Safety device for prefilled syringes, comprising an anti-triggering mechanism

Abstract

Disclosed is a method for assembling a safety device and mounting the safety device on a syringe member before the syringe member is filled, said method comprising the steps of: providing a sleeve, a spring element and a mounting element; introducing the spring element into the sleeve along a mounting direction; introducing the mounting element into the sleeve along the mounting direction; obtaining the safety device; before the syringe body is filled, mounting the safety device on the syringe body by connecting the mounting element to the syringe body.

Claims

1. A method for mounting a safety device on a syringe body before the syringe body is filled, comprising the steps of: a. assembling a safety device comprising a sleeve, a spring element and a mounting element, wherein assembling the safety device comprises the steps of: i. providing the sleeve, the spring element and the mounting element, ii. inserting the spring element into the interior of the sleeve along a mounting direction, and iii. inserting the mounting element into the interior of the sleeve along the mounting direction, thereby assembling the safety device, b. mounting the safety device on the syringe body before the syringe body is filled by connecting the mounting element to the syringe body, and c. mounting the syringe body together with the safety device mounted thereon in a syringe nest for subsequent filling of the syringe body, wherein at least one guide pin is arranged on the mounting element, and the sleeve comprises at least one recess, which forms a guide track for guiding the guide pin, and at least one slanting portion at a proximal end, which constitutes a depression in an inner wall of the sleeve and is complementary to the at least one guide pin, and wherein in step iii., the mounting element is connected to the sleeve by means of the at least one guide pin, the guide pin being guided by the slanting portion and by the guide track, wherein the safety device is first assembled and then mounted on the syringe body in a single step as a unit.

2. The method according to claim 1, wherein the mounting element is connected to the syringe body by the mounting element being placed on the syringe body.

3. The method according to claim 2, wherein the mounting element is clipped onto the syringe body.

4. The method according to claim 1, further comprising an assembly comprising a cap and a needle guard.

5. The method according to claim 4, wherein the assembly is connected to the sleeve by pushing the cap onto the sleeve counter to the mounting direction.

6. The method according to claim 1, wherein the syringe body together with the safety device mounted thereon are sterilised.

7. The method according to claim 1, wherein the syringe nest is mounted in a trough.

Description

(1) Additional aims, advantages and expediencies of the present invention can be found in the following description in conjunction with the drawings, in which:

(2) FIG. 1 shows a detail of the syringe body;

(3) FIG. 2A is a perspective view of the sleeve from the front;

(4) FIG. 2B is a perspective view of the sleeve from behind;

(5) FIG. 2C is a perspective view of the cap;

(6) FIG. 2D shows the cap being mounted onto the sleeve;

(7) FIG. 3A is a perspective view of the mounting element from above;

(8) FIG. 3B is a perspective view of the mounting element from below;

(9) FIG. 4 is a longitudinal section of a syringe body comprising the safety device mounted thereon;

(10) FIG. 5 shows a syringe nest;

(11) FIG. 6 shows syringes mounted in a syringe nest, comprising a syringe body and a safety device; and

(12) FIG. 7 is a flow diagram showing the individual method steps according to one embodiment.

(13) FIG. 1 shows a possible syringe body 1 that forms the basis of the invention. Commercially available syringe bodies 1 are substantially cylindrical, as is the syringe body 1 in the present case, and have a predetermined or predeterminable diameter 13. In this case, the syringe body 1 also comprises a narrower region 15 at its distal end 14, which is also substantially cylindrical. In this case, however, the narrower region 15 is in the shape of a truncated cone, the truncated-cone-shaped narrower region 15 having a diameter 16 at the cover surface (not shown here), i.e. the distal end 17 of the narrower region 15, the diameter 16 of the narrower region 15 being smaller than the diameter 13 of the syringe body 1.

