JP2000109099A - Sterilizing bag - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a sterilizing bag wherein a sealed state may not be broken when a bag body is swollen, and an air-permeable sheet can be easily peeled off at the time of taking out a sterilized object housed in the bag. SOLUTION: The sterilizing bag 10 having an object 18 to be sterilized housed therein is placed in a sterilization chamber, sterilizing gas is made to flow through an air-permeable sheet 13, and subsequently a vacuum process for discharging the gas in the sterilization chamber is performed. During the vacuum process, an internal pressure becomes higher than an external pressure since the gas in a bag body 11 is difficult to be discharged, causing the bag body 11 to swell. Since a seal 14 is positioned inward from a periphery (fixing part 17) of the bag body 11 at this time, force applied by the internal pressure to the seal becomes shearing force. In order that the shearing force may break the seal 14, larger force than a case where peeling force breaks the seal 14 is required. Thus durability in shearing can be increased while peeling force at the time of breaking the seal can be kept small, so that even if shearing force works to the seal 14 when the bag body 11 is swollen, the bag can be designed to withstand the shearing force.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a sterilization bag used for sterilizing objects to be sterilized (for example, medical instruments such as injection needles, syringes, various catheters, various cannulas, etc.).

[0002]

2. Description of the Related Art Sterilization bags are required to have sufficient resistance to bacteria and external forces and to be able to easily remove items to be sterilized such as medical supplies housed therein. For example, in the sterilization bag 60 shown in FIGS. It is known that the breathable sheet 63 is adhered to the bag body 61 in a releasable state. In the sterilization bag 60, the opening 62 is a fraction of the surface area of the bag body 11 and is not too large with respect to the material 68 to be sterilized.
It is widely used because there is little possibility that the object 68 to be sterilized that has been stored by mistake is dropped when it is peeled off.

When performing sterilization using a sterilizing gas such as ethylene oxide using such a sterilization bag 60, first, the sterilization bag 60 in which the object 68 to be sterilized is hermetically stored is placed in a sterilization chamber of a sterilizer. Then, after negative pressure in the sterilization chamber,
A gas for sterilization is supplied under heating (about 50 ° C.), and the state is maintained for a predetermined time. At this time, the bag body 61 is filled with the sterilizing gas via the breathable sheet 63. Thereafter, the gas in the sterilization chamber is discharged (vacuum process). Next, air is supplied to the sterilization chamber until it becomes pressurized (function pressure step). By this function pressure step, the bag body 61 is filled with air via the air permeable sheet 63. Then, the sterilization gas in the sterilization bag 60 is completely discharged by repeating the vacuum step and the function pressure step.

[0004]

The sterilization bag 60 allows gas to flow in and out through the air permeable sheet 53, and therefore has a large resistance to gas flow in and out of the sterilization chamber in the vacuum step and the function pressure step. Therefore, when the process shifts to the vacuum process, the inside of the sterilization chamber is quickly evacuated, but the gas in the bag body 61 is not smoothly discharged, and the internal pressure of the bag body 61 becomes relatively high with respect to the external pressure. The main body 61 expands greatly toward the outside. At this time, as shown in FIG. 11, a force (peeling force or peeling force) for separating the breathable sheet 63 and the back sheet 66 acts on the sealing portion 64 provided on the peripheral edge of the bag body 61, and the two are torn. In some cases, the sealed state of the seal portion 64 was broken.

On the other hand, as a measure for preventing the sealing state from being broken due to such a peeling force acting, a sealing portion 64 is required.
It is conceivable to increase the peeling strength of the material to be sterilized from the sterilization bag 60 when such measures are taken.
There is a problem that it is difficult to peel off the breathable sheet 63 when taking out.

SUMMARY OF THE INVENTION The present invention has been made in view of the above problems, and has as its object to prevent the sealed state from being broken when the bag body is inflated, and to peel off the breathable sheet when taking out an object to be sterilized. It is to provide an easy sterilization bag.

