Multilayer visor system for a surgical hood

Abstract

A multi-layer visor system for surgical hoods or garments is provided. The system includes a base film layer and one or more removable film layers that are coextruded at high temperatures to form a sterile surface between each film layer. The removable film layers can be peeled off if soiled or contaminated during a surgical procedure, maintaining an unobstructed view for the surgeon. Therefore, a separate sterilization step is not required to sterilize the layers of the visor system. Each removable film layer may further include a tab with a unique feature that allows the wearer to easily distinguish between the tabs, allowing the wearer to easily know which tab to pull first to remove the outermost removable film layer. Furthermore, because the tabs are located around the perimeter of the removable film, visibility is not obstructed. Additionally, the film layers are securely held in place until easily removed from the underlying removable or base film layer.

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims the benefit of U.S. Patent Application No. 16 / 681,911, filed on November 13, 2019, the entire disclosure of which is incorporated herein by reference.

[0002] The subject matter of the present invention broadly relates to a visor element of a surgical hood that can be used with surgical gowns (clothes), helmets, and ventilation systems worn by medical providers in operating rooms and people in other environments at risk of exposure to hazardous substances and liquids.

[0003] Medical providers such as surgeons often wear a combination of a non - woven surgical suit or gown, a hood with a visor, and an air - cooled or ventilated system during surgery, particularly during orthopedic total joint replacement surgeries such as knee, hip, and shoulder arthroplasty and replacement surgeries, in order to ensure the sterility of the operating room, protect the wearer, and create a comfortable environment for the wearer. During such surgeries, there is a risk that aerosols or droplet sprays of body fluids may adhere to the visor, obstructing the vision of medical providers such as surgeons. Therefore, to provide better vision for medical providers such as surgeons, the visor includes one or more transparent removable films. When body fluids, tissues, etc. adhere to the transparent removable film and obstruct the vision, the medical provider such as a surgeon can remove or peel off the film to expose the clean, non - soiled surface of another transparent removable film or a transparent base film of the visor located beneath the removed transparent film. The transparent removable films and the transparent base film need to be sterile, but since these transparent films are in close contact with each other, proper sterilization of these transparent films often becomes a problem.

[0004] Currently, ethylene oxide (EO) gas is used for the sterilization of all non-woven surgical suits or gowns and hoods. However, when sterilizing a visor having multiple transparent films using EO gas, usually those transparent films are in direct contact with each other, and there is a problem that such polyester films do not permeate the gas. That is, due to such direct contact between the film layers and the non-permeability of the polyester film, the EO gas is prevented from permeating through the outermost exposed transparent film and sterilizing other transparent films disposed under that transparent film.

[0005] Therefore, in some cases, in order to sterilize the unexposed transparent film disposed on the lower side, radiation sterilization such as gamma-ray irradiation or electron beam irradiation may be used to pre-sterilize a visor having multiple transparent films. However, the radiation sterilization of the visor needs to be performed before the visor is attached to a hood or surgical suit as a personal protection system. For example, when performing radiation sterilization on a final form of personal protection system such as a hood including a visor, or one or more non-woven gowns or suits, it may cause degradation such as loss of strength, durability, or integrity in the polypropylene non-woven fabric, or generate an unpleasant odor. Furthermore, such radiation sterilization may significantly damage the stability of the non-woven fabric over time. Therefore, the pre-sterilization step by radiation needs to be carried out before attaching the multi-layer visor to the personal protection system. And then, by using EO gas, the final form of the personal protection system is sterilized. However, in addition to the sterilization of the final form of the surgical hood or personal protection system by EO gas, separately performing the pre-sterilization step of the multi-layer visor will significantly increase both the manufacturing time and cost.

[0006] Accordingly, there is a need for a visor having a transparent base film and one or more transparent removable films attached to the transparent base film, which does not require a prior sterilization step to be performed separately before the visor is incorporated into a hood and / or a surgical suit or gown that are worn together. In particular, a visor having two or more transparent removable films with one or more features for distinguishing the transparent removable films from each other would also be useful to facilitate removal of the films.

Summary of the Invention

Means for Solving the Problems

[0007] The present invention relates to a method for manufacturing a multi-layer visor system for a personal protection system. The multi-layer visor system includes a base film layer and a first removable film layer removably attached to the outer surface of the base film layer. The base film layer defines a first outer periphery, and the first removable film layer defines a second outer periphery. The second outer periphery of the first removable film layer is completely enclosed within the first outer periphery of the base film layer. The method includes co-extruding a visor including the base film and the first removable film, cutting the base film and the first removable film into the shape of the first outer periphery of the base film layer, and cutting the first removable film into the shape of the second outer periphery of the first removable film layer.

[0008] In certain embodiments, the outer surface of the base film layer is sterilized without performing a separate sterilization step.

[0009] In other embodiments, the co-extruding step is performed at a temperature of at least about 280 degrees Celsius (535 degrees Fahrenheit).

[0010] In a further embodiment, the multilayer visor system further includes a second removable film layer removably attached to the outer surface of the first removable film layer, the second removable film layer defining a third outer perimeter, the third outer perimeter of the second removable film layer being completely encompassed by the first outer perimeter of the base film layer. Here, the step of co-extruding the multilayer film of the visor includes the step of co-extruding the second removable film with the first removable film and the base film. Further, it includes the step of cutting the second removable film to form the third outer perimeter of the second removable film layer. Further, the third outer perimeter of the second removable film layer may be completely encompassed by the second outer perimeter of the first removable film layer. Further, the second outer perimeter of the first removable film layer is sterilized without performing a separate sterilization step.

