WO2011023748A1

WO2011023748A1 - Syringe container for a syringe

Info

Publication number: WO2011023748A1
Application number: PCT/EP2010/062451
Authority: WO
Inventors: Dirk-Henning Menz; Yong Keun Kim
Original assignee: Pharmpur Gmbh
Priority date: 2009-08-27
Filing date: 2010-08-26
Publication date: 2011-03-03
Also published as: DE202009011640U1

Abstract

The invention relates to a syringe container (12) for a syringe (10), comprising a container wall (18) surrounding a chamber (20) for receiving a substance and a tip (22) projecting from a distal end (16) of the container wall (18), the tip having a passage (24) that is connected to the chamber (20), wherein the tip (22) is provided with a connecting assembly for connecting the syringe container (12) to a corresponding connector part (58, 42), said assembly comprising a collar (44) concentrically enclosing the tip (22). In order to ensure that the mating piece, which is placed onto the syringe container and comprises a connector part that corresponds to the connecting assembly on the syringe container, is seated securely, forming a tight seal and to prevent said piece from inadvertently becoming detached during assembly and use, and in order to prevent the collar from also becoming detached during assembly as a result of rotary movements, according to the invention the collar (44) is fastened to the container wall (18) by way of a heat-shrinkable tube (9), wherein the heat-shrinkable tube (9) surrounds the respective exteriors of the collar (44) at least in a proximal region (7) and the container wall (18) in a distal region (8).

Description

Syringe container for a syringe

The invention relates to a syringe container for a syringe according to the preamble of claim 1.

A generic syringe container is known from US 6027482. Therein is described a syringe having a cylindrical syringe container, wherein the syringe container encloses a chamber which serves to receive a substance, such as a pharmaceutically used liquid. At a distal end of the cylindrical syringe container, a tip is arranged through which passes a passage. At the top of a connection arrangement for connecting the syringe container is arranged with a corresponding connector part, said connection arrangement comprises a sleeve which surrounds the tip concentrically. The proximal end of the cuff has an array of inwardly facing projections for frictionally engaging the outside of the tip. A further development of this syringe is shown in DE 19956243 Al, in which on the outside of the tip an annular groove is provided, in which the supernatants arranged on the inside of the sleeve frictionally engage to effect attachment of the sleeve to the tip of the syringe container and to prevent the cuff from detaching from the syringe container.

The known syringe container is preferably made of glass, which is why the sleeve can not be integrally formed on the tip of the syringe container. The sleeve is made of a thermoplastic material and mechanical attachment of the sleeve to the tip of the syringe container is required. In addition to the said attachment of the sleeve at the top of the syringe container via a frictional connection further attachment possibilities are mentioned in DE 199 56 243 A1, for example a sliding seat or a snap fit.

The sleeve is used in the known syringe container in particular to protect the preferably designed as a Luer-lock connector between the tip of the syringe container (which is preferably shaped as a Luer cone) and any counterpart with a corresponding counter-cone against inadvertent release of the compound and to ensure the tightness of the connection. In particular in the case of syringes filled with viscous material or substances which reduce the frictional forces between the luer Koni and can reduce between syringe body and cuff, it has been found that the known compounds are leaking in use or can be removed when screwing the counter cone on the syringe, the sleeve. Another disadvantage arises in the handling of syringes whose caps are fixed with a cuff. In this case, by loosening the connection between the cuff and syringe the whole system can be leaking and there is a risk that the syringe cap (Tip Cap) is stripped off. It has also been found that the connections can be released when larger forces are applied when expressing the contents of the syringe. The problems mentioned are exacerbated when the syringes are subjected to a sterilization process, especially with dry heat or steam.

Proceeding from this, the present invention seeks to further develop a generic syringe container so that the attached to the syringe container counterpart, which has a corresponding connector assembly on the syringe container connector part, tight and tight and can solve neither uncontrolled during assembly nor in use and the cuff does not detach during assembly even by rotational movements. In particular, it is to be ensured that the counterpart attached to the syringe container is as tight as possible and stable against unintentional removal, in particular even when loaded by rotation. In particular, the connection between the connection arrangement on the syringe container and the corresponding connector part of the counterpart should also be after a possibly required sterilization of existing from the syringe container and the counterpart arrangement or be ensured at (too) tightening the connection.

