Patent Grant
10226400
The present invention relates to a multi-cell container of a type having a plurality of compartments, which are for storing separately respective medicines and which are divided by a partition wall as a separable seal, which is separated and opened for mixing the medicines between the compartments. The present invention is suitable for separate storage of two or more medicines of powder state, which are required to be mixed just before use for keeping stability thereof and is, for example, suitable for storage of polyethylene glycol electrolyte for a preparation treatment in a colonoscopy.
In a colonoscopy, a bowel lavage medicine is used for preparative treatment. Such a preparative medicine should be in the form of an aqueous solution for allowing it to be taken by mouth. However, under the aqueous solution, the medicine is subjected to degeneration or coloring with time. Therefore, in an actual shape of product, the medicine of a powder state is tightly stored in a four side seal bag or a self-support bag functioning also as a container for solving the medicine to obtain its solution, which bag is made from soft films. It is, therefore, usual that the bag is opened just before the use and an aqueous solution is obtained for the instant use. See, for example, patent document 1 as far as a container of a soft bag type is concerned, where an application of water is done for obtaining the aqueous solution when used.
In such bowel lavage medicine, which is essentially under a powder state and is solved by water just before the use, a type that includes, in combination, polyethylene glycol (PEG) and electrolyte has conventionally been known. In this type, a large quantity of, at the most, as much as 4 liter is needed, which is highly non-desirable for a people of reduced physical strength, such as an aged person. In view of this, a type of bowel lavage medicine for realizing a reduced quantity of medicine has recently been proposed, in which ascorbic acid (vitamin C) is added to the polyethylene glycol (see patent document 2). This ascorbic acid added type is improved in its bowel lavage ability, so that a reduction of a quantity of medicine to a value between 1 and 2 liter is realized over the large quantity in the prior art of, at the maximum, as much as 4 liter. In short, the ascorbic acid added type is advantageous since a reduction of physical strain is obtained for those who take medicine.
In the patent document 2, the ascorbic acid as well as the polyethylene glycol are under powdered states and are degenerated and/or colored with time when mixed with each other. Therefore, a mixing and solving to water are needed just before use and a container therefor is needed. The patent document 1 discloses a multi-cell container wherein one of medicines is of powdered state and the other medicine is of liquid state. However, a container has not yet been proposed, which is capable of separately storing medicines of powder states and is capable of mixing the medicines and of providing the aqueous solution when used. The present invention is motivated under such an existing state of prior arts.
A multi-cell container according to the present invention comprises a bag of substantially flat shape made of flexible (soft) film, a partition wall as a separable seal welding opposite inner surfaces of the bag and dividing an inner space of the bag into a plurality of compartments and an inlet-outlet port located at a peripheral portion of the bag so as to be opened to one of the plurality of compartments for introduction and/or discharge of liquid, wherein medicines only of powder states are respectively stored in the plurality of compartments. A liquid is introduced into one of the compartments from the inlet-outlet port to solve the powdered state medicine and a separation of the separable seal causes the solution to be introduced into the rest of the compartment among the plurality of compartments, so that the powdered state medicine stored therein is solved. Preferably, the partition wall is arranged so that it faces, at least partially, a gusseted bottom of the bag. More preferably, the partition wall comprises a first part extending in a direction along the bottom of the bag from its side to a middle location along the width of the bag and a second part extending in a direction opposite to the bottom of the bag from an end of the first part to the top side of the bag. Furthermore, one of the compartments, to which the inlet-outlet port is opened, is located on one side of the partition wall adjacent the bottom of the bag while the other compartment with no provision of inlet-outlet port is located on the side of the partition wall remote from the bottom of the bag. The partition wall may be formed with a rounded shape at a corner portion where the first and second parts are connected with each other. A value of the seal strength of the partition wall may suitably selected and may be: a value, which causes the seal to be separated only by a load as generated by the introduction of the water to one compartment among the plurality of the compartments; a value, which causes the seal to be separated by a shaking operation of the bag after the introduction of the water thereto; or a value, which prevents the seal to be separated by the introduction of the water to the bag but allows the seal to be opened by an additional operation such as a pressing after the water introduction. Finally, the separable seal constructing the partition wall may have a value of seal strength in a range between 1 to 5 N/15 mm.
