Fluent material handling – with receiver or receiver coacting mea – Processes – Filling dispensers
Reexamination Certificate
2001-09-14
2003-06-24
Douglas, Steven O. (Department: 3751)
Fluent material handling, with receiver or receiver coacting mea
Processes
Filling dispensers
C141S027000, C141S329000, C604S414000
Reexamination Certificate
active
06581648
ABSTRACT:
TECHNICAL FIELD
The present invention relates to methods and devices for operating a syringes and vials used for injections of liquid medications.
BACKGROUND OF THE INVENTION
Patients sometimes require injections of liquid medication for treatment of medical conditions. In some cases, it may be inconvenient for the patients to travel to their doctor's offices for each injection and accordingly, the patients and their doctors may prefer to have the patients self-administer their injections.
Arthritis is one condition that can now be treated with periodic injections. In one form, the arthritis medication can include a dry powder in a vial and a liquid diluent in a separate syringe. The patient injects the diluent into the vial, mixes the diluent with the powdered medication to reconstitute the medication, extracts the reconstituted medication into the same syringe, and injects the medication into his or her body with the syringe.
One problem with self-administering arthritis medication is that the patient's dexterity may be severely limited by the arthritic condition. Accordingly, many of the operations necessary to accomplish a self-injection become difficult. Such operations include removing a cover from the needle of the syringe, removing a cap from the vial, aligning the needle of the syringe with the top of the vial, piercing the vial with the needle, and holding the body of the syringe while moving a plunger back and forth within the syringe to first inject the diluent into the vial and then extract the reconstituted medication. Patients with limited dexterity attempting the above operations may not only have difficulty performing the operations, but may also inadvertently contact the needle of the syringe with a non-sanitary surface, and may infect themselves when they subsequently administer the injection. Furthermore, patients may inadvertently stick themselves with the needle prior to administering the injection.
One approach to addressing some of the foregoing problems has been to use an apparatus
2
, such as is shown in
FIG. 1
, to axially align the syringe with the vial. The apparatus
2
includes a vial retainer
4
into which the patient snaps a vial
6
, and a shallow syringe cradle
8
into which the patient places a syringe
10
either by sliding the syringe along the groove forming the syringe cradle in a longitudinal direction or by moving the syringe laterally into the syringe cradle in a transverse direction to the main axis of the syringe cradle. The patient slides the syringe
10
along the syringe cradle
8
toward the vial
6
, piercing the vial
6
with a needle
11
of the syringe
10
. The patient then slides a plunger
12
within the syringe
10
to first inject a diluent into the vial
6
and then withdraw the reconstituted medication from the vial
6
. The device
2
also includes a magnifying base
14
to help the patient read the graduations on the syringe
10
.
The device
2
shown in
FIG. 1
suffers from several drawbacks. For example, the syringe cradle
8
does not limit the lateral motion of the syringe
10
in the transverse direction away from the syringe cradle
8
. Accordingly, the patient may not achieve proper axial alignment of the syringe
10
with the vial
6
. In addition, the device
2
is sized to properly align only vials and syringes having particular dimensions (for example, particular diameters), and may not accurately align vials and syringes with different dimensions. Furthermore, by not properly aligning the syringe
10
with the vial
6
, the user may inadvertently contact the needle
11
with the apparatus
2
, thereby contaminating the needle
11
. Still further, the apparatus
2
does not address the patient's difficulty in removing a protective needle cover (not shown) from the syringe
10
, removing a protective cap (not shown) from the vial
6
, or holding the body of the syringe
10
steady in the syringe cradle
8
while moving the plunger
12
within the syringe
10
.
SUMMARY OF THE INVENTION
The present invention is directed toward a device for aligning a syringe with a vial. In one embodiment, the device can include a body having a vial alignment portion and a syringe alignment portion, both aligned on an alignment axis extending between the two portions. The vial alignment portion can have at least one vial engagement surface shaped to removably engage the vial, and the syringe alignment portion can have at least one syringe engagement surface shaped to removably engage the syringe. The syringe engagement surface can include a first portion adjacent the syringe and a second portion adjacent the syringe and extending around a portion of the syringe sufficient to at least restrict lateral motion of the syringe in any direction transverse to the alignment axis.
In one aspect of this embodiment, the vial alignment portion and/or the syringe alignment portion can include spaced-apart arms having concave surfaces and being biased toward each other to clamp the vial and/or the syringe therebetween. In a further aspect of this embodiment, the first portion of the syringe engagement surface can be concave, face upwardly, and can extend axially beyond the second portion so as to receive the syringe when the syringe is moved downwardly toward the syringe engagement surface.
In another embodiment, the alignment device can include provisions for removing a cap from the vial and/or removing a needle cover from the syringe. For example, the device can include a cap receiving surface for receiving the cap and an overhanging surface which allows the cap to be pried away from the vial. The device can also include spaced-apart cover engaging surfaces for clamping the needle cover and removing the needle cover from the syringe. In still further embodiments of the invention, the syringe can include a handle and/or a plunger, each having concave engaging surfaces to more readily engage a user's fingers. In yet another embodiment of the invention, the vial alignment portion and syringe alignment portion can be positioned on the surface of a package or container that holds the vial and the syringe within a shipping box during shipping and storage prior to use of the syringe.
The present invention is also directed toward a method for operating a syringe and a vial. In one embodiment, the method includes securing the vial by releasably engaging the vial with an alignment body to at least restrict motion of the vial transverse to an alignment axis extending between the vial and the syringe. The method can further include releasably securing the syringe by engaging the syringe with the alignment body to at least restrict motion of the syringe in all directions transverse to the alignment axis so as to align a needle of the syringe with an access port of the vial.
In one embodiment, the method can further include removing a protective needle cover from the syringe by pressing the needle cover against a grasping member such as a sharpened edge of the alignment body and moving one or the other of the sharpened edge and the needle cover relative to the other to disengage the needle cover from the syringe. In another embodiment, the method can include engaging a cap of the vial with the alignment body and prying the cap away from the vial. In still a further embodiment of the invention, the method can include removing the vial and the syringe from a single container, engaging the vial and the syringe with the container, and restricting motion of at least one of the vial and the syringe away from an alignment axis that extends between the vial and the syringe by engaging either the vial or the syringe with the surface of the container.
REFERENCES:
patent: 3853158 (1974-12-01), Whitty
patent: 4252159 (1981-02-01), Maki
patent: 5115816 (1992-05-01), Lee
patent: 5697916 (1997-12-01), Schraga
patent: 5716345 (1998-02-01), Halbich
patent: 8006319 (1980-11-01), None
DEBIOJECT “Lyophilized Product Reconstitution” (brochure) (No date).
Bode Robert L.
Luciano Robert C.
Zolentroff William Carleton
Douglas Steven O.
Drinker Biddle & Reath LLP
Immunex Corporation
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