These objects are achieved with a syringe container having the features of claim 1. Preferred embodiments of this syringe container can be found in the subclaims.

The invention will be explained in more detail with reference to an embodiment with reference to the accompanying drawings. The drawings show:

Fig. 1: perspective view of a generic syringe container in a

Exploded view, together with a tip cap to close the Syringe container and a cannula, which can be arranged on the syringe container;

FIG. 2 is a cross-sectional view of the syringe container shown in FIG. 1 with the tip cap attached thereto; FIG.

Fig. 3: Schematic representation of a syringe container according to the invention with a shrunk in the region of the tip and the cuff

Shrink sleeve;

Fig. 4: Schematic representation of a generic syringe container with a

(not yet shrunk) in the area of the tip and the sleeve around the syringe container applied shrink tube.

The syringe container shown in Figures 1 and 2 corresponds to the syringe barrel 12 known from US 6027482. This is made in one piece of a preferably transparent material, such as glass or plastic. Preferably, the syringe container 12 is a glass cylinder. The syringe container has a proximal end 14, a distal end 16, and a cylindrical wall 18 extending therebetween. The wall 18 surrounds a chamber 20. The chamber 20 serves to receive a pharmaceutically used substance or of medical devices or medicaments. However, the syringe container can also be used to hold other substances, in particular liquids. At the distal end 16, a tip 22 is disposed on the syringe container 12. The tip 22 has a passage 24 communicating with the chamber 20.

In the proximal end 14 of the syringe container 12, a piston rod assembly with a piston rod 26 and a piston 28 arranged thereon can be inserted in order to be able to push the substance located in the chamber 20 out of the syringe container 12 through the passage 24.

The syringe container 12 can be used as intended, as shown schematically in Figure 1, with a cannula 30, for example, to inject the substance via the piston rod assembly from the chamber 20 through the passageway 24 and via the cannula into human or animal tissue. For attachment of the cannula 30 to the syringe container 12, a connection arrangement for connecting the syringe container 12 to a corresponding connector part 42 provided on the cannula 30 is arranged at the tip 22. Appropriately, it is at the top 22 of the Syringe container 12 provided connection assembly around the male part of a Luer-lock connection, which cooperates with a corresponding connector part in the form of the female part of a Luer-Lock connection. For this purpose, the tip 22 tapers conically toward its distal end with a 6% Luer cone (preferably in accordance with the standard DIN EN 20594-1: 1993).

The syringe container 12 may be further sealed with a tip cap assembly 54 at its distal end 16. The tip cap assembly 54 illustrated in FIGS. 1 and 2 includes an inner cap 56 and an outer cap 58, wherein the inner cap 56 may be inserted into the outer cap 58 as shown in FIG. The attachment of the outer cap 58 at the top 22 of the syringe container 12 via the arranged at the top 22 connection arrangement. This connection arrangement comprises a collar 44 arranged concentrically around the tip 22, which is preferably made of a thermoplastic. In the embodiment in which the syringe 22 of the syringe container 12 is formed as a male part of a luer-lock connection, the collar 44 is formed as a luer-lock adapter. In an expedient embodiment, the proximal end 46 of the sleeve 44 has inwardly protruding projections 50, which are frictionally seated on the outside of the tip 22 of the syringe container 12. On the outer side of the tip 22 may preferably (not shown here) circumferential annular groove may be provided, in which the supernatants 50 of the sleeve 44 frictionally engage to ensure a first attachment of the sleeve 44 at the top 22 of the syringe container 12.

The outer cap 58 is preferably an integrally molded sleeve having a proximal end 72 and a distal end 74 and a passage 78. The passage 78 is stepped therein with an inwardly projecting annular rib 80. On the outside of the Outer cap 58 ribs 84 are provided to facilitate gripping the outer cap. In the passage 78, as shown in Figure 2, the inner cap 56 is inserted. The inner cap 56 is preferably formed of an elastomeric plastic material which is softer than the plastic material of the outer cap 58. The inner cap 56 has an undercut 70 in the region of its distal end 62. When the inner cap 56 is inserted into the outer cap 58, the annular rib 80 on the inside of the outer cap 58 engages the undercut 70 on the outside of the inner cap 56, thus retaining the inner cap 56. In the area of proximal end 60, inner cap 56 has a cavity 66 communicating with a vent 69 on the outer periphery of inner cap 56. In this cavity 66 projects in the proximal direction, a conical or frusto-conical plug 64 (Figure 2) on the outer circumference of the inner cap 56 ribs 68 are provided to prevent rotation of the inner cap 56 in the outer cap 58.