[0011] In yet another embodiment, the step of cutting the base film and the first removable film to form a visor shape having a perimeter is performed by die-cutting.

[0012] In yet another embodiment, the method includes aligning a first strip of the colored film with the upper end of the second outer perimeter of the first removable film layer adjacent to the first removable film layer, and cutting the first strip of the colored film along the upper end of the second outer perimeter of the first removable film layer to form a first colored tab, the first colored tab being configured to facilitate removal of the first removable film from the base film by a user. Further, the method can further include the following steps. Aligning a second strip of the colored film with the upper end of the third outer perimeter of the second removable film layer adjacent to the second removable film layer, and further cutting the second strip of the colored film along the upper end of the third outer perimeter of the second removable film layer to form a second colored tab, the second colored tab being configured to facilitate removal of the second removable film layer from the first removable film layer by a user.

[0013] The present invention further relates to a multilayer visor system for a personal protection system. The visor system includes a base film layer and a first removable film layer removably attached to the outer surface of the base film layer. The base film layer and the first removable film layer are co-extruded.

[0014] In certain embodiments, the base film layer defines a first outer perimeter, the first removable film layer defines a second outer perimeter, and the second outer perimeter of the first removable film layer is completely encompassed by the first outer perimeter of the base film layer.

[0015] In other embodiments, the outer surface of the base film layer is configured to be sterile.

[0016] In further embodiments, the base film layer includes polyester or polycarbonate.

[0017] In still other embodiments, the first removable film layer includes polyester or polycarbonate.

[0018] In additional embodiments, the visor system includes an anti-reflective coating applied to the inner surface of the base film layer.

[0019] In still other embodiments, the visor system includes a protective film removably attached to the inner surface of the base film layer.

[0020] In yet other embodiments, the first removable film layer includes a tab configured to facilitate removal of the first removable film layer from the base film layer.

[0021] In other embodiments, the first removable film layer includes a transparent viewing portion and a colored tab portion.

[0022] In a further embodiment, the viser system includes a second removable film layer removably attached to the outer surface of the first removable film layer. Here, the first removable film layer and the second removable film layer are co-extruded. Further, the base film layer defines a first outer perimeter, the second removable film layer defines a third outer perimeter, and the third outer perimeter of the second removable film layer is completely encompassed by the first outer perimeter of the base film layer. Further, the outer surface of the first removable film layer may be sterile. Further, the second removable film layer may include polyester or polycarbonate. Further, the second removable film layer may include a tab, and the tab facilitates removal of the second removable film layer from the first removable film layer. Further, the first removable film layer may include a tab. Further, the tab of the first removable film layer may be visually different from the tab of the second removable film layer.

[0023] The present invention further relates to a multilayer viser system as described above, wherein the surgical hood and the multilayer viser system are sterile.

[0024] The present invention also relates to a surgical gown including an integrated surgical hood and a multilayer viser system as described above, wherein the surgical gown, the integrated surgical hood, and the multilayer viser system are configured to be sterile.

[0025] The present invention further relates to a personal protection system including a surgical gown and a separate surgical hood including a multilayer viser system as described above, wherein the personal protection system is sterilized by ethylene gas in one package.

[0026] The present invention further relates to a method for manufacturing a sterile protective surgical garment. The method includes providing a multilayer barrier system as described above configured such that the outer surface of the base film layer is sterile, providing a surgical hood including a nonwoven material and a hat such as a helmet, attaching the multilayer barrier system to the attachment area of the surgical hood, helmet, or hat to form a protective surgical garment, and exposing the protective surgical hood to EO gas to sterilize the protective surgical garment.

[0027] The above and other features, aspects, and advantages of the present invention will be better understood with reference to the following description and the appended claims. The accompanying drawings, which are incorporated herein and form a part of this specification, illustrate embodiments of the invention and, together with the description, serve to explain the principles of the invention.

Brief Description of the Drawings

[0028] A complete and enabling disclosure of the present invention, including the best mode, directed to one of ordinary skill in the art, is set forth in more detail in the remainder of the specification with reference to the accompanying drawings.

[0029]

Figure 1

Figure 2

Figure 3

Figure 4A

Figure 4B

Figure 4C

Figure 4D

Figure 4E

Figure 5

Figure 6

Figure 7

Figure 8

Mode for Carrying Out the Invention

[0030] Hereinafter, various embodiments of the present invention and one or more examples thereof will be described in detail. Each example is presented for the purpose of explaining the present invention and is not intended to limit the present invention. In fact, in the present invention, it will be apparent to those skilled in the art that various modifications and variations of the present invention are possible without departing from the scope and spirit of the present invention. For example, features exemplified or described as part of one embodiment can be used to create still another embodiment using another embodiment. Therefore, the present invention is intended to include such modifications and variations as long as they are included within the scope of the appended claims and their equivalents.

[0031] In this specification, when the terms "about", "substantially", or "broadly" are used to modify a value, it indicates that the value remains within the disclosed embodiment even if it varies by up to 5%. Further, when multiple ranges are provided, any combination of the minimum and maximum values described in the multiple ranges is contemplated by the present invention. For example, if the ranges "about 20% to about 80%" and "about 30% to about 70%" are described, the ranges "about 20% to about 70%" or "about 30% to about 80%" are also contemplated by the present invention.

