The present invention relates to apparatus and method for opening ampoules.
Ampoules are small containers commonly used for storing medical substances such as liquids intended for hypodermic injection. A typical ampoule has a hollow body for containing a substance, a narrow neck, and a top or head portion which is smaller in volume than the body and which is greater in cross-section than the neck. The head portion and body are normally in fluid communication via a passageway in the neck.
Removal of the head portion from the body portion by breaking the ampoule at the neck allows access to the contents of the body portion. The contents may then be conveniently extracted from the body portion by insertion of a syringe needle through the passageway in the neck and aspiration of some or all of the contents into the syringe.
Opening of an ampoule may be achieved by holding the body using the thumb and one or more fingers of one hand, holding the head portion using the thumb and one or more fingers of the other hand so that the thumbs of the user are close together, and snapping the ampoule at the neck. However, opening the ampoule in this way may lead to the user being injured by sharp pieces of glass, especially if the head portion is inadvertently crushed. Other problems with opening of ampoules include regulating finger pressure on the ampoule head, strain to the forearm, especially after repeated operations, and safe disposal of the head.
In order to avoid injury to a user opening an ampoule, protective covers have been proposed for use during the opening operation. U.S. Pat. No. 4,405,069 discloses an ampoule breaker which has a pair of deformable flexible lip portions (preferably made from a cut-resistant flexible plastic) between which an ampoule head may be placed so that the lip portions serve as a protective barrier between the ampoule head and the gripping digits of the user. While this mitigates the problem of injury, the user must still control and regulate finger pressure upon the head in order to retain the head within the lip portions yet avoid crushing the ampoule head and creating hazardous glass fragments. A user may still suffer from repetitive strain injury if repeated ampoule opening operations are performed.
It is an aim of this invention to provide an apparatus and method for opening ampoules which overcome or ameliorate one or more of the disadvantages or problems described above, or which at least provide a useful alternative.
In one broad form, this invention provides an apparatus for opening an ampoule of the type having a detachable head portion, the apparatus comprising:
a body portion having a cavity adapted to receive at least part of the head portion of the ampoule; and
retaining means on the body portion for retaining the head portion at least partially within the cavity after it has been inserted therein;
whereby the head portion may be detached from the remainder of the ampoule by relative movement between the body portion having the head portion retained at least partially therein and the remainder of the ampoule.
With the present invention, the user need not manually retain the head portion in the body portion; it is held therein by the retaining means while the head portion is detached from the remainder of the ampoule. Moreover, it is held therein by the retaining means until deliberately ejected as described below. After ejection of a detached ampoule head, the apparatus may be re-used.
In one embodiment, the retaining means has an expandable opening whose widest dimension at rest is less than the widest portion of the head portion. The retaining means is mounted on the body portion such that at least the widest portion of the head portion passes through the opening when the head portion is inserted into the cavity. The retaining means is expanded by the passage of the head portion therethrough and then automatically constricts behind the widest portion of the head portion to releasably retain the head portion at least partially in the cavity.
The retaining means is a preferably a resiliently expandable annular device such as an O-ring of elastomeric material. The elasticity of the O-ring allows it to be used with differently sized ampoule heads.
The retaining means may take other forms such as a four-lobed O-ring (of the type sometimes known as a quad ring) or a resiliently flexible washer.
The O-ring is suitably located at least partially in an annular groove adjacent the entrance of the cavity in the body portion.
Preferably, the ampoule opening apparatus of this invention further comprises a mechanism for ejecting the head portion of the ampoule from the cavity. This ejecting mechanism may suitably be an elongate member slidable within the body portion. The elongate member is manually operable to contact the head portion of the ampoule retained within the cavity and eject it from the cavity against the action of the retaining means.
More preferably, the elongate member is resiliently biased towards the entrance of the cavity in the body portion by a helical (coil) spring. The bias force is suitably a gentle force.
The elongate member preferably has an axis which is generally aligned with the centre of the entrance of the cavity, and has a concave portion at its end adapted to contact the head portion of the ampoule. In this manner, it retains the head portion centrally relative to the entrance of the cavity after it has been detached. This assists in ejecting the detached head portion from the cavity against the action of the retaining means.
The above described arrangement also provides ideal pressure points for the head portion to be detached easily. When the ampoule is held vertical and the body portion is levered forward to snap the head portion off, pressure occurs at the lowest point of the head portion on one side, and at the highest point of the head portion on the opposite side. This results in the ideal lever action with and less force being required.
Typically, the body portion of the ampoule opening apparatus is generally of elongate cylindrical shape, with the cavity at an end thereof. This enables the body portion to be used in a lever action, with the user positioning his/her hand with the thumb at the top, and the little finger towards the cavity end. This, in turn, results in less stress on the wrist as it used in a more ergonomical manner than that required for known ampoule openers.
Preferably the body portion is at least 3 cm in length, and more preferably at least 8 cm in length.
