EP1919539A1

EP1919539A1 - Gripping strip for a syringe featuring improved burst protection

Info

Publication number: EP1919539A1
Application number: EP06791695A
Authority: EP
Inventors: Norbert Witowski
Original assignee: Bayer Schering Pharma AG
Current assignee: Bayer Intellectual Property GmbH
Priority date: 2005-08-31
Filing date: 2006-08-23
Publication date: 2008-05-14
Also published as: US7846136B2; KR20080043859A; CN101232912B; KR101313996B1; JP4914445B2; US20070088284A1; JP2009505761A; CA2610377C; DE102005042076A1; HK1120447A1; CA2610377A1; DE102005042076B4; WO2007025704A1; CN101232912A

Abstract

The invention relates to a gripping strip (1) for a syringe comprising a sleeve (7) with a first hole (9) to be plugged onto a syringe cylinder (2) and a second hole (10). The gripping strip (1) encompasses a flange (8) that is mounted on the sleeve (7) at a distance from the first hole (9). A plurality of stops (11) which radially protrude inward from the inner wall (21) of the sleeve (7) are provided in order to engage into a groove or protrusions (13) mounted on an external surface of the syringe cylinder (2) and fasten the sleeve (7) and, via the same, the gripping strip (1) to the syringe cylinder (2). A plurality of holes, particularly a plurality of longitudinal holes (14) and/or a plurality of transversal holes (15), are cut into the sleeve (7), thus making it possible for the gripping strip (1) to be locked onto the syringe cylinder (2) using little assembly force such that the tendency of the syringe cylinder (2) to rupture is significantly reduced especially during assembly.

Description

Handle for a syringe with improved burst protection

The present invention relates to a handle for a syringe with improved burst protection.

It is a common problem with syringes constructed of components that assembly of the components must be performed with great force. The expenditure of these high forces has the consequence that the strength of the syringe is reduced. When using the syringe, especially when used for a high viscosity medium such as contrast agent, or even during assembly, it can lead to the destruction of the syringe and thus to a risk for the patient or to a disruption of production processes with economic losses ,

As a solution to the above problem, it has been proposed to incorporate a silicone polymer insert into a syringe barrel receiving device formed on the handle bar. However, the silicone polymer is a very expensive insert which leads to an increase in the production cost of the syringe. From EP 1 123 712 A, a syringe cylinder and a cylinder holder are known. The syringe barrel has at its proximal end, ie at the end facing the user, a flange which can be received by a syringe holder. The molded on the syringe barrel flange increases the mechanical strength of the syringe barrel.

EP 0 723 784 A1 discloses a syringe comprising a glass cartridge which is filled with a pharmaceutical liquid. The glass cartridge is cylindrical and has at one end a circumferential groove around an outer surface. In the groove engage from a sleeve-like receptacle of a handle bar protruding latches. These fix the handle on the glass cartridge of the syringe.

It is an object of the present invention to provide a cost-effective, improved handle bar, which reduces a tendency to burst of a syringe. What is needed is a handle for a syringe which reduces the high assembly forces, ensures the syringe burst protection even when used with mechanical injectors, and prevents twisting of the handle bar, using the syringe for hand and high speed applications.

This object is achieved by a handle bar according to claim 1. Preferred embodiments of the handle are given in the dependent claims.

In particular, a handle for a syringe is provided with: a sleeve having a first opening for attachment to a syringe barrel of the syringe and a second opening; a flange mounted at a distance from the first opening on the sleeve; a plurality of locks made by the Inner wall of the sleeve project radially inward; wherein in the sleeve a plurality of openings, in particular a plurality of longitudinal openings and / or a plurality of transverse openings, is cut out.

Such a handle strip serves to protect the syringe during use, in particular when applying a medium of high viscosity. The handle bar is designed so that a tendency to burst of the syringe barrel when pressing the handle bar is significantly reduced. The handle bar also serves as a flange and as a connection between the syringe barrel and an injector in which to use the syringe.

