WO2004103431A2

WO2004103431A2 - Selective needle shield for syringe needles

Info

Publication number: WO2004103431A2
Application number: PCT/US2004/015599
Authority: WO
Inventors: Francesca Dionigi
Original assignee: Euro 3 S.R.L.; Boshears & Boshears Consulting, Inc.
Priority date: 2003-05-19
Filing date: 2004-05-19
Publication date: 2004-12-02
Also published as: ITRM20030241A1; WO2004103431A3; ITRM20030241A0

Abstract

A needle-shield for hypodermic syringes has a break point (17) and a shape that is easily allows removal of either the whole needle-shield (1) or only its upper part (18). In this last case, the lower part (18) will remain at the base of the needle, reducing its effective length, being the length of the portion that will penetrate into the patient.

Description

SELECTIVE NEEDLE SHIELD FOR SYRINGE NEEDLES

BACKGROUND OF THE INVENTION:

This invention relates generally to devices for injecting medication into a patient and more particularly concerns a needle-shield for hypodermic syringes.

The needles used for injections can be of different lengths. The needle length is chosen based on the administration route of the drug to be injected, for example intravascular, intramuscular, subcutaneous or intradermal, and on the patient typology, for example adults or children.

The needles currently on the market are sold individually or pre-assembled with the syringes. Some injection devices, for example some pens for insulin, have a chill cylindrical element at the needle base that, if rotated before the injection, performs a telescopic motion, hiding a portion of the needle and thus reducing the needle length that penetrates into the patient's skin, as is taught in U.S. Patents Nos. 5,944,700 and 4,841,885. However, these devices require the assembling of one or more specific elements and generally permit only variations of few millimeters in the needle length. It is, therefore, an object of this invention to provide a needle-shield for hypodennic syringes. A further object of this invention is to provide a needle-shield for hypodermic syringes which enables the user to modify the effective length of the needle to be used. Another object of this invention is to provide a needle-shield for a hypodermic syringe which can be modified in its length by simply removing the whole needle-shield or by removing only its upper part, thus selecting a well defined portion of the needle for penetration of the patient's skin. Yet another object of this invention is to provide a needle-shield for a hypodermic syringe which allows the user to exactly decide, for the same needle, in function of its needs, the length to use for the injection. Still a further object of this invention is to provide a needle-shield for a hypodermic syringe such that the user need not replace a needle pre-assembled on a syringe when a different needle length is required. It is also an object of this invention to provide a needle-shield for a hypodermic syringe which reduces handling of the syringe needle before use and, consequently, the risk of contamination. Moreover, it is an object of this invention to provide a needle-shield for hypodermic needle which can be used in every field and for syringes pre-filled with drugs, where the use of different needle lengths ix permitted, such as for pediatric use or for drugs that may be administrated by more than one route.

SUMMARY OF THE INVENTION:

In accordance with the invention, a needle-shield for a needle of a hypodermic syringe has upper and lower parts with a breaking point therebetween so that the upper part of the needle-shield may be removed to reduce the effective length of the needle to a shorter predetermined length.

In one embodiment, the upper and lower parts may be unitary with the breaking point being a thin-walled section of the unitary structure. hi another embodiment, the upper and lower parts may be distinct and preassembled at a predetermined point. The distinct parts may be of different materials, for example the upper part of bromo-butylic rubber and the lower part of polypropylene. The lower part may also have at least three flexible radial flaps blocking the lower part to a luer to which the needle is fixed. Protrusions may be provided on a surface of the shield to facilitate rotation of the upper part with respect to the lower part to separate the upper part from the lower part. In yet another embodiment, the needle-shield may have a base shaped to be fitted into an activation head of an activable hypodennic injection device. The shield base may have flaps that, during activation of the device, fit into guides in the activation head to prevent the base from rotating with respect to the activation head.

