JPH02166073A - Medical appliance package and stacking form thereof - Google Patents

Abstract

PURPOSE:To lengthen the effective storage period of medical appliances not in use by sealing a unit of the medical appliances, together with deoxidation agent, in a packaging material consisting of a sheet of a gas- and vapor-barrier, partly transparent thermoplastic resin product. CONSTITUTION:A medical appliance package 1a contains within its packaging material 2 a unit of medical appliances, e.g. a blood bag 10 and deoxidation agent 20 in a hermetically sealed condition. In this example, the packaging material 2 consists of a sheet of a gas- and vapor-barrier, transparent thermoplastic resin product. Both the edges of this sheet are folded back and sealed together (back seal part 4) into a tubular form. The blood bag 10 is placed in this tube and its top and bottom are sealed into the form of a bag. In this case, the packaging material 2 is of three-sided seal wrap with the ends 3 and the back 4 sealed.

Description

DETAILED DESCRIPTION OF THE INVENTION <Industrial Application Field> The present invention relates to a medical device package for packaging medical devices, such as a blood bag or a blood component storage bag, and an assembly thereof.

<Prior Art> Medical instruments, particularly blood bags, are stored in a sealed state in a packaging material made of a thermoplastic resin sheet material. This packaging material is required to have gas barrier properties and water vapor barrier properties for the following reasons.

In other words, when water vapor from inside the blood bag passes through the sheet of the bag and is released into the packaging material, it further passes through the packaging material and is emitted to the outside. The inside of the blood bag becomes dry or the liquid (anticoagulant liquid) inside the blood bag becomes highly concentrated. Also, inside the packaging material.

In order to prevent the growth of mold, it is said to be in an oxygen-poor state,
If the packaging material is permeable to gases, particularly oxygen, it will not be possible to maintain the inside of the packaging material in an oxygen-poor state, and mold will grow on the labels of blood bags and the like.

Conventionally, such blood bags have been packaged by wrapping multiple blood bags as a whole or each blood bag individually in a water-absorbent material such as Japanese paper, and then wrapping the blood bags in a water-absorbent material such as Japanese paper. A package encapsulated in a packaging material made of sheet material has been developed.

However, in this package, the content of the blood bag is
The drawback is that the condition of the blood bag cannot be confirmed from the outside because it is covered with opaque Japanese paper. In other words, identification of the type and specifications of the blood bag that is the contents of the package, leakage of anticoagulant liquid from the blood bag, dirt, broken tube attached to the blood bag, and presence of mold on the surface of the blood bag. etc. is difficult to confirm.

In particular, in order to identify the contents, it is necessary to attach a label or print indicating the type, specifications, etc. of the blood bag to the outer surface of the package.

Furthermore, in the above package, multiple blood bags are housed in a single packaging material, so when the packaging material is opened to use one blood bag, other blood bags that are not scheduled to be used are also unsealed. Moisture evaporation inside the bag progresses, shortening its expiration date (within about one week after opening).

In addition, in the above packaging, the opening cut has no directionality, so when opening the packaging material, the tearing direction of the packaging material is not constant for each packaging, making it difficult to open. Furthermore, when the bag is opened, the blood bag may fly out and fall to the ground, causing contamination.

Furthermore, such blood bag packages are stored and transported by stacking a plurality of packages and storing them in a case. In its form, a plurality of packages are stacked in a line, pressed and compressed in the stacking direction, and then housed in a single case to form an integrated body.

However, in such a stack, the packages are stacked in a line, so if vibrations or shocks are applied during transportation, for example, they tend to shift laterally, and as a result, the seal part of the packaging material is damaged or a pinhole occurs in the packaging material,
This causes the disadvantage that the gas barrier properties and water vapor barrier properties mentioned above are impaired.

<Problems to be Solved by the Invention> The present invention has been made in view of the above-mentioned shortcomings of the prior art.The purpose of the present invention is to improve the visibility of the contents and to make the packaging material easy to open according to the number of uses. It is an object of the present invention to provide a medical device package that can maintain the effective shelf life of unused medical devices for a long period of time, and that can be opened easily and reliably.

Another object of the present invention is to provide an assembly of medical device packages in which the stacked packages are unlikely to shift and can maintain good gas barrier properties and water vapor barrier properties of the packages.