[0007]

Means for Solving the Problems and Effects of the Invention In order to solve the above problems, the invention according to claim 1 is directed to cover a bag body, an opening provided in the bag body, and a cover for covering the opening. An air-permeable sheet provided, and a seal portion that adheres the air-permeable sheet and the bag body in a releasable state, wherein the bag body is filled with a sterilizing gas through the air-permeable sheet. A sterilization bag for sterilizing an object to be sterilized stored in a main body, wherein when the bag main body is inflated, a shear force in a direction substantially parallel to the air-permeable sheet acts on the seal portion due to an internal pressure of the bag main body. It is a sterilization bag having such a structure.

In the sterilization bag of the present invention, for example, as described in the section of the prior art, after the inside of the sterilization chamber is made to have a negative pressure, a sterilization gas is supplied to the bag body via a breathable sheet. In the case where the gas is filled and then the gas in the sterilization chamber is discharged in the vacuum process, when the vacuum process is started, the sterilization chamber is quickly vacuumed, but the gas in the bag body is not discharged smoothly, and the bag is not discharged. Since the internal pressure of the main body is relatively higher than the external pressure, the bag main body expands greatly toward the outside. When the bag body expands in this manner, a shear force (hereinafter simply referred to as a shear force) in a direction substantially parallel to the air-permeable sheet acts on the seal portion instead of the peel force due to the internal pressure of the bag body. When the sealing portion is broken by the shearing force, the sealing portion is broken by the peeling force (in this case, as shown in FIG. 11, the peeling force acts on one end of the sealing portion instead of the entire sealing surface as shown in FIG. 11). , Requires great power. For this reason,
Even when the peel force at the time of breaking the seal portion is kept small, the durability against the shear force (hereinafter referred to as the shear durability) can be increased, so the shear force acts on the seal portion due to the internal pressure when the bag body expands. Even so, it is possible to prevent the seal portion from being broken by the shearing force.
For example, this effect can be effectively obtained by appropriately adjusting the area of the seal portion.

As described above, according to the sterilization bag of the present invention, the shearing durability can be increased while the peeling force at the time of breaking the seal portion is reduced, so that the air-permeable sheet of the sterilization bag is peeled off to be sterilized. The peeling operation at the time of taking out an object can be easily performed, and even if, for example, a shearing force is applied to the seal portion by the internal pressure of the bag body in a vacuum process at the time of sterilization, the sealed state of the sterilization bag is broken. The effect that there is no fear is obtained.

According to a second aspect of the present invention, there is provided a bag body, an opening provided in the bag body, a breathable sheet provided to cover the opening, the breathable sheet and the bag body. And a seal portion that adheres in a peelable state, and a sterilization bag that sterilizes an object to be sterilized stored in the bag body by filling the bag body with a sterilizing gas through the breathable sheet, The seal portion is provided inside the peripheral edge of the bag body. In this sterile bag, since the seal portion is provided inside the peripheral edge of the bag body, when the bag body expands, for example, as in the case of the above-described vacuum process, the seal portion has a shear force due to the internal pressure of the bag body. Works. Therefore, the same effect as the sterilization bag of the first aspect is obtained.

According to a third aspect of the present invention, there is provided the sterilization bag according to the first or second aspect, wherein the bonding area of a peeling start portion of the seal portion at which the breathable sheet is peeled from the bag body is changed to another portion. And the peel strength is made weaker than other parts. In this sterilization bag, the peeling strength of the peeling start portion of the seal portion was made weaker than that of the other portions, and instead the area was made wider than that of the other portions. Can be equivalent to Therefore, when the bag body is inflated, the sealed state is not easily broken from the peeling start portion. Also,
Since the peeling strength of the peeling start portion is weaker than that of the other portions, when the breathable sheet is peeled off, it is easier to peel off than the other portions. Therefore, the effect of the sterilization bag of the first aspect is more remarkably obtained.

