JPH0841216A - Plastic film for medical use - Google Patents

Abstract

PURPOSE:To obtain the plastic film having barrier resistance helping preventing bacterial infection, both air and water vapor permeability providing- comfortableness to patents or medical workers, and also antistaticity. CONSTITUTION:This plastic film for medical use having bacteria barrier resistance has the water vapor permeability at 40 deg.C and 90% R.H. of >=100g/m<2>.24h and the oxygen permeability at 40 deg.C and 90% R.H. of 1000cc/m<2>.24h. This film is pref. coated with an antibacterial medicine br particles (at least one-sidedly) or incorporated therewith. Besides, it is preferable that this film have such antistaticity as to be <2s in 50% static electricity charge attenuation time at 60% R.H.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a film for medical use, for example, a surgical drape, a surgical gown,
The present invention relates to a plastic film used for medical clothing, sheets, gloves, a head protection cap, a transdermal patch, a sterilization bag, various protective equipment for preventing bacterial infection, and the like. The present invention particularly relates to a plastic film having a bacterial barrier property and a bacterial infection preventive effect and enhancing comfort of a patient or a medical staff to be used.

[0002]

2. Description of the Related Art In recent years, it has been noted that patients and medical staff are infected with bacteria during treatment or hospitalization, and the development of medical devices having a bacterial barrier property for preventing this bacterial infection is underway. The requirements of these medical devices are not only bacterial barrier properties, but also breathability and water vapor permeability for comfortable use by patients and medical staff, and anti-static to prevent dust and dirt from adhering to medical sites. Sex is required. Although the plastic film has suitable properties for the above medical article from the viewpoint of bacterial barrier properties, a plastic film that is satisfactory in terms of other required properties such as air permeability, water vapor permeability, and antistatic property is There has been an unprecedented demand for a plastic film satisfying the above-mentioned required characteristics.

[0003]

That is, the plastic films used for current medical devices and medical articles are
Although it has the effect of preventing bacterial infection, it does not satisfy the breathability and water vapor permeability that bring comfort to patients and medical staff. The object of the present invention is to solve the above problems in the conventional plastic film, has a bacterial barrier property that helps prevent bacterial infection, and also has breathability and water vapor permeability that bring comfort to patients and medical staff. The purpose of the present invention is to provide a medical-use plastic film that has the combined advantages.
Further, an object of the present invention is a medical plastic film having bacterial barrier property, air permeability and water vapor permeability, and further having an antistatic function for preventing adhesion of dust and dust and improving handleability. To provide.

[0004]

The medical plastic film of the present invention is a medical plastic film having a bacterial barrier property, wherein the temperature is 40 ° C. and the relative humidity is 90%.
Water vapor permeability at 100 (g / m ² · 24hr)
It is characterized in that the oxygen permeability at a temperature of 40 ° C. and a relative humidity of 90% is 1000 (cc / m ² · 24 hr) or more. In the medical plastic film of the present invention, an antibacterial agent or antibacterial particles are coated on at least one side of the film,
Alternatively, it is preferably incorporated in the film.
Further, the medical plastic film of the present invention preferably has an antistatic property such that the 50% electrostatic charge decay time at relative humidity of 60% is within 2 seconds.

The present invention will be described in detail below. Specific film compositions of the plastic film in the present invention include polyester type, copolyester type, silicone type, fluorine type, thermoplastic polyurethane type, special vinyl chloride type, polyolefin type, inorganic particle filling polymer type, and blends thereof. And polymer alloys.

