WO2011023147A2

WO2011023147A2 - Locking and intercepting mechanism of the needle for a safety syringe

Info

Publication number: WO2011023147A2
Application number: PCT/CZ2010/000096
Authority: WO
Inventors: Jan Zeman
Original assignee: Kavalirek, Jan
Priority date: 2009-08-28
Filing date: 2010-08-20
Publication date: 2011-03-03
Also published as: WO2011023147A4; CZ302349B6; CZ2009578A3; WO2011023147A3

Abstract

The invention deals with a locking and intercepting mechanism of the needle for a safety syringe containing a barrel and in the barrel containing an inserted connecting foot or hub of the needle adapted for fitting of the connection foot of the needle, where in the connection foot or hub of the needle a cylindrical cavity with conical tapering is created, and the barrel further contains an inserted plunger, fitted at its front with a conical extension with a forward leading cylindrical protrusion and where at the same time in the needle foot or hub adapted for fitting of the connection foot of the needle a transversal slot is created in which a locking plate is inserted that has an oval opening in its centre and with its free ends, which are rounded or chamfered in a roof-like way, overlaps the outer surface of this needle foot or hub while there free ends in the released condition of the inserted locking plate always reach into a recess or groove created in the inner surface of the syringe barrel while on the inner surface of the needle foot or needle hub, at the edge of the conical tapering for the introduction of the conical extension of the plunger there is an intercepting groove or narrowed bottom edge adapted for interaction with the perimeter edge of the base of this conical extension of the plunger while its principle is that the perimeter edge (2141 ) of the base (210) of the conical extension (21 ) of the plunger (2) is adapted for increased flexibility in the radial direction by means of creation of an annular groove (215) on the surface of the base (210) of the conical extension (21 ) of the plunger (2) in the vicinity of the perimeter edge (2141 ) of the base (210) of this conical extension (21 ), and/or by creation of an overlap (214) of the casing (213) over the base (210) of this conical extension (21 ) and/or by creation of radial grooving (2142) in the form of relief slots along the perimeter of the perimeter edge (2141 ) of the base (210) of this conical extension (21 ) of the plunger (2).

Description

Locking and intercepting mechanism of the needle for a safety syringe

Field of the invention

The invention deals with syringes where after use the needle can be retracted into the cavity of the syringe and also locked against further extension while the retraction is enabled through a specific way of seating of the needle in the syringe barrel and at the same time through an adaptation for the connection of the needle with the plunger by means of which the needle is dragged into the syringe cavity. In particular, it is a mechanism for locking the needle in the functional position during drawing of the active substance into the syringe and also during pushing of the active substance out during its application and for subsequent reliable interception of the needle by the plunger for retraction of this needle into the cylinder or barrel of the syringe, namely for the purpose of protected deposition of the needle until safe disposal of the syringe as a whole since such a whole is considered as dangerous waste.

Background of the invention

At present, such syringes are known where the needle is fixed in the barrel of the syringe while after emptying of the syringe content, when the plunger moves towards the needle, the back part of the needle is caught by the front part of the plunger by means of a reverse hook or hooks while then the needle is drawn into the syringe cavity by the return movement of the plunger and at the same time the fixation of the needle in the syringe barrel is released or overcome so the needle can be carried by the plunger into the syringe cavity, where it is safely protected from contact with external objects. This is also the main purpose of the adaptation of the above mentioned type while the primary purpose of the protection is to protect persons from being injured by the otherwise free end of the needle and mainly from possible infection that might occur due to such an injury.