In the container according to the present invention, medicines of powder states are stored in respective compartments and, from the inlet-outlet port, liquid such as water is introduced to the compartment to which the inlet-outlet port is opened, so that the medicine stored in the compartment is solved to obtain its water solution. The separable seal as the partition wall according to the present invention is weaker than that of a conventional double cell container for storing liquid(s). However, according to the present invention, both of the compartments are for storing, purely, the powdered state medicines and, therefore, the weak separable seal as the partition wall according to the present invention is enough for preventing the seal from being non-intentionally opened by an outside force during a handling of the bag such as a product transfer. However, the weakness of separable seal according to the present invention allows the partition wall to be separated (opened) by a force to the sealed portion as generated when water is introduced for solving the medicine or by an outside force applied by the water solution in the compartment, to which the inlet-outlet port is opened, as generated when the bag is merely shaken. Namely, according to the present invention, a solving and mixing of the powder state medicine in the partition with no provision of the inlet-outlet port is taken place without forcibly applying physical force outwardly. In short, the present invention makes it possible that the powder state medicines are positively maintained in the separate respective compartments during the handling such as a product transfer, on one hand and, on the other hand, the medicines are easily and reliably solved and mixed by merely shaking, i.e., without necessity of any outside pressing when used, thereby preventing erroneous operation from being occurred, which may otherwise cause the medicines to be taken without being mixed.
By constructing the partition wall from a first part extending in a direction along the bottom of the bag from its side to a middle location along the width of the bag and from a second part extending in a direction opposite to the bottom of the bag from an end of the first part to the top side of the bag, it is possible that the bag folded in half does not cause its folded line to be crossed by the partition line, which is advantageous in that the partition wall is prevented from being applied to an unreasonable outside force during its handling such as transportation, which otherwise causes the partition wall to be accidentally separated.
Although the bag's openability depends on the height of the partition wall from the gusseted bottom of the bag, it is found that a value of seal strength of the separable seal as the partition wall in the range between 1 to 5 N/15 mm is desirable from the view point that an accidental opening of the partition wall otherwise caused by handling problem during product transfer is effectively prevented, on one hand and, on the other hand, a bag is reliably and positively opened by a few number of shaking strokes, thereby positively preventing an erroneous operation from being occurred, which otherwise causes the medicine to be taken without being mixed.
In
The polyethylene film, which is, in this embodiment, transparent and which may be colored, is of multi-layered structure of a thickness in a range between 50 to 200μ. In place of the polyethylene, a suitable plastic material such as polypropylene may be used. Along a production line for the bag 10, a sheet of polyethylene film as fed is folded in half as shown in
As shown in
As shown in
An inlet-outlet port 16 is arranged in the peripheral strong seal 12 at a top location of the bag 10 opposite the bottom 10A. The inlet-outlet port 16 forms essentially a tubular shape opened at its top and bottom and is for introduction of water for obtaining a solution of the powder medicines stored in the bag 10 and for discharging the water solution as obtained by solving the powdered medicines to the water. The inlet-outlet port 16 has rigidity (wall thickness) capable of keeping its tubular shape and is a non-transparent mold product from the same plastic material as that of the bag, i.e., polyethylene, so that a desired welding strength of the port to the bag is obtained. As shown in a perspective view in
In
The medicines to be stored by the multi-cell container according to this embodiment are polyethylene glycol electrolyte (polyethylene glycol added by electrolyte) added by ascorbic acid, as bowel lavage medicine (see patent document 2). Both of the polyethylene glycol electrolyte and the ascorbic acid are under powdered states and are colored when mixed with each other. Therefore, a requirement exists that they should be kept separate until just before the use. The present invention aims to fulfill this requirement. Namely, according to this embodiment, the polyethylene glycol electrolyte powder 40 is stored in the first compartment 20 of a larger volume while the ascorbic acid powder 42 is stored in the second compartment 22 of smaller volume.