In particular, the openings, which are designed in particular as longitudinal openings and / or transverse openings, serve as expansion openings of the sleeve of the grip strip. A pronounced reduction in the assembly force of the handle bar on a syringe barrel is due to four preferred longitudinal and transverse openings.

The longitudinal openings and transverse openings are usually cut out as through holes. The reduction of the mounting force can also be achieved by an embodiment of the sleeve with a small wall thickness. The longitudinal openings and transverse openings can thus also be designed such that a wall thickness of the sleeve in the cut-out longitudinal and / or transverse openings is only reduced.

As longitudinal openings, openings are considered which have a greater extent in an axial direction of the sleeve than in a radial direction along a circumference of the sleeve. For transverse openings this is exactly the opposite. The longitudinal openings and the transverse openings are preferably as long formed hole-like slots or depressions. However, other shaped or differently oriented openings may be used.

In order to achieve optimum deformation of the sleeve of the handle when pressing, it is advantageous if the plurality of the openings, in particular the plurality of longitudinal openings and / or the plurality of transverse openings are at least partially cut out of an intermediate region of the sleeve, which is between located the catches and the flange. The fact that the openings are cut out in the intermediate area, a high contact pressure stability is not affected in the latched state. In a region in which the latches are arranged, the sleeve has a radially circumferentially closed wall of the sleeve, at least over a large axial expansion region of the latches.

Except when snapping the handle, there is a high risk of bursting of the syringe in situations where an internal pressure in the syringe barrel exceeds a bursting pressure. Such an overrun occurs in the case of mechanical injectors, in part when the mains voltage with which the injectors are operated fluctuates. Thus, a force acting on a stopper serving as a piston can briefly become so great that a pressure arises in the syringe cylinder which exceeds a bursting pressure of the syringe barrel. In such a case, the syringe barrel bursts. Therefore, in a particularly preferred embodiment of the invention, a self-inventive aspect implemented, according to which it is provided that the flange separates from the handle bar, when a limit force is exceeded. It is preferably provided that a plurality of tear-off webs are formed between the flange and the latches. The tearing webs are intended to allow breakage to take place at a predetermined force interval prior to the bursting strength limit of the cylinder so that the connection between the flange and the sleeve is severed. This breaks the transmission of power from the injector to the syringe.

In a preferred embodiment, it is therefore provided that the plurality of tear-off webs is designed such that the break-off webs break open when the force acting in a predetermined force interval is below a bursting force at which bursting of the syringe barrel occurs, so that the flange of the Locking is separated. This embodiment is particularly safe, since even before reaching the burst limit, a separation of the flange from the rest of the handle bar. A risk of bursting during the injection of viscous liquids is thereby significantly reduced. Undesirable disadvantages for medical personnel and / or patients due to splinters arising during bursting or leakage of the viscous fluid are avoided. Medical and technical processes are not or only slightly disturbed, resulting in a cost savings.

The latches are preferably designed such that the assembly forces are reduced, the transmission of forces during assembly is uniform, the deformation during assembly is minimized and the latch in the load case (during injection) maximum fails, so that the handle bar of dissolves the syringe barrel.

Another independent inventive aspect for reducing the tendency to burst of a syringe barrel is thus realized in an embodiment of the invention, in which the Sleeve has a central axis and the plurality of Ver tours- from the inside of the sleeve inwardly to a central axis of the sleeve so that each have a central portion of the plurality of notches a smaller distance from the central axis than edge portions of the notches. An inner edge of the latches facing the central axis does not describe a concentric curve or surface with respect to the central axis of the sleeve, which in the case of a cylindrical basic shape of the sleeve is a cylinder axis. This ensures that the forces acting on the latches (which are often designed as latching noses) when latching on are reduced. The forces no longer work punctually. A deformation of the corners or the edge regions of the locks are reduced or completely avoided. Likewise, the punctually occurring forces are reduced to the syringe barrel. Even with a circular circumferential groove improved fixation is achieved in addition to a reduction in the tendency to burst. Although each contact surface of an abutment surface of the latches, which extends substantially perpendicularly from an inner wall of the sleeve and in the latched state with the groove or the projections of the syringe barrel is engaged with the groove or with the projection (s) is smaller as in catches whose leading edge is a circular sector concentric with the cylinder axis, the peel forces necessary to release the handle as a whole from a syringe barrel increase. This is due to the fact that when latching the edge regions of the locks are no longer or no longer so much plastically deformed. As a result, the contact surfaces of the catches in the latched state are better overall. The bursting tendency according to this aspect of the invention thus also independent of the feature of the cut-out openings (the especially as longitudinal openings and / or transverse openings are cut) reduced.

