JP7510134B2 - Medical head covering, its manufacturing method, fixing tool for medical head covering, and medical head covering set - Google Patents

Description

The present invention relates to a medical head covering that prevents droplets (sneezing, coughing, saliva, etc.) and aerosols emitted by patients from reaching medical staff during examinations, treatments, and tests. It also relates to a method for manufacturing the medical head covering, a tool for fixing the medical head covering around the patient's head, and a medical head covering set consisting of the medical head covering and the fixing tool.

During gastrointestinal examinations, such as gastroscopy and abdominal ultrasound procedures, droplets and aerosols emitted by patients lying on examination beds often reach medical staff. There is a risk that some patients are "asymptomatic pathogen carriers" who are infected with pathogens such as the new coronavirus (SARS-CoV-2) but do not show symptoms, so the development of reliable tools to protect medical staff from droplets and aerosols emitted by patients is an urgent issue in the medical field.

Patent Document 1 relates to a droplet infection prevention device that arbitrarily divides a small closed space to prevent droplets from scattering. The droplet infection prevention device is composed of an isolation panel with fold-back sleeves, a laminar flow blower using parallel thin fans, and a head shield with a super-compact ventilation device, and is expensive, making it difficult to replace for each patient. In addition, in this invention, droplets emitted by patients are blocked by the isolation panel, but in the case of pathogens that remain infectious and float in the air with aerosols for a long time, the panel cannot adequately block them.

In addition, the inventors proposed a method of covering a patient's head with a sealed shield consisting of a vinyl box or the like in Non-Patent Documents 1 and 2. More specifically, during gastroendoscopy or abdominal ultrasound procedures, the patient's head is covered with a box-shaped sealed shield, and aerosol is sucked in through a suction tube while oxygen is supplied into the sealed shield, maintaining a negative pressure inside the box. However, no specific proposals have been made regarding the medical head covering material to be used in this method, or the shape of the jig for fixing the head covering material.

Japanese Patent Application Laid-Open No. 7-461

Dig Endosc. 2020;32:e114-e115 doi: 10.1111/den.13713. Dig Liver Dis. 2020 May 23;S1590-8658(20)30229-2. doi: 10.1016/j.dld.2020.05.024.

The present invention aims to provide a tool for implementing the method of covering a patient's head disclosed in Non-Patent Documents 1 and 2. More specifically, the objective of the present invention is to propose a medical head covering that can be manufactured very inexpensively, can be replaced for each patient, and can protect medical staff not only from droplets emitted by patients but also from aerosols, as well as a jig for fixing the head covering.

As a method for solving the above problems, the present inventors have
(1) A medical head covering made of a bag-shaped plastic film, characterized in that it has a side seal portion extending in the length direction of the bag, and the inside of the bag is divided by the side seal portion into a support insertion portion and a head covering portion;
(2) The medical head covering according to (1), characterized in that a support insertion hole for inserting a support into the support insertion part is provided between the side seal part and the side edge side closest to the side seal part;
(3) The medical head covering according to (1) or (2), characterized in that the bag-shaped plastic film has a gusset portion;
(4) The medical head covering according to any one of (1) to (3), characterized in that the bag-shaped plastic film has an edge seal portion on the side edge;
(5) We propose a medical head covering material as described in any one of (1) to (4), characterized in that the bag-shaped plastic film has a slit for inserting an endoscope and/or a gas transport tube.

Also,
(6) A method for producing a medical head covering according to any one of (1) to (5), comprising a cylindrical processing step of forming a plastic film into a cylindrical shape, a bottom sealing step of sealing one open end of the cylindrically formed plastic film to form a bottom seal part, and a side sealing step of sealing the cylindrical plastic film in the length direction to form a side seal part;
(7) The method for producing a medical head covering according to (6), characterized in that in the side sealing step, a seal bar having a U-shaped cross section is used to form an edge seal part together with a side seal part;
We propose.

Furthermore,
(8) A jig for fixing the medical head covering according to any one of (1) to (5),
We propose a fixing jig for a medical head covering, characterized in that it comprises a rod-shaped support that is inserted into the support insertion portion, a support for holding the medical head covering in an expanded state, and a frame material for holding each support.
together,
(9) We propose a medical head covering set comprising the medical head covering according to any one of (1) to (5) and a fixing jig for the medical head covering according to (8).

