CA1044184A

CA1044184A - Plastic containers for parenteral solutions

Info

Publication number: CA1044184A
Application number: CA235,835A
Authority: CA
Inventors: Kyoichi Komatsu
Original assignee: Otsuka Pharmaceutical Co Ltd
Current assignee: Otsuka Pharmaceutical Co Ltd
Priority date: 1974-09-26
Filing date: 1975-09-18
Publication date: 1978-12-12
Also published as: CH591855A5; NL165380C; SE408615B; NL7511406A; BR7506179A; NL165380B; FR2285901A1; DE2543154C3; DK153630B; BE833777A; DE2543154A1; DK431375A; AU8503175A; GB1526063A; IT1042780B; SE7510712L; DK153630C; DE2543154B2; FR2285901B1

Abstract

Abstract of the Disclosure:
A plastic container for a parenteral solution comprising a main body and a tubular portion extending downward from the lower end of the body and having a closed end openable by cutting, the tubular portion being formed in its outer peripheral surface with a groovelike recess for indicating the cutting position and reducing the wall thickness of the tubular portion at the cutting position; and a combination of the above plastic container and an administration device having one end to be liquid-tightly connected to the tubular portion of the container when it is opened and the other end having an injection needle.

Description

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This invention relates to plastic containers for parenteral solutions such as physiologic saline solution, Ringer's solution and like electrolytic ; solutions~and carbohydrate solution, amino acid solution and like nutritional solut.ions.
.~ Among the above-mentioned solutions to be .
administered to the patient, relatively inexpensive solutions such as physiologic saline solution and .
Ri.ngerls solution are also used to wash the affected part ; 10 during operation. Accordingly containers for these solutions must be adapted for the withdrawal of the enclosed solution with use of an administration device -.', and, moreover, it is desired that they are easily .
openable at the outlet portion thereof~ The solution administration device generally comprises a hollow needle : -to be passed through the closure of the container, a tubu .
; for conducting the solution from the needle to an injection . ~
I needle and a clamp mounted on the tube for regulating t the flow rate of the solutions.
l. 20 : Although glass bottles with a rubber stopper . ~ .
:l have been used as containers for the aforesaid solutions, .

l they are heavy and fragile~ In recent years, therefore, : ' : .: .
there is a tendency to use plastic containers in place of glass bottles~ -.:, .
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, }, ~ ~' '- . ' ' ' ' ' ' ,; ' ' . ' ' ' '` ' . ', ~'' : ' Heretofore known as plastic container for parenteral solutions are:
(a) Those having a closure made of the s~me material as the container and heat-sealed to the outlet thereof a (b) Those with a rubber stopper closing the outlet of the container3 and (c) Those including a rubber stopper closin~
the ouklet of the container and a plastic diaphragm disposed within the neck of the container inwardly of the stopperO
With plastic containers of type (a), however, the outlet is not readily openable and no consideration -` i6 given to the solution for use as a washing solution ~-i 15 Por the affected part~
In the case of plastic containers of type (b), :~
3~ ~ the rubber stopper directly contacts the solution, : pos~ibly causing contamination of the solution due to:
the reaction between the rubber and solution. - ~ :
20 : ~ Plastic containers of type (c), which include ~ .
both the plastic diaphragm and the r~bber stopper9 are complicated in construction and are not:easy to manufacture. In addition, the outlet is not readily :openable and the containers therefore have the same ~ ~drawbacks as t~pe:(a).

lQ 4 ~3 4 With the foregoing constructions (a), (b) and (c), furthermore, the closing member must be pierced by the hollow needle of administration device for the withdrawal of solution, so that the hollow needle mus-t at least be formed with a sharp metal tip. However, a fragment of rubber or plastic is then likely to clog up the opening at the extremity of the tip when the needle pierces the rubber or plastic closing member. Thus the liquid passage needs to be opened at the side of the needle tip. For these reasons/ the hollow needle becomes very complex in construction and expensive.
,~ i:,.. .
~ The present invention provides a plastic container for ;`l . . ' ~ a parenteral solution having an outlet which is easy to open .,i'~ , . , , when so desired to assure extreme convenience when the solution 9 is used to wash the affected part of the patient.

