JP2001190682A - Needling tool and indwelling needle assembly - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a needling tool which is constituted in such a way that the needle point of its needle body can be covered through simple operation after the tool is used without making the structure of the needle body more complicated nor the diameter of the needle body larger and the tool can maintain high safety when the tool is subjected to disposition, etc., and an indwelling needle assembly. SOLUTION: The needling tool has an inner needle 4 having a needle point 41 at its front end, an inner needle hub 5 installed to the base-side end side of the needle 4, and a protector 6 covering the needle point 41. The protector 6 is provided with a protector main body 47 having a needle body passage 71 through which the needle 41 can be passed and a shutter means 8. The means 8 is constituted of a shutter member 81 which can be displaced to a first attitude in which the inner needle 41 can be passed through the needle body passage 71 and a second attitude in which the passing of the needle point 41 is inhibited and biasing means 85 which bias the shutter member 81 to the second attitude. The member 81 has a curved section 82 which is curved along the outer peripheral surface of the inner needle 41 in the first attitude.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

[0001] 1. Field of the Invention [0002] The present invention relates to a puncture device and an indwelling needle assembly. More specifically, for example, the present invention relates to a puncture device used for puncturing a blood vessel during infusion or blood collection, and an indwelling needle assembly provided with the puncture device.

[0002]

2. Description of the Related Art When an infusion is performed on a patient, an indwelling needle connected to an infusion line is punctured into a patient's blood vessel, and is indwelled. Such an indwelling needle has 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 at a distal end, and an inner needle hub fixed to the proximal end of the inner needle. ing.

When puncturing the indwelling needle into a patient's blood vessel, the inner needle is inserted into the outer needle, and the puncture operation is performed with the needle tip of the inner needle protruding from the tip of the outer needle. When the needle tip of the inner needle reaches the inside of the blood vessel, the blood flowing from the opening of the needle tip flows through the inner lumen of the inner needle and flows into the inside of the transparent inner needle hub (flashback). Thereby, it can be confirmed that the inner needle has secured the blood vessel.

[0004] After confirming the flashback, the inner needle and the outer needle are advanced slightly, and the tip of the outer needle is inserted into the blood vessel. Next, while grasping the outer needle by hand, the inner needle is pulled out from the outer needle, and the connector of the infusion line is connected to the outer needle hub. Then, the infusion is administered through the connected infusion line and the outer needle.

By the way, the inner needle extracted from the outer needle is
Since it becomes unnecessary, it is disposed of, but if it is discarded as it is, there is a possibility that an accident may occur in which a discarding worker or the like accidentally points a finger or the like with the tip of the inner needle. In particular, since blood adheres to and remains on the surface and inside of the inner needle, infection may occur due to such a stab.

Accordingly, measures have been taken such as disposing of the used inner needle in the opened packaging material containing the indwelling needle kit, or disposing the inner needle with a cap. I have.

However, even when such an inner needle is wrapped with a wrapping material or covered with a cap, blood adhering to or remaining on the inner needle may reach the operator's hand or work may be performed with the needle of the inner needle. In order to prevent erroneous stabbing of the hand of a patient, great care must be taken, and there is a problem that disposal of the inner needle after use requires a great deal of trouble.

[0008]

SUMMARY OF THE INVENTION An object of the present invention is to cover the needle tip of a used needle body by a simple operation without complicating the structure and enlarging the diameter, and to provide safety in disposal processing and the like. It is an object of the present invention to provide a puncture device and an indwelling needle assembly with high reliability.

[0009]

This and other objects are achieved by the present invention which is defined below as (1) to (14).

(1) A puncture device having a needle body having a needle tip at a tip and a protector for covering the needle tip, wherein the protector has a protector body having a needle body passage through which the needle body can be inserted. A shutter member displaceable between a first posture in which the needle body can be inserted into the needle body passage and a second posture for preventing the needle body from passing through the needle tip; A puncturing device, comprising: a shutter means configured to include an urging member for urging the posture.

(2) The puncture device according to (1), wherein the shutter member is installed in a space formed in the middle of the needle body passage.

(3) The puncture device according to (1) or (2), wherein the shutter member has a curved portion.

