U.S. patent number 3,578,037 [Application Number 04/857,089] was granted by the patent office on 1971-05-11 for method for filling a syringe.
Invention is credited to Thomas J. Flynn.
United States Patent |
3,578,037 |
Flynn |
May 11, 1971 |
METHOD FOR FILLING A SYRINGE
Abstract
An apparatus and method for preventing foreign material from
entering syringes during the filling of the syringes from
containers and thus preventing foreign material from being injected
into a patient. The apparatus provides a liquid container, such as
a vial, having a pierceable self-sealing stopper for inserting the
syringe needle for filling the syringe. A filter material is
attached to the top of the container so that the needle can be
extended therethrough and adapted to filter out foreign material
such as coring that breaks loose as the needle pierces the top of
the container. A method is provided including drawing air into a
syringe prior to inserting the syringe cannula through a pierceable
self-sealing stopper of a container. The air in the syringe is then
injected into the container freeing any coring material that has
broken from the container stopper either into the filtering
material or into the liquid in the container. The cannula tip is
then withdrawn or extended to place the tip either in the liquid or
the filter material where the coring material has not been
deposited and drawing the required amount of liquid from the
container into the syringe.
Inventors: |
Flynn; Thomas J. (Daytona
Beach, FL) |
Family
ID: |
25325156 |
Appl.
No.: |
04/857,089 |
Filed: |
September 11, 1969 |
Current U.S.
Class: |
141/2; 141/330;
141/286; 215/247; 604/414; 141/27; 215/364 |
Current CPC
Class: |
A61J
1/2096 (20130101); A61J 1/201 (20150501); A61J
1/2086 (20150501) |
Current International
Class: |
A61J
1/00 (20060101); B65b 001/04 (); B65b 003/04 ();
B67c 003/00 () |
Field of
Search: |
;215/(Inquired),47
(Medical/ Digest)/ ;128/(Inquired),218 (M)/ ;128/272
;141/1,2,3,18--29,286,329,330 ;220/(Inquired) ;222/(Inquired) |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Bell, Jr.; Houston S.
Claims
I claim:
1. A method for filling a syringe from a container of liquid
comprising in combination the steps of:
a. drawing gas into said syringe;
b. inserting the needle of said syringe through a pierceable
self-sealing stopper located in an opening to said container;
c. injecting gas in said syringe into said container thereby
expelling any foreign material from said needle in one area of said
container;
d. locating the tip of said needle in a second area of said
container separated from said one area by a filtering material;
and
e. drawing liquid from said container into said syringe.
2. The method according to claim 1 in which said locating said
needle tip in one area includes locating said needle tip within a
filter material.
3. The method according to claim 1 in which said locating said
needle tip in one area includes locating said needle tip to one
side of a filter material.
4. The method according to claim 1 in which said gas drawn into
said syringe is air having a volume in approximately the same
volume of liquid that is to be drawn from said container into said
syringe.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to containers, vials and other
bottles, and the like, having pierceable self-sealing-type stoppers
or tops adapted for easy filling of syringes by inserting the
needles through the stoppers into the containers and more
particularly to the method and apparatus utilized in filling
syringes in a manner to prevent coring material or fine pieces of
the stopper for the containers from entering the syringes and being
injected into the patients. "Coring" is a term used in the medical
profession to indicate small pieces of rubber that are cut or
broken loose when the needle or cannula of a syringe is pushed
through the rubber stopper on the top of a container. This piece of
rubber or core is usually forced into the liquid in the container
or vial and then may enter the syringe along with the liquid when
the syringe is filled. Thus a small core can be pulled into the
syringe and injected into the patient, especially in the case of
multiple-dose vials or containers where many penetrations of the
rubber stopper are expected. The problem of coring has plagued the
industry for many years and has resulted in many suggestions to
remedy the problem.
2. Description of the Prior Art
In the past, a number of suggestions have been made for remedying
the coring problem and also for filtering liquids. These prior art
approaches include primarily studies of the type of material used
for the stopper to find a material that is less likely to provide a
coring action, as well as a study of the thickness and shape of the
stopper in order to provide a combination of ingredients in the
stopper to reduce the amount of coring and the amount of foreign
materials that can get into a vial. It has also been suggested in
the past to use various types of pressure to force the stopper into
the vial to reduce the coring as well as to change the shape of the
needle tip cutting edge of the needle to reduce the coring action.
While these various approaches have improved and reduced the coring
problem, they have not to date been successful in eliminating it
and there apparently has been only one successful way that a
core-free injection can be obtained prior to my invention. This is
performed by using a very costly filtered needle for injection into
the patient but the increased cost of this needle makes it
uneconomical, especially in view of the trend toward using
disposable syringes and needles, which disposable syringes are not
only convenient but provide a solution to the sterilization
problem, especially as relates to viruses such as hepatitis that
may be transmitted by reusable needles.