The medical head covering of the present invention can be manufactured very simply and inexpensively, and therefore can be replaced for each patient, making it hygienic. Furthermore, since the head covering is made of a plastic film and bends to fit the patient's body shape, gaps are unlikely to form between the head covering and the patient, and leakage of aerosols emitted by the patient from the head covering can be efficiently prevented. In addition, since the support insertion portion is isolated from the patient's head by the side seal portion, the support is not contaminated by droplets or aerosols from the patient, and the fixing jig for the support and the like can be used repeatedly.

Furthermore, if the medical head covering has a support insertion hole between the side seal portion and the side edge side closest to the side seal portion, for inserting a support into the support insertion portion, the support can be inserted into the support insertion portion even if the support is fixed to a frame that fixes it.
Furthermore, when the medical head covering is made of a bag-shaped plastic film having a gusset, the head covering can be easily expanded into a substantially cylindrical shape, making it easier for the patient to insert his or her head into the head covering.

Furthermore, when the medical head covering is made of a bag-shaped plastic film having an edge seal portion, the head covering is less likely to bend in the longitudinal direction, making it easier to attach the head covering to the fixing jig.
In addition, when the medical head dressing of the present invention has cuts, it is possible to supply oxygen into the head dressing, to exhaust gas from the head dressing, and even to insert a gastroscope, etc. Also, it is possible to adjust the amount of gas in the medical head dressing and to keep the inside of the head dressing under negative pressure.

The method for producing a medical head covering of the present invention makes it possible to produce a medical head covering very easily. In particular, if a seal bar having a U-shaped cross section is used in the side sealing process, the edge seal portion can be formed at the same time as the side seal portion is formed.
Furthermore, the fixing jig for the medical head covering of the present invention can very easily hold the head covering in an expanded state, thereby minimizing the decrease in medical efficiency that occurs when the medical head covering is used.

FIG. 1A is a schematic perspective view of the covering material of the present invention, and FIG. 1B is a schematic perspective view of the covering material expanded and rotated 90° so that the support insertion portion is downward. FIG. 1 is a schematic perspective view showing one embodiment of a fixing jig for a medical head covering of the present invention. 3 is a schematic diagram showing a method of fixing the covering material shown in FIG. 1 by the fixing jig shown in FIG. 2. FIG. 1 is a schematic perspective view showing one embodiment of a fixing jig for a medical head covering of the present invention. 1A shows a second embodiment of a coating material, FIG. 1B shows a second embodiment of a fixing jig, and FIG. 1C shows a method of fixing the coating material with the fixing jig. 1A shows a third embodiment of a coating material, FIG. 1B shows a third embodiment of a fixing jig, and FIG. 1C shows a method of fixing the coating material with the fixing jig.

The present invention will be described in detail below with reference to the drawings. Note that the present invention is not limited to the following embodiments, and various embodiments can be adopted within the scope of the same effects.
The present invention relates to a medical head covering (hereinafter, abbreviated as "covering material" as necessary) and a jig for fixing the covering material around a patient's head (hereinafter, abbreviated as "fixing jig" as necessary).

[Medical head covering]
FIG. 1A is a schematic perspective view of a covering material 10 of the present invention, and FIG. 1B is a schematic perspective view of the covering material 10 expanded and rotated 90 degrees so that a support insertion portion 12 faces downward.
The covering material 10 in Fig. 1 is formed into a bag shape by sealing a cylindrical film with a bottom seal portion 18. The size of the covering material is not particularly limited as long as it can cover the area from the head to the shoulders, but in the case of the covering material 10 shown in Fig. 1 having gussets on both sides that are about 1/2 the width W, it is desirable that the width W is 400 to 650 mm, preferably 450 to 600 mm, and the length L is 600 to 1200 mm, preferably 800 to 1000 mm.
The space within the covering material 10 is divided into a support insertion portion 12 and a head covering portion 13 by a side seal portion 11. The side seal portion 11 extends from a position beyond the bottom seal portion 18 to the open end β of the bag so that the support insertion portion 12 is isolated from the head covering portion 13.