The external surface of the body portion may be provided with a flat portion extending axially along its length, to prevent the body portion from freely rolling about its axis.
The body portion may be provided with a cavity at each axial end thereof, the cavity at one end being sized differently from the cavity at the other end.
In another broad form, this invention provides a method of opening an ampoule of the type having a detachable head portion, the method comprising:
holding the ampoule in a first hand with the head portion uppermost,
holding in the other hand with the thumb uppermost, an ampoule opener having a cavity at its lower end adapted to receive the head portion of the ampoule,
inserting the head portion of the ampoule at least partially into the cavity, the ampoule opener having retaining means for retaining the head portion at least partially within the cavity after it has been inserted therein, and
causing relative movement of the ampoule opener having the head portion retained therein and the remainder of the ampoule to thereby detach the head portion from the remainder of the ampoule.
Preferably, the ampoule opener includes an elongate member slidable therein, and the method further comprises the step of manually operating the elongate member to contact the head portion of the ampoule retained within the cavity and eject it from cavity against the action of the retaining means. The elongate member is typically operated by depressing its upper end with the thumb of the other hand.
In order that the invention may be more readily understood and put into practice, one or more embodiments thereof will now be described, by way of example only, with reference to the accompanying drawings.
a) is a vertical cross-section of the body of the apparatus of
b) is a vertical cross-section of a release mechanism element of the apparatus of
a) shows an ampoule about to be inserted into the apparatus of
b) shows the ampoule head partially inserted into the apparatus;
c) shows the ampoule head inserted into the apparatus;
a) shows the apparatus with inserted ampoule immediately prior to opening of the ampoule;
b) shows the apparatus and ampoule immediately after opening of the ampoule;
a) shows the detached ampoule head retained in the apparatus;
b) shows the detached ampoule head immediately after release/ejection from the apparatus;
a) and 6(b) correspond generally to
a), 7(b) and 7(c) and
With reference to
The apparatus 1 further comprises at least one retaining member which in this embodiment is in the form of an O-ring 30, provided generally at the opening of the cavity 11, that is, at the first end of the generally cylindrical body 10. The plunger 20 is retained in a central bore 12 of the generally cylindrical body 10, and is biased towards the first end of the generally cylindrical body 10, in this embodiment by a resilient member in the form of a helical spring 40.
Referring now especially to
The cavity 11 is open at the first end of the generally cylindrical body 10. Close to the first end of the generally cylindrical body 10 an annular groove 14 is provided in the internal wall of the cavity to receive and retain the O-ring 30. It will be appreciated that the internal diameter of the O-ring 30, when unstretched, is substantially smaller than the diameter of the opening of the cavity 11, so that it somewhat occludes the cavity. The external diameter of the O-ring 30, when unstretched, is considerably smaller than the diameter of the annular groove 14. The O-ring is sufficiently elastic that it can be stretched considerably by passage of an ampoule head therethrough, and the size of the groove 14 accommodates such stretching.
The generally cylindrical body 10 is, in this embodiment, also provided with an external flange or collar 15 at its first end. This may protect a user's hand from contact with the broken upper surface of an ampoule body and also provides a convenient region of increased width, allowing the apparatus to be stored in a rack (in an inverted orientation) which has an aperture corresponding to the cross-sectional shape of the part of the generally cylindrical body 10 which is not widened. As can be seen in
Use of the indicium will be described below.
Referring now to
The ampoule head engaging portion is provided with an upwardly facing shoulder 24 where it joins the stem 21 and is further provided with a concave region 25 at an underside thereof. The concave region 25 is shaped to receive and engage part of an ampoule head.
As shown in
a), 3(b) and 3(c) illustrate insertion of part of an ampoule 50 into the apparatus 1. The ampoule 50, has a body 51, a neck 52 and a head 53. The ampoule 50 is provided with a scored or otherwise weakened region 54 on its neck 52, to facilitate opening, and with an indicium 55, typically in the form of a dot of paint or pigment, to indicate the angular position of the weakened region 54.
a) shows the ampoule 50 adjacent the apparatus 1. The plunger 20 is gently biased towards the first end of the cylindrical body 10 (and thus also towards the O-ring 30) and is in contact with the O-ring 30. The O-ring is in substantially its equilibrium, unstretched, state. The indicium 16 on the body is aligned with the indicium 54 on the ampoule, by a user, so that even with the ampoule head 53 within the apparatus 1 the position of the weakened region 54 will be evident to a user, assisting application of an opening force in an appropriate direction to provide a clean opening operation of the ampoule 50.
b) shows the ampoule 50 and apparatus 1 with the ampoule head 53 being inserted into the cavity 11. The O-ring 30 is stretched by passage of the widest part of the ampoule head 53 therethrough. The ampoule head 53 engages the concave region 25 of the ampoule head engaging portion 23. The plunger 20 is moved towards the second end of the cylindrical body 10, and away from the first end of the cylindrical body 10 by the force applied by the ampoule head 53. The spring 40 is partially compressed.
