WO2022044061A1

WO2022044061A1 - Needle assembly

Info

Publication number: WO2022044061A1
Application number: PCT/JP2020/031751
Authority: WO
Inventors: 保臣田中
Original assignee: 東郷メディキット株式会社
Priority date: 2020-08-24
Filing date: 2020-08-24
Publication date: 2022-03-03
Also published as: JP7313749B2; JPWO2022044061A1

Abstract

This needle assembly is for introducing a catheter into body tissue, and is provided with: a solid or hollow needle that is slidably fitted into the catheter, and has a needle tip that is exposed from the catheter and can be punctured into the body tissue; a hub connected to the needle to convey the needle; a handle for storing the hub and operating the needle, the handle allowing the hub to move in the axial direction from a first position at which the needle tip is exposed from the catheter to a third position at which the needle tip is concealed inside the handle via a second position at which the needle tip is withdrawn into the catheter; a spring provided inside the handle to apply an urging force to the hub from the first position toward the third position; a first engagement part for temporarily stopping the hub at the first position against the urging force; and a second engagement part for temporarily stopping the hub at the second position against the urging force.

Description

Needle assembly

The present disclosure relates to a needle assembly for introducing a catheter into a body tissue, and particularly to a needle assembly in which the needle can be detached from the catheter with a particularly easy operation.

A catheter may be introduced into the patient's body together with the needle, and only the needle may be pulled out to leave the catheter, which may be used for connection to a circuit for infusion or dialysis. After its use, the needle has the patient's blood or body fluid attached to it, which is rarely contaminated with viruses such as HIV and hepatitis. Various needle assemblies have been proposed that are configured to allow the needle to be quickly stowed inside after use to prevent healthcare professionals from accidentally touching the contaminated needle.

The typical operation of this kind of needle assembly is as follows. In the initial state, only the needle tip is exposed from the catheter, and this is punctured into the patient's arm or the like to guide the catheter into the vein. The needle assembly is then left alone and only the catheter is advanced and delivered into the vein, while the needle tip is submerged in the catheter. Then, the storage mechanism is activated to store the needle in the handle.

Patent Documents 1 to 3 disclose related technologies.

Japanese Patent Application Publication No. 2003-180829 Japanese Patent Application Publication No. 2007-296022 Publication of international patent application WO2014 / 054166

According to the conventional technology, the storage mechanism facilitates or automates the procedure for storing the needle in the handle, but there is still room for improvement in the procedure before that. That is, it is inevitably necessary to touch the catheter in order to advance it, and even if a disinfected glove is used, this is not hygienic in the first place. Also, when the catheter is advanced, the side surface of the needle is slightly exposed, so there is a risk that the medical staff will accidentally touch it. Also, at the stage of puncturing, advancing the catheter, and activating the needle retracting mechanism, the position of the finger with respect to the needle assembly must be changed or assisted by the other hand, which is also unintended. It can lead to various problems.

The needle assembly according to the present disclosure was created in view of the above-mentioned problems.

According to one aspect, the needle assembly for introducing the catheter into the body tissue is a solid or hollow needle that is slidably fitted into the catheter, exposed from the catheter and punctured into the body tissue. A needle having a possible needle tip, a hub coupled to the needle to carry the needle, and a handle that accommodates the hub and is used for operating the needle, exposing the needle tip from the catheter. A. The permissible handle, the spring built into the handle to exert an urging force on the hub from the first position to the third position, and the hub against the urging force. It comprises a first engaging portion that temporarily stops at a position and a second engaging portion that temporarily stops the hub at the second position against the urging force.

FIG. 1 is an exploded side view of the needle assembly. FIG. 2 is a vertical cross-sectional view of the catheter. FIG. 3 is a vertical cross-sectional view of the needle and the hub. FIG. 4A is a vertical cross-sectional view of the handle according to one example. FIG. 4B is a vertical cross-sectional view of the handle according to another example. FIG. 5A is a vertical cross-sectional view of the needle assembly showing the hub in the first position. FIG. 5B is a vertical cross-sectional view of the needle assembly showing the hub in the second position. FIG. 5C is a vertical cross-sectional view of the needle assembly showing a state in which the hub is in the third position.

Some exemplary embodiments will be described below with reference to the accompanying drawings. Throughout the following description and the appended claims, the term axial term is used to define the direction in which the catheter and needle extend.

Mainly referring to FIG. 1, the needle assembly 1 according to the present embodiment can be used for the purpose of introducing the catheter 3 into the body tissue. Before use, the catheter 3 is covered with the needle 7 and only the needle tip 7p is exposed. The protector 5 is attached to the needle assembly 1 and circulates so as to cover the catheter 3 and the needle tip 7p, but the protector 5 is removed during use.

