PARENTERAL SOLUTION BAG
United States Patent 3788374
A parenteral solution bag is provided with openings protruding from the perimeter of said bag for taking in or out parenteral solution and with a protective closure for hermetically enclosing this protruded portion. To the protective closure of the protruding portion is fused part of a tab for tearing said protective closure.
US Patent References:
Parenteral container
Bellamy, Jr. - September 1967 - 3343541
Parenteral fluid administration equiment
Bellamy, Jr. - November 1963 - 3110308
PACKAGING ASSEMBLY
Lemelson - February 1969 - 3426959
Bag
Grevich - September 1967 - 3339825
Parenteral container
Bellamy, Jr. - September 1967 - 3343541
Parenteral fluid administration equiment
Bellamy, Jr. - November 1963 - 3110308
PACKAGING ASSEMBLY
Lemelson - February 1969 - 3426959
Bag
Grevich - September 1967 - 3339825
Application Number:
05/220763
Publication Date:
01/29/1974
Filing Date:
01/26/1972
View Patent Images:
Export Citation:
Assignee:
Jintan Terumo Co., Ltd. (Tokyo, JA)
Primary Class:
Other Classes:
604/244, 383/207, 604/262
International Classes:
A61J1/00; B29C59/00; A61J1/05; B29C37/00
Field of Search:
150/1,8,3 229/66,62 128/272,227,214B,DIG.24
Primary Examiner:
Dixson Jr., William T.
Assistant Examiner:
Garbe, Stephen P.
Attorney, Agent or Firm:
Kemon, Palmer & Estabrook
Parent Case Data:
CROSS-REFERENCE TO RELATED APPLICATION
This is Continuation-in-part of the U. S. patent application Ser. No. 71,309, filed on Sept. 11, 1970, now abandoned.
Claims:
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:
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.
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:
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.
Description:
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 view.
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 III--III 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.
The reference 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 a tubular extension 13 connected to a blood drawing needle 12 and a pair of solution ports 14. The numeral 10 indicates a ball valve. Each port 14 is in the form of a hollow cylinder, one end being open to the inside of the bag 11 and the other end open to the outside of the bag 11. Between said two openings is stretched a diaphragm 15, through which a cannula can be pierced into the bag 11 and which prevents the outflow of the liquid existing inside bag 11. Further, protective closures 16 hermetically cover the whole ports 14 so as to prevent the pollution of the ports 14. Each protective closure 16 forms a bag and is provided with a tab 17 on one face. The base end portion 17a of the tab 17 is fused to the protruding front of said protective closure 16 and the other end portion 17b of said tab 17 is lapped over the surface of the protective closure 16 toward the end connected with the parenteral solution bag as a gripping means.
The seal 18 between the joined base portion 17a and the free end portion 17b of tab 17 is so arranged that is preferably placed over the port 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 the tab 17 to the protective closure 16 is that the tab 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 the tab 17 to the protective closure 16 in the direction in which the latter is set in place and fusing together the sheets of both closure 16 and tab 17 to form a V-shaped groove extending into the tab 17. There will now be described the process of the invention by reference to these figures. There is first superposed the protective closure 16 on the tab 17. Then a heater 20 is moved near the superposed assembly from the side of the protective closure 16 (FIG. 4). The heater 20 is forced into the mass until its end reaches the tab 17 to fuse both sheets together (FIG. 5). When the heater 20 is taken off, there is obtained a V-shaped groove 18a, on both sides of which there are formed upward projecting ribs 18b. Another heater 21 is intended to ensure the full fusion of the tab 17 to the protective closure 16, thereby increasing the flexural strength of the tab 17 when it is peeled. As shown in FIGS. 4 and 5, the latter heater 21 is placed adjacent to the first mentioned heater 20 to produce both heat seals simultaneously. Since, however, the latter heater 21 is intended simply to ensure the tight fusion of the tab 17 to the protective closure 16, and also to form ribs 22 so as to elevate the flexural strength of the tab 17, the latter heater 21 need not be inserted into the superposed mass so deeply as the first mentioned heater 20.