[0012]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Preferred embodiments of the present invention will be described below with reference to the drawings. [First Embodiment] FIG. 1 is a perspective view of a sterilization bag of the present embodiment,
2 is a sectional view taken along line AA of FIG. 1, FIG. 3 is a perspective view showing a state in which a breathable sheet is peeled off from the sterilization bag, and FIG. 4 is a front view of the sterilization bag of the present embodiment.

The sterilization bag 10 includes a bag body 11, an opening 12 provided in the bag body 11, a breathable sheet 13 provided to cover the opening 12, a bag body 11 and a breathable sheet 13. And a seal portion 14 for releasably adhering. The bag body 11 is formed by laminating a top sheet 15 and a back sheet 16 made of a polymer film such as a polyethylene film, and fixing the entire periphery thereof by heat welding or the like to form a fixing portion 17, thereby forming a bag-like shape. Is formed. The opening 12 is formed by cutting a part (for example, about ４ to ２) of the topsheet 15 of the bag body 11 into a substantially rectangular shape. The breathable sheet 13 is
A sheet made of a substantially rectangular non-woven fabric or the like formed to be larger than the area of the opening 12, and a top sheet 1 of the bag body 11 is formed by a seal portion 14 provided around the opening 12.
5 in a releasable state. Seal part 14
Is formed along the outer periphery of the opening 12 with a predetermined seal width inside the fixing portion 17 of the bag body 11. The seal portion 14 is formed at a distance of several mm from the periphery of the opening 12. Incidentally, in FIG.
Is shown as a shaded area.

Next, a case where the sterilization bag 10 of this embodiment is used to sterilize with a sterilizing gas (eg, ethylene oxide) will be described. First, medical instruments such as injection needles, syringes, various catheters, and various cannulas are hermetically stored in the sterilization bag 10 as objects 18 to be sterilized.
Into a sterilization chamber of a sterilizer (not shown). Subsequently, after the inside of the sterilization chamber is made to have a negative pressure, a sterilizing gas is supplied under heating (about 50 ° C.), and the state is maintained for a predetermined time. At this time, the bag body 11 is filled with the sterilizing gas via the breathable sheet 13. Thereafter, the gas in the sterilization chamber is discharged (vacuum process). By this vacuum process, the sterilizing gas in the bag body 11 is discharged through the permeable sheet 13. Next, air is supplied to the sterilization chamber until it becomes pressurized (function pressure step). By this function pressure step, the bag body 11 is filled with air through the air permeable sheet 13. Then, by repeating the vacuum step and the function pressure step, the sterilizing gas in the bag body 11 is completely discharged.

When the gas in the sterilization chamber is exhausted in the vacuum step, the interior of the sterilization chamber is quickly evacuated, but the gas in the bag body 11 is exhausted through the air-permeable sheet 13 having high resistance, so that the gas is smoothly exhausted. Not the bag body 11
The internal pressure of the bag body 11 becomes relatively higher than the external pressure, and the bag body 11 expands greatly toward the outside (see FIG. 5).
However, since the seal portion 14 is provided inside the peripheral edge of the bag body 11, the force exerted by the internal pressure on the seal portion 14 is a shear force in a direction substantially parallel to the air permeable sheet 13 as shown in the enlarged view of FIG. Becomes

On the other hand, in order to break the seal portion 14 by a shearing force, the seal portion 14 is broken by a peel force (in this case, one end of the seal portion 14 is peeled off like a case where the seal portion 14 is peeled off with a finger or the like). Seal part 1 by applying peel force
4 is to be destroyed). For this reason, the shearing durability can be increased while the peeling force when breaking the seal portion 14 is kept small, and the seal portion 1 is formed by the internal pressure when the bag body 11 expands.
4 can be designed so that the seal portion 14 is not broken even if a shear force acts on the seal portion 14.

Therefore, according to the sterilization bag 10, since the peeling force at the time of breaking the seal portion 14 is small, the peeling operation at the time of peeling the breathable sheet 13 and taking out the object 18 to be sterilized can be easily performed. In addition, since the shear durability is high, even if a shearing force acts on the seal portion 14 due to the internal pressure of the bag body 11 in the vacuum process at the time of sterilization, there is no danger that the sealed state of the sterilization bag 60 will be broken. can get.