The needle assembly 1 generally comprises a needle 7 and a handle 11 for operating the needle 7, and as shown in FIGS. 5A-5C, a hub 9 coupled to the needle 7 is housed in the handle 11. Has been done. The hub 9 is axially movable within the handle 11, i.e., from the first position shown in FIG. 5A to the third position shown in FIG. 5C via the second position shown in FIG. 5B. Is. At this time, the needle 7 is coupled to the hub 9 and carried, and retracts into the handle 11. For reference back to FIG. 1, the needle assembly 1 may include a release 21 as a trigger to retract the needle 7, preferably the protector 5 also partially or wholly covers the release 21 before use. Prevent its operation.

With reference to FIG. 2 in combination with FIG. 1, the catheter 3 generally comprises a barrel 31 and a tube 33 liquidtightly coupled to the anterior end of the barrel 31. The whole is hollow to allow the needle 7 and the infusion to pass through. The tube 33 is a very flexible elongated cylinder that is inserted into the body tissue such as a vein and deforms accordingly, but the barrel 31 is a relatively rigid cylinder for connecting to the handle 11 and the infusion circuit. Is. The rear end of the barrel 31 comprises a structure for connecting to an infusion circuit, blood circuit, syringe, etc., which usually includes a thread. The cavity of the barrel 31 may contain a valve 35 for preventing infusion or backflow of blood, and may further contain a plug 37 for pushing open the valve 35. The needle 7 penetrates the valve 35, fits into the tube 33, and is slidable.

Refer to FIG. 3 in combination with FIG. 1, the needle 7 is a solid or hollow needle, which is fixedly coupled to the hub 9 near the trailing end. When the entire needle 7 is hollow, the trailing end 7e may be configured to communicate with the cavity 49 in the hub 9 and guide back blood to it. The back blood introduced into the cavity 49 can be used to determine whether or not the needle tip 7p has correctly captured the blood vessel. Alternatively, the needle 7 may have an opening 7f on its side wall to guide back blood into the catheter 3 and thus be used for judgment. In any case, the cavity 49 may be open rearward, which is convenient for forming the hub 9. Alternatively, such an opening may be sealed with an appropriate sealing material, and the sealing material can be a breathable porous body. This prevents back blood from leaking to the outside.

The hub 9 generally consists of a large-diameter body 41 and a smaller-diameter neck 47 extending from its shoulder 45 in the direction of the needle tip 7p. The whole may be integrally molded.

The body 41 is generally cylindrical, and its outer shape is sized so as to have a gap fitting relationship with the inner surface of the handle 11. Therefore, the hub 9 can move in the handle 11 in the axial direction. The outer surface of the body 41 is provided with a flexible engaging projection 43, which is sized to engage the engaging

portions

15, 17, 19 described below. The engaging protrusion 43 and the cavity 49 may be separated by an appropriate partition wall. This helps prevent back blood from leaking out through the gap around the engagement projection 43.

The shoulder 45, which is the front end of the body 41, may be a plane substantially orthogonal to the axis, and is configured to abut on the rear end of the spring 13, which will be described later, to receive the urging force. The neck 47 extending from the shoulder 45 is used to connect to the needle 7, and a spring 13 is attached to the outer periphery thereof.

With reference to FIG. 4A in combination with FIG. 1, the handle 11 includes a substantially cylindrical tubular portion 51 extending in the axial direction and a neck portion 53 extending forward from its front end. The inside of the handle 11 is a cavity 55 extending in the axial direction, which allows the hub 9 to move in the axial direction. Further, the cavity 55 has a sufficient length to accommodate the entire needle 7. The cavity 55 may be open rearward, which is convenient for forming the handle 11 and also for assembling the needle assembly 1. Nevertheless, the opening may be partially or wholly closed. A viscoelastic body can be used as the closing material, which can be used to receive the hub 9 when the hub 9 retracts and to cushion the impact. Alternatively, the rear end of the handle 11 may be provided with an appropriate structure that abuts on the hub 9, such as a structure such as an inward fold back from the opening.

The outer surface of the tubular portion 51 may have an appropriate structure for convenience of handling by the user. For example, both side surfaces thereof can be flattened, and ribs or the like for preventing slipping can be provided on the flat surface.