The present invention also provides a plastic container -for parentexal solution which has no rubber stopper to assure 3 safety of the solution from contamination by any reaction product `~ of the rubber and solution.

,1 The present inven~ion also provides a plastic container ~¦ 20 for parenteral solution which is simple in construction and easy ~ to manufacture. ;~

i The present invention further provides a plastic con-: , .

tainer for parenteral solution from which the solution can be withdrawn by a device of simple construction to eliminate the ;l , ,::, ~ ; necessity to use an expensive hollow needle.
~ . , .
This invention provides a plastics container for apparatus used in administering parenteral solutions to patients, comprising a body portion for the solution and a tubular spout extending downwards from the lower end of the body portion, said 30~ spout~being closed at its outer end and having therein an external annular ~roove recess means extendin~ peripherally intermediate .~
the ends of the spout to facilitate severance of an outer end , ' :
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portion thereof from a base portion thereof whereby solution is . releasable from the body portion, and said base portion having thereon peripherally extending annular groove means engageable by peripherally annular bead means of a coupling for releasably I connecting to the base portion ducting for feeding the solution ~ to the patient.

~`~ The invention also provides apparatus for use in administering parenteral solutions to patients, comprising a plastics container for ~he solution having a body portion and a 10 tubular spout projecting downwards from the lower end of the body portion, said spout being closed at its outer end and having .. ~ therein external annular groove recess means extendiny peripher-. ally intermediate the ends of the spout to facilitate severance .~ of an outer end portion thereof from a base portion thereof : whereby solùtion is releasable from the body portion, ducting for feeding solution from the body portion to the patient, and a coupling including resiliently yieldable gripping means movable . to an operative position in which a peripheral annular bead means . yieldingly engages a peripherally extending annular groove means :~
;1 20 on said base portion to connect the ducting releasably to said -ba~e portion following severance of said outer end portion of the : :
spout. :

The present invention is thus characterized in that the :
~ubular portion of the plastic container has a groovelike recess :
~ ~ for indicating the cutting position and reduc ng the wall thick- ~
.~ .
.~ ness of the tubular portion at the cutting position, and a groove :
for engagement with the connector of an administration device.
Wlth this lnvention, a combination of the above grooves ` - :, :~ :
;.. !~ (a) and ~b) achieves -the following effects, (i3 the tubular 30 portion is easily cut and opened, (ii) the cutting position is .

specified, (iii) thereby a distance between the groove for engage~
.
ment and the end of the opened tubular portion is fixed, and (iv) $~
., _ 5 _ . .
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this,ensures that the connector of the adminis~ration device can be accurately engaged with the groove (b) by a uniform operation.
j The above effects (iii) and (iv) are those peculiar to the specific combination of grooves (a) and (b) and are not attainable without both of them.
The plastic container of this invention can be opened ¦ by cutting the tubular portion at the position of the groovelike ; recess. The solution within the container is administered to the patient by an administration device having a portion to be liquid-tightly connected to the opened end of the tubular portion.
Furthermore by causing the solution to flow out directly from the opened end of the tubular portion, the solution is applicable to the affected part for washing.
The plastic container of this invention is . :' , , :, .:- ' . ' ' ' 1~ 20 ~`
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usable both for administering the solution to the patient and for washing the affec-ted part with the solution. Because the container is wholly made of plastics, it is free of contamination of the solution which would be experienced with the use of rubber : stopper and is extremely simple in construction and easy to manufacture~
Since the present plastic container itself is readily openable and the administlation device to be used in combination therewith i8 easily connectable to : the opening of the container to withdraw the so~ution, ;; the device need not be equipped wi-th an expensive hollow needle conventionally required to pierce the closure.
According to this invention, the container is l 15 produced from plastics by a known method for example .;
by blow molding. As plastics, it is preferable to use .~ polyethylene, polypropylene and the like having the i~ ~ high transparency and good flexibilityc The container .l may have at the midportion of its upper end a tab for .;. 20 suspending the container from a support~ The wall .~i: thickness of main body of the container, which is not particularly limited, is preferably such that the container deformable as thé lnternal pre~sure decreaces with the ~ withdrawal of the solution~ To ensure this, the wall ,, ~ ~ . :, :

