 and a tube or a connector which will be described later.

  A protector 6 for protecting the needle tip 21 of the inner needle 2 is disposed on the outer periphery of the inner needle 2. As shown in FIG. 2, the protector 6 of the present invention includes a protection member 61 and a closing member 62. The protection member 61 includes an internal space 611 that can accommodate the needle tip 21 of the inner needle 2, and the outer needle 2 is connected to the outer periphery of the inner needle 2 in a state where the inner needle 2 is inserted through the distal end side opening 612 and the proximal end side opening 613. 2 can slide in the axial direction. The closing member 62 is disposed on the outer periphery of the protection member 61 and can slide from the proximal end portion to the distal end portion of the protection member 61.

The protective member 61 includes a proximal end wall 614 having a proximal end side opening 613, a distal end wall 615 having a distal end side opening 612, and an axial direction of the inner needle 2 provided integrally with the proximal end wall 614 and the distal end wall 615. And a side wall 616 extending in the direction. The internal space 611 that can accommodate the needle tip 21 of the inner needle 2 is formed by the proximal end wall 614, the distal end wall 615, and the side wall 616. The internal space 611 is a space that is completely shielded from the outside. Or may be partially opened as shown in FIGS.
That is, the shape of the protective member 61 is not particularly limited as long as the inner needle 2 can be inserted into the distal end side opening 612 and the proximal end side opening 613 and the needle tip 21 can be accommodated in the internal space 611. . However, in order to prevent the needle tip 21 accommodated in the internal space 611 from dropping out from the proximal end side opening 613 to the proximal end side, the proximal end side opening 613 can be inserted through the main body of the inner needle 2. The engaging portion 22 of the inner needle 2 has a size that cannot be passed through and can engage with the proximal end wall 614 at the proximal end side opening 613 portion. The distal end opening 612 does not need to be a hole provided in the distal end wall 615 but may be a groove provided for positioning the inner needle 2 at the inner end of the distal end wall 615.

  Specific examples of the protective member 61 include those having shapes as shown in FIGS. The protective member 61 shown here has a square plate-like distal end wall 615 as well as a square plate-like proximal end wall 614, and a pair of side walls 616 opposed from two opposite sides of the proximal end wall 614 are raised. It is installed. One side wall 616 has a plate shape, and one end is provided integrally with the base end wall 614 and the other end is provided integrally with the tip end wall 615 so that the base end wall 614 and the tip end wall 615 are opposed to each other. Placed in. The other side wall 616 is also plate-shaped, and one end thereof is provided integrally with the base end wall 614, but the displacement side wall 63 is provided at a part of the distal end portion of the side wall 616.

  The displacement side wall 63 is provided at the distal end portion of the protection member 61, and is provided on the distal end wall 615 when the needle tip 21 of the inner needle 2 is accommodated in the internal space 611 of the protection member 61. The front end side opening 612 is displaced inward so as to be closed. For example, as shown in FIG. 3, the displacement side wall 63 is composed of a main body portion 631 provided continuously to the side wall 616 in a state along the outer side, and a closing portion 632 provided continuously to the distal end side of the main body portion 631. Is done. The main body 631 can be displaced inward by an external force, that is, can be bent. When the main body 631 is bent inward, the closing portion 632 closes the front end opening 612 of the front end wall 615. Here, the closing of the distal end side opening 612 does not necessarily mean that the distal end side opening 612 is sealed, but the needle tip 21 of the inner needle 2 accommodated in the internal space 611 from the distal end side of the protective member 61 is not limited. It means not to protrude again.

  The side wall 616 may be composed of four plate-like side walls surrounding the needle tip 21 from four sides in addition to the pair of opposed side walls shown in the figure, and may provide a substantially quadrangular prism-shaped protection member 61. Further, the displacement side wall 63 may be provided on the entire one end portion of the side wall 616 as shown in the illustrated example, or may be provided on a part of one end portion of the side wall 616 although not shown. May be. Alternatively, a plurality of displacement side walls 63 may be provided on the plurality of side walls 616.

