SYRINGE INCLUDING DIFFERENT MATERIALS

Abstract

A syringe includes a syringe body, a syringe cone having a distal opening, and a connection arranged in the region of the syringe cone, wherein the syringe body includes a first material and the connection includes a second material, and wherein the first material is different from the second material and the second material is a softer material than the first material.

Claims

1. A syringe, comprising: a syringe body; a syringe cone including a distal opening; and a connection arranged in the region of the syringe cone, wherein the syringe body comprises a first material and the connection comprises a second material, wherein the first material is different from the second material, wherein the second material is a softer material than the first material, and wherein the first material is a cycloolefin-copolymer (COC) or a cycloolefin-polymer (COP).

2. The syringe according to claim 1, wherein the connection comprises a thread having sections.

3. The syringe according to claim 1, wherein the first material has an E-module and the second material has an E-module that is 10 to 60% lower than the E-module of the first material.

4. The syringe according to claim 1, wherein the E-module of the first material is in the range of >2500 to 3500 MPa and the E-module of the second material in the range of 1200 to 2500 MPa.

5. The syringe according to claim 1, wherein the E-module of the first material is in the range of 2700 to 3200 MPa and the E-module of the second material in the range of 1500 to 1800 MPa.

6. The syringe according to claim 1, wherein the impact strength of the second, softer material is greater than 2 Kj/m.sup.2.

7. The syringe according to claim 1, wherein the second material is a thermoplastic elastomer (TPE), an elastomer, a polypropylene (PP), a polycarbonate (PC), a polyethylene (PE), a polyamide (PA) or a COC-E.

8. The syringe according to claim 1, wherein the first and the second material includes materials which can be sterilized at temperatures >100° C.

9. The syringe according to claim 1, wherein the first and the second material includes materials which can be sterilized at a temperature of 121° C.

10. The syringe according to claim 1, wherein the first and the second material includes materials which can be sterilized at temperatures greater than 100° C. and less than or equal to 180° C.

11. The syringe according to claim 1, wherein the syringe body represents a first component of the syringe and the connection represents a second component, wherein the first and second component are definably detachably connected with each other at least one of mechanically and through coalesced and a friction type and a form fitting.

12. The syringe according to claim 1, wherein the connection has an outside geometry and the outside geometry is consistent with the outside geometry of a Luer-Lock adapter.

13. A method for producing a syringe, including: providing a syringe body comprising a first material and a connection comprising a second material that is softer than the first material, wherein the second material has an E-module that is 10 to 60% lower than the E-module of the first material, and wherein the first material is a cycloolefin-copolymer (COC) or a cycloolefin-polymer (COP); and connecting the connection and the syringe body with one another through a coalesced fit.

14. The method according to claim 13, wherein the connection comprises a thread.

15. The method according to claim 13, wherein the coalesced fit is a weld.

16. The method according to claim 15, wherein the weld is an ultrasonic weld.

17. A method for producing a syringe including a syringe body having a first material and a connection having a second material that is softer than the first material, wherein the second material has an E-module that is 10 to 60% lower than the E-module of the first material, the method comprising: producing the syringe through multicomponent injection molding, wherein the first material is a cycloolefin-copolymer (COC) or a cycloolefin-polymer (COP) and the second material comprises an elastomer.

18. The method according to claim 17, wherein the connection comprises a thread.

19. The method according to claim 17, wherein the multicomponent injection molding process is conducted in such a manner that the connection is definably detachable at stresses in excess of at least 25 Ncm.

20. The method according to claim 17, wherein the multicomponent injection molding process is conducted in such a manner that the connection is definably detachable at stresses in excess of at least 35 Ncm.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0032] The above-mentioned and other features and advantages of this invention, and the manner of attaining them, will become more apparent and the invention will be better understood by reference to the following description of embodiments of the invention taken in conjunction with the accompanying drawings, wherein:

[0033] FIGS. 1a-1c is a first version of a mechanical attachment of the connector on the syringe body;

[0034] FIGS. 2a-2c is a second version of a mechanical attachment of the connector on the syringe body;

[0035] FIGS. 3a1-3c is a version with syringe body and connector as individual parts, wherein he individual parts are connected with one another by means of ultrasonic welding;

[0036] FIGS. 4a-4b is a first embodiment of a connector and syringe body created by means of multicomponent injection molding; and

[0037] FIGS. 5a-5d is a second embodiment of a connector and syringe body created by means of multicomponent injection molding.

