JP2001120574A - Disposable sterilized cap for medical apparatus, and method for manufacturing the same - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a disposable sterilized cap which can be easily fitted in a clean condition without using any sterilized gloves. SOLUTION: In the disposable sterilized cap for medical appliances with an elastic material sewn around sheets and a manufacturing method thereof, the sheets are two-ply, and a cutting line is provided in the outer sheet.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a disposable sterilization cap for medical equipment and a method for manufacturing the same. More specifically, a disposable sterile cap used to maintain a clean area of a medical device where the diagnostic or therapeutic medical device is in close proximity to a subject or patient and its manufacture. About the method.

[0002]

2. Description of the Related Art Medical devices such as an X-ray examination device, an angiography diagnostic device, a surgical X-ray device, and a CT angiography device require a doctor, It is necessary to keep a part (image intensifier part or the like) to which a subject or a patient may touch (hereinafter, referred to as a “clean-keeping area”) in a sterilized state.

[0003] Therefore, conventionally, contamination and infection are prevented by putting a disposable sterilization cap on the clean keeping area. As a disposable sterilization cap, a shower cap-shaped one in which a polyolefin sheet is sewn around with a rubber material is folded and inserted into a storage bag, and the opened portion of the bag is sterilized after sealing by thermocompression or the like. (For example, Cap (registered trademark) sold by Toshiba Medical Supplies Co., Ltd.) is known. The attachment of the sterilization cap to the clean keeping area of the medical device is shown in FIG.
As shown in (a) to (c), an operator wearing sterilized gloves (8) opens the storage bag (6) containing the sterilization cap (1) and removes the sterilization cap (1). (FIG. 3A), the image intensifier section (1
0), etc., with a sterile cap over the clean keeping area (FIG. 5).
(B)), it is performed by the procedure of locking with the rubber material (3) (FIG. 5 (c)).

However, in order to attach the cap in this procedure, it is necessary to use expensive sterile gloves used for surgery, and the hand of the sterile cap wearer (ie, the sterile glove portion) at the time of loading. If a person comes into contact with a contaminated area (surface of sterile glove storage bag or medical equipment that has not been sterilized), it is necessary to re-attach new sterile gloves and restart the work. Was. Therefore, an object of the present invention is to solve the above-mentioned problems and to provide a disposable sterilization cap that can be easily attached without using sterile gloves.

[0005]

SUMMARY OF THE INVENTION The present inventor has proposed a cutting line (perforation) on an outer sheet in a conventional sterilization cap.
The cap is made up of a double sheet made by putting two sheets that are easily torn by inserting a sheet and a sheet without a cutting line, and after attaching to the clean keeping area of the medical device, without touching the inner sheet Break the outer sheet, the inner sheet,
That is, the cleanliness of the medical device can be kept clean by rolling the outer sheet between the inner sheet and the device section, and with such a disposable sterilization cap, with bare hands, without using sterile gloves,
The present invention was completed by confirming that the sterilization cap can be easily attached to the clean keeping area.

That is, the present invention relates to the following disposable sterilization cap. 1) In a disposable sterilization cap for medical equipment in which an elastic material is stitched around a sheet material and sterilized, the sheet material is formed by superposing two sheets, and a cutting line is provided on the outer sheet material. And disposable sterile cap. 2) The disposable sterilizing cap according to 1 above, wherein the sheet material is made of a polyolefin sheet and / or a nonwoven fabric. 3) The disposable sterilizing cap according to 1 or 2, wherein the sheet material is made of polyethylene. 4) The disposable sterilization cap according to any one of 1 to 3 above, wherein an identification marker is provided on a cutting line portion of the sheet material. 5) The disposable sterilization cap according to 4 above, wherein the identification marker is a color applied to a region including a cutting line portion. 6) The disposable sterilization cap according to 5 above, wherein the coloring is applied by printing. 7) Put the cap on the clean keeping area of the medical device, fasten it with elastic material, break the outer sheet material along the cutting line, roll the outer sheet material inside the inner sheet, fasten it with elastic material, and sterilize 7. The disposable sterilization cap according to any one of 1 to 6, wherein the inner sheet surface is exposed. 8) The disposable sterilizing cap according to any one of 1 to 7, which is sterilized after being sealed in a storage bag. 9) The disposable sterilizing cap according to the item 8, wherein at least one of the two sheet materials is sterilized after a cap made of a nonwoven fabric is sealed in a storage bag.