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.~ ,: , .,, ,,,, " :, , ... . , ,. , , ~, thickness i~ preferably about 0.3 to 1~0 mm when the container is made of polyethylene or polypropylene.
The tubular portion at the lower end of the body is molded integrally with or separately from the body~ When separately molded, the tubular portion is joined to the open end of the body by high frequency or ultrasonic heating after the solution has been placed into the body.
The tubular portion has an outer diameter of `. 10 5rO to 25~0 mm, preferably of 7~0 to 15~0 ~m, and an ;~ inner diameter of 3.0 to 15.0 mm, preferably 4O0 to 8~0 mmO The inner diameter and the outer diameter are suitably selectively determined within the above-mentioned ranges so that the difference therebetween, namely the ~all thickness of the tubular portion, will be 2.0 to 10~0 mm, preferably 3-~0 to 7.0 mm. To facilitate the connection of the tubular portion to the administration device, the tubular portion can be gently taperedO
~he tubular portion is formed in its outer peripheral sur~ace with a groovelike recess to indicate .;
~ the position where the tubular portion is cut, to reduce i~ ~ its wall thlckness at the cuttin6 position and to I ; facilitate the engagement of scissors or like cutter means i for the purpose of cutting~ The groovelike recess may ~ 7 -., :

:, , , . , be formed over the entire periphery of the tubular por-tion, or at least two recesses may be provided partially of the periphery for example a-t two opposing positions.
Above the groovelike recess, the tubular portion can be provided with an enga~ing portion for connection to the administration device. When -the part of the tubular portion below the groovelike recess, narnely the end part thereof to be cut off to open the container, is so shaped as to snugly fit in the opening of the tubular j . .
portion formed by cutting~ the cut-of~ part is u~able as ~ a plug for the opened tubular portion.
`~ This invention will be described below with reference to the accompanying drawings showing embodiments of the invention.
Fig. 1 is a view partly in vertical section showing an ernbodiment of this învention including a ~ main body and a tubular-portion integrally molded therewith;
'.! Figo 2 is a view partly in vertical section I showing another embodiment of this in~ention including ; 20 ~ a main body and a tubular portion each molded separately;
~I Fig~ 3 is a view partly in vertical section showing ~;
'6 another embodiem~t of this invention in which the part to ; ;be cut of~ from a tubular portion is usable as a plu~, ;
ig~ Lt is a view in vertical section of the ~ principal part of the ernbodiment of Fig. 3 in which thc -4~4 plug is shown as fitted in the opened tubular portion;
Fig. 5 is a perspective view showin~ an embodiment of administration device to be used for the . .
container of thi~ invention;
~ig. 6 is a perspective view showing the embodiment of Fig. 5 as it is being used for withdrawing ~ an solution from the container illustrated in Fig. 2;
;~ Fig, 7 is a view in vertical section showing ~, the embodiment of Fig. 6 as connected to the tubular ...
portion of the containerj 1: ~ Figo 8 is a perspective view shovring another i;~ embodiment of administration device to be used for the .,:
container of this invention;
~ Fig~ 9 ls a perspective vie~ showing the - 15 ~ embodiment o~ Fig~ 8 as it is belng used for withdrawin~
j~ a solution from the~container of Fig. 2; and ,~ ~ Fig. lO is a view in cross section~t~en along l~ the`llne IX-IX in Flg. 9 and~sbowing an exemplary mode `i oP engagement of gripping pieces in~a groove.
~3 ~ ~ ~
~ Basically the plastic container of this invention comprises a main body l and a tubular portion 2 whi~h are molded integrally (see ~ig.~l) or~separately -(see~F1gs~ 2 and~3).
When the~body 1 ~nd tubular portion 2 ara ; ;

