WO2008075368A1

WO2008075368A1 - Ampoule breaker

Info

Publication number: WO2008075368A1
Application number: PCT/IL2007/001595
Authority: WO
Inventors: Zvi Haim
Original assignee: 3By Ltd
Current assignee: 3By Ltd
Priority date: 2006-12-21
Filing date: 2007-12-23
Publication date: 2008-06-26
Anticipated expiration: 2009-06-21

Abstract

A device adapted for breaking open a glass ampoule is provided. The device has tubular member defining an axis and having a proximal opening for insertion of the tip portion of an ampoule and a distal end adapted to accommodate the tip portion. The device has at least one flap hinged to the tubular member adjacent the proximal opening. The flap comprises at least one inner radial projection, and is adapted to be brought between an open state wherein the flap extends in a general lateral direction and a closed state wherein the flap is substantially flush with the tubular member. In a closed state the inner projection bears on the neck portion and has at least one contact point therewith. In said closed state the device permits the application of an off-axis force on the tip portion to cause its breaking.

Description

AMPOULE BREAKER

FIELD OF THE INVENTION

The present invention relates to universal ampoule breakers adapted for breaking ampoules of plurality of sizes and that essentially provides protection for the fingers of a person breaking off the tip of the ampoule.

BACKGROUND OF THE INVENTION

Various liquid medicaments are conventionally supplied in a glass ampoule which has a body containing the liquid, a tip that one holds in order to break open the neck portion that is the breaking point of the ampoule. The neck portion is often provided with an etched break-line adapted to assist in breaking open the ampoule. The neck portion readily fractures when pressure is applied to the neck by gripping the head and the body independently and through the torque applied on the neck portion, the neck portion breaks, the interior of the ampoule can then be accessed and the contents can then be drawn, for example, into a syringe.

One significant problem is that when the braking the ampoule there is a risk that the users might cut his/her hands on the jagged exposed glass surface either during the process of breaking or after the ampoule is open. This procedure was improved by specific tools being designed to help in breaking open an ampoule.

Several types of ampoule breakers designed to mitigate such problems are known. US 6,540,125 discloses a device designed for clamping a breakable article, in particular, a vile provided with the breaking zone dividing said article into two parts, comprising means for clamping one part and means pivotally attached to said clamping means for holding the second part of said article in order to allow safe breaking. Said device is also provided with means for holding a part of the object lying on the other side of the breaking point.

SUMMARY OF THE INVENTION

The present invention provides a novel ampoule breaker device that can be used effectively to safely break-open ampoules. According to the invention there is thus provided a device adapted for breaking open a glass ampoule with a tip portion, a body portion and a neck portion extending therebetween. The device comprises: a tubular member defining an axis and having a proximal opening for insertion of the tip portion and a distal end adapted to accommodate the tip portion, the device further comprises at least one flap hinged to the tubular member adjacent the proximal opening. The at least one flap comprises at least one inner radial projection, and is adapted to be brought between an open state wherein the at least one flap extends in a general lateral direction and a closed state wherein the at least one flap is substantially flush with the tubular member. In a closed state the at least one inner projection bears on the neck portion and has at least one contact point therewith. In the closed state the device permits the application of an off-axis force on the tip portion to cause its breaking.

Typically, the device comprises at least two flaps, whereby when in the closed state, the at least two flaps form an essentially collar structure around the neck portion. By one embodiment the flaps are provided with a locking member integrated to the side of each of the flaps and which is adapted for snap locking with an adjacent member in the closed position.

In accordance with some embodiments of the invention, the distal end of the tubular member is open. In accordance with other embodiments the distal end is closed. By one embodiment of the invention the shape of the tubular member is essentially frusto-conical. By another embodiment the shape of the tubular member is substantially cylindrical.

In accordance with one embodiment the device is adapted for use with an ampoule of a defined size. In accordance with other embodiments the tubular member of the device is adapted to receive ampoules with tip portion of different diameters. For this purpose the tubular member may have a radial flexibility. This may be achieved, for example, by axial slots extending from the distal end to at least a location intermediate between the distal and the proximal end, said axial slots imparting said flexibility. Such an ampoule breaking device may typically be adapted for use with ampoules with volumes in the range of about 1 to about 10ml. Whether having radial flexibility or not, the tubular member is typically designed so as to fit snugly over the ampoule tip.

