NEEDLE FOR MEDICAL USE WITH SAFETY PROTECTION

Abstract: A needle (1) with a protective cap (2), substantially cylindrical in shape, having an open end (9) and the opposite end tapered with a central hole (10) through which the needle (1) can emerge, the cap (2) having a diameter such that it can slide onto a cylindrical body (7 or 7bis, 7', 7'', 7'''), on which it is slided during use.

Description: "NEEDLE FOR MEDICAL USE WITH SAFETY PROTECTION" The present invention refers to a needle for syringes, for drawing samples with a vacuum test-tube for endovasal and similar uses, having a safety protection, suitable for eliminating any danger of wounding after use. 5. As is already known, the throw-away needles which exist on the market are usually applied to the corresponding syringes and ar& covered by a protective cap, which is siid off at the moment they are used. The cap, which is substantiaI Iy cyI indricaI or sI ightIy conicaI in shape, with an opening at the wider end, must be replaced in position 10. on the needle after the injection has been made, and this is necessary obviously to avoid leaving the needle uncovered, which could wound, for instance, the refuse collection staff. Since the opening of the protecti e cap of the needle is relatively smaI I, there exists a risk of the needIe not centring it when it is 15- being reinserted into the cap, and consequently wounding the user. This can happen at any time, simply through carelessness but more probably through the tiredness of the medical or paramedical staff at the end of a hospital duty shift. The danger of the user being wounded is a major problem today, D. considering the existence of diseases, some of them fatal, such as the acquired immunity deficiency syndrome (AIDS), which are transmitted through being pricked by infected needles. In order to eI iminate or at Ieast avoid any danger of wounding when covering the needle after the syringe has been used, it has already been suggested to foresee a protective cap of the needle, which can be adjusted from a rest position, in which it completely covers the needle, to a use position, in which it places itself around the syringe, thus exposing the needle. After the injection has been made 5- the cap can be si id onto the needle again. Such a method is known for example from US-A-4968 304, wherein the needle and the related cap are usually separated by the syringe, the connection of the needle with the sy inge taking place by means of a screw mounting. A closing plug is provided on the cap, which must be 10. removed before use and replaced after use. During such operations there always exists the risk of the user to be wounded. A similar method is disclosed in US-A-4961730 which foresees elastic means, in correspondence with the base of the needle, co-operating ith the inner surface of the cap, suitably shaped, to obtain the 15- locking of the needle inside the cap. This solution which is quite complicated, expensive and difficultly easibIe, does not a11ow a compIeteIy safe Iocking of the needIe due to the presence of said elastic means. Both methods disclosed in US-A-4 968 304 and US-A-4 96l 730 are 20. specifically conceived for hypodermic syringe needles so that their appl ication to needles for different uses, such as cannuIa-needIes or butterfIy need1es for endovasaI use, is hardIy envisageab1e. The aim of the inven ion is to eliminate the drawbacks set forth above and revolu ionize the solution proposed in the aforementioned prior 25. arts, providing an extremely simple, cheap and safe method to protect the needle, which applies to whatsoever kind thereof. The aim is achieved, according to the invention, by means of the features I isted in the characterizing portion of the attached claims 1 and 2. Advantageous embodiments of the invention are disclosed in the 5. dependent claims. In particular, according to a modified embodiment, the needle can be used for drawing samples with vacuum test-tubes in place of syringes. According to the known art, for this type of application two opposed needles with respective protective caps are foreseen. One of such 10. needles is intended to be i serted into the vein whi le the other is for inserting into a vacuum test-tube, in w ich the blood is col lected. At the base of the latter needle a threaded tang is foreseen, onto which a tubular element is screwed at the moment of use. In this application, the same problems arise as those described 15. for syringes. According to this embodiment of the invention, a cylindrical sleeve is foreseen at the opposite part of the needle point, which is enbloc with the base and encloses a second needle which forms an extension of the first, the protective cap being moved on said sleeve during use. 20. After use, the cap is replaced on the first needle, as in the case of the needle for syringes, while the second needle still remains protected by the coupI ing. In a second modified embodiment the needle is a cannula-needle for endovasal use, e.g. to administer fluids or for similar uses. 25. A cannuIa-needIe is made of a metallic guide needle or "mandrel" encIosed in a flexible piastic materiaI cannuIa. During use the whoIe is inserted in the vein as a common needle, then the metallic guide needle is extracted, for example to connect the cannuIa with a phleboclysis to be d ipped to the patient. During such an operation there exists the risk of the user to be wounded. 