IT201900016202A1 - "Improved Safety Needle" - Google Patents

Description

Description of an invention patent

DESCRIPTION

The present invention refers to a safety needle according to the preamble of claim 1.

As is known, safety needles are used in conjunction with various devices to administer drugs to patients such as injector pens or to allow the administration of such drugs (or to draw blood from) patients, such as syringes. In the first case these needles are called safety pen needles and in the second they are called safety hypodermic needles. The pen containing the drug or the syringe thus defines a reservoir (for the drug or for drawing blood).

In general, a safety needle provides a body which can be coupled to this reservoir and contains a cannula through which, for example, a drug can be administered to a patient. The cannula has two tips or ends, respectively distal or proximal to the reservoir; from the end they are also referred to as "patient side tip" or "patient tip" (the distal tip) and "vial side tip" or "vial tip" the proximal tip. This last indication applies when the safety needle is connected, in particular, to an injector pen.

The tank is associated with the safety needle in different ways.

For example, the injector pen is detachably constrained to the safety needle through a usual coupling by screwing between threaded parts of the safety needle and the injector pen (or other suitable coupling according to the regulations in force). In the case of the hypodermic needle, the safety needle usually comprises a conical connection (Luer type) and with wings for screwing (Luer Lock type) according to current legislation.

As is known, the purpose of a safety needle is to prevent sharp devices that come into contact with the human body (such as needles for administering drugs, for example) from being a vehicle for the transmission of infectious diseases (such as AIDS). , hepatitis and similar), this to protect health workers who assist the patient in carrying out the administration of the drug or who directly administer the drug to the patient.

Safety needles are known which comprise solutions suitable for reducing the risk of accidental needle sticks as well as preventing the needle from being reused after drug administration.

For example, it is known to use, at least at the patient tip of the cannula, a movable plastic component (protective element) associated with the body or rigid structure of the safety needle and actuated by a spring contained in said body. With its movement, on the one hand, this mobile component allows the administration of the drug, freeing the patient tip which can thus penetrate the user's skin, and on the other hand acts as a shield against contact with this patient tip after the execution of this administration. . This is achieved by returning to a position which completely covers the patient tip and locking it in this final position, for example by means of suitable plastic protrusions presented both by the mobile element and by the body of the safety needle and which prevent further movement of said tip. protection or shield member able to free again the patient tip of the cannula.

For example, EP3052163 describes a solution similar to the one mentioned above. However, the impediment to movement in this anteriority can be overcome by applying a twist to the protective element, allowing this element to be deactivated and even, potentially, to reuse the needle.

Solutions are also known which provide for plastically and permanently deforming the cannula after its use and in particular for permanently deforming the cannula in correspondence with the patient tip so that the latter remains permanently and safely inside the body. of the safety needle or of the movable element acting as a shield for the patient tip. Examples of these solutions are described in US2012 / 0022461, US2014 / 0221924, GB2532795. These solutions, as in general still others known in the state of the art which nevertheless provide protection of the patient tip without deforming the cannula, comprise a passive safety mechanism able to intervene in order to prevent the patient tip of the cannula from being exposed. upon contact after using the safety needle, said mechanism activates automatically during and after normal use of the safety needle and does not require particular additional operations by the user in order to protect the aforementioned patient tip.

In particular, US2014 / 0221924 describes a mobile protector element inside a rigid body fixed on a cannula holder hub. The protective element is subject to the action of a first spring which rests on the cannula holder hub.

This protector element has two sections of different diameters, in the section of greater diameter there is a deformation element of the needle (needle disabler) coupled to its own support and urged in rotation with respect to this support by a second preloaded torsion spring. in a predefined angular position before the actuation of said deforming element.

The support of this deforming element is placed in a first guide slot made in the protecting element.

The deforming element comprises a channel which passes through the needle and engages it in a state of slight friction to prevent movement of the deforming mechanism with respect to the needle before use.

The protective element comprises a first and a second guide slot having a distal section in which the deforming element is positioned before the use of the device according to US2014 / 00221924, said distal section having a width smaller than that of a proximal section of said slot. The width of the distal section is smaller than that of the proximal section.