The material of the plastic film constituting the covering material 10 of the present invention is not particularly limited, and various films that have been conventionally formed into bags, such as polyolefin resin films such as polyethylene resins and polypropylene resins, polyester resin films such as polyethylene terephthalate and polybutylene terephthalate, polyamide resin films, polyurethane resin films, and polyvinyl chloride films, can be used. Among them, polyethylene resin films, particularly linear low-density polyethylene films, are suitable for the application because they are flexible and inexpensive. In addition, in order to improve the sealing properties of the above-mentioned film, a laminate film in which a polyester resin film or a polyamide resin film having a high melting point is bonded to a polyolefin resin film having a low melting point can also be used. The use of a laminate film can prevent the folded outer surfaces from fusing together when edge sealing is performed in the gusset portion 15.
The thickness of the plastic film is not particularly limited, but is preferably about 15 to 150 μm, particularly 20 to 100 μm, and further preferably about 30 to 70 μm. If the plastic film is too thin, it may flutter due to the flow of gas, causing a gap to form between the patient and the dressing 10. If the film is too thick, the dressing 10 may not bend easily to fit the patient's body shape, and the sealing performance may be reduced.

The covering material 10 in FIG. 1 has a support insertion hole 14 for inserting a support into the support insertion portion 12 between the side seal portion 11 and the side edge side γ1 closest to the side seal portion 11. The support insertion hole 14 is preferably located 400 to 900 mm, particularly 500 to 800 mm, from the bottom seal portion 18 on the opening end β side. If the support insertion hole 14 is too far from the bottom seal, it becomes difficult to fix the vicinity of one end α of the covering material 10 in an expanded state using a fixing jig, which will be described later. Also, if it is too close to the bottom seal, it becomes difficult to expand the covering material. Note that the support insertion hole may be a linear cut as long as a rod-shaped support can be inserted, or may be formed by cutting out a part of the covering material 110 (the side edge side from the side seal portion 111) as shown in FIG. 5.

The covering material 10 in Fig. 1 has a gusset portion 15 on each of both side edges. The covering material 10 having the gusset portion 15 can be easily expanded into a substantially cylindrical shape, and the patient can easily insert the head into the head covering portion. The gusset portion 15 may be formed on only one of the side edges.
In addition, the covering material 10 shown in FIG. 1 has an edge seal portion 16 on the side edge. The edge seal portion 16 makes the covering material 10 less likely to bend in the length direction, making it easier to fix the covering material 10 to a fixing jig described later. In addition, since the side edge of the covering material is folded back, there is a risk of small holes called pinholes being generated. In particular, the side edge supported by the support is easily subjected to impact and pinholes are easily generated. However, if the edge seal portion 16 is present, there is no risk of gas in the covering material 10 leaking through the pinholes even if pinholes are generated on the side edge.

The covering material 10 shown in Fig. 1 further includes a slit 17. This slit is for passing an oxygen tube for supplying oxygen into the head covering part 13, for inserting a suction tube for sucking gas containing aerosols in the head covering material and keeping the inside of the head covering part 13 in a negative pressure state, and for inserting a gastroscope or the like. The length of the slit 17 may be determined according to the diameter of the tube.
In order to prevent leakage of aerosols and the like from the slits 17, the plastic film in which the slits 17 are formed in advance may be replaced with an elastic film 19. Specifically, as shown in Fig. 1, a part of the plastic film may be hollowed out, an elastic film 19 may be attached to the hollowed out part, and the slits 17 may be formed in the elastic film 19. The elastic film 19 prevents the slits 17 from opening too wide, thereby preventing leakage of aerosols and the like from the periphery of the endoscope and/or the gas carrying tube. The elastic film 19 may be a film made of an elastic resin such as a thermoplastic elastomer or rubber. Specifically, a film using one type alone or two or more types in combination of elastomers or rubbers such as styrene-based elastomers such as SBS (styrene-butadiene-styrene), SIS (styrene-isoprene-styrene), SEBS (styrene-ethylene-butadiene-styrene), and SEPS (styrene-ethylene-propylene-styrene), olefin-based elastomers (ethylene-based α-olefin elastomers copolymerized with one or more of propylene, butene, octene, etc., or propylene-based elastomers copolymerized with one or more of ethylene, butene, octene, etc.), polyester-based elastomers, and polyurethane-based elastomers can be used. In the present invention, a polyurethane-based resin film is exemplified as a particularly preferred elastic film 19, but is not limited thereto.

[Method of manufacturing medical head covering]
The manufacturing method for the covering material 10 of the present invention includes (1) a cylindrical processing step of forming a plastic film into a cylindrical shape, (2) a bottom sealing step of sealing one open end of the cylindrically formed plastic film to form a bottom seal portion, and (3) a side sealing step of sealing the cylindrical plastic film in the longitudinal direction to form a side seal portion.