(14) Furthermore, in this case a needle holder 18 having a piercing element 19, a needle 19 in this case, is arranged at the distal end 17 of the narrower region 15, said needle holder 18 having a diameter 20 that is greater than the diameter 16 of the narrower region 15 but smaller than the diameter 13 of the syringe body 1. Furthermore, the needle holder 18 is arranged at the distal end 17 of the narrower region 15 such that a transition region 21 is formed, the transition region 21 forming a region in which the diameter 16 of the narrower region 15 and the diameter 20 of the needle holder meet one another and the diameter is thus intrinsically dramatically changed. The transition region 21 thus forms a type of projection.

(15) FIG. 2A is a perspective view of a first important component of the safety device 2, specifically the sleeve 22. As can be seen clearly from FIG. 2A, the sleeve comprises a recess 24, which forms the guide track 23 for guiding the guide pin 7 (not shown in this case). In addition, the sleeve 22 can comprise a recessed region 25, which is delimited by an edge 26. A mirror-image recess 24 is advantageously arranged opposite the recess 24 in the sleeve 22 and a mirror-image recessed region 25 is advantageously arranged opposite the recessed region 25 on said sleeve.

(16) In this case, the recessed region 25 allows a cap 9 (see FIG. 2C) to be attached in a guided manner in order to increase the safety of the safety device 2. The cap 9 is at least in operative contact with and preferably at least non-positively connected to the sleeve 22 by means of the edge 26 of the recessed region 25.

(17) Furthermore, the sleeve 22 comprises an annulus 28 and an annular region 29 at its distal end 27, which is arranged so as to surround the annulus 28 when viewed in the radial direction. The cap 9 is placed on the annulus 28 such that, in addition to being non-positively connected to the recessed region 25, the cap 9 is additionally non-positively connected to the sleeve 22.

(18) FIG. 2B once again shows the sleeve 22, but from a different perspective to that in FIG. 2A. FIG. 2B shows in particular the proximal end 31 of the sleeve 22, which comprises at least one slanting portion 32. The number of slanting portions 32 is preferably equal to the number of guide pins 7, and said portions are formed on the sleeve 22 so as to be complementary to the guide pins 7.

(19) The slanting portions 32 constitute a guide for the guide pins 7 when the safety device 2 is assembled, the slanting portions constituting a depression in the inner wall 34 of the sleeve so that the wall thickness 35 of the sleeve 22 has been reduced by the magnitude 36 of the depression 32, making it easier to introduce the mounting element 5, in particular to introduce the guide pin 7, into the sleeve 22.

(20) FIG. 2C shows a cap 9, on which a needle guard 10 is likewise arranged. In this case, the cap 9 comprises a first wing element 39 and a second wing element 40, which are designed to be complementary to the recessed regions 25. In this case, the external diameter (not shown here) of the needle guard 10 is smaller than the internal diameter 41 of the exit opening 30 or of the sleeve 22, thus ensuring that the needle guard 10 can be inserted into the sleeve 22.

(21) In the present case, FIG. 2D shows how the cap 9 and the needle guard 10 are pushed onto the sleeve 22 counter to the mounting direction 6, which extends from the proximal end 31 of the sleeve to the distal end 27 along a longitudinal direction of the sleeve 22. Following mounting, an annular region 42 of the cap 9 is preferably in contact with the annulus 28. However, it is also conceivable for the annular region 42 to be in contact with the annular region 29.

(22) FIGS. 3A and 3B show the mounting element 5, by means of which the sleeve 2 and therefore the safety device 2 can be connected to the syringe body 1 as a whole, FIG. 3A being a perspective view from above of the mounting element 5 and FIG. 3B being a perspective view from below of the mounting element 5.

(23) The mounting element 5 is substantially cylindrical in this case, having an external diameter 43 and an internal diameter 44. Reference numeral 45 denotes the distal end of the mounting element 5.

(24) In this case, two guide pins 7 are arranged on a lateral face 46 of the mounting element 5, which lie on opposite sides of the mounting element 5. Said guide pins 7 can then be arranged in the guide track 23 of the sleeve and be operatively connected thereto.

