KR20010071378A - Pre-filled container - Google Patents

Abstract

In the pre-field syringe 1:

(a) barrel 1a; (b) a movable stopper for sealing one end of the barrel; (c) a needle fitting integral to the barrel and positioned at the end of the syringe away from the movable stopper; (d) a closure (9) for sealing the syringe at the needle fitting end, wherein an injection liquid (10) is received in the barrel between the movable stopper and the closure, the closure being the needle fitting and the syringe A pre-field syringe, characterized in that located in the barrel of.

Description

Pre-field Containers {PRE-FILLED CONTAINER}

Applicants have previously proposed various designs for the production of injection molded plastic syringes. For example, the prior patent applications PCT / AU92 / 00007 and PCT / AU95 / 00723 have been made by the applicant. In these pre-applications, the pre-field syringe is sealed at the tip of the needle along with a bag-shaped closure separated from the syringe. While the applicant's preliminary proposals are a major step forward in the pre-field products that have been used prior to these developments, the use of a separate bag for sealing a syringe has created some difficulties. Firstly, the bag protruding from the end of the syringe is sensitive to accidental shock, both in use and in production, which can cause contamination or inadvertent opening of the unit. Second, systems such as those described in PCT / AU95 / 00723 require removing the bag from the needle before the hypodermic needle can be attached. This means that the needle must be fitted immediately at the step it was removed directly before use. This can be inconvenient and also has the possibility of contamination during needle attachment operation.

The present invention relates to pre-filled containers, medicines and syringes, and in particular to new forms of syringes that can be prefilled and fitted with a needle for hypodermic syringes and packaged prior to use of the product.

1 is a schematic diagram showing a pre-field syringe packaged in an outer wrapper.

FIG. 2 is a schematic diagram showing the pre-field syringe shown in FIG. 1 before the wrapper is removed and the syringe is opened.

FIG. 3 is an end section of the pre-field syringe shown in FIG. 2 seen from the plunger end. FIG.

4 is an enlarged schematic of the needle fitting and closure of the pre-field syringe shown in FIG. 2.

5 is an enlarged view of the central cone of the needle fitting and associated closure as seen in FIG.

6 is a schematic diagram showing the needle fitting end of the pre-field syringe shown in FIG. 2 with a hypodermic needle and a needle support positioned over the end of the needle fitting of the syringe and before full engagement.

7 is a schematic diagram showing the needle assembly of the needle fitting and the hypodermic syringe shown in FIG. 6 after the hypodermic needle and the needle support are firmly positioned over the needle fitting of the syringe.

8 is a schematic diagram showing the needle fitting of a pre-field syringe and showing the passageway so that the insertion liquid can flow once the closure is opened.

9 is a schematic of a closure open conduit.

FIG. 10 is a cross-sectional view of the removable band, meaning use by retaining the overcap in position on the hypodermic needle before use. FIG.

11 is a schematic diagram illustrating another embodiment of the present invention using a double sided hypodermic syringe needle.

12 is a schematic representation of the end of the needle fitting of the pre-field syringe shown in FIG.

FIG. 13 is a schematic diagram of the end of a truncated truncated cone in the needle fitting shown in FIG. 11.

14 is a schematic representation of the needle of a double-sided hypodermic syringe with support and overcap.

It is therefore an object of the present invention to provide a pre-filled syringe which is sealed in a way which emphasizes the disadvantages arising in the conventional units described above.

The pre-field plastic syringe according to the present invention,

(a) a barrel;

(b) a movable stopper for sealing the barrel at one end;

(c) a needle fitting integral to the barrel and positioned at the end of the syringe away from the movable stopper; And

(d) a closure that seals at the end of the syringe needle assembly; provides a pre-field plastic syringe comprising: a. The injectable liquid is here present in the barrel between the movable stopper and the closure, which closure is located in the barrel of the needle and / or syringe.

Preferably, the needle assembly comprises a hollow truncated cone and the inside of the pyramid has a structure in which liquid communicates with the interior of the barrel. Most preferably the needle assembly is an "luer rock" needle fitting, an example of such an accessory which is surrounded by a spaced peripheral wall from the cone. The radial lock fitting has threaded grooves on the inner surface of the peripheral wall to facilitate threading of the hypodermic needle into the needle fitting. The hypodermic needle used in combination with the luer lock needle fitting is conical, attached to the joint end of the cavity and sized to be fixed to the central cone of the luer lock fitting. The base of the needle support is the hypodermic needle associated with the needle fitting. It includes a flange shaped to fit a screw groove on the inner surface of the peripheral wall to facilitate its engagement.