[0038] Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate embodiments of the invention, and such exemplifications are not to be construed as limiting the scope of the invention in any manner.

DETAILED DESCRIPTION OF THE INVENTION

[0039] Referring now to the drawings, and more particularly to FIG. 1, there is shown a syringe body 1 which generally includes a syringe cone 3, with a distal opening 5. Of entire syringe body 1, only the upper part of the syringe in the region of syringe cone 3 is shown. Syringe body 1 preferably consists of a hard plastic, for example a cycloolefin-copolymer (COC) or cycloolefin-polymer (COP). A connector 10 for connectors or respectively attachment of syringes is arranged about syringe cone 3. Connection 10 in this example is an attachment with an inside thread 12, without being limited to same. Connection 10 in this example is an independent part vis-à-vis syringe body 3. In the illustrated embodiments according to FIG. 1, the syringe body as the first component and the connector as the second component are only mechanically connected with one another. For example, connection 10 is placed onto the syringe body and is locked in place in an undercut 14, in other words, the connector is held in a form-fit. Separate component 10 can either be screwed into or pressed onto undercut 14. To more effectively hold component 10 on syringe body 1, over-molding may be provided in the region of the connection, for example with a plastic. Over molding stabilizes the connection of component 10 on the syringe body. According to the invention, the material of connection 10 is softer than the material of the syringe body. The E-module of the syringe body consisting of a hard material is preferably 2500-3500 MPa, the E-module of the connection consisting of a soft material 1200-2500 MPa. The module of the softer material of connection 10 is generally 10 to 60% lower than the E-module of the hard material of the syringe body. Whereas the material used for the syringe body is a cycloolefin-copolymer or cycloolefin-polymer, the soft material of the connection is a thermoplastic elastomer (TPE) or an elastomer or polypropylene (PP) or polyethylene (PE). A notched impact strength of more than 2 kJ/m.sup.2 characterizes the specified soft materials. FIG. 1c is a top view of syringe body 1. Same components as in FIG. 1a-1b are identified with same reference numbers. Hard materials such as cycloolefin-copolymer (COC) or cycloolefin-polymer (COP) have a low notched impact strength of less than 2 kJ/m.sup.2.

[0040] FIGS. 2a-2c illustrate an alternative embodiment of a mechanical union of a connection 100 on a syringe body 101. Herein, FIG. 2a depicts connecting piece 100 with inside thread 112. Connecting piece 100 consists of a softer material, for example a thermoplastic elastomer, an elastomer, polycarbonate, polypropylene or polyethylene, compared with the hard material of the syringe body which may consist of COC or COP. Connecting piece 100 is characterized in that, in addition to inside thread 112, it features a circumferential attachment 114 with a hollow space 116, wherein protrusions or elevations 110 of syringe body 101 can engage in hollow space 116. By pressing the connection, it can be held on syringe body 101 via hollow space 116. The detailed design of connecting piece 100 of the syringe body is shown in FIG. 2a. As shown in FIG. 2b, syringe body 101consists of a hard material, for example COC and comprises a syringe cone 103 with a distal opening 105. In addition to syringe cone 103, syringe body 101 features a circumferential elevation 110. Hollow spaces 116 of connecting piece 100 engage into circumferential elevation 110 according to FIG. 2a and are held for example by pressing following the attachment of the connecting piece onto elevation110. FIG. 2b illustrates a complete syringe body 101 with attached connecting piece 110. Same components as in FIG. 2 are identified by the same reference numbers. This applies also to the top view according to FIG. 2c.

[0041] FIGS. 3a1 to 3c illustrates the attachment of the connection with the syringe body by means of material fit, for example by means of welding. FIG. 3a1 shows a view of a syringe body 201 according to the invention, with a connecting piece 210 on syringe body 201. The syringe body in FIG. 3a is a plastic syringe consisting of a hard material, for example cycloolefin-copolymer (COC) or cycloolefin-polymer (COP). Syringe body 201 again includes a distal tip 203 with a distal opening 205. Connecting piece 210 is arranged around distal tip 203, with an inside thread 212 for screwing in of a connector. As in the previously described embodiments, connecting piece 210 consists of a softer material than syringe body 201, for example of polyethylene or polypropylene or COC-E. The softer material can also be used in sections. In that case it is preferably used in areas where high forces occur when screwing in the connectors.