During the use of the aforementioned device, when the protective element of the cannula penetrates inside the sleeve during an injection, the deforming element moves with respect to the cannula as it is pushed by this protective element towards the hub of the cannula; this deforming element, initially present in the distal section of the second guide slot, thus reaches the proximal section of said guide slot.

At the end of the injection, under the thrust of the first spring, the protective element moves away from the cannula hub and the support element of the deforming element comes into contact with a stop provided in the sleeve which blocks this support in the first guide slot . However, the protector element continues to move away from the cannula hub pushed by the first spring of the deforming element and moves into the proximal section of the second guide slot. Since the latter is wider than the deforming element, this element can rotate under the action of the second spring associated with the support element, bending the cannula.

The known solution presents a considerable constructive difficulty above all linked to the presence of the preloaded spring associated with the supporting element of the deforming element and to the presence of the channel containing the needle. These solutions make it rather difficult to produce the known solution with an automated assembly process, an embodiment in which there is a risk of damaging the tip of the cannula during its insertion into the channel of the deforming element.

Furthermore, the through coupling between the cannula and the deforming element keeps the cannula in a state of stress which could also create micro-deformations or micro-bending of the cannula itself when the injection is carried out, which could also cause problems for the patient when injecting the drug and when removing the needle from their body.

WO2018 / 220529 describes a safety needle associated with a drug injector pen and which comprises an external rigid structure inside which there is a cannula holder. The cannula holder element supports a cannula having a first end and a second end for administering the drug; a protective element is associated, movable, with the rigid structure and is placed between the latter and an internal jacket integral with the rigid structure. The protective element covers said second end of the cannula after administration of the drug. A deforming member is provided which is able to deform the cannula after such administration in such a way that the second end of said cannula remains within said protective element. The deforming organ is associated with said protective element and is able to rotate autonomously with respect to it, after administering the drug, to deform the cannula.

The inner jacket has a body in which at least two cavities or hollows having a substantially Y-shaped shape and having a first, a second and a third part differently inclined to each other are preferably made.

Within these slots there are movable protruding projections of a deforming member or pawl having a body able to rotate within said protective element (in which it is inserted) to deform the cannula and keep it within said protective element after use.

The deforming member or pawl has a protruding part adapted to cooperate with the cannula to deform it in the protective element after use, all this automatically or passively without the intervention of the patient or user.

This known solution, while operating in an optimal way, does not provide further safety members which totally prevent a movement of the protective element towards the inside of the external rigid structure and the internal jacket which is integral with it.

The object of the present invention is to provide and offer a safety needle, usable with any tank of medical product, such as an injector pen or a hypodermic syringe, said safety needle being improved with respect to known solutions.

In particular, the object of the present invention is to offer a safety needle of the type suitable for deforming the cannula after its use so as to make it unusable, which is safe to use and which allows, in a certain way, to prevent contact by of a user with such a cannula or with the patient tip of the cannula.

A further object is to provide a safety needle in which the possibility of deactivating the protection function of the contact with the cannula is minimized, especially in relation to torsional stresses applicable from the outside on the protective element.

These and other objects which will be evident to the skilled in the art are achieved by a safety needle according to claim 1.

For a better understanding of the present invention, the following drawings are attached purely by way of non-limiting example, in which:

Figure 1 shows a side view of an embodiment of a safety needle according to the invention which can be used with a hypodermic syringe;

Figure 2 shows a section along the line 2-2 of Figure 1;

Figure 3 shows a view similar to that of Figure 1, but of a safety needle usable with an injector pen;

figure 3A shows an exploded view of the safety needle of figure 3;

Figure 4 shows a section along the line 4-4 of Figure 3;

Figures 5A, 5B, 5C show a longitudinal section view or along the line 2-2 of the safety needle of Figure 1 in various phases of its use or at rest, during injection and after use and in a safety position;

Figures 6A and 6B respectively represent a side view and a perspective view of a part of the safety needle of Figure 1 in operating steps corresponding to those of Figures 5A and 5C respectively;

Figure 7 shows a side view of the safety needle shown in Figure 6B;

figure 8 shows a top perspective view of a component of the safety needle according to the invention;

figure 9 shows a perspective view from below of the component of figure 8;

Figure 10 shows a perspective view of another component of the safety needle according to the invention;

Figure 11 shows a top view of the component of the safety needle of Figure 10;

figure 12 shows an exploded view of a part of the safety needle of figure 1;

Figure 13 shows a partial section along the line 13-13 of Figure 6B.