More preferably, the syringe of the present invention uses a luer lock needle fitting and the syringe is used in conjunction with a hypodermic needle attached to a conical support as described above.

The closure may be a detachment element located in the barrel or needle fitting, such as by friction fixing or other suitable means. In such a case, it is preferred that the closure is also made of such a material that can be easily pierced.

However, the closure is preferably connected to the inner surface of the barrel or to the inner surface of the needle fitting and wall portion extending across the opening in the barrel or needle fitting. Most preferably, the closure is located entirely within the needle fitting of the syringe. In an embodiment of the invention the needle fitting comprises a truncated cone which is a cavity through which the liquid is delivered to the inside of the barrel, preferably an inner wall portion in which the closure is connected to the inner surface of the cone and extends across the opening. In this embodiment of the invention the wall portion may be located at any point along the inner wall of the needle. Preferably, at least 2.0 mm, more preferably at least 4.0 mm, from the open end of the truncated cone and attached to the inner surface of the truncated cone is broken off from the inner wall and furthermore, a seal made inadvertently in the wall portion ( Reduce the likelihood of breaking the seal.

The closure can be pierced by the rear needle of a standard double-sided hypodermic needle (if it is located near the open end of the needle fitting) so that it can be easily opened when it is desired to press the draining liquid, or use an appropriate tool Alternatives are preferred that can be fragile so that they can be separated or partially split from the inner surface of the truncated cone or barrel.

In particular, in a preferred embodiment of the present invention the syringe comprises a truncated conical needle fitting, the closure being a wall portion extending across the inner transmission of the cone and also softly attached to the inner surface of the cone.

In this embodiment, the wall portion preferably includes a peripheral portion connected to the weak side or the inner surface of the cone. Thus, the weak portion occurs along a tear line where the closure can be separated (at least partially) from the inner surface of the cone. The wall portion is preferably between 0.8 mm and 1.5 mm thick except for the weak portion, which is between 0.05 mm and 0.2 mm thick. While it is possible to use a weaker part that extends all the passages around the wall part, it would be undesirable to have the result of complete separation of the closure from the needle fitting. While this does not adversely affect the operation of the syringe, it may be undesirable to allow the closure to freely exit the effluent liquid. Thus, when the closure breaks away from the inner surface of the cone along the weak portion, the weak portion is attached to the inner surface of the needle fitting so that the weak portion can be hinged to that portion or adjacent portion of the inner surface of the cone that is still or weak. It is desirable to extend within about 330 to 350 degrees of circumference.

The seal provided by the wall portion may be broken by a force against the wall portion. The wall part attaches a push rod that is smaller than the inner radius of the cone and a tool of sufficient length to reach the wall part can be used for this purpose. Preferably, the tool has a planar end face sized to contact most of the surface area of the closure. If the closure is detached, the hypodermic needle can be attached to the needle fitting to prepare for direct syringe use.

Alternatively, most preferably, the pre-field syringe of the present invention, wherein the closure is weakly connected to the needle fitting, comprises a joint closure opening conduit and a needle support having a hypodermic needle and an internal cavity, wherein the hypodermic needle It is attached to the end of the needle support and is positioned (but not fully engaged) over the needle fitting. The first end of the closure opening conduit is located in the inner cavity and the second end of the closure opening conduit is located in the needle fitting, the closure opening conduit is in liquid delivery with the hypodermic needle and also moves the movable stopper end of the syringe. Movement of the needle support toward it has a length that will cause the closure opening conduit to break the seal provided by the closure.

Preferably, the length of the closure opening conduit provides sufficient movement of the needle support (and therefore the closure opening conduit) to destroy the thread provided by the closure of the needle support in the needle fitting.