Thee flap, by some embodiments of the invention may pivotally and integrally fixed to the tubular member by a live hinge to the proximal end of the tubular member. The at least one projection, by some embodiments, is in the form of a rib adapted to bear on the neck portion of the ampoule. The rib is typically substantially flat-blade shape. To ensure tight engagement between the rib and the rounded surface of the ampoule neck, its rim is essentially arcuate. According to one preferred embodiment, the at least one flap has an aperture adapted to permit view and alignment of a marking on the ampoule for optimal positioning of the ampoule neck to yield efficient breaking thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to understand the invention and to see how it may be carried out in practice, a preferred embodiment will now be described, by way of non-limiting examples only, with reference to the annexed drawings, in which:

Fig. 1 is an isometric view of a universal ampoule breaker according to an embodiment of the present invention in its opened position.

Fig. 2 is a front view of the universal ampoule breaker of Fig. 1 in an opened position.

Fig. 3A is a side view of the universal ampoule breaker of Figs. 1 and 2 in an opened position.

Fig. 3B is a side view of the universal ampoule breaker of Figs. 1 and 2 in an opened position engaging the tip of an ampoule. Fig. 4A is a universal ampoule breaker of Figs. 1 and 2 in a closed position.

Fig. 4B is a bottom view of the universal ampoule breaker of Fig. 4A after breaking and removal of the body of the ampoule.

Fig. 4C is a universal ampoule breaker of the present invention in a closed position fitted over an ampoule tip and neck portion of the ampoule. Fig. 5 is an illustration of another embodiment of the universal ampoule breaker of the present invention in a closed position.

Fig. 6 is an illustration of yet another embodiment of the universal ampoule breaker of the present invention in a closed position. DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

Various terms as used in the specification and the claims are defined herein below. To the extent a term is not defined below, it should be given the broadest definition person in the pertinent art has given that term as reflected for example in printed publications and issued patents.

The term "tubular member" refers broadly to a member that includes a cavity that is capable of receiving an ampoule tip. Any structure that would be commonly recognized, referred to, or understood as "tubular member" is considered to be tubular member within the meaning of this invention. The term "locking mechanism" means member/members that is/are capable of connecting and preferably holding or securing at least two flaps together. Any structure that is commonly recognized, referred to, or understood as "locking mechanism" is considered to be a locking mechanism within the meaning of this invention. A locking mechanism may, for example include aperture/receptacle and any feature e.g., a protrusion, that fits into the aperture/receptacle and thereby holds two members together due to the interconnectivity that is created. Specific example is disclosed in the drawings, but this term is not limited to such structure.

The term "hinge" means a member, device, or structure defining an- axis around which two elements or members move. The hinge may also be a structure or integral part of another structure that supports movement, or a joint (e.g. live hinge) that itself operates as an axis around which two other members are capable of moving. Any structure that would be commonly recognized, referred to, or understood as "hinge" is considered to be a hinge within the meaning of this invention.

The term "projection" as used herein refers to any portion of the inner surface of the flap that protrudes inward and defines a smaller circumference than that of the surrounding flap. Any structure that would be commonly recognized, referred to, or understood as "projection" is considered to be a projection within the meaning of this invention. The projection may circumference all or part of the inner flap surface. The projection may have an arcuate rim or an essentially plateau rim. The projection may be formed as integral portion of the flap or may be alternatively fixed to the flaps, through one or more connecting members constituting biasing member for biasing the rib inwardly to ensure its tight association with the neck portion of the ampoule. The term "ampoule" refers to hermetically sealed vial, typically made of glass, usually holding a single dose of a solution used for hypodermic injection. The ampoule "tip" is the portion of the ampoule that is typically broken off or removed prior to dispensing of the solution. Typically, for ampoules having narrow neck portions, e.g., ampoule similar to those shown in the drawings, the ampoule tip is narrower than the body of the ampoule but wider than the ampoule neck. The term "ampoule" as used herein refers to ampoules of various sizes varying from ImI to at least 10ml in volume.

In accordance with one embodiment of the present invention, an ampoule (best seen in Fig. 3B) is generally designated 300 and comprises an ampoule body, a tip 305, the tip having a proximal end portion 303 and a distal end portion 304, and a neck portion 302 extending between the ampoule body and the proximal end portion 303.