Further, the tubular portion 51 has engaging

portions

15, 17, 19 for temporarily stopping the hub 9, for example, on the upper side surface thereof. An example of such an engaging portion can be a through hole that penetrates the tubular portion 51 from the inner surface to the outer surface as shown in the figure. As will be described later, the engaging

portions

15, 17, and 19 are structured so that the engaging projection 43 is engaged. Further, since the engaging

portions

15 and 17 are exposed upward, it is easy to disengage them by pushing the engaging projection 43 with a finger through them. For the convenience of finger operation, the engaging

portions

15 and 17 can be made sufficiently large in consideration of the size of the fingers.

Instead of making the engaging

portions

15 and 17 sufficiently large, or in addition, the tubular portion 51 has a structure for assisting disengagement with either or both of the engaging

portions

15 and 17. Can have. An example of such a structure is the

flexible pieces

15b, 17b configured to bend inward. Of course, the

flexible pieces

15b and 17b may be configured to bend outward. The

flexible pieces

15b and 17b can be made into small pieces integrated with the tubular portion 51, and can be formed into a shape extending from the front to the rear of the engaging

portions

15 and 17, respectively. Further, in order to promote bending, notches may be provided on both sides of each of the tubular portions 51. The

flexible pieces

15b and 17b may project so as to partially or almost completely cover the engaging

portions

15 and 17. The upper surfaces of the

flexible pieces

15b and 17b may bulge outward in a button shape, and the lower surface may also have a structure for contacting the engaging projection 43.

The user can directly press the engaging projection 43, or if the

flexible pieces

15b and 17b are pressed, the engaging projection 43 flexes accordingly, so that the engaging projection 43 engages. Disengage from

portions

15 and 17.

The handle 11 may also be provided with a release 21 for releasing the engaging projections 43 engaged with the first engaging portion 15 and the second engaging portion 17, as illustrated in FIG. 4B. good. The release 21 can be, for example, a single flexible piece extending from the outer surface of the handle 11, or may be integrally molded with the handle 11. The release 21 can also be in the form of a cantilever overhanging onto the first engaging portion 15 and the second engaging portion 17, with the first engaging portion 15 and the second engaging portion 15. A first protrusion 23 and a second protrusion 25, which are respectively positioned to act on the portion 17, can be provided. The

protrusions

23 and 25 abut on the engaging protrusions 43 to bend them and disengage them from the engaging

portions

15 and 17, respectively.

The

protrusions

23 and 25 may have similar shapes to each other, or may have different shapes from each other. For example, the first protrusion 23 can be shaped like an isosceles triangle in side view, the second protrusion 25 can be shaped like a right triangle, and the upright surface of the second protrusion 25 is forward. It may be facing. The upright front surface can serve as a stopper that abuts and fastens the retracting engaging projection 43. Of course, the surface facing forward may be an inclined surface, which can be used to decelerate the retreat of the hub 9 by, for example, abutting on and then sliding on the retracting engaging projection 43. can.

The release 21 may be configured to bend exclusively with its base end as a fulcrum, but may have a structure that easily bends at an appropriate position in the middle. For example, the constriction 27 may be provided slightly in front of the second protrusion 25. When the vicinity of the front end of the release 21 is pushed toward the handle 11, only the portion in front of the constriction 27 is bent. The release 21 may further include another constriction 29 behind the second protrusion 25. The combination of the constrictions 27 and the constrictions 29 that bend together facilitates the second projection 25 to approach the engagement projection 43.

The neck portion 53 can be formed into a cylindrical or conical trapezoid with a smaller diameter than the tubular portion 51. The neck portion 53 is long enough to accommodate the neck 47 when the hub 9 is in the first position shown in FIG. 5A, and its front end is the rear end of the barrel 31 of the catheter 3 as described above. It is used to temporarily combine and support this. Further, an appropriate structure for supporting the front end of the spring 13 is provided inside the neck portion 53 and in the vicinity of the front end thereof. By elastically incorporating the spring 13 between such a structure and the hub 9, the spring 13 exerts an urging force on the hub 9 from the first position to the third position, that is, backward. be able to.

In reference to FIG. 5A in combination with FIG. 1, in the pre-use state, the hub 9 is in the most advanced first position and the spring 13 is compressed to urge the hub 9 towards the third position. ing. The engaging projection 43 engages the first engaging portion 15 against the urging force, thereby temporarily stopping the hub 9 in the first position. At such a first position, the needle tip 7p is exposed from the tube 33 of the catheter 3 and can puncture the body tissue.

