D United States Patent 1191 1111 3,788,374 SaijO Jan. 29, 1974 [54] PARENTERAL SOLUTION BAG 3,110,308 11/1963 Bellamy, Jr. 128/272 x I 3,426,959 2/1969 Lemelson [75] nvenmr- Sail, FUJmOmYa Japan 3,339,825 9/1967 Grevich 150/3 x [73] Assignee: Jintan Terumo Co., Ltd., Tokyo,
Japan Primary Examiner-William T. Dixson, Jr. [22] plied 1972 Assistant Examiner-Stephen P. Garbe [21] Appl. No.: 220,763 Attorney, Agent, or Firm-Kemon. Palmer -&
Related US. Application Data Estabrook [63] Continuation-impart of Ser. No. 71,309, Sept. 11,
1970, abandoned. [57] ABSTRACT [521 US. Cl. 150/1, 128/214 B, 128/272,
ISO/8, 229/66 A parenteral solution bag is provided with openings [51 Int. Cl. B65d p r ing fr m he perimeter of said bag for taking in [58] Field of Search 150/1, 8, 3; 229/66, 62; or out parenteral solution and with a protective clo- 128/272, 227, 214 B, DIG. 24 Sure for hermetically enclosing this protruded portion. v To the protective closure of the protruding portion is [56] References Cit d fused part of a tab for tearing said protective closure.
UNITED STATES PATENTS 3,343,541 9/1967 I Bellam Jr, 128/272 3 Claims, 12 Drawing Figures PATENTEDmzsmm 37883 sum 20F 2 FIGS "F169 FIG-'10 PARENTERAL SOLUTION BAG CROSS-REFERENCE TO RELATED APPLICATION This is Continuation-in-part of the U. S. patent application Ser. No. 71,309, filed on Sept. 11, l970, now abandoned.
The present invention relates to a parenteral solution bag, particularly to a parenteral solution bag improved in the mechanism for hermetically sealing the opening for taking in or out parenteral solution.
Parenteral solution bags are used for taking out blood or transfusion. A conventional hermetically sealing mechanism for this kind of bag is a rubber plug sealing in which the outlet opening is sealed with rubber plugs,. This type of sealing has many disadvantages: e.g., it is inconvenient to open the seal, the seal is easily polluted after it is opened, the outlet opening is easily polluted when opened, and sterilization of the rubber plug portion is difficult to effect.
The object of the present invention is to provide a parenteral solution bag having a simple sealing mechanism, not pollutable in the inlet and outlet of parenteral solution while hermetically sealed and when unsealed, and sterilizable as a whole under hermetically sealed condition such as in an autoclave, thus eliminating the above-mentioned drawbacks of conventional parenteral solution bags.
Another object of the invention is to provide a parenteral solution bag capable of having its tab peeled easily and reliably, being conveniently handled when opened and also being safely operated from a hygienic point of VI\V.
The attached drawings show an embodiment of the parenteral solution bag according to the present invention, in which:
FIG. 1 is a plan view of a parenteral solution bag according to the present invention;
FIG. 2 is a perspective view of the outlet of the parenteral solution bag;
FIG. 3 is a cross-sectional view taken along IIIIII line of FIG. 1;
FIGS. 4 to 6 are sectional views showing the process of heat sealing the tab to the protective closure;
FIG. 7 is a sectional view of the tab while it is peeled; and
FIGS. 8 to 12 are lateral views showing the sequential processes of exposing the outlet of the parenteral solution bag.
The present invention will be explained with reference to an embodiment illustrated .in the drawings.
Thereference numeral 11 denotes a parenteral solution bag of a pliable and transparent plastic such as polyvinyl chloride which contains a proper quantity of ACD solution inside and the perimeter 11a of which is heat sealed. From a part of said perimeter 11a are derived atubular extension 13 connected to ablood drawing needle 12 and a pair ofsolution ports 14. The numeral indicates a ball valve. Eachport 14 is in the form of a hollow cylinder, one end being open to the inside of thebag 11 and the other end open to the outside of thebag 11. Between said two openings is stretched adiaphragm 15, through which a cannula can be pierced into thebag 11 and which prevents the outflow of the liquid existing insidebag 11. Further, protective closures l6 hermetically cover thewhole ports 14 so as to prevent the pollution of theports 14. Eachprotective closure 16 forms a bag and is provided with atab 17 on one face. The base end portion 17a of thetab 17 is fused to the protruding front of saidprotective closure 16 and theother end portion 17b of saidtab 17 is lapped over the surface of theprotective closure 16 toward the end connected with the parenteral solution bag as a gripping means.