For placing the top cap assembly 54 on the cuff 44 consisting of the outer cap 58 with the inner cap 56 inserted therein, an internal thread 52 is provided at the distal end 48 of the cuff 44, which has a corresponding external thread 82 arranged on the outer surface of the outer cap 58 in the proximal region interacts. When screwing the external thread 82 of the outer cap 58 into the internal thread 52 of the sleeve 44, the distal end of the tip 22 engages in the cavity 66 of the inner cap 56 until the frontal distal end of the tip 22 abuts the bottom of the cavity 66. In this position, the plug 64 engages the passage 24 of the tip 22 and seals this passage 24 from.

The cuff 44 tends to disengage from the tip 22 during rotational applications. It has been found that in particular when screwing female, conical counterparts into the sleeve 44 leaks between the tip 22 and the conical counterparts used can occur, which can lead to the complete loss of the connection.

To avoid this, the sleeve 44 is erfmdungsgemäß and as shown schematically in Figure 3 via a shrink tube 9 to the container wall 18 of the syringe container 12, wherein the shrink tube 9, the sleeve 44 at least in a proximal region 7 and the container wall 18 in a distal Area 8 engages on the outside. FIG. 3 shows the shrinking tube 9 shrunk over the proximal region 7 of the sleeve 44 and the distal region 8 of the container wall 18. In FIG. 4, the shrinking tube 9 is in a not yet shrunk state around the proximal region 7 of the sleeve 44 and the distal region 8 Container wall 18 is placed to indicate the position of the shrink tube 9, in which it is shrunk over the sleeve 44 and the distal portion 8 of the container wall 18. As a result of the action of heat, the shrinking tube 9 lying around in the position of FIG. 4 is shrunk and lies against the proximal region 7 of the sleeve 44 and the distal region 8 of the container wall 18 positively. By the positive fit of the shrink tube 9, the sleeve 44 is held at the top 22 of the syringe container 12 by positive engagement and in particular fixed against rotation relative to the syringe container 12. As a result, the sleeve 44 can no longer detach from the syringe container 12. A twisting of the sleeve 44 with respect to the syringe container 12 is excluded. As a result, not only a secure seal of the passage 24 is ensured by the tip cap assembly 54 but also a tight fit any counterparts.

The heat shrink tubing 9 is preferably a heat shrink tubing made of a polyolefin such as polyethylene. It may alternatively be a polyvinylidene fluoride (PVDF) heat shrink tubing. Preferably, the shrink tube has a shrinkage ratio of 2: 1 to 3: 1. Suitably, the heat shrink tubing is made of a transparent material so that contents in the (also preferably transparent) syringe container 12 remain visible. However, the shrink tube 9 can also be colored, so as to make a mark at the same time.

As can be seen in FIGS. 3 and 4, the proximal region 7 of the sleeve 44 encompassed by the shrink tubing 9 extends at least over half the height H of the sleeve 44. In a syringe container with 10 ml filling volume, the proximal region 7 covered by the shrink tubing 9 extends Cuff 44 over a height of at least 4 mm. The distal region 8 of the container wall 18 encompassed by the shrink sleeve 9 extends at least as far as the cylindrical outer region of the syringe container, and preferably over more than 10 mm and particularly preferably over more than 12 mm. The total height H of the shrink tubing 9 is expediently between 20 mm and 30 mm in the case of a 10 ml syringe in the form of a HYP AK® syringe from Becton Dickinson, and is preferably approximately 25 mm. From the outset, it is easy for a person skilled in the art to adapt the shrink tubing dimensions to syringes with different nominal contents or differing outside diameters.