(4) The shutter member includes the first member.
The puncture device according to the above (1) or (2), which has a curved portion curved or bent along the outer peripheral surface of the needle body in the posture described above.

(5) The puncture device according to the above (4), wherein the curved shape portion covers the outer peripheral surface of the needle body about halfway in the first posture.

(6) The puncture according to any one of (1) to (5), wherein the displacement of the shutter member from the first posture to the second posture is performed with rotation of the shutter member. Utensils.

(7) The puncture device according to (6), wherein the displacement of the shutter member from the first posture to the second posture is performed by rotation and movement of the shutter member toward the distal end.

(8) The displacement of the shutter member from the first posture to the second posture is made by the rotation and the movement of the shutter member in the direction of the distal end. The puncture device according to (6), wherein the puncture device contacts the inner wall on the distal end side of the main body and prevents the main body from returning to the second posture.

(9) The puncture device according to any one of (1) to (8), wherein the shutter member is prevented from returning from the second position to the first position.

(10) The puncture device according to any one of (1) to (9), wherein the urging member is a spring made of an elastic material.

(11) The puncture device according to (10), wherein the spring is at least one linear body.

(12) The puncture device according to any one of (1) to (11), wherein the needle body is a tubular inner needle, and has an inner needle hub at a base end side of the inner needle.

(13) The puncture device according to (12), a hollow outer needle into which the inner needle can be inserted, and an outer needle hub installed at a base end of the outer needle. Indwelling needle assembly.

(14) The indwelling needle assembly according to (13), wherein the protector and the outer needle hub can be fitted.

[0024]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, a puncture device and an indwelling needle assembly of the present invention will be described in detail based on preferred embodiments shown in the accompanying drawings.

FIG. 1 is a side view showing an embodiment in which the puncture device of the present invention is applied to an indwelling needle assembly, and FIG. 2 and FIG.
Is a perspective view, partially in section, of the puncture device shown in FIG. 1, FIGS. 4 and 5 are longitudinal sectional views, respectively, showing the operating state of the shutter means, and FIGS. 6 and 7 are, respectively, structural examples of the shutter member. 8 and 9 are diagrams each showing a configuration example of the shutter means. In the following description, the right side in FIGS.
The left side is called the "tip".

The indwelling needle assembly 1 shown in FIG. 1 includes an outer needle and an inner needle, and particularly forms an infusion indwelling needle assembly, and includes an outer needle 2 which is an indwelling needle, An outer needle hub 3 provided at a base end of the outer needle 2, an inner needle (needle body) 4 used by being inserted into the outer needle 2, and an inner needle provided at a base end of the inner needle 4 A hub 5 and a protector 6 that covers the needle tip 41 of the inner needle 4 are provided. Of these, the inner needle 4, the inner needle hub 5, and the protector 6 constitute the puncture device of the present invention. Hereinafter, the configuration of each unit will be described.

The outer needle 2 preferably has a hollow shape and has a certain degree of flexibility. The constituent material of the outer needle 2 is not particularly limited.
Various soft resins such as tetrafluoroethylene copolymer (ETFE), polyurethane, and polyether nylon resin are preferred.

The outer needle 2 may have all or part of its internal visibility. Further, an X-ray contrast agent such as barium sulfate or barium carbonate may be blended in the constituent material of the outer needle 2 to provide a contrast function.

The distal end of the outer needle 2 has a tapered shape whose outer diameter gradually decreases toward the distal end in order to easily and puncture the living body with low invasiveness.

An outer needle hub 3 is fixed to the proximal end of the outer needle 2 in a liquid-tight manner, and the inner cavity of the outer needle 2 communicates with the inside of the outer needle hub 3. The outer needle hub 3 is a substantially cylindrical member, and has a tapered shape whose outer diameter and inner diameter gradually increase toward the base end. The tapered portion is fitted with a tip portion of the protector 6 described later.

A flange 32 is formed on the outer periphery of the proximal end of the outer needle hub 3. For example, when the protector 6 is detached from the outer needle hub 3, the operation can be performed more reliably by hooking a finger on the flange 32 and performing this operation.