4~L84 integrally molded, a solution isplaced into the body 1 through an inlet 18 at the upper end of the body 1.
After the solution has been placed, the inlet 18 is heat-sealed.
When the body 1 and the tubular portlon 2 are separately molded, ~he solution is placed into the body 1 through the open end of neck la of the body 1, In this case,the inlet 18 need not be provided. After ` the solution hae been placed, the tubular portion 2 is joined to the open end of the neck la in known manner ' !
as b~ high frequency heating or ultrasonic heating.
For this purpose9 lt is preferable to form flanges 3a and 3b at the ends of the neck la and of the tubular portion I 2 and to join the flanges 3a and 3b together face-to-face .:
by heating as seen in Figs~ 2 and 3 The tubular portion 2 is formed wlth a groovelike --~
recess 4 in its outer peripheral ~ur~ace. To open the .~, , , container9 the tubular portion 2 is cut at the position o~ the groovelike rece~s 4. Since the grooved part 4 has 20 ~ a smaller~thickness than the other portion and is readily -~
~ en~ageabl~ With cutter means such as scissors, the tubular ;~ portion 2 is easy to cut at this part. ~ i ! ` .. -:
hen the portion 2a to be cut off from the tubular portion 2 has an end so shaped as to ba snugly 25 ~ fittable in the opening of the tubular portion 2 formed 'l , ~`'~ ` ' ' ~'' ' ` ' ' ' i' ' ' . ' .

~ f~ 8 4 by cutting, the portion 2a is usable as a plug~
In the case where the solution is used to wash the affected part, the solution is run off from the end of the tubular portion 2 opened by cuttingO
Washing can be done easily as desired by manually pressing and deforming the body 1 to force out the solution~
'i; ' The patient is given the solution fro~ the container suspended from a support 16 by the ' engagement of hook 17 of the support 16 in a tab 15 on,, '~ the upper end of the container and with use of an i administration device as shown in Figs. 5 and 8.
,~ The administration device shown in Fig~ 5 has ~
,,~ a cylindrical connector 5 to be connected to the kubular ~-l 15 portion 2 o~ the container. The cylindrical connector :
'3 5 i~ connected to an injection needle 6 by a outlet tube 7 equipped with a clamp 8 to regulate the flow o~ the ~ , ;1 solution. The cylindrical'connector~5, made of soft ;~3 synthetic resin such as polyethy,lene~ is tightly fitted over ,~
the tubular portion 2 due to its elasticity. (see Figs.
6 and 7)~ The cylindrical connector 5 has an inn~
' diameter corresponding to the outer diameter of the tubular ;,` porkion 2 and is therefare ~lttable around the tubular portion 2. The tubular portion 2 has a kapered outer ~25 ~ peripheral,surface which ensures easy and tight engagement -..~

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ith the cylindrical connector 5. The base end of the tubular portion 2 is formed in its outer peripheral surface with a groove 9 in which an inner peripheral ~ projection lO at one end o~ the cylindrical connector 5 ; 5 is engageable 9 whereby the c~lindrical connector 5 can ` be prevented from disengagement from the tubular portion . 2.
The solution within the body 1 flows through a . pas~age 2b in the tubular portion 2 into the :
cylindrical connector 5 and ii administered ko the : patient by way of t~le outlet tube 7 and needle 6.
; The solution flows down dropwise into the cylindrical ~ :
connector 5 when flowing out from the open end of the pas~age 2b (see Fi~. 7), so that the cylindrical connector 5s when transparent, is serviceable also as a drip chamber.
Alternatively~ the drip chamber may be provided in~ :~
dependently of the cylindrical connector 5~ . ;
~he administration de~ice shown ln Fi~o 8 includes .l a cannula 11 to be intimately inserted lnto the tubular ; 20 ~portion Z for connection to the container. Generally the -:
~ carnula ll can be made of hard synthetic resin such as :
:`j acrylonitrile-butadiene-styrene copolymer resin and rigid ~ -polyvinyl ch1Oride resin~ Integral with the cannula re gripping pieces 1~ engageable in the ~roove 9 of ' 25 ~ the tubular portion 2~ The illustrated embodiment has , . , .
: 1:: - , , :: , :
' i , ' ' ' ' . " ,' three gripping pieces 12 which are cquidistantly spaced apar-t and arranged concentrically with the cannula 11.
; When the cannula 11 is inserted into the tubular portion 2, the gripping pieces 12 engage in the groovc 9 of the tubular portion 2 to prevent the removal of the cannula 11 (see Fig~ 9). Only two grippinG pieces 12 may be provided as opposed to each other, or at least four gripping pieces 12 may be formed as spaced apart equidistan-tly.
When the groove 9 is formed discontinuously in corrcsponding relati.on to the gripping pi.eces 12, the can~ula 11 can be held to the tubular portion 2 against rotation (see Fig. 10).
A cylindrical portion 13 concentric with the cannula ~ 11 can be provided to the rear of the ~rippin~s pieces 12.
`, The cylindrical por-tion 13 is ~srasped when the administration !~ 15 device is to be connected to the container, while when 3: pressed on to disengage the gripping pieces 12 from the groove 9, the cylindrical portion tends to open the gripping ~ pieces to facilitate the disengagement~ The rear end of :, the cannula 11 is connected to the outlet tube 7 by a 20 drip chamber 14~ ;~
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Claims