[0032] Broadly speaking, the present invention relates to a visor system for a surgical hood that can be a component of a personal protection system. In some embodiments, the personal protection system may include a ventilation system. The present invention further relates to a method of manufacturing the visor system and a method of manufacturing a protective surgical garment incorporating the visor system and not requiring a prior sterilization step for the visor system. The visor system includes a base film layer and a first removable film layer removably attached to at least the outer surface of the base film layer. The base film layer and the first removable film layer are co-extruded. Specifically, in one embodiment, the first removable film is removably attached to the outer surface of the base film, and the second removable film is removably attached to the outer surface of the first removable film. Also, each of the base film layer, the first removable film layer, and the second removable film layer is configured to be a co-extruded film. The films are co-extruded simultaneously at a temperature high enough to ensure the sterility of each film layer. Sterility is a concept that conceptualizes the probability of the presence of pathogenic bacteria in a product. The safety assurance level of sterility (the "SAL"), or "Terminal kill", required by the Food and Drug Administration for medical devices is 10 -6 which means that there is a possibility that one microorganism is included at a rate of one in one million. In other words, Terminal kill generally means a 6 log reduction of bacteria. The co-extrusion temperature of the films is high enough to achieve "Terminal kill", so no separate sterilization step is required to sterilize each layer of the multi-layer visor system. The transparent film of the visor system of the present invention may be formed of polycarbonate or polyester, a material that does not permeate EO gas, but the high temperature during co-extrusion of the thermoplastic film material is a temperature sufficient to achieve sterility between the film layers. Also, the oxygen deficiency between each film layer can maintain the sterile state. Therefore, no prior sterilization step for the visor system is required before incorporating the visor system into a sterilized protective garment.

[0033] That is, by using the co-extrusion approach contemplated by the visor system of the present invention, a multi-layer visor system in which each layer is in a sterile state can be formed when forming the visor film. This is in stark contrast to the current film attachment method using adhesives. In currently available visor systems, unlike the visor system of the present invention, EO gas cannot penetrate between films bonded to each other by an adhesive. Also, EO gas cannot penetrate through transparent films made of polyester or polycarbonate. Therefore, prior to attaching the visor system to a surgical hood, an intermediate step of separately sterilizing the visor system using radiation sterilization (e.g., gamma ray sterilization) is often required. Subsequently, since the surgical hood is sterilized, for example, by EO gas, the sterilization process is very inefficient and time-consuming.

[0034] On the other hand, the co-extruded film layers contemplated by the present invention kill biological indicator (B1) microorganisms by a high-temperature co-extrusion process, enabling the provision of a sterile surface to the lower layer of each film layer. Thus, the multi-layer visor system, which is the result of the present invention, may be attached, after formation, to a surgical hood or a surgical gown to which a surgical hood is attached, by means such as adhesion. Then, the entire protective clothing can be sterilized in a single step by being exposed to EO gas. Therefore, there is no need to sterilize the individual components in multiple steps, which is required for currently available multi-layer visor systems. This is because the intermediate surface of the film layer of the visor system is sterilized during co-extrusion of the film by the high temperature of the co-extrusion process, and then the inner and outer surfaces of the visor system are sterilized by EO gas together with the other parts of the protective surgical clothing. As a result, when the contaminated outermost transparent film is peeled off from the visor system and discarded, a surgical hood and / or gown can be obtained in which all of the transparent films (e.g., a base film and one or more removable films) are sterile.

[0035] Furthermore, it should be understood that the visor system of the present invention contemplates the arrangement of one or more peeling tabs for removing each of the removable film layers on the outer periphery of the removable transparent film of the visor system so as not to interfere with medical providers such as surgeons. Further, the various transparent films are joined to each other with an adhesive strength sufficient to fix the transparent films to each other during use. At the same time, they are joined to each other with an adhesive strength that allows medical providers such as surgeons to easily peel off and remove the outermost soiled transparent film without peeling off other film layers or detaching the lower helmet to which the surgical hood and visor system are fixed.

[0036] A more detailed description of certain features of the visor system and the manufacturing method of the present invention can be better understood by referring to FIGS. 1 to 8.

[0037] Figure 1 shows a front view of a visor system 100 contemplated by the present invention. The visor system 100 includes a base film 110. The base film 110 has an upper portion 112, a lower portion 114, a first side portion 116, a second side portion 118, and a first outer periphery 124 that includes an outer-facing surface 111 (see FIG. 2) that faces away from the wearer's face when incorporated into a surgical hood and can be exposed to the external environment, and an inner-facing surface (not shown) that is the surface closest to the wearer's face when incorporated into the surgical hood. The base film 110 may include tabs 120 and 122 that extend from the first side portion 116 and the second side portion 118 of the visor system 100. By using the tabs 120 and 122, the visor system 100 may be fixed to a surgical hood 10 as shown in FIG. 6. The visor system 100 also includes at least one removable film, for example, a plurality of removable films, configured to be easily peeled off to expose a clean film layer disposed on the lower side. For example, as shown in FIG. 1, the visor system 100 may include at least a first removable film layer 140 having a second outer periphery 152 that is completely enclosed within the first outer periphery 124 of the base film layer 110. For example, as shown in FIGS. 1-2, the visor system 100 includes a first removable film layer 140 and a second removable film layer 160, and the second removable film layer 160 has a third outer periphery 172 that is completely enclosed within the first outer periphery 124 of the base film layer 110. The plurality of removable film layers, for example, the removable film layers 140 and 160, may each include tabs (for example, tabs 150 and 170), whereby when the outermost removable film layer 140 or 160 becomes dirty or the wearer's visibility is reduced due to factors such as substances such as blood and tissue that come into contact with those films, the wearer can peel off the outermost removable film layer 140 or 160.