The outer needle hub 3 is preferably made of a transparent (colorless and transparent), colored transparent or translucent resin, and the internal visibility is secured.

In this embodiment, the outer needle 2 is swaged and fixed to the outer needle hub 3 by a swaging member 31 (see FIG. 1). However, the method of fixing the outer needle 2 and the outer needle hub 3 is not limited to this, and may be, for example, a method of fusion (heat fusion, high frequency fusion, or the like), a method of bonding with an adhesive, or a method of these methods. And the above-mentioned caulking fixation may be used in combination.

The inner needle 4 is a hollow needle and is made of, for example, a metal material such as stainless steel, aluminum or an aluminum alloy, titanium or a titanium alloy.
A sharp needle tip 41 is formed at the tip of the inner needle 4. The shape of the needle tip 41 is not particularly limited, and in the present embodiment, has a blade surface inclined at a predetermined angle with respect to the axis of the inner needle 4.

The inner needle 4 is inserted into the inner cavity of the outer needle 2,
Further, the protector 6 is located at the most proximal side, and the outer needle hub 3 is fitted to the protector 6, that is, FIG.
Used in the state shown in Hereinafter, this state is referred to as an “assembled state”.

The length of the inner needle 4 is such that at least the needle tip 41 protrudes from the distal end opening 21 of the outer needle 2 in the assembled state.

The distal end of the inner needle hub 5 is fixed to the proximal end of the inner needle 4, and the lumen of the inner needle 4 communicates with the internal space of the inner needle hub 5. The inner needle hub 5 is formed of a substantially cylindrical hollow member.

The method of fixing the inner needle 4 to the inner needle hub 5 is as follows.
For example, a method such as fitting, caulking, fusion, or bonding with an adhesive, or a method using these in combination is exemplified.

The inner needle hub 5 is preferably made of a transparent (colorless and transparent), colored transparent or translucent resin, and the internal visibility is secured. Thus, when the needle tip 41 secures a blood vessel, it is possible to visually check the flashback of blood flowing through the inner needle 4.

A flange 51 is provided on the outer periphery of the distal end of the inner needle hub 5.
Are formed. For example, when the operation of pulling out the inner needle 4 from the outer needle 2 is performed by hooking a finger on the flange 51 and performing this operation, this operation can be performed more reliably.

A ventilation filter 52 is provided at an opening on the base end side of the inner needle hub 5. This ventilation filter 5
No. 2 has a property of transmitting gas but blocking liquid.

Specific examples of the ventilation filter 52 include various sintered porous bodies, hydrophobic nonwoven fabrics, and other porous bodies. In this case, as the sintered porous body, a material obtained by sintering a material containing a polymer material (powder) such as polyethylene and a hydrophilic (water-soluble, water-swellable) polymer is preferable. When this sintered porous body is used, ventilation is blocked by contact with a liquid (blood), so that invasion of air from the outside can be prevented.

The constituent materials of the outer needle hub 3, the inner needle hub 5, and the protector body 7 described later are not particularly limited, and are, for example, polyolefins such as polyethylene, polypropylene, polybutadiene, ethylene-vinyl acetate copolymer, and the like. PVC, polyurethane, polystyrene,
Polymethyl methacrylate, polycarbonate, polyamide, polyester such as polyethylene terephthalate, polybutylene terephthalate, acrylic resin, ABS
Various resin materials such as resin, AS resin, ionomer, polyacetal, polyphenylene sulfide, and polyetheretherketone are exemplified.

The protector 6 has a protector body 7 composed of a substantially cylindrical member, and shutter means 8 described later. A needle passage 71 through which the inner needle 4 is inserted is formed at the center of the protector main body 7 so as to penetrate from the base end to the distal end of the protector main body 7.

The cross-sectional shape of the needle passage 71 is circular, and the inner diameter of the needle passage 71 is equal to the outer diameter of the inner needle 4.
Or it is set to a slightly larger value.

Further, inside the protector main body 7, that is, in the middle of the needle body passage 71, a space 72 in which the diameter of the needle body passage 71 is enlarged is formed. In this space 72, a shutter member 81 described later is stored.