[0007] 10) A substantially circular outer sheet material provided with a cutting line passing through the vicinity of the center by a sewing machine and a sheet material having no cutting line having the same shape as the sheet material are superposed, and elasticity is provided around the sheet material. A method for producing a disposable sterilizing cap for medical equipment, comprising stitching materials together under a certain tension to form a cap, storing the cap in a storage bag, enclosing the cap, and sterilizing the cap. 11) The method for producing a disposable sterilizing cap according to the above item 10, wherein the sheet material comprises a polyolefin sheet and / or a nonwoven fabric. 12) The method for producing a disposable sterilizing cap according to 10 or 11, wherein the sheet material is made of polyethylene. 13) The method for manufacturing a disposable sterilization cap according to the item 10, wherein two outer sheet materials are provided in a direction substantially perpendicular to each other and passing through the vicinity of the center of the sheet material. 14) The method for producing a disposable sterilizing cap according to the above item 10 or 13, wherein a sheet material having an identification marker applied to a cutting line portion is used. 15) The method for producing a disposable sterile cap according to 14 above, wherein the identification marker is a color applied to a region including a cutting line portion. 16) The method according to 1 above, wherein the coloring is performed by printing.
6. The method for producing the disposable sterile cap according to 5. 17) The method for producing a disposable sterilization cap according to the item 10, wherein the sterilization is performed by irradiation with ionizing radiation. 18) Said sterilization is performed by ethylene oxide or pressurized steam by storing and enclosing a cap in which at least one of the two sheets is made of a nonwoven fabric in a storage bag.
0. The method for producing a disposable sterile cap according to item 0.

[0008]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, a disposable sterilization cap according to the present invention and a method for manufacturing the same will be specifically described with reference to the drawings. 1 (a) to 1 (d) show the outline of the manufacturing process of the disposable sterilization cap of the present invention.

As shown in FIGS. 1 (a) and 1 (b), a disposable sterilization cap (1) of the present invention has a size and shape sufficient to cover a medical device mounting site.
The two sheet materials (2) (the inner sheet (2a) and the outer sheet (2b)) are overlapped, and the periphery thereof is sewn with an elastic material (3) to which a constant tension is applied to form a cap (FIG. 2). Is folded, stored in a storage bag and sterilized (FIG. 3). Of the sheet materials, the outer sheet (2
b) a cutting line (4) passing near the center thereof so as to be easily broken along the line when the work is attached to the clean keeping area;
Is provided by a sewing machine or the like. Usually, one cutting line (4) may be provided, but a plurality of cutting lines may be provided for large-sized equipment. For example, by providing two sheets in a direction substantially orthogonal to each other so as to pass near the center of the sheet material, the work of attaching the sheet material to the clean keeping area becomes easy (FIG. 1C).

[0010] The shape of the sheet material used is not particularly limited as long as it becomes a cap that conforms to the shape of the clean keeping area of the medical device when the elastic material is sewn with tension applied to the periphery. Usually, a circular thing is used.

The material of the sheet may be any as long as it can be easily sterilized and transmits radiation (X-rays, γ-rays, α-rays, etc.) from medical equipment used for diagnosis and treatment. Polyolefins such as polyethylene and polypropylene, which can be obtained at low cost because they are to be incinerated later, are suitable. A nonwoven fabric that easily permeates the gas used for sterilization (such as ethylene oxide and pressurized steam) may be used. The outer sheet (2b) provided with the cutting line and the inner sheet (2a) without the cutting line may be usually made of the same material. However, by using either one of a polyolefin and the other of a non-woven fabric, sterilization by gas is easy. I can do it.

