WO2016177379A1

WO2016177379A1 - Hypodermic needle and protective cap with safety collar

Info

Publication number: WO2016177379A1
Application number: PCT/DK2016/050117
Authority: WO
Inventors: Stig Krarup PETERSEN
Original assignee: Medicosafe Aps
Priority date: 2015-05-05
Filing date: 2016-05-04
Publication date: 2016-11-10

Abstract

The present invention concerns a hypodermic needle and a protective cap as well as a method for handling a hypodermic syringe and a hypodermic needle, the hypodermic needle at a first end including a needle base for mounting on a corresponding mount on a hypodermic syringe, the invention further including that the protective cap further includes a safety collar, where the safety collar is arranged in immediate vicinity of the first end of the protective cap, the safety collar extending away from the external periphery of the protective cap in radial direction thereof. Hereby is achieved the effect that a user's fingers are protected by the safety collar. By prior art protective caps it is necessary to pass the needle part of the hypodermic needle into a relatively small opening at the open first end of the protective cap. The consequence of a user missing the opening will with great certainty cause the user to hit his own fingers and thereby subject him to a so-called jab injury.

Description

HYPODERMIC NEEDLE AND PROTECTIVE CAP WITH SAFETY COLLAR

Field of the Invention

The present invention concerns a hypodermic needle and a protective cap as well as a method for handling a hypodermic syringe and a hypodermic needle, wherein the hypodermic needle at a first end includes a needle base having an internal geometry and an external geometry, the needle base including fixing means suited for mounting on a corresponding mount on a hypodermic syringe, wherein the hypodermic needle further includes a tubular needle part with a pointed/sharp second end, wherein the protective cap in principle is constituted by a tubular member, typically made of plastic, which is open at a first end and closed at a second end, and which at the first end includes a socket at least partially corresponding to the geometry of the needle base and by which the hypodermic needle can be stored fixed in the protective cap, with the needle part protected in the shaft that extends between the first and the second end of the tubular member. Background of the Invention

In connection with use and handling of hypodermic needles, in the following called needles, sometimes so-called jab injuries occur. Some of these jab injuries occur during the work of placing a used needle in a protective cap after use. For example, the case may be that medicine is drawn up from a so-called vial with a "thick" needle mounted on a hypodermic syringe, in the following called a syringe. The thick needle is easier to move through a rubber stopper typically provided in a vial, and additionally the drawing of medicine is performed more easily due to the smaller resistance in the thick needle. After drawing the desired amount of medicine up into the syringe, the thick needle is moved back into the protective cap, is detached from the syringe and replaced by a "thin" needle by which the medicine is injected into a patient. Finally, the thin needle is also moved back into its protective cap, detached from the syringe and disposed of. It is while returning needles to protective caps that a part of the jab injuries occur, primarily caused by the fact that a relatively small opening in the cap is to be targeted by the needle. When the opening in the cap is missed, a finger is often hit implying the hazard of transmitting infection, such as HIV and infectious hepatitis.

Obviously, it is desirable to avoid such jab injuries, for several reasons. One issue is the risk of infection, another is the fact that such a jab injury is regarded as a work accident causing the injured (victim of the jab injury) to leave the work immediately and apply to a casualty ward for possible treatment, followed by a report etc. of the work accident. Moreover, typically one or more blood samples are to be taken for analysis, and the resulting values are to be checked. In other words: there are great expenses associated with jab injuries, and too many of this type of work accidents happen every year. According to Danish Nurses Organization, even in Denmark there are about 3800 nurses who are subjected to jab injuries yearly, and about 2500 of these accidents occur with unclean equipment with a risk of transmitting infection. The number for medical doctors is unknown, but estimated to be high.

Over time, various types of syringes and needles have been developed where the problem is attempted to be solved. For example, a so-called Safety Syringe is known, with a built-in mechanism causing the needle to be retracted into the syringe after use so that it cannot be reused. In particular, reuse of needles is a problem among drug abusers, and this problem can be solved by a hypodermic syringe with a needle as indicated in US 2012/0022498 Al. In many cases, however, this solution is not suited for doctors and nurses who work under more orderly conditions. In the example indicated above where several needles are used on the same syringe for one injection, the solution indicated by US 2012/0022498 Al will not find application.

There is thus a need for a solution enabling a secure and precise protection of a user, in particular the fingers of a user, when the user holds a protective cap during withdrawal as well as while reinserting a needle in a protective cap.