The distal end of the protector body 7 has a shape that can be fitted to the outer needle hub 3. For example, it has a tapered shape whose outer diameter gradually decreases toward the tip.

The proximal end of the protector main body 7 is configured to simply contact the distal end of the inner needle hub 5. However, the present invention is not limited to this. It may be configured so as to be able to fit with the part.

The shutter means 8 is composed of a plate-shaped shutter member 81 and an urging member 85 installed on the shutter member 81.

The shutter member 81 may be, for example, a flat plate as shown in FIG. 6, but as shown in FIG.
It preferably has a curved portion 82. This allows the shutter member 81 to have a large area, so that the passage of the needle tip 41 can be more reliably blocked without increasing the size of the protector 6.

Here, the curved portion in the present invention is
Curved surface (for example, circular arc, elliptical arc, parabolic, etc.)
A general term for a curved portion, for example, a portion bent at least once (preferably a plurality of times) into a polygonal shape, or a portion formed in any combination thereof.

The shutter member 81 in this embodiment
A curved portion 82 having a semicircular central portion, and flat plate portions 83 located at both ends of the curved portion 82
In the space 72, the first posture (the posture shown in FIGS. 2 and 4) in which the inner needle 4 can be inserted (penetrated) through the needle body passage 71 and the needle tip 41 of the inner needle 4 It can be displaced to a second position (position shown in FIGS. 3 and 5) for preventing passage. In this case, the first of the shutter members 81
The displacement from the second posture to the second posture is performed by the shutter member 81.
Is performed with the rotation of.

The curved portion 82 is preferably curved along the outer peripheral surface of the inner needle 4 when the shutter member 81 is in the first position. In this case, the radius of curvature on the inner surface side of the curved portion 82 may be equal to or greater than the radius of curvature of the outer peripheral surface of the inner needle 4.

It is preferable that the curved portion 82 covers the outer peripheral surface of the inner needle 4 for about half a circumference in the first posture.

The constituent material of the shutter member 81 is the needle tip 4
1 may be any as long as it can block the passage of 1, for example, polyethylene, polypropylene, polybutadiene, polyolefin such as ethylene-vinyl acetate copolymer, polyvinyl chloride, polyurethane, polystyrene, polymethyl methacrylate, polycarbonate, Polyester such as polyamide, polyethylene terephthalate, polybutylene terephthalate, acrylic resin, A
BS resin, AS resin, ionomer, polyacetal,
Various resin materials such as polyphenylene sulfide and polyetheretherketone, stainless steel, aluminum,
Various metal materials such as copper or copper-based alloy, titanium or titanium alloy, various ceramic materials such as alumina, etc.
Glass, wood, carbon materials and the like can be mentioned.

The biasing member 85 biases the shutter member 81 in the first position so as to be in the second position. In the present embodiment, the biasing member 85 is formed of a spring made of an elastic material. .

The urging member 85 will be described in more detail. The urging member 85 is, for example, a linear body (including a strip-shaped body) made of a single wire or a composite wire such as a superelastic alloy wire, a piano wire, a stainless wire, or the like. ) Or a coil spring (linear body) formed by spirally forming such a thin metal wire. By using the urging member 85 made of such a linear body, the urging force can be effectively exerted in a narrow space, which contributes to downsizing.

Although the number of the urging members 85 is not particularly limited, in the present embodiment, the urging members 85 are installed on both sides of the shutter member 81 in pairs.

The base end of the urging member 85 is embedded and fixed in the protector body 7. The distal ends of the urging members 85 are fixed to a pair of left and right flat plate portions 83 of the shutter member 81, respectively.

An example of a method of fixing the urging member 85 to the shutter member 81 will be described with reference to FIGS.

As shown in FIG. 8, each flat plate portion 83 of the shutter member 81 is provided with two holes 84 (a total of four holes 84), and the urging member 85 sequentially forms the two holes 84. It is installed so that it passes and turns back.

Further, as shown in FIG.
Are provided with one hole 84 (two holes 84 in total), and after the urging member 85 has once passed through the hole 84, a loop is formed, and the urging member 85 passes through the hole 84 again from the opposite direction. It is installed so that it turns back.