Theseal 18 between the joined base portion 17a and thefree end portion 17b oftab 17 is so arranged that is preferably placed over theport 14 and roughly V- shaped.
It is preferred for the reason given later that the end of the V-shaped seal be superposed, as shown in FIG. 1, on the near upper portion of the diaphragm.
What is important in heat sealing thetab 17 to theprotective closure 16 is that thetab 17 be sealed sufficiently airtight to ensure complete sterilization and, when the protective closure is to be unsealed, be opened easily and reliably without being broken off. Therefore, this invention consists in, as illustrated in FIGS. 4 to 7, heat sealing thetab 17 to theprotective closure 16 in the direction in which the latter is set in place and fusing together the sheets of bothclosure 16 andtab 17 to form a V-shaped groove extending into thetab 17. There will now be described the process of the invention by reference to these figures. There is first superposed theprotective closure 16 on thetab I 17. Then aheater 20 is moved near the superposed assembly from the side of theprotective closure 16 FIG. 4). Theheater 20 is forced into the mass until its end reaches thetab 17 to fuse both sheets together (FIG. 5). When theheater 20 is taken off, there is obtained a V-shaped groove 18a, on both sides of which there are formed upward projectingribs 18b. Anotherheater 21 is intended to ensure the full fusion of thetab 17 to theprotective closure 16, thereby increasing the flexural strength of thetab 17 when it is peeled. As shown in FIGS. 4 and 5, thelatter heater 21 is placed adjacent to the first mentionedheater 20 to produce both heat seals simultaneously. Since, however, thelatter heater 21 is intended simply to ensure the tight fusion of thetab 17 to theprotective closure 16, and also to form ribs 22 so as to elevate the flexural strength of thetab 17, thelatter heater 21 need not be inserted into the superposed mass so deeply as the first mentionedheater 20.
When thetab 17 is thus heat sealed to theprotective closure 16, the boundary (A) between the fused and nonfused portions of theprotective closure 16 becomes slightly thinned, as shown in FIG. 7, and in consequence is reduced in tear strength, permitting its easy breakage when thetab 17 is pulled. Though, therefore, the sheets of bothprotective closure 16 andtab 17 originally had the same thickness, theprotective closure 16 alone is sure to be broken, eliminating the necessity of making the sheet of thetab 17 thicker than that of theprotective closure 16. This offers in manufacture the advantage of using plastic sheets of the same material and thickness in common to theprotective closure 16 andtab 17. As the material forprotective closure 16 andtab 17, a pliable and transparent film such as soft polyvinyl chloride film or polyolefin resin film may be used.
According to a preferred embodiment, theprotective closure 16 has a thickness of a 0.4 mm and an inner width (Y) of about 16 mm as against theport 14 having a diameter (X) of about 7 mm, and the distance (Z) between the end of theport 14 and the inner end of theprotective closure 16 is about 5 mm. Thetab 17 consists of the same kind of plastic sheet as theprotective closure 16, and is heat sealed thereto in advance by the process illustrated in FIGS. 4 to 6. As apparent from FlG. 2, the final heat seal pattern is such that the side of the base portion of thetab 17 which faces theparenteral solution bag 11 is formed into a pyramidic shape above theport 14 with the pointed top of said pyramidic shape disposed slightly above thediaphragm 15. When, as shown in FIG. 8, theport 14 is bent to peel off thetab 17 with itsfree end 17b gripped by hand, the boundary between theport 14 anddiaphragm 15 is naturally bent, enabling saidfree end portion 17b to be easily gripped. There is further advantage that since thediaphragm 15 is difficult to bend, thetab 17 can be peel off, as illustrated in FIG. 9, without loss of the peeling force. The pyramidic heat sealed pattern is not limited to what is indicated, but any other similar pattern may be accepted, provided that it causes the peeling force to be concentrated at a point so as to permit the easy removal of thetab 17.