With reference to the aforementioned figures, a safety needle according to the invention is generally indicated with 1 and comprises a cannula holder element 2 (or simply "cannula holder") fixed in a per se known manner to a first end portion 3 of a rigid jacket 4 of the needle 1. Said cannula holder 2 has a different shape depending on the use of the needle 1 on a syringe (or similar "reservoir" of medicine or fluid suitable for being inserted into a human or animal body or to contain blood) or associated with an injector pen, for example for insulin. This outer jacket 4 defines a rigid structure of the needle 1.

As it will be noted, in fact, in the case of safety needle 1 to be used with a syringe (Figures 1 and 2), the cannula holder 2 comprises a substantially cup-shaped body 8 having a central part 10 protruding along a longitudinal axis W of the The needle has a hole 14 suitable for containing a first end 16 of a cannula 15 which is fixed in the hole 14 in any known way.

The cup-shaped body 8 has an extremal part 17, tubular, suitable for coupling with one end of a syringe (not shown) according to standard couplings defined by the current legislation. This extremal part 17 may have fins to allow screwing to Luer Lock type connections, according to current legislation.

In the case in which the needle is associated with an injector pen (figures 3, 3A, 4) the cannula holder has the cup-shaped body 8 inside the jacket 4 and has an internal threaded part 9 able to allow coupling, for example for example by screwing (or other suitable coupling), removable, of the body 8 to one end of a usual injector pen (not shown) according to the current legislation. The body 8 of the cannula holder 2 still has the central part 10, but protruding from a transverse portion 12 of the cup-shaped body 8 towards the inside of the outer jacket 4 and, as in the case of the needle associated with a syringe (Figures 1 and 2), towards a second portion of said end 13 of said rigid outer jacket 4.

The central part 10 has the axial hole 14 which in this embodiment passes through and inside which the cannula 15 now protrudes from both sides. It has the first end 16 which protrudes from the hole and defines a vial tip terminating within an internal cavity 17 of the bowl-shaped body 8; this end 16 is able to penetrate a drug vial associated with the injector pen, also not shown and according to the current legislation.

In both forms of use, associated with a syringe or an injector pen, the safety needle 1 comprises the cannula 15 having a second patient end or tip 19 able to penetrate into the patient's skin for administration of the drug contained in the vial mentioned above or in the syringe.

The outer jacket 4 has a cylindrical body 18, hollow at 23, and is partially closed, through an annular flat part 20, to its second end portion 13 (or "distal end" of the jacket considering the position of said end portion 13 with respect to the tank, syringe or injector pen, to which the needle 1 is associated). The flat part 20 has a first face 21 facing the cavity 23 of the jacket 4 and a second face 22 facing the outside of this cavity.

Inside the external jacket 4 there is an internal cylindrical jacket 28, having a first end 29 resting on the cannula holder 2 and free to rotate, idle, within the rigid external jacket 4. The internal jacket rests freely on a free edge 24 of the body a cup 8 of the cannula holder 2 in the case of a safety needle that can be used with a syringe (see figure 2) or rests on (or in any case close to) the transverse portion 12 of the aforementioned cup body 8 in the case of use of the needle 1 with a injectable pen (figures 3-4). A second end 30 of the inner jacket 28 resting against (or in any case close to) the first (inner) face 21 of the flat part 20 of the outer jacket 4. The inner jacket 28 is freely rotatable within the outer jacket 4 around the axis W.

The inner jacket 28 has a cylindrical tubular body 33 having at least one and preferably at least two shaped hollows or recesses 38 which can be obtained within the internal wall of this body 33 (and therefore are blind) or, as in the example of the figures, are passersby.

Each slot 38 has a shape that recalls a Y and comprises a first part 39, slightly curved and having a position substantially along a longitudinal axis F lying on an inclined plane with respect to the longitudinal axis W of the needle 1, said first part 39 being closed at a first end 39A and opening at the second end 39B within a second part 40 of the slot 38 with the longitudinal axis K lying on a plane orthogonal of the longitudinal axis W (ie the axis K is parallel to the axis W). This second part 40 communicates with the first part without interruption and ending with a closed end 40A.