Means to solve problems〉 Such objects are achieved by the present invention as described below.

That is, the present invention encapsulates one unit of medical equipment together with a deoxidizing material in a packaging material made of a thermoplastic resin sheet material that has gas barrier properties and water vapor barrier properties and has a transparent portion. This is a medical device package characterized by:

Preferably, the medical device is encapsulated by sealing one sheet material on three sides or sealing two sheet materials on four sides.

Preferably, one is a transparent sheet material and the other is a sheet material having a thin metal layer, and these are stacked and sealed on all sides to encapsulate the medical instrument.

Preferably, the packaging material is made of a sheet material having at least 1M of thermoplastic resin layer oriented in the opening direction.

Preferably, the medical device is a container used for collecting or storing blood or its components.

Further, the present invention provides an assembly of medical device packages in which a plurality of the medical device packages described above are stacked and housed in a case, wherein a plurality of the medical device packages are stacked together and housed in a case. a first stacking section, a second stacking section adjacent to the first stacking section and stacking a plurality of the medical device packages to approximately the same height as the first stacking section; and a third stacking section in which a plurality of the medical device packages are stacked so as to span the second stacking section, and the medical device packages in each stacking section are pressed and compressed in the stacking direction inside the case. This is an assembly of medical device packages, characterized in that the medical device packages are housed in a container.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Preferred embodiments of a medical device package and an assembly thereof according to the present invention will be described below in detail as shown in the accompanying drawings.

FIG. 1 is a plan view showing an example of the structure of a medical device package according to the present invention.

As shown in the figure, a medical device package (hereinafter also simply referred to as a package) la has a blood bag lO, which is one medical device, and an oxygen absorber 20 sealed in a packaging material 2. It has been stored in good condition.

The packaging material °2 is composed of a single transparent sheet material made of thermoplastic resin having gas barrier properties and water vapor barrier properties,
Both ends of the sheet material are folded back to the back side, and the both ends are sealed together (sealing section 4) to form a cylinder.Furthermore, with the blood bag lO inserted, the upper and lower ends of this cylindrical sheet material are folded back. It is sealed (end seal portion 3.3) to form a bag shape. This packaging material 2 is called a three-sided seal because it seals on three sides, the end seal portion 3.3 and the sentimental seal portion 4.

Here, gas barrier property is synonymous with impermeability or low permeability to gases, particularly oxygen, and water vapor barrier property is synonymous with impermeability or low permeability to water vapor. Preferred values for gas barrier properties include oxygen permeation of 0 and 75.
mj/day-atm (30℃, 100% R old or less. 0,75 at/day-atm (30℃
, exceeds 100%R, the oxygen concentration in the packaging material 2 is high (
This is because mold becomes more likely to grow.

A preferable value for water vapor barrier properties is a water vapor permeation rate of 0.34 m! /day-ato+(40℃, 90%
R old or lower. 0, 34 ml/day-atm
(If the temperature exceeds 40°C and 90% R, water evaporation of the anticoagulant liquid in the blood bag 10 becomes significant, and the concentration of the anticoagulant liquid increases, which adversely affects blood cell components.

The total surface area (hereinafter referred to as effective surface area) of the portion of the package 1a excluding the seal portions 3.4 varies depending on the type and size of the contents, the storage condition (for example, whether or not it is folded), but is preferable. is about 200 to 1300 cI112, more preferably about 400 to 10000 m2.

Note that each seal portion is sealed to maintain airtightness by a method such as thermal fusion, ultrasonic fusion, or fusion using high-frequency dielectric heating.

Further, as shown in an enlarged view in FIG. 4, when sealing, it is preferable that the four corners 9 of the packaging material be sealed in a curved shape (so-called rounded). This is because the end seal portion 3 is prevented from being damaged.

For example, in the package of sample No. 1 in Table 1 below, 4
When one corner 9 is not rounded (R=O), the breakage incidence of the end seal part 3 is 0.05%, and the four corners 9 are rounded.
= 14 mm, an experimental result has been obtained that the breakage incidence rate of the end seal portion 3 is 0.001% (rr = 1000).