5. According to this modified embodiment of the invention the protective cap is placed between the guide needle and the cannuIa, more precisely between a cylindrical handle of the guide needle and a tubular support of the cannula, the guide needle being housed in said cap while it is being extracted, and is locked in it after rotation, as in the 10. preceding cases. The guide needle and the cap can be thus removed enbIoc from the cannu1a and thrown in a refuse coI Iector for the further disposal without risk of wounding. In a third modified embodiment the needle is a butterfly needle, always for endovasal use. 15. As known, a butterify needle has, in correspondence with the base, two opposite flexible wings, intended to facilitate its introduction in the vein and the subsequent locking, and carries a rear connecting I ittle tube. According to this modified embodiment of the invention, the two wings 20. are fixed to the base or needle body only for a short part, so as to a11ow the insertion between them of the protective cap which is pIaced on the needle, after use, and locked by means of rotation. In this application two opposite coupled blades forming respective guides for the sliding of the butterfly needle wings are suitably provided on the 25. cap in substitution for the longitudinal guides usually foreseen on the cap. Further characteristics of the invention will be more c1earIy understood from the detailed description given below, which refers to its purely exemplary and therefore not restrictive embodiments, illustrated in the appended drawings, in which: Figure 1 is a side elevation of a needIe for syringes according to 5. the invention; Figure 2 is a view of the needle in figure 1, rotated through 90°; Figure 3 is a top plan view of the needle; Figure 4 is a top plan view of the protective cap of the needle; Figures 5 and 6 are median sections of the cap taken according to 10. lines V-V and VI-VI respectively in figure 4; Figures 7 and 8 are transverse sections of the cap taken aIong I ines VII-VII and VIII—V111 respectively in figure 5; Figure 9 is a median sectional view of the cap, complete with needle, applied to a syringe, before the cap is slid off; 15. Figures 10 and 11 are transverse sectional views taken along line A-A in figure 9, with the cap shown in two positions, rotated through 90° with respect to each other; Figure 12 is a view like the one in figure 9, with the cap carried on the tubular support of the needle, which is ready for use; 20. Figure 13 shows, partially in view and partially in median section, a first modified embodiment of the needle with the safety protection according to the invention, usable for taking sam les with a vacuum test-tube; Figure 14 is an exploded schematic view of a second modified 25. embodiment of the invention concerning a cannuIa-needIe; Figure 15 is a view of the cannuIa-needIe in figure 14 in an assembled posi ion. Figure 16 is a view of the guide needle extracted from the cannuIa and protected by the cap. 30. Figure 17 is an enlarged section of the cap end, indicated by A in figure 14, substantially corresponding to the section of figure 5; Figure 18 is a section, taken along line XVIII—XVIII of fig. 17, equal to the section of figure 7; Figure 19 is a section, taken along line XIX-XIX of fig. 17, equal to the section of fig. 8; 5. Figure 20 is a view along line XX-XX of figure 14 equal to the view of figure 3; Figure 21 is an exploded view of a third modified embodiment relevant to the butterfl needle; Figure 22 is a view of the butterfly needle in figure 21 ready for 10. use. Figure 23 is a view of the butterfly needle after being used with the cap covering the needle; Figures 24 and 25 are top views of the sole cap and of the sole butterfly needle respectively; 15. igures 26 and 27 are sectionaI views taken aIong I ines XXVI-XXVI and XXVII-XXVII in fig. 21; Figure 28 is a section taken along line XXVI I 1—XXVI I I in figure 27- With reference to such figures, and star ing with the figures from 1 to 12, reference numbers 1 and 2 show respectively the needle and the 20. related