Known embodiments deal with various designs of the needle in the syringe barrel and attachment of the needle to the plunger front by which the needle should be retracted to the cavity in the syringe during the return movement. E.g. the document no. US 5405327 describes seating in the syringe barrel by means of an inserted O-ring, which is simple, but the needle may not always be protected from being unwantedly pushed into the syringe during piercing, which causes deterioration of the whole filled syringe with its content. The document no. CZ PV 1996-3167 describes a similar fixation of the needle in the syringe barrel with the only difference that the supporting ring is created directly on the inner surface of the needle insertion socket, which means that there is an analogous risk of premature pushing of the needle into the syringe in this case. In the embodiment described in the document no. US 5417661 the needle is anchored to the barrel in a similar way. A more reliable fixation of the needle in the syringe barrel is offered by the syringe design in accordance with the CZ PV 1996-3021 document where the needle is fixed in the barrel by means of a lock, in the cited document referred to as a pin, where this lock is deformed by a protrusion on the plunger front during the interception of the needle and is ejected from the groove on the inner side of the syringe barrel by which the needle gets released in the barrel and can be then easily drawn into the plunger cavity. As regards interception of the needle by the plunger, such designs are known when a protrusion is created on the plunger, namely a protrusion with edges based on the principle of reverse hooks cooperating with the edge on the needle. Such designs are, among other things, described in the CZ 1996-3021 , CZ 1996-3167, US 5405327 documents. In these documents, a mushroom-shaped protrusion is used that is pushed with its head, for the connection with the needle, into a cavity in the needle base or the carrier of this needle base. In the embodiment of CZ 1996-3021 the mushroom shape is additionally modified to the shape of a cone fitted with a cylindrical protrusion that is introduced into the corresponding cavity created in the needle base, or here, in the carrier of this base. However, here the problem of introduction of this cylindrical part into the above mentioned cavity must be solved. This introduction, in spite of subsequent seating with a certain play, may pose problems as generally completely exact alignment of the above mentioned cylindrical part with the corresponding cavity in the needle base or in the carrier of this base cannot be guaranteed and to achieve intentional offset of the needle seated subsequently in the syringe cavity, the protrusion and consequently the cylindrical part leading forwards from it is often intentionally shaped in misalignment with regard to the above mentioned cavity. A prior art solution, namely described in the CZ PV 1996-3021 documents designs the ending of the front cylindrical part as symmetrically rounded. It is true that this design will help, in addition in cooperation with the conical tapering leading to the corresponding cavity, introduce the cylindrical ending of the protrusion into the corresponding cavity, but after all, in some cases jamming at the entrance to this cavity or breaking off of the front part of the cylindrical protrusion may occur. This inconvenient situation will then be the more probable the larger the offset angle of the needle after its drawing into the syringe cavity or the corresponding offset angle of the protrusion with the cylindrical part directed forwards will be selected. But for higher protection against repeated extension of the needle in the design of this type the offset angles from the longitudinal axis of the syringe of approx. 15 degrees used most frequently so far have been found to be not quite sufficient. Therefore, larger offset angles tend to be selected, which however increases the risk of breaking off or jamming of the above mentioned forward leading cylindrical part. This shortcoming is solved by means of a modification of the forward leading cylindrical part, namely in the embodiment in accordance with the CZ U 17541 document where at the free end of this cylindrical protrusion there is an askew, preferentially planar - -

chamfering. It allows you to select a larger angle of offset of the cylindrical protrusion from the longitudinal axis of the syringe without increasing the risk of jamming or breaking off of this protrusion. In the last-mentioned design, which also contains as the locking element of the needle or needle hub a locking plate in the syringe barrel, mounted transversally in the slot of the needle hub or the needle foot, in the last stage of pushing of the plunger into the syringe barrel, i.e. at the end of application of the effective substance with the syringe, increased resistance is produced caused by deflection of the above mentioned locking place as well as finally by pushing of the conical protrusion of the plunger into the bottom constricted opening in the needle foot or needle hub. Then, there is a danger that the operator will not push the plunger up to the position where this increased resistance is overcome and when the edge of the above mentioned conical protrusion only fits behind the constricted bottom edge of the cavity in the needle foot or needle hub. In this case the needle cannot be retracted into the syringe barrel and if the operator does not make more attempts to intercept and retract the needle, the syringe will be disposed of with the needle unprotected, which is very dangerous.

Summary of the invention

The purpose of the invention is to design such a combination of reliable locking of the needle foot or needle hub in the syringe barrel with subsequent easier unlocking of the needle in this barrel while at the same time ensuring facilitated penetration of the locking conical protrusion or extension of the plunger into the needle foot or needle hub for reliable interception of the needle by the plunger and subsequent retraction of the needle into the syringe barrel.

