WO2010095152A1

WO2010095152A1 - Safety device for disposable sanitary hollow needles and cutters

Info

Publication number: WO2010095152A1
Application number: PCT/IT2009/000059
Authority: WO
Inventors: Mario Gargani; Lina Landini
Original assignee: Mario Gargani; Lina Landini
Priority date: 2009-02-18
Filing date: 2009-02-18
Publication date: 2010-08-26

Abstract

A safety device (1) for disposable sanitary hollow needles and cutters comprises a body (2) having a seat (15) for a needle, and handle means (10) for handling said device (1). The body (2) of the device (1) is made up of two half-portions (3) to be engaged irreversibly to each other to hold permanently a needle or a cutter thereinside.

Description

"SAFETY DEVICE FOR DISPOSABLE SANITARY HOLLOW NEEDLES

AND CUTTERS" Technical Field of the Invention

The present invention relates to a safety device for disposable sanitary hollow-needles and cutters. State of the Art

Within the health facilities, the problem of accidental pricks caused by a used needle is significant, in spite of the preventive measures that have been tried since the nineties, such as the use of rigid containers for prickproof disposal, and the prohibition to re-cap the needle with the traditional needle cover. Such preventive measures, however, relate mostly to the work experience rather than the risky instruments.

By acting also, and above all, on risky instruments, it is possible to reduce the injuries due to accidental pricks and cuts by 80-85%. The injuries due to hollow needles and to cutters imply, for the health facilities, a significant economic burden. The cost for medical analysis and treatments after similar events is high and adds up to human costs in terms of personal anxiety, stress and anguish. After every accident, in fact, it is necessary for the injured persons to follow long medical procedures before ascertaining whether they have contracted a serious illness and, in a positive case, it may be necessary for them to undergo a therapy for a long period of time, and even for all their life.

The researches being conducted have shown that better education and training, and greater care for the professional practice, are not sufficient to eliminate the risk of injuries produced by needles and other cutting devices. However, medical devices are presently known which are made with a technology- directed to protect health personnel against accidental injuries caused by needles and cutting objects . Medical devices for prevention against accidental pricks (commonly called also NPD, Needlestick Prevention Devices) include a protective mechanism making it possible to avoid an accidental prick during and after their use and/or during and after their disposal.

The sanitary instruments provided with needle are many, and for each of them there have been designed specific protective devices inasmuch as each risky instrument has its specific characteristics that have to be carefully taken into consideration. Such devices are directly integrated with the risky instrument, for example with a syringe or a cutter. For example, syringes are known to be provided with a sliding protective sheath which is pushed as far as to cover the needle.

The sheath may be positioned temporarily around the needle to take the syringe up to the location of use and blocked afterwards in a protective position after use . Such devices offer a good protection and are simple to use, but they do not offer the ease of handling of a standard syringe, besides resulting quite expensive . In case of catheters, a protective sheath cover the mandrel when this is retracted therefrom or, alternatively, the mandrel is immediately reclosed inside a safety chamber that cannot be manipulated. Also these solutions, although securing an excellent protection, are difficult to use since they require more manoeuvres and the use of both hands to be made operative, besides having very high costs of production.

Finally, protective sheaths exist which are mounted directly around the needle and are moved temporarily away from the needle when using the syringe, while remaining connected to the base of the latter. Such sheaths are then reclosed again around the needle after use.

This solution, although being economical and simply operable, results awkward during the taking and injection steps.

To overcome the constructional complexity of the above safety devices, other devices have been provided that are separately sold and able to be associated with syringes, catheters, butterfly needles, etc.

Such safety devices are provided with a cap which is pressure-fitted around the needle so as to make the latter result constrained therein without any possibility to be removed therefrom.

The said cap is fitted from above through a slit formed along the wall of the same cap.

Also these devices, however, exhibit disadvantages which are mainly due to the difficulty of centering the needle and to the force that the operator has to exert onto the cap to fit it around the needle.

Also in this case, the operator must use both hands to ensure the needle inside the device.