The second part 40 cooperates with a third part 41 of the hollow 38 placed on the side of the first part 39 and having a position which defines a substantial extension of the second part 40. This third part 41 has an inclined side 41A with respect to the axis K and is closed in 42.

The third part 41 of the groove 38 is wider when compared with the cross section of the other two parts 39 and 40.

Between the first and third parts 39 and 41 of the groove there is a protrusion 48 tapered towards the first part 39 of the groove 38, said protrusion having a curved side 49 which delimits, on one side, the third part 41 of the groove 38.

Obviously, other embodiments of the slots 38 are possible without modifying their function which will become evident from the following description.

The revolving inner jacket 28 also has windows 50, the function of which will be described below, as well as pockets 51 (figure 8) within the inner wall 28D in proximity to the second end 30. In the wall 28D, cavities or cavities 52 can be provided (such as shown in figure 9) whose function will be described later.

Inside the revolving jacket 28 there is a compression spring 55 having a first end 56 resting on the cannula holder 2 and a second end 57 inserted in a first enlarged extremal part 58 of a protecting element 60 of the cannula 15, said protecting element being movable along the W axis in contrast to said spring with respect to the liners 4 and 28. The liner 28 can also rotate around this axis W during the relative movement of the element 60 with respect to this liner 29 along the W axis.

More specifically, the protector element 60 has a body for example substantially cylindrical 61 (as in the figures), hollow in 61A, having the aforementioned first extremal part 58 and a second extremal part 62 having a through hole 63 for the exit of the end 19 of the cannula 15 for administering the drug. This hole is preferably (but not necessarily) turned up towards the inside of the protective element.

The protective element 60, before the use of the safety needle 1 and despite being subject to the thrust of the spring 55, is retained within the outer jacket 4 of the cooperation of its first extremal part 58 with the second end portion 13 of this shirt 4.

This protector element 60 also comprises, near the first extremal part 58 and protrudes outside its body 61, protruding fins 67 adapted to cooperate with the windows 50 of the revolving jacket 28 at the end of the injection so as to block said protector element 60 in a position which prevents any access to the inside of the needle and ensures that the second patient end or tip 19 of the cannula 15 cannot be touched.

The fins 67, substantially L-shaped with protruding ends, are flexible thanks to the compliance of the hollow cylindrical body 61 (and its conformation) and before cooperating with the windows 50 they rest within the pockets 51 provided in the aforementioned movable jacket 28. Note, however, that these pockets are an unnecessary detail and may even be absent. With the relative movement between said body 61 and liner 28, the flaps 67 can move in these pockets until they pass within the windows 50. The pockets allow to prevent the flaps 67 from being subjected to excessive compression before coupling with the windows 50, coupling which occurs at the end of the administration of the drug to the patient. This characteristic is useful for preventing operating problems following storage for a long time, especially in cases in which an elastic material is used for said fins 67 but subject to permanent deformations if subjected to constant load over time. This characteristic is superfluous if an elastic material that is insensitive to the relaxation effects described above is used.

The protector element 60 also has, laterally, two opposite holes 70 and 71 (which in the non-limiting example of the figures are open on one side) suitable for containing corresponding disc-shaped lateral parts 72 and 73 (or of shapes in any case corresponding to that of the holes 70, 71 and suitable for the rotation of said parts 72 and 73 in said holes 70, 71) of a deforming member or pawl 75 having a body 76 and able to rotate within the cavity 61A of said protective element (in which it is inserted) to deform, as will be described, the cannula 15 and to keep it within this protective element 60 after use. The rotation of the body 76 occurs through a rotary movement of the lateral parts 72 and 73 in the holes 70 and 71. This is obtained thanks to protruding projections 78, protruding from said lateral parts 72 and 73, adapted to cooperate with the corresponding slots 38 above. described of the inner revolving jacket 28, the sliding in which leads to the rotation of the jacket 28 around the W axis.