The above mentioned disadvantages are solved and the described purpose is achieved, in accordance with the presented invention, with a locking and intercepting mechanism of the needle for a safety syringe containing a barrel and in the barrel containing an inserted connecting foot or hub of the needle adapted for fitting of the connection foot of the needle, where in the connection foot or hub of the needle a cylindrical cavity with conical tapering is created, and the barrel further contains an inserted plunger, fitted at its front with a conical extension with a forward leading cylindrical protrusion and where at the same time in the needle foot or hub adapted for fitting of the connection foot of the needle a transversal slot is created in which a locking plate is inserted that has an oval opening in its centre and with its free ends, which are rounded or chamfered in a roof-like way, overlaps the outer surface of this needle foot or hub while there free ends in the released condition of the inserted locking plate always reach into a recess or groove created in the inner surface of the syringe barrel while on the inner surface of the needle foot or needle hub, at the edge of the conical tapering for the introduction of the conical extension of the plunger there is an intercepting groove or narrowed bottom edge adapted for interaction with the perimeter edge of the base of this conical extension of the plunger and where the principle is that the perimeter edge of the base of the conical extension of the plunger is adapted for increased flexibility in the radial direction by means of creation of an annular groove on the surface of the base of the conical extension of the plunger in the vicinity of the perimeter edge of the base of this conical extension, and/or by creation of an overlap of the casing over the base of this conical extension and/or by creation of radial grooving in the form of relief slots along the perimeter of the perimeter edge of the base of this conical extension. This will reduce the resistance to penetration of the perimeter edge of the conical extension into the opening or conical tapering in the needle foot or hub without significantly affecting the strength of this perimeter edge, which is important for the transfer of forces during the retraction of the needle into the cavity in the syringe barrel. It is convenient if at the same time the locking plate, inserted in the slot of the needle foot or hub, has at the edges of the supporting surfaces, reaching - -

into the recess or groove, created in these places in the inner surface of the syringe barrel, created rounding or chamfering, reaching from this supporting surface to the distance of 5% to 20% of thickness of this locking plate. This modification makes it possible to limit the resistance to bending of the locking plate in the last stage of penetration of the conical extension into the oval opening in this locking plate as in this stage there is maximum jamming of the ends of the locking plate in the groove created in these places in the inner surface of the syringe barrel. At the same time the carrying capacity of these ends of the locking plate is not virtually reduced as its free ends are mainly exposed to shear stress where the area of the section subject to shear stress is not reduced by the above mentioned modification of the ends. Further, it is also convenient if on the free surface of the locking plate facing the conical tapering in the needle foot or hub direct grooves are created in the perpendicular direction to the longitudinal axis of the locking plate, namely always at least one direct groove lying between the adjacent edge of the conical tapering and the edge of the oval opening in this locking plate. The depth and width of these direct grooves is advantageously in the range from 10% to 50% of the thickness of the locking plate. This way, the sections exposed to shear stress from axial forces between the barrel of the syringe and the free ends of the locking plate are not reduced again, but for the purposes of disengagement of these free ends of the locking plate from the inner perimeter groove in the syringe due to bending of this locking plate by the insertion of the conical extension of the plunger certain deflection of these free ends of the locking plate is enabled, and thus this disengagement is also facilitated. Finally, it is also convenient if the conical extension of the plunger is attached to the plunger by means of a cylindrical neck with a diameter corresponding to 10% to 30% of the diameter of the base of this conical extension of the plunger where the ratio of the height of this neck and the diameter of this neck is from 0.8 to 2.0. This measure facilitates deflection of the needle carried by the conical extension of the plunger after the retraction into the cavity in the syringe barrel. As regards the conical extension, it is also convenient if this conical extension of the plunger is offset in the place of fixation to the plunger by means of the cylindrical neck with regard to the longitudinal axis of the cylindrical cavity in the needle foot or to the longitudinal axis of the cylindrical cavity in the hub. This way, the above mentioned deflection of the needle after its retraction into the cavity in the syringe barrel, which is done in a commonly known way, is achieved while in a convenient embodiment the offset of the conical extension of the plunger amounts to 15 to 25 angular degrees. As compared to the most similar known embodiment a rather lower offset is selected, which has proved to be sufficient for the deflection of the needle and at the same time a certain reduction of forces necessary to overcome this offset is achieved during the insertion of this conical extension into the corresponding cavity in the needle foot or hub. On the whole, in combination with the reduction of these forces achieved through other modifications in accordance with this invention this results in easier introduction of the conical extension of the plunger into the corresponding cavity, as mentioned above. The cylindrical protrusion of the conical extension that conveniently has askew chamfering at its free end, executed in a planar way, namely at the angle of 45 to 75 degrees with regard to the plane perpendicular to the longitudinal axis of this cylindrical protrusion. Also, this modification increasing the value of the chamfering angle as compared to the most similar known design, further reduces the danger of jamming or the danger of increased resistance during the insertion of the cylindrical protrusion into the corresponding opening in the needle foot or hub.