It has also been suggested in the past to provide various types of
combinations or syringes and vials which are either disposable or
may be reloaded and maintained as a combination vial, syringe and
needle. Thus a physician who has to carry a hypodermic syringe
along with the injection material, antiseptic and absorbent
material with him for a specific injection, can have the syringe
and injection liquid and container combination put together in a
manner as not to damage the needle in transit and sometimes even to
incorporate absorbent material and antiseptic in a combination
unit.
It has also been suggested to have stoppered tops with absorbent
material in a chamber therein, which chamber is adapted to allow
sterilized air to enter into the container to replace the space
from the removal of part of the liquid into the syringe.
Finally, one prior art U.S. Pat. No. 2,585,938, has suggested a
bottle seal having a filter in the bottle or container in which
sterile blood is kept for use in blood transfusions. This prior art
filter is in the form of a hollow tube inside of a container with
an open mouth sealed against the inner surface of a stopper, with
indicia on the outer surface of the stopper to indicate the
location for inserting the needle so that it will enter into the
hollow space in the filter. While this prior art filter is
desirable for use with transfusions of blood to remove clotting
material, and the like, it would of course not be satisfactory for
filtering coring material since the liquid is withdrawn from the
same hollow chamber in which it had been inserted leaving the
coring material in a position to be even more likely to be
transferred to the patient.
Accordingly, it is an object of my invention to provide an
economical, anticoring device and method from which foreign matter
and coring material may be prevented from being injected into a
patient in a very inexpensive manner even when used with the
multiple-dose vials while allowing disposable syringes and needles
to be utilized in giving injections.
SUMMARY OF THE INVENTION
An apparatus and method are provided for preventing foreign
particles such as coring material from being accidentally injected
into a patient. A liquid container or vial is provided having a
pierceable self-sealing stopper adapted for piercing with a needle
or cannula of a syringe during filling of the syringe prior to
giving an injection to a patient. The self-sealing stopper has a
filter fixedly attached to the stopper and inside the liquid
container and extending into the container whereby a syringe needle
when inserted through the self-sealing stopper may be extended
through the filter into a liquid for filling, or may be retracted
into the filter for filling with the liquid in a container. A
method for filling a syringe is provided which includes the steps
of drawing air into the syringe in the approximate amount of the
liquid to be withdrawn into the syringe then inserting the cannula
of the syringe through a pierceable, self-sealing stopper or top of
a liquid-containing container, injecting the air from the syringe
into the container thereby expelling any coring material or foreign
matter that may have gotten into the syringe needle either into the
mass of a filter material or directly into one or the other side of
the filter material thereby isolating the foreign material either
in the filter or to one side or the other of the filter. The needle
tip is positioned into the filter material or to either side
thereof but otherwise than where the foreign matter has been
expelled from the syringe needle or broken off from the rubber
stopper and finally drawing liquid in the container into the
syringe in a position isolated from the foreign matter expelled or
broken off.
BRIEF DESCRIPTION OF THE DRAWING
Other objects, features and advantages of this invention will be
apparent from a study of the written description and the drawings
in which:
FIG. 1 shows a sectional view of one embodiment of the present
invention;
FIG. 2 shows a view taken along line 2-2 of FIG. 1; and
FIG. 3 shows an exploded view of the top portion of the container
of FIGS. 1 and 2.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
Referring now to FIG. 1, there can be seen a liquid container or
vial 10 held in a man's hand 11 and having a stopper cover or seal
12 for holding the stopper 13 within the container 10. Stopper 13
maintains a liquid 14 within the container 10 in a manner to
prevent the liquid from leaking out and also to prevent ingress
into the container of contaminations. Container 10 would typically
be a glass container while stopper 13 would be a special rubber or
synthetic resilient material especially adapted for use as stoppers
for vials that hold medicine and sealing member 12 could typically
be a metallic seal such as aluminum. A hypodermic syringe 15 can be
seen having a needle or cannula 16 extending therefrom and through
the rubber stopper 13 into the liquid container 10. The needle 10
has a portion 17 which typically has a cutting edge so that it may
easily pierce the stopper 13 in container 10 and also easily pierce
the skin and flesh of a patient being injected with the syringe 15.