In these cases, the hole 84 may be fixed firmly by bonding with an adhesive, brazing (soldering), welding, or the like.

The shutter member 81 of the urging member 85
It is needless to say that the method of fixing to the above is not limited to the method described above.

Next, an example of a method of using the indwelling needle assembly 1 will be described in detail. [1] While holding the indwelling needle assembly 1 in the assembled state,
The inner needle 4 and the outer needle 2 are punctured into a blood vessel (vein or artery) of the patient.

When the tip 41 of the inner needle 4 is punctured into a blood vessel,
The blood flows backward in the inner needle 4 in the proximal direction due to the internal pressure (blood pressure) of the blood vessel, is introduced into the inner needle hub 5, and the flashback can be visually recognized through the inner needle hub 5 having visibility. . This makes it possible to know that the needle tip 41 of the inner needle 4 has secured a blood vessel.

Incidentally, with the inflow of the blood, the inner needle hub 5
The air inside is discharged through the ventilation filter 52,
Blood cannot pass through the ventilation filter 52 and does not leak to the outside.

[2] When the inner needle 4 and the outer needle 2 are further advanced in the distal direction by a small distance, the distal opening 21 of the outer needle 2 is inserted into the blood vessel. Thereby, the outer needle 2 secures a blood vessel.

[3] While holding the outer needle 2 placed in the blood vessel with the hand, the inner hand hub 5 is gripped with the other hand and pulled in the proximal direction. Thereby, the inner needle 4 is withdrawn from the outer needle 2. At this time, the protector 6 is connected to the outer needle hub 3.
Is maintained.

[4] By the above step [3], the inner needle 4
Moves from the position in the assembled state in the proximal direction, but the shutter member 81 is urged by the urging member 85 until the needle tip 41 of the inner needle 4 passes through the space 72 inside the protector 6. The inner surface of the curved portion 82 engages with the outer peripheral surface of the inner needle 4 to maintain the first posture (see FIGS. 2 and 4).

[5] When the inner needle 4 further moves in the proximal direction and the needle tip 41 passes through the space 72, the engagement is released, so that the shutter member 81 applies the urging force of the urging member 85 ( Due to the elastic force), the base end rotates clockwise in FIGS.
2 is in contact with the inner wall surface 73 defining the front end side. As a result, the shutter member 81 assumes the second posture (see FIGS. 3 and 5).

As described above, when the shutter member 81 is in the second posture, the needle tip 41 comes into contact with the shutter member 81 and cannot return even if the needle tip 41 attempts to move back to the tip direction again.

In particular, even when the stylus tip 41 abuts against the shutter member 81, the shutter member 81 does not rotate and return to the first position because the flat plate portion 83 abuts against the inner wall surface 73. Therefore, the passage (return) of the needle tip 41 is reliably prohibited.

[6] When the needle tip 41 passes through the space 72 and the shutter member 81 assumes the second position, the outer needle hub 3
The protector 6 fitted on the outer needle hub 3 is removed. Thus, the needle tip 41 is covered by the protector 6.

Further, a connector or the like (not shown) of an infusion set is quickly connected to the outer needle hub 3 of the outer needle 2 from which the inner needle 4 has been removed, and administration of the infusion is started according to a standard method.

After the inner needle 4 is extracted from the outer needle 2 in this manner, the puncture device (the inner needle 4 and the inner needle hub 5) becomes unnecessary, and is therefore disposed of. This puncture device has a needle tip 4
1 is covered with the protector 6, and in particular, the needle tip 41 moves beyond the shutter member 81 to the distal end side and does not protrude from the distal end of the protector 6, so that a person who performs disposal processing needs the needle or the like. An accident in which a finger or the like is accidentally stabbed at the tip 41 is prevented.

Although the puncture device and the indwelling needle assembly of the present invention have been described with reference to the illustrated embodiment, the present invention is not limited to this. , Can be replaced with any configuration that can exhibit the same function.

Further, the puncture device of the present invention is not limited to a device constituting an indwelling needle assembly, and can be applied to, for example, an injection needle, a blood collection needle, a suture needle and the like.