The shield may be made of rigid transparent plastic, such as polypropylene, so- as to render the effective length of the needle visible to users. Alternatively, indicia on the lower part of the shield may identify a longer selectable effective length of the needle when the upper and lower parts are removed and a shorter selectable effective length of the needle when only the upper part is removed.

BRIEF DESCRIPTION OF THE DRAWINGS:

Other objects and advantages of the invention will become apparent upon reading the following detailed description and upon reference to the drawings in which:

Figure 1 is a perspective view of a first configuration of the needle-shield, assembled to a hypodermic syringe;

Figure 2 is a cross-sectional view of the needle-shield of Figure 1;

Figure 3 is a perspective view of the syringe of Figure 1 with the needle-shield completely removed to permit use of the whole length of the needle;

Figure 4 is a perspective view of the syringe of Figure 1 with only the upper part of the needle-shield removed to permit use with a shorter effective length of the needle;

Figure 5 is a cross-sectional view of a second configuration of the needle-shield assembled to a pre-filled syringe;

Figure 6 is a front view of the base element of the needle-shield of Figure 5;

Figure 7 is a bottom view of the element of Figure 6; Figure 8 is a side view of the syringe of Figure 5 with only the upper part of the needle-shield removed to permit use with a shorter effective length of the needle;

Figure 9 is a side view of the syringe of Figure 5 with the needle-shield completely removed to pennit use of the whole length of the needle;

Figure 10 is a perspective view of a third configuration of the needle-shield assembled to an activable hypodermic injection device;

Figure 11 is a perspective view of the injection device of Figure 10 after activation;

Figure 12 is a perspective view of the activated device of Figure 11 with the needle-shield completely removed to permit use of the whole length of the needle; and Figure 13 is a perspective view of the activated device of Figure 11 with only the upper part of the needle-shield removed to permit use of a shorter effective length of the needle.

While the invention will be described in connection with preferred embodiments thereof, it will be understood that it is not intended to limit the invention to those embodiments or to the details of the construction or arrangement of parts illustrated in the accompanying drawings.

DETAILED DESCRIPTION:

One preferred configuration of this invention is illustrated in Figure 1. The needle-shield 1, constituted by a single element, preferably of plastic such as polypropylene, may have a tubular or conical shape and is closed at one end 11 and open at its base. Looking at Figure 2, at a determined distance from the base, a breaking point 17 is provided at which the thickness of the plastic wall is sensibly thinner. The base of the needle-shield 1 is similar to those of normal plastic needle-shields and fits the hub 22 of the needle 24 with similar mechanisms. The needle-shield 1 has on its base a flange or a ring 12 of greater thickness that acts as a grip in the operations of capping the needle 24 with the needle-shield 1 and removal of the whole needle-shield 1 or removal of only its upper part 18 if the user wants to reduce the effective length of the needle 24. Two flaps 15 and 16 on the needle-shield 1 provide the user with a stable grip to rotate the upper part 18 with respect to the base 19 and, consequently, to break the needle-shield 1 at the break point 17. Looking at Figure 3, to use the needle 24 at its maximum length, the user must remove the needle-shield 1 handling it from the grip 12, as performed with conventional needle-shields. At the end of the use, the needle-shield 1 can recap the syringe to protect the needle 24 before the syringe is wasted into a suitable wasting container. To reduce the effective length of the needle 24, being the length of the needle that will penetrate into the patient, the user, keeping the grip 12 of the base 19 of the needle-shield 1 blocked with two fingers, will rotate the upper part 18 of the needle-shield with the other hand, causing its rupture at the break point 17. In this case, as shown in Figure 4, the base 19 will remain attached to the hub 22 of the needle 24.

The needle-shield 1, in all of its preferred configurations, may be transparent so as to allow the user to see the needle 24. The needle-shield may indicate, by color or by a printing of indicia such as numbers on its external surface, the effective lengths permitted by the needle 24, that is the whole length and the reduced length.