[0038] As shown in FIGS. 1 to 2, in some embodiments, tabs 150 and 170 may be respectively disposed on opposite sides of the visor system 100. For example, tab 150 of the first removable film layer 140 may be disposed adjacent to the first side portion 116 of the base film layer 110, and tab 170 of the second removable film layer 160 may be disposed adjacent to the second side portion 118 of the base film layer 110. On the other hand, in other embodiments (not shown), both tabs 150 and 170 may be disposed on the same side of the visor system 100. Tabs 150 and 170 may be respectively disposed at the upper portions of the removable film layers 140 and 160, or on one or both of the side portions of the removable film layers 140 and 160, so that neither tab 150 nor 170 blocks the wearer's view through the visor system 100. FIG. 5 shows another embodiment of the visor system 100A having a combination of a first removable film layer 140A having a tab 150A on one side and a second removable film layer 160A having a tab 170A on the other side. As shown in FIG. 5, optionally, the second removable film layer 160A may include a cut portion 161A on the other side portion of the tab 170A and may be arranged to be aligned with the tab 150A of the first removable film layer 140A. Thereby, the tab 150A and the first removable film layer 140A can be exposed to easily distinguish the removable layer.

[0039] As shown in FIG. 1, the base film 110 may have a height H1 in the Y direction in the range of about 13 cm (5 inches) to about 38 cm (15 inches), for example, about 16.5 cm (6.5 inches) to about 33 cm (13 inches), for example, about 20 cm (8 inches) to about 28 cm (11 inches).

[0040] On the one hand, the first removable film layer 140, including the tab 150, may have a height H2 in the Y direction in the range of about 10 cm (4 inches) to about 33 cm (13 inches), for example, about 15 cm (6 inches) to about 28 cm (11 inches), for example, about 17.5 cm (7 inches) to about 25 cm (10 inches). When measured without including the tab 150, the first removable film layer 140 may have a height H3 in the Y direction extending from the upper end 142 to the lower end 144 in the range of about 7.5 cm (3 inches) to about 30.5 cm (12 inches), for example, about 10 cm (4 inches) to about 28 cm (11 inches), for example, about 13 cm (5 inches) to about 23 cm (9 inches).

[0041] The second removable film layer 160 may also have a height H3 in the Y direction in the range of about 7.5 cm (3 inches) to about 30.5 cm (12 inches), for example, about 10 cm (4 inches) to about 28 cm (11 inches), for example, about 13 cm (5 inches) to about 23 cm (9 inches), including the tab 170. That is, the height of the second removable film layer 160 including the tab 170 may be approximately the same as the height of the first removable film layer 140 excluding the tab 150. When measured without including the tab 170, the second removable film layer 160 may have a height H4 in the Y direction in the range of about 5 cm (2 inches) to about 28 cm (11 inches), for example, about 7.5 cm (3 inches) to about 25 cm (10 inches), for example, about 10 cm (4 inches) to about 20 cm (8 inches).

[0042] Furthermore, the base film layer 110 may have an overall width W1 in the X direction in the range of about 33 cm (13 inches) to about 58 cm (23 inches), for example, in the range of about 35.5 cm (14 inches) to about 56 cm (22 inches), for example, in the range of about 38 cm (15 inches) to about 51 cm (20 inches), including the tabs 120 and 122. Also, when not including the tabs 120 and 122, the base film layer 110 may have a width W2 in the X direction in the range of about 28 cm (11 inches) to about 51 cm (20 inches), for example, in the range of about 30.5 cm (12 inches) to about 48 cm (19 inches), for example, in the range of about 35.5 cm (14 inches) to about 43 cm (17 inches).

[0043] Furthermore, the first removable film layer 140 and the second removable film layer 160 may each have a width W3 in the X direction in the range of about 23 cm (9 inches) to about 46 cm (18 inches), for example, in the range of about 25 cm (10 inches) to about 43 cm (17 inches), for example, in the range of about 30.5 cm (12 inches) to about 38 cm (15 inches).

[0044] Furthermore, the tabs 150 and 170 may have a width W4 in the range of about 1.3 cm (0.5 inches) to about 9 cm (3.5 inches), for example, in the range of about 2.5 cm (1 inch) to about 7.6 cm (3 inches), for example, in the range of about 3.8 cm (1.5 inches) to about 6.5 cm (2.5 inches).

[0045] Furthermore, regardless of the respective dimensions of the film layers 110, 140, and 160, or the number of removable films provided in the visor system 100, the films may each be transparent, and each film may be formed from polycarbonate or polyester. In certain embodiments, the films 110, 140, and 160 may be polyester. For example, the film may be formed from a transparent polymer polyethylene terephthalate, commonly referred to as PET. Since PET is thermoplastic, it is configured to soften and melt at high temperatures.

[0046] The film according to the present invention can be manufactured in various ways. In a preferred manufacturing method, for example, co-extrusion by the flat film co-extrusion method is utilized. Further, both the individual coatings and all the coatings of the film according to the present invention may be formed by extrusion, particularly by the flat film co-extrusion method. As shown in FIG. 3, in the flat film co-extrusion of the visor film 200, a molten polymer, such as polyester, is cast through a die slot, such as a flat die, where a plurality of extruders and an exit opening converge, and the flat film shape is adopted. The co-extrusion process can supply polymers, such as polyester, at different ranges of cooling melt temperatures and viscosity / density ranges. The co-extruded films 202, 206, and 208 are bonded to each other by an ultrathin tie layer that provides adhesiveness to the adjacent surfaces (i.e., between the base film 202 and the first removable film 206, and between the first removable film 206 and the second removable film 208), while maintaining the ease of removal between the films 202, 206, and 208 of the final multilayer visor film 200.