In the multi-cell container for the storage of bowel lavage medicine as an embodiment of a multi-cell container according to the present invention, the polyethylene glycol electrolyte powder 40 and the ascorbic acid powder 42 are stored in the first and second compartments 20 and 22, respectively and the cap is mounted tightly to the inlet-outlet port 16 at the screw thread portion 16-1, so that a finished product for shipping is completed. For the sake of convenience of handling, the bag 10 of the entire height of, for example, 280 mm is folded in double along the middle height of about 140 mm and is stored in a wrapping. A relatively small force can generate a pressure applied to the partition wall 18 via the stored contents thereto, as will be explained later, on one hand. On the other hand, the folded state of the bag may promote a generation of an outside force as accidentally applied to the bag by its handling, such as a transfer. However, it is confirmed that the force applied to the partition seal 18 during the product transfer is not large enough to cause the seal 18 to separate because the stored contents are under powder states both in the compartments 20 and 22. In addition, the horizontal portion 18-1 of the partition wall 18 located adjacent the two-fold line of the bag during the handling extends in horizontal direction and does not cross the two-fold line, which makes it less likely that the partition wall 18 is accidentally opened during its handling such as a product transfer.
Now, a manner of use of the embodiment of the multi-cell container is explained. From the port 16 tightly sealed by the cap (not shown), the latter is turned and removed, and, a desired amount of distilled water is introduced into the first cell 20 via the port 16, so that the polyethylene glycol electrolyte powder 40 are solved by the introduced water so as to obtain its water solution. Then, an opening operation of the partition wall 18 is done for causing the ascorbic acid powder 42 in the second cell 22 to be solved by the water solution in the first cell 20. In this opening operation, the introduction of water into the first compartment 20 causes, itself, an erosion to be initiated in the partition wall 18, which may force the latter to open. Such erosion by the introduction of water is, even, enough to completely open the partition wall 18 when the seal strength of the partition wall 18 is weak. According to the present invention, the first and second compartments 20 and 22 store therein just powdered medicines and, therefore, it is possible that such weak setting of the degree of seal strength, that makes the seal to open just by the introduction of the water, does not cause the partition wall 18 to be non-intentionally opened if subjected to any outside force during a handling, such as a product transfer. However, such a weak setting makes it difficult to determine whether the separation of the partition wall 18 as occurred is generated intentionally by the introduction of water into the first compartment 20 or non-intentionally by handling during the product transfer. Such a difficulty must be avoided in order to prevent an erroneous operation from being occurred. In view of this, in the practice of the present invention, the setting of the seal strength of the partition wall 18 is such that no opening occur by a mere introduction of water and an intentional operation for opening the seal can only make the seal to open. In order to obtain such intentional opening, the bag 10, to which first compartment 20 the water introduced has been completed, may be subjected to shaking in the vertical or horizontal direction, which causes a liquid pressure to be generated, which is enough to make the partition wall 18 to open. Namely, a pressing operation from the outside by an operator's palm is not always necessary for carrying out the intentional opening operation, as is the case in a conventional bag where a liquid medicine is stored in at least one compartment.