Preferably, the cavity in the needle support includes an end face with a hole lying in the central axis. The hypodermic needle can be fixed and locked at one end in the hole to extend away from the cavity. The closure opening conduit is preferably located in a cavity, the first end adjacent the end face of the housing with internal transport aligned with the hole in the end face of the needle support. The other end of the closure opening conduit preferably abuts or borders the surface of the closure. In this way, the movement of the needle support towards the movable stopper end of the syringe will cause the end to press against the first end of the closure opening conduit and alternately to apply pressure to the closure. By moving the support completely over the needle fitting, the closure opening conduit will be sufficiently moved to break the weak connection of the closure with the needle fitting, and thus through the closure opening conduit past the closure opened from the barrel of the syringe to the hypodermic needle. Facilitates direct liquid delivery.

The closure opening conduit may be integrated with the needle support and extend from the support but is preferably a separate component.

Preferably, the closure opening conduit includes a central conduit and a pin or a lip extending outward therefrom to reduce contact between the closure opening conduit and the inner surface of the needle fitting. This reduces the friction between the surfaces. Alternatively, other closure opening means may be used that do not narrow the conduit but are of a simple shape to allow liquid movement. For example, the closure opening means may be a solid rod that is less than the minimum diameter of the passageway in the needle fitting with guide lips to make contact with the inner surface of the needle fitting.

Preferably, the pre-field syringe also comprises an overlap placed on the hypodermic needle. Tamper proof bands can be recognized by the elimination of the band's absence or destruction of the overlap.

Embodiments of the present invention that utilize a closure opening conduit provide significant advantages such as ease of use and prevention of contamination. In particular, injection molding of components and assembly and injection of syringes in a sterile environment are possible. The filled and assembled syringe may be aseptically sealed in a clean plastic wrap such as cellophane before delivery of the product in a clean environment.

The pre-field syringe may be delivered to a practitioner with a hypodermic needle in a position above the needle fitting but not completely engaged. In use, the hypodermic needle can be pushed or twisted onto the needle fitting while the product is still in a hermetically sealed package. Complete seating of the hypodermic needle over the needle fitting eliminates the overlap of the hypodermic needle when the package is opened providing an open pre-field syringe ready for use and application of the addition portion or product with the syringe after the package is opened. This causes the seal formed by the closure to break so as not to react sensitively to contamination.

The pre-field plastic syringe of the present invention is preferably made from a hypodermic syringe material such as polypropylene. Other suitable materials include translucent and transparent plastics such as PET, polyamide, TPX. Other suitable materials are well known to those described in the art.

An example of the present invention is a specific and preferred embodiment of the present invention wherein the pre-field syringe is injection molded, packaged and assembled in a sterile environment and ready for use, is now described by reference. This embodiment is shown in the following figure.

1 is a schematic representation of how a preferred embodiment of the present invention may be distributed to physicians and practitioners. The pre-field syringe 1 is preferably manufactured by injection molding all components in an aseptic environment, to assemble and fill the syringe in an aseptic environment and to seal it in the outer wrapper 17.

The syringe 1, shown without protective packaging in FIG. 2, includes a barrel 1a and a plunge rod 2 inserted into the movable stopper 3. The movable stopper 3 seals the barrel at one end of the barrel, and the other end of the barrel is sealed by the central truncated cone 13a of the needle assembly 13 and the integrally closed closure 9 at the other end of the syringe. The barrel 1a is filled with the injection liquid 10 and this liquid is received in the barrel 1a between the movable stopper 3 and the closure 9.

The hypodermic syringe needle 5 is fixed to the needle support 7. The needle support 7 comprises an inner cavity 7a (shown well in FIG. 6) and is positioned over the end of the truncated truncated cone 13a of the needle fitting 13. The hypodermic needle 5 is hollow and the cavity 7a and the liquid are transferred.

In the nature of the detached tube 21 (shown well in FIG. 6), the cavity closing opening conduit is located between the needle support 7 and the closure 9, and the needle support 7 in the separating closure 9. The use of this tube in conjunction with is described below.

The hypodermic needle 5 is protected by an overcap 6 which is fixed in position up to the band 4 of the circumference, as well shown in FIG. The needle fitting 13 also includes an outer circumferential wall 15.

3 shows the syringe, thumb press 12, finger support flange 16 and gripping lip 18 from the plunge rod end of the syringe. These features are shown briefly by way of example of a particular embodiment of the invention. However, it will be appreciated that any form of plunge rod or movable stopper mechanism, as is known in the art, will serve the purpose of the present invention.