(25) In addition, the mounting element 5 comprises one or more, in this case two, cut-outs 47 and one or more, in this case three, latching elements 48, the function of which is outlined below with reference to FIG. 3B.

(26) In FIG. 3B, reference numeral 49 denotes a proximal end 49 of the mounting element 5. As can be seen, the latching elements 48 of the mounting element 5 extend so as to increase in size from the proximal end 49 towards the distal end 45, i.e. the latching elements 48 are larger at the distal end 45 than at the proximal end 49 when viewed in the radial direction.

(27) If, when joining the mounting element 5 and the syringe body 1, in particular the narrower region 15 thereof, the mounting element 5 is first pushed onto the needle holder 18 by its proximal end 49, a first half 50 and a second half 51 of the mounting element 5, which are separated by the cut-outs 47, are moved away from one another as a result of the difference in thickness in the radial direction that increases in the axial direction. It is therefore necessary here for the mounting element 5 to be at least partially resilient.

(28) If the distal end 45 of the mounting element 5 passes the transition region 21, the first 50 and the second 51 halves move towards one another as a result of the resilient design, so that the mounting element 5 and therefore the safety device 2 are ultimately clipped onto the syringe body 1.

(29) In order to secure this clip connection, the latching elements 48 comprise securing portions 52 at their distal end 45, which portions extend in the circumferential direction of an inner circle 53 of the mounting element 5 and are mechanically operatively connected to the transition region 21.

(30) The safety device 2 comprising the sleeve 2, the mounting element 5, the spring element 4 and optionally the cap 9 can particularly preferably be mounted in advance and can be connected to the syringe body 1 as a whole by means of the mounting element 5.

(31) FIG. 4 is a longitudinal section of a syringe body 1 comprising a safety device 2 mounted thereon.

(32) In addition to the cap 9, the sleeve 22 and the mounting element 5, the safety device 2 now also features the spring element 4, which is formed as a spiral spring 4 in this case.

(33) As can clearly be seen, the guide pins 7 are in contact with the recess 24 or the guide track 23, so that the guide pins 7 are guided by the guide track 23 when the syringe body 1 is moved relative to the safety device 2.

(34) The mounting element 5 is clipped together with the narrower region 15 by means of the latching elements 48 and the securing portions 52 thereof, and is connected to the sleeve 22 by means of the guide pins 7.

(35) The sleeve 22 also comprises an internal bearing region 54 at its distal end 27, which can be operatively connected to the spring element 4. The spring element 4 is therefore held in the sleeve 22 by the bearing region 54 on one side and by the mounting element 5 on the other side, and is therefore secured against falling out.

(36) The safety device 2 is dimensioned such that the sleeve 22 has an internal diameter 55 that is greater than the diameter 13 of the syringe body 1, and therefore the syringe body 1 can be moved into the sleeve 22 when it is moved forwards in the longitudinal direction L, the movement direction being shown by an arrow L, relative to the safety device 2. At the same time, the external diameter 56 of the sleeve 22 or of the safety device 2 is selected so as to correspond to no greater than a maximum diameter 57 of a retaining apparatus 58, attached to the proximal end 59 of the syringe body 1, for retaining and securely positioning the syringe. The purpose of this size restriction is explained in more detail with reference to FIGS. 5 and 6.

(37) FIG. 5 shows a syringe nest, as already known in the art, comprising a base plate 60, on which there are arranged hollow cylinders 61, i.e. in particular openings 61, in which the syringes can be mounted. In this case, the base plate 60 is used to fasten the syringe nest in a trough 12 (not shown in this case).