When the tab 17 is thus heat sealed to the protective closure 16, the boundary (A) between the fused and nonfused portions of the protective closure 16 becomes slightly thinned, as shown in FIG. 7, and in consequence is reduced in tear strength, permitting its easy breakage when the tab 17 is pulled. Though, therefore, the sheets of both protective closure 16 and tab 17 originally had the same thickness, the protective closure 16 alone is sure to be broken, eliminating the necessity of making the sheet of the tab 17 thicker than that of the protective closure 16. This offers in manufacture the advantage of using plastic sheets of the same material and thickness in common to the protective closure 16 and tab 17. As the material for protective closure 16 and tab 17, a pliable and transparent film such as soft polyvinyl chloride film or polyolefin resin film may be used.
According to a preferred embodiment, the protective closure 16 has a thickness of a 0.4 mm and an inner width (Y) of about 16 mm as against the port 14 having a diameter (X) of about 7 mm, and the distance (Z) between the end of the port 14 and the inner end of the protective closure 16 is about 5 mm. The tab 17 consists of the same kind of plastic sheet as the protective closure 16, and is heat sealed thereto in advance by the process illustrated in FIGS. 4 to 6. As apparent from FIG. 2, the final heat seal pattern is such that the side of the base portion of the tab 17 which faces the parenteral solution bag 11 is formed into a pyramidic shape above the port 14 with the pointed top of said pyramidic shape disposed slightly above the diaphragm 15. When, as shown in FIG. 8, the port 14 is bent to peel off the tab 17 with its free end 17b gripped by hand, the boundary between the port 14 and diaphragm 15 is naturally bent, enabling said free end portion 17b to be easily gripped. There is further advantage that since the diaphragm 15 is difficult to bend, the tab 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 the tab 17.
There will now be described the process of peeling off the tab 17. The free end portion 17b of the tab 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 the tab 17 has its base portion 17a integrally formed with the protective closure 16 and there are formed a V-shaped groove 18a and ribs 18b in the heat sealed portion 18 of the superposed assembly of the protective closure 16 and tab 17, said heat sealed portion 18 is allowed to have a prominently greater flexural strength than the opposite side 16a of the protective closure 16. When, therefore, the tab 17 is pulled down by the finger as shown in FIG. 11, the tab 17 is not bent, but the protective closure 16 alone is bent. Further, the end 16b of the protective 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, the tab 17 is peeled off, said end 16b of the protective closure 16 is not taken off together with the tab 17.
When the tab 17 is peeled, its base portion 17a is not bent and the end 16b of the protective closure 16 remains fused to the tab 17. Therefore, the protective closure 16 and tab 17 jointly act as a spring to the finger when it presses the tab 17 from the inside, preventing the tab 17 from getting away from the finger. As shown in FIG. 12, therefore, the finger can be inserted fully into the protective closure 16 so as to easily expose the port 14. Accordingly, when there is inserted a cannula into the port 14, the tab 17 plays the part of holding the finger. Namely, the tab 17 not only serves to tear open the protective 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 sealed portions 19 having ribs 22 in the base portion 17a of the tab 17 for reinforcement to increase its stopper action.
The parenteral solution bag 11 provided with ports 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 a hanger hole 23. There is no possibility for hands to touch ports 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.
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 view.
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 III--III 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.
The reference 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 a tubular extension 13 connected to a blood drawing needle 12 and a pair of solution ports 14. The numeral 10 indicates a ball valve. Each port 14 is in the form of a hollow cylinder, one end being open to the inside of the bag 11 and the other end open to the outside of the bag 11. Between said two openings is stretched a diaphragm 15, through which a cannula can be pierced into the bag 11 and which prevents the outflow of the liquid existing inside bag 11. Further, protective closures 16 hermetically cover the whole ports 14 so as to prevent the pollution of the ports 14. Each protective closure 16 forms a bag and is provided with a tab 17 on one face. The base end portion 17a of the tab 17 is fused to the protruding front of said protective closure 16 and the other end portion 17b of said tab 17 is lapped over the surface of the protective closure 16 toward the end connected with the parenteral solution bag as a gripping means.