protective cap according to the invention. The needle 1 is a perfect ordinary needle for a syringe, having a point 3 and a base 4 at the opposite end, from which a tubular support 7 projects, ith a central hole 5 intended for housing the tang 6 of the syringe 7bis (see in particular figures 9 and 12). The differences 25. with respect to a traditional needle are represented by the shape of the base 4, which is widened and substan ially oval, with two opposed notches 8, the purpose of which wi I I be described below, and by the tubular support 7 at the back of the base 4. The cap 2 has a substantially cylindrical form, with an internal diameter which enables it to si ide onto the tubular support 7 (figure 12), and it has an open end 9 and the other end tapered with a central opening 10 for the needle 1 to emerge. A flange 11 can be foreseen in correspondence with the opening 9, to make it easier to hold. 5. Near the opening 9, inside the cap 2, a continuous or broken annular projection 12 is foreseen, which forms a ledge suitable for preventing the needIe emerging from the opening 9. Below the stop collar 12 two opposed half-moon projections 13 are foreseen, in such a way that a seating 14 is defined between the 10. collar 12 and the projections 13, intended for housing the base 4 of the needle i. Inside the cap 2 two opposed longitudinal guides 15 are also foreseen, capable of engaging with the notches 8 foreseen on the base 4 of the needIe 1, to guide the s1 iding of the cap 2. 15. In the seating 14 for the base 4 of the needle, two teeth 16 can be foreseen, acting as stops for the rotation of the cap 2 with respect to the needle 1 or viceversa. The needIe 1 is inserted into the protective cap 2 during the production phase, by making it pass over the annular projection 12 at 20. the base 4 by means of heating and/or pressure. The needle and the related protective cap are then packed in a sealed bag and soId separateIy or aIready appI ied to the syringe 7, as shown in figure 9, and packed together with the latter. During use, if the needle 1 has not been applied to the syringe 7 is 25. yet, the tang 6 of the syringe is inserted into the hole 5 of the tubular support 7 of the base 4 of the needle, as shown in figure 9- In such a position, the base 4 of the needle 1 is positioned so that it is locked between the upper annular projection 12 and the lower projections 13- Then the cap 2 is rotated, through an angle of about 5. 90°, for example, so as to bring the opposed guides 15 in line with the notches 8 of the base 4 of the needle (figure 11). Centring the notches 8 can be facilitated by correctly locating the teeth 16 foreseen in the seating 14. The cap 2 can then be slid off upwards, in the opposite direction from the point 3 of the needle 1, and position 10. itself around the tubular support 7, remaining integral with the Iatter temporari Iy through the s1 ight interference which exists between at least one of the projections 12 and 13 and the outer surface of the tubular body itself, as shown in figure 12. After the injection has been made - an operation which is not in the 15. least impeded by the cap 2 - the cap 2 is once more slid downwards in order to cover the needle 1, until the base 4 of the needle positions itself in the seating 14, after which the cap 2 is rotated in the opposite direction from the previous one, so as to bring the base 4 to engage with the half-moon projections 13, and therefore prevent the 20. possibility of the needle sliding out of its own accord. At this point, since the syringe 7bis is usually of the throw-away type, it is thrown into the appropriate containers together with the needle and the related protection. If, however, for any reason, it is desired to remove the needle from 25. the syringe, this can be done easily by exercising traction on the cap 2 and rotating it further so that the engagement of the teeth 16 with the base 4 of the needle 1 produces a rotation of the latter, and therefore makes it easier to disconnect the tang 6 of the syringe, as, in fact, takes place in the case of needles of the traditional type. From what has been described, it is easy to see the advantages of the needle with its related protective cap according to the invention, which can be applied to a syringe of any size, without varying the 5 > size of the cap 2 and, consequently, the size of the base 4 of the needle 1. As an alternative to what has been shown in figures 1 to 12, the needle 1 can be made without the rear tubular support 7 and the cap have a Iarger diameter so as to be carried directIy on the syringe 10 - 7bis. A description is now given of the modified embodiments of the invention keeping the same references used in the previous figures to indicate the same