Here, it will be described below that the above effects of the present embodiment are supported by specific data. In the sterilization bag 10 of this embodiment, a portion indicated by a two-dot chain line in FIG. 4 was cut out, and this was used as a test piece A (seal width 10 mm, test piece seal length 15 mm) shown in FIG.
On the other hand, a portion indicated by a two-dot chain line in FIG. 8 was cut out from the conventional sterilization bag 60, and this was used as a test piece B (seal width 10 mm, test piece seal length 15 mm) shown in FIG. Note that the method of bonding the seal portions 14 and 64 was the same for both the sterilization bags 10 and 60.

With respect to the test piece A, as shown in FIG. 6, the top sheet 15 of the bag body 11 and the air permeable sheet 13 are pulled substantially parallel to the seal portion 14 to measure the shearing force when the seal portion breaks. As a result, the sealing portion 14 was not destroyed even if it exceeded 500 gf, but the breathable sheet 13 and the topsheet 14 began to expand. For this reason, the shear force at the time of breaking the seal portion was set to> 500 gf. On the other hand, for the test piece B, as shown in FIG.
When the peel force at the time of breakage of the seal portion was measured by pulling the gas-permeable sheet 63 and the air-permeable sheet 63 at substantially right angles to the seal portion 64, the result was 150 to 300 gf. From this result, it was found that even when the peel force at the time of breaking the seal portion was small, the shear force at the time of breaking the seal portion was large.

In the sterilization bag 10 of the present embodiment, the force exerted by the internal pressure of the bag body 11 on the seal portion 14 is a shearing force, so that the force exerted by the internal pressure of the bag body 11 on the seal portion 14 is a peel force. Compared to the bag 60, the sealed state is less likely to be broken in the vacuum process.
In the case of peeling off 3, it can be peeled off with almost the same force as the conventional sterilization bag 60, so that it was experimentally confirmed that it can be easily peeled off.

Next, the manufacturing process of the sterilization bag 10 will be described. A perforation for forming the opening 12 is formed in the top sheet 15, and then the breathable sheet 13 and the top sheet 15 are releasably adhered to each other by the seal portion 14. The portion inside the perforations of the top sheet 15 is removed to form the opening 1.
Form 2 The top sheet 15 and the back sheet 16
The object 18 to be sterilized is sandwiched between the two sheets 1 in this state.
The fixing portions 17 are formed by heat-welding the peripheral edges of 5 and 16. The sterilization bag 10 in which the object 18 to be sterilized is sealed is obtained by performing the above steps 1 to 3. Note that the following steps may be employed instead of the above steps. That is, the top sheet 15 having no opening 12 and the air permeable sheet 13 are releasably adhered to each other by the seal portion 14. '' Top sheet 15
The opening 12 is formed by irradiating a laser beam from the side by the thickness of the topsheet 15. Alternatively, "a laser reflector slightly larger than the opening area is sandwiched between the top sheet 15 and the air permeable sheet 13, and in this state, both are adhered releasably by the seal portion 14." The opening 12 is formed by irradiating slightly along the inside of the outer periphery of the laser reflector.

In addition to the above-described manufacturing method, the top sheet 15 provided with the opening 12 and the back sheet 16 are overlapped, and the peripheral edges of both sheets 15 and 16 are thermally welded. A method of putting the bag into the bag body 11 and then bonding the air permeable sheet 13 and the top sheet 15 with the seal portion 14 is also conceivable.
Since it is difficult to completely seal the sheet with the breathable sheet 13, it is preferable to adopt the above-described manufacturing method.