  The displacement side wall 63 is displaced inward by the closing member 62. That is, when the closing member 62 slidably disposed on the outer periphery of the protective member 61 is disposed on the outer periphery of the distal end portion of the protective member 61, the displacement side wall 63 is displaced inward, and the inner side of the distal end side opening 612 The needle 2 of the needle 2 is closed so as not to protrude. The closing member 62 is normally disposed on the outer periphery of the proximal end portion of the protective member 61 as shown in FIG. 3 before the needle tip 21 is accommodated in the internal space 611, and the needle tip 21 is accommodated in the internal space 611. When this is done, the outer periphery of the protective member 61 slides toward the distal end side and is disposed on the outer periphery of the distal end portion provided with the displacement side wall 63 as shown in FIG. Here, the proximal end portion of the protection member 61 refers to a portion closer to the proximal end than the distal end portion where the displacement side wall 63 is provided.

Other shapes of the protective member 61 of the present invention include a cylindrical side wall 616 so that the inner needle 2 can be completely accommodated, and a substantially cylindrical shape constituted by two or more side walls. May be. Further, the outer periphery of the cross section perpendicular to the axis in the side wall 616 portion of the protective member 61 may be a polygonal shape or the like other than the illustrated rectangular shape or circular shape. The outer peripheral shape of the cross section perpendicular to the axis in the side wall 616 portion of the protective member 61 and the inner peripheral shape of the closing member 62 are not necessarily the same, but the closing member 62 is low on the outer periphery of the protective member 61. It must have an inner diameter and shape that can slide with dynamic resistance.
Further, the closing portion 632 of the displacement side wall 63 of the protection member 61 is provided so as to protrude toward the proximal end side from the distal end portion of the displacement side wall 63, thereby preventing the needle tip 21 from protruding from the distal end side of the protection member 61. It can prevent more effectively.

  When the protective member 61 is entirely formed of the same material, a material capable of forming a displacement side wall 63 that is displaced inward by processing, for example, stainless steel, aluminum or an aluminum alloy, titanium or a titanium alloy, copper or copper Various metal materials such as alloys, polyolefins such as polyethylene, polypropylene, polybutadiene, ethylene-vinyl acetate copolymer, polyvinyl chloride, polyurethane, polystyrene, polymethyl methacrylate, polycarbonate, polyamide, polyethylene terephthalate, polybutylene terephthalate, etc. It is preferably formed from various resin materials such as polyester, acrylic resin, ABS resin, ionomer, polyacetal, polyphenylene sulfide, and polyether ether ketone.

  The protective member 61 formed from such a material can be formed by joining a resin material molded by injection molding or the like, or a metal material molded by bending or the like. The joining method in this case is not particularly limited, and examples thereof include caulking, engagement by unevenness, adhesion using an adhesive, and melting. Further, the protective member 61 can be formed by combining two or more of the materials. For example, by attaching a member made of a hard material such as ceramics to the inner wall of the displacement side wall 63, the strength of the displacement side wall 63 can be improved, and breakage due to displacement can be prevented. Here, when the base member of the protective member 61 is disposed in a state in which the closing member 62 disposed on the outer periphery is urged inward as will be described later, the urging force is directly applied to the inner needle 2. It must have strength that does not cause deformation.

  The closing member 62 disposed on the outer periphery of the protective member 61 has an inner diameter and an inner peripheral shape that can slide on the outer periphery of the protective member 61 as described above. The closing member 62 is a polyolefin such as polyethylene, polypropylene, polybutadiene, or ethylene-vinyl acetate copolymer, polyvinyl chloride, polyurethane, polystyrene, polymethyl methacrylate, polycarbonate, polyamide, polyethylene terephthalate, polyester such as polybutylene terephthalate, or acrylic. Various resin materials such as resin, ABS resin, ionomer, polyacetal, polyphenylene sulfide, polyether ether ketone, or various metal materials such as stainless steel, aluminum or aluminum alloy, titanium or titanium alloy, copper or copper alloy, ceramic, etc. It is formed from a hard material. The closing member 62 may be made of a rubber material such as natural rubber, isoprene rubber or butadiene rubber, or an elastic material such as a thermoplastic elastomer. The closing member 62 is formed into an annular body or an annular body partly cut by injection molding or the like.