Thus, through a combination of more modifications one goal is generally achieved, namely to facilitate the insertion of the conical extension of the plunger into the cavity in the needle foot or hub and to reliably intercept and attach this needle foot or hub to the plunger for the purpose of subsequent retraction of the needle into the cavity of the syringe barrel while - -

maintaining the required reliability of locking the needle foot or hub in the syringe during its active function.

Brief description of the drawings

The presented invention is further described and explained in a more detailed way with the use of a sample embodiment, also with the support of attached drawings, where Fig. 1 shows the detail of the conical extension with the cylindrical protrusion in the position of introduction into the corresponding cavity, namely in an axial section, Fig. 2 presents the ground plan of the entire locking plate of the conical extension of the plunger, Fig. 3 shows the detail of the entire conical extension in a partial longitudinal vertical section, Fig. 4 illustrates the whole assembly of the syringe before application in an axial section and Fig. 5, in an axial section again, shows the whole assembly of the syringe after application and after retraction of the needle into the cavity in the syringe.

Detailed description of the invention

In the sample embodiment the syringe consists of a barrel 1 where a plunger 2 is mounted and in the front part of the syringe barrel 1, here in a narrowed socket H₁ the hub 3 of the foot 4J_. of the needle 4 is inserted. This hub 3 also contains a cylindrical cavity 32 with a conical taper 31.. On the front side of the plunger 2 a conical extension 21 is created that is interconnected with the plunger 2 by means of a neck 211. Further, the front part of the conical extension 2Λ_ is fitted with a cylindrical protrusion 212. This cylindrical protrusion 212 is chamfered at its free end with a planar chamfer 2121 where the chamfering plane 2121 makes the angle of 60 degrees with the plane perpendicular to the longitudinal axis of this cylindrical protrusion 212. The drawings also show the shape of the cylindrical protrusion 212 of the conical extension 21 of the plunger 2 in a design where this cylindrical protrusion 212 has the size corresponding to 10% of the diameter of the base 2JO of the conical extension 2J_. In this embodiment the cylindrical extension 21 of the plunger 2 is attached to this plunger 2 by means of a cylindrical neck 211 with the diameter corresponding to 25% of the diameter of the base 210 of the conical extension 21 of the plunger 2 while at the same time the ratio of the height of this neck 211 and the diameter of this neck 211 has the value of 1.0. Further, the conical extension 21 of the plunger 2 is attached to the plunger 2 via the neck 211 with an offset as considered with regard to the longitudinal axis of the cylindrical cavity 32 in the hub 3. In this sample embodiment the size of this offset of the conical extension 21 of the plunger 2 in the unloaded condition is 20 degrees. From the point of view of the overall design of the seating of the needle 4 in the barrel 1 of the syringe, namely in the presented sample embodiment with the seating of the foot 41 of the needle 4 of the syringe by means of the hub 3 inserted in the barrel 1 of the syringe, the drawings also show a transversal slot 33 created in the hub 3 adapted for mounting of the connection foot 4J_. of the needle 4 while the slot 33 contains an inserted locking plate 34 that has an oval opening 341 in its centre and with its free ends 342. which are chamfered in a roof-like way here, overlaps the outer surface of this hub 3 while these free ends 342 in the released condition of the inserted locking plate 34 always reach into the groove 111 created in the inner surface of the syringe barrel 1, in this particular case a groove 111 produced in the narrowed socket U of the barrel 1 created in the front part of this syringe. The edges of the active bottom surface of the locking plate 34 are rounded at their free ends while the rounding 3420 reaches upwards up to 10% of the thickness of this locking plate 34. Besides, the locking plate 34 also has direct grooves 343 that are perpendicular to the longitudinal axis of the locking plate 34 and are created between the oval opening 341 and the place where in the assembled condition the edge of the top part of the hub 3 of the foot 41 of the needle 4 starts to bear on the top surface of the locking plate 34. '•©• the place where the top free surface of this locking plate 34 ends. As regards the design of the perimeter edge 2141 of the conical extension 21 of the plunger, it is adapted for increased flexibility in the radial direction by creation of an annular groove 2J5 in the surface of the base 210 of the conical extension 2J_ of the plunger 2 near the perimeter edge 2141 of the base 210 of this conical extension 21, by creation of an overlap of the casing 213 over the base 210 of this conical extension 2J_. and at the same time by creation of radial grooving 2142 in the form of relieving slots along the perimeter of the perimeter edge 2141 of the base 2JO of this conical extension 2J_. The syringe or needle 4 is also equipped with a cover or case 5 that protects the needle 4 and/or entrance to the cavity of the barrel 1 of the syringe from damage and contamination in the stage before the use of this syringe. After the use of the syringe this case 5 can be conveniently retracted with its narrower end to the narrowed socket H of the syringe barrel I₁ which will close the space in the barrel 1 of the syringe and the needle 4 will also be secured against possible extension out of the barrel later, which is always undesirable in this stage.