The above polyester is obtained by polycondensation of an acid component and an alcohol component. Examples of the acid component include terephthalic acid, isophthalic acid, sodium sulfoisophthalic acid, azelaic acid, sebacic acid, eicosandicarboxylic acid, dodecanedioic acid, dimer acid, naphthalenedicarboxylic acid, p-hydroxybenzoic acid and ε-caprolactone. be able to. As the alcohol component, ethylene glycol, propylene glycol, 1,4-butanediol, 1,6-hexanediol, 1,8-octanediol, neopentyl glycol, cyclohexanedimethanol, polyethylene glycol, polypropylene glycol, polytetramethylene glycol. Etc. can be mentioned. The copolymerized polyester is obtained by polycondensation of at least three kinds of the acid component and the alcohol component, and the water vapor permeability can be adjusted by appropriately selecting the copolymerization ratio of the acid component and / or the alcohol component. The oxygen permeability can be controlled within the above range. For example, terephthalic acid is used as the acid component, and ethylene glycol (E
G) and polytetramethylene glycol (PTMG) are used, the molar ratio of PTMG / EG is 1/20 to 1
It is preferably set to / 1. When terephthalic acid (TA) and dimer acid (DIA) are used as the acid component and ethylene glycol is used as the alcohol component, it is preferable that the molar ratio of DIA / TA is 1/20 to 1/3. It is used, but is not limited to these. In the present invention, a copolyester film is preferable from the viewpoint of control range of physical properties and safety.

As the composition of the fluorine-based, thermoplastic polyurethane-based, polyolefin-based, special vinyl chloride-based, silicone-based, and polyolefin-based films, various known ones can be used.

In order to control the water vapor transmission rate and the oxygen transmission rate within the above ranges while maintaining the bacterial barrier properties of these films, blending, alloying of the above polymers, and
It is effective to form a non-penetrating groove on the surface of the film, or to form a void or a penetrating groove around the inorganic and organic fine particles by stretching, but it is not limited to this.

In the film of the present invention, a temperature of 40 ° C.
Water vapor permeability at a relative humidity of 90% is 200 (g / m
That it is preferably ² · 24 hr or) more. The oxygen permeability at a temperature of 40 ° C. and a relative humidity of 90% is 3000.
It is preferably (cc / m ² · 24 hr) or more.

In the medical plastic film of the present invention, in order to further enhance the function of preventing bacterial infection of the film, an antibacterial agent is applied to one side or both sides of the film or kneaded into the film, or antibacterial inorganic fine particles are contained in the film. It is effective to include in. In particular, a method of forming voids or through grooves around the antibacterial fine particles by stretching is preferable in terms of achieving both air permeability and bacterial barrier property. Examples of the antibacterial agent used include compounds such as benzalkonium chloride, hexamethylene bigamide hydrochloride, polyhexamethylene amide hydrochloride, organic silicon quaternary ammonium salt, and pyridonecarboxylic acid derivative, silver, copper, Ceramic-based materials in which zinc or the like is introduced into zeolite by ion exchange, metal-based materials such as silver and copper-zinc, and mineral zeolites are preferable. The content of these antibacterial agents is generally 0.1 to 30% by weight based on the resin component.

In the medical plastic film of the present invention, it is preferable that the electrostatic charge decay time at a relative humidity of 60% is within 2 seconds, and more preferably the electrostatic charge decay time at a relative humidity of 40%. Has an antistatic property within 2 seconds. Relative humidity 6
If the static electricity decay time at 0% exceeds 2 seconds, dust and dirt in the environment are likely to adhere, which may adversely affect the bacterial infection prevention function. The preferred medical plastic film of the present invention having a static decay time of 2 seconds or less at a relative humidity of 60% can be obtained by kneading or coating a known antistatic agent on the film.

The film thickness of the plastic film of the present invention can be arbitrarily selected according to its application.

The medical plastic film of the present invention can be used in combination with natural fibers, synthetic fibers, non-woven fabrics, etc., and can be coated with a pressure-sensitive adhesive or the like, as well as various known materials in the plastic film field. It is possible to apply film processing technology.

[0014]

EXAMPLES Next, examples of the present invention will be shown. First, a method of measuring various physical property values will be described. 1) Bacterial barrier property Bacterial barrier property (BFE) according to US MIL standard
Tested by the test method. That is, it is atomized using Staphylococcus aureus and passed through the sample and the undersensor plate (flow rate 28 l / MIN). After that, the cells were cultured in an agar medium (for 2 days), the colonies were counted, and the filter collection efficiency was determined using the designated conversion table and calculation formula. In the evaluation here, if the filter collection efficiency was 95% or more, it was judged to have a bacterial barrier property (◯). 2) Water Vapor Permeability According to the MOCON moisture permeability measuring device, JIS K7129
According to the method B, the water vapor permeability was measured at a temperature of 40 ° C. and a relative humidity of 90%. 3) Oxygen permeability The oxygen permeability at a temperature of 40 ° C. and a relative humidity of 90% was measured by a gas permeation measuring device manufactured by GL Science Co. or a soap membrane method. Oxygen permeability is 10,000 cc / m ² · 24
A gas permeation measuring device was used when the time was less than hr, and the soap film method was used when the time was more than that. 4) Electrostatic charge decay time Static Decay Meter (Model 406
C, Electro-Tech Inc. ), The time for the initial charging potential to decay by 50% at a relative humidity of 60% was measured.