A particularly high risk of breakage exists at the moment in which the catches engage in the circumferential groove on the outside of the syringe cylinder or behind one or more projections. At this moment, the locks snap usually jerky. The force required for latching, which causes a deformation of the sleeve and thus the locking in the radial direction is exerted in the axial direction of the handle. In order to intercept an axial movement resulting from the latching and to be able to cushion the assembly forces released at the moment of latching, a plurality of spring elements are preferably formed in the sleeve between the first opening and the second opening. Preferably, four spring elements are provided. At the same time, the spring elements can serve as tension springs against the rotation of the handle on the syringe barrel.

In a preferred embodiment of the invention, the plurality of spring elements is formed like a leaf spring in a radially inwardly projecting into the sleeve stop. As a result, the forces that occur when hitting the handle bar on the syringe barrel can be cushioned.

An inwardly extending stop also facilitates accurate positioning of the handle. The handle bar is preferably to be designed so that an outer proximal end of the syringe barrel abuts the stop in the latched state and bears against the stop. This also offers the possibility of "jamming" the syringe barrel between the stop and the latches. in that the flange for forming the stop extends inwardly from the sleeve.

The spring elements are preferably designed such that the spring elements substantially taper from an edge region to a center. Thus, the effect of a leaf spring bundle can be imitated. In the middle, the elasticity is greatest. However, the spring elements can also be designed differently. For example, the spring elements may be formed as flexible inwardly projecting from the inner wall of the sleeve projections.

In order to ensure that a force is introduced into the spring elements in the middle, it is advantageously provided that each of the spring elements comprises a projection which serves as an interaction point with the syringe cylinder.

The deformability of the spring elements in the region of the force input is further increased in an embodiment in which the spring element adjacent or adjacent to the projection has notches to increase a deformability of the spring element adjacent to the projection or adjacent to the projection.

In order to prevent the syringe from rolling over a plane, in one embodiment it is provided that the flange has at least one cut-away section.

Polycarbonate is a cost-effective material that allows a stable construction of the handle, so it is advantageous if the handle is made of polycarbonate. The following is a description of an embodiment of the invention with reference to the figures. From the figures show:

Figure 1 is a syringe with an attached handle.

2 is a perspective view of the handle bar according to an embodiment of the invention from below.

Fig. 3 is a plan view from the distal end of the handle bar of Fig. 2;

Fig. 4 is a sectional view of the handle bar according to the embodiment with expansion openings along the line A-A of FIG. 3;

Fig. 5 is a sectional view of the handle along the line C-C of Fig. 4;

Fig. 6 is a partial sectional view of the proximal end of the handle bar of Fig. 2;

Fig. 7 is a sectional view of the handle along the line B-B of Fig. 6;

Fig. 8 is a sectional view of the handle along the line D-D of Fig. 6;

9 shows a detail of the handle strip of the sectional view of FIG. 7;

FIG. 10 shows a detailed view of the proximal end of the syringe barrel with the attached gripping strip from FIG. 1; FIG. Figure 11 is a plan view of the proximal end of the handle.

Fig. 12 is a sectional view of the handle along the line E-E of Fig. 11; and

13 is an enlarged detail of a spring element of FIG. 12th

In Fig. 1, a handle bar 1 is shown, which is attached to a syringe barrel 2. More specifically, the handle 1 is placed on the proximal end of the syringe barrel 2, i. on the end facing the user. The distal end of the syringe barrel is closed by a cap 3. In the syringe barrel 2, a piston 4 is inserted.