Now, a result of tests as to the seal strength of the partition wall 18 will be explained. Multi-layer polyethylene films of thickness of 145 μm were subjected to a non-separable welding at temperature of 200° C. along the outer profile of a bag in order to form a peripheral seal 12 (
The test results will now be studied. When the height H of the horizontal portion 18-1 of the partition wall 18 is h700, the top level of the filled water of quantity of 1000 mL is located considerably above horizontal section 18-1. In this case, an opening of the partition wall 18 can be taken place the most easily. Especially, the seal strength equal to or lower than 3 (N) is enough to cause the seal to be separated even without any shaking of the bag, i.e., can initiate the seal separation merely by an introduction of the water of the amount of 1000 mL into the first compartment 20. In the seal strength of around the value of 4 (N), one or two strokes of the shaking operation are enough for opening. Namely, the amount of water of 1000 mL is enough to fill the first compartment 20 at a level fully above the horizontal section 18-1 of the partition wall 18, which allows the shaking action strongly urges the gusseted bottom 10A to be widened, so that a separation (opening) of the seal is initiated from the rounded portion 18-3. A value of seal strength as high as about 6 (N) does not prevent the rounded portion 18-3 from being separated and a partially non-separated portion is, however, left in the straight section 18-2 above the rounded corner portion 18-3.
When the height of the horizontal section 18-1 of the partition wall 18 is h1000, the top level of the filled water of an amount of 1000 mL is located at just around the horizontal section 18-1. The force for separating the seal constructing the partition wall 18 for opening the bag 10 as generated by the shaking is lowered as compared with that is obtained by the height H equal to h700. However, the force is still high and therefore the mere introduction of water to the first compartment 20 may open the seal without the shaking so long as the seal strength is 2 (N) or less. When a shaking is accompanied, the commencement of the seal separation at the corner portion 18-3 is possible when the seal strength is increased to 7.5 (N) while, however, the portion of the seal above the corner section is difficult to separate, i.e., non-separated portion is left in the straight section 18-2 of the partition wall 18.
When the height of the horizontal section 18-1 of the partition wall 18 is h1300, the top level of the filled water of an amount of 1000 mL is located fairly below the horizontal section 18-1. In this case, the force of filled water of amount of 1000 mL for urging the bag bottom 10A to stretch or to widen is small and therefore mere introduction of the water cannot cause the seal to open even when the seal strength is as small as 1 (N). Furthermore, even when the seal strength is merely increased to value of about 4 (N), 20 strokes or more of the shaking are needed to make the seal to open. Such a large number of shaking is likely to give the user a impression that the bag is difficult to open prior to the completion of the opening and induces him or her to execute an additional operation for opening other than mere shaking, i.e., outside pressing operation.
From the table 1,
A diagram of
Furthermore, a vibration test and a drop test were done for checking suitability during the product transfer. The vibration test is based on the random vibration test stipulated JIS Z 0232 with the vibration time of 60 minutes. An evaluation of the result of the vibration test was done by visually inspecting whether or not an opening occurs for 40 bags of each of the values of seal strength of 0.78, 1.17 and 2.14 N/15 mm, respectively. For the 40 bags for each of values of seal strength subjected to the test, any bag with seal opened could not found.
In view that all of the bags subjected to the vibration test could maintain the seal, the same bags were subsequently subjected to a drop test, which was done by dropping a bag from the height of 90 cm and the dropping is repeated for tree times. For the 40 bags of each of the values of seal strength of 0.78, 1.17 and 2.14 N/15 mm, respectively, any bag with seal opened could also not found. From the result of the vibration test and the drop test, it is understood that the minimum value of the steal strength as small as 0.78 N/15 mm is enough to prevent the seal from being separated with respect to the load as generated when subjected to a dropping. This minimum value of the steal strength of 0.78 N/15 mm has a sufficient margin with respect to the minimum value of 1 N/15 mm in the preferable range of seal strength 1 to 5 N/15 mm during the opening operation by the shaking or pressing as explained with reference to
| Number | Date | Country | Kind |
|---|---|---|---|
| 2011-018245 | Jan 2011 | JP | national |
This application is a continuation of PCT/US2012/052053 filed on Jan. 31, 2012 and based upon and claiming the benefit of priority from prior Japanese Patent Application No. 2011-018245, filed Jan. 31, 2011, the entire contents of all of which are incorporated herein by reference.
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| Number | Date | Country | |
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| Number | Date | Country | |
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| Parent | PCT/JP2012/052053 | Jan 2012 | US |
| Child | 13892783 | US |