parts, and adding a prime to the references which indicate parts which are simi lar. 15. Figure 13 shows a needle for drawing samples with vacuum test-tubes. As can be seen in such figure, the only difference with respect to the needle for syringes illustrated in figures 1 to 12 consists, in substitution for the tubular support 7, in the presence of a second needIe 1', with a point 3', on axis and in opposition to the ain 20. needle 1. The needle 1 ' , which is usually shorter than the needle 1, projects from the centre of the base 4, which in this case obviously does not have the centraI hoIe 5• Likewise, from the base 4, in the same direction as the second needle 1', a cylindrical sleeve 7' projects, which encloses the needle 1', 25 , and on which the cap 2 is positioned during use. ln fact, during use, the needle 1 is inserted into the vein, and the needle 1' is inserted into a vacuum test-tube, which is housed in the cylindrical sleeve 7', for collecting the blood. The needle protection system in figure 13 is therefore exactly the 5. same as that of the needle illustrated in the figures from 1 to 12. The modified embodiment shown in figures 14 to 20 relates to a cannu1a-needIe which, as known, comprises a guide needle or mandrel 1, provided with a rear cylindrical handle 7" and a cannuIa 20 surrounding the needle 1 and having at its back a tubular body 21 10. partially housing the handle 7" of the needle. Two opposed wings 22 intended for example to lock the cannuIa on the patient's skin by means of plasters are foreseen on the body 21. According to the invention the handle 7" of the needle is suitably lengthened and the protecting cap 2, completely similar in its 15. structure to the cap of figures 4-8, is placed between it and the tubular body 21 of the cannula. The cannuIa-need1e is packed in the assembled condition of figure 15, or possibly with the metallic guide needle or mandrel 1 slightly retracted, in such a way that its point 3 does not project beyond the 20. end of the cannuIa 20. During use the needle 1 is inserted in a vein or in an artery causing the contemporary insertion of the cannuIa 20. Then the needle 1 is retracted acting on its cylindrical handle 7", keeping the cap in the position of figure 15, i.e. housed in the tubular body 21 of the 25. cannuIa 20. A coupling with a slight interference between the cap 2 and the tubular bodv 21 can be also foreseen. When the needle is completely retracted so as to be entirely housed in the cap 2, that is when its base or collar 4 positions itself in the seating 14 of the cap, a rotation through about 90° is carried out to lock it in that position. The guide needle 1 and the cap 2 can be thus slid off from 5. the cannuIa, as shown in figure 16, and thrown in a refuse collector for the further disposal thereof without risk of wounding. A connector, for example to drip a phleboclysis to a patient, can be then connected to the end of the tubular body 21. A further connector could be possibly foreseen at a side of the body 21. 10. A desc iption is now given of the modified embodiment shown in figures 21 to 28, relevant to a butterfly needle for endovasal use comp ising a needle 1 with a tubular body 7'" in correspondence of which two opposed flexible wings 30 are foreseen to facilitate the introduction of the needIe into the vein and the subsequent Iocking of the same by 15. means of plasters. A little tube is connected to the back of the body 7"' , in a known way, to drip for example a phleboclysis to the patient. The flexibility of the wings 30 is obtained by means of weakening ribs 31 (see in particular figure 25)■ 20. According to the invention the wings 30 are fixed to the body 7" ' only by a short rear part 32 so as to form long slits 33 for the insertion between them of the protective cap 2. When packed, the cap 2 can be placed in the position shown by dotted lines in figure 22 and brought, du ing use, in the position shown by 25. unbroken I ines in the same figure. In alternative, the cap 2 can be placed during packaging in the position shown by unbroken lines in figure 22, any auxiliary little plastic tube being foreseen to protect the needle 1. After it has been used the cap 2 is slid off onto the needle 1 until 5. its base or collar 1 is inserted in the housing 14 foreseen inside the cap 2. The cap is then rotated through about 90° and locked in such a position (figure 23). According to this embodiment pairs of opposed wings 34, 35, preferably- different in length, are foreseen outside the cap 2 to determine 10. corresponding seatings 36 to house the wings 30 of the butterfly needle. In this way the longitudinal sliding guides 15, which are foreseen in the cap 2 according to the preceding embodiments, can be el iminated.