In Fig. 2, the handle 1 is from below, i. shown from the proximal end 5; in Fig. 3, the handle bar is from above, i. a distal end 6 of the handle bar shown in plan view. In Fig. 4, the handle bar 1 is shown in section along the line A-A. As can be seen from FIG. 2, the gripping strip 1 has a sleeve 7, from which a flange 8 extends radially. The sleeve 7 has, as can be seen in particular in Fig. 4, a first opening 9, which is associated with the distal end 6 of the handle 1. As can be seen from Figs. 2 and 4, the flange is spaced from the first opening 9 substantially attached to a second opening 10 which is associated with the proximal end 5 of the handle 1.

From Fig. 2 it can be seen that extend from the inside of the sleeve 7 catches 11 radially inwardly. The projections 11 formed as projections are in cross section formed "triangular", as is apparent from Fig. 4. At the distal end 6 of the sleeve 7, the catches 11 are not projecting from the inner wall of the sleeve, towards the proximal end 5, the catches 11 are thicker in a direction towards a central axis 12 of the sleeve 7. As can be seen from Fig. 1, when the handle bar 1 is set on the syringe barrel 2, the notches 11 engage behind projections 13 formed on the outside of the syringe barrel 2 at the proximal end thereof. As a result, a secure fit of the handle 1 is made on the syringe barrel 2.

As can be seen in particular in Figs. 2 and 4, in the wall of the sleeve 7, a plurality of longitudinal openings 14 are formed, which extend in the axial direction of the sleeve 7, in the embodiment are four longitudinal openings 14. Furthermore is formed in the wall of the sleeve 7, a plurality of transverse openings 15 which extend circumferentially in the wall of the sleeve 7. In the illustrated embodiment, there are four transverse openings 15. The longitudinal openings 14 and the transverse openings 15 allow the handle bar to respond elastically to occurring forces. The longitudinal openings

14 and the transverse openings 15 are at least partially cut out of an intermediate region 16 of the sleeve 7. As an intermediate region 16, the region of the sleeve is referred to, which is located in the axial direction or longitudinal direction of the sleeve between the latches 11 and the flange 8. The transverse openings

15 are completely cut out of the intermediate region 16. The longitudinal openings 14 are largely also cut out of the intermediate region 16. However, the longitudinal openings partly protrude into a so-called latching region 17, in which the catches 11 are integrally formed on the sleeve 7. In the direction parallel to the central axis 12, however, the latching region 17 is in a large area around an entire circumference of the sleeve 7 closed formed without openings. This ensures that the latching, when the handle bar 1 is fixed to the syringe barrel 2, securely remains in engagement with the projection or the projections 13 of the syringe barrel. The distal end 6 has no openings in the sleeve 7.

In Fig. 5 is a sectional view of the handle bar 1 along the line C-C in Fig. 4 is shown. In particular, in Fig. 5 it can be seen that a plurality of tear-off webs 18 is formed. The demolition webs 18 are realized by particularly thin webs formed between the longitudinal openings 14 and the transverse openings 15. The tear-off webs 18 make it possible, in an emergency, to separate the flange 8 from the sleeve 7.

As can be seen in particular from Fig. 5, the plurality of notches 11 in this embodiment is four. The latches 11 are formed by the inwardly pointing "pointed" edges.

In Fig. 6 is a plan view of the proximal end 5 of the handle bar is shown. The associated sectional views along the lines B-B and D-D are shown in Fig. 7 and Fig. 8 respectively. A section X of FIG. 7 is shown in FIG. 9.

As can be seen in particular from FIGS. 7 to 9, the latches 11 roughly simplified have a triangular shape. Therefore, the latches have an inclined surface 19 and an abutment surface 20 extending substantially at right angles away from the sleeve 7. The inclined surface 19 runs to the distal end 6 of the sleeve 7 at an acute angle to an inner wall 21 of the sleeve 7 and is rounded in this over. The abutment surface 20, which extends substantially at right angles from the sleeve 7, also rounds off into the inner wall 21 of the sleeve 7. Both the sloping surface 19 and the abutment surface 20 may transition into the other embodiments at an acute angle or substantially at a right angle into the inner wall 21.

