Piercing Means Protective Device for a Syringe

Abstract

The invention relates to a piercing means protective device for a syringe having a syringe body and a piercing means arranged at the distal end of the syringe body, comprising a dimensionally stable sleeve element, which extends along an axial direction and at least partially encloses an inner element extending along an axial direction, wherein the inner element consists of a resilient material and at least partially encloses the piercing means. The piercing means protective device is characterised in that a connection element connected to the sleeve element has at least one projection extending in an axial direction, which projection is received at least in portions in a recess of the inner element, so that a connection with a force fit and/or an interlocking fit exists between the sleeve element and the inner element.

Claims

1. A piercing means protective device for a syringe comprising a syringe body and a piercing means arranged at the distal end of the syringe body, comprising a dimensionally stable sleeve element, which extends along an axial direction and at least partially encloses an inner element extending along an axial direction, wherein the inner element consists of a resilient material and at least partially encloses the piercing means, wherein a connection element connected to the sleeve element has at least one projection extending in an axial direction, which projection is received at least in portions in a recess of the inner element, so that a connection exists with a force fit and/or an interlocking fit between the sleeve element and the inner element, wherein the projection is arranged centrally on the connection element with respect to a central axis of the sleeve element.

2. The piercing means protective device according to claim 1, wherein the sleeve element is formed substantially as a circular hollow cylinder and has a distal and a proximal end, wherein the connection element is arranged at the distal end of the sleeve element, wherein the connection between the sleeve element and the connection element is a connection with an interlocking fit and/or a material-uniting connection.

3. The piercing means protective device according to claim 1, wherein the inner element has at its distal end a flange element extending in a radial direction, where said element is received in a receiving means of the sleeve element, wherein the receiving means is arranged on the distal end of the sleeve element and has a first wall which extends in an axial direction starting from the distal end of the sleeve element, and a second wall which extends substantially in a radial direction.

4. The piercing means protective device according to claim 1, wherein the connection element has a circular base element on which the projection is arranged, wherein the circular base element has a radial outer surface which is connected to the sleeve element.

5. The piercing means protective device according to claim 1, wherein the recess is arranged centrally with respect to a central axis of the inner element, wherein due to the respective central arrangement and the connection between the connection element and the inner element, the inner element is be centred with respect to the sleeve element.

6. The piercing means protective device according to claim 3, wherein the projection of the connection element is formed conically, wherein an outer diameter of a first region of the projection is greater than an inner diameter of the recess of the inner element, wherein the inner element is resiliently deformed when the projection is received in the recess of the inner element, wherein the flange element of the inner element is pressed by this deformation in a radial direction onto the receiving means.

7. The piercing means protective device according to claim 4, wherein arranged on the base element of the connection element is at least one axial tolerance-compensation element, which extends in an axial direction towards the inner element and contacts the inner element.

8. The piercing means protective device according to claim 7, wherein arranged on the base element of the connection element are at least two axial tolerance-compensation elements, which are configured as cone-shaped projections, wherein the at least two axial tolerance-compensation elements are arranged in a circular manner around the projection.

9. The piercing means protective device according to claim 7, wherein the axial tolerance-compensation element is configured as an annular element surrounding the projection, wherein the annular element tapers in an axial direction towards the inner element.

10. The piercing means protective device according to claim 1, wherein the projection comprises an outer surface on which ribs running in an axial direction are arranged.

11. A prefilled syringe equipped with a piercing means protective device according to claim 1.

12. The piercing means protective device according to claim 2, wherein the inner element has at its distal end a flange element extending in a radial direction, where said element is received in a receiving means of the sleeve element, wherein the receiving means is arranged on the distal end of the sleeve element and has a first wall which extends in an axial direction starting from the distal end of the sleeve element, and a second wall which extends substantially in a radial direction.

13. The piercing means protective device according to claim 4, wherein the projection of the connection element is formed conically, wherein an outer diameter of a first region of the projection is greater than an inner diameter of the recess of the inner element, wherein the inner element is resiliently deformed when the projection is received in the recess of the inner element, wherein the flange element of the inner element is pressed by this deformation in a radial direction onto the receiving means.

14. The piercing means protective device according to claim 5, wherein the projection of the connection element is formed conically, wherein an outer diameter of a first region of the projection is greater than an inner diameter of the recess of the inner element, wherein the inner element is resiliently deformed when the projection is received in the recess of the inner element, wherein the flange element of the inner element is pressed by this deformation in a radial direction onto the receiving means.