[0047] As shown in FIG. 3, the visor film 200 may optionally include one or more protective films 212, which may form the outermost layer of the visor film 200. The protective film 212 may be formed from any suitable protective thermoplastic film material, such as a polyethylene film. When the protective film 212 is included, it is possible to protect, for example, from scratches by maintaining the sterility of the base film 202 and / or the second removable film 208 and protecting the integrity of the base film 202 and / or the second removable film 208. In other embodiments of the present invention, the protective film 212 may be added to either the outermost layer of the visor film 200 or the visor system 100 after the coextrusion of the base film 202, the first removable film 206, and the second removable film 208. For example, in an embodiment of the visor system 100 (not shown), after adding the adhesive gasket 126, which will be described in detail below, to the base film layer 110, the protective film 212 may be added on top of the second removable film layer 160.

[0048] In some aspects of the present invention, the melting temperature of the polyester material from which films 202, 206, and 208 are coextruded may range from about 280°C to about 288°C (about 535°F to about 550°F). Thus, when coextruded, the layers of molten polyester forming each of films 202, 206, and 208 are generally at a temperature above the melting temperature of about 280°C to about 288°C (about 535°F to about 550°F). The very high melting temperature of the polyester material coextruded to form films 202, 206, and 208 that form layers 110, 140, and 160, respectively, of the visor system 100 contributes to the sterility of the visor system 100 by ensuring the sterility between each of layers 110, 140, and 160.

[0049] On the one hand, the hospital's steam autoclave system achieves terminal kill at a temperature of approximately 134°C to approximately 137°C (274°F to 278°F), which is recommended for sterilizing surgical instruments. Aseptic means conceptualizing the probability of the presence of pathogenic bacteria in a product. The safety aseptic assurance level ("SAL"), that is, "Terminal kill", required by the Food and Drug Administration for medical devices is 10 -6 which means that there is a possibility that one microorganism is contained at a ratio of one in one million. In other words, terminal kill generally means a 6 log reduction of bacteria.

[0050] Therefore, by co-extruding the polyester at a melting temperature of approximately 280°C to approximately 288°C (535°F to 550°F), and co-extruding the films in a space between the films, for example, in the absence of air or oxygen, the recommended temperature range of terminal kill will be far exceeded. The inventors have found that co-extruding the polyester film can achieve sterilization of the outer surface of the base film 202 that forms the base film layer 110 of the visor system 100 and the outer surface of the first removable film 206 that forms the first removable film layer 140 of the visor system 100 without requiring a separate sterilization step for the layers of the visor system 100. In a clinical trial regarding the asepticity of the co-extruded film 200, 20 sample visors 100 formed from the co-extruded film 200 were tested for asepticity and microbial growth. As a result of the test, it was confirmed that no microorganisms had grown and all were aseptic in all 20 visors. In particular, according to the current standards regarding sterilization, the 20 sample sizes tested in 20 visors are considered acceptable to establish the asepticity of the product. Therefore, the visor 100 of the present invention meets the sterilization standards.

[0051] For example, as shown in FIG. 3, a visor film 200 including a base film 202, a first removable film 206, and a second removable film 208 may be co-extruded, and these films form a base film layer 110, a first removable film layer 140, and a second removable film layer 160, respectively, when forming a visor system. As shown in FIG. 3, the visor film 200 may further include a release layer 210 between the base film 202 and the first removable film 206, and between the first removable film 206 and the second removable film 208. The release layer 210 may be a separate film as shown in FIG. 3, or may be one or more additive compositions mixed and co-extruded with the base film 202, the first removable film 206, or the second removable film 208. The release layer 210 is configured to enable each of the removable films 206, 208 to be easily peeled from an adjacent layer of the film when forming the visor system 100. Each release layer 210 is configured to be removed together with the outer removable film layer. For example, when the second removable film layer 140 of the visor system 100 is peeled off, as shown in FIG. 3, both the second removable film 208 that forms the second removable film layer 140 of the visor system 100 and the release layer 210 directly adjacent to the second removable film 208 are peeled off together.

[0052] Furthermore, as shown in FIG. 3, the base film layer 110 formed from the base film 202 of the visor film 200 may have a film thickness T1 in the Z direction in the range of about 150 micrometers (6 mils) to about 350 micrometers (14 mils) (1 mil is 0.001 inch), for example, in the range of about 175 micrometers (7 mils) to about 325 micrometers (13 mils), for example, in the range of about 200 micrometers (8 mils) to about 300 micrometers (12 mils). In one embodiment, the thickness T1 of the base film layer may be about 250 micrometers (about 10 mils). The removable film layers 140 and 160 formed from the removable films 206 and 208 of the visor film 200 may have a film thickness T2 in the Z direction in the range of about 10 micrometers (0.4 mils) to about 125 micrometers (5 mils), for example, in the range of about 25 micrometers (1 mil) to about 100 micrometers (4 mils), for example, in the range of about 30 micrometers (1.2 mils) to about 70 micrometers (3 mils). In one embodiment, the removable film layers 140 and 160 may each have a thickness T2 of about 50 micrometers (about 2 mils). The release layer 210 of the visor film 200 may have a thickness T3 of the film 200 in the Z direction in the range of about 5 micrometers (0.2 mils) to about 25 micrometers (1 mil). Further, when the protective film 212 is provided, the protective film 212 may have a film thickness T4 in the Z direction in the range of about 19 micrometers (0.75 mils) to about 38 micrometers (about 1.5 mils). For example, the total thickness T5 of the multi-layer visor system 100 in the Z direction measured using a caliper may be in the range of about 250 micrometers (about 10 mils) to about 400 micrometers (about 16 mils).