The seal 18 between the joined base portion 17a and the free end portion 17b of tab 17 is so arranged that is preferably placed over the port 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 the tab 17 to the protective closure 16 is that the tab 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 the tab 17 to the protective closure 16 in the direction in which the latter is set in place and fusing together the sheets of both closure 16 and tab 17 to form a V-shaped groove extending into the tab 17. There will now be described the process of the invention by reference to these figures. There is first superposed the protective closure 16 on the tab 17. Then a heater 20 is moved near the superposed assembly from the side of the protective closure 16 (FIG. 4). The heater 20 is forced into the mass until its end reaches the tab 17 to fuse both sheets together (FIG. 5). When the heater 20 is taken off, there is obtained a V-shaped groove 18a, on both sides of which there are formed upward projecting ribs 18b. Another heater 21 is intended to ensure the full fusion of the tab 17 to the protective closure 16, thereby increasing the flexural strength of the tab 17 when it is peeled. As shown in FIGS. 4 and 5, the latter heater 21 is placed adjacent to the first mentioned heater 20 to produce both heat seals simultaneously. Since, however, the latter heater 21 is intended simply to ensure the tight fusion of the tab 17 to the protective closure 16, and also to form ribs 22 so as to elevate the flexural strength of the tab 17, the latter heater 21 need not be inserted into the superposed mass so deeply as the first mentioned heater 20.
When the tab 17 is thus heat sealed to the protective closure 16, the boundary (A) between the fused and nonfused portions of the protective closure 16 becomes slightly thinned, as shown in FIG. 7, and in consequence is reduced in tear strength, permitting its easy breakage when the tab 17 is pulled. Though, therefore, the sheets of both protective closure 16 and tab 17 originally had the same thickness, the protective closure 16 alone is sure to be broken, eliminating the necessity of making the sheet of the tab 17 thicker than that of the protective closure 16. This offers in manufacture the advantage of using plastic sheets of the same material and thickness in common to the protective closure 16 and tab 17. As the material for protective closure 16 and tab 17, a pliable and transparent film such as soft polyvinyl chloride film or polyolefin resin film may be used.
According to a preferred embodiment, the protective closure 16 has a thickness of a 0.4 mm and an inner width (Y) of about 16 mm as against the port 14 having a diameter (X) of about 7 mm, and the distance (Z) between the end of the port 14 and the inner end of the protective closure 16 is about 5 mm. The tab 17 consists of the same kind of plastic sheet as the protective closure 16, and is heat sealed thereto in advance by the process illustrated in FIGS. 4 to 6. As apparent from FIG. 2, the final heat seal pattern is such that the side of the base portion of the tab 17 which faces the parenteral solution bag 11 is formed into a pyramidic shape above the port 14 with the pointed top of said pyramidic shape disposed slightly above the diaphragm 15. When, as shown in FIG. 8, the port 14 is bent to peel off the tab 17 with its free end 17b gripped by hand, the boundary between the port 14 and diaphragm 15 is naturally bent, enabling said free end portion 17b to be easily gripped. There is further advantage that since the diaphragm 15 is difficult to bend, the tab 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 the tab 17.
There will now be described the process of peeling off the tab 17. The free end portion 17b of the tab 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 the tab 17 has its base portion 17a integrally formed with the protective closure 16 and there are formed a V-shaped groove 18a and ribs 18b in the heat sealed portion 18 of the superposed assembly of the protective closure 16 and tab 17, said heat sealed portion 18 is allowed to have a prominently greater flexural strength than the opposite side 16a of the protective closure 16. When, therefore, the tab 17 is pulled down by the finger as shown in FIG. 11, the tab 17 is not bent, but the protective closure 16 alone is bent. Further, the end 16b of the protective 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, the tab 17 is peeled off, said end 16b of the protective closure 16 is not taken off together with the tab 17.
When the tab 17 is peeled, its base portion 17a is not bent and the end 16b of the protective closure 16 remains fused to the tab 17. Therefore, the protective closure 16 and tab 17 jointly act as a spring to the finger when it presses the tab 17 from the inside, preventing the tab 17 from getting away from the finger. As shown in FIG. 12, therefore, the finger can be inserted fully into the protective closure 16 so as to easily expose the port 14. Accordingly, when there is inserted a cannula into the port 14, the tab 17 plays the part of holding the finger. Namely, the tab 17 not only serves to tear open the protective 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 sealed portions 19 having ribs 22 in the base portion 17a of the tab 17 for reinforcement to increase its stopper action.
The parenteral solution bag 11 provided with ports 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 a hanger hole 23. There is no possibility for hands to touch ports 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.