The elastic material (3) to be sewn around the sheet is not particularly limited, but may be a generally used cord made of rubber material or a band having a certain width.

It is preferable to provide an identification marker at the cutting line (4) provided on the outer sheet so that its presence can be easily recognized at the time of attaching the cap. As the identification marker, for example, a chromatic or achromatic color is applied in advance to a region including the cutting line portion by printing with a fixed width (usually about several mm to several cm). Accordingly, the mounting operator can visually recognize the presence of the cutting line (4), and can easily break the outer sheet by pulling the outer sheet at right angles along the cutting line (4) so as not to touch the inner sheet.

The disposable sterilization cap (1) of the present invention is obtained by sewing an elastic material (rubber material) around a sheet material under a constant tension, and then folding the sheet material into a storage bag (6). It is stored, sealed by means such as thermocompression bonding along the sealing line (7), and then sterilized.

[0015] Sterilization is performed by a method using ethylene oxide or pressurized steam, or an irradiation method of irradiating with ionizing radiation (γ-rays or the like). In the former method, a special gas-permeable storage bag (sterilization bag) is used. Because of the necessity and time required for sterilization, an irradiation method that can sterilize in a short time is preferable. The bag (6) for storing and storing the sterilization cap is
Any material can be used as long as it can maintain a sterilized state, but a material made of a thermoplastic resin material that can be sealed by heating is preferable.

Next, a method of attaching the disposable sterilization cap of the present invention to a medical device will be described. FIG.
(A)-(d) shows the process of attaching the disposable sterilization cap of the present invention to a medical device. With the sterilization cap of the present invention, the worker can perform the mounting operation with bare hands without wearing sterile gloves.

First, the storage bag is opened, the sterilization cap is taken out, and the sterilization cap (1) is put on the "cleanliness area" of the medical device (10) (for example, an image intensifier of an X-ray diagnostic apparatus). Then, it is locked by the elastic cord material (3) (FIGS. 4A and 4B). The operation up to this point is the same as that of the conventional product, but since the operation is performed with bare hands, the outer sheet (2b) of the sterilization cap is in a contaminated state. Next, the outer sheet (2b) is broken with bare hands along the cutting line (4) (FIG. 4 (c)). This operation is performed by grasping both sides of the cutting line by hand and pulling the outer sheet at right angles to the cutting line to tear the outer sheet. During this cutting operation, care should be taken to avoid touching the identification marker (colored area) (5) applied to the cutting line as much as possible. The shaded area also indicates the risk of contamination of the inner sheet (when the outer sheet is torn, bare hands touching the inner sheet will contaminate the inner sheet and require rework with a new sterile cap). . Outer sheet (2
b) is in the locked state at the rubber mounting position.

Next, the cut outer sheet (2b) is rolled, and the cut outer sheet (2b) is pulled from the locking portion of the elastic cord (3) to the inner sheet (2b).
a), the inner sheet (2a) and the equipment section (1).
0) (FIG. 4D). Thereby, the outer sheet (2b) touched (contaminated) with bare hands is removed, and a clean inner sheet (2a) is exposed on the surface. As described above, the sterilization cap of the present invention can be easily attached to medical equipment with bare hands, and the replacement of the sterilization cap for each subject or patient can be easily performed.

[0019]

According to the disposable sterilization cap for medical devices of the present invention, two sheets of an outer sheet material provided with a cutting line and an inner sheet material having the same shape are overlapped,
An elastic material is stitched around the periphery of the cap with a certain tension applied to form a cap and sterilized. In conventional sterilization caps, considerable care was required to prevent contamination such as wearing sterile gloves during the mounting work, but the sterilization cap of the present invention assumed that the structure of the cap would be contaminated during work. The dual structure of the outer sheet and the sterilized inner sheet that is exposed after the mounting makes it easy to mount the medical device with bare hands.