  An example of the closing member 62 is an annular body that is partially cut as shown in FIGS. 3 and 4. The closing member 62 includes an opening having an inner diameter that is slightly smaller than an inner diameter necessary for inserting the proximal end portion of the protective member 61, and the protective member 61 is in a state where the cutting portion 621 is expanded. It is arrange | positioned at the base end part outer periphery. Such a closing member 62 is formed of a material having such rigidity that generates a biasing force in a direction in which the cutting portion 621 is closed, that is, inward. Accordingly, the closing member 62 is disposed on the outer periphery of the proximal end portion of the protection member 2 in a state where the cutting portion 621 is pushed and spread inward as shown in FIG. 3, as shown in FIG. When the sliding member 63 is slid to the distal end side and disposed on the outer periphery of the distal end portion of the protection member 61, the displacement side wall 63 is displaced inward by the biasing force.

  When the closing member 62 is slid to the front end side of the protective member 61, the sliding member 63 is prevented from sliding by the locking means provided on the outer periphery of the protective member 61, and the displacement side wall 63 is displaced inward. And is preferably held on the protective member 61. As the locking means, for example, a groove 633 provided on the displacement side wall 63 as shown in the figure and fitted and locked when the closing member 62 contracts inward can be used. At least one groove portion 633 is provided on the outer periphery of the front end portion of the protection member 61. However, by providing a plurality of groove portions 633 as shown in the drawing, the closing member 62 is contracted more inwardly and reliably protected. The member 2 is locked so as not to slide. By providing such a locking means, the distal end side opening 612 is prevented from projecting again from the distal end side of the protective member 61 so that the needle tip 21 accommodated in the internal space 611 of the protective member 61 protrudes from the distal end side of the protective member 61. The closed state can be maintained.

  The protective member 61 may be further provided with a lock mechanism for holding the distal end side opening 612 closed by the closing portion 632. As an example of the locking mechanism, for example, as shown in FIG. 5, there is a mechanism by engagement between a groove 634 provided on the displacement side wall 63 of the protection member 61 and a protrusion 617 provided on the tip wall 615. It is done. By providing such a locking mechanism, the displacement side wall 63 can be more reliably held in a state of being displaced inward, and the needle tip 21 accommodated in the internal space 611 of the protection member 61 protrudes again. Can be more effectively prevented.

  The closing member 64 may be an annular body formed of an elastic material. The closing member 64 includes an opening having an inner diameter slightly smaller than an inner diameter required to pass through the proximal end portion of the protection member 61, similar to the closing member 62 which is an annular body partly cut. The inner circumference is pushed and spread inward and is arranged on the outer circumference of the base end portion of the protective member 61. Therefore, when the closing member 64, which is an annular body made of an elastic material, slides toward the distal end side and is disposed on the outer periphery of the distal end portion of the protective member 61, the displacement side wall 63 is moved inward by the inward biasing force. Is to be displaced. Such a closing member 64 is fitted in a groove portion 633 provided on the outer periphery of the front end portion of the protective member 61 by contracting inward, similarly to the closing member 62 which is an annular body partly cut, and thereafter It is preferable that the sliding is prevented.

FIG. 6 is a perspective view showing a state of another embodiment of the protector in the indwelling needle assembly of the present invention before accommodation of the needle tip, and FIG. 7 is a perspective view showing a state of the protector shown in FIG. 6 after accommodation of the needle tip. FIG.
The closing member of the present invention may be a closing member 64 that is an annular body as shown in FIGS. The closing member 64 includes an opening having an inner diameter through which the proximal end portion of the protection member 61 can be inserted, and is disposed at the proximal end portion of the protection member 61 in a natural state without being biased inward. The closing member 64 shown in the figure is an annular body having a circular outer periphery and a quadrilateral shape whose inner periphery is matched to the outer peripheral shape of the cross section perpendicular to the axis of the side wall 616 portion of the protection member 61. However, the shape is not limited thereto, and any shape may be used as long as it can slide in the axial direction on the outer periphery of the protective member 61. For example, the inner periphery may be circular. The thickness of the closing member 64 is not particularly limited, but it is necessary to have rigidity capable of sliding in the axial direction on the outer periphery of the protection member 61.