Claims: C L A I M S 1. A needle for medical use, provided with a protective cap (2), substantially cylindrical in shape, with one open end (9) and an opposite opening (10), the diameter of the cap (2) being such that it can slide on a cylindrical body provided at the back of the needle to 5. move from a needle covering position to a position in which the needle is uncovered and vice versa, characterized in that said cyI indricaI body is a tubular support (7) integral with the needle (1) and connectable to the tang (6) of a syringe (7bis). 2. A needle for medical use, provided with a protective cap (2) 10. substantially cylindrical in shape, with one open end (9) and an opposite opening (10), the diameter of the cap (2) being such that it can slide on a cyl indrical body (7 or 7bis, 7' 7", 7"') provided at the back of the needIe to move from a needIe covering position to a position in which the needle is uncovered and vice versa, 15. characterized in that inside the cap (2), near the open end (9) a seating (14) is made, suitable for receiving a substantial ly oval widened base or collar (4) of the needle (1), the seating (14) being limited at the top by a continuous or broken annular projection (12) forming an insurmontab1e ledge for the base of the needle, and at the 20. bottom by two opposed "half-moon" projections (13), shaped in such a way as to aI low the base (4) of the needle (1) to pass, after correct positioning. 3. A needle according to claim 2, characterized in that inside the said seating (14) at least one tooth (16) is foreseen, acting as a 25. stop for the rotation of the cap (2) with respect to the base (4) or vice versa. 4. A needle according to claim 2 or 3, characte ized in that on the base (4) of the needle (1) at least one but preferably two opposite notches (8) are foreseen suitable for engaging with the corresponding longitudinal guides (15) foreseen inside the cap (2) for a guided 5. sliding between said elements. 5- A needle according to any one of the claims 2 to 4, characterized in that at least the projection (12) or the projec ions (13), or both, have dimensions such that they interfere slightly with the outer surface of the cylindrical body (7 or 7bis, 7', 7", 7'"), so 10. as to make the cap (2) integral with latter during use. 6. A needle according to any one of the claims 2 to 5, characterized in that the said opening (10) is made central ly at a tapered end of the cap (2). 7- A needle according to any one of the claims 2 to 6, 15. characterized in that said cylindrical body is a tubular support (7) at the back of the base (4) and integral with the needle (1) (figg 1-12). 8. A needle according to any one of the claims 2 to 6, characterized in that said cyI indricaI body is a syringe (7bis). 20. 9. A needle according to any one of the claims 2 to 6, characte ized in that the said cylindrical body is a sleeve (7') integral with the needle (1) and located on the part opposite to the latter, enclosing a second needle (1') on axis with the needle (1) (fig. 13)- 25. 10. A needle according to any one of the claims 2 to 6 wherein the said needle (1) is the guide needle or mandrel of a cannuIa needle, characterized in that said cylindrical body is a handle (7") of the guide needle (1) and that the cap (2) is located between said handle (7") and a tubular body (21) of the cannula (20) (figures 14-20). 11. A cannuIa-needIe according to claim 10, characterized in that 5- two flexible wings (22) are foreseen outside said tubular body (21). 12. A needle according to any one of claims 2 to 6, characterized in that said cylindrical body is the body (7'") of a butterfly needle, provided with two flexible opposite wings (30), said wings (30) being fixed to the body (7'") of the needle (1) only by a short rear part 10. (32), so as to determine longitudinal slits (33) for the insertion between them of the protective cap (2) (figures 21-28). 13. A butterfly needle according to claim 12, characterized in that pai s of opposite wings (34, 35) forming seats (36) are foreseen on said cap (2) to house and make the wings (30) of the butterfly needle 15. (1) slide. 14- A butterfly needle according to claim 13, characterized in that said wings (34 35) are different in lenght. 15. A needle according to any one of the previous claims, characterized in that it is packed in a sealed bag together with the 20. related protective cap (2). 16. A syringe for injections, characterized in that it is provided with a needle (1) with a related protective cap (2), according to any one of the claims 1 to 8.

Inventors: FLUMENE ANTONIO GIOVANNI, PILO GIUSEPPE, FLUMENE, ANTONIO, GIOVANNI, PILO, GIUSEPPE
Applicants: FLUMENE ANTONIO GIOVANNI, PILO GIUSEPPE, FLUMENE, ANTONIO, GIOVANNI, PILO, GIUSEPPE
Application year: 1992
Main classification: A61M5
IPC codes: A61M5, A61M25