Furthermore, the deforming member or pawl 75 has a part 80 for example flat and protruding from a portion 81 for interconnecting the side parts 72 and 73. The protruding flat part 80 is adapted to cooperate with the cannula 15 to deform it in the protective element after use, all this automatically or passively without the intervention of the patient or user. This part 80 can also have another shape different from that described and shown in the figures and in any case such as to deform the cannula 15.

The pawl 75 has a substantially C-shape when viewed from above or in cross section. This maximizes the support of the parts 72, 73 both in the protective element 60 and within the slots 38 of the revolving inner jacket 28. The shape in fact confers an elastic characteristic to the structure of the pawl 75 allowing its lateral parts 72, 73 the possibility of approach, facilitating assembly of the safety needle 1 and contact with the aforementioned guides 38.

Finally, during assembly, the lugs 78 are positioned in the slots 52 which guide the correct positioning of the pawl in the revolving or mobile jacket 28, this pawl being already coupled to the protective element 60.

In use, during the drug administration phase, by resting the protective element 60 on the patient's skin, this element retracts into the outer jacket 4 and into the inner one 28 in contrast to the action of the spring 55. In this movement, the The protective element 60 is in contact with the user's skin and friction is generated between it and the skin, which keeps the protective element substantially stationary against its rotation around the W axis. This element 60 can thus only move along the W axis in contrast to the spring 55.

On the contrary, the inner jacket, freely rotatable around the axis W, rotates around it as the protecting element re-enters the rigid jacket 4.

At the same time, the lugs 78 slide into the corresponding slots 38 along their different parts 39 and 40. This movement does not involve any rotation of the part 80 of the pawl 75 towards the cannula 15. On the contrary, during the descent movement of the protector there may be a slight rotation of the pawl, but in the sense that it leads it to move away from the cannula. This movement is however limited by the inner wall of the protective element.

By moving the needle 1 away from the user's body (or rather by moving the outer jacket 4 away from this body), the spring 50 exerts a thrust on the protective element which tends to come out again from the shirts 4 and 28, always keeping in contact with the body of the patient and "rubbing" on it. This thrust also leads to the movement of the pawl 75 and its projections 78 towards the part 41 of each groove 38 going up along the part 40 until they reach the end of the projection 48. Here each projection 78 is guided by the curved side 49 of this projection within the third part 41 of the corresponding groove 38 which also entails the rotation of the pawl with respect to the protective element 60 thanks to the eccentricity of the projections 78 with respect to the axis of the pawl. This rotation takes place on a Z axis orthogonal to the W axis and passing through the parts 72 and 73 of the pawl 75.

The result is a pushing action of the protruding part 80 of the pawl 75 on the cannula 15 which by now has been covered again by the protective element 60. This action deforms the cannula (as shown in Figure 5C) in this element 60.

At the same time, the rotation around the axis W of the inner jacket 28 led to the entry of the fins 67 into the windows 50, making the protective element 60 and said jacket integral. It follows that any attempt to make the protective element 60 return within the jacket 28 and the rigid jacket 4 is prevented and the protective element can now rotate together with the internal revolving jacket 28 around the axis W, preventing any contact with the end 19 of needle 15.

Thanks to the invention, the inner jacket 28 being rotationally movable together with the elastic blocking projections 67 on the protecting element 60, and being axially constrained, the elastic projections cooperate with windows (or block grooves which can be both passing and blind) 50 formed in the wall of the inner jacket 28 in a suitable position, obtaining an axial constraint between said elastic protruding fins and the inner jacket which prevents movement along the W axis of the element 60. Furthermore, the elastic protrusions 67 are suitably shaped (end a "L") to partially interfere also with the outer jacket 4 when they are inside the windows 50 and if they are passing through, by wedging between the inner jacket 28 and the outer jacket 4 so as to increase the safety of the axial constraint when overstressed.

In the event that there is an external force in a direction such as to impose a torque and therefore a rotation of the protective element, attempting for example to deactivate the safety by rotating this element while holding the external jacket 4 still; the protruding elastic flaps or locking flaps 67 come into contact with the side walls of the windows 50 (or lock recesses) and rotate the entire inner jacket.