There will now be described the process of peeling off thetab 17. Thefree end portion 17b of thetab 17 is gripped by hand as shown in FIG. 8 so as to be taken off through the steps as illustrated in FIGS. 9 to 12. Since thetab 17 has itsbase portion 170 integrally formed with theprotective closure 16 and there are formed a V-shaped groove 18a andribs 18b in the heat sealedportion 18 of the superposed assembly of theprotective closure 16 andtab 17, said heat sealedportion 18 is allowed to have a prominently greater flexural strength than the opposite side 16a of theprotective closure 16. When, therefore, thetab 17 is pulled down by the finger as shown in FIG. 11, thetab 17 is not bent, but theprotective closure 16 alone is bent. Further, theend 16b of theprotective closure 16 is not provided with a V-shaped groove illustrated in FIGS. 4 to 6, but is fully heat sealed by the ordinary method used in fusing together laminated sheets. When, therefore, thetab 17 is peeled off, saidend 16b of theprotective closure 16 is not taken off together with thetab 17.
When thetab 17 is peeled, its base portion 17a is not bent and theend 16b of theprotective closure 16 remains fused to thetab 17. Therefore, theprotective closure 16 and tab 17jointly act as a spring to the finger when it presses thetab 17 from the inside, preventing thetab 17 from getting away from the finger. As shown in FlG. 12, therefore, the finger can be inserted fully into theprotective closure 16 so as to easily expose theport 14. Accordingly, when there is inserted a cannula into theport 14, thetab 17 plays the part of holding the finger. Namely, thetab 17 not only serves to tear open theprotective closure 16, but also acts as a stopper for preventing the finger from slipping.
It is also possible, as shown in FIGS. 1 to 6, to form a pair of heat sealedportions 19 having ribs 22 in the base portion 17a of thetab 17 for reinforcement to increase its stopper action. 7
Theparenteral solution bag 11 provided withports 14 having above-mentioned structure and arranged in the periphery of bag 11' is convenient to manufacture compared with the case in which ports are arranged in the bag face. The advantage of the present parenteral solution bag also lies in that there are further advantages that plastic sheets of the same material and thickness are used for both the protective closure and tab; the tab is unfailingly peeled off; the joint of the protective closure and the tab is easily broken by the peeling of the latter; the tab concurrently acts as a stopper when it is peeled; and the cannula is easily inserted. Further, parenteral solution may be taken out while the bag is suspended by means of ahanger hole 23. There is no possibility for hands to touchports 14, and this is a merit from a hygienic point of view.
In connection with maintaining sterility. since the protective closure is peeled in such a way as illustrated in FIGS. 8 to 12, there is little possibility that germs sticked to the tab or protective closure fall into the port as the tab is turned over. This is one of the important advantages of the present invention over the known parenteral solution bags.
What is claimed is:
1. In a parenteral solution bag comprising at least one port tube protruding from part of the perimeter of the bag and hermetically enclosed by a bag-like protective closure, a diaphragm provided in the port tube sealing off the port tube from flow-off liquid within the bag through the port tube, and a tab peripherally heat sealed to a portion of said protective closure having an unsealed free end, the improvement which comprises in combination:
- a. the free end of the tab extending toward said bag,
1'). a V-shaped groove extending through said protective closure and into said tab, said tab and said closure being connected by a heat seal which extends along the periphery of said groove, and a pair of ribs on said closure, said ribs extending adjacent I said groove, 1 c. the apex of said V-shaped groove facing toward the junction of said port tube with said bag, d. said V-shaped groove being positioned over said I port tube and extending transversely to the port k tube, and i e. the heat sealed portion of said tab being more rigid l than the portion of said protective closure not sealed to said tab so that when the tab is peeled and turned backward towards the opposite side of said port tube, said heat sealed portion of said tab does not bend but instead said portion of said protective closure not sealed to said tube bends.
2. The parenteral solution bag of claim 1 wherein there is on said tab a pair of longitudinal heat seal portions accompanied with ribs spaced apart from one another and depending parallel to the longitudinal axis of said port tube from adjacent said V-shaped groove.
3. The parenteral solution bag of claim 1 wherein said protective closure is a rectangular shaped envelope formed of plastic sheet heat sealed along the two longest sides and one of the shorter sides, the other short side is heat sealed to said bag with said port tube enclosed by said protective closure and said V-shaped groove faces inward toward said port tube and extends from the heat seal along one of said longest sides to the heat seal along the other longest side.