Attention is first directed to Figs. 1 and 2 of the drawings, illustrating a universal ampoule breaker, generally designated 100, in accordance with one embodiment of the present invention. The ampoule breaker 100 comprises an elongated tubular member 102 having an axis X and an inner cavity 108 adapted to essentially receive the tip 305 of the ampoule 300 (as can be seen in Fig. 3A) extending between a proximal open end for insertion of the tip 305 and a distal open end 122 for accommodating the end of the tip 305.

The ampoule breaker 100 is integrated with two side flaps 104 A and 104B fixed to the proximal end of the elongated tubular member 102 such that they can be displaced between an open state in which they are angled with respect to the axis X, e.g. as seen in Figs. 1-3, and a closed state in which they jointly define a generally cylindrical collar structure, such as seen in ₍Fig. 4C, fitting over a neck portion 302 of said ampoule 300. The elongated tubular member 102 is essentially frusto-conical and has radial flexibility imparted by four axial slots 120 extending from the distal end 122 to a location intermediate between the distal and the proximal ends of the elongated tubular member 102.

By imparting flexibility to the distal part 122 of the tubular member the device is adapted to receive the tip portion 305 of different dimensions , of commercially available ampoules, varying from ImI to 10 ml, and to accommodate the ampoule tip therein. Tips of small ampoules, e.g. of 1 ml, will be accommodated entirely within the distal part 122, while the tip of larger ampoules, e.g. of 10 ml, will protrude through the opening at the distal end 122 of the ampoule breaker 100, as can be seen in Figs. 3B and 4C.

According to a specific embodiment, the side flaps 104 A and 104B are provided with an essentially rib structured projection 106 A and 106B, respectively, circumferentially aligned within the proximal end portion of the flaps 104A and 104B, such projection, radially projecting inwardly to bear on the neck portion 302 with a diameter (designated Z in Fig. 4B) narrower than that defined by the flaps (designated Y in Fig. 4B ) for receiving and engaging the ampoule neck 302 (Fig. 4B).

Ribs 106A and 106B are fixed to the flaps 104A and 104B by a connecting member 202, constituting biasing member adapted to bias the ribs 106A and 106B inwardly as these are forced against the neck portion 302 of the ampoule 300. The side flaps 104 A and 104B are pivotally and integrally fixed by a rounded live- hinge member 124 to a proximal end of the tubular member 102.

As illustrated in Fig. 4C, when the side flaps 104A and 104B are closed over and around the ampoule neck 302, the rib structured elements 106A and 106B fit and bear tightly over the neck portion 302 facilitating fast and easy breaking of an ampoule 300 into two parts, i.e., tip 305 and body 304, while the tip portion 305 of the ampoule is essentially encapsulated in the breaker 100 preventing a contact with the exposed, broken and jagged glass surface. The ampoule breaker 100 with the ampoule tip 305 may then be disposed.

According to a preferred embodiment of the present invention, as illustrated in Figs. 1 and 2, the breaker 100 is provided with a locking mechanism, where each flap 104A and 104B is provided with locking members 126A and 126B (on 104A) adapted for snap locking into corresponding receptacles 128A and 128B formed at an opposite flap (104B) so as to retain the flaps at their closed position (e.g. as can be seen Fig. 4A). According to another embodiment one flap 104 A is equipped with a locking member and a receptacle 126A and 128B (not shown) while the second flap 104B is equipped with corresponding receptacle and locking member 126B and 128A. According to yet another embodiment, the flaps 104A and 104B are devoid of locking elements and are firmly held together when breaking the ampoule 300.

The device 100 of the present invention is typically manufactured from flexible and resilient material, e.g. plastic, rubber etc, and according to one preferred embodiment the device 100 of the present invention is of an essentially integral molded structure.

As illustrated in Fig.3A, ribs 106A and 106B according to this embodiment are of substantially flat blade-shape having an essentially arcuate rim 108 to ensure that said ribs 106A and 106B will tightly engage an arcuate surface of the ampoule neck portion 302 in the closed state.

Turning now to Fig. 3B, an ampoule breaker 100 according to one embodiment of the present invention is illustrated, in an open position, fitted over an ampoule tip 305 extending through the distal side of the elongated tubular member 102. In Fig. 4 A an ampoule breaker 100 according to a preferred embodiment of the present invention is illustrated in its closed position, where the two side flaps 104A and 104B are locked by locking member 126A and its corresponding receptacle 128A with flaps 104A and 104B being subsequently retained at their closed position to facilitate the breaking of the ampoule 100. It can be seen in Fig. 4C that when ampoule breaker 100 according to the shown embodiment of the present invention is fitted over an ampoule tip 305 and neck 302, the flaps 104A and 104B are snap-locked over the neck portion 302 of an ampoule 300 while the rib structure 106A and 106B tightly engages the rounded surface of an ampoule neck 302 safely breaking the ampoule 300. Fig. 5 is an illustration of an additional embodiment of the universal ampoule breaker 500 of the present invention, wherein the tubular member 502 is of substantially cylindrical shape. In Fig. 5, elements 504, 506, 522 and 524 are similar in structure and functions to respective elements 104, 106, 122 and 124 in Fig. 1.