  As a locking means for holding the closing member 64 on the protection member 61 with the displacement side wall 63 displaced inward, for example, as shown in the figure, it protrudes outward toward the base end side. What consists of the nail | claw part 635 and the nail | claw part 636 which protruded outward toward the front end side at the base end side of the nail | claw part 635 is used. The closing member 64 slid on the outer periphery of the protective member 61 from the base end portion to the tip end portion moves over the claw portion 636 while urging the claw portion 636 inward, and comes into contact with the protruding end of the claw portion 635 to slide. It stops and is latched between the claw portion 635 and the claw portion 636 released from the urging force from the closing member 64 and returned to the original position.

  The locking means provided on the closing member 64 is basically provided on the displacement side wall 63 because it holds the closing member 64 in a state where the displacement side wall 63 is displaced inward. In the case where the locking means is composed of the claw portions 635 and 636, the claw portion 636 on the proximal end side may be provided on the distal end side of the side wall 616. Further, the locking means may be provided at a tip portion of the side wall 616 that is not provided with the displacement side wall 63 and that faces the displacement side wall 63.

  Before the needle tip 21 of the inner needle 2 is accommodated in the internal space 611, the base of the protective member 61 is used in order to maintain the state in which the closing members 62 and 64 are arranged on the outer periphery of the proximal end portion of the protective member 61. A second locking means for locking the closing members 62 and 64 may be provided at the end. Examples of such second locking means include a pair of claw portions such as the claw portions 635 and 636. In the case of using a ring-shaped closing member 62 that is partially cut, a convex portion that is held in the cut portion 621 by expanding the cut portion 621 may be provided. Further, when the annular closing member 62 made of an elastic material is used, a convex portion that pushes the inner peripheral surface is provided, whereby the closing member 62 is engaged on the protective member 61 by the inward biasing force. You may stop.

  Unlike the locking means provided at the tip of the protective member 61 described above, the second locking means must be capable of easily releasing the locked state. Therefore, when the second locking means is a pair of claw portions, the height of the claw portion on the front end side is set to a minimum that can function, or when a convex portion is provided, the front end side is tapered. It is necessary to consider setting the shape. By providing such a second locking means, the patient can puncture the patient with the needle tip 21 in a state where the protector 6 is disposed on the inner needle 2.

  The indwelling needle assembly 1 of the present invention is arranged so that the outer needle 4 protrudes from the outer periphery of the inner needle 2 and the needle tip 21 of the inner needle 2 protrudes from the distal end side in the state before puncturing as shown in FIG. The distal end portion of the inner needle hub 2 is inserted into the proximal end portion of the outer needle hub 4. An annular flange 31 is provided on the outer periphery of the inner needle hub 3, and the inner needle hub 2 is inserted into the outer needle hub 4 at a position where the needle tip 21 of the inner needle 2 protrudes from the distal end side of the outer needle 4. The flange 31 is stopped by contacting the flange 53 of the outer needle hub 5.

The protector 6 of the present invention is disposed inside the outer needle hub 5 in the state before the puncture of the indwelling needle assembly 1 shown in FIG. Therefore, there is no possibility that the operator erroneously slides the protector 6 during the puncturing operation of the indwelling needle assembly 1.
In addition, the protector 6 is engaged and fixed inside the outer needle hub 5 until the needle tip 21 of the inner needle 2 is accommodated in the internal space 611, and the closing member of the protector 6 is provided on the inner peripheral surface of the outer needle hub 5. Means for engaging 62 are provided. The engaging means is a closing member 62 arranged on the outer periphery of the proximal end portion of the protective member 61 in a state of being urged inward, that is, an annular body that is partially cut or formed of an elastic material. 2 is an annular recess 54 as shown in FIG. 2, for example, and in the case of a closing member 64 that is placed on the outer periphery of the proximal end of the protective member 61 in a natural state, it is placed on the proximal side of the closing member 64, for example It is an annular convex part (not shown).