When the handle bar 1 is pushed onto the proximal end of the syringe barrel 2, engage the notches 11 of the handle bar 1 behind the projections 13 of the syringe barrel 2, as can be seen well in Fig. 10, which shows a Ausschnittsvergrδßerung the proximal end of the syringe barrel 2 with represents the latched handle bar 1. Therefore, the handle bar 1 is easy to defer on the syringe barrel 2, but can not be pulled down again.

As can be clearly seen in particular from FIGS. 7 to 10, at the detents 11 between the oblique surface 19 and the abutment surface 20 extending essentially at right angles from the sleeve, a step extending substantially perpendicularly to a plane spanned by the distal opening 6 is provided - Forming surface 22 formed. This ensures that a front edge 23 of the substantially perpendicularly extending from the sleeve abutment surface 20 is damaged neither during snapping nor upon application of force along a stripping direction.

If this edge 23 is damaged, then the abutment surface 20 is not flat against the projection or projections 13 of the syringe barrel 2. This leads to a reduction of the pull-off forces that are required to pull the handle bar 1 of the syringe barrel 2 again. When snapping a handle bar on a syringe barrel, wherein the front edge and / or support surfaces of the locks are each formed as a concentric circle segments or cylinder sector element to a central axis of the sleeve act at corners or edge regions of the locking much larger forces than in a central region. In the embodiment described here, this disadvantage is eliminated. In the described embodiment, corners 24 and edge portions 25 of the catches 11 have a greater distance r _x from the central axis 12 of the sleeve 7 than a central portion 26. A distance r ₂ from the central axis 12 of the sleeve 7 to the central portion 26 of the latch 11 is thus larger than the distance ri. As a result, in particular plastic deformations of the corners 24 are avoided or reduced when snapped. In this way, although the contact surface 20 is smaller compared to the "concentric" variant of the locking by the improved concern to the one or more projections 13 in the latched state an improved resistance against pulling the handle bar 1 is still achieved.

As can be seen in particular in FIGS. 2, 3, 7 and 10, a stop 27 protruding inwardly from the inner wall 21 is formed. The handle bar 1 can be pushed onto the proximal end of the syringe barrel 2 until the stop 27 abuts against an outer proximal end of the syringe barrel 2. For an accurate positioning of the handle bar 1 is possible.

The force required for latching acts on the handle 1 substantially parallel to the central axis 12 to cause a radial deformation of the sleeve 7 and / or the latches 11. The moment in which the latches 11 behind the or engage the projections 13, the energy stored in the deformed sleeve and / or the deformed locks 11 is released. Furthermore, as a rule, the axially acting force acts. As a result, a shock is exerted on the impact of the stop 27 on the proximal end of the syringe barrel. In order to be able to absorb this shock, 27 spring element 28 are formed in the stop. These can be seen most advantageously in FIG. 12 and FIG. 13, an enlarged detail Z of FIG. 12. FIG. 12 shows a sectional view along a line EE of FIG. 11, which again shows substantially the same view of the grip strip 1 as FIG. 6.

In the stop 27 four spring elements 28 are formed. The spring elements 28 are similar in design leaf springs, which are curved concentrically to the central axis 12.

A material thickness of the spring elements 28 tapers from edge regions 29 in each case toward a center 30. In the middle 30, a projecting towards the distal end 6 of the sleeve 7 each projection 31 is formed. This acts as an interaction point or area with the syringe barrel. As a result, a central force is achieved in the spring elements 28.

In order to maintain a bendability near the center 30 of the spring elements in spite of the projections 31, notches 32 are formed adjacent to the projection 31.

In the latched state, the projections 31 are advantageous at the outer proximal end of the syringe barrel 2 or are in engagement with this. Particularly preferably, the spring elements 28 are even in the latched state slightly tense. As a result, a rotation of the handle 1 relative to the syringe barrel 2 can be prevented.