Example 1 As an acid component, terephthalic acid,
A copolyester was synthesized using 70 mol% of ethylene glycol and 30 mol% of polyethylene glycol (molecular weight 1000) as alcohol components. The obtained copolyester was vacuum dried, melted, extruded using a T die, and cast on a cooling roll to form a sheet. The obtained sheet-like material was stretched in the MD direction, and subsequently silver-based zeolite particles (average particle size:
0.5 μm) and 100% cationic surfactant
A water-dispersible copolyester dispersion containing 0 ppm by weight and 1.0% by weight was applied to both sides of the sheet-like material. Subsequently, by stretching in the TD direction and further heat treatment,
A biaxially stretched film having a thickness of 50 μm was obtained. The results of measuring and evaluating the characteristics of the obtained medical film are shown in Table 1.

[Comparative Example 1] Terephthalic acid as an acid component,
Polyethylene terephthalate was synthesized using ethylene glycol as the alcohol component. The obtained polyethylene terephthalate was formed into a sheet in the same manner as in Example 1, stretched in the MD direction and then stretched in the TD direction, and then heat-treated to obtain a biaxially stretched film having a thickness of 50 μm.
The results of measuring and evaluating the properties of the obtained film are shown in Table 1.

[Example 2] Anhydrous silica fine particles (average particle diameter 0.02 µm) were added to polypropylene resin in a weight ratio of 20%.
After being blended so as to be, the mixture was melted, extruded using a T-die, and cast on a cooling roll to form a sheet. The obtained sheet-like material was stretched in the MD and TD directions and further heat-treated to obtain a biaxially stretched film having a thickness of 50 μm. The results of measuring and evaluating the characteristics of the obtained medical film are shown in Table 1.

Example 3 Polypropylene resin was blended with silver-based zeolite fine particles (average particle diameter: 0.5 μm) in a weight ratio of 20%, melted and extruded using a T-die, and then cooled on a cooling roll. It was molded into a sheet by casting into a sheet. The obtained sheet-like material is MD and T
By stretching in the D direction and further heat treatment, a thickness of 5
A 0 μm biaxially stretched film was obtained. The results of measuring and evaluating the characteristics of the obtained medical film are shown in Table 1.

[0019]

[Table 1]

From Table 1, the medical films of Examples 1 to 3 have excellent bacterial barrier properties, as well as excellent water vapor permeability and oxygen permeability, and therefore have a bacterial infection preventive effect and can be used by patients to be used. The comfort of the medical staff can be improved. In particular, the medical films of Examples 1 and 2 are also excellent in antistatic property, so that dust and dust hardly adhere to them, and are suitable as a medical plastic film. On the other hand, the film of Comparative Example 1 is excellent in bacterial barrier property, but is inferior in water vapor permeability, oxygen permeability and antistatic property.

[0021]

Since the medical plastic film of the present invention is constructed as described above, it has a bacterial infection preventing effect and can enhance the comfort of the patient or medical staff to be used. . The film of the present invention is very suitable for various medical supplies.

Claims (3)

[Claims] 1. A medical plastic film having a bacterial barrier property, which has a water vapor permeability of 100 (g / m ² · 24 hr) or more at a temperature of 40 ° C. and a relative humidity of 90%, and a temperature of 40 ° C. and a relative humidity of 90. % Oxygen permeability of 1000 (cc / m ² · 24 hr) or more, a medical plastic film. 2. The plastic film according to claim 1, wherein the antibacterial drug or antibacterial particles are coated on at least one side of the film or incorporated in the film. 3. The plastic film according to claim 1, which has an antistatic property such that a 50% electrostatic charge decay time at a relative humidity of 60% is 2 seconds or less.