Hereinafter, the indwelling needle assembly of the present invention will be described with reference to FIGS. 1, 2 and 8 by taking as an example the protector 6 in which the closing member 62 is an annular body partially cut or an annular body formed of an elastic material. A method for engaging and fixing the outer needle hub 5 and the protector 6 using the annular recess 54 will be described in detail while explaining how to use the three-dimensional object 1.
As shown in FIG. 1, in the indwelling needle assembly 1 of the present invention, the proximal end portion of the inner needle 2 is inserted from the distal end side of the protector 6 in the order of the distal end side opening 612 and the proximal end side opening 613 of the protector 6. Thereafter, the protector 6 is disposed on the inner needle 2 adjacent to the inner needle hub 3 by fixing the proximal end portion of the inner needle 2 and the inner needle hub 3 with an adhesive or the like. Thereafter, the inner needle 2 and the inner needle hub 3 provided with the protector 6 are inserted into the outer needle 4 from the proximal end portion of the outer needle hub 5, and the flange 31 of the inner needle hub 3 is connected to the flange 53 of the outer needle hub 5. Upon contact, the needle tip 21 of the inner needle 2 is in a state of protruding from the distal end side of the outer needle 4 and the assembly of the indwelling needle assembly 1 is completed. In this state, the inner needle hub 3 and the outer needle hub 5 may be detachably fixed by a free lock mechanism such as a coupler.

  During the assembling operation of the indwelling needle assembly 1, the closing member 62 of the protector 6 is disposed on the outer periphery of the proximal end portion of the protection member 61, and the displacement side wall 63 does not close the distal end side opening 612. Therefore, since the inward biasing force of the displacement side wall 63 is not directly applied to the outer peripheral surface of the inner needle 2, the protector 6 of the present invention can be easily arranged on the inner needle 2. Further, even if the base end portion of the protection member 61 is arranged in a state where the closing member 62 is urged inward, the protector 61 has rigidity that does not transmit the urging force to the inner needle 2. It is not difficult to place the needle on the inner needle 2.

After the indwelling needle assembly 1 is punctured into the patient's blood vessel, the inner needle 2 is removed from the outer needle 4, and only the outer needle 4 is placed in the patient's blood vessel. Simultaneously with the removal operation of the inner needle 2, the indwelling needle assembly 1 of the present invention is a means for engaging the closing member 62 with the inner peripheral surface of the outer needle hub 5 so that the needle tip 21 is protected by the protector 6. An annular recess 54 is provided.
During the extraction operation of the inner needle 2, the inner needle 2 is moved through the outer needle 4 by pulling the inner needle hub 3 toward the proximal end while the outer needle 4 and the outer needle hub 5 are fixed to the patient. Move to the proximal side. At this time, the protector 6 has the closing member 62 fitted and fixed to the annular recess 54 provided on the inner peripheral surface of the outer needle hub 5, and the closing member 62 and the protection member 61 are frictionally engaged. There is no possibility of moving to the proximal end side together with the inner needle 2.