Description of the Invention In this context, the specific technical task of the present invention is to propose a disposal safety- device for hollow needles and cutters which does not exhibit the above drawbacks.

In particular, the object of the present invention is a disposal safety device for hollow needles and cutters able to allow a correct and accurate positioning of the device around a needle or a cutter in order to prevent the operator from suffering accidental pricks and injuries. A further object of the present invention is a disposal safety device for hollow needles and cutters which is easy and quick to use while allowing a shielding starting from the base and not from the tip of the needle or cutter. Finally, the object of the present invention is a disposal safety device for hollow needles and cutters which is simple to make, cost-effective and adaptable to any type of sanitary tool having a needle or a blade, such as a scalpel. The specified technical task and object are substantially achieved by a disposal safety device for hollow needles and cutters including the technical characteristics disclosed in one or more attached claims. Further characteristics and advantages of the present invention will appear more clearly from the indicative and thus non-limiting description of a preferred but non-exclusive embodiment of a disposal safety device for hollow needles and cutters, as illustrated in the accompanying drawings, wherein:

- Fig. 1 is a perspective view of the inside of a disposal safety device for hollow needles and cutters according to the present invention;

- Fig. 2 is a perspective view of the outside of a disposal safety device for hollow needles and cutters according to the present invention;

- Fig. 3 is a side view of the device according to the present invention;

- Fig. 4 is a rear view of the device according to the present invention; and

- Fig. 5 is a top view of the device according to the present invention.

With reference to the attached figures, numeral 1 designates generally a disposal safety device for hollow needles and cutters according to the present invention.

Such a device exhibits a body 2 preferably made up of two substantially symmetrical half-portions 3, apt to be closed irreversibly around a needle or a cutter. The two half-portions 3, making up the body 2 of device 1, are connected to each other through a hinge line 4, about which the two half-portions 3 are pivotally movable. The device 1 has an open configuration prior to its use, and a closed configuration after its use.

In particular, in the open configuration illustrated in Figs. 1, 2, 4 and 5, the device 1 has the two half-portions 3 spaced apart and connected to each other only along the hinge line 4. In the closed configuration illustrated in Fig. 3, the device 1 has the two half-portions 3 facing one another and fully in contact to each other. The device 1 has an internal surface 2a and an opposite external surface 2b. Provided on the internal surface 2a are irreversible closing means 5, such as a restrained element, for example .

As illustrated in Fig. 1, on the internal surface 2a of one of the two half-portions 3 of the body 2 there is provided, preferably, a protruding element 6 which engages a recess 7 located on the other half-portion 3 of the body 2 in a position symmetrical with respect to the hinge line 4. Present on the internal surface 2a of each half- portion 3 is a channel 8 located close to the hinge line 4 and defining a half part of a seat 15 for a needle or a cutter.

Once the two half-portions 3 are closed and the internal surfaces 2a of body 2 face one another, the protruding element 6 engages the recess 7 so that the device 1 is no longer openable.

In the closing configuration, the two half-portions 3 pivot about the hinge line 4 which is longitudinal and parallel to the axis Ia of device 1. The body 2 bends thus in half, and the two channels 8 of each half-portion 3 fit to each other to form the seat 15 for a needle or a cutter.

The seat 15 is counter-shaped relative to a needle and is located centrally with respect to the device 1 along its whole axial development.

In particular, the seat 15 has a first cylindrical portion 8a for holding the sheer needle, and a portion 8b formed by a truncated-cone length and a cylindrical length for holding the base of the needle which fits onto the syringe.

The body 2 advantageously comprises a shank 9 inside which a section of the cylindrical portion 8b of seat 15 is formed for holding the needle's base. The device 1 has a first end 11 and a second end 12 which coincide also with the first 11 and second 12 ends of the seat 15.