Object of the Invention

It is the purpose of the invention to indicate a solution to the above mentioned problem where a user's fingers are protected during work with inserting and withdrawing a needle from a protective cap, and where the former routine in connection with injections is not to be changed. Description of the Invention

As mentioned in the introduction, the invention concerns a hypodermic needle and a protective cap, and in addition the invention includes the protective cap further having a safety collar, where the safety collar is arranged in immediate vicinity of the first end of the protective cap, the safety collar extending away from the external periphery of the protective cap in radial direction thereof. Hereby is achieved the effect that a user's fingers are protected by the safety collar. By prior art protective caps it is necessary to pass the needle part of the hypodermic needle into a relatively small opening at the open first end of the protective cap. The consequence of a user missing the opening will with great certainty cause the user to hit his own fingers.

A typical protective cap for a hypodermic needle has an opening of very few millimetres, typically of 4 to 8 millimetres. A protective cap according to the invention may typically e.g. be with an outer diameter of 6 mm, leaving an opening of about 5 mm corresponding to an area of about 20 mm and a total area of about 28 mm when the edge is taken into account. This area can be termed the "safe" area since no injury will occur as long as the needle part strikes within this area.

By using a safety collar with an outer diameter of e.g. 12 mm, the "safe" area capable of being be hit by the needle without injury to the user will be increased to about 113 mm , corresponding to about 4 times the original area.

If the outer diameter of the safety collar is further increased to e.g. 20 mm, this will correspond to the "safe" area being more than 11 times greater than that of on a protective cap without a safety collar.

In other words, there is an appreciably greater safety for hitting either the opening in the protective cap or the safety collar instead of the fingers of a user. In a preferred embodiment of a hypodermic needle and a protective cap according to the invention, the safety collar can have a conical geometry, with a first area at the shaft of the tubular member and with a second and larger area at the outermost periphery of the safety collar. The geometry of the safety collar may be edged as well as circular. By designing the safety collar with conical geometry, it will function as a kind of funnel and thereby increase safety even more as a needle part hitting the safety collar will be guided towards the centre of the conical safety collar and therefore down into the interior of the protective cap. In a particularly preferred variant of a hypodermic needle and a protective cap according to the invention, the safety collar may be adapted for disposition in a first inactive position and in a second active position, the safety collar in the inactive position extending along the shaft towards the second end of the tubular member, the safety collar in the active position extending away from the first end of the tubular member. The safety collar may advantageously be provided with conical geometry such that the cone in the inactive position faces the shaft of the protective cap, and in the active position is turned so as to appear as a funnel at the opening of the protective cap. The safety collar may e.g. be foldable between a first inactive position and a second active position, and be made of one, two or more parts together forming a safety collar.

In a particularly preferred variant of a protective cap according to the invention, the safety collar may include one or more elastic zones. By having one or more of such resilient zones, the safety collar can be turned from an inactive position and to an active position by simple elastic deformation, readily performed by a finger after mounting the hypodermic needle in the protective cap on a hypodermic syringe. Thus there are no arduous conditions or routines to be learned, accepted or remembered. Whether the safety collar is folded up into the active position during mounting of the hypodermic needle or later, this will be a simple and rapid way of increasing the safety.

Yet a preferred embodiment of a hypodermic needle and a protective cap according to the invention indicates that the safety collar may include at least one lock pin, the at least one lock pin arranged on or in direct or indirect connection with the safety collar, where the lock pin is arranged for engagement with the hypodermic needle. The at least one lock pin may advantageously and simply interact with a corresponding recess in the base of the hypodermic needle when the safety collar is inactive. Only by activating the safety collar it will be possible to separate the hypodermic needle from the protective cap. Hereby it is prevented that the hypodermic needle can be removed from the protective cap without optimising security by unfolding the safety collar acting as a shield for a user's fingers. As mentioned, the lock pin can interact with a recess in the base of the hypodermic needle, but it may also be adapted to lock the needle in the protective cap in other ways, e.g. by squeezing around the base of the needle or by the lock pin or other locking mechanism fixing the needle in the protective cap.

The safety collar can advantageously be made of the same plastic type as the protective cap itself, but a different material may be used as well, including a type of plastic with other properties. The safety collar can be made with one or more zones with increased elasticity in order to enable that it can be turned from the inactive position to the active position right away whereas the other areas on the safety collar can have greater rigidity and elasticity, respectively.

As mentioned by introduction, the invention further concerns a method for handling a hypodermic syringe and a hypodermic needle, the method at least including the following steps:

- mounting a hypodermic needle on a hypodermic syringe on its mount therefor;

- activating the safety collar;

- removing the protective cap;

- using the hypodermic syringe and the hypodermic needle;

- remounting the protective cap;

- detaching the hypodermic needle from the mount of the hypodermic syringe.

The step in which the safety collar is activated can alternatively be performed at any time before the step in which the protective cap is remounted. It is important that activation occurs before the needle part is moved back into the protective cap during the mounting thereof. As the safety collar is an integrated part of the protective cap, it will not entail any difficulties in the form of new routines or other that would make application of the safety collar cumbersome or demanding. If the hypodermic needle, the protective cap and the safety collar include a locking mechanism that only releases the needle from the protective cap by activating the safety collar, there is achieved complete certainty that the protective cap is activated prior to removal of the protective cap from the needle.