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:

1. A plastics container for apparatus used in admin-istering parenteral solutions to patients, comprising a body portion for the solution and a tubular spout extending downwards from the lower end of the body portion, said spout being closed at its outer end and having therein an external annular groove recess means extending peripherally intermediate the ends of the spout to facilitate severance of an outer end portion thereof from a base portion thereof whereby solution is releasable from the body portion, and said base portion having thereon peripherally extending annular groove means engageable by peripherally annular bead means of a coupling for releasably connecting to the base portion ducting for feeding the solution to the patient.

2. A plastics container according to claim 1, wherein the groove means in the base portion consists of an annular groove engageable by an annular bead of the coupling.

3. A plastics container according to claim 1, wherein the groove means in the base portion consists of a series of peripherally spaced part-annular grooves engageable by a series of peripherally spaced part-annular beads of the coupling.

4. Apparatus for use in administering parenteral solutions to patients, comprising a plastics container for the solution having a body portion and a tubular spout projecting downwards from the lower end of the body portion, said spout being closed at its outer end and having therein external annular groove recess means extending peripherally intermediate the ends of the spout to facilitate severance of an outer end portion thereof from a base portion thereof whereby solution is releasable from the body portion, ducting for feeding solution from the body portion to the patient, and a coupling including resiliently yieldable gripping means movable to an operative position in which a peripheral annular bead means yieldingly engages a peripherally extending annular groove means on said base portion to connect the ducting releasably to said base portion following severance of said outer end portion of the spout.

5. Apparatus according to claim 4, wherein the gripping means of the coupling include a resiliently expansible tubular socket engageable over said base portion of the spout and an annular internal bead on the socket engageable with an annular groove on said base portion.

6. Apparatus according to claim 5, wherein the socket consists of an end portion of a flexible plastics tube connected to the ducting.

7. Apparatus according to claim 6, wherein the gripping means of the coupling include a generally tubular socket composed of a plurality of peripherally spaced axially extending resiliently expansible fingers, and a series of internally projecting part-annular beads on the respective fingers engageable in a series of peripherally spaced part-annular grooves in the base portion.

8. Apparatus according to claim 7, wherein the coupling includes a tube and a transverse wall disposed in the tube bore, one end portion of the tube forming said generally tubular socket composed of fingers and the other end of said tube forming a skirt which is compressible to effect resilient expanding movement of the fingers to release the ducting.

9. Apparatus according to claim 8, wherein the coupling includes also a cannula and having a mid portion frictionally engaging an opening in the transverse wall, extending axially through the tube one end portion of the cannula frictionally engaging in the bore of the base portion of the spout and the other end portion frictionally engaging in a bore of the ducting.

10. Apparatus according to claim 9, wherein the ducting includes a drip chamber having an end bore constituting the bore in which the cannula frictionally engages.

11. Apparatus according to claim 4, 5 or 6, wherein the endmost portion of the ducting remote from the container is an injection needle.