The inner jacket 28 is not accessible in any way from the outside and therefore cannot be braked (unless, obviously, the outer jacket is considerably deformed). In this way, only the torque necessary to rotate the movable inner jacket 28 with respect to the outer one can be discharged onto the locking tabs 67. This torque can be conveniently reduced to negligible values by using a correct assembly clearance between the internal jacket 28 and the external one 4 and by using materials with a low coefficient of friction (such as, for example, polypropylene, polyoxymethylene and high density polyethylene).

Thanks to the internal jacket free to rotate with respect to the external one, it is possible to adopt an activation path of the pawl 75 which is only rigid, that is, without elastic elements fundamental to activating the safety, and characterized by a low activation force. This rigid path, only thanks to the fact that the internal jacket 28 can rotate with respect to the external one 4, can avoid the rotation of the protector with respect to the patient's skin. This is in fact obtained by shaping the parts 40 and 41 of each groove 38 so that the protector's ascent path is practically straight. In this way the need for axial rotation of the protector in ascent is avoided (as instead occurs in some configurations shown in WO2018220529) avoiding frictions that could interfere with the last, important, phase of activation of the safety mechanism (pawl 75). In this phase, the projections 78 of the pawl 75 come into contact with the end 42 of the third part 41 of the respective slots 38 and being eccentric and no longer able to advance, they produce the transverse rotation which puts the part 80 or deforming member of the pawl 75 with cannula 15 bending it until the protective element advances until it locks against the end 13 of the outer jacket or until the cannula opposes a force sufficient to oppose that generated by the spring 15 through the safety mechanism ( pawl 75).

Finally, there is the possibility of adopting a particular configuration of the safety needle 1 which provides a clear visual indication of the activated state of the safety mechanism defined by the pawl 75. This visual indication can be obtained by suitably coloring the protruding fins 67 of the protective element. 60, adopting block windows 50 passing through the suitably opaque colored inner jacket 28 and adopting a transparent, semi-transparent outer jacket or with transparent portions so as to make the elastic protrusions of the protector visible when they are inside the block windows 50. This according to modes known in themselves.

Alternatively, the protruding fins 67 can be colorless, but have a different surface finish than that of the remaining part of the protective element. This, in cooperation with the (at least partial) transparency of the jacket 2B allows to detect the activated state of the safety mechanism 75.

It is also possible to insert in the rotary path of the inner jacket 4 an elastic element (for example a tooth) suitably shaped to make the path irreversible and sufficiently rigid to generate a sound indication ("click") that the safety device has been activated. .

Finally, the rotatably movable inner jacket which has suitable slots 52 for the insertion of the pawl 75 already assembled with the protector 60 allows to adopt a shape of the shaped hollows 38 closed at their ends, since the insertion of the pawl 75 mounted in the protector 60 takes place axially, guided, by the lower part of the inner jacket 28. This shape is conveniently more rigid (being a cylindrical shape closed at both ends) than the slots provided in the inner jacket described in WO2018220529 (where one of the two ends remains open ) because it strengthens the component and prevents the inner liners from getting stuck in each other during storage in bags or during feeding in an automatic assembly line.

The solution described is simple, it does not provide for further elastic elements within the safety needle for the movement of the pawl 75 (operating as a passive safety deforming member able to avoid any possible contact with the patient tip 19) and which therefore has costs comparable to those of the needles already known. This is also because, as mentioned, the invention does not use further springs or other thrust elements specifically provided (in addition to the spring 55) to rotate the pawl 75 alone, also simplifying the automatic assembly.

Claims (12)