(1) A method for forming a plastic film into a cylindrical shape may be, for example, to cut a plastic film into a rectangle and heat seal two opposing sides of the rectangle. In addition, since a plastic film formed by inflation extrusion molding is already cylindrical, the film forming process may be a cylindrical processing process.
(2) Next, one open end of the cylindrically formed plastic film is sealed to form a bottom seal portion. The bottom seal may be performed by melt-cutting the plastic film, but in order to prevent aerosols from leaking from the seal portion, it is preferable to use heat sealing using a seal bar or impulse sealing.

(3) In the side sealing process, the cylindrical plastic film is sealed in the length direction to form the side seal portion. At this time, a seal bar with a U-shaped cross section is used to form the side seal portion and edge seal portion at the same time, making it possible to manufacture a covering material that is less likely to bend in the length direction.
Furthermore, if necessary, a support insertion hole for inserting a rod-shaped support, which will be described later, can be provided in the support insertion portion formed by the side seal portion (hereinafter, this step will be abbreviated to "hole forming step"). The support insertion hole in Fig. 1 is formed by punching two sheets of film one on top of the other.
Incidentally, any one of the bottom sealing step, the side sealing step and the hole forming step may be carried out first.

[Fixing jig for medical head covering]
Fig. 2 is a schematic perspective view showing one embodiment of a fixing jig 20 for a medical head covering of the present invention. The fixing jig is a jig for fixing a medical head covering around a patient's head, and includes a rod-shaped support inserted into the support insertion portion of the covering, a support for holding the covering in an expanded state, and a frame for holding each support. The fixing jig 20 in Fig. 2 includes a rod-shaped support 21a that is inserted into the support insertion portion of the covering at a position 10 to 100 mm from the lower end of the jig 20, and also includes a support 21b above the support 21a for holding the covering in an expanded state. These supports 21a and 21b are fixed to a vertical frame 22d, and are further stably installed by other frame members 22a, 22b, 22c, 22e, and 22f.

The supports 21a, 21b and the frame material 22 may be made of metal such as aluminum, stainless steel, etc., in addition to resin. Since the rod-shaped support 21a is passed through the support insertion portion of the covering material, it is preferable that the rod-shaped support 21a is cylindrical so as not to damage the covering material 10, and the frame materials 22a, 22b, 22c are preferably rectangular prism-shaped in consideration of the stability of the fixing jig.
The width W, height H and length L of the fixing jig 20 shown in FIG. 2, which is particularly suitable for use with a patient lying sideways on a treatment bed, such as in a gastroendoscopy examination, are approximately 360 to 560 mm, 360 to 560 mm and 320 to 520 mm, respectively, but are not limited to these.

[Medical head covering set]
When treating a patient, the dressing of the present invention is fixed to a fixing jig and used. A method of fixing the dressing 10 shown in FIG. 1 with the fixing jig 20 shown in FIG. 2 will be described with reference to FIG. 3. First, the rod-shaped support 21a is passed through the support insertion hole 14 of the dressing 10 and the support insertion portion 12. Next, the edge seal portion 16 of the end edge γ2 of the dressing 10 where the support insertion portion 12 is not formed is fixed to the support 21b with adhesive tape (FIG. 3(A)). When using the dressing set, the patient simply puts his or her head into the dressing 10 so that the face faces the supports 21a and 21b (FIG. 3(B)). Since the dressing 10 is fixed to the supports 21a and 21b, the patient's nose and mouth do not come into close contact with the dressing 10, and the patient's breathing is not hindered.
In Fig. 3, the support 21a to be passed through the support insertion portion 12 of the covering material 10 is disposed below the fixing jig 20, but as shown in Fig. 4, the support 321a may be disposed above the frame material, and the support 321b for holding the covering material in an expanded state may be disposed below. In the fixing jig 320 shown in Fig. 4, the frame material 322a is also used as the support 321b for holding the covering material in an expanded state.

[Second embodiment]
A second embodiment of the covering material of the present invention is shown in Fig. 5(A), and a second embodiment of the fixing jig is shown in Fig. 5(B). The covering material 110 in Fig. 5(A) has two support insertion portions 112. One support insertion portion 112 has a support insertion hole 114, and the other support insertion portion 112 does not have a support insertion hole 114. The support insertion hole 114 of the covering material 110 is formed by cutting out a part of the covering material 110 on the side edge side of the side seal portion 112.
5B, a rod-shaped support 121a is detachable from a frame member 122. A joint 123 is attached to the frame member 122a, and the rod-shaped support 121a is fitted into the joint 123.

