Automated drug vial safety cap removal

Details Automated drug vial safety cap removal Automated drug vial safety cap removal

2001-11-30

2003-08-12

Bratlie, Steven A. (Department: 3652)

Material or article handling

Device for emptying portable receptacle

With container opening means

C081S003200, C081S003070, C081S003310, C081S003550

Reexamination Certificate

active

06604903

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates generally to medical equipment, and more particularly, to an automated apparatus for filling unit dose, disposable syringes with one or more medications that are each stored in a vial.
BACKGROUND OF THE INVENTION
Disposable syringes are in widespread use for a number of different types of applications. For example, syringes are used not only to withdraw a fluid (e.g., blood) from a patient but also to administer a medication to a patient. In the latter, a cap or the like is removed from the syringe and a unit dose of the medication is carefully measured and then injected or otherwise disposed within the syringe.
As technology advances, more and more sophisticated, automated systems are being developed for preparing and delivering medications by integrating a number of different stations, with one or more specific tasks being performed at each station. For example, one type of exemplary automated system operates as a syringe filling apparatus that receives user inputted information, such as the type of medication, the volume of the medication and any mixing instructions, etc. The system then uses this inputted information to disperse the correct medication into the syringe up to the inputted volume.
In some instances, the medication that is to be delivered to the patient includes more than one pharmaceutical substance. For example, the medication can be a mixture of several components, such as several pharmaceutical substances.
By automating the medication preparation process, increased production and efficiency are achieved. This results in reduced production costs and also permits the system to operate over any time period of a given day with only limited operator intervention for manual inspection to ensure proper operation is being achieved. Such a system finds particular utility in settings, such as large hospitals, including a large number of doses of medications have to be prepared daily. Traditionally, these doses have been prepared manually in what is an exacting but tedious responsibility for a highly skilled staff. In order to be valuable, automated systems must maintain the exacting standards set by medical regulatory bodies, while at the same time simplifying the overall process and reducing the time necessary for preparing the medications.
Because syringes are often used as the carrier means for transporting and delivering the medication to the patient, it is advantageous for these automated systems to be tailored to accept syringes. However, the previous methods of dispersing the medication from the vial and into the syringe were very time consuming and labor intensive. More specifically, medications and the like are typically stored in a sealed vial. As shown in
FIGS. 1 and 1
a
, a conventional vial
10
is formed of a body
20
(i.e., glass) and is sealed with a membrane (septum)
30
across the open end
22
of the body
20
. The membrane
30
can be formed of any type of material that is typically used in this setting for sealing a container (e.g., vial
10
) yet at the same time permit a user to puncture or pierce the membrane
30
with an instrument to gain access to the inside of the container. In one exemplary embodiment, the membrane
30
is formed of a rubber material that can be easily stretched across the open end
22
while still providing the necessary seal.
The membrane
30
is securely held in place across the open end
22
by a retainer ring
40
that is itself securely attached to the body
20
. The retainer ring
40
circumferentially surrounds a neck
21
formed at the open end
22
and includes an upper section
42
that seats against an upper surface the membrane
30
and a lower section
44
that engages the body
20
underneath the neck
21
. The retainer ring
40
is open in a middle section
23
thereof such that when the retainer ring
40
is securely attached to the body
20
, the retainer ring
40
holds the stretched membrane
30
in place with the membrane
30
being visible in the open middle section of the retainer ring
40
. The retainer ring
40
can be attached to the body
20
using any number of conventional techniques, including a crimping process, so long as the retainer ring
40
securely holds the membrane
30
such that a seal results between the open end
22
and the membrane
30
.
A safety cap
50
is securely attached to the vial
10
to cover the exposed membrane
30
and further seal the open end
22
of the vial body
20
. The safety cap
50
is typically formed of a light, disposable material, such as a plastic, and is attached at the end
22
in a tamper proof manner. For example, the safety cap
50
is attached so that once it is removed, it can not be reattached to the vial body
22
. Thus, a vial that does not contain a safety cap
50
is easily recognizable and indicates that either (1) the safety cap
50
has previously been removed and medication in the vial
20
has been withdrawn, (2) the safety cap
50
was not properly attached and has accidently become displaced, (3) the vial
50
has been tampered with, etc. In any event and unless the exact history of the particular vial is know, any vial that is missing a safety cap
50
is ordinarily discarded and not used.
The safety cap
50
is a solid member that extends completely across the exposed portion of the membrane
30
and, preferably, the peripheral edges of the safety cap
50
are downwardly curved so that the peripheral edges overlap the outer peripheral edges of the retainer ring
40
. The safety cap
50
contains features that permit it to be attached to the retainer ring
40
. In one exemplary embodiment, the retainer ring
40
has a plurality of bosses
60
that extends upwardly from the retainer ring
40
near the inner edge of the retainer ring
40
. When the safety cap
50
is attached to the retainer ring
40
, the plurality of bosses
60
seats within complementary openings formed in the safety cap
50
so as to frictionally couple the two parts together. For example, the safety cap
50
can be injected molded around the retainer ring
40
, thereby resulting in the formation of the safety cap
50
around the plurality of bosses
60
. The connection between the bosses
60
and the safety cap
50
represents a weakened section which breaks when force is applied to the safety cap
50
in an appropriate direction. This results in the safety cap
50
being easily removed, while at the same time provides a tamper proof arrangement because, once the weakened section is broken and the safety cap
50
is free, the safety cap
50
can not later be reattached to the retainer ring
40
or any other part of the vial
10
.
It will be understood that the parts of the vial
10
of
FIGS. 1 and 1
a
are merely exemplary in nature and the many different tamper proof vial constructions are available. The common elements are that the vials each contain a membrane and the safety cap is easily removable but at the same time provides further protection of the membrane and also serves as an indicator of whether the vial has been used.
In conventional medication preparation, a trained person retrieves the correct vial from a storage cabinet or the like, confirms the contents and then removes the safety cap manually. This is typically done by simply popping the safety cap off with ones hands. Once the safety cap is removed, the trained person inspects the integrity of the membrane and cleans the membrane. An instrument, e.g., a needle, is then used to pierce the membrane and withdraw the medication contained in the vial. The withdrawn medication is then placed into a syringe to permit subsequent administration of the medication from the syringe. Often, the membrane is first pierced with an instrument for injecting a diluent into the medication prior to withdrawal of the medication. This is a very time and labor intensive task and what is needed in the art and has heretofore not been available is a system and method for automating the medication preparation process and more specifically, an automated system and m

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