As shown in FIG. 8A, the needle tip 21 of the inner needle 2 is accommodated in the internal space 611 of the protection member 61 of the protector 6, and the engagement portion 22 of the inner needle 2 is the proximal end side opening 613 of the protection member 61. Partial proximal wall 614
After that, the protective member 61 moves to the proximal end side together with the inner needle 2. However, the closing member 62 does not move because it is fitted and fixed to the annular recess 54 of the outer needle hub 5. Therefore, the closing member 62 slides on the outer periphery of the protection member 61 toward the distal end side, and is disposed on the outer periphery of the distal end portion provided with the displacement side wall 63 of the protection member 61. Then, when the closing member 62 slides to the portion where the groove 633 at the tip of the protective member 61 is provided, the closing member 62 contracts inward as shown in FIG. At the same time as it is detached from the annular recess 54, it fits into the groove 633 of the protection member 61 and is locked to the protection member 61. As a result, the engagement and fixation between the outer needle hub 5 and the protector 6 are released, so that the outer needle 4 of the inner needle 2 is protected with the needle tip 21 protected by the protector 6 as shown in FIG. And the extraction operation from the outer needle hub 5 is completed.

  The method for using the indwelling needle assembly 1 according to the present invention has been described above by taking the protector 6 which is an annular body in which the closing member is partially cut or an annular body formed of an elastic material as an example. Even when the protector 6 including the closing member 64 disposed at the proximal end portion of the protection member 61 is used in a natural state without being biased toward the back, the needle tip 21 of the inner needle 2 can be reliably protected by the same operation. It is. When the protector 6 having such a closing member 64 is used, the outer needle hub 5 and the protector 6 are engaged and fixed by an annular protrusion instead of the annular recess 54 as shown. The annular protrusion is formed on the inner peripheral surface of the outer needle hub 5 on the base end side of the closing member 62 before the needle tip 21 of the inner needle 2 shown in FIG. 2 is accommodated in the inner space 61 of the protection member 61. The closing member 62 is prevented from moving by the operation of removing the inner needle 2 up to the state shown in FIG. However, in the state after the needle tip 21 is accommodated as shown in FIG. 8C, the closing member 62 is more firmly engaged by the claws 635 and 636 of the protection member 61 than the engagement with the annular protrusion. The protector 6 can be detached from the outer needle hub 5 together with the inner needle 2.

  Even when the protector 6 of the present invention has the second locking means for locking the closing members 62 and 64 to the proximal end portion of the protective member 61, the second locking of the protective member 61 and the closing member 62 or 64 is also possible. By setting the shape such that the engagement force between the closing member 62 and the annular recess 54 or the annular protrusion is stronger than the engagement by the means, the above-described operation of protecting the needle tip 21 of the inner needle 2 is performed more reliably. It is possible.

It is a longitudinal cross-sectional view which shows the state before inner needle extraction of one Example of the indwelling needle assembly of this invention. FIG. 2 is an enlarged longitudinal sectional view of a protector portion of the indwelling needle assembly shown in FIG. 1. It is a perspective view which shows the state before needle-tip accommodation of one Example of the protector in the indwelling needle assembly of this invention. It is a perspective view which shows the state after the needle tip accommodation of the protector shown by FIG. It is a perspective view which shows the state before needle-tip accommodation of the other Example of the protector in the indwelling needle assembly of this invention. It is a perspective view which shows the state before needle-tip accommodation of the other Example of the protector in the indwelling needle assembly of this invention. It is a perspective view which shows the state after needle tip accommodation of the protector shown in FIG. In the indwelling needle assembly shown in FIG. 1, it is explanatory drawing which shows a mode that the needle tip of an inner needle is accommodated in a protector at the time of inner needle removal.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Indwelling needle assembly 2 Inner needle 21 Needle tip 22 Engagement part 3 Inner needle hub 4 Outer needle 5 Outer needle hub 54 Annular recessed part 6 Protector 61 Protection member 611 Inner space 612 End opening 613 Base end opening 614 Base end wall 615 End Wall 616 Side wall 62, 64 Closing member 63 Displacement side wall 633, 634 Groove 635, 636 Claw

Claims (12)

