JP4228159B2 - Packaging material to prevent blocking - Google Patents

Description

[0001]
BACKGROUND OF THE INVENTION
The present invention relates to sterilized medical devices, and more particularly to medical devices having conduits and other accessories for administration to a patient.
[0002]
[Prior art]
In medical facilities, sterilized medical instruments are widely used due to high interest in contamination and infection. However, there are many problems that must be solved in sterilized medical devices. As one of them, there is a problem of adhesion of medical instruments due to heat sterilization or the like. Medical instruments are packaged with packaging materials and sterilized, but high-pressure steam sterilization is usually selected as a sterilization method because of the certainty of sterilization and the advantage that a large amount of processing can be performed safely. However, medical instruments currently used in medical facilities are often made of a vinyl chloride resin from the viewpoint of processability and cost, and a lot of plasticizer is added to the vinyl chloride resin. And many medical devices consist of several components, such as a container, a conduit | pipe, and an accessory. For this reason, when a medical instrument made of vinyl chloride resin is subjected to high-pressure steam sterilization, so-called blocking occurs in which the constituent elements come into close contact with each other and are difficult to separate. When this blocking occurs, not only is it troublesome to peel off, but also the medical device itself may be damaged in some cases. For this reason, various attempts have been made to prevent blocking when medical instruments are sterilized with high-pressure steam. However, there are drawbacks such as a complicated structure and increased cost, which is simple and reliable. No solution has been obtained.
[0003]
In addition, a sterilized medical instrument composed of a plurality of components has a problem that it is difficult to handle at the time of use or manufacture. For example, as a replacement container, not only a simple container containing a single drug solution but also one with a drip set with a conduit for administration into a patient and an accessory such as a drip tube or clamp In order to perform peritoneal dialysis, the peritoneal dialysis set is connected to a plurality of containers and conduits necessary for injecting and discharging a drug solution. When using such sterilized medical devices in the field, containers, conduits, and other components are scattered, contaminating parts that should not be contaminated during use, and manufacturing medical devices. The work efficiency has been significantly reduced, such as difficulty in getting on the line due to the lack of components, and difficulty in packaging.
[0004]
When using or manufacturing a container having these conduits and accessories, it is desirable that these components be integrated together in accordance with the application so as not to be separated. However, if the medical instrument or packaging material is complicated for that purpose, the cost is increased, and there is a drawback that it is difficult to handle at the time of manufacture and use.
[0005]
[Problems to be solved by the invention]
Accordingly, the object of the present invention is to produce a blocking between medical devices even if a treatment such as thermal sterilization is performed when manufacturing a medical device comprising a plurality of connected components as described above. It is to make it difficult. The second object is that the medical devices are collected so that they are not contaminated at the time of manufacture or use, and the work efficiency is not lowered. And it is providing the medical device packaged with the packaging material and its packaging material which can solve the said subject.
[0006]
[Means for Solving the Problems]
In this invention, the said subject was solved by putting together the thin film which blocks a part of medical instrument with a specific packaging material, and prevents blocking to a medical instrument. That is, according to the present invention, a part of a medical device that easily scatters (a covering) composed of a plurality of connected components is opened at both ends made of a material that does not substantially stick to the medical device even by thermal sterilization. In a sterilized medical device that is collected by a covering member that is a belt-like bag, and the covering is stored in an outer packaging material in a manner that overlaps with a medical device that is not put together by the covering member (non-covered material), The present invention provides a sterilized medical device characterized in that an anti-sticking thin film is attached to an object.
[0008]
Since the covering is collected by the covering member and the constituent elements are three-dimensionally held, the remaining medical device (hereinafter also referred to as an uncovered covering) that is not put together is covered compared to the case where the covering member is not interposed. The number of parts that come into contact decreases. As a result, the possibility of blocking both is reduced. Moreover, since the said coating | coated material is coat | covered with a coating | coated member and the part which contacts a non-coating material directly decreases, blocking is further suppressed.
[0009]
Moreover, there exists the following advantage by making the shape of a coating | coated member into the strip | belt-shaped bag which the both ends opened. First, even if one part of the covering is separated after the covering is gathered by the covering member, both ends of the covering member are opened, so that it can be easily repaired. Second, during use, the covering member can be quickly and easily removed and is easy to handle.
[0010]
Although the magnitude | size of a coating | coated member can be suitably changed according to a use, an example is shown below as generally preferable. As shown in FIG. 3, in the packaging material, the planar area of the covering member is 80% to 120% of the planar area of the non-covered object. If the size of the covering material with respect to the covering is made too small, the components of the medical device are not easily integrated as a single body, and the blocking suppression effect is also reduced. Conversely, if the covering material is too large, it is not only wasteful but also difficult to handle.