The function of the whole mechanism produced in accordance with the sample embodiment described above is as follows. The needle 4 is applied on the hub 3 and if the syringe is not supplied in the filled condition the liquid for application is suctioned from an ampoule or a liquid sample is drawn by aspiration and the suctioned liquid is applied or the drawn sample is pushed out into a transport ampoule. At the end of the pushing movement the cylindrical protrusion 212 is first introduced into the conical taper 3_1 and then to the cylindrical cavity 32 in the hub 3, where finally the perimeter edge 2141 of the base 210 of the conical extension 2J_. of the plunger 2 gets locked behind the narrowed bottom edge 311 of the conical taper 3_1 of the cylindrical cavity 32 of the hub 3. During the penetration of the conical extension 21 through the conical taper 3_1 the conical extension 2J_. first passes through the oval opening 341 in the locking plate 34, deforming this locking plate 34 subsequently and dragging it into the conical taper 3J. at the same time, which results in the free ends 342 of the locking plate 34 being removed from the grooves Hl in the syringe barrel 1 and the entire hub 3 ceases to be fixed in the barrel 1. Subsequently, the plunger 2 is retracted into the syringe barrel 1 while the hub 3 carrying the attached needle 4 is retracted as well. After retraction of the needle 4 into the cavity of the barrel 1 the needle is deflected from the straight axial direction due to the offset of the extension 2± of the plunger 2. In such an offset it is no longer possible to extend the needle 4 again, which is the main purpose with this type of syringes. Finally the opening on the narrowed socket H is blinded by the reversely applied or retracted case 5.

Important preconditions for achievement of the final goal, i.e. protection of the needle, comprise, at the beginning of the whole process, securing the needle or needle with the hub against being pushed into the cavity in the syringe barrel, which is conveniently ensured with the use of a locking plate with a strong, unweakened structure and unweakened seating, further, reliable releasing of the hub from the syringe barrel before retraction into its cavity, which is conveniently achieved here by unlocking of this locking plate by its dragging into the hub while for reliable guiding during the introduction of the cylindrical extension into the conical taper of the cylindrical cavity of the hub, or mainly to the entire cylindrical cavity, respectively, it is important for this cylindrical protrusion to have such a shape of its end that will facilitate this introduction even with certain misalignment and at the same time will be as resistant as possible to its jamming at the entrance to the cylindrical cavity on the one hand and as resistant as possible to breaking off of the end of the cylindrical protrusion on the other hand. Besides the principal idea of facilitated attachment of the needle to the plunger it is the optimization of the shape of this end of the cylindrical protrusion that contributes to the result that this arrangement conveniently works as a whole with the facilitated attachment of the needle in combination with further technical features that this invention deals with. However, the most important contribution is in the sphere of safety of disposal of used syringes where the facilitation of interception of the needle by the catching mechanism for its retraction into the cavity of the barrel will eliminate cases when after the first unsuccessful attempt to intercept and retract the needle in such a way the syringe is thrown away with the needle extended. This facilitated retraction of the needle is the consequence of the principal technical features of the submitted invention and it supported and improved in adaptations containing further convenient technical features.