The attachment of the sleeve 44 at the top 22 of the syringe container 12 is also with the use of the syringe container 12 with any conical counterparts such. B. a cannula 30 of advantage. The cannula is also screwed to the internal thread 52 of the sleeve 44 via a flange 42 (FIG. 1) provided at the proximal end of the cannula. Again, the shrink tube 9 prevents twisting or loosening of the sleeve 44th relative to the container wall 18 of the syringe container 12 and thereby releasing the connection between the cannula 30 and the tip 22 of the syringe container 12. Even when using the syringe container 12 according to the invention in combination with an infusion line or a three-way valve or other syringe accessories, the shrink tube 9 a ensure safe connection of the respective connector part to the connection arrangement of the syringe container according to the invention.

Particularly useful is the use of the syringe container 12 according to the invention for syringes which are prefilled with a substance and which must be sterilized before use. The shrinking of the shrink tube 9 can in this case take place during the sterilization process, wherein the material of the shrink tube is adapted to the sterilization temperatures. If the shrink tube shrunk at the usual sterilization temperatures (for example, 121 ⁰ C in a steam sterilization), then this is in particular heat shrink tubing made of polyethylene.

Claims

claims

A syringe container (12) for a syringe (10) having a chamber (20) for

Recording a substance surrounding container wall (18) and one of a

5 distal end (16) of the container wall (18) projecting tip (22) having a chamber (20) in communication with the passage (24), wherein at the top (22) has a connection arrangement for connecting the

Syringe container (12) with a corresponding connector part (58, 42) is arranged, which is a the tip (22) concentrically comprehensive sleeve

10 (44), characterized in that the sleeve (44) via a

Shrink tube (9) is attached to the container wall (18), wherein the

Shrink tube (9) the sleeve (44) at least in a proximal

Region (7) and the container wall (18) in a distal region (8) in each case on the outside engages.

15

2. syringe container according to claim 1, characterized in that the

Shrink tube (9) engages around the sleeve (44) in the proximal region (7) and the distal region (8) of the container wall (18) in a form-fitting manner.

> 0

3. Syringe container according to claim 1 or 2, characterized in that it is the shrink tube (9) is a heat shrink tube made of a polyolefin.

25 4. syringe container according to claim 3, characterized in that it is the shrink tube (9) is a heat shrinkable tube made of polyethylene.

5. syringe container according to claim 3 or 4, characterized in that the shrink tube (9) has a shrinkage ratio of 2: 1 to 4: 1 and preferably from 3: 1.

5. syringe container according to claim 1 or 2, characterized in that it is the shrink tube (9) is a heat shrink tube made of polyvinylidene fluoride (PVDF).

7. Syringe container according to one of claims 1 to 6, characterized in that it is the shrink tube (9) is a heat shrink tube made of a transparent material.

8. Syringe container according to one of the preceding claims, characterized in that it is in the connection arrangement to the male part 15 of a Luer-lock connection, wherein the tip

(22) tapered conically towards its distal end.

9. Syringe container according to one of the preceding claims, characterized in that the sleeve (44) is additionally frictionally fixed by a latching or 20 clamping arrangement at the top (22).

10. syringe container according to claim 9, characterized in that on the sleeve (44) inwardly projecting locking lugs (50) are provided, which rest frictionally on the outside of the tip (22).

> 5

11. syringe container according to claim 9, characterized in that on the sleeve (44) inwardly projecting locking lugs (50) are provided which engage in an annular groove (54) on the outside of the tip (22).

12. Syringe container according to one of the preceding claims, characterized in that the shrink tube (9) at the distal region (8) extends at least to the cylindrical portion of the container wall (18).

13. Syringe container according to one of the preceding claims, characterized in that the of the shrink tube (9) encompassed proximal region (7) of the sleeve (44) extends at least over half the height (H) of the sleeve (44).

14. The syringe container according to claim 12, characterized in that the proximal region (7) of the sleeve (44) encompassed by the shrink tubing (9) extends over at least 4 mm.

15. syringe container according to claim 12, characterized in that the of the shrink tube (9) encompassed distal region (8) of the container wall (18) extends over at least 10 mm, preferably over more than 12 mm.

16. Syringe container according to one of the preceding claims, characterized in that the height of the shrink tube (9) is between 20 mm and 30 mm and preferably at about 25 mm.