An inner needle having a sharp needle tip at the tip and an engaging portion in the vicinity of the tip; an inner needle hub provided at the proximal end of the inner needle; an outer needle disposed on the outer periphery of the inner needle; In an indwelling needle assembly comprising an outer needle hub provided at a proximal end portion of the outer needle, and a protector for protecting the needle tip of the inner needle that is slidably disposed in the axial direction on the outer periphery of the inner needle.
The protector is provided with an internal space that can accommodate the needle tip of the inner needle, and a protective member that can slide in the axial direction on the inner needle, and is slidably disposed on the outer periphery of the protective member from the proximal end to the distal end. A closure member,
The protection member is provided with a distal end side opening through which the inner needle can be inserted and a proximal end opening through which the inner needle body can be inserted but the engagement portion cannot pass. A displacement side wall is provided that can be displaced inward to close the opening on the front end side when accommodated in a space, and the displacement side wall is inward by disposing the closing member on the outer periphery of the front end of the protective member. Is displaced to
The closure member is disposed on the outer periphery of the base end portion where the displacement side wall of the protection member is not provided before the needle tip is accommodated in the internal space of the protection member, and the needle tip is accommodated in the internal space of the protection member. When the outer periphery of the protection member is slid to the tip side when it is done, it is arranged on the outer periphery of the tip portion provided with a displacement side wall of the protection member,
The protector is disposed in the outer needle hub before the needle tip of the inner needle is accommodated in the inner space of the protection member, and the inner peripheral surface of the outer needle hub and the closing member are engaged and fixed, In the engagement, the inner needle is withdrawn from the outer needle to the proximal end side, and the engaging portion of the inner needle engages with the proximal end opening of the protecting member, so that the protective member and the inner needle are in the proximal end. The locking member is maintained until the closing member slides and is arranged on the outer periphery of the distal end portion of the protective member, and the engagement is provided with the locking member provided at the distal end portion of the protective member. The indwelling needle assembly which is released by being locked by the hook and enables the protector to be detached from the outer needle hub. The protective member of the protector includes a proximal wall having a proximal opening, a distal wall having a distal opening, and a side wall extending in the axial direction of a needle provided integrally with the proximal wall and the distal wall. The indwelling needle assembly according to claim 1, wherein the displacement side wall is provided on a part of the side wall. The indwelling needle assembly according to claim 2, wherein the protection member of the protector has a pair of opposing side walls, and one tip portion of the side walls is a displacement side wall. The indwelling needle according to claim 2, wherein the protective member of the protector has four side walls that surround the needle tip from four directions, and a pair of displacement side walls are provided at a pair of tip portions opposed to the side walls. Assembly. The closing member of the protector includes an opening having an inner diameter slightly smaller than an inner diameter required to pass through the proximal end of the protective member, and the proximal end of the protective member is urged inward. The indwelling needle assembly according to any one of claims 1 to 4, which is disposed on an outer periphery. The indwelling needle assembly according to claim 5, wherein the closing member of the protector is an annular body partly cut. The indwelling needle assembly according to claim 5, wherein the closing member of the protector is an annular body formed of an elastic material. The indwelling needle assembly according to any one of claims 5 to 7, wherein the locking means provided at the distal end portion of the protection member is at least one groove portion into which the closing member can be contracted by an urging force. . The closing member of the protector is an annular body that includes an opening having an inner diameter through which the base end of the protection member can be inserted, and is disposed on the outer periphery of the base end portion of the protection member in a natural state. The indwelling needle assembly according to any one of the above. The locking means provided at the distal end portion of the protective member is a claw portion projecting outward toward the proximal end side and a claw portion projecting outward toward the distal end side. The indwelling needle assembly as described. Engaging and fixing the inner needle surface of the outer needle hub and the closing member before the needle tip of the inner needle is accommodated in the inner space of the protection member is formed by the closing member formed on the inner peripheral surface of the outer needle hub. The indwelling needle assembly according to claim 1, wherein the indwelling needle assembly is formed by fitting into an annular recess. Engagement and fixing of the inner peripheral surface of the outer needle hub and the closing member before the needle tip of the inner needle is accommodated in the inner space of the protective member is performed by the closing member on the inner peripheral surface of the outer needle hub. The indwelling needle assembly according to any one of claims 1 to 10, wherein the indwelling needle assembly is formed by engaging an annular protrusion formed on the proximal end side.

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