15. The piercing means protective device according to claim 5, wherein arranged on the base element of the connection element is at least one axial tolerance-compensation element, which extends in an axial direction towards the inner element and contacts the inner element.

16. The piercing means protective device according to claim 6, wherein arranged on the base element of the connection element is at least one axial tolerance-compensation element, which extends in an axial direction towards the inner element and contacts the inner element.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0029] FIG. 1 is a sectional view of a piercing means protective device;

[0030] FIG. 2 is a perspective view of a connection element;

[0031] FIG. 3 is a sectional view of the connection element from FIG. 2;

[0032] FIG. 4 is a perspective view of another connection element;

[0033] FIG. 5 is a perspective view of the inner element;

[0034] FIG. 6 is a sectional view of the inner element;

[0035] FIG. 7 is a sectional view of the sleeve element;

[0036] FIG. 8 is a perspective view of the sleeve element;

[0037] FIG. 9 is another perspective view of the sleeve element;

[0038] FIG. 10 is a side view of a syringe.

DETAILED DESCRIPTION OF THE INVENTION

[0039] FIG. 1 shows a piercing means protective device (1) for a syringe (2) having a syringe body (3) and a piercing means (5) arranged at the distal end (4) of the syringe body (3), comprising a dimensionally stable sleeve element (6), which extends along an axial direction (X) and at least partially encloses an inner element (7) extending along an axial direction (X), wherein the inner element (7) consists of a resilient material and at least partially encloses the piercing means (3), wherein a connection element (8) connected to the sleeve element (6) has at least one projection (9) extending in an axial direction (X), which projection is received at least in portions in a recess (10) of the inner element (7), so that a connection with a force fit and/or an interlocking fit exists between the sleeve element (6) and the inner element (7).

[0040] A typical syringe which can be provided with a piercing means protective device is shown in FIG. 10. The syringe (2) comprises a syringe body (3) configured as a hollow circular cylinder. The syringe body has a distal end region (3b) with a distal end (4). Arranged at the distal end (4) is a piercing means (5). This piercing means (5) is connected via a bore in the distal end region (3b) to the cavity of the syringe body (3), so that the medium to be injected during application of the syringe (2) can emerge from the cavity through the piercing means (5). The distal end region (3b) is configured as a conical end piece which has a smaller outer diameter than the syringe body (3). The syringe also has a transition region in which the outer diameter of the syringe body (3) merges into the outer diameter of the end piece.

[0041] The sleeve element (6) is formed as a circular hollow cylinder and has a distal (11) and a proximal (12) end. This can be seen in FIGS. 1, 7, 8 and 9. FIG. 1 is a sectional view of the piercing means protective device (1) with the sleeve element (6), the inner element (7) and the connection element (8). In FIG. 7, only the sleeve element (6) is shown in a sectional view. In FIG. 8, the sleeve element (6) is shown in a perspective view, with the distal end (11) of the sleeve element (6) being particularly visible. In FIG. 9, the sleeve element (6) is shown in another perspective view, the proximal end (12) of the sleeve element (6) being particularly visible. The proximal end (16) of the inner element (7) can also be seen.

[0042] The inner element (7) is shown in a sectional view in FIGS. 1 and 6. In FIG. 5, the inner element (7) is shown in perspective. The inner element (7) is configured as a circular cylinder and at its distal end (15) has a cylindrical recess or a blind hole (10). At its proximal end (16), the inner element (7) also has another recess (28) in which the piercing means (5) of the syringe (3) can be arranged.

[0043] The other recess (28) has a first portion (29) having a constant inner diameter (29a) in which a distal end piece (3a) of the syringe body (3) can be received. The other recess (28) further has a second portion (30) having an inner diameter (30a) which decreases in an axial direction (X). As a result of the distal end piece (3a) of the syringe body (3) being received in the inner element (7), the piercing means (5) can be closed off in a sterile manner.

[0044] At its distal end (15), the inner element (7) also has a flange element (17) extending in a radial direction (R). The flange element (17) is arranged circumferentially on the outer surface (7a) of the inner element (7) and comprises an outer surface (17a) extending in an axial direction (X) and a contact surface (17b) extending in a radial direction (R).