[0053] When viewed through the visor system 100 having a base film layer 110 and a plurality of removable film layers, such as layers 140 and 160, the visor system 100 appears like a single plastic film. The inventors have found that the transparency of the visor system 100, i.e., the light transmittance, is inversely proportional to the number of film layers used to form the visor system 100. Thus, a visor system 100 having fewer layers may generally have a higher percentage of light transmittance than a visor system having more layers. The visor system 100 of the present invention has a target light transmittance of about 85% or more, such as about 88% or more, such as about 90% or more, in order to provide a sufficient field of view for a user such as a surgeon. Further, a high transparency is required for the visor system 100 of the present invention to provide a sufficient field of view for a user such as a surgeon. The visor system 100 has a target transparency of about 95% or more, such as about 96% or more, such as about 97% or more. The inventors have found that the desire of a user such as a surgeon for the removable release layer of the visor system 100 is of the same degree as the importance for a user such as a surgeon to ensure transparency and clarity of the visor system 100, such as a clear field of view during a medical procedure such as surgery. The visor system of the present invention may generally include several release film layers, such as 1 to about 4 release layers, while maintaining a light transmittance of at least about 88% and a transparency of at least about 96%.

[0054] Typical polyester films reflect about 8 - 11% of the back - incident light, which is a sufficient value to cause eye strain / fatigue. Therefore, the anti - reflective coating 204 may be, for example, water - based coated or co - extruded onto the inner surface of the base film 202 as shown in FIG. 3. The anti - reflective coating 204 is configured to reduce the glare of the visor system 100. Glare occurs when the luminance ratio between the task (what is being looked at) and the glare source (such as a light source) increases. In some embodiments, the anti - reflective coating 204 may be an anti - reflective and anti - fog coating for reducing both the glare and fogging of the visor system 100. For example, an anti - reflective and anti - fog coating applicable to the base film 202 is the AFAR anti - fog and anti - reflective agent provided by 3M (registered trademark). Since the AFAR technology has more than 80% light absorption, it significantly reduces glare.

[0055] After the formation of the visor film 200, for example, by co-extrusion as described above, the visor system 100 may be formed by cutting each of the individual layers 110, 140, and 160 from the visor film 200. As one such method, the visor layers 110, 140, and 160 are formed by die-cutting or kiss-cutting the visor film 200. For example, a first die-cut in the shape of the outer periphery (upper part) 112 of the base film layer 110 of the visor system 100 may cut through all the layers of the visor film 200. Next, a second die-cut in the shape of the second outer periphery 152 of the first removable film layer 140 may form the first removable film layer 140 by cutting through the second removable film 208 and the first removable film 206 together with the release layer 210. Next, a third die-cut in the shape of the third outer periphery 172 of the second removable film layer 160 may form the second removable film layer 160 by cutting through only the second removable film 208 and its adjacent release layer 210. Thus, each of the film layers 110, 140, and 160 of the visor system 100 may be die-cut from the visor film 200, each having a distinct shape and dimension as described above and shown in FIGS. 1-2. In another aspect of the present invention, the visor system 100 may be formed from the visor film 200, for example, by laser-cutting each of the layers 110, 140, and 160 into a desired shape, or by any other suitable method capable of cutting each of the layers 110, 140, and 160.

[0056] Referring to FIGS. 4A to 4E, the tabs 150 and 170 of the first removable film layer 140 and the second removable film layer 160 may be formed to have unique features such as different shapes, colors, textures, etc., so that the wearer can easily distinguish the tabs 150 and 170. Therefore, the wearer can more easily know which tab should be pulled first to remove the outermost, i.e., the second removable film layer 160, using the tab 170. For example, as also shown in FIGS. 1 to 2 and FIGS. 4A to 4B, the tab 150 shown in detail in FIG. 4A has a different shape from the tab 170 shown in detail in FIG. 4B. For example, the tab 150 may be triangular with an upper part 151a, a lower part 151b, and a side part 151c adjacent to the first removable film layer 140, as shown in FIGS. 1 and 2. The upper part 151a may be inclined between the upper end of the side part 151c and the other end of the lower part 151b, as shown in FIG. 4A. In contrast, the tab 170 may be quadrilateral with an upper part 171a, a lower part 171b adjacent to the second removable film layer 160, a first side part 171c, and a second side part 171d. The first and second side parts 171c and 171d may connect between the upper part 171a and the lower part 171b so that the tab 170 forms a substantially quadrilateral shape, for example, a rectangle or a trapezoid. Therefore, the different shapes of the tabs 150 and 170 can facilitate the user to distinguish the two tabs and determine which tab should be pulled first.

[0057] Furthermore, the second tab 170 may be formed to have a first color, and the first tab 150 may be formed to have a second color, but the second color is different from the first color. It is desirable that the second color is visually contrasting to the first color so that the two colors can be easily distinguished. The respective colors of the tabs 150 and 170 may be formed from two different colored tapes, which may be co-extruded with the visor film 200, for example, or attached to the removable film layers 140 and 160 after cutting the visor system 100 from the visor film 200.

[0058] Tabs 150 and / or 170 may be further formed to have different textures so that the wearer can distinguish the tabs based on touch. For example, tab 170 may include textured elements 176 as shown in FIG. 4C, while tab 150 may be smooth without textured elements. The textured elements 176 may be formed on the tab by any suitable means, such as co-extrusion, printing, imprinting, etc. during the formation of the visor film 200, or any other suitable means for obtaining a three-dimensional shape, molding, or textured surface. Generally, the outer surface of the tab includes the textured elements 176 so that the wearer can recognize the textured elements 176, but in some embodiments, both surfaces of the tab may include the textured elements 176. The textured elements 176 may be formed, for example, in a pattern of lines such as straight or curved lines, dashed lines, dots, and / or dash-dot lines, circles, spirals, check patterns, diagonal patterns, or any other pattern, and the textured elements 176 may be formed randomly rather than in a uniform pattern.