CLAIMS 1. Safety needle (1) adapted to be used with a drug injector pen or with a syringe, said safety needle comprising a cannula holder element (2) to which an external rigid tubular structure (4) is associated inside the which there is an internal tubular jacket (28), said cannula holder element (2) supporting a cannula (15) placed along a longitudinal axis (W) of the external rigid structure (4) and having a first end (16) and a second end (19) for administering the drug, a protector element (60) being movable along the aforementioned longitudinal axis (W) within the inner tubular jacket (28), said protector element covering said end (19) of the cannula (15 ) after administration, a deforming organ (75) associated with said protective element (60) and adapted to deform the cannula (15) after administration of the drug in such a way that the second end (19) of said cannula remains ent said protective element (60), characterized in that the inner tubular jacket (28) is freely rotatable around the aforementioned longitudinal axis (W) and comprises hooking and locking means (50) for protruding members (67) associated with said element protector (60), said protruding members cooperating with said hooking and locking means (50) after administration of the drug, so as to constrain said revolving tubular inner jacket to said protective element. 2. Safety needle according to claim 1, characterized in that said revolving tubular inner jacket (28) rests with a first end (29) on said cannula holder element (2) and has a second end (30) at least close to a face (21) of a flat part (20) of the external rigid tubular structure (4) in such a way that said internal revolving tubular jacket (28) is axially constrained between said cannula holder element (2) and said external rigid tubular structure ( 4). 3. Needle according to claim 1, characterized in that the hooking and locking means are blind recesses or alternatively through recesses made within the body (33) of the revolving inner tubular liner (28), said recesses (50) cooperating with wings protruding laterally from said protective element (60) and defining said protruding members, said cooperation being obtained when the deforming organ (75) has deformed the cannula (15) after administering the drug. 4. Safety needle according to claim 2, characterized in that said body (33) of the inner jacket has an inner wall (28D) in proximity to its second end (30), said inner wall (28D) comprising pockets (51 ) adapted to contain the protruding organs (67) of the protective element (60) before the start of the administration of the drug. 5. Safety needle according to claim 1, characterized in that the protruding members (67) of the protector element (60) are placed in proximity to a first end part (58) of this protector element (60) opposite to a second extremal part (62) of the latter provided with a through hole (63) for the exit of the second end (19) of the cannula from said protective element (60). 6. Safety needle according to claim 1, characterized in that the deforming member (75) comprises a body (76) inserted into a cavity (61A) of the protective element (60), said body having a portion (81 ) adapted to connect disc-shaped side parts (72, 73) of said body (76), said disc-shaped parts (72, 73) being inserted in opposite holes (70, 71) made in the protector element (60) and rotating within said holes (70, 71), said body (76) of the deforming member having a substantially C-shaped cross section. 7. Safety needle according to claim 6, characterized in that said discoidal lateral parts have protruding protruding lugs (78) and inserted into corresponding recesses (38) made within the revolving inner tubular liner (28) in which said protective element ( 60) is inserted movably in contrast to the spring (55), said recesses (38) guiding the rotation of the deforming member (75) in said protective element (60) with the rotation of said internal revolving tubular jacket (28) around said longitudinal axis (W). 8. Safety needle according to claim 7, characterized in that the recesses (38) in which the projections (78) of the deforming member (75) move comprise at least a first part (39) inclined with respect to the longitudinal axis aforementioned (W) and connected without solution of continuity with a second part (40) of recess (38) having a longitudinal axis (K) parallel to the longitudinal axis (W) of the safety needle, a third part being provided (41) of said recess (38) placed on the side of the aforementioned first part (39) and arranged substantially in a rectilinear and continuous manner with respect to the second recess part (40). 9. Safety needle according to claim 8, characterized in that the third part of the recess (41) is closed at one of its ends (42), between the first and the third part (39, 41) of the recess being present a projection (48) adapted to guide the corresponding projection (78) of the deforming member (75) moving within the second part of the recess (40) towards the third part of the recess (42). 10. Safety needle according to claim 1, characterized in that means are present for visually highlighting a use of the needle (1), said means comprising at least one of the following characteristics: - the protruding members (67) of the protective element (60) are colored and the external rigid structure (4) is alternatively completely transparent or partially transparent or semi-transparent, - the protruding members (67) of the protective element (60) are colorless but distinguishable thanks to the different surface finish and the external rigid structure is completely transparent, partially transparent or semi-transparent. 11. Safety needle according to claim 1, characterized in that said protruding members are wings (67) substantially L-shaped protruding laterally from the protective element. 12. Safety needle according to claim 1, characterized in that it comprises an elastic element functionally associated with said internal rotatable tubular liner (28) and adapted to make the movement of the deforming member (75) inside said liner irreversible (28) after the administration of the drug has taken place, said elastic element generating a sound at the end of this movement such as to confirm the cooperation between the protruding members (67) of said protective element (60) and said coupling means and locking (50).