[0011]
The material of the covering member may be any material as long as it does not easily block the medical instrument by heat sterilization, and can be selected from polyolefin resins such as polyethylene and polypropylene, PTFE resin, and the like. Even if the above-mentioned materials are heat sterilized, they do not block with a medical device made of vinyl chloride resin, and sticking does not occur substantially.
[0012]
Moreover, this invention is a sterilized medical device using the said coating | coated member. That is, it is a sterilized medical instrument characterized in that a part of a medical instrument which is easily scattered and composed of a plurality of connected components is collected with the packaging material and stored in an outer packaging material. With such a configuration, the components of some medical instruments that are easily separated not only at the time of use but also at the time of manufacture are integrated together, so that it is easy to get on the production line and work efficiency is increased.
[0013]
Furthermore, various embodiments as shown below are mentioned. That is, as shown in FIG. 2, the width w and the height h are w / in the cross-sectional shape obtained when the medical device collected by the covering member is crossed on a plane parallel to the open end of the covering member. The sterilized medical device is characterized in that it is three-dimensionally arranged so as to satisfy 5 ≦ h ≦ w. As described above, when the covering is three-dimensionally gathered, even when a portion of the covering is exposed from the covering member, there are few portions that are in close contact with the non-covering and blocking can be reduced.
[0014]
Or as another aspect, the said sterilized medical device with which the coating | covering overlapped with the non-coating | covering and was accommodated in the outer packaging material is mentioned. This product requires only a small storage portion and can prevent substantial sticking.
[0015]
As seen in FIG. 4, the exposed portion (planar surface) of the medical device exposed from the open end of the covering member is 5 to 70% of the entire medical device (planar surface). This is a sterilized medical device. This further reduces the chance that the exposed portion of the covering will come into contact with the non-covering.
[0016]
In the sterilized medical device in which the non-sticking thin film is attached to the non-covered material, there is almost no chance of even the exposed portion of the coating directly contacting the material to be sterilized.
[0017]
If the thickness of the anti-sticking thin film is 50 μm to 500 μm, the thin film is easily adhered by press-contacting the non-sticking thin film to the uncoated material before heat sterilization, preventing sticking before or during sterilization. The film becomes difficult to move. Moreover, it can be easily peeled off manually after sterilization.
[0018]
As the material for the sticking prevention thin film, the sterilized medical device made of olefin such as polyethylene that does not block vinyl chloride resin is preferable.
[0019]
Further, the anti-sticking thin film is composed of two layers: a layer that does not substantially stick to the medical device even if one side is heat sterilized, and a layer that is easier to stick to the other side. If so, the above effect is further improved.
[0020]
DETAILED DESCRIPTION OF THE INVENTION
In the following, an embodiment of the present invention will be described with reference to the drawings. FIG. 1 shows a state in which a part of a peritoneal dialysis set 1 used for peritoneal dialysis is collected and covered by a covering member 2. The peritoneal dialysis set 1 includes a drug solution container 3 containing a dialysate, a conduit 4 connected thereto, a drainage container 5 for draining dialysate stored in the abdominal cavity, and other accessories (not shown). Etc. In this example, a part of the peritoneal dialysis set such as the conduit 4 and the drainage container 5 that are easily separated is gathered together by the covering member 2 that is a belt-like bag.
[0021]
The collected coverings such as the conduit 4 and the drainage container 5 are three-dimensionally held by the covering member 2, and as a result, the chance that the covering comes into contact with the chemical container 3 that is an uncovered material is greatly reduced. To do.
[0022]
In addition, by forming the shape of the covering member 2 into a belt-like bag having both ends opened, there is an advantage that the covering can be easily reworked after the covering is collected by the covering member 2. For example, even when a part of the covering such as the conduit 4 gathered just before sterilization is scattered, both ends of the covering member 2 are open, so that it can be easily repaired. It is also easy to check the contents of the coating.
[0023]
The magnitude | size of the coating | coated member 2 can be suitably changed according to a use. When examining the size of the covering member 2, the reference is based on two points: the size of the covering member 2 with respect to the covering (conduit 4 and the like) and the size with respect to the non-covering (chemical solution container 3). If the size of the covering member 2 with respect to the covering is made too small, the components of the medical device are not easily integrated as a single body, and the blocking suppression effect is also reduced. Conversely, if the covering member 2 is too large, it is not only useless but also difficult to handle. In addition, when the covering member 2 is considerably larger than the covering, the above-described retouching after the covering becomes difficult, so that the covering is slightly exposed from the covering member 2. As a reference for the size of the covering member 2, the exposed portion 7 (shaded portion in FIG. 4) of the covering from the covering member as viewed in a plan view as shown in FIG. 2 is preferably in the range of 5% to 70% of the white covering portion 8 made of a conduit covered with 2 or a drainage container and the exposed portion 7).