Industrial applicability

The mechanism can be used as a safe single-use syringe while it can be applied in all areas where a cheap but reliable structure preventing injury from the syringe needle is required, including protection from repeated extension of the protected needle. Its important contribution is in the sphere of safety of disposal of used syringes where the facilitation of interception of the needle by the catching mechanism for its retraction into the cavity of the barrel will eliminate cases when after the first unsuccessful attempt to intercept and retract the needle in such a way the syringe is thrown away with the needle extended.

Claims

C L A I M S

1. A locking and intercepting mechanism of the needle for a safety syringe containing a barrel and in the barrel containing an inserted connecting foot or hub of the needle adapted for fitting of the connection foot of the needle, where in the connection foot or hub of the needle a cylindrical cavity with conical tapering is created, and the barrel further contains an inserted plunger, fitted at its front with a conical extension with a forward leading cylindrical protrusion and where at the same time in the needle foot or hub adapted for fitting of the connection foot of the needle a transversal slot is created in which a locking plate is inserted that has an oval opening in its centre and with its free ends, which are rounded or chamfered in a roof- like way, overlaps the outer surface of this needle foot or hub while there free ends in the released condition of the inserted locking plate always reach into a recess or groove created in the inner surface of the syringe barrel while on the inner surface of the needle foot or needle hub, at the edge of the conical tapering for the introduction of the conical extension of the plunger there is an intercepting groove or narrowed bottom edge adapted for interaction with the perimeter edge of the base of this conical extension of the plunger, c h a r a c t e r i z e d i n that the perimeter edge (2141 ) of the base (210) of the conical extension (21 ) of the plunger (2) is adapted for increased flexibility in the radial direction by means of creation of an annular groove (215) on the surface of the base (210) of the conical extension (21 ) of the plunger (2) in the vicinity of the perimeter edge (2141) of the base (210) of this conical extension (21), and/or by creation of an overlap (214) of the casing (213) over the base (210) of this conical extension (21) and/or by creation of radial grooving (2142) in the form of relief slots along the perimeter of the perimeter edge (2141 ) of the base (210) of this conical extension (21 ) of the plunger (2). - -

2. The locking and intercepting mechanism according to claim 1, characterized in that the locking plate (34), inserted in the transversal slot (33) of the foot (41 ) of the needle (4) or of the hub (3), has at its free ends (342) at the edges of the supporting surfaces, reaching into the recess or groove (111), created in these places in the inner surface of the syringe barrel (1), created rounding or chamfering, reaching from this supporting surface to the distance of 5% to 20% of the thickness of this locking plate (34).

3. The locking and intercepting mechanism according to claim 1 or 2, characterized in that on the free surface of the locking plate (34) facing the conical tapering (31 ) in the foot (41 ) or hub (3) of the needle (4) direct grooves (343) are created in the perpendicular direction to the longitudinal axis of the locking plate (34), namely always at least one direct groove (343) lying between the adjacent edge of the conical tapering (31) and the edge of the oval opening (341) in this locking plate (34).

4. The locking and intercepting mechanism according to claim 3, characterized in that the depth and width of these direct grooves (343) is in the range from 10% to 50% of the thickness of the locking plate (34).

5. The locking and intercepting mechanism according to any of claims 1 to 4, characterized in that the conical extension (21 ) of the plunger (2) is attached to the plunger (2) by means of a cylindrical neck (211) with a diameter corresponding to 10% to 30% of the diameter of the base (210) of this conical extension (21) of the plunger (2) where the ratio of the height of this neck (211) and the diameter of this neck (211) is from 0.8 to 2.0.

6. The locking and intercepting mechanism according to claim 5, characterized in that the conical extension (21 ) of the plunger (2) is offset in the place of fixation to the plunger (2) by means of the cylindrical neck (211) with regard to the longitudinal axis of the cylindrical cavity (32) in the foot (41 ) of the needle (4) or to the longitudinal axis of the cylindrical cavity (32) in the hub (3).

7. The locking and intercepting mechanism according to claim 6, c h a r a ct e ri z e d i n that the size of the offset of the conical extension (21 ) of the plunger (2) is from 15 to 25 degrees.

8. The locking and intercepting mechanism according to any of claims 1 to 7, characterized in that the cylindrical protrusion (212) of the conical extension (21) has askew chamfering (2121) at its free end, executed in a planar way, namely at the angle of 45 to 75 degrees with regard to the plane perpendicular to the longitudinal axis of this cylindrical protrusion (212).