[0042] FIG. 3a2 details the area from FIG. 3a1 that shows the connection between separate connecting piece 210 and syringe body 201. This connection can occur selectively or over the complete support surface. Separate connecting piece 210 is located with protrusions 212 of the syringe body. After placing separate connecting piece 210 on the syringe body, connecting piece 210 is joined the syringe body through coalescent fit, in other words material bonding, for example by means of welding, in particular ultrasonic welding. For the purpose of ultrasonic welding, connecting piece 210 or syringe body 201 have material provisions 220, that—by means of a sonotrode—are caused to oscillate and thus to bond. The ultrasonic welding can occur selectively or across the surface. If material provisions 220 are used, the welding occurs selectively. In heated ultrasonic welding the selection of the materials, especially their combination is important. If there is too great a difference between the fusion points, bonding of the materials is no longer possible

[0043] FIG. 3b again illustrates in detail the entire syringe body 201 with ultrasonically welded connecting piece 210. FIG. 3c is a top view of the design according to FIGS. 3a1-3a2. Same components are identified with the same reference numbers.

[0044] In an alternative arrangement of the invention, the complete syringe body with connecting piece can be produced by a multicomponent injection molding process, instead of bonding the connector with the syringe body by means of welding, in particular ultrasonic welding. This is shown in FIGS. 4a-4b for a first embodiment, and in FIGS. 5a-5d for a second embodiment.

[0045] FIG. 4a illustrates syringe body 301, produced by multicomponent-injection molding. Syringe body 301 includes again a connecting piece 310 in the region of syringe cone 303 with an inside thread 312, consisting of a softer material than syringe body 301. As stated previously, the softer material is characterized by an E-module.

[0046] FIG. 4b is an overall view of the syringe from FIG. 4a. The material of syringe body 301 is a hard plastic material, for example COC or COP, whereas the material of connecting piece 310 is a soft material, for example polypropylene or polyethylene or COC-E. Also, clearly visible in FIG. 4a is the inside thread of connecting piece 312. Same components as in FIG. 4a are identified with the same reference numbers.

[0047] FIGS. 5a to 5d illustrate a second embodiment of a syringe body 401, produced by multicomponent injection molding. Connecting piece 410 in the region of syringe body 401 again consists of a softer material. The softer material has an E-module that is 10-60% lower than that of the hard material of the syringe body. It is typical for the second embodiment that syringe body 401 has a circumferential seating 420 in the region of cover 421 of the syringe body. The connecting piece consisting of a soft material engages into the seating. In the variation according to FIGS. 5a to 5d a larger contact surface is provided that permits improved adhesion of the materials with each other. This design also shows a connection of the softer material in the cone area, which effects development of the force peaks that occur there. The soft material of the connecting piece moreover surrounds also syringe cone 403 of tip 400 on outside 405. Clearly visible is also thread 412. FIG. 5b shows the entire syringe with connecting piece 410, FIG. 5c the top view and FIG. 5d a three-dimensional view. Same components as in FIG. 5a are identified with the same reference numbers.

[0048] In multicomponent injection molding the entire injection molded component is produced from two different plastics. For this purpose, the injection molding machine includes two injection units, whereby however only one clamping unit is required. The component that is produced in a multicomponent injection molding according to FIGS. 4a-5d can be produced cost effectively with only one tool in only one work cycle. In addition, geometries can be realized that would not be possible on an assembly.

[0049] The invention provides for the first time a syringe body with which it is possible to connect a multitude of different connectors with one connecting piece, wherein the insertion torque can fluctuate in a wide range, wherein the thread does not transfer the mechanical stress to the syringe body, which would result there in leaks.

[0050] Moreover, all materials of the syringe body as well as of the connecting piece are to be steam-sterilizable.

[0051] Moreover, the materials are selected so that they do not change when in contact with pharmaceutical media. Due to the softer material of the connecting piece, the coefficient of friction between the connector and the syringe is met, so that the thread cannot be over tightened.

[0052] While this invention has been described with respect to at least one embodiment, the present invention can be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains and which fall within the limits of the appended claims.