[0059] As shown in FIGS. 4D - 4E, one or more tabs, such as tab 170, may further include a crease 178 for forming a three-dimensional shape by folding or creasing the tab 170. FIG. 4E is a cross-sectional view of tab 170 of FIG. 4D taken along line E - E. The tab may include one or more creases 178. For example, by including a plurality of creases 178, a wrinkled or non-uniform texture may be formed. The crease 178 as shown in FIGS. 4D and 4E allows the wearer to more easily find and grasp the tab 170, for example, by folding the upper portion 171a of the tab 170 away from the visor system 100. The crease 178 may form an angle of about 20 degrees to about 100 degrees, such as about 30 degrees to about 90 degrees, such as about 45 degrees to about 60 degrees.

[0060] In FIGS. 1 and 2, an adhesive gasket 126 may be applied to the base film layer 110. The adhesive gasket 126 is configured to adhere the visor system 100 to the surgical hood, for example, as shown in FIG. 5. The adhesive gasket 126 is defined by an inner circumference 130 and an outer circumference 128, such that the inner circumference 130 surrounds the second outer circumference 152 of the first removable film layer 140 so that the removable film layers 140, 160 remain fully exposed when the visor system 100 is attached to the surgical hood 10. The adhesive gasket 126 may be formed from any suitable adhesive material. For example, a hot melt adhesive, such as a low temperature polyolefin hot melt adhesive or an adhesive, may be used. Other adhesives may include pressure sensitive adhesives or heat activated adhesives. After applying the adhesive gasket 126 to the base film layer 110 and before attaching the visor system 100 to the surgical hood 10, a protective film 212 may be placed on the visor system 100 in contact with the adhesive gasket 126 to protect the outer layer of the visor system, such as the second removable film layer 160 and the adhesive gasket 126, until the surgical hood 10 is ready for assembly.

[0061] As shown in FIG. 6, during the assembly or transfer of the visor system 100 to the surgical hood 10, the protective film 212 adjacent to the second removable film layer 160 may be removed to expose the adhesive gasket 126. The visor system 100 may then be inserted into the surgical hood 10, the inner portion of other medical helmets or medical garments. For example, the surgical hood 10 may be made of a non-woven barrier fabric, such as a polypropylene non-woven fabric 12. The surgical hood 10 may include a cutout region 20 configured to receive the visor system 100 surrounded by the attachment region 14. The adhesive gasket 126 is then applied to the attachment region 14 of the inner portion of the surgical hood 10 as shown in FIG. 6. After assembling the surgical hood 10, if the protective film 212 is provided inside the base film layer 110, remove it. At this time, the surgical hood 10 is ready for final packaging and sterilization. The entire protective surgical garment, for example, the surgical hood 10 including the visor system 100, can then be sterilized in a single step by exposure to ethylene oxide (EO) gas. The EO gas sterilizes by penetrating the non-woven fabric of the surgical hood 10 and the exposed surfaces of the visor system 100, while the inner layers of the visor system 100 remain sterilized by the high temperature during the co-extrusion of the visor film 200 forming the visor system 100. This provides a surgical hood and / or gown in which all transparent films (e.g., the base film and one or more removable films) are sterile in case one or more of the outermost transparent films become soiled, peeled off from the visor system, and discarded. As described above, due to the sterilization of the inner layers of the visor system 100 caused by the high temperature co-extrusion of the visor film 200, the visor system 100 does not require a prior sterilization step before assembling the surgical hood 10.

[0062] As shown in FIG. 7, the present invention further relates to a multilayer barrier system and a method of manufacturing a protective surgical garment incorporating the multilayer barrier system. In step 702, a barrier composite film including a base film and a first removable film is co-extruded. Optionally, a second removable film is also co-extruded in forming the barrier composite film. The base film, the first removable film, and the second removable film are formed from a thermoplastic polyester or polycarbonate material having a melting temperature in the range of about 280° C. to about 288° C. (about 535° F. to about 550° F.). The co-extrusion step 702 is carried out at a temperature higher than the melting temperature, i.e., about 280° C. (about 535° F.). Then, starting from step 704, a barrier system 100 is cut out from the barrier composite film. Specifically, in step 704, each layer of the barrier composite film is cut to the shape of the outer periphery of the base film layer. Next, in step 706, if the first removable film and the second removable film are provided, it is cut to the shape of the outer periphery of the first removable film layer. Optionally, the second outer periphery 152 of the first removable film layer 140 includes the shape of the first tab 150. Next, in step 708, the second removable film is cut to the shape of the outer periphery of the second removable film layer. As a result, a barrier system 100 having two removable film layers is obtained such that both the second outer periphery 152 of the first removable film layer 140 and the third outer periphery 172 of the second removable film layer 160 are respectively included within the first outer periphery 124 of the base film layer 110. Optionally, the third outer periphery 172 of the second removable film layer 160 includes the shape of the second tab 170. Further, the shape of the first tab 150 and the shape of the second tab 170 are different from each other or distinguishable so that a user can easily distinguish between the first tab 150 and the second tab 170.Furthermore, due to the high temperature when performing the co-extrusion step 702, the outer surface of the base film layer 110 adjacent to the first removable film layer 140 and the outer surface of the first removable film layer 140 adjacent to the second removable film layer 160 are sterilized during manufacturing without the need for additional or separate sterilization steps to sterilize the layers of the visor system 100. Depending on the aspects of this method, the cutting performed in steps 704, 706, and 708 may be performed by die cutting, such as kiss cutting, or laser cutting, or by other suitable means for cutting some of the film layers, if not all.