[0024]
Further, by making the covering material 2 substantially the same size (shape / dimension) as that of the non-covered material, when the both are placed on top of each other, the covered material exposed from the covering member 2 and the non-covered material (for example, the conduit 4). The chance of contact with the chemical container 3) can be reduced. As a result, the risk of blocking between the medical devices (components thereof) is also reduced. Therefore, it is preferable that the covering member 2 has a shape similar to that of the non-covered object 3 in a plan view, and the size of the covering member 2 with respect to the non-covered object 3 has a planar area as shown in FIG. The range of 80% to 120% is desirable.
[0025]
The material of the covering member 2 is not particularly limited as long as it does not easily block with the vinyl chloride resin, and polyolefin such as polyethylene and polypropylene, fluorine resin such as PTFE, and the like can be used.
[0026]
In addition to covering and covering the covering with the covering material 2, the blocking preventing effect is further enhanced by mounting the blocking preventing means on the chemical solution container 3 that is not covered. However, simply by interposing a sheet of a material that is difficult to cause blocking between the non-covered material and the coated material, the anti-sticking sheet moves before sterilization, and the non-coated material is not attached to the coated material. There is a risk that it will not help prevent sticking. Therefore, a preferable sticking prevention means is a thin film that should also be referred to as a thin sheet or film, and is preferably one that easily adheres to the uncoated material. This does not mean that blocking is easily caused by high-pressure steam sterilization, but it can be easily adhered by pressure welding, but can be easily peeled off manually. Further, it is desirable that the degree of adhesion is almost the same before and after sterilization, but at least before sterilization, it is necessary to maintain appropriate adhesion. Thereby, before sterilization, the sticking prevention film is held at a predetermined position between the non-covered material and the coated material, and does not move. As a result, the covering exposed from the covering member does not come into direct contact with the non-covering, and blocking is further prevented. For example, in FIG. 1, when a thin synthetic resin sticking prevention film 6 is adhered to the surface of the chemical solution container 3 on the side in contact with the coating, the exposed portion of the conduit 4 and the chemical solution are subjected to high-pressure steam sterilization. Direct contact with the container 3 is almost completely prevented and blocking is prevented. And when using, after peeling the sticking prevention film 6 closely_contact | adhered to the chemical | medical solution container 3, the coating | covering put together from the coating | coated member 2 is taken out.
[0027]
The above has described an example of a peritoneal dialysis set. However, the packaging material and the packaging method of the present invention can be widely used in medical devices made of a material that easily connects and blocks many components that easily scatter. .
[0028]
【The invention's effect】
By using the packaging material of the present invention, the medical instrument packaged thereby, and the packaging method using these, the following advantages can be obtained. First, it is possible to easily prevent and suppress blocking of medical devices by heat sterilization or the like at the time of manufacture. Secondly, since a plurality of components of a medical instrument that easily scatters are integrated together, it is easy to use at the time of use, and it is easy to get on the production line at the time of manufacture, thereby improving efficiency.
[0029]
Thirdly, even if the collected conduits and containers are somewhat disturbed, they can be easily repaired, and it is easy to check the contents such as checking for leaks. Moreover, the means for putting together the medical devices of the present invention has a simple configuration and is easy to install because it can be easily attached to a medical device.
[Brief description of the drawings]
FIG. 1 is a schematic diagram illustrating one embodiment of a packaged medical device of the present invention.
FIG. 2 is a schematic view showing a three-dimensional arrangement state of a covering by a cross-sectional view taken along line AA ′ in FIG. 1;
FIG. 3 is a schematic plan view for showing a standard of a planar size (area) of a covering member with respect to an uncovered member.
FIG. 4 is a schematic plan view for showing a ratio of an exposed portion from a covering member to the entire covering.
[Explanation of symbols]
1. Peritoneal dialysis set (whole medical device)
2. 2. Cover member Chemical container 4. 4. Conduit 5. drainage container 6. Anti-sticking film Exposed site 8. Covering part

Claims (4)

A coating in which a part (covering) of a medical device that is easily scattered, which is composed of a plurality of connected components, is made of a material that does not substantially stick to the medical device even by heat sterilization, and is open at both ends. In a sterilized medical device that is collected by a member and is stored in an outer packaging material overlaid with a medical device (non-covered material) that is not bundled by the covering member, the covering is prevented from sticking to the uncovered material. A sterilized medical device characterized by wearing a thin film. The anti-sticking thin film consists of two layers, a layer that does not substantially stick to the medical device even if one side is heat sterilized, and a layer that the other side is more likely to stick. The sterilized medical device according to claim 1. The sterilized medical device according to any one of claims 1 and 2, wherein a thickness of the sticking prevention thin film is 50 µm to 500 µm. The sterilized medical device according to any one of claims 1 to 3, wherein the anti-sticking thin film is made of polyolefin.

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