[0045] The inner element (7) or the flange element (17) thereof is received in a receiving means (18) of the sleeve element (6). The receiving means (18) is cylindrical and formed integrally with the sleeve element (6). The receiving means (18) is arranged at the distal end (11) of the sleeve element (6) and comprises both a first wall (19), which extends in an axial direction (X) starting from the distal end (11) of the sleeve element (6), and a second wall (20), which extends substantially inwards in a radial direction (R) to a central axis (M.sub.IE) of the inner element (7). The contact surface (17b) of the inner element (7) rests on the second wall (20). Furthermore, the second wall (20) extends, starting from the first wall (18), inwards towards the central axis (M.sub.IE) with a gradient in the distal direction (X.sub.1).

[0046] The connection element (8) is also shown in FIG. 1 and is arranged at the distal end (11) of the sleeve element (6) and is connected thereto. This connection may be a connection with a force fit and/or an interlocking fit and/or a material-uniting connection. Furthermore, the connection element (8) is connected with a force fit and/or an interlocking fit to the inner element (7). FIGS. 2 and 4 show a connection element (8) according to a first embodiment and FIG. 4 shows a connection element (8) according to another embodiment.

[0047] The connection element (8) comprises a circular base element (13) having a central axis (M.sub.V). The projection (9) is arranged centrally with regard to the central axis (M.sub.V) on the base element (13). The circular base element (13) further has a radial outer surface (14) connected to the sleeve element (6). In particular, a projection (14a) is formed in the radial outer surface (14) and is received in a groove (6a) of the sleeve element. A clip-on connection is thereby achieved between the sleeve element (6) and the connection element (8).

[0048] The projection (9) of the connection element (8) is formed conically. An outer diameter (21a) of a first region (21) of the projection (9) is therefore greater than an inner diameter (22) of the recess (10) of the inner element (7). Furthermore, an outer diameter (23a) of a second region (23) of the projection (9) is smaller than an inner diameter (22) of the recess (10). The projection is further formed as a conical hollow cylinder which is closed off at its distal end by the base element (13).

[0049] The inner element (7) is resiliently deformed when the projection (9) is received in the recess (10) of the inner element (7). Due to such an interference fit, a resilient force acts between the inner element (7) and the connection element (8) or the sleeve element (6). Due to this deformation, the flange element (17) of the inner element (7) is further pressed in a radial direction (R) onto the receiving means (18). In particular, the outer surface (7a) of the inner element (7) is pressed against the first wall (19) of the receiving means (18). Another connection with a force fit is thus created between the inner element (7) and the sleeve element (6).

[0050] A front face (20a) of the second wall (20) is also pressed against a portion (7b) of the inner element (7), which portion lies in a proximal direction (X.sub.2) below the flange element (17). On the one hand, another connection with a force fit between the inner element (7) and the sleeve element or the second wall (20) is achieved by this. On the other hand, the flange element is deformed by the conical shape of the projection (9) and the gradient of the second wall (20) in such a way that it approaches or adjoins the second wall. The contact surface (17b) of the flange element (17) thus runs following the deformation in a radial direction outwards with a gradient in a proximal direction. In other words, the receiving means (18) and the inner element interlock in an axial direction (X). A particularly strong connection is therefore created between the inner element (7) and the sleeve element.

[0051] The projection (9) on the connection element (8) is arranged centrally with regard to a central axis (M.sub.H) of the sleeve element (6). The recess (10) is arranged centrally with regard to a central axis (M.sub.IE) of the inner element (7). Due to the respective central arrangement and the connection between the connection element (8) and the inner element (7), the inner element (7) can be centred with regard to the sleeve element (6).

[0052] The connection element (8) further has at least one axial tolerance-compensation element (24) on the base element (13) of the connection element (8). According to the embodiment shown in FIGS. 2 and 3, six axial tolerance-compensation elements (24) are arranged on the circular base element (13). These tolerance-compensation elements (24) are arranged in a circular manner around the projection (9) and the central axis (M.sub.V). Furthermore, these tolerance-compensation elements (24) are configured as cone-shaped projections (25) or mandrels which extend in a proximal direction (X.sub.2) towards the inner element (7) and contact and deform the inner element (7) or even penetrate it.

[0053] According to another embodiment, the axial tolerance-compensation element (24) is configured as an annular element (26) surrounding the projection (9), wherein the annular element (26) tapers in an axial direction (X) towards the inner element (7) and in a proximal direction (X.sub.2). The annular element (26) thus has a broad base area (26a) which is arranged on the circular base element (13). In addition, the annular element (26) has a narrow edge (26b) which lies centrally above the base area (26a) and deforms/compresses or penetrates the inner element (7).