As can be seen in particular from Fig. 2, 3, 6 and 11, the flange 8 is not formed completely circular. Rather, a segment is cut away so that a straight portion 33 is formed which prevents rolling when the syringe is deposited on a flat surface.

The handle 1 is preferably made of polycarbonate. Polycarbonate can be easily sterilized, but has sufficient strength so that the handle bar 1 can protect the proximal end of the syringe barrel 2 against mechanical damage.

LIST OF REFERENCE NUMBERS

1 handle bar

2 syringe barrels

3 cover

4 pistons

5 proximal end of the handle

6 distal end of the handle

7 sleeve

8 flange

9 first opening

10 second opening

11 latches on the inside of the sleeve

12 central axis of the sleeve

13 protrusions on the syringe barrel

14 longitudinal openings in the axial direction

15 transverse openings in the circumferential direction

16 intermediate area

17 rest area

18 demolition bars

19 inclined surface 20 contact surface

21 inner wall of the sleeve

22 support surfaces

23 front edge of the catch

24 corners of latching

25 edge areas of the locking

26 Middle area of locking

27 stop

28 spring elements 9 edge region of the spring element

30 middle of the spring element Projection notch straight section

Claims

claims

A handle (1) for a syringe comprising: a sleeve (7) having a first opening (9) for attachment to a syringe barrel (2) of the syringe and a second opening (10); a flange (8) spaced from the first opening (9) on the sleeve (7); a plurality of latches (11) projecting radially inwardly from an inner wall (21) of the sleeve (7); wherein in the sleeve (7) has a plurality of openings, in particular a plurality of longitudinal openings (14) and / or a plurality of transverse openings (15), cut out.

2. handle strip (1) according to claim 1, characterized in that the plurality of openings, in particular the plurality of longitudinal openings (14) and / or the plurality of transverse openings, at least partially from an intermediate region (16) of the sleeve (7) are cut out which is located between the catches (11) and the flange (8).

3. gripping strip (1) according to claim 1 or 2, characterized in that a plurality of tear-off webs (18) between the flange (10) and the latches (11) are formed.

4. handle strip (1) according to claim 4, characterized in that the plurality of tear-off webs (18) is designed so that the tear-off webs (18) at a force acting in a predetermined force interval below a bursting force at which a bursting of Spritzenzylin- ders (2) break open, so that the flange (8) is separated from the latches (11).

5. gripping strip (1) according to any one of the preceding claims, characterized in that the sleeve (7) has a central axis (12) and the plurality of notches (20) from the inner wall (21) of the sleeve (7) inwardly so extend to the central axis (12) of the sleeve (7), that in each case a central region (26) of the plurality of notches (11) have a smaller distance from the central axis (12) than edge regions (25).

6. gripping strip (1) according to one of the preceding claims, characterized in that a plurality of spring elements (28) in the sleeve (7) between the first opening

(9) and the second opening (10) are formed.

7. gripping strip (1) according to claim 6, characterized in that the plurality of spring elements (28) are formed like a leaf spring in a radially inwardly into the sleeve (7) projecting stop (27).

8. gripping strip (1) according to claim 6 or 7, characterized in that the spring elements (28) from edge regions (29) to a center (30) substantially taper.

9. gripping strip (1) according to one of claims 6 to 8, characterized in that each of the spring elements (28) comprises a projection (31) which serves as an interaction point with the syringe barrel (2).

10. handle strip (1) according to claim 9, characterized in that the spring element (28) adjacent to or adjacent to said projection (31) has notches (32) to increase deformability of the spring member (28) adjacent to the projection (31) or adjacent to the projection (31).

11. Gripping strip (1) according to one of claims 7 to 10, characterized in that the flange (8) for forming the stop (27) extends from the sleeve inwardly.

12. gripping strip (1) according to one of the preceding claims, characterized in that the flange (8) has at least one cut away portion.

13. Handle strip (1) according to one of the preceding claims, which is made of polycarbonate.