[Second Embodiment] FIG. 7 is a front view of a sterilization bag according to a second embodiment. In the sterilization bag 20 of the second embodiment, the seal width of the peeling start portion 25 of the seal portion 24 is wider than other portions (for example, 1.5 to 3 times as compared with other portions).
By doing so, the sealing area of the peeling start portion 25 is made wider than the other portions, and the peeling strength of the peeling start portion 25 is made weaker than the other portions, with the same configuration as the first embodiment. is there. Therefore, the same reference numerals are given to the same components as those in the first embodiment, and the description thereof will be omitted.

Although the peeling start portion 25 has a lower peeling strength than the other portions, it is designed so that the sealing area is increased accordingly and the same shear durability as the other portions can be obtained. For example, if the seal width of the peeling start portion 25 is N times (N is an integer) compared to other portions, the peeling strength may be 1 / N of other portions.

In the sterilization bag 20 of the present embodiment, since the shearing durability of the peeling start portion 25 is equivalent to that of the other portions, when the bag body 11 expands, the sealed state is broken especially from the peeling start portion 25. Nothing is easier. Further, since the peeling strength of the peeling start portion 25 is weaker than other portions, when the breathable sheet 13 is peeled off, it is easier to peel off than the other portions.

The embodiments of the present invention are not limited to the above-described embodiments, and it goes without saying that various embodiments can be adopted as long as they fall within the technical scope of the present invention. For example, in the above-described embodiment, the opening 12 is formed to have a relatively small area (１ ／ to 表面 of the topsheet 15), but the seal portion 14 is provided inside the peripheral edge of the bag body 11, that is, inside the fixing portion 17. The opening 12 may be formed in any shape as long as it is provided. For example, the opening 12 may be formed so as to be slightly inside the peripheral edge of the bag body 11, that is, the fixing portion 17.

[Brief description of the drawings]

FIG. 1 is a perspective view of a sterilization bag according to a first embodiment.

FIG. 2 is a sectional view taken along line AA of FIG.

FIG. 3 is a perspective view showing a state in which a breathable sheet is peeled off from the sterilization bag of the first embodiment.

FIG. 4 is a front view of the sterilization bag according to the first embodiment.

FIG. 5 is a cross-sectional view of the sterilization bag according to the first embodiment during a vacuum step.

FIG. 6 is an explanatory diagram of test pieces A and B.

FIG. 7 is a front view of a sterilization bag according to a second embodiment.

FIG. 8 is a perspective view of a conventional sterilization bag.

9 is a sectional view taken along line AA of FIG.

FIG. 10 is a perspective view showing a state in which a breathable sheet is peeled off from a conventional sterilization bag.

FIG. 11 is a sectional view of a conventional sterilization bag during a vacuum step.

[Explanation of symbols]

DESCRIPTION OF SYMBOLS 10 ... Sterilization bag, 11 ... Bag main body, 12 ... Opening part, 13 ... Breathable sheet, 14 ... Seal part, 1
5 ... top sheet, 16 ... back sheet, 17 ...
・ Fixed part, 18: object to be sterilized.

Claims (3)

[Claims] 1. A bag body, an opening provided in the bag body, a breathable sheet provided to cover the opening, and a state in which the breathable sheet and the bag body can be peeled off. A sterilization bag for sterilizing an object stored in the bag body by filling the bag body with a sterilizing gas through the air permeable sheet, wherein the bag body is inflated. A sterilizing bag, wherein a shearing force in a direction substantially parallel to the air-permeable sheet acts on the seal portion by an internal pressure of the bag body. 2. A bag main body, an opening provided in the bag main body, a permeable sheet provided so as to cover the opening, and a state in which the permeable sheet and the bag main body can be peeled off. A sterilization bag for sterilizing an object stored in the bag body by filling the bag body with a sterilizing gas through the air-permeable sheet, wherein the seal portion is the bag. A sterilization bag provided inside the periphery of the main body. 3. The sterilization bag according to claim 1, wherein a peeling start portion of the seal portion, at which the breathable sheet is peeled from the bag body, has a larger bonding area than other portions and peels. A sterilization bag characterized by having a lower strength than other parts.