[0054] In the embodiment according to FIG. 4, the projection (9) comprises an outer surface (9a) on which ribs are arranged. The ribs (27) run in an axial direction (X) and extend outwards in a radial direction (R). These ribs (27) can deform/compress or penetrate the resilient material of the inner element (7). A more stable connection can thus be achieved between the inner element (7) and the connection element (8).

[0055] All the features disclosed in the application documents are claimed as essential to the invention if they are novel individually or in combination compared with the prior art.

[0056] Having now fully described the present invention in some detail by way of illustration and examples for purposes of clarity of understanding, it will be obvious to one of ordinary skill in the art that the same can be performed by modifying or changing the invention within a wide and equivalent range of conditions, formulations and other parameters without affecting the scope of the invention or any specific embodiment thereof, and that such modifications or changes are intended to be encompassed within the scope of the appended claims.

[0057] When a group of materials, compositions, components or compounds is disclosed herein, it is understood that all individual members of those groups and all subgroups thereof are disclosed separately. Every formulation or combination of components described or exemplified herein can be used to practice the invention, unless otherwise stated. Whenever a range is given in the specification, for example, a composition range, all intermediate ranges and subranges, as well as all individual values included in the ranges given are intended to be included in the disclosure. Additionally, the end points in a given range are to be included within the range. In the disclosure and the claims, “and/or” means additionally or alternatively. Moreover, any use of a term in the singular also encompasses plural forms.

[0058] As used herein, “comprising” is synonymous with “including,” “containing,” or “characterized by,” and is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. As used herein, “consisting of” excludes any element, step, or ingredient not specified in the claim element. As used herein, “consisting essentially of” does not exclude materials or steps that do not materially affect the basic and novel characteristics of the claim. Any recitation herein of the term “comprising”, particularly in a description of components of a composition or in a description of elements of a device, is understood to encompass those compositions and methods consisting essentially of and consisting of the recited components or elements.

[0059] One of ordinary skill in the art will appreciate that starting materials, device elements, analytical methods, mixtures and combinations of components other than those specifically exemplified can be employed in the practice of the invention without resort to undue experimentation. All art-known functional equivalents, of any such materials and methods are intended to be included in this invention. The terms and expressions which have been employed are used as terms of description and not of limitation, and there is no intention that in the use of such terms and expressions of excluding any equivalents of the features shown and described or portions thereof, but it is recognized that various modifications are possible within the scope of the invention claimed. The invention illustratively described herein suitably may be practiced in the absence of any element or elements, limitation or limitations which is not specifically disclosed herein. Headings are used herein for convenience only.

LIST OF REFERENCE SIGNS

[0060] 1 Device [0061] 2 Syringe [0062] 3 Syringe body [0063] 3a Distal end piece of the syringe body [0064] 3b Distal end region of the syringe body [0065] 4 Distal end of the syringe body [0066] 5 Piercing means [0067] 6 Sleeve element [0068] 6a Groove in sleeve element [0069] 7 Inner element [0070] 7a Outer surface of the inner element [0071] 7b Portion of the inner element [0072] 8 Connection element [0073] 9 Projection on the connection element [0074] 9a Outer surface of the projection [0075] 10 Recess of the inner element [0076] 11 Distal end of the sleeve element [0077] 12 Proximal end of the sleeve element [0078] 13 Circular base element [0079] 14 Radial outer surface [0080] 14a Projection on the radial outer surface [0081] 15 Distal end of the inner element [0082] 16 Proximal end of the inner element [0083] 17 Flange element [0084] 17a Outer surface of the flange element [0085] 17b Contact surface of the flange element [0086] 18 Receiving means of the sleeve element [0087] 19 First wall of the receiving means [0088] 20 Second wall of the receiving means [0089] 21 First region of the projection [0090] 21a Outer diameter of the first region [0091] 22 Inner diameter of the recess of the inner element [0092] 23 Second region of the projection [0093] 23a Outer diameter of the second region [0094] 24 Axial tolerance-compensation element [0095] 25 Cone-shaped projections [0096] 26 Circumferential ring [0097] 26a Base area of the ring [0098] 27 Ribs [0099] 28 Other recess of the inner element [0100] 29 First portion of the other recess [0101] 29a Inner diameter of the first portion of the other recess [0102] 30 Second portion of the other recess [0103] 30a Inner diameter of the second portion of the other recess [0104] M.sub.H Central axis of the sleeve element [0105] M.sub.IE Central axis of the inner element [0106] M.sub.V Central axis of the connection element [0107] R Radial direction [0108] X Axial direction [0109] X.sub.1 Distal direction [0110] X.sub.2 Proximal direction