c) shows the situation with the ampoule head 53 inserted into the cavity 11. The O-ring 30 has contacted to its equilibrium (or close to equilibrium) size and substantially surrounds the neck 52 of the ampoule 50. A lower part of the ampoule head is engaged by the O-ring 30, and the resilience of the O-ring 30 offers resistance which prevents the ampoule head 53 from exiting the cavity 11. The plunger 20, being biased by the spring 40 is kept in contact with the ampoule head 52, and also provides a gentle force keeping the bottom part of the ampoule head 52 in contact with the O-ring 30. The bias force is indicated by the arrow BF in
a) and 4(b) show schematically a preferred way of operating the apparatus 1 in order to break or open the ampoule 50. As positioned in
As shown in
a) and 5(b) show schematically a preferred way of operating the apparatus 1 in order to eject the ampoule head, for example into a sharps safe container 60. As shown in
The preferred hand positions of a user, during operation of the apparatus 1 are illustrated schematically in
The thumb 71 of the second hand may be placed on the plunger 20 during the opening operation if desired, as illustrated in
As illustrated in
It will be appreciated that the illustrated hand orientation is the natural orientation for holding a vertically orientated elongate object in each hand, and results in natural arm position. In contrast, holding the upper hand with the thumb or navicular side of the hand downwards (as is required in ampoule opening procedures in which the ampoule body is held vertical in one hand and the ampoule head is held between the thumb and first finger of the other hand) results in an uncomfortable arm position with the elbow raised. Use of some prior art ampoule opening devices has required the ampoule to be orientated other than substantially vertically in order for a user to attain a less uncomfortable position, resulting in an increased likelihood of spilling the ampoule contents upon opening.
It will be appreciated that it is desirable to provide ampoule head retaining member(s), such as the O-ring (although different arrangements could be used) operation of which to retain an ampoule head does not require a gripping pressure to be applied to the ampoule from outside the apparatus in order to retain the ampoule head during the opening operation. This eliminates the need to position the thumb and index finger close to, and on either side of, the ampoule head, and allows the part of the apparatus where the ampoule head is retained to be held by the relatively weak ulna side of the hand. Thus the apparatus can be held by a hand in the natural and comfortable “thumb up” position. Using an apparatus body that is approximately as long as the width of a user's hand provides ample leverage, allows a user's hand to fit comfortably around the apparatus body, and allows the ampoule neck to be close to, and between, both hands during the opening operation while retaining easy access to the part of the plunger (ejecting mechanism) which extends from the second end of the body. For this reason the body of the apparatus is preferably between about 5 cm and about 15 cm in length, and most preferably between about 8 cm and 12 cm in length.
A further benefit of the preferred embodiment is that because the O-ring has considerable elasticity a relatively wide range of ampoule head diameters can be admitted and retained in the apparatus. This allows a wide range of ampoule sizes to be opened using a single device (rather than the device being limited to only a very limited range of ampoule sizes, as might have been expected).
It will be appreciated that many variations are possible. For example the cavity could be shaped so that a part of the cavity wall contacts and operates on the upper part of the ampoule head during the opening operation. The apparatus need not necessarily be generally cylindrical or generally symmetrical, although these characteristics are currently considered desirable in a preferred embodiment. In a preferred embodiment the body is made from metal. The body may be cast or lathe formed steel or aluminum. In alternative embodiments the body may be moulded from a suitable plastic.
One alternative embodiment 100 is illustrated in
A further variation, in the form of an apparatus 200 is illustrated in
It is to be understood that the terminology employed above is for the purpose of description and should not be regarded as limiting.
The foregoing embodiments are intended to be illustrative of the invention, and it is to be understood that the scope of the invention is not to be limited to the exact construction and operation described and illustrated, but only by the following claims.
In the claims which follow and in the preceding description of the invention, except where the context requires otherwise due to express language or necessary implication, the word “comprise” or variations such as “comprises” or “comprising” is used in an inclusive sense, i.e. to specify the presence of the stated features but not to preclude the presence or addition of further features in various embodiments of the invention.
It is to be clearly understood that although prior art publication(s) are referred to herein, this reference does not constitute an admission that any of these documents forms part of the common general knowledge in the art in Australia or in any other country.
Number | Date | Country | Kind |
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2006903449 | Jun 2006 | AU | national |
This divisional application claims priority under 35 U.S.C. §121 of application Ser. No. 12/306,651 filed on Dec. 24, 2008 which in turn is a national stage application which claims the benefit under 35 U.S.C. §371 of International Application No. PCT/AU2007/000894 filed on Jun. 27, 2007, all of which are entitled APPARATUS AND METHOD FOR OPENING AMPOULES, which in turn takes its priority from Australian Application No. 2006903449 filed on Jun. 27, 2006, and all of whose entire disclosures are incorporated by reference herein.
Number | Date | Country | |
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Parent | 12306651 | Dec 2008 | US |
Child | 14864244 | US |