A method for handling a hypodermic syringe and a hypodermic needle according to the invention may further include at least the following step:

- deactivating the safety collar after remounting the protective cap on the hypodermic needle for locking and securing the hypodermic needle in the protective cap.

Hereby is ensured that the hypodermic needle cannot be drawn out of the protective cap while detaching the base of the needle from the corresponding mount of the hypodermic syringe. By a locking between the protective cap and the hypodermic needle, e.g. effected by a lock pin which in a suitable way is in active and activateable connection with the safety collar, or alternatively only accessible after activation of the safety collar, there is achieved certainty that a hypodermic needle cannot be released from the protective cap without a positive action, why it can be expected that a user will be aware of a possible remaining risk of jab injury. Description of the Drawing

The invention is described in the following with reference to the drawing, wherein:

Fig. 1 shows a hypodermic syringe and a hypodermic needle in a protective cap where the safety collar is folded down;

Fig. 2 shows a hypodermic syringe and a hypodermic needle in a protective cap where the safety collar is folded up;

Fig. 3 shows a hypodermic syringe with a hypodermic needle and with a protective cap with unfolded safety collar;

Fig. 4 shows a protective cap as delivered with folded safety collar;

Fig. 5 shows a protective cap as delivered with unfolded safety collar;

Fig. 6 shows the top of a protective cap and its safety collar with a lock pin, in folded condition; Fig. 7 shows the top of a protective cap and its safety collar with a lock pin, in unfolded condition.

In the explanation of the Figures, identical or corresponding elements will be provided with the same designations in different Figures. Therefore, no explanation of all details will be given in connection with each single Figure/embodiment.

List of position numbers

1. hypodermic syringe

2. syringe mount

3. hypodermic needle

4. needle base

5. protective cap

6. shaft on protective cap

7. first end of protective cap

8. safety collar

9. second end of protective cap

10. needle part

11. lock pin on safety collar

12. recess on needle base

13. opening at side of shaft

14. zones on safety collar

Detailed Description of Embodiments of the Invention

On Fig. 1 is seen a hypodermic syringe 1 with a syringe mount 2 and a hypodermic needle 3 with a needle base 4. The hypodermic needle 3 is securely provided in a protective cap 5 in a condition corresponding to the condition in which it is found after unpacking from the package in which the hypodermic needle 3 and thereby the protective cap 5 are delivered. The protective cap 5 is seen as an elongated tubular member with a shaft 6 and an first end 7, which is open, and where at this first end 7 there is arranged a safety collar 8 which in the shown Figure is folded down, thus facing the second closed end 9 of the protective cap and partly along the shaft 6. Disposed in the protective cap 5 is seen, as mentioned, a hypodermic needle 3 which at the external surface of its base 4 is fixed internally of the protective cap 5 at its first end 7. The needle part 10 extends from the needle base 4 internally of the protective cap 5 towards the closed second end 9 of the protective cap.

Fig. 2 shows a hypodermic syringe 1 and a hypodermic needle 3 in a protective cap 5 as in Fig. 1, here with the safety collar 8 unfolded such that it extends away from the first end 7 of the protective cap and towards the shown hypodermic syringe 1. It appears on the Figure that the safety collar 8 has a conical funnel-shape by which is achieved a shielding and protecting effect on a user's fingers, which typically will hold around the shaft 6 of the protective cap in the area immediately under the unfolded safety collar 8. In this Figure is also seen a lock pin 11 at the bottom side of the safety collar 8. This lock pin 11 is adapted to engage a corresponding recess 12 on the needle base 4. In order for a user to draw the hypodermic needle 3 out of the protective cap, the lock pin 11 is to be released from the recess 12, which is effected by activating the safety collar 8. Activation of the safety collar 8 can be effected by actuating it with a finger such that the conical, funnel-shaped safety collar 8 is turned from the inactive position on Fig. 1 to the active position on Fig. 2.

Fig. 3 shows a hypodermic syringe 1 on which is mounted a hypodermic needle 3, and to one side thereof is seen a loose protective cap 5 having an unfolded safety collar 8. In this Figure is clearly seen the opening 13 provided at the side of the shaft 6 on the protective cap and through which the lock pin 11 comes into contact with the said recess 12 at the base 4 of the hypodermic needle. The recess 12 is also seen clearly on the hypodermic needle 3. Fig. 4 shows a variant of a protective cap 5 as delivered and with folded safety collar 8. The safety collar 8 is seen here with indication of zones 14 that for illustrative purposes are shown and delimited by radial lines on the safety collar 8. These zones 14 may have different elastic properties, e.g. such as being a very narrow zone - the line - having less stiffness or greater elasticity than the remaining part of the safety collar 8, such that the latter may right away be turned or unfolded from the inactive position shown in Fig. 4 to the active position shown in Fig. 5. The safety collar 8 may also be provided with one and the same elasticity and operate as described above. It is also possible that the safety collar itself 8 is divided into several parts, e.g. two or three parts, that are activated in the same way as described above, namely by actuating respective parts by a finger or similar before use.