4 shows the end of the needle fitting of the pre-field syringe shown in FIG. 2. The needle fitting comprises a truncated central truncated cone 13a and a circumferential outer wall 15. This is similar to a standard "luer lock" type needle fitting support and is therefore suitable for use in combination with a standard hypodermic syringe and needle support of the type shown in FIG. The circumferential wall 15 comprises a helical lip 20 which facilitates the meshed deployment of the helix of the needle support 7 above the needle fitting 13. The needle fitting 13 has an opening 22 between the wall 15 of the circumference and the truncated truncated cone 13a at the center.

The difference from the standard luer lock is the provision of the closure 9 in the form of the entire end wall located in the central truncated truncated cone 13a.

The closure 9, which is the entire inner surface of the central truncated truncated cone 13a, is weakly connected thereto, as is shown in FIG. The closure 9 adjacent to the inner surface of the truncated truncated cone 13a is truncated along the tare line 8 with reduced thickness of the force generation against the closure 9 with the movable stopper end of the pre-field syringe. A tear line 8, which is a portion of the circumference of such a reduced thickness from which the closure is to be removed from the inner surface of the. In the embodiment shown the syringe is made of polypropylene and the closure 9 is about 1.2 mm thick. The tear line is 0.1 mm thick. Preferably, the tear line 8 is attached to an inner surface of the truncated truncated cone 13a when a force is applied against the closure, to which part of the inner surface of the truncated truncated cone 13a. ) Does not extend around all of the circumference closures 9. The diameter of the inner passage of the truncated truncated truncated cone 13a adjusts the closure when separated or superimposed by the tube 21 to be slightly larger on the barrel face of the closure 9.

The operation of the syringe is shown in more detail in FIGS. 6, 7, 8. In FIG. 6, the needle fitting end of the syringe is shown with the closure 9 sealed in the syringe. This shows how the product is delivered to the end user. The needle support 7 is located above the truncated truncated cone 13a, but the flange 7b of the needle support 7 does not engage the spirally running portion 20 of the wall 15 of the circumference. The tube 21 is located at the first end of the junction to the end of the cavity 7a and at the other end of the junction to the face of the closure 9. The tube 21 has a central passage 21a which is aligned so that there is direct liquid movement with the passage 5a in the hypodermic needle 5. A band 4 representing a tamper holds the urban wrap 6 in a suitable position.

7 shows the needle fitting end of the pre-field syringe after the closure 9 portion has been separated from the inner surface of the central truncated truncated cone 13a. Preferably, this is done by forcing the overcap 6 or the circumferential band 4 in the direction of the movable stopper of the pre-field syringe. This force will move the needle support 7 further away from the truncated truncated cone 13a. In order to engage the helix 20, a joint is preferably used which is wound to turn the needle support 7 over the central truncated cone 13a. This movement of the support 7 causes the force to be applied to the tube 21 which in turn applies the force to the closure while providing a cause of tearing from the inner surface of the truncated truncated cone 13a along the tear line 8. In the preferred embodiment shown in FIG. 7, the tare line 8 does not extend about the complete circumference of the closure, so it hinges one side as can be clearly seen in FIG. 7. Preferably, the tube 21 is chamfered at the end. This facilitates the insertion of the tube 21 into the truncated truncated cone 13a when the product is assembled, but this also means that the tube 21 does not completely separate the closure 9 from the inner surface of the truncated truncated cone 13a. . The open closure 9 is secured between the truncated truncated cone 13a and the outer surface of the tube 21 if the needle support 7 is fully engaged with the needle fitting 13.

In Fig. 8 the needle fitting end of the pre-field syringe 1 is ready for use. The tamper proof band 4 is removed together with the overcap 6 (as opposed to FIG. 7). Injection liquid 10 can now be ejected out of the syringe 1 in the direction of the arrow shown in FIG. 8 by moving the plunger rod 2 towards the needle fitting end of the syringe. The liquid 10 will move in the direction of the arrow in FIG. 8 through the passage 21a and thereafter through the common hypodermic needle 5.

9 is a schematic diagram showing the tube 21 and FIG. 10 is an enlarged cross-sectional view of the tamper proof band 4. This band includes an end rib 14a that is employed to cut around the flange 6a of the inner rib 14 and the overcap 6.