The user can operate this by, for example, holding the thumb and middle finger on the side surface of the handle 11, and at the same time, disengage the engaging protrusion 43 with the index finger. The user appropriately manipulates the handle 11 to guide the catheter 3 into a vein or a target tissue, and then pushes down the engaging projection 43 engaged with the first engaging portion 15. When the handle 11 includes the release 21, the handle 11 pushes down the vicinity of the front end thereof. Then, the pressed engaging protrusion 43 bends inward, disengages from the first engaging portion 15, and the hub 9 starts retracting together with the needle 7 by the action of the spring 13.

An appropriate cushioning material or friction material may be used to moderate the retreat. For example, a friction material or a viscous body that slows down the movement of the hub 9 may be interposed between the inner surface of the handle 11 and the outer surface of the hub 9. Alternatively or additionally, the latter half of the handle 11 may have a function like an air damper. Alternatively, the finger attached to the hub 9 may be used to decelerate the speed, or the hub 9 may be retracted by a finger operation without relying on the spring 13.

When the hub 9 retracts and the engaging projection 43 reaches the second engaging portion 17, the engaging projection 43 rapidly bends outward and engages with the second engaging portion 17. The hub 9 temporarily stops at the second position shown in FIG. 5B. Alternatively, before that, the engaging projection 43 may be temporarily received by the second projection 25. At this time, the needle tip 7p also retracts and sinks into the catheter 3, but the catheter 3 still remains connected to the handle 11. The user can change the position of the index finger and press the engaging protrusion 43 while the handle 11 is still sandwiched between the thumb and the middle finger. The pressed engaging projection 43 is disengaged from the second engaging portion 17, and the hub 9 can be further retracted toward the third position.

Although not essential, the handle 11 can include a third engaging portion 19, and the engaging projection 43 engages with the third engaging portion 19 to stop at the third position shown in FIG. 5C. .. Instead of or in addition to the third engaging portion 19, the structure at the rear end of the handle 11 may abut against the hub 9 to stop its retreat.

The handle 11 can be detached from the catheter 3 before and after the hub 9 retracts to the third position. After withdrawal, the catheter 3 can be connected to an infusion circuit or the like.

After retreating to the third position, the needle tip 7p is hidden inside the handle 11, and once hidden, the needle 7 does not protrude to the outside again due to the urging force of the spring 13. Alternatively, the handle 11 may additionally be provided with a mechanism for preventing the needle 7 from being reexposed. For example, the flexibility of the engaging protrusion 43 may be used to shift the needle 7 from the center so that the needle tip 7p is caught by any of the neck portions 53. Alternatively, after the needle 7 is retracted, any portion of the neck portion 53 may protrude inward and be caught by the needle tip 7p to prevent the needle 7 from being re-exposed. Of course, the needle 7 may be intentionally reexposed.

As can be understood from the above explanation, the user can operate the needle assembly 1 without changing the positional relationship of the fingers while operating the needle assembly 1. Further, in the process of storing the needle 7 in the handle 11, the side surface of the needle 7 is not exposed, and the risk of the user touching the needle 7 is particularly reduced.

Although some embodiments have been described, it is possible to modify or modify the embodiments based on the above disclosure contents.

A needle assembly that can store needles more safely and easily is provided.

Claims

A needle assembly for introducing a catheter into body tissue
A solid or hollow needle that is slidably fitted into the catheter and has a needle tip that is exposed from the catheter and can puncture the body tissue.
A hub coupled to the needle to carry the needle,
A handle that accommodates the hub and is used for operating the needle, from a first position where the needle tip is exposed from the catheter and via a second position where the needle tip is submerged in the catheter. A handle that allows the hub to move axially to a third position that hides the needle tip in the handle.
A spring built into the handle to exert an urging force on the hub from the first position to the third position.
A first engaging portion that temporarily stops the hub in the first position against the urging force, and a first engaging portion.
A second engaging portion that temporarily stops the hub in the second position against the urging force.
Needle assembly with.
Further provided with a release that releases the hub from the first engaging portion and the second engaging portion.
The release is a single flexible piece, and includes a first protrusion acting on the first engaging portion and a second protrusion acting on the second engaging portion, claim 1. Needle assembly.
The needle assembly according to claim 2, wherein the release is a cantilever lever integrally extending from the handle and overhanging on the first engaging portion and the second engaging portion.
The first engaging portion and the second engaging portion are through holes drilled in the side surfaces of the handle, respectively, and the hub is attached to the first engaging portion and the second engaging portion. The needle assembly of claim 2 or 3, comprising a flexible engaging projection to engage.
4. The first protrusion and the second protrusion are configured to abut on the engaging protrusion and disengage from the first engaging portion or the second engaging portion. Needle assembly.
The needle assembly according to claim 5, wherein the handle includes a third engaging portion that stops the hub at the third position.