[0079]

As described above, according to the present invention, the needle body after use can be covered with the protector quickly and safely by a simple operation, and once covered by the action of the shutter means. The stylus tip does not protrude from the tip of the protector. For this reason, accidents such as accidentally stabbing a finger or the like with a needle point at the time of disposal or the like are prevented, and safety is high.

The present invention can achieve the above-mentioned effects with a small and simple structure and a small number of parts. In particular, the structure of the shutter means contributes to reducing the diameter and weight of the protector.

[Brief description of the drawings]

FIG. 1 is a side view showing an embodiment in which the puncture device of the present invention is applied to an indwelling needle assembly.

FIG. 2 is a partial cross-sectional perspective view showing a state where a shutter member is in a first posture in the puncture device shown in FIG. 1;

FIG. 3 is a partial cross-sectional perspective view showing a state where the shutter member is in a second posture in the puncture device shown in FIG. 1;

FIG. 4 is a longitudinal sectional view showing an operation state of a shutter means (a shutter member is in a first posture).

FIG. 5 is a longitudinal sectional view showing an operation state of the shutter means (the shutter member is in a second posture).

FIG. 6 is a front view illustrating a configuration example of a shutter member.

FIG. 7 is a front view illustrating a configuration example of a shutter member.

FIG. 8 is a diagram (perspective view) showing a configuration example of a shutter means.

FIG. 9 is a diagram (a perspective view and a sectional view) showing a configuration example of a shutter means.

[Explanation of symbols]

 REFERENCE SIGNS LIST 1 indwelling needle assembly 2 outer needle 21 tip opening 3 outer needle hub 31 caulking member 32 flange 4 inner needle 41 needle tip 5 inner needle hub 51 flange 52 ventilation filter 6 protector 7 protector body 71 needle body passage 72 space 73 inner wall surface 8 Shutter means 81 Shutter member 82 Curved portion 83 Flat plate portion 84 Hole 85 Urging member

Claims (14)

[Claims] 1. A puncture device having a needle body having a needle tip at a tip and a protector covering the needle tip, wherein the protector has a protector body having a needle body passage through which the needle body can be inserted. A shutter member displaceable between a first posture in which the needle body can be inserted into the needle body passage and a second posture for preventing the needle body from passing through the needle tip, and the shutter member in the second posture And a biasing member for biasing the puncture device so as to provide a puncturing tool. 2. The puncture device according to claim 1, wherein the shutter member is installed in a space formed in the middle of the needle body passage. 3. The puncture device according to claim 1, wherein the shutter member has a curved portion. 4. The puncture device according to claim 1, wherein the shutter member has a curved portion that is curved or bent along the outer peripheral surface of the needle body in the first posture. 5. The puncture device according to claim 4, wherein the curved shape portion covers the outer peripheral surface of the needle body about half a circumference in the first posture. 6. The puncture device according to claim 1, wherein the displacement of the shutter member from the first posture to the second posture is performed with rotation of the shutter member. 7. The puncture device according to claim 6, wherein the displacement of the shutter member from the first posture to the second posture is performed by rotating the shutter member and moving the shutter member toward the distal end. 8. The displacement of the shutter member from the first posture to the second posture is performed by turning the shutter member and moving the shutter member in the direction of the distal end. 7. The puncture device according to claim 6, wherein the puncture device abuts on an inner wall on the distal end side of the puncture member and prevents the inner wall from returning to the second posture. 9. The puncture device according to claim 1, wherein the shutter member is prevented from returning from the second position to the first position. 10. The puncture device according to claim 1, wherein the urging member is a spring made of an elastic material. 11. The puncture device according to claim 10, wherein the spring is at least one linear body. 12. The puncture device according to claim 1, wherein the needle body is a tubular inner needle, and has an inner needle hub at a base end side of the inner needle. 13. An indwelling device, comprising: the puncture device according to claim 12, a hollow outer needle into which the inner needle can be inserted, and an outer needle hub installed at a base end of the outer needle. Needle assembly. 14. The indwelling needle assembly according to claim 13, wherein the protector and the outer needle hub are fittable.