[Brief description of the drawings]

1 (a) is a plan view of an inner sheet of a disposable sterilizing cap of the present invention, (b) is a plan view of an example of an outer sheet, and (c) is a plan view of another example of an outer sheet.

FIG. 2 shows one of the disposable sterilization caps of the present invention.
It is a perspective view of an example.

FIG. 3 is a plan view showing a state in which the disposable sterilization cap of the present invention is stored in a storage bag.

FIG. 4 is an explanatory view of a mounting operation of the disposable sterilizing cap of the present invention.

FIG. 5 is an explanatory view of a conventional disposable sterilization cap and a mounting operation thereof.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Disposable sterilization cap 2 Sheet 2a Inner sheet 2b Outer sheet 3 Elastic material (rubber string) 4 Cutting line 5 Identification marker 6 Storage bag 7 Sealing line 8 Sterile gloves 10 Medical equipment

Claims (18)

[Claims] 1. A disposable sterilization cap for medical equipment in which an elastic material is stitched around a sheet material and sterilized, wherein the sheet material is composed of two superposed sheets, and a cutting line is provided on the outer sheet material. A disposable sterilization cap, characterized in that: 2. The sheet material is a polyolefin sheet and / or
Or the disposable sterilization cap according to claim 1, which is made of a nonwoven fabric. 3. The disposable sterilizing cap according to claim 1, wherein the sheet material is made of polyethylene. 4. The disposable sterilization cap according to claim 1, wherein an identification marker is provided on a cutting line portion of the sheet material. 5. The disposable sterilization cap according to claim 4, wherein the identification marker is a color applied to a region including a cutting line portion. 6. The disposable sterilization cap according to claim 5, wherein the coloring is performed by printing. 7. After covering the cap on the clean keeping area of the medical device and fastening with the elastic material, the outer sheet material is broken along the cutting line, the outer sheet material is rolled inside the inner sheet and fastened with the elastic material, The disposable sterilizing cap according to any one of claims 1 to 6, wherein the sterilized inner sheet surface is exposed and used. 8. The disposable sterilization cap according to claim 1, which is sterilized after being enclosed in a storage bag. 9. The disposable sterilizing cap according to claim 8, wherein the cap is made of a nonwoven fabric and at least one of the two sheets is sealed in a storage bag and then sterilized. 10. A state in which a substantially circular outer sheet material having a cutting line passing through the vicinity of the center provided by a sewing machine and a sheet material having no cutting line having the same shape as the sheet material are superimposed on each other.
Manufacturing a disposable sterilization cap for medical equipment, wherein a cap is formed by sewing an elastic material around the circumference thereof under a certain tension, the cap is stored in a storage bag, sealed, and then sterilized. Method. 11. The method for producing a disposable sterilizing cap according to claim 10, wherein the sheet material comprises a polyolefin sheet and / or a nonwoven fabric. 12. The method according to claim 10, wherein the sheet material is made of polyethylene. 13. The method for manufacturing a disposable sterilizing cap according to claim 10, wherein two cutting sheets are provided in a direction substantially perpendicular to each other and passing through the vicinity of the center of the sheet material. 14. The method for producing a disposable sterilization cap according to claim 10, wherein a sheet material having an identification marker applied to a cutting line portion is used. 15. The method for manufacturing a disposable sterilization cap according to claim 14, wherein the identification marker is a color applied to a region including a cutting line portion. 16. The method for manufacturing a disposable sterilizing cap according to claim 15, wherein the coloring is performed by printing. 17. The method for producing a disposable sterilization cap according to claim 10, wherein the sterilization is performed by irradiation with ionizing radiation. 18. The disposable sterilization cap according to claim 10, wherein the sterilization is performed by ethylene oxide or pressurized steam by enclosing and enclosing a cap in which at least one of the two sheets is made of a nonwoven fabric in a storage bag. Production method.