Syringe 15 is shown being held by hand 9 pushing a finger plate or
handle 18 which is adapted to operate a piston or plunger 19 for
filling the syringe or injecting the liquid in the syringe into a
patient. Container 10 stopper 13 can be seen to have a filter 20,
such as may be a foamed plastic material, which is especially
adapted for filtering out small particles of foreign matter that
may enter into the container 10. Filter 20 can be seen to be
connected to stopper 13 and extending into container 10 a short
distance relative to the larger tubular length of container 10. In
a typical operation for injecting a patient, the syringe 15 might
be filled with air in approximately the same volume as the liquid
injection medicine 14 that is to be injected into the patient. The
syringe is inserted through rubber stopper 13 which is a
self-sealing pierceable stopper and into container 10. The air in
syringe 15 is injected into the container 10 and the desired amount
of liquid 14 withdrawn into syringe 15 for injection into a
patient. The syringe needle would then be withdrawn from the
container and injected into the patient. However, one of the
problems experienced in this operation is that small pieces of
stopper 13 break off inside the container when the needle 16 is
inserted therethrough, resulting in small bits of foreign matter
entering the liquid 14 which may then be drawn into the syringe 15
and injected into a patient accidentally. In addition to coring
material other foreign matter may also accidentally get into the
container 10. This problem is especially troublesome in multiple
injection vials in which small pieces of coring material may
accumulate and increase the probability of accidentally getting a
piece of material in the needle 16 or syringe 15 and injecting the
material into the patient. It is accordingly desirable to have a
stopper 13 made of a material that is both inert to the medicine 14
while having desirable anticoring characteristics.
Turning now to FIG. 2, there can be seen a view taken along line
2-2 of FIG. 1 showing a portion of container 10 having a liquid 14
therein maintained in the container 10 by stopper 13 which has a
sealing member 12 for assuring that the stopper 13 is not removed
and is held tightly in place in the container 10. A portion 21 of
stopper 13 can be seen to be not covered by the winding 12 so that
needle 16 can be easily pierced through stopper 13 for withdrawing
liquid 14 into the syringe. An arcuate portion 26 of the stopper 13
provides the stopper with desirable anticoring characteristics
while leaving a space 22 located within the general confines of the
stopper 13. Filter material 20 is illustrated as an inorganic
flexible cellular material such as a foamed resilient polyurethane
plastic which must be desirably inert to the liquid 14 while acting
as a filter to filter out or hold foreign particles such as coring
material. Filter 20 is held to stopper 13 by a heat seal at surface
23 connecting the rim 24 of stopper 13 to filter 20 thus leaving
the space 22 totally enclosed on one side of the filter 20.
With reference to FIGS. 1 and 2, the following embodiments of my
method for filling a syringe are provided. The syringe 15 may be
filled with air or other gas as desired in approximately the same
volume as liquid 14 that is to be withdrawn from container 10 for
injection into a patient. The needle portion 16 of the syringe 15
is then inserted through stopper 13 into container 10 where it
could pick up a piece of coring material in the cutting end 17 of
the needle 16 or the coring material could break off directly into
space 22. Needle 16 could be extended past filter 20 and the air
injected into the container 10 which would inject any foreign
material therein into the liquid 14. The tip 17 of needle 16 could
then be withdrawn into filter 20 prior to the step of withdrawing
the desired amount of the medicine 14 from a zone isolated from
that of where the coring material was injected or broke off in
container 10 whereby the syringe 15 is filled substantially free of
foreign matter or coring material. Alternatively, the needle tip 17
could originally be inserted into the area 22 or into filter 20 and
in these zones inject the air from syringe 15 into container 10
thus trapping any foreign particles or coring material either in
the isolated portion 22 or within the filter material 20 then
pushing the tip 17 of needle 16 further into container 10 into the
open area of liquid 14 and filling any desired amount whereby
foreign matter is again isolated from the needle tip 17 and from
entering into the syringe 15 thus protecting patients from having
foreign materials injected into them.
FIG. 3 shows an exploded view with the top or lip of bottle 25 or
bottle 10 being visible with the stopper 13 being removed therefrom
along with the sealing member 12 which desirably is wrapped around
stopper 13 top and around lip 25 of container 10 when the container
is filled. The filtering material 20 can be seen heat sealed to
stopper 13 at 23. It will of course be clear that material 20 can
be varied as well as can be the means for connecting material 20 to
the stopper 13 without departing from the spirit and scope of the
invention. The filter 20 by preventing coring materials from
entering the bottle may allow top 13 arcuate portion 26 to be
changed.
It will of course be clear that an anticoring method and apparatus
have been provided for the inexpensive prevention of foreign
materials from being injected into patients but this invention is
not to be construed as limited to the particular forms disclosed
herein since these are to be regarded as illustrative rather than
restrictive.
* * * * *