Another embodiment of the invention is shown from FIG. 11 to FIG. 14. In this embodiment, similar features of those described with respect to the first embodiment of the present invention have been similarly numbered. The main difference between the embodiment of the invention shown in FIGS. 11 to 14 and that shown in FIGS. 1 to 10 relates to the position of the closure 9 and to the use of a double-sided hypodermic needle.

In FIG. 11 a pre-field syringe including a barrel 1a, a plunger rod 2 and a movable stopper 3 is shown. The needle fitting 13 comprises a central truncated truncated cone 13a and a circumferential wall 15. The hypodermic syringe needle 5 is fixed to the needle support 7. In contrast to the embodiment shown in FIGS. 1 to 10, the hypodermic needle 5 has a sharp end 5b extending through the needle support 7 and located in the cavity 7a. When the product is assembled or filled, the sharp end 5b is close but not in contact with the closure 9.

The needle fitting 13 and the center cut truncated cone 13a are shown in greater detail in FIGS. 12 and 13. In order to ensure proper opening of the closure 9 by means of the sharp end 5b of the hypodermic syringe needle 5 when the needle support 7 is fully fixed on the needle fitting 13, the closure 9 is a central truncated cone. It is important to be located near the end of (13a). This may be located at the distal end of the central truncated cone 13a while preferably at a short distance, for example within 0.5 mm from the distal end of the truncated cone 13a.

In use, the safety of the needle support 7 completely above the needle fitting 13 is directed towards the closure 9, such that the injection liquid 10 can be ejected from the syringe in a similar manner as described for the first embodiment. It will be appreciated that the movement of the sharp end 5b of the communicating hypodermic needle 5 breaks the seal formed by the closure 9.

14 is an enlarged view of the hypodermic needle 5, the needle support 7, and the overcap 6.

It will be demonstrated previously that preferred embodiments of the present invention, as described and shown above, can be manufactured in a sterile or clean environment, assembled and all sealed in a wrapper. The product can only be removed and delivered when it is delivered and stored with minimal contamination of the contamination and the syringe is ready for use. The device for opening the syringe is made by engaging the needle support 7 over the needle fitting so that the needle fitting or needle support does not need to be exposed to the environment and possible contamination. Conclusions in ease of use will be apparent to those skilled in the art.

Various modulations and / or additions may be made to the described embodiments without departing from any of the spirit or scope of the invention as set forth in the following claims.

Claims (34)