In Fig. 6, another embodiment of the universal ampoule breaker 600 is illustrated. The elements 602, 622 and 624 illustrated in fig.6 are similar in structure and function to respective elements 102, 122 and 124 in Fig. 1.

On ampoule 650 of relatively small volume, e.g. ImI and/or 2ml, a break line 654 is etched on the neck 652. The ampoule 650 also includes a single small dot 653 on a proximal portion 658 of the ampoule tip 656 above the break line 654. In use, the ampoule 650 is inserted and positioned such that dot 653 is aligned with an aperture 603 and when so positioned ribs 606 come in contact with the break line 654. According to this embodiment the aperture 603 is circular; however the aperture 603 can be of any shape that will enable the user to see the marking on the tip 656.

According to yet another embodiment (not shown) the ampoule breaker of the present invention or at least part thereof is sufficiently transparent to allow a user an essentially clear view of the ampoule surface and any markings thereon.

Those skilled in the art to which this invention pertains will readily appreciate that numerous changes, variations and modifications can be made without departing from the scope of the invention mutatis mutandis.

Claims

CLAIMS:

1. A device adapted for breaking open a glass ampoule with a tip portion, a body portion and a neck portion extending therebetween, the device comprising: a tubular member defining an axis and having a proximal opening for insertion of the tip portion and a distal end adapted to accommodate the tip portion; at least one flap hinged to the tubular member adjacent the proximal opening,; the flap comprising at least one inner radial projection, and being adapted to be brought between an open state wherein the flap extends in a general lateral direction and a closed state wherein the flap is substantially flush with the tubular member; in a closed state said inner projection bears on the neck portion and has at least one contact point therewith; in said closed state the device permitting the application of an off-axis force on the tip portion to cause its breaking.

2. A device according to Claim 1 comprising at least two flaps, whereby when in the closed state, the at least two flaps form an essentially collar structure around the neck portion.

3. A device according to claim 2, wherein each of the flaps is provided with a locking member integrated to the side of each of the flaps and which is adapted for snap locking with an adjacent member in the closed position.

4. A device according to any one of the preceding claims, wherein a distal end of the tubular member is open.

5. A device according to any one of the preceding claims, wherein the shape of the tubular member is essentially frusto-conical.

6. A device according to any one of claims 1-4, wherein the shape of the tubular member is substantially cylindrical.

7. A device according to any one of the preceding claims, wherein the tubular member is adapted to receive ampoules with tip portion of different diameters.

8. A device according to claim 7, wherein the tubular member has a radial flexibility.

9. A device according to claim 8, comprising axial slots extending from the distal end to at least a location intermediate between the distal and the proximal end, said axial slots imparting said flexibility.

10. A device according to any one of claims 7-9, adapted for use with ampoules with volumes in the range of about 1 to about 10ml.

11. A device according to any one of the preceding claims, wherein the tubular member is designed to fit snugly over the ampoule tip.

5 12. A device according to any one of the preceding claims, wherein the flap is pivotally and integrally fixed by a live hinge to the proximal end of the tubular member.

13. A device according to any one of the preceding claims, wherein the projection is in a form of a rib adapted to bear on the neck portion of the ampoule.

14. A device according to Claim 13, wherein the rib is of a substantially flat-blade 10 shape.

15. A device according to any of the preceding claims, wherein the projection has an essentially arcuate rim to ensure that said projection will tightly engage a rounded surface of the ampoule neck in the closed state.

16. A device according to any of the preceding claims, wherein the tubular 15 member and the flaps are integral.

17. A device of claim 16, made of plastic and formed by molding.

18. A device according to any of the preceding claims, wherein the jflaps| have an aperture to permit view and alignment of a marking on the |ampoule| for optimal positioning of the ampoule neck to yield efficient breaking thereof.

20 19. A device according to any of the preceding claims, wherein the device is formed from a substantially transparent plastic material.