The constituent materials of the packaging material 2 include polyethylene (PE), oriented polyethylene (OP E), low density polyethylene (L
DPE), polypropylene (pp), polyvinylidene chloride (PVDC), polyester, polyethylene terephthalate (PET), and the like.

Further, the sheet material constituting the packaging material 2 can have a single-layer structure made of one of the above-mentioned materials, or a multi-layered structure made of two or more of the above-mentioned materials.

In addition, in a package with a three-sided seal, the information seal part 4
A sheet material in which sugar beets having different melting points are laminated may be used so that the intersection between the end seal portion 3.3 and the end seal portion 3.3 is not fused.

Further, the sheet thickness of the packaging material 2 varies depending on the constituent materials of the packaging material, but may be set to a level that allows desired gas barrier properties and water vapor barrier properties to be obtained.

Notches 8 for opening the packaging material 2 are formed at the edges of the end seal parts 3, 3, respectively. This notsuchi 8
Then, the packaging material 2 is torn in the opening direction A shown by the arrow in FIG. 1 to open it. Considering this opening, packaging material 2
It is preferable to use a single-layer sheet material made of a material having orientation in the same direction as the unsealing direction A (for example, the above-mentioned oriented polyethylene), or a laminated sheet material having at least one layer of the material. As a result, the packaging material 2 can be easily broken with a slight force, and the direction of breakage of the packaging material 2 is constant.
Can be opened reliably and predictably.

Next, the blood bag 10 and oxygen absorber 20 housed in the packaging material 2 will be explained.

A blood bag 1O, which is a container for collecting or storing blood, is made of a sheet bag made of, for example, soft polyvinyl chloride, and is heat-sealed at a seal portion 11 at its periphery.

A blood component storage portion 12 in which blood components are stored is formed in the inner portion surrounded by this seal portion 11. This blood component storage section 12 usually contains CP D solution, AC
Solution D, CPDA; night.

Contains an anticoagulant solution such as heparin solution.

Two outlets 13.13 with beer tabs are formed in the upper part of the blood bag IO.

Furthermore, a blood component storage section 1 is provided at the top of the blood bag IO.
One end of a flexible tube 16 communicating with 2 is connected,
A capped blood collection needle 17 is attached to the other end of the tube 16.

Furthermore, a label 18 is attached to the outer surface of the blood bag 10 for displaying the blood bag's manufacturing number, date of blood collection, blood type, etc.

The contents of the packaging material 2 are not limited to the above-mentioned blood bags, but may also include multiple bags connected to bags for collecting or storing blood components such as platelets, containers such as infusion bags, or other medical equipment. There may be.

The oxygen scavenger 20 absorbs oxygen within the packaging material 2, and includes one containing reduced iron as a main component (trade name: Ageless). By including such an oxygen absorber 20, the inside of the packaging material 2 is maintained in an oxygen-poor state, and the growth of mold, especially mold on the label 18, is prevented.

FIG. 2 is a plan view showing another example of the structure of the medical device package of the present invention, and FIG. 3 is a sectional view of the medical device package.

As shown in these figures, the medical device package lb includes one blood bag 10 and an oxygen absorber 20 sealed in a packaging material 2.

The packaging material 2 is made by overlapping two sheet materials 6.7 having gas barrier properties and water vapor barrier properties with the blood bag 10 sandwiched between the two sheet materials 6.7, and sealing the upper and lower ends (edges). The bag is shaped like a bag by sealing the left and right ends (side sealing parts 5.5). This packaging material 2 is called a four-sided seal because it is sealed on all four sides, including the end seal portion 3.3 and the side seal portion 5.5.

This four-sided sealed package 1b also has gas barrier properties, water vapor barrier properties, effective surface area, sheet thickness, sealing method of each seal portion 3.5, rounded corners 9, and opening notch 8.
The structure of the sheet material suitable for forming and opening is the same as that for the package 1a.

Each of the sheet materials 6 and 7 constituting the packaging material 2 can have a single-layer structure or a multi-layer laminated structure made of the same constituent materials as described above.

Further, the sheet material 6 and the sheet material 7 may have the same configuration or different configurations, but the latter is preferable in that they can have different properties.