(38) For this purpose, FIG. 6 shows a detail of a longitudinal section of a syringe nest 11 comprising syringes mounted therein, the syringes comprising a syringe body 1 and a safety device 2. In this case, the syringe body 1 has been mounted in the syringe nest together with the safety device 2. In order to be able to mount a syringe in the syringe nest 11, the diameter 57 of the retaining apparatus 58 is selected to be greater than the diameter 62 of an opening 61. In order to be able to mount the syringe body 1 together with the safety device 2 in an opening 61, the external diameter 56 of the sleeve 22 and the external diameter 56 of the safety device 2 therefore have to be selected to be smaller than the diameter 57 of the retaining apparatus 58. It is therefore possible to already mount the syringe in the syringe nest together with the safety device 2, and to sterilise and fill it therein.

(39) The syringe nest 11 comprising the syringe body 1, the syringe nest 11 being mounted in the trough 12, can then be sealed and/or closed by means of a cover, in particular a film and/or a membrane. The film is, for example, made of plastics material and the membrane is a Tyvek film. Once the trough 12 has been sealed and/or closed, the arrangement in the present case is sterilised.

(40) FIG. 7 depicts a method sequence according to a particularly preferred embodiment.

(41) In a first step, step S.1, the respective elements, the sleeve 3, the spring element 4, the mounting element 5 and the assembly 8 comprising the cap 9 and the needle guard 10 are provided. These elements are preferably prefabricated components, which are mass-produced.

(42) In step S.2, the spring element 4 is inserted into the interior of the sleeve 3 and is secured against falling out by the mounting element 5 being inserted into the interior of the sleeve 3 in step S.3.

(43) In a subsequent step, step S.4, onto the sleeve 3 an assembly 8, in particular the cap 9, is pushed onto the sleeve 3 so that the safety device 2 is mounted in advance and obtained in step S.5.

(44) The safety device 2 obtained is mounted on the syringe body 1 in a single step in step S.6 by the safety device 2 being pushed onto the distal end of the syringe body 1 and the mounting element 5 therefore being connected to the syringe body 1.

(45) Once the safety device 2 has been mounted on the syringe body 1, the entire arrangement can be mounted in a syringe nest 11 and a trough 12 in step S.7, and in step S.8 the trough 12 can be sealed, for example by means of a protective film and/or a membrane, preferably a Tyvek film.

(46) In a subsequent step, step S.9, the arrangement consisting of the syringe body 1 comprising the safety device 2 and the trough 12 comprising the syringe nest 11 is sterilised, preferably under cleanroom conditions.

(47) In a final step, step S.10, the film is preferably removed again so that the syringe body 1 can be filled. In a subsequent step (not shown), the syringe bodies 1 that have been filled are provided with stoppers or the like and thus sealed and then placed in commercially available packaging.

(48) All of the features disclosed in the application documents are claimed to be essential to the invention provided that they are novel over the prior art, either on their own or in combination with one another.

LIST OF REFERENCE NUMERALS

(49) 1 syringe body 2 safety device 3 sleeve 4 spring element 5 mounting element 6 mounting direction 7 guide pin 8 assembly 9 cap 10 needle guard 11 syringe nest 12 trough 13 diameter of the syringe body 14 distal end of the syringe body 15 narrower region 16 diameter of the narrower region 17 distal end of the narrower region 18 needle holder 19 piercing element 20 diameter of the needle holder 21 transition region 22 sleeve 23 guide track 24 recess 25 recessed region 26 edge 27 distal end of the sleeve 28 annulus 29 annular region 30 exit opening 31 proximal end of the sleeve 32 slanting portion 33 transition 34 inner wall of the sleeve 35 wall thickness 36 magnitude of the depression 37 distal end of the cap 38 proximal end of the cap 39 first wing element 40 second wing element 41 internal diameter 42 circular edge 43 external diameter of the mounting element 44 internal diameter of the mounting element 45 distal end of the mounting element 46 lateral face 47 cut-out 48 latching element 49 proximal end of the mounting element 50 first half 51 second half 52 securing portion 53 inner circle 54 bearing region 55 internal diameter of the sleeve 56 external diameter of the sleeve 57 maximum diameter 58 retaining apparatus 59 proximal end of the syringe body 60 base plate 61 opening 62 diameter of the opening