The first end 11 is provided with an annular and radial shoulder 13 raising from the inner surface 2a which defines, when the device is in closed configuration, a retaining edge for the needle also when the latter is of "butterfly" type. The second end 12, instead, is provided with two tabs 14, as shown in Fig. 5, also raising from the inner surface 2a and axially offset between them, so that, when the device 1 is in a closed configuration, the said tabs overlap each other, thereby closing completely the second end 12 of the seat 8. In this way, any leakage of haematic liquid is prevented. On the external surface 2b, the device 1 exhibits handle means 10. Each half-portion 3 is provided, on the respective external surface 2b, with a relevant handle means 10. Advantageously, the handle means 10 comprise two seats 16 to allow the insertion of two fingers of the user, for example, the forefinger and the thumb. Advantageously disposed inside the seats 16 are one or more antislip elements comprising for example, projections 17 and 18. This preferred solution of the handle means 10 makes it possible to securely grasping the device 1 thereby increasing its safety on use.

The device 1 is preferably made enbloc and in plastic material, that is, through a single molding operation.

When the syringe, or any other instrument provided with a needle or cutter has been used, the operator has to put the needle or cutter under safe conditions to avoid injuries. To shield the needle or cutter, the operator holds the device in open configuration with a hand, and uses the other hand to manipulate the syringe or the cutter, by making the needle or cutter to rest against the internal surface 2a of device 1 inside one of the two channels 8 which define the seat 15.

At this point, the operator closes the device 1 around the needle or cutter by rotating the two half- portions 3 about the hinge line 4 and exerting a pressure onto the surface of the handle means 10 in correspondence of the closing means 5. The protruding portion 6 fits into the recess 7 and the device 1 results thus irreversibly closed around the needle which is to be removed and disposed of. The needle remains permanently closed inside the seat 15 without any possibility to be removed therefrom. Advantageously device 1 further comprises two tongues obtained respectively on the two channels 8 defining the seat 15 so that in the closed configuration the needle remains crushed between them inside device 1. The tongues should be partially deformable elastic material to be adaptable to different needle sizes and not to impede the closure of device 1 itself. The invention achieves the proposed objects and important advantages. Since the device according to the present invention is not directly assembled on the risky instrument, it does not affect in any way the operational capacity of same instrument. Moreover, it can be produced separately and be used afterwards with different instruments (syringes, butterfly needles, cannulae, scalpels, etc.) inasmuch as it can be associated only with the needle or the risky instrument. Accordingly, as it is a product made independently from the instrument carrying the needle or the cutter, the safety device has extremely reduced production costs, not to be compared with any other device presently available on the world market. The device above described is extremely easy to use and does not imply any risk for the user: the needle or the cutter is wrapped up sideway from the base and is not capped from above, as it happens with many devices presently available on the market.

Claims

1. Safety device for disposable sanitary hollow- needles and cutters comprising a body (2) having a seat (15) for a needle, and handle means (10) for handling said device (1), characterized in that said body (2) is made up of two half-portions (3) irreversibly engageable to each other to hold permanently a needle thereinside.

2. Safety device according to claim 1, characterized in that said two half-portions (3) are connected along a hinge line (4); said body (2) being movable around said hinge line (4) only between an opening configuration and a closing configuration.

3. Safety device according to claim 2, characterized in that said hinge line (4) is longitudinal and parallel to the axis (Ia) of device (1).

4. Safety device according to any of the preceding claims, characterized in that the seat (15) of said body (2) is countershaped with respect to a needle.

5. Safety device according to any of the preceding claims, characterized in that each portion exhibits a relevant handle means (10) .

6. Safety device according to any of the preceding claims, characterized in that said two half-portions (3) are irreversibly associated with each other by irreversible closing means (5) .

7. Safety device according to claim 6, characterized in that said irreversible closing means (5) comprise a protruding element (6) which fits with restraint into a respective recess (7) .

8. Safety device according to any of the preceding claims, characterized in that said body (2), when the two half-portions (3) are associated and closed one with the other, comprise a closed end (12) .

9. Safety device according to any of the preceding claims, characterized in that said body (2), when the two half-portions (3) are associated and closed with one another, comprise an open end (11) provided with a retaining annular edge (13).

10. Safety device according to any of the preceding claims, characterized in that it is made of one piece .

11. Safety device according to any of the preceding claims, characterized in that it is made of plastic material.