In particular, when the front sheet material 6 (labeled side of the blood bag IO) is a transparent sheet material and the back sheet material 7 is a sheet material having a thin metal layer, especially a thin aluminum layer, gas barrier properties and It has excellent water vapor barrier properties and can ensure visibility of contents. That is, since a sheet material having a thin aluminum layer has excellent gas barrier properties and water vapor barrier properties, if this is used on one side of the packaging material 2, the gas barrier properties and water vapor barrier properties of the entire packaging material will be improved. However, since the sheet material having aluminum thin 1 is not transparent, the other sheet material is made transparent to ensure visibility of the contents. In this case, the transparent sheet material is preferably applied to the sheet material 6 on the side to which the label is attached, where it is highly necessary to recognize the conditions and confirm the properties of the blood barrag 10.

Specific examples of the medical device package of the present invention are shown in Table 1 below.

Next, the stack of medical device packages of the present invention will be explained.

FIG. 5 is a cross-sectional side view showing an example of the configuration of a stack of medical device packages. As shown in the figure, the stack 30 of medical device packages includes a first stack 31, a second stack 32, and a third stack, in which a plurality of the above-mentioned medical device packages 1a or 1b are stacked. 33 are installed in a predetermined arrangement, and these are housed in a case 34.

The first accumulation section and the second accumulation section 32 are adjacent to each other, and the heights of both accumulation sections are approximately equal.

Further, the third stacking section 33 is installed so as to span over the first stacking section 31 and the second stacking section 32 at a ratio of about half each.

The packages 1a or 1b of each stacking section 31-33 are housed in the case 34 in a pressed and compressed state in the stacking direction (indicated by arrow B in FIG. 5).

With such a configuration, vibrations and
Even when an impact is applied, the packaging 1a or lb is unlikely to shift (and the packaging will not damage the seal or cause pinholes in the packaging material, which will not impair gas barrier properties and water vapor barrier properties). .

Note that it is preferable that the end portions of each package 1a or lb in the first and second stacking portions 31,32 are in contact with or close to the side wall 35 of the case 34. This results in
This is because the effect of preventing the package from shifting is greater.

The number of packages 1a or 1b stacked in the first stacking section 31 and the second stacking section 32 is approximately 5 to 10, respectively, and the number of packages 1a or 1b stacked in the third stacking section 33 is 1 to 5. Although it is preferable to set the number to about 1,000, it is not limited to this.

Furthermore, in the present invention, in addition to the first to third accumulation sections 31 to 33, other similar accumulation sections may be provided, and the first to third accumulation sections 31 to 33 may be provided.
The accumulation parts 31 to 33 may be one unit, and a plurality of l units may be arranged horizontally and/or vertically.

The case 34 may be made of either a rigid material or a flexible material, and only a portion of the case 34 (for example, the side wall 35) may be made of a rigid material.

Note that when the entire case 34 is made of a flexible material, a negative pressure is applied inside the case 34 to apply a pressing force to each package 1a or lb. In this case,
The case 34 itself needs to have gas barrier properties.

In this case, since the packaging material 2 of each package 1a or lb has gas barrier properties and water vapor barrier properties, there is almost no gas permeation through the packaging material 2 even if the inside of the case 34 is under negative pressure, and the contents of the package are There will be no negative impact on.

In addition, regarding case 34, in order to ensure visibility,
Preferably, it is constructed from a transparent material.

Specific examples of the constituent material of the case 34 include paper, various resins, etc., and a multilayer laminate of two or more of these materials may be used.

FIG. 6 and FIG. 7 are a cross-sectional front view and a cross-sectional side view, respectively, showing configuration examples of stacks in which the third stacking section has different stacking modes. Note that the description of the structure similar to that of the integrated body shown in FIG. 5 will be omitted. As shown in the figure,
The packages 1a or 1b of the third stacking section 33a are placed in a direction perpendicular to the packages of the first and second stacking sections 31, 32, so that they overlap sequentially from the left side to the right side in FIG. are accumulated in.

By adopting such a configuration, the number of voids in the case 34 is reduced (reduced), the filling rate is increased, and the packaging body 1 is
The effect of preventing displacement of a or 1b becomes higher.

FIG. 8 is a cross-sectional front view showing an example of the structure of the stack in which the third stacking section has a different stacking mode.