In Figs. 6 and 7 the upper part of a protective cap 5 and its safety collar 8 with a lock pin 11 appear in folded condition and in unfolded condition, respectively.

The lock pin 11 is shown schematically in the above described Figures, and it is noted that the shapes of the lock pin 11 as well as the protective cap 5 and the needle base 4 are to be designed so as to interact in a suitable way. The shown examples are therefor only to be regarded as illustrative examples of how these parts of the invention can be adapted in principle.

Claims

1. A hypodermic needle (3) and a protective cap (5), wherein the hypodermic needle (3) at a first end includes a needle base (4) having an internal geometry and an external geometry, the needle base (4) including fixing means suited for mounting on a corresponding mount (2) on a hypodermic syringe (1), wherein the hypodermic needle (3) further includes a tubular needle part (10) with a pointed/sharp second end, wherein the protective cap (5) in principle is constituted by a tubular member, typically made of plastic, which is open at a first end (7) and closed at a second end (9), and which at the first end (7) includes a socket at least partially corresponding to the geometry of the needle base (4) and by which the hypodermic needle (3) can be stored fixed in the protective cap (5), with the needle part (10) protected in the shaft

(6) that extends between the first (7) and the second end (9) of the tubular member, characterised in that the protective cap (5) further includes a safety collar (8), where the safety collar (8) is arranged in immediate vicinity of the first end (7) of the protective cap, the safety collar (8) extending away from the external periphery of the protective cap in radial direction thereof.

2. A hypodermic needle (3) and a protective cap (5) according to claim 1, characterised in that the safety collar (8) has a conical geometry, with a first area at the shaft (6) of the tubular member and with a second and larger area at the outermost periphery of the safety collar.

3. A hypodermic syringe (3) and a protective cap (5) according to any of claims 1 and 2, characterised in that the safety collar (8) is adapted for disposition in a first inactive position and in a second active position, the safety collar (8) in the inactive position extending along the shaft (6) and towards the second end (9) of the tubular member, the safety collar (8) in the active position extending away from the first end

(7) of the tubular member.

4. A hypodermic syringe (3) and a protective cap (5) according to any of claims 1 to 3, characterised in that the safety collar (8) is foldable between a first inactive position and second active position.

5. A hypodermic syringe (3) and a protective cap (5) according to any of claims 1 to 4, characterised in that the safety collar (8) includes one or more resilient zones (14).

6. A hypodermic syringe (3) and a protective cap (5) according to any of claims 3 to 5, characterised in that the safety collar (8) includes at least one lock pin (11), the at least one lock pin (11) arranged on or in direct or indirect connection with the safety collar (8), where the lock pin (1) is arranged for engagement with the hypodermic needle (3).

7. A hypodermic needle (3) and a protective cap (5) according to claim 6, characterised in that the at least one lock pin (11) interacts with a corresponding recess (12) in the base (4) of the hypodermic needle when the safety collar is inactive.

8. A method for handling a hypodermic syringe (1) and a hypodermic needle (3), the hypodermic needle (3) including a protective cap (5), wherein the hypodermic needle (3) at a first end includes a needle base (4) having an internal geometry and an external geometry, the needle base (4) including fixing means suited for mounting on a corresponding mount (2) on a hypodermic syringe (1), wherein the hypodermic needle (3) further includes a tubular needle part (10) with a pointed/sharp second end, wherein the protective cap (5) in principle is constituted by a tubular member, typically made of plastic, which is open at a first end (7) and closed at a second end (9), and which at the first end (7) includes a socket at least partially corresponding to the geometry of the needle base (4) and by which the hypodermic needle (3) can be stored fixed in the protective cap (5), with the needle part (10) protected in the shaft (6) that extends between the first (7) and the second end (9) of the tubular member, characterised in that the method includes at least the following steps:

- mounting a hypodermic needle (3) on a hypodermic syringe (1) on its mount (2) therefor;

- activating the safety collar (8);

- removing the protective cap (5);

- using the hypodermic syringe (1) and the hypodermic needle (3);

- remounting the protective cap (5);

- detaching the hypodermic needle (3) from the mount (2) of the hypodermic syringe.

9. A method for handling a hypodermic syringe (1) and a hypodermic needle (3) according to claim 8, characterised in that the method further includes at least the following steps:

- deactivating the safety collar (8) after remounting the protective cap (5) on the hypodermic needle (3) for locking and securing the hypodermic needle (3) in the protective cap (5).