Figure 5 (C) is a schematic diagram for explaining a method of fixing the covering material 110 with the fixing jig 120. If the rod-shaped support 121a is detachable from the frame material 122, the covering material 110 does not necessarily require a support insertion hole. The rod-shaped support 121a can be inserted into the support insertion part 112 from the open end β side of the covering material 110 in advance. In Figure 5 (C), the rod-shaped support 121a is placed in the lower support insertion part 112 in advance, and the support 121a is fitted into the joint 123 of the frame material 122a to fix one side of the covering material 110. In addition, the upper support 121b is inserted into the upper support insertion part 112 from the support insertion hole 114, and the covering material 110 is held in an expanded state, completing the fixing of the covering material 110.

[Third embodiment]
A third embodiment of the covering material of the present invention is shown in Fig. 6(A), and a third embodiment of the fixing jig is shown in Fig. 6(B). The first embodiment (Figs. 1 to 3) and the second embodiment (Fig. 5) are both designed on the assumption that the patient lies sideways on the examination bed. However, during abdominal ultrasound procedures, the patient lies face up on the examination bed. The third embodiment is designed on the assumption that the covering material is used on the patient lying face up.

As shown in FIG. 6(A), the dressing 210 has a gusset on each side that is about 1/2 the width W, and the width W is 400-800 mm, preferably 400-700 mm, and the length (not shown) is 600-1200 mm, preferably 800-1000 mm. The width W, height H, and length L of the fixing jig 220 in FIG. 6(B) are preferably about 440-640 mm, 230-430 mm, and 200-400 mm, respectively, but are not limited to these. The rod-shaped support 221a and the support 221b for holding the dressing in an expanded state are both preferably located above the fixing jig 220. When the patient's face is facing up, the dressing 210 is fixed to the upper supports 221a and 221b, so that the patient's nose and mouth are not in close contact with the dressing 210, and the patient can breathe normally.

Figure 6 (C) is a schematic diagram for explaining a method for fixing the covering material 210 with a fixing jig 220. The rod-shaped support 221a is inserted into the support insertion portion 212 from the support insertion hole 214 of the covering material 210, and the edge seal portion 216 of the end edge γ2 where the support insertion portion 212 is not formed is fixed with adhesive tape to the support 221b for holding the covering material in an expanded state, completing the fixing of the covering material 210.

10, 110, 210 Medical head covering 11, 111, 211 Side seal portion 12, 112, 212 Support insertion portion 13, 113, 213 Head covering portion 14, 114, 214 Support insertion hole 15, 115, 216 Gusset portion 16, 116, 216 Edge seal portion 17 Cutout 18, 118, 218 Bottom seal portion 19 Elastic film 20, 120, 220, 320 Fixing device for medical head covering 21a, 121a, 221a, 321a Rod-shaped support 21b, 121b, 221b, 321b Support for holding in expanded state 22, 122, 222, 322 Frame material 123 Joint

Claims (8)

A medical head covering made of a bag-shaped plastic film, characterized in that it has a side seal extending in the length direction of the bag, and the inside of the bag is divided by the side seal into a support insertion section and a head covering section. The medical head covering according to claim 1, characterized in that it has a support insertion hole between the side seal portion and the side edge side closest to the side seal portion, for inserting a support into the support insertion portion. The medical head covering according to claim 1 or 2, characterized in that the bag-shaped plastic film has a gusset portion. The medical head covering according to any one of claims 1 to 3, characterized in that the bag-shaped plastic film has an edge seal portion on the side edge. A medical head covering according to any one of claims 1 to 4, characterized in that the bag-shaped plastic film has a slit for inserting an endoscope and/or a gas carrying tube. A method for producing the medical head covering according to any one of claims 1 to 5, comprising the steps of:
A cylindrical processing process in which the plastic film is formed into a cylindrical shape;
a bottom sealing step of sealing one open end of the cylindrically shaped plastic film to form a bottom seal portion;
a side sealing process of sealing the cylindrical plastic film in the length direction to form a side seal portion;
A method for manufacturing a medical head covering, comprising: A jig for fixing the medical head covering according to any one of claims 1 to 5,
A fixing jig for a medical head covering, comprising: a rod-shaped support that is inserted into the support insertion portion; a support for holding the medical head covering in an expanded state; and a frame material for holding each support. 8. A medical head covering set comprising the medical head covering according to claim 1 and a fixing jig for the medical head covering according to claim 7.

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