In the stack 30 shown in the figure, the third stack 33 is similar to the above.
The package 1a or lb of b is located in the first and second stacking parts 3.
They are placed in a direction perpendicular to the package No. 1.32, and are stacked so as to overlap one after another from near the center in the figure toward the left and right.

Even in the case of such a configuration, the above-mentioned figures 6 and 7
Effects similar to those of the configuration shown in FIG. 3 can be obtained.

<Effects of the Invention> According to the medical device packaging body of the present invention, since the packaging material is made of a sheet material having a transparent portion, the visibility of the contents is good, so that the contents of the packaging body can be easily seen in the blood bag. If so, it is easy to identify its type, specifications, etc., or check for leaks or dirt from the anticoagulant solution in the blood bag, bent tubes attached to the blood bag, or presence of mold on the surface of the blood bag. It becomes possible.

In addition, since one unit of medical equipment is stored in one package, it is only necessary to open the required number of packages when using the package. There is no inconvenience that the expiration date is short.

In addition, if the packaging material of the medical device package is composed of a sheet material having at least one thermoplastic resin layer oriented in the opening direction, the packaging can be opened easily and reliably. .

Furthermore, according to the stack of medical device packages of the present invention, even if vibrations or shocks are applied during transportation, for example, the packages are unlikely to shift (and the gas barrier properties and It can be stored and transported without impairing its water vapor barrier properties.

[Brief explanation of the drawing]

FIG. 1 and FIG. 2 are plan views each showing an example of the structure of a medical device package according to the present invention. FIG. 3 is a sectional view of the medical device package shown in FIG. 2. FIG. 4 is a plan view showing an enlarged corner of the medical device package shown in FIG. 1. FIG. FIG. 5 is a cross-sectional side view showing an example of the configuration of a medical device package stack according to the present invention. 6 and 7 are a cross-sectional front view and a cross-sectional side view, respectively, showing other structural examples of the integrated body of the present invention. FIG. 8 is a sectional front view showing another example of the structure of the integrated body of the present invention. Explanation of symbols 1a, 1b...Medical instrument package 2...Wrapping material 3...End seal part 4...Yoibari seal part 5...Side seal part 6...Front side sheet Material 7... Back side sheet material 8... Notch 9... Corner 10... Blood bag 11... Seal portion 12... Blood component storage section 13... Outlet 16... Tube 17...Blood collection needle 18...Label 20...Oxygen absorber 30...Medical device package stack 31...First stacking section 32...Second stacking section 33.33a, 33 b-...Third accumulation part 34...Case 35...Side wall A...Opening direction B...Pushing direction FIG, 1 FIG, 3 a Doh FIG, 2 FIG, 5 1a, Ib / 30

Claims (6)

[Claims] (1) One unit of medical equipment is enclosed together with a deoxidizing material in a packaging material made of a thermoplastic resin sheet material that has gas barrier properties and water vapor barrier properties and has a transparent part. A medical device package characterized by: (2) The medical device package according to claim 1, wherein the medical device is encapsulated by sealing one sheet material on three sides or sealing two sheet materials on four sides. (3) The medical device package according to claim 1, wherein one side is a transparent sheet material and the other side is a sheet material having a thin metal layer, and the medical device is encapsulated by stacking these and sealing them on all sides. . (4) The medical device package according to any one of claims 1 to 3, wherein the packaging material is made of a sheet material having at least one thermoplastic resin layer oriented in the opening direction. (5) The medical device package according to any one of claims 1 to 4, wherein the medical device is a container used for collecting or storing blood or its components. (6) A collection of medical device packages, which is formed by stacking a plurality of medical device packages according to any one of claims 1 to 5 and storing them in a case, wherein a plurality of the medical device packages according to a first accumulation section in which instrument packages are stacked; adjacent to the first accumulation section;
a second stacking section in which a plurality of the medical instrument packages are stacked at approximately the same height as the first stacking section; and a plurality of the medical instrument packages so as to span the first and second stacking sections. What is claimed is: 1. A stack of medical device packages comprising: a third stacking section in which the medical device packages of each stacking section are stacked, and the medical device packages of each stacking section are stored in a case in a state of being pressed and compressed in the stacking direction.