In another preferred configuration of this invention, show in Figure 5, the needle- shield is constituted by two elements, made of the same material or of different materials and assembled at a point 17a. For example, butylic rubber may be used for the upper part 18a and polypropylene for the base 19a. This configuration of the needle-shield can be applied, for example, to a pre-filled syringe 2a, for which an hermetic closure of the needle tip is needed to preserve the stability of the drug during storage. If the user wants to use the syringe 2a with the shorter effective length of the needle 24, it is sufficient that only the rubber element 18a is removed, keeping the plastic element 19a on the luer 25 of the syringes 2a, as is seen in Figure 8. If the user wants to use the syringe 2a with the whole length of the needle 24, then handling it from the base 19a, the whole needle- shield group constituted by the two parts 18a and 19a must be removed, as seen in Figure 9. The base 19a has a tronco-conical part 193, seen in Figure 6, which is made to fit the rubber element 18a. The system to block the needle-shield to the luer 25 of the syringe 2a consists of three or more flexible radial flaps 192, seen in Figure 5 and Figure 7, or in a simple sealing ring. The flaps 191 also stabilize the position of the base 19a, as they put it in contact with the needle 24. hi a third preferred configuration shown in figures 10-13, the special needle- shield of this invention replaces the needle-shield of an activable hypodermic injection device 3b like the device submitted on July 15, 2002 in Italian Application No. RM2002A000278, and can be activated by pushing the grip 12 of the needle-shield lb against the activation head 3. hi this particular configuration, the needle-shield lb has a narrower base 13 that fits into the guide 31 of the activation head 3. After activation of the device, the flaps 20 on the external surface of the base 13 slide into the guides 311 on the internal surface of the activation head 31 port. When the upper part 18 of the needle- shield 1 is rotated, the guides 311 block the flaps 20 on the base of the needle-shield lb and, consequently, block the component 19b, making easier the rupture of the needle- shield at the break point 17. For this reason, for this configuration, it is not necessary that the user keeps the base element 19b of the needle-shield lb blocked with the fingers when the upper part 18 is rotated to remove it.

Thus, it is apparent that there has been provided, in accordance with the invention, a selective needle shield for syringe needles that fully satisfies the objects, aims and advantages set forth above. While the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art and in light of the foregoing description. Accordingly, it is intended to embrace all such alternatives, modifications and variations as fall within the spirit of the appended claims.

Claims

WHAT IS CLAIMED IS:

1. A needle-shield for a needle of a hypodermic syringe comprising upper and lower parts with a breaking point (17) therebetween whereby the upper part of the needle-shield may be removed to reduce an effective length of the needle to a predetermined length.

2. A needle-shield according to claim 1, said upper and lower parts being unitary and said breaking point (17) being a thin- walled section thereof.

3. A needle-shield according to claim 1, said shield being of rigid transparent plastic, such as polypropylene.

4. A needle-shield according to claim 1, said parts (18a and 19a) being distinct and pre-assembled at a predetermined point (17a).

5. A needle-shield according to claim 4, said parts being of different materials, for example said upper part (18a) being of bromo-butylic rubber and said lower part (1 a) being of polypropylene.

6. A needle-shield according to claim 4, said lower part (19a) having at least three flexible radial flaps (192) blocking said lower part to a luer (25) to which the needle (24) is fixed.

7. A needle-shield according to claim 1 further comprising flaps or protrusions (15 and 16) on a surface thereof facilitating rotation of said upper part (18 or 18a) with respect to said lower part to separate (19 or 19a) said upper part (18 or 18a) from said lower part (19 or 19a).

8. A needle-shield according to claim 1 having a base (13) shaped to be fitted into an activation head (3) of an activable hypodennic injection device.

9. A needle-shield according to claim 8, said base (13) having flaps (20) that, during activation of the device, fit into guides (311) in said activation head (3) to prevent said base (13) from rotating with respect to the activation head (3).

10. A needle-shield according to claim 1 further comprising indicia on said lower part identifying a longer selectable effective length of the needle when said upper and lower parts are removed and a shorter selectable effective length of the needle when only said upper part is removed.