[0063] Next, in step 710, the first strip of the colored film may be aligned with the upper end 142 of the second outer periphery 152 of the first removable film layer adjacent to the first removable film layer 140. In step 712, the first strip of the colored film is cut along the upper end 142 of the second outer periphery 152 of the first removable film layer 140 to form the first colored tab 150. The first colored tab is configured to facilitate removal of the first removable film from the base film by the user. Next, in step 714, the second strip of the colored film may be aligned with the upper end 162 of the third outer periphery 172 of the second removable film layer 160 adjacent to the first removable film layer 140. In step 716, the second strip of the colored film is cut along the upper end 162 of the third outer periphery 172 of the second removable film layer 160 to form the second colored tab 170. The second colored tab 170 is configured to facilitate removal of the second removable film 160 from the visor system 100 by the user.

[0064] In step 718, the adhesive gasket 126 is applied to the outer surface of the base film layer 110 having an adhesive gasket inner circumference 130 surrounding the second outer circumference 152 of the first removable film layer 140, and to the adhesive gasket outer circumference 128 included in the first outer circumference 124 of the base film layer 110. In step 720, one or more protective films 212 are attached to the outer surface of the viser system 100 to protect the viser system 100 and the layers of the adhesive gasket 126.

[0065] As shown in FIG. 8, the present invention further relates to a method of manufacturing a sterile protective surgical hood including a viser system 100. In step 802, the viser system 100 described above and shown in FIGS. 1 and 2 is provided. For example, the viser system 100 may be manufactured according to the method 700 shown in FIG. 7. The outer surface of the base film layer 110 of the viser system 100 is sterile due to the high temperature when the base film layer 110 is co-extruded with the first removable film layer 140 and the second removable film layer 160. Therefore, no prior sterilization step of the viser system 100 is required. Next, a surgical hood including a non-woven material and a protective cap such as a helmet is provided in step 804. If the viser opening has not yet been provided, it is cut out from the surgical hood, helmet, or cap. In step 806, the multi-layer viser system 100 is attached to the attachment area 14 of the surgical hood, helmet, or cap to form a protective surgical gown. The adhesive gasket 126 of the multi-layer viser system 100 is used for attachment to the attachment area 14. Next, in step 808, the entire protective surgical gown is sterilized in a single package, for example, by exposure to EO gas. In other words, by using the viser system 100 made from the viser film 200 co-extruded as described above, a sterilized inner surface of each viser layer is provided, and the entire protective surgical gown can be sterilized in a single sterilization step without requiring a prior sterilization step for the viser system 100.

[0066] This specification discloses the content of the present invention including the best mode using examples, and enables those skilled in the art to practice the present invention (including the fabrication and use of any device or system, and the practice of any method incorporated in the described content). The patented technical scope of the present invention is defined by the claims in the claims section, and other embodiments conceivable by those skilled in the art may also be included therein. Such other embodiments shall be within the technical scope specified by those claims if they include components that are not different from the language of each claim, or if they include equivalent components that are not substantially different from the language of each claim.

Claims

1. A multilayer visor system for a personal protection system, comprising: a base film layer; a first removable film layer removably attached to the outer surface of the base film layer; a first protective film removably attached to the inner surface of the base film layer; a second protective film removably formed on the outermost removable film layer among one or more removable film layers; and the base film layer and the first removable film layer are formed of a first material which is a thermoplastic material, the first protective film and the second protective film are formed of a second material different from the first material.

2. The multilayer visor system according to claim 1, wherein the base film layer defines a first outer periphery, the first removable film layer defines a second outer periphery, and the second outer periphery of the first removable film layer is completely included in the first outer periphery of the base film layer.

3. The multilayer visor system according to claim 1, wherein the outer surface of the base film layer is configured to be sterile.

4. The multilayer visor system according to claim 1, wherein the base film layer comprises polyester or polycarbonate.

5. The multilayer visor system according to claim 1, wherein the first removable film layer comprises polyester or polycarbonate.

6. The multilayer visor system according to claim 1, further comprising an anti-reflection coating applied to the inner surface of the base film layer.

7. The multilayer visor system according to claim 1, wherein the first removable film layer includes a tab, and the tab facilitates removal of the first removable film layer from the base film layer.

8. The multilayer visor system according to claim 1, wherein the first removable film layer includes a transparent viewing portion and a colored tab portion.

9. The multilayer visor system according to claim 1, further comprising a second removable film layer removably attached to the outer surface of the first removable film layer.

10. The multilayer visor system according to claim 9, wherein the base film layer defines a first outer periphery, the second removable film layer defines a third outer periphery, and the third outer periphery of the second removable film layer is completely included in the first outer periphery of the base film layer.

11. The multilayer visor system according to claim 9, wherein the outer surface of the first removable film layer is sterilized.

12. The multilayer visor system according to claim 9, wherein the second removable film layer comprises polyester or polycarbonate.

13. The multilayer visor system according to claim 9, wherein the second removable film layer comprises a tab, and the tab facilitates removal of the second removable film layer from the first removable film layer.

14. The first removable film layer comprises a tab, The multilayer visor system according to claim 13, wherein the tab of the first removable film layer is visually different from the tab of the second removable film layer.

15. A surgical hood comprising the multilayer visor system according to claim 1, A surgical hood, wherein the surgical hood and the multilayer visor system are sterilized.

16. A surgical gown comprising an integral surgical hood and the multilayer visor system according to claim 1, A surgical gown, wherein the surgical gown, the integral surgical hood and the multilayer visor system are sterilized.

17. A personal protection system comprising a surgical gown equipped with the multilayer visor system of claim 1 and a separate surgical hood, A personal protection system, wherein the personal protection system is sterilized with ethylene gas in a single sterilization step.

Images