For pre-field plastic syringes: (a) with a barrel; (b) a movable stopper for sealing one end of the barrel; (c) a needle fitting integral to the barrel and positioned at the end of the syringe away from the stopper; And (d) a closure for sealing the syringe at the syringe needle fitting end; wherein an injection liquid is received in the barrel between the movable stopper and the closure and the closure is in the needle fitting and / or barrel of the syringe Pre-field plastic syringe, characterized in that located. The pre-filled plastic syringe of claim 1, wherein the needle fitting comprises a hollow truncated truncated cone and an inner element through which the liquid is delivered within the barrel. 3. Pre-filled plastic syringe according to claim 1 or 2, characterized in that the needle fitting is in the form of a truncated truncated cone surrounded by a wall of circumference at a distance from the truncated cone. 4. Pre-filled plastic syringe according to any of the preceding claims, wherein the closure is made of such material and thickness that can be easily pierced. The pre-field plastic syringe of claim 1, wherein the closure is a separate component located within the barrel or needle fitting. 5. The free of claim 1, wherein the closure is a wall portion that is weakly connected to the inner surface of the barrel or the needle fitting and that extends across the opening of the barrel or the needle fitting. 6. -Field plastic syringe. 7. Pre-filled plastic syringe according to any one of the preceding claims, wherein the closure is located entirely within the needle fitting of the syringe. 8. The needle fitting of claim 7, wherein the needle fitting is an opening end for delivering liquid into the barrel and includes a hollow truncated truncated cone and the closure is connected to and extends across an opening of the truncated truncated truncated cone. A pre-field plastic syringe, characterized in that it is an integral wall part. The pre-filled plastic syringe of claim 8, wherein the wall portion is positioned at a position along the length of the inner surface of the needle fitting. 9. The pre-field plastic syringe of claim 8, wherein the closure is a wall portion that is weakly attached to the inner surface of the truncated truncated cone and is located at least 2.0 mm from an open end of the truncated truncated cone. 11. The pre-field plastic syringe of claim 10, wherein the wall portion is weakly attached to the inner surface of the truncated truncated cone and is located at least 4.0 mm from the open end of the truncated truncated cone. 12. Pre-field plastic syringe according to any of the preceding claims, wherein the needle fitting is a luer lock needle fitting. 13. Pre-filled plastic syringe according to any of the preceding claims, wherein the closure can be perforated by a rear needle of a double-sided hypodermic needle. 14. Pre-filled plastic syringe according to any of the preceding claims, wherein the closure is separated or partially broken from the needle fitting or the inner surface of the barrel by using a suitable tool. 15. The pre-field plastic syringe of any of claims 8-14, wherein the closure is a wall portion extending across the inner passage of the truncated truncated cone and weakly attached to the inner surface of the truncated truncated cone. 16. A pre-filled plastic syringe according to claim 15, wherein the wall portion comprises a weakened portion of the circumference to the inner surface of the truncated truncated cone or a junction of the inner surface of the truncated truncated truncated cone. The pre-filled plastic syringe of claim 16, wherein the wall portion is between 0.8 mm and 1.5 mm thick, excluding the weakened portion having a thickness between 0.05 mm and 0.2 mm. 18. The pre-field plastic syringe of claim 17, wherein the weakened portion does not extend all of the way around the wall portion. 19. The needle fitting of claim 18 wherein the weakened portion extends circumferentially in a range between 330 ° and 350 ° and when the closure breaks away from the inner surface of the needle fitting along the weakened portion A pre-field plastic syringe, which will remain attached to the inner surface of and can be adjacent to or hinged against the inner surface of the needle fitting that has not been weakened. The needle support of claim 1, further comprising a needle support having a cavity closure conduit and a hypodermic needle and an internal cavity, wherein the hypodermic needle is attached to one end of the needle support. A needle support is located above the needle fitting, a first end of the closure opening conduit is located in the inner cavity of the needle support, and a second end of the closure opening conduit is located in the needle fitting, the closure The opening conduit delivers the hypodermic needle and liquid, and the movement of the needle support towards the end of the movable stopper of the syringe is such that the closure opening conduit is long enough to break the seal provided by the closure. Pre-field plastic syringe. 21. The closure opening of claim 20 wherein the length of the closure opening conduit is such that the full engagement of the needle support to the needle fitting provides sufficient movement of the closure opening conduit to break the seal provided by the closure. Pre-field plastic syringe. 22. A pre-filled plastic syringe according to claim 21, wherein the needle support comprises an end face with a hole lying about its central axis. 23. The pre-field plastic syringe of claim 22, wherein the hypodermic needle is secured and seated at one end in the bore at the needle support and extends away from the cavity. 24. The closure opening as recited in claim 23, wherein the closure opening conduit is positioned in the cavity with the first end aligned with the aperture at the end face of the needle support and adjoining the end face of the cavity having an internal passage therein. Pre-field plastic syringe. The pre-field plastic syringe of claim 24, wherein one end of the closure opening conduit is adjacent or adjacent to the face of the closure. 26. A pre-field plastic syringe according to any one of claims 20 to 25, wherein the closure opening conduit is integral and extends with the needle support. 27. The pre-field plastic syringe of claim 26, wherein the closure opening conduit is a separating component. 28. A pre-field plastic syringe according to any one of claims 20 to 27, wherein the closure opening conduit comprises a central conduit extending therefrom and a pin or lip. 29. A pre-filled plastic syringe according to any one of claims 20 to 28, further comprising an overcap positioned on the hypodermic needle. 30. A pre-filled plastic syringe according to any one of claims 1 to 29, wherein the filled and assembled syringe is sealed in a clean plastic wrapper. 30. The method of any one of claims 20-29, wherein the hypodermic needle is pushed or twisted onto a needle fitting. 32. The method of claim 31, wherein movement of the hypodermic needle over the needle fitting causes the closure opening conduit to break the seal provided by the closure. 33. Pre-field syringe according to any one of the preceding claims, characterized in that it is made of a heated plastic material. A pre-field plastic syringe as substantially described above with respect to what is shown in any one of the figures.